Vioxx, Celebrex and Aleve: Ills of a too-free market?

"Major drugmakers are having a run of bad luck that could make for a sequel to the box-office hit ``Lemony Snicket's A Series of Unfortunate Events'' - but for the fact that this is no mock-Gothic story line, and that real-life patients' health is at risk." [Fort Wayne News-Sentinel]

FDA urges limits on Celebrex, Bextra

"The Food and Drug Administration issued a public health advisory Thursday, recommending doctors limit the use of Pfizer Inc.'s Celebrex and Bextra to patients who can't take other pain medicines." [CNN.com]

Study halted due to increased heart attacks, strokes in those taking naproxen (Aleve)

"An Alzheimer's disease prevention trial was suspended after researchers said there were many more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve." [Canada.com]

US regulator calls for limits on use of Celebrex, Bextra

"US regulators called Thursday for use of Pfizer's painkilling drugs Celebrex and Bextra to be limited, urging doctors to keep in mind indications of higher heart attack and stroke risks." [Turkish Press]

Health Canada issues safety information on Vioxx, Celebrex, Bextra & Mobicox

"Health Canada wishes to inform Canadians of safety concerns regarding the group of drugs known as selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib), and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain)." [Medical News Today]

EMEA Statement On Valdecoxib (Bextra/Valdyn) & Parecoxib Sodium (Dynastat/Rayzon)

"The European Medicines Agency (EMEA) and its Scientific Committee for human medicines have been made aware of new safety information on cardiovascular and serious skin adverse events in relation to the use of valdecoxib and parecoxib sodium." [Medical News Today]

Pfizer Suspends Celebrex Advertising

"Pfizer Inc. is indefinitely suspending all consumer advertising of its arthritis drug Celebrex, following last week's revelation of a study that showed high doses caused an increased risk of heart attacks among cancer patients." [Atlanta Journal-Constitution]

Merck's shares slide in wake of news report on Vioxx

"BOSTON (CBS.MW) -- Merck & Co. shares fell more than 10 percent Monday on a news report that the company may have known for years that Vioxx, the pain reliever it recently withdrew from the market, could cause cardiac problems in some patients" [NewsRatings.com]

World of Pain for a Class of Drugs

"Right now, the COX-2 inhibitor drug market is riddled with uncertainty and in desperate need of pain relief." [TheStreet.com]

CBS News | Pfizer: Celebrex Poses Heart Risk

"(CBS/AP) Pfizer Inc. says it has found an increased risk of heart problems with patients taking its painkiller Celebrex, a drug that is in the same class as Vioxx, which was pulled from the market in September because of safety concerns." [CBSNews.com]

A Brief History of Celebrex and Bextra

"Pfizer didn't have much time to take advantage of Merck's misery after withdrawing its painkiller Vioxx from the market. Two of Pfizer's arthritis drugs, which belong to the same class as Vioxx, are now under regulatory and investor scrutiny. Here's a list of key events and dates." [TheStreet.com]

Germans restrict COX-2 inhibitor use

"The Drug Commission of the German Medical Association says COX-2s should not be used for more than six months. Anyone who is already at risk of heart disease, stroke or other cardiovascular disorders should not have the drugs at all, they say." [MedicalNewsToday.com]

Essay: We Love Them. We Hate Them. We Take Them.

"Medical anthropologists have written at length about how medications 'commodify' health, fostering the illusion that it is something bought and sold at market. In doctors' offices and in medicine cabinets, though, a reverse process takes place: we all anthropomorphize pills right back from commodities to willful agents of good or evil." [NYT]

Merck to Cut About 5,100 Jobs by Year's End

"Merck & Co., under siege because of lost revenues from its recalled blockbuster arthritis drug Vioxx, will cut about 5,100 jobs by year's end, 700 more than originally planned, and will slash hundreds of millions of dollars in spending, Chairman Raymond V. Gilmartin said Tuesday." [Forbes.com]

Ex-judge says Vioxx probe won't hide facts

"Merck & Co.'s internal investigation of the withdrawal of its Vioxx painkiller will take months to complete and won't hide any facts, said John Martin Jr., a retired federal judge hired to conduct the probe."

[Martin currently works for a defense law firm. And . . .]

