Ailing Dallas Lawyer Fred Baron Denied “Miracle Drug”
Several concerned FrontBurnervians have passed along this Gawker item: Fred Baron, known most recently for his involvement in the John Edwards scandal, was diagnosed with final stage multiple myeloma. Biogen makes an antibody that doctors believe to be an exact match to Baron’s tumors. The CEO of Biogen has said no, despite pleas on Baron’s behalf from the likes of Lance Armstrong, John Kerry, Bill Clinton, and others. Baron’s son Andrew has written an open letter to the Biogen CEO, hoping to change his mind before it’s too late.
Update: According to Andrew’s Twitter feed, his father got access to the drug in question. Continued best wishes to the Barons.
29 Comments to “Ailing Dallas Lawyer Fred Baron Denied “Miracle Drug””
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That is cold but I, as the Gawker commenters obviously are too, am wondering why he can’t find a doctor or clinic willing to administer the drug for an off-label use or find a doctor that will diagnose him as having MS, the ailment the drug is FDA-approved to treat?
I fear the answer may be not in the drug company or the doctors but something to do with insurance approval. But if that is the case, surely he could just pay for it out of pocket without it being covered by insurance, right?
This is just screwy. It is akin to seeing a wreck victim on the side of the road and standing still and ho-humming while blood pumps out of an artery instead of trying to stop the bleeding.
The behavior by this guy really has the appearance of a felony. Failure to render aid.
And, look, my fellow chumps, if these guys will screw over Fred Baron, the rest of us are no doubt regarded as more worthless than the splat of a tiny bug on the windshield of a Bentley.
@amandacobra echos my thoughts. Also, how often do pharma companies directly distribute medications to users? Seems that would only open the company up to a bunch of liability, for rushing to provide a drug that has just as much potential to be blamed in a court of law for *not* working.
I’ve known several people who’ve received drugs for other than their intended use. The doctor diagnosed them with whatever the intended use was and then administered the medication. This sounds more like a political stunt than a true plea for help.
But I hope his father gets treatment. My own father died from Multiple Myeloma 3 years ago.
to amandacobra
no release is 100% fool proof.
Sometimes doing the right thing ought to triumph over caution, pettiness and fear.
no upside? i’ll forgo the obvious retort.
but what about the PR upside? (and downside of not providing it)
As I posted on Gawker earlier there’s a significant problem regarding everyone’s suggestion that it simply be prescribed and administered “off label”…which, with many drugs would be easily accomplished. The problem is that this particular drug is released and administered via an onerous review and approval process.
“Tysabri is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive Tysabri, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.”
As a physician i can tell you that the company is simply following the rules that the FDA has for drugs that are in trial. If he does not fit the criteria that the FDA has deemed appropriate the coompany will be in violation of the rules and risks the trial being shut down. Having said that there is often a “compassionate use” clause in all these trials that has been used many times with new anti-HIV drugs. Hopefully someone at the FDA and Biogen will see fit to help him…
It is stated in a dembot.com comment (where the letter is posted) that “…Tysabri has just started clinical trials for Multiple Myeloma and they may feel this would compromise the trial somehow.” I think that pretty well nails it from where I sit.
I’m in a clinical trial right now for a cancer drug. The paperwork, and what conditions you must be in, are strict and methodical. No off-schedule use is allowed — period. I fear that’s the predicament he’s in. If Tysabri WASN’T in a clinical trial for the very cancer he has, then off-schedule or “compassionate” use may be an option.
What’s missing from the letter by his son are the facts around this. I’m guessing that he tried to qualify for the trial and was rejected. NO use of it at all would then be the result.
So THEN the letter and connection-pulling started. That’s what I think is going on.
I applied once to be in a drug trial but was turned down when they found out that I had had a certain test. That test disqualified me. I suspect that we don’t have the full story with regards to Mr. Baron’s condition and the pharma firm
Mayo Clinic is NOT the place to go for any kind of cancer. Get to MD Anderson, or believe it or not—University of Arkansas Medical Center. It’s THE world-famous center for multiple myeloma treatment; they treat more of it than any other place in the world: http://myeloma.uams.edu/
Mayo is known for doctors being stodgy, stubborn, and conservative.
And by the way…even tho the FDA said they will give Baron a waiver to get treated, a bad result in Baron with Tysabri will STILL torpedo the Tysabri trials in MM. That’s because our FDA sucks very badly, and they will not be able to separate, in their pea-brains, Baron’s experience from the trials….and Biogen/Elan KNOWS THIS. That’s why Biogen is not allowing your dad treatment.
Also–”giving” Tysabri is not just a simple injection. It’s an infusion, which means there are other drugs that MUST be given before and maybe after.
Slight correction to the above….Mayo is known for their ONCOLOGY doctors being stodgy, stubborn, and conservative. I wouldn’t let them treat my dog’s cancer. I can’t imagine how Baron ended up there, what with MD Anderson right down the road….oh, I know: he was referred first to a doc in Dallas, and Dallas oncs feel competitive with MD Anderson. So they won’t send patients there.
