dietary supplements: when a medication isn’t

Sunday, August 2, 2015

Elite athletes know their bodies well. They understand the signals that push them to perform and those that may cause potential damage and injury. They also know that what they put into their body for fuel is an important part of the equation. For that reason, an athlete who tests positive for a performance-enhancing drug, can reasonably presume that it was illegal. So it was not unreasonable to hear the collective sigh of disbelief, when Antonio Gates of the San Diego Chargers told reporters that he was shocked when he failed his drug test. Mr. Gates said he was not quite sure how the illegal drugs got into his body but he had not necessarily changed his routine and had never before tested positive.

Fans may roll their eyes and stare in disbelief, but Mr. Gates may be the victim of the dietary supplement and alternative medication industry that has grown without oversight and regulation. While pharmaceutical companies are held to stringent production and distribution standards by governmental agencies around the world, those companies who tout the benefits of their “nutraceuticals” can do so because of large loopholes found in the Food and Drug Administration (FDA) regulations. There is no guarantee that what is listed on the label is actually contained in the pill.

This year the New York attorney general’s office found that the majority of herbal supplements tested did not contain any of the herbs listed on their labels. These were supposedly reputable brands sold at major retailers like Walgreens, Target, Wal-Mart and GNC. This was not necessarily news, since past studies had documented similar inaccuracies. Not to be outdone, this month, the Department of Justice sued three Wisconsin manufacturers (Atrium, Nutripak and Aspen Group) for mislabeling multiple supplements and because it was a repeat offense, asked that they be continually monitored at company expense by the FDA. European researchers found that more than 10% of dietary performance supplements were contaminated, often with steroids and other stimulants (Judkins, C. Investigation into supplementation contamination levels in the UK market. HFL Sport Science 2008).

So why does this matter and why should we care what a pro athlete puts into their body? The answer is relatively simple. Dietary supplements are not innocuous. They can have significant side effects if take inappropriately and may also interact with prescription medications to cause problems.

Excessive caffeine can affect blood pressure, heart rates and rhythms. St. Johns Wort can interact with blood thinning drugs to decrease their effectiveness and lead to increased risk of stroke. Bodybuilding and weight loss supplements contain chemicals and proteins that may stimulate increased production of anabolic steroids in the body, increasing the risk of liver disease, cancer and other illnesses. Some, like androstenedione, were available for years before being banned by the World Anti Doping Agency and other pro sport organizations. Other chemical supplements are now marketed to take their place. Plus, there is the potential for contamination in the manufacturing process. A hepatitis outbreak in 2013 was related to the weight loss supplement OxyElitePro. In 2014, the probiotic, ABD Dophilus Powder, was found to be contaminated with fungus.

While all manufacturers should not be painted with the same brush, industry lobbied hard for Congress to exempt them from the tighter FDA regulations that are imposed on pharmaceutical companies. In 1994, Congress exempted supplements from the FDA approval process required of pharmaceutical companies. In 2012, an amendment to register products with the FDA and list their ingredients was defeated. Now, all the FDA can do is ask that makers of dietary supplements voluntarily adhere to good manufacturing practices and guarantee the identity, purity, strength and composition of their product.

The National Institutes of Health notes that “research studies in people to prove that a dietary supplement is safe is not required before the supplement is marketed…the manufacturer does not have to prove that it is effective.” Dietary supplements cannot be marketed to treat, prevent or cure a disease or illness. Therefore, the weight loss or male sexual enhancement claims are not meant to treat obesity or erectile dysfunction. Supplements developed to regulate acid secretion or bowel habit are not directed to peptic ulcer disease or constipation.

With the inaction by Congress and the FDA, other companies have filled the void. NSF International will certify products as safe, containing what the label says it does, and sports leagues like the NFL accept that certification. But it is a leap to say that the manufacturing standards of dietary supplements meet those of pharmaceutical companies, without the stamp of approval of a governmental agency. And while it is sometimes hard to believe the explanations that athletes give for failing a drug test, it is a distinct possibility that Mr.. Gates did nothing wrong and was the victim of circumstance beyond his control.

For Mr. Gates, the potential lack of manufacturer accountability led to a missed paycheck. For those who developed hepatitis or a fungal infection, or had a heart attack or stroke, the loss was much more tangible. Without aggressive FDA oversight and action, the self-regulation in the industry will only get better only if the risk of an expensive lawsuit outweighs the benefit of increasing their standards. And that’s asking a lot for a company to balance corporate ethics against their bottom line.

