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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

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Earlier this week, the Washington Post’s Elizabeth Williamson reported on industry-financed trips that Consumer Product Safety Commission chairs had taken. Today, she writes about other CPSC staff members (from both the Clinton and Bush administrations) who took such trips, and about proposed legislation spurred by the CPSC travel revelations. Meanwhile, eight new toy recalls have been issued.

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On Friday, the Washington Post reported that Consumer Product Safety Commission acting chair Nancy Nord and her predecessor, Hal Stratton, accepted dozens of trips paid for by companies and industries they oversee. (Nord, you might remember, is in the spotlight for objecting to legislation that would give her agency more money and authority.) Nord defended her actions by saying that they all went through the agency’s usual approval process, though she also called for an outside review of CPSC travel policies after news of her trips sparked anger in Congress.

In today’s Washington Post, Elizabeth Williamson provides more details about Nord’s and Stratton’s industry-sponsored travel and gets ethics experts’ reactions to the situation.

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 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. 

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 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.

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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 Liz Borkowski 

Revere’s been keeping us up to date on the latest news about the National Institute of Environmental Health Sciences – specifically, the stepping aside of Director Dr. David Schwartz for an NIH investigation, and the letter sent to NIEHS employees with the apparent goal of discouraging whistle-blowing. It seems like a good time to review some NIEHS happenings that had already attracted congressional scrutiny.

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Our regular readers may remember that back in March, environmental advocates raised concerns about the National Toxicology Program contractor preparing a draft report on bisphenol A, because the contractor had ties to companies that manufacture this particular chemical. (Read past posts on the issue.) After investigating the allegations, the NTP fired the contractor, Virginia-based Sciences International.

Now, Susanne Rust of the Milwaukee Journal Sentinel reports that the NTP has conducted an audit and found no imporpriety in the preparation of the report, which will provide background material for an expert panel evaluating the chemical’s safety. Evironmental advocates interviewed say the audit findings don’t put their concerns to rest. From the article:

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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).

In a post last week entitled Mining Professors Oppose Mine Safety Bill, I invited the signatories of a letter opposing new mine safety legislation to disclose their financial ties to the mining industry (if any) or other related conflicts of interest.  A couple of days later, one of the letter’s signers, Larry Grayson, PhD of Penn State University, responded thoughtfully and thoroughly (here and here) to my post.  I respectfully invite the other signatories to follow Dr. Grayson’s lead and provide their own disclosures.

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