Note to Dallas cancer patients: go STRAIGHT to Houston to MD Anderson. Don’t waste time. Hate to say it but it’s true.
“While I agree with you completely, I think the other comments are saying that if you were injured and bloody by the side of the road, a lawyer would either give you his card or sue you for making him late for court.”
They are hanging around the wrong lawyers then. This wouldn’t describe any I spend any my time with and I hope not me. I understand the animus against attorneys, but the generalizations wear awfully thin.
Best wishes and prayers for Mr. Baron and his family.
I too suspect that we don’t have the full story with regards to Mr. Baron’s condition and the pharma firm. The way I figure it, he has enough pocket change to buy Biogen. Its the few bad apples and jealousy that that give the profession a bad rap. I have met Fred a hand full of occasions in both personal and professional occasions and I always found him to be a cool dude. If Im not mistaken, he is about to or just had some new babies. I wish him and his family the best.
Julie, MD Anderson is great, but it is not the be-all and end-all of cancer care in the U.S. There are many centers of excellence DEPENDING on what you have. UT Southwestern is huge in many kinds of cancer. I know - I researched them all for mine, inc. MDA. I stayed here.
Blanket statements such as “Note to Dallas cancer patients: go STRAIGHT to Houston to MD Anderson. Don’t waste time. ” are only as good as blankets themselves. They may provide comfort for the person with it, but provide nothing of substance for those looking for one themselves.
Thus, please temper your enthusiasm, as it’s hard enough already for people walking in those shoes.
Also, WRT Baron the drug: it’s important to note that it’s not just the FDA that’s involved. All clinical studies have internal review boards that are set up by the funding company (Biogen, in this case) and the hospital. If the Nationla Cancer Institute has provided money, then they will be involved, too. The boards run the trial and it’s via said trial that the hospital gets the drug. It’s not just sitting on shelf 6 floors away, being kept from Baron.
It might as well be in Bogata if he didn’t qualify up front — which is what I said earlier is the likely case.
Is Mr. Baron at an end stage part of a disease and Biogen is refusing to give him a chance at extended life?
Are we assuming that they are not doing this because of his political beliefs or they fear a lawsuit? This is the way I read it but know that can’t be right.
In the peak of the AIDS epidemic in Los Angeles, they had some sort of compassionate fast track for people without much hope. In order to get the experimental medications, one had to sign multiple legal papers that would insure the patient or the family would not sue. It was pretty much a no sue contract.
I don’t believe that any company would withhold potential live saving medication due to someone being a liberal or conservative.
Again, I think I must be missing a part of the story. Regardless, my heart goes out the Baron family and my chants are with them.
MD Anderson is a tired cliche. They do some good work, but I wouldn’t send my dog there after seeing too many friends go there and come home to die. I’d opt for National Cancer Institute in Bethesda - they are truly on the leading edge of cancer therapies and research.
I doubt Baron is seeking a trial and it would take too long for him to go through the qualification process anyway. But it is surprising that here Biogen has a willing guinea pig which could potentially create a new kind of trial application in addition to the one already going on and yet they’re turning their back on this prime opportunity. We don’t have the whole story. But I do wish the best for Baron in his last days and peace for his family and friends.
The National Cancer Institute in Bethesda is a funding and a research facility. Only patients with the precise kind or stage of illness under investigation are admitted for treatment to their clinical operations. ALL patients must be referred by their physicians.
The reason many patients come home to die after going to Anderson is because they go there too late…after they’ve spent too much time being under- or mis-treated in Odessa or Lubbock or Timbuktoo.
Sorry, but I’ve been involved in oncology therapeutics for 20 years, and Dallas can’t shine MD Anderson’s shoes. Dallas is improving, and they are serious about improving the quality of cancer care here, but they have a very long ways to go. I know oncologists at both institutions (as well as San Antonio, Los Angeles, Chicago..) and that’s just the way it is.
My husband went to MD Anderson, and while they couldn’t recommend any treatments other than what his local Dr. had prescribed, we had the most amazing experience. It was quiet, serene, comfortable and for being so busy amazingly not “crowded”.
One elderly man was there alone, and a nurse came to cover him with a blanket in the waiting room. He must have been lonely, he started telling her how he’d worked aboard a nuclear submarine all his career, and this was his 4th time to be diagnosed with cancer in 20 years - you could hear the fear in his voice. She must have been busy, the waiting room was full, but she patiently listened and then asked if he would like a glass of water or something else.
All of our scheduled appointments with doctors, tests, nurses were spot-on timewise, the only reason we had any wait at all was because we arrived early.
My father went to MD Anderson and although the situation was difficult, the care he received was top notch. He had Cancer of an Unknown Primary Origin and when you don’t know where your cancer is coming from, it’s exceedingly tough to treat. His cancer was aggressive, but the staff at MD Anderson was determined, through and creative when they needed to be.
