November 29, 2021 by John Fernandez
Roundup: FDA Takes Action Against ‘Illegal Cancer Treatments’; Energy Drinks Linked to Heart Risks
The U.S. Food and Drug Administration said it has sent warning letters to 14 U.S.-based companies that the agency says are “illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.”
The products are marketed and sold without FDA approval, most commonly on websites and social media platforms, the FDA states. The products cited include pills, topical creams, ointments, oils, drops, syrups, teas and diagnostic tools (such as thermography devices).
It is a violation of federal law to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases — without first demonstrating to the FDA that the products are safe and effective.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, in a prepared statement.
Individuals should consult a healthcare professional about proper prevention, diagnosis and treatment of cancer, the FDA says.
In its warning letters, the FDA has requested that the 14 companies explain how they will address violations. Failure to take action will result in legal action by the agency, including product seizure, injunction and/or criminal prosecution, the FDA states.
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Energy Drinks Tied to Irregular Heartbeats, Elevated Blood Pressure
So-called energy drinks, sometimes containing heavy doses of caffeine and sugar, could pose health risks such as triggering irregular heartbeats and pushing blood pressure higher, a new study has found.
These drinks can temporarily boost a person’s energy level to get through a workout or a busy day at work. Researchers at a United States Air Force base conducted the research to determine the effects of energy drinks on military personnel.
The study involved 18 healthy volunteers. Researchers at the U.S.A.F. Medical Center at Travis Air Force Base in California monitored the group of young adults, between the ages of 18 and 40. The participants were divided into two equal groups. Each member in one group was asked to consume 32 ounces of a readily available, off-the-shelf energy drink. Each energy drink contained 320 milligrams of caffeine, 108 grams of sugar and other herbal ingredients.
The members in the other group were given a “control drink” which contained 320 milligrams of caffeine, 140 milliliters of cherry syrup in carbonated water and 40 milliliters of lime juice. This group’s beverage, although packing similar amounts of caffeine, was not considered a drink typically marketed for its energy boost.
“Consumers should be aware that drinking an energy drink is not the same as drinking coffee or soda. There are differences,” researcher Emily Fletcher told Philly.com. Fletcher is a deputy pharmacy flight commander from David Grant U.S.A.F. Medical Center at Travis Air Force Base.
ECGs (electrocardiogram) revealed that only participants who consumed energy drinks caused a 10-millisecond increase in the heart’s “QT interval” — the time it takes the lower chambers of the heart to repolarize and prepare to generate another heart beat. Such prolonged QT can cause serious irregular heart rhythms (arrhythmias). Abnormal heart rhythms can be life-threatening, increasing the risk of heart attack or stroke.
Both the energy and control drinks elevated blood pressure. But for those who consumed the control drink, blood pressure returned to normal much sooner than the blood pressure of those who took the energy drink. Researchers concluded that energy drinks may create a longer-lasting increase in a person’s blood pressure, compared to caffeine.
Only 30% of Men Fully Discuss Prostate Cancer PSA Test With Their Doctors
Less than one third of men in the United States said they discussed both the advantages and disadvantages of undergoing prostate-specific antigen (PSA) testing as a screen for prostate cancer, according to a national survey.
The study adds to the ongoing debate over the effectiveness of the PSA for men ages 55 to 69.
“Men who were neither told about advantages nor disadvantages were more likely to be Hispanic, not a high school graduate, have low income and no health insurance,” researchers said.
Earlier this month, the U.S. Preventive Services Task Force (USPSTF), a panel of healthcare experts, reversed its previously stated opposition to the PSA, which was based on the screening’s tendency for inaccurate readings that can result in over-diagnoses and unnecessary biopsies with potential side effects. The USPSTF now says that men ages 55 to 69 should seek their doctors’ advice on the likelihood that the PSA test can detect prostate cancer.
The results of the latest study, which shows that less than one-third of men have a balanced discussion with the doctors about the PSA, comes from a national survey conducted in 2014 and were published in Urology.
“The concept of ‘shared decision making’ for prostate cancer screening is not occurring in the community,” study co-author Joseph Renzulli II, M.D., associate professor of surgery, Minimally Invasive Urology Institute at Miriam Hospital in Rhode Island, commented in a statement.