August 7, 2011 – Drug Shortage

On Friday, I rode the train into Manhattan for a consultation with Dr. Stephanie Fish, my newly-assigned endocrinologist from Memorial Sloan-Kettering.

I found Dr. Fish to be well-informed about my case, and ready with answers to all my questions about my upcoming radioactive-iodine treatment (the routine follow-up to my thyroid surgery recommended by the surgeon, Dr. Boyle).

I did encounter one problem I hadn’t expected. Dr. Fish explained that, as an essential part of my preparation for taking the radioactive-iodine pill, I will be injected with a drug called Thyrogen a few days before. There’s currently a shortage of this drug, due to some manufacturing problems at Genzyme, the company that makes it. It’s simply not available.

Genzyme has been acquired by a larger pharmaceutical company, Sanofi-Aventis. I don’t know if that acquisition has any role in the supply problem. I did learn that there were some quality-control issues with Genzyme’s manufacturing process for Thyrogen, which led the FDA to order a temporary suspension of sales.

This shortage was reported in the New York Times in May, although I missed reading about it.

Genzyme has issued an advisory statement about future availability of the drug.

Dr. Fish explained that Memorial Sloan-Kettering is the single largest user of Thyrogen in the country (and is therefore Genzyme’s best customer), so they expect to be at the head of the line when the medicine is finally handed out. Even so, she doesn’t expect that to be for several weeks at least, and even that is uncertain.

What Thyrogen does, she explained, is to raise the level of TSH, or thyroid stimulating hormone, in the body. For people who still have their thyroids, TSH is what tells the thyroid to ratchet up its production of thyroid hormone. In order for the radioactive iodine to be effective in hunting down and destroying any stray particles of thyroid tissue that may still be present after surgery, the level of TSH must be high.

The old-fashioned way to do this is to have patients simply stop taking their thyroid medication (synthroid or levothyroxine) for a couple of weeks. This makes them feel really lousy, as the body copes with the acute shortage. Thyrogen directly raises the TSH level, without the side effects, so it’s by far the most desirable way to conduct the radioactive-iodine treatment.

This would be well and good, were Thyrogen presently available. But, it’s not. So, patients are faced with an undesirable choice between two options. They can either proceed with the treatment and brave the miserable side-effects, or wait until the drug is available, and risk the consequences of delaying treatment.

In my case, she says, there’s no extreme hurry. The papillary thyroid cancer I have is generally slow-moving, and even though my tall-cell subtype is a bit more aggressive, still there’s nothing to be lost from waiting till sometime in the fall to undergo the treatment.

Even so, this shortage makes me uneasy, and also a bit angry. The pharmaceutical companies are protected by patents, which allow them to make a great deal of money for a period of time after they bring out a new drug. This, they claim, is the only way they can recover their substantial research and development costs. Yet, that also means that, if there's a manufacturing or distribution problem, the patients are out of luck. There's no competitor to fill the gap.

Dr. Fish’s office will call me as soon as they know for sure when they’ll have my Thyrogen injections in stock, so we can get some dates on the calendar.

There’s a lot more to say about the details of the radioactive-iodine treatment, the extensive dietary preparation leading up to it, and the safety procedures that must be followed afterwards, but I’ll save that for a subsequent blog post. The drug-shortage problem must be overcome first.