Monthly Archives: December 2007

Former Baseball Star Jim Leyritz Charged with DUI Manslaughter

Former baseball star and World Series hero Jim Leyritz has been charged with DUI manslaughter after he killed another driver in an auto crash in Ft. Lauderdale. Leyritz refused a blood test but because of the crash fatality he was forced to submit to one anyway. According to eyewitnesses, Leyritz ran a red light and crashed into the other driver’s car causing the auto crash fatality.

Eli Lilly’s Claims Regarding Anti-Depressant Drug Cymbalta are Overstated

A new anlaysis of data claiming that Cymbalta relieves physical pain as well as the symptoms of depression, are overstated, according to Glen Spielmans, an assistant professor of psychology at Metropolitan State University in Minnesota. Professor Spielmans claims that Eli Lilly’s “Depression Hurts” campaign is a marketing effort that doesn’t live up to its own hype. Spielmans performed a meta-analysis of five published studies and found that Cymbalta has a minimal effect on physical or emotional pain. This is important since Spielmans does not receive drug industry funding and is arguably more objective in drawing conclusions. Once again, pharmaceutical companies can afford to spend lots of money on slick marketing campaigns that often have a tenuous relationship to the truth or scientific data.

Medtronic Settles Defibrillator Lawsuits

Medtronic has agreed to settle 2,682 lawsuits fro $114 million. The settlement agreement concerns Medtronic’s Marquis line of defibrillators. Medtronic was sued because of problems with the batteries in the Marquis defibrillators. The batteries had shorts that could cause faulty elecrical signals designed to keep the heart in a normal rhythm. This settlement has nothing to do with Medtronic’s Sprint Fidelis leads which can fracture causing electrical impulse malfunctions. The Sprint Fidelis leads were recalled in October 2007. They include model numbers 6930, 6931, 6948, and 6949. Leads comprise cardiac electrodes (thin wires) that connect heart devices directly to the heart. Sprint Fidelis leads were used in conjunction with ICDs and CRT-Ds – not pacemakers.
Defibrillator Information

Zetia Liver Injury Studies Kept Secret

Merck and Schering-Plough Pharmaceutical companies have not disclosed long term medical studies concerning the risk of liver injury from the cholesteral drug Zetia according to a New York Times article published yesterday. Could this be yet another incidence of a drug company concealing information about the danger of a drug to increase sales? We may not know until March 2008 when these studies will be released.
Zetia is used with statin drugs such as Zocor and Lipitor. It is also included in Vytorin in the same pill with Zocor. Zetia is often used along with statin drugs because it is promoted to reduce cholesteral in a different way than statins. There is no medical study that establishes that Zetia actually results in lower heart attack or stroke rates than use of statins alone.
Most of the studies on Zetia that have been published are only 12 weeks long. There apparently are 5 long term studies that were not published. The Zetia label in the U.S. contains only minimal warnings about the drug’s risk of liver damage. The warnings on the product required in Australia and Canada cautions about risks of hepatitis, pancreatitis, and depression.
In the clinical studies submitted to the FDA for the 2002 approval of the drug 11 times as many people who took Zetia along with a statin had serious health problems, mostly liver related, than those that took a statin alone.
I hope this is not another example of the marketing of a pharmaceutical product where company profit is given a priority over public safety.

Former Pfizer Official Sues Company for Marketing Practices

A former Pfizer employee has sued the company over its marketing of Lipitor. The suit claims that Pfizer mislead doctors in its educational programs. According to the suit, the drug was prescribed unnecessarily and could have proved harmful to those patients who didn’t need the drug. The suit was sealed in order for the government to intervene. However, it has chosen not to take action which may mean the government thinks the case has no merit. However, the government has intervened in situations where pharmaceutical companies have marketed their products for off label use or advertised their drugs for uses which were not approved by the FDA. This is a case worth watching. We’ll wait and see what happens.
Drug Class Action Lawsuit And Recall Information

Feds Probe Medtronic’s Sprint Fidelis

At least three federal agencies are asking for information from Sprint Fidelis’ manufacturer, Medtronic, including information about possible illegal payments to foreign doctors. The probes come at a time when Medtronic had to inform doctors about potential lead fractures in the Sprint Fidelis causing irregular electrical impulses to the heart.
The Securities and Exchange Commission is looking into the payments to doctors and the Justice Department wants to be copied on any material given to the SEC. The US Attorney’s Office for the Eastern District of Pennsylvania is inquiring about gifts or payments to doctors relating to Medtronic’s stents.
My Defibrillator Leads Recall Lawyer Website

Eli Lilly Wants to Expose Children to Zyprexa

In a St. Pete Times article in which I’m quoted extensively, Eli Lilly is on the verge of receiving FDA approval for Zyprexa with children. The drug is marketed to treat adults with schizophrenia and bipolar disorder but carries with it the dangerous side effect of diabetes. The risk of diabetes is even greater in children. Yet the underfunded FDA is about to approve its use in children. As I stated in the St. Pete Times article, “Why did it take 10 years to warn people about something they knew from their clinical trials? The reason is clear: They were making billions and billions of dollars selling it.”
Zyprexa Recall Lawyer Main Page

Sprint Fidelis Defibrillator Leads Patients Caught in the Cross Hairs

With the recent spate of bad news about Sprint Fidelis defibrillator leads, patients who’ve had the pacemaker inserted in their chests are now left wondering what to do about their fragile lead wires. There’s definate evidence that the Sprint Fidelis lead wires are prone to fracture but is that evidence enough to have the leads removed and risk the chance of another surgical procedure? That’s the quandary patients find themselves regarding the Sprint Fidelis lead defribrillator wire.

Merck Recalls Pediatric Vaccine

Merck has recalled a widely used childhood vaccine because it was contaminated with bacteria. The vaccine had been used to ward off meningitis, pneumonia, and other childhood illnesses. The director for the Centers for Disease Control and Prevention noted that there was no immediate threat to children regarding the vaccine known as Hib. The recall involved those vaccines shipped since April 2007.