Archive for October 9th, 2008

Pfizer’s Neurontin Caper

October 9th, 2008 | No Comments | Source: Boston Globe

seenoevil 300x214 Pfizers Neurontin CaperDocuments from a suit in Boston’s US District Court show that Pfizer executives suppressed the results of a 1999 European trial showing their drug Neurontin didn’t work for chronic nerve pain at the same time they promoted the drug for that purpose.

Pfizer’s Neurontin marketing campaign transformed a low-impact epilepsy drug into a $2 billion per year blockbuster before generic versions became available in 2004.

Referring to the European trial by its code number in September, 2000, Pfizer marketing executive John Marino wrote, “We must delay publication of 224, as its results were not positive.”

Later that month, Neurontin team leader Michael Rowbotham worried about a 224 investigator who was pressing Pfizer to publish his findings. “It will be…important how WE write up the study,” Rowbotham wrote. “We are not allowing (the investigator) to write it up himself.”

Results of that trial never did see the light of day.

(more…)

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Fortune’s Power Women

October 9th, 2008 | No Comments | Source: Fortune

This week’s Fortune magazine includes its annual list of the 50 most powerful women in business. The remarkable people on the list include Sunoco’s Lynn Elsenhans, the first woman to run a major US oil company and Google’s Marissa Mayer, who at 33 oversees thousands of engineers and is the youngest woman ever to make the list.

Congratulations to the women in health care who made the list:

Angela Braly, President and CEO of Wellpoint
Susan Desmond-Hellmann, President, Product Development, Genentech
Colleen Goggins, Worldwide Chairman, Consumer Group, J & J
Carrie Cox, EVP and President Global Pharmaceuticals, Schering-Plough
Melanie Healey, Group President, Global Feminine and Health Care, P & G
Dierdre Connelly, President, Lilly USA, Eli Lilly
Sherilyn McCoy, Worldwide Chairman, Surgical Care Group, J & J
Gail Boudreaux, President UnitedHealthcare, and EVP UnitedHealth Group

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How the FDA Tried to Fix its Image Problem

October 9th, 2008 | No Comments | Source: Washington Post

Knowing their agency’s reputation has been tarnished by a series of misadventures, underfunded initiatives and Congressional hearings, FDA officials recently decided to contract with a PR firm to “create…a lasting positive image of the agency for the American public.”

fda How the FDA Tried to Fix its Image ProblemThat decision might have triggered yet another misadventure for the FDA, but Washington Post Staff Writer Robert O’Harrow sniffed it out before any bad money changed hands.

After reviewing emails and conducting interviews with FDA staff, O’Harrow reported last week that FDA officials did not use a competitive process, as per government policy, to secure a low bid on the $300,000 PR contract. Instead they schemed to award the contract to Qorvis Communications, a beltway firm with links to the FDA official organizing the deal.

The scheme involved awarding the contract to a company belonging to an Alaska Native corporation which needs not compete for federal contracts since it qualifies for certain set-asides. This corporation would then subcontract all the work to Qorvis.

When the Post informed FDA deputy commissioner John Dyer of the scheme, he pulled the plug and requested an independent investigation. Energy and Commerce Committee Chairman John Dingell (D-Mich) also plans to investigate. There is no evidence that senior FDA officials were involved.

Mildred Cooper, an FDA contractor who was the scheme’s mastermind, had worked with Qorvis on behalf of another company earlier in her career. “I had experience with Qorvis” she said. “It was a matter of efficiency.”

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