Friday, January 23, 2009

Should sunshine on my pharma make me happy?

With apologies to the late songwriter John Denver, will doctors be happy if their ties with drug companies are exposed to sunshine?

If Senators Chuck Grassley (R-IA), and Herb Kohl (D-WI) have their way, it won't matter - disclosure will be required by law.

Medical Marketing & Media news reports that the senators have re-introduced the Physician Payments Sunshine Act. The bill would require companies to disclose payments or transfers of value to physicians of $100 or more. The bill is similar to a bill they introduced in the last Congress, but this time, it has more hefty enforcement penalties.

According to the article, "beginning in April, 2011, companies would be required to report payments and other transfers of value for: consulting fees; compensation for other services; honoraria; gifts; entertainment; food; travel; education; research; charitable contributions; royalty or license fees; current or prospective ownership or investment interests; CME speaker fees and grants, along with anything else the HHS secretary deems necessary. Where payments are related to marketing, education or research specific to a covered drug, device, biological or medical supply, the company would be required to furnish that information, including the name of the therapy.

Manufacturers or group purchasing organizations that fail to report payments can be fined between $1,000 and $10,000 per infraction, up to a total fine of $150,000 per company per year, where failure to report is deemed an oversight. For 'knowing failure to report,' the ceiling on total fines goes up to $1 million per company."

ACP has not yet analyzed the bill nor determined our position on it. Last year, we declined to take a position on the bill, based in large part on the advice of our Ethics, Professionalism and Human Rights Committee. Some members of the committee felt that a mandatory disclosure requirement would actually undermine professionalism, because it could send a signal that acceptance of gifts are okay as long as they are disclosed (by someone other than the physician, in this case) or fall below the $100 threshold. (ACP policy on physician-industry relations says that "the acceptance by a physician of gifts, hospitality, trips, and subsidies of all types from the health care industry that might diminish, or appear to others to diminish, the objectivity of professional judgment is strongly discouraged.")

With the focus in Washington on "transparency" it is likely that some version of the Grassley/Kohl bill could become law. The sense is that the public is served when potential conflicts are exposed to sunshine, whether it applies to lobbyists' contacts with federal officials, freedom of information requests to federal agencies, or doctors' financial ties to pharma.

Today's questions: Do you think companies should be required to disclose contributions of $100 or more of value to doctors, including gifts, consultant fees, honoraria, education, research, and charitable contributions? What impact do you think this will have on medical education, research, or other potentially beneficial arrangements?


Steve Lucas said...

Health Care Renewal highlights this issue in the Monday, January 19, 2009, On Wisconsin's "Talking Heads" post. Of interest to me was the admission by a doctor that much of the CME given at the dinners is pure sale pitch and the whole process is essentially a shame.

A conversation with a laid off sales rep focused on his dissatisfaction with doctors and the issue of food. He would fight with the staff about their lunch orders, bring in $300+ worth of food past a group of waiting patients, who could not afford his medication, and then receive about 10 minutes of the doctors time.

The doctors would often make disparaging remarks about him. Claim they are not influenced by lunch since they did not eat, but then advertise in staff postings, lunch provided. As a business person I feel such self-deception is detrimental to the doctor/patient relationship.

We do not have to look hard to find legal settlements concerning device manufacturers regarding essentially kickbacks or payment for studies never performed.

CME needs to be more than just an academic exercise. My hope is that changes will push these activities back into an academic setting with tight controls concerning content.

I am sure these disclosures will make many doctors uncomfortable, but will add confidence to patients that they are not receiving treatment based on short term financial gain.

Steve Lucas

Jay Larson MD said...

Advertising may be described as the science of arresting human intelligence long enough to get money from it.

Stephen Leacock (1869-1944)

Sure companies should report gifts more than $100 given to a physician. The reporting will probably not have any impact on medical education or research. If anything, the transparency will help physicians attending CME determine if a bias is potentially present. Currently it is hard to know how much information is biased, intentionally or unintentially.

An important part of pharmaceutical companies’ successes is advertising. The 1-8-09 New England Journal of Medicine had an article about the advertising of Neurontin. Parke Davis saturated all sources of physician information (including paying physicians to speak on behalf of Neurontin) to use Neurontin for many off label uses. Parke Davis is now paying the price for their greed.

Advertising may be described as the science of arresting human intelligence long enough to get money from it.

Stephen Leacock (1869-1944)