Personalized Medicine: What You Need to Know About Supplements

Personalized Medicine: What You Need to Know About Supplements

Do you really need supplements? Personalized medicine is identifying the level of nutrients in your body to determine exactly what supplements you need. Let’s find out what we need to know about supplements

Our bodies function by the air we breathe, the water we drink, and the food we eat. No one eats perfectly. Stress, toxins, processed foods, fast foods, the microwave, and the Standard American Diet all contribute to nutrient deficiencies. In addition, individuals may have food restrictions such gluten sensitivities, food allergies or sensitivities, or gastrointestinal issues restricting digestion and the absorption of nutrients. Personal preferences and specific diets such as vegetarian, vegan, Mediterranean, and Paleo are also factors. To supplement what our bodies need to function well and provide us with energy, almost all of us need a multivitamin, perhaps fish oil, and antioxidants.

A specific blood test, however, can help you determine the level of the nutrients in your body. You will then know more precisely what your body needs to be healthy. This is personalized medicine.

Supplements and the FDA

Supplements, however, include much more than just vitamins and minerals. As we learned in June 2017, it is not OK to make supplement claims. Dr. Mehmet Oz testified before the US Senate to answer questions regarding making claims about promoting weight loss products which some experts have called unscientific claims. Terms he used were “magic weight –loss cure” and “the No. 1 miracle in a bottle” (Congressional hearing investigates Dr. Oz ‘miracle’ weight loss claims).

According to the FDA, “a product sold as a dietary supplement and promoted on its label as a treatment, prevention, or a cure for a specific disease or condition would be considered and unapproved – and thus illegal – drug. To maintain the product’s status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplements Health and Education Act (DSHEA) of 1994.”

When a supplement manufacturer makes a claim about the role of a nutrient or dietary supplement on its label, they must include a disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by the FDA.

It is interesting because generally prescribed conventional pharmaceutical drugs do not make these claims either. They may say, “supports, heals, decreases, alleviates” or site percentages of positive outcomes. This, of course, is because the effectiveness of any drug or supplements is also based on the individual genetic variations, lifestyle choices, and nutrient status.

The FDA can have a supplement removed from the market only if it proves the supplement is unsafe. Unfortunately, a supplement can be on the market for years before enough individuals had adverse side effects to prove it’s unsafe.

This is exactly how drugs can be removed from the market. We all know about pharmaceutical drugs removed because they were shown to be harmful after being approved by the FDA and on the market for years. Here are a few…..

Accutane: 27 years. Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.

Baycol: 3 years. Rhabdomyolysis (breakdown of muscle fibers) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases

Darvon and Darvocet: 55 years. Serious toxicity to the heart; over 2,11o deaths were reported between 1981 and 1999

Meridia: 13 years. An appetite suppressant. Serious toxicity to the heart; over 2,110 deaths reported between 1981 and 1999

Vioxx: 5.3 years. Pain relief. Linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003

In 2000 while I was teaching at the University of Minnesota Medical School, the producer of 20/20 called to ask how many of my patients had died from taking vitamins and minerals. I said, “none”. The question actually surprised me. I explained I had never known of any cases, but I would conduct research to look for any cases. After extensive research I was unable to find even one death. When the producer called me back, I gave her the information and offered to send her the volumes of mainstream medical journals and other sources I had reviewed, she simply said, “We will not be doing this segment, we were looking for poor outcomes.”

Oncologists often tell their patients not to take any vitamins and minerals. I then ask the patient if the oncologist told them not to eat. Food is the source of vitamins and minerals. Research and clinical trials show the need for adequate nutrition and the health risks with severe deficiencies. People with disease, chronic illness, medications, and decreased gastrointestinal absorption need adequate nutrients to help heal their bodies.

In June 2002, the Journal of the American Medical Association (JAMA) published a two-part paper by two researchers associated with Harvard Medical School that sparked widespread media attention in recommending vitamin supplements for the general public.

The abstract of that paper reads as follows:

Vitamin deficiency syndromes such as scurvy and beriberi are uncommon in Western societies. However, suboptimal intake of some vitamins is a risk factor for chronic diseases, and common in the general population. Suboptimal folic acid levels, along with suboptimal levels of vitamin B6, and vitamin B12, are a risk factor for cardiovascular disease, neural tube defects, and colon and breast cancer; low levels of vitamin D contribute to osteopenia and fractures; and low levels of antioxidant vitamins (vitamin A, E and C) may increase risk for several chronic diseases. Most people do not consume an optimal amount of all vitamins by diet alone.

Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements. Little evidence based on specific characteristics of patients such as age, sex, and physical activity and for testing vitamin levels to guide specific supplementation practices exists. Physicians should make specific efforts to learn about their patients’ use of vitamins to ensure they are taking vitamins they should.

Identifying Quality Supplements

Using quality supplements is very important. Many over-the-counter or online supplements contain contaminates 40-50% of the time and not contain what the label indicates 40-50% of the time. GMP (Good Manufacturing Practices) certification means that the manufacturer has tested all the batches of raw materials used to make the vitamin or mineral supplement. Manufacturers have found bacteria, mold, pesticides, lead, steroids, stimulants, prescription drugs, and even strychnine! Other manufacturers, unfortunately, do not test at all.

Recently the FDA came out with a cGMP (Current Good Manufacturing Practices) which is quite frankly ridiculous. I have read all qualifications for this designation.  These qualifications state that we can determine contamination by looking at  a raw batch, tasting it, or smelling it. Really? It is doubtful that this method could actually identify any of the contaminants. Strict laboratory analysis, however,  is the only method to truly identify any contaminants.

This is why many physicians trained in nutrition and health care providers provide GMP certified, pharmaceutical grade, organic, gluten-free supplements in their office. Years ago I would just recommend to patients to get their supplements in a grocery store or a drug store.  I take care of complicated sick patients and the walking well. I can’t send them out to get an unknown quality supplement that might compromise their ability to get well. Ever patient deserves the best in care, and accurate information can help patients make the best decisions for themselves and their loved ones.

1. Eat well
2. Test your nutrient status
3. Buy the best quality supplements
4. Supplement your oral vitamins with intravenous vitamins and minerals for much better absorption
5. www.consumerLabs.com is a good resource for information on supplements.


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