The moment I saw the article in the Journal of the American Medical Association (JAMA), in which a group of cholesterol research physicians from Greece tell the world that fish oil supplements don’t prevent heart disease, I knew I’d be receiving calls and e-mails asking about it. I wasn’t mistaken. Any reasonable person would leap at the chance to save a few bucks, take two fewer pills, and put an end to that occasional fishy burp.
The short answer to this JAMA research? If I were you, I’d keep taking my fish oil and stop reading now. And if you’re upset that your brand has a fishy burp effect, go upscale. Your omega-3s might be super-cheap at Sam’s Club, but just like paint and tires with fish oil you get what you pay for.
For the long answer regarding this fish oil research, you need to know more about the study itself, randomized clinical trials (RCTs), and evidence-based medicine (EBM). You may want to leave this acronym-filled forest while you’re ahead.
The JAMA article was based on what’s called a meta-analysis. A research paper like this doesn’t offer anything original, instead analyzing numerous older papers on the subject and then looking for trends and outcomes and drawing conclusions from them.
Each of the studies reviewed for this meta-analysis contained some variation of that alleged chestnut of medical research–the RCT, dubbed the “gold standard” by doctors who make millions conducting them. Here’s how an RCT works: let’s say you’re testing a new drug. You select a group of patients who have certain factors in common. For a new drug, that would be patients with the same disease. On the other hand, an RCT looking at prevention, such as “effects of exercise on health,” works with a healthy population.
The subjects in an RCT are divided into two groups called “arms.” In a typical drug study (the most common type of RCT), one arm receives the drug, the other a placebo. Ironically, there is virtually never a much-needed third arm that evaluates “lifestyle modification only” because there’s no profit for anyone when it comes to living a healthful life. Most RCTs are also double-blind, meaning neither the investigators nor the subjects know if they’re giving/getting the actual drug or the placebo. Investigators agree on a length of time for the study, with subjects recording side effects along the way. At the end of the study, the envelopes are opened and the investigators can see if the drug worked.
Evidence-based medicine (EBM)
It is the RCT that gives rise to the important sounding “evidence-based medicine,” which, like my description of RCTs, sounds a whole lot more scientific than it actually is. There is an irritating pomposity about physicians who crow about their devotion to EBM. They usually do so when their patients report that some form of alternative medicine actually helped them more than a drug that made them sicker or nearly killed them. The mantra: Well, dear, you can try those herbs from the guy in Chinatown, but I’ve been trained in evidence-based medicine. (Ugh!)
I myself became extremely suspicious of the term EBM when I started receiving a free subscription to the Journal of Evidence-Based Medicine from United Healthcare, one of the nation’s largest and most parsimonious health insurance companies. Why would they be sending this to me (and all physicians) if not to save themselves some serious money? As you might guess, one article after another offered algorithms for conditions that ended up using cheap generics and disparaging anything remotely alternative. An algorithm, by the way, is a super simplistic cookbook approach to treating any illness that uses charts so basic (“If this, do this; if that, do that”) that any reasonably intelligent seventh grader could practice, by evidence-based standards, quality medicine.
The idea is that by following the algorithm, EBM will lead to “positive outcomes.” On the surface, having positive outcomes sounds like a good thing, but try asking any elementary education teacher about the correlation between test scores and kids actually learning anything and you’ll get an idea about outcomes. Unfortunately, the new Affordable Care Act will base much reimbursement to doctors and hospitals on these so-called positive outcomes (essentially the same issue that the Chicago Teacher’s Union has been battling over).
But since lifestyle changes are virtually never addressed in all this, the real beneficiaries of the Affordable Care Act will be the big boys in the insurance and pharmaceutical industries.
I promise I’ll get back to fish oil in a minute.
As Bill Clinton kept saying during his convention speech, “Listen, people, this is important. Follow me here.
RCTs have come under a lot of criticism recently, so everything about RCT “evidence” and “outcomes” needs to be taken with a grain of Kosher salt. In fact, several investigators have suggested that, in retrospect, some 75% of RCTs are so flawed that the conclusions they reach, if not entirely worthless, are very suspect. One real problem with virtually all RCTs is that they’re extremely expensive to undertake, and the results belong to the companies that own them. It takes multiple millions of dollars over long periods of time to gather physician-investigators, patients with specific conditions, nurses to keep track of all these patients, data analysts, and other study members. In fact, these days, with reduced government spending on health research, the only people with money enough to run RCTs are (surprise!) pharmaceutical companies, who can make all their money back if an RCT turns out in favor of their drug.
