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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.

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 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.

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 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.

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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. 

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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.

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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.

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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.”

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