Heather White is a 41-year-old woman who was diagnosed with common variable immune deficiency (CVID) back in 2004 after fighting frequent bouts of pneumonia. Doctors believe that she probably has had the condition since childhood. Essentially, CVID means that the body does not make enough antibodies, which are responsible for fighting infection. Most patients don’t receive a diagnosis until their 3rd or 4th decade of life. By this point they already have permanent damage in their respiratory tract.
This frequently misdiagnosed disease has no cure and requires lifelong intravenous immunoglobulin replacement therapy (IVIG). The immunoglobulin helps protect patients from infection, replacing the antibodies they don’t have.
One day White showed up for her regular, weekly infusion and was told that she had one dose left of her therapy before she would be forced to switch to a different brand. She knows she responds well to the Gammagard she is on so what was the reason for this switch?
This is when White found out there is a plasma shortage, which has led to a shortage of the brand of immunoglobulin she typically takes.
White describes the situation as frightening.
Gammagard is manufactured by Takeda Pharmaceuticals. The company did not respond to inquiries about the shortage. However, in 2018 their production was increased due to the perceived short supply.
Not all brands will affect all patients the same way. Gammagard works for White but only when it is divided into 4 small weekly doses. Other brands she can’t tolerate at all. Now White is left in a place where she is forced to figure out if any other brand will work for her.
5 of the 9 companies affected by the plasma shortage say that it is due to an increased demand. When the FDA was contacted, they said they could not explain this increase.
The Immune Deficiency Foundation’s Take
The Immune Deficiency Foundation (IDF) CEO and president, John Boyle reassures immunedeficiency patients that the short supply doesn’t mean peril. He says that it’s not even really new news.
From his perspective, the shortage is due to an increase in off-label use of the drug and investigatory use. This increase has caused those who take the therapy on-label (like those with CVID and primary immunodeficiency (PI)) to become fearful for their continued access.
This new patient population if you will, has been increasing the demand on hospitals providing the treatment.
However IVIG therapy is being continually investigated as a treatment for other illnesses. For instance, while it is not considered the preferred treatment, it may be prescribed to those living with Multiple sclerosis.
The difference is, for some patients access to this specific therapy is a matter of life and death.
One of the issues is that the drug manufacturers can’t just hire more employees to make more product. We need a supply.
Here’s the good thing. There is a supply, it’s really about obtaining it. While donating plasma isn’t as easy as donating blood, there are many individuals who can take that step to donate. That said, it does take almost a full year to produce the drug derived from plasma.
The fact of the matter is there is an increase in demand, and therefore we need to up our supply. It comes down to donations from individuals like you and like me. White says she’s turned to social media to ask for donations for the first time. Four of her friends have already agreed to donate.
Currently, donors from the United States supply the majority of plasma in Europe and many other areas of the world. Maybe it’s not just about increasing the number of donors in our country, but across the world.
Another solution, and one that’s been in frequent conversation within the medical field, is communication. Say patient A needs IVIG and their local hospital doesn’t have it. While the hospital in the next town may have the treatment, if the two hospitals don’t communicate about patient A’s needs, they won’t receive the care they need.
In this scenario patients need to be their own advocate. By working with their insurance company, they may be able to switch to a hospital system that has the treatment they need. Boyle encourages them to contact the IDF if they need support.
More Production Efforts
While pharmaceutical companies can’t get more IVIG without plasma donors, they can take steps like creating new collection centers and opening new plants to increase the capacity of their production. Thankfully, they are making these kinds of changes.
Additionally, hospitals need to be more scrupulous on the prescriptions of IVIG they are providing. Patients needing the therapy for its on-label use require it to survive. Hospitals need to ensure that these patients receive the treatment they need.
Whether or not they realized this was becoming a problem before, it’s clearly a problem now, and it can no longer be “business as usual.”
You can read more about this plasma shortage here.