"Many lawyers at the firm will help him review documents and interview workers at Merck, based in Whitehouse Station, N.J., he said." [Salt Lake Tribune]

Cummings company revealed Vioxx problems to the nation

"Two years ago, researchers at a Beverly company thought there might be something wrong with Vioxx, the prescription pain-killer pulled from the market on Sept. 30, 2004. Instead of helping heart disease patients, researchers at Elucida Research said Vioxx seemed to becausing heart attacks and strokes." [TownOnline.com]

Merck sets up new Vioxx review

"Drugmaker Merck has set up an independent committee to review the firm's actions prior to the withdrawal of its painkiller Vioxx from the market in September.

. . .

"Merck has appointed William Bowen, chair of the firm's corporate governance committee, to chair the special committee. " [Guradian UK - Emphasis added]

Merck Slashes Its 2005 Estimates on Vioxx

"The withdrawal of painkiller Vioxx will reduce 2005 earnings of Merck & Co. Inc. to between $2.42 and $2.52 a share, below the already diminished expectations of Wall Street analysts, the huge drug maker said Wednesday." [Forbes.com]

Cramer: What's going on? Merck execs do not deserve big pay packages

"Does anyone ever lose in high-level corporate America? I have to tell you, as I read about how these Merck people will be compensated after what has happened under their watch, frankly, I am embarrassed for us as a country." [Rocky Mountain News]

Questions loom over Merck’s severance plan

"What does it take to stop executives from lining their own pockets? Not much, at least when you look at the recent decision by Merck & Co. to give fat severance packages to 230 of its top managers if there is a buyout or a merger." [DailyItem.com]

Lipitor - Vioxx: Discovering The Statin - Painkiller Chain Reaction - Health Supreme

"The recent withdrawal of Merck's blockbuster painkiller Vioxx may actually afford us a glimpse of a chain of events that is normally well hidden in research papers, at best selectively disclosed to the medical community. Vioxx and other new-generation painkillers such as Bextra and Celebrex have all come under fire for their tendency to cause an increase of heart attacks." [New Media Explorer]

With or Without Vioxx, Drug Ads Proliferate

"JUST seven years after the Food and Drug Administration ended decades of restrictions by allowing drug makers to advertise prescription products directly to consumers, spending on such ads has reached $3.8 billion." [NYT]

Corporate arrogance still rules, despite recent scandals - 12/01/04

"Free-market capitalists tired of the cliche that Big Business Bosses do what they do mostly to enrich themselves should take a look at embattled Merck & Co. Inc.'s latest executive pay trick.

"It would make any self-respecting executive a little sick because it's another exception that confirms the stereotype.

"Here's a company whose shares have tanked 38 percent since it pulled its Vioxx arthritis drug from the market Sept. 30 because of links to heart problems. Yet, in the name of 'retention,' Merck is giving 230 executives rights to one-time payouts equal to as much as three times their annual salary and bonus should Merck be acquired." [The Detroit News - Opinion]

UN pricks pharma's conscience

"A US opinion poll published last week showed that the percentage of adults who think drug companies 'generally do a good job of serving their consumers' had dropped from 80 per cent to just over 40 per cent since 1997." [swissinfo.org]

Study finds risk with Pfizer drug

"Patients who had been given the Pfizer painkiller Bextra had more than twice as many heart attacks and strokes as those given placebos, according to preliminary results of a study presented at an American Heart Association meeting in New Orleans." [International Herald Tribune]

What Next? Former Vioxx users have several options

"Patients with osteoarthritis who took the pain medication Vioxx have several options to discuss with their doctors . . ." [Winston-Salem Journal]

Merck Demands Specific Proof in Vioxx Suits, Court Records Show

"Keith Stubblefield took Merck & Co.'s Vioxx painkiller for six weeks before he had a fatal heart attack while washing his car. His widow sued Merck, saying that Vioxx killed him and that the company hid the drug's risks." [Bloomberg.com]

Merck to Award Hefty Severance in Event of Merger

"Merck & Co. implemented a sweeping plan to award more than 200 company executives hefty severance packages in the event of a major merger or acquisition." [Smartmoney.com]

FDA Interfered With Vioxx Article Publication

"An official from the U.S. Food and Drug Administration took the unusual step of calling a medical journal's editor to question the legitimacy of an article critical of the now-defunct painkiller Vioxx, only days before the article was to run, USA Today reported Monday." [The Atlanta Journal-Constitution]

You Want A Moral Issue? How About Drugs That Don’t Kill?

