"Drug Approvals Gone Wild"

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This article on the Guardian’s website, on the failure of the Food and Drug Administration to be sufficiently pro-consumer, pro-safety in its drug approval process, does a nice job of summing up the issues (and poking holes in the FDA’s lame defenses). One particularly fine observation:

Let’s not forget that a provision in the FDA reform bill calling for a two-year moratorium on DTC [direct to consumer] ads on some new drugs was rejected because it limited commercial freedom of speech. In 21st century America, the right to misinform consumers is protected, but consumers’ right to information is denied because they might misinform themselves.

There is complete and utter schizophrenia on the question of consumer information and choice in the medical arena. One popular school of thought holds that consumers need to exercise greater control over their medical decisions, out of the the view that medicine is just another market, consumers can think for themselves, and given the realities of stretched medical budgets, they can make the best determination as to how to spend their limited medical dollars.

Nice theory, and if you tease that logic out, you’d give every consumer his own prescription pad and let him order his own medical tests too (at least in our paternalistic state of New York, that’s a no no). I can see it now: Botox parties where people get together to shoot each other’s foreheads up….

More seriously, Maggie Mahar, in her excellent book Money-Driven Medicine, depicts the American health care problem as a market failure created by information assymetry. As Tyler Cowen explained in his comment on the book:

….the American health care cost spiral comes from suppliers and their entrepreneurial abilities to market expensive and highly specialized services of dubious medical efficacy. Medical care starts off as ambiguous in value and hard to measure in quality. Customers are cowed by doctors and other family members into accepting or even demanding what is offered to them. Third-party payments make the problem worse, and government intervention has stoked rather than checked the basic dynamic. You end up with massive expenses, lots of stupidity, and – because of its expense — radically incomplete coverage. Every now and then the extra services do pay off, but not frequently enough to boost American stats on health care quality.

Back to the immediate FDA issue. One way to alleviate this imbalance, and it’s admittedly a modest step, is to let consumers have more information, particularly about drug efficacy and trial results. Yet the FDA is resisting that move, saying that letting consumers have all that information will confuse them.

Again, that argument doesn’t hold water. Consumers can already get tons of information about drug studies (haven’t they heard of PubMed?). It would be better for the research-minded to have access to the full data set rather than be limited to a selection that is arbitrary (due to what is available on line) and pro big Pharam (by the studies pointing to little or no efficacy and side effects being withheld).

From the Guardian:

“Sunlight is said to be the best of disinfectants,” Supreme Court Justice Louis Brandeis famously wrote. Alas, if mother nature submitted sunlight as a new drug to the food and drug administration, she would get turned down flat.

In the wake of the latest study showing heart attack risk in Avandia, an FDA-approved diabetes drug – a study that was only enabled by the company’s public release of dozens of clinical trials on its own website – there have been increased calls for greater transparency of clinical trial results. The FDA reform bill passed by the Senate two weeks ago had a limited disclosure requirement, which was backed by the Pharmaceutical Research and Manufacturers Association, the drug industry’s powerful lobbying arm.

There was nothing in the bill requiring that companies and independent investigators post all trial results, including those conducted after drugs hit the market. Companies often run dozens of these trials to promote new drugs among the practicing physicians paid to enlist their patients in the trials.

What does the FDA think about public release of data? Barry Meier in Wednesday’s New York Times elicited this quote from Steve Galson, director of the drug evaluation and research division of the FDA: “I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” he said.

Meier then noted the recommendations in last year’s Institute of Medicine report, which called on the FDA to release summaries of all clinical trial data it collects on new drugs, both pre- and post-approval. The FDA sees the recommendation as overly burdensome. “It is not that we are philosophically opposed to it, but the work would be enormous,” Galson said.

I spoke Tuesday with Steve Nissen of the Cleveland Clinic, who conducted the analysis of Avandia, GlaxoSmithKline’s diabetes drug that probably carries an increased risk of heart attack compared to cheaper alternatives. “This whole situation shows how important transparency is,” he said. “There are independent players out there without axes to grind who need access to this data.”

Nissen’s statistician (he himself is not an expert in manipulating statistics) pooled the results of 42 clinical trials to come up with the analysis. Would individual consumers, if given access to the data, get confused or misled if they looked up an individual trial and drew an incorrect conclusion?

It’s a risk, of course. But would they be any more confused than they now are from the information they get from direct-to-consumer (DTC) advertising? Let’s not forget that a provision in the FDA reform bill calling for a two-year moratorium on DTC ads on some new drugs was rejected because it limited commercial freedom of speech. In 21st century America, the right to misinform consumers is protected, but consumers’ right to information is denied because they might misinform themselves.

“To have a drug on the market for eight years and still not have the outcomes data is too long,” Nissen said.

What does the top official at the FDA think about greater and earlier disclosure? In a response printed alongside a USA Today editorial that pointed out that the company gave the FDA much of the latest data about Avandia last August, FDA commissioner Andrew von Eschenbach noted the warning issued Monday by the agency. “Our policy, which we followed with Avandia, is to inform the public about potential risks at the earliest appropriate time, even if our investigation is not complete,” he wrote.

The timing of this warning undermines the credibility of von Eschenbach’s claim. The warning was issued a few hours after the release of Nissen’s study.

Art Levin of the Center for Medical Consumers, who serves as the consumer rep on the drug safety advisory committee at the FDA, yesterday outlined what he thought ought to be in the House version of the FDA reform bill:

* Complete transparency of data derived from all studies and trials; and FDA access to insurance industry (including Medicare) databases so the agency can determine how drugs are being used and what outcomes they are generating. “The public health can only benefit from having lots of good minds analyzing complete data and reaching their own conclusions,” he said.

