A critical shortage of cancer therapies is forcing thousands of patients to lose life-saving treatments, several major health organizations have warned.
There are 14 cancer drugs listed in 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 at the American Society of Clinical Oncology, said hospitals were already rationing some drugs and doctors were being forced to make difficult decisions about delaying chemotherapy treatment or using replacement medicines, which may not be equally effective.
The concern there, of course, from patients and their doctors is: are we sure of that [substitute drug] is it equally effective? Are we potentially reducing the chances of a cure in any way? I don’t think we have solid data on this, but this is 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 cisplatin and carboplatin shortages, highlighting the urgent need for policymakers to strengthen supply chains, she said.
Drug shortages are nothing new. But experts warn that growing reliance on offshore production, rising demand, market consolidation and price pressures have made the United States particularly vulnerable.
There were 301 drugs in all therapy areas listed as deficient at the end of March, which is the most 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 findings found shortages of key cancer drugs in 40 US states.
This is a public health crisis. We’ve never seen a shortage like this, said Angeles Alvarez Secord, the company’s president.
Some newly developed cancer treatments, such as Novartis’ Pluvicto prostate cancer therapy, are lacking. The company stopped taking on 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 generics, which require complex manufacturing processes and yet tend to be sold at very low prices, are the most vulnerable to shortages. They make up 90 percent of all drugs sold in the United States but only 18 percent of all drug costs, according to a March report by the Senate Committee on Homeland Security and Governmental Affairs.
We need to rethink the whole generic drug market, which is where most of the shortages are, said Laura Bray, founder of Angels for Change, a non-profit group advocating action to end drug shortages .
He said the generics industry has become a race to the bottom on price which has made quality control more difficult, particularly for complex drugs such as chemotherapy drugs. When only a handful of companies supply a medicine, a single event can cause the kind of perfect storm event, which is happening with chemotherapy drugs, Bray said.
Most generic companies rely on active pharmaceutical ingredients produced in low-cost countries, mainly China and India, to make drugs.
The cisplatin shortage is linked to quality control issues at a factory in India operated by Intas Pharmaceuticals, which supplies about half of the entire US supply of the chemotherapy drug. The company ceased production of cisplatin and carboplatin destined for the United States following an inspection by the FDA in December that described a cascade of failures in its quality control unit.
Intas and its U.S. subsidiary Accord Healthcare said they are working with the FDA on a plan to return to production.
The oncologists say they have found it more difficult to obtain supplies of both chemotherapy drugs soon after production of Intas has been halted.
Patients with newly diagnosed ovarian cancer had to switch medications in late April and May because we didn’t have the kind of first-line drugs available, said Jennifer Rubatt, an oncology specialist in Denver, Colorado.
He said patients reported more serious side effects when they used the replacement drugs, rather than the platinum-based chemotherapy drugs cisplatin and carboplatin.
A cancer patient living in Sacramento, California, told the Financial Times he was taken off cisplatinum in April because his condition was not deemed curable by his doctor, Kaiser Permanente.
Cisplatin is now under protocol reserved for curable cancers. And because mine isn’t curable, it’s not something I qualify for at the moment, said Michael Griffith, a 51-year-old father of three.
He said when he was previously taking cisplatin, his oncologist told him the cancerous tumors in his liver’s bile ducts seemed blocked. But a recent CT scan suggested his tumor had grown slightly since he was taken off the chemotherapy drug, Griffith said.
Griffith’s healthcare worker, Kaiser Permanente, said he could not comment on individual cases, but acknowledged that whenever there is a national shortage of a drug, affected patients can feel anxious.
Our doctors and pharmacists are working with their patients to ensure their treatment plan is as effective as possible and to identify alternative treatments when needed, he added.
The scale of the cancer drug shortage is prompting authorities to consider short-term solutions. The FDA is considering allowing the import of chemotherapy drugs from foreign manufacturers that are not currently approved for distribution in the United States on a temporary basis.
But health experts and the generics industry say key reforms are needed to encourage manufacturers to stay in the market to strengthen supply chains. The April closure of a major US generics company Akorn Pharmaceuticals and Teva Pharmaceuticals’ decision last month to cut its generics portfolio highlight the extreme pressure the industry is under, they said.
A consistent thread here is price 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 policies and alliances at the Association for Accessible Medicines.
When only one or two manufacturers remained on the market for a drug, then if something happened there was a greater risk of shortages, he said.
A Senate hearing on the drug shortage crisis in March raised the prospect of providing tax incentives to encourage investment in more US-based manufacturing or mandate stockpiling of essential medicines.
Burton said consolidation in the drug procurement market has allowed wholesale buyers to squeeze manufacturers on price in both the retail and hospital markets.
Big three buying groups Red Oak Sourcing, Walgreens Boots Alliance Development and ClarusOne, which includes Walmart and McKesson, control about 90% of the retail prescription market. The market for the supply of generic medicines to hospitals is similarly concentrated.
For cancer patients like Griffith, who fear their lives could be shortened because they can’t access standard chemotherapy drugs, change can’t come soon enough.
This weighs on my mind every day. I just don’t know why the country, a corporation or the FDA wouldn’t have stepped in for the greater good? Griffith said.
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