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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:
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′ “
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?
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:
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.
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.
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.
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.
by Susan F. Wood, PhD
Today’s Washington Post writes about one more instance where women’s health and children’s health were a lower priority than the interests of a powerful group. In this case, it was breastfeeding vs. the formula industry.
Marc Kaufman and Christopher Lee write:
In an attempt to raise the nation’s historically low rate of breast-feeding, federal health officials commissioned an attention-grabbing advertising campaign a few years ago to convince mothers that their babies faced real health risks if they did not breast-feed. It featured striking photos of insulin syringes and asthma inhalers topped with rubber nipples.
Plans to run these blunt ads infuriated the politically powerful infant formula industry, which hired a former chairman of the Republican National Committee and a former top regulatory official to lobby the Health and Human Services Department. Not long afterward, department political appointees toned down the campaign.
The ads ran instead with more friendly images of dandelions and cherry-topped ice cream scoops, to dramatize how breast-feeding could help avert respiratory problems and obesity. In a February 2004 letter, the lobbyists told then-HHS Secretary Tommy G. Thompson they were “grateful” for his staff’s intervention to stop health officials from “scaring expectant mothers into breast-feeding,” and asked for help in scaling back more of the ads.
By Susan F. Wood, PhD
The Journal of Women’s Health published a special report and an editorial last month on the FDA’s Office of Women’s Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there. The special report, “The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy” identifies some of the major projects initiated by the FDA OWH, more than 100 studies costing more than $14 million over 10 years. This is a very small amount compared to NIH or to what the regulated industry funds (billions each year), but is focused on elucidating data that can help the FDA make regulatory decisions that affect the health of both women and men.
by Susan F. Wood, PhD
The last week of August is full of anniversaries for me, both public and personal. On August 24, it has been one year since the partial approval of Plan B emergency contraception over-the-counter (OTC) for those over 18 years old. Two days later on August 26 is the 87th anniversary of the day that women got the right to vote, Women’s Equality Day. It also is the 2nd anniversary of the day that FDA leadership once again denied the approval of Plan B OTC despite all of the evidence and support within FDA for its approval. August 31st, just 5 days later, marks the two-year anniversary of my resignation from FDA as Assistant Commissioner for Women’s Health in response to the Aug. 26th decision.
The Boston Globe, home town paper of Senator Ted Kennedy, Chair of the Senate Health, Environment, Labor and Pensions Committee, ran two important commentaries on the FDA this week.
First was an editorial yesterday strongly urging Congress to pass a strong FDA reform bill, including restricting financial conflicts of interests for advisory committee members.
Today the Globe ran an oped coauthored by David Michaels and me, again calling for leaders in Congress to ensure that the final bill (it is now in “conference” between the House version and the Senate version) come out as strong a bill as possible.
Take a look, I hope the Senator does!
Susan Wood 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).
By Susan Wood
The recent study in the NEJM clearly points out that our drug safety system is in need of repair. We shouldn’t need these constant reminders, from Vioxx to Ketek and now to Avandia. Indeed FDA reform legislation is moving through Congress as we speak. But does it do what we need it to do?
The DrugWonks blog has accused those of us who are advocating for a more safety-focused FDA that is less dependent on restricted user fees of “bullying” the agency, but I only wish we were as powerful as they seem to think we are. The Senate bill, now known as S. 1082, the FDA Revitalization Act (new acronym: FDARA), unfortunately got weaker as it went through the process.
By Susan Wood
Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation. The Senate will be “marking up” a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. The version of the bill that has been released is nearly 300 pages long, and so far only takes small steps toward strengthening the Kennedy-Enzi drug safety bill introduced earlier this year.
If you want to learn some of the basics linking user fees, the FDA budget and drug safety, we have just issued a white paper “Reauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA budget, and Drug Safety Related?” This is not a position paper, but rather a brief overview of the history, legislation, connections and varying positions that are in play now as these legislative actions take place.
The first part of the current bill in the Senate is reauthorizing PDUFA for the next five years. As was written in our open letter to Congress last month, “User fees may appear to save the taxpayer money, but at an unacceptable cost to public health.”
