This is a story that’s bound to explode onto mainstream media today. RocketBoom founder Andrew Baron’s father, Frederick Baron, is dying of multiple myeloma, a particularly nasty form of cancer. Last week doctors gave him days to live – as of this morning he’s still fighting.
According to a blog post by Andrew, the family was preparing for the worst. And then a possible miracle cure: one of Frederick’s doctors discovered last week that a multiple sclerosis drug called Tysabri, produced by Biogen Idec, may cure the cancer.
The drug was not FDA approved for treating multiple myeloma, but Baron’s father has friends in the right places – Lance Armstrong, President Bill Clinton, Senator John Kerry, Senator Tom Harkin and Senator Ted Kennedy all personally requested that the FDA approve the use. FDA head Andrew von Eschenbach ok’d it, and the drug was moved to Baron’s hospital.
But then things get crazy. The CEO of Biogen Idec, James Mullen, has apparently refused to approve the experimental use of the drug for Baron, despite personal telephone calls from all of the individuals above.
What is he thinking.
As far as I can tell, there is no downside at all to letting this go through. It’s not like there’s any lawsuit that might come of this if he approves it. And he can then call in favors from, well, Lance Armstrong, President Bill Clinton, Senator John Kerry, Senator Tom Harkin and Senator Ted Kennedy. But by denying the request, and angering some of the most powerful people in the country, he’s setting up a PR nightmare for himself and his company. Plus, there’s some serious bad karma coming his way.
Either there’s more to this story or we’ve just been introduced to one of the dumbest CEOs in America. I’ve emailed Biogen Idec for their side of things.
This is one of those times where someone in our community needs our support. Andrew tells you how we can do just that in his blog post.
FYI, it’s Senator Tom Harkin, not John. He’s been instrumental on issues like this before.
And my best to the Baron family. I’ll say a prayer.
thanks, corrected.
Michael – you need to monitor the comments, do a quick bit of fact checking and then seriously update this. The stary as stated smells fish y and looking through your own commenters for the serious ones you find out that
a) the person dying is a famous trial lawyer known for taking drug companies to court for off label use of drugs
b) there are so serious side effects from this drug that the suggested use is quite possibly going to kill him ANYWAY
c) letting him use the drug ‘officially’ will open a can of nasty legal worms in the future for other people that could in turn open the company to lawsuits that could shut it down
d) the doctors in question are refusing to step up and dispense the drug outside of a complex legal process – surely they are as much at ‘fault’ as anyone else
interesting tidbit about the fellow as well can be found here…
http://www.pega...t-life-threate/
gee I wonder what is going on? Perhaps the guy wants to make sure that their IP for this application of the drug is protected before we find out if it works or not…
American Medical System: SURPRISED!!!!!!!!!!!!!!!!!!!!!!!!!
Just vote Obama, his mother died from Cancer and couldn’t get help from Insurance companies.
Maybe someone like this in Office will understand
…or you can tell the world what you think about James Mullen’s behavior on his profile: http://www.pers...ames/Mullen/148
Before anyone posts a comment bashing you for non-tech related news, let me commend you, Mike, for keeping things in perspective and giving your readers things to think about that are more important than startups and Web 2.0.
I’ve lost a close family member to cancer, and will do all I can to help Andrew and his father.
yeah well today is biotech day at techcrunch.
if there’s a chance biotech day can save a life, let every day be biotech day at techcrunch!
Michael-
I’m no expert, but I am fairly certain that in the US, a doctor can prescribe a medicine for use, whether it’s approved for that purpose or not. This happens all the time – the drug companies apply to the FDA for an indication (i.e. an approved use for the drug), yet doctors prescribe drugs for non-indicated uses.
What does this mean? It means that the doctor can prescribe this medicine for this use, and the patient can be treated.
What you are discussing here is an issue of liability and payment. Who is liable if something goes wrong? Who pays for the medicine?
I think it would be reckless for the CEO of the company to listen to a bunch of non-experts and make a decision based on that. If there’s a doctor who wants to prescribe it for a NON-INDICATED PURPOSE, and the drug company distributes it, the drug company’s liability can be reduced.
