Despite threats to take medical industry conventions elsewhere and full-page ads in the Boston Globe last year warning of the “chilling effect” of the Massachusetts gift restrictions and disclosure law on the states convention industry and greater economic health, the Globe reports today that one of the major forces behind the threats, the Biotechnology Industry Organization – BIO – has come right back to the Bay State for its 2012 international convention.

“The gift ban still has a chilling effect,’’ Massachusetts Biotechnology Council chair Robert Coughlin told the Globe. “Fortunately, this convention primarily attracts biotech workers and researchers, not doctors, so it wasn’t a major factor.’’

But to hear Coughlin and others talk just months ago, one couldn’t be blamed for thinking it was the only factor standing between a vibrant drug and device industry and economic doom and gloom. “Massachusetts is now seen as the most unfriendly state in the nation toward industry,’’ Coughlin said in March, as the Massachusetts Department of Health prepared to pass the final regulations.

The law, which took effect July 1, 2009, bans companies from giving marketing gifts to physicians –putting into law what PhRMA had already sworn off in its voluntary code.  It also requires drug and device companies to disclose payments above $50 to physicians that will be made available to the public, while exempting certain types of legitimate research payments. All along, the authors of this bill and the regulators at DPH who implemented it took express care to protect both patient treatment and innovation, and the BIO announcement is powerful proof of that.

Another headline in the Globe today highlighted the importance of Massachusetts’ new law (and of proposals like the federal Physician Payments Sunshine Act): data disclosed by Eli Lilly showed that the drugmaker paid 60 Massachusetts physicians half a million dollars in the first quarter of this year to be on speakers’ bureaus, including two physicians at Boston Medical Center for whom such a gig is prohibited by BMC’s strong conflict-of-interest policy.  Such disclosure is not only good for patients, who have the right to know whether their doctors are doing marketing for drug companies,  but serves as an important crosscheck tool for medical centers and other research organizations aiming to curb the marketing relationships of their faculty and staff.

–Kate Petersen, PostScript blogger

The FDA has announced it will hear public comment on the use of social media to advertise prescription drugs and medical devices. There is a hearing scheduled for Nov. 12 and 13 of this year, and the docket is open for public comment through Feb. 2010.

Our curiosity is piqued, especially around these two questions:

-How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?

-How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products? Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?

In December 2008, Community Catalyst and the Prescription Project filed a series of petitions asking the agency to establish rules and protocol around the dissemination of risk information in online media, and to advise the manufacturers behind some YouTube ads lacking risk information to review their compliance with current rules.

As for reaction? Mark Senak over at Eye on FDA may win for online enthusiasm: “This is historic.  Pass the word.  This is a game changer.” But all parties – industry, commentators, and watchdogs – seem to be welcoming the conversation and the clarity this hearing offers.

For more, read the questions on the docket, and our YouTube petitions to the FDA.

In a red-letter week for the Physician Payments Sunshine Act (which appeared in the Senate Finance Chairman’s Mark of health reform yesterday), the transparency bill got another nod from the editors of Nature, who endorsed the measure as part of a necessary move toward better oversight and clarification of researchers’ financial relationships to industry, arguing that such transparency is critical to preserving industry-academic collaboration and public trust in the National Institutes of Health. (It’s important to note, as the editors do, that the Sunshine Act would only apply to physicians, and not all scientific researchers.)

“An honor system is only as good as the clarity of its rules — and the effectiveness of the oversight,” write the editors, pointing to a series of investigations by Sen. Grassley’s aide Paul Thacker, whose work revealing academic researchers’ undisclosed millions from industry is spotlighted in the issue. The Sunshine Act would require drug and device companies to disclose payments to physicians, hospitals, and medical schools. The payments would be posted in a publicly-searchable online database.

The editors caution that such a website “should…make it very clear that industry–academic collaboration is a valuable, indeed an essential, driver of biomedical innovation,”  so that researchers listed on the website are not automatically suspected of any wrongdoing, which could stifle legitimate and scientifically important research relationships.

