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PeacheyCarnehan

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  1. When I mentioned 'minions' I had in mind the people who work for drug companies and those who make decisions about drugs after taking drug company money. And also lobbyists. About taking medications: anyone who needs a pharmaceutical drug has no option but to use one that has been tested on non-humans. I would say avoid them if you can but don't be a martyr if you do need them. And hope they do work and won't poison you. As I said in my first post, if one is opposed to the oppression of humans one shouldn't use anything that has been made by humans. At one time, human oppression will likely have been part of it. I also said that all non-Indians should leave the American continent because the first white people who invaded the continent slaughtered and oppressed the indigenous peoples. And then later brought in black slaves. Those slaves had an important part in making much of North America prosperous. But I don't expect people to leave America. To live in this world we need to make compromises. I'm not against profit. I merely point out that where there is big money there will be big corruption. It's human nature. The article does support what I said. Both Leavitt and von Eschenbach said that 90% of new drugs fail in clinical testing, largely because the preclinical lab animal and lab studies couldn't accurately predict how the drugs would behave in humans. They say that modern methods must be used to decide what goes into clinical trials, because the current methods - including the use of non-humans - are not good enough and get it wrong very often. They want the use of new technology to better decide which drugs have a chance of succeeding in clinical trials. They think the new guidance on exploratory studies will help in this area. Janet Woodcock was saying that the burden of abiding by rules for manufacturing drugs for phase 1 studies can prevent research institutions from even putting them into clinical trials. Those drugs, that didn't go into clinical trials because the researchers couldn't provide proper manufacturing procedures, aren't counted amongst the 9 out of 10 that fail in clinical trials. David Graham, of the FDA Office of Drug Safety, doesn't think the rules are skewed towards safety. I said they place great reliance on lab animal data. I wasn't talking about drugs that fail in the preclinical stages. I was talking about drugs that go to clinical trials. I said the reliance on that lab animal data is misplaced. It leads to very few drugs getting through the clinical trials. I was replying to a statement that said the drug companies don't need to find a reason. My reply showed why they do need to find reasons. I thought you were joking when you earlier said something similar. Lions can't do things differently. They evolved to kill zebras and other animals. We didn't evolve to torture other species. We choose to do it. For our own ends. We can decide not to do it. I don't eat eggs or dairy products. It is merely opinion that murder is wrong. Lions kill for their personal gain. They don't think it's wrong. We do think it's wrong because we can think it's wrong. The ancient Romans didn't always think it was wrong. It was sometimes entertainment for them. Eh? Are you a wind-up merchant? I am a vegan. Plants don't suffer. There are people here who don't think rats suffer by losing their lives or being imprisoned and experimented upon. No, I haven't tried. I don't need to. I wouldn't take up an offer by the Mafia to see how law abiding their daily lives are and what nice people they are, either. No sensible person would believe anything they showed to prove those things. The pulling of drugs is not a true indication of corruption. It is sometimes corruption that helps them to be approved and to stay on the market. If there was no corruption, more would fail to be approved and more would be recalled or relabelled. I have no evidence of IACUC corruption but I have shown evidence of negligence and incompetence. There is lots of evidence for the corruption and conflicts of interest in other parts of the drug/medical research world. From the United States Department of Agriculture's 2005 Audit Report on Animal Care Programme Inspection and Enforcement Activities: ====== OIG’s (Office of the Inspector General) previous audit28 of APHIS’(Animal and Plant Health Inspection Service) enforcement of the AWA (Animal Welfare Act) found that the activities of the IACUCs did not always meet the standards of the AWA. Some IACUCs did not ensure that unnecessary or repetitive experiments would not be performed on laboratory animals. In addition, the audit found numerous problems with protocols and reporting. To assist the IACUCs in accomplishing their responsibilities, APHIS and the National Institutes of Health issued detailed laboratory guidelines on animal care. Nonetheless, we noted some IACUCs are still having problems in such areas as adequately monitoring researchers for compliance with their protocols (e.g., the search for alternatives, review of painful procedures, and unnecessary duplication of research) and following up on the correction of deficiencies. During FYs (Financial Years) 2002 through 2004, the number of research facilities cited for violations of the AWA has steadily increased. In FY 2002, 463 of the 1,030 facilities were in violation. In FY 2004, that number increased to 600 of 1,176 facilities. IACUC Monitoring of Research Facilities In FY 2000, APHIS conducted a survey of 40 VMOs (Veterinary Medical Officers) and their 9 supervisors to assess their opinions on the effectiveness of the IACUCs. In general, VMOs concurred that IACUCs need to improve the search for alternatives, the review of painful procedures, and monitoring the researchers’ use of animals to ensure compliance with approved protocols and standard operating procedures. The survey concluded that “IACUCs seem to be doing well at functions related to setting up the administrative structure and developing the process but not as well at monitoring and follow through.” In FY 2004, we re-surveyed 30 VMOs and their supervisors to determine if the IACUCs improved their performance. Although most VMOs believed that the IACUCs improved in certain areas, VMOs still found a total of 6,801 violations at these facilities from FYs 2002-2004. The VMOs believe there are still problems with the search for alternatives, veterinary care, review of painful procedures, and the researchers’ use of animals. Using AC’s (Animal Care unit) database, we compiled and analyzed the data for all inspections conducted at research facilities from FYs 2002-2004. Table 2 shows the most frequent violations cited by the VMOs. IN THEIR TABLE FOR THE MOST FREQUENT VIOLATIONS AT RESEARCH FACILITIES FOR FINANCIAL YEARS 2002-2004, THEY SHOW THE FOLLOWING INFORMATION: 29% of facilities were in violation of a Search for Alternatives to painful procedures. 26% were in violation for not reporting by IACUCs of evaluations of animal facilities to the institutional official. 18% were in violation for not maintaining adequate veterinary care that includes appropriate methods and availability. 17% were in violation for not having protocols containing a complete description of the proposed use of animals. 9% were in violation for not meeting standards of care regarding housekeeping for rabbits. We reviewed AC files for 58 research facilities; some of the violations we noted were: • An IACUC in California approved a protocol for the production of antibodies using approximately 80 rabbits. Instead, 1,024 rabbits were used under this protocol. IES (Investigative and Enforcement Services) is currently investigating this case. • Another research facility in California failed to give a post-surgical nonhuman primate analgesic to relieve unnecessary discomfort and pain after a craniotomy in which four burr holes were made into the cranium. It also failed to provide post-surgery veterinary care. At the same facility, a post-surgical lamb was observed to have difficulty breathing and was frothing from the mouth. The lamb was not monitored until an AC inspection identified it to be in distress. A second post-surgical lamb was found dead. This facility was referred to OGC (Office of the General Counsel) for legal action. • A research facility in Illinois failed to provide adequate veterinary care, which resulted in the death of a primate and a pig. The IACUC also failed to approve protocols or to review significant changes to protocols. The fine was $9,400. • At a research facility in Indiana, AC inspectors found proof that a summer intern was improperly trained to perform operations on animals. Evidence indicated that the trainer left the area during another intern’s first surgery. The fine was $4,000. According to our analysis, 33 of the top 50 (66 percent) research facility violators in the nation were educational institutions suggesting that IACUCs at universities are less effective (see exhibit C). The VMOs explained that universities usually have more protocols, the protocols are more varied, and students are less experienced in good laboratory practices. Even though the top 50 facilities were cited for numerous violations over a 3-year period, records indicate that only nine were referred to IES for investigation. In FY 2003, AC received a petition from the Association of Veterinarians for Animal Rights, which cited frequent violations concerning the search for alternatives. AC responded to the petition by conducting inspections at all veterinary schools in the nation. The inspections focused on teaching protocols and cited numerous violations in the search for alternatives, unnecessary duplication of research, and justification for the number of animals used. We also learned that in a very few cases, the facilities were resistant to change, showing a general disregard for APHIS regulations. VMOs informed us that some institutional officials were not supportive of IACUC activities and APHIS regulations, resulting in significant issues with animal care at the facilities. In one example, the research facility ignored the VMO’s reports of violations and did not take corrective action for several years. In cases of negligence of fiduciary duty, APHIS should seek an OGC opinion to determine if institutional officials can be held personally liable. Inaccuracies in Annual Reports We also found that the majority of research facilities we reviewed misreported the numbers of animals used in research. Some facilities did not follow APHIS guidelines for completing their annual reports, while other facilities are not using the numbers of animals supported by their records. As a result, APHIS is misinformed about the true number of animals used annually in research facilities throughout the nation (as noted in finding 3). Regulations state, “The annual report shall state the common names and the numbers of animals upon which teaching, research, experiments or tests were conducted…” AC Policy as well as the instructions attached to the template annual report state that animals used in multi-year studies will be counted once each year. We visited 16 registered research facilities that were cited for violations in the past 3 years. After comparing the most current annual report submitted by each facility to the supporting documents on hand, we found that 13 of the 16 research facilities misreported the numbers of animals used in their research. Of these facilities, nine had underreported, three had overreported, and we could not determine the actual number of animals used in the remaining facility. Some facilities agreed to resubmit an amended annual report. Although research facilities must be registered, APHIS has no authority to revoke the registration of a noncompliant research facility. Even administrative law judges may find it difficult to terminate or refuse to renew registrations in cases where serious or repeat violations occur because USDA does not have the authority to interrupt the conduct of research. We concluded that IACUCs need to improve their monitoring of researchers for compliance with the protocols (e.g., the search for alternatives, review of painful procedures, unnecessary duplication of research), in following up on the correction of deficiencies, veterinary care, and in reporting accurate annual reports to APHIS. This is imperative because although AC can temporarily revoke licenses for breeders and exhibitors, this is not the case with research facilities. The AWA does not authorize “the Secretary, during inspection, to interrupt the conduct of actual research or experimentation…” Therefore, it is more critical for AC to take enforcement actions against research facilities that violate the AWA (refer to finding 1). ======= So much for IACUCs. APHIS and the NIH had to issue IACUCs with guidelines. This means that some of them didn't know how to do the job they were supposed to do. They had to be held by the hand and shown what to do - after they hadn't been doing what they were supposed to do. And even after that some were still not doing their job. How many times do they need to be told or shown what to do and how to do it? In 2002, 40% of research facilites were in violation of AWA rules. That increased to 50% in 2004. Of the worst 50 violators amongst research facilities only 9 were referred to the IES. Not an indication that much is done to bring perpetrators to book. And then they only get fined a few thousand dollars. That's only an 18% chance of being punished. Bank robbers would jump at that chance - especially if the punishment was a slap on the wrist. There seems to be even little chance of a research facility, guilty of serious and repeat violations, losing its registered status or of being refused renewal of registered status. Your reply is to something different. Originally, there was a comment somewhere that said: 'In my mind, cruelty is putting a cat into a microwave. Cruelty comes in many forms, but the responsible tests done in the name of science does not fit those criteria.' I replied to that on page 20, post 393 with: 'In my mind, using any animal that can feel pain or fear in ways that will cause it pain or fear or that will cut short its life, is cruel. As has been said before, at one time it was not thought cruel to kidnap humans, take them across the sea, and make them work as slaves.' There was a reply to the part about slaves: 'Yes, however this was due to the appalling conditions (of both transport and treatment after sale), and the use of sentient, self-aware, and self-determining beings as unpaid, "owned" labourers.' AND: 'The second objection is not applicable to animals. The first is not manifest in the vast majority of animal test organisations, due to the incredibly strict regulatory practices which have already been described at length in this thread.' I wanted to reply to the bit about 'strict regulatory practices' so I quoted part of it: '...due to the incredibly strict regulatory practices which have already been described at length in this thread.' And replied to that quote with: 'I have already shown that these regulatory practices are open to abuse. Well, I haven't shown evidence for that yet but I can. I was waiting until someone challenged me. I have all the evidence just waiting. If some system can be abused and there is money to be made by doing so, it will be abused. Drug companies and some medical researchers have already shown their disregard for human life. The welfare of rats and monkeys will be of even less concern to them, especially when measured againt profits or the thoughts of prestige for making some discovery or authoring some highly-praised study.' Sayonara quoted part of my reply, the bit beginning with: 'If some system can be abused and there is money to be made by doing so....' And said: 'I don't particularly disagree that any of this can or does happen, but unfortunately for you it is not an argument against the conventionally regulated system of animal testing which is in place.' I replied to that with: 'We can't have any faith in the system. When someone involved says that something is necessary we can't know if they believe that, mean that, or just want to protect their interests.' Your reply of 'This is science. We can independently check it.' is not relevant. I was talking about the lack of trust that can be placed in anyone involved in this business who says that there are safeguards and that the lab animals don't suffer. I said that they might or might not even believe what they say. They could say it because it protects their interests. Or because it will trick a gullible public into believing that the cruel experiments they perform aren't cruel. But there is lots of evidence that the strict regulatory practices are not being strictly practised. It is cruel to subject anyone to torture. Whether it is expedient is beside the point. Moral standards concerning pain and suffering apply to all those who can suffer or feel pain. By 'torture' I mean here causing pain or fear for any purpose that doesn't benefit the one on the receiving end. I don't believe it is right to subject anyone to pain for the good of others. And I have not suggested we let prisoners out of prison. They are locked up because they are a danger. The animals in labs are locked up for purposes that don't benefit them, not because they are a danger. The two cases are completely different. I have not proposed that drug companies should go out of business or regulators be abolished. I am calling for proper policing of those areas. I pointed to wrongdoing to show that there is the real possibility that any of them could be corrupt. No, we don't shut down all nursing homes because of the wrongdoings of some people. We put in place better methods of catching them early. Merck's wrongdoing is just one small part of the corruption and conflicts of interest that are widespread in the drug and research world. Another recent case of withheld data was that of Bayer's drug trasylol. Here's part of an article about Bayer's withholding of information about the drug during an FDA committee meeting. They later admitted that they had extra data but only when a whistleblower threatened to expose them. There will be other cases that haven't come to light where drug companies have withheld data from regulatory bodies. ============ On September 21, the FDA held a meeting of their Cardiovascular and Renal Drugs Advisory Committee specifically to discuss the safety of aprotinin injection, which is sold by Bayer under the trade name Trasylol. (Trasylol is used to reduce blood loss, prevent low blood pressure, and limit the need for transfusions in patients undergoing major heart surgery.) The main question at hand at the meeting: Is Trasylol usage associated with elevated risk of renal failure, myocardial infarction, heart failure, or stroke? Present at that meeting were two Bayer executives: Michael Rozycki, Ph.D., director of U.S. regulatory affairs, and Pamela Cyrus, M.D., vice president of U.S. medical affairs. Joined by two outside professors, the Bayer group made a presentation to the committee that included an overview of the subject, a risk-benefit assessment, a review of clinical data, and a discussion of the methodology of two independent studies published in 2006–one in Transfusion and one in the New England Journal of Medicine–that called into question the safety of Trasylol. They were also asked to provide their own “recent safety and efficacy data” to the committee. According to the FDA's official minutes of the meeting, committee members were then asked to vote on the following: “Based upon the presentations today, do you regard the totality of clinical data as supporting acceptable safety and efficacy for Trasylol