DESPITE a warning last week from a senior US Food & Drug Administration drug researcher that four drugs currently prescribed in Bermuda "should be looked at seriously to see whether they should remain on the market", there is no formal system here to act on such warnings.

The president of the Bermuda Pharmaceutical Society said that there was no cause for concern, but local consumers should take an active interest in their health care

Dr. David Graham, Associate Director of Science at the FDA's Office of Drug Safety, appeared at a specially-convened Senate Finance Committee hearing into the FDA's handling of the prescription drug Vioxx, and testified that consumers were "virtually defenceless" if another medication such as Vioxx proved to be unsafe after being approved for sale.

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said Dr. Graham. He told the Committee that there were at least five other drugs on the market today that should be looked at seriously to see whether they should remain there, four of which are prescribed in Bermuda: the acne drug Accutane, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.

Tracy Marra, president of the Bermuda Pharmaceutical Society, assured customers that local pharmacists keep abreast of drug-related news, but customers have a responsibility to be proactive in their health care.

"Because we don't have the resources that they do in larger countries," advised Ms Marra, "our practice here, with approvals or withdrawals of drugs, is to follow the lead of two out of the three regulating countries: the US, the UK, and Canada. That's not in stone, it's just what we tend to do. If a pharmaceutical company voluntarily withdraws a drug, that's straightforward.

"Dr. Graham may have expressed some reservations about these drugs, but there's a reason they're on the market, and people do get use out of them. Also, if people hear something negative about a drug like Serevent, for example, they may stop taking it and not get on another medication, and end up having an asthma attack.

"That would be the wrong thing to do. As pharmacists, we explain the risks and the benefits of taking any medication, and if a customer is still unwilling to take a medication, we refer them back to their physician, so that they're not in a position of not replacing a medication they are uncomfortable with.

"Ultimately, it is up to patients to decide what is best for them, and it is important that they have all of the appropriate information on medications, knowing the risks and benefits. You have to be in charge of your own health. You have to get the knowledge, and that's what your physician and pharmacist are there to help you with.

The 'cox-2 inhibitor' drug Vioxx was withdrawn by manufacturer Merck amid allegations that it had been aware for a number of years that the pain-killer could be responsible for an increased incidence of heart attacks and strokes.

Ms Marra reported last week that Merck had finally agreed to take direct responsibility for the recall of the drug in Bermuda, but said yesterday that so far nothing had happened.

"Merck took out a double-page ad for Vioxx this week in TheRoyal Gazette," said Ms Marra, "and said they would reimburse patients directly, but they have had no contact with any of the pharmacists. I have been waiting to hear from Merck representatives to work out the details, and the next thing I know, there's this huge ad in the paper, and I haven't heard anything. The pharmacists are getting questions from customers, and we don't know what to tell them.

"Customers are meant to call a local number, and I called yesterday, and gave Merck a piece of my mind, which may be why I haven't heard back from them. Merck had a page-and-a-half on the product 'monograph' which tells you about dosage and side effects, health care information, which was pretty baffling, since Vioxx has been withdrawn!

Dr. John Cann, Bermuda's Chief Medical Officer, said that "there was no clear answer" to warnings by an individual, even one as relatively eminent as Dr. Graham.

"The Pharmacy Council and the Ministry of Health all have a responsibility to maintain oversight, and to make decisions based on available information," said Dr. Cann. "We also have to be careful that we don't take actions that are not based on consensus information on particular drugs.

"If the Ministry is to say that a drug is not to be allowed into the country, we have to do that with information which will back up that decision. I think that we would have to look at the way in which you arrive at those conclusions, and in a very small place, without the infrastructure to do all of the evaluation and investigation, it makes it a little more difficult.

"I don't think these are decisions that we can always make without being able to convince Ministers and the Government that a consensus exists within the scientific community to take such an action, or that some well-resourced entity has evaluated the particular product."

Dr. Cann said the Pharmaceutical Council meets on a monthly basis, and that if the Council had a concern, it would communicate with him, and indicate a desire for some action to be taken.

"There have been some instances where we have taken action on that basis," said Dr.Cann, "and perhaps before decisions were made in other jurisdictions. A warning from someone like Dr. Graham should act as a signal to us to pay closer attention to the literature, and to what's happening, and yes, that works; if we are warned, we start to pay closer attention to the situation, so that we are better-equipped to make decisions fairly quickly.

"Our pharmacists do an excellent job of keeping a 'watching brief', and raising concerns. In certain situations, we may raise queries with relevant bodies overseas, and sometimes with a pharmaceutical company itself.

"There is oversight taking place, but generally a small island community has to depend on what happens in other jurisdictions. It's an advantage that Bermuda doesn't rely on one system, but on multiple systems, looking to Canada, and the US and the United Kingdom."

In response to Dr. Graham's assertions last week about their drugs, the manufacturers gave positive responses.

AstraZeneca, maker of Crestor, said it was confident the drug was safe.

"To date, the FDA has not given us any indication of a major concern regarding Crestor," said spokeman Emily Denney.

Carolyn Glynn, spokeswoman for Roche Pharmaceuticals, maker of Accutane, said: "It's important to point out that this drug is reserved for a very, very serious indication, that it does carry risks, and that it's very important for physicians, patients and pharmacists to monitor, and to conform to all of the risk programmes, because this drug is extremely beneficial as long as it is used safely and appropriately."

GlaxoSmithKline, maker of Serevent, issued a statement saying that it "stands firmly behind" the product, and that it is safe and effective when used appropriately and in accordance with labelling and treatment guidelines.

Pfizer, maker of Bextra, defends its drug just as Merck defended Vioxx. But Dr. Graham told the Senate panel last week, that, "with Bextra, we are in the same situation as we were with Vioxx in terms of needing data".

Dr. Eric Topol, a cardiologist at the Cleveland Clinic, and an early critic of Vioxx, said Bextra should immediately have a strong "black-box" warning placed on its label saying that the drug should not be used in patients with cardiovascular disease.

Dr. Gail Cawkwell, Pfizer's world-wide medical director for Bextra and Celebrex, both 'cox-2 inhibitors' like Vioxx, agreed that the company could not, ethically, test Bextra in patients at high risk of heart disease.

As with Vioxx, Dr. Graham hopes to launch a study with Kaiser Permanente, the giant HMO, to examine Bextra's effects in a large patient population.