Doctors Often Recommend Omega-3 Supplements For High Cholesterol – Survey

A survey of doctors and pharmacists reports 83% of their patients with abnormally high cholesterol express interest in using omega-3 supplements. But the survey sponsored by Rx omega-3 firm Amarin also raises questions about health care professionals’ knowledge of FDA regulation of supplement products.

Doctors and pharmacists regularly recommend omega-3 dietary supplements for patients with abnormally high cholesterol or triglycerides and those consumers more frequently ask about the products, according to a survey sponsored by an Rx omega-3 product firm.

However, the survey sponsored by Irish firm Amarin Corp. PLC also raised questions about health care professionals’ knowledge of FDA regulation of supplement products. The results showed varied levels of understanding about FDA’s oversight of dietary supplement manufacturing and marketing, with 11% of the professionals contacted stating the agency regulates supplements and OTC drugs in the same way.

The survey conducted in 2013 by Fairleigh Dickinson University’s PublicMind research center showed that 78% of the 200 doctors and 55% of the 150 pharmacists said in the previous 12 months they had recommended use of a supplement containing eicosapentaenoic or docosahexaenoic fatty acids for patients with abnormally high cholesterol or triglyceride levels (see table below).

The survey group included 150 primary care doctors and 50 cardiologists, and 75 pharmacists from each of the chain and independent store categories, according to PublicMind, which announced the information in a Feb. 13 release.

In Fairleigh Dickinson University’s PublicMind survey conducted in February and March 2013, physicians and pharmacists were asked to consider the previous 12 months in answering these questions.
	Total	Physicians	Pharmacists
Have you recommended a dietary supplement to any patient for abnormally high cholesterol or triglycerides?
Yes	68%	78%	55%
No	32%	22%	45%
Have any patients with abnormal cholesterol and/or abnormally high triglycerides indicated a desire to take nonprescription omega-3?
Yes	83%	87%		77%
No	17%	13%		23%

Rich Higginson, director of PublicMind’s Consumer Research division, pointed out that the disparity in the doctors’ and pharmacists’ familiarity with regulatory oversight of supplement products could influence consumers’ understanding of the products.

Although no omega-3 product is approved as a nonprescription drug in the U.S., 50% of the physicians and 79% of the pharmacists said they had recommended a patient use an OTC product containing the ingredient, according to the survey (see table below).

“With confusion among health care professionals it is likely this may be even more confusing to patients. Consumers may not know that there are no OTC omega-3s – only supplements or prescription products,” Higginson said.

PublicMind’s survey* also asked participants about patients’ interest in omega-3 supplements and about their familiarity with FDA oversight of the supplement industry.
		Total	Physicians		Pharmacists
When patients indicate an interest, do you typically recommend a nonprescription omega-3 or not?
Yes	82%		77%	89%
No	18%		23%	11%
Would that have been an “over-the-counter” omega-3 product, a dietary supplement omega-3, or both?
OTC	61%		50%	79%
Supplement	14%		17%	11%
Both	24%		33%	11%
Are nonprescription omega-3s similar in strength and content to prescription omega-3s?
Yes	25%		22%	30%
No	62%		62%	62%
Not sure	12%		16%	8%
* PublicMind hired OpinionAmerica Group, Cedar Knolls, N.J., to contact participants using a computer assisted telephone interviewing system.

Michael Farrell, finance VP for Amarin’s Bedminster, N.J., business Amarin Pharma Inc., said the firm decided it needed information on health care professionals’ understanding of the difference between omega-3 supplements and its Rx omega-3 Vascepa, indicated for lowering triglycerides in patients with extremely high triglycerides.

“In speaking with doctors and pharmacists it appeared that many think incorrectly that supplement omega-3 is the same as a FDA-regulated OTC,” he said, adding, “It is clear from the survey that there is confusion between OTC and supplement regulatory terms.”

“We wanted an objective polling source to outline the awareness challenge. Patients who use supplements incorrectly to treat diagnosed disease may be putting their health at risk,” Farrell said in an email.

Amarin Mines Omega-3 Awareness

Amarin commissioned the survey around the time it launched Vascepa. FDA in July 2012 approved Vascepa capsules “as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia,” according to the agency’s drug approvals database.

Higginson said Amarin received the results soon after the survey was completed in March 2013.

Amarin’s clinical trials showed that unlike the Lovaza (omega-3-acid ethyl esters) Rx product marketed by GlaxoSmithKline PLC, Vascepa does not increase low-density lipoprotein cholesterol, which could appeal to consumers already on a regimen of statins to lower their cholesterol levels (Also see "Will The Rising Tide Of Rx Omega-3s Float The Fish Oil Supplement Market?" - Pink Sheet, 24 Jan, 2011.).

To distinguish its product from supplement fish oils, the firm has described it as semi-synthetic, ultra-pure ethyl icosapentate and a single-active moiety with composition “highly regulated with no variations or deviations."

Farrell said Amarin currently does not plan to sponsor a follow-up survey to gauge whether physicians and pharmacists better understand omega-3’s place on the regulatory landscape. “If the need exists we will look into that possibility,” he said.

Amarin is interested in expanding the indication for Vascepa to include patients with mixed dyslipidemia and coronary heart disease or a CHD risk equivalent, asking FDA to accept an unproven surrogate endpoint, assuming the drug is safe. However, in 2013 an advisory committee voted against approving the expanded use and FDA rescinded special protocol assessment it had granted Amarin for a trial examining an expanded label based on a surrogate marker of triglycerides (Also see "Omega-3 Questions Could Pull Plug On Sales Growth" - Pink Sheet, 19 Feb, 2014.).

Omega-3 Tide Raises All Boats

The Global Organization for DHA and EPA Omega-3s expects that publicizing some misunderstanding by health care professionals about FDA regulation of the ingredient would not prompt a drop in consumers’ regard for the products.

“The survey results are interesting, but typically surveys like these do not influence opinion by themselves unless the insights are turned into marketing messages,” said GOED Executive Director Adam Ismael.

“It will be interesting to watch how Vascepa is marketed and whether they leverage these survey results because traditionally there has been little competition between the pharmaceutical and dietary supplement markets. On the contrary, marketing one in the past has benefited both,” Ismael said in an email.

He also would be interested in comparing these results to information from similar questions on multivitamins or other well-known supplements. A comparison would show whether the PublicMind survey “insights are specific to omega-3s or to general differences among the OTC pharma, prescription pharma and dietary supplement industries,” Ismael said.

The survey was PublicMind’s first about a consumer health care product. Higginson said PublicMind, in Madison, N.J., opted to announce the information this month due to media attention to the New York attorney general’s investigation of herbal supplements marketed in the state.

“We just thought it was good timing with all new news hitting now about dietary supplements,” he said.

PublicMind’s Consumer Division conducts sponsored surveys and a separate division in the center launched in 2001 publishes monthly surveys, primarily New Jersey-focused, on political, cultural and social topics.