A new study has shed light on why Merck & Co.’s a once-promising HIV vaccine actually made people in a clinical trial more likely to become infected.  A phase II clinical trial for the HIV vaccine, known as STEP, was halted in September 2007 after researchers realized it put participants at a higher risk of contracting HIV.

The Merck vaccine was the first of a new class of HIV vaccines to get to an advanced stage in human testing.  It consisted of a  modified form of a common cold virus — Adenovirus 5.   Vaccine developers believed Adenovirus 5 would carry elements of HIV into the body, which would then trigger the immune system to start fighting a subsequent HIV infection.   (more…)

The dangerous diet drug fenfluramine, an ingredient in Fen-Phen, may continue to damage the heart years after a patient stops taking it, according to a study published online today in BMC Medicine.  The study has shown  that people who stopped using Fen-Phen eleven years ago had damaged heart valves up to seven years later.

The study, conducted by researchers at the Central Utah Clinic, involved both fenfluramine and dexfenfluramine, another diet drug that is closely related to fenfluramine.  The Food & Drug Administration (FDA)  ordered fenfluramine and dexfenfluramine off the market in September 1997 after those drugs were linked to heart valve problems. Since its withdrawal, tens of thousands of lawsuits have been filed against the maker of fenfluramine by people injured by the drug. (more…)

Federal regulators have seized contaminated heparin from  Celsus Laboratories Inc. in Cincinnati, Ohio.  According to the Food & Drug Administration (FDA), the heparin was tainted with over-sulfated chondroitin sulfate, a counterfeit ingredient that mimics heparin’s blood thinning properties.

Heparin was the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths. (more…)

With a Barack Obama presidency just months away, both industry representatives and consumer groups are lobbying for strong new leadership at the Food & Drug Administration  (FDA).  Both groups believe that such leadership could restore confidence in the much-maligned agency, which has been seen as weak,  incompetent and too-political during the last eight years.

That the FDA was neglected during the Bush Administration is an understatement.  For more than half of the last 8 years, the agency lacked a permanent commissioner.  Critics of current Commissioner Andrew von Eschenbach complain that he has maintained a largely hands-off policy. Meanwhile, scandals involving drugs like Vioxx and heparin, dangerous side effects from other medicines, plus recalls of peanut butter, spinach and other foods, hurt the FDA’s reputation. (more…)

A new study that confirms the heart risks associated with a class of drugs called NSAIDs has found that the increased risk correlates to the specific pain-causing molecule they act against.   According to the study, NSAIDS that are cox-2 inhibitors are more likely to increase the risks of heart attacks and strokes.

NSAIDs  are the most prescribed medications for treating conditions such as arthritis. Most people are familiar with over-the-counter, nonprescription NSAIDs, such as aspirin and ibuprofen. NSAIDs also include prescription drugs like Celebrex, as well as the now-banned Vioxx. (more…)

A new version of Byetta, a diabetes drug made by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., isn’t going to be approved by the Food & Drug Administration (FDA) anytime soon.  Amylin said yesterday in a regulatory filing that data for the new Byetta didn’t satisfy the FDA’s  standards.

The original Byetta was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.  The new version of Byetta would be taken once-weekly. (more…)

Earlier last month we reported that Eli Lilly & Company, in its ongoing Zyprexa  scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  Late last month we reported that Lilly posted a third-quarter net loss of $465.6 million—43 cents a share—amid charges related to the government investigations into its marketing of antipsychotic drug Zyprexa.  Now, the Associated Press (AP) is reporting that Minnesota has joined the many states looking for compensation from Lilly over its popular anti-psychotic drug, Zyprexa.

In addition to states, insurers, pension funds and unions have been among those groups legally seeking compensation from Lilly and accusing it of concealing Zyprexa’s tendency to cause weight gain and diabetes and of marketing the drug for off-label uses.  Now, the Minnesota’s state attorney general’s office has filed a complaint in federal court, reports the AP. (more…)

Vytorin, Merck and Schering-Plough’s controversial cholesterol medication, is the subject of two more state and federal investigations.  In a regulatory filing, Merck revealed that the U.S. Justice Department and 35 state attorneys general have opened separate probes into the marketing of Vytorin.

Vytorin has been under the microscope since the ENHANCE study was released in January.   That study showed that Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users. When ENHANCE was vetted during the annual meeting of the American College of Cardiology in March, doctors there recommended that it be used only as a last resort. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz. (more…)

Caraco Pharmaceuticals has received a Food & Drug Administration (FDA) warning letter because of conditions at its Detroit, Michigan plant.  The FDA is  withholding all future marketing approvals for medicines manufactured at the plant until the problems cited in the letter are corrected.

The letter, dated October 31, followed an  inspection held at the company’s manufacturing facility in Detroit, Michigan which was initiated in May 2008.   The problems cited in the warning letter included the inadequate and untimely investigation of certain incidents by the quality control unit at the facility contrary to the company’s standard operating procedures. The FDA considered some of the observations to be repeat observations. (more…)

The pharmaceutical manufacturing market is clearly being taken over by low-cost Chinese producers.  For instance, China today produces about two-thirds of all aspirin and is preparing to become the world’s only global aspirin supplier.

If not for the low prices from foreign producers such as China and India, millions worldwide would likely go untreated.  In the U.S., purchasing foreign generics is a way for individuals and companies to save on ever-increasing health care costs.  But in the absence of proper regulation, some drugs have turned out to be ineffective or dangerous.  For instance, a 2006 study revealed over half of all anti-malarial drugs sold in Southeast Asia contained no active ingredients and the World Health Organization (WHO) estimates that as many as 10 percent of pharmaceuticals sold worldwide are counterfeit or contaminated.  In some poor countries, the figure is over 30 percent. (more…)