yanked Vioxx off the market, nearly a third of the employees at Ricci Leopold -- a law firm now suing the company -- used the blockbuster painkiller themselves.
Senior partner Edward Ricci actually suffered chest pains just 10 days before the stunning drug recall. He had been taking Vioxx for 11 months to ease the pain caused by bone spurs in his left foot. He never knew the popular "super aspirin" posed cardiac risks until he saw a headline announcing the drug's withdrawal on Sept. 30.
"I was stunned," Ricci said. "I stopped taking the drug immediately."
He also telephoned his son-in-law at the high-profile law firm founded by David Boies. Boies had worked with the federal government on its big antitrust case against
. He had represented former Vice President Al Gore in litigation stemming from the 2000 Florida vote recount. He had successfully defended Lloyd's of London and other insurers in the World Trade Center trial.
To Ricci's surprise, however, Boies had already filed a class-action lawsuit against Merck and rival
. (Like Vioxx, Pfizer's Celebrex has since been linked to heart attacks.) The Boies complaint accused both companies of concealing cardiac risks posed by their so-called COX-2 inhibitors for pain relief. The case was more than three years old.
Ricci now had a fresh reason to doubt that Merck -- under attack by such a prominent law firm -- was itself unaware of Vioxx's dangers until a few days before it yanked the drug. Still, Merck continued to maintain its innocence during testimony before the Senate as recently as November.
Merck CEO Raymond Gilmartin, who pocketed seven-figure annual bonuses during the painkiller's popular run, insisted that the company had done the right thing at the right time.
"Withdrawing Vioxx was consistent with an ethic that has driven Merck's actions and decisions for more than 100 years," Gilmartin stated. "Merck puts patients first."
But crowds of Vioxx users, lining up to sue Merck by the thousands, feel less than reassured. Instead, they see a company that rushed to protect one of its best-selling drugs instead of the consumers who risked their lives by taking it. Ranking fourth in company sales behind such blockbusters as Zocor, a cholesterol treatment facing patent expiration in 2006, Vioxx generated $2.5 billion in revenue last year. Before the recall, an estimated 10 million patients -- many coaxed by heavy advertising -- used Vioxx to treat their pain.
Medical experts believe that more than 100,000 people may have suffered cardiac problems as a result.
Now Merck faces serious side effects itself. Assuming just 28,000 Vioxx-related heart attacks -- a number deemed "very conservative" by Food and Drug Administration veteran David Graham -- Ricci believes the company could wind up shelling out nearly $10 billion in actual damages alone. And if Merck knowingly placed consumers at risk, he says, the company could find itself paying massive punitive damages as well.
"Then," he says, "it's anybody's guess what the high end of their exposure will be."
Merck's mishandling of Vioxx -- and how much company executives knew about the dangers of the drug and their decision to not only release it but promote it heavily to consumers -- may become one of the costliest calamities in American corporate history.
In a series of upcoming articles,
examines Merck's handling of Vioxx and the company's growing dependence on a drug that ultimately proved hazardous to consumers and to the giant drug maker itself.
Moreover, given the subsequent controversy that has blown up around the Cox 2 inhibitor class, the scandal looks like it is just beginning. Popular but dangerously old-fashioned ways of finding and marketing drugs are no longer working, leaving an entire industry in search of answers. The wounds inflicted on a distrusting public, meanwhile, might never fully heal.
Tale of Woe
...after fall 2004's plunge
Already, Merck has lost nearly $35 billion in market value as a result of the Vioxx scandal. The company's stock has traded in the low $30s since the news emerged. Near the end of 2000 -- Vioxx's first full year on the market -- Merck stock fetched more than $80 a share.
Gurkipal Singh, an adjunct professor of medicine at Stanford University, believes that Vioxx looked risky even before regulators approved it for public use. During November's Senate hearing, Singh portrayed Vioxx as a drug that -- by its very design -- can lead to blood clotting and, thus, cardiac problems.
Many over-the-counter painkillers, such as Ibuprofen and Aleve, block enzymes that trigger inflammation. But those enzymes help protect the body as well. The first, COX-1, shields the stomach lining and can prevent ulcers from forming. The second, COX-2, defends blood vessels against clotting and potential heart attacks.
Drugs like Vioxx focus on blocking COX-2 and, some feel, leave the heart without one of its major protectors in the process.
