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Generics Are as Good as Branded Drugs’

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There is no evidence that brand-name drugs given to treat heart and other cardiovascular conditions work any better than their cheaper generic counterparts, US researchers said.
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The findings run counter to the perception by some doctors and patients that pricier brand-name drugs are clinically superior, said Aaron Kesselheim of Brigham and Women’s Hospital and Harvard Medical School in Boston, who led the study.

Kesselheim and colleagues combined the results of 30 studies done since 1984 comparing nine sub-classes of cardiovascular drugs to generic counterparts.

The brand-name drugs did not offer any advantage for patients’ clinical outcomes in those studies, they wrote in the Journal of the American Medical Association.

“Brand-name drugs for cardiovascular disease can be as much as a few dollars a pill, whereas generic drugs might be as little as a few cents a pill,” Kesselheim said.

“If a patient is prescribed a generic drug because that’s what’s appropriate for their condition, then they should feel confident taking that drug. And physicians themselves should also feel confident prescribing generic drugs where appropriate,” Kesselheim said. He said rising costs of brand-name prescription drugs strain the budgets of patients as well as public and private health insurers. Overall US prescription drug sales hit $286.5 billion in 2007.

Pharmaceutical companies retain exclusive rights to drugs they develop for a certain number of years, after which others can sell generic versions that are chemically equivalent. The active ingredient is the same, but the colour and shape may differ and they may have different inert binders and fillers.

In the US, the Food and Drug Administration must approve a generic version of a drug before it can be sold. Kesselheim said cardiovascular drugs to treat conditions of the heart and blood vessels are the most commonly prescribed category.

The study covered beta-blockers, diuretics, calcium-channel blockers, statins, antiplatelet agents, ACE inhibitors, alpha-blockers, anti-arrhythmic agents and warfarin.

Sources: The Times Of India

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Unapproved Drugs are Killing Dozens

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Millions of private patients are taking medications that have never been reviewed by the US government for safety and effectiveness, an Associated Press investigation found. And taxpayers have shelled out at least $200 million since 2004 for the unapproved medications that are still covered under Medicaid, according to the analysis of federal data has found.

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The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold.

The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market. Medicaid officials acknowledge the problem, but say they need help from Congress to fix it.

Sources: The Times Of India

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FDA Slammed for Calling BPA Safe

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In a highly critical report, a panel of scientists from government and academia said when the FDA completed a draft risk assessment of bisphenol A (BPA) last month, they did not take into consideration numerous studies that have linked the chemical to prostate cancer, diabetes and other health problems.

The scientists took the FDA to task for basing its safety decision on three industry-funded studies.

The report was written by a subcommittee panel of the FDA’s outside science board, experts who advise the FDA on complex issues. The panel concluded that the FDA’s margin of safety is “inadequate.”

The panel said the FDA also didn’t use enough infant formula samples and didn’t adequately account for variations among the samples.

Studies the FDA did not consider when making their assessment suggest that BPA could pose harm to children at levels at least 10 times lower than the amount the agency called safe. Another government agency, the National Toxicology Program, concluded that there is “some concern” that BPA alters development of the brain, prostate and behavior in children and fetuses.

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Can Food Actually Prevent Diseases?

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Eating tomatoes to help prevent cancer, garlic to prevent AIDS or drinking fruit juice to ward off Alzheimer’s? Despite a bevy of research, the impact of food on killer diseases remains to be proved.

Scientists agree that a balanced quality diet is key to good health, and most governments in past years have urged citizens to adopt a daily diet of five portions of fruit and vegetable, and three each of dairy products and starch, while cutting back fats, sugar and alcohol.

Watching what you eat, experts say, does help prevent illnesses such as diabetes, hypercholesterolaemia – which leads to cardio-vascular disease – or osteoporosis.

But researchers are in disagreement over illnesses not directly related to nutrition, such as cancer, AIDS or neurodegenerative diseases – though again all recommend a balanced diet.

Among the thousands of studies on hand, one European investigation concluded that eating fruit and vegetable fibre might limit the risk of colorectal cancer.

