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The Food and Drug Administration (FDA) is taking a remarkable step regarding the use of placebos in clinical drug trials.
In new guidance set to be published in the Federal Register on Thursday, the agency proposes that certain patients with serious medical conditions—including some forms of cancer—shouldn’t have to take placebos if there’s a therapy on the market that already works.
“Placebos are often used in clinical trials. However, patients fighting life-threatening diseases, like certain cancers, shouldn’t be given a placebo when there is a known effective therapy,” wrote Acting FDA Commissioner Ned Sharpless in a tweet on Wednesday. (Relatedly, Sharpless was the director of the National Cancer Institute prior to his selection as the acting FDA chief.)
“Today’s guidance provides clarity to industry regarding our recommendations regarding the use of placebos and advises that they should only be used in select circumstances or in certain trial design features for patients with cancer,” he added.
Under the guidance, the FDA states that cancer clinical trials which use a placebo should largely be limited to those that involve follow-on, “adjuvant” therapies (i.e. additional treatments used to support a primary drug regimen), add-on trials, or studies for cancer types which have no currently approved therapies.
One key detail to keep an eye on as the public comment period on the guidance commences: Will patients with rare disorders with no approved treatments insist the same guidance applies to them?
Read on for the day’s news.
Sy Mukherjee, @the_sy_guy, email@example.com
Fitbit plans to significantly expand its product and service offerings. Fitbit CEO James Park spoke to Fortune on Wednesday about a suite of new health care offerings and products being launched by the company—an effort to continue to differentiate it from competitors such as the Apple Watch. The headline new product is the Versa 2 smartwatch, an upgrade over existing Versa devices, which will hit stores in mid-September at a $200 price point. Some of the big additions? Connectivity with Amazon Alexa and a longer battery life (Park tells Fortune that the battery for the Versa 2 lasts five days rather than four, and even up to a full week for some users, and that the longer battery life can be especially useful for people who want to track their sleep or other biometrics overnight.) The other major Fitbit push is a subscription service called Fitbit Premium, priced at $10 per month or $80 per year, that provides access to coaching and personalized exercise and diet plans. "The Apple Watch doesn't have a service component to it," said Park. "For us, about a year ago, we started on a strategy to really boost the number of our active users in preparation for the launch of this premium service."
AstraZeneca gears up for battle with Glaxo in the lung disease space. AstraZeneca just got some positive news in its battle with fellow U.K.-based drug maker GlaxoSmithKline. The company's experimental three-drug therapy to treat chronic obstructive pulmonary disease (COPD) reportedly showed efficacy in the degenerative lung condition (which is the number three killer of Americans), and the FDA granted the firm a coveted "orphan drug" status for another treatment meant to treat a rare lung condition caused by inflammation of the esophagus. (Reuters)
Sackler clan, Purdue Pharma reportedly negotiate $11 billion bankruptcy settlement. The Sacklers, the powerful family which owns the private firm Purdue Pharma, the manufacturer of OxyContin, has reportedly backed a bankruptcy settlement that would strip them of control of the company and transform it into a public beneficiary trust. Under such an arrangement, the Sacklers would pay more than $11 billion (including $3 billion in cash) that would largely be funneled to states and locales affected by the opioid crisis, and Purdue would be run by managers appointed by independent trustees. Earlier this week, a judge ruled that Johnson & Johnson should pay $572 million for its alleged role in fueling the opioid epidemic in Oklahoma. (Fortune)
THE BIG PICTURE
California lawmakers pass transparency bill targeted at Kaiser Permanente. The California state legislature has passed a bill targeted at the sprawling Kaiser Permanente health federation that would require Kaiser to disclose revenue and profits by each of its individual hospitals (rather than, as under the current system, providing aggregated data based on "Northern" and "Southern" California institutions). It's unclear whether or not Gov. Gavin Newsom will sign the bill. Kaiser has been facing pressure from the Service Employees International Union in California; the organization said it was disheartened that the bill's author and the major sponsor didn't engage in further compromise. (ModernHealthcare)
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