About Covid-19
Fauci says the public is ‘misinterpreting’ the CDC’s latest mask guidance: “‘I think people are misinterpreting, thinking that this is a removal of a mask mandate for everyone. It’s not,” he told Axios. ‘It’s an assurance to those who are vaccinated that they can feel safe, be they outdoors or indoors.’
Fauci emphasized that the health agency did not explicitly tell unvaccinated people to go without masks but instead communicated to vaccinated individuals that they won’t get infected indoors or outdoors.”
Brussels seeks to regain initiative on Covid vaccine patent debate: “Valdis Dombrovskis, executive vice-president of the European Commission, said World Trade Organization members should use existing rules to make it easier to share intellectual property for coronavirus jabs, rather than expand the ability of governments to override patents, as proposed by the US. Given the pandemic represents a national emergency, the requirement to negotiate with rights holders to license the production of Covid-19 vaccines could be waived, he said in prepared remarks to the European Parliament. The intervention was a plea for countries to increase access to vaccine technology under the existing WTO agreement known as Trips, rather than create a major new loophole in the IP regime by waiving patents.”
Oxford/AstraZeneca booster works well, study finds: “A study has found that the Oxford/AstraZeneca Covid-19 vaccine works well as a third booster shot, despite concern that the immune system might fight off the adenovirus used as a delivery mechanism. A third dose was shown to boost participants’ antibodies to the coronavirus’s spike protein in an upcoming study by Oxford university, according to people familiar with the matter.”
Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations: “When Fuad El-Hibri, founder and executive chairman of Emergent BioSolutions, appears Wednesday before a House subcommittee to explain how the company’s Baltimore plant ruined millions of doses of coronavirus vaccine, he will be questioned by lawmakers he and his employees spent tens of thousands of dollars helping to elect.
Since 2018, federal campaign records show, Mr. El-Hibri and his wife, Nancy, have donated at least $150,000 to groups affiliated with the top Republican on the panel, Representative Steve Scalise of Louisiana, as well as Mr. Scalise’s campaigns. At least two other members of the subcommittee received donations during the 2020 election cycle from the company’s political action committee, which has given about $1.4 million over the past 10 years to members of both parties.”
About pharma
Judge OKs classes in case accusing Ranbaxy of delaying generics: “A federal judge has approved multiple classes in litigation accusing Indian generic drugmaker Ranbaxy Laboratories Ltd of delaying the launch of generic drugs by submitting false applications to U.S. regulators.
In an opinion issued Friday, U.S. District Judge Nathaniel Gorton in Boston certified classes of both direct purchasers, including drug wholesalers, and indirect purchasers, such as health plans and insurance companies.”
Big Pharma spent a record $92M on lobbying in Q1— for what?: “The pharmaceutical industry is on track to break its annual lobbying spending record for the second year in a row, with most of the $92 million it spent during 2021's first quarter going toward efforts to block Medicare reform and protect patents
The pharmaceutical lobby spends more than any other industry, according to a May 8 Truthout report. During the first three months of 2021, Pfizer alone spent $3.7 million on lobbying. PhRMA, a prevalent industry trade group, spent $8.7 million on lobbying during the same time period.“
COVID-19 impact on oncology clinical trials: a 1-year analysis: From Nature: “The pandemic affected all trials during the earlier waves, but the impact on oncology trials has been less severe compared with non-oncology trials. As vaccines continue to be rolled out, we expect this impact to continue to lessen.”
The chart provides a good graphical explanation of what happened to the trials over the past year.
And in a related monograph from IQVIA: Global Trends in R&D:
Funding for early- and late-stage R&D and strategic transactions increased significantly in 2020; aggregate R&D spend for the top 15 companies reached a record high.
The number of first-time launches of novel active substances (NAS) reached an all-time high of 66 in 2020 – with success for treatments in oncology and rare diseases.
Clinical trial starts increased 8% in 2020, similar growth to the prior three years, with oncology trial starts reaching historically high levels.
