September 13, 2019
September 13, 2019
After six deaths and nearly 500 reported cases of severe lung damage across the country, the Trump administration announced on Wednesday its plan to ban the sale of flavored e-cigarettes, including mint and menthol flavors. Vaping has become increasingly common among teens and young adults, with many health officials labeling it an “epidemic.”
“We can’t allow people to get sick. And we can’t have our kids be so affected,” said President Trump.
A survey conducted among high schoolers revealed 5 million minors using e-cigarettes recently, with 25 percent saying they had used one within the past 30 days.
The Food and Drug Administration (FDA) moved away from a threat to ban flavored e-cigarettes last year, prompting outrage from health advocates across the country who have accused companies such as Juul for creating fruity flavors like mango and cotton candy that appeal to youth.
Administration officials had hoped that restricting access over a full ban would curb the use among teens, but new data revealed yet another increase in usage.
“What we’ve seen has been, and it may be connected, a huge spiking of children’s utilization of mint and menthol e-cigarettes, which remain, by all manufacturers, available in retail stores,” Health and Human Services Secretary Alex Azar said.
Azar then said the FDA would develop a plan in the coming weeks to remove flavored e-cigarettes and nicotine pods from the market.
Both the White House and the Food and Drug Administration (FDA) have received growing pressure from health officials, lawmakers and advocates to take action as an alarming amount of lung damage cases across multiple states have cropped up over the past few months. Michigan made a move to ban the sale of e-cigarettes, as New York, Massachusetts and California debate similar bans.
The Centers for the Disease Control and Prevention (CDC) this week urged people not to vape at all as they investigate the cause of these cases of pulmonary disease.
A new drug pricing proposal from Speaker of the House Nancy Pelosi was released this week. As constituents are increasingly concerned about increasing drug prices, many members of Congress are submitting plans to address the topic.
Though there have been rumors about Pelosi’s plan for months, many on the Hill knew little about what would actually make it into the final proposal. Reactions on the Hill indicate it is much more aggressive than anticipated, and is likely an attempt to win over progressives in the Democratic Party.
The bill takes multiple steps to address rising costs. The government would be able to negotiate prices with drug makers for 250 medicines and force drug manufacturers to offer those prices on the market. It also eliminates third parties from negotiating prices between insurers and drug companies. Instead, it ties costs to drug pricing in other countries through a pricing index—similar to a proposal from the President.
In Pelosi’s plan, instead of tying prices directly to the index, it would use those prices as a cap for what Medicare can pay in price negotiations. The countries outlined in the proposal are: Australia, Canada, France, Germany, Japan and the United Kingdom. Prices could not exceed 1.2 times the average price charged in those countries. Should companies refuse to offer those prices, they would be required to pay a 75% tax of the annual gross sales of the product.
One of the more far-reaching elements in the proposal is a new rebate system based on inflation. If drug companies increase the price of their products in Medicare Part B and D, they would be forced to refund all price increases since 2016 that are over the inflation rate.
Given some of the more aggressive proposals in the bill, it is unlikely to get much support from Republicans in its current form.
This is a developing story. We will provide updates as they become available.
As the Food and Drug Administration (FDA) has pushed for more involvement from women in clinical trials for new drugs through lifting bans on including women of child-bearing age, among other things, they have also identified one key group they say lacks representation in breast cancer trials: men.
Though breast cancer is rare in men, comprising less than one percent of overall cases, the FDA is calling for more research in treatment for men, even if trials only pull in a handful of male participants. As new treatments become available in clinical trials, men are often barred from the studies, limiting potential treatment options.
“It’s so frustrating in clinic to see patients and say, ‘Well, we don’t really know — the drugs have been tested in women. We think it should work in men, but there’s no real evidence to back that up,’” said Dr. Sharon Giordano, a professor of breast medical oncology at M.D. Anderson Cancer Center in Houston.
Without any data, treatments options are limited, and many oncologists may have never provided care for men, adding to poorer outcomes. Male patients may also have limited knowledge of their treatment options.
“Some men are not even aware they have breasts and not aware they can have breast cancer,” Dr. Cardoso said. “Even health professionals often don’t think about it. General practitioners who see male patients don’t pay attention to the breast.”
To learn more about the FDA guidance, review it here. Comments may be submitted until October 26, 2019.