Ice cream sales must be booming this summer. July was officially the hottest month on Earth ever (or at least since record-keeping began 140 years ago) according to the National Oceanic and Atmospheric Administration. We’ve broken the record every year for the past five years, and last month was the 415th consecutive month with above-average global temperatures. Curious what that means for your community? The Washington Post has an interactive feature where you can track how climate change has impacted your county over the past 124 years.
In case you were wondering: here at Syneos Health HQ in New York, we’ve seen an average 2.5°C increase, with a continued upward trajectory since 1895 (no plateaus). We’re higher than the national average of 1°C and also above the critical 2°C threshold climate change experts say is a trigger point for “catastrophic changes.”
Nearby New Jersey is one of the fastest warming states. The average temperature between December and February no longer falls below freezing. While we relish in the air conditioning, here are some cool healthcare stories in The Week That Was.
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THE WEEK THAT WAS | Monday |  This week, a federal judge upheld the validity of two patents on a popular biologic, which were being challenged by a biosimilars manufacturer. The ruling keeps an approved-but-not-marketed biosimilar off the market, potentially until 2029. The biosimilar manufacturer is appealing the decision. The result is likely to have an impact on the market entry of several FDA-approved biosimilars. Our legal communications expert Amanda Eibert is tracking the case!
| Tuesday |  We’ve all heard of the National Institutes of Health’s (NIH) Human Genome Project. Now pharma is getting in on the genome mapping game, contracting with hospitals to sequence the genomes of hundreds of thousands of patients. But it’s not without controversy. The deals are often top secret - so secret some patients don’t know that their data is being shared, or who its being shared with. And they often come with exclusivity agreements that bar the hospital systems from sharing its data with others. Pharma companies say the genetic data they obtain will uncover disease insights and support drug discovery.
| Wednesday |  The U.S. Preventive Service Task Force (USPSTF), the experts that make recommendations regarding preventive care, recommend doctors screen all adults for illicit drug use. It’s not just illegal drugs they’re recommending physicians look for. Misuse of prescription drugs is also a part of the proposed guidelines. USPSTF says the guidelines address “alarming high rates of substance abuse.” Some are questioning why teenagers weren’t included.
| Thursday |  One month ago, the WHO declared the Ebola outbreak in Congo an international health emergency. Now, experts say two of the four experimental drugs being tested amidst the crisis seem to be working – increasing survival rates for people who recently contracted the disease to between 89 and 94%. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said, “This is the first time that a randomized, controlled trial has shown quickly and successfully what the best drugs are in the middle of an ongoing outbreak.” The drugs are being offered to more patients at no cost under expanded access.
| Friday |  Did you know smoking could cause erectile dysfunction? And bladder cancer? The FDA unveiled graphic new warning labels for cigarettes that depict those conditions and other ailments that may be linked to tobacco. The proposed warning labels were mandated under the Family Smoking Prevention and Tobacco Control Act of 2009. Prior efforts to add graphic warnings were defeated by tobacco companies in court, where judges said they violated the companies’ First Amendment rights. Under the law, the labels must be finalized by March 2020. Time will tell if this effort goes up in smoke.
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 Is everything you buy at CVS legal?
By Michelle Leeds Everyone is talking about CBD – including us! This week, RRM team member and former FDA Associate Commissioner Peter Pitts led a discussion at our New York offices about the regulatory and communications challenges facing the CBD, or cannabidiol, industry. Since the 2018 Farm bill legalized hemp, CBD products (and ads for them) have been popping up everywhere – in medical marijuana dispensaries, drug stores, and even your local smoothie shop – marketed as wellness products to alleviate your headaches, anxiety, and you-name-it! It’s becoming such a hot topic that several media outlets now have dedicated reporters covering the CBD/Cannabis beat. For those who missed it, here are some of the topics we covered in our session: Legality - Legality of the products is questionable - while the federal ban on hemp ended last year, hemp-derived CBD could come from hemp plants with enough THC to be classified as marijuana. States and cities have their own patchwork of laws regarding marijuana that don’t always align with federal regulations. And, regardless of marijuana classification, CBD still falls under the federal purview of the Food, Drug & Cosmetic Act when it’s marketed with a health claim, leading to recent instances of products being pulled off store shelves (including this high-profile incident at CVS last month).
Quality - The manufacturer is not necessarily the one putting their name on the product label so there is sometimes no accountability for quality – often a third party company puts the packaging together (ideally with the help of a good team of lawyers!)
- There isn’t much quality assurance that the products are what they say they are and have the THC content marked on the packaging. Even though some packages are claiming “absolutely no THC”, you can’t guarantee that THC won’t show up on a drug test (kind of important for folks who may have to be subject to routine testing by their employers)
Big Business - If you think CBD will stay mom-and-pop shop forever, think again. The best-positioned company to move into this space is none other than Phillip Morris. (Think built-in regulatory relationships and knowledge, teams of lawyers, relationships with farmers/growers and capital to support marketing campaigns.)
Data - We don’t have enough data about CBD usage to back up any health claims. Dosing and drug interactions are currently untested factors.
Timing - Speaking of data, the FDA doesn’t necessarily have a trigger point to move into regulating these products, since we don’t yet know of many adverse events from CBD reactions.
Right now, CBD is the Wild West. We’ll keep you posted if the FDA makes any moves to regulate. Want more from Peter? Check out his oped on CBD in the Washington Times.  Is an economic storm coming to healthcare?
A new Bank of America Merrill Lynch survey finds one third of investors think a recession is likely in the next twelve months. The issues causing the most concern among those surveyed include the China-U.S. trade war and monetary policy. The Dow saw its worst day all year. So, what does this portend for healthcare? Life Science companies are not recession proof. Their R&D programs require a constant supply of funds, and many are at a point where they don't yet have revenue. If Wall Street shuts off the money, what’s next? Smart management teams will have raised the money to get them through a significant milestone or launch. If companies conserve their cash, they may be able to “outwit, outplay, and outlast” their competitors. But, there’s no guarantee. In 2008/09 the industry held on until the cash ran out. Some companies became desperate, but those with cash were in position to benefit from a fire sale. BioPharmaGuy has a list of the victims. If a recession hits, times may get tougher for healthcare companies and businesses could contract severely. As a consequence, we might begin to see R&D programs be shelved or cut, restructuring, and consolidation. Like a forest fire, the devastation brings new growth and innovation. Entrepreneurs, VC’s and scientists may buy shelved assets, IP, restart programs, and build new companies. Sound familiar? Have questions? Our financial communications strategist, Eric Laub, is keeping tabs on the situation for us. Feel free to reach out to him.  Who wrote this? The managing editor of TWTW is Randi Kahn, who had the best tiramisu this week right near Syneos Health HQ - lunch at Serafina’s anyone? Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
 Got thoughts? Contact Randi   
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