By Julie Burger

When allegations were made public that academic researchers who conduct clinical trials were failing to report funding they received from industry (including the drug companies which produced the drug being tested), I suggested some ways medical centers or the government could assure the disclosure of these relationships.  U.S. Sen. Charles Grassley (R, IA) has launched an investigation into whether researchers are failing to disclose payments from pharmaceutical companies.  He found evidence that prominent physicians at prestigious universities failed to disclose payments from drug companies–some payments were even received while the doctor was conducting trials on a drug made by the company paying the physician.  Now the U.S. Attorney for the District of Massachusetts and the Inspector General of the Department of Health and Human Services have issued a subpoena to a law firm that represents States in their claims of Medicaid fraud against manufacturers of antipsychotic drugs.  The subpoena asks for information about researchers and their connections with the drug companies.

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By Tim Welch

In February 2009, the Institute of Medicine (IOM) released a report, "Beyond the HIPAA Privacy Rule:  Enhancing Privacy, Improving Health Through Research," which outlines the IOM's evaluation of the effectiveness of the 1996 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in the context of today's electronically-intertwined world.  The report, by the IOM's Committee on Health Research and the Privacy of Health Information, assessed the impact of the HIPAA Privacy Rule on health research in the United States and made recommendations to encourage health research while preserving and improving the privacy protection of personally identifiable health information.

Every American doctor's office contains endless rows of file cabinets which house the confidential medical records of the office's patients.  Modern technology offers us the time- and space-saving convenience of storing, organizing, accessing, and transmitting these records electronically.  However, such a free flow of information—in a less-tangible and more easily-shared form than classic paper records—raises privacy and security concerns.  Medical records often contain personally identifiable information that could be damaging to a patient's dignity and lead to discrimination in other aspects of a patient's life.

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By Julie Burger

University medical centers are cutting down on relationships with drug and device manufacturers.  Less free pizza, less free pens.  That’s great, since studies show that even nominal gifts can influence prescribing and practice habits.  But it turns out that cold hard cash rather than trinkets might be the real culprit.

Conflict of interest and government grant funding rules say that investigators on federally funded studies must report whether they receive $10,000 or more a year from, for example, the drug company which makes the drug being studied.  A Congressional investigation spearheaded by Sen. Charles Grassley (R, IA) has highlighted several troublesome alleged undisclosed conflicts of interest incidents: psychiatrist Dr. Charles B. Nemeroff of Emory University reportedly failed to disclose $1.2 million in outside income from drug makers (including money from GlaxoSmithKline) while running a $3.9 million taxpayer-funded study to test GlaxoSmithKline drugs; Drs. Joseph Biederman and Timothy Wilens of Harvard each earned at least $1.6 million in consulting fees from drug makers but reportedly stated they earned only several hundred thousand dollars; Dr. Melissa DelBello of Univ. of Cincinnati allegedly reported around $100,000 from 8 drug companies over two years, while one alone had paid her $238,000.

I don’t know about you, but I would sure notice an extra million dollars in my bank account.  Even a cool hundred K would make a noticeable impact.

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