The FDA Has A New Commissioner

The FDA officially has a new Commissioner. The Senate quietly…very quietly…confirmed Dr. Margaret Hamburg as the new Agency head.

Dr. Hamburg was the youngest New York Health Commissioner and has had several decades of experience in public health, bio-terrorism and communicable disease prevention. Like President Obama, she is a Harvard alum and is of mixed race ancestry. She serves on the Board of Sidwell Friends, where the Obama’s send their daughters.

Hopefully, Dr. Hamburg is up to the challenge of leading such a large and complex agency. God knows the agency could use her – the FDA desperately needs consistent leadership.

Risperdal Consta Approved for Bipolar Disorder

J&J’s Janssen has received approval from the FDA for the long-acting version of Risperdal Consta (risperidone) for the treatment of bipolar I disorder. Risperdal Consta was approved for schizophrenia in 2003.

Also benefitting from the announcement is Boston biotech Alkermes, which provides technology to make long lasting drugs.

CDC Gets New Director

President Barack Obama has appointed Dr. Thomas Frieden as the new Director of the Centers for Disease Control and Prevention (CDC). Dr. Frieden is currently serving as the Commissioner of the New York City Health Department. I don’t have actually have anything snarky to say about Dr. Frieden as he is one of the few appointments from President Obama that doesn’t have a huge cloud of suspicion over him.

President Obama sayz: "America relies on a strong public health system and the work at the Centers for Disease Control and Prevention is critical to our mission to preserve and protect the health and safety of our citizens. Dr. Frieden is an expert in preparedness and response to health emergencies, and has been at the forefront of the fight against heart disease, cancer and obesity, infectious diseases such as tuberculosis and AIDS, and in the establishment of electronic health records. Dr. Frieden has been a leader in the fight for health care reform, and his experiences confronting public health challenges in our country and abroad will be essential in this new role."

Congratulations to Dr. Frieden!

Source: President Obama’s press release

FDA Declares War on Cheerios

The U.S. FDA seems more like a political tool of whatever Administration is in charge than a serious scientific agency. First Bush played games on Plan B. Now, the Obama crew is having the FDA go after Cheerios.

For the last 12 years, the FDA has permitted General Mills to make claims about heart health benefits. For the last 2 years, General Mills and Cheerios have been making claims about a diet low in saturated fat that includes Cheerios can lower cholesterol - claims backed by serious scientific study.

After the change in the White House, the FDA now claims this is a serious violation of law. Either the FDA is bowing to political pressure or they are grossly incompetent. If Cheerios are so bad, where has the FDA been for the last 12 years?

I'm getting tired of politicians playing politics with scientific agencies.

Better Off Dead

Centers for Medicare and Medicaid Services' (CMS) has rejected a proposal to cover virtual colonoscopy for Medicare recipients. The answer from the agency is that some Americans are better off dead.

"We were hopeful CMS would allow seniors access to virtual colonoscopies, which can aid in the early detection and prevention of colon cancer and save lives," said Andrew Spiegel, CEO of the Colon Cancer Alliance. "While we believe ample data currently exists to support a positive decision today for Medicare reimbursement of virtual colonoscopy, CMS should immediately re-open the review process to account for any new data and evidence that emerges showing efficacy of CTC in the Medicare population."

While the agency tried unsuccessfully to question the science, this decision was all about costs. The Bush Administration gave us the practice of medicine based on theology. The Obama Administration has given us the practice (or lack thereof) of medicine based on economics. ObamaCare is not care, but the absence of care. I'm one of the lucky Americans - I don't have to rely on Medicare.

Virtual colonoscopies are proven. And people (most notably Black Americans according to recent studies) will get virtual colonoscopies when they not get a traditional one. Is the CMS/Obama decision racist? Probably not. But the Obama Administration is willing to accept some collateral damage and thinks some of America's seniors are better off dead.

Colorectal cancer is terrible and deadly. But as the Katie Couric "inside out" tour taught us, it doesn't have to be a death sentence. Sreening, including virtual colonoscopies, can catch disease early.

It's a sad, sad day for America's senior citizens.

Angie’s List Takes On Doctors

As listeners of NPR are painfully aware, Angie’s List is now providing a forum for rating and ranking doctors. There’s certainly a plethora of doctor rating companies, including Health Grades, DrScore.com and others. I’m not clear what Angie’s List value proposition for their service is, but they’ll face strong competition from other companies in the same.

But that’s not all. Angie’s List is now squarely in the sights of anti-patient advocates, like Dr. Jeffrey Segal and his company, Medical Justice. I’ve talked about this before in Physician Takes Aim at First Amendment and also Ranking Your Doctor.

Dr. Segal started the company when he was sued for medical malpractice. It’s not clear in anyone’s mind how you get from being sued for malpractice to trying to get patients to sign gag orders not to talk about your bedside manner. About 1,000 doctors subscribe to his service – mostly plastic surgeons, but also a strong cadre of physicians with nearly mail-order diplomas from “medical schools” in the Caribbean. Segal himself is no longer a practicing neurosurgeon and it is unclear if he has chosen not to practice or if he is not able to practice because of some other reason. Segal himself hasn’t been exactly been clear on this issue in previous media interviews.

If you’re a patient and your physician presents you with one of these gag orders, you should probably look for another physician. Given the kind of physicians that are drawn to this company, do you really want to have them as your physician?

Physician rating sites need to be taken with a grain of sale just like restaurant reviews, hotel reviews and nearly every other kind of third-party information. But trying to shut them down is futile. Truth will always come out, despite the best efforts of paranoid individuals.