usage among certain patients?” Eighteen members voted yes, one abstained. There was some talk of changing the label warning language–from “increased risk” to “high risk”–but no changes were approved. All things considered, there was nothing out of the ordinary to be found here. But on September 29, about a week after that meeting took place, the FDA made a rather unusual statement regarding Trasylol and its safety: “Since January, 2006, the Food and Drug Administration (FDA) has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack, and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database. “On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.” While the FDA was “not aware of these new data” at the time of its meeting, Bayer's Global Drug Safety Group certainly was–and yet the company failed to share these new findings with committee members at the September 21 meeting. So far, Bayer has not been punished in any way for what they officially called an “error.” Yet, the question remains: Was Bayer engaged in any criminal wrongdoing and should they be subject to criminal charges? “The FDA ought to be investigating whether there was a willful attempt to withhold relevant information at this hearing,” says Steven Findlay, a health care analyst at Consumers Union and managing editor of Consumer Reports Best Buy Drugs. Findlay is the “consumer representative” of the Cardiovascular and Renal Drugs Advisory Committee and a voting member who was present at the meeting. If Bayer representatives at the meeting “knew of the existence of the study and consciously, with conspiracy, withheld the results,” Findlay says, they may be vulnerable to criminal proceedings by the Justice Department. Another voting committee member present at the meeting, John R. Teerlink, M.D., associate professor of medicine at the University of California, San Francisco, claims that Bayer did not provide sufficient and accurate data on which to base his decisions. “I believe that there should be consequences for Bayer in withholding this information,” Teerlink says. “If possible, the punishment should be severe enough to provide a deterrent for future such actions.” It is quite possible that the FDA would not have known of the existence of Bayer's most recent data had it not been for a whistleblower who forced Bayer to disclose the information following the September 21 meeting. Apparently, that whistleblower was Alexander Walker, a professor at Harvard and a researcher at Ingenix, the research group that was contracted to do the study and analyze the data. Bayer subsequently notified the FDA of its internal study on September 27. In that internal study, the contractor examined 67,000 hospital patient records and found an elevated risk of death, serious kidney damage, congestive heart failure, and stroke in Trasylol patients. According to the company, the results were originally withheld because they considered the data preliminary and questioned the validity of the methodology. But at the September 21 meeting, they failed to even acknowledge the study's existence. http://www.newsinferno.com/archives/1284 ===================== I don't recall what my original full statement was about nor what it was in reply to, and I'm not going to look back to see what it was. I will reply to your above post. Loopholes can usually be found. And if they can't be found, the rules can be ignored, especially when many millions are involved. Very often it is only whistleblowers who alert us to the rule breaking. The FDA wanted to (and perhaps still does want to) allow drug companies to use journals for promoting drugs for unapproved uses, as shown in the letter below. Letter to Andrew von Eschenbach, Commissioner of the FDA From Henry Waxman, Chairman of the US Committee on Oversight and Government Reform November 30, 2007 ======== Dear Dr. von Eschenbach: I have obtained a copy of an October 2007 internal draft of new FDA guidance that would allow drug companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval. It is my understanding that the FDA intends to issue this guidance without significant changes in the very near future. I urge you to refrain from going forward with this ill-advised guidance. A fundamental tenet of our drug and device laws is that a manufacturer cannot market a drug or device for a therapeutic use without FDA approval. The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products without first obtaining FDA approval by passing out journal articles about the off-label use to physicians. Published reports of company funded studies can be biased in favor of the company’s product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products. The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns. This undercuts the prohibition on marketing of unapproved uses of drugs and devices and puts the public at risk for ineffective and dangerous uses of drugs. The draft guidance poses multiple risks. First, it appears to be based on the premise that peer-reviewed reports provide accurate, validated information and that even if individual articles are biased, the published literature as a whole can provide balance. Regrettably, recent experience shows that this is not always the case. There have been a number of high-profile instances in recent years where journal articles provided a distorted picture of a drug’s safety or effectiveness. This has been in particular a problem in the case of journal articles based on studies funded by drug companies.4 The danger to patient health should be readily apparent from the examples of journal article abuses described in the addendum, including anti-depressants, Vioxx, Celebrex, antiarrhythmics, Neurontin, and other False Claims Act settlements. Drug and device companies can manipulate and selectively distribute studies in order to make their products appear safer and more effective than they truly are. Where the unapproved uses are actually ineffective, patients have been denied other, more effective treatments and have been unnecessarily exposed to the ineffective products’ known side effects. Even worse, patients have suffered serious harm due to unanticipated and serious side effects of unapproved uses. online.wsj.com/public/resources/documents/waxmanletter_113007.pdf Read the whole letter. Very interesting. ====================== Can we really be sure that no data is ever withheld from regulatory bodies? Can we be sure that regulatory bodies always have the best interests of the public in mind? David Graham of the FDA said that drug firms try to get their drugs approved for anything if they can't get it approved for the condition they really want it to be used for. Once it's approved, their salesforces can then whisper into the ears of physicians about how it can be used for other things. There have been cases where physicians prescribed some drug for some patients with some ailments for which the drug was not proven safe or where there was a definite possibility of danger - despite the label mentioning these concerns. A database of clinical trials is no more likely to influence prescribing patterns than are those drug labels if journal articles and drug company representatives can put ideas into physicians' heads. If elements in the FDA had their way, the drug companies could make all sorts of claims in medical journals about the efficacy of their drugs without having to go through the usual approval process. David Graham, of the Office of Drug Safety, says that the FDA's Office of New Drugs likes to accomodate the drug companies in getting drugs approved for some condition or other if at all possible, perhaps for some condition that only affects a small number of people. The drug companies can then persuade physicians to use it for other things. And I would add: as long as they are not definitely obvious killers. Various members of the US Congress have repeatedly written to the FDA with concerns about their attitude to drug safety. Anyone who makes a study of the drug world will come to the realisation that the FDA has influential members who are more interested in pleasing the drug companies than in ensuring drug safety. There are many people in the FDA who try to do a good job but they are not powerful enough to change the organisation from within. Congress recently subpoenaed documents from the FDA. The Health and Human Services Secretary refused to hand them over, saying that the FDA was conducting an internal investigation and they didn't want to jeopardise that by handing over documents! They refused to comply with a subpoena. If some workers in an iron foundary were killed in an accident and the police went in to investigate if there had been a case of criminal negligence, the company wouldn't be able to tell them to go away. I can imagine what the chairman would say to the police: 'No, no, we won't co-operate with you. Our security staff are carrying out an investigation. They are all good people, all ex-coppers. The head is actually your esteemed ex-colleague, Bazza Blenkinsop of the Yard. So go away and let us get on with our investigation.' I believe that some access to the documents has more recently been granted after the HHS Secretary, Leavitt, was threatened with contempt of Congress. Many times, the FDA has been advised by its own scientists to put certain warnings on drug labels but the FDA has not done so. Some of these scientists are then demoted or moved to another job. One such case was that of Rosemary Johann-Liang, the Deputy Director of the FDA's Division of Drug Risk Evaluation. According to insiders, she was demoted after she approved recommendations for black box warnings for the drug avandia. And another of their scientists, Andrew Mosholder, was muzzled when he found the possibility of antidepressant danger in children and wanted to make his findings public. It was mentioned in US journals. And, rules have been ignored before. The rules in universties could be ignored. For example, a certain university person has exceeded the $10,000 a year amount for income from drug companies. On two or three occasions when the university reminded him that he was receiving more than he should he told them that he would keep to the agreed maximum amounts. Then proceeded to take more money. SenateLetter081003.pdf . This will only apply to the member journals of the ICMJE. There are about 11 or 12 members. And even then, there have been cases throughout history where people have signed documents without any intention of honouring the spirit of the document. But, on the whole, this is a good move - to require the authors to confirm they have had full access to the data. I was asked for evidence for what I said. And it is partly in support of my argument that the evidence for the rightness or wrongness of cruel experiments is filtered through the potential for corruption. You said above that something is a separate issue from whether or not cruel experiments on lab animals are right or wrong. So is the question of human safeguards. I have shown that IACUCs can be and have been negligent and incompetent. And that those that deal with commercial research can be even worse. I said, and demonstrated, that the safeguards for the lab animals are inadequate and often ignored. You had said: PC, you are slipping between 3 different claims: 1. Animal studies themselves are immmoral 2. There are NO safeguards for animals. 3. There are abused of the existing safeguards on animals. AND: You are trying to use examples of #3 to argue for #1. But that doesn't work. Let's take this out of animal testing. As you noted, there are occasional abuses of children in orphanages and the elderly in nursing homes. In both cases there are safeguards in place. However, even tho there is the occasional abuse it does not follow that it is immoral to have children in orphanages or the elderly in nursing homes! So I replied: 1. I do say that cruel experiments are immoral. 2. There are no effective safeguards. The safeguards in place can be and have been ignored. 3. There are abuses of the rules. AND: It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims. See above. You quoted my reply to your statement: 'But animal models do simulate reliably. All the drugs and treatments on the market, and all the drugs and treatements witheld from clinical trials attest to that. Clinical trials are done because we insist on double-checking the results from animals.' My full reply to that was: 'But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans.' I have not said, nor do I believe, that all the drugs that were harmful in other species would be safe in humans. I have said that we can't know what they would do in humans. I am saying that by using other species you can't know beforehand what a new drug will do in humans. And I have not said that all of the 9 in 10 new drugs that fail in clinical trials fail for reasons of safety. It can't be known what the drugs that haven't been tested in humans will do to humans. You are referring to something that wasn't said. I have never said that drugs should be tested on humans without previous testing on other things. You believe that other species should be these other things. I don't. I think you believe that when I said: 'If it is similar to other existing drugs, why does it need testing?' I was advocating that similar drugs don't need testing and can be given to humans. That is not what I meant. I said that it is not known what a new drug will do. If it is a new drug - even a drug very similar to an existing one - it will need testing. It is not an identical drug. It would only be identical if it was the same drug. I went on to say that it needs testing - no matter how similar - because it is a new drug and it is not known what it will do. Your above statement was in reply to my statement that I hadn't said a new drug should be first tested in humans. You even quote me as saying the first trial in humans should be a mini-micro dose. That is after extensive in silico, in vitro and other testing. When everything else has been done, the drug can then be given to patients or volunteers at a dose that is all but non-existent. And gradually increased. Even if it takes a year or more to get to a pharmacological dose or a therapeutic dose. At present, humans test a drug that has had its starting dose devised by previous investigations. Mainly in other species. It is not known how a new drug will affect those first humans. That is why many drugs are pulled at that stage for safety reasons. Those first humans could be putting their lives or health in danger until it is known for sure what the new drug will do. It can only be known for sure what it will do in humans after it has been used in humans. I didn't advocate exhaustive safety testing in humans. I'm not going to check if I first said 'no money' or 'not enough money'. I think I said that not enough is used. It doesn't matter, though. I have been aware for many years of the search for other methods. And I have known for years that that search needs money and that money is being spent. Not enough money is being spent. I know there is a finite budget because that's what priorities have dictated. I have been saying for years that more needs to be spent. It all depends on what is considered most important. I don't want to get into a discussion on economics and politics. I say that not enough money is being spent. And I am saying that killing is killing. I can do that. But I was saying why the term 'animal testing' is not the correct term. It should be 'vivisection' because that gives a better sense of what is going on. 'Testing', as I said, could be something pleasant and desirable. 'Vivisection' cannot be seen as pleasant or desirable. It conveys a better idea of the abuse that occurs. By 'abuse' I mean here using anyone in ways that can damage them or deprive them of their natural lives for purposes that don't benefit them (quite apart from any pain or terror that might be caused). Just as experimenting on a brain damaged human would be abuse - even if that person didn't know what was going on and didn't feel any pain. That is what I was referring to. Whatever you call it, it is wrong. Unless those animals volunteer. As I explained above, I was originally referring to the placebo effect of drugs that are on the market. They are not being measured against a placebo. I was referring to drugs already on the market. It was in reply to someone's reference to the wonders of drugs on the market. I said that those wonderful effects could be due to the placebo effect of those drugs. I was referring to drugs already on the market. It was in reply to someone's reference to the wonders of drugs on the market. I said that those wonderful effects could be due to the placebo effect of those drugs. If you give someone a drug - after all the clinical trials have been done and the drug has been on the market for some time - and tell them that it is a wonder drug, they will believe you. The drug will then have a placebo effect on them. I don't presume that drugs that fail in preclinical testing will pass in human testing. Some might. Some might not. I have never said, nor assumed, that all the failures in clinical trials are due to the failure of testing in other species. As I had no such assumption, presumption or consumption, my statement about commercial reasons cannot destroy such a non-assumption. I know how much corruptiont there is. And I know human nature. I do believe there will be corruption in IACUCs. I have no proof. Yet. I have shown proof of their incompetence/negligence. You quoted part of what I said and then replied to it without taking into consideration the full, original statement. I first mentioned a paucity of results in answer to your statement of: 'But of course the AR people are all saints, with no agenda and they would never distort the truth for their cause, would they?' My reply to that was: 'There's no need for distortion. The paucity of reliable, accurate results in humans that come out of non-human tests speak loud and clear to anyone who will listen and who hasn't been deafened by the vile din of the vivisection propaganda.' --------- Now, the part about 'paucity' referred to the fact that very few drugs succeed in clinical trials despite the many that go into clinical trials. There is a paucity. A paucity of 10%. ---------- You quoted me: 'The paucity of reliable, accurate results in humans that come out of non-human tests speak loud and clear to anyone who will listen and who hasn't been deafened by the vile din of the vivisection propaganda.' And then you replied: 'All you have to do is a superficial PubMed search on ANY disease and drug to refute that "paucity of reliable, accurate results" claim. ALL the currently used treatments, and the ones that never made it to humans, went thru animal testing. All you have to do is go LOOK at the evidenced....' To which I replied: 'I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans.' When I said more drugs would succeed if there wasn't a paucity, I meant that if more drugs succeeded more drugs would succeed. Your above reply is to my statement about the unknown effects of drugs that have never been tested on humans. I was simply pointing out that it is not known how drugs that fail in the preclinical stages would have performed if given to humans. I care about the safety of all animals, including humans. I want the best medical care for humans. They are not getting it. David Graham of the FDA doesn't think it means very very safe. The 'proper' medical research is failing humans. Were teratogenic studies done before the thalidomide tradegy? I don't suggest using the current microdose dosage for microdosing. 1/100 of the therapeutic dose is too high. I suggest using a-sixteenth of a thimbleful in 1 million gallons to start with. Or some such figure.
