Merck cites new cholesterol drugs, boosts cost cuts

NEW YORK - Merck & Co. Inc. (NYSE:MRK - news) on Thursday said it plans to seek U.S. approvals in 2007 for two new cholesterol fighters and raised by $1 billion the amount of cost savings it expects to achieve through 2010, sending shares higher.
The company, whose stock rose 2 percent, unveiled its two new cholesterol drugs at its annual meeting with industry analysts and portfolio managers at Merck headquarters in Whitehouse Station, New Jersey.
It said they are among a handful of experimental drugs that will be in late-stage trials by the first quarter of 2006. Merck is counting on the medicines to help revive earnings growth after its cholesterol fighter Zocor, the company‘s biggest product, begins facing competition from cheaper U.S. generics in mid-2006
One of the new cholesterol drugs, MK-524A, works by a new approach to raise levels of heart-protective "HDL" cholesterol and also lowers artery-clogging fats called triglycerides, Merck said.
The other new drug, MK-524B, combines MK-524A in a single pill with Zocor, which works through the standard approach of cutting levels of "bad" LDL cholesterol.
Merck said it hopes to seek approvals for both drugs by 2007. That is about the time that Pfizer Inc. (NYSE:PFE - news) is expected to disclose data from late-stage trials on its own experimental product that pairs its top-selling cholesterol fighter Lipitor Lipitor with a new compound called torcetrapib that sharply raises levels of HDL.
Merck, which is facing lower profits due to generic competition and which is fighting thousands of lawsuits related to its withdrawn Vioxx Vioxx arthritis drug, last month forecast cost savings of up to $4 billion through 2010 through elimination of 7,000 jobs and manufacturing improvements.
The company said accrued cost savings could now reach $5 billion through 2010.
To boost productivity further, Merck on Thursday followed the lead of other struggling drugmakers by announcing it will narrow its focus to nine disease areas. The pared-down approach will allow the company to use fewer sales representatives to pitch its products to specialist doctors.
The disease areas include Alzheimer‘s disease Alzheimer‘s disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, oncology, pain and sleep disorders.
The company reaffirmed it expects earnings to fall 4 percent this year and perhaps by the same magnitude in 2006, as Zocor faces competition from cheaper generics.
"Merck will remain a research-driven pharmaceutical company, but we need to change our approach to virtually every aspect of our business, and we must act with a sense of urgency," Richard Clark, the company‘s recently named chief executive, said in a release.
Clark, the former head of company manufacturing who was promoted in May to CEO, had provided few other specifics, until Thursday, on how he hopes to revive the company‘s fortunes.
During the five-hour event on Thursday, Merck officials will review the company‘s roster of other experimental drugs and discuss financial strategy.
Merck was up 60 cents to $29.80 in morning trade on the New York Stock Exchange New York Stock Exchange.

Merck's Sneak Attack

Merck unveiled a new cost-savings plan in an attempt to assuage the fears of investors panicked by the thousands of Vioxx lawsuits the drug giant is facing. But the embattled company also announced a drug to prevent heart attacks that could pose a major headache for rival Pfizer. The moves highlight how quickly Richard Clark, who has been Merck's (nyse: MRK - news - people ) chief executive for only six months, is moving to repair the drugmaker. The big question is whether his efforts will be enough. Merck announced an additional $1 billion in cost savings through 2010, bringing the total cost-savings to as much as $5 billion, and argued that it will be able to grow sales by 4% to 6%. Earnings per share will begin to grow again in 2007, but those numbers exclude special items. That leaves open the possibility that some of Merck's earnings projections could be overly optimistic. The company also reiterated its plan to fight all of the 9,000 Vioxx lawsuits that have so far been filed in court. The new heart drug is an entry into what could be the biggest drug market left in the treatment of cardiovascular disease--the race to raise HDL, or good cholesterol, which prevents heart attacks in big population studies. Pfizer (nyse: PFE - news - people ) is paying $800 million to develop an HDL-raising combo that some predict could become one of the world's best-selling drugs. In one study, a synthetic version of HDL actually cleared cholesterol plaque out of the arteries, an unprecedented result. But Pfizer's big bet faces a new threat from Merck. For years, doctors have used niacin, a B-vitamin that can raise HDL and cut triglycerides, heart attack-causing particles of fat in the blood. But many patients cannot take niacin, because it causes a facial-flushing side effect. Merck has developed a new drug that counters this side effect, making it possible for patients to take higher doses of niacin. The drug, code-named MK-0254, could be filed in 2007, about the same time as Pfizer's entrant. Forbes.com has previously reported that Merck was involved in niacin-based research (see: "Can Good Cholesterol Cure Big Pharma?"). Recently, niacin use is in resurgence thanks to Niaspan, a sustained-release version from Kos Pharmaceuticals (nasdaq: KOSP - news - people ). The preparation increases HDL by 20% or more and cuts triglycerides by 25%. It has given Kos a market value of more than $1 billion and helped founder Michael Jaharis become a billionaire. But flushing may still be a problem. Merck says that 90% of patients experience the side effect, and that only 10% of prescriptions are written at the 2-gram dose, the target for therapy. With this new drug, more patients may be able to raise their HDL. For Pfizer, that could complicate its plans. Pfizer is aiming to raise HDL by an entirely new mechanism that could be even more powerful than Niacin. In mid-stage studies, Pfizer's combination of its new drug, torcetrapib, with its blockbuster cholesterol-lowering medicine Lipitor has raised HDL by a whopping 60%. But torcetrapib is no sure thing--some doubters say that raising HDL in this new way just won't be as good. Moreover, Pfizer is expecting imaging studies showing the effect of the Lipitor-torcetrapib combo on artery plaques to be unveiled in 2006 or 2007. It hopes that the U.S. Food and Drug Administration will allow those studies to be the basis for approving the drug. But another HDL-raising entrant could complicate that plan, especially if torcetrapib raises blood pressure as it has in some early studies. Moreover, it could cause complications for Pfizer's plan to sell torcetrapib only in combination with Lipitor, which is already drawing the ire of some doctors who want to be able to prescribe it with any cholesterol-lowering drug they want. Novartis (nyse: NVS - news - people ), Roche and Eli Lilly (nyse: LLY - news - people ) are also known to be developing HDL-raising drugs. Merck also unveiled a promising AIDS drug, which works by inhibiting the ability of the HIV virus to mix its genetic information with that of a patient's cells, and Merck's first cancer drug, targeted against cutaneous T-cell lymphoma.

Group sues drugs maker

GRANDFATHER who says his life was blighted by an anti-arthritis drug yesterday became the face of a class action against a pharmaceutical giant.
Graeme Peterson, 55, says he was healthy but that after taking Vioxx he devloped heart problems.
Mr Peterson suffered his first heart attack in December 2003 after taking Vioxx for almost four years to treat arthritis in his hips and neck.
"I took it for an arthritic condition," he said.
"I would have lived with that arthritic condition given the choice. I wasn't given the choice."
Law firm Slater and Gordon yesterday launched a Supreme Court class action against American maker Merck & Co and its Australian subsidiary Merck Sharpe & Dohme (Australia) Pty Ltd.
The firm represents more than 400 people who took Vioxx and suffered heart attacks and strokes but it is believed 250,000 Australians used the drug.
It was withdrawn from sale last year because of safety fears.
The writ alleges Merck failed to warn doctors, pharmacists and the public that an ingredient of Vioxx significantly increased the risk of arterial thrombosis and cardiovascular conditions.
Mr Peterson, of Mornington, said his heart condition meant he was much less active.
The grandfather of seven was global safety manager for BHP but now works only part-time.
Slater and Gordon special counsel Richard Meeran said Merck had not warned doctors and the public about possible cardiovascular risks associated with Vioxx.

What The Vioxx Mistrial Means Anyone Who Takes Medication

A federal jury in Houston couldn't decide whether Vioxx was responsible for causing a patient's heart attack. If a jury couldn't decide whether Vioxx was safe, what does it mean for you as a consumer?The main claim against Merck, the pharmaceutical giant who manufactured and distributed Vioxx, was that Vioxx caused all sorts of cardiac complications, and Merck never told the doctors or patients about these significant side-effects.Why is this so important to consumers who take prescription medication? To answer this question we need to understand how we prove that medication causes injuries.In New York, we must prove that the pharmaceutical company knew about dangerous side effects and failed to tell the physicians and the public that their product was inherently dangerous. We must also prove that the failure to inform was a substantial factor in causing the patient's injuries. Finally, we must also show that the injuries are significant and permanent.There is also a legal defense in New York called 'the learned intermediary doctrine'. This dooms many claims involving failure to warn about risks of a medication. The pharmaceutical companies use this legal defense by saying that they informed the physician about all the risks and benefits of the medication, and therefore they shouldn't be held responsible for any injuries the patient received. Since the physician is the 'learned' one, it would be the doctors' obligation whether to prescribe the medication to you and he'd know whether the medicine is right for you.Let's turn now to Vioxx and why the jury mistrial is significant for you, the consumer. As with all medication, there are known side-effects, even relatively 'harmless' medications such as over the counter Tylenol and other pain relievers. Just read the warning labels and you'll begin to see that such common pain relievers are filled with potential side-effects such as liver damage. In the Vioxx case, the injured victim claimed that Merck failed to warn the doctors about the likelihood of serious side-effects like heart attacks. The argument was that if the company who manufactured the medicine didn't tell the doctor about the serious risk, how then could this doctor pass the information along to the patient? Also, how could the doctor correctly judge whether or not this particular medicine was the right one for the patient's complaints?If you've taken a prescription medication in New York, and you believe that the medication caused you injury, you need to know 5 things-(1) Whether the injuries you suffered were a known risk of the medicine,(2) Whether the doctor who prescribed your medication knew that your injury was a potential risk of the medication,(3) Whether the pharmacy that dispensed your medication, did it correctly,(4) Whether there is any other explanation for your injuries, other than the medication, and(5) Whether the injuries you suffered are permanentTo answer the original question, "If a jury couldn't decide whether Vioxx was safe, what does it mean for you as a consumer?" it means that you must be able to prove your case with a reasonable degree of probability using medical and pharmaceutical experts. You must be able to prove that the pharmaceutical company failed to warn doctors about the significant risks of your injury, that the injury was a cause of your injury, and that the injury is permanent. In the Vioxx case, evidence revealed that certain medical studies showed Vioxx caused heart attacks, and that this information had never been made available to the doctors or the general public. However, the jury appeared to be deadlocked on Merk's responsibility to the consumer.Veteran New York malpractice lawyer, Gerry Oginski, offers 4 important holiday tips to keep you from being a potential medication victim:(1) When your doctor prescribes you medication, ask "What is it for," "Why are you giving me this prescription," "What are the side effects," "Will this interact with my other medications", "Are there other medications with less side-effects available?"(2) When you arrive at your pharmacy to pick up your medication, don't just pay and race out the door. Take a moment to look at your medication bottle. Is it labeled correctly? Is your name on it, and not someone else? Open the bottle up and check to see what the pill looks like. If you've never taken this pill before, ask the pharmacist if they're sure this is right pill. (It's happened plenty of times where the pharmacist mixed up your pills with another prescription simply through careless error.)(3) Read about the risks that come with your medication bottle. If you have no other choice but to take this medication then you understand the potential risks- even a small one. (4) If there are alternative medications you can take, you must decide with your doctor whether the risk of taking the medication outweighs the benefits the medication has to offer.As always, be an informed consumer. Doing so will minimize your risk of becoming a medication victim during this holiday season.

