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Healthfacts - Vytorin and Zetia continue to be prescribed despite hints of harms and no proof of benefit

admin — Thu, 01 Jan 2009 01:11:02 +0000

There is no proof that Zetia can do anything beyond lowering cholesterol–no evidence that it can reduce heart attacks or cardiovascular disease, which, of course, is the ultimate goal. Once again, this blockbuster drug sold alone or as a combination medicine has produced negative clinical trial results. This time it failed to provide any benefit to people with heart-valve disease. Worse, there were more cancers and cancer deaths among the drug-treated participants than in those taking a placebo, though these findings are described as “due to chance.”

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Release of preliminary results of this trial had generated so much interest in the media last summer that The New England Journal of Medicine allowed the final results to be available on its Web site in early September–well in advance of the planned publication date.
Zetia is a relatively new cholesterol-lowering drug that can be prescribed alone. Vytorin combines Zetia with the 22-year-old statin drug, called simvastatin (brand name Zocor), into a single pill. Last year this expensive, heavily promoted combination drug became what only can be described as a drug maker’s worst nightmare. Study results showed that Vytorin was no better at reducing atherosclerosis of the carotid (neck) arteries than the older, cheaper simvastatin alone. There was also a hint that Vytorin might actually worsen artery disease.
And if that’s not bad enough, Merck and Schering-Plough Corp., which jointly market Vytorin, had withheld these unfavorable study results for nearly two years. It was, of course, in the financial interest of both companies to do so because Vytorin and Zetia are among the top-selling drugs worldwide. Four years after both drugs went on the market, backed by an aggressive ad campaign that featured a “food and family” cholesterol theme, yearly sales reached $5.2 billion.
On its Web site last month, The New England Journal of Medicine also published an editorial and an analysis that addressed Vytorin’s possible cancer-causing effect. The analysis was based on all the people diagnosed during the new heart-valve study and two other, much larger ongoing Vytorin trials. It was conducted by an Oxford University, U.K, research team, which found no increase in cancer incidence, but did find an increase in cancer deaths among those taking Vytorin. This finding was described as due “entirely to the play of chance rather than to a true increase in cancer mortality.”
The New England Journal of Medicine editors, however, are not so sure. In an editorial, they described a plausible mechanism for a cancer-causing effect, “[Zetia] interferes with the gastrointestinal absorption not only of cholesterol, but also other molecular entities that could conceivably affect the growth of cancer cells.” Once the cancer concerns were made public again last month, the FDA announced that its own analysis is in the works.
What makes this Vytorin/Zetia story so appalling is the fact that Zetia’s only advantage over the older statin drugs is a 17% greater reduction in LDL cholesterol. Incredibly, Merck and Schering-Plough were able to sell doctors and the public on the idea that this is more important than proof that this drug can cut the risk of heart attack (which has been proven for statins prescribed to high-risk men and people with heart disease). Zetia was studied for only 12 weeks before it went on the market.
Despite their uncertain safety records, Zetia and Vytorin continue to be prescribed to people with high LDL cholesterol. After the initial bad publicity, sales of Vytorin and Zetia dropped 40% in the first six months of 2008. That’s encouraging. But the question remains: Why is anyone still taking these drugs?
Maryann Napoli, Center for Medical Consumers [C] 2008
COPYRIGHT 2008 Center for Medical Consumers, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

USA TODAY - Vytorin doesn't prevent deadly hardening of heart valve

admin — Thu, 25 Dec 2008 09:21:02 +0000

The blockbuster cholesterol-lowering drug Vytorin failed to slow age-related hardening of the heart valve that without surgery can lead to heart attack, stroke or death, doctors said Monday.

Vytorin worked no better than a placebo at blocking aortic stenosis, which leads to 95,000 valve-replacement operations and 25,000 deaths in the USA each year, says lead investigator Terje Pedersen of Ulleval University Hospital in Olso.

“We can conclude it will not affect the course of aortic stenosis,” Pedersen says.

The study was designed to determine whether reducing a major risk factor for aortic stenosis, the buildup of plaque in arteries supplying the heart, might prevent valve damage. Within five years of diagnosis, most patients require surgery, develop heart failure or die.

