Shortfall of chemotherapy drugs hits Connecticut
Shortages ‘putting thousands of people at risk’ in state, health experts say
National shortages of two generic brands of chemotherapy used to treat a variety of cancers could impact thousands of patients in Connecticut as oncologists struggle to deal with the shortfall and even consider prescribing drugs that may not be as effective, health officials said.
The U.S. Food & Drug Administration reported the shortage of carboplatin in April and cisplatin in February.
At one point, the Hartford HealthCare Cancer Institute only had a two-day supply left of carboplatin, a chemotherapy drug used to treat lung cancer, gynecological cancers, two of the most aggressive forms of breast cancer — HER2 positive and triple negative breast cancer — and others, according to Dr. Peter Yu, physician-in-chief of the institute.
“In our conversations with oncologists at Memorial Sloan Kettering, Mayo Clinic and across Connecticut, shortages of cancer drugs is a shared problem,” Yu said. “Because generic drugs have been in use for a long time by the time the patent expires, these drugs are widely used to treat many types of cancers and the impact of the shortage is on many patients with cancer.”
The Hartford HealthCare supply has since rebounded, but Yu considers the shortages an ongoing problem that could put existing and future cancer patients in jeopardy.
“This affects all of the patients who potentially have cancer in Connecticut,” Yu said. “At Hartford HealthCare, we see about 7,000 patients with cancer a year. There’s probably 30,000 people a year in Connecticut who need treatment for cancer. Not all of them need chemotherapy, but clearly this is putting thousands of people at risk.”
Across the country, health care providers are facing the same dilemma.
“We’re basically going day by day,” said Dr. Eleonora Teplinsky, head of Breast and Gynecological Medical Oncology at Valley Health System in Paramus, N.J. “We have it this week, but it’s not guaranteed that it will stay that way. I’ll have to talk to my patients and say I know we have enough for this round, but I don’t know about the next round.”
The shortages of the drugs have become so acute that U.S. Rep. Frank Pallone Jr., D-N.J., the ranking member of the Energy and Commerce Committee, issued a statement Thursday, saying committee staff members are working with the Biden administration and the U.S. Food and Drug Administration to get the drugs back in circulation and find solutions to future shortfalls.
“It is both heartbreaking and unacceptable that patients are experiencing delays in access to the lifesaving cancer medications carboplatin and cisplatin due to supply shortages,” Pallone said in the statement.
The push to get the drugs in the hands of U.S. health care providers will include expediting review of new manufacturing lines, facilities and ingredient suppliers, and finding ways to temporarily import the chemotherapies so patients can get their treatments on time, Pallone said.
The drugs are often manufactured overseas as generic since their patents have expired, which immediately drops the price and the profit margin, officials said.
“In one of the wealthiest nations on earth, there should be no reason doctors are forced to ration lifesaving medical care to compensate for a shortage of prescription drugs and other medical supplies,” U.S. Rep. Rosa DeLauro, D-Conn., said in a statement. “The shortage of vital chemotherapy drugs
unveils a disturbing trend across the U.S. economy. We are unable to compensate for these shortages because domestic manufacturing is virtually nonexistent because of outsourcing — all allegedly in the name of lower prices.”
At the Yale New Haven Health system, which includes five hospitals and various satellite practices throughout Connecticut, a mitigation plan has been discussed in case the shortages become so acute that choices in care have to be made, said Sam Abdelghany, executive director of Oncology Pharmacy for Yale.
“As a mitigation strategy, we have to consider whether the drug is curative or for a patient with metastatic disease, (which can’t be cured),”Abdelghany said. “We also have to consider patients who don’t have any other options.”
The shortages of cisplatin, also used as standard chemotherapy treatment for a variety of cancers, can be traced to a recent halt in production of the drug by Intas Pharmaceuticals and its American subsidiary Accord Healthcare, according to a spokesperson for the FDA.
Accord officials did not respond to a request for comment.
The company informed the FDA that it has temporarily stopped production, according
to agency officials. The stoppage occurred after an FDA inspection of an Intas plant in India uncovered several issues, according to agency documents. But the FDA did not require the company to stop production, officials said. Since the company is one of a handful that produces the drug, there is no way to make up the difference to meet the demand in the U.S., FDA officials said.
The same company manufactures carboplatin, which is also in short supply, according to the
FDA. The drug shortage list indicates the medications are on back order in some cases or will released by the end of May. Other companies will not be able to meet the demand until the third or fourth quarter of 2023, the FDA said.
That could be disastrous for patients who may have to wait for treatment or get a replacement drug that is not as effective, said Teplinsky, who is also a clinical assistant professor of medicine at Icahn School of Medical at Mount Sinai in New York.
She is looking into whether a dose can be reduced safely or given in longer intervals or if an adequate substitute can be found, Teplinsky said.
“This can’t be resolved on a case-by-case basis,” she said. “It has to be resolved on a national scale.”
In the past few weeks, Teplinsky has led the charge on social media, asking patients, their families and consumers to write to their U.S. congressional leaders, demanding a long-term fix for the problem.
“This is going to really highlight inequities that are already in the health care system,” Teplinsky said. “Some hospitals will have the drugs and some won’t. Some patients will be able to go someplace else to get them, but some won’t.”
As the impact of the shortages unfold, Benjamin Ryan, an independent health and science writer in New York City, is grateful that he was able to get chemotherapy he needed last year to beat testicular cancer that had spread to the lymph nodes near his kidney.
He was treated with several rounds of cisplatin, finishing in July. As of last week, he is still cancer free, Ryan said.
“If they had said we can’t get this treatment for you, I can’t even tell you the amount of panic I would have been under,” the 44-year-old said. “It’s shocking that in this modern age that we could be subject to supply chain issues. This drug has been on the market for four decades. The thought you can’t get it on demand is unbelievable.”