Overall, clinical trial activity recovered from mid-year 2020 to levels above 2019 – even without COVID-19 trials.
Health Plans Win Class Cert. In CVS Price-Gouging Suit: “A Rhode Island federal judge granted certification to multiple classes of insured health plans that say CVS schemed with pharmacy benefit managers to overcharge the plans for generic drugs while providing discounted prices for uninsured customers, according to an order unsealed Tuesday. In a partially redacted decision that was filed under seal May 11, U. S. District Judge William E. Smith allowed certification for four classes of health plans in two consolidated suits, encompassing thousands of health plans.”
Triple vs Dual Inhaler Therapy and Asthma Outcomes in Moderate to Severe Asthma: A Systematic Review and Meta-analysis: “Among children (aged 6 to 18 years) and adults with moderate to severe asthma, triple therapy, compared with dual therapy, was significantly associated with fewer severe asthma exacerbations and modest improvements in asthma control without significant differences in quality of life or mortality.”
This study could change the way these patients are treated from the start- as opposed to step therapy.
Bristol-Myers pays up to $1.2bn to enter artificial-intelligence pact: “Bristol-Myers Squibb has agreed to pay up to $1.2bn to enter a drug discovery collaboration with artificial intelligence start-up Exscientia as the Big Pharma company bets on the power of the technology to turbocharge drug development. The agreement comes as the biotech industry deploys AI to speed up the process of screening molecules that can then be tested as drugs to tackle illnesses ranging from cancer to heart disease.”
About healthcare IT
Anthem, Epic team to enhance data sharing with providers: “The insurer announced Wednesday that the partnership would harness Epic's Payer Platform, which will be embedded directly into Anthem's Health OS and thus into providers' workflows. The platform will allow the payer and providers to share clinical data and information at discharge from the hospital, for example.”
Johns Hopkins spinout Emocha Health closes $6.2M series A for video-based medication adherence: “Emocha’s approach to medication adherence looks to scale directly observed therapy (DOT), the gold standard approach to ensuring medication adherence. But rather than require patients to meet in person with nurses or other practitioners on a regular basis, the company allows patients to record themselves taking a medication and send it off for review.”
Cerner slips 2nd year but holds dominance alongside Epic for EHR market share: “While Cerner's hold of the EHR market share dropped for the second consecutive year, the EHR vendor still maintained the second largest share after Epic for acute care hospitals in 2020.
For its ‘U.S. Hospital EMR Market Share 2021’ report, KLAS Research examined EHR purchasing activity and contracts across the country from Jan. 1 to Dec. 31, 2020.”
Here are the top 5 EHRs measured by market share:
—Epic: 31 percent
—Cerner: 25 percent
—Meditech: 16 percent
—CPSI: 9 percent
—Allscripts: 5 percent
Ro will acquire women's health startup Modern Fertility in $225M deal: “Digital health company Ro is adding reproductive health to its growing platform with plans to acquire Modern Fertility.
The deal, announced Wednesday, is valued north of $225 million, according to sources familiar with the deal.
Modern Fertility launched in 2017 offering at-home fertility tests for women.”
About hospitals and health systems
One of America's largest hospital chains has been suing thousands of patients during the pandemic: “Hospitals owned by Community Health Systems, Inc., one of America's largest hospital chains, have filed at least 19,000 lawsuits against their patients over allegedly unpaid medical bills since March 2020, even as other hospitals around the country have moved to curtail similar lawsuits during the coronavirus pandemic, a CNN investigation found.
The company's 84 hospitals, which are concentrated in the South and stretch from Alaska to Key West, Florida, have taken their patients to court for as little as $201 and as much as $162,000. They say litigation is a last resort.”
