Is the FDA undermining its own study and the experts it sent to review it?

The American Psychological Association has warned that the FDA may be winding down its own primate study, despite having started– but not completed, nor made public– an independent FDA review process. Why the FDA would stop the study before any report has been published will lead many into further questioning the influence that certain animal rights groups appear to have on FDA policy.

Last September, British chimpanzee researcher Jane Goodall wrote to the FDA to criticize one of its scientific research programs aimed at better understanding nicotine addiction and its effects on young people. As reported by the Washington Post, the agency’s head, FDA Commissioner Scott Gottlieb, responded to Goodall with a publicly posted letter in which he indicated the research had been halted.

Squirrel monkey. Source: Wikipedia Commons.

Gottlieb’s response to Goodall raised concerns in the scientific community and beyond. Multiple organizations responded by reaching out to the FDA commissioner. Scientists and scientific organizations questioned the federal agency’s unusual actions in abruptly halting an ongoing and approved study without providing full information about the decision-making process, the nature of the review, and the timeline for a public report.  Speaking of Research published a letter of concern signed by 46 researchers and endorsed by 78 additional scientists, including well-known experts in substance use disorders. We also analyzed the problems in Goodall’s letter to FDA and her previous efforts in various campaigns against animal research.

In a publicly posted letter, the American Psychological Association (APA), American College of Neuropsychopharmacology (ACNP), and College on Problems in Drug Dependence (CPDD) wrote:

“Your decision to suspend the research is extremely troubling because it appears to have occurred without any substantive input from experts in the scientific community who have deep knowledge and understanding of research on substance use disorders. Furthermore, the methods and technologies used in this study have been rigorously validated and commonly used in studies of substance use disorders, including research that is funded by other federal agencies, such as the National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA). Your letter to Dr. Goodall states that ‘currently there are still some areas for which non-animal testing is not yet a scientifically valid and available option.’ We strongly agree with that statement. We also believe that it falls short of fully recognizing and communicating the important role of nonhuman animal research in both basic and applied science.”

Months later, Gottlieb has apparently not responded to concerns raised by the scientific organizations, nor has the FDA provided a public account of the review process mentioned in the Sept. 25 letter to Goodall. In that letter, Gottlieb mentions two review teams:

“After learning of concerns related to the study you [Goodall] referenced, I directed the Agency to place a hold on the research study earlier this month. Accordingly, at this time, all experimentation involving the monkeys in the study you referenced has been halted. I asked for a medical team of primate experts to conduct a site visit to evaluate the safety and well-being of the monkeys and to understand whether there are additional precautions needed. I also appointed an independent FDA review team, led by senior career experts and with the guidance of primate veterinarians, to assess the science and integrity of the animal research process for this study. I also asked this team to evaluate whether the re-initiation of the study you referenced is necessary to fulfill FDA’s public health responsibilities, or if the study should be halted indefinitely.”

To date, to our knowledge, there has been no public information about what appears to be a highly unusual, perhaps unprecedented, process. The impetus and criteria for review; the identity, expertise, and selection process for the review teams; the charge, scope, and process for review; the review teams’ reports; the agency’s conclusions; whether these represent a change in policy for FDA research all remain largely unknown.

Now, however, there are indications that the agency was already taking actions to end the research program well ahead of the conclusion of the review or response to the concerns. Today, APA expressed continuing concern and request for response from the FDA in a science alert titled, “FDA Shuts Down Nicotine Research Study, Overlooking Concerns of Scientific Organizations:”

“Update — There are indications that prior to completion of the FDA review and promised report, the agency has already taken multiple steps to effectively end the research program. Even if the reviews are positive, the research cannot be resumed with those animals, and the FDA is preparing to transfer the study animals to new locations, some of which may not ensure adequate protections. This process upends procedures of the National Center for Toxicological Research, which sponsors the research, and ultimately wastes public dollars since the study cannot be followed to its conclusion.

Conclusion  FDA appears to be ignoring the concerns of established scientists and scientific organizations, while placing nonhuman animals at potential risk and failing to fund research in the public interest.”

