Prize for a cure: 4 years later, legislative push to end diseases loses steam

Gilead Sciences earned more than $10 billion in sales in 2014 after it released Sovaldi and Harvoni, miracle drugs that cure the bloodborne infection in more than 90% of cases after only a 12-week regimen.

Sales reached $12.5 billion the following year but then steadily declined, the report states. The patient pool shrunk and, in the case of Hepatitis C, fewer patients means less infections as the disease is slowly eradicated.

In 2019, the pharmaceutical industry spent $83 billion on research and development – about 10 times the amount spent per year in the 1980s (after adjusting for inflation).

Researchers have made significant strides in the treatment of many chronic diseases. In 1985, the average lifespan for someone diagnosed with AIDS was a little more than a year. Today, it’s possible for patients to live long and healthy lives thanks to advances in therapies. The outlook has improved substantially for those suffering from schizophrenia, diabetes and heart disease.

Yet cures remain elusive.

Charles Silver, a law professor at the University of Texas at Austin who studies health care policy, said the problem isn’t science — it’s economics.

It’s been known for decades that the marketplace creates perverse incentives when it comes to developing and manufacturing drugs, Silver said.

Pharmaceuticals are big business. The cure for a rare disease could cost billions of dollars to discover with only a small return on investment. Meanwhile, a new treatment that marginally improves outcomes for a widespread disease, like diabetes, can earn greater revenue with less risk. It leads to incrementalism and “me-too drugs” that piggy-back off existing products, Silver said.

Cures can also self-cannibalize business. A cure for diabetes would earn a fortune for its inventor, but it would wipe out future revenue from treatments. No more need for insulin boosters or blood-sugar stabilizers. Dialysis clinics would shutter as kidney disease became less common.

Dave Westbrock, an Ohio endocrinologist who testified on behalf of Butler’s bill, said there are no advantages to curing a disease if it can be treated. Publicly traded companies are ultimately beholden to shareholders and leaders live or die by the company’s stock price.

“When there’s a potential cure, and if you’re a good guy, you say, ‘Well, cure it and let the disease be damned,’” Westbrock said. “But that’s not the way human existence works, is it?”

One solution is to simply charge more for cures.

When Gilead Sciences first introduced its cure for Hepatitis C, the company charged approximately $1,000 per pill, or $84,000 for the full regimen. To treat every American with the disease that year, the government would have needed to spent more on Sovaldi than all other prescription drugs combined, Silver said.

Since that was infeasible, many patients went without the cure, including prison inmates and veterans, both populations that have higher rates of infection, according to Silver.

Although the cost has dropped substantially, a study published in December found that less than two-thirds of Hepatitis C patients have received the cure, even as the opioid epidemic has caused a dramatic rise in cases.

Reid Porter, a spokesman for Pharmaceutical Research and Manufacturers of America, or PhRMA, said members of the interest group have invested more than $1.1 trillion over the past decade in the search for new treatments and cures, including $102.3 billion last year.

Porter pointed to Sovaldi and Harvoni as an example of the industry’s commitment to finding cures, but also progress on a cure for Type 1 diabetes and the potential offered by gene therapy.

Prizes, not patents

Butler’s odyssey into health care law began with his parents’ illnesses. Why weren’t researchers looking for cures for these horrible illnesses, he wondered.

Richard Nixon announced the “War on Cancer '' in a 1971 State of the Union speech. By the end of the year, he had signed the National Cancer Act into law, which launched the National Cancer Program (later renamed the National Cancer Institute) while providing new funding for research into cures.

As one researcher put it, the war has gone “poorly.” Treatment and survival rates have improved, but no cures have been found for any of the 200-plus cancers that are expected to kill more than 600,000 Americans this year.

Cancer is an enormously complex disease, but as Butler researched the issue, he began to understand the market forces that make cures an even greater challenge.

If there wasn’t enough incentive for companies to find cures, why not sweeten the pot?

It’s an idea that has circulated for years.

Joseph Stiglitz, a Nobel Prize winner and former chief economist of the World Bank, argued in 2007 for creating a government-funded prize to stimulate medical research.

“Of course, the patent system is itself a prize system, albeit a peculiar one: the prize is temporary monopoly power, implying high prices and restricted access to the benefits that can be derived from the new knowledge,” he wrote in an editorial for Project Syndicate. “By contrast, the type of prize system I have in mind would rely on competitive markets to lower prices and make the fruits of the knowledge available as widely as possible.”

U.S. Senator Bernie Sanders of Vermont first introduced legislation in 2005 that would replace the medical patent system with rewards based on the health impact of the innovation. The Health Impact Fund, launched in 2008, has proposed a similar fix to the patent system.

Silver said what makes Butler’s idea so interesting is the way it creates clear government priorities for research.

“We’re not going to pay for this incremental bullshit, right,” Silver said. “We’re gonna have a list of things we want cures for and, if you create cures, we’ll pay you a hefty chunk of change for those things.”

