The Office of Inspector General of HHS recently released a report on the FDA's oversight concerning financial conflicts of interest on the part of investigators involved in new drug applications. (H/T to Bridget Kuehn, the JAMA public affairs reporter, for bringing this to attention.) You may be vaguely aware that when drug companies submit studies to support approval of new drugs, they are supposed to tell the FDA when the researchers were in their pay or stand to benefit from approval. Yeah, right.
42% of marketing applications were missing financial disclosures - sometimes because they were just missing, and sometimes because the sponsors claimed a "due dilligence" exemption. That means they called the researchers twice and sent them two letters, and didn't get an answer, therefore they don't have to provide any disclosure. Uh, since they're the ones who paid the people in the first place, they probably already know. Duhh. But if you don't want to disclose, all you have to do is ignore the requirement, and you're exempt! Gee, do you think that's too easy?
For some reason, the companies and investigators do sometimes disclose financial conflicts of interest, but most of the time, the FDA didn't do anything about it. Sometimes the sponsors submitted information to indicate that they had tried to minimize resulting bias, but the FDA doesn't try to assess the validity of such claims. The bottom line is that although independent research finds that about 25% of clinical trials investigators have financial conflicts of interest, only 1% of investigators listed in approved marketing applications include a disclosure. Not only that, the FDA doesn't even require a complete list of investigators in the first place.
That the drug approval process is deeply corrupt is not news, but this crosses the line from tragedy to farce. Maybe we should all just try to stick to aspirin for the time being.
Wednesday, February 18, 2009
FDA = Feckless Drug Administration
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The Conversion of Our Protector
Not long ago, what we as American citizens ingested into ourselves what may have been at times possibly dangerous due to flaws in the process of producing food and drugs in particular at that time. With the absence of regulation of the manufacturers of such items, American citizens could not be assured of what they may take to eat or restore their health was safe for them, and this was understandably concerning for many people.
Nearly 100 years ago, one man changed the fears and concerns of American Citizens regarding what they may eat, or what medicine they may be given to restore their health. And this man simply improved the way things were without intent, and by writing a book.
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume. The administration was created to regulate the manufacturers who make items people do consume are safe for them.
The man responsible for the development of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book he wrote several decades ago, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in his book. Called, “The Jungle”, the one particular issue in his book regarding the lack of food safety is what caught the attention of the public who read his book, and this included the U.S. president. The impact caused by this book on others is what ultimately led to the development of the FDA.
However, and with great disappointment, the purpose and function of the FDA seems to have changed in the past few decades. The FDA appears to have decided to instead ensure the health of the pharmaceutical industry, an industry the FDA was designed to regulate. This is one of many disturbing flaws and concerns expressed by others regarding the FDA.
One example is the large amounts of money the pharmaceutical industry gives the FDA for various reasons created recently, which the FDA accepts without objection. These various amounts of money are so large that the money given to the FDA accounts for nearly half of the FDA’s entire budget. An example of what was a stated reason by the FDA for receiving these funds is due to what is known as the PDUFA ( the prescription drug user fee act), which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their medications awaiting approval by the FDA. The FDA also accepts from this industry over a million dollars from certain drug companies in order to give their pending new drugs a priority review of 6 months instead of a year, along with a creating an etiology for this urgency to occur, others have said.
Results of this relationship between the FDA and the pharmaceutical industry, which some have called collusive and pathologically intimate, may be a reason some newly approved drugs by the FDA are quickly proven to be unsafe, if not deadly.
The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns, one could safely say.
The FDA and the drug industry continues to attempt to validate and explain often what many others have questioned about the FDA and its lack of focus on the safety of the public- the public the FDA is suppose to protect to assure their safety. Yet the protection by the FDA is not observable at this time.
The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA announced they were allowing the pharmaceutical industry to allow their promoters of their branded drugs they market to discuss these products for disease states and medical conditions that have not been studied or evaluated by the FDA, if thoroughly studied at all. This process use to be mandatory before a drug company could claim that their drugs were beneficial for a particular disease state. Many remained shocked on this decision made by the FDA that is now in effect- speaking about drugs for medicinal uses that have not been validated.
Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of the public health, allows for potential dangers associated with this practice. This autonomy of the FDA illustrates once again the present state of the FDA and its need for reform.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, and they do so based upon their own discretion, and they often do. Historically, however, a pharmaceutical drug promoter was legally forbidden to suggest to a health care provider to use their promoted drugs for disease states not approved by the FDA already.
In fact, it was a federal offense for such drug representatives and their employers to speak off-label about the drugs they promoted to health care providers. In the past, drug companies have had to pay settlements to the DOJ when they fractured these laws regarding off label promotion of medications.
This new and frightening off-label FDA protocol for drug representatives that has been allowed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.”
This overt and absurd benefit for the pharmaceutical industry is that now they can have their pharmaceutical sales representatives, unregulated themselves, speak about their promoted medications to health care providers essentially in any way they choose.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss the complex considerations a health care provider is able to do because of their microscopic training related to such areas.
Most drug representatives have little medical or clinical training in any objective way, and they are not chosen to be hired for having such a background, usually. So this seems to further complicate the idea of this off-label authorization by the FDA due to the ignorance of the representatives to discuss such clinical matters. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to further embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them.
In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of the typical pharmaceutical sales representatives that now exist. This study also concluded that around 80 percent of health care providers prefer not to interact with pharmaceutical representatives, yet still accept drug samples from them for their patients. The results are rather understandable considering what we now know.
So, our previous safety government association we created for our needs as citizens, the FDA, appears to be evolving into a harmful association with the pharmaceutical industry by suggesting such practices that aggravate and further illustrate the unsafe conditions we are now faced with as we were before the FDA was created.
It is unbelievable this good reprint practices that was somehow created ever came into existence- with the delusional fallacy that it would be of any benefit to the patient and the restoration of their health. Furthermore, this may complicate if not increase existing patient medication errors, such as in the elderly or dosing for children.
So there are enough problems with prescribing medications, and adding this FDA seems to be making the issues with medications in the U.S. worse instead of better, quite clearly. We as citizens are no longer the concern of the FDA, one could safely conclude, and this is clearly dangerous to the health of the public.
Perhaps another alternative to the FDA’s Good Reprint Practices would be to have clinically trained people discuss such issues regarding the benefits of medications with prescribers, unaffiliated with the makers of such medications. Instead, pharmaceutical marketing representatives, whose sole objective is to increase the market share of their promoted medications, are assigned to be the clinical experts they most certainly are not.
Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain drug was initially indicated for upon approval. Yet this should not be determined by those who promote such drugs. Now, unfortunately, pharmaceutical representatives are allowed to determine how they can promote their drugs for their employer’s benefit. I find this rather frightening.
Regardless, awareness needs to happen by the citizens involving these tactics progressively allowed by the FDA that are dangerous and deceptive to the health of the public. As citizens, we have the right to insist that the FDA- our FDA- maintains focus on the safety of the public and their health. Reform of the FDA appears to be necessary for this to occur to re-establish the FDA as the administration that was created for our protection, and not to protect others financially.
About half of all drugs approved presently by the FDA have had serious post-approval side effects that should have already been known or suspected of these drugs. Well over 100 thousand people die every year from drug reactions or mistakes. This seems to be a rather significant concern for those who are need to restore their health. But it does not to be a concern of some.
Dan Abshear
Congratulations Dan! You've said the record for longest comment on this blog. Fortunately it's a good one.
As for the meat processing industry, it's only marginally less yucky today than it was in Sinclair's time, not much less exploitive of workers, and certainly no more humane. I personally don't eat meat, and people can't understand why I can nevertheless endorse hunting. People are omnivorous by nature, but the meat industry is unnatural and morally unacceptable to me.
Found something else at FDA: fun and games. Really.
See
http://notionscapital.wordpress.com/2009/02/19/fda-inspectors-at-work/
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