Hospitals Serving The Poor Struggled During COVID. Wealthy Hospitals Made Millions: “This past year, the nation's more than 300 safety-net hospitals found themselves on the front lines of the coronavirus pandemic, which disproportionately affected the communities that safety-net hospitals are most likely to serve. They took on a greater share of the patient burden, even as other hospitals emerged from the pandemic with huge profits, an investigation by NPR and the PBS series Frontline has found…”
Financial reports:
Sutter Health posts $49M operating loss in Q1 after rough 2020 and
CommonSpirit Health accelerates COVID-19 rebound with $539M in operating gains
About health insurance
Dual Eligibles in Medicare Advantage Faced Fewer COVID-Related Disruptions in Care than Those in Traditional Medicare: “Despite being older and sicker, dual eligibles in MA were less likely to report difficulty accessing care during the COVID-19 pandemic. Only 35 percent of dual eligibles in MA said they were unable to get a regular check-up during the pandemic, compared to 51 percent in FFS. Similarly, dual eligibles in MA were less likely to report that they were unable to get diagnostic or medical screening tests, treatment for ongoing conditions, and urgent care for accidents or illnesses during the pandemic.”
HHS Must Redo Medicare Pay for Physician Training Programs: “Hundreds of hospitals throughout the country will receive a boost in their Medicare reimbursements for training medical residents, as the government unlawfully changed how those payments are calculated, a federal court said.
The Secretary of Health and Human Services acted arbitrarily and capriciously, and in contravention of the Medicare Act, when he adopted a regulation that effectively changed the weighting factors statutorily assigned to residents and fellows, the U.S. District Court for the District of Columbia said.”
Cancer Outcomes Among Medicare Beneficiaries And Their Younger Uninsured Counterparts: “The main outcomes were survival at one, two, and five years for sixteen cancer types in 1,206,821 patients. We found that uninsured patients ages 60–64 were nearly twice as likely to present with late-stage disease and were significantly less likely to receive surgery, chemotherapy, or radiotherapy than Medicare beneficiaries ages 66–69, despite lower comorbidity among younger patients. Compared with older Medicare patients, younger uninsured patients had strikingly lower five-year survival across cancer types.”
About the public’s health
HHS Announces $3 Billion in American Rescue Plan Funding for SAMHSA Block Grants to Address Addiction, Mental Health Crisis: “The Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding — the largest aggregate amount of funding to date for its mental health and substance use block grant programs.
The Community Mental Health Services Block Grant (MHBG) Program and Substance Abuse Prevention and Treatment Block Grant Program (SABG) will disperse $1.5 billion each to states and territories (with the latter also awarding money to a tribe). This follows the March announcement of supplemental funding of nearly $2.5 billion for these programs. SAMHSA, an operating division of the U.S. Department of Health and Human Services, has expedited federal funding to grantees to help communities grappling with mental health and substance use needs during the COVID-19 pandemic.”
SCOTUS Dismisses Title X Family Planning Cases to AMA Applause: “The Supreme Court of the United States has dismissed Title X cases, a move that will likely amount to overturning a Trump-era rule that some industry leaders, like the American Medical Association, said is akin to a gag clause in patient-provider communication.
The Court’s dismissal of the cases means it will not hear the cases arguing against the prior Administration’s rule.
It is up to the Biden Administration to ultimately overturn the rule…
The Title X Family Planning rule issued out of the Trump Administration’s Department of Health & Human Services (HHS) withdrew any federal funding from medical providers offering family planning counseling, including referral to abortion services.
The rule also pulled federal funding from Title X clinics that provide abortion service referrals or counseling about abortion services; got rid of requirements that Title X care sites offer multiple family planning methods and counseling on those methods; and funneled new funding opportunities toward faith-based or other groups that promote fertility awareness and abstinence-based family planning education.”
About diagnostics
Amazon may expand into diagnostics: “Amazon is planning to launch a business that will offer at-home medical tests…
The new brand, Diagnostics, would first offer testing kits for COVID-19. Eventually, Amazon plans to expand the business to offer testing kits for other diseases, such as sexually transmitted infections.
People familiar with the new brand said Amazon's long-term goal is to offer clinical genomics and launch a third-party marketplace that sells medical tests from other companies.