I was broad-sided: Rolling meta-analyses to detect drug side effects

Anthony De Carlo's story:
In an auto accident on 6/15/01 in New Jersey, I was broadsided by a woman on a phone running a red light. I was in the hospital three days, banged up. I hurt my knee and back when I was hit.

I took Bextra for two years, 
and Celebrex. I have had one heart attack and two smaller heart attacks. An EKG revealed I have had three silent strokes, one in 2003 while I was taking Bextra and also Celebrex. I later had the EKG confirmed at a teaching hospital in New York City. I was also diagnosed with a deteriorating heart valve, which will probably require surgery.

Due to complications, I am disabled and can't work.


Though studies had been performed about the side effects of Bextra, the results had not been put together. If they had been, the dangers of Bextra would have been known years sooner. Instead, many people like Anthony suffered from major side effects. Eventually, Pfizer took Bextra off the market in 2005, acknowledging its dangerous increase in heart attacks and strokes.

Drug makers have removed several other drugs from the market after learning of their health problems. In the most recent issue of the Archives of Internal Medicine, Dr. Joseph Ross and his colleagues describe a method of statistically pooling data on drug effects in a rolling meta-analysis that could have informed Merck of the cardiovascular effects of Vioxx years before it withdrew the highly profitable drug from the market. Dr. Michael Steinman mentioned Bextra as a case in point, and added several other examples: Bayer removed the cholesterol-lowering drug Baycol from the market in 2001 after reports of serious muscle problems. Novartis withdrew Zelnorm, a drug for irritable bowel syndrome, from the market after learning of its increased risk of heart problems.

Advice: Read the story of a whistleblower on the BBC website.

Read another story about Vioxx. Thanks to Natasha Singer for the source story in today’s New York Times.

Each widow will get $72,000: Merck's settlement for Vioxx adverse drug reactions

Merck will pay almost $5 billion in a settlement with the 27,000 plaintiffs. Each plaintiff who took Vioxx for a month or more, and had a heart attack or stroke within two weeks of taking Vioxx, will get an average of $120,000. When attorney's fees are subtracted, each plaintiff will wind up with an average of only $72,000.

Yale Law School Professor Peter Shuck says Merck "played hardball, and the settlement reflects that. The predicted liabilities for them were much, much higher."

Dr. Eric Topol agrees: "They've gotten off quite easily for the problems they've engendered," said the co-author of an important medical journal article warning of the risks of Vioxx.

Advice for users of Vioxx: Ask a lawyer for advice. You don’t necessarily need to accept the settlement, but note that most people who sued Merck individually have lost.

Read the story of a successful Vioxx plaintiff, or read more from the source article by Alex Berenson in today’s New York Times.

He lost the first battle but he’s winning the war: An adverse drug reaction lawsuit

Earlier I reported on Frederick Humeston’s lawsuit against Merck over Vioxx. After losing the first lawsuit, new evidence emerged, and the ex-Marine won the first phase of his three-phase lawsuit. Yesterday a jury awarded him and his wife $20 million in damages, in part two.

Advice for victims: If other approaches don’t get you justice, find a good advocate, maybe a lawyer.

Read another lawsuit story.

27,000 lawsuits - Ambushed by Merck: An adverse drug reaction

Frederick (“Mike”) Humeston is a tough guy, an ex-Marine who won two Purple Heart medals in Vietnam. By 2001, at age 61, he had gained some weight, and had high blood pressure. He testified that he was a healthy outdoorsman before the heart attack. But since then, he no longer can hike and lead canoe trips as a wilderness guide. He took Vioxx to dull the pain in his left knee, which was damaged by shrapnel in Vietnam. He took 54 Vioxx pills in the two months before his heart attack and two pills within hours of the incident.

He lost his first lawsuit. Then he was granted a second trial because of new evidence that even short-term Vioxx use could increase cardiac risks. Merck had repeatedly insisted that Vioxx didn't increase cardiac risks until after 18 months of use. On Friday, a jury unanimously ruled that Merck had committed consumer fraud by misleading doctors and patients and by intentionally suppressing, concealing or omitting information about the risks of Vioxx, which was withdrawn from the market in September 2004.

Advice to victims: Sometimes you need to get a good lawyer. And take the least medicine you need.

Advice for the NY Times headlines writer: “Mixed Verdicts for Merck [one win, one loss]” is like saying, “Half of the Bridal Couple Shows Up for Wedding.” The newsworthy event is the guilty verdict, especially when 27,000 lawsuits have been filed against Merck over Vioxx. We expect big pharma companies will be found innocent of fraud. Or do we?

Read another lawsuit story. Or read the sources: Andrew Pollack’s NY Times story,or Linda Johnson's account, or Marc Kaufman’s Washington Post article in Nov. 2005.