How Clinical Guidelines Can Fail Both Doctors and Patients

Today's post was shared by The Health Care Blog and comes from thehealthcareblog.com

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer no substantive benefits. The controversy highlights a problem mired in an outdated way of thinking about health care and the doctor-patient relationship. Guidelines came about after generations of physicians wanted to bring something more than “opinion and experience” to the patient’s bedside. In the late 1960s legislation for the U.S. Food and Drug Administration was amended to call for a demonstration of efficacy and an assessment of benefits and risk as prerequisite to the licensing of any pharmaceutical. Modern clinical science resulted, first slowly and now with an avalanche of clinical trials, each pouring forth outcome data galore. The Burden of Clinical Data Clinicians are expected to stay current with this wealth of information. The modern medical curriculum instructs all budding physicians on how to evaluate the quality and the clinical relevance of all such contributions to the body of clinical science. Because some (or perhaps many) find this exercise overwhelming, there are organizations—many academic and some without any discernible relationships with purveyors that could pose...

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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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Doctors Say Heart Drug Raised Risk of an Attack

Today's post was shared by FairWarning and comes from www.nytimes.com

Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead. The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year. “Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday. Dr. Nissen was the senior author of a report on the data that was published online Monday by The Journal of the American Medical Association and presented at the annual meeting of the American Heart Association in Dallas. In unveiling the results there, the lead investigator, Dr. Stephen Nicholls, publicly admonished the company. Dr. Colin Hislop, the chief medical officer at Anthera, denied the accusations, saying it simply took time to gather and organize the data. “I don’t think the timeline was particularly protracted, nor were we being difficult,” he said in an interview Tuesday. Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge. “We think that when you enter...

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FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)

The U.S. Food and Drug Administration (FDA) is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine).  We have approved changes to the drug labels to reflect these serious events and updated our recommendations for use of these agents.  Health care professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions.    Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal. The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs.  However, recent reports of serious adverse events in the FDA Adverse Event Reporting...

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Working Overtime Results in Compensation Heart Attack

Working overtime that resulted in a heart attack was deemed to be a compensable dependency claim.

"The compensation judge held that Anthony's overtime work contributed in a material way to his heart attack. In reaching that conclusion, the judge found that the work effort was more intense than the normal wear and tear of Anthony's daily living."

"The parties agree that the overtime work was more strenuous for Anthony than daily living tasks. Glen Gery required Anthony to change heavy paddles or blades that churned the water and shale. To access the blades, he was required to use a jackhammer to remove hardened material, each chunk weighing between thirty and forty pounds. Once the hardened material was removed, certain blades had to be replaced. To replace the blades, a shaft weighing approximately 200 pounds had to be lifted off the ground by at least two workers who were required to push, lift and pull until each new blade was secured. Anthony worked that day performing intense manual labor in a hot and dusty environment."

"Dr. Malcolm Hermele, petitioner's expert, opined that the heart attack occurred on the day Anthony worked overtime, and that his work effort contributed materially to it. Hermele pointed to the results of tests performed the day after Anthony worked overtime to prove when the heart attack occurred. A creatine kinase (CK) enzyme test showed a reading of 1453. A normal reading would be zero. He explained that the CK enzyme is released into the blood stream when there is damage to the heart. Anthony's troponim levels and the result of his brain natriuretic peptide test show that he was experiencing a heart attack. Hermele concluded that a 1453 reading was evidence that Anthony's heart attack occurred within a day or two of the test, during which Anthony performed the overtime maintenance work."

Reading v. Glen Gery Shale and Brick Company, Not Reported in A.3d, 2010 WL 4137298 (N.J.Super.A.D.)Decided October 21, 2010
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For over 3 decades the Law Offices of Jon L. Gelman 1.973.696.7900jon@gelmans.com have been representing injured workers and their families who have suffered work related accident and injuries.

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