One of the signers of this letter, Dr. Jerry Avorn, has an article today in the New England Journal of Medicine, entitled “Paying for Drug Approvals – Who’s Using Whom?” Today’s early release of three articles on FDA reform demonstrate the depth and breadth of need for change at the FDA. Former Commissioner Dr. Mark McClellan also has an article, as do Drs. Sean Hennesey and Brian Strom.
by Susan F. Wood
Yesterday’s hearing (Feb 13, 2007) before the House Energy and Commerce Oversight and Investigations Subcommittee was amazing in several ways. What struck me was the willingness of senior FDA physician-scientists (who have recently left FDA) to speak publicly about their concerns about the ignoring of safety and efficacy data quality when there is an apparent push for approval. The specific product they were talking about is Ketek, an antibiotic that has had much written about it including on the Pumphandle. The specific issues identified have to to with the use of non-inferiority studies to assess efficacy, significant safety concerns being overlooked when Ketek was approved for conditions such as sinusitus, and the reality of serious fraud during the safety trials that was not revealed to the advisory committee. Read the rest of this entry »
by Susan F. Wood, PhD
On Wednesday Feb 21 at 3:00, the project on Scientific Knowledge and Public Policy at GWU School of Public Health and Health Services is hosting what hopefully will be a very exciting afternoon. Former Commissioners of the FDA will gather to discuss the future of FDA, bringing their experience and priorities together for an unscripted public conversation. FDA faces many challenges - some new, some old - but we need new ideas to help shape the upcoming legislative proposals that Congress will be taking up this year. Hearing from several former commissioners, including David Kessler, Jane Henney, Don Kennedy, Frank Young and hopefully Mark McClellan will bring focus to the critical functioning of FDA.
This ”Conversation with FDA Commissioners” is open to the public and the press and will be webcast the next day on Kaisernetwork.org. It will be held from 3:00-5:00 on Wednesday, Feb. 21 at the Jack Morton Auditorium, 805 21st St. NW, Washington, DC 20052. If you would like to attend rsvp to Janet at eohjip@gwumc.edu .
The following day, an invitation only workshop of former FDA leaders, scientists, and legal experts will gather to discuss issues of how to improve the use of science at the FDA, the impact of resources, and independance.
With PDUFA reauthorization just around the corner, new but limited initiatives underway on drug safety, ongoing problems with food safety, and a host of other FDA issues, now is the time to get new ideas on the table. (Background on this issues is available on SKAPP’s website.) Hopefully these efforts will add to the conversation.
Susan Wood 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).
by Susan F. Wood
After the recent post here on KETEK, both the Wall Street Journal and Senator Grassley are on the move. The WSJ reports today on another antibiotic Cubicin which has been seeking approval for use in endocarditis and discusses the competing issues of data quality and high standards, with the push for more antibiotics, particularly in the case of serious infections without effective treatment. The case of Cubicin in some respects serves as an example of this, however Ketek does not. They both illustrate problems identified by the recent Institute of Medicine Report on drug safety.
by Susan F. Wood
Much has been written about the antibiotic drug, telithromycin, otherwise known as Ketek. It seems to combine a host of concerns all in one place (see also Matthews, AW, WSJ, May 19, 2006:B1). Critically, concerns about safety, from visual effects to fatal liver toxicity, are paired with questions about lack of relative efficacy. These very basic concerns are then confounded with problems in particular safety studies that were carried out fraudulently and the faulty data derived from it provided to the FDA. But FDA leadership/management apparently discounted these problems, did not relay this information to the advisory committee which recommended approval, and approved this new drug in 2004. This past summer more concerns were raised about studies on Ketek in children; these are no longer ongoing, but FDA has yet to take specific action on whether these studies are permissible.
In last week’s New England Journal of Medicine, David Graham points out another weakness in the approval of Ketek(NEJM, 355(21), November 23, 2006, 2260-2261). He reports on the fact that given the fraudulent safety study, FDA used adverse event data from Germany and France where Ketek is marketed. Unfortunately, Dr. Graham’s analysis points out that the data was insufficient to detect a signal for a safety problem, but “the FDA interpreted the absence of a signal of acute liver failure in the overseas data as confirmation of telithromycin’s safety when the data could not be used to identify the problem.”
