Now Congress is investigating the promotion of Vytorin as lawsuits against its makers pile up in state and federal courts. But Vytorin isn’t the only heavily promoted new drug to cause problems, so some congressmen are planning to pull in the reins of direct-to-consumer (DTC) drug advertising.

Rep. Henry Waxman (D-Cal.) has renewed the call to give regulators the power to ban DTC advertising for new prescription drugs when their safety profiles aren’t fully known. The would-be legislation, which emerged in 2007 but ultimately failed to pass, is plowing ahead in the wake of some heavily promoted but beleaguered blockbuster drugs.

Like Vytorin, Chantix and Vioxx were more or less indicted after tests and reports brought unknown risks to light, and each made billions in profit before negative news rained on their parade.

Rep. Waxman, who becomes chairman of the House of Representatives Energy and Commerce Committee when the new Congress convenes in January, has expressed his interest in revisiting the drug ad issue.

“It is these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a Prescription Project Conference.

Merck’s blockbuster anti-inflammatory drug Vioxx was taken by approximately 20 million people before its risk of cardiac events became known. Chantix was taken by millions of people as well before researchers understood the risks the drug posed for depression, suicide, and other serious side effects. And, of course, Vytorin, which millions of people took before one test exposed it as a dud and another as a possible caner risk.

To help ease the dangers posed by new medicines, Congress sought last year to give the FDA the authority to ban the television advertising of new prescription drugs for as long as three years if it was deemed necessary to protect the public. The ban would not be a blanket ban on all new prescription drugs, but would be enacted on a case by case basis.

Exaggerated benefits and minimized perception of side effects are two pitfalls of DTC advertising for the general public. Excessive prescribing is another, but that seems to be the whole point, at least from the drug manufacturers’ point of view. Television ads for new prescriptions aren’t made with the public’s good in mind. They’re made to maximize profit. Advertising for profit is the American way, but when it amounts to messing with the health of millions, clearly some restraint is needed.

According to a report by Reuters, drug makers claim that their ads are informative to the general public and that they have adopted voluntary guidelines that have them refrain from advertising for “an appropriate amount of time” so doctors can be informed of the new drugs first.

In the case of Merck’s diabetes drug Januvia, however, little time was wasted between the drug’s approval and Merck’s massive marketing efforts.

Another report by Reuters says that the “the product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of [Januvia] to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”

The 2007 attempt failed after some lawmakers objected it would violate constitutional protections of free speech. Instead, Congress gave the FDA authority to fine companies for running false or misleading promotions.

Whatever restraint is exercised, no time is wasted in infiltrating the market.

The 2007 attempt to reign in advertising for new drugs failed after some lawmakers objected it would violate constitutionally protected free speech. Congress instead granted the FDA authority to fine drug companies for false or misleading advertising.

SOURCE: Vytorin Recall › Vytorin illustrates the problems of direct-to-consumer advertising

Not surprisingly, Merck and Schering-Plough have been taking hits quarter after quarter because of Vytorin’s disastrous performance in clinical trials. Nearly a year ago, Schering-Plough promised to provide regular reports on the performance of its anti-cholesterol market. Their last update, which was filed with the Securities and Exchange Commission in mid November, indicates that Vytorin’s plunge has actually leveled off.

Much speculation has been made about where Vytorin and Zetia (Zetia is a component of Vytorin, as well as a freestanding prescription drug) would bottom out. The total number of prescriptions written in October was 2,186,000, which represents a slight increase over September’s figure of 2,171,000.

Despite the slight gains, however, the chances of a future Vytorin / Zetia freefall still look good. In 2009, many Medicare Part D changes take effect, and many of the providers have kicked Vytorin down to Tier-3 status or worse in their formularies based on the clinical evidence that Vytorin is no more effective than cheaper, generic statins. Therefore, Vytorin will become a much more expensive option for patients. In today’s economy — and most likely even in tomorrow’s economy — a prescription that costs much more than generics yet performs on par with them or even worse than them, is not likely to be winner.

SOURCE: Vytorin Recall › Have Vytorin’s falling sales finally stabilized?

New Haven City Hall spent more than $400,000 on Vytorin and Zetia (ezetimibe) prescriptions for members of the city’s healthcare plan when it could have spent a fraction of that amount for cheaper generic statins that have proven to be as or more effective and less risky.

Zetia is Merck’s anti-cholesterol drug that works by blocking absorption of cholesterol in the digestive tract. It is combined with Schering-Plough’s statin drug Zocor, which targets cholesterol produced by the liver, to form Vytorin – a drug that works to diminish cholesterol on both hereditary and dietary fronts. Studies have shown, however, that cheaper generic statins are in some cases more effective and safer than the Vytorin cocktail.

“This drug doesn’t work. Period. It just doesn’t work,” Steven Nissen, head of cardiology at the Cleveland Clinic, told Forbes magazine.

