Breaking News: Cancer Drug Shortage in U.S. Leads to Life-Saving Treatment Rationing by Doctors!

A severe shortage of cancer therapies is forcing thousands of patients to miss out on life-saving treatments, several leading health organizations have warned.

There are 14 oncology drugs listed as “shortage” by US regulators, including the generic chemotherapy drugs cisplatin and carboplatin, which are first-line treatments for many common types of cancer.

Julie Gralow, chief medical officer of the American Society of Clinical Oncology, said hospitals were already rationing some drugs and doctors were being forced to make tough decisions about postponing chemotherapy treatment or using substitute drugs , which may not be as effective.

“The concern here, of course, on the part of patients and their clinicians is, ‘are we sure this [substitute drug] is just as effective? Are we potentially in any way reducing the chances of recovery? I don’t think we have hard data on that, but it’s a serious concern. »

Gralow said the crisis was particularly acute due to the widespread use of chemotherapy drugs. Between 100,000 and 500,000 patients could be affected by shortages of cisplatin and carboplatin, underscoring the urgent need for policymakers to strengthen supply chains, she said.

Drug shortages are not new. But experts warn that a growing reliance on offshore manufacturing, growing demand, market consolidation and price pressure have made the United States particularly vulnerable.

There were 301 drugs across all therapy areas listed as “shortage” at the end of March, the highest number in nearly a decade, according to the American Society of Health-System Pharmacists.

The Society of Gynecologic Oncology, which is conducting a survey to determine the extent of the crisis, said initial results revealed shortages of key cancer drugs in 40 US states.

“This is a public health crisis. We have never seen a shortage like this,” said Angeles Alvarez Secord, president of the company.

Some newly developed oncology treatments, such as Novartis’ Pluvicto prostate cancer treatment, are in short supply. The company stopped taking new patients in February following quality control issues reported by the U.S. Food and Drug Administration at two manufacturing sites.

But supply chain experts say generic drugs, which require complex manufacturing processes to manufacture and which tend to be sold at very low prices, are the most vulnerable to shortages. They represent 90% of all drugs sold in the United States, but only 18% of all drug costs, according to a March report report by the Senate Committee on Homeland Security and Governmental Affairs.

“We need to rethink the whole generics market, where most of the shortages are,” said Laura Bray, founder of Angels for Change, a nonprofit group that advocates for action to end drug shortages.

She said the generics industry had become a race to the bottom on prices that made quality control more difficult, especially for complex drugs such as chemotherapy drugs. When only a handful of companies supply a drug, a single event can cause the kind of “perfect storm,” which occurs with chemotherapy drugs, Bray said.

Most generic manufacturers rely on active pharmaceutical ingredients produced in low-cost countries, mainly China and India, to manufacture drugs.

The cisplatin shortage is linked to quality control issues at an Indian factory run by Intas Pharmaceuticals, which supplies around half of the US’s total supply of the chemotherapy drug. The company ceased production of cisplatin and carboplatin destined for the United States following an FDA inspection in December, which detailed a “cascade of failures” in its quality control unit.

Intas and its U.S. subsidiary Accord Healthcare said they were working with the FDA on a plan to return to manufacturing.

Oncologists say they had more difficulty getting supplies of these two chemotherapy drugs soon after Intas’ production was suspended.

“In late April and May, for patients with newly diagnosed ovarian cancer, I had to do drug substitutions because we didn’t have the kind of first-line drugs available,” Jennifer said. Rubatt, an oncology specialist in Denver, Colorado.

She said patients have reported more serious side effects when using the replacement drugs, rather than the platinum-based chemotherapy drugs cisplatin and carboplatin.

A cancer patient who lives in Sacramento, Calif., told the Financial Times that he was taken off cisplatin in April because his condition was not deemed curable by his healthcare provider, Kaiser Permanente.

“Cisplatin is now under a protocol reserved for curable cancers. And since mine is not curable, it’s not something I’m qualified for at the moment,” said Michael Griffith, a 51-year-old father of three.

He said that when he previously took cisplatin, his oncologist told him that the cancerous tumors in the bile ducts of his liver appeared to be “locked up”. But a recent CT scan suggested his tumor had grown slightly since he stopped the chemotherapy drug, Griffith said.

Griffith’s healthcare provider, Kaiser Permanente, said he could not comment on individual cases, but acknowledged that whenever there is a nationwide shortage of a drug, affected patients “may feeling anxious”.

“Our doctors and pharmacists work with their patients to ensure their treatment plan is as effective as possible and to identify alternative treatments if needed,” he added.

The scale of the shortage of anti-cancer drugs prompts the authorities to consider short-term solutions. The FDA is considering allowing the importation of chemotherapy drugs from foreign manufacturers that are not currently licensed for distribution in the United States on a temporary basis.

But health experts and the generics industry say fundamental reforms are needed to encourage manufacturers to stay in the market to strengthen supply chains. The April closure of a major U.S. generics company Akorn Pharmaceuticals and Teva Pharmaceuticals’ decision last month to reduce its generics portfolio highlight the extreme pressure the industry is under, they say.

“A common thread here is pricing and vulnerability. Typically what you see are market forces driving prices down, which is great for patients and everyone involved except manufacturers. said Craig Burton, senior vice president of policy and alliances at the Association for Accessible Medicines.

When there were only one or two manufacturers left in a market for a drug, if something happened you would be at greater risk of a shortage, he said.

A Senate hearing on the drug shortage crisis in March discussed the possibility of providing tax incentives to encourage investment in more U.S.-based production or mandating stockpiling of essential drugs.

Burton said consolidation in the drug procurement market has allowed wholesale buyers to squeeze prices from manufacturers in the retail and hospital market.

Three major buying groups – Red Oak Sourcing, Walgreens Boots Alliance Development and ClarusOne, which includes Walmart and McKeeson – control about 90% of the prescription retail market. The market for supplying generics to hospitals is just as concentrated.

For cancer patients like Griffith, who fear their lives will be cut short because they don’t have access to standard chemotherapy drugs, change can’t come soon enough.

“It runs through my head every day. I just don’t know why the country or some association or the FDA wouldn’t step in for the greater good?” says Griffith.