HEALTH CARE BRIEFING: New Covid Treatment Owed to Carter-Era Law

The most promising Covid-19 treatments and vaccines being explored right now were made possible by a little-known law that encourages licensing agreements between private pharmaceutical companies and government-funded researchers.

Treatments such as Gilead’s remdesivir, Ridgeback Biotherapeutics’ EIDD-2801 drug, and Moderna’s vaccine candidate were all achieved through public-private partnerships that didn’t exist before the Bayh-Dole Act in 1980.

The law, best known for giving the government the never-used authority to seize licensing rights for any product funded by taxpayer dollars, changed the pharmaceutical industry dramatically. It made it possible for drug companies to profit when they license new inventions from universities, nonprofits, or any government-funded entities or partner with them for early stage research and testing.

“Before Bayh-Dole, if the government funded an invention, even a small percentage of funding, the government would take the invention away and try to license it non-exclusively,” said Joseph Allen, a former Senate staffer who was instrumental in passing the act.

“It sounds noble, but it completely failed because there was no incentive if a university made an invention for a company to license it,” added Allen, who is also founder of consulting firm Allen & Associates.

For companies developing potential Covid-19 treatments and vaccines, being able to profit by building on university research has been critical.

Gilead partnered with various universities, led by the University of Alabama, for remdesivir research in 2014. Moderna collaborated with Harvard and the University of Pennsylvania on its vaccine. Ridgeback licensed its Covid-19 technology from Emory University.

Without the flexibility of Bayh-Dole “you kill innovation,” Wendy Holman, CEO and founder of Ridgeback, said during an April webinar on Bayh-Dole.

“I say that having licensed 2801 from Emory,” she added. “It would have been irresponsible of me to have licensed it if I didn’t think I could raise money around it.” Read more from Valerie Bauman.

Congressional Virus Efforts

Seniors, Virus Care: The Senate Special Committee on Aging holds a hearing on caring for seniors during the Covid-19 pandemic.

Scott, Murray Push to Keep Students Insured: House Education and Labor Chairman Bobby Scott (D-Va.) and Senate Health, Education, Labor and Pensions ranking member Patty Murray (D-Wash.) urged HHS Secretary Alex Azar in a letter “to take proactive steps to help more than 14 million displaced college students maintain access to health care coverage,” according to a statement. They argue that many students who rely on health insurance plans sponsored by their universities “may face a break in coverage as these institutions remain closed” due to lockdowns. Read the letter here.

DeGette Outlines Oversight Plan: The House Energy and Commerce Committee plans to hold its first oversight hearing on Covid-19 testing in the coming weeks, Oversight and Investigations subcommittee Chairwoman Rep. Diana DeGette (D-Colo.) said yesterday.

Her comments at a virtual community forum come one day after she and Energy and Commerce Chairman Frank Pallone (D-N.J.) unveiled an oversight agenda. DeGette, who heads the oversight subcommittee, said they’ve been “paralyzed for a couple of months” in their ability to oversee the Trump administration’s response to the pandemic until House rules changed last week that allowed for remote hearings. Testing will be the first issue in a series of hearing to be held “throughout the summer designed to hold the administration’s feet to the fire on this,” DeGette said in response to a question about President Trump’s decision to fire inspectors general, Jeannie Baumann reports.

Durbin Wants Remdesivir Transparency: Senate Minority Whip Dick Durbin (D-Ill.) yesterday hosted a briefing call with HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec, and pressed him concerns from states, hospitals and patients on the opaque manner the federal government is distributing Gilead’s coronavirus drug remdesivir, according to a statement. The administration committed to a public dashboard with information on shipments, the release said. Durbin had led a dozen Senators in a letter on the issue last week.

Testing, Treatment & Reopening Efforts

CDC Publishes Detailed Reopening Guidance: The Centers for Disease Control and Prevention has issued a 60-page document providing detailed suggestions for different phases of reopening workplaces, schools and restaurants, after an earlier draft was rejected by the White House for being “too prescriptive.” The document, which expands on several tools that the agency released last week to guide specific types of organizations, was posted on the CDC’s website over the weekend without fanfare. They’re similar to ones included in the draft, although they pertain to fewer types of businesses and are less restrictive.

Much of the new guidance provides an overview of public-health measures like testing aimed at tracking the coronavirus’s spread and guiding the government’s response. The final 20 pages lay out stages of opening up child-care programs; schools and day camps; companies with high-risk employees; restaurants and bars; and mass transit. The document also gives detailed suggestions for social distancing, hygienic practices and symptom-checking. Emma Court has more.

The new guidance advised that masks should be worn by staff and encouraged for students at reopening K-12 schools, and it said schools should cancel extracurricular activities in areas still most affected by the virus, Andrew Kreighbaum reports.

