Pubdate: Sun, 01 Jan 2012
Source: New York Times (NY)
Copyright: 2012 The New York Times Company
Contact: http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
Website: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Gardiner Harris

F.D.A. IS FINDING ATTENTION DRUGS IN SHORT SUPPLY

Medicines to treat attention deficit hyperactivity disorder are in 
such short supply that hundreds of patients complain daily to the 
Food and Drug Administration that they are unable to find a pharmacy 
with enough pills to fill their prescriptions.

The shortages are a result of a troubled partnership between drug 
manufacturers and the Drug Enforcement Administration, with companies 
trying to maximize their profits and drug enforcement agents trying 
to minimize abuse by people, many of them college students, who use 
the medications to get high or to stay up all night.

Caught in between are millions of children and adults who rely on the 
pills to help them stay focused and calm. Shortages, particularly of 
cheaper generics, have become so endemic that some patients say they 
worry almost constantly about availability.

While the Food and Drug Administration monitors the safety and supply 
of the drugs, which are sold both as generics and under brand names 
like Ritalin and Adderall, the Drug Enforcement Administration sets 
manufacturing quotas that are designed to control supplies and thwart 
abuse. Every year, the D.E.A. accepts applications from manufacturers 
to make the drugs, analyzes how much was sold the previous year and 
then allots portions of the expected demand to various companies.

How each manufacturer divides its quota among its own A.D.H.D. 
medicines - preparing some as high-priced brands and others as 
cheaper generics - is left up to the company.

Now, multiple manufacturers have announced that their medicines are 
in short supply. The F.D.A. has included these pills on its official 
shortages list, as has the American Society of Health-System 
Pharmacists, which tracks the problem for hospitals. And the American 
Academy of Child and Adolescent Psychiatry has told the more than 
8,000 doctors in its membership that shortages seem to be "widespread 
across a number of states" and are "devastating" for children.

Officials at the Food and Drug Administration say the shortages are a 
result of overly strict quotas set by the Drug Enforcement 
Administration, which, for its part, questions whether there really 
are shortages or whether manufacturers are simply choosing to make 
more of the expensive pills than the generics, creating supply and 
demand imbalances.

The situation has made for a rare open disagreement between two 
federal agencies.

"We have reached out to the D.E.A. and told them that there are 
shortage issues," said Valerie Jensen, associate director of the 
F.D.A.'s drug shortage program. "But the quota issues are outside of 
our area of responsibility."

Still, Special Agent Gary Boggs of the Drug Enforcement 
Administration's Office of Diversion Control, said in an interview, 
"We believe there is plenty of supply."

Some high-priced pills are indeed readily available, and D.E.A. 
officials said that so long as that is the case, they believe that 
A.D.H.D. drug supplies are adequate. Agent Boggs attributed any 
supply disruptions to decisions made by manufacturers.

Novartis, for instance, makes both branded and generic versions of 
Ritalin; Shire Pharmaceuticals does the same for Adderall XR. In both 
cases, the companies have ensured that supplies of branded drugs are 
adequate while allowing generic versions to go wanting.

"We are working diligently to ensure our supply of these products 
meets demand, including discussions with D.E.A. regarding our quota 
levels for these controlled substances," said Kathy Bloomgarden, a 
spokeswoman for Novartis.

But those who rely on the drugs can react very differently to 
apparently similar medicines, so an adequate supply of one drug does 
them no good when their preferred medicine is unavailable, patients 
and their doctors say. And prices can vary so much that some patients 
say they cannot afford to switch.

Lynn Whitton of Westport, Conn., who has an attention deficit 
hyperactivity disorder, expressed disbelief when told that the Drug 
Enforcement Administration said there were no shortages of A.D.H.D. 
medicines. "What?" she said. "I'm just flabbergasted!"

Ms. Whitton said she had recently gone to more than a dozen 
pharmacies in Westport and New York City before finding one that 
would partially fill Ritalin prescriptions for her and her 
18-year-old son, who also has the disorder.

Erin Fox, manager of the drug information service at the University 
of Utah, said problems arise when there is a mismatch between what 
manufacturers choose to make and what patients are prescribed.

And, Dr. Fox said, while manufacturers sometimes use their limited 
quotas to ensure adequate supplies of high-priced branded drugs at 
the expense of low-profit generics, all of the issues would be 
resolved if the Drug Enforcement Administration were simply more 
generous with its quotas, particularly since sales of A.D.H.D. 
medicines have risen so rapidly.

Doctors wrote 51.5 million prescriptions for A.D.H.D. drugs in 2010, 
with a total sales value of $7.42 billion - an increase of 83 percent 
from the $4.05 billion sold in 2006, according to IMS Health, a drug 
information company.

Agent Boggs of the Drug Enforcement Administration said his agency 
was concerned that A.D.H.D. drug abuse was on the rise. "We see 
people abuse it in college and then continue to abuse it nonmedically 
once they leave," he said.

Since the drugs have been shown to improve concentration, and not 
just in people with A.D.H.D., they have become popular among students 
who are seeking a study aid. And since they can impart a euphoria 
that users have likened to a cocaine high, the pills are sometimes 
ground up by people who snort them for a thrill.

On the other hand, there are people like Sheryl Greenfield of Bryn 
Mawr, Pa., an A.D.H.D. patient who spent days calling dozens of 
pharmacies to find a generic substitute for Adderall XR. She finally 
gave up and bought the brand, and her co-pay went to $200 from $10. 
"I can afford the difference, but I know some people who can't," she said.

Shortages of amphetamine-based drugs like Adderall became so endemic 
that many doctors switched patients to methylphenidate-based drugs 
like Ritalin, creating shortages among those medicines as well, 
according to the F.D.A.

Ruth Hughes, chief executive of Children and Adults with Attention 
Deficit Hyperactivity Disorder, a patient advocacy organization, said 
the drug shortages had become so acute that many patients were going 
untreated, increasing their risks of deadly traffic accidents and job 
dismissals. "The consequences of not getting treatment can be 
devastating," Ms. Hughes said.

Dr. Alexander Lerman, a psychiatrist from Chappaqua, N.Y., said his 
patients could not simply switch from one medicine or dosage to 
another without consequences. And some of his patients, he said, 
cannot afford the branded version of the drugs.

"For the first time in my career," Dr. Lerman said, "there is this 
enormous and mysterious scarcity of the basic product that is proven to work."
- ---
MAP posted-by: Jay Bergstrom