Full article reprinted from "The Pink Sheet" Oct. 19, 2009
The most highly paid Lilly outside physician consultant in the first quarter of 2009 - San Jose, Calif., psychiatrist Manoj Waikar ($70,050) - says he was convinced that the public listing of financial ties was a good idea when his patients said they approved of his work with pharmaceutical companies. Read on...
Full article reprinted from "The Pink Sheet" Oct. 19, 2009
Lilly Outside "Faculty" Is Headed By 22 Physicians Receiving $50,000 Or More
The most highly paid Lilly outside physician consultant in the first quarter of 2009 - San Jose, Calif., psychiatrist Manoj Waikar ($70,050) - says he was convinced that the public listing of financial ties was a good idea when his patients said they approved of his work with pharmaceutical companies.
In a series of short e-mail interviews with "The Pink Sheet" about his appearance on the Lilly list of paid outside "Faculty," Waikar said he was initially concerned that payment databases could be misleading or used to attack a physician's credibility.
Waikar changed his mind, however, once he told his patients about his work with pharma companies and they responded positively.
Waikar's response to public disclosure suggests a second-wave reaction to the effect of transparency in relationships between doctors and medical products companies. After the first fear of taint, both companies and doctors appear to see a positive benefit from identifying some physicians as leaders in certain areas of practice - and making the financial connections open and above board.
Lilly is the first pharma company to move into the new world of public disclosure of payments to individual doctors. Lilly did not venture in completely on its own volition; it was edged into public disclosure by its settlement of off-label marketing allegations related to Zyprexa .
During the first quarter of 2009, Lilly paid $22 million to nearly 3,400 physicians and healthcare professionals for educational and advisory services. Twenty-two doctors received $50,000 to $70,000. Fifteen of these top earners were psychiatrists (see chart: " 1 Lilly's $50,000 Club: The Doctors The Drug Firm Pays The Most "). Lilly refers to those receiving payments as its faculty and the listing of recipients as the Lilly faculty registry.
The payments are a small amount of Lilly's promotional budget - the $22 million is 1.5 percent of the $1.5 billion Lilly spent on marketing, sales and administrative activities for the first quarter. But the sums for individual doctors are not insignificant.
Peter Lurie, deputy director of Public Citizen's Health Research Group, said Lilly's registry will identify those doctors who fear the exposure. "Some people will not want their name on a website," he said. "This is a kind of test. If there is nothing to be ashamed of, why object?"
CEO Lechleiter Does Video Pitch
Lilly has sought to dispel concerns about its contracts with healthcare providers. In a video clip introducing the registry website Lilly CEO John Lechleiter describes what kind of services they provide.
"Among the things they do is speak to their peers about our medicines, presenting information Lilly provides to help their colleagues learn about treatment options for patients," Lechleiter states. He adds that Lilly has learned from experience that healthcare professionals prefer to receive such information from their colleagues.
The registry also includes payments for patient education and for advising Lilly on development of tools, programs and clinical information. Lechleiter said that over time Lilly will disclose additional information, such as expenditures for clinical research assistance, meals and textbooks. A bill pending in Congress, the Physician Payments Sunshine Act, would require manufacturers to report all payments or other transfers of vale to physicians. Such a provision is also included in the Senate Finance Committee's health reform bill.
Psychiatrist Lectured on Zyprexa, Cymbalta
Sen. Chuck Grassley, R-Iowa, one of the sponsors of the bill, has probed the relationships between physicians and drug companies. He has particularly focused on several psychiatrists who have failed to disclose the payments they received from industry.
Not surprisingly, based on Lilly's product profile, psychiatrists have a prominent place in Lilly's registry, dominating the ranks of those paid $50,000 or more. Behind Waikar in terms of size of payments on the first list was Roueen Rafeyan, a psychiatrist from Kenilworth, Ill., who specializes in treatment of addictions. Lilly caps payments for an individual physician at $75,000 per year.
Waikar said each of the 42 activities recorded for him in the first quarter (averaging about one event every other day) consisted of a presentation to healthcare providers, either onsite at an office or clinic or offsite at a restaurant, about either Zyprexa (olanzapine) or Cymbalta (duloxetine).
