Ads for Pfizer's arthritis drug Celebrex are not only misleading
and not supported by evidence, but also they overstate the drug's
benefits while understating its risks, according to the Food and
Drug Administration (FDA).
This finding prompted the FDA to call for "an immediate halt"
to all ads (TV, print, infomercials and direct-mail) for Celebrex,
which was also found in December 2004 to increase the risk of heart
attacks. The government called the ads' claims, which also included
claims made for related drug Bextra, "serious violations of
federal law."
The FDA is considering ordering warning labels or a market withdrawal
for Celebrex due to the heart risk findings. Vioxx, a related drug
made by Merck & Co., was pulled from the market in the fall
of 2004 due to findings that it increased risks of heart problems
and stroke.
Though Pfizer, which spent over $70 million advertising Celebrex
to Americans in the first nine months of 2004 alone, voluntarily
pulled its ads in December 2004, they say they plan to continue
marketing the drug to doctors. Sales from Celebrex and Bextra were
projected to reach more than $4 billion in 2004--nearly 10 percent
of Pfizer's revenue.
Five ads for Celebrex and/or Bextra were
found to be in violation of federal law. Violations included:
- Omitted facts, including information about risks
- Wrong claims of superiority
- Unsubstantiated claims about the drugs' effectiveness
The FDA mentioned specific ads in a letter
to Pfizer, which included:
- A woman playing guitar with a voiceover saying, "With
Celebrex, I play the long version." The FDA said this makes
a claim about the drug's benefits without explaining side effects.
- A 27-minute infomercial that promises dramatic effects and pain-free
relief, yet doesn't include information about the drug's safety
or risks.
Seattle
Post-Intelligencer January 13, 2005
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