Texas attorney general Greg Abbott announced yesterday that he has filed a lawsuit against Merck & Co. in state court alleging that the company bilked Texas out of about $170 million in Medicaid payments by misrepresenting the safety of its Vioxx painkiller. Although a flurry of personal injury lawsuits have been filed against Merck throughout the country after the company pulled the Vioxx drug late last year, Texas is apparently the first state to file such a suit against the company.
A one-time popular arthritis drug, Merck voluntarily withdrew Vioxx from the market last fall after a study of cancer patients correlated use of the drug with an increased risk of heart attack and stroke. As is typical in such situations, the numerous private lawsuits that have been filed against Merck allege that the company knew of potential problems with Vioxx, but disregarded them and marketed the profitable drug anyway.
Greg Abbott is one of the genuine good guys in Texas politics, but he is wandering far afield with this latest salvo against Merck. As Dr. Rangel has noted here and here, lawsuits such as this follow a troubling pattern of attempting to feed off of the sensationalism and publicity of a side effect of a new and popular drug. It’s not at all clear that Merck did the right thing in pulling Vioxx off the market, but the mainstream media and plaintiffs’ personal injury lawyers have seized on the company’s removal of the drug from the marketplace by drumming the theme that Vioxx is an excessively dangerous drug that could kill you. Not mentioned in such propaganda is the fact that there are plenty of other medications on the market that have side effects that are more common and worse than those of Vioxx, but those drugs remain on the market for patients who are willing to risk the side effects of the drugs to obtain the benefits from them.
As one doctor observed in the Wall Street Journal awhile back, given the known side effects of aspirin, that drug “probably couldn’t gain FDA approval today.”

This NY Times article reports on a new research study to be published today in the New England Journal of Medicine that is strong evidence that chemotherapy greatly improves the chances of survival for early-stage lung-cancer patients. Lung cancer is by far the leading cause of death from cancer, exceeding annual deaths from colon, breast, pancreatic and prostate cancer combined.
Lung cancer has long been one of most difficult cancers to treat. A high percentage of lung cancer victims are are smokers or former smokers, and because there is no systematic screening process for lung cancer, almost half of the 175,000 annual lung cancer cases are not discovered discovered until the cancer is metastatic (i.e., spreading), which makes survival unlikely. Currently, only about 15% of lung cancer victims survive beyond five years.
The standard treatment for early-stage lung cancer has long been surgery to remove the lobes containing the tumor, but that treatment has resulted in only a 54% survival rate beyond five years. Until this new study, no published research studies had shown a substantial benefit from chemotherapy after surgery for early-stage lung-cancer patients, who represent nearly a third of all cancer cases.
The results of the 10-year trial of 482 patients with early-stage lung cancer show that intravenous chemotherapy drugs improved five-year survival rates to almost 70%. That 15-point improvement will make doctors and patients much more willing to consider follow-on chemotherapy, which sometimes requires hospitalization. “There’s never been a lung-cancer trial that showed this benefit of treatment in any stage of disease,” commented Katherine M.W. Pisters, M.D., an oncologist at Houston’s M.D. Anderson Cancer Center in the Texas Medical Center, who has an op-ed on the study in the current issue of the Journal. In response to the findings, the American College of Clinical Oncology and the American College of Chest Physicians are currently rewriting their official guidelines to physicians to recommend chemotherapy for early-stage lung-cancer patients.
The study was funded by the American and Canadian governments’ National Cancer Institutes, and received $1.6 million from GlaxoSmithKline PLC.

