The FDA and You
Up Close and Personal
We’re still waiting to see what the FDA will do about Phase 2 of Dr. Denise Faustman’s BCG trials. That is, whether they will be as unreasonably restrictive as they were in Phase 1.
In Phase 1, as you recall, Dr. Faustman had asked for 12 test subjects. The FDA said she could use 3 test subjects each receiving a total of two doses of BCG, timed 4 weeks apart. Ref:
Do you remember wondering how there could be any measurable effect with the small amount of medication timed so far apart? And oddly, with so few test subjects. It seemed like the FDA was far from excited about the possibility of finding a cure. However a statistically significant change was proven, enough to warrant another study.
BCG has rid the world of Tuberculosis since about the turn of the century, and relatively few health problems have occurred throughout the lives of the people who had been treated. However this process has never been used to treat Diabetes 1. Perhaps this is the reason the FDA were so cautious?
The FDA’s Job
The FDA is the regulatory agency that tests pharmaceuticals for their safety. It prevents Snake Oil salesmen from plying their ineffective or unhealthy wares on an unsuspecting public. The process it uses is the scientific trial.
All well and good. But what if I told you that no entity anywhere has an obligation to publish a study either in whole or in part? Thus if a study found a drug or device that caused a health problem, or if a drug or device helped a condition, there is no legal obligation for Pharma to report it to the FDA or anyone else.
In Bed Together
The FDA has long been accused of having a conflict of interest with Pharma. In fact there is so much Conflict of Interest (COI) that it would be laughable if it wasn’t so shocking.
The most obvious COI is the revolving door of employees between Pharma and the FDA. There is a constant stream of experts who work for Pharma a few years, then for the FDA, then back again. For example, the current Head Commissioner of the FDA has been paid huge amounts in consultation fees for an amalgam filling company. Quote:
1) Margaret Hamburg had an ethical problem that should have prevented her from being involved in the amalgam rule
Not until mid-July, after being pressed by a trade news reporter, did Commissioner Hamburg admit that she had to recuse herself from the amalgam rule "based on the requirements of federal ethics laws and the standard of ethical conduct."11 She refuses to explain what led to her recusal, but it was believed to have been her intertwining relationship with dental products colossus Henry Schein Inc.,12 a relationship that began in 2003, existed until the day before the rule was announced on July 27, 2009, and caused Schein's CEO to boast the morning after the rule was published on August 4.
While on the corporate side of the revolving door, between stints in the Clinton Administration and the Obama Administration, Dr. Margaret Hamburg served on the board of directors for Henry Schein, Inc., receiving, for example, $282,365 in 2006 and $249,151 in 2007 for the handful of hours generally involved in being a corporate director. With a court settlement requiring FDA to classify amalgam within the first 75 days of her taking office,13 Dr. Hamburg's remaining interest in Schein – including stock options held until July 27, just 24 hours before the rule was announced – should have resulted in her immediate public recusal from the amalgam rulemaking.
(2) Hamburg was involved in the rulemaking despite her ethical problem
And there have been similar accusations against other former FDA heads and executives. Also see: http://theconversation.com/show-and-tell-conflicts-of-interest-undeclared-for-clinical-guidelines-3890
The revolving employment door between pharma and the FDA is explained by there being a shortage of experts in that field. Whether they work for Pharma or the FDA, you would think their mandate would surely change from one of making money, to holding the public health in highest regard? It's possible. But the only way to know for sure is from a variety of sources, including the people who work for, or used to work for Pharma.
Oh Those Entrepreneurs!
Both Pharma and the FDA have been accused of buying the research patent to studies that show some rate of cure. This means that neither the original researcher nor other scientists interested in pursuing that line of reasoning, can use that same method. Many promising studies have never been heard from again. E.g. the successful regeneration of Beta cell functioning with Capsaicin by Drs. Dosch and Salter. www.naturalnews.com/021345.html Dr. Dosch is on record as saying that the study had been cancelled due to lack of funds!
The FDA bases its decisions on studies submitted by Pharma on their own drugs. There is absolutely no way of knowing if the results have been altered in any way. For example, if Pharma sponsors 10 studies on a drug, they might publish the only study that had positive results. Ref:
Note especially at 5 minutes 30 seconds.
