Scarcity prevents patients from undergoing chemotherapy in the USA – 12/23/2023 – Health

Stephanie Scanlan found out about the shortage of basic chemotherapy drugs last spring in the scariest way. Two of the three medications normally used to treat his rare bone cancer were in very short supply. She would have to move on without them.

Scanlan, 56, manager of a busy state office in Tallahassee, Florida, had sought the drugs for months as the cancer spread from his wrist to his rib and spine. By the summer, it became clear that his left wrist and hand would need to be amputated.

“I’m scared to death,” she said as she faced surgery. “This is America. Why are we having to choose who to save?”

This year’s disruption in the supply of key chemotherapy drugs confirmed the worst fears of patients — and the broader U.S. health care system — because some people with aggressive cancers were unable to get the treatment they needed.

These drugs and hundreds of other generic medications, including amoxicillin to treat infections and fentanyl to ease pain during surgery, remain in short supply. But the deepening crisis has not generated solutions to improve the delivery of generic medicines, which represent 90% of prescriptions in the United States.

Robert Califf, commissioner of the FDA (the agency that regulates drugs and foods in the country) outlined changes that the agency could make to improve the situation. But he said the root of the problem “is due to economic factors that we do not control.”

“They are beyond the scope of the FDA,” he said.

In interviews, more than a dozen current and former executives affiliated with the generic drug industry described many risks that discourage a company from increasing production that could alleviate shortages.

They said prices were so low that making life-saving drugs could result in bankruptcy. It’s a system in which more than 200 generic drug manufacturers compete for contracts with three intermediary companies that guard the door for a large number of customers.

In some cases, generic drug manufacturers offer very low prices to outbid competitors for coveted deals. In other situations, intermediaries — called group purchasing organizations — demand lower prices within days of signing a contract with a drug manufacturer.

The downward pressure on prices — undoubtedly often a benefit to patients’ and taxpayers’ pockets — is intense. Group buyers compete with each other to offer hospitals the lowest-priced products, which intermediary companies say also benefits consumers. They receive fees from drug manufacturers based on the amount of drugs hospitals purchase.

“The business model is broken,” said George Zorich, a retired pharmacist and former generic drug industry executive. “It’s great for group purchasing organizations. It’s not great for drug manufacturers, it’s not great for patients in some cases.”

In a speech to drug supply intermediaries last month, Califf urged them to “pay more,” saying it would improve access to medical products and be “good for business.”

Prices have dropped in recent years for two of the three drugs Scanlan initially received to treat his cancer. During those years, Intas Pharmaceuticals, a generics giant in India, steadily gained market share as other companies exited, according to data from the United States Pharmacopeia, a nonprofit organization that tracks drug shortages.

But the company had to halt production in the U.S. to deal with quality issues that the FDA cited following a surprise inspection at one of its massive factories in India. Inspectors discovered quality control employees tearing up and throwing acid at important records. The production shutdown caused a supply shock in February that would be felt across the country.

Intas recently resumed production, but the FDA still lists the drugs as being in short supply. Large cancer centers report that shortages are decreasing, although there are lingering concerns about supplies in rural areas.

The scarce drugs are cheap and essential and revolutionized their field decades ago, curing some patients with testicular, lung, ovarian, pancreatic and breast cancer for the first time, oncologists say.

Scanlan’s cancer, called osteosarcoma, was considered curable for about 65% of patients after cisplatin was added to the cocktail regimen in the 1970s.

Not ‘a first world nation’

Julie Gralow, chief medical officer for the American Society of Clinical Oncology, discovered signs of stockpiling at some health systems as early as February, when the FDA first announced shortages, while shelves were empty at other health centers.

“We’re calling this maldistribution based on who has access — who can afford to create a small inventory at their location,” Gralow said.

The emotional impact has varied widely. Some people with cancer were so focused on paying the rent or feeding the family that they didn’t fight for the medications they desperately needed, said Danielle Saff, a social worker at CancerCare, a nonprofit that supports patients. Others, including Lucia Buttaro, 60, professor at Fordham University, were furious. She did not receive her carboplatin prescription for a recurrence of ovarian cancer in May or June, even though the cancer had spread to her lungs.

“In my opinion, we don’t qualify as a first world nation if you can’t get what you need,” she said.

In Scanlan’s case in Florida, because her cancer was rare, invasive and advanced quickly, it remains unclear whether scarcity played a role.

Still, cancer experts have expressed concerns that she had not received standard chemotherapy cocktail regimens before her amputation in September.

The lack of use of the three generic “modern miracle” chemotherapy drugs for osteosarcoma patients “is a real problem,” said Lee Cranmer, a sarcoma specialist at Fred Hutch Cancer Center in Seattle who was not involved in Scanlan’s treatment.

She has since received radiotherapy. Last month, she discovered that the cancer already in her rib and spine had not spread further. Although her new care team at Moffitt Cancer Center in Tampa, Florida, recently recommended palliative care, she said she felt defeated and terrified.

The shortage has had an impact, she said, adding, “I can’t help but think what would have happened if something different had happened from the beginning.”

This article was originally published in The New York Times.