Feb 28 2005
In 2003, drug manufacturers spent more than $1.5 billion promoting their drugs and by 2003, sales topped $5.3 billion.
Vioxx, Celebrex and Bextra hit the market in the late 1990s & 2001, as a breakthrough class of drugs for arthritis that would help avoid ulcers and other digestive ailments linked to medicines such as aspirin.
With their debut coinciding with a surge in advertising aimed directly at consumers, they and Bextra, which was approved in 2001, quickly became one of the most heavily promoted drug classes.
These drugs have now been linked to an increased risk of heart attacks and strokes and many people were exposed unnecessarily to those dangers. Intense advertising helped make them some of the most widely prescribed medicines in the United States and a harsh lesson has been learned.
The FDA needs to change the way drug companies launch their new products. The explosion of new drugs on to the market is an inherent threat to the public and many more people are at risk than in past years as no time seems to be allowed for these products to develop a track record.
While the FDA decides how these & other as COX-2 inhibitors can be safely marketed, some doubt the agency ‘s ability to limit consumer advertising if the pharmaceutical industry takes it to court.
The tools available to regulate prescription drug promotion are limited & lengthy to apply. , drug companies argue adamantly that patients gain important information from advertising.
Former FDA officials, declare the agency has the power it needs to tighten up direct-to-consumer advertising & make sure that the promotion is in the public interest.
Celebrex, Vioxx and Bextra promotions have all drawn FDA warnings. Celebrex promotions to consumers and doctors were the subject of eight separate complaints between 1997 and 2005, when the drug changed hands among three different companies.
Bextra's manufacturer, Pfizer Inc., denies promoting the drug directly to consumers; the FDA sent the company a warning January for misrepresenting or completely omitting information about serious risks in their advertising.
In 2001, the FDA cautioned a Vioxx campaign which denied the heart attack risks surfacing in connection to the drug.
Neither Vioxx manufacturer Merck & Co. nor Pfizer Inc., which makes Celebrex and Bextra, will agree voluntarily to forego direct-to-consumer ads permanently if the FDA requests it, and might start a legal battle if the FDA seeks a court injunction. Pfizer honored the FDA's request for a suspension of consumer ads for Celebrex after Merck's voluntary withdrawal of Vioxx from the market last year raised concerns that the whole COX-2 group increased heart risks.
Both companies are negotiating with the FDA over possible changes to the drug labels that could include safety warnings.
Direct-to-consumer advertising, campaigns aimed at doctors, began in the 1980s. The rules of the game changed in 1997 & opened the floodgates to the pervasive drug commercials seen today.
Hopes that the COX-2 drugs would solve the serious dilemma of providing relief from chronic Arthritis pain without causing stomach bleeding and other serious gastrointestinal problems, and deaths cannot be totally guaranteed. The risks with this class of drug has been understated and misleading.
The consumer needs to be empowered against brainwashing by huge companies focused too often on their profits rather than on public health and safety.
The FDA could have a major fight on its hands if it does take on some of these companies.
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