COVID Vaccines Put Anti-Science Activists to Shame
On a rain-soaked day, thousands marched on Washington, D.C. to fight for science funding and scientific analysis in politics.
It turns out that, despite the destruction and heartbreak caused by the COVID pandemic, there is a silver lining: Scientists from academia, government, and industry worked together and, using the tools of biotechnology, created multiple vaccines that surely will put an end to the worst of the pandemic sometime in 2021. In short, they proved that science works, particularly that which comes from industry. Though politicians and the public love to hate Big Ag and Big Pharma, everybody comes begging for help when the going gets tough.
The change in public attitude is tangible. A headline in the Financial Times declared, "Covid vaccines offer Big Pharma a chance of rehabilitation." In its analysis, the FT says that the pharmaceutical industry is widely reviled because of the high prices it charges for its drugs, among other things, but the speed with which the industry developed COVID vaccines may allow for its reputation to be refurbished.
The Media's Role in Promoting Anti-Biotech Activism
Of course, the media is partly to blame for the pharmaceutical industry's dismal reputation in the first place because of journalists' penchant for oversimplifying complicated stories and pinning blame on an easy scapegoat. While the pharmaceutical industry is far from angelic and places a hefty price tag on its products in the U.S., often gone unmentioned is the fact that high drug prices are the result of multiple factors, including lack of competition (even among generic drugs), foreign price controls that allow citizens of other countries to "free load" off of American consumers, and a deliberately opaque drug supply chain (that involves not only profit-maximizing pharmaceutical manufacturers but "middlemen" like distributors). But why delve into such nuance when it's easier to point to villains like Martin Shkreli?
Big Ag has been subjected to identical mistreatment by the media, with outlets such as the New York Times among the biggest offenders. One article it published compared pesticides to "Nazi-made sarin gas," and another spread misinformation about a high-profile biotech scientist. The website Undark, whose stated mission is "true journalistic coverage of the sciences," once published an opinion piece written by a person who works for an anti-GMO organization and another criticizing Monsanto for its reasonable efforts to defend itself from disinformation. These aren't cherry-picked examples. Overall, the media clearly has taken sides: Science is great, unless it's science from industry.
If the scientific community can use the powerful techniques of biotechnology to cure a previously unknown infectious disease in less than a year, then why shouldn't it be able to cure genetic diseases in humans?
Now, the very same media – which has portrayed the pharmaceutical and biotech industries in the worst possible light, often for political or ideological reasons – is wondering why so many Americans are reluctant to get a COVID vaccine. Perhaps their reportage has something to do with it.
Tech Strikes Back
For years, the agricultural, pharmaceutical, and biotech industries fought back, but to no avail. GMOs are feared, pharma is hated, and biotech is misunderstood. Regulatory red tape abounds. But that may be all about to change, not because of a clever PR campaign, but thanks to the successful coronavirus vaccines produced by the pharma/biotech industry.
All of the major vaccines were created using biotechnology, broadly defined as the use of living systems and organisms to develop products intended to improve human life or the planet. The Pfizer/BioNTech and Moderna vaccines rely on mRNA (messenger RNA), which is essentially a molecular "photocopy" of the more familiar genetic material DNA. The mRNA molecules were tweaked using biotech and then shown to be 95% effective at preventing COVID in human volunteers. The AstraZeneca/Oxford vaccine is based on an older technology that genetically modifies a harmless virus to resemble an immunological target, in this case, SARS-CoV-2. Their vaccine is 62% to 90% effective.
Even better, the pharma/biotech industry showed that it can work hand-in-hand with the government, for instance the FDA, to produce vaccines in record-breaking time. Operation Warp Speed provided some financing to facilitate this process. History will look back at this endeavor and likely conclude that the unprecedented level of cooperation to develop a vaccine in less than 12 months was one of the greatest triumphs in public health history. (The bungled slow rollout is another story.)
Perhaps the most important lesson that society will learn is that the scientific method works.
The pharma/biotech industry has thus gained tremendous momentum. For the first time it seems, those who are opposed to scientific progress and biotechnology are on the defensive. If the scientific community can use the powerful techniques of biotechnology to cure a previously unknown infectious disease in less than a year, then why shouldn't it be able to cure genetic diseases in humans? Or create genetically modified crops that are resistant to insects and drought? Or use genetically modified mosquitoes to help fight against killer diseases like malaria? The arguments against biotechnology have been made exponentially weaker by the success of the coronavirus vaccine.
Perhaps the most important lesson that society will learn is that the scientific method works. We observed (by collecting samples of an unknown virus and sequencing its genome), hypothesized (by predicting which parts of the virus would trigger an immune response), experimented (by recruiting tens of thousands of volunteers into clinical trials), and concluded (that the vaccines worked). It was a thing of pure beauty.
