Idea #315 for December 30th, 2009: Passing Muster or Stricter Device Approval Guidelines At The FDA

The FDA has announced plans to implement a more strict process for the approval of medical devices. This decision comes after several journal articles brought to light flaws in the current approval process. For instance, an article in JAMA showed that the approvals of a number of cardiovascular devices in the last decade were based on a single study. Also, only about half of the outcomes in the studies were compared to control groups. Rigor has certainly been lacking in these FDA approvals. It might be a case of too little, too late, but at least the FDA has admitted to the problem and will make an effort to address it.

Read more about this story here.

Idea #268 for November 13th, 2009: The Wrong Course or Getting Industry Money Out of CME

As part of the medical licensing process administered by states, physicians must earn credits in continuing medical education (CME) by attending qualifying classes. The way in which some of those classes are being paid for has come under scrutiny recently. About $1 billion per year is spent by drug and device makers on funding CME courses, creating the suspicion of conflict of interest.

Not all CME programs are tainted, but some are run by for-profit organizations that use industry money to promote certain products. For instance, MedImmune paid a for-profit CME program over $300,000 this year to sponsor courses on a virus called RSV. Coincidentally, MedImmune sells a drug that prevents RSV in babies. Clearly, drug companies aren’t interested in donating vast sums of money to education programs without expecting some return on investment.

We should not allow this kind of tainting of our healthcare system with money from medical corporations. Luckily, there is language in the House’s healthcare legislation that would force drug and device makers to disclose all money given to doctors and third-parties such as CME organizations. That’s a start. Hopefully, just disclosing the payments will lead to further backlash that will eventually strip all industry money from the education of our physicians.

Read more about this in the Wall Street Journal.

Idea #97 for May 26th, 2009: How Many Free Meals? or Gift Reform in Vermont

Vermont is moving forward with a law that will require all gifts from drug and device be disclosed to the public. The law, which will take effect July 1st, will also ban the free meals often given by drug companies to healthcare providers. Data from 2008 in Vermont shows that about half of the state’s licensed practitioners received some sort of payment or gift from drug or device makers. The gifts totaled $2.9 million in that year, about a third of which was used for free meals.

Vermonters will soon be able to know which (if any) of their providers received gifts from which drug company, as well as the value of the gifts. Gifts can include things like lodging, paid speaking engagements, free meals, or direct payments. Greater transparency in healthcare is always welcome, and this is a major step forward. The public has a right to know if the possibility of conflict of interest exists among their providers. Since the FDA has not implemented major reform or regulation in this regard, it’s good to see Vermont’s state legislature stepping up.

Read about the bill in the NY Times or on this blog.