FDA Approval of Alzheimer’s Drug Sparks Controversy: Last week the FDA granted conditional approval of the first new treatment for Alzheimer’s disease in almost twenty years. Although the decision may have come as welcome news to the millions of Americans suffering from the disease and their families, it also sparked plenty of controversy.
Unlike other Alzheimer’s drugs that treat symptoms of the disease, the new drug, called Aduhelm, targets clumps of toxic proteins called beta-amyloid that some believe causes dementia. Breaking with decades of precedent, the FDA granted the drug conditional approval based on its ability to remove those plaques. The drug’s manufacturer, Biogen, will have to conduct a large clinical trial proving that eliminating the plaques has cognitive benefits for Alzheimer’s patients in order to continue marketing the drug.
The approval came in spite of strong objections from a panel of independent experts convened by the FDA who voted nearly unanimously that Biogen’s clinical data failed to provide sufficient evidence that the drug would significantly benefit patients. Two members of that advisory panel resigned over the FDA’s decision.
“I’m quite surprised. The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” said Johns Hopkins epidemiologist and advisory panel member Caleb Alexander. “It’s hard to find any scientist who thinks the data are persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold.”
Biogen stands to make billions from the drug, with the list price for a year’s worth of treatment expected to run about $56,000. (STAT, KAISER HEALTH NEWS)
CO Passes Major Healthcare Reform Bill: Colorado lawmakers passed sweeping legislation aimed at driving down healthcare costs in the state. The bill (HB 1232) was approved without Republican support in either chamber of the state’s General Assembly and despite a handful of Democratic defections over concerns about the measure’s effectiveness and potential impact on the healthcare industry.
The version of the bill now eligible for Gov. Jared Polis’ (D) signature is considerably different from the one that was initially introduced. The original version would have required the healthcare industry to reduce costs by 20 percent in order to avoid the implementation of a public health insurance plan. The version ultimately approved by lawmakers would require private insurers to provide a state-regulated plan that cuts costs by 15 percent.
The plan is similar to one recently launched in Washington, which has actually ended up raising healthcare costs instead of lowering them. But Colorado Democrats say they’ve made tweaks to the approach taken by Washington that they believe will allow them to avoid the Evergreen State’s problems.
The legislation was a top priority for Gov. Polis, and he is expected to sign it into law. (COLORADO SUN)
NV Becomes Second State to Offer Public Option: Nevada Gov. Steve Sisolak (D) signed legislation (SB 420) making his state the second - after Washington - to offer a public health insurance option. The new law mandates that companies participating in the state’s Medicaid program offer lower-cost, mid-tier insurance plans on the state’s online healthcare marketplace. (LAS VEGAS REVIEW JOURNAL)
Biden Administration Narrows COVID Safety Rules to Healthcare Sector: The Biden administration decided to limit its emergency COVID-19 workplace safety rules, under review since April, to healthcare workers, who research indicates tend to be most at risk, according to Labor Secretary Marty Walsh. The rules had been expected to apply to all workplaces and require workers to wear face masks while on the job. (POLITICO)
WA Using Program to Reduce Vaccine Waste: Washington launched a program on May 14 that streamlined the process for transferring unused doses of COVID-19 vaccines between different providers to reduce waste. Over 16,000 providers have enrolled in the program, called Vaccine Marketplace.
MO Finally Adopts Medication Tracking Database: Missouri became the last state to adopt a prescription drug monitoring database allowing the identification of opioid misuse, with Gov. Mike Parson’s (R) approval of SB 63. Missouri had been the only state without such a program for years due to privacy concerns mainly among Republican lawmakers. (ASSOCIATED PRESS)
Amazon Attracts Customers for Telehealth Service: Multiple companies have signed up for Amazon’s telehealth service, known as Amazon Care. The company announced in March that it would be opening up the service - launched as a pilot program for employees at its Seattle headquarters in 2019 - to other companies later this year. (CNBC)
Amazon Offers $1-Per-Month Prescriptions: Amazon said it is now offering six-month, $6 prescriptions for select medications, including diabetes and blood-pressure drugs. The company launched an online pharmacy in November, putting it in direct competition with drug retailers like CVS, Walgreens and Walmart. (INSURANCE JOURNAL)
-- Compiled by KOREY CLARK
U.S. House Dems Target Big Tech with Draft Antitrust Bills: A group of Democrats in the U.S. House is circulating drafts of antitrust legislation targeting big tech companies like Amazon, Alphabet (parent company of Google), Apple and Facebook.
