Opinion: Cancer patients should never be put in this situation

Editor’s Note: Dr. Eric Winer is the Director of the Yale Cancer Center and Physician-in-Chief of Smilow Cancer Hospital. He was president of the American Society of Clinical Oncology (ASCO) in 2022-2023 and is now chair of the Board of ASCO.  The views expressed here are his own. Read more opinion on CNN.

Unprecedented drug shortages are pushing hospitals and clinics around the country to the brink. Physicians are being forced to choose who can receive the recommended treatment for their illness — and who must wait.

The drug supply in the US is more vulnerable than ever and, ironically, it is often the least expensive generic drugs that are most impacted. Clinicians must work together with policymakers to ensure that the drug shortages are reversed and the health of our patients is protected.

In the second quarter of 2023, 309 prescription medicines were in short supply across the US, according to the University of Utah Drug Information Service. This represents a substantial increase over the last five years — in quarter two of 2018, there were about 224 active shortages. Alarmed by the potential risk this poses to patients, public health and even our national security, stakeholders from across the oncology community are working to identify both crisis and long-term solutions to this chronic and worsening problem.

Cancer specialists, like me, are particularly worried about the 14 cancer drugs currently in short supply. Cancer drug shortages force doctors to make difficult decisions: Should we reduce the doses that we administer to individual patients so we can treat as many people as possible, or should we turn to alternate treatments?

Reducing doses of chemotherapy or other anti-cancer therapies could compromise patients’ results and, in some cases, even shorten a patient’s life. On the other hand, substituting another drug might also lead to an inferior outcome, and could also lead to more side effects. Simply delaying therapy would almost certainly result in harm.

I have been an oncologist specializing in breast cancer for over 30 years. I know firsthand, from having cared for thousands of patients, that a diagnosis of breast cancer is frightening, challenging and truly one of the most difficult experiences most people have faced.

Women, and occasionally men, are forced to deal with affronts to their body image, treatments that impair quality of life, worries about cancer recurrence and the fear that their lives will be cut short. As oncologists, we try to form partnerships with patients, and we do our best to understand every patient’s unique circumstances.

Today, an increasing number of individuals with breast cancer in the US are cured, as are many patients with other types of cancer. Survival rates have improved substantially because of earlier diagnosis and more effective treatment. But if patients are to benefit from improved treatment, they need to have access to that therapy. The drug shortages pose a threat to the improvements that we have made in cancer outcomes.

When oncologists tell their patients that the standard, and usually best, therapy is unavailable, the conversation quickly becomes both challenging and heart-wrenching. The reactions can vary quite dramatically. Some patients are angry, and that anger can be directed toward the doctor, the health care system or even the government for failing to protect them.

Others are simply terrified, overwhelmed by the fear that their lives will be shortened as a consequence of the shortages. Finally, some may just become withdrawn and depressed, believing that this new challenge is another part of nightmare they have been living through since their day of diagnosis. No matter what the reaction, the discussion can strain the doctor-patient relationship and adds to the burden of coping with a cancer diagnosis.

This crisis affects all patients with cancer, but its impact is particularly hard on children with cancer. Between 2010 and 2020, 8 of the 10 most frequently used drugs to treat acute lymphoblastic leukemia — the most common childhood cancer — were, at some point, temporarily unavailable. We do not know the full extent to which this has impaired our ability to cure children with cancer.

Current drugs in shortage include the chemotherapy agent carboplatin, considered an important option for treating breast, ovarian, lung, head and neck and other cancers. Another scarce medicine, fludarabine, treats several types of leukemia and lymphoma. It has been on the FDA’s drug shortage list since 2020, and many American cancer centers have completely run out.

Regulators and legislators must act urgently to alleviate these shortages and develop long-term solutions. Part of the challenge is that they stem from multiple causes, including lack of availability of raw ingredients, quality issues in plants which are largely located outside of the US, regulatory barriers and global emergencies that lead to supply-chain disruptions.

To prevent these shortages, US regulators should expand on the existing essential medicines list to create a more comprehensive list of critical drugs — both for cancer and other conditions — needed for emergency responses and saving lives. Every drug on the list should be evaluated for availability, quality, manufacturer reliability and potential weaknesses in the supply chain.

The list of drugs should be used as a starting point to coordinate access to drugs in anticipation of natural disasters, public health crises and other unforeseen events. In the same vein, the government should consider establishing and maintaining a buffer supply of critical drugs, which would help avert shortages. Manufacturers, the FDA, the Administration for Strategic Preparedness and Response and other government agencies would all have to work together.

Drug shortages are acute today in the US, but the drug manufacturing and supply chain is global. Assuring consistent access to life-saving drugs will require the international community to work together to achieve a regulatory and manufacturing environment that incentivizes production of high-quality drugs and allows quick response when production is jeopardized by global events.

To be sure, these aren’t quick fixes, but drug shortages did not come about overnight. The lack of critical medicines available to cancer patients is a disgrace and is emblematic of a system gone awry.

We need the government and manufacturers to do everything they can.  And we can never forget about the patient who is in desperate need of therapy that can save their life.  If we put the patient first, we have no choice but to act in all due haste.

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