"As Democrats continue to search heaven and earth for a moral values issue they can call their own, I have just the prescription: Why not start with the immoral behavior of giant drug companies such as Merck that continue to sacrifice the health of the public on the altar of higher and higher profits?" [Arianna Huffington, Editorial @ Common Dreams]

Merck execs protected in case of takeover

"Merck & Co. Inc. has adopted a severance benefits plan aimed at protecting key managers in the event the company is taken over — a growing possibility since the withdrawal of arthritis drug Vioxx sent shares tumbling." [MSNBC]

Big pharma haunted by the spectre of Pinto

"Remember the Ford Pinto? It was a small car with a poorly located fuel tank, which happened to explode if someone went into the back of it. Ford had lobbied US regulators against making changes to the car, producing a cost/benefit analysis that said 'only' 180 people were likely to be killed by the Pinto's faults. And that was not worth the $137m . . . that would have been needed to sort out the problem. The regulators were not impressed. Nor were the courts. Nor were the public. Ford's reputation went through the floor.

"Is the same thing happening in pharmaceuticals? " [The Independant]

Fool.com: 5 Drugs to Worry About?

"By comparison, Vioxx is estimated to have been used by 84 million worldwide and was thought to have been in use by more than 2 million at the time of the drug's withdrawal. Vioxx can cause strokes and heart attacks. [FDA scientist] Graham estimates the number of victims in the U.S. as high as 139,000 -- significantly greater than the 27,785 the FDA estimated in October, based on analyzing a database of 1.4 million patients in the Kaiser Permanente health care system." [Fool.com - Commentary]

Lessons From The Vioxx Fiasco

"What a mess. Weeks after Merck & Co. (MRK ) yanked its blockbuster painkiller Vioxx off the market, the furor is still raging. How could a drug get to $2.5 billion in annual sales despite evidence that it caused heart problems?" [BusinessWeek Online]

NPR : Drugs' Safety Questioned in Hearing on FDA

"All Things Considered, November 19, 2004 - A scientist singles out five drugs as unsafe while testifying before a Senate committee on the Food and Drug Administration's oversight of Vioxx. David Graham said Thursday that the agency suppressed his criticism of the pain medication, which has since been withdrawn from the market." [NPR Audio]

VIOXX HEARINGS: GET A TASTE OF YOUR OWN MEDICINE

"When pharmaceutical giant Merck & Co. abruptly pulled its arthritis pain medication Vioxx from the marketplace on Sept. 30, more than 2 million patients were taking the drug. Until then, they likely didn't know that the medicine designed to lower their risk of stomach bleeding also doubled the risk of heart attacks and stroke."

"But officials at Merck had suspected as much for at least four years." [The Southern Illinoisan - Editorial]

Merck steps up PR campaign after recall

"Merck & Co.'s campaign to defend itself in the wake of the recall of the pain reliever Vioxx intensified as it placed a package of three full-page ads in seven prominent newspapers beginning last Friday. That follows several television appearances as well as testimony before Congress by the company's chief executive.

"But public relations experts are calling the campaign predictable and said it lacks a crucial element necessary to bolster Merck's claims that it acted responsibly and timely in removing Vioxx from the market: Parties with no self interest or financial ties to the company coming to its defense." [Seattle Post-Intelligencer - AP]

Betterhumans > Heart Finding Raises More COX-2 Concerns

"A new study by researcher Garret FitzGerald and colleagues at the University of Pennsylvania in Philadelphia shows for the first time that in female mice, hardening of the arteries isn't prevented directly by estrogen, but rather is more directly stopped by cyclooxygenase 2 (COX-2).

"The finding raises even more concerns about the use of COX-2 inhibitors such as Vioxx (which was recently pulled from the market) in premenopausal women." [Betterhumans.com]

Study Suggests How COX Drugs Cause Heart Disease

"Painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries, researchers proposed on Thursday.

"The drugs, known as COX-2 inhibitors, include Merck and Co.'s Vioxx, which earned the company $2.55 billion a year but was pulled off the market on Sept. 30 after a study showed it doubled the risk of heart attack and stroke." [Reuters]

The Murky History of Merck's Vioxx

"Merck's (MRK :NYSE - news - research) decision to withdraw its popular arthritis drug Vioxx from the market in late September has raised questions about the process leading up to its regulatory approval in 1999 as well as the importance of subsequent medical studies.

