Wednesday, October 04, 2006

Post-heart attack prescriptions: aspirin, beta-blocker, ACE inhibitor... and fish oil?

In Germany, St. John's Wort is first-line treatment for mild depression, thanks to findings by the country's government-funded Commission E. But not here in the States, where SJW is not taught as being a therapy for depression, at least at my school. And there may be reason for that, as two US trials (with some funding by drug companies, apparently) found the herbal pills to be ineffective.

I learned earlier today that this isn't the only discrepancy between what is prescribed here versus what is prescribed across the Atlantic for the same exact ailment. From a 3 October 2006 NY Times artcle entitled "In Europe It’s Fish Oil After Heart Attacks, but Not in U.S.":

Every patient in the cardiac care unit at the San Filippo Neri Hospital who survives a heart attack goes home with a prescription for purified fish oil, or omega-3 fatty acids.

“It is clearly recommended in international guidelines,” said Dr. Massimo Santini, the hospital’s chief of cardiology, who added that it would be considered tantamount to
malpractice in Italy to omit the drug.

In a large number of studies, prescription fish oil has been shown to improve survival after heart attacks and to reduce fatal heart rhythms. The American College of Cardiology recently strengthened its position on the medical benefit of fish oil, although some critics say that studies have not defined the magnitude of the effect.

The article's author Ms. Rosenthal then writes about the way American patients are dealt with post-myocardial infarction:

But in the United States, heart attack victims are not generally given omega-3 fatty acids, even as they are routinely offered more expensive and invasive treatments, like pills to lower cholesterol or implantable defibrillators. Prescription fish oil, sold under the brand name Omacor, is not even approved by the Food and Drug Administration for use in heart patients.

There are two websites for Omacor, one tailored to Continentals it seems, and the other seems British.

“Most cardiologists here are not giving omega-3’s even though the data supports it — there’s a real disconnect,” said Dr. Terry Jacobson, a preventive cardiologist at Emory University in Atlanta. “They have been very slow to incorporate the therapy.”

She then states that the reason behind this discrepancy is "the central role that drug companies play in disseminating medical information" in the U.S. "

“If people paid more attention to guidelines, more people would be on the drug,” Dr. Jacobson said. “But pharmaceutical companies can’t drive this change. The fact that it’s not licensed for this has definitely kept doctors away.”

Interestingly, Europeans have found that Omega 3 fatty acids are so cardio-protective that it is unwise to not prescribe them. Even critics arguing that the benefit is overstated still swallow their fish oil pills.

“Using this medicine is very popular here in Italy, I think partly because so many cardiologists in this country participated in the studies and were aware of the results,” said Dr. Maria Franzosi, a researcher at the Mario Negri Institute in Milan. “In other countries, uptake may be harder because doctors think of it as just a dietary intervention.”

In the largest study of fish oil — conducted more than a decade ago — Italian researchers from the Gissi Group (Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto), gave 11,000 patients one gram of prescription fish oil a day after heart attacks. After three years, the study found that the number of deaths was reduced by 20 percent and that the number of sudden deaths by 40 percent, compared with a control group.

Later studies have continued to yield positive results, although some scientists say there are still gaps in knowledge.

This summer, a critical review of existing research in BMJ, The British Medical Journal, “cast doubt over the size of the effect of these medications” for the general population, said Dr. Roger Harrison, an author of the paper, “but still suggested that they might benefit some people as a treatment.”

Dr. Harrison said he believed that people should generally increase their intake of omega-3 acids, best done by eating more fish.

Still, he acknowledged that it was difficult to eat foods containing a gram of omega-3 acids each day. “If you ask me do I take omega-3 supplements every day, then, embarrassingly, the answer is yes,” said Dr. Harrison, a professor at Bolton Primary Care Trust of the University of Manchester in England.

“I, too, am caught up in this hectic world where I have little time to shop and prepare the healthy foods I know I should be eating,” he said.

Since the 1990s, much praise has been showered on the "Mediterranean diet," which is high in fats and yet seemingly causes less cardiac events than other diets. This counterintuitive phenomenon may be explained outright by the high content of Omega 3 fatty acids found in fish and nuts that are integral parts of the Mediterranean diet. And likely this is why Italy has been home to the most research on the effects of fish oil, and why it is so popular among doctors there.

Nonetheless, the practice of prescribing fish oil by American doctors for cardio-protection may be increasing thanks to guidelines and the existence of a purified fish oil in the form of Omacor.

The American College of Cardiology now advises patients with coronary artery disease to increase their consumption of omega-3 acids to one gram a day, but it does not specify if this should be achieved by eating fish or by taking capsules. But over-the-counter preparations of fish oil have much less rigorous quality control and are often blends of the two fish oils know to be beneficial in heart disease with other less useful fatty acids.

For that reason, Dr. Jacobson of Emory gives the prescription drug, “off label,” to cardiac patients, even though the F.D.A. has not approved it for that use. “Then I know exactly what they’re getting, and there is no mercury,” he said.

2 Comments:

At 10/04/2006, Anonymous Anonymous said...

Hmmm...that's interesting stuff. The key question, I think, is why there is such a delay at the FDA? The article seems to suggest some nefarious influence from the pharmaceutical industry, and I'm sure that is indeed a factor. But perhaps another factor is needless testing and precautionary measures that the FDA feels compelled to do because the risk -- "risk" meaning a possible hundred-million dollar lawsuit -- of having a defective product in the marketplace is too great. This isn't necessarily a bad thing (we can't simply disband regulation in our country, after all) but one wonders whether our legal system creates problematic disruptions in the cost-benefit analysis? Are we overstating the costs of fish oil (and other medicines and treatments) and thus needlessly sacrificing the overwhelming benefits? I don't know the answer too that question, but I think it is worth some reflection.

 
At 10/06/2006, Blogger Niraj "Raj" Patel said...

The delay in the FDA's potential approval of fish oil for management after heart attacks is delayed for one reason: there isn't enough scientific evidence to support the position that this is of any benefit.

The reason there isn't much evidence in the U.S. (as opposed to in Italy & Europe in general) is because there isn't much research done on the specific effects of fish oil use in patients who have recovered from heart attacks.

And the reason for this is that most research on the efficacy of treatments is mostly funded by drug (and device) makers.

There is no incentive for any company to pay for research, which is always a great expense, to show that fish oil is cardio-protective, because no company can patent fish oil and reap monopolistic profits from the product.

Thus it is not very likely fish oil will ever be tested according to FDA-approved research procedures funded by a for-profit company, meaning that it may never be approved for something that is approved in Europe. That's how it looks to me right now...

 

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