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But the study did not answer the most important question: whether Vytorin prevents heart attacks, strokes and deaths in patients who have coronary artery disease. …

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Chain Drug Review - Congressional committee wants to see Vytorin analysis

admin — Sun, 21 Dec 2008 11:21:02 +0000

WASHINGTON — The House Energy and Commerce Committee wants the Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and the cholesterol drug Vytorin, which is sold jointly by Merck & Co. and Schering-Plough Corp.
A recent study indicated that Vytorin not only failed to help people with heart value disease avoid further problems but also appeared to increase their risk of cancer.
The study, known as SEAS, revealed that slightly higher incidents of cancer deaths were seen in those taking Vytorin–39, versus 23 on a placebo.
Scientists who conducted the study cautioned against panic, noting that even well-designed clinical trials sometimes produce erratic results.

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But other scientists and cardiologists say the study cannot be so easily dismissed.
Both Vytorin and Zetia, a companion drug, are prescribed monthly to nearly 3 million people and are among the world’s top-selling medications.
The drugs had combined sales of $5 billion in 2007.
The results of the study heighten concerns about the safety and effectiveness of Vytorin, according to Dr. Steven Nissen, a former president of the American College of Cardiology.
Six months ago a clinical trial of Vytorin failed to show that the medication helped patients, which led to a panel of cardiologists recommending that Vytorin and Zetia be used only as a last resort. Since that time sales of both drugs have plummeted, with analysts saying the SEAS study represents a worst-case scenario for Merck and Schering.
“We believe the commercial downside of a negative study is likely greater than the upside on positive results,” says Steve Scala, an analyst at Cowen Investment Bank.
For its part, Merck says its long-term financial earnings remain un clear after the result of the study.
Meanwhile, Fred Hassan, Schering’s chief financial officer and chairman, says the company’s strong stable of drugs in late-phase development would help supplement the “cholesterol challenge we’re facing.”
Vytorin is a single pill that combines Zocor (simvastatin) and Zetia (ezetimibe), two cholesterol-lowering medications. Both are also available as single pills.
Decades of research has revealed that statins reduce the risk of heart attacks and do not raise the risk of cancer, but the new safety concerns center around ezetimibe.
About 2 million prescriptions a month are written for ezetimibe–either independently as Zetia or in the Vytorin combination pill–in the United States alone. The SEAS trial involved nearly 1,900 patients whose heart valves were partially blocked. The patients were given either Vytorin or a placebo pill.
“No significant difference was observed between the treatment groups for the combined primary endpoint,” said Dr. Terje Pedersen, the principal investigator for the study.
The primary endpoint is the result that scientists hope to prove when running clinical trials.
However, a patient in the SEAS trail taking Vytorin had a sharply higher risk of developing cancer.
The analysis of potential links between cancer and Vytorin was given to the FDA but not to the House Commerce Committee, which has been investing the safety of prescription drugs and has reviewed the marketing of Vytorin.
COPYRIGHT 2008 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Internal Medicine News - Major CV events not decreased with Vytorin

admin — Fri, 19 Dec 2008 18:26:04 +0000

Combined simvastatin plus ezetimibe treatment not only failed to reduce major cardiovascular events, but also was linked to an increase in cancer deaths among asymptomatic patients with aortic stenosis, according to the first report of a randomized, placebo-controlled, phase III trial.
The only positive outcome of the 1,873-patient SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study was in the secondary end point of reduced ischemic events. Relative risk fell 22% in patients treated with the drug combination, which is marketed as Vytorin in the United States.

