The topic of “Supplments” comes up often in clinic.  Sometimes its related to taking Vitamin D because we don’t get much sun in Seattle, or perhaps someone wondering if there is a supplement that will help with hairloss, or perhaps whether there is a supplement that will help with eczema.

I hate talking about supplements.  I really do.  The reason I hate talking about supplements is because my PhD in Biological Chemistry and Molecular Pharmacology made me skeptical.  Of everything.  On one hand, I’m like Fox Mulder, and want to believe that these things can help, but I relate very well to Dana Scully (who was my celebrity crush for quite a few years) who wanted proof.

Do supplements work?

Maybe, but no one knows for sure.  Entire industries are built upon them, including the supplement industry itself, but also naturopaths, homeopaths, and others.  But data, and I mean real data, not your Aunt Millie talking about how good glucosamine makes her feel is sparse, almost non-existent.  So my first beef with supplements is that they are not subject to the same scientific scrutiny as drugs.  To bring a drug to the market you have to:

1. Prove that it is reasonably safe or that its risks are justified for the disease it is treating (chemotherapy medicines are NOT safe, but are thought to be better than the alternative of being dead).
2. Demonstrate in clinical trials that it does what you claim it does.  Ideally, this is done using at least two large randomized controlled trials in which neither the patient or their doctors know whether the patient is taking the medicine or a sugar pill (placebo).  When there are multiple good drugs already on the market for a disease, the FDA will also sometimes require you to prove that it is not just better than placebo, but is actually better than what is already out there.

There are very few WELL done studies on supplements, and most of the good studies were flops.  A good example is the echinacea studies first in the New England Journal of Medicine in 2005 and then in the Archives of Internal Medicine in 2010.  Both of these studies failed to find any benefit from taking Echinacea.  Or at least not enough benefit to matter (from comments on the 2010 study):

The study covered 719 patients ages 12 to 80 who had new colds. The participants were assigned to groups that received echinacea, or else a placebo or no pills at all. People given the placebo, and half of those taking echinacea, weren’t told what they were taking.

Patients who didn’t know they were on echinacea had colds that lasted about 6.34 days on average compared with 6.87 for people on placebo, the researchers said.

While the researchers said echinacea was associated with an estimated 10 percent lessening in the severity of colds, they said no more than a quarter of people “would judge this level of benefit worthwhile, given the cost, inconvenience and possible side effects,” such as stomach upset, nausea and diarrhea.

Echinacea is still on every pharmacy shelf I’ve seen and my parents still take it when they get a cold.  The herbal world still says it works, and says that the studies tested the wrong type of echinacea plant.  Echinacea sales are about $150M per year in the United States.  Perhaps its harmless, but this isn’t like having soup when you have a cold.  I do have soup when I have a cold.  I also like soup, soup is cheap, and I have to eat something.  But until I see some convincing evidence, echinacea is pretty much a ground up weed that people waste $150M a year on, money that could be spent on something more useful like public health, bringing back school nurses, or school nutrition, all of which are far more likely to affect colds.

But supplements are safe!

BS.  Every time I hear someone say that supplements are no big deal because they are “safe” my blood boils.  Seriously.

This, I think, is the single biggest problem I have with supplements.  When a drug is brought to the market, safety studies need to be done.  This is what you read about when you hear about drug trials-Phase 1, 2, and 3 trials.  Phase 1 trials usually make sure the stuff doesn’t kill anyone.  Phase 2 trials are usually a bit larger and test whether less serious adverse effects are seen in a larger study population.  Phase 3 trials focus on whether the drug actually works, but safety data is also collected.  For many drugs, and certainly anything widely used (Lipitor, Plavix, Accutane, Enbrel, Humira), safety data continues to be gathered long after initial drug approval.

So for a drug like Accutane, which was approved in the US in 1982, and is a very serious medication we have TONS of safety data.  Is the drug safe?  No, you can’t just take the drug and forget about it like you do with Advil.  It has real side effects.  But by this point in time, we have a VERY solid understanding of what they all are, how often they occur, and whether they are reversible or not.

