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November 5, 2007

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Integrity in Science Watch

Week of 11/05/2007

Orthopedic Surgeons' Buck-raking Exposed

Nearly 50 orthopedic surgeons, many affiliated with the nation's top teaching hospitals, each earned over $1 million a year in consulting contracts and royalties from the five companies that make artificial knees and hips. The payment disclosures were posted on the companies' websites last week as part of a $311 million anti-kickback settlement between four of the firms and the U.S. attorney for northern New Jersey. The complaint had accused the companies of using consulting contracts as an illegal kickback scheme to get surgeons to use a particular company's artificial joints.

The top two earners were Thomas Thornhill, chair of the orthopedics department at the Harvard-affiliated Brigham and Women's Hospital in Boston, and Robert Scott, also at Brigham and Women's, who each collected $6.7 million in the first ten months of 2007 from DuPuy Orthopaedics, a unit of Johnson & Johnson. In a statement released Friday, the two men claimed the money came from consulting fees and from patent royalties on an artificial knee licensed to J&J in 1986 and an artificial hip licensed to J&J in 1991. They said in a prepared statement that they collected no royalties on DuPuy products used at their hospital, and all the consulting fees were donated to charity.

Norman Scott of the Insall Scott Kelly Institute for Orthopaedics and Sports Medicine in Manhattan collected $5.5 million in payments so far in 2007 or about $25,000 a day from Zimmer Inc. The institute's website claims an affiliation with the Albert Einstein School of Medicine, but the Yeshiva University affiliate says Scott's appointment ended in 2005. A secretary at the institute refused to comment or put a call through to Scott. Richard H. Rothman of the Rothman Institute, the former chairman of the orthopedics department at the Thomas Jefferson Medical School in Philadelphia, received $2.4 million in 2007 or about $12,000 a day from Stryker, a division of Howmedica Osteonics Corp. A spokesman for the institute, contacted Sunday, refused to comment. A full list of the surgeons who collected more than $1 million in payments can be found here.

With seniors accounting for nearly 70 percent of the knee and hip replacement market, Medicare spent $16 billion on the procedures last year. A typical knee replacement costs $33,000, according to Medicare records. A spokesman for Christopher J. Christie, the U.S. attorney in Newark, said the investigation into the alleged kickback scheme is ongoing.

Gas Industry Flouts Clean Water Laws; BLM Dithers

Natural gas companies that use an underground extraction process pioneered by Halliburton Co. may be violating the nation's clean water laws, but the Bush administration refuses to exercise scientific oversight, Rep. Henry Waxman (D-CA) charged at a House Committee on Oversight and Government Reform hearing last week. The Bureau of Land Management has failed to complete a study of the environmental and health impacts of the process that was promised in 2005. The process, known as hydraulic fracturing, injects hydrocarbon waste fluids into underground coal beds. That forces natural gas to the surface, but leaves behind a toxic residue of benzene, toluene, mercury, and other waste products, which may migrate into underground water supplies.

The Energy Policy Act of 2005 exempted hydraulic fracturing from groundwater protections that would normally apply under the Safe Drinking Water Act and the Clean Water Act. But the law required the Interior Department to commission a National Academy of Sciences study of hydraulic fracturing. The study, due 14 months ago, hasn't been started. The agency chose a less expensive alternative, which the BLM itself concluded would be of "limited value," because the cost of conducting the more extensive review "would have an impact on BLM's ability to provide sufficient funding to process additional" oil and gas drilling applications, according to internal agency documents obtained by Waxman’s oversight committee.

Shining Light on Physician Payola Gets Boost

A New England Journal of Medicine article assessing the prospects for the Physician Payments Sunshine Act, which would require that drug companies reveal all their payments to physicians, listed the consequences of the ubiquitous conflicts of interest that plague modern medicine. While granting that physician-industry interaction was important for clinical trial enrollment and occasionally educated physicians about drugs that are underused, the review emphasized the negative effects of the payments:

  • "Doctors with ties to industry may be more inclined than their colleagues to prescribe a brand-name drug despite the availability of a cheaper generic version.
  • "The provision of free samples may reinforce this behavior and perhaps stimulate off-label use of medications, which can pose risks for some patients.
  • "Industry relationships may stimulate the premature adoption of novel treatments, which could lead to serious health problems for patients.
  • "Industry inducements may reduce physician adherence to evidence-based practice guidelines in favor of company medications or interventions that are not recommended in independently developed guidelines.
  • "Finally, the financial rewards from industry relationships may reinforce a culture of entitlement among physicians, which could limit their ability to honestly acknowledge and manage the potential negative effects of these relationships.
"In general, physicians vehemently deny that their industry relationships have any of these negative effects - but they are less convinced that the same is true of their physician colleagues," Eric Campbell, an associate professor of health policy at Harvard Medical School, wrote. He also reminded doctors that their patients ultimately pay the tab for these emoluments through higher prices.

