>> Cancer and Breast Implants
>> A Long COVID Risk Factor
>> Drug for Fatal Illness Gets Second Chance
The Med & Mic™ 09.09.22
MED NEWS blog post from Dr. Maria ON Speaking, LLC
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FDA Alerts to Cancer and Breast Implants
The FDA issued a safety alert about squamous cell carcinoma (SCC) and lymphomas in the capsule or scar tissue around breast implants. The government agency says these associated cancers are rare. A review of the literature shows fewer than 20 cases of SCC and fewer than 30 cases of various lymphomas in the capsule around breast implants. In addition, the FDA has received 10 medical device reports about SCC and 12 reports about various lymphomas related to breast implants. Signs include swelling, pain, lumps, or skin changes. Any cancer in the scar tissue around any type of breast implant should be reported to the FDA. (Source: MedPage Today, M. Bassett, 9.8.22)
Psychological Distress Linked to Increased Risk for Long COVID
Stress, anxiety, and loneliness prior to getting sick with COVID were linked to a higher likelihood of persistent COVID symptoms beyond four weeks, according to a Harvard study in JAMA Psychiatry. The findings are based on survey responses from nearly 55,000 people in the U.S. and Canada from April 2020 to November 2021. People with psychological distress had a 32% to 46% higher risk of long COVID, and if they had both depression and anxiety, the risk increased to 50%. This was greater than the risk with physical factors, such as obesity, asthma, and high blood pressure. The researchers emphasize the symptoms are real and result from the infection. Neuropsychologist Jacqueline Becker, who was not involved in the study, tells NBC News, “The results shouldn’t be misinterpreted as supporting post-COVID conditions as psychosomatic.” (Source: NBC News, A. Bendix, 9.7.22)
ALS Drug Gets Nod from Advisory Panel
In a second review, FDA advisors voted 7-2 to recommend approval of an experimental drug to treat amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease. The panel debated the strength and reliability of the single study from pharmaceutical company Amylyx. The drug maker says there is enough evidence that patients live longer on the drug. The panel voted down the medication in March due to concerns over missing data and other issues. At diagnosis, people with ALS have a two to five year life expectancy. There are only two FDA-approved therapies for the disease in which nerve cells to muscles degenerate. Withdrawal of the new medication in the future is a consideration if benefits aren’t confirmed by a large, ongoing study. ALS patients and their families have lobbied aggressively for FDA approval. (Source: AP, M. Perrone, 9.7.22)
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