I find this news topic intriguing on a number of levels. First, why wouldn't the FDA slap a 'negligent attitude' type lawsuit against Big Pharma? Because that's exactly what they are, negligent. Second, can anyone else read between the lines here? We're being exterminated, one sick population segment at a time. I smell something in the air.... could it be.. maybe? .... a newly formed underground black market for these types of 'discontinued' or 'unavailable drugs.' Either way, the company gets it's money.
150 medications in short supply so far this year; deaths, injuries have followed
By JoNel Aleccia Health writer msnbc.com msnbc.com
updated
10/27/2010 8:24:19 AM ETCancer 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.
“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.
But a nationwide survey of 1,800 health care workers conducted this summer by the Institute for Safe Medication Practices left little doubt about the impact on patients.
Two deaths blamed on morphine shortage
“It’s really a mess out there,” said Michael Cohen, director of ISMP, a nonprofit group that aims to reduce medical errors. “It is making us compromise the way we do things normally.”
More than half of the respondents to ISMP said that in the past year they had “always” or “frequently” encountered shortages of a list of common drugs.
One in three reported that the shortages caused medication errors that could have harmed patients and one in four said the mistakes reached patients. One in five said patients were actually harmed.
“We had two deaths where there was a morphine shortage,” Cohen said, explaining that a much more potent replacement drug, hydromorphone, was given at the level of the original, overdosing the patients.
Another patient woke up mid-way through surgery because medical crews trying to conserve the sedative propofol had given too little medication for the patient’s weight.
Such critical mistakes are bound to happen when shortages of so many drugs start to add up, said Thomas Burnakis, clinical coordinator of pharmacy services at Baptist Medical Center in Jacksonville, Fla.
“If I am the best centerfielder in the world, you can hit me a pop fly and I’ll catch it. You can hit me two or even three and I’ll catch them,” he said. “If you start hitting me 15, I’m going to start dropping them.”
It’s not just the mainstream drugs that are the problem. Shortages of niche drugs or those used for rare conditions have occurred, too.
In January, sufferers of a potentially blinding condition called birdshot retinochoroidopathy uveitis learned that Zenapax, the best drug for keeping symptoms at bay, had been discontinued by drugmaker Roche.
“I cannot tell you the panic I felt,” said Lynn Shaw, a 60-year-old nurse from Franklin, Mass., who was diagnosed with the disease 2 ½ years ago. “I was positive I was going to lose my vision. I thought, ‘Oh, my god, I’m going to go blind because of these jerks.'”
Chris Vancheri, a spokesman for Roche, said the company decided to stop making the drug, which is normally used in kidney transplant patients, because there were alternative treatments available. The problem, Shaw and other patients said, is that alternative drugs are either less effective or pose unacceptable side effects such as life-threatening high blood pressure and liver damage.
Drug companies won't talk
Shaw believes that Roche, like many manufacturers, stopped production when generics undercut the brand name price. Vancheri would not comment on the profitability of Zenapax. Nor would representatives for Teva Pharmaceuticals and Bedford Laboratories, the makers of leucovorin, discuss the reasons for the shortage of the generic drug that has left Bob Dierker, the Virginia lawyer, with depleted cancer treatments.
Bedford representatives did not return repeated calls and e-mails from msnbc.com. Teva representative Denise Bradley would only confirm what patients have known for months, that the drugmaker halted production at its Irvine, Calif., plant in April.
"I do not have an estimated date of when we will resume manufacturing at this time," Bradley wrote in an e-mail.
Representatives for the drug manufacturers’ trade group, PhRMA, declined to discuss the largest-ever drug shortage in the nation, referring questions to individual manufacturers.
But Dierker thinks he knows what’s behind the recent shortage of generic leucovorin, the second since 2008. In some regions, a 50-milligram dose of generic leucovorin costs 98 cents; a newer brand-name alternative called Fusilev costs $184.08. But many insurance companies, including Dierker's, won't pay for it.
“It’s money, pure and simple,” said Dierker, a new grandfather who fears he won’t see 6-month-old Rhett grow up.
He’d like to do something about the shortage: organize a class action lawsuit, get a colleague to pursue a criminal case. But for now, he’s just angry.
“To have some faceless, nameless coward running a pharmaceutical lab decide he wants a bigger BMW and isn’t going to make your drug — I feel helpless,” Dierker said. “That’s the really frustrating thing, not to be able to do anything about it.”
