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From 1999 to the 2007 black box warning, Glaxo upgraded Avandia’s label over a dozen times. Despite that fact, Avandia’s sales skyrocketed to an all-time high in 2006. Since most people don’t read disclaimers on labels, Avandia users remained ignorant of its life-threatening side effects. Apparently so did the doctors who prescribed the drug. In the U.S., we are programmed by drug commercials to believe that a number of life-threatening prescription drugs are safe. Further, doctors are held to an almost God-like standard by most patients. So if your omniscient healthcare provider prescribes a drug, it must be good for you, right? As with so many other so-called “safe” prescription drugs, in Avandia’s case, nothing could be further from the truth.

But wait, there is hope! David Blumenthal, a Harvard Medical School professor and Director of Massachusetts General Hospital’s Institute for Health Policy was a huge contributor to the Obama health plan.  Rumor has it that Mr. Blumenthal is now being considered for the top position at the FDA. The Obama administration might just bring the FDA back to relevance.

For more information on Avandia, read the Wall Street Journal article below:
  

Doctors Claim Glaxo Dismissed Worries on Avandia
NOVEMBER 19, 2008
By ALICIA MUNDY
Drug Maker Tried to Make Physician at Maryland Hospital Stop Talking About Concerns; Company Defends Its Effort

HAGERSTOWN, Md. -- Last year, after news broke that the diabetes drug Avandia was linked to a high risk of heart attacks, reports that the drug's maker had tried to stifle safety questions from a prominent Duke University researcher years earlier provoked a furor.

Now it turns out that the Duke researcher wasn't alone in suggesting a tie to heart problems. A doctor from a small Maryland hospital linked Avandia to congestive heart failure in 2000, but the drug's maker, GlaxoSmithKline PLC, rejected her warning and tried to make her stop talking about it with other doctors and hospitals, according to documents and interviews. Glaxo defends its effort, which it says was an attempt to correct "inaccuracies." The head of the doctor's hospital says he ignored Glaxo's overture.

Internist Mary Money of Hagerstown, Md., said in an interview that she first noticed problems with Avandia shortly after it came on the market in the summer of 1999. When she and a colleague began to raise concerns, Dr. Money said, the company dismissed their concerns. The Food and Drug Administration was unresponsive, the doctors say.

The Senate and House in 2007 began looking at whether Glaxo suppressed information and threatened the Duke researcher, charges that Glaxo has denied. Now the Senate probe, led by Chuck Grassley of Iowa, is investigating whether Glaxo's efforts to defend Avandia's safety led to intimidation against other doctors who were suggesting possible links to cardiac dangers. Mr. Grassley, the ranking Republican on the Finance Committee, has demanded documents from Glaxo and is expected to release a detailed report on Avandia soon, according to staffers.

Earlier in 2007, a study in the New England Journal of Medicine reported that Avandia could raise the risk of heart attack by 43%. The FDA called for a black-box warning on the drug's label about the risk of congestive heart failure and heart attack.

Dr. Money talked recently about a patient who came to her in 1999 with congestive heart failure. "That fall, I had a woman patient with massive fluid overload and such shortness of breath that she had to sit up at night," she said.

The patient had begun taking Avandia two weeks earlier, and an echocardiogram showed high pressure in the arteries of the lungs. Dr. Money said she took the patient off the drug, and within a few days the symptoms almost disappeared.

In the next few months, Dr. Money and the head of the hospital's diabetes center, Stephen Lippman, found other patients who had similar symtoms.

Dr. Money alerted SmithKline Beecham, the name of the drug maker before a 2001 merger. The company met with her and Dr. Lippman at Washington County Hospital in Hagerstown in April 2000.

The two doctors presented data on 85 of their patients who had used Avandia, according to documents from the meeting. More than half of the patients had significant edema, or swelling, and about half of that group also had high pulmonary pressure and shortness of breath. Three had been hospitalized for congestive heart failure.

The meeting was a waste of time, Dr. Money said. "They came to tell us how wrong we were, not to listen," she said.

Meanwhile, a company consultant who called into the meeting from the University of Pennsylvania dismissed the Hagerstown doctors' echocardiograms as too poor to show anything useful.

"They suggested we were country bumpkins, and practically said, 'Don't worry your pretty heads. We have smarter people than you looking at this, and there's no problem,'" recalled Dr. Lippman, a physician who also holds a doctorate in molecular biology.

A GlaxoSmithKline spokeswoman, Mary Ann Rhyne, said Dr. Money's theories were "unsubstantiated" and she was misinterpreting journal articles to support her case.

The next month, two SmithKline executives wrote to the hospital's chief of staff, calling on him to stop Dr. Money from talking about her concerns to other hospital doctors.

"[W]e respectfully ask that your hospital not involve itself in the dissemination of information which has not been substantially verified, and that you take immediate steps to stop the dissemination of this unsubstantiated information to your medical staff," said the letter, signed by two SmithKline executives, which was viewed by The Wall Street Journal.

GlaxoSmithKline's Ms. Rhyne said the letter was justified. "When GSK learns about statements by physicians that are inconsistent with the scientific data on its medicines, it has the responsibility to do what it can to correct these inaccuracies," she said.

The hospital's then chief of staff, Salvatore DiMercurio, said he decided to ignore the letter after consulting the hospital's executive committee. "It came down to whom do you trust -- a doctor you know and have worked with, or the people who are threatening you?" Dr. DiMercurio said.

Dr. Money also contacted the FDA, but she received only a form letter in response. The FDA didn't respond to requests for comment.

Drs. Money and Lippman said they found themselves at an impasse after the company and the FDA failed to listen to their concerns. Meanwhile, Dr. Lippman took a job in California.

Dr. Money said she continued to discourage the use of Avandia when speaking to colleagues. But she didn't seek broader attention until last year, when she read about the Duke researcher, John Buse, and Glaxo's reponse when he raised questions about Avandia.

In testimony to the House in 2007, Dr. Buse said he was characterized as a "liar" and threatened with a lawsuit if SmithKline's stock dropped because of his statements about Avandia's possible dangers.

Glaxo upgraded the warnings on Avandia's label more than a dozen times between 1999 and the 2007 black box, the strongest level of warning. One change, in 2001, said the drug could lead to excessive edema, which in turn could lead to congestive heart failure.

The changes got relatively little notice, and Avandia reached peak world-wide sales in 2006 of $2.5 billion.

In May 2007, after the New England Journal of Medicine reported the high risk of heart attack linked to the drug, officials in the FDA's safety division recommended the drug be pulled from the market.

An outside advisory committee disagreed, but sales since then have plunged. In the first three quarters of this year, Avandia sales were $856.7 million, down 45% from a year earlier, according to the company.

The American Diabetes Association and its European counterpart told doctors last month not to use the drug, though it remains on the market.

In addition to the Senate probe over Avandia, GlaxoSmithKline has been under investigation by the Senate over the safety of its antidepressant Paxil. The Justice Department is also investigating the company over marketing issues, the company has said, and a grand jury in Boston has asked witnesses about Paxil's safety, according to the witnesses.

It isn't clear whether Avandia is also part of that investigation. The Justice Department declined to comment.

—-- Louise Radnofsky contributed to this article.

Write to Alicia Mundy at alicia.mundy@wsj.com