U.S. House of Representatives passes health care reform legislation

In a historic vote and a major victory for President Obama and Speaker of the House Nancy Pelosi, the U.S. House of Representatives has passed health care reform legislation, giving final approval of the Senate bill by a vote of 219-212. The new legislation is likely to reshape the way Americans deal with medical conditions and prevention measures. It is expected to cost $940 billion and to be implemented over a 10-year period. The measure will provide health insurance for more than 30 million uninsured and will provide protections for millions more against losing their coverage. In a last-ditch effort to kill or stall the bill, there was a Republican motion to recommit the bill to change some language, particularly on abortion, but the move to recommit failed to pass by a vote of 232-199. A reconciliation bill (HR4872)that will allow amendments to the legislation also passed by a slim margin. Republicans have argued that the package is too expensive and promotes excess government powers. Democrats consider the legislation comparable historically to enactment of Social Security after the Great Depression of the 1930s and Medicare in the 1960s. One move that helped secure the victory was President Obama's executive order stating that the healthcare bill would not interfere with an existing ban on federal funding for abortions. That helped change the votes of at least seven pro-life Democrats, led by Rep. Bart Stupak of Michigan. The reconciliation bill now goes to the Senate, where it cannot be filibustered. Acknowledging that the vote was not an easy one for some House members, President Obama said "we proved that the government...still works for the people." He called it a victory of "common sense." One thing remains certain...the debate and disagreement over this legislation is likely to continue for years.

Let the patient participate in drug-safety reporting, NEJM commentary says

There's an interesting "Perspective" on drug-safety reporting in the March 11 issue of The New England Journal of Medicine. The article, by Dr. Evan Baugh of Mount Sinai Hospital in New York, notes that when a patient wants to know about symptoms related to a prescription drug he is taking, he might consult the information on the label or in the package insert. However, this information on side effects is based mostly on clinical trials and clinicians' impressions of their patients' symptoms, rather than on the firsthand reports of patients taking the drug. Yet,a substantial body of evidence contradicts the assumption that this information is truly representative of the patient experience. Instead, Baugh says, research indicates that clinicians systematically downgrade the severity of patients' symptoms, that patients' self-reports frequently report side effects that clinicians miss, and that clinicians' failure to note these symptoms results in the occurrence of preventable adverse effects. Patient self-reporting offers one solution that would enhance the capture of subjective elements of safety information. Baugh believes patient-reported adverse events provide both clinical and scientific value and arutes that patients are entitled to know the impressions of their peers. Scientist, regulators, and clinicians should have access to patient impressions when evaluating drugs, Baugh says. He also suggests that administrative efficiency might actually improve if patients reported adverse events before clinical interactions. Self-reports, Baugh concludes, are more sensitive to underlying changes in patients' functional status than are clinicians' reports. The patient is more likely to identify symptoms earlier during a course of treatment. It seems like a common sense approach to drug-safety reporting.

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.

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.

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.

Low-carb diets may help to lower blood pressure

If you are looking to shed some pounds AND lower your blood pressure you might want to try a low-carbohydrate diet, according to a new study appearing in the current issue of the Archives of Internal Medicine. The study found that twice as many people on a low-carb diet lowered their blood pressure than those who were taking the diet drug orlistat (the active ingredient in over-the-counter Alli and the prescription drug Roche's Xenical.) Both approaches were equally effective at improving cholesterol and glucose levels, as well as reducing waist size and weight, the researchers from Duke University and the Veterans Administration reported. (See also: BBC News report)

Counterfeiting hits the OTC diet drug market with fake versions of Alli

Reports this week that there were counterfeit versions of the over-the-counter weight loss drug known as Alli were compounded by the news that the fake versions were contaminated with another weight loss drug known as subutramine. Subutramine is the active ingredient in Abbott's weight-loss prescription drug known as Meridia. The counterfeit Alli contained twice the normal amount of subutramine in Meridia and could have caused considerable adverse effects in some individuals, according to the U.S. Food and Drug Administration. The drug apparently can interact with other drugs to cause adverse effects and needs to be closely monitored. GlaxoSmithKline, the manufacturer of Alli, ran some preliminary tests on the counterfeit Alli and found it did not contain any of the GSK active ingredient, orlistat, but instead contained the dangerous levels of subutramine. It's amazing how sophisticated counterfeiting has become, because Alli comes in a distinctive larger package than most drugs and one would have thought it would be harder to reproduce the packaging, but in this modern age of electronic magic, everything is fair game. Fortunately, the counterfeiters failed to put a fake lot number and expiration date on the box and those are the clues that the packages are counterfeit. This is a case where a drug we would not expect to become life-threatening is counterfeited into a substance that threatens many unsuspecting individuals. So far it is believed that the counterfeit Alli has been sold only over the Internet and has not made its way to drug stores or other retail outlets.

A New Year, new health resolutions?

It's a new year, a new decade and that means it's time for many of us to take a look at our health and to make some lifestyle changes that could help add a few more years to our lives. After two weeks of "happy eating" that we all blame on the holidays, most of us want to change our bad habits. Some promise to exercise more often, to eat more of the healthful food groups in place of the empty calories of snacks and fast food. Others have made a vow to lower their blood pressure and their stress levels and to re-evaluate their time expenditures for work vs. family and fun. As we decide to change about our lifestyles in the new year, we should set aside time to achieve the goal, so that the resolutions don't fade into oblivion by the Ides of March! Health information on the Internet can help many of us change our evil ways. A new diet doesn't have to be drastic, nor does an exercise program. We all can start small by just picking one bad food habit to eliminate and by starting with excercise of 10 minutes a day, even if it is a few leg kicks after you get up in the morning or running in place in the bathroom as you brush your teeth. We can add some low fat dairy products, such as yogurt and fruits to our morning breakfast and skip the bagel or corn muffin. We can cut our stress by better time management. A bit of cinnamon and mustard instead of mayonnaise can help lower blood pressure and better regulate blood glucose, some studies show. Changing isn't easy, but the rewards are great when we see the pounds disappear or when we feel better because we've reduced our stress. Good luck with you resolutions in this year. You can change, you really can!