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US Health Care System

Published studies

Project: US Health Care System
Open-Content project managed by kuhan, mtuck

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The Journal of the American Dental Association publishes a study concluding that Bextra, a new drug manufactured by Pharmacia, offers relief to the acute pain patients feel after dental surgery. [Daniels et al., 2002] Just six months before, the FDA investigated the claim and found no evidence to support it. [New York Times, 11/22/2002] Bextra is only approved to treat pain caused by arthritis or painful menstrual cycles. [US Food and Drug Administration, 11/22/2002] During the three-month period following the article’s publication, Bextra sales increase by 60 percent. It is later learned that the authors of the article were not independent scientists, but rather employees of Scirex, a research company owned partially by Omnicom, one of the world’s largest advertising firms. When the New York Times asks three doctors to review the Scirex article, the doctors say its conclusions are not persuasive. “All three said that one of Scirex’s conclusions was insignificant: that one dose of Bextra worked longer than a single dose of a medicine containing oxycodone and acetaminophen, a combination often sold under the brand name Percocet. Patients rarely receive just one dose of that combination drug, the doctors said, because it wears off in four to six hours.” One of the doctors, Eric J. Topol, says the studies cited in the article make “a contrived comparison.” He notes that patients in the study had an average age of 23, which is not representative of the age group that would mostly likely use the drug. Judy Glova, a spokeswoman for Pharmacia, denies in a statement to the New York Times, that the article was an attempt to bypass the FDA regulation. And Pat Sloan of Omnicom insists the company has “nothing to do with the design of clinical studies.” [New York Times, 11/22/2002]

Entity Tags: Pharmacia & Upjohn Inc, Eric Topol, Omnicom, Scirex

Category Tags: Published studies

Dr. Maria Rosa Costanzo presents the findings of a study on the effectiveness of a $14,000 blood filtering device manufactured by Minnesota-based CHF Solutions. The study—performed by Midwest Heart Foundation, but designed with the help of CHF Solutions—concluded that the device does a better job of removing excess fluid from patients with heart failure than intravenous diuretic drugs. Costanzo does not disclose to her audience that CHF Solutions is one of Midwest Heart Foundation’s largest donors—contributing about $180,000 in 2004. She does say that she is a paid consultant of the company and a stockholder. Some doctors criticize the study, noting that subjects of the study may not have taken enough medicine to provide meaningful comparisons. [New York Times, 6/28/2006] Cardiologist Dr. JoAnn Lindenfeld, for example, tells Heartwire, “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.” [HeartWire, 3/15/2006]

Entity Tags: CHF Solutions, Midwest Heart Foundation, JoAnn Lindenfeld, Maria Rosa Costanzo

Category Tags: Published studies

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