A retrospective analysis of data from the Women’s Health Initiative study, which was presented at ASCO, showed that women with non-small-cell lung cancer who used hormone replacement therapy were more than twice as likely to die from their cancer as those who did not take HRT. Richard Schilsky, president of ASCO, stated that the findings are “another piece of evidence to suggest that hormone replacement therapy should be used with great caution.”

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Researchers examined data from more than 16 600 women who were divided approximately equally into groups who took HRT or placebo. After more than five years taking HRT, data showed 96 cases of NSCLC and 67 deaths from the disease. In comparison, there were 72 cases of NSCLC and 39 related deaths among women in the study who took placebo. Researchers noted that the difference in the number of cases was not significant, but that the difference in the number of deaths was.

Further analysis indicated that among smokers in the study, 3.4 percent of women treated with HRT died of lung cancer, compared with 2.3 percent of those who received placebo. For non-smokers, 0.2 percent of women in the HRT group died from the disease, compared with 0.1 percent of those in the placebo arm. In response to the data, lead author Rowan Chlebowski warned that “women almost certainly shouldn’t be using combined hormone therapy and tobacco at the same time.”

Commenting on the findings, Wyeth, which markets Prempro (oestrogen and progestin), stated that the same risks observed in the analysis might no longer apply, given the current manner in which the drug is prescribed. The company’s head of medical affairs Joseph Camardo remarked that women in the WHI trial used high doses of HRT over a long period of time and started treatment at an average age of 63 years. “Practice has already changed significantly. Guidance and the label have changed…use has shifted toward much shorter duration and lower doses,” he explained.

In addition, Len Lichtenfeld of the American Cancer Society noted that the number of deaths so far in the study is too small for researchers to be able to make broad conclusions about risk in the general population.

Source: FirstWord

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Ahead of an appearance in the Supreme Court next week, Wyeth is explaining its side of things in the closely watched case known as Wyeth v. Levine — or, as the U.S. Chamber of Commerce calls it, the business case of the century.

The case hinges on whether FDA’s approval of drugs should shield their makers from liability claims under state laws, and the court’s verdict will likely affect other industries that are regulated by both the feds and the states.

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For starters, Wyeth said in an interview with the WSJ that it complied with FDA guidelines on how to label its anti-nausea drug, Phenergan. The drug was improperly injected into musician Diana Levine, leading to the amputation of her arm after gangrene set in. She argued Wyeth should have put stronger warnings on the label and won a case in Vermont state court.

Wyeth argues that it can’t rush to the FDA for talks on changing the label every time an issue arises in one of the 50 states — Levine’s state of Vermont had stronger law on labeling — and the company also believes it can’t change the label on its own.

“It would be a chaotic system if you can relabel anything as long as you mumble safety,” said Bert Rein, Wyeth’s lead outside counsel, who also noted that Wyeth, and not the tort bar, brought this case forward. Rein also confirmed, though, that he knew of no instances on record in which the FDA had punished a company for amplifying its label warnings.

Meantime, Joseph Camardo, head of global medical affairs for the drug maker, called the number of reports of gangrene amputation “infinitesimally small,” and added there’s been successful administration of the drug “in a huge number of patients over the past 50 years.”

Wyeth’s arguments are at odds with those of Levine’s lawyers, who say Congress never intended to stop drug makers from proactively toughening warnings to doctors and consumers. They add that FDA guidelines are the floor, not the ceiling, when it comes to safety standards.

Source: The Wall Street Journal

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