Roundup: FDA's Supplements Crackdown; Low-Risk Prostate Cancer; and Perinatal Depression Treatment

FDA to Provide Stricter Oversight of Supplements, False or Misleading Health Claims

The U.S. Food and Drug Administration (FDA) said this week it is tightening its policies on dietary supplements, which the agency said has erupted into a $40 billion industry with more than 50,000 products.

The FDA said it has warned 17 companies about illegally marketing nearly 60 products, many that are sold as dietary supplements. Many of the products are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions, the agency said.

“These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat,” the FDA stated.

Moreover, these products “may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment,” the FDA said.

Also this week, FDA Commissioner Scott Gottlieb, M.D., announced a series of steps the agency would take in coming months to crack down on manufacturers that promote their formulas or supplements “to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety.”

These steps include:

  • Communicating to the public as soon as possible when there is a concern about a dietary supplement on the market,
  • Ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation,
  • Continuing to work closely with our industry partners,
  • Developing new enforcement strategies and,
  • Continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

“On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health,” explains Dr. Gottlieb. ” At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.”

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More Men With Low-Risk Prostate Cancer Putting Off Treatment, Study Says

Conservative management of low-risk prostate cancer with “active surveillance or watchful waiting” provides an alternative to radical treatment involving surgery or radiation, a new study published in the medical journal JAMA .

Among men with low-risk prostate cancer in the U.S., 42.1 percent opted for the watch-and-wait strategy in 2015, significantly up from 14.5 percent in 2010, the study found. In 2010, the U.S. National Comprehensive Cancer Network updated its prostate cancer guidelines, urging active surveillance for patients with low-risk cancers or a short life expectancy.

About 1 man in 9 will be diagnosed with prostate cancer during his lifetime. Other than skin cancer, prostate cancer is the most common cancer in American men. The study’s findings are being met with praise among medical experts. Surgery and radiotherapy can come with some side effects, including a higher risk of erection problems or accidental urine or stool leakage.

“Overall, these numbers are a good sign and a good thing,” said Brandon Mahal, M.D., a clinical fellow in radiation oncology at Harvard University’s Dana-Farber Cancer Institute in Boston and first author of the study. “From 2010 to 2015, there’s been a lot of new evidence — the highest level of evidence we can get in medicine, which are prospective trials and some of them randomized trials — that have shown that active surveillance, conservative approaches or non-treatment approaches of low-risk prostate cancer have very favorable outcomes.”

The new study involved data on 164,760 men diagnosed with prostate cancer in the U.S. between 2010 and 2015.

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Mothers At-Risk of Perinatal Depression Benefit from Counseling, National Task Force Recommends

The U.S. Preventive Services Task Force (USPSTF) recommended on Tuesday a specific type of therapy for mothers-to-be who are at risk of depression. The recommendation for “counseling intervention” applies to women at increased risk for perinatal depression, including single mothers and those with a low socioeconomic status, lack of social support and history of physical or sexual abuse.

The recommendation is based on a study that found women who received either type of counseling were 39 percent less likely than those who didn’t to develop perinatal depression. The USPSTF panel is urging these at-risk expectant moms to receive cognitive behavioral therapy or interpersonal therapy to prevent the condition. Cognitive behavioral therapy involves managing thoughts to change behaviors, while interpersonal therapy centers on improving relationships and social conditions to ease depression and anxiety.

The recommendation “focuses on identifying women who are at risk for depression and proactively preventing its onset, using concrete guidelines,” according to the USPSTF panel.

Perinatal depression, which affects up to 13 million women worldwide, according to the World Health Organization, can negatively affect the health of mothers and their babies. It’s different than the more commonly known postpartum depression because perinatal depression can happen in a mother before and after her baby is born. Perinatal depression can also linger for months, compared to postpartum depression which typically occurs and resolves within the first six weeks after a baby’s birth date.

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