| "Arthritis drugs Vioxx, Celebrex safety in | | | | the same benefit in protecting theheart. |
| doubt" | | | | |
| | | | Several doctors say they are worried about |
| In doubt and may not be as safe as previously | | | | the possibility of heart attacksbecause many |
| thought. Research earlier thisyear has shown | | | | of the arthritis patients taking the drugs |
| that these drugs increased the risk of heart | | | | are elderly and have ahigher risk of |
| attacks although arelatively low risk, over | | | | cardiovascular problems to begin with. |
| those taking a pain reliever. The FDA is | | | | |
| debatingwhether to add information about the | | | | The current debate centers on whether the |
| increased risk on both drugs' labels. | | | | higher heart attack rate found inpatients |
| | | | taking Vioxx is a result of the drug's |
| One Wall Street analyst has warned that this | | | | actually causing damage in somepatients or to |
| problem could have an adverseeffect on Merck, | | | | an absence of the heart-protecting benefits |
| the drug company responsible for these drugs | | | | that Naproxen mayhave. |
| be placed on themarket - along with | | | | |
| Pharmacia, which makes Celebrex, generating | | | | "Naproxen had a similar anti-platelet effect |
| $2.3 billion in | | | | to aspirin," said Dr. Eve E. |
| | | | |
| 12 months to March 31 of this year, Merck | | | | Slater, senior vice president of external |
| having sold $1.7 billion Vioxx duringthe same | | | | policy for Merck's research labs, |
| 12 months. | | | | |
| | | | "and those people had fewer heart attacks." |
| Studies done last year showed that patients | | | | |
| taking Vioxx had four times the riskof heart | | | | Neither Vioxx nor Celebrex has been shown to |
| attacks over patients taking Naproxen - | | | | have the same heart-protectingbenefit. |
| another pain reliever. Naproxenis also sold | | | | |
| under the brands names of Naprosyn and Aleve. | | | | Slater also said that Stover's report was |
| The risk of heartattacks increases over time, | | | | flawed and biased in favor of |
| at about four heart attacks per 1,000 | | | | |
| patients. | | | | Pharmacia. But regulators and some doctors |
| | | | say they still worry that there maybe more of |
| This study was sponsored by the Merck | | | | a problem with Vioxx. |
| company, which also stated that theirresearch | | | | |
| does not show this problem of increased heart | | | | And even if Vioxx and Celebrex do not damage |
| attacks with Vioxx. | | | | the heart, the fact that they donot have the |
| | | | heart-protecting benefits of aspirin reduces |
| These two drugs are among the best-sellers of | | | | the ability of thecompanies to market them as |
| prescription drugs in the world. | | | | being significantly safer than other pain |
| | | | relievers. |
| They cause fewer ulcers that many other drugs | | | | |
| given for pain. Richard R. Stover,a | | | | Merck recommended last year that doctors |
| pharmaceutical industry analyst at Arnhold & | | | | involved in clinical trials of Vioxxconsider |
| S. Bleichroeder Inc, reported on | | | | prescribing low doses of aspirin to patients |
| | | | taking Vioxx if they areat high risk of heart |
| April 27 that he did his own analysis on what | | | | attacks - although low doses of aspirin could |
| he called "disturbing data" from | | | | increase therisk of ulcers. Ulcers are the |
| | | | main side effect that Vioxx and Celebrex |
| Merck's study. He stated that he was warning | | | | weredeveloped to avoid. |
| his clients, many of whom wereinstitutional | | | | |
| investors holding stock in Merck, that they | | | | There have been no studies done to determine |
| should watch the issuecarefully because it | | | | whether patients have fewer ulcersif they |
| could effect the company's stock price. | | | | take low doses of aspirin with either Vioxx |
| | | | or Celebrex. In February |
| Dr. M. Michael Wolfe, chief of the | | | | |
| gastroenterology section at the Boston | | | | Dr Maria Lourdes Villalba, at an FDA advisory |
| | | | meeting, stated that Merck hadproved Vioxx |
| University School of Medicine and a member of | | | | [Rofecoxib] caused fewer serious ulcers than |
| the FDA advisory committee statedthat there | | | | Naproxen. However,she also state that the |
| should be a warning, after a review of the | | | | potential safety advantage was offset by a |
| issue earlier this year,stating that | | | | higher riskof heart problems,in her opinion. |
| | | | She reported that "Overall, there was |
| "The marketing of these drugs is | | | | nosafety superiority of Rofecoxib over |
| unbelievable, I'm sure there are many | | | | Naproxen, mainly due to an excess of |
| peopleout there who are taking these drugs | | | | seriouscardiovascular events". |
| that should not be." | | | | |
| | | | Dr Villalba also stated that there had been |
| There is a current debate going on between | | | | no studies to prove Merck's claim that |
| some doctors and Merck's scientistsas to | | | | |
| whether the higher risk of heart attacks is a | | | | Naproxen worked like aspirin in decreasing |
| result of Vioxx causingdamage in some | | | | heart attacks. The FDA expressed someconcern |
| patients or to an absence of the benefits | | | | over the higher rate of heart attacks with |
| that Naproxen may havein protecting the | | | | Vioxx, stating that this couldbe caused by |
| heart, that Naproxen stops or slows the | | | | the drug's ability to produce blood clots. |
| production ofthromboxane, which is thought to | | | | |
| cause platelet in the blood to form | | | | "There is still a tremendous benefit with |
| clots,similar to the aspirin effect. | | | | these drugs" reported Dr Eve Slater of |
| | | | |
| Vioxx and Celebrex have been shown to have | | | | Merck. |