  2. The statements below are from FDA documents or communications written in 2006 that are talking about improving the drug development process: 'Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.' http://www.fda.gov/bbs/topics/news/2006/NEW01296.html 'Consider just one stark statistic: Today, nine out of 10 compounds developed in the lab fail in human studies. They fail, in large part because they behave differently in people than they did in animal or laboratory tests. 'The initiative we are here to discuss is one of many we at FDA are implementing that will remove some of the hurdles from the earliest phases of drug testing and medical development in people, so that researchers can more rapidly establish whether or not a new compound truly has a real clinical benefit for people. This is about saving lives — and building medicine’s future.' Andrew C. von Eschenbach, M.D. Acting Commissioner of Food and Drugs http://www.fda.gov/oc/speeches/2006/fdateleconference0112.html The system doesn't work, unless you mean that getting a minority of drugs through clinical trials so they are approved, is proof that it is working. That is after all the drugs had lab animal data that the drug companies thought was predictive of the drugs' ability to get through the clinical trials. Remember, the clinical trials are the most costly part of the drug development process. Do you think a drug company is going to risk all those millions on putting a drug through the trials unless they are very certain it will succeed or succeed long enough for them to make a profit? The lab animal data, they think, tells them the drugs have a good chance of doing so. It's not the only data, as there are many other methods, but as people here have said, if in silico indicates a drug is safe but rats indicate it's not, then it's goodbye drug. The lab animal data, being in living organisms, is what they place so much reliance upon - it must be if it overrides the results of in silico or any other pre-clinical testing. And that reliance is misplaced. Most new drugs fail in the clinical testing on humans. Also, the drug companies and their minions do need to find a reason. That is why they have bribed physicians to prescribe their drugs and why they have enough salesmen and women to form an army that would be big enough to invade a small country. It is the reason why they have a large number of lobbyists to pester every politician and spend millions doing it. It is also the reason they place false or misleading advertising about their drugs to make them look better than they are - sometimes in ways that could lead to danger. It is also the reason so many people in the FDA, NIH, IRBs and XYZs have received money from them - even those whose job it is to decide on which drugs to approve. It is probably also the reason they give top jobs to top officials who leave jobs in places like the FDA and NIH or government posts. From the Los Angeles Times. 22nd December, 2004: 'And when congressional critics surface, the industry has a way of winning them over: This year's top two recruits had recently launched a congressional investigation of conflicts of interest at the NIH. 'Rep. W.J. "Billy" Tauzin (R-La.), as chairman of the House Energy and Commerce Committee, had cited "secret consulting fees and stock options from drug companies" to NIH scientists as a reason for requesting that the agency produce documentation of all the payments. Tauzin, who did not seek reelection, was hired this month to be the president of the Pharmaceutical Research and Manufacturers of America, the group that represents the nation's largest drug companies. 'Rep. James C. Greenwood (R-Pa.), who led three hearings this year on NIH conflicts of interest, had criticized the agency for allowing its scientists to use "a swivel chair" to make government decisions while taking drug company fees. In July, Greenwood announced that he would give up his position as chairman of the Energy and Commerce subcommittee on oversight and investigations and retire from Congress to become president of the Biotechnology Industry Organization — a group that urged policymakers this year not to prohibit NIH scientists from paid consulting deals.' Greenwood did take up that job. These two cases are like gamekeepers suddenly becoming poachers. In December, 2004, the Los Angeles Times said: 'For 15 million Americans, it is a daily ritual: gulping down a pill to reduce cholesterol. 'They do it because their doctors tell them to. Their doctors, in turn, rely on recommendations from the National Institutes of Health and its scientists, such as Dr. H. Bryan Brewer Jr. 'Brewer, as a leader at the NIH, was part of a team that gave the nation new cholesterol guidelines that were expected to prompt millions more people to take the daily pill. He also has written favorably of a specific brand of cholesterol medication, Crestor, which recently proved controversial. 'What doctors were not told for years is this: While making recommendations in the name of the NIH, Brewer was working for the companies that sell the drugs. Government and company records show that from 2001 to 2003, he accepted about $114,000 in consulting fees from four companies making or developing cholesterol medications, including $31,000 from the maker of Crestor. 'Brewer was far from alone in taking industry's money: At least 530 government scientists at the NIH, the nation's preeminent agency for medical research, have taken fees, stock or stock options from biomedical companies in the last five years, records show.' SEE THE ARTICLE FOR OTHER EXAMPLES SUCH AS: 'Dr. Harvey G. Klein, the NIH's top blood transfusion expert, accepted $240,200 in fees and 76,000 stock options over the last five years from companies developing blood-related products. During the same period, he wrote or spoke out about the usefulness of such products without publicly declaring his company ties.' December 22, 2004 Los Angeles Times. http://www.latimes.com/news/nationworld/nation/la-na-nih22dec22,0,6610329,full.story?coll=la-home-headlines 'Note: In February 2005, NIH Director Elias A. Zerhouni placed "'drastic' restrictions on stock ownership and other forms of outside income ... for all agency employees," according to a Washington Post article by Rick Weiss.' BUT HOW CAN THEY CHECK? It says in the L. A. Times article that Zerhouni didn't know the extent of the problem and that bureaucratic means were used to hide the payments from Congress. I don't believe that 'conflicts of interest' are no longer a problem in the NIH. What was hidden once can be hidden again. The Once and Future Hidden Thing. It also says that some of these NIH employees had used their NIH credentials (or allowed them to be used) when promoting some drug - as if the drug was being endorsed by a government agency. They also say: 'The pharmaceutical bonanza that has swept the country in the last decade has created one of the most influential lobbies in Washington. A total of 3.5 billion prescriptions — medicating about 129 million Americans — were filled last year. Drug industry revenue in the U.S. tops $231 billion annually. The drug companies donated $41 million to candidates for federal offices in the last four years, according to the Center for Responsive Politics.' And add: "The pharmaceutical industry has never been more powerful than now," said Rep. Henry A. Waxman (D-Los Angeles). "The companies have made investments in the people who have power in Washington. And they've gotten a very good return on those investments." Ah, well, I use 'vivisection' in its now common meaning. 'Evil', as you rightly point out, has taken on a common meaning which has no bearing on its earlier philisophical/religious sense. It is quite common now to talk about evil landlords whose only crime is to cheat their tenants. But it is now used in common English phrases. To save the delicate sensibilities of the supporters of cruel experiments - although they are not offended by the torture, terrorising and killing of rats and monkeys - I will henceforth use the term 'cruel experiments' when referring to lab animal experiments that don't involve the use of a knife on living tissue. And to save myself from being banned. That way, I can still be here in years to come when this thread is 200 pages long. However, if I don't think this thread is generating enough interest from those who are undecided, I might visit less often. I like to make better use of my time. I prefer threads with lots of readers and lots of contributors. Even if we use the term 'lab animal experiments' those animals possess health and life. It is wrong to take those away from them. It is wrong to use them in painful or potentially painful ways that don't benefit them. Even those that are drugged senseless are often killed. That is wrong. Anyone who can't see that, is probably incapable of understanding. Just as anyone who couldn't understand that it was wrong to keep slaves was unable to understand the issue. MPs and judges changed their minds about abortion. Even deep philosophcal thought results in the forming of opinions. There is no universal, immutable law that says one thing is right and another thing is wrong. It is all opinion. At one time they were of the opinion that it was wrong and then, at another time, they were of the opinion that it wasn't wrong. In the Republic of Ireland, where they will have the same data, they still think it is wrong. No doubt, it is part of their constitution. That will be informed by Catholic doctrine. But they are of the opinion that their beliefs are right or that it's right or of benefit to them to respect those beliefs. They might change their minds if they get even newer data or the Pope changes his mind. Constitutions can have amendments added when opinions change. Laws are opinions. Some, like the laws against killing and theft, are accepted by most people. Some are of the opinion that these laws can be ignored in certain circumstances. Others are of the opinion that they can never be ignored, not even to save their own lives or the lives of others. The laws of physics are not opinions and they never change. Our understanding of them might change but they don't. Human-made laws do change. That is why I said that we all have different opinions. Laws are opinions. It is presently the opinion of the law in the UK that it is wrong to put people to death for capital crimes. Fifty years ago it wasn't. I know that many here don't have the same opinions about what is right and wrong, cruel and not cruel. You sound like Jim in The Vicar of Dibley. You say it is a propoganda term but I say it is a word that can more accurately describe what a disgusting and vile business it all is. It is to medical science what the Roman gladiatoral contests were to sport. Laws often reflect the current ethical beliefs of any nation, or those of the lawmakers. They sometimes reflect the vested interests of the lawmakers. That some beliefs are common to most people doesn't mean they aren't beliefs. Beliefs change as opinions change. It used to be legal to throw Christians to the lions. Or to execute people in this country for pickpocketing or murder. Opinion, amongst those who make the laws, now is that those things are wrong. There are countries where adulterers can be stoned to death. I am of the opinion that that is wrong. And cruel. I have read the opinions of those who believe the opposite of my beliefs. As I said somewhere, I used to believe that non-humans could be used as models for humans. Only when I started to do my own studying did I realise that what I had been told or read was wrong. No. I know that it is anything to do with cruel medical research - and some other forms of research - which use any animal to test drugs, psychological reactions, and other things. As I mentioned earlier, testing chemicals on servicemen was vivisection. As was testing drugs such as LSD if it was against their will or without them being fully informed. Killing rats or monkeys that have had drugs tested on them to find out what the drugs did to them is already very negative. If you think there is nothing wrong in doing what you would call vivisection (actually cutting into living animals), you have no reason to object to the 'wrong' use of the word. Objecting so strongly because a word is used inappropriately - according to you - seems a bit much, especially if there is nothing wrong with the practice. I don't demand changes from people here who use terminology I disagree with. There is a world-wide concerted effort to make medical research look clean and humane. Using anyone against their will, human or not, is not humane. Forcing them to ingest chemicals, even if they are anaesthetised, is not humane. And killing them is not humane. They are used in place of words with unpleasant meanings to distance the person doing them from the reality of what they are. A slaughterhouse is a place where slaughter is done. 'Abattoir' is a French word for the same place but is only a sound with no negative associations in English. 'Abattoir' is a euphemism in English. Why won't some people use the correct English word? The images conjured up by the word 'vivisection' are those of victims who feel fear and pain, and images of beings used against their will for the benefit of others. That is what cruel medical experiments are, even if no cutting is involved. And people in general don't have etymological meanings in mind when they use words, such as 'vivisection'. They use them in the senses that they understand or in ways that they are used now. And, in recent years, vivisection has taken on a wider meaning. It might very well have started amongst anti-vivisection campaigners but it has been accepted now. As I said, that's how language changes. Many words we use today have almost the opposite meaning (or a very different meaning) to what they did a few hundred years ago. I am not crow-barring anything. I am using a word as it is now used. It is an honest word that lets people know that cruelty and other wrongdoings are involved in the practice. I believe they are. My definition of 'suffer' is obviously very different to the one used here by, I think, most of the contributors. And when people say that forcing any animal to be the subject of cruel experiments is not cruel, well, words fail me. I can't understand the thinking of such people. That is what I did when my opinion of medical research changed. But, in this type of debate, what is truth? So many of the positions are based on opinions. A few posts above, when I had said that everything I have read has led me to my present beliefs, you said that my beliefs only represent what I have chosen to read. And, by implication, I have chosen not to read things that differ from my views. I had the compelling evidence. That is why I changed my opinion. Since then, I have seen nothing to convince me otherwise. You expect me to prove that lab animals don't have good lives? It is plain for anyone who thinks they shouldn't be imprisoned, tested on and killed, that they are not having good lives. If they are, so are human prisoners who are given food and beds. In fact, the human prisoners are better off as they are not used for testing and, in this country, they are not killed. Anyone who believes humans should be slaves wouldn't understand that it is wrong. That is my opinion. Is it yours? At one time, white people could ignore the wrongness of slavery because they had the law on their side. Then one day they woke up and found that the law was no longer on their side. How many brain damaged humans are worth how many non-brain damaged humans? The regulatory bodies have proved how unreliable they can be. As I said, I give the benefit of the doubt to those who can suffer. We don't know who is suffering what or how much. It is callous to go on subjecting them to things that might be causing them more suffering than any human could ever know. Just as other species have senses that we don't have or senses more refined or stronger than ours, they may have the capacity to suffer in ways we can't measure. Many people have said that just having their minds taken off some pain, such as talking to someone, or going shopping, can help to lessen the pain. Or becoming engrossed in some task. Slight pain can disappear completely. As other animals are not the same as humans, we can't know what they are feeling. It doesn't matter how much we study them. Anything we postulate about their subjective feelings based on their responses to stimuli can't be verified except by asking them. Is there a doctor Doolittle in the house? It doesn't matter to those who suffer what the thread meaning means. I mean the word to mean what most people mean it to mean. I prefer to give the benefit of the doubt to those who can suffer . I wouldn't have free access to everywhere in a lab or to any lab I chose. I would be shown something that tests how much rabbits like a new type of lettuce. I know I can't force my views on others. I can only do my best. I changed. Vivisectors have changed. IRA bombers have changed - well, some of them. So there is hope. I think my original statement was about people's opinion of using other animals. Many people think it is wrong but necessary. Others don't care if it is right or wrong as long as (they believe) it can help them or other humans. I pointed out that there has been widespread corruption. I believe there still is despite some laws that have been introduced recently. I am having difficulty in keeping my posts short-ish. I can only do so by not posting lots of quoted evidence or links that no one might follow. I have learnt that people will ask for evidence if they want it. If they don't ask, I usually provide it at a later date. We can't have any faith in the system. When someone involved says that something is necessary we can't know if they believe that, mean that, or just want to protect their interests. From what I understand of 'Godwin's Law', it is said that any debate of this type that goes on long enough will result in the Nazis being brought in. A later addition to the law was that the first person to bring them in, automaticlly loses the debate. I have introduced slavery - the Nazis would have done nicely as an example, too - because the slavers used others for their own ends and cared nothing for the welfare or rights of the slaves. They only cared enough to keep them well enough to work. Comparing slavery or the Nazis to vivisection, slaughter, or factory farms is not inappropriate. Comparing them to a school bully is. In the case of comparison to a school bully, Godwin's Law could be invoked. So, torturing an enemy soldier - or civilian - is not cruel? The torturer is just doing his job. He bears no malice towards his victim. He might even wish he didn't have to use torture. He does it to try to save lives. Someone being sentenced to stoning to death for adultery is not being sentenced out of malice. They are being sentenced because they broke that country's God's law. But it is still cruel. If you want to be pedantic you should use vivisection to include operations on people and tatooing. Online dictionaries do use a definition similar to the one I used. As for a word not being English if it doesn't appear in the Oxford dictionary, standard English was originally just an opinion. All forms of British English dialects are as English as any other form. No one invented the language. It developed differently in different parts of the country. The ruling class decided, because it was their opinion, that a certain dialect or modified dialect should be the standard. If things had been different, the standard now could be Glaswegian, Geordie or Liverpudlian. ME- Cambridge University Press. Definition vivisection noun the cutting up or other use of living animals in tests which are intended to increase human knowledge of human diseases and the effects of using particular drugs vivisectionist noun [C] a person who is involved in the activity of, or believes in the use of, vivisection http://dictionary.cambridge.org/define.asp?key=88539&dict=CALD --------------------------- Merriam-Webster Dictionaries. Main Entry: viv·i·sec·tion Function: noun Etymology: Latin vivus + English section Date: 1707 1: the cutting of or operation on a living animal usually for physiological or pathological investigation; broadly : animal experimentation especially if considered to cause distress to the subject 2: minute or pitiless examination or criticism http://www.merriam-webster.com/cgi-bin/dictionary?book=Dictionary&va=vivisection They do eventually when the fire goes out. Or the balloon catches fire. I'm sure you don't believe that no data has ever been hidden. Individuals and companies in all sectors of business have lied to the police, regulatory bodies and governments. According to the Journal of the American Medical Association, Merck failed to provide data to the FDA which indicated that vioxx caused more deaths amongst Alzheimer patients than other data they did provide. 'In December 2001, when the FDA raised safety questions about the submitted safety data, the sponsor did not bring these issues to an institutional review board for review and revealed that there was no data and safety monitoring board for the protocol 078 study.' JAMA. 2008;299(15):1813-1817 And there are many examples of data being withheld from medical journals. There was an agreement between medical journals a few years ago that they would only review studies that had been submitted to the FDA trials database. But that doesn't affect studies from years before, nor is it a requirement of all medical journals. From November 2005 the FDA was supposed to bring an end to conflicts of interest caused by their advisors having financial ties to industry. They had to declare any conflicts of interest. But what's to stop a drug company from simply making the payments under the table so the recipient can claim he or she has no financial ties? Things like this have happened since business was invented. As the Boston Globe said in 2006: 'WASHINGTON -- When a Food and Drug Administration panel of a dozen experts voted to bring back to market the multiple sclerosis drug Tysabri, five had financial ties to the drug's maker, Biogen Idec Inc., or one of its competitors. 'The financial ties were disclosed under a law passed last November meant to limit industry influence on the FDA's actions. The law doesn't bar doctors, researchers, statisticians, and other experts from participating if they have received drug company money. Instead, the FDA can grant them waivers but makes the experts disclose those financial ties. 'Managing conflicts of interest that accompany top scientists is a juggling act the FDA has been doing for years. The new law was supposed to make it better without grinding FDA approvals to a halt. Since the law was passed, the FDA has issued nearly 100 waivers -- and the controversy hasn't faded. 'Critics say the new transparency has changed little and scientists who have conflicts of interest can still guide FDA decision making. The FDA counters that public health would suffer if the agency bypassed the nation's best scientists because of funding sources.' Boston Globe, 21st April 2006. http://www.boston.com/business/healthcare/articles/2006/04/21/no_end_to_fda_disclosure_debate/ It is only in the last three years that drug firms were required by law to include all details of their trials on websites. Even then, some of them provided the bare minimum of information and even withheld the names of drugs. In the New England Journal of Medicine, Deborah Zarin, the director of the FDA's clinical trials website, said: 'Completion of the Intervention Name field is mandatory for all trials in ClinicalTrials.gov, but the use of specific terms has not been enforced. We determined that three industry data providers — Merck, GlaxoSmithKline, and Pfizer — used a nonspecific term, such as "investigational drug," between 29 percent and 91 percent of the time in trials registered as of May 20, 2005. These three companies are ranked in the top five according to volume of U.S. drug sales.' Volume 353:2779-2787 December 29, 2005 Number 26 http://content.nejm.org/cgi/content/full/353/26/2779 The New York Times online on 23 May 2007, said: 'Recently, a report issued by the Institute of Medicine, a part of the National Academy of Sciences, recommended that the F.D.A. release all summaries of study data it had collected in the process of approving new drugs as well as all post-marketing studies of those products. 