Fruit was tipped as a possible protection against cancer of the lung, and to ward off prostate cancer, the study recommended five cups a day of catechin-rich green tea – catechins are polyphenolic antioxidant plant metabolites.

Industrial – or processed – fats, already known to be harmful for the cardiovascular system, could double the risk of breast cancer while soybeans reduced the risk threefold. But soybeans, which are rich in anti-oxydants that help cells survive, could increase the risk of infertility.

Lycopene, the bright red anti-oxydant pigment found in tomatoes and other red fruits, also was found by some researchers to reduce the risk of cancer, but the US Food and Drug Administration (FDA) says there is no solid proof for the claim. Alzheimer’s on the other hand could be kept at bay by pomegranate juice.

But while fish are hailed for their omega-3, a family of unsaturated fatty acids, fish are also rich in mercury and toxic PCBs, or polychlorinated biphenyls.

Experts at France’s national food and cancer research centre, NACRe, said a varied diet of mainly fruit and vegetables with not too much alcohol would help prevent cancers of the mouth, pharynx, oesophagus, lung, stomach, pancreas, colon-rectum and bladder.

Eating well is also key to treating HIV-positive patients as malnutrition weakens the immune system, lowering resistance to secondary effects.

But good food cannot replace antiretrovirals despite claims to the contrary by South Africa’s controversial health minister – “Dr Beetroot” – on fighting AIDS with garlic, lemons and veggies.

Sources:The Times Of India

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Rotavirus Vaccine Reduces Diarrhea

An oral vaccine for diarrhea reduced hospitalizations of children with rotavirus by 70 percent in Philadelphia, saved money and prevented infections among unvaccinated children, researchers reported.

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Three reports presented to a meeting of infectious disease specialists showed the benefits of the vaccine, which prevents the most common cause of severe diarrhea.

In one report, Irini Daskalaki of Drexel University College of Medicine reported that hospitals in North Philadelphia had seen a 70 percent drop in rotavirus-associated hospitalizations since rotavirus vaccinations began in 2006.

The number of babies aged 6 to 11 months admitted to the hospital with rotavirus plummeted by 94 percent, Daskalaki told a meeting of the American Society of Microbiology and the Infectious Diseases Society of America.

“The extent of the decrease in cases … is unprecedented and greater than any variation in numbers previously observed, suggesting that the vaccine played an important role,” researchers wrote in a summary released before the presentation.

Merck and Co’s Rotateq was recommended in 2006 for routine immunization of U.S. infants, while GlaxoSmithKline Plc’s Rotarix, was approved by the U.S. Food and Drug Administration in April. Both are considered equally safe.

Rotavirus is the leading cause of severe gastroenteritis, with vomiting and diarrhea, in infants and young children.

Before routine vaccination, the condition sent 410,000 children to a doctor every year, with more than 200,000 needing emergency care and 20 to 60 dying in the United States.

Globally, rotavirus kills 1,600 children under age 5 every day.

Doctors had been desperate for a vaccine to prevent the highly contagious infection. But the first one, sold by Wyeth, was pulled from the market in 1999 after it was linked to a rare, life-threatening type of bowel obstruction known as intussusception.

The new vaccines do not have that problem. A team at the University of Texas Medical Branch in Galveston also found a 94 percent reduction in diarrheal disease after Rotateq was introduced.

Researchers at Children’s Mercy Hospital in Kansas City, Missouri, found only 62 children were admitted for rotavirus infection in 2008, compared with more than 300 a year in previous years, saving about $3 million a year in hospitalization costs.

A team at Quest Diagnostics, a company that tests lab samples, said it found evidence the vaccine lowered rotavirus infections in every state by between 18 and 87 percent.

“These data show a marked reduction in rotavirus disease in the U.S. after licensure of a live, oral rotavirus vaccine, although some states experienced greater declines than others,” they wrote in a summary.

“Evidence of herd immunity was also observed.” Herd immunity means even people who are not vaccinated are less likely to become infected because a disease is circulating less.

Sources: The Times Of India

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