drug shortages


WSJ: Fake Avastin Found In United States

Chemotherapy drugs

As if it weren’t bad enough that some vital drugs are in critically short supply, the Wall Street Journal reports here today that a phony cancer drug has been found in the United States:

The maker of the widely used Avastin cancer drug said Tuesday that it is warning doctors, hospitals and patient groups that a counterfeit version of the medicine has been found in the U.S…

It isn’t clear how much of the counterfeit product was distributed in the U.S. or whether it has caused any harm. A Genentech spokeswoman said the company doesn’t know if any patients were given the fake drug.

The Food and Drug Administration is investigating, and has sent letters to 19 medical practices in the U.S. that the agency says buy unapproved cancer medicines and might have bought the counterfeit Avastin.

More here.

Cancer Drug Shortage All Too Real For Some

Betsy Neisner at the Cancer Connection’s 10th Anniversary Celebration.

By Karen Weintraub
Guest Contributor

Betsy Neisner of Northampton has survived a decade with ovarian cancer – half her daughter’s life and long enough that her 17-year-old son doesn’t remember her before she became a patient.

As if living under this sword of Damocles weren’t enough, Neisner is now faced with the shortage of the drug that has kept her cancer in check since last April. Doxil, which has worked well for her with minimal side effects, is being severely rationed after the single plant that manufactures it shut down late last year. She has one month’s supply left. After that, her choices get grim: switching to another medication with much rougher side effects, or doing without and risking a recurrence.

There’s a chance she’ll be able to get more Doxil – if the drug stops working for people with a few months supply left, or if they die before using up their allotment.

Methotrexate is also the drug of biggest concern locally.

So, Neisner’s future quality of life is hostage to someone else’s misery.

Doxil is one of 250 drugs in extremely short supply in the US right now – many of them cancer drugs. The same shuttered plant – Ben Venue Laboratories in Bedford, OH – that left Doxil patients adrift also manufactured methotrexate, a drug also used to treat young children with an aggressive – but curable – form of blood cancer. Continue reading

Deep Murk On Cause Of ADHD Drug Shortage

When I wrote about the rising shortage of ADHD drugs earlier this month, I felt like a failure for my inability to offer a clear explanation for what lies behind it. I ran into a sort of hall of mirrors, with conflicting accounts from federal officials and drug companies, some of it frustratingly off the record — and I threw up my hands, hoping some more investigative type with more time would ferret out the truth.

So I’m a little comforted that in his excellent report today for NPR on the national ADHD drug shortage, Dick Knox, a veteran health and science reporter whom I respect maximally, seems to have run into the same thing. He says that the ADHD drug Adderall has become hard to get in recent months “for reasons that are unclear.”

And in the Web version of his story, he writes, near the end, “For one version of what really may be going on behind the scenes to cause (or exacerbate) the shortages – or market distortions, as the DEA would have it – read this.”

“This” is a long and fascinating piece on “the fix,” a Website on addiction and recovery. It has “The Great American Adderall Drought” in the headline, and in the sub-head, “Naturally, it’s all about Big Pharma profits.”

Please forgive my prudishness, but I’m going to delete a profane gerund in this quote: Continue reading

Where Have All The ADHD Drugs Gone? Patchy Shortages Abound

The other day, my friend went in to a suburban Boston CVS to fill the regular prescription for Ritalin that helps her focus and keeps her attention deficit disorder at bay.

But the pharmacist sent her away empty-handed, saying that the store had not been able to get the generic drug in months and did not know when that would change.

“The pharmacist said that all the area CVS’s were out of it, along with Adderall and similar drugs,” my friend reported. Later, when she called around, she found odd clumps of supply: One store might have the generic but not the brand-name, or vice versa. Maybe, the pharmacist told my friend, she should try getting farther out of the city, away from the Boston colleges whose students generate high demand.

But it’s not only a college-area problem. There are patchy reports of drug stores around the state running out of ADHD drugs for children and adults (see our follow-up post here), and the FDA has just posted several new ADHD drugs on its national list of medications in short supply.

In Michigan, pharmacists say the shortage is among the worst drug dry-ups they’ve seen, according to this television report about disappointed customers who break into tears; and in Washington, D.C., some expect shortages to last until January at least, according to local reports.

Critical shortages of scores of important medications, including chemotherapy drugs, have been building for months, to the point that President Obama issued an executive order aimed at alleviating them earlier this week.

But those shortages tend to revolve around intravenous drugs with such low profit margins that manufacturers have little incentive to make them. (See NPR’s Dick Knox on the issue here.) They don’t tend to concern pills that, whether generic or brand-name, are blockbusters any way you look at them in a country where 9 percent of the children are diagnosed with ADHD.

So what’s happening? Has demand simply risen beyond drugmakers’ capacity as all those diagnoses have been made? On the FDA Website, rising demand is one of the reasons given for the shortages. But it may be more complex than that.

When I think ADHD, I think Dr. Edward Hallowell, a leading authority on the topic who writes books and runs treatment and education centers. Yes, he told me, over the last several weeks, he has heard from some patients that they have been forced to search from pharmacy to pharmacy for the ADHD medication Adderall.

“Just this morning, I changed someone’s medication because they were having such trouble finding it,” he said. “It seems crazy to me, and I don’t know what to tell my patients other than, I guess, ‘Go shopping,'” he said.

A drug representative for Shire Pharmaceuticals, a company known for ADHD medications among others, told him recently that the shortage is the result of federal quotas on how much of the drugs can be made, Dr. Hallowell said.

“I honestly don’t know, but I think that’s the answer,” he said, “and it just seems bizarre that they put a quota on it. I don’t understand the rationale behind that: If a medication is prescribed, it should be prescribed.”

Quotas? Continue reading

Drug Shortage Crisis: The View From Mass. General

Just one other don’t-miss on-air highlight for today: The disturbing report from Dick Knox of NPR about shortages of critical medicines.

It includes extensive reporting from Massschusetts General Hospital that reveals just how dire the situation has become. The full report is here, and here’s the MGH segment:

Across town at the Massachusetts General Hospital, New England’s largest, pharmacist Paul Arpino says drug shortages were once rare. Now they’re routine.

Arpino often gets calls in the middle of the night from desperate doctors and nurses. “We try to react as quickly as possible to these shortages,” he says. “Sometimes there’s not a lot of notice. But when we’re informed of the shortage, we really get all hands on deck.”

He says drug shortages plague every corner of Mass General, from the emergency department to operating rooms to intensive care.

Currently, for example, intensive care doctors are coping with a shortage of a drug called labetalol that’s used to treat patients whose blood pressure is going through the roof. Labetalol is so scarce that the hospital recently decided to reserve it only for patients having a brain hemorrhage.

Dr. Taylor Thompson, medical director of the Mass General’s medical ICU, calls it rationing – something most people think happens only in socialized medical systems or developing nations, not in America. But experts say the problem has been building over the past decade, and has accelerated since 2006. Continue reading