You are currently browsing sfwskapp’s articles.

by Susan F. Wood, PhD

Recently the New York Times and RHRealityCheck reported on a leaked internal proposed regulation that calls for more and different enforcement of anti-discrimination provisions for health care providers.  The provisions are forms of conscience clauses that do not allow discrimination in hiring or promotion of health care workers who do not wish to perform abortion or sterilization (or indeed in the reverse, no discrimination against those who do perform abortions or sterilizations) in federally funded settings.

The draft regulation goes into detail outlining the history of the laws protecting the conscience of health providers and entities and then outlines the problem.  It seems that the central concern is not discrimination against those who won’t perform abortions, but that the US Department of Health and Human Services sees a real problem with requiring health professionals (and anyone in the healthcare workforce) to be involved with contraception, even if it is part of the job.  The majority of the section outlining “The Problem” concerns states that have passed laws or issued executive orders requiring pharmacies to dispense contraception, including emergency contraception, and that require hospitals to provide emergency contraception to rape victims. 

From the regulation:

Read the rest of this entry »

By Susan F. Wood, PhD

Much has been written at the Pump Handle and elsewhere in the media and scientific literature about ensuring that science appropriately drives government policies.  Questions and concerns have abounded regarding inappropriate non-scientific interference, while at the same time many health and environmental agencies (and the scientific staff within them) continue their incredibly important work in research, evaluation, development, regulation and service delivery.  Several organizations have done surveys and developed principles on scientific integrity including the American Association for the Advancement of Science, the Union of Concerned Scientists, and Scientists and Engineers for America.

At the Project on Scientific Knowledge and Public Policy at George Washington University School of Public Health, we are launching a multi-part study to get a strong handle on the written policies regarding the role of scientists in government that are currently in place, an understanding of how they are implemented at various agencies, and what recommendations can be made to specifically create policies that support strong science and the appropriate role of scientists and researchers within our health and environment agencies.

This is where we need your help:

We are seeking current and former government scientists to participate in interviews for the Scientists in Government project.  Interviews will be conducted in Summer 2008.
 
If you are a current or former government scientist (with an advanced degree and at least five years of experience working for a science-based health or environment federal agency), you can help us in our work to strengthen policies on science in the federal government.  Participation involves a phone or in-person interview of 1-2 hours.  Our study is approved by George Washington University’s IRB (#030823).

More information about the project can be found at: http://www.defendingscience.org/Scientists-in-Government-Project.cfm.
 
If you are interested in participating, please contact Ruth Long at 202-994-7993 or eohrwl@gwumc.edu. If you know others who might be interested in participating, please send them to this webpage: http://www.defendingscience.org/Participate-in-the-Scientists-in-Government-Project.cfm

 

Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).  She also served as Director of the FDA Office of Women’s Health from 2000-2005 and is a member of the Board of Directors for Scientists and Engineers for America.

by Susan F. Wood, PhD

Last year, Congress passed new legislation on the Food and Drug Administration, known as the FDA Amendments Act (FDAAA) of 2007.This legislation, while limited, made some significant steps forward, see here and here. It reauthorizes the user fee systems for drugs, biologics and medical devices, and expands FDA’s authority on labeling, requires new transparency for the Agency and establishes broader registries of clinical trials and requires results from clinical trials to be released to the public The public concern over the handling of medications like Vioxx and Ketek highlighted problems ranging from companies misleading FDA, to fraud by investigators, to FDA scientific management and lack of priority on safety studies. The new law provided some additional requirements on safety as well as some additional resources for this critical area. It also added some new requirements focused on reducing financial conflicts of interest of FDA Advisory Committee members.

When FDAAA was signed into law last fall, many thought that this would be the last major FDA legislation to be taken up by Congress for another 5 years.  But it seems we were mistaken. Read the rest of this entry »

by Susan F. Wood, PhD 

The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising.  The bill doesn’t limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market.  A moratorium was recommended by the IOM in it’s drug safety report in 2006, but was not adopted by Congress – perhaps due to arguments about first amendment rights, but perhaps due to objections by both the pharmaceutical industry and the advertising industry.

What was included is a small section requiring that all print DTC ads carry “the following statment printed in conspicuous text:  ‘You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088′ “

Read the rest of this entry »

by Susan F. Wood, PhD 

We are excited to be starting up a new research project here at the Project on Scientific Knowledge and Public Policy: Scientists in Government: An Examination of their Rights and Responsibilities in Civil Society.  The goal of this initiative is to provoke and shape the public discussion about the rights and responsibilities of government scientists, as part of the larger effort to ensure that government uses the best science to protect and promote the health and wellbeing of Americans. 

We are looking for a research associate/qualitative researcher who will lead the process of collecting and analyzing data on the role and functioning of scientists employed by government agencies.  This person should have experience designing and conducting qualitative research, including the development of interview instruments and analysis.  The candidate should also have a masters degree in public health, sociology, management, organizational structure, or a related field; 3 – 5 years of direct research experience; and experience in qualitative research design and implementation.
Are you that person or do you know someone who is?

http://www.gwumc.edu/sphhs/studentres/careers/jobs/jobs.cfm?job=ResearchAssociateQualitativeResearcher_F118 

 email a cover letter and CV to eohsfw@gwumc.edu

Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).  She also served as Director of the FDA Office of Women’s Health from 2000-2005

by Susan F. Wood, PhD 

It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA.  The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that.  Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science.  The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impact of this one.  Most of the press coverage has been on the call for expanded resources – which are truly needed – but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency.  I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.

From the report:

Read the rest of this entry »

by Susan F. Wood, PhD 

FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures

  Read the rest of this entry »

by Susan F. Wood, PhD 

Over the last 2 days, we’ve seen two political leaders speak out on the need for science and evidence to drive our policy decisions in areas such as health, food safety, enviroment, climate change, and renewable energy.

Read the rest of this entry »

 By Susan F. Wood, PhD

 Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007″ (FDARA).  And they both related to public transparency and public accountability. 

Read the rest of this entry »

 By Susan F. Wood, PhD 

In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety.  That study and its recommendations took on the question of how to improve our nation’s drug safety system, specifically through regulation by FDA.  In her Perspective article, Dr. Smith writes:

In general, the IOM implored the agency to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error, To Err Is Human,2 has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves.

Read the rest of this entry »

Archives

We are proud to partner with Image and video hosting
by TinyPic
Follow

Get every new post delivered to your Inbox.

Join 53 other followers