The New England Journal of Medicine yesterday published the findings of a large-scale study that indicate that angioplasty — an increasingly popular invasive procedure for patients with blocked coronary arteries — carries a higher risk of death over the long term than open-heart bypass surgery. The researchers were led by Edward L. Hannan, chairman of the Department of Health Policy Management and Behavior at the University at Albany School of Public Health.
The study is particularly significant because it raises questions regarding the shift in treatment for blocked coronary arteries over the past decade or so — the shift away from coronary bypass surgery in favor of angioplasty, which involves sliding a balloon into an artery through a small incision and then propping it open with a wire-mesh stent.
Inasmuch as angioplasty procedures require a far shorter recovery time and lower risk of in-hospital complications than bypass surgery, it is currently performed more than one million times a year in the U.S., which is about three times the rate of bypass operations. Bypass surgery generally costs between $25,000 to $35,000 while angioplasties run from around $10,000 to $15,000.
The study involved a review of almost 60,000 patients from 1997 through 2000 with serious heart disease in two government databases in New York state. Researchers concluded that those with three blocked arteries who received stents were 1.56 times as likely to die within three years as those who had bypass surgery. Similarly, those with two blocked arteries who got stents were 1.33 times as likely to die as those who had bypass surgery. Finally, over a third of the angioplasty patients required either surgery or additional stents within three years, while only 5% of the bypass surgery patients required either angioplasty or further surgery within the same period. The researchers note that the study does not include findings on the newer generation of drug-coated stents, which some cardiologists believe will improve the outcome for angioplasty.
This large scale study adds to an increasing number of smaller studies finding advantages of bypass surgery over angioplasty for long-term survival. Last year, a Cleveland Clinic study that followed 6,000 patients found that the risk of death over time was more than twice as high in the angioplasty group of relatively high-risk patients.
Both the Cleveland Clinic and New York studies involved review of registry data and not the controlled clinical trials that scientists consider the best form of evidence. In registry studies, researchers must adjust existing data for various factors, which can lead to debate and criticism over the effect such adjustments have on the ultimate findings of the study. Nevertheless, registry data studies allow the reearchers to involve much larger patient groups than clinical trials and to evaluate medical practices that are being most commonly performed in the medical marketplace.

This BBC News article reports on a University of Minnesota Medical School study that links use of Viagra to vision loss:

[Researchers at the University of Minnesota Medical School] writing in the Journal of Neuro-ophthalmology, said it brought the total number of reported cases to 14. But Pfizer, the makers of the drug which has been used by more than 20m men since its launch in 1998, said the cases were a coincidence. The seven men, aged between 50 and 69 years old, had all suffered from a swelling of the optic nerve within 36 hours of taking Viagra for erectile dysfunction.

If the plaintiffs’ lawyers can use this information to prompt Pfizer to use Viagra’s advertising budget for defense costs rather than advertising, then I will be strong advocate of the plaintiffs’ bar in this case. Hat tip to the HealthLawProf Blog for the link to the BBC News article.

A new Journal of the American Medical Association ($) article (abstract here) described in this summary reports on a once-monthly, injectable medication that has been shown to reduce heavy drinking substantially among alcoholics.
The drug is a formulation of naltrexone, a drug that is currently approved to treat alcohol dependence. However, the drug is currently rarely prescribed because it must be taken daily, which most alcoholics simply will not do. Cambridge, Mass.-based Alkermes Inc. filed an application with the Food and Drug Administration earlier this month to approve the drug, which will be known under its brand name of Vivitrex. According to the study, Vivitrex — which must be taken only monthly — has the “potential to improve intervention strategies for alcohol dependence.” Alkermes funded the JAMA-Vivitrex study and the development of the drug was supported by a grant from the National Institute on Alcohol Abuse and Alcoholism, a unit of the National Institutes of Health.
The NIAAA estimates that up to 18 million Americans have an alcohol-related disorder. Alcohol dependence is defined as women who consume four or more drinks a day on a regular basis and men who consume five or more drinks, which researchers used to define a “heavy drinking” day in the JAMA study involving Vivitrex.
James C. Garbutt of the University of North Carolina at Chapel Hill headed up the study, which involved 624 alcoholic adults. The patients received either an intramuscular injection of 380 milligrams of Vivitrex, 190 milligrams of Vivitrex, or a placebo (i.e., a fake injection), and all of the patients received counseling. Overall, the study showed that the number of “heavy drinking” days was cut by 25%, a drop that researchers deemed “significant” among those using the highest dose of the drug.