Editorials, Opinion Pieces Examine Merck’s Withdrawal of Vioxx from Market

Several recent editorials and opinion pieces examined Merck's withdrawal of blockbuster arthritis drug Vioxx from the market in light of a study that confirmed concerns that the drug raises the risk of heart attack and stroke. Although Merck had been "dogged for several years" by research suggesting the drug increased risks of heart problems, the company denied there was a connection until Thursday's announcement. The data that persuaded the company to recall Vioxx came from a three-year trial designed to determine how effective a standard 25 milligram dose of Vioxx is in preventing recurrence of potentially cancerous colorectal polyps. The study was stopped prematurely on Sept. 23 when the trial's external data-monitoring board notified Merck of results indicating a possible link between Vioxx and heart problems. The data indicate that 45 of 1,287 patients taking Vioxx, or 3.5%, have had a heart attack since taking the drug, compared with 25 of 1,299 patients taking placebos, or 1.9%. Five patients in each group died (Kaiser Daily Health Policy Report, 10/1).

Editorials

• Los Angeles Times: The Vioxx recall "should cast scrutiny on at least two problems inherent in the nation's system for assessing and monitoring drug safety," the Times writes in an editorial. "[M]isleading ads ... show how far [FDA] has slipped in enforcing its own rules," and the nation relies "almost exclusively ... on drug companies to police the safety and efficacy of their own drugs," the editorial continues. The Times concludes that "FDA's current hands-off approach to drug companies doesn't just endanger consumers, it hurts investors -- who shouldn't be caught by surprise over a drug whose dangers have long been clear" (Los Angeles Times, 10/1).
  


• New York Times: Merck "bowed to the inevitable" when it took Vioxx off the market in "the latest twist in a sorry tale of how" COX-2 inhibitor drugs "have been oversold," the Times states in an editorial. "The belated discovery that Vioxx can be harmful suggests that federal regulators will need to ensure that the other COX-2 inhibitors" -- on the market or in development -- "are tested long enough to ensure their safety in prolonged use," the editorial concludes (New York Times, 10/1).
  


• Wall Street Journal: Although Merck's decision to pull Vioxx off the market is "sure to have damaging consequences for the company, ... the real danger to public health will be if Washington overreacts" with "an even longer and more arduous FDA approval process," according to a Journal editorial. Even though Vioxx lost the "healthy competition among COX-2 inhibitors -- all risks and benefits considered" -- it is "no reason to conclude that Vioxx should never have been approved or that its class of drugs has been a bust," the editorial states. "Knowledge has been gained and millions of lives improved along the way," the Journal says (Wall Street Journal, 10/1).
  

Opinion Pieces

• Eric Topol, New York Times: The impact of Vioxx's withdrawal is "far-reaching," as it highlights the "absence of [FDA] oversight of the pharmaceutical industry" and the possible dangers of all COX-2 inhibitors, Topol, chair of the Cleveland Clinic's department of cardiovascular medicine, writes in a Times opinion piece. Topol cites, among other trials, a 2001 study he worked on that found Vioxx had a heart attack risk that was five times greater than the over-the-counter drug naproxen, and he states that Merck "finally had to acknowledge the truth [about Vioxx], but only by accident." However, Topol notes that the Merck study, which found that 3.5% of patients taking Vioxx experienced heart problems, might have "greatly underestimated" the risk of the drug and other COX-2 inhibitors. Topol states that the study "avoided" patients with heart disease, "who frequently have arthritis as well and are thus prime users of anti-inflammatory medicines." Topol writes that FDA could have "forced Merck to do the appropriate research studies, but instead it was a bystander." Topol concludes that the nation needs a "stronger regulatory agency" that would limit manufacturers' direct-to-consumer advertising and "compel pharmaceutical companies to do the proper studies" (Topol, New York Times, 10/2).
  


• Terry Keenan, New York Post: The "one-day meltdown" of Merck's stock -- "once considered the safest of the blue chips" -- shows Wall Street is "flashing a warning that there are broader implications [of the recall] that could extend well into the future," Keenan, senior business correspondent and anchor on Fox News Channel's "Cashin' In," writes in a Post opinion piece. Keenan writes that on "Vioxx Thursday," investors "wiped away within minutes" $27 billion in market value. "Never before has an announcement cost more investors more money more quickly," Keenan writes, adding that the "Merck mess" is "not good news, and Wall Street is warning as much." Keenan says the company now faces an "avalanche of lawsuits as far as the eye can see," adding that "the tort bar has just found its next big, rich target, and the stock market is starting to discount the fallout." Keenan also notes that the withdrawal of Vioxx could "cast a pall over the entire drug sector" by causing FDA to "do the right thing and start to become more cautious in the way it approves drugs" (Keenan, New York Post, 10/3).