* Prescribers and the public should always be immediately alerted to any signals of serious toxicity – the duty to warn should take precedence over any other considerations; and

* An independent safety office, one whose culture is all about public protection and whose triumphs are uncovering safety problems and resolving them appropriately.

The IOM report noted problems in the internal culture at the FDA. Since passage of industry user fees in 1992, the mindset at the agency has gone from protecting the public from unsafe or ineffective drugs to one of helping industry get more and faster new drug approvals. Galson’s comments are a perfect reflection of that mindset.

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  1. Quiact

    Not long ago, what we as American citizens ingested in ourselves may have been at times dangerous due to flaws in the process of producing food and drugs in particular. With the absence of regulation of the manufacturers, American citizens could not be assured in what they may take to eat or restore their health was safe for them, and this was understandably concerning for many people.

    Nearly 100 years ago, one man changed the fears and concerns of American Citizens regarding what they may eat, or what medicine they may be given to restore their health. And this man simply improved the way things were by writing a book.

    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. The administration was created to regulate the manufacturers who make items people do consume to ensure the safety of the American citizens.

    The man responsible for the development of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book he wrote several decades ago, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. Called, “The Jungle”

    The one particular issue in his book regarding the lack of food safety is what caught the attention of the public who read his book, and this included the U.S. president. The impact caused by this book on others is what led to the development of the FDA.

    However, and with great disappointment, the purpose and function of the FDA seems to have changed in the past few decades. The FDA appears to have decided to ensure the health of the pharmaceutical industry, an industry the FDA was designed to regulate. This is one of many disturbing flaws and concerns expressed by others regarding the FDA.

    One example is the large amounts of money the pharmaceutical industry gives the FDA for various reasons created recently. These amounts of money are so large that this money given to the FDA accounts for nearly half of the FDA’s entire budget.
    An example of stated reason by the FDA for receiving such funds is due to what is known as the PDUFA (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 medications awaiting approval by the FDA.

    And it has worked.

    Of the department that receives these funds of the FDA, the CDER, this largely provides for their nearly 300 million dollar a year budget. About 75 percent of this budget of the CDER goes towards new drug reviews. However, the CDER’s Office of Drug Safety receives less than 10 percent of the CDER’s budget.

    The FDA has a staff of about 11,000 employees, with about a 2 billion dollar a year budget. It is suspected that half of their budget is provided by the industries the FDA is obligated to regulate- with is well over 1 trillion dollars worth of products.

    The FDA also accepts from this industry over a million dollars from certain drug companies in order to give their pending new drugs a priority review of 6 months instead of a year, along with a creating an etiology for this urgency as it happens, others have said.

    Results of this relationship, which some have called collusive and pathologically intimate between the FDA and the drug industry, may have something to do with the actual removal of newly approved drugs due to safety reasons. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns, one could safely say.

    The FDA and the drug industry continues to attempt to validate and explain often what many others have questioned about the FDA and its lack of focus on the safety of the public- the public the FDA is suppose to protect to assure their safety. Yet the focus of the FDA and the purpose of their creation seems to be absent.

  2. Quiact

    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 announced they were allowing the pharmaceutical industry to allow their promoters of their branded drugs they market to discuss these products for disease states not studied or evaluated by the FDA.

    This process use to be mandatory before a drug company could claim that their drugs were beneficial for a particular disease state. Many remained shocked on this decision made by the FDA.

    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, allows for potential dangers associated with this practice. This autonomy of the FDA 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, and they do so based upon their own discretion. Historically, a pharmaceutical drug promoter was legally forbidden to suggest to a health care provider to use their promoted drugs for disease states not approved by the FDA already.

    In fact, it was a federal offense for such drug representatives to speak off-label about the drugs they promoted for their employers. In the past, drug companies have had to pay settlements to the DOJ when they fractured these laws regarding off label promotion of medications.

    This off-label FDA protocol for drug representatives that has been allowed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.” This overt and absurd benefit for the pharmaceutical industry is that now they can have their pharmaceutical sales representatives, unregulated themselves, speak about their promoted medications to health care providers essentially in any way they choose.

    Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss the complex considerations a health care provider is able to do because of their training.

    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 authorization 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. The results are rather understandable considering what we now know.

    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.

  3. Quiact

    It is unbelievable this good reprint practices ever came into existence- with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate if not increase existing patient medication errors, such as in the elderly or dosing for children.

    So there are enough problems with prescribing, and adding this FDA seems to be making the issues with medications in the U.S. worse instead of better. We as citizens are no longer the concern of the FDA, one could safely conclude, and this is clearly dangerous to the health of the public.

    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 have the sole objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part, or the consequences of their actions as they promote their drugs in this way.

    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. Now, unfortunately, pharmaceutical representatives are allowed to determine how they can promote their drugs for their employer’s benefit.

    Regardless, awareness needs to happen by the citizens involving these tactics progressively allowed by the FDA that are dangerous and deceptive to the health of the public. 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 the administration that was created for our protection, and not to protect others financially.

    About half of all drugs approved presently by the FDA have had serious post-approval side effects that should have already been known or suspected of these drugs. Well over 100 thousand people die every year from drug reactions or mistakes. This seems to be a rather significant concern for those who are need to restore their health.

    Dan Abshear

  4. skippy

    Whilst were on health care, its associated costs and the powers of drug company's vs the FDA vs consumers, how about opening the biggest can of worms in the room or the AMA the biggest, oldest and most powerful union America has ever had in connection to public health. I've always found it interesting in regards to union bashing that this one is always off the radar.

    How many tasks could be handled by medical technicians rather than the bottle neck created by the AMA and its projection of the oracle of health (if your not talking to a doctor your getting second class treatment). I could prattle on, but you get the drift of my argument.

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