Crisis of Insufficient $15 Cancer Drug Supply Disrupts Treatment Landscape

This spring, Tony Shepard discovered he had vocal cord cancer, but he was hopeful after learning that chemotherapy and radiation may heal him.

The cancer clinic he regularly visits in Central California has intermittently ran out of the life-sustaining drug he requires, casting a shadow over his prognosis in recent weeks.

Every treatment since Mr. Shepard’s doctor told him about the scarcity has felt like “Russian roulette,” he said, since he knows that if it doesn’t work, his vocal chords will be removed and his voice would be gone forever.

Because of the nationwide lack of highly effective cancer medications, patients and their physicians are facing even more bleak realities than disease already brings. Thousands of patients like Mr. Shepard have been facing heartbreaking choices, treatment delays, and uncertain prognoses.

The replacements to two essential chemotherapy medications are less effective and, in some cases, more hazardous than the originals, raising serious concerns among oncologists. Patients with ovarian, testicular, breast, lung, and head and neck cancers, they argue, have especially bleak prognosis due to the absence of backup therapy.

The scarcity shows no indications of ending any time soon. The stockpile of the most popular pharmaceuticals has been depleted since a factory that was a major manufacturer of them closed late last year and has not restarted. While this month’s loosening of limits on Chinese medication imports has been helpful, physicians say it hasn’t made a significant dent in the shortage. Companies providing these pharmaceuticals predict that the shortfall will last far into the autumn.

Experts convened by the Biden administration and leading medical groups have not yet discovered a solution to the problem of limiting access to life-saving chemo medicines.

Some physicians are increasing the time between visits and skimming the surface of valuable millilitres to prolong dosages in order to make ends meet. Some patients are choosing to wait for supplies to return before undergoing treatment, while others are opting for surgery first.

The American Society of Clinical Oncology, one of the nation’s premier cancer treatment organisations, has just issued guidelines recommending that physicians with limited supplies of the drugs provide them to patients who have a reasonable chance of being cured, while denying them to those whose cancer has returned or expanded.

Cisplatin and carboplatin are two of the most often used chemotherapy treatments in combination with other medicines to reduce or eradicate tumours. Antibiotics and other sterile injectable fluids are among the hundreds of treatments that are officially in short supply, and so are more than a dozen cancer therapies. However, specialists fear that patients will suffer the most from the lack of potent chemotherapies.

According to the U.S. Pharmacopoeia, a non-profit that works to ensure the quality and availability of medicines, the cost of a vial of cisplatin or carboplatin is only $15 or $23. To produce the medications safely, however, a sterile facility and other safeguards are needed to protect employees from the pharmaceuticals’ hazardous effects. Therefore, only few manufacturers provide them.

Intas Pharmaceuticals, a major producer, halted manufacturing in December following a surprise inspection by the FDA at its factory in Ahmedabad, India, causing a scarcity of these commonly used medications. As per study shared by a U.S. government agency, workers at the facility experienced a “cascade of failure” that included the destruction of quality control documents by being shredded, torn apart, and doused with acid.

Accord Healthcare, a division of the parent firm, has lately said that it is still making the necessary upgrades to the factory in order to resume production.

The impacts of the Intas closure were significant by this spring. Ninety-three percent of the 27 centres responding to a survey of academic treatment centres conducted by the National Comprehensive Cancer Network and published earlier this month reported a carboplatin scarcity. As a consequence, 36% of doctors said they were modifying their patients’ therapy, often by giving them fewer treatments or spacing them farther apart.

Despite attempts to extend supplies, access has been spotty at the cCare Cancer Centre in Fresno, California, where Mr. Shepard is covered help of the vocal. Dr. Ravi Rao, an oncologist, stated that for the last six weeks, almost half of the time, vials of the platinum medications have been unavailable.

Without the medication, he warned, Mr. Shepard’s chance of recovery would drop from 90% to 45%. Mr. Shepard noted that the medications needed for the first two of seven courses of therapy are now accessible.

Ovarian cancer patients have the poorest prognosis, according to Dr. Rao, since the illness is so prevalent and platinum medications have been so essential in treating it for decades. One patient with advanced ovarian cancer would have less than 10% chance of life without such medications, he added.

Dr. Karen Knudsen, CEO of the American Cancer Society, has said that immediate action is required. The White House and Congress have addressed the issue, but they have offered few answers.