'The F.D.A. rejected the first recommendation as overly burdensome and Dr. Galson, the director of the F.D.A.’s drug evaluation and research, said that the agency already released much of this information. “It is not that we are philosophically opposed to it, but the work would be enormous,” he said.' They also reported that Deborah Zarin had said: '...reviewing a study’s results to make sure that it was free of any biases interjected by researchers involved in a study or by its sponsor was a major undertaking.' PloS Medicine, on 15th July 2008 (doi:10.1371/journal.pmed.0050160) said: 'As Zarin and Tse have pointed out, FDAAA (FDA Amendments Act of 2007) promotes transparency by outlawing concealment of a trial's existence or results, but does not directly address problems arising from flawed study design, failure to adhere to ethical principles, presentation of fraudulent data, or misrepresentation of actual results. These matters of research quality and interpretation routinely fall to editors and peer reviewers to identify and, when possible, to correct.' --------- 'Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial's registration, generally within a year of the trial's completion, whether or not these results have been published.' The FDAAA comes into force later this month. And PLoS also says: 'In June, members of the World Health Organization's Registry Platform Working Group on the Reporting of Findings of Clinical Trials advanced a position that “the findings of all clinical trials must be made publicly available,” but noted that “Although some journal editors have acknowledged the changing climate around results registration and reporting…they may have a conflict of interest in that they will probably want the key (and potentially most exciting) messages from a trial to appear first, and perhaps exclusively, in their publication”.' They were referring to Bulletin of the WHO, June 2008, 86 (6) -------------- I suspect that the drug companies already have a strategy for concealing what they want to conceal. No law can be completely binding and there are always those who are willing to risk punishment if the rewards are great enough. We have to rely on people like David Graham, Senator Charles Grassley, Representative Henry Waxman and investigative reporters to bring corruption and wrongdoing to our attention. Sometimes, we only learn about unethical or criminal behaviour because reporters or lawyers have gained access to information that was not publically available, or not easily available. That's not what I meant. 'The scientists, often from cash-starved university departments, may be prevented from having access to the raw data gathered in the trial which would tell them how well or not the drug worked and whether there were side-effects. They may be given no say in the way the trial is designed and they may have only limited participation in interpreting the results. "These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavourable to the sponsor's product," says the commentary which will run this week in 12 of the journals. The British Medical Journal is running a separate editorial with the same message. 'The editors say that the study produced for publication may be skewed in the interests of the pharmaceutical company....' The Guardian also quotes: 'Where the company controls the trial, the data and the writing of the study, he said, "the research will be presented to favour the product that company makes. I think it happens all the time - certainly in most papers that involve a new drug. It's obvious that that will happen. For the company it is their profit we are talking about. There is a clash of interests". ' Monday September 10, 2001 http://www.guardian.co.uk/uk_news/story/0,3604,549283,00.html Some journals now demand that authors sign a document to say that they have seen the data. I have already shown a small part of the evidence that the rules can be and are being broken and that the transgressors are not always adequately punished if at all. Quote: 'Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation. 'Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.' JAMA. 2008;299(15):1800-1812. 1. I do say that cruel experiments are immoral. 2. There are no effective safeguards. The safeguards in place can be and have been ignored. 3. There are abuses of the rules. It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims. I'm not being paid thousands of pounds to look favourably on the products of a certain company. I am not conducting research which will benefit my paymasters. As I have said, rules and laws can be broken. Many believe that recent laws demanding transparency in cases of potential conflicts of interest will not work if there is a desire to get round them. My reason for pointing out all this potential corruption is to show that there can be tremendous incentive to show drugs as safer or more efficacious then they might be. But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans. As for vioxx - merck produced seminars for physicians where they were given information which misrepresented the known safety and, I think, efficacy data of vioxx. Their presentations minimised the potentially serious side effects of the drug and made unsubstantiated claims about its superiority. The FDA sent a warning letter to the company to tell them to stop. Physicians could have been mislead into thinking vioxx was safer than the data from trials indicated. Merck also gave their sales people training and prompt cards to handle any concerns from physicians over safety. There are many cases where drug companies have hidden data. They are legally obliged to provide all data to the FDA in the US but they have withheld data from medical journals. Recent decisions by journal editors are supposed to make this impossible now. Supposed to. Laws are supposed to stop criminals. I didn't say that drugs should be first tested in humans. This should only happen after all the other non-cruel experimental methods have been used. And then the first trial in humans should be a microdose that is much less than the usual one-hundredth. I haven't had so much as an aspirin since I was aged about 14. Why should I start now? Those who need drugs should usually be the ones to test them - after exhaustive safety testing has been done. But very little money is spent on developing these other methods. Just a few days ago the US government promised to bail out two large mortgage lenders. They are willing to pay out thousands of millions of dollars. People's property and the housing market are very important but so is health. Not enough money is being spent. I don't know what you are trying to say here. As I said, in the clinical trials many or most of the people will hope or think they are on the drug. That will give whatever it is a boost. After a drug has been approved, it is invested with a certain power. The more it is hyped, the more powerful it becomes. The drug companies have been caught out playing up their new drugs and there have been many cases where the FDA has had to warn them to tone down their advertising. +++++++++++++++++++++++ This always happens in these debates. Someone says something. Someone else refers to part of what they said, taking it out of context. The original person, if they are not careful, replies to that without realising what they originally said and, within four or five posts, is saying that black is white. Here is how the comments about placebos started: I said, in reply to someone's comment that there are lots of drugs that have saved people's lives: ' Claims that a certain drug has saved someone's life might just be claims in some cases. How do we know the drug alone did it? It might have been the placebo effect of the drug that did it. Placebos have a placebo effect. A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect - especially if the drug companies put out misleading advertising about it. It might have been the result of the person just getting better - as sometimes happens. It might have been a combination of factors. How do we know that the drug, or an even better one, couldn't have been developed without vivisection? Then you qouted part of that: 'Placebos have a placebo effect.' And you replied by saying: 'That's why clinical trials are designed in such a way as to eliminate the placebo effect. Haven't you ever heard about "randomized double blind" studies? Phase II clinical trials are all randomized double blind.' To which I replied: 'I was referring to drugs already on the market. Some drugs, quite often due to marketing hype, are thought to be miracle drugs. These drugs might work, or work better than they would, because people - patients and medical staff - believe the hype. 'But even in clinical trials which are double-blinded and Random-Housed the placebo effect is impossible to eliminate. Many, or most or even all, in the trials will hope and/or assume they are being given the drug rather than the placebo. That will make whatever they take work better. The drug might even have a slight therapeutic effect. That will be maginified by its own placebo effect.' And then you said: 'It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.' And also: 'Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.' And: 'Sigh. PC, you are making lots of Arguments from Ignorance. This is one of them. If ALL the patients think they are getting the drug but only half are, then what the placebo effect is going to do is make it look like the drug has no therapeutic effect because the controls will also do better. This will eliminate the difference between those that take the drug and those that don't. THINK ABOUT IT! The effect of a double-blind trial will be exactly opposite of what you think.' ME, NOW: - I was saying that drugs already on the market could have a placebo effect and cures ascribed to their therapeutic action might not be entirely - or at all - due to it. I also know what 'randomised' and 'double tightened' mean. My use of 'Random House' was a joke. And now you have ruined the much funnier joke I was going to tell in relation to this. It would have had people howling with laughter and rolling on the floor. Again, all this quoting can lead to confusion. I originally referred to computers in reply to what Cap'n Refsmmat said. He or she said: ''To program the computer, you need to know a heck of a lot about the animals that we don't know, and that means, yes: DISSECTING THEM!!!!!! Really, we don't know about every compound an cell in animals and humans, it would take an insane amount of research before we did.' I replied by saying: 'Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans.' To which you posted: '1. Because of evolution, knowing about other animals does help us know about humans. We are related to other mammals by descent with modification. 2. And that part of research "not applicable to humans" is part of the falsification I talked about above. That is the part we are certain about. However, we wouldn't know it was not applicable to humans unless we had done it first.' Aaaaand then, still talking about computers, I said: 'The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes.' To which you replied: 'that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.' And now I say: 'Again, all this quoting can lead to confusion. I originally....' and so on. I know that drugs can fail for commercial reasons. I've referred to that before. I said that I have no evidence for IACUC conflicts of interest. But, as other regulatory bodies have been proven to have such conflicts, it's not unlikely that they can be found in IACUCs. IACUCs have shown negligence and incompetence. Were they really incompetent or were they nobbled? If they can be so incompetent, it doesn't say much for their ability to do the job they are supposed to do. I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans. If it doesn't begin to approach being very reliable then what is the point of it? It's not 100% reliable. How reliable is it? 50%? More? Less? Most drugs that go through cruel testing don't manage to wangle their way through human testing. They are found wanting. And what they are wanting is proper medical research. It was known decades earlier that substances could cross the placenta. Which species could they have used to check for teratogenicity? Which species would they have believed? If they'd never tested for it before, how would they have known which species was supposed to be a model? See above. I have never said that a new drug should just be given to people without proper testing. As I have said, a drug that gets through clinical testing will have a clear record going back to the preclinical stages. That is why it was approved. It it had behaved differently in humans to how it had behaved in non-humans, it wouldn't have been approved. Then you wouldn't be able to trace its success back to the preclinical stages - because it wasn't successful. Only a small number of drugs are approved. The majority that go into clinical trials aren't approved. Quote: 'Context Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation. 'Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.' JAMA. 2008;299(15):1800-1812. 1. I do say that cruel experiments are immoral. 2. There are no effective safeguards. The safeguards in place can be and have been ignored. 3. There are abuses of the rules. It is my opinion that cruel experiments are immoral and that they should not happen. Regardless of what the rules are. But the purpose of orphanages is to protect the children and the purpose of cruel experiments is to do things that lead to the harm, terror and death of the victims. I'm not being paid thousands of pounds to look favourably on the products of a certain company. I am not conducting research which will benefit my paymasters. As I have said, rules and laws can be broken. Many believe that recent laws demanding transparency in cases of potential conflicts of interest will not work if there is a desire to get round them. My reason for pointing out all this potential corruption is to show that there can be tremendous incentive to show drugs as safer or more efficacious then they might be. But all the clinical trials that fail for reasons of efficacy or safety show that the earlier, non-human, testing was wrong. The drugs withheld from clinical trials were never tested in humans and it can't be known what they would do in humans. With a new drug it is not known how it will affect humans. If it is similar to other existing drugs, why does it need testing? If it needs testing it is because it is not known how it will affect humans. As for vioxx - merck produced seminars for physicians where they were given information which misrepresented the known safety and, I think, efficacy data of vioxx. Their presentations minimised the potentially serious side effects of the drug and made unsubstantiated claims about its superiority. The FDA sent a warning letter to the company to tell them to stop. Physicians could have been mislead into thinking vioxx was safer than the data from trials indicated. Merck also gave their sales people training and prompt cards to handle any concerns from physicians over safety. There are many cases where drug companies have hidden data. They are legally obliged to provide all data to the FDA in the US but they have withheld data from medical journals. Recent decisions by journal editors are supposed to make this impossible now. Supposed to. Laws are supposed to stop criminals. I didn't say that drugs should be first tested in humans. This should only happen after all the other non-cruel experimental methods have been used. And then the first trial in humans should be a microdose that is much less than the usual one-hundredth. I haven't had so much as an aspirin since I was aged about 14. Why should I start now? Those who need drugs should usually be the ones to test them - after exhaustive safety testing has been done. But very little money is spent on developing these other methods. Just a few days ago the US government promised to bail out two large mortgage lenders. They are willing to pay out thousands of millions of dollars. People's property and the housing market are very important but so is health. Not enough money is being spent. I don't know what you are trying to say here. As I said, in the clinical trials many or most of the people will hope or think they are on the drug. That will give whatever it is a boost. After a drug has been approved, it is invested with a certain power. The more it is hyped, the more powerful it becomes. The drug companies have been caught out playing up their new drugs and there have been many cases where the FDA has had to warn them to tone down their advertising. +++++++++++++++++++++++ This always happens in these debates. Someone says something. Someone else refers to part of what they said, taking it out of context. The original person, if they are not careful, replies to that without realising what they originally said and, within four or five posts, is saying that black is white. Here is how the comments about placebos started: I said, in reply to someone's comment that there are lots of drugs that have saved people's lives: ' Claims that a certain drug has saved someone's life might just be claims in some cases. How do we know the drug alone did it? It might have been the placebo effect of the drug that did it. Placebos have a placebo effect. A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect - especially if the drug companies put out misleading advertising about it. It might have been the result of the person just getting better - as sometimes happens. It might have been a combination of factors. How do we know that the drug, or an even better one, couldn't have been developed without vivisection? Then you qouted part of that: 'Placebos have a placebo effect.' And you replied by saying: 'That's why clinical trials are designed in such a way as to eliminate the placebo effect. Haven't you ever heard about "randomized double blind" studies? Phase II clinical trials are all randomized double blind.' To which I replied: 'I was referring to drugs already on the market. Some drugs, quite often due to marketing hype, are thought to be miracle drugs. These drugs might work, or work better than they would, because people - patients and medical staff - believe the hype. 'But even in clinical trials which are double-blinded and Random-Housed the placebo effect is impossible to eliminate. Many, or most or even all, in the trials will hope and/or assume they are being given the drug rather than the placebo. That will make whatever they take work better. The drug might even have a slight therapeutic effect. That will be maginified by its own placebo effect.' And then you said: 'It's "randomized". You really don't know what that experimental design is, do you? Go do some reading. "Randomized means that patients are randomly assigned to a the control group or the group receiving the drug.' And also: 'Double-blind means that neither the patient nor the person evaluating the effect know which patients got the drug and which did not. This eliminates bias and also means, if there is a placebo effect, it will be in both groups. That means that any effect of the drug above and beyond a placebo effect is going to be detected. If instead, the drug is ineffective and there is only a placebo effect, then both groups are going to be the same. You won't get a false positive. You may get a false negative if the real effect of the drug is smaller than a placebo effect.' And: 'Sigh. PC, you are making lots of Arguments from Ignorance. This is one of them. If ALL the patients think they are getting the drug but only half are, then what the placebo effect is going to do is make it look like the drug has no therapeutic effect because the controls will also do better. This will eliminate the difference between those that take the drug and those that don't. THINK ABOUT IT! The effect of a double-blind trial will be exactly opposite of what you think.' ME, NOW: - I was saying that drugs already on the market could have a placebo effect and cures ascribed to their therapeutic action might not be entirely - or at all - due to it. I also know what 'randomised' and 'double tightened' mean. My use of 'Random House' was a joke. And now you have ruined the much funnier joke I was going to tell in relation to this. It would have had people howling with laughter and rolling on the floor. Again, all this quoting can lead to confusion. I originally referred to computers in reply to what Cap'n Refsmmat said. He or she said: ''To program the computer, you need to know a heck of a lot about the animals that we don't know, and that means, yes: DISSECTING THEM!!!!!! Really, we don't know about every compound an cell in animals and humans, it would take an insane amount of research before we did.' I replied by saying: 'Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans.' To which you posted: '1. Because of evolution, knowing about other animals does help us know about humans. We are related to other mammals by descent with modification. 2. And that part of research "not applicable to humans" is part of the falsification I talked about above. That is the part we are certain about. However, we wouldn't know it was not applicable to humans unless we had done it first.' Aaaaand then, still talking about computers, I said: 'The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes.' To which you replied: 'that part about computer programs is complete does-not-follow. We are talking about anatomy and physiology, not the ability to write computer programs. WOW, it's difficult to conceive how you thought computer programming was relevant.' And now I say: 'Again, all this quoting can lead to confusion. I originally....' and so on. I know that drugs can fail for commercial reasons. I've referred to that before. I said that I have no evidence for IACUC conflicts of interest. But, as other regulatory bodies have been proven to have such conflicts, it's not unlikely that they can be found in IACUCs. IACUCs have shown negligence and incompetence. Were they really incompetent or were they nobbled? If they can be so incompetent, it doesn't say much for their ability to do the job they are supposed to do. I have looked. Many times. Not all data are published. Sometimes, it is not published because it is deemed to be commercially sensitive. That is not the correct term but it will do. Sometimes it is not published for other reasons. If there wasn't a paucity more drugs would succeed. It can't be known if those that never reached human testing would have been successful or unsuccessful in humans. If it doesn't begin to approach being very reliable then what is the point of it? It's not 100% reliable. How reliable is it? 50%? More? Less? Most drugs that go through cruel testing don't manage to wangle their way through human testing. They are found wanting. And what they are wanting is proper medical research. It was known decades earlier that substances could cross the placenta. Which species could they have used to check for teratogenicity? Which species would they have believed? If they'd never tested for it before, how would they have known which species was supposed to be a model? See above. I have never said that a new drug should just be given to people without proper testing. As I have said, a drug that gets through clinical testing will have a clear record going back to the preclinical stages. That is why it was approved. It it had behaved differently in humans to how it had behaved in non-humans, it wouldn't have been approved. Then you wouldn't be able to trace its success back to the preclinical stages - because it wasn't successful. Only a small number of drugs are approved. The majority that go into clinical trials aren't approved.
