By Catherine Smith
“What medications do you take?”
“What?” She appeared to be sleeping. I guess it took her a moment to realize she was in her hospital bed. I was waiting for her eyes to open. I don’t usually talk to the hospitalized patients directly, but in this case, I had to make an exception.
“I take lisinopril and metformin. Who are you?”
“I’m your pharmacist. I’m dosing the blood thinner your doctor prescribed for you… to help make sure you don’t get a stroke? Your lab work came back all wacky and I’m just trying to figure out why. Do you happen to be taking any dietary supplements?”
“Turmeric” she said. “It helps with my arthritis.”
“Do you know that certain supplements can significantly interact with your medications? You should always tell your health care provider what you’re taking, even if it’s just a multivitamin. Herbs, you won’t be able to take while you’re in the hospital, but when you leave here, please notify your doctor and your pharmacy. It’s probably just a lab error, but I better have the phlebotomist come back and draw blood from you again. I handed her a copy of the hospital’s policy on herbal medication, and then left.
- Complementary or Alternative Medications such as herbal medications are not approved or recognized as medications by the Food and Drug Administration (FDA). These products have not met the scrutiny of the FDA approval process. Therefore, their content and product integrity cannot be ascertained to meet the rigor of USP and FDA standards for manufacture. As such, it will not be possible to state that the product is acceptable or safe for patient administration.
- CAM’s will be considered non-formulary and will not be recommended for use due to lack of available clinical information from research trials demonstrating their effects, doses and side effects, lack of consistent standards in content and manufacturing, and potential deleterious effects on other treatments.
- If the product is brought into the facility by the patient or caregiver, it will be sent home with the family/caregiver.
- If the patient insists on continuing with their Complementary or Alternative Medications, and there is no known harm and the physician’s approved continuum of care, then the patient shall sign the waiver entitled “patient Request and Assumption of Risk For Use of Own Medication Supply Form.” The product(s) will be stored in a secure locked area on the unit in the medication room. Upon discharge it is the nursing unit’s responsibility to ensure that all medications are returned to the patient.
I saw Turmeric Lady a couple of weeks later. “I just want to thank you for your advice,” she said. “I told your colleagues at the clinic about all the medications I was taking, including the turmeric. They did some research for me, and based on the evidence they presented, I decided to stop taking it right away. From now on, the only turmeric I will supplement my diet with is this.” She reached into her bag and handed me a large covered dish.
“Curry Chicken!” Curry is a mixture of spices, usually consisting of turmeric (which gives it that yellow color), coriander, cumin, and ginger. The aroma was just fantastic!
“I found out so many things I should have known even before I started taking it. It could have saved me so much trouble and money. I learned what makes mainstream medicine different from complimentary and alternative medicine, how they’re regulated by the FDA, why the public and the supplement industry find them so appealing, how consumers can make smart and informed choices about taking dietary supplements, and how they can report serious adverse events to the FDA.”
Mainstream medicine uses a science-based approach to healthcare. It’s what you can expect when you go to a licensed doctor or a hospital to get treatment for any medical condition. Practitioners rely on the latest research and well-designed studies to guide their treatment choices. Many recommendations change whenever stronger and better evidence is found or when new treatment is available.
Drugs, according to the FDA, are substances used to prevent, diagnose, treat or cure a disease or condition. The fact that they get FDA approval means that they’ve gone through an extremely rigorous process to prove they’re safe as well as effective. While mainstream medicine has advanced greatly over the years, it has not yet been perfected. Many people suffer serious harm from prescription drugs and devices. But the benefits greatly outweigh the risks. If that is found no longer to be true, the FDA can recall that drug. Over the last couple of generations, our average life expectancy has gone up about thirty years mostly due to the marvels of modern medicine.
Yet, about forty percent of Americans have turned to Complementary or Alternative medicine (CAM). Examples of CAM include acupuncture, spinal manipulation, therapeutic touch, kinesiology, detoxification, colon cleansing, ear candling, homeopathy, and taking dietary supplements. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are regulated by the FDA as foods, not as drugs, and are intended to supplement the diet. Dietary supplements that have been proven to prevent, diagnose, treat or cure a disease or condition are, by definition, drugs. (fda.gov/Food/DietarySupplements/QA) The only type of claims allowed by dietary substances, under the DSHEA, are those related to nutrient content, health, or structure and function. For example, a calcium supplement maker is allowed to claim it is high in potency, that calcium builds strong bones, and that consuming calcium reduces the risk of osteoporosis. If a structure and function claim is made, the following disclaimer must also be on the label: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The FDA doesn’t approve dietary supplements
Drugs are required to undergo rigorous research and testing, costing millions of dollars and years to develop. Only 1 in 5,000 new drugs ever make it all the way though the approval process.