Thanks to all the players involved – from Big Government to Big Pharma – we are beginning the process of being rescued from a modern-day plague. Let us hope that this scientific success also deals a fatal blow to the forces of ignorance that have held back technological progress for decades.
[Editor's Note: LeapsMag is an editorially independent publication that receives program support from Leaps by Bayer. LeapsMag's founding in 2017 predates Bayer's acquisition of Monsanto in 2018. All content published on LeapsMag is strictly free of influence, censorship, and oversight from its corporate sponsor. Read more about LeapsMag's organizational independence here.]
Breakthrough therapies are breaking patients' banks. Key changes could improve access, experts say.
Single-treatment therapies are revolutionizing medicine. But insurers and patients wonder whether they can afford treatment and, if they can, whether the high costs are worthwhile.
CSL Behring’s new gene therapy for hemophilia, Hemgenix, costs $3.5 million for one treatment, but helps the body create substances that allow blood to clot. It appears to be a cure, eliminating the need for other treatments for many years at least.
Likewise, Novartis’s Kymriah mobilizes the body’s immune system to fight B-cell lymphoma, but at a cost $475,000. For patients who respond, it seems to offer years of life without the cancer progressing.
These single-treatment therapies are at the forefront of a new, bold era of medicine. Unfortunately, they also come with new, bold prices that leave insurers and patients wondering whether they can afford treatment and, if they can, whether the high costs are worthwhile.
“Most pharmaceutical leaders are there to improve and save people’s lives,” says Jeremy Levin, chairman and CEO of Ovid Therapeutics, and immediate past chairman of the Biotechnology Innovation Organization. If the therapeutics they develop are too expensive for payers to authorize, patients aren’t helped.
“The right to receive care and the right of pharmaceuticals developers to profit should never be at odds,” Levin stresses. And yet, sometimes they are.
Leigh Turner, executive director of the bioethics program, University of California, Irvine, notes this same tension between drug developers that are “seeking to maximize profits by charging as much as the market will bear for cell and gene therapy products and other medical interventions, and payers trying to control costs while also attempting to provide access to medical products with promising safety and efficacy profiles.”
Why Payers Balk
Health insurers can become skittish around extremely high prices, yet these therapies often accompany significant overall savings. For perspective, the estimated annual treatment cost for hemophilia exceeds $300,000. With Hemgenix, payers would break even after about 12 years.
But, in 12 years, will the patient still have that insurer? Therein lies the rub. U.S. payers, are used to a “pay-as-you-go” model, in which the lifetime costs of therapies typically are shared by multiple payers over many years, as patients change jobs. Single treatment therapeutics eliminate that cost-sharing ability.
"As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket,” says Patricia Goldsmith, the CEO of CancerCare.
“There is a phenomenally complex, bureaucratic reimbursement system that has grown, layer upon layer, during several decades,” Levin says. As medicine has innovated, payment systems haven’t kept up.
Therefore, biopharma companies begin working with insurance companies and their pharmacy benefit managers (PBMs), which act on an insurer’s behalf to decide which drugs to cover and by how much, early in the drug approval process. Their goal is to make sophisticated new drugs available while still earning a return on their investment.
New Payment Models
Pay-for-performance is one increasingly popular strategy, Turner says. “These models typically link payments to evidence generation and clinically significant outcomes.”
A biotech company called bluebird bio, for example, offers value-based pricing for Zynteglo, a $2.8 million possible cure for the rare blood disorder known as beta thalassaemia. It generally eliminates patients’ need for blood transfusions. The company is so sure it works that it will refund 80 percent of the cost of the therapy if patients need blood transfusions related to that condition within five years of being treated with Zynteglo.
In his February 2023 State of the Union speech, President Biden proposed three pilot programs to reduce drug costs. One of them, the Cell and Gene Therapy Access Model calls on the federal Centers for Medicare & Medicaid Services to establish outcomes-based agreements with manufacturers for certain cell and gene therapies.
A mortgage-style payment system is another, albeit rare, approach. Amortized payments spread the cost of treatments over decades, and let people change employers without losing their healthcare benefits.
Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
The new payment models that are being discussed aren’t solutions to high prices, says Bill Kramer, senior advisor for health policy at Purchaser Business Group on Health (PBGH), a nonprofit that seeks to lower health care costs. He points out that innovative pricing models, although well-intended, may distract from the real problem of high prices. They are attempts to “soften the blow. The best thing would be to charge a reasonable price to begin with,” he says.
