A severe shortage of immune globulin is forcing doctors nationwide to cancel patients’ lifesaving infusions.
Immune globulin helps protect patients from infections, and is used in many medical conditions, including seizures, leukemia, autoimmune diseases, organ transplants, acute muscle illnesses and nerve disorders. “It is miraculous,” said John Boyle, president of the Immune Deficiency Foundation, a national nonprofit group. “It is the one thing, if you have an antibody deficiency, that gives you gas in the tank. It is necessary to live.”
Made from human blood donations, immune globulin contains infection-fighting antibodies derived from blood plasma, and it is typically administered to patients intravenously in a hospital or an infusion center. The medicine is highly effective and has become popular in recent years among doctors who prescribe it for off-label conditions such as strep infections that have crossed the blood-brain barrier, infertility and even toe fungus.
Shortages of immune globulin have become more frequent in the past few years, spurred by demand for the medicine. Nevertheless, manufacturers say the current shortage is among the worst they have experienced since the treatment has been on the market.
In a statement in August, the FDA said that “despite increased supply of immune globulin products in recent years, the demand for IG products has also increased over the same time and there is an ongoing shortage.” FDA officials said they are working with drug companies to boost supply.
Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said doctors are responding to the shortage by reducing doses and lengthening the time between treatments. He pointed out that, in the past few weeks, many medical offices have been calling patients to tell them that their infusion appointments were canceled. “People are taking a hard look at who is receiving the medicine, and really, is it the right treatment,” Ganio said.
Some say that, given the shortage, certain illnesses should get priority. The Immune Deficiency Foundation put out a statement in July saying doctors should find suitable alternative medicines. “For our population, there is no substitute,” said Boyle, the IDF president.
According to the Plasma Protein Therapeutic Association, which represents makers of plasma-based medicines, while collections continue to rise in the United States, supply is failing to meet the steady increase in demand. Manufacturers operate collection centers throughout the country that pay people about $30 for donated plasma. It can take seven to 12 months to produce and supply plasma-based medicines to customers. It can take more than 1,000 plasma donations to make a one-year supply for a patient.
Manufacturers are increasing efforts to meet the demand. Takeda is planning to optimize both plasma collecting and manufacturing capacity, opening more collection centers and more recently investing in a new manufacturing facility in the US. CSL Behring noted that it, too, was working hard to manufacture more product. Grifols plans to open more infusion centers for collecting plasma. The company is building a new plant in Clayton, NC.
In Massachusetts and other areas, some hospitals have notified patients that immune globulin will not be available to them until next year.
Juli Hunt, whose son, Colton, 8, was airlifted to Children’s National Hospital four years ago during an attack of anti-NMDA receptor encephalitis, has been traveling to the hospital for monthly IVIG. Last month, she received a notice that he would no longer be receiving the IV treatments, and that the subcutaneous version is a solid option.
“I get that they are saving what they have for those who are critical,” Hunt said. “But I am very worried about how we are going to do without it.”
Source:The Washington Post, Nov. 4, 2019