Bayer, FDA and Congress

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By Ed Silverman // October 14th, 2008

<http://www.pharmalot.com/2008/10/14/> // 3:05 pm

As part of its ongoing investigation into direct-to-consumer

advertising, the House Energy & Commerce Committee is exploring two new

lines of inquiry - why Bayer ignored FDA recommendations to refrain from

marketing a version of its aspirin that is also a dietary supplement,

and why the FDA hired a public relations firm that works for pharma to

develop a consumer web site.

The committee wants to know why Bayer promoted its Bayer Aspirin with

Heart Advantage as safe and effective, when the FDA had warned against

marketing such a combo. The tablet combines aspirin with a supplement

Bayer claims can lower cholesterol. The FDA, however, only regulates the

drug.

In a letter

<http://energycommerce.house.gov/Press_110/110_OI.101408.DTCBayer.pdf>

to Bayer Healthcare prez Balkema, committee chairman Dingell

and Bart Stupak, who heads the Oversight and Investigations

Subcommittee, asked Bayer to turn over all studies that show Aspirin

with Heart Advantage has positive affects on cholesterol and heart

disease. A separate letter

<http://energycommerce.house.gov/Press_110/110_OI.101408.DTCHHS.pdf>

was sent to US Health & Human Services Secretary Mike Leavitt to ask

what, if anything, the FDA did about Bayer's marketing.

Meanwhile, the committee also sent a letter

<http://energycommerce.house.gov/Press_110/110_OI_101408.DTCFDA.pdf> to

FDA commish Andy von Eschenbach to learn more about the FDA decision to

hire a non-profit organization called EthicAd to develop an FDA web site

about DTC ads. EthicAd, you may recall, is funded by Shaw Science

Partners, a public relations firm that works for drugmakers and helped

launch more than 30 drugs, according to its web site (you can the back

story here

<http://www.pharmalot.com/2008/09/fda-tapped-pharma-consultant-for-dtc-w

eb-site/> ). The committee also wrote Mike Shaw and EthicAd to learn

more about their involvement (here

<http://energycommerce.house.gov/Press_110/110_OI_101408.DTCFDA.pdf>

and here

<http://energycommerce.house.gov/Press_110/110_OI_101408.DTCEthicAd.pdf>

).

S. Kalman PhD, RD, CCRC, FACN

Miami Research Associates

Director, Nutrition & Applied Clinical Research

6141 Sunset Drive #301

Miami, FL. 33143

(fax)

www.miamiresearch.com <http://www.miamiresearch.com>