Sunday, February 28, 2010

Stents as effective as surgery for clearing neck arteries, study says

While surgical treatment (carotid endarterectomy) has been the gold standard for removing plaque from clogged neck arteries to prevent stokes, a new study shows that the less invasive method of using stents to open blocked neck arteries, can be just as effective, according to WebMd. This new finding could mean that cardiologists now can offer patients two options for treating these problems. The study, presented at the American Stroke Association's (ASA) International Stroke Conference, reported that in the weeks after the procedure, patients who received stents suffered slightly more strokes, and patients who underwent surgery had slightly more heart attacks. However, after an average of 2.5 years, "there was no significant difference in the number of events between the two groups," said researcher Dr.Wayne Clark of Oregon Health & Science University. The study also reported another interesting finding: patients under age 70 appeared to benefit slightly more from stents, while older patients benefited slightly more from surgery. A similar European study presented at the same conference found stenting somewhat inferior to surgery, but one doctor notes that patient selection could have accounted for the disparate results, along with differences in they types of stents used.

Monday, February 22, 2010

While FDA and Glaxo fiddle over Avandia, patients remain at risk

As a debate over the safety of Avandia has brewed for more than two years, patients still taking the drug have remained guinea pigs for science. This week the New York Times issued a report suggesting Glaxo, the maker of the billion dollar a year diabetes drug knew the drug had significant side effects, but maneuvered to keep the drug on the market. Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, who raised the initial red flag concerning Avandia's cardiac risks, renewed his attack against the drug and its manufacturer, telling The Times that the medical community is still waiting for Glaxo to publish results of a safety study and suggesting the company is trying to whitewash reports of adverse events. HNe criticized the company for failing to publish a followup study, saying the results of Glaxo's Avandia study appear only on the company's web site. To fuel the debate, Nissen gave The Times a secret recording of a 2007 meeting with Glaxo executives. A 2007 study by Nissen found that the risk of cardiac death increased by 64% among patients on Avandia, a finding the company refuses to embrace. Nissen said in an interview that a taped recording of his meeting with Glaxo executives in 2007 showed the excecutives trying to persuade him not to publish his study, suggesting that they had contradictory information they would share with him in a joint study. Nissen said Glaxo did not have any contradictory data. Glaxo executives maintain they visited with Nissen to discuss a possible collaborative study. Meanwhile, the U.S. FDA has failed to take any action to truly protect patients, even after two officials from the FDA issued a report recommending the drug be removed from the market. Glaxo issued a press release refuting the charges in The Times article. When in doubt and when patients health is at stake, shouldn't the U.S. FDA err on the side of overprotection and pull this product, at least temporarily, before more innocent patients are harmed needlessly? If further studies definitively prove Avandia's cardiac safety, then the product can return to market. The FDA needs to adopt a common sense approach to safety in order to prevent any further adverse effects. One death is one too many.

Tuesday, February 2, 2010

Medical journal retracts research paper that linked autism to MMR vaccine -- 12 years later

The British medical journal, The Lancet, has issued a full retraction of a research paper it published 12 years ago, linking a cause of autism to the vaccine for measles, mumps and rubella (MMR). A BBC report says the journal has now accepted that the report was false. The move came after Britain's General Medical Council ruled last week that Dr Andrew Wakefield, the lead researcher in the 1998 paper, broke research rules. After the study appeared, a controversy erupted in the UK over vaccinations and many parents were afraid to vaccinate their children. As a result, the measles rate increased. The paper had been partially retracted years ago after the journal learned that Dr. Wakefield had accepted money from attorneys who represented parents who believed their children were harmed by the MMR vaccine. The full retraction goes further, saying saying the research was fundamentally flawed because of a lack of ethical approval and the way the children's illnesses were presented. Dr Wakefield, who now lives and works in the U.S. said the findings were "unjust and unfounded." As one doctor commented, the entire episode makes doctors and the media realize that they must be very certain of the strength of a study that affects public health before publishing it.