December 22, 2017
Women’s health issues took center stage in the 2017 arena of risky prescription drugs and medical devices, with a ban on controversial transvaginal mesh implants in three countries.
The U.S. Food and Drug Administration and medical journals also released new warnings and studies linking popular prescriptions drugs to serious risks.
Some of the biggest studies and FDA warnings of 2017 involve the opioid epidemic, heartburn drugs known as proton pump inhibitors, the diabetes drug Invokana (canagliflozin) and testosterone replacement therapy.
This year also saw studies pointing out the failures of the FDA’s drug and device approval process, and Big Pharma’s kickbacks to doctors.
Top Studies, Regulatory Decisions Drugwatch Covered in 2017 Involved:
- Transvaginal mesh implants
- Proton pump inhibitors
- Testosterone replacement therapy
- FDA approval process
- Big Pharma Kickbacks
Transvaginal Mesh Bans, Women’s Health Updates Lead News in 2017
Three countries issued various bans on transvaginal mesh, a product doctors have used to treat incontinence and organ prolapse in the U.S. since the 1990s.
Transvaginal Mesh Bans in 2017:
- Australia – The Nov. 28, 2017, ban focuses on transvaginal mesh used for pelvic organ prolapse and certain slings for incontinence.
- New Zealand – The Dec. 11, 2017, ban includes all gynecological uses for mesh, including prolapse and incontinence.
- U.K. – The Dec. 15, 2017, ban includes transvaginal mesh for pelvic organ prolapse.
The decisions were big victories for patient advocacy groups campaigning to ban mesh.
In their decisions, all three countries cited complaints and concern from the public as well as studies detailing complications linked to the plastic, net-like implant. Reported complications include organ damage and chronic pelvic pain.
New Zealand became the first country to ban all types of mesh for gynecologic uses, such as bladder slings for incontinence and mesh for prolapse. Bans in Australia and the U.K. focused only on mesh used to treat prolapse.
Aside from the ban on mesh, several studies and reports focused on drugs and devices that affect women.
Other Studies, Reports and News on Women’s Health in 2017:
- In a January 2017 study, researchers at the Tisch Cancer Institute of Mount Sinai Hospital in Manhattan found women who used talcum powder for feminine hygiene had a 20 percent increased risk of ovarian cancer.
- In February 2017, a Government Accountability Office report found the FDA took 23 years to warn the public that a surgical device called a power morcellator could spread aggressive uterine cancer.
- In May 2017, an American Association for Justice report showed that dangerous prescription drugs and medical devices disproportionately affect women.
- In May 2017, health advocate Amy Reed died at 44 from uterine cancer spread by a power morcellator — a device she fought to ban.
- In December 2017, a BMJ Open review revealed manufacturers sold 61 transvaginal mesh devices in the U.S. without clinical trials.
Top Drug and Device Studies in 2017 Focus on Risks
A number of studies published in 2017 focused on risks associated with prescription drugs and medical devices. Some highlights include hernia mesh and the diabetes drug Invokana.
Notable Drug and Devices Studies in 2017:
- In February 2017, a JAMA Surgery study showed that although hernia repair with mesh may have a lower recurrence rate, major complications can occur up to five years after surgery.
- In May 2017, the FDA added a black box warning — the agency’s strongest warning – to Johnson & Johnson’s blockbuster Type 2 diabetes drug Invokana for increased risk of leg and foot amputations.
- In June 2017, clinical trial results published in JAMA showed men with low testosterone who used AndroGel had more coronary artery plaque buildup than those who did not.
- In July 2017, a BMJ Open study found long-term use of heartburn drugs called proton pump inhibitors such as Nexium and Prilosec could increase the risk of death by as much as 50 percent.
- In October 2017, a report from the Centers for Disease Control and Prevention found six out of 10 U.S. teens received the human papillomavirus (HPV) vaccine in 2016. The number is up from previous years.
Reports Reveal Big Pharma Doctor Kickbacks, FDA Drug & Device Approval Flaws
Reports and studies in 2017 criticized the FDA drug and device approval process. Other data showed Big Pharma spent billions on doctor kickbacks in the form of free meals, gifts and trips.
Important 2017 Reports on FDA, Big Pharma:
- In July 2017, the Centers for Medicare and Medicaid Services released data revealing drug and device companies gave $8.18 billion in the form of free meals, speaking fees, gifts and travel to hospitals and doctors in 2016.
- In July 2017, a study in JAMA Internal Medicine revealed clinical trials for medical device safety and effectiveness don’t always account for race, sex and age in data. For example, researchers may overlook how a medical device performs in a woman as opposed to a man.
- In August 2017, a study in the American Journal of Public Health found pharmaceutical companies gave more than $46 million to doctors to promote opioid drugs over a 29-month period.
- In August 2017, a JAMA study revealed the FDA’s approval process for some prescription drugs has “major flaws.” Only about a third of clinical studies include randomized trials — the gold standard of evidence.
- In October 2017, the FDA launched a Public Dashboard to help consumers find side effects (adverse events) linked to certain prescription drugs. The data comes from the FDA Adverse Event Reporting System and includes the number of deaths tied to pharmaceuticals.