Sounds like either they are asking the CEO to step up and act as the doctor in this case, which is inappropriate (even if he has an M.D. – has he even seen the patient??) Perhaps a better approach would be for Clinton, etc., to appeal to the doctors and/or insurance companies to prescribe and pay for the medicine.
I think there are more facts here that are missing.
I repeat my disclaimer – I am no expert in this field, though.
Bob, doctors can prescribe medication to people for off-label purposes, but only if the drug is approved by the FDA for administration in the first place.
James,
Michael mentioned that the FDA approved it. See Michael’s next green comment below…)
So – and what do I know – I think that a doctor just needs to prescribe it. Not the company CEO. A Doctor.
Maybe I missed something, but isn’t off-label use OK? How can the CEO of the company legally stop that?
http://en.wikip...i/Off-label_use
“…However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine, and so the physician makes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates, even though it is a common misconception that it is unlawful to do so.”
From the OP:
“The CEO of Biogen Idec, James Mullen, has apparently refused to approve the experimental use of the drug for Baron, despite personal telephone calls from all of the individuals above.”
Tell me I’m not reading that. Please someone – tell me I’m not reading that. How can he interfere?
Talk about bad PR. Take a look at the #1 paid Google result from “James Mullen”: http://www.goog...;q=James+Mullen
Could it be because Biogen could be liable for damages since the drug is experimental? Although an indemity form might solve it, FDA might not see it the same way?
I don’t think you read the article, he’s friends with the FDA head and they approved it.
well idk but the dumbest ceo ! comeon …maybe he knows something we don’t know! or he has this thing in mind ” if it doesn’t work …say goodbye to my company”
Yeah really. Dumbest CEO? Don’t you remember Carly Fiorina?
While I send my best wishes out to the Baron family, at the same time there are usually pretty good reasons for the FDA to disapprove of anything going public. As you say yourself, you don’t know all the facts – perhaps it would have been better to collect them before laying into a company?
Another thing that is slightly worrying is the “names” that believe they can change federal ruling just because they have a little star power attached to them. Unless my missed my updates on celebrity bios, I don’t think any of the senators you mentioned (or Lance Armstrong) are medically qualified to decide whether a drug goes public or not.
By all means, I’m for fighting cancer at every turn (I lost several immediate family members to various forms). But the research needs to be carried out, checked and double-checked before unleashing something that could potentially cause even more pain, discomfort (as well as any health risks).
The FDA approved it.
Sorry, what I meant was that the FDA did not approve it for use in this particular cancer treatment. Only after severe pressure from non-qualified “names” was it approved. Which makes it even more worrying.
he has days to live. not sure what the downside is to trying anything that has a chance of working at this point.
How about liability for side effects? The FDA must have had a reason for not approving it in the first place, and also who better than the owner of the company to know whether the product is “right” or “ready”?
Again, more facts are needed for the whole story before deciding someone is in the wrong.
The FDA approved it only for his case. It means it can’t harm anyone else.
No? So no-one else will clamour for this if Baron receives it? And what happens if Baron passes before there is any proof either way whether the drug was effective or not? Will Biogen/doctors say to other terminally ill patients: “Sorry, you can’t have this – it shouldn’t have been okayed, we only did it for those with influence”?
Sorry, there still needs to be full facts on why it was rejected by James Mullen as opposed to painting him and his company into a “bad corner”.
It’s nice that the have’s are able to jump and get attention – what about the have not’s/ Guess they are suppose to die. We are all connected, so why not reach out to help all?
The easiest way to think about it is the rich get to be the test subjects. The bottom line here is with this news lots of people with this desease might have hope now. Yes it is hard to swallow that the rich get everything first but that is kind of why you want to be rich…
Andrew,
I just emailed you, please get in touch. For the benefit of the community, and maybe Mr. Mullen….
Having lost my father to cancer last week, I understand what you and your family are going through and my prayers are with you. I grasped at any glimmer of hope, new treatments, pushed doctors to listen…it’s frustrating when you here “we can’t do it because it’s not approved yet”.
