Supplement Safety: What’s in a Supplement? 

Shayne RobinsonBy Shayne Robinson, RD, CSO, CDN

The first question a cancer patient often asks is, ‘Will this supplement help?’ but an equally important (and often overlooked) question is, ‘What’s in this supplement?’

While many scientific studies have questioned the benefit of nutritional supplements in cancer prevention, others have questioned the integrity of the supplements themselves. They have raised serious questions about the quality and consistency of the contents inside the bottle and how these may differ from what the label says.

It’s important to know that dietary supplements are exempt from the Federal Drug Administration (FDA) enforced safety and efficacy laws that regulate prescription and over-the-counter medications. This means that a manufacturer does not have to prove the safety and effectiveness of a supplement before it is put on the market! If a supplement on the market is suspected of being unsafe, then the burden is on the FDA to prove that the supplement is unsafe before it can be taken off the shelves.

There is also little assurance that the labels of the supplements provide accurate information. In 2013, an unpublished abstract looked at the best practices of 12 different supplement manufacturers with reasonable reputation’s as quality providers of supplements. While all 12 companies claimed to be operating in full compliance with FDA regulations, three had received warning letters from the FDA for manufacturing violations, two had a product recalled within the last five years, four reported that their products failed Consumerlab.com’s standards for potency or purity, one did not have any product specifications, one was found by the FDA to have inadequate testing, one was found to have a lack of sufficient controls throughout the supply chain to guard against microbiological contamination (a potentially fatal oversight for any patients with compromised immune systems), and two had melamine contamination or lacked melamine testing.

Another reason to steer clear of supplements is the lack of data to support expiration dates, material discrepancies between claims and actual practice, and failure to change the Universal Product Code numbers when active ingredient formulas change. Unknown formula changes are especially concerning for allergy sufferers. The study concluded there was considerable variation in the quality of dietary supplements, raising concerns for patient safety. These concerns were reinforced by a report from the New York State Attorney General in 2015, which found that supplements sold across the state at major retailers were routinely mislabeled and did not contain their purported ingredients.

So, as an oncology dietitian, I encourage my patients to be weary of supplements and instead to eat a balanced diet of whole, unprocessed foods.

Shayne Robinson RD CSO CDN is an oncology dietitian at NewYork Presbyterian Weill Cornell’s Ambulatory Care Network’s Outpatient Practice.  To see a dietitian at our outpatient nutrition practice call (212) 746-0838 (physician referral required).

Previous Post: Supplements

What are the Guidelines for Cancer Patients?

Supplements: What are the Guidelines for Cancer Patients?

Shayne RobinsonBy Shayne Robinson, RD, CSO, CDN

As an oncology dietitian, I encourage my patients to eat a balanced diet of whole unprocessed foods. To quote the author Michael Pollan, “Eat food, not too much, mostly plants.” So where do supplements fit in the treatment of a cancer patient?

The latest National Comprehensive Cancer Network (NCCN) Guidelines on Cancer Survivorship does not recommended supplements for most survivors except, when there are nutritional deficiencies, or concurrent conditions like osteoporosis or cirrhosis. Furthermore, there is little data to support using vitamins or other dietary supplements to either prevent cancer, control cancer, or prevent the reoccurrence of cancer after treatment. Taking vitamin supplements does not replace the need to maintain a healthy diet. It is better to get these nutrients straight from the source, and all efforts should be made to obtain nutrients naturally. Survivors of certain cancers are at risk for vitamin deficiencies based on their cancer treatment, and supplements should be recommended by a healthcare professional on a case-by-case basis.

The American Cancer Society (ACS) and The American Institute of Cancer Research (AICR) also review nutrition research to develop guidelines for cancer prevention and cancer survivors. The ACS guidelines on nutrition and physical activity for cancer prevention clearly state, “Can dietary supplements lower cancer risk? Present knowledge indicates no. While a diet rich in vegetables, fruits, and other plant-based foods may reduce the risk of cancer, there is little evidence that dietary supplements can reduce cancer risk.” The AICR’s guideline on supplements states, “Don’t use supplements to protect against cancer. To reduce your risk of cancer, choose a balanced diet with a variety of foods rather than taking supplements.” These guidelines do acknowledge that there are special individual situations where supplements would be appropriate, but these do not include cancer prevention, treatment, or survivorship.

So remember moderation is key, and a diet rich in fruits, vegetables, and other plant based sources is best.

Shayne Robinson RD CSO CDN is an oncology dietitian at NewYork Presbyterian Weill Cornell’s Ambulatory Care Network’s Outpatient Practice. To see a dietitian at the outpatient nutrition practice, call (212) 746-0838 (physician referral required).

How Important is Minimal Residual Disease Negativity in Measuring the Successful Treatment of Chronic Lymphocytic Leukemia

Dr. Richard Furman, M.D.
Dr. Richard Furman, M.D.

Recently the Oncology Times asked Dr. Richard Furman his opinion on whether a complete response (CR) and minimal residual disease (MRD) negativity are still requisites for the successful treatment of CLL patients. MRD refers to the small number of leukemic cells that remain in a patient after treatment and can only be detectable using sensitive techniques. In patients who achieve complete responses, MRD can remain and cause relapse. Dr. Furman believes that while MRD negativity is always preferred, it is not the most important measure of outcomes. He stated,

“The most important part of the debate surrounds survival. From a patient’s perspective,  overall survival is the single most important goal,” Furman said. “If achieving MRD negativity comes at a cost of toxicities, short term or long term, it may not translate into improved survival.”   

The combination of fludarabine, cyclophosphamide, and rituximab (FCR) generates deeper remissions and more MRD negativity than fludarabine and rituximab (FR), but can have an impact upon long term marrow health, leading to 8 percent of patients developing secondary myeloid neoplasias (MDS and AML). We may have 60 percent long-term survival with FCR in mutated CLL patients, but if we are losing 8 percent of patients to bone marrow failure, that has to be considered. Still the long-term effects of FCR chemotherapy are unknown. 

Fortunately, CLL patients have another option with BCR and Bcl2 antagonists that may markedly improve survival. The ideal circumstance for a CLL patient would be to obtain MRD negativity without having any additional toxicities. This is where the novel treatments, including BCR antagonists, BCL2 antagonists, and CAR T cells will hopefully take us. With BCR antagonists, the depth or remission continues to improve with continued therapy. While almost all of the initial responses were partial responses with very few complete responses, over time the number of complete responses has increased. This will hopefully translate into MRD negative responses one day. This is the importance of progression free survival, as these patients who have not progressed, and remain on therapy, have the potential to continue to improve their response.

Improved survival of CLL patients over the past few decades shows an apparent change in the natural history of the disease. But Furman claims the advance in overall survival is related to lead-time bias. “We are diagnosing patients earlier in Binet stage A. There has been an increase in overall survival for patients as a group. By stage, there is no benefit for Binet stage A and B. A benefit is seen for Binet stage C. This may be due to better supportive therapies and novel agents, or to a shift to earlier stage disease at diagnosis,” he said, noting there is a great need for prognostic markers.

The full debate and rest of Dr. Furman’s response can be read on the Oncology Times website.