) -- A large study has once again demonstrated the failure of fish oil supplements to reduce heart disease or death in patients at higher risk for heart disease. The negative results of the Italian Risk and Prevention Study, published yesterday in the
New England Journal of Medicine
, could not come at a worse time for
and its prescription fish oil pill Vascepa.
Amarin is already struggling to convince doctors and patients to try Vascepa, so the last thing the company needs is more definitive clinical evidence ripping apart the theory that daily fish oil intake leads to improved heart health.
Vascepa was not used in the Italian study published Wednesday, but still, the odds of Amarin convincing a large pharmaceutical company to partner up on Vascepa's marketing or acquire the entire company went from low to nearly impossible.
Amarin will release first-quarter financial results and hold an investor conference call after the close of regular trading today. Street consensus for Vascepa first-quarter sales is $3.65 million, according to
enrolled 12,513 patients with multiple cardiovascular risk factors or evidence of heart disease but no prior history of heart attacks. Half the patients were randomized to receive 1 gram per day of n-3 fatty acids (fish oil) or an olive oil placebo.
After five years of follow up, 11.7% of the patients taking daily fish oil died or were hospitalized due to cardiovascular disease compared to 11.9% of patients treated with a placebo. There was also no difference in any of the prospective secondary endpoints.
"On the basis of the results, we conclude that there was no significant benefit of n-3 fatty acids in reducing the risk of death from cardiovascular causes or hospital admission for cardiovascular causes," the researchers conclude.
Eric Topol, a well-known cardiologist at the Scripps Clinic who was not involved in the study, was even more blunt in
"Fish oil does nothing," said Topol. "We can't continue to argue that we didn't give the right dose or the right preparation. It is a nada effect."
Amarin supporters were quick to defend Vascepa Wednesday night, with some taking to Twitter to argue the negative findings from the fish oil supplement study had no bearing on Vascepa because it contains more fish oil manufactured at a higher purity.
Amarin executives will likely make the same argument if/when they're asked to comment on the Italian study during tonight's conference call.
But in the Italian study, daily use of the fish oil supplement resulted in a statistically significant reduction in triglycerides, a type of fat found in the blood believed to have a negative effect on heart health. This is exactly what Vascepa does and is the basis for the pill's approval last year.
Yet now we have another study showing fish oil's role in lowering triglyceride levels, which is only a laboratory measurement, doesn't help patients avoid heart disease or reduce heart-related deaths, not even a little bit.
The evidence against fish oil's benefits is growing, and Amarin will have hard time explaining why Vascepa, even at a higher dose, should perform any better.
-- Reported by Adam Feuerstein in Boston.
Follow Adam Feuerstein on
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.