The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, did not favor the drug. Not only did researchers find that Vytorin worked no better than cheaper, generic statins, they also discovered that patients taking Vytorin experienced 50 percent more new cancer cases and cancer deaths than the subjects who took placebos.

Merck and some of the researchers connected to the SEAS study dismissed the results as a “fluke,” while many physicians and medical researchers not connected to the drug company remained skeptical and cautioned consumers to stick with traditional statins to control cholesterol levels. For instance, Merck’s Zocor, taken alone, was shown to be more effective than Vytorin and cost about one-third as much because it had become available as a generic drug.

That research promoted many municipalities that had included Vytorin in their health plans to file lawsuits against Merck, essentially asking for their money back. Vytorin and its sister drug Zetia, made by Schering-Plough, brought in sales of more than $5 billion at their peak. The sales have fallen but continue to earn $4 billion annually.

Vytorin is a hybrid drug which combines Merck’s Zocor with Schering-Plough’s Zetia to combat both dietary and hereditary cholesterol. The FDA said that ample evidence exists showing Zocor to be safe, but insufficient evidence exists on Zetia to “rule out a cancer risk at this time.”

Two additional Vytorin studies known by the acronyms SHARP and IMPROVE-IT are ongoing and scheduled to end in 2010 and 2012.

SOURCE: Vytorin Recall › FDA says it finds no Vytorin-cancer link, but unsure

Merck

The Enhance study revealed that the pairing of Schering-Plough’s Zetia and Merck’s Zocor, which constitutes Vytorin, to be no more effective and possibly even less effective than Zocor alone or other much cheaper, generic statins 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.

Many plaintiffs, including a number of municipalities, sued Merck and Schering-Plough upon discovering that the drug makers knew the results of the Enhance trial but withheld them from the public for up to 2 years. The trial revealed Vytorin to be no more effective than cheaper generic statins in controlling cholesterol.

Nevertheless, the drug makers forged ahead with aggressive marketing campaigns for Vytorin, earning billions while allegedly knowing about the drug’s shortcomings.

Last month, Merck and Schering agreed to settle with attorneys general from 35 states who claimed the drug makers improperly marketed Vytorin and Zetia. Merck agreed to pay the states $5.4 million for costs accrued in investigating the potential violations of consumer-protection laws.

The settlement announced this week resolves all of the lawsuits seeking class-action status that were filed in New Jersey federal courts by consumers who bought and used Vytorin or Zetia. Many of the complaints sought compensation for personal injury caused by the drugs. The SEAS trial uncovered a possible link between Vytorin and higher cancer risks.

Lawsuits against the companies over securities law violations are still pending, as is the U.S. Department of Justice’s investigation into whether the drug makers’ marketing tactics led to false claims being submitted to federal healthcare programs. Moreover, congressional committees continue to inquire about the companies’ handling of the Enhance trial.

SOURCE: Vytorin Recall › Merck and Schering pay $41.5 million to settle NJ lawsuits

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?

If Vytorin ad campaigns and promotional media were based on a false or misleading premise, and the drug isn’t all its manufacturers publicized it to be (as the drug trials suggest), then government programs spent millions of dollars on reimbursement for a drug that is ineffective, possibly dangerous, and much more expensive than generic cholesterol medications.

Additionally, 35 attorneys general are investigating to see if any state consumer protection laws were violated by the marketing.

Connecticut Attorney General Richard Blumenthal is one of the state attorneys investigating the matter. “We believe that there are very real and serious issues that may have affected consumer pocketbooks, if not their health, and we intend to pursue these issues vigorously,” he told the Wall Street Journal.

Merck and Schering-Plough, both New Jersey based corporations, said they were cooperating with the investigations and jointly responding to the inquiries.

Earlier this year, the House Energy and Commerce Committee launched an investigations into the safety of Vytorin and the ways in which the drug was marketed.

It is widely believed that Merck and Schering Plough concealed unfavorable trial results for up to two years in an effort to protect the drug’s stellar sales. Both companies deny the accusation that trial data were withheld.

Vytorin is already the subject of a number of lawsuits seeking class action status. Approximately 140 such suits have been filed across the country.

SOURCE: Vytorin Recall › Investigations of Vytorin marketing intensifying

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