Major Painkiller Trial to Start

The Cleveland Clinic will direct a large-scale clinical trial to determine the cardiovascular safety of three painkillers commonly used by arthritis sufferers.
The trial will focus on three drugs — ibuprofen (Advil/Motrin), naproxen (Naprosyn or Alleve) and celecoxib (Celebrex) — all of which belong to the class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Celebrex is a cox-2 inhibitor, a member of a newer class of NSAIDs that avoided the gastrointestinal problems of the older drugs. Two other cox-2 painkillers, Vioxx and Bextra, have been pulled off the market because of documented heart risks.
The Cleveland Clinic trial, which will enroll 20,000 at-risk heart patients, is an attempt to figure out whether the NSAIDS that remain on store shelves pose any cardiovascular risks.
"We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded," said lead investigator Dr. Steven Nissen, who is the director of the clinic's Cardiovascular Coordinating Center.
"This is the trial that we've all been waiting for," added Dr. Mark Fendrick, an internal medicine professor at the University of Michigan. "It examines commonly used pain relievers at dosages frequently used in primary care, in patients at risk for cardiovascular events."
But the trial is also being funded by Pfizer Inc., which makes Celebrex, and experts worry that the integrity of the results could be called into question.
"I think the National Institutes of Health should take responsibility for conducting this type of clinical trial, where controversy and potential harm to the population are at stake," said Adil Shamoo, a professor of bioethics at the University of Maryland and co-founder of CIRCARE, a nonprofit dedicated to the protection of people used in research and medical treatment.
There is also the fact that the Cleveland Clinic itself was the subject of a lengthy expose published Monday by the Wall Street Journal. The article highlighted extensive ties between the institution and AtriCure, a company that makes equipment used in surgeries performed at the clinic.
According to the Journal article, a venture-capital partnership that the Cleveland Clinic helped found and invested in owns about 4.1 percent of AtriCure's stock. Patients were not told of these ties.
"In light of the problems they just had, I'm surprised they're doing this," Shamoo said. "What I would like to see are conflict-of-interest statements and complete financial disclosures for all involved, and the patients should be told that. This will affect what they're doing and the integrity of the research."
Nissen, who is also the president-elect of the American College of Cardiology, noted that special measures have been taken to guard the integrity of the trial's findings.
Pfizer will basically stay out of the trial, which has been dubbed the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) trial, he stressed.
"We've done some very unusual things," Nissen added. "The executive committee to run the trial does not have a Pfizer person on it. It's all academic. I have asked the academic participants to all agree that they will accept no honoraria, speaking fees, etc. from any manufacturers of drugs in this class."
In addition, Nissen intends to place the trial's database into the public domain by giving it to the National Heart, Lung, and Blood Institute.
"We're going to make this trial so transparent that everybody will believe it," he said. "We're committed to doing this in a way that, for patients and physicians, answers the questions using the best scientific methods and integrity."
Nissen, along with Dr. Eric Topol (also of the Cleveland Clinic), was one of the first to reveal the potential risks associated with Vioxx. Since then, several studies have pointed out similar risks, and Vioxx manufacturer Merck & Co. is now immersed in litigation over whether the drug caused heart deaths.
The Vioxx saga took a new twist last week, when the editors of the prestigious New England Journal of Medicine published a rare "Statement of Concern." It charged that the authors of a major study called VIGOR, published in the journal in 2000 and subsequently used as a strong argument for the drug's safety, withheld information on three heart attacks and other cardiovascular events among participants taking Vioxx. Executives of Merck were among that study's authors.
The unusual accusation was released last Thursday afternoon, as jurors in Houston began deliberations in the first federal trial against Merck. On Monday, a mistrial was declared after the jury declared it could not reach a unanimous verdict.
Topol, who testified against Merck during the latest Vioxx trial, is not on the executive committee of the Cleveland Clinic study that is about to get underway. However, he is advising Nissen. "We didn't want to have more than one individual from any single center," Nissen said. "He has been very generous with advising us. I will keep him engaged."
The trial participants are expected to be enrolled over 18 months and will be followed for an average of two years. In addition, the researchers will be collecting information on pain relief and on gastrointestinal bleeding.
The study will end when 700 of the participants have died or suffered a heart attack or stroke, according to a New York Times report. That's a number consistent with what would be expected in such a group even without use of painkillers, the newspaper said.
More information
The American Heart Association has a statement on pain medications.
Copyright 2005 HealthDayNews, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Will side effect of Vioxx cases be a bitter pill for consumers?

Imagine a pharmaceutical company putting a prescription medication on the market knowing that its use could result in death. In August, a jury in Texas awarded the wife of a Vioxx user $253 million in damages for the wrongful death of her husband, concluding that Merck & Co. had done just that.
But in the second state-level Vioxx trial, decided last month in Atlantic City, Merck and its executives were found not guilty. This week, the jury in the first federal Vioxx trial deadlocked. These results will affect the more than 6,000 complaints that have been filed against Merck, as both sides adjust their strategies.
Merck has already lost sales and, perhaps, consumer confidence. This large New Jersey company announced massive layoffs and five plant closings.
But one question needs to be answered: "Were Merck executives really at fault for not disclosing the potentially fatal side effects of Vioxx?" I recently asked the students in my MBA economics class. "I guess Merck should pay dearly if there was deception that resulted in deaths."
"That's not exactly true," one of the students said. She and about five others worked in the pharmaceutical industry. I encouraged her to continue.
She said pharmaceutical companies were in business to help people while making a profit for their stockholders. Her company invests years and often hundreds of millions of dollars in research and development to try to discover drugs that can help cure diseases and other medical conditions.
For every 15 drugs that look promising, she continued, maybe one makes it to market. Numerous and expensive clinical trials are conducted to determine the effectiveness of the medication and any negative side effects. The federal Food and Drug Administration then determines whether the benefits outweigh those potential side effects. If they do, the company is allowed to sell the drug. If not, the company absorbs a huge loss.
Many Vioxx users have had their pain reduced with no side effects. In her opinion, Merck did nothing wrong.
There is a potentially long-term problem here, she added. No one wants a high-risk product on the market, but lawsuits may do more harm than good. (Law firms are already advertising on TV for former Vioxx users to represent.) If Merck is unsuccessful in defending itself, it may have to scale back its business or close altogether.
If someone in the company did something improper, let's ensure it doesn't happen again. If damages to life have occurred because of Vioxx, let's fairly compensate, she said. But by awarding ridiculously large punitive damages, we are threatening the existence of drug companies. Look at all of the diseases and conditions that have been cured or minimized. Do we want to reverse that?
She has a point. Do we really want to punish an entire industry, prevent lifesaving medications from becoming available, and curtail future research?

Drug company's defence in Vioxx case suffers setback

THE drug company Merck's defence against claims for damages by people who suffered heart attacks after taking its painkiller Vioxx has taken a blow from a pillar of the medical establishment. In an online "expression of concern", The New England Journal of Medicine claims that Merck knowingly omitted three instances of heart attacks from a clinical study published in the journal in 2000.
The journal learned of the omission from documents submitted in one of around 7000 lawsuits pending against Merck since it withdrew the drug in September 2004. So far, Merck has suffered a $253.4 million loss from a wrongful death lawsuit in August, but successfully defended a personal injury suit last month. A third case ended on Monday when it was declared a mistrial.
The editorial calls for a correction to be submitted to the journal (DOI: 10.1056/NEJMe 058314). Merck responded with a statement denying that it had deliberately deleted any significant information from the study.
George Moseley, an expert in health law at the Harvard School of Public Health, says that issuing a correction to the published results would be seen as an admission of wrongdoing. Courts will now have to judge whether the omission of the data put patients at risk. "What the courts really have to decide is whether or not that led to injury," he says.

Expert Available to Comment on Merck's Document Gaffe, Data Leaks and How to Prevent Them

Pharmaceutical heavy hitter Merck, already plagued with lawsuits surrounding the safety of its Vioxx drug, is the latest to enter the ugly world of dirty documents and data leaks. According to New England Journal of Medicine (NEJM) Executive Editor Dr. Gregory Curfman, the Journal discovered that incriminating data regarding the link between heart attacks and Vioxx use had been deleted from Merck's study submission to the publication. The deleted content was revealed through a simple "Track Changes" manipulation in Microsoft Word.
Track changes misuses are just the tip of the iceberg when it comes to document mishaps and data leaks. And, the Merck incident is just one of many recent highly-publicized leaks of both hidden and obvious content in documents, leading to negative company perception or loss of business. Merck's mistake comes on the heels of document data leaks stemming from the White House, Pentagon, United Nations, Australia's banking big wig Westpac and several leading mutual fund firms.
Joe Fantuzzi, CEO of document integrity company Workshare, is available for immediate comment. Fantuzzi can walk you through the following document integrity and security issues:
* Merck's mistake and other common document mishaps
* Why Adobe PDFs lull users into a false sense of security
* How to identify a company's risk level for a potential document blunder
* Steps companies can take to proactively audit documents and prevent
these embarrassing and costly leaks from occurring
About Workshare
Workshare is the industry leading provider of Document Integrity software applications for professionals. Its products include Workshare Professional, DeltaView, DeltaView PE, Protect and TRACE! Workshare's customer base spans small to large organizations in every industry segment with more than 55 percent of the Fortune 1000 and 85 percent of the ProServices 250. In total, more than 5,000 companies and over 800,000 professionals in 65 countries use Workshare software. The company has offices in London, New York, Chicago, San Francisco, Frankfurt, The Hague, Hong Kong and Sydney. Workshare is the sponsor of http://www.metadatarisk.org, the definitive source for content security. For more information, visit http://www.workshare.com.
If you are interested in speaking with Joe Fantuzzi about document integrity issues, please contact Dave McKee at (781) 684-0770 or workshare@schwartz-pr.com.