  3. I use 'vivisetion' in its modern definition. I am talking about new drugs. It is in their use that most failures are found There have been cases where researchers aren't even allowed to see the data they've collected. The researchers have no say in which studies are presented and which are hidden. Studies have been hidden. Medical journal articles have been ghost-written by drug company employees. And there's the well known effect on medical studies in which drug company-sponsored trials are more likely to be favourable to the drug than in those trials that are not sponsored by drug companies. I will write it a bit more clearly. I thought the meaning might have been clear from what I have already said: Lab animals cannot reliably simulate the effects of a new drug in humans so that it is known beforehand that their results will be accurate. It is only when the drug is tested on humans that it can be seen if they were accurate. Drug companies hide data from clinical trials where it says the drug is ineffective. I think they have also hidden data which suggested potential harm. They have certainly tried to play down the potential danger. This is after the previous tests in non-humans said it would be effective. If there was nothing else, if they were tested properly and I had a serious disease, and I thought it might help, yes. I think I was replying to a vivisection supporter who used the term. But my criticism stands - you lot seem afraid to call a spade a spade. Are you ashamed to use the correct word in case it makes you look bad? I was referring to drugs already on the market. Some drugs, quite often due to marketing hype, are thought to be miracle drugs. These drugs might work, or work better than they would, because people - patients and medical staff - believe the hype. But even in clinical trials which are double-blinded and Random-Housed the placebo effect is impossible to eliminate. Many, or most or even all, in the trials will hope and/or assume they are being given the drug rather than the placebo. That will make whatever they take work better. The drug might even have a slight therapeutic effect. That will be maginified by its own placebo effect. Some here will say that is ridiculous. Careful thought will make you think otherwise. I think. The fact remains most new drugs fail in clinical trials. I don't think we should put much trust in other species to help us with computer programmes. And we have all those drugs that didn't get through the clinical trials. About 90% of them. If someone desperately wanted to do the research and they had powerful backers, the law/legislation/rules would fly out of the window. They might not even need the powerful backers. I didn't say that IACUC's definitely had conflicts of interest or had corrupt members. But other regulatory bodies do or have had. There's no need for distortion. The paucity of reliable, accurate results in humans that come out of non-human tests speak loud and clear to anyone who will listen and who hasn't been deafened by the vile din of the vivisection propaganda. My reply, though true, was slightly tongue in cheek. Not one. I choose my friends carefully. Well, I would if I had any. See above. What about the drug that does no harm to a rat or dog but might harm a human? You wouldn't know until it harmed a human. I'm replying to your comment. I haven't checked Dalek's original post nor my original reply to that post. The unpredicted rare side effect could be picked up by more advanced testing, if enough money was spent on developing more advanced systems and there was the will to do it. But most drugs fail in the clinical trials. But serum-fee media are avaliable now and being used. I think they are more expensive and have to be made, whereas foetal calf serum is easy to obtain and they could even be specially bred for the purpose. No, I'm not advocating that. Just acknowledging how barbarous the human race can be. If you have a prediction that drug B will be harmless but you know from previous testing that drug B caused liver toxicity then you don't trust the prediction. Ray! Given the old-fashioned, Victorian methods used now, the prediction and the liver toxicity would probably have come from non-human testing, but that is what these people believe in. Even now, one species might predict non-toxic and another might show liver toxicity. If in silico is not given the seal of approval no court will believe it no matter how accurate. Perhaps I should say that, because of possible future litigation, no court will risk giving it much weight if lots of money is involved . I would object because I am against forcing people or duping people when doing so could lead them into harm. Any humans should be willing and informed. But before they are used other methods should be used to make sure the drug is safe. Other methods? QSAR, imaging, microdosing. These and others have been mentioned before. I am of the opinion that it is wrong to use other species to test drugs for humans. And wrong to use humans as vivisection subjects. I think that's what the original poster was going on about - using murderers. I still say that rats don't normally kill their own pups. It is more likely they are stressed or the pups are unhealthy. I'm not sure now what the original reason for this bit about rats was. Probably fattyjwoods' contention that testing on rats is disgusting. And then you said that he or she can't project human feelings onto rats, that rats eat baby rats and that if we projected our feelings onto them perhaps we should eat babies, too. It is not normal for rats to kill healthy babies of their own if the adults aren't stressed. Other, unrelated, rats sometimes do for various reasons including wanting to bring the female into mating readiness, wanting to take over the nest, and hunger. But it dosen't really matter to this discussion. Well, we'll have to take your word for it and that nothing else was done to them that could have caused them pain or distress. Lab animals can and do feel pain, stress or terror. It is still wrong to use them. My postition is that rats and humans do not react to drugs in the same way. They do react to other things in very similar ways, though. Things like being chased by a predator, being frightened or being subjected to something painful or stressful. Fair enough. But you are willing to put them at risk of feeling such pain. I would not be. It does not benefit them. Your job depends upon your willingness to put rats at risk of suffering pain, stress and terror. If you were only using cells, it wouldn't. I know that the test animals can feel pain. If it is possible for any procedure to cause them to feel pain, there will be times when they do feel pain. How much depends on the experiment and the experimenter. I have also read testimony from ex-vivisectors and lab assistants who said that the lab animals do feel pain. I don't think anyone would deny that animals feel pain. I also object to them being used in any way that can harm them, stress them or make them feel fear and that is not for their benefit. I don't expect certain people here to pay attention to, or have any faith in, anything I say. I am here to reach those who are willing to learn and to think for themselves. What a terrible thing to happen to the poor rat. I would have killed it immediately if I thought there was no way to save it. Killing does not need to imply or cause pain or fear. I have killed different types animals to put them out of their misery, in ways that didn't cause pain or fear. It was instantaneous. They never knew what was going to happen and didn't know what did happen. I killed them. I didn't euthanase them. I would never use such a word. Has this been translated to humans? Does it involve a new drug that needs to be metabolised in the body? Sciecewiz is the person you were answering. http://www.guardian.co.uk/science/2008/aug/13/controversiesinscience.ethicsofscience?gusrc=rss&feed=networkfront Vivisection: Study finds 115 million animals used in tests worldwide, guardian.co.uk http://www.bret.org.uk/gov.htm or 150 million http://pharmatimes.com/Forums/forums/p/2093/2102.aspx#2102 I don't always trust figures from anti-vivisection sources. I check them myself when I can. I know that any body of people who are involved in making decisions which can have huge financial implications for their employers can be biased. Corruption is harder to prove but we know that there are corrupt police and polititians. There is proof of corruption in other regulatory bodies. It seems the IACUC of the university of Washington did not do its job properly. They receive millions of dollars in grants to do vivisection: http://www.komonews.com/news/local/15988507.html There's also more evidence of IACUC negligence (to put it politely): ================= According to a USDA inspection report, the Institutional Animal Care and Use Committee (IACUC), which oversees UT's (University of Toledo) animal research, failed to notice how researchers weren't following protocol. One of the monkeys received a tracheotomy, an incision in the windpipe, which was a breach in procedure, the inspection report said. "The monkeys were supposed to be intubated," said Michael Budkie, executive director of SAEN. Budkie said that the primates died under questionable circumstances. According to the UT statement, John Wall, a neuroscience professor, "deviated slightly" from approved protocol during an experiment. Wall declined to comment. http://media.www.independentcollegian.com/media/storage/paper678/news/2007/02/08/News/Monkey.Deaths.Stir.Rights.Organization-2706641.shtml ===================== If the link doesn't work - it's a longun - and anyone is interested, I can post the whole article. Whether or not the monkey felt pain, the IACUC was negligent. Cases like this only come to light when someone makes the effort to report them, and is in the right place at the right time to learn about them. That doesn't answer the question of: 'How do you know it speeds up research? How do you know it is not holding up research? Don't ask the vivisectors, they are biased.' New England Journal of Medicine, Volume 355:2321-2329 November 30, 2006 Number 22 http://content.nejm.org/cgi/content/full/355/22/2321 We have to hope that those who responded were telling the truth and not hiding even more conflicts of interest. This is also interesting but refers to for-profit IRBs which, presumably, are not in universities: 'Second, the U.S. oversight system is not well equipped to monitor a highly competitive, market-based, multinational research industry. The Office for Human Research Protections has no jurisdiction over privately sponsored studies, and the Food and Drug Administration inspects only about 1% of clinical trials.2 IRBs, the most important bodies charged with protecting subjects, were designed primarily to review trial design, risk–benefit ratios, and informed-consent documents. Recent research scandals — which have been uncovered largely by investigative reporters rather than regulators — have concerned a very different set of issues: fraud, conflicts of interest, unfair payment practices, and unsafe or degrading trial conditions. Such problems are magnified still further when studies are conducted at private testing sites and reviewed by for-profit IRBs that are financially dependent on research sponsors.' http://content.nejm.org/cgi/content/full/358/22/2316 There is mention of the TGN1412 case in the second paragraph of the article quoted from above. There is also this for British Phase 1 trials: 'Payments Many trials are demanding of the subject and involve long periods of residence, many visits to the trial site, urine collections, and multiple blood tests and other procedures that cause discomfort, as well as lifestyle restrictions. So it is right to pay subjects - healthy subjects and patients - who volunteer for phase 1 trials more than just any expenses that they incur.5 The amount should be related to the duration of residence on the unit, the number and length of visits, lifestyle restrictions, and the type and extent of the inconvenience and discomfort involved. As a guide, payments should be based on the minimum hourly wage 5 8 and should be increased for procedures requiring extra care on the part of the subject or involving more discomfort.5 Payment must never be related to risk. 'Subjects who withdraw or are withdrawn even for medical reasons should not always be paid the full amount.' Guidelines for Phase 1 Clinical Trials 2007 edition. The Association of the British Pharmaceutical Industry I am reluctant to say but it is a big country that recently held the olympics. I know you were arguing against human vivisection. I was just adding more information. See above somewhere for my reasons for being against forcing humans to be test subjects. In all the years I have been involved in AV I have seen nothing to change my views on this matter. Some workers might do their best for the lab animals but they are still involved in cruelty. There is also the very real possibility that people who are involved in such things can become inured to the suffering of others, due to long exposure. What might have been bizarre or unacceptable to them can become normal and acceptable. These 'experiments' that GPs conduct on their patients are done with the patitents' consent. There have been numerous cases where animal 'welfare' rules were broken and where the relevent authorities were negligent in enforcing them. I don't know how many humans report pain whilst anaesthetised. More care will be taken with them. Humans can be nusiances who complain and whinge. As I said above, it is possible that people involved in cruel work can become used to seeing and inflicting suffering. They might even think they are not doing anything cruel. There is evidence - gained by those wicked AR people - that lab workers are sometimes routinely cruel, and many times are indifferent to suffering. The fear a human experiences before an operation is for something they are willing to undergo. And it's for their benefit. The lab animals don't benefit and they would rather be somewhere else doing something else. You don't need to tell me that. I am a member of the PLO (Plant Liberation Organisation). Those other animals can't change their behaviour. We can. I am at present trying to convince a local tiger to use humane methods of killing. As I said above, corruption is not always easy to prove. There is evidence that IACUCs can be incompetent. In 'Science' 27 July 2001: Vol. 293. no. 5530, pp. 608 - 609 they have an article. I've only seen the comment: Reliability of Protocol Reviews for Animal Research Scott Plous* and Harold Herzog A random sample of 50 Institutional Animal Care and Use Committees (IACUCs) participated in a study of the protocol review process. Each committee submitted three animal behavior protocols it had recently reviewed, and these protocols were reviewed a second time by another participating committee. The results reported in this Policy Forum showed low levels of reliability in protocol judgments within and between committees. In addition, a majority of approved research protocols were disapproved or deferred by the second committee. ============== In their supplementary information they show a table of protocols. In that section they say: '*In one case, a protocol involved both rats and primates (categorized in the table as "primates") and in four cases, protocols involved rats and other mammals (categorized as "other mammals").' That doesn't stop rule breaking. And rule breakers aren't always punished. See above for evidence of IACUC negligence and incompetence. There are researchers and lab assistants who have been caught out but have not been punished. Here are excerpts from an article in the Guardian of 5 years ago, which show rules were broken and crimes went unpunished: To the dismay of animal rights activists, the documents reveal how primates were used in the search for a solution to the chronic global shortage of human organs for transplant. Baboons were transported from the African savannahs to die in steel cages the size of toilet cubicles. The documents show that a quarter of the primates died from 'technical failures'. Researchers describe how monkeys and baboons died in fits of vomiting and diarrhoea. Symptoms included violent spasms, bloody discharges, grinding teeth and uncontrollable, manic eye movements. Other animals retreated within themselves, lying still in their cages until put of their misery. Others never even made it to HLS (Huntingdon Life Sciences), suffering painful deaths en route. Faxes from global wildlife dealers reveal how at least 50 baboons were taken from the African plains for the experiments. In one shipment the creatures spent 34 hours in cramped transport crates - 10 hours longer than approved by the Home Office, which chose not to take any action. Many of the 1,274 pages of documents reveal a litany of failings that will serve to ignite further controversy over HLS, which last week won a ground-breaking injunction preventing animal protesters getting close to employees' homes. Fundamental questions over the value of vivisection itself will also be asked. The papers reveal attempts to bury the true extent of animal suffering from experiments conducted at the HLS laboratories between 1994 and 2000. Serious incidents of unlicensed animals suffering were not adequately investigated and regulations were not enforced properly. Breaches of the law even went unpunished in some cases, with the Home Office limiting itself to letters of 'admonishment'. One previously confidential paper reveals how the Home Office worked with Imutran - the former British subsidiary of multi-million drug giant Novartis, which was in control of the programme - to underestimate the suffering caused by the most severe experiments. http://www.guardian.co.uk/uk/2003/apr/20/health.businessofresearch Again I say, I and others would not agree with you on what is ethical. See above somewhere. There's very little real protection. Regulations are just as good as the will to keep them and police them. See above somewhere. But, have you never heard of humans breaking rules and regulations? 1. Because you can't do them in humans doesn't mean they couldn't be done without non-humans. There are already many other methods that should be used and should be improved. 2. David Graham, of the FDA Office of Drug Safety, said that the system is biased towards efficacy and that safety gets an easier ride. ================ Testimony of David J. Graham, MD, MPH, November 18, 2004. Before the US Congress. Pages 4-5. The corporate culture within CDER (Centre for Drug Evaluation and Research - part of the FDA) is also a barrier to effectively protecting the American people from unnecessary harm due to prescription and OTC drugs. The culture is dominated by a world-view that believes only randomized clinical trials provide useful and actionable information and that postmarketing safety is an afterthought. This culture also views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards and disrespects drug safety. Finally, the scientific standards CDER applies to drug safety guarantee that unsafe and deadly drugs will remain on the US market. When an OND (Office of New Drugs) reviewing division reviews a drug to decide whether to approve it, great reliance is placed on statistical tests. Usually, a drug is only approved if there is a 95% or greater probability that the drug actually works. From a safety perspective, this is also a very protective standard because it protects patients against drugs that don’t work. The real problem is how CDER applies statistics to post-marketing safety. We see from the structural and cultural problems in CDER, that everything revolves around OND and the drug approval process. When it comes to safety, the OND paradigm of 95% certainty prevails. Under this paradigm, a drug is safe until you can show with 95% or greater certainty that it is not safe. This is an incredibly high, almost insurmountable barrier to overcome. It’s the equivalent of “beyond a shadow of a doubt.” And here’s an added kicker. In order to demonstrate a safety problem with 95% certainty, extremely large studies are often needed. And guess what. Those large studies can’t be done. =============== 3. Every successful new drug for humans that had earlier non-human testing will have lab animal data that you can trace back to. That is because those treatments are the minority that succeeded in humans out of the large number that don't but that also had non-human testing. But the majority of new drugs that fail cannot be so traced. And that is because there is a break in the line of data when the human effects don't agree with the non-human. Furthermore, the 'successful' results from non-humans might just be those that happen to agree with the human. There could be other non-human results that didn't agree. Whole clinical trials can be hidden. It would be even easier to hide the results from some dogs or monkeys. You're right. Not a good answer as there is some funding, but I didn't say there was none. But it is a pittance. Humans can tell about abuse to them, or their relatives can. Human carers, however cruel, are unlikely to be as uncaring as those who are cruel to non-humans. Most humans in those places are probably well cared for. They are there to be taken care of. That is the purpose of those places. Vivisection labs are there to do things that deliberately lead to pain or suffering or death. It is more likely that people looking after humans will treat them well. Not necessarily so with those who are in charge of non-humans. They don't have to keep them well for longer than the duration of the experiment. Even then, some don't even manage that. You have a motive for saying non-humans can be reliable models for humans. All these models for humans still manage to give such wrong information that most new drugs fail in clinical testing. No. Not unless I needed the drug and I was sure it had gone through an extensive battery of tests. I have mentioned new drugs before. I'm tired and can't be bothered to check back but I probably said something about the non-human models not being good enough for it to be known beforehand that their data will be accurate and applicable to humans. Mostly, it isn't. I've already said that the first human is the first human to test something. The non-humans are so unreliable that the human becomes a guinea pig. Without going back over posts I'm not really sure what you're going on about. But there are many scientists who call into question the whole peer review process. There is evidence that medical journal reviewers have conflicts of interest. In some disciplines there are so few potential reviewers that it is not wise to give a really bad review because they might do the same to you next time. And they will know who you are even if you use a nom-de-guerre. I was referring to drugs. That's not like testing a drug. I would say that stem cells work in similar ways in mammals just as cells divide in similar ways. Stem cells are common to both species. Human stem cells are used in humans and mice stem cells in mice. It's the stem cells, which are part of the particular animal, which do the work not some drug that is thought to work in similar ways in mice and humans - and usually doesn't. I would say that the drug equivalent of this would be like giving one drug to mice for, say, cholesterol lowering and another drug to humans for the same purpose. You can't give the mouse drug to humans. You give each species the drug that has been seen to do the job in that species. You just used the mice to see if their drug would work in them. Even with drugs that are tested on non-humans and then work in humans, you are just seeing those that happened to do so. Forgetting that most don't. That is not reliability. Human heart problems are often caused, or exacerbated, by lifestyle. The mice don't have human lifestyles. Even if this procedure helps humans it won't change their lifestyles and they are likely to develop the same problems again. The money would be better spent on educating and motivating people to lead healthier lives instead of living unhealthily and expecting mice to be killed so these people can later have the damage to their hearts undone. Not sure what you mean. When the lead compound gets through non-human testing the drug company is fairly certain they have something worthwhile. But mostly they don't have when it goes into humans. Indeed it was legal and convenient. I believe most white people - or at least the legislators - thought it was not cruel. But if most people did think it was cruel and still did it - why, that's like the present attitude towards non-humans: It's cruel but has to be done. The people doing these vile things will be of the same mind as those people who saw nothing wrong in slavery or thought it wrong but neccesary. I believe that the whole system needs changing. That extensive, non-vivisection safety testing needs to be done. That it should take as long as it needs to take. That no expense should be spared. That a constant search be conducted to improve everything. Not similar enough. Plants might share a common pathogen recognition pathway with animals. Perhaps we should experiment on beech trees. I read somewhere that a gene has been found in two distinct types of monkey. The gene is actually a combination of two other genes. At the DNA level the genes are similar but molecularly, their beginnings were different. If this is true, even very close similarities are not close enough. jdurg #400 quote: A drug might do everything the company wants it to, but might be too expensive to produce at the level needed to provided the benefit. That drug will be removed. quote: It is the tests on human subjects that determine if it's worth proceeding. I know that some drugs are stopped in the clinical trials for commercial reasons. But most fail for reasons of safety or effectiveness. Of those that fail for commercial reasons, there's a possibility that some of them could fail for reasons of safety or effectiveness if they had been allowed to continue.
