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