Capitalism Kills #3: Case Studies In An Immoral System- Merck and Vioxx, plus the new bankruptcy law

The free enterprise system, AKA the free market, AKA capitalism, is an economic system, as we all know, that is dedicated to maximizing profits at any cost. Neither ethics, morality, honor, environmental concerns, nor human life itself will be spared by this system and its quest to put profits before people (and everything else). Here are some case studies of the system at work. The previous five case studies are archived on our website. CASE 6. We all see the ads on TV from the big drug companies, telling us how devoted they are to our health and well being. Here is a good example of their devotion from the New York Times of 12-9-05: “Medical Journal Criticizes Merck Over Vioxx Data” by Alex Berenson. It seems Merck was more devoted to profits than to human health. The New England Journal of Medicine is criticizing Merck for the way it faked its results on the safety tests on Vioxx its arthritis and pain drug. Berenson quotes Dr. G. D. Curfman, an editor at the journal: “They did not disclose all they knew. There were serious negative consequences for the public health as a result of that.” Merck is being sued now on the grounds that Vioxx causes people to have heart attacks and strokes. Could it possibly be that the executives, good honorable American businessmen, could have decided to hide and cover up that information for the sake the big bucks? In 2000 the journal published the result of the clinical trial of the drug-- the trial done by Merck to show, among other things, that Vioxx was safe. Well, Berenson reports that “the journal said the authors of the study had deleted some data about strokes and other vascular problems suffered by patients....” He also reports that the journal said the authors “also underreported the number of heart attacks suffered by patients taking Vioxx....” In fact, it seems that Merck knew that people taking Vioxx were four times more likely to have a heart attack than those who took an older pain killer such as Aleve! Dr. Curfman said, “The totality of the data didn’t look good for Vioxx.” But that didn’t stop the rush to market the drug which was not recalled until 2004. Let this be a warning for anyone who thinks the capitalist system has your interests at heart. Don’t trust anything corporations tell you! CASE 7. This is a great case. It shows how our government teams up with big business groups, in this case the banks, to take advantage of working people and the poor-- to keep them as debt slaves for their entire lives-- no joke! Lets look at another article from the Times-- “Newly Bankrupt Raking In Piles of Credit Offers” by Timothy Egan (12-11-05).
As you know, we now have a new tougher bankruptcy law-- one that banks spent over 100 million dollars lobbying for so you also know who benefits from the new law-- not the American people you can be sure. Right before the new law took effect, there was a surge of bankruptcies as people raced to take advantage of the older law to get out from under crushing credit card debt. Most of these people were not irresponsible spendthrifts. Many were in fact people who had no medical insurance and had to use credit cards to get treatment to just stay alive. The banks want these newly bankrupt people in their clutches again “because it [the new law] makes it harder for them to escape new credit card debt and extends to eight years the time before which they could liquidate their debts through bankruptcy again.” What banks are counting on is these people will still need money to survive, but this time around they can charge higher interest rates and get a lot of late fees, make people wait the eight years, instead of the old six, and the credit card debts, forgiven under the old law, must still be paid under the new one. This is, of course, all done for the benefit of the people: “The people coming out of bankruptcy need an opportunity to get back on their feet.” That noble sentiment came from the mouth piece for the American Bankers Association. Egan says that “consumer groups say that the new law has put millions of Americans at risk of being in a continuous debt loop through their credit cards.” In other words, of being permanent debt slaves to the banks! This was done by “our” United States Congress-- its obvious its not “we the people” who really run the show in Washington. The banks will make out like bandits because, consumer groups say, “ the new law makes it much easier to make money on people who live near the edge every month on their credit cards.” So, that’s the system--designed to exploit and make miserable the lives of the working people and the poor so the fat cats can live it up. “The banking industry,” Egan reports, worked in Congress for nearly ten years to pass the law, and critics say it gave them everything they wanted to increase profits from people prone to debt.” Finally note this information from a study called “The Plastic Safety Net”-- it reveals, according to Egan, that a full third of American households of low and middle income families “used credit cards for basic expenses-- rent, groceries and utilities-- in any four of the last 12 months.” This doesn’t include those who had to use the cards for medicine or hospital and doctor bills. Most of the victims of the banks are also older people (50 to 64). This Xmas when you watch, if you do, for the umpteenth time Frank Capra’s “Its A Wonderful Life” just keep in mind the real bankers are represented by Lionel Barrymore-- the James Stewart character is totally make believe. --Thomas Riggins is the book review editor of Political Affairs and can be reached at pabooks@politicalaffairs.net.

· Vioxx · Medicare

The Associated Press reports that Monday's mistrial "leaves Vioxx's maker Merck & Co. with the prospect of facing a new jury that could hear allegations that the company withheld information from the New England Journal of Medicine about a 2000 Vioxx study so the drug would appear safer than it was."Wolfe is director and founder of Public Citizen's Health Research Group and co-author of the newsletter "Worst Pills." He said today: "Public Citizen warned consumers in 2001 not to take the Vioxx because of adverse effects and evidence of a higher risk of heart attack. The fact that Vioxx can cause heart damage was known for years, but the FDA continually ignored warnings about it -- the FDA has sided time and again with the drug companies instead of the public."Wolfe added: "Vioxx was the ninth prescription drug to be taken off the market in seven years that Public Citizen warned Worst Pills subscribers not to use. ... There are 100,000 deaths a year in the United States from adverse drug reactions, and nearly 1.5 million people are injured so seriously by adverse drug reactions that they require hospitalization."More InformationJOHN GEYMANGeyman is professor emeritus of family medicine at the University of Washington. He is president of Physicians for a National Health Program and author of the just-released book Shredding the Social Contract: The Privatization of Medicare.He said today: "As a result of the Medicare act of 2003, many seniors are now picking drug benefit plans. The choices are confusing and meager for Medicare recipients, while the plans create lucrative new markets for the pharmaceutical and insurance industries. The underlying issue -- the uncontrolled escalation of drug prices -- was completely avoided, even to the point of prohibiting the federal government from negotiating deep discounts of drug prices through its bargaining clout, as it already does for the Veterans Administration. The Medicare bill of 2003 required the prescription drug benefit to be provided by private drug plans, even though private plans have been conclusively demonstrated by experience over the last 20 years to be more expensive and less efficient than the traditional Medicare program."Attempts to privatize Medicare are as old as the program itself and they have continued. A three-year $30 million media campaign launched in 1995 by the Heritage Foundation helped to promote market-based solutions to the 'Medicare problem.'"

Merck faces lawyer who beat them before on Vioxx use

Merck & Co, after one win, one loss and one mistrial in defending lawsuits over its Vioxx painkiller, will next face the lawyer who beat the company in the first case.
Thomas Cona, a Vietnam War veteran who took Vioxx over a two-year period for lower-back pain, claims the drug caused his heart attack. Merck has said there is some risk of heart attack or stroke after at least 18 months of Vioxx use. Cona will be represented by Mark Lanier, the Texas lawyer who won the first case, which produced a $253 million verdict against Merck.
At Cona’s trial, scheduled for February 27 in Atlantic City, New Jersey, Merck will have to persuade jurors that Cona wasn’t at risk notwithstanding its statements or that something other than Vioxx caused his heart attack, lawyers said.
Merck, the world’s third-largest drugmaker, is defending about 7,000 Vioxx lawsuits. “The plaintiffs already have part of their case established,” said Arnold Levin, a partner in Philadelphia’s Levin, Fishbein, Sedran & Berman, who represents federal Vioxx claimants and isn’t involved in the New Jersey case.
Merck will also have to explain the December 8 disclosure by a scholarly journal that the company withheld three heart attack cases from a study about risks to patients who took the drug.
Whitehouse Station, New Jersey-based Merck has set aside $675 million to fight Vioxx claims. A judge overseeing federal cases filed over the drug said in May the company ultimately may face more than 100,000 such suits. Bloomberg

