Drug Injury Attorney Blog

As a dangerous prescription drug attorney,I have paid close attention to the diabetes drug Avandia (rosiglitazone) ever since a 2007 study showed it increased risk of heart attacks substantially. That study, authored by Dr. Steven Nissen of the Cleveland Clinic and published in the New England Journal of Medicine, found that taking Avandia increased the risk of cardiac death by 64%. The study was particularly alarming because Avandia is taken by Type II diabetics, whose disease already puts them at high risk for heart problems. Among other things, this spurred a black box warning about heart failure and a Congressional investigation into allegations of unethical behavior by manufacturer GlaxoSmithKline. On Feb. 20, the Senate Finance Committee released the results of its investigation, and according to a Feb. 22 article from USA Today, the results are damning.

Most importantly, the Finance Committee found that GSK knew Avandia carried heart risks for several years before Nissen’s study. It accused GSK of trying to intimidate doctors who came to negative conclusions about the drug and minimizing or misrepresenting scientific evidence. It also said from U.S. Food and Drug Administration employees want the drug taken off the market. The FDA released a statement Monday telling patients not to quit taking Avandia without talking to their doctors, and announcing a panel meeting in July to discuss the results of a long-term, GSK-funded study of the cardiovascular risks of Avandia in Type II diabetics. The results are already in, but the agency said it needed more time to analyze them. An earlier panel voted 20-3 that Avandia does raise risk of heart attacks, but voted 22-1 to recommend keeping it on the market. It currently has sales of $1.19 billion in the United States.

Also on Feb. 22, the New York Times ran a related piece about a meeting between Nissen and GSK, just 11 days before Nissen’s study was published. Nissen legally audiotaped the meeting, concerned about intimidation by the company. He said executives made several false claims, including suggesting they had contradictory information that they could publish jointly with his study. According to the Congressional report, GSK already had the results of Nissen’s study, thanks to a journal reviewer who was also a consultant to the company. But it pretended it did not at the meeting. And even though GSK publicly criticized Nissen’s evidence and methodology, Congress found that GSK’s own scientists said Nissen’s work was sound.

We still don’t have the final results of the RECORD study, and the Times said its interim results were not conclusive. But as a pharmaceutical liability attorney, I don’t believe the public can trust a study funded by GSK. If the claims made by Congress and Nissen are true, GSK has repeatedly attempted to cover up, misrepresent or downplay scientific evidence that Avandia is dangerous, sometimes through intimidation. That behavior casts doubt on any conclusions reached by scientists on GSK’s payroll. Given that patients may risk death or lifelong heart problems from taking Avandia, the risk is just too great. If the existing evidence is not great enough to justify pulling Avandia from the market, as some regulators and safety groups want, the FDA should severely limit its use while it conducts a rigorous independent study.

Continue reading " Senate Investigation of Avandia Shows Manufacturer Knew About Risks Years Ago " »

I wrote here last week about a heightened risk of death in cancer patients taking the antidepressant Paxil. This week, the FDA announced more bad news for cancer patients taking another commonly prescribed class of drugs. The agency announced Feb. 16 that it will require drug manufacturers to strictly control how three anti-anemia drugs -- Procrit, Epogen and Aranesp -- are prescribed and used among cancer patients. The move came after the agency spent about two years reviewing studies showing that this class of drugs, called erythropoiesis-stimulating agents (ESAs), can actually increase the risk of tumor growth and death in cancer patients. Studies have also shown that ESAs increase the risk of heart attacks, heart failure, stroke and blood clots in patients taking the drugs for other conditions.

This announcement is important for cancer patients, because ESAs are frequently prescribed to them. Cancer itself can cause anemia in some patients, and chemotherapy causes it in many others. Prior to the invention of ESAs, the Associated Press reported Feb. 16, the only treatment available was blood transfusion. Not all ESAs are approved for use in cancer patients in the United States, but they are prescribed with the goal of improving patients’ energy levels and quality of life. As a dangerous prescription drug attorney, however, I have been following this issue since 2007, when evidence emerged that ESAs may increase risks for cancer patients without increasing quality of life. That year, the FDA ordered “black box” warnings on this class of drugs, and Congress launched an investigation into off-label use and allegedly false quality-of-life claims.

This new order strengthens patient protections considerably. Doctors treating cancer of the lungs, head, neck, cervix and breasts will not only have to talk to patients about the risks, but document those talks. Every doctor who prescribes the drugs will have to join a safety register and complete education offered by drug makers Amgen and Johnson & Johnson. The manufacturers will also distribute a pamphlet on the risks.

