Wednesday, April 05, 2006

Collateral Damage in the War on Terrorism
Medical Ethics in Inaction

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.

(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
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As a Muscular Dystrophy Clinic director, let me say that the connections to the war on terror are unclear to me.

It is connected to this whole business about the source of pharmaceuticals and people getting cheaper drugs from Canada or wherever.

It's also a bit of an exaggeration to characterize Deflazacort as life-saving. Yes, it does help to some extent, but only to some extent -- the older the child gets the less apparent the benefit can be.
It really came about after prednisone was shown to be helpful, then a drug sought with similar benefit but fewer steroid side-effects.
Admittedly, this post was not a carefully-crafted argument. I agree, there is no connection to the War on Terrorism. Rather, the point is that the involvement of the Department of Homeland Security is inappropriate. Somehow, DHS has gotten itself involved in medical matters that it is ill-prepared to handle. It seems to me that the whole thing stems from over-reaching by the DHS, and that the over-reaching is a side effect of the War on Terrorism. That is where the "collateral damage" reference comes from.

You would know better than I if Deflazacort really extends life. The article implies, but does not explicitly state, that some patients live longer. That probably is based upon anecdotal evidence, though.
This life-extending thing is very hard to assess. Many of my DMD patients are living longer, some much longer, but only one that I know of is on Deflazacort (if his parents can still get it).
The connection to the Perpetual War on Terror is simply that the Customs Department has been placed in the Department of Homeland Security.

It's collateral damage to the War on Something -- civil liberties? But it has a stronger connection to our failure to address the health insurance issue.

Other medications being confiscated: asthma inhalers from people who can't afford their meds, and hydrocortisone tablets from Addison's patients, who have problems with the two formulations available in the US. (Hydrocortisone is the natural hormone that drugs like Deflazacort imitate, and which Addison's patients DO need to stay alive more than a short time).

The problem is that Congress -- our representatives -- have decided that we should not be allowed to make decisions about where we get our medications. Yes, there are arguments as to why it's better to buy them in the US, and I do and will continue to do so, as long as I can afford to do so and the medications I need are available.

The irony is that Congress forbids the regulation of anything that can be labelled a "supplement", unless it starts killing people. So we get worthless or dangerous "supplements" being marketed to "control diabetes naturally". They finally cracked down on things claiming to help you lose weight by reducing cortisol (aka hydrocortisone! -- i.e. claiming to give you temporary Addison's!)

Yet real drugs, for real patient with chronic, life-long diseases, from countries with real controls on quality, are being confiscated.

My insurance company and I spend nearly $20,000 per year on medications. I expect this number to rise. If I lost insurance, I would be forced to make substantial cuts -- which of the half-dozen hormones that my body doesn't make should I do without? Or do I skip the expensive asthma inhalers, and risk suffocating if my asthma flares up? Just so I can afford my insulin and hydrocortisone?

Importing drugs brings some risks, but NOTHING compared to the risks I would take by not being able to afford my medications.
i am a grandmother of a boy who has duchene/becker MD/i have searchedthe US and Canada/dr jacques trembly from quebec is doing muscle cell transplant/with good success/but not available in US/ this medicine would perhaps save my grandsons life/IT IS WORTH A TRY anything is that allows him to live/not DIE/how can we communicate with this dr? thank you
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