On the other hand, if a company wants to market a new dietary ingredient or combination of products not previously found in the food supply, it just needs to notify the FDA at least 75 days in advance of its intent. Instead of having to conduct research on their product, proving it’s safe and effective, the company only needs to submit information showing that it’s ‘reasonably expected to be safe.’ Unfortunately, very few companies have complied. Since the passage of the DSHEA, 51,000 new products hit the dietary supplement market, but the FDA only received safety data from 170 of them. (Lexi.com)
The FDA doesn’t recall dietary supplements
Only drugs for humans and animals, medical devices, radiation-emitting products, vaccines, blood and blood products, transplantable human tissue, animal feed, cosmetics, and about 80 percent of the foods eaten in the United States are subject to being recalled by the FDA.
If a dietary supplement’s safety comes into question, it’s up to the FDA to prove it poses an imminent hazard to public health and safety before it can take action, which is usually in the form of warning letters to the company, and consumer education. Consumer Reports has identified twelve dangerous supplements that are still legally sold: The dirty dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe.
These products have been reported to cause fainting, heart attack, involuntary muscle movements, irregular heartbeat, irreversible skin discoloration, kidney failure, liver damage, seizures, strokes and death, and are associated with DUI citations.
Other FDA actions against the dietary supplement industry involve the distribution of illegal products. Many have been found either adulterated with heavy metals or pesticides, or do not contain the quantity of ingredients as stated on the label. Many have been tainted with prescription drugs. The FDA has removed at least 50 sexual enhancement supplements found to contain sildenafil (Viagra). It identified more than 40 weight loss supplements containing sibutramine (Meridia), which is no longer available due to its potential damage to the heart. At least 80 body building supplements were removed from the market because they contained anabolic steroids or synthetic analogs of such. (fda.gov.newsevents/testimonies)
The Modern Medicine Show
The public is drawn to dietary supplements because they seem to promise what mainstream medicine can’t deliver, they don’t require a doctor’s visit for a prescription, they woo the consumer into having a sense of control of their own health care, and they deceptively serve as naturally safe alternatives. Ron Paul, former U.S. Representative of Texas and physician, expresses his viewpoint.
Millions of Americans take dietary supplements every day, and the numbers are growing as the Baby Boom generation ages. More and more Americans understandably are frustrated with our government-controlled health care system. They have concluded that vitamins, minerals and other supplements might help them stay healthy and less dependent on the system. They use supplements because they can buy them freely at stores and research them freely on the Internet, without government interference in the form of doctors, prescriptions, HMOs and licenses.
The health nannies insist that many dietary supplements are untested and unproven, and therefore dangerous. But the track record for FDA-approved drugs hardly inspires confidence. In fact, far more Americans have died using approved pharmaceuticals than supplements. Not every dietary supplement performs as claimed, but neither does every FDA drug.
The FDA simply gives people a false sense of security, while crowding out private watchdog groups that might provide truly disinterested consumer information. It fosters a complacent attitude and a lack of personal responsibility among people who assume a government stamp of approval means a drug must be safe, and that they need not study a drug before taking it.
In 2009, Americans spent $26.7 billion dollars on dietary supplements. One of the websites I visited, Mercola.com, made close to $7 million in 2010. (chicagomag.com) Their marketing strategy is quite aggressive. The website is chock full of ‘health articles,’ basically criticizing every thing about mainstream medicine, from the drug industry to vaccinations, and promoting anything alternative or complimentary, such as thermographic imaging. Mercola.com is a strong proponent of healthy lifestyles and supports good nutrition along with regular exercise, and insists this goes against mainstream medicine. Health education is a service that they happily provide at no charge. Sales revenue from their natural health supplements, help finance their ‘research.’ Of course, optimum nutrition can’t possibly be achieved by healthy eating alone, but supposedly, taking eight tablets a day of their proprietary blend, in addition to a well balanced diet, will. A one-month supply of Whole Foods Multivitamin Plus is $47.97 plus $4.95 S&H. (Mercola.com)
Legitimate reasons for taking dietary supplements are plentiful. Mainstream medicine utilizes vitamin D to treat deficiencies, gives folic acid to expectant mothers to prevent neural tube defects, and administers thiamine to prevent Wernicke-Korsakoff syndrome in alcoholics. Various supplements are essential in treating certain types of anemia. Sometimes people may have serious medical conditions, causing them not to eat properly, so they become malnourished. Bariatric surgery patients often have malabsorption problems. Women with heavy menses often need iron supplementation. People with restricted diets either by choice or due to food sensitivities may also need dietary supplementation. Generally, if you don’t suffer from these types of conditions and you eat a well balanced diet, supplementation is not necessary. To date, no known medical condition has been associated with a deficiency in turmeric.
Beware of the Snake Oil Salesman
Once it has been decided that a supplement is advisable, how does one decide which product to choose? No one wants to waste their money or risk their health. One suggestion is to check out the advertisement or ‘health education’ articles on the company’s website. The following red flags are indicators that their products are likely to be scams:
- Any claims that it treats multiple unrelated ailments. Mercola.com suggests that turmeric may be beneficial for cancer, Alzheimer’s, arthritis, cystic fibrosis, type 2 diabetes, Crohn’s disease, psoriasis, rheumatoid arthritis, cataracts, gallstones, muscle regeneration, and inflammatory bowel disease.
