New York, NY - "Around the country, doctors in private practice have set up tax-exempt charities into which drug companies and medical-device makers are, with little fanfare, pouring donations—money that adds up to millions of dollars a year," according to an article in the June 28, 2006 New York Times [1].

"The charities are typically set up to engage in medical research or education," according to the story, "and the doctors involved defend those efforts as legitimate charitable activities that benefit the public. But because they operate mainly under the radar, the tax-exempt organizations represent what some other doctors, as well as regulators and industry consultants, say is a growing conduit for industry money."

"It obviously sets a fertile ground for conflict of interest and misuse of funds," comments Dr Robert M Califf (Duke University Medical Center, Durham, NC) in the article, by reporter Reed Abelson.

The Times article focuses on such gifts from the Johnson & Johnson company Scios (Fremont CA) and especially CHF Solutions (Brooklyn Park, MN) to the nonprofit Midwest Heart Foundation (Lombard, IL), described as "an arm" of the for-profit Midwest Heart Specialists (Bartlett, IL). It notes that a cardiologist with the group, Dr Maria Rosa Costanzo, had presented the results of a trial comparing a CHF Solutions peripheral ultrafiltration device with conventional diuresis in patients with acute decompensated HF at "a March conference of cardiologists," later confirmed in the story as the American College of Cardiology 2006 Scientific Sessions.

As she presented research results indicating that a new medical device was 'an important breakthrough,' the doctor's enthusiasm was clear. Less evident were some of the financial links between the researchers and the device's maker.

As reported then by heartwire, Costanzo presented the results of the Ultrafiltration vs IV Diuretics for Patients Hospitalized for Acute Decompensated CHF (UNLOAD) trial, in which the CHF Solutions device was associated with significantly more fluid loss and a lower rate of HF rehospitalization compared with IV diuretics.

"As she presented research results indicating that a new medical device was 'an important breakthrough,' the doctor's enthusiasm was clear. Less evident were some of the financial links between the researchers and the device's maker," the Times article states. Although Costanzo disclosed that she consulted for and had stock and stock options with the company, it continues, she did not mention that "CHF Solutions was also one of the largest donors to the nonprofit research foundation that had overseen the study." The article, having clearly implied a potential for bias in Costanzo's involvement in UNLOAD, for which she was principal investigator, reports that the Midwest Heart Foundation also has received donations from Amgen, AstraZeneca, Cordis, and Scios.

The article also appears to imply that Costanzo could have overstated the trial's clinical implications. Citing a March 15, 2006 article by heartwire as the source, the report observes that "some doctors" have said the UNLOAD's methods "may have been flawed" and reprints a quote from Dr JoAnn Lindenfeld (University of Colorado Health Sciences Center, Denver): "I wouldn't view these data as persuasive enough to use it full-scale in a million patients a year with acute decompensated heart failure." Abelson, apparently after contacting her, wrote that "Dr Lindenfeld did not dispute the accuracy of that quote but declined to comment further."

The article also says that "a separate controversy surrounds the heart-failure drug Natrecor, made by Scios, which gave the Midwest Heart Foundation a total of more than $300 000 for the years 2003 and 2004, according to federal filings."

Whatever the issues of tax-exempt status among the various charities, federal regulators say the groups could find themselves in trouble . . . if donations appear to be little more than a way for companies to funnel money to doctors.

The high-profile controversy about the drug, nesiritide, and its alleged renal toxicity and 30-day mortality risk in patients with acute decompensated HF, have been extensively chronicled by heartwire. The cardiology community is divided over whether the drug, frequently described as an impressive therapy acutely, should be on the market.

The Times article states that "Natrecor's enthusiasts included some Midwest Heart doctors, who participated in studies of the drug and also used it in outpatient settings," which it observes is an off-label use. It also reports that one of the group's cardiologists, Dr Mitchell T Saltzberg, has been "a paid Scios consultant" and has "continued to staunchly defend the drug."

Many physicians across the US have supervised the outpatient use of nesiritide, experts have consistently told heartwire, but most of the sources who are HF specialists or researchers have criticized the practice.

The "increasingly popular" corporate donations have attracted the attention of regulators, according to the article. "Whatever the issues of tax-exempt status among the various charities, federal regulators say the groups could find themselves in trouble in another way—in violation of federal antikickback laws—if donations appear to be little more than a way for companies to funnel money to doctors."

If the donations are essentially gifts to doctors in exchange for the use or recommendation of corresponding drugs or devices, "companies could be breaking the law," according to Vicki Robinson, as paraphrased in the article. Robinson, it says, is "a top lawyer in the Office of Inspector General at the federal Health and Human Services Department."

Also quoted is Patrick L Meehan, who is described as "the United States attorney in Philadelphia, whose office has a long history of prosecuting healthcare fraud," as observing that the donations may be legally questionable. In the article he says, "What we would be concerned about are end runs around the system. . . . We want to be sure there is independent and fully informed medical judgment at the heart of the physician-patient relationship."