In their current form, the bills would reportedly limit the ability of Amazon and Apple to operate marketplaces for apps and products where they also sell their own wares. The measures would also make it more difficult for Alphabet and Facebook to execute mergers and make it less difficult for their users to leave the platforms.
The draft legislation follows a 16-month investigation of the four companies by the U.S. House Judiciary’s antitrust subcommittee. (CNBC)
FBI Likely Hacked Colonial Pipeline Hackers, Not Bitcoin to Recover Ransom: The FBI was likely able to recover $2.3 million in bitcoin that Colonial Pipeline paid ransomware hackers in April because of poor password storage by the hackers rather than a security vulnerability in the cryptocurrency, according to crypto experts.
Nic Carter, founding partner of Castle Island Ventures said the FBI probably accessed a server on which the hackers stored the password, or “private key,” for the digital wallet in which they had deposited the ransom.
Carter said it was highly unlikely the FBI had broken the algorithm that ensures bitcoin is only spent by its rightful owner.
“In fact, that is so far-fetched, as to be impossible,” he said.
Jesse Spiro, global head of policy for Chainalysis, meanwhile, said “because of the transparency and traceability that cryptocurrency provides, you can actually more effectively follow the money and potentially mitigate and arrest illicit activity within this ecosystem, than you can with traditional finance and fiat currencies and payments.” (CNBC)
JBS Paid $11M to Ransomware Attackers: JBS USA paid an $11 million ransom to the hackers that forced it to suspend operation at more than a dozen of its meat processing plants this month. The company made the payment, after consulting with cybersecurity experts, in order to avoid further disruption of its operations. (CBS NEWS)
Biden Shifts U.S. Approach on Tik Tok: President Biden revoked a series of executive orders issued by President Trump that sought to ban the popular Chinese-owned apps TikTok and We Chat but which were blocked by federal courts from ever taking effect. Biden replaced those orders with one of his own mandating a review of apps connected to foreign adversaries to determine if they pose a security threat to the United States, which could ultimately make it possible for bans on Chinese apps to actually be implemented. (WALL STREET JOURNAL, VERGE)
Facebook Allowing More Employees to Work from Home: Facebook said that starting June 15 it will be giving employees at all levels of the company the option of working from home if their jobs can be done remotely. The company also said that employees who do return to the office, likely in September or October, will probably be there about 50 percent of the time. (CNET)
IBM Employees Back to the Office in September: U.S. employees of IBM will return to the office the week of Sept. 7, according to a memo from Chief Human Resources Officer Nickle LaMoreaux. The memo didn’t indicate whether employees would have the option of continuing to work from home either full or part time. (CNBC)
-- Compiled by KOREY CLARK
The DELAWARE Senate approves HB 88, which would do away with a law that allows employers to temporarily pay 50 cents an hour less than the minimum wage to teens and those being trained. It moves to Gov. John Carney (D), who is expected to sign it into law.
TEXAS Gov. Greg Abbott (R) signs HB 4474, which establishes a legal framework for cryptocurrency investments in the Lone Star State. The measure ensures that the state’s main business regulations also apply to cryptocurrencies.
VERMONT Gov. Phil Scott (R) signs HB 360, which funnels $150 million of the $1 billion in federal relief aid the state is receiving from the American Rescue Plan Act toward the goal of improving broadband access in underserved rural areas.
NEVADA Gov. Steve Sisolak (D) signs SB 386, a so-called “right to return” bill that gives hospitality and travel industry workers the right to reclaim their previous jobs. The law applies to workers laid off after March 12, 2020, for economic reasons due to the pandemic the ability to return to their jobs starting July 1, 2021, through August 21, 2022.
MICHIGAN Gov. Gretchen Whitmer (D) signs SB 157, SB 312, HB 4376 and HB 4377, which collectively ensure the state will waive fees for veterans, active-duty service members and their dependents with valid out-of-state professional licenses when they seek to obtain those licenses in the Wolverine State.
