There are concerns that pressures on regulators to approve new drugs more quickly have reduced the focus on patient safety, and this problem is exacerbated by new efficiencies in drug marketing which can quickly expose large numbers of patients to unknown risks, warns a researcher writing in this week’s British Medical Journal (BMJ).
New medicines which receive approval by the US Food and Drug Administration (FDA) up to two months before the deadline set for a decision are more likely to be subsequently withdrawn from the market on safety grounds or to have to carry safety warnings, writes David Kao, fellow in cardiovascular medicine at the University of Colorado Health Sciences Center, USA in the current BMJ (BMJ 2008;337;a2591).
For example, he says, it is estimated that 20 million patients were prescribed Merck & Co’s non-steroidal anti-inflammatory drug (NSAID) Vioxx (rofecoxib) over five years before it was taken off the market, and events attributable to the drug “may number in tens to hundreds of thousands.”
Dr Kao points out that, as a result of the US Prescription Drug User Fee Act (PDUFA), FDA approval times for new drugs more than halved, from an average of 33.6 months during 1979-86 to 16 months by 1992-2007. Moreover, regulators in the USA, European Union (EU) and UK are “somewhat dependent on the industry for funding,” given that user fees account for 43% of the FDA’s drug oversight budget, 75% of European Medicines Agency (EMEA)’s funding and 100% of that for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), he says.
At the same time, drugmakers’ marketing techniques are now so sophisticated that a new product can be released onto websites within 90 minutes of being granted approval, says Dr Kao, and he calls for these techniques to be used to improve post-marketing surveillance and adverse drug reaction reporting.
By Lynne Taylor
More at PharmaTimes
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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)
really very good explanation. Nice post. Good job. Thanks for sharing....
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