As a defective medication lawyer, I am surprised only that this announcement took so long. Drug industry watchers have expected it since 2008. While I am pleased that the FDA’s action will do more to increase public awareness of the risks, I am concerned that it fails to address problems on several other fronts. This action affects only the risks suffered by cancer patients; patients taking ESAs for other problems must wait for an FDA ruling. But perhaps more importantly, the FDA’s action ignores clinical trials showing weak, if any, evidence that ESAs improve patients’ quality of life. If there is no benefit, why should patients assume the well-documented risks of taking ESAs? This is especially important considering their expense and the allegations of kickbacks raised in a 15-state lawsuit against manufacturers.

Continue reading " FDA Puts Severe Restrictions on Use of Anemia Drugs in Cancer Patients " »

As a dangerous drug attorney, I was interested to see a recent study adding information to the debate about antidepressants and breast cancer. A Feb. 9 article from HealthDay reports that researchers have found an increased risk of dying for breast cancer patients taking both the cancer drug tamoxifen and the antidepressant Paxil (paroxetine). The study is important because antidepressants are frequently prescribed to tamoxifen-taking patients to help reduce the menopause-like hot flashes that are a side effect of the drug. It also helps to clarify previous studies that have found mixed and uncertain results when examining the relationship between tamoxifen and antidepressants.

The study, conducted at Sunnybrook Health Sciences Center in Toronto and published in the Feb. 8 issue of the British Medical Journal, looked at the medical records of 2,430 women taking tamoxifen for breast cancer between 1993 and 2005. About thirty percent of the patients were also taking an antidepressant, with Paxil the most common antidepressant. The risk of dying from breast cancer went up significantly for the patients taking Paxil, the study found, and the risk was greater the longer patients took both drugs. Paxil, a selective serotonin reuptake inhibitor, inhibits a bodily enzyme needed to process tamoxifen, the researchers said. This was not seen with other SSRIs, like Effexor or Celexa. Lead researcher Dr. David Juurlink suggested that patients and doctors discuss transitioning to an antidepressant other than Paxil, but warned that quitting the SSRI cold turkey can cause withdrawal.

This study interests me as a defective prescription drug lawyer because it may help settle a debate in the medical community. Scientists already knew that SSRIs can interfere with the enzyme described above, but two 2009 studies conflicted about whether this lead to an increased risk of death. This study provides strong evidence that Paxil, at least, may interfere with the effectiveness of the breast cancer drug. And that means that thousands of patients may have been put at an unnecessary risk of dying. It also means that breast cancer patients may have been unnecessarily exposed to the numerous serious side effects of Paxil. Paxil already carries a warning about increased risk of suicidal thoughts and can cause reproductive and sexual problems in both men and women. As the article mentioned, it can also cause severe withdrawal symptoms.

Continue reading " Study Shows Common Antidepressant Lowers Effectiveness of Breast Cancer Drug " »

The psychiatric drug Zyprexa (olanzapine) has been at the center of several controversies interesting to defective drug attorneys like me, due to its illegal off-label marketing and its connection with major metabolic disorders like diabetes. On Jan. 29, the U.S. Food and Drug Administration struck another blow against the drug when it announced it will require more stringent warnings on the label about the risk of weight gain in teenagers. The FDA’s announcement said doctors should carefully consider the increased potential for weight gain and hyperlipidemia among teenagers, as opposed to adults, taking Zyprexa. It said this should lead doctors to consider prescribing other drugs, and reminded them that the drug should be part of a comprehensive treatment plan.

Zyprexa is an atypical antipsychotic approved for use in patients with bipolar disorder or schizophrenia. Research has connected its long-term use among adults to weight gain, high blood sugar, diabetes and pancreatitis. According to a Jan. 29 article on the Los Angeles Times blog Booster Shots, a study published in October showed an even more dramatic weight gain in teenagers taking Zyprexa -- an average of 17 pounds over 12 weeks. The teenaged participants also had more dramatic increases in triglycerides (fats in the blood) and cholesterol levels than adult patients. The FDA cited that study in its letter informing drug maker Eli Lilly about the label order. A year ago, Lilly settled a federal lawsuit claiming it put adults at unnecessary risk of these injuries by illegally marketing Zyprexa for off-label uses like dementia and anxiety. The new FDA letter also mentions Zyprexa’s greater potential for liver damage and sedation in teenagers.

I am pleased that the FDA is taking the risk of metabolic problems from Zyprexa seriously. But as a dangerous prescription medication lawyer, I’m disappointed that the label wasn’t stronger. For one thing, seventeen pounds in 12 weeks is a very dramatic weight gain -- 1.4 pounds a week. By contrast, scientists believe the average, non-dieting American adult gains half a pound to two pounds a year. With Zyprexa use, that weight gain is associated with life-altering or even life-threatening disorders like pancreatitis and diabetes. For another, the FDA’s warning entirely omitted mention of the results showing higher risks of sedation and liver damage in teenagers. Liver damage can cause permanent, lifelong disabilities, and while sedation itself may not be dangerous, it can impair judgment and motor skills, leading to dangerous situations.

Continue reading " FDA Issues Stronger Warning About Metabolic Problems for Teens Taking Zyprexa " »