Stupak

Congress asks CEOs to pledge truth in DTC

Tracy Staton — Wed, 21 May 2008 10:24:15 -0400

Dingell and Stupak strike again. Fresh on the heels of their DTC hearing, the two Congressmen have issued letters to four top pharma execs--CEOs at Merck, Pfizer, Schering-Plough, and Johnson & Johnson--asking them to commit to honest-Abe advertising. "Consumers should not have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said, calling DTC advertising a "privilege" that comes with responsibility.

The two men also question the industry's own DTC guidelines. In a separate letter to the Pharmaceutical Research and Manufacturers of America, they say that the guidelines should be updated. Among the suggested changes: Ads for drugs with "black box" warnings have to specifically include that cautionary tale.

- check out the House Energy and Commerce Committee's release
- get the article at CNN Money
- see the story in PharmaTimes

FDA panel to mull DTC changes

Fri, 16 May 2008 06:59:55 -0400

Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. The meeting comes at a time when drug ads are under increased scrutiny; just last week, Congress heard testimony about the ads, including expert assessment that commercials are engineered to play down warnings and emphasize benefits. One researcher said she'd found that 80 percent of TV viewers could recall drug benefits mentioned in commercials, but only 20 percent remembered side effects.

Print ads, you'll recall, already include FDA contact info so patients can report side effects. Some lawmakers and consumer groups say adding that info to TV ads as well would help regulators catch drug safety problems sooner.

- see the item at Pharmalot
- check out the Associated Press story

ALSO: A stent skeptic assails DTC advertising for Johnson & Johnson's Cypher product in the New England Journal of Medicine, saying the TV commercials cross an ethical line; J&J says the ad is balanced and points viewers to sources of more detailed information. Report

DTC hearing has high-powered guest list

Fri, 02 May 2008 06:59:54 -0400

Hail, hail the gang's all here...at the House Subcommittee on Oversight and Investigations hearing on direct-to-consumer ads. Next week, Rep. Bart Stupak will preside over testimony from Pfizer, Merck, Schering-Plough, and Johnson & Johnson. Kaiser Permanente, the GAO, and the AMA may be there, too.

The official title of the hearing? "Direct-to-Consumer Advertising: Marketing, Education, or Deception?' Not surprising, considering Stupak's history as an industry critic, but definitely not comfortable for those scheduled to say their piece. If you're interested, the committee will offer a video feed.

- see the Pharmalot item
- get the link to the webcast at the committee's site

Vytorin records created after the fact

Mon, 14 Apr 2008 06:59:58 -0400

Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Merck and Schering-Plough face new questions about their controversial Enhance trial as a Congressional committee releases documents that raise "serious concerns" about the companies' delay in reporting the results of that study, which showed that their high-priced combo drug Vytorin did no better at preventing artery-clogging than Zocor alone. The documents--unearthed by the committee in an ongoing probe of Enhance--show friction between Merck and Schering-Plough and questions about why the results weren't reported sooner. At one point, the tensions ran so high, a top Schering exec resorted to, shall we say, colorful language in an email.

But the most obvious question raised by the document dump is this: Why did the companies create minutes for a key meeting--in which experts and company execs discussed changing the study's primary endpoint--a month after the fact? Are those minutes inaccurate, as one participant in that meeting alleges? The minutes suggested that outside consultants recommended changing the endpoint--but James Stein, an imaging expert at the University of Wisconsin, said Merck and Schering-Plough made that choice. "We did not vote on this," Stein said in an email.

Meanwhile, some FDA documents have surfaced, showing just why Merck and Schering-Plough elected to pull Vytorin ads back in January. Apparently, the agency had been asking the joint venture to tone down the ads--which claimed superiority for Vytorin over statin therapy alone--at least since January 23. DTC promotions needed to be revised to show that "Vytorin has not been shown to provide any additional cardiovascular outcome benefits compared to using Zocor alone," the FDA letter said. Reps. John Dingell and Bart Stupak want to know what the company has done to comply--especially given that their deadline is April 24.

- see the M/S-P documents released by Congress (.pdf)
- read the story in Forbes
- see the Wall Street Journal article about the minutes
- check out the DTC item and FDA letters at Pharmalot

Related Articles:
Insurers, PBMs mull Vytorin data. Vytorin report
Congress: M/S-P sat on bad news. Report from Congress
Companies saw Vytorin threat in 2005. Vytorin report
Congress: Were Enhance results secret? Enhance report
Congress promises Vytorin hearings. Vytorin report
Merck, Schering's Vytorin fails trial. Vytorin report