"Here are some key dates in the Vioxx saga . . ." [TheStreet.com]

Early Vioxx Alarms Alleged

"Federal regulators and the drug maker Merck & Co. were aware of risks that the company's Vioxx painkiller could cause serious heart problems before the drug was approved in 1999, government and expert witnesses told a Senate committee Thursday." [LA Times]

Forbes.com: Say No To (Prescription) Drugs

"The results of pill dependence are insidious and devastating: billions of dollars in ever-higher drug costs; millions of people enduring sometimes highly toxic side effects; and close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the elderly, one major study estimates. And every few years comes the ultimate medical catastrophe: a miracle cure that turns out to be toxic--the latest case being Merck's" [Forbes.com]

Merck Strikes Back: Episode II

"Merck, the New Jersey drug-maker, plans a counter-offensive in the escalating battle over Vioxx, the Financial Times reported Monday.

"The company plans to produce internal documents and e-mails to rebut allegations it tried to protect annual sales of $2.5 billion with a five-year campaign of deceitful science and marketing." [Forbes.com]

Gilmartin Strikes Back

"Merck & Co. Chief Executive Officer Raymond Gilmartin said his first indication that the painkiller Vioxx carried a heart risk came on Sept. 23, and the company withdrew the medicine a week later."

. . .

"Dr. Eric Topol, the Cleveland Clinic's chairman of cardiovascular medicine, told the CBS news program ``60 Minutes'' last night that data from a 1998 Merck clinical trial called ``Study 090'' found that serious cardiovascular events occurred about six times more often in patients taking Vioxx than in those taking other arthritis drugs or a placebo. The study was never published, Topol said.

"The combination of 'Study 090' with a larger trial, known as Vigor, performed a year later should have raised alarms at Merck in 2000, Topol told the show." [Bloomberg]

HoustonChronicle.com - Vioxx maker nixed heart study, report says

"Vioxx maker nixed heart study, report says: "Top executives at pharmaceutical giant Merck & Co. decided in May 2000 against developing a study to test directly whether its Vioxx painkiller drug might pose a heart risk, The New York Times reported today.
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"Just two months after results from a clinical trial suggested that the popular anti-arthritis drug might cause a higher risk of heart attacks, company scientists questioned whether a focused trial was possible, the Times reported." [Houston Chronicle]

Reuters AlertNet - Merck knew Vioxx was unsafe by 2000 - report

"Pharmaceutical giant Merck & Co Inc. had evidence by 2000 that its painkiller Vioxx, which was pulled off the market on Sept. 30, was not safe, a heart specialist told CBS News program '60 Minutes' on Sunday" [Reuters]

"Ethical Bottom Feeder"

"Merck did more than that. It tried to intimidate scientists who spoke out in public about possible heart risks. In the most extreme case, a physician in Spain was actually sued by Merck for writing about Vioxx concerns in a newsletter. (A court eventually found in the physician’s favor and ordered Merck to pay court costs.) Several American medical school professors who raised questions about Vioxx’s safety found their colleagues or superiors receiving angry phone calls from company staff." [Editorial - Lansing City Pulse]

NPR : Merck Faces Proliferating Lawsuits over Vioxx

"All Things Considered, November 12, 2004: Pharmaceutical giant Merck is braced for a big legal battle over its pain medication Vioxx. The drug was pulled from the shelves when research showed users were at increased risk of heart attack. Now, the Vioxx lawsuits are multiplying. NPR's Scott Horsley reports." [NPR Audio]

Merck Runs Full Page Ads in WSJ & NYT

"With less than two years left until retirement, Gilmartin is defending his handling of Vioxx, the biggest prescription-drug recall. In full-page newspaper advertisements in the Wall Street Journal and New York Times today, Gilmartin said his company acted promptly to pull the drug from the market after studies showed a risk of heart attack and stroke." [New York Times] [Emphasis added]

MSNBC - CEO defends Merck on Vioxx heart dangers

"[Merck] tried to pressure doctors who raised concerns.

Gilmartin: 'We basically approached, you know, in terms of a rigorous scientific debate, in terms of wanting all the information out there in a balanced way.'

