A sharply worded editorial in the Oct. 25 issue of The Lancet accused AstraZeneca of an "unprincipled campaign" to market its antihyperlipidemia drug rosuvastatin (Crestor) and urges clinicians to "tell their patients the truth about rosuvastatin - that, compared with its competitors, rosuvastatin has an inferior evidence base supporting its safe use." AstraZeneca U.K. immediately issued a response in the form of a letter to the editor, which it circulated to the media. The letter, under McKillop's (CEO) signature, defended rosuvastatin's efficacy and safety data, claiming that the drug is "an extensively studied and well-tolerated drug with a safety profile comparable to other marketed statins combined with a greater ability to get patients to their cholesterol goals than any other single product." Dr Horton, the Editor of Lancet stated that there is no evidence to support prescribing rosuvastatin over "simvastatin or atorvastatin, both of which have hard end points to support their use."
US FDA chief says fewer new product applications being made
The top U.S. drug regulator said that fewer new product applications are being made now than at any time in more than a decade and said that he does not see that situation changing in the foreseeable future. "While FDA has met or exceeded all of our review goals we've committed ourselves to achieve in order to reduce the time it takes for us to approve a new treatment, that's not enough to change the picture of a decline in R&D productivity," the commissioner McClellan said. The FDA is working closely with the National Institutes of Health to help improve the overall development of drugs by improving clinical trial design and setting electronic standards for monitoring patients in clinical trials, he said. McClellan added that fundamental scientific improvements need to be made as well. "We're still using the same methods for testing and refining and manufacturing drugs similar to those used decades ago even though the science for discovering those drugs has undergone monumental change," he said.
New estrogen therapy (topical form) for treatment of menopausal hot flashes
US FDA approved Estrasorb (estradiol emulsion), an estrogen therapy product in a topical form. Current estrogen products available for treatment include oral pills, transdermal patches, and a vaginal ring. Estrasorb has been proven effective for treating moderate to severe symptoms of hot flashes and night sweats associated with menopause. . The product is absorbed through the skin into the blood stream to achieve its Based on the latest evidence, FDA believes that estrogens and estrogen with progestin products, such as this new product, provide valuable therapy for many postmenopausal women, particularly those with "hot flashes." FDA reminds women that these treatments also have important risks, and should be used in the lowest dose and for the least duration required to provide relief.
Vardenafil may work for sildenafil nonresponders
Nearly half of men who did not respond to sildenafil (Viagra) achieved successful sexual intercourse when given Bayer AG and GlaxoSmithKline's rival drug vardenafil (Levitra), said researchers. The study showed that 46.1 per cent of men who had failed at least four of the last six attempts at successful intercourse while on Viagra were successful when given Levitra. That success rate was three times greater than the 16.1 per cent seen among men taking placebo. Levitra was launched in the United States in September, ahead of another challenger to Viagra, called Cialis, from Lilly-Icos. All three drugs are already competing in Europe, where Cialis was launched ahead of Levitra earlier this year.
US FDA eyes faster generic approvals against big drugmakers' wishes
The US Food and Drug Administration (FDA) is likely to signal that it will allow some generic drug makers to use a faster approval process, disappointing large drug companies that have protested the alternative route. The alternative method of drug approval, called 505(b)(2), could cut years off some generic drugs' entrance to the market and could be used to approve the first generic biotechnology drugs, the Wall Street Journal reported. Three opponents to the drug approval process have filed petitions with the FDA to limit the back-door process, but the agency will find it difficult to rescind the system that is used for other kinds of pharmaceutical products, the Journal reported. The 505(b)(2) process for generic drugs does not require the original proof of safety and effectiveness mandatory for approving new brand-name drugs, nor does it require the same reams of data needed for approving of non-branded generics, the Journal reported.
Bone loss from rosiglitazone, the oral diabetes drug
The researchers at the University of Arkansas for Medical Sciences report that in a laboratory study the anti-diabetic compound rosiglitazone, caused a significant decrease in total body bone mineral density, suggesting that the drug therapy may pose a significant risk of adverse skeletal effects in humans.
"Avandia (rosiglitazone) is an US FDA-approved and clinically successful treatment for type 2 diabetes. The findings suggest that doctors should watch the skeletons of patients who use this drug, especially older patients, because their patients may be at increased risk of bone loss over time," said lead researcher Beata Lecka-Czernik, Ph.D., a molecular and cell biologist. Rosiglitazone, a very effective anti- diabetic agent that reduces insulin resistance, has had federal approval since 1999. The researchers next plan to test the effects of the drug on mice and rats with diabetes.
Potential blockbuster drugs
With at least half of the top-selling drugs currently on the market slated to lose patent protection by 2008, drugmakers will need to prepare new products to take their places. Pfizer is one of many companies readying prospective blockbusters in its pipeline. Inspra, Caduet and pregabalin are three drug products that could rake in over $4 billion combined by 2008. . Inspra has already garnered FDA approval for the treatment of hypertension and was just approved for the treatment of congestive heart failure. Pfizer is also developing two more drugs with potential sales of $600 million by 2008.