Merck and Schering-Plough are under Congressional inquiry for possibly withholding study data that indicated Vytorin was a flop while collecting billions in sales from the drug. The companies collected windfall profits knowing that cheaper and possibly more effective drugs were on the market.

Growing controversy over Vytorin’s performance and the way its makers have handled both past and ongoing studies have spawned a number of class action lawsuits. New Haven wasn’t able to find a suit that it could join, so it’s striking out on its own.

SOURCE: Vytorin Recall › New Haven wants to recover Vytorin money

Suffolk County joins Congress and a growing number of individuals and municipalities in claiming it had been ripped off by the pharmaceutical giants. Suffolk County’s case states that Merck and Schering-Plough engaged in a “scheme … calculated to ensure that Plaintiff would pay for Zetia and Vytorin despite cheaper and effective alternatives.

However, Suffolk County has added a little more heft to its lawsuit than other similar suits filed against the drug companies. On page 25 of the deposition, Suffolk County claims:

“Defendants have conducted and participated in the affairs of the Enterprise through a pattern of racketeering activity that includes acts indictable under 18 U.S.C. ++ 1341 and 1342 (mail and wire fraud) …”

Confusion and outrage have surrounded the ENHANCE trial results and the way in which Merck and Schering-Plough officials released the results, sparking Congress to launch an investigation. The Suffolk County lawsuit, however, goes further than just accusing the companies of negligence; it claims the companies may have acted criminally. In this lawsuit we see phrases indicating some serious charges:

“…concealing from Plaintiff and physicians, and the public the results of the ENHANCE study …”

“… deliberately misrepresenting the efficacy of Zetia and Vytorin …”

“publishing or causing to have published materials containing false information …”

“… pattern of racketeering activity …”

SOURCE: Vytorin Recall › Suffolk County NY sues for return of Vytorin money

To be completely fair, pharmaceutical companies continually develop vaccines and medicines that improve the quality of life for millions of people throughout the world. Many modern pharmaceuticals also extend and save lives. In the western world, we can’t imagine life without these modern medicines.

However, events surrounding the drug Vytorin have cast into doubt the intentions – and the integrity – of pharmaceutical giants Merck and Schering-Plough. As marketing expert Rob Frankel recently told Advertising Age magazine, “The pharmas are in big trouble in terms of credibility. They’re just above congress and used-car salesmen.”

Why?

First there is the ENHANCE study that revealed the pairing of Zetia and Zocor to be no more effective than Zocor alone in treating arterial plaque. But more than the disappointing results, there was the delay in making this information public. Results of the ENHANCE trial were completed in April 2006 but were not released until January 2008, after mounting pressure and suspicion over the delay.

On May 1, 2007, before the ENHANCE results were made public, Schering-Plough’s president Carrie Smith Cox, dumped 900,000 shares of company stock, worth an estimated $28 million. The sale prompted Congress to investigate the upper realms of Schering-Plough for concrete evidence of insider trading.

While ENHANCE data were being withheld, Merck and Schering-Plough continued to heavily advertise Vytorin, spending hundreds of millions on the famous commercials featuring the aunt who looks like a pot roast. The companies knew the results of the study, yet their aggressive marketing raked in $3-5 billion per year since Vytorin’s appearance on the market. Meanwhile, patients continually overpaid for a drug that didn’t do what the ads claimed it would do.

Congress again stepped in to demand answers as to why consumers, including the federal government, had been fleeced for so long. Senator Chuck Grassley of Iowa sent a letter to the top of both companies in which he stated, “I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are spent in a fiscally sound manner.” In the same letter, he also pointed out that at, “… a Wal-Mart pharmacy in Iowa City, generic simvastatin costs $54.54 for a month’s supply. On the other hand, Vytorin costs $112.46–more than twice as much.”

The federal government is also investigating why the ENHANCE test results released by Merck and Schering-Plough differ from the information released by those who conducted the study. A letter from the U.S. House of Representatives Committee on Energy and Commerce to Fred Hassan (Schering-Plough) and Richard T. Clark (Merck) states, “The ENHANCE trial was completed in 2006, and yet no data from the trial have been published or presented in their entirety. In fact, it appears that the study itself was not registered with ClinicalTrials.gov until October 31, 2007, a full 18 months after completion of the study. In addition, the endpoint indicated in the ClinicalTrials.gov web site appears to differ from the endpoint described in the initial study design.”

Representative Bart Stupak , D-Mich, told CBS’s Early Show “There’s certainly major misrepresentations 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 was designed to do.”

With all of the controversy surrounding Vytorin, it would seem that Schering-Plough has sought to earn more mistrust every day and that Merck intentionally put profits before people.

SOURCE: Vytorin Recall › Vytorin scandals evoke mistrust