But that’s the very strength of the Sunshine Act, Nature says:

“[T]he ubiquitous interconnections between industry and academia — and the very desirability of a permeable boundary between the two — are probably the most compelling argument for the Sunshine Act. The transparency it would provide is a long overdue corrective to a culture that has too often seemed to look the other way when it comes to potential conflicts of interest. Such transparency would both shore up public trust and prompt researchers to tougher self-scrutiny as they complete their disclosures.”

Read the full editorial here.

We posted earlier this year on the efforts by National Institutes of Health to shore up its disclosure and transparency policies, and our recommendations to the Institutes.

- Kate Petersen, PostScript blogger

Drug and medical device companies would have to report most payments to doctors above $10, under a version of the Physician Payments Sunshine Act included in the Senate health reform bill introduced this morning.

The Chairman’s Mark, the health reform bill language released by Senate Finance Committee Chairman Max Baucus today, applies to all U.S. drug, device, biologics, and medical supply manufacturers. It requires those companies to report payments over $10 made to physicians, physician practices, hospitals and academic medical centers. If an individual receives a total of more than $100 per year, then all payments would have to be reported (i.e., even those smaller than $10). The data will be publicly available on a website to be created by the Department of Health and Human Services (up and running by 2012, according to the Mark).

Certain gifts and payments would not be reported, including the provision of patient education materials and drug samples for use by patients. However, a separate provision of the Mark requires companies to provide information on samples to HHS. Delayed reporting is permitted for payments related to product development, in order to protect commercial sensitivities.

The bill would create a uniform national disclosure database across all states, but it would not pre-empt aspects of state laws or regulations (such as those in Vermont, Minnesota and Massachusetts) that go beyond its provisions—such as payments to non-physician providers, other types of payments or prohibitions on some payments.

Companies that knowingly fail to report could be fined up to $1 million.

The Senate Finance provisions are broadly similar to Sunshine provisions included in health reform legislation passed by the House Energy and Commerce Committee in July.

Today’s bill establishes physician-industry transparency as a bicameral priority within health reform. A national disclosure law has the support of major consumer, physician and industry groups – and of legislators from both parties. Today’s Senate provisions are thorough and comprehensive, and we strongly endorse them.

For more, visit the Pew Prescription Project’s Sunshine Act Guide.

-Marcia Hams, Director of Prescription Access and Quality,

Community Catalyst

A paper in the Archives of Ophthalmology published yesterday suggests that something has to change about the way the profession interacts with the pharmaceutical industry. Since a symposium on physician–industry relations in May 2008,  a group of authors from the American Ophthalmological Society have taken a long, hard look at their interactions with industry and how those can interfere with their obligations as practitioners and teachers.

Moving through the five roles that ophthalmologists play in medicine — practitioner, researcher, academic physician, teacher, and member of a professional organization – the authors discuss the dynamics and problem of bias in all the major areas of industry influence:  drug reps, samples and gifts; speakers’ bureaus, continuing medical education support (CME),  medical advisory boards, and research relationships.

“To preserve our professionalism, it is clear that changes must be made in ophthalmologist-industry relationships,” the authors write. Sensibly, the authors acknowledge the advantages of working with the pharmaceutical industry – namely innovation for better patient care – rule out full divestiture from industry relations as a practical way to eliminate bias.

“[W]e do not live in an idealist’s vacuum. There are clearly advantages to maintaining communication and collaboration with industry that result in improved patient care. However, relationships that cede to industry the research and continuing medical education (CME) agendas should be averted. In short, we must modify our dealings to enable ophthalmologists to regain and retain the public trust.”

But they reaffirm that in daily therapeutic decisions, “[t]he ophthalmologist’s duty is to the patient when making those choices.”

The authors conclude with a statement of principles, and we think they get it right (bolding ours).

1. Ophthalmologists are professionals. We are given a place of value in society, with society’s trust. Our first consideration must be the patient’s welfare, and we must consider the needs of society. The same is true of our professional organizations.

2. Taking gifts and other items of value from pharmaceutical companies can change a physician’s perspective and behavior.  Although we often believe that we are immune, studies have clearly shown that our prescribing practices and other aspects of our behavior are influenced by receiving these gifts.

3. We are not entitled. Nothing we did during medical school, internship, or training entitles us to such gifts as free meals, reduced registration fees, and paid travel.

