Zyprexa Lawsuit News

A Sea Change For Schizophrenia Treatment?

The biggest ever government study comparing the safety and efficacy of four big-selling schizophrenia treatments is expected in next Thursday's New England Journal of Medicine, industry sources say.

Eli Lilly's (nyse: LLY) Zyprexa is likely to come out ahead in the study, but Pfizer's (nyse: PFE) Geodon could also get a big benefit. And if Lilly does win, some may dismiss its success because of the way the study was designed.

Still, the results are expected to shed light on the sometimes subtle differences in effectiveness and side effects among various treatments for schizophrenia, a disabling mental illness marked by hallucinations, delusions and numbed emotions. Since all these drugs are treatments rather than cures for the illness, most patients need to take them for years, or indeed the rest of their lives.

“The difference between an antipsychotic and a drug administered for an infection is it’s really a drug you want the patient to be on for years,” says Steven Marder, a professor of psychiatry at the University of California, Los Angeles. “Even small differences can affect a patient’s quality of life.”

The outcome of the study could have a substantial impact on the bottom line of Eli Lilly, where it's the company's top drug, as well as Pfizer, Johnson & Johnson (nyse: JNJ) and AstraZeneca (nyse: AZN), which have been battling fiercely in the $14 billion market for antipsychotic drugs.

Some clear answers as to how the drugs differ from each other are expected from the study, called the Trials of Intervention Effectiveness (CATIE) and funded by the National Institute of Mental Health. It will compare four of the top-selling schizophrenia drugs and one older medicine in 1,600 patients who have each been followed for a year-and-a-half.

To examine all the drugs’ safety and efficacy, CATIE’s main goal is to see which drug patients stayed on the longest. The logic is that patients are likely to be switched to a new drug if they have either a bad side effect, such as diabetes or involuntary movements, or a worsening of schizophrenia symptoms.

Already, researchers, have announced, it is clear that none of the drugs truly did that well. Some 75% of patients in all treatment groups had to be switched from one drug to another. The switches were about equally likely to be due to shortfalls of safety or efficacy.

“That’s going to probably be news to some people,” says Daniel Casey, a psychiatrist at Oregon Health & Science University who did not participate in CATIE.

For drug companies, which had little control of the government-run study, the financial stakes are huge. Eli Lilly’s Zyprexa rules the antipsychotic market, but U.S. sales for the year to date have dropped 14% to $2.8 billion because of concerns that it causes more weight gain, diabetes and high cholesterol than its competitors. A CATIE win might stem the bleeding.

But Pfizer’s Geodon is another potential winner. It is the only drug in the study that does not cause weight gain, but is currently used less than Johnson & Johnson’s Risperdal or AstraZeneca’s Seroquel, the other two big name drugs in the study.

One grim possibility for all of the companies is that phenerzine, the cheap generic, will look as good on paper as the newer drugs. The side effects that caused it and other antipsychotics like Haldol to fall out of favor, including serious neurological problems, might take longer than a year and a half to develop.

Most experts predict that Zyprexa will win, however--even naysayers such as Casey who view the drug as their last choice because of its side effects of weight gain and elevated blood sugar. Part of the issue, UCLA’s Marder points out, is that patients might drop out faster because of nerve tremors, but weight gain might be a bigger long-term concern.

But there is another reason Zyprexa has an advantage. When the clinical trial was designed, it was decided that patients in CATIE receiving Zyprexa could receive a dose that is higher than that recommended on the drug’s label. But that is not true for the other medicines. If Zyprexa does come out ahead, competitors will jump all over this fact.

“It could be a subject of criticism,” says Henry Nasrallah, a professor of psychiatry, neurology and neuroscience at the University of Cincinnati Medical Center who was an investigator in CATIE. However, he said, it’s worth waiting for the data before making any judgments.

Another clue to the outcome of the study could come from another study, called CAFÉ, that was funded by AstraZeneca and whose results were unveiled in June. The study was run by the same researcher who headed up CATIE: Jeffrey Lieberman, chairman of psychiatry at Columbia University's College of Physicians and Surgeons. It had a similar design, comparing Zyprexa, Risperdal and Seroquel in newly diagnosed patients, but didn’t show any difference in how long patients stayed on a given drug.

If that happens again, doctors and drug firms will have to drill down into the data to find other differences--such as whether the drugs cause weight gain or other side effects that might become a problem over the long haul. The big question--once the data is out--will be whether those differences really matter.

“The size of the trial is very large,” says Marder, “but one should look at whether the differences are substantial enough that they would affect clinical practice.” And hence the drug companies' bottom lines.

Zyprexa Lawyers

If you believe that you or a loved one has suffered an injury or death as a result of Zyprexa call the Zyprexa lawyers of VanDerGinst Law. P.C. at (877) 786-1LAW (877-786-1529) or submit the free online case evaluation. The initial consultation is free of charge. If we agree to handle your Zyprexa case, we will work on a contingency fee basis, which means we get paid for our services only if, and when, there is a money recovery for you. In many cases a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. So please contact our Zyprexa lawyers right away to ensure that you do not waive your right to possible compensation. We can tell you if you have a case for a potential Zyprexa lawsuit.