Scientists plan huge painkiller risk study

The Cleveland Clinic Foundation said yesterday that it will direct a massive, $100 million clinical trial to assess risks that three popular painkillers may pose to people with heart problems.
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The study comes after the withdrawal of Vioxx and Bextra from the market, and the Food and Drug Administration's addition of warnings on other painkiller labels, left many patients fearing fatal consequences from their choice of pain relievers. The new trial will look at 20,000 arthritis patients with heart risks -- people typically excluded from clinical trials -- around the globe to determine the safety and effectiveness of Celebrex, ibuprofen, and naproxen.
''From a public health point of view, this may be the most important study that I'll ever do," said Dr. Steven E. Nissen, a Cleveland Clinic cardiologist who will lead the study. ''We've had all kinds of alarms raised. We've put black boxes on the entire class of drugs. So confusion has been enormous."
Pfizer Inc., the world's largest drug maker and manufacturer of Celebrex, will pay for the trial. But Nissen said it has been designed with safeguards to prevent the controversy raised by recent news that authors with financial ties to Merck & Co. misrepresented the heart risk of Vioxx in a pivotal New England Journal of Medicine article.
Scientists overseeing the new painkiller trial, which will be conducted in several countries, cannot accept funding from companies with similar drugs on the market or in development. Pfizer will get a courtesy copy of study results but cannot change how it is reported in scientific journals. The federal government will store a copy of the entire completed trial database, ensuring public assess.
The immediate past president of the American College of Rheumatology called the study ''very much needed." Many doctors have shied away from nonsteroidal anti-inflammatory drugs because of the new heart risk warnings in favor of narcotic painkillers, like OxyContin and morphine, that won't cause heart disease, but carry other risks.
''We're seeing a real increase in narcotics use, with all of its problems," said Dr. Elizabeth Tindall, a practicing rheumatologist in Oregon. The nonsteroidal painkillers ''all have black box warnings, so it's really created fear on the part of patients and on the part of docs. No one knows what to do."
Patient enrollment in the trial begins in mid-2006. People will be randomly assigned one of three daily drug doses to take for 24 months: 200 mg of Celebrex, 2,400 mg of ibuprofen (sold as Motrin), or 1,000 mg of naproxen (sold as Aleve).
Because of their existing heart risks, many will also take baby aspirin, which has been shown to help prevent strokes and heart attacks. And they'll receive a drug that protects against stomach bleeding associated with some painkillers, which will also help test the safety of a drug combination many patients turned to after Vioxx was withdrawn.
Celebrex is the sole drug in the troubled class of cox-2 inhibitors currently sold. Its sales from January to August this year totaled $1.05 billion, a 41 percent drop compared with the same period in 2004, according to IMS Health, a healthcare information company. Meanwhile, the arthritis drug Mobic benefited. Mobic sales for the first eight months of 2005 totaled $719 million, a 178 percent sales increase compared with the same time frame in 2004, IMS Health reported.
People in pain may have to wait up to four years to learn which of the trio of painkillers is safest.
Jason Napodano, an analyst at Zacks investment research in Chicago, applauded the study but predicted it would have little impact on Celebrex sales until results are reported. Celebrex, like Vioxx, was heavily marketed as a safer, superior alternative to naproxen in the absence of data to the contrary.
''Vioxx took 18 months to see a real statistical difference between Vioxx and naproxen, and we know that Vioxx clearly is not as safe. But Celebrex, I don't know," Napodano said. ''I think Celebrex is safer than Vioxx, but how it will compare to naproxen?"
Merck pulled Vioxx from the market in September 2004 after a company-sponsored clinical trial confirmed that it doubled the risk of heart attack and stroke. Pfizer withdrew Bextra from the market in April 2005. Merck has won one lawsuit filed in a New Jersey state court alleging that it failed to warn patients of Vioxx's heart risks, and lost one in a Texas state court. A third lawsuit ended in a mistrial in federal court on Monday.

2 Volusia residents join Vioxx lawsuits

Maureen Perricone and David Byrd of Volusia County were among the millions of people who found relief from nagging pain with Vioxx, a popular painkiller often praised as a wonder drug that worked when others failed.
But while taking Vioxx, both Perricone and Byrd suffered heart attacks, and claim in lawsuits the drug was to blame.
The two Volusia suits are among the nearly 7,000 suits facing Merck & Co. over its once-lucrative drug. This week, a judge in Houston declared a mistrial in a case brought by the widow of a 53-year-old Florida man who died after taking Vioxx for about a month.
In Volusia County, Perricone, of Port Orange, alleges in her suit that she suffered a heart attack in January 2004, just eight months before Merck withdrew Vioxx from the market. She alleges Merck concealed the cardiovascular risks associated with Vioxx.
Byrd, of Daytona Beach, makes the same allegations against Merck in his suit, but also named two of the company's sales representatives as defendants. Byrd alleges Daniel G. Myers of Duval County and Laura Swidler of Orange County promoted and encouraged physicians, including Byrd's doctor, to prescribe Vioxx and misrepresented the drug's safety and effectiveness.
Byrd, who had a heart attack in 2002, and Perricone say they have suffered permanent damages and disabilities. They seek unspecified damages in excess of $15,000.
Tampa attorney Brenda Fulmer, who represents Perricone and Byrd, said she has filed about 40 Vioxx cases statewide. She declined to discuss the Perricone and Byrd suits. But she said Merck "chose to ignore the safety risks" of Vioxx.
"If patients were properly warned, they wouldn't take the drug," she said.
Jeanine Clemente, a spokeswoman for Merck, said Tuesday the company has acted in the best interests of patients and will "vigorously defend itself" in the Volusia suits.
"Merck acted responsibly every step of the way -- from researching the drug prior to approval to monitoring the drug while it was on the market and to voluntarily withdrawing the drug when it did," Clemente said.
The Volusia suits allege that as a result of Merck's misrepresentations about Vioxx, it reaped more than $2 billion in profits in the 2000 alone.
Merck emerged from its first federal trial Monday with a hung jury when the panel failed, in about 18 hours of deliberations over three days, to reach a verdict. The panel was at odds over whether Merck was liable in Richard "Dicky" Irvin's 2001 death and whether the company failed to issue safety warnings that the drug could have serious cardiovascular repercussions.

Mistrial for Merck

MARGARET WARNER: Jury deliberations had resumed for just 20 minutes this morning when a judge declared a mistrial in the latest liability case involving the former blockbuster painkiller drug, VIOXX.
The jury had been deadlocked for three days in this first federal trial on whether VIOXX caused heart attacks and strokes, and whether its manufacturer, MERCK, failed to disclose the risks to the public.
The mistrial comes in the wake of an editorial by the New England Journal of Medicine last week. That editorial accused MERCK of omitting key data from a report on a VIOXX clinical trial that the Journal published in 2000.
For more on all this, I'm joined by our health correspondent, Susan Dentzer.
Susan, first of all, the judge wasn't talking and the jurors I don't think are talking -- but why do the attorneys think the judge declared a mistrial after what was I just think 18 hours of deliberation?
SUSAN DENTZER: Well, Margaret, in a federal case like this, the jury must reach a unanimous verdict. And the jurors had signaled, having started deliberating on Friday, the jurors had signaled to the judge as early as Saturday morning that they were deadlocked.
So the judge apparently let the deliberations continue Saturday and Sunday but concluded this morning that letting them deliberate any longer was not likely to produce any convergence among the jurors. If it was, it was going to be for a reason like everybody wanted to knock it off and go home and do their Christmas shopping and wasn't going to be for a substantive reason that they had really bridged their differences so the judge concluded a reasonable amount of time had passed and it was time to declare a mistrial.
MARGARET WARNER: Now this does come on the heels of this very widely publicized New England Journal editorial, which criticized VIOXX and VIOXX researchers. Do the attorneys think it's related in any way to the judge's concerns perhaps about the publicity that that editorial which came out late last week received?
SUSAN DENTZER: It does not appear to be the case. The attorneys for the plaintiffs asked the judge to dismiss the case, to declare a mistrial on Friday because of the editorial that had appeared on Thursday.
The judge, however, did not do that and then waited until today to declare a mistrial so it seems to be unrelated.
MARGARET WARNER: Tell us a little more about the New England Journal editorial. I mean, were they accusing MERCK of essentially cooking the results of this study?
SUSAN DENTZER: This is very murky but the language of the editorial does seem to do that.
In effect, this all goes back to a trial that took place in 1999 and the results were published in 2000. The trial weighed the results of taking VIOXX against another group that was also in the trial that was taking another painkiller, naproxen, commonly sold in brands like Aleve.
Essentially what the trial results showed at least in the published version that made it into the New England Journal is that there was a four times greater risk of heart attack and stroke among the patients taking the VIOXX versus the patients taking naproxen.
What the Journal editorial last week said was that the MERCK authors had omitted from those results three additional heart attacks which included in the trial sample would have knocked that rate to five times the number of heart attacks and strokes.
Now what the Journal article said was that MERCK researchers had deleted some of this data from the diskette that was sent to the Journal for the publication.
MERCK has said that, no, in fact what happened was the MERCK authors were leaving out the additional heart attacks that occurred after a preset window that was going to bear on the publication. They then though went on to report those three additional heart attacks to the FDA so that by the time the Journal article was out in November of 2000, the FDA knew about these additional heart attacks and those results became broadly public in 2001.
MARGARET WARNER: How unusual is it for a prestigious journal like the New England Journal to go back and critique a study they printed now, they published five years ago?
SUSAN DENTZER: It's unusual but it's becoming increasingly common in this environment that has grown up the last several years as we've had several very profile -- high-profile instances of drug safety issues like this.
And I suspect it will become more common in the future as people understand increasingly that a lot is riding on the publication results reported in these various journals about drug trials.
MARGARET WARNER: Because, again, they get a lot of publicity and then patients start asking the doctors for them.
Now we know, of course, that the companies developing the new drug, they pay for the study because nobody else even has the drug. But then if it goes to something like the New England Journal, how much independent or outside review, vetting, is there before they publish the study?
SUSAN DENTZER: There's a lot of outside review. All of these journals are so-called "peer review journals" so that other researchers in the same field will scrutinize the data.
But on the other hand they can't redo the trial so a lot is riding on the trust that is placed in the original investigators that they've collected -- that they've first of all designed the study accurately, they've collected the data accurately and so forth and so on.
So there's no completely foolproof way to keep misconduct from occurring in these publications but nonetheless I think they are scrutinized pretty heavily.
MARGARET WARNER: Now back to the MERCK -- the trial involving VIOXX that was declared a mistrial today. As Jim announced in the News Summary there's 7,000 of these lawsuits. Only two have been decided so far in state courts. Are all the plaintiffs essentially alleging the same thing?
SUSAN DENTZER: Well, they all allege that VIOXX caused the heart attacks and strokes in either the plaintiffs themselves if they're still alive, or their loved one if the loved ones have deceased after -- allegedly after taking VIOXX.
But there also are additional allegations in many of the suits: For one allegation that MERCK knew about the dangers of VIOXX and failed to warn the public until 2002 when the risks about VIOXX were included in the so-called "drug label," the information that goes to doctors. Anybody who was taking VIOXX before that could argue and has argued certainly in these cases that they were not adequately warned about the risks. And other cases have alleged misconduct on the part of MERCK, that MERCK hid the data, misinformed doctors about the risk, and so on.
MARGARET WARNER: So what's ahead for this particular case?
SUSAN DENTZER: This case is clearly going to be retried and there will be a conference with the judge and the attorneys for the plaintiffs and the defendants later this week to decide when. MERCK counsel said today they were very hopeful that that would happen as soon as February when more federal litigation is supposed to take place.
The bigger question though is: What's coming down the line in terms of other cases that are going to be litigated particularly at the state court level? One very important distinction among the cases is: How long were the plaintiffs taking the drug? This is important because when the drug trials were announced in September of 2004 that caused MERCK to pull the drug off the market, essentially those results only emerged after patients had been taking the drug for 18 months.
So MERCK has in essence played that up and said, see, the risks occur, the doubling of the risks of heart attack and stroke occur after you have been on the drug for 18 months.
Well, in this case in which the mistrial was just declared, the plaintiff --
MARGARET WARNER: One month.
SUSAN DENTZER: -- was only taking it about three weeks.
So in January we will see the first of these cases at the state court level where a plaintiff genuinely had been taking the drug for more than 18 months. This will go right to the heart of MERCK's defense in this case and will be a very serious -- if in fact the jury decides in favor of the plaintiff and not MERCK, it will be a very serious setback for MERCK.
MARGARET WARNER: Susan, thank you.
SUSAN DENTZER: Thanks, Margaret.