  4. The fact that most drugs fail when they are tested in humans should be enough to convince anyone that the drugs can't be tested in other species with any prior knowledge of what they will do in humans. They are tested in humans to see what they will do in humans. Usually, they don't do well in the humans. I was simply using your statement about different species to point out that the differences can also be seen in drug testing. I included the number of your post so anyone could check the context of what you posted. The two sides here have different beliefs about the validity of using non-humans to save humans. Some on my side believe that using them leads to millions waiting in vain for cures. I'm glad you believe that using non-humans is an evil. They possess lives and health. Vivisection takes those away from them. It causes them pain and/or fear/distress. And death. Forty-odd years ago it was the opinion of the Law in the UK that it was wrong to do abortions on healthy babies. Then it became the opinion of the Law that it was not wrong. I'm glad to hear that. The original poster was saying, I think, that humans, having taken over the world, thought they could do whatever they wanted to its inhabitants. That humans subjugate other species simply because they can. The original poster thinks that's wrong. So do I. Yes. The non-human animals are used to test for both. Drugs do fail in the human trials for safety and effectiveness reasons, amongst other things. My definition is correct. As I said, the meaning of words changes over time. Have I demanded citations? I can provide evidence for anything I've stated as a fact. My analogy isn't weak. Perhaps I could have been more clear on occasion but I was trying to keep my posts as short as possible. Laws are opinions. I have said that my belief that vivisection is morally wrong is my opinion and that others might not share it. It is hard to find any unbiased opinion with this subject. Even medical studies can be biased - especially if they are funded by the drug companies. Everything I have read has led me to the belief I have now. Many years ago I was opposed to vivisection on moral grounds only. I believed that it was scientifically valid. Probably because I had been told it was. When I started to look into it and think for myself, I found that it is not science - that it can't be used to reliably know in advance what a new drug will do. Come on, now. Would you deny me free speech? I have told you why I call it vivisection. 'Animal testing' is a euphemism, like 'sacrificing', 'abbatoir', 'euthanising', and many others. It conjures up a vision of rats sitting with pencil and paper doing a spelling test. If you say that causing fear and pain to anyone for the purpose of medical experiments is not vivisection and that vivisection is only to be used when referring to cutting into live tissues, you must use the term when talking about operations on humans, tatooing, ear piercing, and perhaps even pruning roses. I think the word 'vivum' refers only to animals and not plants, but why stop at animals? It is not used when referring to operations, because the full literal meaning of the word was never intended to be used. As the literal meaning is not used, other meanings can be attached to it. As have been over the years. That's the way language changes. I don't ask anyone to stop saying that other animals can't suffer. I find those statements very annoying but I know it's pointless asking people to stop saying them. The people on this thread already have differences in opinion about the meanings of 'suffering', 'ethical behaviour', and 'cruelty'. No doubt, our opinions of the meaning of 'vivisection' will remain different. Will someone who says goats can suffer be accused of strawmanning? Now that is propaganda. The animal abusers put that lie about. As Mandy Rice Davis would have said: 'They would say that, wouldn't they?' It is not a good life to be kept prisoner, denied your natural life, tested on and then killed. It doesn't matter how quick or painless the death is. It is wrong to treat any animal like that. If you can't understand that, no amount of explaining will change your mind. Probably not. I give the benefit of the doubt to people who say they are in pain. But I also know that other animals feel pain. In fact, they might feel it more. Intellect can control pain. We can rationalise and take our minds off pain. Other species can't do that. There can be no evidence of what a non-verbal animal is feeling subjectively (and there's none for what a human is feeling, except what they say). For that reason, if for no other, we should give them the benefit of the doubt. The dictionary definitions of 'suffer' include 'to bear', to undergo. Someone who is undergoing pain or distress is suffering. Unless the meaning has changed lately, like another word has. I mean the word to have the definition given above. I think most people understand it like that. The amount of suffering between species might be different but which species suffers most? There is no way of telling. Temple Grandin wrote: 'When the structure of the brain and nervous system is studied, there is no black and white line between people and higher mammals such as chimps, dogs or cows. The genome project has shown that humans and mice share many genes (Gunter and Dhand, 2002). In mammals 30 to 40% of all genes are involved in nervous system development and function. The basic design of the nervous system and the neural mechanisms that process fear and pain are similar in humans and other mammals (Rogan and LeDoux, 1996).' http://www.grandin.com/welfare/animals.are.not.things.html I don't agree with her on many things but she believes, as I do, that other animals can suffer. It is enough for me that they feel pain, distress and fear. Deliberately causing them those feelings during experiments is wrong. It is cruel. Polititians believe the vivisectors that it is necessary. Money comes into it. Just as it did with slavery. No. If you are talking about suffering, I didn't think anyone still believed that responses to damage in non-humans were simply unfeeling responses - if that is what you believe. To quote Temple Grandin again: 'Science has shown that animals such as mammals and birds feel pain in a manner similar to humans. Insects, viruses and microbes are not able to feel pain or suffer. More research is needed to determine the extent that fishes and amphibians feel pain. Present research shows that they do experience fear. Fear is very aversive and animals should be shielded form situations that cause great fear. Fear will cause a great rise in stress hormones.' I refer to what vivisection-supporters say because they have similar beliefs to some people here. I'm not sure if Temple Grandin is a vivisection supporter, though. Many white people thought black people weren't as aware as white people. That they were sub-human. My point was that at one time it was not thought wrong. And then, at a later time, it was thought to be wrong. I have already shown that these regulatory practices are open to abuse. Well, I haven't shown evidence for that yet but I can. I was waiting until someone challenged me. I have all the evidence just waiting. If some system can be abused and there is money to be made by doing so, it will be abused. Drug companies and some medical researchers have already shown their disregard for human life. The welfare of rats and monkeys will be of even less concern to them, especially when measured againt profits or the thoughts of prestige for making some discovery or authoring some highly-praised study. I don't understand what you mean. I hadn't heard of Godwin's Law before but I looked it up. I still don't understand what you mean. If you think it inappropriate to liken vivisection to the slave trade, I and many others don't think it is. To use the slave trade again, at one time if someone had said that black slaves should be treated well - and shouldn't even be slaves - because puppies were treated more kindly, they could have been denounced for using an inappropriate comparison. After all, it could have been argued, puppies have more right to good treatent than do slaves. People treat puppies kindly because they deserve it, being such nice little dears. Slaves don't deserve kindness. In fact, it makes them lazy. Anyone using that argument would be of the opinion that slaves are not worth any more than the use that can be wrung out of them. That person would not be able to understand that black people are humans and should be treated well. Just as there are people here who don't believe or can't understand that other species that can suffer should be treated well. Other species, they argue, don't suffer. I said that some people didn't believe that black people could suffer in the same way as white people. As far as I can tell, you think that something done to non-humans that can cause pain and fear is not cruel if done for a good ( to humans) purpose. But it would be cruel if just done for no reason except the desire to do it. Glad to hear it. What would you like? Just ask.
  5. After logging in again, I simply hit the reply button. The reply box had all of the text of the post I wanted to reply to. That's when I posted my previous reply. I then tried to use the multi-quote and quote button again. Again the message that my post was too short. I am going to another forum to practise there. They have a multi-quote system but I've never needed to use it. I have quite a lot to say.
  6. Thanks. But I'm sure I did that. Now, when I click only 'Reply' after logging out and logging back in again, I get all of the post that I wanted to reply to. I did not use the 'quote' button this time.
  7. As I said, the meaning of words changes. It is not just anti-vivisectionists who use the modern definition of the word. Many modern dictionaries do - well, online ones. No. Rape is against the victim's will. The multi-quote system is not working. If I have to do each one separately it will take me about an hour. If I can't work out how to use the multi-quote within the next twelve hours I will have to use the method I used for my first post. Or perhaps it is working. But when I try to post anything a message comes up saying my post or message is too short.
  8. I was using your comment to make a point about using non-humans. Not about subjectivity. You were saying that results (or was it observances - I don't have time to check) in one species cannot be used to predict them in another. I used that and applied it to drug testing. No, I don't think it is a rational approach. I am opposed to vivisection on anyone. I was pointing out that Bosun's statement made sense. You suggested it didn't. [quote name='Sayonara³; Holding that belief has a name: it is called being a sociopath. I don't hold that belief. But holding the belief that we can use other species or those weaker than ourselves in cruel ways - causing them harm or fear - means that the believer is cruel. You actually believe that might is right? That it is moral for the strong to take what they want from the weak? There is the fact that most new drugs fail when tested in humans. They didn't fail in the earlier non-human tests otherwise they would be unlikely to go to human trials. The results, in those cases - the majority - aren't repeated in humans. And I am trying not to be rude but this forum is very different to other forums I have been on and I find it puzzling. I won't say more as I don't want to be rude. My 'agenda' is to educate those who might be reading this thread and who are being fed misinformation. I have quite a few clues about this subject. I have done research in non-biased sources. I have seen quite a bit of not-too-convincing information on anti-vivisection sites. But much more of that on pro-vivisection sites. I'll keep that in mind. Which thread? There's no information in this thread that convinces me that vivisection, oops, lab animal testing, is right or accurate. They might not know what pain is. What someone thinks is agony might be a mild ache to someone else. Other animals can tell us by their actions. Anyone with a dog or cat knows when the animal is suffering or fearful. Most countries have laws to protect various animals from cruelty. I am not alone in believing that they suffer and feel pain. Can a brain damaged human suffer? Or a one-week-old human baby? In my mind, using any animal that can feel pain or fear in ways that will cause it pain or fear or that will cut short its life, is cruel. As has been said before, at one time it was not thought cruel to kidnap humans, take them across the sea, and make them work as slaves. Cruelty can be an act that will cause pain or suffering to any animal and that you know will cause pain or suffering. Malice can come into it, but not always. Quite possibly true. I believe that it is cruel to use anyone against their will in ways that will cause them harm, fear or death. Some people don't believe that. There are even some people who don't think it's cruel to torture humans. iNow, in post 388 linked to some site that denounces AR people. Not all AR people are like all other AR people. Even if any of the actions were carried out by real AR people they are not representative of the majority. And, whatever AR people do it does not invalidate their argument that other animals are treated cruelly. This is well known. Probably why there is such an interest in pharmacogenomics. But other species are even worse models for humans than other humans are.
  9. I have copied and pasted excerpts from this discussion. It would have taken too long to use the quote system on all the posts I have responded to - too much going backwards and forwards. I don't think the quotes system tells us where a quote comes from. With all the pages preceding my post there could be some confusion. I will use the quotes system after this. This is a very long post but I couldn't let some of the things that have been said go without comment. Vivisection ? It is wrong because it is cruel. It is also scientifically flawed. No one can tell in advance if results in non-humans can be extrapolated to humans. No wonder that most clinical trials fail after the drugs seemed to work well in non-humans. What a waste of time and money. There has been so much corruption involved in medical research and drug development/marketing , and so much money has been thrown about in bribes and inducements, that the data these people produce cannot be relied upon. You can't even be sure that any data is complete or that whole studies, that don't support the desired outcome, haven't been hidden away. These people often speak with forked tongues. From this point I will start my answers with the initials PC. ---------------- Daisy, (post 16): 'What I will say is this....those of you out there who say "there's all sorts of other models we can use other than animals" please tell us what they are??? Are you talking about tissue culture....because if so, you are never going to recreate the situation that exists in a real living organ, such as cell-to cell-communication between different cell types. Not unless you have somehow managed to create an incredibly complex co-culture of cells such as that which exists in the brain. And in addition, those of you who are dead set against animal testing are obviously not undergoing ANY medical treatment EVER. Because just about any treatment you can think of (even surgical) has been tested on animals. So the anti-vivisectionists/anti-animal testing lobby, think about this....there is no modern medical treatment that hasn't been tested on an animal at some stage (even if it was hundreds of years ago) so if you are totally serious in your beliefs, you better not benefit from any of it. And another thing (just by the way) for those of you who think cell culture/tissue culture is the way forward....where do you think the cells and tissue come from....sacrificed animals usually.' PC -There are many things that can be used. Most of the initial discovery and much of the development of drugs involves in vitro (test tube-like testing) and in silico (computers). As well as in vitro and ex vivo, there are computer modelling of how drugs react, different types of imaging devices, epidemiological studies, post mortems, various bio chips, QSAR, and micro dosing. If there are any areas where these can't accurately simulate a human being it must be remembered that other animals can't simulate humans with any reliability. These other methods are being improved., and their evolution could be accelerated if enough funds were made available and there was proper co-operantion between developers. Other animals will never be humans. Even those that have been genetically modified are unreliable. Testing something in an ape or mouse won't give you a reliable indication of what it will do in a human. One difference between apes and humans could change how a drug is metabolised or change its effects. Vivisection could be responsible for the scrapping of drugs that were ineffective in, and harmful to, non-humans but that would have been useful to humans. It's interesting that vivisectors use the word 'sacrifice' when they mean 'kill'. The Aztecs used to sacrifice people. They believed in things as nonsensical as is vivisection. Perhaps people who believe in stupid things think alike. PC - If you, Daisy, are against, say, human exploitation you should never use anything that humans have made because at some point in history it has probabaly been made by exploiting humans. Non-Indian Americans had better leave America because the continent was developed by them by exploiting and slaughtering Indians. Pack your bags and get out by midnight. If you don't, you are as guilty as Custer and Cortez. Or so the reasoning of Daisy would have it. PC - Claims that a certain drug has saved someone's life might just be claims in some cases. How do we know the drug alone did it? It might have been the placebo effect of the drug that did it. Placebos have a placebo effect. A drug that has passed the clinical trials and is believed to be a miracle drug will have an even greater placebo effect - especially if the drug companies put out misleading advertising about it. It might have been the result of the person just getting better - as sometimes happens. It might have been a combination of factors. How do we know that the drug, or an even better one, couldn't have been developed without vivisection? Lance (post 27): '...but if killing my dog would save my brother then I would do it in an instant.' And Lance (post 37): 'Right, So If your brother had cancer and you knew that killing a rat would save him you would choose to save the rat instead of your brother?' PC - But you wouldn't know in advance what results would come from testing on your dog. As dogs are not human, the results could be completely different. And probably would be. The dog might indicate that a treatment was safe. And then the treatment could kill your brother. You wouldn't know until it had been tested on humans. Most drugs tested on humans fail because they are ineffective or unsafe. After being found effective and safe in non-humans. PC - What if testing on one human could save your whole family and everyone in your street? Would you be willing to let some human be experimented on? Perhaps a brain damaged orphan with less capacity than a dog to feel or think? BrainMan (post 44): 'I am willing to bet that those animals suffered less than the luckiest of rats living in the wild. We worked very closely with the animal welfare people, and the total comfort of the animals was ensured every step of the way. They were put down peacefully with gas so we could get to thier brains afterwards (and you just can't do that with humans). They generally had access to food, drink, and sex at a level unprecedented for wild rats. [What else do rats want, anyway?] We even managed to argue with each other a bit over which type of bedding was most comfortable for transport and such. There was some level of necessary suffering (like recieving injections), but I've seen humans put through far worse in experiments and walk away content.' PC - As rats aren't humans, you can't be sure that any neurological testing or any drugs would affect humans in the same way. It doesn't matter how comfortable the prisoner rats were - they didn't choose to be there. Most humans would prefer to lead natural lives, with all the discomforts and dangers, than to be kept safe in a prison. Especially so if they were being experimented on in the prison. The suffering of humans who walk away contented is irrelevant - they chose to undergo the suffering. Cap'n Refsmmat (post46): 'Seriously though, you want your animal happy before he is tested on, since stress can cause such a reaction. If you didn't treat them right, that wouldn't be very representative of the human population, which typically treated OK.' PC - It can't be known how much stress a lab animal is feeling or if the same stress will be felt by others or by the same animal at a different time. The data produced by such animals cannot be relied upon to be accurate. It can't be known what might cause stress at any given time. It could be different each time and with each animal. Cap'n Refsmmat (post 56): 'To program the computer, you need to know a heck of a lot about the animals that we don't know, and that means, yes: DISSECTING THEM!!!!!! Really, we don't know about every compound an cell in animals and humans, it would take an insane amount of research before we did.' PC - Knowing about other animals won't help to produce a computer programme for humans. You need to know about humans. There is already an insane amount of research and most of it is not applicable to humans. blike (post 60): 'If animals are our "equals", then we have no responsibility not to act like one.' PC - But we have the capacity to consider how much suffering we cause. We can empathise with others. Most other animals can't. We don't have to use them as models for our behaviour. Sayonara (post 63): 'That doesn't mean that you can take any random feature of any random animal and assume that there are similar processes behind it just because it looks a bit like a human response.' PC - The same can be said for any response to a drug in one species when comparing it to another species, such as a human. Lance (post 79): 'And those people with the website protesting a single company REALLY need to get a life.' PC - They have lives and part of their lives are dedicated to saving the lives of the innocent. Before you try to counter by saying they should be saving human lives, many AR people also campaign for human rights. And opposing vivisection is opposing bad science that fails to reliably find cures for humans. However much frustration or damage they might cause, they do not torture and slaughter animals, unlike the people they are campaigning against. Newtonian (post 114): 'Interestingly some hair dyes are no longer tested on animals, especially here in the UK.Which has led to some horrific injuries to women.' PC - Well, if they want to dye their hair, they should be willing to take a risk. Or use one that has been used for years and is known to be safe. Mokele (post 156): 'What about terminal animal experiments that aren't of medical use? Ones where the goal is simply to find out how the animal itself works; knowledge for the sake of knowledge. What would various people consider justifed?' PC - No, it wouldn't be justified. Just as medical experiments on non-humans are not justified. jdurg (post 157): 'Here's another way to look at it. If you went into an organic chemistry lab and threw some things together, would you be willing to put whatever you created right into your mouth? In a sense, by removing animal testing that is exactly what you'd be doing with any new "drug".' PC - You can't know what the drug will do in humans until after you try it in humans. The earlier non-human testing cannot be relied upon to predict what the drug will do in humans. As is seen when a drug is found to be unsafe in the phase 1 trials. Or later. Lance (post 190): 'Why should we ease every animal from harm. Why shouldnt we take advantage of animals? ' PC - In that case, why shouldn't we take advantage of humans? Mokele (post 192): 'EVERY university that does *any* vertebrate research *must* have an IACUC committee, which oversees all animal welfare and makes sure humane procedures are used.' PC - I'm not sure what the US legislation says but the UK one is so worded that any researcher can claim that the suffering that will be involved in their research is essential to the outcome. I'm sure that US 'humane' committees, if they work for the research establishment, just might give a nod to the establishment's needs to do research. Even if these committees are supposed to be independent there is no guarantee that they will really be independent. The committees that sit to decide which drugs should be approved often have people on them with vested interests or conflicts of interest. 