We were told last December that my father had a few weeks left. He fought like a champ but ultimately passed on Oct 6, 2008 as I was by his bedside.
Mr. Mullen – Please allow this drug a chance to work. Do it because it might make histroy. Do it because if it works your company might be the first to cure cancer. Do it because no matter the risk, the reward is worth it. But ultimately do it because it is humane, logical, and a show of inhumanity and evil if you say no.
Andrew – KEEP FIGHTING. STAY STRONG. Again, I have emailed you personally and will help in any way I can.
Thanks,
Jaafer
As much as I’ll probably go to hell for saying it – this response feels like a “Excuse me Sir, there is a pigeon in your bank account” e-mail from Uganda. Andrew, don’t give him your bank account details!
p.s. Michael I agree with you – either there’s an alien conspiracy behind this or James Mullen is a first rate ArrTard.
Hey asshole, this is a genuine offer to help as I just lost my father to cancer last week so I know what Andrew and his family are going through. Guess you weren’t in line when God gave out human decency.
Unfortunately, Mr. Barron’s case is not new nor unique by any stretch, as tens or hundreds of thousands of patients lose their lives each year without being able to access the promising and potentially lifesaving new therapies that are either in our clinics being tested right now (and have been on average for more than
7-10 years).
I hope some of you’ll take the time to come visit our site, read our introduction, see the passion in our mission and work and understand how sadly necessary our work is for people just like Mr. Barron (or Anna Tomalis, who couldn’t get access to a new drug to save her life because she was only 12 1/2, or Bruce Tower who can’t get access to a biologic that already helped him and is probably the reason he’s still alive, but he is not allowed to get a booster…the list goes on). We must address the systemic issues that create so
much volume in ’symptoms’ like this case.
I hope you’ll help us so that we can create a system where there are far fewer families going through this hell.
This is a very, very difficult issue to build awareness about. Drug safety issues are easy by comparison. Failures to approve new therapies in a timely manner,
slowdowns in development of new molecular entities, lack of funding
for other important initiatives like Critical Path and issues facing
those with more rare cancers, are not “sexy” issues, but they are
vitally important ones. The amazing research we are doing in
understanding cancer biology, in developing translational medicine
approaches to truly personalize treatments against cancer, none of
these advances achieve societal benefit if they can’t reach patients
and right now, they can’t and they don’t. We, as a society, are
incenting continued development of ‘me-too’ incremental additions to
existing therapies rather than the truly paradigm-shifting advances
that are so desperately needed. We are incenting a “one-size-fits-all”
approach over the truly individualized biomarker-driven therapy that
is so desperately needed.
I welcome your visits and comments and your help in accelerating progress for all those in such need.
–
Scott Riccio
Director
Accelerate Progress
http://www.acce...ateprogress.org
director@accelerateprogress.org
In today’s market it is common for pharmaceutical companies to get additional patents on drugs as they change certain factors like the delivery system (pill A made of talc vs pill B made of supertalc+) perhaps the CEO is seeing a possibility of a break in the patent chain for his drug and huge potential for lost revenue.
Good thing Lance Armstrong, President Bill Clinton, Senator John Kerry, Senator Tom Harkin and Senator Ted Kennedy are all medical school graduates, as otherwise their “medical requests” would be meaningless…
Didn’t know you had to be a medical student to understand that if someone is about to die, and you have a drug that has a chance of working… you try it. You don’t exactly need Dr. House for that one.
House would just give him the treatment… so should they.
This has nothing to do with them being medical school graduates or not. They already said some of the best doctors suggested the use of that drug.
I don’t understand how the drug company (CEO or otherwise) can block off-label use of their drug, especially if it has regulatory (FDA) approval. Baron mentions that the drug is “readily available, cheap and even sitting in our clinic’s pharmacy.”
If the pharmacy has it, the physician prescribes it, the pharmacist dispenses it, and oh, by the way, the FDA is okay with it (generally an unnecessary step in the common practice of off-label use)… what is the CEO of the drug company going to do about it?
