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A National Cancer Institute researcher waited several months before notifying authorities that 2 patients in a lymphoma trial died of fungal infections that may have been caused by the treatment. According to The Washington Post, the early-stage trial was examining the efficacy of a treatment that combines the drug ibrutinib with a cocktail of chemotherapy drugs. Steroids were also used to help reduce swelling in the brain. In 2015 and 2016, there were 4 patients who developed an aggressive form of aspergillus, a common fungal infection. Additionally, another 3 patients may have possibly had the infection. In May and December of 2015, two of the patients died of infections. Although concerns began to increase and enrollment was stopped in April, principal investigator Kieron Dunleavy did not file an official unanticipated problem report until May that recorded the suspected association between the treatment and the infections. Dunleavy has been suspended from clinical research until he undergoes additional training.
There are currently many medical myths that remain in existence, therefore a new report by Live Science, address some of these myths in order to demystify them, according to The Washington Post. Although the flu shot contains dead flu viruses, these flu vaccinations do not actually cause the flu. It’s commonly believed that the weather turning cold causes people to get sick; however, the report stated that individuals are not more likely to get sick from colder temperatures. One of the most commonly believed myths is that eating turkey at thanksgiving makes you tired, pointing fingers at the tryptophan found in the meat. However, the drowsiness is most likely due to people overeating and ingesting lots of carbohydrates or alcoholic beverages. Lastly, sitting too close to a TV or computer or reading in the dark does not damage your eyes. According to the study authors, there is no evidence that this causes any long-term damage.
In an attempt to combat the steady rise of the opioid epidemic, the DEA launched an aggressive campaign nearly a decade ago that targets wholesale companies distributing these addictive pills to corrupt pharmacies and pill mills. According to The Washington Post, investigators from the agency’s Office of Diversion Control began filing civil cases against distributors and issuing orders that immediately suspended the drugs, producing hefty fines. Unfortunately, the industry fought back and hired former DEA and Justice Department officials to begin pushing for a softer approach. Soon after a meeting between the deputy attorney general and the DEA’s diversion chief, who was chastised for going after the industry, officials at the DEA headquarters began delaying and blocking enforcement actions, which caused the number of cases to nose dive, according to the Post. In fiscal 2011, civil case filings against distributors, pharmacies, manufacturers, and physicians reached 131, before plummeting to 40 in fiscal 2014. Meanwhile, the amount of immediate suspension orders dropped from 65 to 9 during the same period. This major slowdown started in 2013 after DEA lawyers began requiring a standard of proof before cases could move forward. In a statement issued by the department, they said that the drop in diversion cases was a reflection of the shift from crackdowns on ubiquitous pill mills to a small group of physicians, companies, and pharmacists who continue to violate the law, reported the Post.
FDA Grants Accelerated Approval to Asciminib for Adult Patients With Newly Diagnosed Ph+ CML-CP