‘Marketplace’ (American Public Media) takes a look at what some states are doing to combat pharmaceutical sales reps influence on prescribing, and help get doctors the best evidence–without the sales pitch.

‘Marketplace’ followed “academic detailers” employed by the state of Pennsylvania as they visit with physicians. Tom Snedden, the director of the program, which employs 11 academic detailers–often nurses or pharmacists–said the program was small but effective in improving quality and reducing unnecessary costs.

“The industry’s trying to sell a product. What we’re trying to sell is clinically-appropriate prescribing,” he said. “Since the program began in 2005, the doctors who have met with academic detailers have prescribed fewer brand name drugs and fewer drugs overall.”

Other states have taken their cue from Pennsylvania since it implemented it’s academic detailing program 5 years ago. Three New England states are sharing best practices and resources in a regional academic detailing initiative. Legislation has passed in four states and D.C., while three additional programs were implemented by state Medicaid agencies.

This session in Wisconsin, Rep. Chuck Benedict has introduced an academic detailing bill, which is backed by the broad group of supporters, led by the Coalition of Wisconsin Aging Groups. The bill will be heard in a joint public hearing on prescription drug reform in March.

And in Minnesota, academic detailing legislation is being considered as part of a prescription reform package. The bill (Sen. Sheran) backed by the newly-formed Minnesota Prescription Coalition, has cleared two key committees in the Senate and is now before the Finance Committee; a House counterpart (Rep. Liebling) is due to be heard by the House Health Policy Committee in early March. (More information at the coalition website)

Because of the success of such programs at the state level, development of a federal prescriber education program is underway.

Wisconsin Sen. Herb Kohl, Chair of the Congressional Special Committee on Aging, sponsored the federal Independent Drug Education and Outreach Act of 2009.

And the Obama administration and Agency for Healthcare Research and Quality have demonstrated support for this approach, too, including academic detailing as an example of an intervention to promote the adaptation and dissemination of comparative effectiveness research products in a request for proposals the Agency posted in September, 2009—a new round of AHRQ grants was announced last week as well.

Listen to the full Marketplace story, or learn more about prescriber education at Prescription Access and Quality and the Pew Prescription Project.

–Kate Petersen, PostScript blogger

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

In her testimony before the House Energy and Commerce committee on health appropriations, HHS Secretary Kathleen Sebelius called for $101 million of FDA’s 2011 budget request to be used for a “medical product safety initiative” to increase inspections and “invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products.”

We are glad to see the Secretary recognizing the need for increased inspections –  the lack of foreign inspections is a  problem highlighted recently by FDA itself and the GAO, which found that FDA is able to inspect just seven percent of prioritized foreign drug manufacturing sites every year. This, despite evidence that foreign India and China alone produced close to 70 percent of the global supply of active drug ingredients in 2007 – up from just under half of the APIs three years before.

Doing the math, that means plants making U.S drugs overseas may wait well over 10 years between FDA inspections, while domestic plants are inspected every 2.7 years on average.   The rate of inspection within China is even lower. If unchanged, it would take nearly 50 years to inspect all 700 or so FDA-registered Chinese drug-manufacturing sites.

Recent increases in budget appropriations for FDA have allowed the agency to begin to build its foreign inspections program, as well address structural problems at the agency like understaffing and IT capacity.  But serious structural problems affecting the agency’s ability to regulate drug manufacturing and importation remain.  And considering the growth rate of foreign manufacturing plants and how thinly resources must be stretched.  The increased appropriations the Secretary recommends will likely still be insufficient to bring foreign inspection up to speed with domestic inspection rates.

One way to help correct for this would be to consider a user fee system as proposed in legislation introduced in both the House and Senate in the current Congress. The agency already employs user fees with drug manufacturers during the approval process, and with food and drug companies whose manufacturing violations require re-inspection. A similar user fee for general Good Manufacturing Practice (GMP) inspections inspections would help protect consumers.

Inspections alone are not the solution. FDA must find better ways to predict risk. And the agency is taking steps. For example, at the border, the agency uses  PREDICT, a new web-based risk-based assessment system that incorporates inspection histories, counterfeit risk, and environmental influences. But such a system could also be used earlier in the inspection process, to target overseas manufacturing inspections before risky products ever get shipped or unloaded at the docks.

–Kate Petersen, PostScript blogger

As Cephalon joins the ranks of pharmas disclosing payments to physicians or health care entities under corporate integrity agreements, John Mack at the Pharma Marketing Blog and Eric Milgram over at Pharma Conduct have good posts on the importance of the format in which companies have posted data about who’s getting what.

In a distinction Mack describes as translucent vs. transparent, Cephalon’s payments are posted in FlashPaper, a format that does not allow the data to be copied and is hard to search. So are Eli Lilly’s, which began disclosing under a similar agreement late last year. Merck and GlaxoSmithKline, who began disclosing some payments (these were not court-ordered disclosures) last month, publish the data in PDFs, which are unsortable and hard to search, but at least allow data to be extracted.

All the companies fall short in that they provide little or no additional detail on the nature or purpose of the payments. Merck only reports payments to U.S.-based health care professionals who speak on behalf of Merck or its products through Merck Medical Forums, presumably excluding payments to providers who provide other types of services.  And no companies have provided complete disclosures that include all those paid for clinical trials and every type of research, although GSK plans to begin reporting compensation to research investigators in 2011.

Eric Milgram’s checklist for what details make disclosure data usable and valuable to the public is a great place to start. He says at minimum, disclosure data should include a provider’s name, specialty, main hospital or practice affiliation, and a brief description of the reason for payment.  And he says that companies shouldn’t only have to disclose those payments made to physicians, but to all health care providers.

The lesson in all this? When it comes to disclosure, details matter. The program Cephalon and Lilly have used to date make searching difficult and copying impossible. There are easier programs out there: it’s time to use them. Without useful markers—(it’s not as helpful to search for a doctor by the letters in her name if you can’t also search by state, specialty, or practice location)–it’s difficult for consumers and researchers to use the data to make informed decisions or analyze trends in industry-physician relations—arguably the very reason such disclosures are part of court settlements.

These first disclosure attempts provide good lessons for courts that wish to make meaningful disclosure a part of future settlements, as well as state and federal regulators who are developing or may have to plan for uniform disclosure databases such as those proposed in the Physician Payment Sunshine provisions and bills being introduced in several states this year.

As a postscript, it’s worth remembering that despite the good publicity some pharmas have gotten for putting this data on their websites “voluntarily” (see: Eli Lilly), half of the companies that have disclosed payments so far (and more than half, if you count medical device companies) have done so by order of a court because they settled on charges of systematic inappropriate marketing – cases that have yielded enlightening documents about company marketing practices and their sway over company research, authorship, and publication.

–Kate Petersen, PostScript blogger