Likely by telling the hospital;
“If you ever want another shipment of the life saving drugs our company produces don’t you dare go against our wishes.”
Yes, rahlquist, agreed. That trumps my reply to Eric made just seconds ago.
I agree with Eric; if the drug is physically available and the physician OKs its use, especially if the patient & family acknowledge the risk and the fact that this is experimental, then by all means, the patient should be taking the drug! There should be nothing the CEO of Biogen Idec can do about it at this point. If this drug is needed for this use in the long-run, he could possibly convince his company to pull the drug from the market to prevent this use, but for right now, his viewpoint is irrelevant in my opinion. (Probably much like my opinion here.)
I wish people would not use their “friends” in the “right places”. That’s just one way of corruption (emotional corruption), not true democracy where everybody has the same rights and duties.
I’m sorry for the person dying.
Get his Dr. to say he’s suffering from Chrones or he has been dx’ed with RRMS.
How many people have died of multiple myeloma who did not happen to have Bill Clinton and Lance Armstrong in their Rolodex?
Perhaps the CEO is making a point about the FDA limiting access to life saving drugs?
Should Frederick Baron get a special allowance because he has political influence over the head of the FDA?
Would the head of the FDA afford the same to you?
And the best way to go about this is to force someone to die to make the statement? I dont think so. I think what you see here is the fact that corporate America has more power over healthcare than the people administering the care.
Who cares? We’re not here to debate the workings of the system. Yes, we all know that those with the right connections get preferential treatment; but that’s no reason to let a man die just to make a point.
Brandon, just to clarify, the tone of my statement is directed not at you, but rather at the situation in general; it’s a completely despicable mess. Sacrificing a man’s life to make a point about equality – or lack thereof – would be about as callous as it can get.
Here’s hoping the CEO has better reasons than that…
Oh, I totally agree.
I’d give the guy the drug, no doubt.
And then I’d make the case afterwards.
Plus, i’m only speculating the issue Biogen has is with the FDA playing favorites to politically well-connected individuals.
It could be that the Biogen guy really is evil, but I doubt it.
Either way, my cancer doc, with 48 hours to live, shouldn’t need to know Lance Armstrong and Bill Clinton and special approval from the head of the FDA to get me the good stuff.
There is a point to be made here, but Biogen *is* committing PR suicide.
The press will paint this as an evil drug company killing a man, while ignoring all of the previous multiple myeloma victims who died without access to the drug.
Well .. Since you got nothing to lose you should look into taking loads of Maitake D fraction . Its a supplement that fights cancer cells ..
Google – Maitake + Cancer ..
This makes no sense. Doctors constantly prescribe things off-label, I dont understand why the CEO of Biogen was contacted in the first place? If the physicians thought it would work, they would have just prescribed it. They do it all the time. For years they have been giving PD drugs to RLS patients.
This definitely comes down to a liability issue, and I think I give more fault to the hospital and the doctors for going to Biogen/FDA in the first place to try to cover their butt from a lawsuit than I do Biogen for doing so.
Thoughts and prayers are with the family.
Bosgal is right. Why on earth wouldn’t the family get a doc to Rx the drug and then have the father take it under the radar. Ditto on the prayers.
I agree to this. The hospital paid for the drug so it should be the doctor’s right to use it as they wish. they should not have contacted the ceo.
Odd how the man dying has made his fortune suing companies like Biogen and helping to create the atmosphere that makes the company/CEO turn down his request for fear of legal repercussions.
I am sympathetic to the family but in this case the caution seems warranted. Tysabri was pulled from the market once before in 2005 after a few patient deaths. It was put back on the market with a black box restriction and very narrow use cases. It is a very powerful drug but there are side effects that are unknown outside of ms patients.
The downside for the company is that regardless of the outcome of this specific case, patients everywhere will start requesting off label usage of Tysabri without knowing the true implications of the drug. How do you say yes to this one case due to political pressure while denying other patients also looking for the miracle cure? But in the end, this is one of those decisions without a clear right or wrong answer.
No, not really. He’s going to die. If he agrees not to sue and wants the drug, he should get the drug, period.
