Feb 10, 2012 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology
Clinical laboratory managers and pathologists can expect more companion diagnostics in responses to advances in molecular knowledge about various diseases
Recently, the Food and Drug Administration (FDA) cleared two products for market, one of which may be of particular interest to anatomic pathologists. The first product is a therapeutic drug for the treatment of late-stage skin cancer. The second product is a companion clinical laboratory test that will be used to identify skin cancer patients most likely to benefit from this new drug.
This development is attracting attention by experts watching the molecular diagnostics marketplace. That’s because both products were developed by the same company on a tight timeline and this process is likely to be much studied by other pharma companies and genetic test developers.
The company that developed the new drug and its companion diagnostic test is Roche Holdings AG (OTCQX: RHHBY). In its press release about the FDA’s decisions, the company simultaneously announced market clearance of the drug Zelboraf (vemurafenib) and the approval of the companion diagnostic, the cobas 4800 BRAF V600 Mutation Test.
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Aug 17, 2009 | Laboratory News, Laboratory Pathology
Young physicians want more transparency in financial relationships
By their actions, Generation Y doctors are sending a clear message that they want to take the ethical high road in their dealings with drug companies and medical device developers. In medical schools across the nation, young physicians are speaking up about what they consider to be one element of greed in their profession.
Their advocacy group, the American Medical Student Association (AMSA), is calling for a crackdown on professional ethics violations. Medical students are particularly concerned about relationships with drug and medical device developers that pose a conflict of interest. To call attention to this issue, AMSA now rates academic medical centers on how well they monitor and control money from drug and medical products companies. These results are available to the public.
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Jul 15, 2009 | Laboratory News, Laboratory Pathology
Goal is to address conflict of interest in clinical studies and CME programs
Each year, clinical laboratories and laboratory medicine associations receive less financial support from industry vendors and suppliers. This is a response to tougher Medicare compliance requirements and tighter ethics guidelines. Now comes a report from the Institute of Medicine calling for further reforms on how companies work with physicians to conduct clinical trials and publicize the findings.
The IOM committee’s report, Conflict of Interest in Medical Research, Education and Practice, stresses the importance of preventing bias and mistrust upfront, rather than trying to remedy damage after the fact. It focused specifically on financial conflicts of interest involving pharmaceutical, medical device, and biotechnology companies.
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