The use of Hormone Replacement Therapy (HRT) and its side effects is once again making its rounds in the news papers and online news. The main reason for this sudden rise of an old story is since the merger of Wyeth and Pfizer trial attorneys now have a bigger target.
This past weekend the New York Times ran a story on HRT and side effects titled: Menopause, as Brought to You by Big Pharma by Natasha Singer and Duff Wilson.
Physicians use hormone replacement therapy because it helps women with the side effects of menopause. Unfortunately the story as most on this issue, did not focus on the reason women use HRT or the reason the FDA keeps it on the market. They also did not include interviews of women going through menopause to give an added context to the discussion of the benefits of hormone replacement therapy, there has been a great deal of attention to only the risks involved, mainly because of the lawsuits being filed.
The claims apparently show from recently unsealed court documents that Wyeth, who made Prempro, a hormone drug, oversold the benefits of menopausal hormones and failed to properly warn of the risks. In October, a jury in a Pennsylvania state court awarded Ms. Barton $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million, according to the New York Times.
NYT uses quotes from Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School to try and substantiate the potential for claims against Wyeth. Although Dr. Avorn may have written about the subject in The Journal of the American Medical Association, he is far from an expert in the area of hormone drugs, and runs a small business the Independent Drug Information Service providing academic detailing to governments. Moreover, the idea he uses, that “thousands of doctors prescribed the drugs for millions of women,” only to find out in later studies some information was not true is problematic.
Science will always continue to question outcomes and look for more evidence, at least while someone is still paying for the research. To use hindsight and question good research methods and evidence only years after it has been disproven is inappropriate.
Still, the article does state that: “To be sure, even some doctors who think hormone therapy has risks say it is the most effective treatment for symptoms directly associated with menopause.”
Interestingly, the article also notes that previous labels on Wyeth’s hormone drugs for decades gave the same advice as today, for example, prescribing for the shortest duration appropriate for the treatment goals and risks of the individual woman.
In response to the lawsuit verdict, the drug giant Pfizer, which absorbed Wyeth and its hormone drugs in a merger this year, said that Prempro “is a safe, federally approved drug that did not cause cancer.” In fact, Chris Loder, a Pfizer spokesman, said that “Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged.”
The over promotion of hormones was true in the past, and not so much today because it was a natural adaptation to opportunity, based on antidotal observation and standards of evidence prevalent at the time. Since menopause is associated with perceived loss of youth, selling youth only made sense, particularly because other aspects of medical-industry collaboration were substantively extending longevity.
The real “story” is therefore that, unlike smoking tobacco, hormones are not almost entirely harmful: they have benefits as well as risks, and judicious use, applicable due to the emergence of new information, appears to mitigate the risk.
In comparison, the NY Times story is framed as if hindsight always existed, and on the predicate that any glimmer of risk must always be acted upon immediately and decisively, irrespective of unintended consequences. Controversial situations are really not controversial since the critics and precaution-obsessed regulators are always right, irrespective of evidence. Based on this reasoning, concerns that statins promoted cancer, eventually shown to be bogus, should have kept thousands from benefiting from these agents.
While evidence on this issue exists on both sides, trying to use a selected group of “court documents” from discovery items leaked to the press by litigants is not a fair practice. Ultimately, the idea that science is always evolving and can change our views and the results of medicine must be taken in careful consideration. Otherwise, every drug maker that ever has a chance at producing a drug that could help people will be scared away by the chances that new breakthroughs will show that some of the risks outweigh some of the benefits.