'Humane' committees are unlikely to be any different. As I said above, the whole system is shot through with corruption and nothing these people say can be reliably taken as gospel. PC -Mokele said that intelligence evolved so we could take advantage of others. There are a lot of intelligent rapists, paedophiles, confidence tricksters and villanous polititians. The Nazi and Soviet leadership used their intelligence to subjugate and slaughter millions of humans. Such noble examples of human intelligence. Others use their intelligence to torture rats, dogs and monkeys, to turn chickens into caged egg machines, cows into bloated milk machines, ships into ocean-going fish death rafts, and buildings into slaughterhouses where millions of animals are slashed and stabbed in scenes that are reminiscent of mediaeval paintings of Hell. PC - Sayonara (post 197) mentions optically inverted vitamins. What are they? albertlee (post 208): 'Some of you said that animal testing indeed saves millions of lives, but on the contary, some said that it isn't accurate enough, because they have different physiology...... So, how can an inaccurate test on for eg, medicine save millions of lives???? Secondly, a topic like cloning, why do we examine this unsophisticated-still technology on animals first instead of human??? if it is not going to be accurate, why do we continue, which could be very unprdoctive??' PC - Are millions of lives being saved? Many drugs are used to alleviate something, such as pain, acne, high blood pressure and anxiety. Many of these conditions can be alleviated by a change of lifestyle. Many people are killed by prescribed drugs. One estimate - accepted by the FDA - is that 100,000 Americans die every year, and 2 million suffer serious side effects. Some approved drugs are found to be almost, or actually, useless. Most drugs are just slightly altered variations of existing drugs. Why is cloning done in non-humans instead of humans? One answer is that rats and monkeys never make complaints and are unable to sue. Why is anything done that might not be accurate? For some researchers, the aim is to stay in work and get grants - if they happen to make something useful, it's a serendipitous bonus. jdurg (post 216): 'If you give a drug to an animal test subject and it dies shortly after ingesting the drug, then you have a pretty good idea that it will be toxic to humans.' PC - But you couldn't be sure until a human is given it. And you can't be sure that a drug that does no harm to a rat or a dog won't harm a human. A drug that kills another animal might be a wonder drug for humans. tejaswini (post 248): 'and talking on the pro side it necessary that we test animals . because if we want to mimic the effects that the pathogen will have on human cells. then it becomes a esssential act.' PC - Very often, the pathogen does not do in one animal what it does in another. Three animals can all give different answers. You won't know which might apply to humans until you test it on humans - and it might do something completely different in them. The species differences are too great and unpredictable. staceisace (post 251) replying to YT2095: 'I'm sorry, but you are an absolute fool. firstly, when you or your kids get ill, do you turn down treatment? i didn't think so. we have a real problem here with animal rights campaigners, not just because of some grave robbing and sending threatening letters to elderly shareholders (god they are tough) but because of the misinformation and blatant lies they tell. if peole bothered to do proper research they would see that very few animals are used in ratio to humans, its not all cute rabbits and endangered monkeys. secondly, humans are used to test drugs after and this has been common practise since the 60s after the thalidamide disaster. i'm sorry, but unless you refuse drug treatment, do not use cosmetics and only shop for organic foods then you have no moral high ground whatsoever.' PC - If you or your children get ill, would you turn down treatment that had been tested on unwitting African children? Or something that had been developed by the Nazis with tests on Jews? The drug companies and many medical researchers tell more lies and much more egregious ones than any that AR people may have told. The lies of the drug dealers can, and do, lead to human deaths and disablement. Millions of non-humans are used in research every year. Many more than the humans who take part in clinical trials. Yes, humans are used to test drugs but, legally, most often only after they have been tested on other species. As for moral high grounds, because of the present, corrupt system, the only mainstream medical treatments available have all been tested on non-humans. Dr. Dalek (post 253): Often rare side effects aren’t detected until the drug reaches the market. Now many people opposed to Animal testing for drugs point out that using human cell cultures, and "simulated" organs such as Micro-brain (used to study cancer), pose no means of harming animals and are cheaper than using animals. However one has to ask the question, if these systems are cheaper than why aren’t the greedy, money grubbing corporations using them? Its because despite the use of said cell cultures one cannot get an accurate picture of what happens to a whole organism with many interacting parts from a cell culture, or a simulated organs. An organism is many interacting cells, tissues, and chemicals, not all of which are present in cultures. Now, I don't exactly like the idea of animals suffering, however I'd say that when introducing a new drug, some animal testing may be needed. Granted animals don't always react exactly as a human would to a drug, it would be good to know before using Human subjects if all the pigs, and rabbits died a month after the drug was administered. After all the effects of the drug might not be apparent or even existent for a long time, it might have a slight effect on the endocrine system, for example, and slowly cause a chain reaction within the body over a series of months. If that was found in even one of the types of animals used it would make people think twice about administering it to volunteers.' PC - There are many systems that can be used in the testing of drugs. They are very expensive to develop. It is not always easy to get them approved by the regulatory bodies. Competing companies and organisations own the patents on them. They don't want just anybody using them and learning their secrets. The greedy, money-grubbing corporations would use them if they were forced to do so. However, in a court of law more weight will be given to tests done on living animals than to those done on bio chips and computers. The tests done on living animals can protect the drug companies from law suits as they can say they did everything in their power to test for safety. There are many people who depend on the use of vivisection, from those who have never done any other work to those who breed and trade in lab animals. These people have a vested interest in keeping the present system. PC - You cannot get a reliable picture of what a drug will do in one species by testing it in another. There are too many differences. A whole organism does have many interacting parts but each species has differently interacting parts, and data from one cannot be reliably extrapolated to another. A drug might have an adverse effect on the endocrine system of a rat after one week, and on a monkey after one year. But it might have no such effect at all on a human even after 20 years. It is only when a drug has been tried in humans that you can know what it will or won't do. zyncod (post 254): 'Actually, such cell cultures are far from cruelty-free. I'll be decorous for once and not say how exactly they get the fetal calf serum that is an integral part of mammalian culture systems, but it's pretty disgusting.' PC - They take it from the still beating heart of a foetus in a slaughtered cow in a slaughterhouse. It is thought that foetuses feel pain and might feel it more intently than adults. This foetus might be close to birth time. Serum-free culture should be used. Bovine culture can contain diseases and cells that could affect the outcome of experiments. =================== IN THIS SECTION, 'S' IS USED FOR SAYONARA, 'B', FOR BOSUN. MY COMMENTS ARE IN UPPER CASE. Sayonara (post 259): Originally Posted by bosun I would just like to say that animal testing is WRONG! we shouldn't sacrifice an animals life for humans it is selfish and inhumane. S: These are called "conclusions". They come after the reasoning, not before it. BOSUN CAN PUT CONCLUSIONS ANYWHERE. THIS IS NOT A MEDICAL STUDY WITH AN ABSTRACT, METHODS, MATERIALS, CONCLUSIONS, ETC. B: People are saying that you can't prove that animals suffer pain but why risnk it? S: Because the current alternatives suck even more. IF BY 'SUCK' YOU MEAN THEY ARE NOT GOOD, THE VIVISECTION METHODS ARE MUCH MORE UNGOOD. B: im sure none of you would like to be caged up and only let out to be tested on. S: No, probably not, but that doesn't really mean anything does it? IT IS AN OPINION. PEOPLE ARE ALLOWED TO SAY WHAT THEY THINK. B: If humans want to live then it is them who should be sacrificed. S:Do you not see the fatal flaw in this approach? (pun intentional) THE MEANING IS QUITE CLEAR - SOME HUMANS WOULD HAVE TO SUFFER AND DIE FOR THE COMMON GOOD SO THAT OTHERS MIGHT LIVE. B: Why dont we test our products on rapists and murderers and pedofiles then there not just rotting away in a prison there being made use of. S: Because (a) that would be a severe breach of human rights, and (b) it would be worse than the "inhumane" behaviour you are currently decrying. VIVISECTION IS A BREACH OF ANIMAL RIGHTS. BEFORE WE HAVE TO START TALKING ABOUT RIGHTS, RESPONSIBILITIES, VOTING RIGHTS, AND STATUTORY TEA BREAKS, I MEAN THE RIGHT TO NOT BE IMPRISONED, TESTED ON AND KILLED. HUMANS HAVE NO RIGHT TO DO ANY OF THOSE THINGS. IF ANYONE BELIEVES THEY DO, THEN I WOULD HAVE THE RIGHT TO BELIEVE THAT I HAVE THE RIGHT TO KILL THAT PERSON IF I WANT TO. B: It is not fair because animals have no vioce and no way of defending it self it is slavery. S: The responses to this have already been made in the thread. Refute those replies instead of stating the same position again. PEOPLE CAN SAY WHAT OTHER PEOPLE HAVE SAID. NOT EVERYONE HAS READ THIS THREAD FROM THE BEGINNING. I DON'T BLAME THEM AS MUCH OF IT IS IRRELEVANT. B: Humans have took over everything and now they think they own the world S:Yes, you generally do own something when you take it over. It might not be top draw for all the fluffy bunnies but that's the way the trophic web crumbles and if they don't like it, they had better just go and evolve faster. DO YOU BELIEVE THAT IF I ENTERED SOMEONE'S HOUSE AND SMASHED THEM TO THE GROUND, I WOULD OWN THEIR HOUSE? B: Any way be sides the piont animal testing is wrong and should be band and especially for produncts like shampoo and body spray because that is even more pethetic!! S: Yes, let's ignore pharmaceuticals and life saving drugs. That will work. HOW DO YOU KNOW VIVISECTION IS NEEDED TO MAKE PHARMACEUTICALS? BECAUSE THE DRUG COMPANIES AND MEDICAL RESEARCHERS TELL YOU? ===================== reyam (post 262): 'umm, they do feel pain. if you kick a dog, it will yelp. if you step on a cats paw, it will yauwll and hiss.' PC - The poster you are answering said that some people have said you can't prove animals feel pain. Some people have, indeed, said that. Mokele (post 263): 'Frankly, is pure, non-applied knowledge worth some death? In my view, yes.' PC - Joseph Mengele would have been right with you on that, I'm sure. Mokele (post 263): 'It's a systems problem. You can test a drug on in-vitro stomachs and find that it cures indigestion without any side-effects, but without organism-scale testing, your company won't know that it also causes birth defects until the lawsuits start rolling in and thousands of lives have been ruined.' PC - You can test a drug in a rat's stomach and a dog's stomach without any side-effects. But it might kill humans. You do not know until you try it in humans if the rat and dog gave the correct answers. You hit the nail right on the head with your reference to law suits. That is why lab animals are used. Their data would be believed but the data from in silico and other non-vivisection methods wouldn't be - because for years vested interests have been spewing out propaganda. I can imagine a lawyer making fun of data from a machine but putting full faith in data from a mouse. Cap'n Refsmmat (post 266): 'But does it feel pain the same way a human does, or is that a reflex reaction to excess pressure?' PC - Do you feel pain the same way as other humans do? Sayonara (post 269): 'Please try to add something to the discussion next time.' PC - The poster was asking a question. Quite possibly in reference to the remark about rabbits having to suffer so someone can use a new shampoo without hurting their eyes. PC - If you are reading this, Sami17, don't be put off. Ask any question you want - as long as it's relevant. The person you were asking just might have had something to say and you could have asked another question or made a statement. And, judging by the responses after your question, some people wanted to answer you. They thought it was worth answering. Dr. Dalek (post 272): 'So you have no good strong argument but you make up for it with a big font?' PC - I think the big font was to emphasise that the poster thinks it is wrong. Some people here have said that ethics are a matter of opinion. The poster offered an opinion. Many think vivisection is wrong. You might not think so. Some people thought that it was not wrong for white people to keep black people as slaves. That was their opinion. Some people thought it was wrong. Their opinion. Not a strong argument for emancipation. Would you have commented about the anti-slavery supporters' lack of strong argument? scicop (post 277): 'As far as those who don't believe in animal experimentation, lets directly go to human experimentation, starting with those who oppose. Let's see if they're willing to step up the plate and take some injections of Avian Bird Flu for the sake of vaccine development 'I know some principal investagtors who would love to have a human guinea pig (providing that you sign the necessary waivers for accidental death, financial obligations, associated medical treatments expeditures, and liability). 'I don't see any PETA members volunteering themselves for research. I would have loved to test my recombinant constitive active p53 adenvovirus on humans.' PC - You can't be sure that giving bird flu injections to mice or monkeys will give you reliable information about humans. That information will only come after it is given to humans. Anything destined for humans should be tested without other species. The first dose in humans should be determined after other non-vivisection methods have been used, including microdosing. PC - There are humans in Africa who have been given untested drugs. After their governments were given large cash payments. There are humans in Africa who were given untested drugs, apparently without their government's knowledge. There are children in New York, diagnosed as having HIV, who were were given AIDS drugs in what are probably unethical experiments. Human experimentation has always gone on. Usually, we never hear about it. Usually, it is only when someone breaks ranks and tells the truth that we hear about it. Mokele (post 279): 'You have three choices: Animal experimentation, human experimentation on a huge scale (probably on the unwilling too, due to the numbers needed), and a total cessation of all medical and biological advances. There's no other option, period. PC - No. You can use all the existing non-vivisection methods, force companies and institutions who hold patents on new methods to co-operate, and pour massive amounts of money into developing and finding other methods. Massive amounts of money are now wasted on the present system and most drugs fail when tested on humans. A lot of that money is from taxpayers. All that is needed is the political will. But polititians can be swayed by the millions of pounds and dollars and the lobbyists (more than two for every member of the US congress) that drug companies use to get their way. PC - If you keep using the same methods, you will get the same results. Those results are that only about 1 in 10 new drugs that enter the human, clinical trials will be approved for human use. All of them will have had non-human data before they reach human trials. But the big drug companies still manage to make their millions in profits, so they are quite happy. Too risky to start doing proper research with all the costs in time, effort and money. PC - Pure knowledge might be of some benefit at some time. But knowledge based on human data is more likely to be of use to humans. How do you know how much share of the money to give to research that's done in the hope that it just might, possibly, maybe, perhaps be useful one day? Better to use scarce money looking at things that would be more likely to be useful now. Mokele (post 279): 'So basically, in any animal test, we cannot predict the outcome. Cancer drug trials could fail, while some useless work like mine could have implications I've never dreamed of. Either way, it's a gamble, so the ends cannot justify the means, since we have no way of assessing the ends before the experiment.' PC - You have no reliable way of assessing what results might be applicable to humans until after they've been applied to humans. Using non-humans will not reliably give you that knowledge. It's more likely to lead you up the garden path and into a blind alley. Whilst you are being led on this merry dance, humans are waiting for cures. blackhole123 (post 280): 'im going to pretend i didnt hear that.' PC - I have no bones to pick about that statement but it is strange that no one said the poster should try to add something to the discussion. Mokele (post 282): 'First, much of what the Nazis did was applied, not pure.' PC - We'll never know exactly what the Nazis did. Most documents were destroyed. Allied governments will have wanted any data for their own purposes and would not have wanted the source to be known. Nazis who did pure research would not have been able to use an excuse of trying to help humanity or the glorious aryan nation - more likely they would have kept quiet to try to cheat the gallows. lucaspa (post 285): 'Your opinion is not backed by the data. In my work, there is no other way to see if regeneration happens but to use animals. ' PC - Once again, the results from non-humans are not a reliable indicator of what might happen in humans. You say there is no other way but that has been said about other things that were thought to be impossible. Perhaps the much-vaunted pure research could throw up something by accident. If enough money is spent. What type of regeneration are you working