An FDA-approved slide set was part of the presentation, Waikar said. The doctor says he explained both the positive, therapeutic effects of the medication and potential adverse effects.
Waikar, who has been on Lilly's speaking faculty for five years, is an adjunct clinical instructor in Stanford's Department of Psychiatry & Behavioral Sciences, a non-paying position. Stanford has a policy prohibiting its faculty from participating in speakers bureaus but it does not apply to adjunct staff.
Waikar said he speaks for other companies as well. His website shows that he speaks for AstraZeneca, Bristol, Janssen, Pfizer and Wyeth. The website says Waikar gives "100+" presentations per year.
Asked about concerns expressed by legislators that doctors may be encouraged to overstate the benefits of a drug if they have ties to the manufacturer, Waikar said there are procedures in place to assure balanced reporting.
"The educational services I provide to other physicians under sponsorship from pharma companies are so tightly regulated and rigorously policed that I believe we spend equal time discussing potential risks as we do potential benefits," he stated. "Also, my own credibility with my audience of peers at any educational event where I'm speaking depends on my honest portrayal of data and, when asked, of my own experience with any particular medication and its use."
The registry includes many other specialists and health care providers. No members of FDA drug advisory committees are on the list. Lilly said the average payment per service is just over $1,000 and that recipients conducted six activities on average. The figures cited by Lilly correlates with the total payments to Waikar and the number of events listed.
Payment Registries To Become the Norm
While Lilly is the first to post payments on a national level, it is likely to become an industry-wide practice. Several states have enacted laws requiring such disclosure and federal prosecutors now routinely require posting of physician payments in their settlements with companies.
Lilly announced in September 2008 that it would voluntarily disclose these payments, months before it was required to do so as part of a settlement with the Department of Justice over its off-label marketing of Zyprexa. Lilly agreed to pay $1.4 billion and entered a corporate integrity agreement with the HHS Office of Inspector General.
Lilly was the second company required to post physician payments under a CIA. Cephalon, the first company required to do so, will post its physician payments in January. A payment registry is also mandated in the CIA Pfizer signed as part of its $2.3 billion settlement with the DoJ.
[Editor's Note: The implications of the Pfizer settlement will be discussed in further detail during a webinar on Oct. 21. The event features Delaware Deputy Attorney General Daniel Miller, former DOJ Civil Fraud Section Director Laurence Friedman, and former Pfizer Senior Corporate Counsel Arnie Friede. To hear their unique insights, register by emailing 5 custcare@elsevier.com , calling (800) 332-2181, or visiting 6 ezine/html/ac1009-3lp.htm"http://www.windhover.com/ ezine/html/ac1009-3lp.htm .]
Several companies have announced plans voluntarily to post certain payments to physicians, including AstraZeneca, Merck and Johnson & Johnson. AstraZeneca said it would disclose compensation for speaking engagements beginning in August 2010 (7 'The Pink Sheet' DAILY, May 21, 2009).
Public Citizen's Lurie said the piecemeal process is not satisfactory as individual registries include different exemption and disclose different things. "We need a standardized reporting form or the data won't be comparable," he said. "That's why we need the federal approach."
Vermont Providers Received $2.9 Million
Several states, including Vermont, Minnesota, Massachusetts, Maine and West Virginia, as well as the District of Columbia, have comprehensive laws on disclosure. Vermont's disclosure law had a provision allowing companies to claim payments as trade secrets and thereby avoid reporting how much they paid individual doctors; the state passed a law this year, effective July 1, which eliminates the trade secrets designation. The law also bans all gifts of any value, including coffee and donuts for physician staff.
Vermont's attorney general collects data and issues an annual report on the payments. In its most recent report, released in April, the AG said that in the 12 months before July 1, 2008, 78 pharmaceutical manufacturers spent $2.9 million on Vermont doctors, hospitals, universities and others. Twenty-five doctors and nurses received more than $20,000 in cash or benefits, 10 received more than $50,000, and one psychiatrist received more than $112,000.
- Brenda Sandburg
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