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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

Thursday, April 20, 2006

Linking Tobacco to Risk Assessments
Tobacco industries employed scientists “to convince public health officials not that cigarettes were safe, but that there was not yet sufficient evidence of their danger to justify limiting places where tobacco could be smoked,” according to Environmental and Occupational Health Professor David Michaels. Now, under laws like the Data Quality Act, manufacturing doubt to keep harmful substances in the air and on the market is common practice. In a great Op-Ed for the Baltimore Sun, Michaels links the historic example of the tobacco industry manufacturing uncertainty to keep people smoking with OMB’s new bulletin on risk assessment. Michaels explains how OMB’s onerous new risk assessment guidelines for agencies create another way to use uncertainty as an excuse to not regulate:

Except when political appointees override the judgment of career federal scientists (as when a White House staffer rewrote an Environmental Protection Agency report on global warming to highlight scientific uncertainty), the nonpolitical staff at regulatory agencies can generally see through these crude efforts to create doubt. And Congress has refused to pass the Bush administration's attempts, such as the initiative with the Orwellian name "Clear Skies," to weaken environmental laws.
Clearly frustrated, the White House is making a run around Congress to change the way the agencies conduct risk assessments, the studies that form the basis for health protections. The Office of Management and Budget has proposed mandatory "guidelines" that would require agencies to conduct impossibly comprehensive risk assessments before issuing scientific or technical documents, including the rules polluters have to follow.
What appears at first blush to be good government reform is in fact a backdoor attempt to undermine existing environmental laws. If this is successful, the uncertainty manufactured by polluters will be written into federal risk assessments, providing the justification to weaken public health protection.

Posted by Genevieve Smith, 03:30:27 PM

Saturday, April 15, 2006

Good Jobs, Safe Jobs: Protect Workers Now
Worker Memorial Day is coming up -- Friday, April 28. It is a time to reflect upon the vital importance of safety and health for the men and women of America who work for a living. Get more info here.

And just in time for Worker Memorial Day comes the revelation that the incidence of workplace injury is significantly understated by federal statistical programs. The Journal of Occupational and Environmental Medicine published a study comparing its own estimates of illness and injury in Michigan over a 3-year period against the BLS statistic. The difference is huge: the BLS estimates suggest 1 in 15 workers in Michigan experienced occupational health and safety issues, whereas the researchers believe the rate is closer to 1 in 5. And the researchers didn't pull their numbers out of thin air: they used government databases!

If the BLS numbers are that wrong just in Michigan, how wrong are they nationwide? Is the need for occupational safety and health improvements greater than we already know? If so, what does that tell us about the Bush administration OSHA, which has become the black hole of government that fails to do anything of substance for workers?

Posted by Robert Shull, 02:00:37 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

Tuesday, April 04, 2006

Gaps Remain in Nuclear Facility Security
New from the GAO:

The nation's commercial nuclear power plants are potential targets for terrorists seeking to cause the release of radioactive material. The Nuclear Regulatory Commission (NRC), an independent agency headed by five commissioners, is responsible for regulating and overseeing security at the plants. In April 2003, in response to the terrorist attacks of September 11, 2001, NRC revised the design basis threat (DBT), which describes the threat that plants must be prepared to defend against in terms of the number of attackers and their training, weapons, and tactics. NRC has also restructured its program for testing security at the plants through force-on-force inspections, which consist of mock terrorist attacks.
NRC revised the DBT for nuclear power plants using a generally logical and well-defined process in which trained threat assessment staff made recommendations for changes based on an analysis of demonstrated terrorist capabilities. The process resulted in a DBT requiring plants to defend against a larger terrorist threat, including a larger number of attackers, a refined and expanded list of weapons, and an increase in the maximum size of a vehicle bomb. Key elements of the revised DBT, such as the number of attackers, generally correspond to the NRC threat assessment staff's original recommendations, but other important elements do not. For example, the NRC staff made changes to some recommendations after obtaining feedback from stakeholders, including the nuclear industry, which objected to certain proposed changes such as the inclusion of certain weapons. NRC officials said the changes resulted from further analysis of intelligence information. Nevertheless, GAO found that the process used to obtain stakeholder feedback created the appearance that changes were made based on what the industry considered reasonable and feasible to defend against rather than on an assessment of the terrorist threat itself.

Nuclear power plants made substantial security improvements in response to the September 11, 2001, attacks and the revised DBT, including security barriers and detection equipment, new protective strategies, and additional security officers. It is too early, however, to conclude that all sites are capable of defending against the DBT because, as of November 1, 2005, NRC had conducted force-on-force inspections at about one-third of the plants. NRC has improved its force-on-force inspections--for example, by conducting inspections more frequently at each site. Nevertheless, in observing three inspections and discussing the program with NRC, GAO noted potential issues in the inspections that warrant NRC's continued attention. For example, a lapse in the protection of information about the planned scenario for a mock attack GAO observed may have given the plant's security officers knowledge that allowed them to perform better than they otherwise would have. A classified version of this report provides additional details about the DBT and security at nuclear power plants.

[Via GAO Reports]

Posted by Robert Shull, 05:56:32 PM

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