Bazell: 'You sued a doctor in Spain for suggesting a cardiovascular problem with Vioxx.'

Gilmartin: 'Well, the people in Spain felt strongly that the data with Vioxx was not being presented in a balanced way.'

Bazell: 'And in hindsight they were correct, right?'" [MSNBC]

You know it's a bad day when...

"On Sunday, 60 Minutes will run a story asking if Merck . . . knew about the dangers of Vioxx, the arthritis drug that was pulled from the market because it doubled the risk of heart attack and stroke." [Forbes]

The Vioxx Board - Questions, Answers, and Discussion About Vioxx

The Vioxx Board - Questions, Answers, and Discussion About Vioxx

Our firm is proud to sponsor the first "Vioxx-specific" BBS. The purpose of the Vioxx Board is to provide a place where former Vioxx users, attorneys, doctors, and members of the press can share information about the Vioxx recall and Vioxx litigation.

"Ethics is all about behavior"

"[Merck CEO] Gilmartin was in Ann Arbor to deliver a speech Wednesday on ethics at the Stephen M. Ross School of Business at the University of Michigan.

'Ethics is all about behavior,' Gilmartin said. 'It's not about what people say about you . . . What matters at the end of the day is what you did.'

"Not everyone agrees that Merck has acted ethically." [Detroit Free Press]

Opinion: Vioxx: A case against tort reform

"The best argument against the kind of tort 'reform' aimed at limiting damage awards for plaintiffs is emerging in the current scandal over Merck's arthritis drug Vioxx.

"Though Merck pulled the drug from the market Sept. 30 when a study indicated increased risk of heart attack and stroke among users, evidence surfaced recently that the drugmakers may have - or at least should have - known for years that Vioxx produced such elevated hazards. Both the Justice Department and the Securities and Exchange Commission have opened investigations." [St. Petersburg Times - Editorial]

Minimizing the Mess at Merck

"With the Vioxx mess, it's now more likely that Merck's board will accelerate its search for a successor to Chairman and CEO Raymond V. Gilmartin. And increasingly, Wall Street analysts believe Gilmartin may step down ahead of his announced retirement in the spring of 2006. The stock price has been hammered, falling more than 40% since Vioxx was taken off the market Sept. 30." [Business Week]

Merck Loses AAA Rating

"Merck & Co.'s long-term debt rating was lowered two levels by Moody's Investors Service because the Sept. 30 withdrawal of the Vioxx painkiller reduced revenue and elevated the No. 2 U.S. drugmaker's litigation risks.

. . .

"The downgrade came as 300 lawyers at a conference today in Pasadena, California, discussed litigation strategies for hundreds of lawsuits filed against Merck over Vioxx. The company disclosed yesterday that the U.S. Justice Department demanded Vioxx-related documents in a criminal probe. Merck's liability in Vioxx suits may reach $4 billion to $18 billion, Merrill Lynch estimated last week." [Bloomberg.com]

Drug Ads -- Without Harmful Side Effects

"'Vioxx is a great illustration of what concerns many physicians,' says Jerry Avorn, associate professor of medicine at Harvard Medical School and author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. 'The ads distorted the medical marketplace by encouraging the use of an option that's more expensive and less cost-effective that older options.'

"Despite the renewed criticism of DTC advertising as a result of the Vioxx fiasco, the industry has done little self-reflection so far. Instead, Pfizer (PFE ), which makes Vioxx competitor Celebrex, has boosted its spending to fill the void. And pharmaceutical analysts expect advertising for blockbuster drugs to continue unfettered. 'I don't buy the idea that the ads educate,' Avorn says. 'What they do is educate patients to demand more.' " [Business Week]

MERCK & CO. INC. (Quarterly Report - SEC Filing)

"In addition, in November, the Company was advised by the staff of the Securities and Exchange Commission (SEC) that it was commencing an informal inquiry concerning Vioxx. Also, the Company has received a subpoena from the U.S. Department of Justice requesting information related to the Company’s research, marketing and selling activities with respect to Vioxx in a federal healthcare investigation under criminal statutes. The Company will cooperate with the SEC and the Justice Department. The Company cannot predict the outcome of these inquiries, however, it is possible that highly unfavorable outcomes, including a potential civil disposition from the SEC and/or potential civil or criminal dispositions from the Justice Department, could have a material adverse effect on the Company’s financial position, liquidity and results of operations.

