Think the FDA is Looking Out for You? Think Again!

Back in the 1970s, when I sat on the FDA Consumer Consortium, an eclectic advocacy group comprised of organizations concerned with the health and well-being of various constituencies, I quickly learned that the FDA approval process needed watching. That was never truer than now.

Recently, as reported by the New York Times, the Food and Drug Administration went public with the fact that it couldn’t guarantee the long-term safety and efficacy – FDA’s twin mission – of a particular medical device, vaginal mesh products, that have been on the market for decades. Women were not surprised. Many of them remembered what Thalidomide and DES had done to them or their mothers, and many had experienced the failures and problems associated with breast implants.

Despite well-documented breast implant problems, an implant linked to a rare cancer is still being sold in the U.S., even though it’s banned in many other countries, because the FDA says there isn’t enough data to justify banning them. The vaginal mesh products in question, which support pelvic organs, have long been tied to life-altering injuries, according to the Times report. Eighty deaths were reported as of last year as a result of mesh complications, and over the past decade several companies have paid out $8 billion to resolve over 100,000 patient claims. Here’s what’s really shocking: Most of these medical devices were approved with almost no clinical data to support their safety.

As the Times story noted, “When trouble arises, devise makers equivocate, regulators dither, and patients seeking redress are forced into lengthy, expensive court battles.” That means that faulty or dangerous products can be on the market for years.

Vaginal mesh products were finally removed from the market in April, but the FDA has said it will not ban the breast implant linked to cancer and other forms of “breast-implant illness” because FDA regulators claim there is insufficient evidence of harm to justify pulling the product.

It’s not only women who are affected by poor FDA oversight or sheer negligence. Metal hips, implantable defibrillators, and artificial heart valves have also proven disastrous in some instances. “There have also been staples that misfired, temperature control machines that spray bacteria into open chest cavities, and robotic surgeons that slap, burn and main patients,” according to the Times story.

In every one of these cases, dubious regulatory approvals, poor post-market surveillance, and inadequate responses from regulators have caused irreversible, and avoidable, harm.

According to the International Consortium of Investigative Journalists, nearly two million injuries and over 80,000 deaths have been linked to faulty medical devices, many approved with little or no clinical testing. The FDA has continued to promised “transformative” changes to medical device regulation, but it’s ideas for improved regulation have yet to be realized, while regulation of the device approval process has generally accelerated. The head of the FDA office responsible for device regulation, Dr. Jeffrey Shuren, a former venture capitalist, is fine with that. He’s on record saying the benefits of getting innovative products to the marketplace quickly is worth the increased risks.

The FDA’s history hardly encourages hope that its regulation and oversight will improve any time soon. Its numerous scandals include a 2016 insider trading prosecution and a 2009 politicized medical device approval. A 2013 ProPublica investigation found the agency had overlooked fraudulent research and allowed potentially unsafe drugs to remain on the market.

How can such corruption be explained? First, follow the money. According to a 2018 report in Science Magazine, 40 physician advisors out of 107 who voted on FDA committees received more than $10,000 in post hoc earnings or research support from drug manufacturers whose products were approved by panels on which the physicians served. Almost half of the 40 physicians who were rewarded for their vote got more than $100,000, and six received more than $1 million.

As a blogger on http://globalnaticorruptionblog.com noted in 2017, “Corruption blooms where transparency and accountability are lacking.”

Because of that, “Instead of a regulator and a regulated industry, we now have a partnership,” Dr. Michael Carome, director of the health research group at Public Citizen, told ProPublica last year. “That relationship has tilted the FDA away from a public health perspective to an industry friendly perspective.”

So what can be done about a growing list of FDA disasters? Most advocates agree approval standards must be tightened so that loopholes can be closed, most importantly those that allow medical devices to hit the market in the absence of human testing. Post-market surveillance also needs to be fixed. It’s unbelievable that medical devices can be on the market before enough rigorous testing has occurred by manufacturers who argue that further testing of products occurs once they are being used. Finally, the revolving door that allows manufacturers and Big Pharma folks, who fund much of FDA’s mission, to work for the industry, then for the FDA, and back with industry again must be disallowed.

No patient should have to worry about medical devices, procedures or drugs being dangerously flawed or life-threatening. For those who have died when they are, the least the FDA can do is to correct course on their behalf, quickly and completely.

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Elayne Clift writes about women, health, and social justice issues from Saxtons River, Vt.

