effectiveness

Study: Data doesn't support women's Lipitor use

Tracy Staton — Fri, 19 Sep 2008 11:34:29 -0400

Should women stop using statins? A new study is taking issue with the efficacy--or lack thereof--of the cholesterol fighters when women are the ones using them. Analyzing a group of studies that looked at Pfizer's Lipitor and other statins, Cornell University researchers found that the drugs didn't prevent heart attacks in women with cardiovascular risks in any statistically significant way, although they did in men.

Lipitor's label already points out a dearth of efficacy data in women, the researchers said. But Lipitor advertising typically doesn't. "Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks, but that scientific evidence supporting their hope does not exist,” the authors concluded.

The study wasn't published in a medical journal, but a law journal: the Journal of Empirical Legal Studies. In fact, Pfizer was sued back in 2006 by a class of women and seniors over the lack of outcomes data supporting their use of the drug. At press time we couldn't find out whether the suit has been resolved, but we'll update when we do.

- read the Science Daily article

Amgen defends Enbrel after J&J wins trial

Tracy Staton — Fri, 19 Sep 2008 10:27:29 -0400

A new Johnson & Johnson drug trial has put Amgen on the defensive. According to the 903-patient study, J&J's experimental drug ustekinumab (Stelara) proved more effective at treating psoriasis than Amgen's blockbuster Enbrel was. "We've never really seen clearance [of psoriasis] along the lines of what we've seen with ustekinumab," one of the trial's lead investigators told the Wall Street Journal.

Amgen fired back, saying that the J&J trial only lasted 12 weeks, and so it didn't address the new drug's long-term safety. Enbrel has a "consistent safety profile," an Amgen spokeswoman said, and 16 years of clinical experience. It's true that the FDA is digging into links between the fungal infection histoplasmosis and TNF-alfa meds, but only 17 of the 240 cases occurred among Enbrel patients. Stelara works via a different mode of action than Enbrel does: It's an interleukin inhibitor, rather than a TNF blocker.

Amgen's safety focus may be well targeted. The FDA recently delayed approving the J&J drug for three months, with a decision now expected in December; this after the FDA advisory panel unanimously recommended approval. The expert panel did discuss worries about possible cancer risks with Stelara, and according to the WSJ Health Blog, safety appears to be the FDA's overriding concern. “We have submitted a summary of safety data to the FDA but efficacy will probably not play a major role in the approval," a J&J biologics exec told the blog. We'll have to wait and see what the agency decides.

- read the WSJ story
- check out the article in Forbes

Comparative effectiveness bill hits Senate

Tracy Staton — Thu, 07 Aug 2008 11:05:11 -0400

How do different antidepressants stack up? Blood-pressure meds? Diabetes drugs? Do we know? Well, Sen. Max Baucus says he aims to find out: He's introduced a bill that would create an institute for comparative-effectiveness research. The not-for-profit would operate separately from the government, but would include reps from Health and Human Services, National Institutes of Health, and the Agency for Healthcare Research and Quality--plus drug and device makers, patients, and doctors.

The institute would be funded by public and private payers--a.k.a. Medicare and insurance companies. “Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible," Baucus said in a statment, "but right now that data is scarce and unorganized."

Not everyone is sold on the comparative effectiveness idea. Some fear that it would end up going the way of the U.K.'s National Institute for Health and Clinical Excellence--which, though well respected, does get into hot water from time to time for rejecting treatments based on cost. We'll see who prevails.

- read the press release
- see the post at Pharmalot

Bill to propose federal drug comparisons

Wed, 02 Apr 2008 07:59:57 -0400

Should the feds fund studies to compare drugs' effectiveness? The idea appears to be gaining traction. Two congressmen are readying legislation that would create an institute to systematically examine drugs and devices.

It's a controversial idea: Drug and device makers are naturally worried, but so are anti-big government types who fear that a British-style drug review board would interfere with consumer choice, physician autonomy, and market dynamics. But on the pro side of the ledger are some economists and business groups who think that this sort of research could cut healthcare spending by hundreds of billions annually.

- read the item at Pharmalot

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