The Rest of the Story

This post is about the case of a patient with Duchenne Muscular Dystrophy, whose life-prolonging medication was intercepted at the border by Homeland Security agents.  The post includes a long excerpt from the Grand Rapids Press.  I would not ordinarily excerpt so much of an article, but I think the article will disappear behind a firewall in a couple of weeks.

Boys' medicine held up by Homeland Security
Monday, April 03, 2006
By Pat Shellenbarger
The Grand Rapids Press

Tyler Fehsenfeld's doctors said the 6-year-old needs a drug from a company in England to delay his deterioration from muscular dystrophy.

The U.S. Department of Homeland Security said he couldn't have it.

Only after U.S. Rep. Vern Ehlers' office intervened last week did the U.S. Food and Drug Administration release it.

Tyler's parents, Anessa and Scott Fehsenfeld, of Rockford, were relieved but perplexed the federal agencies blocked a medication vital to their son's health.

"I'm choosing to give this drug to my son that a doctor says he needs, and my country says he can't have it," Anessa Fehsenfeld said. "As if the diagnosis isn't bad enough, and then you have this to deal with."

She ordered the drug, Deflazacort, in late January after Tyler's doctor prescribed it to slow rapid muscle decline and perhaps prolong his life. On March 6, the couple received a letter from Homeland Security's border protection division saying it confiscated the medicine because it is not approved by the FDA.

"I was shocked," Fehsenfeld said, frantic that her son soon could lose his ability to walk. "You think of sneaking it over the border. You're willing to do whatever you have to."

Several other parents of boys with an aggressive form of muscular dystrophy called Duchenne received the same form letter. In November, Customs began cracking down on shipments of prescription drugs from outside the United States.

While Deflazacort is available in Canada and throughout Europe, the company that makes it has not sought FDA approval to sell it here. The reason, some doctors and advocates for muscular dystrophy patients believe, is because it is an "orphan drug," with a market too small to be profitable.

An estimated 12,000 U.S. children have Duchenne, which affects only boys, said Pat Furlong, president of nonprofit Parent Project Muscular Dystrophy. [...]

Margaret Wilkinson, of Spring Lake, said she was notified Dec. 23 that the Deflazacort she ordered for her 14-year-old son, Jeffery, was confiscated. The FDA released it a month later after she called U.S. Rep. Pete Hoekstra's office. [...]

Without the drug, Duchenne patients typically lose their ability to walk between the ages of 6 and 12, said Marianne Knue, a nurse practitioner who works with Wong. Since the disease also affects the heart and breathing muscles, they often die in their teens.

"But with Deflazacort, we are finding boys are able to ambulate much longer, well into their teens," Knue said, adding she has patients on the drug still living in their late 20s.

Knue said she has heard from several parents whose Deflazacort orders were impounded. She began calling Customs and the FDA.

"They wouldn't give me a straight answer," she said.

Ehlers had better luck. After a Press reporter called his Washington office this week, a staff member contacted the FDA on the Fehsenfelds' behalf.

Tyler Fehsenfeld is the grandson of Press Publisher Dan Gaydou. [...]

In the USA, a drug can be sold only if it is approved by the FDA.  The approval process is excruciatingly complex, and costs millions of dollars to do.  And the longer the clinical trials take, the more expensive it is.  Because MD develops so slowly, the trials for this drug, in this disease, would take many years.  In order for it to be worthwhile getting the approval, the potential profits from the drug sales would have to be greater that the profits that could be gotten merely by investing those same millions of dollars for the same number of years.  Evidently, the analysis of the potential profits failed that test, so approval was never sought here.

Now, obviously, nobody would have thought that this kind of outcome, bizarre and inhumane as it was, would come from the Global and Perpetual War on Terrorism.  Call it collateral damage.  Still, in any massive, complex undertaking, there are bound to be unanticipated consequences.  

The thing is, intercepting unapproved drugs really has nothing to do with terrorism.  In this case, the War on Terrorism was merely a cover for another part of the Administration's agenda.  The Department of Homeland Security surely has better things to do than confiscating some terminally-ill patients medication.  It is difficult to figure out exactly how this fits in with their mission.  Sure, stopping some overseas drug shipments might protect pharmaceutical industry profits, but that clearly does not apply here, even though it would be consistent with the mission of our current Administration.  Likewise, stopping shipments of abusable drugs would fit in with their puritanical notions, but that clearly does not apply in this case.   No, this case was the result of a mindless power struggle.  

All ethical questions eventually boil down to the central question: who gets to make the decision?  That is, who is in charge here?  Who has the power?  Clearly, the Administration has decided that it has the power.  Not the doctor.  Not the patient.  Rather, some nameless Customs agent who has no idea what the drug is for, or why it is being imported, or whose lives will be affected by the confiscation.  None of that matters.  The only thing that matters is that it is that the Administration has to be in control of all things, at all times.  The War on Terrorism is used to justify this power grab.

In this case, the patient was the grandson of a newspaper publisher.  He eventually got the drug, but you have to wonder what would have happened if he hadn't had such an influential relative, and a Congressman had not gotten involved.  

This case arose from a longstanding problem with the FDA approval process.  The thing is, the system has been broken for a long time, and it still is broken.  It's just that for decades, doctors and their patients acted in accordance with common sense.  The government, rather than fix the broken system, simply looked the other way.  That was a fair solution, until some ideologically-driven zealots decided that they would not look the other way.  Instead, they now insist that the rules be followed, even thought the rules don't make any sense.