The FDA uses advisory panels or review boards to determine if a drug is safe. These review boards are made up of employees of Pharma who contract out their advice. Also see:
Both FDA and Pharma have been accused of putting the profit motive before issues of safety. Former employees report they were intimidated into overlooking health risks in order to pass drugs that later harmed people, but were profitable for the Rx companies. Ref:
There have been many cases of drugs being passed with only a six month or less testing record which later on turned out to kill people. Example: Vioxx, Avandia, Gardasil, Paxil, to name only a few. By the time doctors started noticing a pattern (reading the wrong studies perhaps?), many years had gone by, but by that time, the company had already grossed enormous profits. In some cases the company received a fine, which was miniscule in comparison to those profits.
Most shocking of all, both the FDA and Pharma have been accused of forcing scientists to alter their findings through threats and intimidation. If scientists comply, it forwards their financial, employment, or academic careers. If they don’t comply, they are publicly ridiculed, threatened with expulsion, or lawsuits.
Also, this is an article from the NY Times that showed 80,000 leaked documents where the FDA was spying on its staff, firing and intimidating scientists for refusing to rig outcomes.
Lines of Communication
The FDA has been accused of all these things, and you would never have heard about them if it weren’t for the internet. But can you really believe anything you hear on the internet? Shouldn't you just believe the information that official sources are telling you?
Doctors get their information from medical journals, like the New England Journal of Medicine, Journal of American Medical Association, Journal of American Physicians and Surgeons and so on. Doctors believe this information because scientists have designed and conducted the trials, and medical journalists who have a great deal of scientific knowledge, review and publish these findings. Aha! A place where Truth resides!
An independent study has shown a much greater chance of a drug being seen as risk free IF the drug company that makes the drug SPONSORS THE STUDY. Quote:
In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.
Up until recently, the New England Journal of Medicine has not been required to disclose the sponsors of drug trials. Please see this informative quote from an article by a former Editor of the New England Journal of Medicine, Marcia Angell: (about ¾ of the way down, but the entire article is a must-read).
“The problems I’ve discussed are not limited to psychiatry, although they reach their most florid form there. Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
Also see: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001280
For a discussion on doctors who have received payment for promoting off-label uses of products.
So if doctors believe only what they read in these hallowed publications, then the information is skewed in favour of Pharma and they would never know any different. This makes doctors no better than for profit drug pushers. In most cases, I would hope it’s unknowingly, but in others, apparently not.
Now a story from my own experience. My own family doctor, a good, kind, gentle and intelligent man, refused to discuss Dr. Faustman’s work with me. His face got very red and he told me I had to leave his office. So I went to a walk-in doctor to get her opinion. Having a pleasant manner before this, her face turned beet red and she said in a loud, shaking voice “Why haven't I heard about this before? Do you expect me to prescribe something you learned about on the internet.” She said ‘internet’ like it was vile.
Well Missy, to that I’d say it seems that I have more possibility of finding truth on the internet than you would from your sources.
A Change of Opinion as Proof of Corruption Spreads
It’s interesting to note that at one point, accusations against the FDA were from the public -- ordinary people. These were non-professionals who had suffered directly from the FDA’s decisions
Also google: Index to SSRI stories.
More recently however, we’re seeing accusations from professionals: from insiders, academics, doctors and scientists
www.youtube.com/watch?v=UIm8fHxqUAM about what an ex-pharma representative has to say about pharma. Also,
The above article has interesting comments following, from professionals formerly working for Pharma. Their comments are understandable to the layperson, and are a real eye-opener to the conflicts a scientist would have between a high paying employer, and the truth.
Some doubters, like the frightened doctor mentioned above would say that you can’t believe someone on the internet. But so many people from so many different sources are coming out with stories of corruption in both the for-profit medical field and the FDA.
It’s much more likely that the truth comes from people who have lived it rather than from a party line given by people who work for authoritarian institutions who have no choice but to obey their hierarchical masters.
