Is Baby Powder Dangerous? Does Industry Even Care?

https://www.nytimes.com/2018/07/13/opinion/editorials/johnson-johnson-baby-powder-talc.html

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A St. Louis jury this week ordered Johnson & Johnson to pay $4.69 billion, one of the largest amounts ever awarded in a product liability case, to 22 women and their families who say the company failed to warn people that its talcum-based baby powder contained dangerous levels of asbestos. The plaintiffs argued that years of daily use caused the women to develop ovarian cancer; six of them have died from the disease.

The decision is precarious, to be sure. The science linking baby powder to ovarian cancer is shaky at best. And judgments for several similar suits — against the same company, regarding the same product — have been overturned on appeal. But in this case, the plaintiffs marshaled reams of documents, going back decades, to show that at least some scientists within the company had expressed concern about asbestos contamination, only to be ignored by executives. (Asbestos is commonly found near talc mines, but it is supposed to be stripped from commercial products.)

The size of the award sends a message that should be heard by the whole drug and medical device industry: Stop placing profits over safety. Or, as the women’s lawyer, Mark Lanier, put it in his closing remarks, “You don’t jack with people’s lives like this.”

Johnson & Johnson and its peers were once lauded as a collective of hero-innovators and credited with bringing an avalanche of lifesaving, world-changing technology from lab bench to patient bedside. Today they are more readily associated with rampant price gouging, the worst drug overdose epidemic in modern history and a steady beat of cases similar to the talc-cancer one, in which profitable products caused real harm.

In recent years, Johnson & Johnson has seen a number of its products — from surgical mesh to metal-on-metal hip replacements to blood-thinning medication — linked to serious injury, subject to patient lawsuits and, in some cases, pulled from the market.

The company is not alone. Essure, Bayer’s permanent birth-control implant, has been linked to a string of life-threatening side effects, including ectopic pregnancies, severe bleeding and serious autoimmune disorders, in tens of thousands of women. It has since been pulled from the market — in every country except the United States.

And Nuedexta, Avanir’s blockbuster drug, has been maligned after a CNN investigation found the company was marketing it aggressively to nursing home patients. The drug was approved to treat pseudobulbar affect, or PBA, a very rare condition that causes people to laugh or cry uncontrollably. PBA affects less than 1 percent of the population, but Avanir made hundreds of millions of dollars off it, in part by offering generous kickbacks to nursing homes that dispensed it. As CNN reported, the drug’s main side effect — it causes a weakness that leads to falls — can be especially dangerous for the elderly.

And it’s not just industry that has stoked suspicion, frustration and anger. Even amid a laudable campaign to curb tobacco use and a popular one to bring more generic medications to market, the Food and Drug Administration has been charged with catering to industry in a way that exposes patients to harm. According to a recent ProPublica investigation, the agency has granted speedy approvals to an alarming number of medications with serious side effects and few proven benefits. According to that report, less than 20 percent of all new drug applications were rejected in 2017, compared with nearly 60 percent in 2010.

All the while, the revolving door between industry and regulatory agency is turning as rapidly as ever. According to a study by the journal Science, 11 out of 16 F.D.A. medical examiners who left the agency after working on drug approvals are now employed by the same companies they regulated. Science also found that the agency has failed to police conflicts of interest among its currently employed consultants — many of whom have accepted between tens and hundreds of thousands of dollars in speaking and consulting fees from companies whose products they were tasked with evaluating.

Johnson & Johnson has called the verdict in the St. Louis case unfair and implied that it was based on emotions, not science. “Yes, this is terrible,” the company’s lawyer said during closing arguments. “But just because something terrible happened doesn’t mean Johnson & Johnson had anything to do with it.”

Whether talc exposure leads to ovarian cancer is an important question, and a definitive answer still evades researchers. The National Cancer Institute says the balance of evidence does not indicate that asbestos can be absorbed into reproductive organs at a level that would cause harm, and the American Cancer Society says that more study is needed.

But the protocols and basic principles of trust that might have once held sway in cases of scientific uncertainty have been eroded by too many violations. Consumers have long bore the brunt of those violations; it’s about time companies did, too.

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