Even though he should have gotten it already without the drug company involved.
This nanny-state bs has to stop.
1.) My heart and prayers go out to the family.
2.) I think if a patient wants a treatment and the doctor is OK with it then I am all for wide latitude in such matters.
3.) I think the FDA should be privatized and operate something like an Underwriters Laboratory – there is definitely some role, however the FDA is far too bureaucratic.
HOWEVER – if I or one of my family members end up in similar circumstances, I don’t think Lance Armstrong, President Bill Clinton, Senator John Kerry, Senator Tom Harkin and Senator Ted Kennedy will have my back.
Perhaps they could all get together and lobby to change the laws for ALL of us.
Welcome to the world of tort lawyers. Also, welcome to the world where drug companies spend a lot of money trying to make the right drug and don’t want the entire program scrapped by allowing random uses that could lead to death or serious injury. In a perfect world, this would be a no-brainer. Unfortunately, we live in the real world. Leave the CEO alone.
i notice no.3 on his post …i emailed andrew ,i guess we can do something for this in jordan ,middleast…lets hope he can solve it without traveling
There’s a wider issue here, which is why terminally ill people should have any restrictions at all on what they can try to do to save their lives. There ought to be a place you can go, where you can be educated about all the experimental treatments available and then take your chances. Allowing people to die because a drug is not approved yet seems very callous indeed.
It could also be that this treatment is bogus, the CEO knows it, and he doesn’t want it used on a patient with friends in “high places”, not to mention the fact that his son is entrenched in the social media world.
Of course this speaks volumes to the state of health care in this country. In order to even try and get a new treatment, someone has to know politicians and ex-presidents. This is a disgraceful form of un-natural selection. An individual’s health shouldn’t be subject to the laws of capitalism.
Here’s hoping we evolve….eventually.
yeah thats what i was trying to say on my early comment..i agree with u
1. Let everybody have access, not just those with friends in high places
2. Give drug Companys immunity from tort if drugs tried under such circumstances don’t work.
3. FDA not to hold side effects seen on unauthorised use against the Company.
Now THAT is a common-sense idea. Which is why, sadly, those in power won’t let it through…
If the patient has been immunocompromised, giving him Tysabri would put him at extreme risk of PML, a brain virus that has a lethal history. While Biogen and Elan have developed a way to remove Tysabri from the system quickly, in an immune compromised patient, a patient that doesn’t have the natural ability to produce the antibodies necessary to check the virus, the PML would continue to develop and eventually kill the patient. Biogen and Elan are both struggling against a pr nightmare with Tysabri and PML.
On top of that, they have initiated trials specifically for multiple myeloma. Their hope is to carefully select patients who can benefit from Tysabri that also have a relatively intact immune system. Outside of the trial, if the patient dies, it will have negatively impact the trial results even though the person wasn’t in the trial under controlled conditions.
In the big picture, they may not want to risk drug development complications by providing it to a patient for whom it may have an unacceptable risk profile. If the drug works, think of the thousands of multiple myeloma patients who would suffer if development of the drug were slowed or stopped. Beyond those patients, another incidence of PML would affect the perception of Tysabri risk overall. The loss of Tysabri to patients could go well beyond the multiple myeloma indication which would be a catastrophe for Biogen, Elan and the many patients who suffer from diseases for which Tysabri helps.
Exactly. Tysabri is approved for relapsing forms of MS in the United States and relapsing-remitting MS, not cancer.
While its tragic that this guys is dying, the company risks more by providing the drug to patients that are out of the approved scope of the drug. The drug has serious side effects, like PML (progressive multifocal leukoencephalopathy).
Drug trials are carefully designed and patients are carefully screened so data that is collected can be properly analyzed. Just giving the drug to some random guy, doesn’t advance the drug development and may put the franchise in jepordy.
So a person is dying and there is a chance he can survive. So someone is able to pull strings and get some drugs, the full facts beyond that are unavailable to all and therefor it is unreasonable to pass judgment.
