Who Should Determine Drug Labeling Language: Juries Or The FDA?
 |
Wyeth vs. Levine is an important legal case being tried before the US Supreme Court. You may have read about the lawsuit in the New York Times, NEJM, JAMA, the Wall Street Journal, or my own blog. It revolves around the tragic story of a woman (Ms. Levine) who experienced an extremely rare side effect (severe tissue damage resulting in the amputation of her right arm) because a drug was administered improperly (into an artery rather than a vein). Ms. Levine is arguing that her injury could have been avoided if the drug label had stronger warning language, and the Vermont Supreme Court ruled in her favor, awarding her $7 million. The court ruled that a jury in the state of Vermont had the right to hold Wyeth accountable for a different labeling standard than the one approved by the FDA.
The plot thickens, however, in that Wyeth’s FDA-approved label very clearly discourages injection of their drug into or near an artery, and it also describes the potential consequence (including gangrene) of such an action. The FDA approved Wyeth’s label in full knowledge of the potential risks and benefits of the drug. In fact, Wyeth asked to strengthen the language of the label before Ms. Levine was injured, and the FDA declined to make the change because label changes are based on new information about a drug’s frequency or severity of risks. Wyeth had nothing new to disclose.
Why didn’t the FDA allow Wyeth to strengthen the warning language? Imagine if you were responsible for the drug labels of 10,000 different drugs, and you had to review and approve every proposed change? You’d probably want to limit the changes to substantive requests (rather than matters of semantics and word preferences) or else you’d have ten times the work with no real benefit to consumers. Imagine all the synonym swaps that would be requested: “Dear FDA, could you please change the word “rather” to “quite” on page 7 of drug label 986.01?” It would drive you nuts.
So to help drug companies understand which sort of changes should be submitted, the FDA requested that label changes be related to new information only (meaning: they’d be happy to change the label to reflect a change in risk based on new data suggesting a different frequency or severity of potential injury – otherwise leave the language alone).
The State of Vermont essentially ruled that local juries had the right to re-assess the risk/benefit analysis described on drug labels, and hold pharmaceutical companies to the jury standard, regardless of what the FDA had decided previously about appropriate labeling. Wyeth has appealed this to the US Supreme Court.
I have written quite extensively about what’s at stake in the Wyeth vs. Levine case at Science Based Medicine. Feel free to add your 2 cents – should juries set drug labeling standards, or should the FDA’s approval process preempt litigation in cases related to known risks (without new information)?
I disagree with the ruling. I think the practitioner should have been sued, and if Ms. Levine’s argument is that the drug should have had a stronger label, then blame the FDA, not Wyeth.
I guess it begs the question.. then what is the FDA for? If we’re going to override their decisions anyway?
What purpose is the FDA serving(at the state level) if the state is not recognizing it’s efforts concerning safe labeling practices?
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, primarily. 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 the effects of capitalism, the issue regarding food safety is what ultimately captured the attention of everyone, including the president, so the FDA began during this time.
However, their purpose and function seems to have changed the past few decades, as the FDA appears to have decided to ensure the health of certain industries instead of the public health.
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.
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.
Results of this relationship, which some have called collusive and intimate, between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs as demonstrated by their removal of, or the 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 such industries as the pharmaceutical one may be why there is this progressive safety concern of medications prescribed to many in the United States. In addition, perhaps, the FDA continues to validate what has been surmised through their known financial support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public.
Yet, the presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales representatives to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval and presumed elation to possibly create harm to patients with this proposal due to the obvious uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional if not absurd, to say the least.
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 this type of activity that deviates from the product insert that illustrates the medication’s indications. 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 in the past as determined to some degree by the department of justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, rarely admit guilt as part of such settlement agreements, which include agreements where the corporation is not prosecuted. Off-Label activities are only some of the federal laws that have been frequently fractured in a progressive manner as well.
This off-label FDA protocol for drug representatives that has been described and proposed by our FDA is called, “Good Reprint Practices.” This would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials that aseptic and without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug representatives, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the medications involved in such trials- often 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 suggested by the FDA, yet possibly a protocol influenced by others. 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.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug representatives have little medical or clinical training in any objective way. So this seems to further complicate the idea of this off-label concept due to the ignorance of the representatives In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to 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 pharmaceutical sales representatives, which according to this study, 80 percent of doctors do not wish to interact with these reps, yet will accept samples and literature related to of their products
So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices that aggravate the existing situation with the lack of efficacy of the FDA.lth, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this 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.
However, there is freedom of speech, but in the amendment should certainly be restrictions in regards to public health, as speech should be accurate and objective when conducting dialogues with prescribers. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the 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 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, which could be the case now with the FDA. And the health of the public is that interest, and I believe we as public citizens demand that the FDA be reconstituted.
“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)