Author: Sarah Smedley

Patients and doctors are clamoring to recall Essure, a nickel-based birth control device implanted into a woman’s fallopian tubes to make her permanently sterile. The FDA fast-tracked its review process, thanks to the device’s promise as a viable, safe alternative to surgical sterilization, and approved Essure in 2002. It has taken years, but Essure is finally coming off the market, by the end of 2018. In July 2018, Essure’s manufacturer, Bayer, said it would stop selling Essure because of waning sales, although it stands behind the safety and efficacy of the product Since 2002, roughly 17,000 adverse event reports worldwide have…

Breast cancer patients met with the FDA in April to talk about living with this disease and to describe how treatments have changed their lives. While the women have survived breast cancer, some for 20 years after their diagnosis, they are tolerating unanticipated and unwanted changes to their bodies and moods due to excruciating side effects of powerful drugs they take for most of their lives. Patients in remission face the nagging uncertainty about possible tumor recurrence, which causes lingering anxiety about going back on treatment and learning to live with different side effects. The women were asked to take…

Waiting for results of a lab test? Not to make you worry even more, but — according to federal regulators — you might not be 100% able to trust those results, if they come from certain laboratory-developed tests, or LDTs. An LDT is a test that’s designed, developed and used within a single laboratory. LDTs cover a wide range of diagnostics, from basic things like a CBC (complete blood count) to complex multigene panels. The common thread is that the tests are only used in that particular lab, which means the test may differ from lab to lab. In the…

“This country has a real problem with narcotics.” That was the response when I asked a friend of mine, a pediatrician with 30 years’ experience who’s been in private practice and now works at a neighborhood clinic, what she thinks about prescribing codeine for kids. “I can’t tell you the last time I prescribed codeine for my patients. I just don’t prescribe it for anything, including pain or coughs,” she told me, not when there are good, safe options like Motrin or Tylenol. It’s not that a child would never receive a narcotic drug -– in a hospital setting, there…

If you’re an American who spends even a tiny amount of time watching TV, you can’t have missed the explosion of advertisements for prescription drugs. You know the ones: “Ask your doctor if whatever-the-drug-is-called is right for you!” The average TV viewer can expect to spend as many as 16 hours per year watching pharmaceutical ads ranging from rheumatoid arthritis to erectile dysfunction — and that doesn’t include print ads cluttering magazines or splashed on billboards. But are these commercials (which feature actors who look suspiciously healthy!) a good thing for the average consumer? The American Medical Association (AMA) doesn’t…

There’s been gridlock in recent years surrounding the regulation of dietary supplements. Should the FDA focus on whether these vitamins, minerals and herbal extracts actually do what they claim — or leave that concern be for now and instead take important steps to improve their safety? Option 2 is the solution proposed by a former principal deputy commissioner of the FDA, Joshua M. Sharfstein, MD, associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health, and Akshay Kapoor, MSPH, in a recent paper. Why the standstill in keeping supplements safe — free of…

Clinical trials are designed to test and measure the safety and efficacy of a drug. Does it treat the disease it’s meant to address and does it do so with a minimal amount of negative side effects? If that’s the goal, it seems logical that trials should enroll a representative sample of people who could potentially suffer from the condition the drug is intended to treat — including, you know, women. Yes, that does seem logical. But it’s not what always happens. Women and children haven’t always been represented in the clinical trials that led to the approval of the…

Now that Addyi (flibanserin), the first drug for women to treat low sexual desire (hypoactive sexual desire disorder, or HSDD), has been approved, what happens when the drug actually becomes available for use in October 2015? HSDD affects up to 1 in 10 women in the US, according to research cited by Addyi developer Sprout Pharmaceutical, Inc. That’s a large potential market. But we already know how the company benefitted. Only 2 days after approval, Sprout sold the company to Valeant Pharmaceuticals International for $1 billion. Call me cynical, but the turnkey sale of Addyi makes me think that Sprout…

The FDA has approved Addyi (flibanserin), the first drug to treat low libido in premenopausal women who are diagnosed with hypoactive sexual desire disorder (HSDD), otherwise known as low sex drive. According to the FDA press release, the drug is being approved with a risk evaluation and mitigation strategy (REMS), because an interaction between Addyi and alcohol increases the risk of severe low blood pressure (hypotension) and loss of consciousness (syncope). Health care professionals who prescribe Addyi and pharmacies that dispense Addyi must be certified with the ADDYI REMS Program, and must counsel patients about this risk. “Because of a…

When I applied for long-term care insurance, I didn’t think I needed to be worried about the over-the-counter (OTC) drugs I had taken for 40 years. Boy, was I wrong. Part of the application process was an interview by a nurse from the insurance company. She asked me a lot of questions about my medical history. I am well past my child-bearing years, so I had a cheat sheet to help me remember the many abdominal surgeries I had to treat infertility, along with the names of the strong hormones I took for 10 years. The nurse listened, but didn’t…