It is interesting though that of the millions who are dying of cancer rare or common most have little or no recourse to the path of their journey to the end, here we may have a chance to change that using the influence few if at all have, lets hope the person gets a chance, we can always discuss the merits of how and who gets to benefit later.
If they cured this man’s father miraculously in his last days of life with this new drug, they’d have to cure everyone thereby ending the drug companies’ hold on the American people.
Why are we still treating symptoms and not the cause of this disease and others just as devastating? That’s a question to ask these multi-billion dollar companies who have their hand in everyone’s pocket in Washington. And why are we (meaning people who should know better) accepting that this is the only way to deal with dis-ease? Why do we take western medicine at it’s word and continue to pump chemicals into our bodies that do nothing but mask the cause? We all have the ability to succumb to illness, we also have the ability to make and keep ourselves as healthy as we can thereby limiting our vulnerability to these terrible things. When will drug companies encourage us to do so? Never would be my guess. A world of healthy people would put them out of business. No junkies left. No drug pushers needed. Just some stuff to think about…..
Ok rant over. If I was a good christian woman, I’d keep this man in my prayers. Since I am not I will just send positive energy and thoughts out to him and his family.
This is so ironic.
Fred Baron, millionaire trial lawyer who dedicates his life to promoting lawsuits– including those against drug companies for allowing “off-label” uses of their products– now is begging a drug company to let him use its product off-label.
Of course the company should comply with his wishes. And then Fred Baron should repent and apologize to not just drug innovators, but the millions of patients who didn’t get their cure because the lawsuits Baron promoted pinned our drug industry down, focused on fighting off parasites like him and not curing cancer.
Yes, based on what you can read on Wikipedia (http://en.wikip...Frederick_Baron), everybody should be scared of the guy. He even sued his own company.
In any case, does a CEO of the company has a say on when a drug can or cannot be used? Isn’t it what the FDA and doctors are for? I don’t think CEO should be put in such position, it’s not fair on the guy.
from Wikipedia:
Baron has joked about the prominence he and other trial lawyers have in the Democratic Party. In a July 2002 speech, he noted a Wall Street Journal editorial that said that “the plaintiffs bar is all but running the Senate.” Baron pointed to the editorial and said, “Now I really, strongly disagree with that. Particularly the ‘all but.’”[7]
interesting article
His doctors cannot get Tysabri for MM. It is disallowed. This is not standard off-label use. Tysabri for MS can only be obtained by registering a patient through TOUCH registry and Baron does not qualify (he does not have relapsing MS or Crohn’s and likely is on concurrent chemo). The FDA mandated TOUCH, Primary progressive MS patients can not get Tysabri. Non-relapsing SPMS pateints cannot get it..how dare the FDA deny these patients more legitimite needs while caving in to politicos.
The only way Baron can legitimately get Tysabri is to be in an FDA approved study of one individual (him), signed off by (1) him (2) FDA and (3) the sponsor (BIIB, ELN). If any one of the three parties says no, then the study of one can not occur. That’s how things work. The government sets up these rules.
Why would BIIB not do this? Easy, he is outside parameters for clinical study (too sick) and his death will add a further stain to Tysabri, still reeling from 2 recent PML cases.
A 6 year old girl received Tysabri fro very aggressive MS in 2003 and died. SHe was set up in a trial of one (just her) because she was too young, too sick and on prohibited medications to be enrolled in one of the other 2 Tysabri studies. They just don’t want to be burned again and I can’t blame them.
Where are Kennedy, Clinton and Harkin for all the other people fighting the FDA. The hypocrisy of this group of hired help politicians is appalling.
I had my mother pass away from cancer, and I would not wish that on anyone…
That said, this is carma bitting him in the ASS. The greed of money drove this guy to SCREW the drug companies so he could laugh to the bank, well who’s laughing last? I feel bad for the guy but in the end, after reading up on him, I think its kinda funny how his life will end.
Something about this whole story is out of whack. The FDA approved clinical trials for treating multiple myeloma with Tysarbi over a month ago see: http://www.fdan...p;issueId=11938
I am assuming that what Biogen determined was that his father was not suitable to be included in the clinical trials (either because he was so far progressed in his cancer or for other reasons). Given that clinical trials have to be conducted under very defined conditions, nothing unreasonable about that.
