• Drug firm comes to call in Vt. with cash
     | October 11,2009

    MONTPELIER – The letter begins with pure flattery.

    "As a recognized thought leader and well-respected health care professional among your peers, we are seeking your participation as a speaker in our Schering-Plough SAPHRIS Speaker's Bureau …," it reads.

    On the second page of the letter in the 14-page packet, New Jersey drug company Schering-Plough offers $170,000 over two years to promote Saphris, its new drug to treat schizophrenia.

    "I was a little surprised to get this in the mail," said Dr. Sandra Steingard, the director of medical services at Burlington's Howard Center, a private nonprofit that offers mental health treatment and other services. "I don't take money from these companies. And I'm very outspoken about my concerns."

    Doctors and medical experts are engaged in a heated debate nationally over the financial relationships between the companies that make drugs and the doctors who prescribe them. Common practice in the industry is to hire a series of doctors and pay them to tell other doctors how good new medications are.

    Schering-Plough has seemingly reached out to the wrong people in its marketing blast to promote Saphris, which was approved by the Food and Drug Administration in August and launches this fall.

    "I just had a letter printed in the American Journal of Psychiatry about this issue in August," Steingard said. "The drug reps don't even bother visiting me."

    Schering-Plough's job offer was simple: Spend a few lunchtimes giving presentations to local doctors about the company's new product. That's worth a few hundred dollars. Sometimes the company could even send you to another part of the country – flights, cars and hotels all paid for – to talk to larger groups of doctors.

    The company will pay a doctor up to $3,000 for one of those sessions.

    Pharmaceutical companies – and some doctors – say this relationship is necessary to supply medical professionals with information about new drugs and technologies. Critics say drugmakers are literally paying doctors to prescribe their newer, and usually more expensive, medications.

    "This is marketing masquerading as education," Steingard said.

    Rapid corporate growth

    Originally a German company, Schering-Plough was founded in 1851 (then called Schering AG) and is now known for its allergy medicine Claritin and various women's beauty and foot health products. Business has grown in the last several years as Schering-Plough's sales went from $8.6 billion in 2003 to $15.2 billion in 2007.

    Saphris is designed to treat schizophrenia and bipolar illness. It's the first psychotropic medication that doesn't need to be swallowed; it dissolves under the tongue. Research performed this year showed that only 12 percent of patients relapsed. That study was performed by a Schering-Plough employee.

    "We are very pleased with the U.S. Approval of Saphris, which represents an important new choice for acute treatment and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment," Dr. Thomas Koestler, the president of Schering-Plough's research division, stated in a news release in August.

    But critics of Saphris say it is a "me too drug" — industry slang for a product that is only slightly different from drugs already on the market. Dr. Daniel Carlat, a professor of psychiatry at Tufts University's School of Medicine, said the drug has "no real advantages that I can see."

    "It doesn't have to be swallowed because it dissolves on the tongue," he said. "It will be good for the pill-phobic. That's it."

    Carlat runs the Carlat Psychiatry Report, a blog that tracks industry marketing trends. He's also the author of a 2007 New York Times Sunday Magazine memoir about his own experiences promoting a depression drug for Wyeth Pharmaceuticals in the early 2000s.

    "You can make anywhere from a few hundred dollars to more than $200,000 a year by joining a speakers bureau," said Carlat, who stopped accepting those offers in early 2002.

    And that means he is a strange person for Schering-Plough to approach to promote Saphris. He got the letter from the company last month, around the same time that Steingard did.

    "I was dumbfounded," Carlat said. "Why would they think I would do this?"

    Schering-Plough has been accused of questionable marketing practices in the past. In 2004, the company allegedly sent doctors contracts and checks made out for $10,000.

    These mailings were unsolicited.

    Three years ago, Schering-Plough agreed to settle a Justice Department investigation by paying $435 million after allegations that the company lied to the government about its drug prices and improperly marketed a cancer drug for an unapproved use.

