Subscribe to RSS feed“Bioidentical hormones,” the FDA and Congress – a perspective from National Women’s Health Network
Back in February, we ran a guest blog post here on the Prescription Access Litigation blog titled “Nat’l Women’s Health Network debunks ‘Hands Off My Estrogens!’ Ad on FDA enforcement re: “bioidential hormones”” The post addressed ads that a group called Hands Off My Estrogens ran in several major newspapers. The ads criticized the FDA for cracking down on the sales of estriol, an unapproved drug that has not been proven safe and effective. The National Women’s Health Network’s blog post analyzed the ad and its claims.
Well, we’re back for some more on the hot-button issue — last month, a group of Congressional Reps sponsored a resolution criticizing the FDA for taking action on unapproved hormones distributed by compounding pharmacies. Below is another guest blog entry by the National Women’s Health Network on this issue. We note that the National Women’s Health Network does not accept money or donations from pharmaceutical companies.
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The public’s confidence in the safety of the U.S. drug supply and in the Food and Drug Administration’s (FDA) commitment to protecting public health have been shaken by repeated drug safety scandals in recent years. So when your health care providers say one thing and the FDA says another, whom do you trust?
It’s not always an easy question to answer, but one thing is clear: drug safety decisions shouldn’t be made by politicians. We need legislators who will make sure the FDA has the authority and resources to protect our health. Unfortunately, last month members of Congress jumped into the fray in a less than helpful way, challenging an FDA decision that had stirred up controversy about the safety and effectiveness of “bioidentical” – or natural – hormones that compounding pharmacies had been selling to women as an alternative to conventional hormone replacement therapy.
Earlier this year, the Food and Drug Administration took a firm and public stand against the false and misleading promotion of natural hormones and outlined several marketing claims that it had found to be unsupported by medical evidence. The agency specifically warned that selling estriol, a chemical that has never been approved by the FDA, is a violation of federal law. (See PAL’s blog entry from dateTK, to read more about the FDA decision.)
It is this last action – the effort to stop sales of estriol – that prompted Congressional action. House Concurrent Resolution 342 calls on the FDA to reverse its policy on compounded medications containing estriol. Representative Gabrielle Giffords of Arizona, one of the original cosponsors of the resolution, says that allowing the FDA’s action on estriol to stand “would unnecessarily disrupt the lives of countless women.” She says doctors should decide which medications are safe for their patients, and the FDA shouldn’t “inject itself into the doctor-patient relationship.”
In a world turned upside down, consumer advocates who have been responsible for helping to bring to light many of the drug safety scandals that have shaken public confidence in the FDA have come to the agency’s defense. The National Women’s Health Network (NWHN), the Center for Medical Consumers, the Government Accountability Project, the National Consumers League, and the National Research Center for Women & Families wrote to Congress, to express our strong opposition to the resolution. We pointed out that estriol has not been clinically proven safe and effective and has not been approved by the FDA for any use. We also noted that compounding pharmacies selling estriol are telling women that estriol is safer and more effective than other hormone therapy products and that it will prevent serious diseases, despite a lack of scientific evidence to support these claims.
With doctors and pharmacists telling them one thing and the FDA telling them another, where can women go to get the facts? On the NWHN website, we have fact sheets for women with reliable, science-based information about conventional hormone therapy and alternatives, including natural hormones. Research on conventional hormone therapy has shown that it can increase a woman’s risk for heart disease, breast cancer and stroke. Research on natural hormones is spotty, and most of these drugs haven’t been adequately tested to support the claims being made and safety or effectiveness. When it comes to estriol, studies have found mixed results about whether it hurts or helps with breast cancer, but it’s clear that it increases the risk for endometrial cancer. Yet few of the women taking estriol have been provided with that warning.
But it’s not enough to give women information on a case by case basis. We need an FDA that we can count on to make sure that the drugs being marketed to women are safe and effective. And we need a Congress that understands and supports the important role of the FDA in regulating the drug industry. Preventing the sale of an unapproved drug is one of the most basic functions of the FDA; and yet with the estriol resolution in the House of Representatives, we have legislators claiming that it’s inappropriate for the agency to come between patients and doctors to do just that.
It’s unfortunate that the FDA’s failure to act on drug safety problems in so many cases has left women uncertain about whom to trust on questions about the safety and effectiveness of natural hormones. The case of estriol is a powerful example of why we need to build up the FDA’s capacity to evaluate and monitor drug safety, and reinvigorate the scientific leadership and integrity of the agency.
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Thanks to National Women’s Health Network for contributing this guest blog post… Readers, we welcome your comments!
July 1st, 2008 at 7:36 PM
The FDA and Its Progressive 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. A book written by Upton Sinclair, while fictional, addressed the working conditions in a meat packaging company. While the author intended to address the effects of capitalism, the issue regarding food safety is what ultimately created the FDA.
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. However the growth of generics is about twice of branded meds annually, though, I believe.
Yet, the presumed intimacy between these two organizations, the FDA and the pharmaceutical industry, does in fact seem to continue to worsen- possibly due to the growth of generics. 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. Especially when one considers the high number of drugs that have been removed from the market or have been given a black box warning, which is possibly the equivalent of the drug being placed in a minimum security prison.
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. Off-Label activities is only one of laws that have been fractured by pharmaceutical companies that have paid settlements.
This FDA protocol for drug reps. described and proposed is called, “Good Reprint Practices”, and would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials, aseptic and sterile without bias, 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 interest 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 (author’s note: what has been written was based on information and belief)
July 8th, 2008 at 7:09 PM
Yet, it is not only difficult to manufacture a biopharmaceutical, it is in fact impossible to replicate an existing biopharmaceutical, as no two cell banks/shells are the same, like fingerprints. While likely a biosimiliar could be created with similar if not greater efficacy and safety, the rule need to change with duplications in the pharmaceutical world in regards to these new innovative creations.