- If it depicts testimonials: “I tried it and it really works!” The plural of anecdote is not data. Testimonials have no scientific value. Feelings and emotions are powerful motivators for making purchasing decisions, even when scientific evidence is lacking.
- If it promises quick fixes: “Lose 30 pounds in 30 days!”
- If it claims to be ‘all natural.’ The word natural is completely meaningless in this context. The safety and efficacy of any substance can be measured whether it’s natural or unnatural. A direct correlation has never been established.
- If it’s portrayed as a miracle cure, scientific breakthrough, new discovery, or secret ingredient. One would expect to find things like that on the front page of the news, not on the back cover of a magazine or on an infomercial.
- Conspiracy theories are always scams. At least that’s what the government, together with Big Pharma, wants you to believe.
These are just some basic tips to watch out for. For more information, it’s best to consult a physician, registered dietician, or pharmacist. They have the education and knowledge skill set to evaluate the benefits and risks, and to make informed recommendations for the individual’s medical needs. The following are some very reliable resources:
- National Institutes of Health – Dietary Supplement Fact Sheets
- Federal Trade Commission – Consumer Information
- National Institutes of Health – Frequently asked questions
- National Institutes of Health – Evaluating Health Information on the Internet
- U.S. National Library of Medicine
- PubMed Office of Dietary Supplements
- How to Read a Consumer Lab Seal
- NSF Public Health & Safety Organization
- U.S. Pharamacopeial Convention Dietary Supplements
Smoke and Mirrors
Once the lawmakers realized that dietary supplements have the capacity of causing serious harm, even deaths, they decided to make it mandatory for manufacturers and distributers to submit all reports of serious adverse events to the FDA within 15 days of receiving them. In December of 2007 The Dietary Supplement and Nonprescription Drug Consumer Protection Act went into effect. The intent was to expedite the removal of harmful dietary supplements from the market.
This act, however, doesn’t seem to adequately safeguard consumers who have already purchased these harmful products. Between March 12 and March 25 of 2008, the FDA received 26 reports from consumers who ingested the liquid dietary supplement products, Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. Symptoms included significant hair loss, muscle cramps, diarrhea, joint pain, and fatigue. Upon analysis, the products were found to contain 200 times the amount of selenium and 17 times the amount of chromium as was stated on the label. By March 27, the FDA issued a consumer warning letter, and the manufacturer voluntarily recalled these products. The FDA continued to receive a total of 97 serious adverse event reports through October 2008. http://www.in.gov/isdh/21746.htm
To report a serious adverse event directly to the FDA’s MedWatch Program, call 1-800-FDA-1088 or go online: https://www.accessdata.fda.gov/scripts/medwatch/
I’d like to say all ended well with Turmeric Lady. So I’ll say it: “All ended well with Turmeric lady.” She decided to get her ‘health education’ from a place that does not sell dietary supplements. She learned that turmeric has been studied for a variety of medical conditions, but to date, no strong evidence of effectiveness exists for any of these conditions. Turmeric should not be taken by anyone taking blood thinners, drugs to lower blood pressure, blood sugar or cholesterol, or drugs that are metabolized by the liver. Anyone with diabetes, men, current or former smokers, anyone with a gastrointestinal disorder, or people with gallstones are just examples of conditions where taking turmeric should be avoided. It has been associated with many side effects including abnormal liver function tests, altered levels of drugs processed by the liver, delusions (a psychiatric false belief), heart problems, increased bleeding, liver toxicity, and worsening of arthritis symptoms. (Natural Standard Monograph)
I wonder if Turmeric Lady’s arthritis got so bad that she exceeded the recommended amount in hopes of relieving her pain, or if she got a bad batch, which contained multiple amounts of what it should have. If so, is it possible that she took enough to cause her heart to beat too fast, and that’s when she went to the emergency room? Did the turmeric cause her abnormal blood tests? Since then, she has lost about twenty pounds with the help and encouragement of her physician, and occasionally, she’ll take an over the counter, FDA approved, anti-inflammatory drug for her arthritis. Her pain is much improved and she has had no issues with her heart.
Cathy Smith has a Bachelor of Science in Biology from the University of Texas at San Antonio, and a Bachelor of Science in Pharmacy from the University of Texas at Austin. She is licensed in Pharmacy in the States of Texas and Michigan, and was licensed in California for some time. She has been a hospital pharmacist for twenty-three years and has worked as a clinical hospital pharmacist at a southeast Michigan teaching hospital for the last thirteen years. Her dietary turmeric needs are met monthly, as she enjoys Shrimp Curry at her local Skeptics in the Pub meeting.