We have previously expressed concern about the process and potential precedents in the way FDA has approached this research. We call on the FDA to explain its procedures and rationale for this abrupt action, including why it did not seek counsel from experienced substance abuse researchers who were qualified to evaluate a study that had been lauded and highly rated. For a federal agency to suspend and ultimately stop research on a critical public health topic using such an unusual and opaque process is of deep concern for public interests in scientific and medical progress.

We again call on the FDA to provide greater transparency about the motivations and evidence behind its decision to terminate important research. The FDA is in a better position than most to understand the important role that animal studies play in the development of modern treatments. Instead of seemingly pandering to animal rights groups, it should be at the forefront of the scientific community – explaining how and why animals are used to further medical developments.

Speaking of Research

 

3 thoughts on “Is the FDA undermining its own study and the experts it sent to review it?

  1. This isn’t about the scientific method or even animal welfare. The Animal rights Philosophy was originally created by Adolf Hitler to promote hatred toward all races other than the suppose Aryan race. By using the principles of breeding better stock the neo Nazis could create a special category for their preferred Aryan race of people. Animal rights was created specifically by Hitler and his followers to demonstrate that human beings were not divinely created equal by God, but that there were higher and lower levels of human beings and the Aryan Race was the most pure and therefore should rule above all other races. Hitler felt that eating meat weakened the Aryan race. In fact science has proven that not eating meat actually causes the human brain to not be able to think rationally at all. These philosophies have been appropriated by the radical animal rights cult members of such organizations as HSUS, ASPCA and PeTA who promote that all species not pure “native or original species” should be removed and that veganism is the most healthy diet when in fact it has been shown by science that eating no meat causes irreversible brain damage that causes the brain to be unable to think rationally. The Human brain requires ACTIVE Vitamin B12 which is only found in meat based products such as eggs, milk, meat and even fish. Today these people are now attacking any science that does not support that view point. Even though scientific studies have shown that the human brain requires meat to think rationally and that without meat the only source of ACTIVE VB 12 those brains so deprived will become irrational and overly emotional in their response. Only a few plants carry VB12 and it is the INACTIVE TYPE that does not move nutrients to the brain cells. This is the same type of mind control promoted by radicals who used this method to control the minds of their followers. In fact the first step toward this type of mind control was to remove all meat from the diet of the followers. This allowed them to get their followers to do whatever they said from giving over all money, to working towards this goal of promoting animals over human beings and lowering the status of all human beings except those who run these organizations. Even to giving their own children poison Kool-aid as seen in the Jim Jones cult. These organizations HSUS, the ASPCA, PeTA and the USDA are now peopled by such extremists. These extremists work to control all food sources and stop all scientific research as it runs counter to their lies put out by the so called Physican’s committee for responsible medicine created by these radical groups. If these groups can remove active VB12 from the diets of every American then they can control the minds of all Americans. Hence their reliance on ads that tear at the heartstrings and the laws they need to pass, that take away personal rights from all citizens. That is to remove your property rights and your right to face your accusers in a court of law. These people swoop down on unsuspecting farmers and those who work with animals and remove their animals under laws they themselves wrote that give no possible recourse. The first step is to remove the animals with fines so large you cannot afford to pay then you can’t afford to get your animals back. If you do, it has cost you so much time and money you will probably find yourself no longer interested in raising animals. They make the process so obnoxious that only the very wealthy can fight them. Even wealth does not protect those susceptible to nasty propaganda such as businesses that depend upon what a customer thinks about their product. If you don’t recognize this method just google the JIM JONES cult, or the Savitri Devi prophet who loved Hitler and became the most active neo-Nazi promoter in the US. Goebbels also agreed with Hitler that “meat eating is a perversion in our human nature,” and that Christianity and equality of citizens was a “symptom of decay,”. The Nazis abolished moral distinctions between animals and people. The result was that some animals could be considered ‘higher’ than some races of people. Thus specific people identified by certain physical