Attorney Brian Kabateck Named to California Vioxx Litigation Plaintiffs' Steering Committee

Los Angeles attorney Brian Kabateck has been appointed to the California Vioxx Litigation Plaintiffs' Steering Committee by California Superior Court Judge Victoria Chaney. The goal of the 13-member committee is to coordinate the thousands of California Vioxx cases, promote litigation efficiency and to minimize the risk of inconsistent rulings in similar cases in California and the nation. Committee members were selected based on their litigation experience and the number of Vioxx plaintiffs they represent.
LOS ANGELES, CALIF.--Los Angeles attorney Brian Kabateck has been appointed to the California Vioxx Litigation Plaintiffs' Steering Committee by California Superior Court Judge Victoria Chaney. The goal of the 13-member committee is to coordinate the thousands of California Vioxx cases, promote litigation efficiency and to minimize the risk of inconsistent rulings in similar cases in California and the nation. Committee members were selected based on their litigation experience and the number of Vioxx plaintiffs they represent.Committee members are currently interviewing witnesses, selecting experts and developing litigation strategies. They are also meeting with attorneys for Vioxx manufacturer Merck and with other state and federal Vioxx steering committees.All California Vioxx cases have been transferred to Superior Court Judge Chaney in Los Angeles who has implemented special procedures, including the use of the steering committee, to manage the Vioxx caseload. Currently, Kabateck's law firm, Kabateck Brown Kellner LLP, represents more than 800 individuals who have filed Vioxx lawsuits, the largest number of cases filed in California by a law firm."Trial dates for California Vioxx cases filed several years ago are being decided within the next few months," says Kabateck. "Before the trials begin, the steering committee must review seven million Merck documents and depose hundreds of key Merck employees."In addition to Kabateck, California Vioxx Plaintiffs' Steering Committee members are Tom Girardi and James O'Callahan, (plaintiffs' liaison counsel), Greg Owen, Mark Robinson, Thomas Brandi, Walter Lack, Joy Robertson, Brian Depew, Steve Skikos, Brian Panish, Tina Nieves and Rob Cartwright.

Vioxx mistrial a blip in Merck's radar

NEW YORK (CNNMoney.com) - The mistrial in the third Vioxx case gave investors a scare on Monday, but analysts say that it changes little for Merck, which has an improving pipeline but still faces thousands of lawsuits and is unlikely to show real growth for years.
"This case doesn't change anything," said Barbara Ryan, analyst for Deutsche Bank North America, who has a "neutral" rating for Merck. "This is going to play out over a very long period of time."
Evelyn Irvin Plunkett of St. Augustine, Fla., sued the company for the 2001 death of her husband, Richard Irvin, who died of a heart attack after taking Vioxx for one month. The federal judge overseeing the wrongful death case in Houston ruled a mistrial on Monday because the jury deadlocked.
Merck's stock price dropped 3 percent on Monday, but mostly recovered Tuesday morning.
Chris Shibutani, analyst for J.P. Morgan, referred to the mistrial in his note as a minor loss for Merck because it was unable to win a case which had been "largely favorable" for the company. Shibutani, who rates Merck a "neutral," said the downslide in stock price was "an appropriate market response."
The mistrial occurred on the trial's fourth day of deliberations, which began on Thursday just before the New England Journal of Medicine published an editorial accusing Merck of deleting information about Vioxx heart risks from a study provided to the journal in 2000. Merck denied the allegation. The Wall Street Journal reported that the jury was 8 to 1 in favor of Merck.
The first two cases in Vioxx litigation, both in state court, resulted in one loss and one win for the drug making giant, which still faces about 6,500 lawsuits and has vowed to fight them all. Merck requested that a retrial in the Plunkett case begin in February, and says the next scheduled trial is in federal district court in January, possibly to be held in New Orleans.
So what's the market landscape for Merck going forward?
John Boris, analyst for Bear, Stearns, painted a portrait of anemic but sustainable growth over the next few years.
"We see only limited upside to the stock, since earnings growth is not expected to resume for Merck until 2009 and the litigation news flow on Vioxx in the near term will be a major overhang," wrote Boris, who rates the company a "peer perform" or "neutral," in a note published Tuesday. Boris projects growth of 1 percent or 2 percent from 2004 to 2009.
In his Monday note, Boris outlined some of the problems that have been haranguing Merck all along, including the absence of Vioxx, an arthritis painkiller that had $2.5 billion in annual sales before it was pulled of the market in 2004; the long list of Vioxx lawsuits that have yet to go to trial; the impending 2006 patent expiration of Zocor, a $5.2 billion cholesterol-lowering statin; and the company's plan to cut 7,000 jobs and close or sell five plants to save $4 billion.
Boris said Merck's experimental vaccine Gardasil, for the prevention of cervical cancer, is the company's biggest potential product for bringing in new revenue. Boris projects $1.2 billion sales for Gardasil in 2010, assuming the Food and Drug Administration approves the drug.
The analysts interviewed for this story do not own stock in Merck, but the firms they work for have done business with the company.
Merck is holding a meeting for analysts and the press on Thursday regarding its financial future. To read more about this meeting

University issues statement on Vioxx study

On Dec. 8 the New England Journal of Medicine (NEJM) posted on its website an editorial article which calls into question certain data contained in the VIGOR (Vioxx gastrointestinal outcomes research) study published in the NEJM in 2000, whose lead investigator was a faculty member from U of T, Mount Sinai Hospital and the University Health Network. The study examined the gastrointestinal safety of the painkiller Vioxx.
The editorial alleges that at least two of the study's authors failed to disclose certain data that they had become aware of prior to publication. The university and Mount Sinai Hospital have discussed this issue with the lead investigator.
The lead investigator and her co-authors have begun a scientific evaluation of the scientific facts and data that the NEJM published this week. They will make every effort to complete this evaluation - in full accordance with applicable medical and scientific standards - as promptly as possible. Further comment on the data would be inappropriate until that scientific analysis is complete.
This evaluation of data published this week by the NEJM does not constitute or imply any investigation of the research by the university. The university will be closely monitoring further developments reported by the journal, the Food and Drug Administration in the U.S. and Merck & Co and the response of the authors. In the event that any information is brought to light that would require an official investigation by the university, due process would be initiated immediately.

Hung Jury in First Federal VIOXX(R) Product Liability Trial

Merck & Co., Inc. is disappointed a federal court jury in Houston, Texas could not return a verdict in Plunkett v. Merck and is prepared for a retrial, if that becomes necessary.
"We presented evidence that there is no medical or scientific evidence showing short-term use of VIOXX increases the risk of heart attack and no evidence that it contributed in any way to the unfortunate death of Richard Irvin," said Philip Beck, of the law firm of Bartlit Beck, Merck's lead trial lawyer in the case. "Mr. Irvin only took VIOXX for less than a month. He suffered multiple long-standing risk factors for a heart attack including partially clogged arteries. We believe that Mr. Irvin would have suffered a heart attack when he did, whether he was taking VIOXX or not."
"If a retrial is scheduled we will be right back with the same facts," said Kenneth C. Frazier, senior vice president and general counsel of Merck. "The VIOXX litigation will go on for years. We have the resources and the resolve to address these cases, one by one, in a reasonable and responsible manner."
The lawsuit was originally filed in Palm Beach County, Florida in May 2003 by Mr. Irvin's surviving spouse, Evelyn Irvin Plunkett. The case was re-filed in the federal Multidistrict Litigation (MDL) as case number 05-4046 in 2005.
The MDL is based in federal court in New Orleans; the Plunkett case was tried in Houston because of the effects of Hurricane Katrina. The Judge presiding over the MDL has said he plans to schedule three additional trials on a monthly basis, starting in February 2006. Merck is represented in the Plunkett case by Philip Beck and Tarek Ismail of Bartlit Beck of Chicago.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but also help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Key figures in first federal Vioxx trial

