Healthy Skepticism Library item: 12185
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Publication type: news
Stewart N.
D.C. Effort to License Drug Sellers Advances
Washington Post 2007 Dec 12B01
http://www.washingtonpost.com/wp-dyn/content/article/2007/12/11/AR2007121102284.html
Full text:
Bill, Which Would Also Ban Data Mining by Manufacturers, Faces Final Vote
The D.C. Council voted 7 to 6 yesterday to give initial approval to legislation that would make the District the first jurisdiction in the country to license pharmaceutical sales representatives, a major blow to the prescription drug industry and one that could have national implications if states follow the District’s lead.
The legislation breaks new ground in the effort to reel in the multibillion-dollar prescription drug trade. In recent weeks, lobbyists for the industry doggedly pressed the council to reject the SafeRx Act of 2007 because federal laws and policies of the American Medical Association already monitor the salespeople.
Council member David A. Catania (I-At Large), who has become known in national health circles as an industry watchdog, argued that those laws and policies still allow salespeople to misinform doctors and patients about the drugs they peddle as they pursue commissions. The marketing of more expensive, brand-name drugs drives up the costs for patients who receive little information about generics and more reasonably priced drugs that are equally effective, critics say.
“For too long, we have allowed profit and paternalism to be our guide for patient safety,” Catania said in an interview after the narrow vote. “The truth is, no one is minding the store.”
Yesterday’s vote, however, will not end the debate. The council must vote again Jan. 8 on final approval of the legislation.
In recent days, it appeared that the bill would be defeated. It got a last-minute boost Monday from Mayor Adrian M. Fenty (D), who wrote a supportive letter to council Chairman Vincent C. Gray (D).
He also praised the work of Catania, who heads the council Health Committee. He noted the committee’s “steadfast commitment” to combating substance abuse and HIV-AIDS and increasing access to quality health care — a swipe at the contention of opposing council members and pharmaceutical lobbyists that Catania has neglected the city’s health crises to join the national debate on prescription drugs.
Gray also influenced the vote, sitting quietly during contentious debate, then emerging as the tiebreaker.
Afterward, Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, issued a statement through spokesman Jeff Trewhitt.
“We regret that the council voted in favor of legislation that creates unnecessary financial burdens for the District of Columbia at a time when the money would be better spent addressing a wide array of health care challenges confronting the city including HIV/AIDS, diabetes and heart disease,” the statement said. “The bill passed by the council puts the city into a regulatory arena that has been effectively addressed by federal laws and federal government agencies for years.”
Some council members agreed.
Marion Barry (D-Ward 8) called the debate “misdirected energy.”
“As soon as it passes, it does nothing to enhance the health of our citizens,” he said.
Council member Harry Thomas Jr. (D-Ward 5) said the legislation was so flawed from the beginning that he had a document before him yesterday with 38 revisions “to the point that you can’t even read the bill.”
“If it’s so bad with so many edits . . . let’s just start over,” he said.
Thomas stopped Catania from rebutting his statements. “I’m not asking a question, so I don’t want a response,” he said.
But other council members came to Catania’s defense, with council member Phil Mendelson (D-At Large) saying that amendments, part of the normal legislative process, had made the bill better.
Tommy Wells (D-Ward 6) dismissed the arguments of some opposing council members that the pharmaceutical industry and doctors could police themselves. “To say just trust the business is to say trust the oil companies, trust Enron,” he said.
Under the bill, salespeople would have to be licensed and sign a code of ethics and would be regulated by a pharmacy board. To qualify for a license, the representatives, dubbed “detailers” in industry lingo, would have to be college graduates. They would also have to refrain from using titles that would give the impression that they are licensed to practice pharmacy, nursing or medicine.
The bill, which has several parts, also would ban pharmaceutical manufacturers from engaging in a practice called “data mining,” when doctors’ prescription data are used for marketing purposes without their knowledge and consent.
Critics say the information trickles down to detailers who can then target a doctor for a particular drug by looking at his or her prescribing habits. District doctors could opt in to the program to allow firms to get their prescription data from pharmacies.
The pharmaceutical group and the AMA both argued that the data mining is often used for research. “It is the AMA’s position that an opt-in system would have substantially the same effect as an outright ban on the commercial use of these data, which would result in a major setback for the medical research community and the health outcomes that they are trying to improve,” AMA Chief Executive Michael D. Maves wrote in a letter to the council.
New Hampshire, Maine and Vermont, which have passed similar legislation, are in court with data collection companies and manufacturers fighting the new laws. New Hampshire is appealing the decision of a U.S. District Court judge to block the state from enforcing its new data mining law on the grounds that it restricts commercial free speech.
The District could face the same fight, council members said.
Catania said that is to be expected. “They are taking their playbook from the tobacco industry,” he said. “Sue, sue, sue.”
