UPDATEX2: Dallas attorney Fred Baron has urgent life-threatening illness but can’t get experimental meds from Biogen

John McClelland, verified:

That is just another sad example of our healthcare system in this country. If the man is going to almost surely die, why can't they use him as an experiment to see if the drug works? The worst it could do is kill him, which is what he is expecting to happen if he doesn't get the drug.

Sander Wolf, verified:

how is it that the drug company gets to decide what the use is? I thought doctors had the right to prescribe medicine even for "off-label" usage.

Mike Orren, verified:

Scott, I agree with you philosophically, but my understanding is that the fact in this case is that there is no shortage of the drug.

Biogen isn't talking, but I suspect this may have more to do with Baron's history as a plaintiff's attorney who has taken on drug companies. Whether it's retribution-mindedness or fear that if the drug didn't work to a T, Baron's family would sue, it isn't surprising that Biogen isn't racing to hand over the drug.

That said, a life is in the balance, and I think the right thing to do is hand over the drug along with an extensive release.

Scott Doyle, verified:

Google ftw! Per <a href="http://www.xconomy.com/boston/2008/10/14/biogen-turns-down-dying-patients-request-for-tysabri-and-explains-why/">this article</a>, following is their explanation for the declination:

<i>Under FDA rules, the company has discretion to give out the drug for such unapproved uses—what is known as “emergency use” or “compassionate use”—but it chose not to, Aoki says. If something went wrong in an uncontrolled setting, it might lead to further restrictions on the drug’s use among existing patients with MS and Crohn’s disease, she says.

“We concluded when we re-introduced Tysabri that we cannot make it available for uses other than the FDA-approved use, or for an FDA-approved clinical trial,” Aoki says.

Still, I asked if this was a difficult decision, given the life and death nature of the matter. Andrew Baron’s letter says his father may have only a day or two left to live. “Of course, it’s a difficult decision for us. Our thoughts go out to the family. We don’t take this lightly, but we feel we have a responsibility to protect patients already on this drug who are benefiting from this drug,” Aoki says.

When asked if legal liability is part of the company’s concern, Aoki referred back to her statement about protecting the interests of patients already on the drug.</i>

Honestly, I don't blame them.

Tracy Yost, verified:

they don't give a rat's a$$ about their current patients, they are thinking of their financial future.

Scott Doyle, verified:

Considering their current patients are their future, I'm relatively sure they care. Private companies staying solvent, just like an individual's survival, is the name of the game.

They've weighed their risks. How many lives *wouldn't* be saved if this matter took a turn for the worse and the drug was kept off the market? If you or someone in your family were lined up for clinical testing and this decision posed a threat to that, would you feel differently?

Mike Orren, verified:

Nice find, ScoD. Note interesting comments in that post too, from Andrew Baron claiming that the FDA has said that they would give Biogen a pass on any failures in this case and prominent Texas trial attorney Mark Lanier who says that the Barons have offered a full release and that he has offered to represent the company pro bono in any fallout.

http://www.xconomy.com/boston/2008/10...

The regulatory process, legal system and protocols for drug approvals can be a gut-wrenching mess. This book is a must-read, not only to understand the system, but as one of the most compelling stories I've ever read:

http://www.amazon.com/Cure-Million-Me...

Scott Doyle, verified:

Miko, regardless of what the FDA claims up front, seems this isn't what the drug was initially designed for and you bet your ass that detrimental repercussions would be felt if anything went awry. The media coverage alone could bring production/testing to a screeching halt. Methinks mention of this being an uncontrolled setting holds ridiculous water for their decision not to release.

These kinds of decisions are not for the faint of heart. No doubt it's an emotionally grinding time for everyone involved. Unfortunately there will be no steadfast proof this was the right call...but I feel Biogen keeping the interests of everyone who could potentially benefit in mind is the appropriate stance.

Tracy Yost, verified:

Mike - did the kids live ? Scott, I understand your point but it's sad that they would have to take that stand.... why can't immunity be offered in cases like this ?

Pavel Lishin, verified:

You can't provide immunity from bad press. A drug passing clinical trials would be on page 40 of the New England Journal of Nobody Reads This Thing. If a drug failing in a controversial, high-profile case, the newspapers would invent a way to have two front pages just so they could put the story on both.

Mike Orren, verified:

More:

http://www.pharmalot.com/2008/10/biog...

Mike Orren, verified:

Some of my uber-practical friends brought up a good point last night. Ethics aside, why doesn't a guy as wealthy as Fred go buy some of this stuff on the black market. Or just ask someone with Chrohn's to contribute a couple doses. If there are thousands of people taking the drug, seems someone would pony up.

Lisa Lawrence Merritt, verified:

Well DC, it is that time of year. Garlic and steak anyone?

Scott Doyle, verified:

You're saying something that was newsworthy beforehand no longer applies simply because someone's dying or dead?