Monday, December 01, 2008

Meet the Person Likely to be the Next FDA Commissioner

To date, nearly 250 people have responded to my Who Should Obama Nominate for FDA Commissioner? survey. The results so far show Rost, Wood, Nissen, Woodcock, and Califf as the top 5 contenders.

Eighty-six percent (86%) of respondents are from the US and the charts below focus on choices made by these respondents. These are preliminary results -- I intend to keep the survey going until someone is nominated. If you haven't yet voted, I hope you will take a couple of minutes to do it now and include what you think should be at the TOP of the new commissioner's agenda.

Peter Rost -- who has made a reputation as whistle blower, muckraker, and Pfizer nemesis -- holds the lead among all US respondents, 31% and 28% of whom are very and somewhat supportive of the pharma industry, respectively. Most of Rost's US voters are among those who claim to be very or somewhat unsupportive of the industry (see chart below).
"[Peter Rost] knows how Big Pharma operates, isn't owned by them and probably wouldn't be bought, either. He is also two cents short of a dollar, which helps." -- Anonymous respondent
Among industry supportive US voters, Susan Wood is the person of choice, but Steve Nissen, M.D., who has often criticized clinical trial data, is the #2 choice among US voters who support the drug industry.

"[Susan Wood is] a true believer in the promise of change. Return the FDA to science based leadership." -- Anonymous

"[Steve Nissen] is a doctor, he's not scared to stand up to pharma, he's intelligent, and the new commish should clean house of the 'insiders' who have gotten too cozy to big pharma." -- Robert Lands, Engineer, Union Pacific Railroad. Robert says he "somewhat supportive" of the pharma industry.
The level of industry support of voters for the top 5 contenders is illustrated in the chart below. Industry support is rated on a scale of -2 (very unsupportive) to +2 (very supportive) with neutral=0.

Some comments about other contenders include:
"[Robert Califf has an] excellent background and credentials...does not come from pharma." -- Vince DeChellis, Principal, NHHS Healthcare Consulting

"I think [Dora Hughes] will offer a balance between business and science that will ring true." -- Norma-Jeanne Hennis, President, MedPharm Communications

"[David Kessler is] Someone who is familiar with industry and how it works but who will call the executives on the carpet when they knowingly are pushing medicines for dollars not patient quality of life." -- Juanita Hawkins, President, Juanita Hawkins Consulting LLC

"[FDA] needs [Janet Woodcock who has a] ... deep history and knowledge of FDA." -- Anonymous
Who's your choice? Vote here.

1 comment:

  1. Anonymous1:34 PM

    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, 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. A new commissioner may have a positive effect on the public’s health. If one considers the following:
    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. The following is an example of how corrupt the FDA now is:
    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 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 any disease state the individual corporation may decide may be best for them, and certainly not the patients of the health care providers who may receive such discussions and encouragement. 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 public health, and this is rather delusional if not absurd, to say the least, as likely any clinician would argue this dangerous methodology.
    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 and reformed to their original purpose.
    “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)


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