    Just this year, the company paid $5.4 million to end a multistate investigation into whether it delayed the release of tests that cast doubt on the effectiveness of two of its top-selling cholesterol drugs. Schering-Plough has fines going even farther back and has been investigated by nearly every attorney general in the country.

    Nothing about the offers Schering-Plough made to Steingard, and presumably to other Vermont psychiatrists, is illegal, according to Wendy Morgan, the chief of the public protection division of the Vermont attorney general's office.

    Vermont soon will have one of the strongest bans in the country on marketing between the industry and doctors. For years, drug companies were able to claim that many of their payments and gifts to doctors were trade secrets. Starting with a report to be released in early 2011, the true total of these relationships will come out.

    That bill also bans gifts such as meals and office supplies that drug companies offered to doctors. But it does not eliminate the practice of speakers bureaus; instead it requires that the payment to a doctor giving a speech or presentation should be "fair market value."

    "Fair market value doesn't sound like $170,000," Morgan said.

    The pitch to psychiatrists

    Schering-Plough's 14-page pitch sent to Steingard, the Burlington psychiatrist, contains a legal agreement outlining what a speaker can and can't say about the company's drug products and the necessary forms to fill out, such as supplying a taxpayer identification number, to start work for the firm.

    The agreement allows a doctor to perform up to 125 presentations for a total of $170,000 over a two-year contract. The company also agrees to reimburse a doctor for "reasonable out of pocket expenses."

    Drugmakers are prohibited by federal law from marketing their products to treat ailments for which they are not approved by the FDA, so the agreement makes it clear that doctors speaking for Schering-Plough will comply with regulations.

    But the company also reminds doctors that "you will use only the Schering-approved materials for all presentations performed under this agreement."

    "Your remarks will conform to the package insert for any product discussed," the document reads. "Your answers to questions should also conform to the package insert."

    Bob Consalzo, a spokesman for Schering-Plough, said the company likes to "reach out to experts in the field" to spread information about its new medications. Doctors who are part of its speakers bureau always stick to information from clinical trials and to FDA-approved uses.

    He would not say why invitations went to doctors who clearly found the program anathema to the ethics of their field.

    "We expect that there would be a few people out there who were not interested in being part of the speakers bureau," Consalzo said.

    More than a decade ago, much earlier in her career, Steingard gave a talk for Eli Lilly about its anti-depression medication, Zyprexa. She said she did so because she felt it was a good drug that worked for many of her patients.

    "I also felt flattered that they approached me," she said. "I was naive."

    At the presentation, held at a fancy Vermont inn, Steingard said she was required to use slides provided by the drug company. She was also told to stick directly to its talking points. Her feelings about the gig quickly changed and she donated half her fee, about $250, to the National Alliance on Mental Illness, an advocacy organization.

    "I just didn't feel right, so I stopped right after that," she said. "Sometimes I still get invited out to fancy meals, but I say no thanks. I'm a doctor. I can afford to buy my own dinner."

    In Vermont, several mental health advocacy organizations also have sworn off taking money from the pharmaceuticals industry. The first among them was the Vermont Association for Mental Health, based in Montpelier.

    Executive Director Ken Libertoff said the speakers bureau packet sent out by Schering-Plough is "indicative of what we call the cavalier and oftentimes irresponsible behavior of the pharmaceutical industry in Vermont and throughout the country."

    Libertoff said that, even in a small state like Vermont, psychiatrists and other doctors can make a lot of money promoting new drug products. The most recent report from the Vermont attorney general's office showed $3 million in payments and gifts to medical professionals in a single year.

    "This cozy relationship is nothing short of a national disgrace," Libertoff said. "There is a real loss of integrity when medical professionals accept payments from the pharmaceutical industry."

    Some of the largest drug companies, responding to new interest among states and on the federal level in bringing more transparency to these relationships, have vowed to make voluntary changes, including posting the names of doctors they have financial relationships with on their Web site.

    Schering-Plough is not one of those companies. Consalzo said the company will adhere to all applicable state and federal laws but does not plan to release the names of the doctors that it pays to tell people about its medications.

    "That's not something we are considering," he said.


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