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failing the dietary supplement test

Monday, July 15, 2013

The work of track and field took another shot across the bow this week, when three more sprinters were notified that they had failed drug tests. American Tyson Gay and Jamaicans Asafa Powell and Sherone Simpson all tested positive for oxilofrine, a stimulant in the same drug class as amphetamine, and now await their competitive fate to be determined by their sports federations. Gay and Powell were two of the three fastest men in the world this year.

Oxilofrine, also known as methylsynephryn, is available by prescription in some countries to help patients suffering from low blood pressure, but it is not licensed or approved in the US. Instead, it has found its niche in the world of body building because its amphetamine and adrenaline type properties might help with weight loss and fat burning. The problem is not the benefit that it might have but the side effects that can be potentially lethal.

Oxilofrine and similar chemicals can be thought of as uppers, providing an adrenalin boost to the body. Unfortunately, the downsides and complications on the cardiovascular systems can far outweigh the benefits. Patients can develop rapid heart rates, high blood pressure and hemorrhagic stroke or bleeding in the brain.

Most people have episodes of palpitations where their heart skips a beat, beats quickly, beats irregularly or all three. Most often, the episodes are momentary, lasting a second or two and quickly forgotten, but they sometimes persist causing the patient to present to their doctor’s office or the ER. The complaint can be a fullness or heaviness in the chest, an occasional thump or fluttering and shortness of breath. It all has to do with the heart functioning as an electrical pump and an electrical short circuit. The underlying cause is usually benign, but the patient always fears that their heart will stop.

The heart is a two stage electrical pump. An electrical impulse is automatically generated in the atrium or upper chamber of the heart. This impulse causes the atrium to contract and send blood collected from the body, to the ventricle or lower chamber of the heart. The electrical impulse is slowed for a fraction of a second at the atrioventricular junction allowing the ventricle to completely fill and then the electricity allows the ventricle to contract, pumping blood to the body. The heart goes lub-dub, the cycle repeats itself 60-80 times a minute and all is good.

Palpitations are caused when the electrical system becomes irritated. It can be a wiring problem that needs fixing or it can be due to the effects of “poisons” on the heart, those from within the body or those put in the body. The poisons within include thyroid problems or changes in electrolytes like potassium, magnesium and calcium that can affect the heart’s electrical conducting system. The ingested poisons are those that get converted to adrenalin-like substances and affect the heart. Common ones include caffeine, alcohol, amphetamine, cocaine and over the counter cold medications that contain pseudoephedrine or phenylephrine. Oxilofrine fits in here, as a “dietary supplement”, along with a variety of herbal medicines that can cause the heart to be irritable and drive up blood pressure.

Too often, when a patient presents with palpitations, the episode has passed and the heart rate is normal. It’s like having a noise in your car that magically disappears when you pull it into the mechanic’s bay. Their solution is to come back when the noise happens again or to leave the car and they’ll drive it when they have a chance. Both are not reasonable options for the human body. There are occasional times when the palpitation may be life threatening.

Rapid heart rhythms that originate in the atrium tend not to be emergently life threatening but those that start in the ventricle can be associated with sudden death and it is the doctor’s job to gather enough information to make certain that it is safe for the patient to go home. It’s easy if the monitor shows an occasional premature ventricular contraction (PVC) or premature atrial contraction (PAC) which are normal variants but can cause a characteristic thump in the chest and the sensation of a missed beat. It’s harder when the monitor shows a normal sinus rhythm and electrical conduction.

The history and physical exam, along with a heart monitor strip and EKG, are usually the bare minimum required to figure things out, come to a diagnosis and reassure the patient. Sometimes, the answer is not so clear and more testing is needed. From blood tests to echocardiograms to heart monitors worn at home, the art and skill of medicine is deciding how much or how little technology is needed.

As with much of medicine, the best treatment is prevention. In the case of over the counter medications or dietary supplements, there are chemicals that can cause harm and the key is to avoid them. Your doctor or pharmacist may or may not be aware of the contents of the latest GNC product and it is unlikely that the sales clerk will appreciate the interactions of some of the ingredients with prescription medications. There is a false perception that a drug available over the counter without prescription must be safe. In reality, there is little quality control or public information necessary to release a dietary supplement to market.

There are too many athletes who have failed drug tests because they took a dietary supplement or workout aid that contained a substance not listed on the bottle. That is the position taken by Gay, Powell and Simpson who have declared their innocence. While it may be the truth, the anti-doping agencies do not consider intent. Intent also doesn’t make much of a difference for the non-athlete who suffers a major complication. Whether it is palpitations, heart attack or stroke, the body doesn’t much care what you meant to do.

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