Don't get burnt

Everyone likes their place in the sun, right? Well maybe not so much when sunspots start showing on our faces and we hear warnings of sun-related dangers ranging from superficial carcinoma to deadly melanoma. By late 2013, under Section 6002 of the Affordable Care Act (ACA) – also known as the 'Sunshine Act' – the federal government will have established a public web site that details all payments to doctors and teaching hospitals. Like sun exposure, financial relationships between physicians and industry should be managed actively but with moderation and common sense.

Without adequate protection, complying with the Sunshine Act could damage our relationships with doctors and patients as well as endanger the improved patient care that results from collaboration. To avoid this damage, the medicines industry must begin by facing and embracing the reality. The days of avoiding sunshine and public scrutiny of industry-doctor relationships in the United States are over.

Transparency is a favored concept in Washington. Today, being against transparency is about as popular as standing up for porn. Anyone who thinks it is going anywhere should step aside so the rest of us can better manage, report and explain these relationships to a largely hostile press corps. If we don't, we may well lose much of the clinical education, research and medical innovation these relationships foster.

High noon
High noon is imminent. Lawyers at the Department of Health & Human Services (HHS) are drafting rules to implement the Sunshine Act and the web registry now. Further, although company tracking will begin January 1, 2012, and the first reports are due on March 31, 2013, no one in the press or the public policy arena is waiting for a federal registry to criticize these relationships.

For example, Minnesota has required such reporting for more than a decade and Massachusetts, Vermont and others states have followed suit. Moreover, few companies have missed the menacing letters from Sen. Charles Grassley (R-Iowa) over the past few years, nor the reporting that accompanied them. Meanwhile, many companies – pursuant to prosecutorial agreements with federal and state law officials – are reporting payments on their own sites, including such device companies as Medtronic and Striker, and such drug companies as Lilly, GSK and Pfizer.

None of this has escaped major media outlets, including The New York Times, The Boston Globe, National Public Radio and ProPublica. The 'Dollars for Docs' landing page of ProPublica highlights the evolving history of these public reports as well as object lessons on how we must better prepare our constituencies for the first of the federal annual reports.

While I was drafting this article, ProPublica posted two new stories, bringing their total number of articles covering physician-company financial relationships to 30 since the series launch in mid-October of 2010. Meanwhile, major plaintiff lawyers continue to comb the existing databases for information on current or potential new lawsuits against industry.

It's not just about transparency
Industry needs to understand that many of the primary proponents of these registries are not just interested in shedding light on these relationships. Many, including the Institute of Medicine (IOM), major medical schools and some 'consumer' groups, would like to see an outright ban of many of the financial relationships that fuel medical collaboration. Some major medical schools already have imposed bans, including Harvard, Stanford and others.

Until late last year, most publicity about medical conflicts of interest and payments to doctors has taken place in industry circles, fed by journal articles, leaders of organized medicine, politicians, plaintiff lawyers and government medical institutions, including the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). However, recent reporting, especially from ProPublica and its associated media outlets, is aimed largely at patients, with the apparent hope that patient pressure will cause doctors to discontinue their relationships with industry.

These efforts may be misguided, however, because they underestimate the value of industry-physician relationships to both doctors and to patients, and because they undermine the reservoir of good faith that doctors have in companies and patients have in their doctors.

Indeed, in a private conversation after the press conference where the IOM called for the more rigorous conflict of interest rules and elimination of speaker bureaus, Professor Eric Campbell of the Harvard Institute for Health Policy said that his unpublished research suggested that most patients were unconcerned about their doctor's relationships with industry. I would assert that doctors with strong industry ties are better informed and presume that most patients agree with me in considering these relationships a credential, not a cause for concern.

Although medical elitists often condemn industry relationships, a recent physician survey supported by the Pharmaceutical Research and Manufacturers of America (PhRMA) found companies to be a valuable resource, with 94 percent of physicians reporting that information from company reps is up-to-date, useful and reliable.

Indeed, nearly eight out of 10 physicians view this information as helpful, and more than 90 percent of physicians surveyed responded that interactions with biopharmaceutical representatives allow them to learn about new indications for approved medicines, about potential side effects of medicines and both the emerging benefits  and risks of medicines, according to the survey.

Pushing back
Industry, researchers and medical groups sent clear messages to HHS lawyers working on the Sunshine Act regulations recently. The Coalition for Healthcare Communication's Jack Angel told regulators during a stakeholders call to avoid sending a signal to the press and the public that collaboration between industry and providers is inherently bad. Indeed, the CHC strongly believes such collaborations improve patient care by providing enhanced communications that result in better use of medicines and devices with patients.

Angel and others said that the rules must be clear so that companies and doctors can easily comply, and that the HHS reports must include enough context on the nature and purpose of these collaborations to enable professionals, patients and the public to understand their importance. For example, Sandi Dennis, Deputy General Counsel for BIO, advised HHS to include objective background for consumers. “We recommend that the agency consult with experts to ensure that the information provided is clearly defined and explained," Dennis said, and that it is “useful and not misleading."

Julie Cohen, Vice President, Governmental Affairs, for AdvaMed, stated that reports should include clear background information about why these relationships exist and benefit patients. “For example, physicians themselves are often the inventors of new technology. Other physicians provide valuable feedback, research and technical expertise to improve existing technology," she said.

But much of the hard work to protect these collaborations will need to be done by public relations practitioners. The residual goodwill of doctors and patients gives us the opportunity to move our industry into the sunshine without being burned in the short run or fried in the end.

The author
John Kamp, Executive Director of the Coalition for Healthcare Communication and Attorney at Law at Wiley Rein LLP, can be reached at jkamp@cohealthcom.org or +1 (212) 850-0708