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Editorial JUNE 2006
The Culture of
Misinformation: An Adverse Influence
on the Health Care of Women
Lee P. Shulman, MD
The past several months have witnessed a torrent of misinformation concerning womenÍs health care. This is nothing new—we watched the press eliminate intrauterine contraception in the 1970s and 1980s, and more recently perform a major disservice to mature women around the world with biased reporting
of findings from studies on postmenopausal therapies. However, recent events concern me even more, combining a mix of surrogate markers, pseudoscience, and presumptions that promises to adversely affect the care of millions of women.
Specifically, a change in the labeling for the transdermal contraceptive patch provides information about a pharmacokinetic study showing that the average estrogen exposure of patch users is approximately 60% greater than for women using an oral contraceptive (OC) containing
35 mcg of estradiol. The subliminal message is that greater estrogen exposure increases the risk of adverse events—in particular, thromboembolism. However, no epidemiologic data have as of yet demonstrated such an association; in fact, the package insert repeatedly states that it is not known whether there is an increased risk of adverse events due to this pharmacokinetic phenomenon.
Why would the package insert present information that suggests a severe adverse event in the absence of any clinical data to support such a finding? I have no idea. No purported reason—from concerns over the cyclooxygenase-2 inhibitor fiasco, to the growing intrusion of product liability and malpractice attorneys into medicine, to the incursion of politics into medical science and research—provides an appropriate explanation for the abandonment of evidence-based medicine by regulatory agencies and professional organizations.
Even more concerning is the apparent acquiescence of so many clinicians to this abandonment of evidence-based medicine. I was recently giving a presentation to a talented group of OB/GYNs, and the topic of the labeling changes was raised. The group stated that they were still offering the transdermal patch to patients, but were concerned about the increased risk of venous thromboembolism with its use. I asked where they heard about this increased risk, and one of the members said that a patient had told her. The group was surprised when I read them the actual package insert, even though another member stated that she knew there was no mention of an increased risk, but she had presumed it existed. She was relieved when I showed her a recent study that found no difference in the risks for severe adverse events among OC and patch users,1 as many women in her practice use the patch and would have difficulty finding an alternative method of contraception
There was a rise in the rate of unintended pregnancies as the use of all intrauterine devices plummeted in the wake of the distorted coverage of the Dalkon Shield. Physicians must never again allow presumption and innuendo to remove safe, reliable methods of contraception from consideration of use by patients. While we cannot control the press, we can make sure that we are well informed on the topics that concern our patients. While physicians must strive to listen to what patients have to say, they must also refuse to accept hearsay as medical information or use it to guide their clinical practice. Physicians must actually read the package inserts, the studies in the headlines, and the studies that may refute them. And if this is not feasible, the physician should at least use peer-reviewed, respected sources of information—such as The
Female Patient—that provide accurate information.
On a personal note, I would like to thank Thomas E. Nolan, MD, MBA, for his guidance and leadership as the former Editor-in-Chief of The Female Patient. Renaissance man or a bull in a china shop, Dr Nolan is truly one of the most gifted OB/GYN teachers and practitioners in the United States, and I am proud and honored to be his friend and colleague. Although I will miss working with him on the journal, I know that he is the best person to help rebuild womenÍs health care and OB/GYN education in New Orleans. I wish him good health and good fortune, and the promise of help whenever needed.
Lee P. Shulman, MD
Associate Editor
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References
- Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73(3):223-228.
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