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 In 2013, an unpublished abstract looked at the best practices of 12 different supplement manufacturers with reasonable reputation’s as quality providers of supplements.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).

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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).

The FDA Accelerated Approval Designation: A Primer

Picture1By Peter Martin, M.D.

As a response to the HIV/AIDS crisis of the 1980s the United States FDA developed guidelines for the Accelerated Approval designation in 1992. The purpose was to speed up the approval process and provide new treatments to the patients most in need. The program was an instant improvement, resulting in the approval of 80 drugs, including 29 cancer drugs, in the first decade, and was subsequently updated as part of the Food and Drug Administration Safety and Innovation Act in 2012. Under these guidelines the FDA can designate the Accelerated Approval label for new treatments that address a serious medical condition, and which are thought to offer a meaningful advantage over existing therapies.

The FDA’s criteria for making this designation is based on the scientific support for the measurement of surrogate or intermediate clinical endpoint in the treatment, and the likelihood it will predict a clinical benefit compared to available therapies in an area of unmet need. For example, in the past it may have been necessary for a new drug to prove a survival advantage compared to standard therapy in the context of a randomized phase III trial. It could take up to a decade to reach this benchmark for approval. Under the Accelerated Approval designation, a drug might be approved for an unmet need if it could demonstrate tumor shrinkage based on radiological imaging, which would likely be associated with a durable clinical benefit. Because the FDA requires a high degree of scientific support for the use of a surrogate endpoint, drugs that are approved under the Accelerated Approval program usually go on to receive full approval 3-4 years later on average, following the completion of confirmatory studies demonstrating clinical benefit.

This is not always the case, however, and some drugs that receive Accelerated Approval designation are subsequently withdrawn from the market when a confirmatory study fails to provide sufficient evidence of clinical benefit (e.g., bevacizumab for breast cancer). There is also the risk that a drug that had received accelerated approval will later demonstrate significant side effects during larger studies (e.g., this was part of the reason that gemtuzumab ozogamicin was withdrawn from the market in 2010). Other times, an application for accelerated approval might be denied, but the drug eventually receives full approval following completion of larger studies (e.g., TDM-1 for breast cancer). The definition of “unmet need” is another stumbling block to efficient drug development. Some developers might perceive an unmet need in settings where all available therapies have been exhausted, while the true need lies much earlier in the course of a disease where available therapies provide only limited benefit.

The Accelerated Approval program has provided access to dozens of drugs years earlier than they would otherwise have become available, improving the lives of countless patients with cancer and other conditions. However, the designation is not a panacea.  Physicians and patients should be aware of the evidence behind the designation of a given drug and should continue to follow the drug development process as new information comes to light.

Previous Entries in the Primer Series

The FDA Approval Process
The FDA Breakthrough Therapy Designation

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