Posted: 11/19/2013 1:36 pm
by guest blogger Diana Zuckerman, PhD, president of the National Research Center for Women & Families
"Was I just unlucky, or is this medical product not really safe?" That's a question I get asked often, and was recently asked about Essure, a "permanent birth control" device made by Bayer.
At first it seemed these women were just unlucky. But after gathering more information, it now looks like there could be much greater risks than patients are being advised of.
In case you're wondering, permanent birth control means sterilization. The purpose of Essure is to prevent a woman from ever getting pregnant again. For some women, preventing any future pregnancies could save their lives. So it is obviously a problem when Essure doesn't work and women get pregnant, which was one of the problems I heard about. But I also heard from women who were in terrible, unrelenting pain, feeling that their lives had been ruined by this product.
Since National Research Center for Women and Families is known as an objective source of medical information and isn't on the payroll of any companies, the women asked, "What do you know?" and "Is this product really safe, or are there a lot of other women like me?" And also, "Can you warn other women?"
The Food and Drug Administration (FDA) has much lower standards for medical implants than it does for prescription drugs, so I checked out Essure on the FDA website and was pleasantly surprised to see that the FDA had required clinical trials, which the agency often doesn't require for implants. These studies of women with Essure implants showed that Essure patients had a rather low rate of complications.
The studies showed that the main problem was that sometimes the device fell out. If the woman didn't realize it, she could get pregnant. If she did realize it, she'd need to get a replacement implant or use another type of birth control.
There was about a 5 percent rate of serious complications reported--not great (especially if a complication happens to somebody we care about), but not a bad rate, either. Since all birth control has some risks (such as potentially fatal blood clots), and since pregnancy has rather substantial health risks (an even greater risk of potentially fatal blood clots), the studies of Essure seemed reassuring (no pun intended).
Sometimes studies can be deceiving, however, especially when conducted by the company trying to sell you the product. An NBC news investigative team interviewed Kim Hudak, one of the women in the study who has had terrible pain in the years since she got Essure. The reporters found that the telephone surveys and medical visits that were used to provide data for the company's study had yielded information about her terrible health problems after Essure but hadn't counted them as complications. The health professionals conducting the study had made very subjective decisions: for example, that excruciating pain in the same part of her body as the Essure device somehow was unrelated to Essure and therefore needn't be counted as a complication. Instead, they reported Kim's experience with Essure as "excellent" and Kim as "very satisfied." Meanwhile, Kim was in excruciating pain--and had gained 100 pounds from the medications she was given as doctors tried to figure out what was wrong. Kim told me that she thought her health problems might possibly be caused by Essure but believed the doctor when he told her they weren't.
Eventually, Kim was in so much pain that she ignored the doctor's advice and had her Essure implant removed. Kim told me that her health has dramatically improved ever since, and she has lost most of the weight she had gained.
This is not the story of one woman. It's a story about how poorly conducted research provides inaccurate information that can potentially harm thousands if not millions of patients. Whether the study was intentionally fraudulent or just badly conducted by some of the medical professionals involved, the results are the same for Kim and anyone misled by the completely inaccurate reporting of her terrible medical problems. The fact that Bayer was accused just two years ago of covering up deaths from Yasmin, another one of its birth control products, does add extra drama. Can the company's studies be trusted? And should the FDA do a better job of scrutinizing them?
It doesn't take much to monitor these studies. For example, you can see in Kim's study survey where her health problems were clearly written and then somebody crossed them out, added his or her initials to show this was an official revision, and changed the answer from "Yes" (I have health problems since getting Essure) to "No." The woman interviewing Kim also checked "excellent" and "very satisfied."
If that had only happened to Kim and nobody else, then perhaps Essure could be almost as safe as the company reported. But the same people who collected data on Kim also "studied" other women, so it's likely that such changes and inaccuracies happened numerous times. That would mean that FDA's decision to approve Essure was based on inaccurate information.
Instead of monitoring the company's studies, unfortunately, the FDA has defended them. While the NBC investigative reporters were gathering information, the FDA wrote a new article for its website defending the safety of Essure.
As a person who uses medical products, what can you do to make sure you aren't harmed by implants or medications that aren't really safe? There is no easy answer. But there are a few things you can do:
. Before starting a new medication or agreeing to a new medical implant or device, go online. Go to your favorite search engine and type in the name of the product and the word "problems" or "risks" or "complications." That will usually take you to web pages that list the possible problems with the product. You can even go to the official website for the product. Although a company's website will advertise how great the product is, by law the company is also required to list all the possible complications that the FDA has found. This isn't a perfect source of information (as my Essure example shows), but it will provide some warnings of what the risks are.
. For prescription drugs, you can also go the ConsumerReport.org's Best Buy Drugs website to get information that compares the drug you are considering with other drugs that can be used for the same purpose. The site doesn't have information about all drugs, but it does have good comparison information about many widely used drugs.
. Check out www.center4research.org and www.stopcancerfund.org for information about many drugs and devices. And, if you are having trouble finding the information you're looking for, you can contact our Center's free hotline at firstname.lastname@example.org to ask us. You'll receive a free, personal response within days.
One more thing to remember: The newest medical products are often not the best, even though they're the most expensive. FDA approves new medical products on the basis of information that is provided by the company making the product. It isn't until the product has been used by many thousands of patients in the real world that it's possible to learn what all the risks are and how it compares to other treatments.
Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals as well as in newspapers across the country.