Feb. 17, 2012 at 8:39 AM ET
An Ohio drugmaker began releasing limited supplies of a crucial medication to treat childhood leukemia Thursday, sending hospital pharmacists facing life-threatening shortages scrambling for their share.
Jerrod Milton, chief of pharmacy at Children’s Hospital of Colorado, was among those first in line as Ben Venue Laboratories began accepting new orders for the drug methotrexate, three weeks before the hospital would have run out completely.
“I had a tip that it was going to be available,” he said. “I put my pharmacy team on notice.”
Ben Venue officials said product would be allocated starting now and continuing over the next several weeks to oncology clinics, hospitals and pediatric facilities, easing the shortage crisis. No information was available about which sites would get the scarce drugs first, or in what order.
Milton is awaiting the arrival Friday of what he hopes will be 300 250-milligram vials of the widely-used drug to treat acute lymphoblastic leukemia, known as A.L.L., a blood cancer that mostly affects young children. It's a virulent cancer of the white blood cells that spreads to other parts of the body.
The drug is short-dated, meaning it is set to expire in two weeks, but Milton is requesting it anyway to replenish vital supplies of the medication that makes A.L.L curable in about 90 percent of cases, cancer doctors say. The amount and timing of the drug used varies widely according to age, weight and other patient factors. The Colorado hospital has dozens of patients on the protocol.
“It extends our supply by essentially up to a month,” said Milton, who is also his hospital’s vice president of operations. “But it’s still a very uncomfortable place to be.”
News this week that hospitals across the country were within a couple weeks of running out of the critical drug prompted herculean negotiations involving the federal Food and Drug Administration and the five manufacturers of methotrexate. The story was first reported in the New York Times.
It also prompted anxiety and anger for parents like Christine Farinick of Fort Mill, S.C., whose 13-year-old daughter, Justine, was diagnosed with A.L.L. a year ago. She has received dozens of treatments of methotrexate and is scheduled for another session in three weeks -- as long doctors can get it.
“Without it, there’s a high rate of relapse,” said Farinick, who is getting a passport and researching ways to obtain methotrexate from suppliers in Europe and Canada if she can’t obtain it in the U.S. “It is available.”
Bedford Laboratories, which runs Ben Venue, worked with the FDA to arrange allocation of strictly limited supplies of the drug. The product was produced before the troubled firm voluntarily shut down its operations in November because of manufacturing and quality problems identified during FDA inspections.
“We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production,” Ben Venue officials said in a statement.
The four other manufacturers of the drug -- Hospira Inc., Mylan Institutional, Sandoz and APP Pharmaceuticals LLC -- indicated they were trying to increase production or work with the FDA to allow production of the preservative-free version of the drug. Methotrexate without preservative is given intravenously or injected into spinal fluid, where preservatives could cause toxic reactions.
Neither Bedford officials nor the FDA would say how much product is available, or how many hospitals would be served. Hospital buyers say they’re being quizzed about patient need and allowed a two-week supply of the drug, said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages.
The new availability is both a relief and a reminder of the seriousness of drug shortages that now number about 287, the most in U.S. history, cancer experts said.
“Every little bit helps, but it’s so wrong that we have to live like this,” said Dr. Harvey Cohen, a professor of pediatrics at the Stanford School of Medicine and a member of the American Society of Hematology’s government affairs committee. After decades of progress in finding the right drugs to treat -- and cure -- A.L.L., not being able to obtain them is a huge setback, Cohen said.
He was waiting to hear Thursday whether he would get an order of 20 grams of methotrexate to treat a 16-year-old boy with a bone tumor on Friday.
“His tumor responded beautifully to the medicine. We know the medicine works,” Cohen said. “We have the orders in. I signed them myself yesterday. I just don’t know if we will get it.”
Cohen said he and his colleagues essentially have to ration the drug, giving highest doses to children with difficult-to-treat cancer and lower doses to those whose condition is easier to treat.
"Given the shortage, we have to be able to give that to the children who will benefit the most," he said.
Some experts are breathing a brief sigh of relief at the stop-gap supplies of methotrexate. Dr. Michael Link, president of the American Society of Clinical Oncology, praised the FDA’s efforts to avert a total shortage.
“The FDA deserves a fair amount of credit for really stepping up to the plate and resolving this for the short term,” he said. “It’s unfortunate that we had to get to a crisis situation.”
Five U.S. senators demanded more information about the problem on Thursday, sending a letter to Ben Venue officials saying patients and providers have been given no timeline for fully resolving the crisis. They asked for more information about the quality problems at Ben Venue that prompted the shutdown, stalling production not only of methotrexate, but other drugs in short supply. The senators asked if reimbursements for the drug, which is a low-profit generic, played a role in the current shortage.
That echoes the concerns of Christine Farinick, who said she believes that low returns are at the root of the problem.
"All the medication shortages are because the drugs are not profitable to make," she said, adding: “I think that’s absolutely disgusting."