"The Company currently anticipates that one or more of the Vioxx Personal Injury Lawsuits may go to trial in the first half of 2005. The Company cannot predict the timing of any trials with respect to the Vioxx Shareholder Lawsuits. The Company believes that it has meritorious defenses to the Vioxx Lawsuits and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the Vioxx Lawsuits. The Company has not established any reserves for any potential liability relating to the Vioxx Lawsuits. A series of highly unfavorable outcomes could have a material adverse effect on the Company’s financial position, liquidity and results of operations." [Emphasis Added]

Criminal Probe?

"The Justice Department demanded information about sales and marketing practices related to Vioxx in connection with a federal criminal health-care investigation, Whitehouse Station, New Jersey-based Merck said in a filing with the Securities and Exchange Commission. The SEC is also conducting an informal probe concerning Vioxx, Merck said." [Bloomberg]

Editorial: Vioxx and veracity

Editorial: Vioxx and veracity: "It's a Hollywood movie plot, right?

"Calculating corporation, well aware that its product is harmful, even fatally so, sells it anyway. Along the way to billions of dollars in profits, the company coaches its workers to deflect questions about safety. And it intimidates, then threatens, anyone who dares question it. Meanwhile, the government hides in the shadows." [TheJournalNews.com - Editorial]

Crisis Management - Crisis Public Relations

Crisis Management - Crisis Public Relations

In an interesting article, a public relations consultant talks about what Merck SHOULD DO in the Vioxx case.

Merck v. The Lancet

In an interesting move, Merck has posted a reply to the article that appeared in the November 5, 2004 Lancet, and which appears to show an increased risk of heart attacks among Vioxx users.

Vioxx's Fall No Surprise to Some Doctors

"'There will be a lot of angry consumers, a lot of angry researchers -- a lot of angry people in general saying why did it take so long to take Vioxx off the market,' Mamdani says. 'But to make a big decision about a drug that affects so many people's lives, and with so much money at stake -- $2.6 billion -- you do need more information. When we make decisions like this, we need lots of evidence from many directions to say something really is going on. Should that have occurred faster? Yes. But much faster? I am not so sure.'" [Web MD]

. . . And with so much money at stake?

Vioxx suits could be bitter pill for Merck

STLtoday - Business - Story: "'This has a credibility cost. Merck's brand and stature are tarnished by this,' said David Moskowitz, an analyst at Friedman, Billings, Ramsey. "

. . .

Some doctors had complaints about Merck, saying the company tried to squelch negative opinions on Vioxx's safety and play down the drug's risks. [St. Louis Today]

The Five Dumbest Things on Wall Street This Week

Last Monday, Merck released numerous documents related to Vioxx:

"'Past experience of other companies,' said Merck, 'suggests that documents will be presented out of context. ... As such, the documents, the surrounding events and the business practices of Merck may well be misinterpreted in any reporting.'

Commentators did not see this as a good move.

"On Monday, The Wall Street Journal wrote a 3,500-word story based on the documents -- a detailed article that, rather than simply presenting documents out of context -- used additional reporting to persuasively portray a Merck that fought vigorously to stamp out any suggestion that Vioxx could be linked to heart problems.

Shares fell $4.51, or 14%, over the next two days. [TheStreet.com]

Guardian Unlimited | The Guardian | Drug giant 'ignored Vioxx heart risk'

"Last night a group of independent scientists published their analysis of all the relevant clinical trial data on Vioxx - which has the generic name rofecoxib - that would have been available to Merck in 2000."

According to the Guardian article, their findings indicate that rofecoxib should have been withdrawn several years earlier.

They also found that patients are at risk after only a few months, contrary to Merck's statement that problems only occur after 18 months on the drug, and that the risk does not depend on the dose of the drug taken. [The Guardian UK]

FDA Indicates Vioxx Might Have Contributed to About 27K Heart Attacks, Deaths

FDA Indicates Vioxx Might Have Contributed to About 27K Heart Attacks, Deaths: "Arthritis medication Vioxx, which maker Merck voluntarily withdrew from the market in September, might have contributed to an estimated 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003, according to an FDA memo published online " [Medical News Today]

Here's a link to that FDA memo.

That is not going win them any points with a jury...

