Saturday, October 30, 2010

Need Meds?

By JoNel Aleccia
Health writer MSNBC

Cancer patient Bob Dierker had just finished eight of 12 chemotherapy sessions when technicians broke the news.

Next time, they said, he'd get no leucovorin, the generic medication long used to battle his type of aggressive Stage 3 colorectal cancer. The drug was in short supply across the nation and he'd have to go without.

“It was like getting shot in the stomach,” said Dierker, 64, a lawyer from Fairfax, Va. “My odds just dropped dramatically because I can’t get this drug.”

Exactly how Dierker’s chances of beating the cancer will be affected is unclear, said his oncologist, Dr. Alexander Spira. Leucovorin has been used to boost the effectiveness of cancer drugs for decades, so no one knows how badly patients will fare without it. But Dierker is not alone.

Across the United States, life-saving or medically necessary drugs are running low — or running out — endangering care and increasing the odds of medication mistakes for a broad swath of patients.

Health officials say drug shortages pose a growing public health crisis, fueled in large part by financial motives of drugmakers who’ve watched low-cost generics erode their profits.

Numerous drugmakers contacted by msnbc.com either refused to comment on the shortages or confirmed only that they exist. None would discuss financial considerations.

Unprecedented numbers
“It’s disaster management, daily,” said Erin Fox, manager of the Drug Information Service at the University of Utah Health Care, who has tracked drug shortages for a decade. “The numbers are unprecedented.”

In 2005, Fox recorded 74 drug shortages in the U.S. By 2009, the number had jumped to 166. As of Sept. 10 this year, Fox had logged 150 new shortages — in addition to 30 drug shortages still unresolved and more being reported every week.

Worse, the drugs that are in short supply are often the ones needed most. This year has seen shortages of common drugs used for basic treatments: morphine for pain relief, propofol for sedation, Bactrim injections for infections.

Sterile injectables, including the pre-filled epinephrine syringes used in emergencies for heart attacks and allergic reactions, have been particularly hard to get.

“Our usual, everyday workhorse drugs are no longer available,” said Fox. “It’s just the unavailability of everything that we need every day.”

About 40 percent of the shortages are caused by manufacturing problems, including safety issues, said Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program. Nearly 20 percent are caused when firms simply stop making drugs and another 20 percent are due to production delays. The rest are chalked up to raw material shortages, increased demand, site issues and problems with parts such as syringes or vials.

But underlying them all is the profitability problem, said Jensen.

“Normally, it’s a business decision. That does lead to shortages,” said Jensen. "These are just not usually money-makers."

FDA can't require drug production
Despite the concerns of doctors and pharmacists — and the distress of patients — no one can force the drugmakers to address the problem.

The FDA has no authority to compel drugmakers to continue producing a certain drug, or to require them to make a drug that’s in short supply, Jensen confirmed. And companies aren’t required to inform the agency about impending shortages unless the drugs don't have an alternative. Even then, there are no sanctions if they don’t.

When firms do tell FDA about a problem, the agency can’t publicly divulge proprietary information, Jensen said. Shortages on the FDA’s website are often chalked up to mysterious “manufacturing delays,” or frequently, no reason at all.

That has created a system in which pharmacists, doctors and patients may not know that a shortage exists until a drug is needed — and even then they don’t know how long it will last.

“There has been a lot of 11th hour scrambling,” said Dr. Richard L. Schilsky, a professor of medicine and chief of hematology/oncology at the University of Chicago. “We literally don’t know from week to week who’s going to be able to be treated.”

The problem has reached such a peak that four leading groups representing cancer doctors, anesthesiologists, pharmacists and safety advocates have convened an invitation-only meeting in Bethesda, Md., on Nov. 5. They’re asking drugmakers and supply chain representatives to join health experts and observers from the FDA to hammer out solutions.

“I’m going to give these folks the benefit of the doubt and assume they don’t know the impact at the patient care level,” said Bona Benjamin, director of medication-use quality improvement at the American Society of Health System Pharmacists.

2 comments:

James Taggart said...

Wow. Headline story here... Remove profits, inject a large dose of gov't intrusion, and the market responds. Shocking.

Gov't mandates will solve this.

Conchscooter said...

As long as you kleptocrats don't have suggestions on how to improve things I can onloy hold on to what I know works- universal single payer health care.
Unless you are blind stupid and on the Humana payroll you know the current non system doesn't work. My posts cite chapter and verse on why not, yet you can't come up with a constructive suggestion on how to make things better.
Oh sorry- I forgot, allowing corporations to rape us is our sacred duty in this Brave New World.