Influence Of Doctor/Pharma Relationships On Prescribing Habits May Be Next Big Congressional Inquiry; Sunshine Act Could Be Investigation Boon

If provisions in the Sunshine Act are included as part of a final health care reform bill, agencies would be able to directly estimate for Congress the financial impact of physician/pharma relationships on prescribing trends.

"That has never been a possibility, but it will be possible in the future," said Eric Campbell, an assistant professor at Harvard University's Institute for Health Policy and a member of the Institute of Medicine committee that published a report on conflicts of interest in medicine in April 2009.

Campbell suggested Oct. 2 at the FDA Regulatory Symposium sponsored by Health Care Conference Administrators that the data would be among the key elements of further congressional inquiries into drug firms' promotional operations.

There's A First Time For Everything

"The next thing that's going to happen, I believe, is that once physician relationships ... are available, we will be able to hook up the relationships doctors have with drug companies to the actual care those physicians provide to Medicare patients."

To date, there has never been a way to link doctors and relationships with industry and the care that those doctors actually provide.

"For example, we've never been able to say, 'If a doctor consults for Pfizer, is that doctor more or less likely than a similar doctor, with a similar patient panel, to use Pfizer drugs,'" explained Campbell.

This type of data could, for example, reveal that physicians with relationships with industry prescribe more expensive, brand-name drugs when equivalents are available, Campbell posited.

"That's an example of something we don't want, where someone is using expensive medications to provide marginally no better benefit to patients," he said. "And yet the reason they are doing it is because of the marketing relationship they have with companies."

The data also could show the impact of pharma-sponsored continuing medical education if doctors are shown to use specific drugs off-label.

"All of those things are potentially possible when you can link doctors' relationships with industry to the care that they provide patients," he said.

Campbell was quick to point out, however, that the findings could do more than just reveal inappropriate prescribing habits. The opposite holds true as well: If a physician has a patient panel that could benefit from specific drugs that the doctor is not prescribing, for example, this would also come to light. The doctor could then meet with a drug representative and learn about different treatments.

"That's a good thing," Campbell said.

"To be honest, if people are able to do the research and if they find there is no relationship, then we can say, 'Look, this isn't leading to higher cost of care. It's not leading to overuse. In fact it shows underuse and it's a good thing,' and then we can move on."

Potential Barriers To Spotting Trends

While 97 percent of all physicians have some relationship with industry, the impact of those relationships has never been studied.

"Relationships with industry are ubiquitous," said Campbell. "In fact, it's difficult to find physicians who don't have them."

Campbell is not yet working on such a study. Indeed, the laws requiring the data necessary have not yet been passed.

But if provisions in the Sunshine Act - which would require companies to report individual payments to doctors to the federal government for public posting - are enacted as part of a final health reform bill, any agency or academic organization could link up doctors with its claims in a data set (¹ (Also see "Sunshine Requirements In House Reform Bill Include Federal Pre-emption" - Pink Sheet, 10 Aug, 2009.)). The most likely target for such a study would be the Medicare program, which already has a nascent system for allowing researchers access to its prescribing data (² (Also see "Part D Data Sharing Rule Allows External Researchers Access, With Limits" - Pink Sheet, 26 May, 2008.)).

"You would be able to get the very first estimate of the extent to which drug company marketing and other activities are associated or not with the overuse of medication and also financially estimate how much that overuse impact is," Campbell said.

There are, however, some seams to be ironed out. For starters, some states have laws that attempt to keep prescription data out of the hands of pharma companies, and those same measures could mean that they wouldn't be available for academics. A federal court, for instance, upheld a Vermont law in April restricting the use of physician prescribing data for commercial purposes (³ (Also see "Vermont Restriction On Prescribing Data Is Upheld By Court" - Pink Sheet, 24 Apr, 2009.)).

Impact Of Conflict Provisions Questioned

Even if the Sunshine provisions are passed as part of a final health care reform bill, and even if Campbell and others are able to link physician prescribing habits to relationships with industry, Campbell said there is still more that could have been included in the bill regarding conflicts of interest.

"Conflict of interest does not appear to be a very major portion of any health reform proposals that are out there," he said. "It clearly could play a role of reducing health care costs in America if one found that conflicts of interest lead to inappropriate use, overuse and so on."

The different provisions in the bill surrounding conflicts of interest are numerous, but not necessarily robust. One of the requirements for the Senate Finance Committee's bill's co-op plan, for example, states that its governing documents must incorporate ethics and conflict of interest standards protecting against insurance industry involvement and interference.

Campbell said he does not understand why members would not have included more stringent proposals since they would be cost-saving measures. "I certainly think it has the potential to be one source and an important source of spending or cost, and should be looked at," he said.

Other speakers at the meeting disagreed with Campbell's conclusions about the impact of conflict of interest provisions. Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner for external relations at FDA, warned of potential "unintended consequences of looking at conflict as an inherently negative proposition."

"You heard about the Sunshine Act, the need to make payment to physicians for various things transparent, and yet within the Sunshine Act, there is not a word - not a letter - that discusses the need for transparency when it comes to insurance companies [convincing] doctors to switch their products from innovator product to generics."

"There is not one word about the inherent necessity for transparency for those who fund comparative effectiveness trials, and yes, that includes the government," Pitts continued.

"The government is today the nation's largest payor and they are going to become even bigger as time marches on. Is the government going to become non-conflicted when it comes to health care technology assessment?"

Does Spending on Doctors Create Conflicts?

Pfizer Assistant General Counsel Marc Wilenzick questions some of the underlying assumptions behind the effort to disclose, and fundamentally limit, company spending on doctors.

"I think many of the recommendations in the IOM report are very interesting and provocative and they spent a lot of time hearing testimony," Wilenzick, a former assistant chief counsel at FDA, said.

But "if you actually read what the report says, it actually is fairly upfront about the limited amount of data. There is limited data on these practices and to go from small psych studies about if you give someone a gift, do they like you, is that a good way to open up a discussion and people say, 'they are more receptive to people giving you a gift?' There is that kind of evidence, but there is not any real evidence about these specific practices," he said.

- Lauren Smith ( ⁴ [email protected] )