Articles Posted in Pharmaceuticals

Reglan is a presciption drug pushed by pharmaceutical companies to patients to treat Gastroesophageal relfux (GER) Gastroesophaegeal reflux disease (GERD). Many studies dating back from the 1970s, have shown that Reglan is ineffective in resolving GER and GERD. A 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that “the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis.” The studies also indicate patients suffer from irreversible side effect if used for longer than a 12 week period called Tardive Dyskinesia. TD is a tragic life-long medical condition that causes involuntary and abnormal body movement.


Please see our Avandia information page to learn about the most up to date news on the harmful diabetes drug. The attorneys and lawyers at the Branch Law Firm can help you take action against the pharmaceutical giant Glaxo Smith Kline, makers of the diabetes drug Avandia; also known as Rosiglitazone

According to Bloomberg News, 94% of researchers who found positive results from using Avandia had financial ties to pharmaceutical companies. Avandia, is a controversial diabetes drug that has been linked to increased sharp increased risk of heart attack and death.

Despite the FDA’s issuance of a formal safety alert concerning the risks associated with Avandia, GlaxoSmithKline continues to market and sell the drug.

The FDA has now also decided to hold public hearings in July to determine whether Avandia should be removed from the market after scores of lawsuits in New Mexico and across the country have been filed based on the increased risk of heart attack resulting from Avandia usage, along with several studies showing a substantial correlation.

While reviewing documents in preparation for the hearing, Mayo Clinic researchers noted that an astounding 45% of the researchers who had weighed in on the Avandia controversy had financial conflicts of interests and about a quarter of those failed to report those conflicts.
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Recent allegations of research collaboration between the FDA’s top drug official – Dr. Janet Woodcock – and a pharmaceutical company underscore the potential for conflicts of interests and the high stakes involved in drug marketing. In fact, over the years the FDA has been involved in many conflicts of interests involving dangerous drugs.

In August, 2009 Amphastar Pharmaceuticals, Inc. filed an ethics complaint against Woodcock alleging that she delayed approval of Amphastar’s application for approval of a generic blood thinner because of her ties to it’s competitor, Momenta Pharmaceuticals, Inc.. Woodstock co-authored medical articles with Momenta while both companies were competing to win FDA approval for their generic blood thinners.

Although ultimately Woodcock was cleared, this episode shows how closely FDA officials may work with those pharmaceutical companies who seek their approval. It is crucial these contacts be disclosed. The drugs that are eventually approved by those officials are the ones that end up in our bodies. Where the motives of officials at the FDA are compromised, it is those individuals who end up taking the potentially dangerous drugs that suffer the consequences.

This is not the first time Woodcock has come under fire. From the late 1990s through the early 2000s several dangerous drugs approved by the CDER on her watch were pulled from the market because they were sickening and killing people. She has also been criticized for her handling of Avandia, a diabetes drug linked to fatal heart attacks and heart failure.
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The U.S. Senate Finance Committee has recently issued a report on Avandia, a controversial drug produced by GlaxoSmithKline (“GSK”) to control diabetes.

According to the report, GSK knew of possible heart attack risks tied to Avandia many years before the information became public.

The report unequivocally states “GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.”

However, according to the report, GSK failed to warn patients and states: “GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”

This latest report reveals in great detail the length that pharmaceutical companies are willing to go to avoid revealing legitimate health risks associated with their drugs. It further exposes the widespread practice of pharmaceutical companies using supposedly “independent” scientific research to bolster their claims, when in actuality the company has sponsored the research.

Adding to the controversy, questions remain why the U.S. FDA continued to allow clinical trials of Avandia even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

In addition to heart attacks, Avandia has been linked to several significant health risks including:

• Congestive heart failure
• Liver damage
• Increased cholesterol levels
• Swelling of arms and legs
• Anemia
• Fluid retention
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In a victory for consumers, last Friday the Fifth Circuit Court of Appeals agreed with the lower court that individuals may sue generic drug makers in state court for the “failure to warn” consumers of of potentially dangerous side effects from taking their drugs. This decision shadows last March’s Supreme Court decision in Wyeth v. Levine, which held that federal law did not pre-empt state law failure to warn claims against pharmaceutical companies.

The U.S. Fifth Circuit of Appeals joins a handful of federal district courts that have extended Wyeth v. Levine to cover generic drugs. However, the issue has divided a “rapidly growing” number of district courts which may increase chances of Supreme Court review.

The Tenth Circuit Court of Appeals has not yet weighed in on whether Wyeth v. Levine extends to generic drug manufacturers.

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