Not being a TV watcher, I’d never actually seen PBS Frontline until I received some emails from patients and medical colleagues asking for my reaction to what sounded like a Fox News rant against the nutritional supplement industry. Since it’s my belief that such exposé-type shows exist mainly to enhance ratings, I wasn’t enthusiastic. If it were as dismal as I expected, it would be an hour of my life irretrievably lost.
It was Fox News disguised as Frontline, and yes, the hour is gone forever.
I’ll organize the program into its components and give my take on each:
Tainted supplements The first segment interviews the owners of a tiny supplement company that inadvertently mixed into a supplement blend what was discovered to be a tainted product from China. Although they recalled it as soon as possible, allegedly several consumers became ill. I say “allegedly” because there was a little inconsistency in the reported symptoms, which included hair loss, liver failure, skin rashes, and breasts developing in men. You did get the electric thrill of watching an outraged personal injury lawyer salivating over the financial possibilities of his lawsuit while the extent of the actual injuries remained hearsay. Unfortunately, the Frontline takeaway seemed to be that you face a risk of exposure to tainted product from all supplements and that you’re safest when you place yourself in the hands of your doctor and limit yourself to prescription drugs.
In actual fact, manufacturers of both generic pharmaceuticals and supplements purchase ingredients from chemical manufacturers worldwide. India has more than 400 such companies and China more than 500, producing the drugs and supplements you take every day. Anything might show up on our shores: capsules, tablets, or bulk containers with powders and liquids destined for encapsulation before being packaged into the bottle you see on your pharmacy or health food store shelf.
If you’re puzzled about why your generic drug comes from Hyderabad, India, as opposed to say, Naperville, Illinois, think Economics 101. Multinational companies–whether producing a Toyota or a Topamax, a Samsung or a statin–hunt out the cheapest labor force they can find. If you think the pharmaceutical industry is exempt from product recall, think again. Ranbaxy Labs (India) has had FDA citations for impurities. Click here for a list of generics they produce (you’ve probably taken one). And here’s an article from The People’s Pharmacy about the FDA’s reluctance to make the public aware the problem.
Only brand-name pharmaceuticals are the best in terms of reliability and product purity. They’re also egregiously expensive and generally not covered by insurance.
Labeling inaccuracies Frontline was outraged that they found evidence showing what a supplement said on a label did not match the capsule content itself. Herbal products didn’t contain the herb as listed. There was too much or too little of a vitamin.
Yes, this is a bad thing. But this is also old news and the problem exists with generic drugs as well. What’s supposed to happen is that manufacturers of both supplements and generic drugs are to certify they’re abiding by an honor code of good manufacturing standards. You may not know this, but no clinical testing–that is, checking for a drug’s effectiveness–is required of generic drugs. They simply sign a form promising their product is completely identical to the branded version.
Although Frontline implies the pharmaceutical industry is squeaky clean when compared to the unregulated supplement industry, anyone (physician or patient) involved with generic drugs will tell you there’s broad variability in quality. One brand of generic Ambien (zolpidem) will put you to sleep, another brand will do absolutely nothing. The generic version of Lexapro (escitalopram) usually requires a 50% dose increase to provide the same degree of effectiveness as the branded version.
Several months ago, I wrote about the attorney general of New York pulling a variety of supplements (mainly herbs) from the shelves of Walmart and GNC because the labeling didn’t match an analysis of the capsule contents. My advice in that Health Tip was this: when it comes to paint, tires, or nutritional supplements, you get what you pay for.
The superstars of the supplement industry operate manufacturing facilities that are indistinguishable from the best of Big Pharma. These companies sell products, labeled “pharmaceutical grade,” mainly to physicians, meticulously testing bulk product as it arrives from suppliers before encapsulating it or molding it into tablets. Their products are more expensive because they purchase the highest-grade product available and test it before you swallow it.
Regulation As for being unregulated, in fact once generic drug and nutritional supplement manufacturers provide the certifying documents of good manufacturing standards, they are subjected to FDA scrutiny. The manufacturers provide documentation when they’re about to introduce a product. If the FDA sees nothing amiss in their paperwork, they’re given a thumbs-up.
Once the new product is out, the manufacturer can be visited by the FDA if there are complaints or there may be spot checks like random IRS tax audits. However, there are thousands of companies around the world and the FDA can’t inspect them all, although especially in response to complaints by physicians or consumers the FDA will check the strength and purity of generic drugs and supplements. It was in response to one such complaint that the tainted product described earlier was found.
If something’s not right, the FDA issues cease and desist orders. In the case reported earlier, Frontline accused the FDA of not acting quickly enough. Considering the vast number of products and foods it investigates (it was the FDA that handled the Chipotle mess), I thought they did a reasonably good job. The moment the owners received word of a possible problem with their product, they concealed nothing and promptly recalled it.
Unsubstantiated claims Frontline suggested there are unsubstantiated health claims made by supplement manufacturers and if such claims are made, they should be subjected to the same scrutiny as new prescription drugs. In fact, there are only very vague statements on product labels. You’ll never see “Helps Depression” on a bottle of St. John’s wort but rather “supports mood.” In addition, there will always be wording that releases the FDA from actually recommending the supplement.
What Frontline is asking of the supplement industry is actual clinical testing of each supplement. This means placebo-controlled clinical trials, which cost millions. Big Pharma will spend money like this only on products that can be patented and sold exclusively by them. Since herbs and supplements cannot be patented (hence their reasonable prices when compared to branded prescription drugs), no one will spend the money on clinical trials.
Parenthetically, you must know by now that clinical trials are not all they’re cracked up to be. The physicians conducting these trials are vastly overpaid and have been known to conceal data from the FDA if a drug isn’t working as well as it was hoped. They’ll sweep side effects under the rug. Volunteers in clinical trials receive a paycheck for their work and are skilled at telling the physicians what they want to hear so they’ll be rehired for the next clinical trial.
But the real issue of asking supplement manufacturers to produce clinical trials is this: how much proof for an herb or supplement is needed when there are already dozens of published studies from around the world? If, for example, the British Medical Journal reports that St. John’s wort is as effective as Zoloft for mild depression, do we really want or need another study on St. John’s wort, this time funded by the makers of Zoloft?
Conclusions
My suggestion is that you not let Frontline do your thinking for you. If you’re concerned about a particular supplement or manufacturing company, investigate it yourself. Let’s say you’re wondering whether or not to start the popular supplement Resveratrol, reportedly effective in preventing age-related dementia and even cancer. Don’t just accept the hype. Type into your Google bar “resveratrol effective for” or “resveratrol clinical studies” and make your own decision.
And since tainted anything–from supplements to generics to Chipotle burritos–is certainly a cause for concern, stick with quality. When it comes to supplements, buy fewer but buy the best you can afford. Don’t go bargain hunting (would you choose to be operated on by the cheapest surgeon you could find?).
Choose from among the top brands. These include Metagenics, Integrative Therapeutics, Pure Encapsulations, Emerson Ecologics, Allergy Research, Xymogen, Ortho Molecular, Eclectic, Douglas Labs, Thorne, and Designs for Health.
Be well,
David Edelberg, MD