DEC. 12 12:56 P.M. ET Here's a look at key players in the nation's third Vioxx-related civil trial, and the first to go before a federal jury. The judge in the case declared a mistrial Monday because of a hung jury after about 18 hours of deliberations over three days.
--EVELYN IRVIN PLUNKETT, 56. Widow of Richard "Dicky" Irvin, a 53-year-old manager of a wholesale seafood distributor in St. Augustine, Fla. He died in May 2001 after taking Vioxx for about a month to ease back pain. The couple was married about 30 years, and had four children. Plunkett is a retired school secretary. Other plaintiffs are the couple's two youngest children, Richard Irvin III and Ashley Irvin.
--JERE BEASLEY, 69. Lead lawyer for Plunkett. Born in Tyler, Texas, and raised in Alabama, Beasley was the state's lieutenant governor from 1971-1979 and filled in for Gov. George Wallace for 20 days in 1972 when Wallace was hospitalized for the shooting that left him disabled. Beasley founded his Beasley, Allen, Crow, Methvin, Portis & Miles law firm in Montgomery, Ala., after he lost a 1978 gubernatorial run. In late 2003 and early last year Beasley represented Alabama Gov. Bob Riley in the retrial of the state's lawsuit against Exxon Mobil Corp. in a dispute over royalties from natural gas wells and won an $11.9 billion verdict. A judge cut the amount to $3.6 billion, and the company is appealing. Beasley also was among 27 lawyers who secured a $300 million settlement from Monsanto Co. in a federal lawsuit over PCB contamination in Anniston, Ala.
--ANDY BIRCHFIELD, 42. Co-lead counsel for Plunkett. A member of Beasley's firm since 1996, Birchfield manages the firm's mass torts section, which is handling cases involving Baycol, Rezulin, Celebrex, Bextra and hormone replacement therapy as well as Vioxx. Helped headline a conference on Vioxx for plaintiffs' lawyers in Philadelphia last January where he told attendees, "The liability picture, from a corporate conduct standpoint, we feel, is very, very strong."
--PHIL BECK, 53. Lead lawyer for Vioxx maker Merck & Co. A partner at Bartlit Beck Herman Palenchar & Scott in Chicago, Beck is a veteran litigator on behalf of corporations. He helped represent President Bush in the Florida "hanging chad" case during the disputed 2000 presidential election, and was the lead lawyer for Bayer Corp. in the nation's first Baycol trial in Corpus Christi in 2003, where Bayer was cleared of ignoring research linking the cholesterol-lowering drug to dozens of deaths. He also represented the Justice Department in its historic antitrust case against Microsoft Corp. and guided a 2001 settlement of allegations that the company was an illegal monopoly that thwarted competition.
--ELDON FALLON, 66. The former trial lawyer has been on the federal bench in the Eastern District of Louisiana in his hometown of New Orleans since 1995. Nominated by President Clinton to be a federal judge. In February, a panel of federal judges who serve on the Judicial Panel on Multi-District Litigation in Fort Myers, Fla. decided to transfer all pending federal Vioxx lawsuits to Fallon's court so he could streamline trial preparations such as depositions and document preparation. Fallon will preside over three more federal Vioxx trials early next year and then meet with attorneys on both sides to gauge the possibility of crafting a global settlement of all federal Vioxx litigation. Since 2000 the judge has been handling pretrial proceedings in thousands of lawsuits involving the former heartburn drug Propulsid, withdrawn from the market by Janssen Pharmaceutica Inc., part of Johnson & Johnson of New Brunswick, N.J.

Merck head 'misled jury in Vioxx court cases'

THE head of clinical trials at Merck faces claims that she misled jurors, after the publication of evidence allegedly showing that Merck failed to release data on the risk of heart problems in patients who took the painkiller Vioxx.
The allegations about Alise Reicin came as the latest trial involving a patient who died of a heart attack after taking the drug was declared a mistrial in federal court in Houston — the jury failed to reach a unanimous verdict following more than 18 hours of deliberation.
In the case, Ms Reicin gave evidence that Merck had never tried to withhold relevant findings from clinical trials.
However, last week, as the jurors were deliberating a verdict, the New England Journal of Medicine claimed that Merck had excluded data relating to three patients who had suffered heart attacks after taking the drug.
Lawyers acting for those now suing Merck have seized on the Journal’s findings. Mark Lanier, the lawyer who represented the first winning plaintiff to sue Merck over Vioxx, is in the process of filing a complaint against Ms Reicin.
Merck has in the past repeated that it never withheld any evidence. It said yesterday that there was a “misperception” about the data that was not included in the trial results, adding that the heart attacks happened after a “cut-off date” for clinical evidence to be included in the study.
Phil Beck, the chief external counsel for Merck, said: “The information in question came to light after a pre-specified cut-off date. Additional information about the studies was given to the FDA (US Food and Drug Administration). Alise Reicin testified to this effect in this case and has never lied in court.”
The mistrial verdict in Houston, which was the first Vioxx case to be heard in a federal court, was greeted by the plaintiffs as a huge failure for Merck and as a “big disappointment” by the company.
Roche, the pharmaceuticals company, has finally signed a subcontractor to bolster supplies of its antiviral drug, Tamiflu, which could help to stop a pandemic flu outbreak (Richard Irving writes).
Roche said that it had agreed a deal with Shanghai Pharmaceutical Group. It is in talks with a further 12 potential partners to sign sub-licensing deals that would alleviate any supply shortages of the drug.

Judge declares mistrial in Vioxx case

The latest trial accusing Merck, the struggling pharmaceuticals giant, of negligence in the development and marketing of its now withdrawn painkiller Vioxx, ended abruptly yesterday after the judge dismissed the jury because it had been unable to reach a verdict.
The mistrial offers little more than a reprieve to Merck. It faces roughly 7,000 different lawsuits related to Vioxx, which it took off the market last year amid claims that it caused heart attacks in patients who took it for 18 months or more. The company's share price slipped slightly on the news of the mistrial

Merck cuts highlight how ball game has changed for big drug makers

Merck & Co.'s announcement that it is slashing its work force by 11 percent and shuttering several plants is as much a reflection of pharmaceutical industry belt-tightening as of Merck's financial and Vioxx-related legal woes.
The reasons are many: Increased generic competition, pressures from health insurers to lower prices, rising drug development and marketing costs, fewer new blockbuster medicines, and worries about possible governmental price controls.
The upshot is that double-digit profit increases, routine for drug companies through most of the 1990s, now look to be history. It's also why drugmakers feel a sense of urgency to focus on leaner, faster production and other ways to hold down costs just as the airline and auto industries have been doing, experts say.
Drug makers "didn't have to worry about efficiency" before because they could demand virtually whatever price they wanted for products, said Albert Rauch, pharmaceuticals analyst at A.G. Edwards & Sons Inc. in St. Louis. "They just sort of got a little fat."
And extraordinarily profitable. The five largest U.S. drug companies — Pfizer Inc., Johnson & Johnson, Merck, Bristol-Myers Squibb Co. and Wyeth — earned $29.5 billion in 2004 on sales of $160 billion. Analysts estimate they will earn more than $37 billion this year as revenues rise to $162.4 billion.
Gross profit margins — revenues minus the cost of producing goods — also are still in the range of 70 percent to 80 percent, many times the 10-percent margins in some other industries.
Job cuts are one way of keeping margins high, and they are up 150 percent from the first 11 months of last year. That amounts to almost 25,000 pink slips so far for the industry in 2005, according to John Challenger, CEO of outplacement firm Challenger, Gray & Christmas, who predicted "we're going to continue to see increasing layoffs."
Generic drugs, which now account for 53 percent of U.S. prescriptions, contribute to these pressures. Next year, drugs with $28 billion in annual sales lose patent protection, according to health information company IMS Health. Those include Merck's Zocor and Bristol-Myers Squibb's Pravachol, both for high cholesterol, plus Pfizer's Zoloft and GlaxoSmithKline's Wellbutrin, both for depression.
Brand-name drugmakers also must offer rebates and discounts to get on managed care companies' lists of preferred drugs, a key factor, according to Tony Butler, pharmaceuticals analyst at Lehman Brothers.
Another problem is shrinking pipelines of new drugs.
"For at least 10 years, some of the brand companies were expending a lot of their effort and a lot of their time extending their monopolies instead of using their resources for innovation," focusing on legal loopholes and minor improvements in drugs that could extend their patents, said Kathleen Jaeger, chief executive of the Generic Pharmaceutical
Association.
Rauch said it's also getting harder to find drugs that are better and safer than existing ones. "Drug companies have become the next big target for lawyers," after the asbestos and tobacco industries, he added, and their legal costs are mounting.
So the U.S. drugmakers have begun to change, and their European counterparts such as GlaxoSmithKline and Sanofi-Aventis likely will follow suit, Butler said.
When Merck Chief Executive Richard T. Clark announced plans on Monday to cut 7,000 jobs and close or sell eight factories and research facilities by 2008, he said the goal was to make the Whitehouse Station, N.J.-based company more competitive and efficient, starting with its supply chain and manufacturing.
Analysts say Clark has been studying manufacturing in the computer industry, which has steadily decreased prices while making better products.
Butler said Eli Lilly & Co. has been working on improving efficiency using a program for boosting productivity and quality. That system is favored by high-tech conglomerates such as General Electric and Honeywell International.
Pfizer, the world's biggest drug company, in April said it plans to cut $4 billion in costs — about the same as Merck's goal — partly by closing 23 of its 93 factories. That's despite Pfizer having one of the highest operating profits of any company, 38 percent in the third quarter, Butler noted.
Bristol-Myers Squibb Co. and Schering-Plough slashed costs a few years ago when their profits were down significantly. And Wyeth is restructuring its sales force, one of the last areas companies usually target for cutbacks, to make more sales representatives part time.
Experts say they anticipate the cost-cutting to continue and even accelerate, particularly because the huge costs expected for the new Medicare prescription drug program are likely to drive the federal government to seek price controls or discounts to limit the program's costs.
Despite all the cuts announced at Merck this week, the company has said this is only the first part of its reorganization and it will announce further plans at its annual business briefing on Dec. 15.
Meanwhile, Merck's first federal trial over its withdrawn painkiller Vioxx began this week in Houston. Merck has won a state trial in New Jersey after losing one in Texas, but analysts say its liability could reach $50 billion and that the company will have to start settling cases as its legal bill rises.

