Fleeing The FDA For Industry And Retirement
1 CommentBy Ed Silverman // June 3rd, 2008 // 3:12 pm
When drugmakers want to hire a new employee, the first place they look is the FDA, because former insiders bring critical expertise. But there is also an unintended downside - for the agency, that is. As companies siphon off FDA’s most experienced scientists, they leave an increasingly leaner, less confident staff that is hesitant to put new drugs on the market, the Associated Press writes.
FDA’s staffing pains, which are exacerbated by the departure of a baby boomers and increasing competition for science grads, has caught the attention of lawmakers and consumers, who blame declining inspections for a string of problems with tainted food and drugs.
“What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely,” Steve Brozak, an analyst with WBB Securities, tells the AP. “This cannot have any positive effect whatsoever.”
The agency is scrambling to recruit a new generation of regulators, as the average age of FDA’s 10,100-person work force reaches 54, the AP writes. Thirty percent of the regular staff are already eligible to retire and FDA hopes to hire 600 staffers by October to replace those leaving. Job fairs, for instance, are being held around the country.
FDA’s outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies, the AP writes. Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on FDA’s drug safety system. And agency staffers also say strict deadlines for the review of drugs also contribute to stress.
“People are under enormous pressure to meet those review dates and they get burned out,” says David Ross, a former FDA drug reviewer who now teaches at George Washington University’s medical school after leaving the agency in 2006 after a dispute with supervisors over the safety of the Ketek antibiotic.
FDA’s outside advisers point the blame for staffing problems toward the White House and Congress, which have heaped new responsibilities on the agency without increasing its funding. In the last 15 years, FDA received more than 100 new assignments, but the number of government-provided staffers has fallen from roughly 9,000 to 8,000.
The image of an overburdened agency has not made things easier for FDA recruiters, who are crisscrossing the country seeking applicants with science backgrounds. At the center of the staffing effort is a proposed fellowship program that would bring 2,000 scientists and doctors into the agency every two years, with the goal of convincing some to stay on, the AP notes.
But with no funding set aside for the program, even those pulling for FDA are skeptical. “It’s very unrealistic,” Gail Cassell, a Lilly researcher who advises the agency, tells the AP. “Both in terms of attracting the best minds and being able to provide them with financial support, it would be very challenging.”
The average medical student graduates with about $130,000 in debt, making a government fellowship financially daunting, the AP writes. And so the FDA faces tough competition from more traditional, and better paying, careers for graduates. “If you look at the 20,000 medical students graduating each year, only a very small portion would even be interested in a career that leads to a government agency,” Michael Ehlert, president of the American Medical Student Association, tells the AP.
Dan
The FDA and Its Damaging Lack of Citizen Protection
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. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor 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. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.
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 reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to 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, to say the least.
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 pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated 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, so it appears the FDA did not take this into consideration.
Furthermore, this proposal is flawed in that most pharmaceutical reps 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 reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate 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 embellish 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 a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, 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 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 are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. 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 interests what I believe we as citizens demand, and should be enforced than it appears to be presently.
“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