Healthy Skepticism Library item: 14974

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Physician Payments Sunshine Act Reintroduced
gooznews.com 2009 Jan 22
http://www.gooznews.com/archives/001309.html

Full text:

Sens. Herb Kohl (D-WI) and Charles Grassley (R-IA) reintroduced the Physician Payments Sunshine Act today. This year’s bill is stronger than last year’s version because it requires drug, device and other medical supply manufacturers to report any type of payment over $100 that they make to physicians. It also includes penalties up to $1 million for non-compliance, and would create a publicly accessible database containing all the information. The law specifically states it wouldn’t preempt stronger state laws.

I was especially pleased to see the proposed law covers payments for “research,” which presumably includes payments made to physicians for enrolling their patients in industry-funded clinical trials. Unfortunately, putting that information in a database doesn’t mean that it will be given to patients in a form that they can understand at the moment when they are being enrolled in the clinical trial and are being asked to sign informed consent documents. Recent research suggests that most patients who enroll in clinical trials do not understand the significance of conflict-of-interest disclosure information.

The proposed law is also silent about making companies submit conflict-of-interest information about their clinical trial physician partners to the Food and Drug Administration before clinical trials get underway, a subject addressed by a Health and Human Services Inspector General report last week. The OIG found that most companies also fail to include clinical trial financial conflict-of-interest information when they submit the final data to the FDA as part of a new drug or medical device application. Even when they do, the FDA does almost nothing with the data. In its response to the report, the FDA said it wasn’t interested in getting the data before the trials get underway.

As the report pointed out, the FDA could use that information to pinpoint where its inspectors should be extra vigilant about policing clinical trial sites. Physicians with extensive financial ties to the companies sponsoring the trials may be more prone to violating human subject protections or manipulating data, the OIG report said.

As things stand now, the FDA does almost nothing to protect human subjects in clinical trials. Its few inspections are paper checks. And, according to the OIG report, the agency isn’t interested in getting financial conflict-of-interest information that would allow officials to spot potential trouble spots. The law’s sponsors ought to address this issue when the Physician Payments Sunshine Act comes up in committee. It could do so by making the companies report the conflict-of-interest information not only to a publicly available database, but to the FDA when it involves physicians who enroll their patients in clinical trials.