The funding mechanism is also unique. By tying the reward to the cost savings of the participating states, the program would pay for itself while still providing rewards large enough to encourage cure research.

For example, South Carolina’s Medicaid program spent $389 million in 2017 treating diabetes, which afflicts more than a half million of the state’s residents, or about 13% of the population, according to a study by the American Diabetes Association.

Diabetes treatment drained another $1.2 billion from Ohio’s Medicaid program. In North Carolina, it cost almost $800 million.

Based only on Medicaid costs, the prize for curing diabetes in 2017 would have amounted to roughly $12 billion from those three states alone. That does not include insurance expenditures for state employees or the cost of treating inmates, who are generally not eligible for Medicaid.

Silver believes such a large prize would incentivize research. By taking ownership of the cure and paying a lump sum, the government could quickly distribute the medicine while the inventor enjoys an immediate financial benefit from the breakthrough.

Silver pointed out it was often difficult to quantify cost savings, however. Butler’s plan also likely wouldn’t help find cures for diseases that cost states less to treat, such as rare cancers.

An ounce of prevention

Butler faced significant resistance from lobbyists when he first introduced the Cure Bill in 2018.

That included the pharmaceutical industry, he said, but a cure would be disruptive to the whole medical industry. Cancer hospitals, mental health clinics and addiction centers could all be impacted. It made people nervous.

Meanwhile, the advocacy organizations that would seemingly support an effort to find cures were mostly silent, Butler said. A lobbyist for the Alzheimer’s Association told Butler’s staff in an email the organization could not support his legislation.

“The bill specifically references supporting diseases that have treatments that cure the disease, and unfortunately with Alzheimer’s currently there are no effective treatments and we are nowhere close to curing the disease,” she wrote.

The resistance was frustrating, but it sharpened Butler’s arguments and encouraged him to add ethical standards for research to the bill, addressing one concern that was raised.

Butler reintroduced the bill in 2019, after he was named speaker pro tempore, and managed to push it through as a budget amendment.

After his bill passed in Ohio, Butler promoted the idea at a legislative conference in Miami. He then drove to statehouses across the South and East Coast to drum up further support.

“Everybody was very excited,” he said.

The idea took root in states as far away as Hawaii and Utah. Altogether, cure bills were introduced in 14 states in 2020.

The bills easily passed in the Georgia and Tennessee Senates, but later died in House committees. In Utah, the bill was narrowly defeated on the Senate floor after flying through the House.

The House version of the bill in Kentucky garnered more than 40 sponsors, but never made it out of committee.

Courthouse News contacted more than two dozen state lawmakers to discuss the bills. Ultimately, only a few were willing to talk about why they fizzled.

In Georgia, state Senator Kay Kirkpatrick said the bill garnered support from Emory, one of the nation’s leading research universities, but lawmakers got skittish.

State compacts are still a foreign concept for most lawmakers, the Republican said, and the idea of using future cost-savings to pay for cures was difficult to understand.

“It’s an innovative idea,” Kirkpatrick said. “But how it actually fits with the way the budgeting process works? I think that’s what kind of made it difficult for people to understand down here.”

Tommy Pope, speaker pro tempore for South Carolina, has introduced a cure bill in each of the last three legislative sessions, but it has never left committee.

The Republican representative agreed it was difficult to explain the idea to colleagues.

“It’s more of an algebraic equation than an arithmetic equation,” Pope said.

State Representative Norm Thurston said he didn’t know how the Utah Senate was going to vote on his bill, but he knew it would be close. Ultimately, he thinks it came down to money, which made no sense to him.

“If you said to any state, for $100 million, I could guarantee you a cure for diabetes, every single state in the country would take that deal, right,” said Thurston, a Republican. “Even the smallest of small states would say, ‘Yeah, we can find the money.’”

The hope for cures

Cure bills were introduced in a few states this year, including New York and the Carolinas, but none have gained traction.

Despite its promise, Butler’s idea hasn’t found many allies. None of the national advocacy organizations have thrown their support behind the legislation.

Spokespeople for Susan G. Komen and the American Heart Association said their organizations did not have a position on the bill. Jennifer Rosen, senior director of state affairs for the Alzheimer’s Association, said her organization had no position on the bill, either.

“Unfortunately the Association is not able to weigh in on every piece of legislation, but we are always grateful for the work other stakeholders are doing in the areas where we may not have the capacity to fully engage,” Rosen said in a statement.

Butler reached his term limit in 2021 and rejoined his former law firm, Thompson Hine, where he practices commercial litigation.

But the Cure Bill remains important to him.

Butler said he believed cures for major diseases would be found in the next 5 to 10 years if the commission was created, but there was still a benefit if not.

“If this bill passes and the compact is formed — that’s hope,” he said. “That’s a reason for people who are given grave news to have hope for the future.”

Follow @SteveGarrisonPC

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