When he was originally diagnosed in Dallas he was given 6 months to live, he died 2 and a half years after that first prognosis. I credit MD Anderson for giving me that extra time.
Folks:
To those late to this post, Wick has been suppressing (don’t say “censoring”) opinions that he finds objectionable. There were interesting, and arguably important, comments about the nature of our litigious society and its unintended (and in Fred Baron’s case, tragic) consequences.
Suppression of opinions with which Wick disagrees is certainly within his rights as the owner of this blog, but it’s regrettable. Anyone can see that the post itself, like O. Henry’s “The Gift of the Magi,” was intended to show irony in the classic sense. The deleted posts explored that irony, in some cases crudely but in the bulk of them with sophistication and nuance. If Wick was concerned about the sensitivity of the subject to Mr. Baron and his family, that’s certainly laudable and legitimate — but the post itself should have been taken down, not selective comments.
True conservatives, of course, believe in the marketplace of ideas — and are not afraid to pit the strength of their ideas against those in opposition. None of the comments that Wick deleted were attacks on Fred Baron personally — but rather commented on the perversion of the plaintiff’s bar in general, which is fair game.
Our hearts go out to Mr. Baron and his family, but the unique factual circumstances of his case cast in high relief the problems of high-dollar litigation run amok. It’s something worth talking about.
@ Marty Cortland: It’s fairly obvious, I would think, that we do not delete posts with which we disagree. We do delete posts, and will continue to delete posts, that cast personal aspersions on others or indulge in uncivil discourse. The marketplace of ideas allows you to set up your own blog, publish your own magazine, buy your own radio station, or hang flyers on doorknobs. It also allows me to operate my business by my rules. (Of course, if you’re willing to pay last year’s multiples, you could make any rules you like!)
Wick:
Meaning this as high praise, it is always a pleasure to disagree with you. With our fellow countryman Mr. Obama poised to take the presidency, I expect to have the opportunity to indulge that pleasure for at least the next four years (which is all the pleasure I can stand).
That said, we see eye to eye on a Dow 14,000.
“We do delete posts, and will continue to delete posts, that cast personal aspersions on others or indulge in uncivil discourse.”
Wick Thank you!
It has become tiresome to on other blogs to see the personal attacks or slurs tossed at others. So thank you for keeping the postings here civil
Jeffrey Weiss (who, incidentally, himself has had cancer) has an informative article on the front page of today’s Metro section of the Dallas Morning News explaining why Biogen’s hands are essentially tied from permitting off-label or compassionate use in Mr. Baron’s case. It should clear up a lot of the speculation in the comments to this post.
“We do delete posts, and will continue to delete posts, that cast personal aspersions on others or indulge in uncivil discourse.”
Mr. Allison is exactly right — he can do whatever he wants with this blog. However, his description of what is being deleted is flat out incorrect. I had a post deleted that did not cast personal aspersions on Mr. Baron or his family or indulged in “uncivil discourse” — my post simply pointed out that while I certainly felt empathy for Mr. Baron and his family, Biogen’s hands were tied because you can never come up with a release that is foolproof, particularly when one would argue that any release signed by Mr. Baron at this point would be signed under significant duress given the situation. Biogen’s fear of litigation
By the way, it is correct to call what is being done censorship. It is not censorship by the government, which has constitutional implications, but it certainly is censorship (even if Mr. Allison has every right to do it). Note that I do not object to deleting the vulgar comments such as those posted by “wannabe,” but what has happened here has gone far beyond that.
Oh, and it turns out that some of the claims being made by Mr. Baron’s son in his attack on Biogen apparently are incorrect. (Per the DMN, “Andrew Baron says on his blog that the FDA agreed not to consider his father’s case in future evaluations of the drug – a claim denied by an FDA spokesman.”) Again, you can’t help but feel for Mr. Baron and his family. However, as my deleted post said, there are two sides to this story and the tarring and feathering of Biogen is unwarranted.
And now the rest of the story:
Naomi Aoki, a spokeswoman for Biogen: “The FDA notified us yesterday afternoon that they’re going to be working directly with the Mayo Clinic to address this situation,” she told the Law Blog. Aoki went on to explain that the Biogen drug, Tysabri, was approved for multiple sclerosis in 2004. But then Biogen, according to Aoki, voluntarily withdrew Tysabri from the market because it had caused a brain infection, known as PML, in three patients.
“We did a safety review, consulted with experts on PML, and worked closely with FDA to come up with a risk management program that allowed us to bring it back on the market in a way that limited its use,” says Aoki. Tysabri, she says, is now one of the most regulated drugs on the market and the risk management program prohibits its off-label use. She says Biogen is currently conducting a phase-one safety trial testing Tysabri on multiple myeloma — the type of cancer that Fred Baron was reportedly diagnosed with last week.
http://blogs.wsj.com/law/2008/.....harma-ceo/