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Concern over the unexpected increase in cancer deaths prompted an immediate independent analysis of cancer incidence and mortality among 20,000 patients treated so far in two other ongoing Vytorin trials: SHARP (the Study of Heart and Renal Protection) and IMPROVE-IT (the Improved Reduction of Outcomes: Vytorin Efficacy International Trial).
Dr. Richard Peto of the clinical trial service unit at the University of Oxford (England) and his colleagues found no increased cancer risk in those studies, and concluded that “the SEAS, SHARP, and IMPROVE-IT trials do not provide credible evidence of any adverse effect on cancer.”
“Even if you add them together, the total evidence of adverse effect is no more surprising than getting heads if you toss a coin,” Dr. Peto, a professor of medical statistics and epidemiology at the university, said in a Webcast presentation of SEAS results and the analysis.
Dr. Terje R. Pedersen, chairman of the SEAS trial, said the investigators would have preferred to report the data at a scientific meeting, but intense interest made secrecy difficult. “There were a lot of rumors out there,” said Dr. Pedersen, professor of medicine and head of the center for preventive medicine at Ulleval University Hospital, Oslo.
Merck Sharp & Dohme and Schering-Plough Corp. (companies that market the two drugs as Vytorin) funded the SEAS study. Starting in 2001, investigators enrolled 1,873 patients with mild to moderate symptoms of aortic stenosis at 173 centers in seven countries in Northern Europe.
The population was randomized to 40 mg of simvastatin (Zocor) plus 10 mg of ezetimibe (Zetia) daily, or to placebo. Data collection ended June 30, 2008, after the last patient had been followed for 4 years. As expected, Vytorin reduced LDL cholesterol significantly, from 140 mg/dL at baseline to 52 mg/dL at 8 weeks; little change was seen in the placebo group.
The combination failed to meet the primary end point of significantly fewer major cardiovascular events. These occurred in 355 patients on placebo and 333 in the Vytorin group. A secondary end point of fewer aortic valve events also did not show a significant difference (326 events with placebo vs. 308 with Vytorin).
Ischemic cardiovascular events were significantly reduced, occurring in 187 patients on placebo and 148 in the Vytorin group. Dr. Pedersen attributed this to fewer coronary artery bypass grafting procedures when aortic stenosis patients underwent cardiac surgery.
In the safety analysis, significantly more placebo patients developed cancer during the study: 93 (9.85%) vs. 65 (7.0%) in the treatment group. More cancer deaths occurred, however, in the Vytorin cohort vs. the placebo group: 39 (4.13%) vs. 23 (2.48%), a nonsignificant difference.
Dr. Peto used different figures, reporting the total number of patients with cancer as 102 in the treatment group and 67 in the control group. He reported that “no overall increase” in incidence was found in the combined SHARP and IMPROVE-IT data, in which 313 treated patients and 326 controls had cancer.
Other factors arguing against increased risk, he said, were that the cancers did not concentrate in any one anatomical site and that relative risk did not increase significantly over time in all three studies. Based on cancer incidence, the relative risk with treatment went from 0.95 in the first year to 1.15 in the second year, to 1.17 in the third year, and to 1.01 in the fourth year.
“Likewise, nor does the relative risk for cancer mortality increase with time,” he said.
Summarizing the SEAS findings, Dr. Pedersen called the combined treatment “safe and well tolerated.”
In a subsequent interview, Dr. Richard Steingart, chief of cardiology at Memorial Sloan-Kettering Cancer Center, New York, challenged the SEAS hypothesis that Vytorin could slow aortic stenosis. “I think that was a bit of a reach anyway, and it turned out it didn’t,” he said.
Moreover, SEAS did not answer questions raised by the ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) trial, according to Dr. Steingart and Dr. Harlan M. Krumholz, a professor of internal medicine, epidemiology, and public health at Yale University in New Haven, Conn. As designed, it could not tease out whether ezetimibe adds any benefit when combined with a statin.

FDA Setting the Bar to Low? Cause for Medical Malpractice in New York

admin — Thu, 18 Dec 2008 02:01:04 +0000

One of the FDAs responsibilities is to regulate and control prescription drugs available on the market. However recently questions have risen as to whether the FDA is setting the proper controls on how drugs get approval. The FDA in the past has had numerous drugs that have had to be recalled because they were causing negative side effects for people taking the drugs. Serious complications have risen and just to make a few kidney failure from the use of Trasylol, birth defects and suicidal tendencies from Paxil which have both been proven to be life threatening. Recently the drug Zetia/Vytorin has been on the chopping block for failure to provide evidence that the drug actually reduces heart attacks or cardiovascular disease. Sales of this drug have reached over $5 million last year alone. Prescriptions are being filled at an alarming rate causing the drug to maintain high profits.
However, what we do not know about this drug is if it is actually proven to reduce the risks that it claims. The FDA approved the drug back in 2002 based on small testing methods that did not last over 3 months in duration. Researchers reported last month that patients in three clinical trials had a 40 percent higher chance of dying from cancer if they took Vytorin instead of a sugar pill or another medicine, although the leader of that study says the finding might be due to chance. This shows how the FDA has been eager to get drugs such as Vytorin on the market in a hurry. The evidence supports the fact that the FDA is also being pressured by pharmaceutical companies to get their drugs on the market. The whole basis of this kind of pressure is obviously profits. Profits are what drive an economy, but when the economy is in such distress from being pelted with lawsuit after lawsuit it is bound to collapse. When one industry is taking advantage of another the lesser of the two is bound to fall causing the other one to come down with it. Medical malpractice in New York has reached a peak due in large part to the pressures put on medical professionals, including the FDA, from large pharmaceutical companies.
Suggestions that the FDA might be too loose on the allowance of new drugs on the market may be true; however they are not the only ones to blame. The fact that pharmaceutical companies and doctors are supporting these happenings places the blame on all three parties. Medical malpractice in New York has become such a problem that both patients and doctors are threatening to go elsewhere for their medical needs. If this keeps occurring within our economy it will weaken until the medical industry in New York is obsolete. If you have witnessed these types of behaviors that have directly and negatively affected you, contact a medical malpractice New York Lawyer as soon as possible. For you may be qualified to receive compensation for medical expenses and other expenses that you might have incurred.