Singh claims that scientists understood the biology behind this threat as early as 1996. He says that small studies, carried out each of the three years after that, caused additional reasons for concern. And he adds that a major study, known as Vigor, soon "proved conclusively" that Vioxx could trigger heart problems.
When defending his company, however, Gilmartin told the Senate last month that past trials showed that Vioxx posed no greater cardiac risks than other popular painkillers or even placebos. Still, medical experts immediately attacked the design -- and the very intent -- of those Merck-ordered studies.
"It appears ... that in early 1997, Merck scientists were exploring study designs that would, in fact, exclude people who may have a weak heart ... so that the heart attack problem would not be evident," Singh told the Senate. "We need to know how a drug behaves in people who are going to take it -- even if it, I quote
from an alleged Merck document, 'kills the drug.' It is better to kill a drug than kill a patient."
At last, the Vigor study -- completed in 2000 -- examined the cardiac risks associated with Vioxx. It showed a fivefold increase in heart attacks. Singh, who was conducting his own research in this area, felt "stunned."
He sought additional information from Merck but, for the first time, found the company uncooperative. Indeed, he said, the company actually threatened him.
"I persisted in my inquiries and I was warned that if I continued in this fashion, there would be serious consequences for me," Singh said. "Subsequently, I learned that this was a persistent pattern of intimidation."
Only after Stanford complained to Merck's CEO, Singh said, did threats from the company stop.
By the end of 2000, results of the Vigor study had surfaced in the
New England Journal of Medicine
. Public Citizen, a consumer watchdog organization, placed Vioxx on its "
worst pills" list a few months later.
Eric Topol, head of cardiology at the Cleveland Clinic, followed up with yet another damaging Vioxx study shortly afterward. But Merck consistently fought back.
"Each time a study was presented or published, there was a predictable and repetitive response from Merck, which claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk," Topol wrote last fall in the
New England Journal of Medicine
. "But if Merck would not initiate an appropriate trial -- and the FDA did not ask them to do so -- how would the truth ever be known?"
Topol specifically blames senior executives at Merck and leaders at the FDA for the Vioxx fiasco. Merck secured a "priority" review, spanning only six months, for approval of Vioxx. The heavily advertised drug hit the market in the summer of 1999. The first study to examine its heart risks had not even ended.
Bruce Psaty, an epidemiologist and drug safety expert, suggests that timing made a big difference.
"If the Vigor trial results had been available ... it's possible the FDA never would have put Vioxx on the market," he said.
Instead, Merck found itself celebrating a turnaround after Vioxx hit the drugstores.
The Wall Street Journal
gushed. During 2000, the newspaper reported, Merck increased its revenue more than any of its peers. It grew profits more than most, the paper stated, even as it increased research spending and expanded its sales force -- which heavily marketed Vioxx -- by nearly a third.
Merck's stock, the newspaper added, surged 26% as the broader market slid.
That year, Merck exceeded the performance targets linked to annual bonuses. The company raised Gilmartin's salary by $100,000 to $1.3 million. It increased his bonus by twice that amount to $1.7 million. It based the multimillion-dollar compensation package, in part, on the company's "earnings-per-share growth, sales growth ... and continuing strong progress in research."
But one of Merck's own executives specifically credited Vioxx for the company's newfound success. Edward Scolnick, Merck's research director at the time, told
The Wall Street Journal
that Merck would have been a "very different company" without the blockbuster drug. He confessed that he had worried for years whether Merck -- faced with patent expirations on many popular drugs -- could even survive as an independent company in the end.
Ultimately, Scolnick portrayed Vioxx as the company's savior.
"He didn't need a committee to tell him that
Vioxx had the potential to be a blockbuster -- and a critical bridge out of Merck's patent problem,"
The Wall Street Journal
reported in early 2001. "Merck's success demonstrates that in the drug business, as in Hollywood, one big hit can sway the fate of an entire company."
By then, Merck's stock had just passed its peak. Fears about Vioxx had started to mount. But Merck kept defending -- and promoting -- its prized painkiller until the very end.
Don Strong, an Oklahoma City attorney handling thousands of Vioxx cases, insists that Merck placed profits ahead of safety in the process.
"For a corporation," he said, "it's really easy to make that choice."