Vioxx Jurors Struggle for Verdict, Told to Keep Trying

Saturday was a tense day in Courtroom 11B of the Federal Courthouse in Houston, where the first federal Vioxx case is being heard.
Mid-morning, the five men and four women on the jury sent word to U.S. District Judge Eldon Fallon that they were having trouble reaching a verdict. They've been working since Thursday afternoon to decide if Vioxx played a role in the fatal heart attack of 53-year-old Richard "Dickie" Irvin in 2001.
The judge called the jury into the courtroom and instructed them to keep deliberating for a "reasonable" amount of time and try to reach a verdict. After the jury left the courtroom, the judge told the lawyers that he wouldn't ask the jury to deliberate for an "undue" amount of time. He asked the lawyers to remain in court in case the jury returned.
Lawyers for both sides sat at the same spots they've occupied over the past two weeks, looking tired and sometimes pensive. Occasionally, the plaintiff's lawyers lounged in the jury box. Plaintiff Evelyn Irvin Plunkett and her family also waited.
This case was expected to be an easy win for Merck. Irvin had used the drug for less than a month. The study that led Merck to withdraw Vioxx from the market last year showed that risk of heart attack rises after 18 months. Merck says there's no evidence of short-term risk.
There were other factors that made this case weak for the plaintiff. Vioxx was prescribed to Irvin by his son-in-law, an emergency room doctor -- not by a doctor who had been the subject of aggressive marketing by Merck salesman. And Irvin's wife has remarried, which may make her a less sympathetic plaintiff in the eyes of some jurors.
Twice on Saturday afternoon, the lawyers were summoned to the judge's chambers, but returned without word of a verdict.
Around 5 p.m., the jury quit work for the day. They'll resume deliberations at 8:30 a.m. Monday.
About a third of the roughly 7,000 Vioxx cases against Merck are under Judge Fallon. He’s hoping that the verdict in this and a handful of other cases will help plaintiffs and Merck to craft a broad settlement. Merck's stance is that it will take every case to court.
Judge Fallon has estimated that the total number of Vioxx cases against Merck will reach a 100,000.

Stocks Rise Despite Smaller Intel Forecast

NEW YORK - Stocks rose in early trading Friday as Wall Street reconciled itself with Intel Corp.‘s tightened forecast and a recent runup in energy prices.
Oil and gas prices were higher in premarket activity but fell slightly despite a snowstorm in the Northeast that was expected to drive a spike in heating fuel demand. On the New York Mercantile Exchange, natural gas lost 13.4 cents to $14.86 per 1,000 cubic feet, and a barrel of light crude dropped 6 cents to $60.60.
Broader stock indicators were also higher. The Standard & Poor‘s 500 index was up 2.07, or 0.16 percent, at 1,257.91, and the Nasdaq composite index added 4.20, or 0.19 percent, to 2,250.66.
Intel trimmed $200 million from both the high and low ends of its fourth-quarter sales estimate, narrowing its forecast to a range of $10.4 billion to $10.6 billion. Intel‘s revision, which fell slightly below Wall Street expectations, follows a sharpened outlook at rival Texas Instruments and improved guidance from Xilinx Inc. Intel fell 23 cents to $25.47, while TI gained 25 cents to $32.88 and Xilinx rose 51 cents to $26.53.
Merck & Co. slipped 71 cents to $28.97 after the New England Journal of Medicine New England Journal of Medicine on Thursday said researchers failed to disclose that three patients suffered heart attacks in a 2000 Merck-funded study of its Vioxx Vioxx painkiller. Meanwhile, jurors in the first federal Vioxx trial were to continue deliberating whether Merck failed to warn about the drug‘s risks.
The Russell 2000 index of smaller companies rose 0.99, or 0.14 percent, to 686.21.

Vioxx witness fired from top posts

A cardiologist who testified at a federal trial in Houston that Merck & Co. Inc.'s Vioxx pain reliever posed an "extraordinary risk" of causing heart attacks has been removed from two leadership positions at the Cleveland Clinic medical school.
Eric Topol, 51, criticized Merck in testimony Dec. 3 at the trial of a lawsuit by the widow of Richard "Dicky" Irvin, who blames her husband's fatal heart attack on Vioxx. Two days later, Topol was removed as provost and chief academic officer at the medical school. He remains chairman of the clinic's cardiovascular medicine department.
Federal jurors began deliberating Thursday on whether Merck, which has significant operations in the Philadelphia area, failed to warn of Vioxx's risks before pulling it off the market last year. The jury is to return today to resume deliberations.
In August, a Texas state jury ordered Merck to pay $253 million to the widow of a Vioxx user, an amount that will be reduced to $26 million under state law. Last month, a New Jersey jury ruled that Merck was not liable for the heart attack of an Idaho postal worker.
Topol's removal from the academic posts had "absolutely" nothing to do with his testimony or his views on Vioxx, said Eileen Sheil, a spokeswoman for the Ohio hospital system. "We've had a series of changes in the administration and the way things are structured. Dr. Topol is a key physician here at the clinic, and he's done a tremendous amount that has contributed to the success of the clinic."
Topol did not immediately return a phone call or e-mail seeking comment. He has been a professor at the Cleveland Clinic since 1991, and assumed the medical school posts in 2001.
Topol has been a central figure in the scientific debate over Vioxx - which generated $2.5 billion in annual sales before Merck withdrew it last year - saying it doubled the risk of heart attacks and strokes in long-term users.
Topol wrote a paper in 2001 highlighting the risks of Vioxx, concluding that patients experienced sharply higher rates of heart problems four to six weeks after starting the drug. Merck says Vioxx poses a risk only after 18 months of daily use.
Topol testified that he and his colleagues urged Merck to conduct clinical trials on the risks and that the company refused.
Topol told jurors in the Irvin case that Merck researchers visited him before he published his paper and said "we had gotten it wrong, and we'd be embarrassed if we published it."
In a videotaped deposition, he said former Merck chief executive officer Raymond Gilmartin called Malachi Mixon, chairman of the Cleveland Clinic's board, in October 2004 to question why Topol had targeted Vioxx.
As Topol recalled it, Gilmartin said: "What has Merck ever done to the Cleveland Clinic to warrant this?" Topol testified that the approach by Gilmartin "appalled" him.
In 2002, Topol helped found the medical school, which accepted its first students in 2004, Sheil said. On Monday, the clinic's board will review Topol's removal from the leadership posts by chief executive officer Delos Cosgrove, Sheil said.
Topol created the clinic's division of clinical research, and oversaw an increase in National Institutes of Health grants from $50 million in 2001 to $90 million in 2005, Sheil said.
Shares of Merck fell 55 cents to $29.13 in New York Stock Exchange trading.

Divided Vioxx jury told to keep trying

HOUSTON, Texas (AP) -- Jurors considering whether Vioxx contributed to a man's death told the judge Saturday they could not reach a unanimous verdict, but the judge told them to keep trying.
The nine-member federal jury has deliberated more than 12 hours over three days.
"It is your duty to agree on a verdict if you can do so without surrendering your own conscientious opinion," U.S. District Judge Eldon Fallon told jurors.
The judge told the panel that if they fail to reach a unanimous verdict, the case would be tried again, resulting in additional cost, time and effort by both sides.
He added that another jury wouldn't be any more qualified to consider the evidence.
The panel is considering whether the drug was defective, and whether New Jersey-based Merck & Co. failed to warn about its risks and was negligent in designing and marketing Vioxx.
If jurors answer yes, they then must decide whether any of those factors contributed to the 2001 fatal heart attack of Richard "Dicky" Irvin, 53, of St. Augustine, Florida, whose widow is suing Merck.
Merck pulled Vioxx from the market last year when a study showed the drug could double risk of heart attack or stroke if taken for 18 months or longer. Irvin died of a heart attack after taking Vioxx for about a month to ease back pain.
Merck claimed Vioxx couldn't be responsible for Irvin's death because he took Vioxx for such a short time. The plaintiff's lawyers said several studies among the 58 clinical trials involving 10,000 patients conducted before Vioxx was launched in 1999 showed dangers after only a few weeks' use.
If the jury finds Merck liable, the punitive damages will be determined in a later hearing in which attorneys can make arguments or call witnesses. Then the panel will deliberate and consider awarding punitive damages.

Merck Shares Drop on Vioxx Study Report

Shares of Vioxx maker Merck & Co. fell for a second day Friday after the New England Journal of Medicine said authors of a study funded by Merck failed to disclose that three additional patients in a 2000 clinical study suffered heart attacks while using the now-withdrawn painkiller.
Dr. Alise Reicin, of Merck & Co., testifies in Atlantic City, N.J., in this Oct. 14, 2005, file photo during the second trial over the safety of arthritis drug Vioxx. Vioxx maker Merck & Co. concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller in a report on the study published in the New England Journal of Medicine in 2000, the journal wrote in an editorial released Thursday, Dec. 8, 2005. Reicin, Merck's vice president for clinical research was one of the study's authors. (AP Photo/Mary Godleski, File)
Shares of Merck fell 55 cents, or 1.8 percent, to close at $29.13 Friday on the New York Stock Exchange.
Authors of a study funded by Vioxx maker Merck & Co. failed to disclose in a report published in the New England Journal of Medicine in 2000 that three additional patients in a clinical study suffered heart attacks while using the now-withdrawn painkiller, the journal wrote in an editorial released Thursday.
The editorial, written by the journal's editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and managing editor Stephen Morrissey, also alleges the study's authors deleted other relevant data before submitting their article for publication.
"Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," the doctors wrote. Excluding the three heart attacks "made certain calculations and conclusions in the article incorrect."
Adverse cardiovascular events include heart attacks, strokes and deaths.
The findings of what became known as the VIGOR study have been a key part of testimony in the three product liability trials to date over the withdrawn drug, including one in which a federal jury in Texas began deliberations Thursday afternoon. The research was published more than a year after the Food and Drug Administration approved Vioxx in May 1999.
The study was intended to compare whether Vioxx caused more stomach ulcers and bleeding among patients with rheumatoid arthritis than for those using the older, cheaper anti-inflammatory naproxen. Over an average nine-month period, Vioxx did score better on that count, but the study also showed there were a greater number of heart attacks among Vioxx users.
In the article, Merck explained differences found in that study by saying naproxen is cardioprotective.
Merck shares fell 61 cents, or 2 percent, to $29.68 in regular trading on the New York Stock Exchange, then fell an additional 85 cents, or 2.8 percent, to $28.85 in after-hours trading, after news of the journal editorial circulated.
In a statement issued late Thursday, Merck said the additional heart attacks "did not materially change any of the conclusions of the article." The company also said the information was not included because the heart attacks were reported after Merck's cut-off date for collecting information on the patients in the study.
"Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, and included in numerous press releases subsequently issued by Merck," the company statement reads.
In a statement, article lead author Dr. Claire Bombardier of the University of Toronto, said she believed "the VIGOR paper appropriately disclosed the data as per the prespecified plan of analysis." She and the other authors are preparing a response to the Journal's editorial although she didn't specify a timeline for the piece. Bombardier has received research grants from Merck according to her disclosure on the original VIGOR article.
But Curfman said in an interview that Merck's arguments about the cut-off date "don't hold water" because journal articles are routinely updated with new data in the weeks before publication. "The health of the public, of many, many thousands of people, was at stake here," he said.
Data in Thursday's editorial show that 20 patients on Vioxx suffered heart attacks, instead of the 17 originally reported. Among patients in a comparison group taking naproxen, there were four heart attacks.
None of the three extra heart attacks was fatal, but that all three of those patients were in a group at low risk of heart attack, Curfman said.
The journal editor said he learned of the extra heart attacks and deleted data _ including the number of patients in the study who died _ when he gave a deposition on Nov. 21 for attorneys representing Vioxx plaintiffs in the Houston trial and three other federal trials slated for early next year. At the deposition, the plaintiff lawyers showed him documents they subpoenaed from Merck, including a July 2000 internal memo containing the deleted data.
Curfman said he and Morrissey spoke Monday with two researchers who led the study and the two, who do not work for Merck, said they would submit a correction to the journal as the editors requested.
The third author of the study was Dr. Alise Reicin, Merck's vice president for clinical research. Reicin testified on Wednesday in the Houston trial that the company never misled doctors and the public about studies linking heart attacks to Vioxx.
Plaintiff's attorneys declined comment in Houston on Thursday when asked if the New England Journal revelations might prompt them to ask for a mistrial. Attorneys in that trial are honoring the judge's request that they not to speak to the media until a verdict is reached. The jury ended deliberations on Thursday without reaching a verdict.
Merck withdrew Vioxx, once one of its top-selling drugs, from the market on Sept. 30, 2004, after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use. The company now faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated could reach $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.
Dr. Eric Topol, chairman of cardiovascular medicine at the Cleveland Clinic, first published his concerns about Vioxx's safety in 2001 after finding discrepancies between the Journal article and data at the FDA. In a videotaped deposition shown at the Houston federal trial, Topol accused Merck of scientific misconduct by misrepresenting data.
Topol said he felt vindicated by the journal article. "This is what I've been asserting for some time," Topol said.