4. We accept additional professional responsibilities when we teach or perform research. Both are founded on seeking of scientific truth to care for our patients.

5. We and our organizations should not be marketers for the company. This compromises our professionalism.

6. The fundamental mission of for-profit pharmaceutical companies and device manufacturers is not charity.  When they give away money, rarely is it for the welfare of humanity but to influence behavior to improve their profitability. This is their duty to their stockholders and owners.

7. If we do not behave as professionals, government bodies and society will impose on us regulations that will be onerous. We stand to lose our valued place in society.

Oh, and we liked reading this, too: The American Ophthalmological Society does not now and has never taken any monies from industry to support its annual meeting or for its publication, Transactions of the American Ophthalmological Society.

The Archives paper signals growing momentum among professional medical associations (PMAs) to re-examine and redefine their relationship with the pharmaceutical and medical device industry. In JAMA in April of this year, current and former specialty society leaders laid out ten recommendations to move PMAs toward a zero-dollar reliance on industry, including an immediate interim cap on using industry funding for no more than 25 percent of a society’s operating budget, banning all industry satellite symposia and branded promotional items from conferences and annual meetings,  establishing a central fund into which all industry research and education funds would go to be distributed by a conflict-free committee, and requiring that members of committees that write guidelines have zero-dollar financial interest in any company whose sales might be affected by the guidelines.

Read the paper in the Archives of Ophthalmology and the PMA recommendations in JAMA.

-Kate Petersen, Postscript blogger

Documents that have surfaced about Medtronic’s marketing strategies down under shed more light on the Fridley, Minn.–based medical device company’s marketing operation in Australia and the lengths it has gone to get its product in the operating room.

The Sydney Morning Herald reports that a Medtronic marketing presentation explicitly describes the purpose of the company’s Global Fellowship Program as securing “new business revenue streams” and to “nurture and support potential customers.” And by customers, they mean doctors.

That’s not all: the documents even goes so far as to predict a return on investment. According to the Herald, “The documents state that if the company spends $1.5 million on fellowship grants, it can expect a ‘potential 200 per cent return on investment’” and “a graph compares the expense of putting 18 doctors through the program with the potential revenue the doctors will return to the company.”

And in a letter obtained by the Herald, a doctor who received a Medtronic educational grant indicates he plans on using the company’s devices because the company awarded him a scholarship.

We’ve been here before with Medtronic. Most recently, the company has been under scrutiny for its payments to University of Minnesota spine surgeon David Polly, who is being investigated for leading three research studies of Medtronic products while being retained by the device maker as a consultant, for which he received $1.2 million between 2003-2007. Earlier this year, the company announced it would begin to disclose consulting, travel and honorari payments over $5000 to physicians beginning in March 2011.

While Medtronic is hardly the only company to have steered scholarship funds toward doctors and trainees (the practice is so common that many academic medical centers have policies and firewalls to separate the companies from the fund recipients) – measured in headlines, the company’s physician marketing antics have tended to be a little more egregious than the field.

Last year, for instance, a Wall Street Journal report on searing allegations in a 2002 whistleblower suit around Medtronic inducements to physicians featured a surgeon that counted his surgeries toward billable consulting hours, and a Medtronic-hosted “think tank” convened on an Alaskan fishing vessel.

And indeed, this story has its own colorful moments. A Medtronic spokesperson, defending why the company flew a consulting surgeon from the hospital to the airport to avoid rush hour, told the Herald this:

“This [the helicopter flight] was the only viable option to ensure timely attendance at an international conference without compromising patient safety.”

A health reform proposal presented today to members of the Senate Finance Committee would bring new transparency to financial relationships between drug or device companies and the medical profession.

A form of the Physician Payments Sunshine Act was included in a widely-circulated plan that Sen. Finance Chair Max Baucus sent to committee members today ahead of a meeting with the “Group of Six,” the cadre of lead committee negotiators on health care reform.

Baucus’ plan calls for drug, device and biologic companies to report, with limited exceptions, payments made to physicians and teaching hospitals, which would be posted in a public and searchable format. Companies would be required to report drug samples as well, though that information would not be made public.

