Cancer Drug Breakthroughs Threatened

In my last blog post, I discussed the real cost of lowering drug prices by government price controls. (The Real Cost of Lowering Drug Prices) The Biden Administration just passed the misnamed Inflation Reduction Act of 2022, which includes giving the Centers for Medicare and Medicaid Services (CMS) new powers to negotiate with pharmaceutical companies on drug prices. While some are touting this legislation as a boon to seniors because it may lower drug prices in the short run, the larger issue is its impact on the development of life-saving new drugs – which impact seniors more than anyone.

A real-life example of this impact is reported by The Wall Street Journal editorial board today. President Biden gave a speech promoting his “Cancer Moonshot” initiative and a new government health agency that he says will drive treatment breakthroughs. But the reality is his new drug policy will actually make such breakthroughs less likely, not more.

The perfect example is a new drug for treating lung cancer called Lumakras, produced by Amgen pharmaceutical company. How important is treating lung cancer? Lung cancer kills more Americans than any other cancer. The five-year survival rate is only 18.6% for newly diagnosed cancers and a mere 5% for advanced forms. While treatment advances targeting particular protein or gene mutations have improved survival odds for breast, melanoma and some other cancers, lung cancer progress has been far slower. Many cancers driven by a mutation in the KRAS gene have eluded breakthroughs and lung cancer is one of them.

The KRAS gene regulates cell growth and division and mutations are found in many tumors, including 32% of lung and 90% of pancreatic cancers. Yet the KRAS protein has long been considered “undruggable’ because its small size and smooth surface are difficult for drug molecules to block. Amgen’s Lumakras pill proves it can be done.

How successful is Lumakras is treating lung cancer?

The Food and Drug Administration approved Lumakras last May under its accelerated approval pathway for patients with advanced non-small cell lung cancer bearing a particular KRAS gene mutation. Results from early trials showed promise and this week were borne out by a late-stage trial that showed more than twice as many patients responded to the drug than they did to chemotherapy.

Only 10% of patients receiving chemotherapy lived at least a year without their cancer getting worse compared to 25% receiving Lumakras. Survival benefits were hard to assess since a third of the chemotherapy patients received Lumakras only after their disease progressed. Amgen also announced results from a separate small trial this week showing Lumakras may help patients with metastatic colorectal cancer.

This is not to suggest that this drug is a cure for lung cancer, but it is evidence of progress. Progress occurs at the margin and some patients who had what amounted to a death sentence how have hope to live. Lumakras is also much less brutal than chemotherapy. Yet the WSJ editors say the drug might not have been developed at all had the Medicare take-it-or-leave-it negotiations that Democrats recently enacted been in effect earlier. Their price controls will penalize in particular small molecule drugs like Lumakras that have the potential to help large numbers of patients. Within six years, Lumakras could be targeted by bureaucrats for price controls and the payoff on Amgen’s invested billions could vanish.

All of this is in stark contrast to President Biden’s stated desire to promote faster cancer cures. The old saying is “talk is cheap,” but not so much when people’s lives are at stake. Biden is trading life expectancy in the long run for political points in the short run. That’s a dangerous game to play.

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