NEW YORK -- The scandal over a painkiller implicated in thousands of heart attacks is gaining international scope, as lawsuits against the drug's maker spread to other countries and the credibility of the industry and its Washington regulators nears an all-time low.

”The numbers are just staggering in terms of how many people could be affected,” said Ricky Bagolie, a U.S.-based lawyer who recently founded the International Vioxx Practice Group. ”It takes a while for everyone to catch up with the news, although there has been a lot of worldwide attention. Every other week something new comes out.”

His firm, Bagolie Friedman, is already recruiting potential plaintiffs in the United States, United Kingdom and Australia, and could eventually represent others from China to Mexico.

Since its approval in 1999, Vioxx has been used by two million people in more than 80 countries. Its manufacturer, the U.S. pharmaceutical giant Merck & Co, earned 2.5 billion dollars from the drug last year alone.

”We think New Jersey, where the company is based, is the proper jurisdiction,” Bagolie told IPS. ”One of the issues will be whether people have a legal remedy in their home country; it remains to be seen if we'll be able to represent them here.”

The company voluntarily withdrew Vioxx on Sep. 30 after a study confirmed years of suspicions that the drug raises the risk of heart attack, stroke and death. The recall soon exposed serious flaws in the regulatory activities of the Food and Drug Administration (FDA), which stood behind Vioxx despite studies indicating the drug had dangerous side effects.

In congressional hearings last month, David Graham, an FDA drug safety reviewer, testified the agency downplayed mounting negative data on Vioxx, and that it ”seriously undervalues, disregards and disrespects drug safety” in general. He listed five other potentially dangerous medications currently on the market -- Accutane, Bextra, Crestor, Meridia and Serevent.

Some observers are now suggesting that the United States should take a cue from the European model, where new drugs are reevaluated five years after they are marketed and where pharmaceutical companies must follow through on promised safety studies.

Under the current FDA system, drug companies have finished less than one-half of the post-approval studies they pledged to conduct, and many have not even been started, according to the 'Journal of the American Medical Association'.

”At one time, only a small percentage of drugs were approved in the United States,” said Larry Sasich, a pharmacist and analyst with the health research division of Public Citizen, a watchdog group. ”Now the tables have turned.”

According to the Center for Medicines Research International, the FDA takes an average of 1.3 years to approve a new drug, compared to Europe, which takes 1.4 years, and Japan, which takes 1.6 years.

As one of the most influential health regulatory agencies in the world, the FDA's decisions on the safety of new drugs have rarely been questioned by other governments, Sasich added.

”I worked in a developing country for five years and they really relied on FDA approval. With this scandal, they will obviously have to stop and think.”

Activists fighting for wider use of generic HIV/AIDS drugs say the Vioxx debacle also raises questions about the FDA's role in approving generic drugs for the developing world, and the pharmaceutical industry's mantra that ”branded equals safe”.

For example, the Bush administration's President's Emergency Plan for AIDS Relief, which funds treatments in developing countries, stipulates that if cheaper generic drugs are to be used, they must be approved for ”bio-equivalency” to their brand-name counterpart by the FDA.

We use generics in the United States and basically everywhere in the world,” said Michael Weinstein, president of the AIDS Healthcare Foundation in California. ”The issue is having safe AIDS drugs for the people who desperately need them.”

According to Weinstein, while an estimated 136,000 people suffered heart attacks because of Vioxx, there has not been a single recorded case of someone being harmed by generic AIDS drugs.

”Norvir, a brand name liquid AIDS drug, crystallized and had to be pulled off the market,” Weinstein said in an interview. ”The point is that any drug could have problems. Just as there are some dangerous branded drugs, there are also some excellent generic drugs.”

The international charity Doctors Without Borders notes that thanks to pressure from generic competition, the price of antiretrovirals (used to treat HIV/AIDS) in South Africa has plunged from 15,000 dollars per person per year, to185 dollars.

While several of these drugs were recently withdrawn from the World Health Organisation-approved list, advocates dispute that generics should now be regarded with heightened suspicion.

”As the recent recall of Merck's Vioxx shows, regulating brand-name, as well as generic, drugs requires constant vigilance,” Dr Eric Goemaere, head of mission for Doctors Without Borders in Khayelitsha, South Africa, wrote in the 'Seattle Times' on Nov. 20.

”Unlike Vioxx, the generic AIDS medicines were withdrawn from the WHO list to resolve important questions about the paperwork demonstrating the drugs' bioequivalence -- not because of deadly side-effects,” he added.

”There is no doubt that the generic-drug manufacturers whose AIDS medicines were delisted must adhere to strict international standards and submit new data to WHO and drug authorities urgently,” he said.

”But the United States Food and Drug Administration is not the global arbiter of drug quality. If we had waited for the U.S. stamp of approval, as the Bush administration is requiring in the President's Emergency Plan for AIDS Relief, thousands of lives would have been needlessly lost.”

Copyright © 2004 IPS-Inter Press Service

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