In the mid-1990s when Republicans in Congress were pushing to make regulations harder to enact, consumer, labor and environmental groups sought an ally committed to government oversight and capable of grasping the complexity of the rules.

Their choice was John Kerry. Since coming to Congress in 1985, Kerry had advocated the stricter regulatory agenda that liberal groups say will protect consumers, workers and the environment but that businesses charge hurt the economy.

Now as Kerry runs for president, many close advisers come from those special-interest groups, and his platform supports some of their causes. So would a Kerry presidency, advocates say.

That's what worries business groups . . . .

Though studies dating as far back as 2000 pointed to increased risk of cardiovascular disease and stroke for users of Vioxx, FDA has stood quietly on the sidelines while more than 27,000 users of the drug experienced serious side effects. In fact, a top FDA scientist in the Office of Drug Safety alleged yesterday that higher-ups at FDA attempted to suppress his conclusions about the dangers of Vioxx. According to the Washington Post,

[Sen. Charles] Grassley said in a news release that David Graham, associate science director of the Office of Drug Safety, told him that agency officials "ostracized" him and subjected him to "veiled threats" as he tried to have his study cleared for publication. When a top FDA official suggested "watering down" the report, Graham responded in an e-mail: "I've gone about as far as I can without compromising my deeply-held conclusions about this safety question."

Said Washington Post,

Both commentaries in the journal took the FDA to task for not being sufficiently aggressive in making sure that Vioxx and other COX-2 inhibitors are safe. Topol, in particular, was highly critical of the agency for allowing Merck to aggressively advertise Vioxx despite concerns going back to 2000 about the increased risk of cardiovascular disease. The papers had been scheduled for publication on Oct. 21 but were released early by the journal yesterday.

"The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health," Topol wrote.

FitzGerald wrote: "Only the FDA can provide unbiased and informed guidance; it has a role to play beyond watchful waiting. In the absence of such guidance, what should physicians and patients do?"

FDA's inaction also speaks to the increased need for registered clinical trials. If we can't rely on objective health experts at FDA to protect us, then it becomes even more critical that experts in the medical community have access to clinical trial data.

• Products subject to recall aren't being returned to the manufacturer:

  Whether the reason is better policing, more diligent reporting of problems to agencies, or worse products, the rise in recalls doesn’t necessarily mean that more faulty products are being repaired or returned to stores. A large percentage of them remain on the road and in the home: almost one-third of all vehicles subject to recall; more than half of toys, clothes, appliances, tools, and electronics gear; and three-fourths of child car seats.

  Part of the reason lies in the system itself. Despite talk years ago about consolidating recall authority, there is no single recalls czar with the power to banish all problem products from the marketplace immediately--or else. What we have is a complex, decentralized system granting recall authority to six federal agencies, each with its own rules and procedures. . . . When a manufacturer resists a recall, the agencies are empowered to take it to court, but they prefer to gain a company’s cooperation. If many companies were to balk at recalling flawed products, the agencies simply wouldn’t have the money or staff to force them all to do the right thing. . . .

  But a major reason that products officially declared problematic are still in homes and garages is that word too rarely reaches the people who need to hear. For every Firestone/Ford Explorer media-fest, there are thousands of choking hazards, breaking straps, and contaminated foods that get little publicity.

• Among the regulatory agency weaknesses that contribute to the problem: (1) there are holes in the safety net, so that most products are not certified to be safe before going on the market, and (2) some agencies "announce" recalls in ways designed to ensure that the notification stays under the radar -- such as Consumer Product Safety Commission recall notices that get hidden in the agency website's archive section without ever making it to the front page or the press, or NHTSA's controversial regionally limited recalls.

Check out the reports: "The Trouble With Recalls" and "Rejected by U.S., Unsafe Goods Go Abroad"

Posted by Robert Shull, 05:22:05 PM

Friday, October 01, 2004