Drug Maker Lundbeck's Chemo Shortage Could Cost Kids' Lives

Cancer headlines, as portrayed in the media, appear to bring jaw-dropping news of breakthroughs and cures every day. Several studies have shown how mainstream outlets tend to favor positive news or positive spins on cancer. As a consequence, the general public gets the underlying impression that for this or that cancer there is surely something of late, some major development that can overcome a cancer diagnosis.

This really could not be further from the truth. Treatment success rates have improved dramatically in lymphomas and leukemia, but for many other cancers they haven't changed much in decades. Maybe 99 times out of 100 times that you see a headline about how 'mistletoe eliminates cancer cells' it is pre-clinical—meaning achieved in a dish or a mouse. A whole host of crap kills cancer cells in a dish. In the human body it's much different.

The point is that truly jaw-dropping cancer-related news—good or bad—happens as infrequently as in any other field.

It happened today. And it was bad.

The NEJM

The December 27 issue of the New England Journal of Medicine includes what could reasonably be considered among the top three or four cancer stories of 2012.

Researchers from St. Jude's Children's Hospital are reporting that their two-year cancer-free survival rate for patients with high-risk Hodgkin's lymphoma dropped from 88% to 75%. Put another way, the relapse rate went up. The reason?

A drug shortage. For reasons unknown--either a manufacturing breakdown or plain old profiteering by artificially creating an imbalance between supply and demand--the drug manufacturer Lundbeck couldn't produce enough of a specific drug, and kids suffered for it.

Whereas St. Jude's would typically include the drug mechlorethamine (trade name: Mustargen) in the treatment of these patients, when Lundbeck had a three year shortage occur, St. Jude's replaced that drug with a very old and reliable alternative, cyclophosphamide. And that's when their relapse rate began to climb.

The researchers wrote:

":We can think of no credible explanation for this dramatic difference in event-free survival other than the drug substitution."

The patients, in case it's not obvious, are kids, with half of them younger than 14.

Nobody's dead—yet. That's in part because it hasn't been long enough. But those who experienced relapse required additional treatment, and in these cases it was no ordinary additional treatment: these kids had to have radiation and high-dose chemotherapy followed by an autologous stem cell transplantation.

The question now becomes, will these patients suffer any long-term consequences because of this shortage?

Who knows … but we do know that the more chemo you get, the better the chance you have health problems later in life. The better the chance you develop a secondary cancer later in life. Or problems with fertility. Or cardio-pulmonary problems. There's a good reason why so many people are trying to reduce the toxicity of Hodgkin's treatments—because while they are curable, it would be even better if they weren't so toxic.

The high-dose preparative chemotherapy regimens used in stem cell transplants tend to be especially nasty. Especially vomit-inducing. Especially miserable. And often, especially compromising to one's health, short and long term.

It's too soon now to know whether any of these patients will be the first documented victims of this unacceptable drug shortage, and a good lawyer could argue any such accusation away in a court of law.

Unresolved

The FDA currently regards the mechlorethamine shortage as having been resolved.Sure, the drug might be back in supply but what's unresolved is exactly why Lundbeck ran short of the drug in the first place.

New laws have since gone into effect that see to it that the FDA has some warning before a shortage occurs so it can order the drug from overseas.

But don't let that stop you from asking them yourselves.

Lundbeck customer service meanwhile can be reached at 1-888-514-5204.

Sally Young is the company's Public Affairs VP. She can be reached either at SYOU@lundbeck.com or 847-282-5770, while Matt Flesch is the Sr. Manager of Communications. He can be reached at MFLE@lundbeck.com or 847-282-1154.

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