So it’s no surprise that the single greatest flaw in the RCT system has been called “investigator bias,” which you can read as a reluctance of the investigator to make a meal of the hand that’s feeding him. So the doctor tweaks the data just enough to make the RCT look better than it is, and the drug gets its precious FDA approval.
But all RCTs can’t turn out in favor of the drug being tested, and thus to avoid putting all their potentially golden eggs in one basket a drug company will fund five or more studies on a single drug. But here’s the kicker: they don’t have to worry about bad results! Current legislation allows the industry to hide negative studies and submit only the positive ones, the ones with the tweaked data.
Now back to the JAMA fish oil study
First, the investigators signed the standard conflict of interest disclosure, swearing they’d received no funding from any company making fish oil. They did acknowledge, however, “participation in trials by industry not associated with omega-3 capsules.” Since the paper comes out of the Lipid Disorders Center, we can assume this is a very disingenuous way of saying they did receive big bucks from statin manufacturers.
The investigators reviewed a grand total of 3,635 clinical studies that had used fish oil. Of these, they then selected 20. Most of remaining 3,615 were eliminated because either the studies were not RCTs or were, to use their term, “irrelevant reports.” (Irrelevant reports may have included nutritionally oriented chiropractic physicians writing about fish oil in one of those pesky alternative medical journals.)
Now, follow closely. Of these 20 selected studies, with a total of 68,680 patients, just two, with a total of 473 patients, had received no pharmaceutical industry funding. We can safely assume that by “industry” they mean the statin manufacturers and therefore each investigator in the remaining 18 studies had a financial incentive toward the success of the statin and failure of the fish oil.
But that’s just half of it.
In this meta-analysis, all the patients–all 68,680 of them–already had heart disease. Many of them were taking statin drugs, most were on aspirin or other blood thinners, and many were also taking meds for high blood pressure or diabetes. In other words (and significantly the media fails to mention this point), these were studies designed to assess the use of fish oil as an add-on for an established heart patient who is already taking heart meds and who, quite frankly, may have had one foot in the grave. The article calls this “secondary prevention.” I call it too little, too late. To ask fish oil to prevent heart disease in someone who already has heart disease is like expecting St. John’s wort to reverse depression in someone being wheeled in for electroconvulsive therapy.
Most of us who dutifully take our daily fish oil capsules are using them for “primary prevention.” We try our best to eat healthfully, keep our weight under control, not smoke, limit stress, and exercise (or at least feel genuine guilt when we don’t).
The actual question then becomes “Does fish oil help with the primary prevention of heart disease?” The answer (sorry) is that it depends on whose RCT you read. Some studies show good benefits, others less so. But to me, since the omega-3s in fish oil have so many other benefits for our bodies (brain, skin, hormones, neurotransmitters, immunity) and no negatives whatsoever, I’ll go with “yes.”
So, really, what was the purpose of publishing this JAMA study? Is there a hidden agenda? I’ve mentioned before, and likely will remind you in the future, of the serious trend on the part the federal government, the pharmaceutical industry, and organized medicine to get all nutritional supplements off the shelves and regulated by the FDA as prescription medications.
This has already occurred in Europe and the writing’s on the wall here in the US. In conventional medical journals I’m seeing one article after another, backed by the flimsiest of biased research, “disproving” supplements that people have been taking for years.
Let me end with where this might be heading. Consider Lovaza, capsules of fish oil available by prescription only. When the FDA approved fish oil to lower triglycerides, health insurers were required to cover prescription fish oil. Lovaza capsules contain a high-grade fish oil that’s not really better than any other good brand. The only difference is that your better quality over-the-counter fish oil costs about $35 a month. And Lovaza? $350 a month.
Now tell me, if you were the CEO of a pharmaceutical company wouldn’t you like an iron grip on America’s nutritional supplements.
David Edelberg, MD