Here's an interesting tidbit from The Washington Post:

"Merck general counsel Kenneth C. Frazier said heart attacks happen frequently in the general population and there are numerous factors, including obesity and age, that increase the risk.

'These cases are not a slam dunk,' said Frazier. He said when all the facts are before a judge it will be clear that 'Merck acted responsibly every step of the way.'

'It would be pretty callous of Merck to say these are old people and they were going to get heart attacks and strokes anyway. That is not going win them any points with a jury,' said [a partner with a firm], which has filed two cases against Merck and is preparing another 38." [Washington Post]

Corante > In the Pipeline > Let's See What the Sharks Think of These Steaks!

One training document is titled "Dodge Ball Vioxx" and consists of 16 pages. Each of the first 12 pages lists one "obstacle," apparently representing statements that might be made by a doctor. Among them are, "I am concerned about the cardiovascular effects of Vioxx" and "The competition has been in my office telling me that the incidence of heart attacks is greater with Vioxx than Celebrex." The final four pages each contain a single word in capital letters: "DODGE!"

RangelMD.com (Merck Pulls Vioxx from Market)

RangelMD.com: "But then the pharma companies began aggressively marketing these drugs with the perception being that they were more effective painkillers than the much cheaper over-the-counter NSAIDs. The marketing worked (we've all seen the ads on TV) and each of these medications became multibillion dollar sellers. When I started practicing medicine in 2001 I saw the change. Every arthritis patient was on either Celebrex or Vioxx despite the fact that few of these patients had pre-existing gastric disease or were at increased risk for gastric disease."

Kevin, M.D. - Medical Weblog: Merck withdraws Vioxx

Kevin, M.D. - Medical Weblog: Merck withdraws Vioxx

Yahoo! News - Report: Merck Tried to Bury Vioxx Concerns for Years

Yahoo! News - Report: Merck Tried to Bury Vioxx Concerns for Years: "But a memorandum dated Nov. 21, 1996, by a Merck official illustrated that the company wrestled with Vioxx's potential to induce a cardiac event, the report said. Another e-mail highlighted the possibility that patients could suffer blood clots unless they were also given aspirin." [Reuters]

Vioxx vs. Naproxin

Click above to see the report....

Easy on the Stomach, but at What Price?

"Studies done five years ago when Celebrex and Merck & Co.'s Vioxx were approved suggest that the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist." [SF Examiner]

S&P: Merck on Watch for Debt Downgrade

"The rating agency's big concern: the magnitude of possible litigation against the AAA-rated drugmaker after its Vioxx withdrawal " [Business Week]

NPR : Report Finds Merck Hid Vioxx Concerns

"According to the Wall Street Journal, pharmaceutical company Merck fought to conceal safety concerns for several years before withdrawing the painkiller Vioxx from the market in September. Hear Journal reporter Barbara Martinez, who coauthored the report." [NPR]

Click on the above link to hear the audio report.

FDA Concluded there were "Increased Risks" back in 2001.

"This Medical Reviewer is concluding that there is an increased risk of cardiovascular thrombotic events, particularly myocardial infarction, in the rofecoxib group compared with the naproxen group." [FDA]

See page 34 of Dr. Shari L. Targum's memo (linked above).

A Product Liability Nightmare

"Merck shares fell as much as 10.5 percent after the Wall Street Journal published e-mails from company officials that suggested Merck knew about the heart-attack risks of the arthritis drug years before the recall." [Reuters]

Forbes.com: Merck's Legal Nightmare

Forbes.com: Merck's Legal Nightmare: "'This is going to be a nightmare of unbelievable proportions in terms of legal liability' for Merck, says independent analyst Hemant Shah of Warren, N.J., who was one of the first to predict that Wyeth (nyse: WYE - news - people ) would face enormous legal liability from its recall of the diet drugs fenfluramine (part of the fen-phen combo) and Redux in 1997." [Forbes]

MSNBC - FDA accused of silencing Vioxx warnings

"WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday." [MSNBC]

Times Online - Industry sectors

Times Online - Industry sectors: "Merck directors got $85,000 on day of Vioxx news

"SEVEN directors on the board of Merck received $85,000 in shares on the day that the drugs maker shocked Wall Street with news that it would withdraw Vioxx, The Times has learnt." [The Times Online]