Apple, Google Release Covid-19 Tool: Apple and Google released their Covid-19 exposure-notification tools today, along with changes that will help public health authorities gather more information on who has the virus. The system—called Exposure Notification—helps authorities develop apps that notify users if they have come into contact with a person who has tested positive for the novel coronavirus. Users who’ve downloaded the app for their region will be able to update their status if they test positive. The iOS and Android system will then anonymously notify other users who have come into contact with that person. Read more from Mark Gurman and Gerrit De Vynck.

1980 Law Helps Develop Virus Treatments: The most promising coronavirus treatments and vaccines being explored right now were made possible due to a little-known law that encourages licensing agreements between pharmaceutical companies and government-funded researchers. Treatments including Gilead’s remdesivir, Ridgeback Biotherapeutics’ EIDD-2801 drug, and Moderna’s vaccine candidate were all achieved through public-private partnerships that didn’t exist before the Bayh-Dole Act in 1980. Valerie Bauman explains.

HHS Awards $225 Million for Rural Testing: Rural health clinics will get $225 million to expand Covid-19 testing, the Health and Human Services Department announced yesterday. The funds will be divided among 4,500 clinics and can be used to implement testing programs, buy testing supplies, train staff, find and build new facilities, and report data to the HHS, Health Resources and Services Administration head Tom Engels said in a statement, Shira Stein reports.

N.Y. Sees New Infections in Low-Income Areas: New York City is seeing the coronavirus continue to spread in lower-income and predominately minority communities as the state’s overall numbers get better, Gov. Andrew Cuomo (D) said yesterday. The majority of new cases are originating in those parts of the city, he said. A review of 8,000 antibody tests conducted in those areas found an infection rate of 34% in the Bronx, 29% in Brooklyn and 25% in Queens, higher than the city’s 19.9% average, he said. Keshia Clukey has more.

• Cuomo yesterday also said he stood by his handling of coronavirus patients in nursing homes as calls mounted for an independent investigation. State Senate Republicans along with five New York Republicans in Congress, are demanding a federal probe into the state’s guidance for nursing homes and long-term care facilities, which required the facilities to admit coronavirus-positive patients. Read more from Clukey.
• A government watchdog report found infection control deficiencies were widespread in nursing homes even prior to the Covid-19 pandemic. A Government Accountability Office report released yesterday found 82% of nursing homes surveyed from 2013 to 2017 were cited for deficiencies, and half of the homes had persistent problems cited over multiple years. Read the report here.

More Headlines:

• U.S. Cases Rise 1.3%, Lower Than Past Week’s Average of 1.6%
• Chinese Genetics Firm’s Middle East Testing Raises U.S. Tensions
• WHO Says U.S. Funding Cut Would Hurt Emergencies Program
• The WHO Is Caught in a Dangerous Place Between Trump and China
• Minnesota Governor Calls Pence on Missing Diagnostic Machines
• EPA Should Develop Coronavirus Sampling Methods, Advisers Say
• Ohio Senate Kills Measure To Limit Gov. DeWine’s Virus Orders
• NYC Offers Free Child Vaccinations After Rate Drops by 63%

What Else to Know Today

Hospitals Urged to Cut Ties With Anti-Single Payer Coalition: Advocates for shifting the U.S. to a single-payer health-care system will start a campaign today aimed at getting the American Hospital Association to cut ties with an industry coalition that opposes “Medicare for All” efforts. Physicians for a National Health Program, a group of doctors backing Medicare for All, will kick off a letter-writing and educational campaign to urge the AHA to separate from the Partnership for America’s Health Care Future, a consortium of hospitals, doctors, and insurance groups working through a D.C.-based lobby shop to oppose single-payer efforts, PNHP President Adam Gaffney said.

The effort was supposed to start with a rally outside of AHA’s annual meeting in Washington last month, which was called off due to the pandemic, Gaffney said. Still, the spread of the disease and the shutdown of many of America’s hospitals could be making a case for shifting to a system in which the government would pay health-care bills, Gaffney said. “The fact that hospitals aren’t resilient in the face of a major health crisis makes you see it might be time to rethink the way we pay doctors and hospitals,” he said.

The AHA was among the earliest members of the Partnership, and the hospital industry would stand to lose billions of dollars each year if forced to accept only Medicare or Medicaid rates for their services. Gaffney’s group was encouraged last year when the American Medical Association, the country’s largest doctors’ lobby, pulled out of the Partnership after his group started a similar campaign that included protesting at the AMA’s annual meeting, Alex Ruoff reports.

More Headlines:

• Insurers, U.S. Debate Obamacare $2.5 Billion Pay Program Loss
• U.S. Joins False Claims Suit Against California Radiology Firm

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com