M2 Presswire - FDA announces labeling changes on heart benefit associated with cholesterol drug zocor.

admin — Thu, 11 Dec 2008 14:41:03 +0000

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

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But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.
When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.
Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved with way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about stat-ins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.
LDL Reduction Irrelevant
Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).
The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/ Schering-Plough Pharmaceuticals.
One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said Dr. Allen Taylor, chief cardiologist at Walter Reed, who is quoted in Berenson’s article.
Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

M2 Presswire - FDA Issues Early Communication about an Ongoing Review of Vytorin.

admin — Sat, 06 Dec 2008 02:26:02 +0000

On the eve of a date with congressional investigators, executives from Merck and Schering-Plough acknowledged Monday that their blockbuster cholesterol drug, Vytorin, offered no benefit over Zocor.

The news that Vytorin fell short of an old stand-by statin drug, now sold as a cheap generic, sent worried patients scurrying to call their doctors for reassurance and advice.

The irony is that many of those patients are enrolled in a high-stakes clinical trial that might show, once and for all, whether Vytorin and its sister compound Zetia are worth the $5 billion each year that people worldwide are spending on them. If patients in the study decide to bail out, the answer may never be known.

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“We already have people calling clinical investigators and asking if they should stay in the clinical trial,” says Robert Harrington, director of the Duke Clinical Research Institute. “If you’re a patient taking …

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News: Merck Shares Slide over 7% with Regulatory Stall of …

admin — Tue, 02 Dec 2008 07:51:03 +0000

Merck & Co. received a second blow to its cholesterol-management program sending its stock down $7.72%. FDA issued a not approvable letter for MK-0524A, while earlier this year data was published showing that another Merck cholesterol product, Vytorin, was no more effective than a cheaper generic drug.
Merck opened the day at $38.24. The companys shares have been trading below $42 ever since news of Vytorin. This is the lowest value the company has seen year-to-date.
Merck did not report the agencys reason behind the not-approvable letter. The company says that it will meet with the FDA and submit additional data to support approval.
In our opinion, says Seamus Fernandez, pharmaceutical analyst at Leerink Swann, the issuance of a not-approvable letter suggests a serious deficiency in the NDA. We are particularly surprised since the EMEA/CHMP concluded that the risk/benefit favored approval of the drug and Merck is conducting a major outcomes study. At a minimum, we expected FDA to issue an approvable letter pending the completion and results of the 20,000 patient HPS2-THRIVE study; results are likely in 2012.
Merck only revealed that the FDA rejected the proposed trade name, Cordaptive. The company expects to pursue the alternative trade name Tredaptive. Merck reports that it submitted an NDA for MK-0524A for the treatment of primary hypercholesterolemia, or mixed dyslipidemia.

Business Wire - Merck and Schering-Plough Respond To Issues Raised About ENHANCE Clinical Trial

admin — Sat, 29 Nov 2008 11:21:02 +0000

SAN FRANCISCO — Girard Gibbs LLP (http://www.girardgibbs.com) is investigating an alleged securities fraud by Schering-Plough Corp., Inc. (”Schering-Plough”) and certain of its executives between July 24, 2006 and January 14, 2008.
It is alleged that Schering-Plough issued a series of material misrepresentations in its filings with the Securities and Exchange Commission and press releases which artificially inflated the value of Schering-Plough shares. It is alleged that Schering-Plough misled investors regarding the increased efficacy of Vytorin, a combination of Zetia and Zocor, over the cheaper generic form of Zocor (simvastatin), alone, and delayed disclosing results of the ENHANCE study demonstrating that Vytorin was not more effective than Zocor.

