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Pharmaceutical Industry Disclosure Practices


Under Criticism, Drug Maker Lilly Discloses Funding
by Avery Johnson, Wall Street Journal (May 1, 2007)


Amid criticism that money from drug companies is overly influential in the practice of medicine, Eli Lilly & Co. for the first time plans to release a detailed report today on its grants to nonprofit groups and educational institutions.

Recipients of the $11.8 million that the Indianapolis-based drug maker gave out in the first quarter of 2007 include some of the best-known medical institutions in the country, a range of foundations devoted to disease research and education and some for-profit companies specializing in continuing medical education for doctors.

The largest single grant was $825,000 to Massachusetts General Hospital's psychiatry department for a year-long educational program with more than 150,000 registrants.

The National Alliance for the Mentally Ill, an advocacy group for patients, received $544,500. Of that, $450,000 went to fund a project called "Campaign for the Mind of America."

Some grants went to for-profit education companies. Optima Educational Solutions, based in Arlington Heights, Ill., received nearly $75,000 for a project called "Current Strategies and Needs for Managing the Critically Ill Patient with Diabetes."

Lilly's best-selling drug is Zyprexa, a schizophrenia medicine that has come under scrutiny for serious side effects, including obesity and diabetes, in long-term users. It also makes insulins like Humulin and Humalog and sells the diabetes drug Byetta with Amylin Pharmaceuticals Inc.

But Lilly says there is no connection between its grants and efforts to market its drugs. "These grants are first and foremost designed to improve patient care, and they are unsolicited," says Alan Breier, Lilly's chief medical officer, whose division oversees the grant office. "We desire to be a reliable and trusted partner and transparency is a critical aspect of trust." Lilly plans to list its grants on its grant-office Web site quarterly.

Lilly's move reflects how, amid increasing criticism, some drug companies have begun to lift the veil on their funding. Drug makers' grants help cover the costs of nonprofit groups that raise awareness about diseases and treatment options for patients. The money also goes to educational institutions that provide doctors with courses to keep their licenses up-to-date.

But critics argue grants curry favor with physicians and influential organizations, and allow companies to defend newer, more expensive medications against generic remedies and expand use of medicines for unapproved purposes.

The companies, including Lilly, say these funds help assure that patients and doctors have up-to-date information on treatment options. Only a handful of drug companies have begun revealing funding details, and it's not clear how many others will follow.

Lilly's decision to disclose its grants was prompted in part by an investigation into drug company donations by the Senate Finance Committee. The committee's report last week said while there is separation between grants and sales and marketing, potential for abuse remains. Some Eli Lilly executives had worried revealing the company's grants could expose recipients to criticism and bring more scrutiny. But ultimately, Lilly decided to disclose the details after an internal analysis showed the marketing department wasn't influencing the grant office's decisions, says Michael Bigelow, Lilly's assistant general counsel. Lilly shouldn't have to feel "apologetic" about the grants, he adds.

Sen. Charles Grassley of Iowa, ranking Republican on the Senate Finance Committee, says "Eli Lilly's action is a positive step, and I hope other drug companies will do the same thing."

A Lilly spokesman says the company funds about a third of the grant proposals received. The majority of grants are awarded in categories in which the company markets medicines. The spokesman says that's because grant seekers are aware of Lilly's expertise and because the company's reviewers are more knowledgeable in those areas. In deciding on a particular grant, Lilly considers the potential clinical value of the projects and whether they would improve patient care.

The Wellness Community, a nonprofit focused on cancer, got a $37,500 Lilly grant last quarter for a program called "Frankly Speaking about Lung Cancer." Lilly makes Alimta, a drug to treat lung cancer. The Wellness Community's president and chief executive, Kim Thiboldeaux, says it shouldn't necessarily be a "bad thing" when nonprofit and drug company interests align: "They want to get information to patients and so do we," she said, adding that her organization presents information without any influence from the funding companies.

Asked about the Eli Lilly grant, Jerrold Rosenbaum, psychiatrist-in-chief at Massachusetts General Hospital, says, "We issued a challenge to the pharmaceutical industry: You say you believe in [continuing medical education], then give to academic institutions without any direct knowledge of what the curriculum will be." He says his program receives funding from a number of drug companies and that their support doesn't influence its content.

"We have strict guidelines that govern corporate relationships and protect against conflicts of interest," says Bob Carolla, NAMI's director of media relations. "We do not endorse any specific treatment, medication, service or product."

Other drug makers have begun taking steps toward fuller disclosure. Earlier this year, GlaxoSmithKline PLC started posting online its payments to European groups that work as advocates for patients. The posts show that Glaxo, based in London, gave about $12.2 million to 424 groups last year. Glaxo was spurred by new rules from the Association of the British Pharmaceutical Industry.

Pfizer Inc. yesterday began posting an online status report on follow-up studies the Food and Drug Administration has required for company drugs already on the market. Critics have hammered the drug industry for not living up to these commitments and the FDA for not enforcing them adequately.

But some critics say disclosure does little to make up for the fact that drug companies have become such important benefactors of education, especially continuing education for physicians. "Drug companies are not educational institutions," says Eric Campbell, assistant professor of medicine at Massachusetts General Hospital and Harvard Medical School. "They're beholden to stockholders and exist to develop and sell drugs," he says.


Pharmaceutical Industry Donations & Continuing Medical Education
Pharmaceutical Industry Donations & Policy Think Tanks and Advocacy Groups
Pharmaceutical Industry Support for Patient Groups/Promotion of Prescription Drugs
Pharmaceutical Industry Donations & Charitable Conduits to Doctors
Pharmaceutical Industry Donations & Influencing Prescribing Guidelines

Pharmaceutical Industry Disclosure Practices