“The plan, described as a “framework for consideration,” is the first concrete and comprehensive proposal to come out of the bipartisan talks, which have been ongoing since the spring,” according to Politico.

This blog will provide more detail on the transparency proposals as soon as they become available.

Bextra, Bextra!

This week, the Dept. of Justice announced that Pfizer will pay $2.3B in civil and criminal penalties for off-label marketing of four drugs.  The settlement, which alleges that off-label marketing tactics led to over-prescribing of Bextra, Lyrica, Geodon and Zyvox for unapproved indications, is the largest of its kind on record. The company plead guilty to misbranding Bextra, a pain medication pulled from the market in 2005, and along with returning funds to the Medicaid and Medicare programs, the settlement includes an corporate integrity agreement that, among other things, will require Pfizer to disclose payments made to doctors for honoraria and travel.

More at the Los Angeles Times, WSJ Health Blog, and ABC.

Such a corporate integrity agreement entered into as part of an earlier $1.4B settlement this year around the marketing of Zyprexa — has already yielded Eli Lilly’s “faculty registry” – a fancy name for a list of what doctors the company paid, for what, and how much. The St. Petersburg Times looked at what local docs took home from Lilly in the first quarter of 2009, and topping the list of Tampa-area docs was Dr. Maria-Carmen Wilson, a neurologist at the University of South Florida who gave an average of two talks a week at about 2000 per talk – by May she’d hit Lilly’s own $75,000/year per physician payment cap.

The Times reminded us of this striking industry calculus: “The drugmaker’s payoff for each dollar paid to physicians: more than $12 in additional prescription sales.”

The $36 million lunch

Documents released to Senate investigators reveal part of Forest Laboratories’ marketing strategy for the anti-depressive Lexapro was an aggressive physician payments plan much bigger than other companies its size, the New York Times reported. The company paid 2000 doctors a total of $34.7 million to give 15,000 talks to their peers – and that’s just in 2008.  Though it’s ranked 18th among U.S. pharmaceutical companies in revenue, Forest was number four among top spenders on physician payments in Vermont.

A Pew Prescription Project analysis of physician payments in Minnesota found that there, too, Forest spent a whole lot more on speaking and travel fees for doctors than other companies its size, reports the Minneapolis Star-Tribune. Both Minnesota and Vermont require companies to disclose payments made to practitioners.

“The analysis tells us that a lot of doctors in Minnesota have become extensions of Forest’s marketing campaign,” Project director Allan Coukell told the Star-Tribune.

And in other Minnesota news, University of Minnesota spine surgeon Dr. David Polly has resigned from the board of the American Academy of Orthopedic Surgeons in the wake of extensive investigations around payments he received from Medtronic medical device company.

FDA to increase overseas GMP inspections, albuterol sulfate goes missing

The FDA says it will double the number of foreign good manufacturing practices (GMP) inspections this year from 50 to 100 as a part of effort to “beef up” oversight, according to FDANews Drug Industry Daily. The announcement came at an annual GMP conference in Maryland.

And a subsidiary of Mylan, Dey, has reported that two lots of albuterol sulfate inhalation solution was stolen from a truck in McKinney, Texas.  The episode echoes the theft of batches of Levemir insulin in June; the FDA recently updated the Levemir advisory to say that only 2 percent of the 129,000 vials have been recovered and accounted for.

Mums-no-more at Harvard Medical School

And Harvard Medical School has lifted a new policy that would have restricted students from talking freely with the media, reports the New York Times. The school doesn’t deny that recent high-profile media stories in which students discussed the problem of faculty conflicts of interest contributed to the now-retracted policy.

“It is hard to imagine that this new policy is not somehow related to the past advocacy efforts of students,” two students that spoke out in March wrote the Times. “The reason we spoke out against conflicts of interest was to promote patient welfare as the primary concern of medicine, in the face of institutional practices that can harm patient care.”

The Other Big Ten

The University of Iowa has rounded out the ten medical schools that received an “A” on the AMSA Scorecard, which assesses conflict-of-interest policies at all U.S. med schools. The Hawkeye’s new policies went into effect July 1.