The FDA and Dr. Faustman
Getting back to our original purpose, we ask: how would an entity such as the FDA, which seems from all observable evidence to have profit for Pharma most at heart instead of public health, ever allow Dr. Faustman reasonable and rigorous enough parameters for the Phase 2 study?
Dr. Faustman has stated on Facebook that the Faustman lab will be working in conjunction with the FDA to set up Phase 2. This means that she will propose guidelines of Phase 2 to the FDA, and the FDA in their wisdom, will counter with what they think is appropriate. But she will not, and indeed cannot go against the FDA, because the FDA’s decision is law. It doesn’t seem right that we have to take this hidden agenda from Pharma through its puppet, the FDA.
We at Hdiabetes.com feel that Dr. Faustman should get anything and everything she needs for Phase 2 trials. Whether it’s dosages, timing, sources of medication, the number of test subjects and the choice of test subjects. Anything less than this is probably designed by the FDA to fail.
Take the number of test subjects in particular. BCG is currently approved for treating bladder cancer. One of the first preliminary trials, which occurred in 1987, had 191 participants chosen from 428 volunteers. Ref:
Why wouldn’t the FDA allow Phase 1 the miniscule amount of 12 test subjects instead of the ridiculously small number of 3?
The Faustman lab should especially have complete freedom to randomly choose test subjects from their own sources. This last point is especially important. Since the FDA have been shown to conduct and accept fraudulent studies, this shows that they are ethically bereft. That they would want to choose their own participants is very highly suspicious.
What Can We Do?
In a perfect world professionals from all over would be able to contribute their advice regarding the safety of Phase 2 parameters. However, we’d be naïve to think that they’re able to. Doctors and scientists working outside “accepted” medical practice as dictated by the FDA, would be afraid of being sued or of losing their license or otherwise being persecuted by Pharma, whom they have very close ties every single day.
Perhaps Independent Medical Associations?
In a free democracy doctors would just be able to circulate the parameters in an internet survey to see if they think Phase 2’s parameters are reasonable and safe. They can’t be persecuted if a lot of them do it. And it’s just opinions, not demands. You’d think doctors and other health professionals would be very interested in doing things that would bring about health in people, instead of continued illness.
Why can’t Phase 2 be put forward to an independent medical board? There are a few, as well as an independent union of scientists. If they deem the parameters safe, then the FDA can be called to task. The FDA would have to justify its decision to other scientists. They wouldn’t be able to use bullshit scientific terms designed to make people think they know more than they do.
A very obvious requirement for the FDA in the future would be that no employee who has ever worked for or has done consulting work for a pharmaceutical company, would ever be able to work for the FDA, and vice versa. This includes any members of their family as well. Could this ever happen with a Congress or the US Regulatory Agency making decisions in favour of corporations? Certainly not at this stage of the game.
We the people have to practice using our voice. But we diabetics are not known for our loud personalities. Write to the FDA if you don’t like the restrictions it has put on Phase 2, if you think it may help. Or to a political leader. But it’s our belief that this plea to the establishment wouldn’t work.
What can we do? Look at all the websites cited here, and their connected websites. See how many people are saying the same thing. Then brainstorm how we could possibly be vocal to the highest-ups in peaceful protest. Other than that, pray, visualize – all the important things that come before action.
Somehow we have to collect our voices to this cause. Because a lot of people are wanting what we’re wanting, and that is the discovery of a cure for T1D. We want true research, and freedom from the restrictions Pharma and other corporations have put on research. Let’s try to find the truth and not unthinkingly accept what’s being increasingly realized as lies.
Lastly and most importantly, we must stand by Dr. Faustman and support her in this task she has taken upon herself on our behalf. We support her work wholeheartedly with this website, and are thrilled and encouraged to see word of her research reaching more and more people. Thanks to everyone out there for your help in this regard.
A must see movie from many points of view, including some very official sources. Be warned that it is very long – at least 40 min. and you can skip the first ¼ of it because of hype. But the rest is excellent.
Also if you can find it, read Ben Goldacre’s piece in the Guardian. Or you can read excerpts of it in:
This article was mysteriously pulled. If anyone has copied this article, please send it to us (“contact us at hdiabetes.com”) so we can put it on our website. We’d be very grateful.