September 19, 2013
UCSF Awarded $20 Million Federal Grant on Tobacco Regulatory Science
New Research Will Help in Regulation of Tobacco Products to Protect Public Health
UC San Francisco will receive a five-year, $20 million grant as part of a first-of-its-kind tobacco science regulatory program by the U.S. Food and Drug Administration and the National Institutes of Health.
The overall aim is to conduct programs of multidisciplinary research that will inform the FDA’s regulation of the manufacture, distribution and marketing of tobacco products to protect public health.
UCSF is one of 14 institutions nationally to be awarded the new Tobacco Centers of Regulatory Science (TCORS) grants.
The UCSF principal investigator is Stanton A. Glantz, PhD, director of the UCSF Center for Tobacco Control Research and Education.
“Our results will provide information that the FDA can use to improve its regulatory decision making,” Glantz said. “They will also help the public and public health authorities around the country and the world to develop better policies to curb the global tobacco epidemic.”
September 18, 2013
In my experience Big Tobacco usually wins when the policy discussion is out of sight, in behind-the-scenes backroom negotiations. And that is certainly where the Trans Pacific Partnership negotiations have been happening.
Things started to change a couple weeks ago when the Sacramento Bee critized Obama for backing down on his already-tepid attempt to protect tobacco regulations from Big Tobacco. Things accelerated substantially when the New York Times published an op-ed by NY Mayor Bloomberg crititizing Obama's back down, followed by a strong New York Times editorial supporting Malaysia's tobacco carve out from the TPP (and citicisim Obama for not supporting Malaysia).
September 17, 2013
I just submitted a public comment to the FDA opposing the proposal to have the FDA establish a third party process for handling industry research. My cover letter said
I wish to submit the attached material, which includes comments I originally posted to my blog (http://tobacco.ucsf.edu/blogs/sglantz), including the comments submitted by a wide spectrum of academic and other leaders in the tobacco control community, for the FDA’s consideration in evaluating the possible role of independent parties in industry sponsored research.
As detailed in the attached comments, creating such an arrangement is a very bad idea.
Thank you for your consideration.
And I attached the full range of blog comments triggered by Ruth Malone's letter on why she did not go to the FDA's "moderated dialog" with the industry. You can read the full blog posts here and here.
September 15, 2013
Freedom to Harm: The Lasting Legacy of the Laissez Fare Revival, by Thomas O. McGaritya Professor of Administrative Law at the University of Texas at Austin School of Law., is a great overview of how the regulatory safety net has been shredded over the last 30 years as well as a shocking and detailed description of how little President Obama has acted to restore public health, occupational, and financial and consumer protections for the US population. No wonder the FDA has done so little to control tobacco.
My only (minor) criticism of the book is that, while he mentions the tobacco industry, he does not fully develop the industry's behind-the-scenes role in a wide range of activities, including, among many other things, tort reform, the development of the Data Quality Act, the rise of "good epidemiology" and "junk science," and, of course, the Tea Party.
September 15, 2013
During a wide-ranging interview on ABC's This Week, President Obama had the following interchange with host George Stephanopoulos:
GEORGE STEPHANOPOULOS: –and still, 95% of the gains [of the economic recovery} go to the–
PRESIDENT BARACK OBAMA: Right.
GEORGE STEPHANOPOULOS –top 1%. Do you look at that, four and a half years in, and say, “Maybe a president just can’t stop this accelerating inequality?”
PRESIDENT BARACK OBAMA: No, I think– I think the president can stop it. I– the problem is that– there– continues to be a major debate here in Washington. And that is: How do we respond to these underlying trends? If– if you look at– at– at the data–couple of things are– are– are creating these trends.
Number one, globalization. Right? Capital, companies, they can move businesses and– and jobs– anywhere they want. And so they’re lookin’ for the lowest wages. That squeezes workers here in the United States, even if corporations are profitable.