Instead, he proposes making better use of research on cost and clinical effectiveness. The Institute for Clinical and Economic Review (ICER) conducts such research in the U.S., determining whether the benefits of specific drugs justify their proposed prices. ICER is an independent non-profit research institute. Its reports typically assess the degrees of improvement new therapies offer and suggest prices that would reflect that. “Publicizing that data is very important,” Kramer says. “Their results aren’t used to the extent they could and should be.” Pharmaceutical companies tend to price their therapies higher than ICER’s recommendations.
Drug Development Costs Soar
Drug developers have long pointed to the onerous costs of drug development as a reason for high prices.
A 2020 study found the average cost to bring a drug to market exceeded $1.1 billion, while other studies have estimated overall costs as high as $2.6 billion. The development timeframe is about 10 years. That’s because modern therapeutics target precise mechanisms to create better outcomes, but also have high failure rates. Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
Skewed Incentives Increase Costs
Pricing isn’t solely at the discretion of pharma companies, though. “What patients end up paying has much more to do with their PBMs than the actual price of the drug,” Patricia Goldsmith, CEO, CancerCare, says. Transparency is vital.
PBMs control patients’ access to therapies at three levels, through price negotiations, pricing tiers and pharmacy management.
When negotiating with drug manufacturers, Goldsmith says, “PBMs exchange a preferred spot on a formulary (the insurer’s or healthcare provider’s list of acceptable drugs) for cash-base rebates.” Unfortunately, 25 percent of the time, those rebates are not passed to insurers, according to the PBGH report.
Then, PBMs use pricing tiers to steer patients and physicians to certain drugs. For example, Kramer says, “Sometimes PBMs put a high-cost brand name drug in a preferred tier and a lower-cost competitor in a less preferred, higher-cost tier.” As the PBGH report elaborates, “(PBMs) are incentivized to include the highest-priced drugs…since both manufacturing rebates, as well as the administrative fees they charge…are calculated as a percentage of the drug’s price.
Finally, by steering patients to certain pharmacies, PBMs coordinate patients’ access to treatments, control patients’ out-of-pocket costs and receive management fees from the pharmacies.
Therefore, Goldsmith says, “As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket.”
Transparency into drug pricing will help curb costs, as will new payment strategies. What will make the most impact, however, may well be the development of a new reimbursement system designed to handle dramatic, breakthrough drugs. As Kramer says, “We need a better system to identify drugs that offer dramatic improvements in clinical care.”
In today's podcast episode, law professor Gaia Bernstein talks about the challenges of keeping control over our thoughts and actions, even when some powerful forces are pushing in the other direction.
Each afternoon, kids walk through my neighborhood, on their way back home from school, and almost all of them are walking alone, staring down at their phones. It's a troubling site. This daily parade of the zombie children just can’t bode well for the future.
That’s one reason I felt like Gaia Bernstein’s new book was talking directly to me. A law professor at Seton Hall, Gaia makes a strong argument that people are so addicted to tech at this point, we need some big, system level changes to social media platforms and other addictive technologies, instead of just blaming the individual and expecting them to fix these issues.
Gaia’s book is called Unwired: Gaining Control Over Addictive Technologies. It’s fascinating and I had a chance to talk with her about it for today’s podcast. At its heart, our conversation is really about how and whether we can maintain control over our thoughts and actions, even when some powerful forces are pushing in the other direction.
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We discuss the idea that, in certain situations, maybe it's not reasonable to expect that we’ll be able to enjoy personal freedom and autonomy. We also talk about how to be a good parent when it sometimes seems like our kids prefer to be raised by their iPads; so-called educational video games that actually don’t have anything to do with education; the root causes of tech addictions for people of all ages; and what kinds of changes we should be supporting.
Gaia is Seton’s Hall’s Technology, Privacy and Policy Professor of Law, as well as Co-Director of the Institute for Privacy Protection, and Co-Director of the Gibbons Institute of Law Science and Technology. She’s the founding director of the Institute for Privacy Protection. She created and spearheaded the Institute’s nationally recognized Outreach Program, which educated parents and students about technology overuse and privacy.
Professor Bernstein's scholarship has been published in leading law reviews including the law reviews of Vanderbilt, Boston College, Boston University, and U.C. Davis. Her work has been selected to the Stanford-Yale Junior Faculty Forum and received extensive media coverage. Gaia joined Seton Hall's faculty in 2004. Before that, she was a fellow at the Engelberg Center of Innovation Law & Policy and at the Information Law Institute of the New York University School of Law. She holds a J.S.D. from the New York University School of Law, an LL.M. from Harvard Law School, and a J.D. from Boston University.
Gaia’s work on this topic is groundbreaking I hope you’ll listen to the conversation and then consider pre-ordering her new book. It comes out on March 28.
