FDA device chief under fire: Did Dr. Jeffrey Shuren lie to Congress?

Shuren

MASSDEVICE ON CALL: An evident untruth made during questioning by a U.S. House committee is landing Dr. Jeffrey Shuren, head of the FDA’ medical device branch, in hot water with scientists and bloggers.

Testifying before a House Energy & Commerce Committee on direct-to-consumer genetic tests last summer, Shuren told Rep. Henry Waxman (D-Calif.) that companies that make the tests do not conduct their own research.

Read about the FDA’s decision on direct-to-consumer genetic testing

"From the information we know, they’re not adding — they’re not doing their own research on the genetic profiles, but they’re interpreting the studies that have been performed by others," Shuren said during his July 22, 2010 testimony.

But just two days earlier, according to a video posted on FDAblog.org, Shuren attended a presentation by 23andme founder Anne Wojcicki detailing her company’s studies of its database of human genetic information.

It’s an especially sensitive issue given an FDA panel’s vote yesterday to recommend that the federal watchdog agency require a doctor to dispense DTC genetic tests. Genomics researchers and science bloggers hate that idea, arguing that the benefits for patients who delve into their genomes far outweigh any potential risks.

But it’s unclear from the FDAblog.org video, which contains only snippets of Shuren and Wojcicki, whether Shuren is speaking about all companies that offer home genetic tests, or merely some players in that space. Calls and emails to the FDA seeking comment were not immediately returned.

The blogosphere, undeterred, was quick to pounce. "Did the FDA’s Jeffrey Shuren mislead a Congressional hearing?" asked Wired magazine’s Daniel MacArthur.

"If last year’s monkey trial hearings were predicated on testimony that turns out to have been anything less than cricket, then — in my mind, at least — it calls into question whether the self-righteousness of those who were doing the finger-pointing ought to be taken at face value,” added Misha Angrist on his GenomeBoy blog.

"This is a power grab, this is not about safety or ethics," fulminated Razib Khan on his Gene Expression blog at Discover. "Let’s make our voices heard. If they take away our rights because we’re silent, we have only ourselves to blame. If they take aware our rights despite our efforts, we’ll set up the infrastructure for the day when we can take back what is ours" [emphasis his].

Here’s a look at the FDAblog video that kicked up the fuss:

Are you sick of healthcare reform yet?

They sure aren’t in Washington, where Rep. Mike Rogers (R-Mich.) is pushing a measure that would allow all Americans to seeka waiver from the healthcare reform law’s individual mandate and Dept. of Health & Human Services secretary Kathleen Sebelius warned that de-funding the law would cut off Medicare payments for millions of elderly Americans.

Meanwhile, in North Carolina, a GOP bid to exempt Tar Heel State residents from the individual mandate fell by the wayside (paid). Further south in Florida, the scene of a court ruling that the law is unconstitutional, the Office of Insurance Regulation says it will not enforce any of the new rules enshrined in the Patient Protection & Affordable Care Act.

The beat goes on… and on… and on…

Docs look to sidestep insurers

There’s a growing move afoot among medical practices to sidestep health insurers altogether in favor of collecting a monthly "membership fee" from their patients, according to the Washington Post:

"Seattle-based Qliance Medical Management’s three clinics typically charge a patient about $65 a month for unlimited access to the practice’s 12 physicians and nurse practitioners. (Fees vary depending on the level of service and the patient’s age.) Office appointments last up to an hour, and clinics have evening and weekend hours, with e-mail and phone access to clinicians as well. Routine preventive care and many in-office procedures are free; patients pay for lab work and other outside services “at or near” cost, and they get discounts on many medications.

"The average $700 to $800 per patient that Qliance receives annually in membership fees is up to three times more than a doctor in a standard insurance-based practice might make per patient, says Norm Wu, the company’s president and chief executive."

Cancer survivors quadrupled from 1971 to 2007

The number of people who survived cancer over a 36-year span nearly quadrupled, according the Centers for Disease Control.

That’s due to earlier detection, improved diagnostics, more effective treatments, improved follow-up and the graying U.S. population, the Los Angeles Times reports.

JAMA taps new editor

The Journal of the American Medical Assn. named a new editor, Dr. Howard Bauchner of the Boston University School of Medicine, to replace the retiring Dr. Catherine DeAngelis, according to Reuters.

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