Forbes.com: Merck's FDA Delay, Pfizer's Problem

Forbes.com: Merck's FDA Delay, Pfizer's Problem: "Merck's FDA Delay, Pfizer's Problem

"NEW YORK - In a capstone to the withdrawal of Vioxx, the U.S. Food and Drug Administration has decided to delay the approval of successor drug Arcoxia until more safety data are available. But the news may not be as much a problem for Arcoxia's maker, Merck, as for rival Pfizer." [Forbes]

All painkillers similar to Vioxx under scrutiny

NEW DELHI, OCTOBER 22: After making public the ban on Merck’s arthritis drug Vioxx (Rofecoxib), the Central government today took decision on other coxib drugs belonging to same class of selective Cox-2 inhibitors. It has initiated a National Pharmacovigilance Programme to scrutinise these drugs and collect data on their side-effects.

In its first meeting held on October 11, the National Pharmacovigilance Advisory Committee had, apart from banning Vioxx, cautioned against the use of other drugs in the same class and said ‘‘their use in patients with coronary heart disease/cardiovascular disease be stopped by appropriate labeling changes’’. The related drugs are celecoxib, parecoxib, valdecoxib.

MSNBC - Europe to probe five Vioxx-like drugs

MSNBC - Europe to probe five Vioxx-like drugs

SignOnSanDiego.com > News > Business -- Merck profit falls 29 percent on costs of Vioxx recall

SignOnSanDiego.com > News > Business -- Merck profit falls 29 percent on costs of Vioxx recall

They were Warned...

The U.S. Department of Health and Human Services sent Merck a strong Warning Letter regarding Vioxx promotional activities in 2001. Click to read it.

FDA Public Health Advisory: Safety of Vioxx

FDA Public Health Advisory: Safety of Vioxx

Sept. 30, 2004 - Merck & Co., Inc. today announced a voluntary withdrawal of Vioxx from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. . . .

. . . Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.

Failing the Public Health — Rofecoxib, Merck, and the FDA

"On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.

"Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its responsibilities to the public. The pivotal trial for rofecoxib involved 8076 patients with rheumatoid arthritis and demonstrated that this coxib had lower gastrointestinal toxicity than naproxen"

New England Journal of Medicine, October 21, 2004

The FDA announcement is not surprising.

The FDA announcement is not surprising. In Merck's Vioxx Gastrointestinal Outcomes Research report published in the New England Journal of Medicine (November 23, 2000), Merck compared the effectiveness of Vioxx (rofecoxib) to naproxen. The study shows a statistically significant increase in heart attacks in the rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). There were 20 heart attacks suffered by 4,047 Vioxx patients and 4 heart attacks in 4,029 naproxen patients. While the absolute numbers are low, this is a five-fold increase that statistically is highly significant and merited further studies. In addition the study reported increased problems with blood clotting that results in strokes and leg clots.

The drug has been on the market around the world since about 1999 and has been prescribed millions of times...

More info here: http://www.alexanderlaw.com/vioxx/

FDA STUDY ESTIMATES VIOXX LINKED TO 27,000 HEART ATTACKS.

A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug's abrupt withdrawal last week by Merck & Co. (MRK), according to an October 6, 2004 Wall Street Journal report.

CNN Money, October 6, 2004.

MERCK'S CONFLICT OF INTEREST.

Dr. Topol said that "despite studies showing the magnitude of the public health problem, for several years Merck did nothing to investigate. This surely represents a conflict between the interests of the public and the interests of the company. Instead of doing the requisite research in patients with heart disease - who frequently have arthritis as well and are thus prime users of anti-inflammatory medicines - the company undertook studies that avoided them. At the same time Merck spent at least $100 million a year for direct-to-consumer Vioxx advertising, while the company's employees and their consultants published several papers in medical journals rebutting studies reporting Vioxx's heart attack risk."

New York Times, October 2, 2004.

Vioxx Recall

US pharmaceutical giant Merck announced a global withdrawal of its blockbuster arthritis drug Vioxx (Rofecoxib) after a study showed it increased the risk for strokes and heart attacks. Law firms have already filed cases, or are otherwise investigating individual lawsuits against Merck, the maker of Vioxx.

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

(Reprinted from http://www.fda.gov/bbs/topics/news/2004/NEW01122.html)

FDA News

FOR IMMEDIATE RELEASE P04-95 September 30, 2004

Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

[. . .]

Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.