The FDA has posted a policy draft: “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” A better name would be: “Let’s Give Away the Shop to Industry and Encourage Bad Medical Practice.”
Here's the essence of the FDA’s reasoning:
FDA…recognize[s] the important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities…These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved or new uses of approved or cleared medical products that are truthful and not misleading.
This proposal to abdicate responsibility for public health didn’t fool Henry Waxman, the ever-vigilant chair of the House Committee on Oversight and Government Reform, Waxman's letter to the FDA is worth reading. Here is his conclusion:
I recognize this area of the law is complex and that FDA needs to respect the First Amendment rights of drug and device companies to communicate truthful and non-misleading information to doctors and patients. But the draft guidance…would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.
The danger to patient health should be readily apparent from the examples of journal article abuses…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.
This story demonstrates how the big bucks to be made in pharmaceuticals can foster ethical degradation in major health institutions. The FDA panders to marketing. Journals publish skewed studies. Respected clinicians become industry shills.
The ethical quality of our health care system depends on checks and balances. An entrepreneurial pharmaceutical industry is a public good. But entrepreneurialism, like a rifle, has to be aimed correctly. Breakthrough drugs that meet real health needs and create mega-profits should be celebrated. Me-too drugs and spurious promotion of off-label uses should be fought against, as Representative Waxman's committee is doing.
I don't think the people in the pharmaceutical industry are any worse than those who deliver health care. We are all influenced by our environments and the incentives we encounter. What we are seeing in stories like this one is what will happen if we squander the crucial checks and balances process.
[On this topic, see also the excellent blog postings by Merrill Goozner and John Grohol. And, for a recent example of how the journal process has been corrupted, the Carlat Psychiatry Blog.]
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3 comments:
Is the FDA Failing It’s Sole Objective, You and Me?
The Food and Drug Administration originated in its primitive form at the time several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, amounts so large that are issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income. Results of this relationship, one could posit, have been the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit, as these unfortunate events have occurred quite often.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way, claiming that this would enhance the education and knowledge of the prescriber.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The pharma companies that allowed such criminal offenses, through vicarious liability at times, perhaps, never admit guilt as part of such settlements.
This FDA protocol that is now being considered, called, “Good Reprint Practices”, would require reps to use what does not truly exist likely, which is truthful and authentic clinical trials when they do speak off-label to prescribers, if this becomes allowed. This in itself lacks etiology for such discussions by reps, as many clinical trials may be flawed due to the trials being possibly manufactured by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue accurately is unlikely, for the most part, I surmise. Remember that most pharma reps have no medical or clinical training in any objective way, and, in my experience, have no interest is such training. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. Yet this situation appears to be of most benefit for drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens do not to be the focus of this administration.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Because historically medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit.. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves. And the health of the public is that interest.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung
Dan Abshear
The Conversion of Our Protector
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 that is provided to them by manufacturers for their intake. The one person who became the catalyst for the formation of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. While the author intended with composing this book, “The Jungle”, to address and focus for the benefit of the readers his paradigm regarding capitalism, the issue in his book regarding food safety is what caught the attention of the public, including the president, who was involved with the development of the Food and Drug Administration soon afterwards.
However, the purpose and function of the FDA seems to have changed the past few decades, as the FDA appears to have decided to ensure the health of the pharmaceutical industry instead of the public health. A new FDA commissioner who is willing to resurrect the apex of the FDA and its purpose may have a positive effect on the public’s health. As presently, there are disturbing flaws within the FDA.
One example is the large amounts of money the industry gives the FDA for various reasons created recently- amounts so large that this accounts, according to some, for about half of the FDA’s total income, although it is by definition a governmental administration. An example of stated reason for receiving such funds is due to 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 pending medications after pharmaceutical companies submit a new drug application to the FDA. This act now accounts for nearly 50 percent of the FDA’s drug oversight budget through this operational funding given to them by those who the FDA is suppose to regulate for the safety of the public health. The FDA also accepts over a million dollars from the pharmaceutical industry to give their pending new drug a priority review of 6 months instead of a year, along with a created etiology for this urgency often, it has been reported.
Results of this relationship, which some have called collusive and pathologically intimate, this collaboration between the drug industry and the FDA, could be a contributing factor the progressive and recent approval of unsafe drugs, so it seems. This has been demonstrated by their removal of, or a labeling change, requiring what is known as a black box warning of such drugs, which means that the drug is basically on probation. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns. In addition, the FDA continues to validate what has been surmised by many regarding their financial support from the drug industry that appears to be reciprocal. The result of this relationship has resulted in less than optimal protection regarding the health of the public with pharmaceuticals made available to them.
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 considered supporting overtly this massive and necessary client of theirs, the pharmaceutical industry, to allow their promoters to discuss their products that may or may not have been approved by the FDA for particular disease states. 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 and potential dangers associated with this practice, 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, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting indications assigned to their promoted drugs by the FDA. In fact, it is a federal offense for such representatives to speak off-label about the drugs they promote, and more pharmaceutical companies are and have been penalized for this activity in the form of large settlements paid by such pharmaceutical corporations in the past as determined by the department of justice.
This off-label FDA protocol for drug representatives that has been described and proposed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.” This absurd benefit for the pharmaceutical industry would have pharmaceutical sales representatives use what may not truly exist, which is truthful and authentic clinical trials illustrating any off label claim regarding their promoted medication to health care providers. It is believed that many clinical trials are biased if not manipulated, so this strategy that apparently adds comfort to this protocol is invalid. Additional trial deception may include such factors as ghostwriting and fabricated authors of such trials, and this is one of many concerns of this FDA protocol that has been, or is now being considered. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration when they did suggest this ridiculous and frightening authorization offered to their client, the pharmaceutical industry.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss aspects of clinical trials. Most drug representatives have little medical or clinical training in any objective way, and they are not hired with having such a background, usually. So this seems to further complicate the idea of this off-label concept proposed 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.
So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association with the pharmaceutical industry by suggesting such practices that aggravate the existing situation with the lack of protection that was once offered and required from the FDA.
It is unbelievable this good reprint practices proposal ever came into existence, with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude, and this is clearly dangerous to the public’s health.
Perhaps another alternative would be to have clinically trained people discuss such issues regarding the benefits of medications with prescribers, instead of existing drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. 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.
Regardless, awareness needs to happen by the citizens involving such tactics allowed by the FDA that are dangerous and deceptive. 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 an administration that was created for our protection.
“Unlimited power is apt to corrupt the minds of those who possess it.” --- William Pitt
Dan Abshear (author’s note: what has been written was based on information and belief)
Hi Dan -
Thank you for these two very full comments about the FDA. I believe the FDA shows two failings of the current administration - (1) an overly anti-regulatory/ideologically driven orientation and (2) underfunding of the agency, which decreases its capacity to do its job. I completely agree - as do many of the career FDA employees - that significant reform is needed.
Best
Jim
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