ExxonMobil Sullies Science on Polar Bear Decline

A recent study that claims polar bears are not harmed by global warming was funded by ExxonMobil, New Scientist reported. The study, which appears in the September 2007 issue of Ecological Complexity, claims that a human-caused role for warming Arctic temperatures "remains difficult to identify," and that predictions of polar bear decline are "highly premature." The study's authors include Willie Soon and Sallie Baliunas of the Harvard-Smithsonian Center for Astrophysics, both of whom are affiliated with the George C. Marshall Institute, which receives funding from ExxonMobil; David Legates of the University of Delaware Center for Climatic Research, who has received funding from ExxonMobil, the DaimlerChrysler Corporation, and the El Paso Energy Foundation; and Timothy Ball of the Natural Resources Stewardship Project in Calgary, which has ties to lobbyists for Canadian utility companies.

The article received no peer review and the journal Ecological Complexity has no disclosure policy for its authors. The article was cited by the State of Alaska in its filing with the Fish and Wildlife Service opposing endangered species protections for the polar bear. Brad Miller (D-NC) of the House Committee on Science and Technology last month demanded that ExxonMobil turn over all records of its support for polar bear research.

IOM Adds Two to Conflicts of Interest Panel

Responding to criticism that the panel investigating conflicts of interest in medicine lacked balance, the Institute of Medicine last week added two prominent researchers to its roster. Lisa Bero of the University of California at San Francisco and Eric Campbell of Massachusetts General Hospital, both of whom have documented the extent and impact of financial conflicts of interest in medicine, join the now 17-member committee. The panel includes three members granted conflict-of-interest waivers because of their ongoing ties to drug and medical device companies, and at least one other with recent ties to industry that were neither waived nor revealed on the IOM website. The committee holds its first meeting today and Tuesday.

Odds and Ends

The Food and Drug Administration proposes posting the entire roster of an advisory committee meeting on the day that it releases briefing materials for the meeting, which is usually a day or two early, according to a draft guidance . . . . Michigan Democrats introduced legislation last week that would limit drug company gifts to doctors to $100 a year. The legislation makes Michigan the first state to consider limiting the practice; Minnesota and Vermont require disclosure of all physician gifts. The bill isn't expected to go far since the state Senate is controlled by Republicans . . . . Consumers International issued a new report "Drugs, Doctors and Dinners" that claims multinational drug companies showering gifts on doctors in the developing world leads to half of all drugs sold there being wrongly prescribed, the London Independent reports. The report calls for banning the practice . . . . Office of Science and Technology Policy director John Marburger, President Bush's chief science adviser, was responsible for severely editing CDC Director Julie Gerberding's testimony on climate change and health impacts, Naturenews reports (subscription required) . . . . the United States Department of Agriculture's Wildlife Services agency, which according to its website implements "sound, science-based projects designed to reduce conflicts between humans and wildlife," last year spent $108 million to kill 1.6 million animals. A record number of those killed were protected under the federal Endangered Species Act, according to agency statistics compiled by Sinapu and Public Employees for Environmental Responsibility . . . . The revolving door keeps spinning: Robert E. Brackett, director of the FDA's food safety division, will join the Grocery Manufacturers Association, which represents food, beverage and consumer-products companies, the Washington Post reports. His predecessor, Joseph Levitt, moved to Hogan and Hartson, a lobbying firm whose clients include numerous food firms.

Cheers and Jeers

  • Cheer to Roy Poses of the HealthCareRenewal blog for exposing the conflicts of interest of two physicians listed as PBS advisers for the recently aired program, "The Mysterious Human Heart." The show included sections on new technologies for treating heart disease and was underwritten by Medtronicand AstraZeneca. Advisers to the show included Peter Libby of Harvard Medical School, a consultant for AstraZeneca, and Douglas P. Zipes of Indiana University, a consultant for Medtronic. PBS ombudsman Michael Getler criticized the show's producers for failing to mention safety problems with the two sponsors' products.
  • Jeer to Cindy Skrzycki for failing to note in her regular column in the Washington Post that the American Council on Science and Health is largely corporate-funded.
  • Cheer to Science writer Jocelyn Kaiser for uncovering Texas supplement maker Mannatech's successful effort to squelch an editorial in the journal Glycobiology, which, while briefly posted online, called on scientists to boycott a scientific meeting in Dublin sponsored in part by the company (see below). The Texas attorney general is suing Mannatech to prevent it from claiming the scientific literature shows its products cure diseases. "It's none of our business as glycobiologists if nutraceutical companies want to sell bark extract. When they begin to tie it to our discipline, that is the problem," Ronald Schnaar of Johns Hopkins University in Baltimore, editor-in-chief of Glycobiology, and lead author of the withdrawn editorial, told Science (subscription required).
  • Jeer to Oxford University Press for temporarily removing the Schnaar commentary (see above), which it plans to post later with company responses. It had received protest letters from Mannatech and John Axford, a British rheumatologist, former Mannatech board member, and organizer of the Dublin conference. They claimed the editorial had not passed peer review.