If drugmakers can’t turn a profit owing to his tax and regulatory policies, who’ll develop new treatments?
In his last year as vice president, Joe Biden launched a “cancer moonshot” to accelerate cures for the disease. It was short-lived, but he did help negotiate an agreement in Congress easing regulation of breakthrough drugs and medical devices.
In February, President Biden revived the initiative, setting a goal of reducing cancer death rates by at least 50% over the next 25 years. It’s ambitious but may be achievable given how rapidly scientific knowledge and treatments are advancing. Other Biden policies, however, are at odds with the goals of this one.
Two pharmaceutical breakthroughs were announced only last week that could save tens of thousands of lives each year and redefine cancer care. Yet the tax hikes and drug-price controls that the Biden administration is pitching would discourage the private investment that has delivered these potential cures.
The overall annual cancer mortality rate has fallen 27% over the past two decades. This progress is in part thanks to preventive screenings like mammograms and reduced smoking rates. But much recent progress has come from newer treatments that target specific tumor biomarkers—often a mutated gene or protein—and immunotherapies that harness the immune system to fight cancer. Some biomarkers are unique to individual patients, but scientists have identified some 160 that are shared by some subset of cancer patients. For instance, mutations in the KRAS gene have been found in non–small cell lung, colorectal and pancreatic cancers.
Cancer innovations are accelerating as the gains from research and investment over many years accrue and compound. The risk of death from cancer fell about 2% a year from 2015 through 2019, compared with 1% annually during the 1990s. It is set to fall even faster in coming years as treatments become available for stubborn cancers that resist chemotherapy and radiation.
While common cancers like prostate and breast cancer have a nearly 100% survival rate if caught early, drugmakers and biotech startups are increasingly channeling investment into rare and aggressive forms of the disease. About two-thirds of the 2,335 trials that launched globally last year focused on novel treatments for rare cancers with smaller patient populations. These include glioblastoma, which killed Mr. Biden’s son Beau.
Consider GlaxoSmithKline’s immunotherapy Jemperli, which targets cancers caused by a rare genetic disorder known as mismatch repair deficiency, or dMMR, that tend to be less responsive to chemotherapy and radiation. The Food and Drug Administration granted Jemperli accelerated approval last August after it demonstrated promising results in patients with recurrent or advanced colorectal, small-intestine and stomach tumors caused by dMMR.
But could Jemperli work for other rare cancers? Researchers at Memorial Sloan Kettering Cancer Center with funding from GlaxoSmithKline decided to test the drug on a small group of patients with advanced rectal cancer caused by dMMR. The genetic disorder accounts for 5% to 10% of the 45,000 rectal cancers diagnosed annually.
Oncologists were blown away by the results reported last week in the New England Journal of Medicine: All 12 patients receiving the drug achieved complete remission after six months of treatment. None needed surgery, chemotherapy or radiation. Although some may relapse, the 100% success rate is unprecedented even for a small trial.
Doctors are hopeful that Jemperli might help some patients with pancreatic cancer, which can also be caused by dMMR and is usually a death sentence. Follow-up research and trials often reveal that treatment benefits extend to cancers other than the ones for which they were initially developed. This is how therapies like Merck’s Keytruda—which treats metastatic melanoma, non–small cell lung cancer, Hodgkin lymphoma and bladder cancer, among many others—become blockbusters.
Profit nowadays is a dirty political word, but it is what funds research and creates incentives for drugmakers to study how approved drugs can help different classes of patients.
AstraZeneca’s breast-cancer treatment Enhertu is a monoclonal antibody attached to a chemotherapy drug. Breast cancers are now classified as HER2-positive or -negative based on whether they have an abnormal number of proteins that cause cells to multiply too quickly. Not long ago, HER2-positive breast-cancer patients were at higher risk of recurrence and death. But their survival rates have improved dramatically over the past two decades thanks to HER2-targeting immunotherapies including Enhertu, which the FDA approved in 2019.
Most patients are categorized as HER2-negative. Many actually have a small amount of HER2, and doctors are increasingly describing them as “low HER2” so they could potentially be treated with Enhertu. Though this concept hasn’t been universally accepted, it soon may be.
Last week AstraZeneca in partnership with Daiichi Sankyo reported that Enhertu reduced the risk of death by 36% in patients with metastatic breast cancer with low HER2 and by half for the subset who were hormone-receptor negative. These results blow the outcomes for other metastatic breast-cancer therapies out of the water. Oncologists estimate that Enhertu could reduce disease progression for half of patients now classified as HER2-negative, or about 40% of all breast-cancer patients. They are also hopeful that the drug’s mechanism could be applied to other hard-to-treat cancers.
These treatment breakthroughs aren’t happening because of government programs. They’re happening because pharmaceutical companies have invested decades and hundreds of billions of dollars in drug research and development. It typically takes 10.5 years and $1.3 billion to bring a new drug to market. About 95% of cancer drugs fail.
This is important to keep in mind as Mr. Biden and Democrats in Congress push for Medicare to “negotiate”—i.e., cap—drug prices and raise taxes on corporations and investors. The large profits that drugmakers notch from successful drugs are needed to reward shareholders for their investment risk and encourage future investment. Capital is mobile.
Mr. Biden’s proposal to increase the top marginal individual income-tax rates, including on capital gains, would punish venture capitalists who seed biotech startups, which do most early-stage research on cancer drugs and are often acquired by large drugmakers. At the same time, his proposed corporate global minimum tax would raise costs of intellectual property, which is often taxed at lower rates abroad.
There aren’t many things to celebrate nowadays, but biotech innovation is one. Let’s hope the president doesn’t kill his own cancer moonshot.
Ms. Finley is a member of the Journal’s editorial board.
Reprinted by permission of the Wall Street Journal, Copyright © 2022 Dow Jones & Company, Inc. All rights Reserved Worldwide. License number 5333210478327.