characteristics could be promoted as closer in purity than others allowing the believers to make the laws by which they insisted everyone should follow, not God, not citizens rule, not democracy. These radicals have even entered into our law schools not realizing that they are eating away at the rights of all human beings to the nutrients their bodies need. They don’t even acknowledge that carnivores require this food called meat. These cults intend to end democracy by slowly removing all personal rights the most important being are property rights, better thought of as personal freedoms to choose to eat meat which is at the root of these cults because without it they cannot make the rules nor can they create followers. One must ask why at the basis of all of these cults formed in different parts of the world over time all rely upon adherence to a strict vegan diet when its been proven to weaken the human mind. In fact we know that we owe our brain power not to plants but to eating and cooking meat which allowed our brains to grow to hold about 100 billion neurons (or nerve cells) while the nearest animal species cannot compare nor do the things we can do to live as a society. Although animal rights cult members try to rig the comparisons by creating fake committees to promote their views. No monkey or ape has built something that compares with the ability of human beings. So they promote that their very basic structure is more correct than what the human brain can do. At the basis of this animal rights cult is a desire to control all human beings by removing their ability to think for themselves. Thus the animal rights cult member ignores laws, ignores facts and of course must attack all scientific methods. Their danger to all societal structure is in controlling the minds of all human beings through propaganda, emotions, and lies. Nothing facilitates that more than facebook or the internet where such people can promote their viewpoints without being held to the peer review process which is what the USDA is doing now by avoiding the peer review process. Not only avoiding it but ignoring scientists altogether. It is time to stop avoiding this take over of the USDÅ, but to push back with demands that science prevail and not this radical extremist philosophy promoted strait out of the neo nazi literature of the past. By the way they had to push for the strict vegan diet because vegetarianism promotes eating eggs, drinking milk and eating fish where one can get active VB12. So being a vegetarian is not the same as being vegan. We all know that people who don’t get enough protein leads to the condition known as kwashiorkor. Lack of protein can cause growth failure, loss of muscle mass, decreased immunity, weakening of the heart and respiratory system, and death. Protein is built from building blocks called amino acids. Our bodies make amino acids in two different ways: Either from scratch, or by modifying others. A few amino acids (known as the essential amino acids) must come from food.
    Animal sources of protein tend to deliver all the amino acids we need. Other protein sources, such as fruits, vegetables, grains, nuts and seeds, lack one or more essential amino acids and most importantly for our brain the essential vitamin ACTIVE VB12 found only in meat based life forms not plants. Vegan diets remove all essential amino acid combinations that are healthy for you such as chicken, fish, white meats and red meat which eaten occasionally will provide Active VB12 whereas no plant material can provide this truly essential vitamin required by the human brain. If the scientists of the world sit back and allow these cults to propagate, to influence your children, then the human race is doomed faster than it would be if one person set off an atomic bomb. The human brain would disappear except in a select few who hold the reins of control. Are you ready for a world without true science? Facebook is not peer reviewed nor is the internet since anyone can change anything at any time on the internet. You will notice the first to attack this reply will focus on details rather than on what is actually happening worldwide with these groups and how uniform their tactics are in pushing the public to follow their ideas. They are in our schools, in our courts and in our lives slowly taking it all apart until you will have no food other than what their laws control or allow and it certainly won’t be ACTIVE Vitamin B12.

    1. I think animal rights, as a movement and philosophical idea, significantly predates Nazism or Hitler. Science has not proven that eating meat causes humans to lack rationality. Vitamin B12 can be found in varying cereals, or even just taken as vitamin supplements.

      We should reject nonsense from all sides of the argument

  2. Very much resembles the type of process and “logic” that NIH used to respond to HSUS objections to all “invasive” research involving chimpanzees that resulting in the appointment of a group of “experts” with little or no chimpanzee expertise that resulted in NIH imposing a moratorium on ALL/any research – even those that would benefit wild populations of chimpanzees.
    This decision was heavily biased by animal rights pressure and impacted important health research studies.

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