Cummings Center company revealed Vioxx problems to the nation
By BobGates
Friday, December 10, 2004

	Dr. Preston Mason, founder of Elucida Research, unveiled the harmful effects of Vioxx, a prescription pain-killer, to the nation a day after the manufacturer pulled the drug from shelves. (Staff photos by Toni Carolina)

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.

Under the leadership of Dr. Preston Mason, the company's founder, researchers Dr. Mary F. Walter and Dr. Robert F. Jacob began studying how Vioxx affected molecules differently than similar drugs like Celebrex, all known generally as Cox-2 inhibitors. In addition, Elucida Research included painkillers Bextra and Arcoxia in its study.

"The first signals were when we began the study two years ago," Mason told theCitizen last week, in his Cummings Center laboratory.

Then, a day after Vioxx's maker Merck and Co. pulled the drug from the market, Elucida's study was released. It showed what has been suspected for some time - the drug caused heart problems, including heart attacks.

Now, Merck faces hundreds of personal injury lawsuits and investigations from Congress and the Justice Department. Last year, Vioxx sales totaled $2.5 billion.

Antonius Plohoros, a Merck spokesman, said the company declined to comment on Elucida's study. In a WebMD article, a company spokesman said that Merck is aware of several different factors which could explain the difference between Vioxx and similar cox-2 inhibitor drugs.

"We know they are aware of the results," Mason told the Citizen. "They are investigating our results."

In no way was the study funded or solicited by Merck or any other drug maker, Mason said.

"We saw the initial indications, but we really wanted to make sure, given the provocative nature of the results," Mason said. "There was concern, but it was not definite."

It was not until the study became public, when it was published in Atherosclerosis, a medical journal, that the exact dangers of the drug and what made it different than similar drugs became clear. The Beverly company outlined a biological explanation for the difference between Vioxx and similar drugs.

Essentially, Elucida Research showed that Vioxx made certain components of the blood more susceptible to chemical changes which contribute to heart disease.

Mason and his coworkers used a process called X-ray diffraction, which allowed researchers to see how Vioxx effects humans at a molecular level.

"This is an innovative technology that leads to very important results," Mason said.

All of the research was done in the company's Beverly laboratory on human tissue. No live subjects were involved. Nevertheless, the study provides the best information yet about the differences between Vioxx and other drugs in its class.

"I don't want to say it is the only difference," Mason said of the findings.

Mason said nothing was wrong with the way that Merck or the FDA went about testing Vioxx before putting it on the market in 1999. He said Merck followed well established steps before introducing the drug. He said the cardiovascular effect of Vioxx may not have shown up on the smaller test population and may have only become clear when millions of people start taking the drug.

"The techniques we use are not generally used yet in the development of drugs," he said.

But that may be changing.

The FDA has "taken great interest" in X-ray diffraction and Mason said he has been talking with them about how it may be used in the future before a drug is cleared to go on the market.

In fact, a FDA-funded study of 1.4 million Vioxx patients found that those taking higher doses were three times as likely to have heart problems, while those on Celebrex had no increased risk. And an FDA scientist's study found that as many as 27,000 users experienced heart attacks or death from Vioxx.

In general, Elucida's work centers on developing new treatments for heart disease, the number one killer in the United States, taking more lives than all other causes of death combined.

A faculty member at Harvard Medical School, Mason founded Elucida in 2001 when he and Jacob came to the North Shore, where Mason had received his undergraduate degree at Gordon College. He lives in Manchester-by-the-Sea with his wife.

Mason said he was led to his study of Vioxx because it is an anti-inflammatory and heart disease is linked to inflammation.

"We thought these drugs would be beneficial, instead we saw an adverse effect with Vioxx," he said.