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Tuesday, February 14, 2012

Patients Suffer as Drug Shortages Snowball

By Daniel J. DeNoon

Deathly ill patients, many of them children, aren’t getting the drugs they desperately need.

Why? The drugs — most of them sterile, injectable drugs used to treat cancer or infections or for anesthesia during operations — are in short supply.

Every year since 2001, there have been more and more drug shortages. This year there may be an estimated 200 to 300 drug shortages, far outpacing the record set just last year.

“Usually these are inexpensive generic drugs that have been available for a long time,” pediatric oncologist Bruce Bostrom, MD, of Children’s Hospitals of Minnesota, tells WebMD. “They are only made by a few companies. So if one plant goes down for improper manufacturing practices, the others can’t make up the difference.”

But expensive brand-name drugs are only made by single companies, too. Aren’t they hit by shortages?

“The very expensive drugs still on patent? I have never seen a shortage,” Bostrom says.

Bostrom isn’t a whiner. He’s on the front lines. The drugs he needs are for kids who will die if they don’t get them.

One of those kids is Rowan Carr, who was 3 years old in August 2010. That’s when her mom learned Rowan had a deadly form of leukemia.

“Rowan’s leukemia has a 90% to 95% cure rate. We look at it as a 5% chance she could die,” Brenda Carr tells me. We hold on to that hope, but we have it only because of the strides made in curing childhood leukemia. And now this key medicine — that every kid with leukemia needs — is not available?”

That drug is methotrexate, one of the generic drugs that have been in chronic short supply. A recent breakthrough in cancer research showed that high-dose methotrexate can be used if given with another drug called leucovorin.

Guess what? There’s a shortage of leucovorin, too.

It’s a frustrating situation for most of us. For Brenda and Rowan Carr, and thousands like them, it’s a cruel twist of the knife.

“I’d like to think when we are done that we have had all the treatments, and that we and the doctors have done everything possible to keep Rowan’s cancer from coming back,” Carr says. “But if it does come back because we’ve had to change the treatment schedule, we will not have done everything we could have done for her. We were not prepared; we didn’t pull through in the ninth inning. Are we still going to win? We don’t know.”

While money is at the root of the problem, the solution isn’t merely financial. There’s a limit on reimbursement for generic injectable drugs, so there’s not a huge profit in making them.

If a plant has manufacturing problems — and FDA inspectors have documented serious safety issues — it takes a long time to get that plant back on line. If anyone else makes the drug, they have only a limited ability to fill the supply gap.

And that’s only one type of problem. The raw materials for the drugs often are in short supply. And since 80% of these materials come from outside the U.S., the FDA can do little about it.

Help is on the way, but it’s not likely to affect drug shortages for at least the next 18 months — and it will be years before new manufacturing plants come on line.

Meanwhile:

  • Last year, President Obama issued an executive order to require drug companies to report factors leading to shortages, requiring the FDA to expedite regulatory review of plants making drugs that might be in short supply, and getting the Department of Justice to investigate price gouging by “gray market” drug suppliers.
  • Legislation has been introduced in both houses of Congress to increase FDA authority and staffing to prevent and respond to drug shortages.
  • Generic drug makers are building new plants, although others are closing. And increased FDA scrutiny of overseas suppliers, while increasing safety, may decrease supply in the short term.

Meanwhile, patients suffer. Some die. It shouldn’t have to be this way.

“I am doing my best to hold it together,” Carr says. “All we can do is hope, and hold it together. And this makes is just a little harder.”

 

Posted by: Daniel DeNoon at 6:11 pm

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