I'm a cancer doctor. The Biden administration is putting drugs my patients rely on at risk.

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As a physician who specializes in treating myeloma, I worry that the Biden administration may soon inadvertently snuff out new therapies for myeloma and cancer in general.

I like the fact that the Inflation Reduction Act paves the way to limit copays for patients with cancer, but I worry about the long-term effects on medical innovation.

The Centers for Medicare & Medicaid Services – the agency that oversees the government’s two largest insurance programs – is deciding how to implement this legislation, which directs the agency to “negotiate” lower prices for many common drugs.

It gives officials relatively wide latitude in determining which drugs to select for the negotiation program, and how aggressively to negotiate.

But the agency’s recent guidance is concerning, because it seems likely to discourage critical “follow-up” innovation, the important research that takes place after a drug is first approved.

Research continues, years after approval

The guidance suggests that the government will effectively dissuade companies from looking for new uses of a medication that is already approved, even if those discoveries necessitated years of expensive and risky research. 

Clinical researchers regularly conduct more clinical trials long after a medicine has received approval from the Food and Drug Administration. This research can help uncover additional benefits for patients.

For example, follow-up research can reveal that a medicine approved to treat a disease in a specific phase can also treat the same disease in other phases, as we have seen many times in the field of myeloma.

Other times, we discover that a drug intended for one illness can treat one or more entirely different conditions. In my experience, subsequent uses for cancer drugs are just as important – if not even more important – than the initial ones.

Imposing price controls so early in the life cycle of a new medicine will make it harder to fund this post-approval research.

This could result in doctors having less rigorous evidence regarding other possible uses of such drugs. This will slow the pace of progress in our fight against cancer. 

Legislation threatens critical cancer drugs

The Inflation Reduction Act provisions also threaten cancer research more generally, by discriminating against conventional “small-molecule” medications in favor of large-molecule “biologic” treatments.

My daughter has cystic fibrosis. Democrats made it harder to get the medicine she needs.

The law subjects new small-molecule drugs to price setting after just nine years, while biologic medications are exempt from price setting for 13 years following regulatory approval.

This will inevitably steer investment dollars away from important small-molecule research. 

Small-molecule medications can usually be taken in pill form in the comfort of one’s home. This enables individuals to bypass the time and costs associated with visiting hospitals or clinics, where biologic medicines often have to be administered under the supervision of trained (and expensive) professionals.

The fact that small-molecules are easier to administer makes them valuable options for rural, economically disadvantaged and minority populations.

Unlike conventional chemotherapy, small-molecule drugs also are able to target particular proteins or genes within cancer cells, avoiding harmful spillover into normal, healthy cells.

This can mean fewer side effects for patients. 

This could cost us more, hurt patient health

Since becoming a physician, I've seen firsthand how new therapies have transformed the prognosis for myeloma.

Thirty years ago, patients with myeloma survived for a median of two years following diagnosis. Today, a myeloma patient can expect to live for more than eight years after diagnosis.

Thanks to the revolutionary therapies now available, some patients can be cured of the disease completely. 

These drugs don’t merely save lives – they also save society money by reducing hospitalizations, surgeries and other complications.

Without a more rigorous attempt to lessen the negative consequences of the Inflation Reduction Act, the impacts on future biopharmaceutical innovation – and thus, patient health – could be catastrophic.

And the worst part is that we will not know what we are missing.

Rafael Fonseca, M.D., an Arizona-based physician, has served as a consultant to pharmaceutical companies. This column first published at The Arizona Republic. On Twitter: @Rfonsi1