Experimental drug for AIDS resistant therapies gets fast track status by US FDA
The US company, Tanox said that the U.S. Food and Drug Administration (FDA) will review its experimental HIV drug on an accelerated basis. Tanox, based in Houston, said in giving the drug "fast track" status, the agency will review data from the company's clinical trials as it becomes available. Typically, the FDA only accepts data once trials have been completed. Fast track status is given to promising drugs that are designed to treat unmet medical needs. The drug, known as TNX-355, is one of a new class of drugs called viral entry inhibitors. The company hopes the drug will treat HIV that has become resistant to standard antiretroviral therapies.
New York stipulates compulsory counsellig to patients by pharmacists
New York State has long required pharmacists to offer customers a chance to get answers to their questions about prescription medications. As of July 10, that discussion has moved from voluntary to mandatory. Under new regulations first proposed by the Pharmacists Society of the State of New York, pharmacists must engage customers picking up new or changed prescriptions in a discussion about what condition the drug is for, how it is to be taken, possible adverse effects, and dangerous interactions with other drugs. The goal: reducing the incidence of medication errors.
Test helps predict heart disease risk
A blood test that physicians can use to identify patients facing higher risk of coronary heart disease even when cholesterol levels are within the normal range was approved by the US FDA. The PLAC test measures the enzyme lipoprotein-associated phospholipase A2. In a study of more than 1300 persons, those who had low-density lipoprotein (LDL) cholesterol levels below 130 mg/dL were at higher risk for coronary heart disease if they had high scores on the PLAC test. LDL cholesterol levels below 130 mg/dL are viewed as normal. An elevated PLAC test result with an LDL cholesterol level below 130 mg/ "gives physicians increased confidence that patients have 2 to 3 times the risk of having coronary heart disease when compared with patients who have lower PLAC test results," said the FDA.
US FDA launches initiative to fight counterfeit drugs
The US FDA is creating an internal task force as part of a new initiative to make it more difficult to produce counterfeit drugs and introduce them into the health care system. Although drug counterfeiting is rare in the United States, the FDA has recently seen an increase in counterfeiting activities as well as a more sophisticated ability to introduce finished dosage counterfeits into legitimate drug distribution channels. FDA investigations into such activities have totaled more than 20 per year since 2000 after averaging only about 5 per year during the late 1990s.
"The sole purpose of this initiative is to develop new and innovative ways to make sure that Americans can continue to have confidence that the drugs they buy are, in fact, the real deal," said Mark B. McClellan, MD, PhD, FDA commissioner.
One factor that the FDA said has contributed to the increase in counterfeiting activity is "online sale of prescription drugs by unlicensed pharmacies and/or foreign Web sites." Other factors are better counterfeiting technology, counterfeiting activity by organized groups attracted by financial opportunities, and weak spots in the domestic wholesale drug distribution chain.
The FDA's Office of Criminal Investigations has recently launched a major counterfeit investigation relating to Lipitor. Another investigation related to counterfeit versions of Procrit led to 3 convictions. Shortly after the discovery of counterfeit Procrit, Ortho Biotech, the drug's manufacturer, announced changes to it's packaging to inhibit counterfeiting, including seals that leave a striped pattern when removed from the carton.
Japan drug makers take drug development abroad
Faced with high costs at home, Japan's drug makers are increasingly taking their new drug development overseas where clinical trials are cheaper and regulatory approval comes more quickly. Leading pharmaceuticals such as No.1 Takeda Chemical Industries Ltd and Yamanouchi Pharmaceutical Co have been conducting overseas development for their key new drugs ahead of that in Japan where the costs for late-stage clinical trials are two to four times higher than those abroad Yamanouchi, Japan's No.3 drug maker, has said it will keep its priority on over overseas clinical trials to shorten drug development time to five to six years from eight to 10 years. Sankyo, Japan's second-largest drug maker whose flagship cholesterol treatment Mevalotin faces stiff competition from generic drugs, aims to halve drug development time from the 12 years it now takes.
Supersized cholesterol carriers key to long life?
Researchers say genetic variation necessary for longevity. One reason some people live into their 90s and beyond may be a genetic variation that makes the cholesterol particles in their blood really big. 'Supersize it' is not usually associated with good health, but evidence increasingly is showing that bigger is indeed better when it comes to the lipoprotein particles that carry cholesterol through the bloodstream. Smaller particles, it is believed, can more easily embed themselves in the blood vessel walls, contributing to the fatty buildups that lead to heart attacks and strokes. A study in Journal of the American Medical Association suggests that the tendency to have large cholesterol particles can be inborn. The study, led by Dr. Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine, found that people in their late 90s and beyond are more likely to have a gene variation that causes large particles of both HDL cholesterol -- the good variety -- and LDL cholesterol, the bad kind. 'We basically think the size is necessary for longevity,' Barzilai said. Nevertheless, while genes probably determine particle size, recent research has suggested that exercise can enlarge the particles.
Compiled from WWW
By Dr. VenkatAppaji Padmanabhuni
E mail: appajipv@hotmail.com