New Drugs and the Inefficiency of the Patent System

BEAT THE PRESS: "Once an effective treatment for Hepatitis C has been developed, there is little medical benefit in having a second or third effective treatment. The resources to develop these alternatives to Sovaldi could have been much better utilized researching treatments for diseases which do not presently have a cure. However the incentives provided by the massive patent rents being earned by Gilead Sciences (the patent holder for Sovaldi) give a huge incentive to other companies to carry through duplicative research. If anyone cared about efficiency in the health care system this point would be widely publicized."

PHARMA ETHICS, AGAIN

If this week's SCOTUS ruling on Wyeth vs. Levine wasn't enough, there are two New York Times stories by Duff Wilson about the influence of corporate pharmaceutical companies on faculties - and their veiled threats on students - at Harvard Medical School.

One is about the ethics of faculty being paid consultants of pharmaceutical companies:-- In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

This is all to reminiscient of the commotion in 2006 about pro-fluoridationist Dr. Chester Douglass, a professor of Dentistry at the Harvard School of Dental Medicine, who also served as editor of one of COLGATE's company publications and was the Chairman of the Board of Trustees for the Delta Dental Foundation of Massachusetts, a trade organisation. Harvard did indeed investigate Dr Douglass' questionable ethics, but it was a whitewash. We'll have to wait and see what comes of the med students' protests.

In 2005, a scientist at NIH was punished by that government agency for asking that pharmaceutical companies' payments to academic researchers be made public.

The second article concerns Pfizer photographing Harvard Medical School student protesters:-- ... David Tian, a first-year Harvard medical student, said he found it “strange and off-putting” last fall when a man who identified himself as a Pfizer employee took a cellphone photo of students as they demonstrated against pharmaceutical industry influence on campus. “We could only assume he intended to share this with his company,” Mr. Tian said.

The students did not get the man’s name, but they took his picture.

Asked about the mysterious Pfizer man on campus and shown his picture, a company spokesman said he had recently contacted the employee and concluded that he had done nothing wrong. Declining to name him, the spokesman, Ray Kerins, said the employee had photographed the students for personal use.

Mr. Kerins preferred to talk about Pfizer’s support of the medical school, which, according to Harvard officials, includes private payments to at least 149 faculty members, corporate donations of $350,000 to the school last year, $234,000 for continuing medical education classes, and two Pfizer-financed research projects on campus.

QUESTIONS: What are the pressures of pharmaceutical companies put on students, researchers and faculty UVM's College of Medicine and the Dartmouth Medical School? Which members of their respective faculties are paid consultants of corporations and trade organisations? Is there a code of ethics in place against such influence?

(Thanks to The Cockroach Catcher for the heads-up about the NYT story.)

US SUPREMOS RULE AGAINST WYETH IN VERMONT CASE

Maggie Gunderson in GMD:-- The Supreme Court ruled 6-3 in favor of Vermont resident Diana Levine in Wyeth v. Levine, Dkt. 06-1249 (3/4/09). Levine had won her case in Vermont, but drug company Wyeth had appealed the almost $7 million award all the way to the U.S. Supreme Court.

Senator Patrick Leahy filed a "friend-of-the-court" brief to a Vermonter Diana Levine's U.S. Supreme Court case. Leahy was joined in his "amicus" legal brief, which was filed in August 2008, by 17 members of Congress, including Vermont Senator Bernard Sanders and Vermont Congressman Peter Welch and Senators Edward M. Kennedy, Sheldon Whitehouse, Tom Harkin, Dianne Feinstein, Richard J. Durbin, and Russell D. Feingold, and Representatives Henry A. Waxman, John Conyers, Jr., John D. Dingell, Frank Pallone, Jr., Bart Stupak, Zoe Lofgren, Linda Sanchez, Debbie Wasserman-Schultz, and Maxine Waters.

FDA GUIDELINES ADDRESS JOURNAL REPRINTS ON UNAPPROVED DRUG USE

The FDA has released guidelines concerning journal reprints distributed to physicians that cite the off-label use of drugs and devices. Although some welcome the guidelines as a way to help clear up the issues surrounding the practice, others say they may cause confusion about what should or should not be considered promotional.

Source: AMANews (subscription required)