Vytorin Ads Face Congressional Scrutiny

(CBS/AP)  Congress is investigating advertising for the cholesterol-busting drug Vytorin following a study that suggested the pill may have no advantage over a generic cholesterol medicine, according to letters released Wednesday.

In letters dated Wednesday and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine.

In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."

"There's certainly major misrepresentation, not only to the effectiveness of the drug, but manipulating of the scientific data to further promote a product that isn't doing what it is designed to do," Stupak told CBS' The Early Show.

Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicated the drug may be no better than a generic statin at slowing the progression of heart disease.

"The FDA certainly doesn't look good generally on monitoring advertisements. They've done a miserable job stopping ads that misrepresent drugs," Dr. Sidney Wolfe, director of Public Citizens Health Research Group, told The Early Show.

In the FDA letter, the lawmakers write that they are "concerned that the study's results may have been available to Schering-Plough and Merck officials, and yet the massive advertisement campaign for Vytorin was allowed to continue." They ask for agency records related to the Vytorin ads.

The congressmen also asked the companies for records related to the ads as well materials related to Enhance study leader John Kastelein, a cardiologist in the Netherlands. They also seek information about the press release this Monday that disclosed the Enhance results, almost two years after the last patient completed the study.

In 2005, the companies spent $155 million on Vytorin ads, a budget exceeded that year only by Sepracor Inc.'s Lunesta campaign and AstraZeneca PLC's Nexium ads, according to an article in the New England Journal of Medicine.

"There are several cholesterol-lowering drugs on the market that have been studied enough to show that they actually prevent heart attacks and strokes," Wolfe told The Early Show. "Vytorin, the combination of Zetia and another statin drug, is not one of these."

The companies have defended their handling of the Enhance study.

[diportnoy]

I was on VYTORIN 10/20 for 2 years + then on VYTORIN 10/10 for 8 months and lost a lot of leg mussel strength. Then for 2 months drug free, cholestral was elevated, so I was put on ZETIA for 1-1/2 months and I have the same mussel problems I have decided to go drug free since they are more harmful with thier side
effects thn taking a chance with blockage.

[flreason]

"This is a prime example as to why drug companies should be banned from doing direct to consumer advertizing. Only over the counter meds should be allowed to advertize to the public.

Posted by connapa at 09:57 AM : Jan 17, 2008"

Even over-the-counter drugs are not exempt. Recently the drug companies had to pull children''s cold and flu remedies from the market because they pose a risk of death, while having little effect on the infection or symptoms.

[esteban2007-2009]

There is not much truth in advertising, which can be deadly when medicines are the proudct.

[godofredo29]

One word: rhabdomyolysis. That "rare but serious side effect" isn''t really that rare, especially for guys.

[cantshutup]

BTW, the American public is a bunch of suckers...only Americans spend millions apon millions of dollars to take a pill for everything...in Europe, they have enough sense to eat right and exercise and you NEVER see drug commercials on European TV...they do have ads that encourage improving lifestyle...they aren''t just stupid suckers like us Americans! wake up AMERICA!!! The pharmacutical corporations are poisoning us and we''re giving them all our money to do it!!!

[cantshutup]

I think it''s hilarious that Congress is jumping on this...granted, it''s serious but maybe Congress should have jumped on Bush and Cheney when they were signing secret laws and circumventing the Constitution and our rule of law and taking over the government and destroying our rights and liberties...Congress is weak, they can''t stop a rogue president and his criminal cabinet so they think they can earn points by appearing tough with the pharmicutical companies that have lined their pockets their whole careers...CONGRESS--DO YOUR JOB AND TRY AND CONVICT THE CRIMINALS BUSH, CHENEY, AND ALL THE OTHER KEY PLAYERS FOR THE TREASON THEY HAVE COMMITTED AGAINST OUR GREAT COUNTRY!!!! Jumping on a drug scandal and not doing a *** thing about the criminals bush and cheney is the greatest crime the weak, ineffective Congress has done! SHAME ON CONGRESS YOU SORRY YELLOW BELLIED UN-AMERICAN COWARDS!!!!!!!!!!!!!

[vastr-wcon]

.
This is so simple even a moron could understand it: THERE IS NO JUSTIFIABLE REASON FOR MASS ADVERTISING PRESCRIPTION DRUGS ON TV OR ELSEWHERE!

Congress should BAN all advertising to the public (doctors excepted) for ALL prescription drugs.

.

[loudias]

What do we do now? Two years on this drug has cripped me. My muscles my legs arm. I hope the FDA and these Drug Co.are made to pay for all of our suffering.
thank you
Florida

[extremophil]

Whine, snivel.......I hate the government..sneer sneer...I hate the president...whine.

[micma-2009]

Bush appointed a bunch of drug lobbyists to run the FDA.