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On January 14, 2008, investors learned there were severe safety and efficacy issues related to the Schering-Plough’s sale of Vyotorin and that Schering-Plough had purposefully delayed the publication of a study showing that Vytorin was neither safe nor effective. Upon the release of this news by the company, Schering-Plough stock dropped to $26.09, a 5.9% decrease in overall value. By January 17, 2008 the stock price had plummeted even further, to a low of $20.50.
If you purchased or otherwise acquired Schering-Plough securities between July 24, 2006 and January 14, 2008, you may have suffered losses. For more information or to discuss your rights as an investor, please visit our website, http://www.girardgibbs.com/sgp.html, or contact Jonathan K. Levine, Esq. (jkl@girardgibbs.com) or Aaron M. Sheanin, Esq. (ams@girardgibbs.com) toll free at 866-981-4800.
COPYRIGHT 2008 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Daily Record and the Kansas City Daily News-Press - Missouri joins flurry of suits over Vytorin

admin — Mon, 24 Nov 2008 21:11:03 +0000

More than 50 cases pending, including Missouri’s Western, Eastern districts
Recent controversy surrounding the cholesterol pill Vytorin has attorneys across the country filing lawsuits and scrambling for class action status.
Since a study was released about two weeks ago questioning Vytorin’s ability to reduce plaque buildup in the arteries, more than 50 lawsuits have been filed in U.S. federal courts against the drug’s manufacturers, Merck & Co. and Schering-Plough Corp. Numerous lawsuits also have been filed in state circuit courts.

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Missouri attorneys also are getting into the act. This week, a federal lawsuit was filed in Missouri’s Western District seeking more than $5 million in damages. And a lawsuit filed in Missouri’s Eastern District last week is demanding $1 billion from the drug’s makers. Both lawsuits are seeking class action status for Missouri residents.
Two similar federal lawsuits have been filed in Kansas federal courts. There also have been four lawsuits filed in Missouri’s circuit courts stemming from the Vytorin controversy: Three in St. Louis area courts, and one in Jackson County.
While the legal claims for the suits differ, they all revolve around the Jan. 14 release of a medical study showing that Vytorin, a combination of Schering-Plough’s Zetia and Merck’s Zocor, worked no better than Zocor alone for reducing cholesterol. The two federal lawsuits filed in Missouri claim the study showed Vytorin can actually increase cholesterol.
The lawsuits also claim the companies purposefully hid the study from the public since April 2006 so sales of the drug wouldn’t be affected.
“The case is a straight, consumer-base claim,” said Benjamin Bertram, of Bertram & Graf, who filed a lawsuit in Jackson County Circuit Court last week regarding the Vytorin controversy. “By not releasing data from the study … patients were buying Vytorin when they could have had the same results from Zocor for a third of the costs.”
With the flurry of lawsuits seeking class action status, multidistrict litigation is the most probable solution, said Matthew Clement, a partner with Cook, Vetter, Doerhoff & Landwehr, based in Jefferson City.
“Probably what will happen in this case is … there will be a hearing in front of a panel of federal judges to decide if it’s appropriate for multidistrict litigation,” said Clement, the lead plaintiffs’ attorney in the lawsuit filed Monday in federal court in Kansas City. “Then they will select a court and that court will handle the case so they don’t have 25 different cases going at the same time.”
State circuit court cases could then be transferred to federal court to join the class action. This process could unfold in the next three months, Clements added, but final disposition could take years.
Bertram expects the lawsuits to be consolidated into multidistrict litigation as well. He said in similar cases, a steering committee of attorneys has been formed to guide the litigation. Plaintiff attorneys can apply to be on the committee or work in subcommittees to deal with such areas as discovery.
In a class action suits, Bertram said, that’s usually the only avenue for attorneys to get paid.
“At the end of the day and when there’s resolution, that’s how you can recoup for the amount of time you spend on the case,” Bertram said, adding that it’s too early in the process to determine if he would apply to be on a hypothetical committee.
Merck and Schering-Plough officials have publicly denied any wrongdoing and have backed Vytorin’s ability to cut cholesterol. Attorneys general in New York and Connecticut have launched investigations into the allegations that the companies concealed the study’s findings.
The federal lawsuits filed in Missouri claim that Merck and Schering-Plough received approximately $5 billion in sales from the drug since April 2006, when the companies allegedly knew the study’s findings. Since more affordable cholesterol drugs were available, the lawsuits seek monetary amounts for the difference in the price of the generic Zocor in addition to punitive damages. Vytorin costs about $3 per pill, while generic Zocor costs less than $1 per pill.
Clement said the request for in excess of $5 million in damages is an estimate in how much Missouri residents lost by paying for the more expensive Vytorin.
“In our case, there have been all kinds of things in the media about how much they made since they knew about the study and when it was released,” he said. “We didn’t think it was productive to make an outrageous demand (for punitive damages) until discovery.”
Calls to Kimberly Lowe, of Lowe & Lowe in Waynesville, who filed the suit in Missouri’s Eastern District, were not returned by press time Tuesday.
Copyright 2008 Dolan Media Newswires
Provided by ProQuest Information and Learning Company. All rights Reserved.