Get rid of this obstacle to developing revolutionary drugs that made me cancer-free | Opinion

Cancer is the leading cause of death for Hispanic Americans, responsible for one-fifth of all deaths, according to the American Cancer Society. Roughly 50,000 Hispanic men and women die of cancer every year.

As a Latina and a cancer survivor myself, I want to see cancer deaths in our community go down in the decades ahead. Unfortunately, a seemingly minor provision in last year’s Inflation Reduction Act could make it much more difficult to achieve that goal — by preventing revolutionary cancer drugs from ever reaching patients.

Here’s my story. In July 2017, I was diagnosed with large B-cell lymphoma, a deadly and fast-moving blood cancer. After several courses of chemotherapy, I went into remission later that year.

In the following years, my cancer returned not once, but twice. Thanks to more chemotherapy, bone marrow transplants and a breakthrough cancer treatment known as CAR T-cell therapy, I am beyond grateful to say I’ve been cancer-free for more than three years.

We should be working together to make success stories like mine commonplace. But the IRA discourages companies from investing in the research and development required to end cancer as we know it.

The legislation empowers Medicare to lower certain drug prices through negotiation and penalties. The problem is that the new law doesn’t treat all types of drugs the same way.

The research community distinguishes between small-molecule drugs, which are typically pills, and large-molecule or biologic drugs, which are made from living cells and usually administered intravenously or via injection in clinics. Both are essential to modern medicine, but small-molecule drugs are often cheaper and more convenient for patients.

Both types of drugs are exempt from price negotiations for a set period following Food and Drug Administration approval, which gives companies and their investors time to recoup what they’ve spent on research and development. But while biologics are exempt for 13 years, small-molecule drugs are exempt for just nine.

There’s no medical basis for that four-year gap, but it makes an enormous financial difference for drug developers. An analysis by the investment bank Jefferies found that over the first 13 years after launching a new medicine, about half of sales occur between years 10 and 13. That makes those last few years crucial. Without them, drugmakers may conclude they don’t have time to earn a return, and opt out of certain research altogether.

Indeed, since the IRA passed in 2022, dozens of drug companies have expressed concern that the new rules may shift pipeline priorities.

This is a problem for the cancer patients, for whom small-molecule drugs can be critical treatment options. Many of the conventional cancer treatments we have today are biologics, and have to be administered via injection or infusion sessions in hospitals or clinics. Small-molecule drugs, by contrast, can typically be taken as pills or tablets conveniently at home.

In many respects, small-molecule drugs represent the cutting edge of cancer care. Because of their large molecular size, traditional biologic therapies can impact both healthy and tumor cells, leading to unwanted — and sometimes excruciating — side effects for patients. But small-molecule therapies are capable of traveling inside diseased cells, directly targeting the underlying cause of cancer with minimal collateral damage.

We need more innovative treatments, yet cancer drugs are especially vulnerable to the impact of IRA price negotiations. Clinical trials for cancer therapies often take much longer than for other illnesses, which can make the development process more expensive and risky. In addition, cancer researchers often have trouble recruiting enough participants for trials.

The IRA as currently written creates yet another obstacle to development. Many life sciences companies could be forced to put small-molecule cancer therapies on ice because of the IRA. Every one of these paused drug development projects could translate to hundreds of lives being cut tragically short.

Hispanic Americans already face obstacles to getting high-quality health care. Nationwide, some 28% of Latino adults between ages 18 and 64 lack health insurance — the highest rate for any racial or ethnic group in the nation. Our communities should not have to face a slowdown in finding cures for our leading cause of death.

Thankfully, it would be relatively easy to implement a solution. Lawmakers could update the IRA to get rid of the small-molecule penalty, instead making all drugs exempt from price negotiations for 13 years. This would restore incentives to pursue much-needed cancer research.

In addition to beating lymphoma myself, I’ve seen too many friends suffer from cancer. The last thing Hispanic patients need is a new barrier to good health.

This story was originally published December 15, 2023 at 7:32 AM with the headline "Get rid of this obstacle to developing revolutionary drugs that made me cancer-free | Opinion."