“It’s striking how virtually every COVID breakthrough developed through public/private sector partnerships gets attacked…. Rather than praising our system for leading the world in creating therapies to fight the pandemic, companies are accused of malfeasance, justifying government micromanagement.”
The lead story in last weekend’s Wall Street Journal made an exciting announcement: “Merck Covid-19 Pill Cuts Risks of Hospitalizations and Death”:
Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at home treatment.
In case its readers missed the significance, the same issue included an editorial, “There May Soon Be a Covid Pill”, stating:
In what is rare good news these days, Merck and Ridgeback Biotherapeutics said Friday that their Covid pill molnupiravir reduced hospitalizations by about half… Since the beginning of the pandemic, doctors have been hoping for an oral antiviral that could prevent recently infected patients from getting sicker…
Merck has also signed licensing agreements with generic manufacturers to accelerate the pills availability world-wide. Manufacturers in low-income countries don’t need special expertise and supervision to produce the pills, unlike with Covid vaccines. Molnupirvir can be easily distributed in poorer countries…
Evidence also indicates that the drug is effective against different variants and is unlikely to produce viral resistance.
The partnership between Emory University, Ridgeback Biotherapeutics and Merck could turn out to be one of the most significant Bayh-Dole alliances ever, yet just a few months ago all three were under fire. And the critics are renewing their attacks.
The Real Ridgeback Story
Let’s step back a little more than a year ago to gauge what really happened, what it means, and what these continued attacks on the people who are saving humanity from the worst pandemic in 100 years portends for our future.
While putting together a webinar last spring as the impact of the pandemic was becoming apparent, I asked some of the folks at the National Institutes of Health (NIH) who were developing industry partnerships to create desperately needed therapies if they could recommend an entrepreneur who was a good spokesperson. The name of Wendy Holman, CEO and Founder of Ridgeback Biotherapeutics kept coming up so I asked if she was interested in being on a panel focusing on how federally funded inventions could help in the fight against COVID-19. Ridgeback had just exclusively licensed an unusual, but potentially very exciting invention from Emory University.
Wendy agreed and did a terrific job. She explained the risks involved in developing new drugs, particularly when speed was of the essence and we couldn’t tolerate business as usual. She explained why efforts to impose artificial price controls on those working 24/7 to find cures were so harmful. She also expressed frustration in trying to secure federal support to keep the project on the fast track.
A few months later, Wendy and her husband were attacked in a Washington Post article, “Hedge fund manager stands to profit on ‘flip’ of tax-payer-funded coronarivus drug.” It was alleged that Emory has licensed a company with “a minimal track record,” which had placed a bet on acquiring the treatment only to make a potential killing by subsequently licensing it to Merck for development. Further, it was claimed that Ridgeback had “mounted a campaign to win hundreds of millions in government funding to develop the drug” according to a whistle blower who denied the application because the company had not “followed proper application procedures.”
“Molecule-flipping is a good characterization of what it is,” said James Love, director of Knowledge Ecology International, a nonprofit watchdog group that tracks public investments and intellectual property.”
Where the critics see venality, a closer look reveals a more likely motivation. Emory and Ridgeback were working with a sense of urgency to develop a potential groundbreaking therapy in the face of a growing global catastrophe. Business as usual wouldn’t cut it.
At the time, there were no effective drugs or vaccines available to fight COVID-19, which was overwhelming hospitals around the world. So, when Emory University was approached by an energetic company which had been involved in fighting the Ebola virus and had a game plan to hit the ground running, they quickly licensed their technology. Ridgeback immediately went to work and obtained Food and Drug Administration (FDA) approval to begin patient studies. The company applied for federal funding to prepare for large scale production, pushing the system as hard as they could, as millions of lives were at stake. Time was of the essence.
In April, 2020 Ridgeback was denied government support, so “[i]t started its safety trial on April 10, testing the EIDD-2801 drug against a placebo in 122 healthy volunteers in England, according to its disclosure on clinicaltrials.gov. It hired a contract research organization called Covance to conduct the study. The NIH said in an email that “Ridgeback conducted the study at its own expense,” according to the Washington Post.
After obtaining positive results, Ridgeback approached Merck. They reached an initial agreement on May 26, 2020, which said:
Ridgeback will continue to fund and conduct multiple Ridgeback-sponsored Phase 1 and 2 trials and fund manufacturing campaigns for clinical supply. Going forward, the parties will collaborate on clinical development for COVID-19 and manufacturing, to be led by Merck. Consistent with the shared history and commitment to addressing global unmet needs in grievous illness, Merck and Ridgeback also plan to explore the potential for EIDD-2801 in other severe acute viral diseases, such as Ebola.
A Tired Claim
That sounds like Ridgeback did a lot more than “molecule flipping.” What Ridgeback did is what drives our drug development system. About half of our new drugs come from entrepreneurial companies like Ridgeback. They are laser focused on development, taking early-stage inventions through the initial trials to see if they are effective. If they are, they partner with larger pharmaceutical companies like Merck, with the resources and expertise for conducting the expensive, high-risk, later stage human trials. These established companies also have expertise on developing large scale manufacturing to meet global needs.
But don’t hold your breath that an enormous advance for public health will win praise from the critics. They wasted no time in launching a new complaint—that the Biden Administration didn’t negotiate a lower price when it agreed to buy the drug from Merck. They are asserting their tired old claim that because Emory made their inventions with federal funding under the Bayh-Dole Act, that the government has the right to set the price.
They couldn’t even sell that to The Washington Post, whose fact checker examined their price control theory, concluding:
In the two decades since march-in (under Bayh-Dole) was identified as a way to control drug prices, advocates of this approach have struck out every time they have sought to advance it. No administration or court has ever accepted this reasoning. For now, it remains just a theory, not a tool that has ever been used in this way by the federal government.
The fact checker didn’t give the theory any “Pinocchio’s” (meaning that it’s obviously untrue) “despite its dismal track record” because it falls into the realm of opinion. Ouch!
The Critics Want a Villain
It’s striking how virtually every COVID breakthrough developed through public/private sector partnerships gets attacked on these same grounds. Rather than praising our system for leading the world in creating therapies to fight the pandemic, companies are accused of malfeasance, justifying government micromanagement. Adding insult to injury, the Biden Administration is trying to give away our COVID-19 related therapies to our international competitors.
It makes you wonder how long entrepreneurs like Wendy Holman will continue to run the commercialization gauntlet required to bring federally funded inventions to the marketplace. Even when they beat the odds—and have clearly benefitted humanity—they are often vilified.
I don’t know about you, but I’m grateful to Emory University, Ridgeback Biotherapeutics and Merck. Good job, Wendy; thanks!