Documents Indicate Glaxo Hid Test Data on Risks of Avandia

The New York Times (7/13, A1, Harris) reported that, according to recently obtain documents, SmithKline Beecham (the precurser to GlaxoSmithKline) spent years attempting to cover up a study that found that Avandia (rosiglitazone) was “riskier to the heart.” In an email message dated March 29, 2001, Dr. Martin I. Freed wrote, “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

The Wall Street Journal (7/13, Mundy) reported that Dr. Rosemary Johann-Liang (a former FDA official) said that there were early reports written by company researchers that noted scientists’ concerns about heart risks of taking Avandia.

Pain Pumps Can Cause Cartilage Damage

Pain Pumps were developed and marketed as a way to speed up recovery following surgery for post-operative pain management.  Recent studies have shown that intra-articular pain pumps can cause catastrophic cartilage damage.

Pain pumps deliver anesthetic directly into a patient’s joint following orthopedic surgery.  Pain management pumps are used to control pain without the side effects of narcotics.  They also control breakthrough pain and result in less recovery time post-surgery.  However, research now indicates that shoulder pain pumps should be avoided following arthroscopic surgery because any benefits are greatly outweighed by the risk of permanent damage.

Pain pumps may also deliver a dangerous side effect:  degeneration of cartilage, a condition known as chondrolysis.  Chondrolysis is irreversible, disabling and painful.  The most common adverse effect from pain pumps is chondrolysis of the joint.

If you or a family member have used a pain pump to regulate pain following shoulder, knee, back, hip or ankle surgery, consult your physician if you experience continued pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; loss of strength in the joint; and decreased range of motion in the shoulder.  If a pain pump has caused you or a family member to develop chondrolysis, be sure to follow through with all medical treatment prescribed by your physician. 

If you have been injured by a pain pump, or have been diagnosed with chondrolysis or postarthroscopic glenohumeral chondrolysis (PAGCL), you may have a claim against the manufacturers of the pain pump.  PAGCL typically manifests itself 3 to 12 months after surgery. 

One of our experienced attorneys would be pleased to assist you in seeking legal remedies.  Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.

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FDA Advisory Panel to Review Data Regarding Safety of Avandia

CNN (7/9, Hellerman) reported that, “A decade after critics first accused the Food and Drug Administration of downplaying side effects from Avandia (rosiglitazone), the agency says it will reveal on Friday the data it is reviewing ahead of an advisory panel meeting about the safety of the popular diabetes drug.” The meeting is scheduled for July 13 and 14, and follows  two new studies suggesting that Avandia may cause serious or even life-threatening heart problems — and a third study that seems to show just the opposite.”

An editorial in the USA Today (7/9) stated, “Since 2005, evidence has mounted that the blockbuster diabetes drug Avandia (rosiglitazone maleate) might increase the risk of cardiovascular complications — including heart attacks, one of the major causes of death among diabetics.”

NY Times Suggests that Patients Seek Avandia Alternatives

The New York Times (7/5) suggested in a recent editorial that the recent controversy over the diabetes drug Avandia (two major studies indicating that Avandia raises the risk of cardiovascular ailments) that patients should ask their doctors about alternative medications.

Healthcare Experts Not Surprised at Avandia Findings

The Los Angeles Times (7/2, Lazarus) reported that, following recent research linking Avandia (rosiglitazone) to increased heart risks, healthcare experts and federal regulators are not surprised.  Sidney Wolfe, director of health research for the advocacy group Public Citizen, stated that a key problem with the FDA’s drug-approval process is that a much greater emphasis is placed on the effectiveness of a medication than on its safety.

Avanda Controvery Exposes FDA’s Murky Drug Approval Guidelines

The Associated Press reports (7/1, Marchione) that the FDA did not have firm rules for deciding when a drug is too risky to stay on the market.  “Each drug has its own complex story,” said Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner. Regarding the debate surrounding the GlaxoSmithKline diabetes pill Avandia (rosiglitazone), Sharfstein indicated that the case will not be decided in reference to Vioxx (rofecoxib) but would stand on its own.  The FDA sought advice from a group of outside scientists (The Institute of Medicine) and scheduled a special meeting in July to hear from experts on its endocrinology and drug safety panels. Sharfstein stated that “the internal staff analyses of risks have not been released yet, and will shed more light on the situation.”