on? GammaMambo (post 287): 'I've often thought about people on death row or in prison for life....why not?' PC - Because it is wrong. Even if it weren't wrong, how do you know people who have been convicted of a crime are guilty? In the last 20 years here in the UK at least 13 people who were convicted for murder were, years later, released because it was found that they were innocent. No doubt, there are many more innocent people in gaol. Do you think they should have been used for vivisection? lucaspa (post 295): 'Because "do unto others as you would have them do unto you" applies and using them as experimental subjects without their consent violates that. What if someone would say "how about everyone who uses "GammaMambo" as their screen name", why not?' PC - GammaMambo was expressing an opinion. He or she believes it is all right to experiment on certain humans. You are of the opinion that it is all right to experiment on non-humans. That is just an opinion, too. lucaspa (post 296): 'As I noted, male rats are quite capable of looking at newborn rat pups as a tasty snack. PC - Is it normal for rats to behave this way? Would a rat in the wild do this? There are male humans who kill babies; who have sex with four-year-old girls; who will rape anything that moves. Normal men are not like that. Are these rats like normal rats? Or are they stressed by the abnormal conditions in which they live? http://www.guardian.co.uk/uk/2004/apr/18/highereducation.research PC - Several sites about rats say that rats make good fathers. Of course, they are talking about rats that are not tortured and that haven't been driven insane in rat Belsens. PC - Some of these vivisection-supportng comments seem as if they are designed to mislead. lucaspa said, (post 302): 'Many years ago I witnessed an experiment where the rats were being injected in the abdomen every day for several months. After the first 3-4 days, I saw the researcher simply reach into the cage and pick the rats up by the scruff of their necks. No gloves, just his bare hand. The rats just hung there passively while the researcher used his other hand to stick a long 20 guage needle into their abdomen and inject the material. No squirming, no squeaks, NOTHING. If anything, they acted "bored". So, were they feeling pain or were they suffering? Not from any outward sign.' PC - Some animals have an instinctive behaviour that makes them go still when a predator catches them - they might struggle at first but soon stop. They don't thrash about much or vocalise. No thoughtful person would think they weren't feeling pain or alarm. Some humans, who are used to abuse, make no sounds when they receive their habitual beating. Are they feeling pain or are they suffering? Are they just bored? Perhaps they grow to like it. They give no outward sign. Animals that adopt this strategy may have an increase in opiates in their blood to dull pain - or may not - but would anyone like to test this by jumping into a tiger's cage to see if they become insensitive to pain? PC - Do you, lucapsa, know how to recognise pain in rats? It seems to me that either you don't or you are deliberately trying to mislead. As your job depends on causing pain or terror to animals, anything you say about vivisection should be taken with a large pinch of salt. PC - We really need to be careful when considering anything a vivisector says. They make their living causing pain and fear. They will say anything to try to justify what they do. lucapsa (post 307): 'The testing doesn't kill the animal. Instead, research animals are painlessly euthanized at the end of the experiment. There are only a few methods of euthansia allowed, and all of them are painless, unlike the hypobaric chambers used to kill unwanted pets.' PC - Why do vivisectors have to use euphemisms? When they talk about euthanising, they mean killing. It is killing, not sacrificing. Another euphemism, 'Final Solution', sounds nicer than the reality of what it meant. lucapsa (post 307): 'Now, I have used rabbits as experimental animals to test a new treatment for osteoarthritis. This treatment would completely cure arthritic knees and prevent people from having total hips or knees done because of the pain and crippling of arthritis. Would you have me stop? If I do, then you and any of your loved ones will never get that cure.' PC - Has your research found a cure? I would have you stop what you are doing. I would have you do human-based research, which would use every non-vivisection method that was needed. lucapsa (post 307): 'Even at a 1,000 animals a day -- the number YOU quoted -- that is only 365,000 animals a year! You need to get your own facts straight' PC - Sciecewiz originally said that over a million animals a month are killed in vivisection. In the UK alone, more than 3 million animals were used last year. I'm sure that at least 2 million of these will have been killed. It is estimated (estimated because not all animals are recorded) that well over 100 million animals are used each year in labs. How many are killed? Probably most of them. This estimate comes from anti-vivisection advocates the BUAV and also the Hadwen Trust. Some people here might not believe the figures. Perhaps they would prefer to believe the lies and propoganda of the drug-dealing companies. lucapsa (post 307): 'Do you know what an Institutional Animal Care and Use Committee is' PC - Do you know how much corruption there is in medical research and drug making? Can any committee be fully trusted when the drug companies want profits and have millions to use in bribes? Cap'n Refsmmat (post 308): 'You do realize that the video was probably horribly biased, don't you?' PC - I don't realise that. I know people who have been in those hell holes. And they've told me that chickens are crammed into cages, and dead and injured birds are in cages. Mr Skeptic (post 310): 'Animal testing speeds up research and in doing so saves human lives and increases human comfort.' PC - How do you know it speeds up research? How do you know it is not holding up research? Don't ask the vivisectors, they are biased. lucapsa (post 315): 'In the United States ALL clinical research MUST go through an IRB -- Institutional Review Board. The purpose of the IRB is to safeguard the interests of the test subjects.' PC - Did you know that many, or sometimes most, members of IRBs have financial connections of some sort with drug companies? Can these people be trusted? Perhaps many, or most can be. Perhaps not. The same can be said for those bodies that look into drug safety, drug recalls, and everything to do with drugs. The whole system needs changing to ensure corruption can't raise its ugly head. PC - lucapsa then said that he or she doesn't know of payments for phase 1 clinical trials. The recent phase 1 trial for TGN1412 involved payments to volunteers. Non-patients will likely always be paid for taking part in trials. It would be hard to get them otherwise. Unless they are in Africa or India where they are duped into thinking they are getting some revolutionary, already tested and safe, drug. Mr Sceptic (post 316): 'Competition and natural selection are not kind. Life is a competition, and we can compete pretty well.' PC - But humans can be kind, if they choose to be. We don't have to take 'Nature red in tooth and claw' as our model. lucaspa (post 317): 'Larry Niven did a series of science fiction stories exploring the unintended consequences of this policy -- as well as requiring those on death row to be organ donors. Basically, if your life and the quality of your life depends on criminals, it becomes VERY tempting to legislate more and more crimes as deserving the death sentence. In one story, the end result was that too many traffic tickets within a period of time was a capital crime!' PC - A certain communist country in the far east has a very high execution rate. One theory about why they sentence so many people to death is that they want to harvest their organs for transplants. I wouldn't put it past them. Sayonara (post 325): '1 - We definitely know that testing on animal subjects relieves massive human suffering, 2 - We do not yet know whether or not testing on animal subjects causes animal suffering.' PC - Do we know that vivisection relieves massive human suffering? I and many others say it doesn't and that it is holding up the relief of massive human suffering. And that any relief is more likely not due to the vivisection but is in spite of it. Can we know if others suffer? As for vivisection victims, we know they can and do feel pain, terror and stress. That is enough for me and many others. Sayonara (post 327): 'Well this is the thing, isn't it? Does a flinch response to pain or a learned evasion response indicate a form of suffering which is comparable or analogous to the human perception of suffering? Read back a few months for previous discourse on that issue.' PC - If a human is seen writhing on the ground, does this mean they are in pain or suffering? How can we know? They might look to us as if they are suffering something that we have suffered, but how do we know that we are not mistaken? lucaspa (post 333): 'Well, you have just admitted that you are not holding a rational discussion because you won't accept any data contrary to your view.' PC - I took lovejunkie02's meaning to be that he or she wouldn't believe any vivisector who claimed that the lab animals are treated humanely. I would have difficulty believing such a person. People who experiment on anyone who can feel pain and terror would not convince me that they are humane or that they treat their victims humanely. Just as I wouldn't believe the rapist who says that his victims were asking for it. lucaspa (post 333): 'The reason I ask is because the animals I work on -- and yes, I do animal research -- are treated just like human patients. Right now we are doing an bone gap model in rats. The rats are anesthetized with ketamine and acepromazine....' PC - I'm not sure that I would believe anything you say. See above for one reason. How do you know those animals feel no pain? Human patients have reported feeling pain whilst under anaesthetic. Some people here - I'm not sure if you are one - seem to doubt that other animals feel pain or are fully aware of it. Those people would not understand the need to give anaesthetics or analgesics. Animals that feel no pain can still feel fear whilst conscious. lucaspa (post 333): 'After all, we do have to exploit other species as animals. Isn't a farmer's field another type of cage? Would you have use give up farming?' PC - If you are talking about sheep and cows, yes, I would have us give up farming. Animal farming. mooeypoo (post 336): 'Perhaps but the problems start with defining what a "Good Cause" is (to you it can be one thing, to me another, and we each can consider each-other's subjective 'good causes' as absolutely not worth it), and the second problem is what TYPE of actions justify what type of means.' PC - Yes. There were causes good enough for the Aztecs to sacrifice humans. There are causes good enough to lead one nation to attempt genocide. lucaspa (post 345): 'I really don't think you are aware of the regulations in place currently on the use of animals in research. If you want, I'll attach the forms I have to fill out before I can do research on animals. Each investigator must have his research approved by the IACUC, which consists of scientists and non-scientist members of the community. The purpose of the IACUC is to ensure that the animals are used to develop treatments for diseases and are adequately protected from pain, not to rubberstamp the researcher. As a member of an IACUC, we shut down the research of a scientist for not taking proper care of his animals.' PC - I have already mentioned that committees and regulatory bodies involved in this cruel business can be corrupt. Some have been seen to be corrupt. Whatever is decided, there's no way to ensure researchers stick to the rules. In the UK, at least, there are very few inspectors to inspect thousands of experiments. The ratio of inspectors to researchers will be less than the ratio of police to bank robbers. Bank robbery is against a law. That doesn't stop bank robbers robbing banks. They know there is a high risk of getting caught. They do it all out in the open. The punishment if caught is a long prison sentence. Researchers have little chance of getting caught if they break their laws. They do it all behind closed doors. The punishment - if any - is minor. Safety laws and approval committees are only as good as the personnel involved. And their resistance to bribes. lucaspa (post 345): 'It's not entirely "subjective". We can define what ethical principles we agree on (and these are not derived "subjectively", either) and then reason to conclusions.' PC - I, and many others, would not agree with you on what is ethical. lucaspa (post 345): 'What I find is that a lot of the emotion against using animals for testing comes from examples that are stated but do not exist. Some of the examples are outdated. They did exist but were the reasons regulations and IACUCs were established; to eliminate those situations.' PC - No, I don't believe that IACUCs or the FDA can eliminate those situations. cellbios (post 356): 'The funny thing is that some drugs, etc may be very effective when studied in vitro but are toxic once in vivo.' PC - Another funny thing (but not funny for the rats and monkeys) is that a drug could be effective and safe in rats and monkeys but be useless and dangerous in humans. lucaspa (post 358): 'Nan, are you aware that any animal testing must be done under appropriate pain medication? Euthanasia must be done in a painless fashion. It's part of the requirements every scientist must go thru to get permission to do animal testing.' PC - I might have mentioned this before but I don't believe what vivisectors say. It is law that cattle should be slaughtered whilst unconscious in slaughterhouses (unless they are killed in ritual slaughter) but I know that the workers sometimes don't bother to obey the law. Humans cut corners, they don't always bother to adhere to rules and regulations. lucaspa (post 358): 'We do say this. Because it is true. All the wonderful medical treatments you see today, all the "miracles" of modern medicine, are due to animal research. Do you want us to stop those? Do you want us to stop looking for cures for Alzheimer's because you don't want animals to "suffer"? In particular, think of whether you want us to stop working on a cure for a disease that your parents or your children have.' PC - How do you know these wonderful cures couldn't have been made without vivisection? Or that vivisection resulted in better cures being scrapped? Using non-humans is a lottery. You can't know which data will be applicable to humans. Most of it isn't. lucaspa (post 358): 'Again, already being done! NIH comes out with Requests for Applications for NIH grants on new cell culture and computer modeling techniques to cut down the number of animals used. Go to the NIH website and look at the grants requested and awarded.' PC - I'm sure it's a drop in the ocean compared with the money spent on marketing drugs. lucaspa (post 358): 'ALL lab facilities must be accredited. One of the requirements for accreditation is policies in place that have the animal care attendants report any suffering of the animals.' PC - The same could be said about children's homes and retirement homes. From time to time, reports of abuse emerge. But the residents are not supposed to suffer abuse. Does that stop abuse? Does it heck as like! iNow (post 361): 'I'd argue that most people don't want to harm animals. That makes good sense. Where I struggle is when people are blinded to the reality around them in their attempts to force such testing to stop. The world is complex, and not everything is so black and white. Sometimes we have to do cost-benefit analyses and make tough choices.' PC - Animals are complex and one species cannot be a reliable model for another. When all the steps have been taken to test a drug at the cellular level and its chemistry has been analysed and it is time to test it in a whole, living orgnism, that organism should be a human. By using QSAR, imagining and microdosing. At present, the first human to test anything new IS the first human to test it. Nothing that has gone on before can reliably predict what it will do to that human. At present, all the drugs that are first tested in humans have lab animal data (with some rare exceptions). Most fail when tested in humans. Most of the failures are for safety and efficacy reasons. PC - If there are any perceived or actual limitations in any non-vivisection methods it must be remembered that the limitations in vivisection are legion - as vivisector supporters here have alluded to. Non-human animals will never be humans. Non-vivisection methods can improve. The only possible barrier to their improvement would be caused by political and commercial inertia or rivalry. lucapsa (post 362): 'All those determine the actual concentration of the drug at the particular site you want it.' PC - But the concentration in a rat might not be the same as the concentration in a human. Only after a human has concentrated it can you see how the human has concentrated it. lucapsa (post 362): 'People who want to stop all animal testing must face this reality: to give up animal testing means giving up new drugs/treatments for human health and new cleaning solutions and other chemicals that make our lives easier. If you give up animal testing, you freeze our medical technology and chemical technology where it is today. Is that what they really want?' PC - New cleaning products are not needed - especially not if their development leads to the harm, pain or death of any animal. Non-humans can't be relied on to predict toxicity or efficacy. Has anyone mentioned that before? Mr Sceptic (post 365): 'TheAM, if a drug works for an ass, then it will probably work for you. If a drug is safe for an ass, it will probably be safe for you. This is because you and an ass are both mammals, and are very similar at the cellular level. Basically, animal testing can find medicines that work for all or most mammals, rather than only a certain species, since mammals are so similar to each other.' PC - But one difference anywhere along the line between two species could mean that species A is cured but species B is crippled, sent mad or dies. Mr Skeptic (post 365): 'If you actually had honest doubts about animal testing, consider that it is only one phase in an imperfect process of elimination.' PC - Indeed it is imperfect and it is the vivisection bit where most of the imperfection lies. Mr Skeptic (post 365): 'If you have a better process for finding new medicines, feel free to share.' PC - Do everything the way it is done now but leave out the vivisection. Use QSAR and other in silico, PET, AMS, microdosing, fMRI and uncle Tom Cobley and all to test for toxicity, find therapeutic and starting doses, PK/ADME, PD. If any part of this process isn't as near perfect as it would be liked, spend some money, pull out all the stops, bang heads together, change laws and do whatever is necessary to ensure that it becomes nearer to perfect. Human lives depend on it. You can't continue to *****foot around with the Victorian ideas of vivisection. Vivisection is not perfect and never will even approach perfection. You would have to change other animals into humans before they would become good models and predictors for humans. Far easier to change the system than change the animals. Mr Skeptic (post 371): 'That's the part you are not understanding. If any of the tests show a drug is toxic, the drug gets dumped. Why test it on animals if it kills cells?' PC - The drugs that reach clinical trials have been through these batteries of testing. But many fail in the trials because they are toxic. PC - I interpreted TheAM's question as being about the source of the cells and that they should be human. The second part of his or her statement was, I think, pointing out the absurdity of comparing human and non-human to find something about humans. TheAM's response was to: 'Then, the chemical can be tested on live things, working the way up from cell cultures, tissues/organs, animals, and finally people.' PC - Which, to me, means it is tested in non-human cells and then human. What if it shows toxcity in non-human? Is it then tested in human cells? I would say it should be, as the non-human cells, not being human, cannot reliably predict what will happen to the human cells. And then, you have to decide which results to believe. But far better to leave out the non-human cells. lucaspa (post 372): 'That is the fallacy. Pharmacokinetics are remarkably similar between mammalian species. The distribution of metabolic routes of drugs is different, but all the routes are there in different mammalian species.' PC - Slight differences anywhere can have large implications. lucaspa (post 372): 'That's a bare assertion. Please post the peer-reviewed scientific papers to back that up' PC - What, the peers who are vivisectors? That's rather like asking a freemason to back up the story of a fellow mason or to denounce freemasonry. lucaspa (post 372): 'Because of evolution, the differences between species are not as great as you make out.' PC - The differences are great enough. If they weren't you could go straight from mouse to patients with as much confidence as going from Canadian to Russian. lucaspa (post 372): 'Again, untrue. Because of evolution many of the biological systems are very similar.' PC - Not similar enough when condidering how a drug will work. lucaspa (post 372): ' The actual record is that animal efficacy is a strong predictor of human efficacy.' PC - Can you guess what I am going to say? Correct - give that person a cigar! It is not strong enough when considering what a drug will do. It is very late. I can hardly keep my eyes open. To be contiued.
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