However, the supplement industry does not do this.  After a natural sleep remedy was associated with 20 deaths in the early 1990’s, the FDA took an aggressive move to regulate the supplement industry.  But, what happened instead is that in 1994 Congress passed a law that specifically excludes the FDA from regulating the industry.  It was the result of a remarkably effective lobbying campaign that creates a dramatically different set of rules for supplements called the Dietary Supplement Health and Education Act (DSHEA):

“the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

At first glance this might sound ok, but the reality is different.  For drugs, safety trials must be performed.  That data is submitted to an FDA review committee who evaluates the data and determines if the drug can continue to be developed. This process is NOT perfect, but contrast that with the supplement industry which does not have to do any trials and instead allows the sale of any supplement as long as the manufacturer SAYS it is safe.  No one ACTUALLY checks.  The FDA is specifically forbidden from evaluating supplements before they are sold and is ONLY allowed to take action if they receive reports from the public or from doctors that some supplement is harming (killing) people.

So the reason my blood boils is because people assume that supplements are safer than drugs.  And in some cases they probably are correct, but the safety of drugs on the market has been tested while the safety of supplements on the market has not.  So, when I think about supplements, the Fox Mulder in me says “I hope they are safe”, but Dana Scully cannot say “I know they are safe”.

I hate doubletalk

I hate doubletalk.  Doubletalk is what we do to cover our butt.

The 1994 Dietary Supplement Health and Education Act went on to say:

Manufacturers must make sure that product label information is truthful and not misleading

That sounds perfectly responsible.  We will let the supplement manufacturers police themselves.  My first problem with that is that we definitely don’t let drug companies police themselves, we watch their every move, and with good reason.  But maybe the supplement manufacturers aren’t evil.  Maybe they can police themselves.

These are claims you will find on bottles of supplements:

• enhance your immune system function, especially if you have a chronic disease
• maintain your optimal health by removing toxic and radioactive metals in your body
• slow down the doubling time of your PSA (male prostate) levels when cancer is present
• help prevent aberrant cells from adhering to your critical organs and tissues like the prostate, breast, colon, lymphatic system, skin, brain and larynx
• promote normal cholesterol levels
• take a supplement that has been successfully clinically tested

Then, on the back in small print, you ALWAYS find:

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

The law says they cannot make misleading statements.  In fact, if you make claims that the product is intended to diagnose, treat, cure or prevent a disease it is deemed a drug subject to FDA approval.  So what almost every supplement maker does is in BOLD BRINT state what disease their supplement will treat or cure but then on the back of the bottle in teeny tiny fine print say that they aren’t actually making those claims.  This is done because it allows them to sell their product without having to go through a drug approval process with the FDA and the FDA can’t touch them unless or until there are safety problems found after the fact.  To me, its like having a conversation with someone who has their fingers crossed the whole time.  To come clean, they would have to either make no claims or put their product through FDA evaluation.  It remains a very, very shady industry.

The Bottom Line:

After all that, it may surprise you to hear that I take supplements.  I take fish oil, Vitamin D, and a multivitamin.  Fish oil has shown beneficial cardiac and lipid effects in lots of studies.  There is a lot of controversy regarding Vitamin D and how much to take, but there is very good data that most people in the northern US are deficient in Vitamin D because our body cannot produce it in the winter because their isn’t enough sun.  I ignore all other claims about what fish oil and Vitamin D do.  I take a multivitamin for the simple reason that it eliminates any worry about whether I am getting enough X, Y, or Z.

But, if you take supplements you should always remember:

1. It is highly unlikely that anyone has ever done any safety testing on the product (making you and your family the guinea pig) and ;
2. The FDA is only allowed to step in if they start receiving reports of harm.  They receive about 1000 reports per year, which I suspect is only a small fraction of problems that actually occur.

I would say trust, but verify.  However, I think that as an individual that is difficult to do and the FDA has had its hands tied behind its back by the Dietary Supplement Health and Education Act.  So please –  use a hefty dose of caution.