America's Shameful Maternal Mortality Rate

This being the month to celebrate mothers, it seems timely and important to ask, why is maternal morality so high in this country?

According to a recent report by the Commonwealth Fund, American women have the highest risk of dying from pregnancy complications than in any other high-income country. Their report shows that we have 14 deaths per 100,000 births; the Centers for Disease Control puts it even higher at 18 per 100,000 births. Compare that to Sweden’s 4 per 100,000 or the UK rate of 9 per 100,000 and we are not so “developed” as we think.

Maternal mortality is “a death that occurs during pregnancy or within a year postpartum from a pregnancy complication, a chain of events initiated by pregnancy, or the aggravation of an unrelated condition by the physiological effects of pregnancy.” In the U.S. it has risen to the level of social crisis from a public health perspective. Our maternal mortality rates have more than doubled in the last twenty years, with African American women suffering at the alarming rate of 40 deaths per 100,000. Some experts say it’s getting deadly to give birth here.

Several factors are at play, but one big problem relates to our high C-section rate. A third of American mothers are now delivering by Cesarean section, an increase of more than 500 percent since the 1970s. That’s an astounding figure even if surgery can be necessary sometimes. But what doctors, and moms who elect to have a section, often forget is that we’re talking about major surgery, not something as simple as a tooth extraction.

As the World Health Organization notes, C-sections are effective in saving maternal and infant lives, “but only when they are required for medically indicated reasons.” C-section rates higher than 10 percent, the organization says, are not associated with reductions in maternal and newborn deaths.

“We’ve designed the birth environment to resemble an Intensive Care Unit. Ninety-nine percent of American women deliver in environments that resemble ICUs, surrounded by surgeons,” Dr. Neel Shah, a professor at Harvard Medical School, told a New York Times reporter.

Midwives, who’ve been delivering babies for millennia, have known for a long time that woman-centered childbirth is basically a natural process that, with appropriate support, ends well; it is not routinely a medical emergency. Women who elect to have midwife-assisted deliveries, a practice that has grown since the 1970s thanks to women’s health advocates, know this too.

The midwifery model espouses a holistic approach to childbirth that includes affirmation and comfort as a woman experiences one of the most significant lifetime events. Midwives are highly trained professionals who call in a physician if the situation warrants, and research shows they have better outcomes than physician-directed births. In addition to skills and techniques that can avert an intervention, midwives have an abundance of patience. They understand that birth cannot be rushed, and they know that less medicalization is appropriate in normal births rather than more.

In most countries, mothers deliver their babies with midwives, who provide a relaxed but watchful environment. In this country, as research by Dr. Shah noted, a surgical delivery has less to do with health issues or particular physicians than with the hospital in which a mom delivers. “Your biggest risk factor is which door you walk into,” he says. That’s particularly true in urban cities and teaching hospitals. It’s also why women are now alert to “buyer beware birthing environments.”

Birthing centers like the one at South Shore Hospital in Weymouth, Massachusetts are breaking new ground in woman-centered childbirth. A team of experts there committed to reducing the C-section rate have developed a model to reduce Cesarean sections in collaboration with Dr. Shah and others at physician-writer Atul Gawande’s Boston Ariadne Labs. Recently they made national news when the team delivered twins naturally, one of whom (at least) would have been deemed a section in most other delivery suites.

In 2017 the House of Representatives introduced the Preventing Maternal Deaths Act which directs the Department of Health and Human Services to offer a range of ways to reduce the maternal mortality rate, including Maternal Mortality Review Committees, at the state level. It also provides for public disclosure of information in state reports. Passed by the Senate, Donald Trump signed the bill into law in December 2018.

In the U.S., the C-section rate continues to vary from seven to 70 percent, while the CDC estimates that 60 percent of maternal deaths in the U.S. are preventable. Those are shocking numbers, especially in a so-called developed country that reveres motherhood, at least rhetorically.

The lives of childbearing women in this country depend on the success – and implementation – of established and proposed legislation, especially to address structural inequities that put black, indigenous and rural families at disproportionate risk, making policy changes relating to Medicaid imperative. Several Democratic legislators have introduced such legislation.

For it to make its way through the labyrinth of public policy, people who care about moms, wives, and other American women, urgently need to advocate on their behalf.

What better time to start than on Mother’s Day?

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Elayne Clift writes about women, health, and social justice issues from Saxtons River, Vt. (www.elayne-clift.com