Federal Vioxx trial in the jury's hands

Merck & Co. knew that its painkiller Vioxx increased heart-attack risks but misled doctors and the public because it was more concerned with profits, a plaintiff's attorney said yesterday in closing arguments of the first federal trial involving the drug.
"They could take the high road to patient safety, or they could take the low road to sales," attorney Andy Birchfield told jurors. "What did they do? They pushed forward."
Merck's lead attorney, Phil Beck, said that the pharmaceutical company issued adequate warnings based on studies showing that Vioxx was safe. He said that Merck scientists put patient safety first and were not "evil" or "out to make an extra buck."
Beck said that evidence showed ruptured plaque in an artery caused a blood clot - not Vioxx - leading to the 2001 death of Richard "Dicky" Irvin, 53, of St. Augustine, Fla., whose widow is suing Merck. Beck said studies show Vioxx can lead to cardiovascular problems after 18 months but isn't considered a real risk until after three years. Irvin had been on Vioxx only a month when he died.
Although Merck voluntarily took Vioxx off the market last year, jurors cannot consider that as evidence that the product was defective or the company negligent, Beck said.
Jurors began deliberating yesterday afternoon.
The nine jurors, whose decisions must be unanimous, will decide whether Merck failed to warn Irvin's doctor about the risks of taking Vioxx, whether the painkiller was defective and whether Merck was negligent in designing and marketing the drug. If jurors answer yes to any of those questions, they must decide whether any of those factors helped cause Irvin's death.
This is the first federal trial over Vioxx; Merck has already lost one state trial over the drug and won another, but it faces about 7,000 lawsuits. The Irvin case was moved to Houston from its original venue of New Orleans because of damage from Hurricane Katrina.
Birchfield urged jurors not to award anything to Irvin's family for the loss of his estate and for funeral expenses, but to award about $350,000 to his widow, Evelyn Irvin Plunkett, and $53,000 to his youngest daughter for their loss of support and services. Birchfield said he did not know an appropriate amount for the companionship and parenting lost by Plunkett and her two youngest children, who were minors when Irvin died.
Plaintiff's attorneys told jurors that Merck rushed Vioxx to the market in 1999, despite studies showing safety risks, because it was about to lose patents on other profitable drugs. They also said that Merck should have issued label warnings promptly after a study in 2000 showed that Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen.
Instead, Merck explained the results by saying that naproxen has a protective effect on the heart and by denying that Vioxx leads to heart attacks.

Merck Allegedly Withheld Vioxx Data

As Nils Lofgren would say, 'Can't buy a break.' Stocks stank up the place on Thursday. Why? Because it's winter and oil prices went up and that sent stocks down? Come on! Dow fell 55 to 10,755, while Naz was off 5 to 2,246. Get it together stocks! Hey watch me, Rosemary Clooney (I'm not sure why. I was just thinking "Mambo Italiano.")* I mean Andy Serwer on CNN's American Morning and In the Money. Read Loose Change to see my new favorite lemur picture! Here's what is going on:
MERCK: This in from David Stipp: The New England Journal of Medicine (NEJM) just came out with a release saying that Merck deleted data about three heart attacks among patients on Vioxx before sending in a key paper to the NEJM. This is very bad news for Merck--rarely, if ever, has the world's No. 1 medical journal starkly accused a company of withholding important data on a potentially fatal risk. The NEJM has requested that Merck submit a correction. Woe is they. Merck closed down nearly 3% to $29.68.
In a statement issued late Thursday, Merck said its paper "fairly and accurately described the results of the study as of the pre-specified cutoff date for analysis. The additional [heart attacks]…were reported after the pre-specified cut-off date and therefore were not included in the primary analysis reported in the New England Journal article. Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA's Advisory Committee in February 2001, included in numerous press releases subsequently issued by Merck, disclosed to physicians given a copy of the article by Merck and detailed in the updated prescribing information for VIOXX. We also note that these additional events did not materially change any of the conclusions in the article."
YARD: Don't blame Toll Brothers for Wall Street's disappointing session. The company announced its best quarter ever—yes we expected that—but then said that next year's profit would be less than anticipated. But maybe not THAT much less than anticipated, because the stock rose 3.6% to $35.55….How big is the iPod? The first 14 pages of the Sharper Image catalog (excluding the inside cover) are iPod peripherals. Apple up a bit today, to $74.08. Company has a $62.4 billion market cap. Time Warner has an $82.8 billion market cap. CEO Dick Parsons was addressing the Credit Suisse First Boston media conference Thursday and according to Reuters spoke about how "We've been talking to a whole range of people about how we can make more robust technology, get a principal position in (search technology), and get more traffic." He added: "We were late to the game. We have to catch up." I guess the market wasn't too excited. TWX was off almost 2% today....WAL-MART WARS #238: "Wal-Mart Runs Local Newspaper Ads After Publishers Complain They're Ignored by Retailer" SPRINGFIELD, Mo. (AP) — Wal-Mart Stores Inc. placed full-page advertisements in 336 Midwestern newspapers after publishers nationally complained they are ignored by the world's largest retailer. The move comes at a time when the company is trying to address accusations it treats workers poorly and drives local shops out of businesses."
BAD FOOTBALL: Did you see this? From Sportsinteraction.com, one of the oldest sports books on the web: Bookies Take a Battering on NFL's "Black Sunday"....DECEMBER 7, NEW YORK — "An unprecedented run of favourites winning last weekend in the NFL has left the bookmaking industry paying out millions to its football bettors, a leading online sportsbook has revealed....Sixteen NFL games were played last Sunday and Monday, and twelve favourites won and covered the spread. The culmination was Seattle's demolition of Philadelphia on Monday Night Football. Good news for bettors, but not so good for the bookmakers who have to write the checks....'We're calling it "Black Sunday",' revealed Anthony Munnelly, vice president of Sports Interaction, the first online sports book licensed and registered in the United States. 'In my time in the industry I have never seen a Sunday like it. It's very unusual to see that many favourites cover at any one weekend, especially in this era of parity,' added Munnelly. 'I'm happy for our customers, they won their money fair and square and good luck to them. But when I'm writing my letter to Santa later this week I'm going to ask for some underdogs to start biting, before I end up standing on the street wearing a red hat and ringing a bell.'"
DON'T GIVE UP. DON'T EVER GIVE UP: Watched the Jim Valvano speech for the third time. Todd says I'm a sucker. This speech always chokes me up. "Cancer can take away all my physical ability. It cannot touch my mind; it cannot touch my heart; and it cannot touch my soul. And those three things are going to carry on forever."
Loose Change
: Oh what I would give to have a light switch in my office! Anything!!!!...Lemur!....Mike says: "NY Times reports Jet coach Herm Edwards told his friend, Colts coach Tony Dungy, not to call him "because we have bad karma over here. We don't want you to catch it over the phone." This sounds like a scene from the NBC's comedy, My Name is Earl....From Corey: "We sampled the Grizzly Flat Petite Sirah last night with steaks that Jim prepared for four of us. Ok, we did more than sample, we drank the whole bottle. Comments around the table were the following: 'Very simple, very dry,' 'makes the taste buds tingle,' 'robust.' All fancy descriptions aside—although we are just a bunch of amateurs who probably know their beer better than their wine—we liked it." Corey also sent me this: "Tuesday night I went to the best press event. Ever. Hershey hosted a night of indulgence that included LOTS of dark chocolate, chocolatinis, yummy appetizers, manicures, pedicures and massages. Ladies flocked from publications such Jane, Good Housekeeping, Newsweek, Self and of course FORTUNE. There were several points Hershey was trying to make. First of all, Hershey chocolate, even though you can buy it in a drugstore, can taste VERY premium. Second, there are health benefits from the dark chocolate flavanols (a kind of antioxidant). Third, and maybe I am reading too much into this, but, after all the hard work, journalists deserve a spa day."....Check this out: "Attached please find an invitation to our annual 'off-the-record' press reception to be hosted by Merrill Lynch executive and senior management. It will take place on the evening of January 18. Below is a list of expected Merrill Lynch attendees." WHY????....*Check out Rosemary's website here.