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Tuesday, April 25, 2006

Industry-Funded Scientists Flood FDA Advisory Panel
A science advisory panel for FDA is scheduled to consider new labeling guidelines for blood pressure control drugs tomorrow. Yet, according to information compiled by the Center for Science in the Public Interest, three-fourths of the 12-member panel received conflict of interest waivers. Many of those conflicts of interest relate directly to the issues of drug labeling to be discussed by the panel.

35 million Americans take drugs for hypertension. "rug labels - and the permissive statements those labels allow drug salespersons to make to physicians - can have a major impact on prescribing patterns," according to CSPI.

While 2003 guidelines developed by the National Institutes of Health have recommended a cheap, generic diuretic as the best treatment for hypertension with the fewest complications, the FDA’s proposed label uses a wording ambiguous enough to give the drug industry leeway to push inferior drugs, stating that "numerous drugs from a variety of pharmacologic classes, whose only common property is to reduce blood pressure, have been shown to reduce cardiovascular morbidity and mortality."

"[FDA’s] document is written so industry can go out and say that it doesn't matter which drug you use," said Curt Furberg, a hypertension expert at Wake Forest University who sits on the FDA's Drug Safety committee. He wasn't invited to be part of this panel.
Several of the physicians who will play key roles in the committee's deliberations have conflicts of interest that relate directly to the labeling discussion. For instance, committee chair William R. Hiatt, a professor of medicine at the University of Colorado, has conducted research for Bayer Pharmaceutical showing the benefits of controlling blood pressure in diabetics with peripheral arterial disease. The label guidelines suggest secondary benefits like improved PAD can be used as a basis for recommending one drug over another. None of the 11 physicians associated with the National High Blood Pressure Education Program Coordinating Committee, which wrote the 2003 peer-reviewed guidelines, was chosen for the FDA panel.

CSPI goes on the list a litany of other examples of conflicts of interest involving scientists making health policy decisions, including industry-funded doctors defining mental disorders and biases in a CDC vaccine report. It’s enough to raise your blood pressure.

More information on conflicts of interest in science can be found in the Integrity in Science Database of Scientists and Organizations With Ties to Industry.

Posted by Genevieve Smith, 06:23:41 PM

Spring 2006 Unified Agenda Now Available
Agencies released their Spring 2006 regulatory agendas on Monday, April 24. To get the low-down on the agencies’ plans for the coming six months and what they accomplished in the last six month period, go to the Federal Register.

Posted by Genevieve Smith, 03:16:12 PM

Friday, April 14, 2006

Another Potential Case of Mad Cow in North America
The Canadian Food Inspection Agency is announcing that testing is underway to confirm a suspected case of mad cow.

If Canada does have another mad cow case, that country's food safety agency will probably be able to trace back from that cow to locate other cows that may have consumed the same feed, which could be at the root of the infection. The U.S. has resisted the animal ID system that would make that same level of traceback possible here; instead, a recent USDA announcement calls for a system that would be administered by a private organization controlled by the cattlemen's industry.

For more info on the broken promises and special interest takeover that has left us less well protected than consumers in Canada, check out the new white paper from CSPI, OMB Watch, and Consumer Federation of America: Cow Sense.

Posted by Robert Shull, 10:57:47 AM

Thursday, April 06, 2006

How Now, Mad Cow?
Despite the discovery of three cows infected with bovine spongiform encephalopathy (BSE), or mad cow disease, long overdue measures to ensure the safety of the food supply and to keep foreign markets open to American beef have been stalled. Find out more in Cow Sense: The Bush Administration's Broken Record on Mad Cow, a new white paper from CSPI, OMB Watch, and the Consumer Federation of America, documenting how special-interest lobbying at federal agencies and at the Office of Management and Budget (OMB) helped keep reforms, such as a nationwide animal identification system and a strong regulation governing cattle feed, from being finalized.

Posted by Robert Shull, 05:31:05 PM

Sunday, April 02, 2006

White House Says, 'Let's Have More Arsenic in Drinking Water'
You might have read in the news about an EPA plan to make it easier for drinking water systems to reduce the quality of your drinking water, even when it comes to such hazards as arsenic, radon, and lead. What hasn't been reported is that the push for the policy came from the White House itself.

The White House released a report in 2004 that invited industry to nominate regulatory protections to be weakened or eliminated, and in that report OMB offered its own list of rollbacks. One of the rollback demands on the White House's own hit list was a call for EPA to be looser with its Safe Drinking Water Act authority to grant "economically disadvantaged drinking water systems" variances from safe drinking water standards.

After all, god forbid that poor communities be entitled to the same level of safe drinking water that everyone else enjoys.

Now EPA has bent to OMB's will. A March 2 Federal Register entry that proposes allowing small drinking water systems to serve us water with up to three times the maximum contaminant levels! The standard of affordability that would open the way to variances would also change: the proposed rule would count spending as little as $100 per year (which NRDC notes is a mere 0.25% of median household incomes) on drinking water as unaffordable.

Here's a tasty example: if your drinking water system (which may be owned by a distant corporation rather than your local government) has arsenic in the water at 29 parts per billion -- well over the standard of 10 parts per billion that the Bush administration threatened to roll back until the public cried out -- it can be considered safe.

Learn more about what's at stake from NRDC's safe drinking water program.

Posted by Robert Shull, 01:03:18 PM

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