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How Good Reporting Revealed A Serious Cancer Risk

February 9, 2017, 4:29 PM UTC

Over the past week or so, I’ve read, watched, and listened to two dozen smart, well-reported stories about cancer—tales of biological mysteries, crusading patients, the challenges of survivorship, and the newly seen quantum effects of an age-old treatment.

But while it’s too early to spotlight this year’s best in class, this is a fine opportunity to call out some previous investigative reporting in the cancer arena. And these stories, without a doubt, saved lives.

The articles, in late 2013 and throughout 2014, probed the dangers of a device called a laparoscopic power morcellator—which, for years, had been used to grind up uterine fibroids and make them easier to remove. In December 2013, Jennifer Levitz of the Wall Street Journal broke the news that several Boston area doctors were concerned about the procedure, worrying that it could spread hidden cancers by dislodging malignant cells in or near the benign fibroid tissue in the abdomen and essentially “seed” them in other parts of the body.

At the time, the morcellation procedure was used in an estimated 11% or more of the roughly 500,000 hysterectomies performed annually, the Journal reported—and the American Congress of Obstetricians and Gynecologists considered it “low-risk.”

Yesterday, the Government Accountability Office, an investigative agency of Congress, cited the Journal’s sleuthing in an analysis that, rather gently, faults hospitals and doctors for not reporting to the FDA cases in which women’s cancers were spread after morcellation. But the bigger culprit, they found, is the very passive, volunteer system we have for reporting adverse events—one in which the rules regarding medical devices are particularly murky. (Here’s the summary, but the full report has some eye-opening nuggets and is worth reading.)

The GAO, for example, points to a 2012 study that reviewed 1,091 cases of uterine morcellation at one hospital, reporting “that the rate of unsuspected cancer (uterine sarcoma) after laparoscopic morcellation was 9 times higher than the rate quoted to patients at the time (1 in 10,000).” The study concluded that uterine morcellation carried “a risk of spreading unsuspected cancer.” But no one, it seems, reported the specific cases to the FDA.

The bottom line is that hundreds of thousands of women, over a number of years, went through a procedure that was far more dangerous than they were led to believe. Experts in the field appeared to know that. The government’s watchdog, however, was none the wiser.

More news below.

Clifton Leaf


MIT is getting $20 million to study autism. The Massachusetts Institute of Technology is launching a new center focused on autism research - and it's getting a $20 million cash jolt from Broadcom to help get things started, writes my colleague Barb Darrow. The purpose of the new Hock E. Tan and K. Lisa Yang Center for Autism Research is to uncover "the genetic, biological, and neural bases of autism spectrum disorder." For Tan, Broadcom's CEO and an MIT alum, the issue is personal: he has two children with autism. CDC data shows that one in 68 American children have an autism spectrum disorder. (Fortune)

There's a massive chasm between digital health supply and demand. A new Accenture survey finds that there's still a long way to go when it comes to meeting market demand for digital health services. While 78% of the 1,500-plus respondents said that they would like to use telemedicine, health apps, and activity trackers in a virtual care setting, just 21% has actually done so. More than a third of respondents said that they wanted to pursue digital care thanks to the convenience factor. But, from a business context, the convenience could go both ways - doctors in isolated areas with limited resources could expand their businesses by offering virtual options, says Accenture's Frances Dare. "Given evolving consumer attitudes toward virtual care, making virtual health a priority could be a boon for provider organizations that are resource- and finance-constrained," said Dare in a statement. "As more and more patients take control of their own healthcare in the age of consumerism, provider organizations must be able to offer meaningful choices for virtual care, in-person care and a combination of both." (MobiHealthNews)


Sanofi and Regeneron get a new lease on life for cholesterol-buster Praluent. French pharma giant Sanofi and partner Regeneron were slammed with a stunning legal setback when a federal judge ruled that its pricey new cholesterol-fighting therapy Praluent infringed on patents for a rival treatment called Repatha from Amgen. What was truly extraordinary about the judge's decision is that it would have forced Sanofi and Regeneron to pull the product from the market entirely within the next two weeks. But for now, the firms can breathe a sigh of relief, as the U.S. Court of Appeals granted a stay on the ruling Wednesday. Amgen wasted little time in responding to the news. "While we respect the Court’s decision in staying the injunction pending the appeal, Amgen remains confident in the validity of our patents and the correctness of the jury verdict and district court’s judgment," said the company in a statement.

Mylan's EpiPen competitor has a few drug pricing demons, too. Mylan has been roundly slammed for its hefty price hike on the life-saving EpiPen device. But even one would-be competitor has its own issues with pricing - and more than 30 U.S. Senators want answers. Kaléo, which makes a more high-tech epinephrine injector called Auvi-Q, has hiked the list price of an opioid overdose-fighting device called Evzio, which has gone from $690 for a two-pack in 2014 to $4,500 for the same quantity today. Furthermore, Auvi-Q itself has a high list price, and Kaléo's strategy to keep the backlash at bay has been to offer aggressive patient assistance programs (in essence, passing the costs on to insurance companies). The Senators, many of whom come from states where the opioid epidemic has been particularly devastating, are asking the firm to explain its pricing rationale. (Fortune)


Federal judge blocks Anthem-Cigna merger. A federal judge has slammed the brakes on the proposed $54 billion mega-merger between insurance giants Anthem and Cigna. Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia said that the deal would be a raw one for consumers and give the two firms far too much control over a market that already has a dearth of competitors. The Justice Department has sued to block both the Anthem-Cigna merger and another proposed deal between Aetna and Humana. It's unclear whether or not the companies plan to appeal, although some legal experts say that a successful challenge to the ruling is unlikely. (Fortune)

Millennials' earbud obsession is ruining their ears. A new analysis from the Centers for Disease Control finds that a quarter of people between the ages of 20 and 69 have damaged hearing. And what's particularly concerning is that 53% of these people aren't exposed to loud noises in the workplace, suggesting that audio technologies like earbuds are wreaking havoc on younger people's auditory capacities. (Washington Post)


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Produced by Sy Mukherjee

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