IOWA Gov. Kim Reynolds (R) signs HF 802, legislation intended to ban the teaching of critical race theory, an academic theory that seeks to examine the ongoing impact of systemic racism on society. Her signing comes days before the FLORIDA state board of education unanimously votes to ban teaching ideas related to critical race theory from being taught in Sunshine State public schools.
The COLORADO House and Senate approve HB 1162, which would gradually ban single-use plastic bags and polystyrene containers by 2024. It moves to Gov. Jared Polis (D), who is expected to sign it into law.
HAWAII Gov. David Ige (D) signs HB 1020, which authorizes the Board of Land and Natural Resources to implement effective and adaptive management measures in response to rapidly changing conditions, such as size and bag limits, closed seasons and gear restrictions when needed in extraordinary situations.
The NEW YORK Senate and Assembly each endorse SB 7196, which would make it easier for consumers to file civil suits against gun manufacturers and dealers. It moves to Gov. Andrew Cuomo (D) for consideration.
The CONNECTICUT Senate approves SB 1118, which would legalize adult recreational use of marijuana. It is now in the House, which has indicated it will wait for a special session later this month to consider the measure.
The LOUISIANA Senate approves HB 578, which would require Pelican State doctors to tell women taking the abortion pill that the drug-induced effort to terminate a pregnancy could be stopped midway through the process, a scientifically questionable claim. It moves to Gov. John Bel Edwards (D) for consideration.
The PHILADELPHIA City Council unanimously approves an ordinance (210081) creating a new type of licensing system and other regulations designed to treat short-term rentals like Airbnb and VRBO more like traditional businesses. The measure moves to Mayor Jim Kenney for consideration. (PHILADELPHIA TRIBUNE, WHYY [PHILADELPHIA])
-- By RICH EHISEN
Abbott Signs TX Power Grid Overhaul: Months after a deadly February storm killed hundreds of people, Texas Gov. Greg Abbott (R) signed a pair of bills that together overhaul the governance of the Lone Star State power grid that many blame for their deaths.
State officials say the bitterly cold storm, which left almost 5 million homes and businesses without power for five says, killed 151 residents. Analysis by media outlets, however, claims the figure is much higher: a Houston Chronicle review in April said 194 died, while a Buzzfeed analysis from May pegs the figure at approximately 700.
Abbott signed SB 3, which requires upgrades for power generators and transmission lines to make them better withstand extreme weather and establishes an emergency alert system to warn Texans of weather emergencies and power outages. Power operators that fail to cooperate will face fines of up to $1 million.
He also signed SB 2, which overhauls governance of the Electric Reliability Council of Texas (ERCOT), which oversees the state’s main power grid. The legislation shrinks ERCOT’s board from 16 to 11 members and gives the governor and lawmakers more influence over the board’s makeup. (AXIOS, TEXAS TRIBUNE)
CA Recall Will Cost over $200 Million: Election officials from all 58 California counties have calculated the impending recall election of Gov. Gavin Newsom (D) will cost their municipalities approximately $215 million. In a letter to lawmakers, state Department of Finance Director Keely Martin Bosler notes that figure “does not reflect the Secretary of State’s costs associated with a statewide recall election.” The cost to individual counties ranges from as low as $198,645 for tine Glenn County to $49,154,000 for Los Angeles County. (SACRAMENTO BEE, LOS ANGELES TIMES)
NV Gov Signs Bill Overhauling Investor Regulations: Nevada Gov. Steve Sisolak (D) signed a bill last month (SB 9) that defines how investors and entrepreneurs should comply with investment laws and exempts small investor funds from regulations designed for larger funds. (LAS VEGAS REVIEW-JOURNAL)
-- Compiled by RICH EHISEN
Something Good Before You Go
We’ve all heard of paying it forward, the concept of doing good to others to show appreciation for good shown to us in the past. Well, nobody has to explain it to recent Massachusetts high school grad Verda Tetteh. The 17-year-old is bound for Harvard this fall on a full-ride scholarship, which is already pretty awesome. But when she learned she had been awarded an additional $40,000 scholarship from her high school, she asked the school to give it to a classmate who was planning to attend a community college instead. Her rationale? Her mom had attended one at age 39, and it was life changing for her. “It is such a great honor, but I also know that I am not the most in need of it,” she said. Her classmates gave her a standing ovation. That sound you hear now is me joining in from my office.
--By RICH EHISEN
That’s it for this week!