However, I don’t see why that would prevent off-label usage. It is, as others have pointed out, a widely used proceedure that doesn’t require any permission from the drug company (or for them to even know). See also: http://www.canc...el_Drug_Use.asp
Who gives a crap.
I waiting for the new Macbook Pros.
Steve Jobs is my God.
What the hell wrong with you?
god bless the internet
fuck it. If the drug is @ the hospital, break into the medicine cabinet, and administer it. Sometimes it’s morally right to break laws.
I agree. This is your father’s life and I would bribe a pharmacist or steal the drug to get it to my dad. I think something else is going on though because if the drugs are in the building, why not use them – permissions be damned.
@ianubis Your lack of reverence for life is terrible. Clearly you have not experienced the emotional roller coaster of having a loved one devastated by cancer and wanting to try anything to hold on a little longer. I hope you never do, even though it would give you some much needed perspective.
I hope you enjoy the empty happiness of your new Macbook.
breaking news!!!
rich famous person treated JUST LIKE EVERYONE ELSE!!
story at 11
Wait, do people like Andrew Baron again? I thought he was the power-hungry jerk who kicked Amanda Cogdon off Rocketboom back when it was good. I thought he was the guy who is not allowed on TWIT ever again because he annoyed so many listeners. I’m SO out of the loop when it comes to who’s a hero of the community and who’s a pariah.
This whole story reeks. Not because it’s non-tech, but because it tries too hard to rally the community to fight on the side of a multi-millionaire, who has pulled a lot of strings in government to get a quick decision on something that an ordinary citizen would have no chance to get.
What exactly has the drug company done wrong here? They’ve decided they will NOT make special rules for someone who has rich and has powerful friends. How is that PR suicide? If anything, the FDA committed PR suicide. It’s much easier to ask why the average citizen never gets the same treatment as this powerful man.
I’m sorry to say, but if Fred Baron has “days” to live, one little drug injection is NOT going to save his life. It doesn’t work that way. It’s not as if the cancer cells are had a meeting and decided that this coming Friday is the day they will attack his body. They are attacking now. They have been attacking for months. His body is ravaged. Not to mention pumped full of the other drugs and treatments he’s tried up til now.
This drug treatment is not, and cannot be, a miracle cure. It would be like throwing water on a fire that is almost done. The house is already destroyed – the fire has done its work.
This is precisely why the drug company has denied it. It’s right to deny these last chance, days to live cases, because it has absolutely nothing to gain from it and a lot to lose.
And I say this as someone who lost his own father to cancer.
you know i don’t wanna be jerk, here but let me tell you something, unless u r in the same situation as he is now don’t say the fire done its work …i hope u never c same thing but if a kid of urs in same place , what will be ur reaction!
I understand both sides. I lost my father to cancer. I can see how someone would want to do anything and everything, and that an argument can be made that standard morality doesn’t apply. “Who cares if a dying man wants to take an untested drug.” I get that.
But on the flip side, there are rules about drug injections for a reason. Things have to be tested in a lab, tested on rats, tested in limited trials. Results have to be gathered, and success measured. Being rich and powerful does not mean you get to have your name at the top of the list to get this drug, when hundreds or thousands of other patients who are not rich are told “no, it’s not approved for general use yet”.
Either you say yes to everyone, and terminally ill patients have the right to whatever treatment they wish no matter if it’s approved or not… or you do things by the rules. And it goes without saying that the drug company, doctors, and hospital should not in any way be liable if this guy dies 20 minutes after taking this drug. You can’t have it both ways.
Prayers for Mr. Baron and his family.
My sympathies go out to the Baron family.
This unfortunately is a common problem in the fight for cancer. I lost my brother to cancer and saw many of the same issues. On cause of this problem is that drug companies & researchers attempt to find cures that can be isolated and proved in formal FDA trials if they hope to get a drug approved as a treatment option (which can be worth billions ala Avastatin etc. and cost hundreds of millions to go through the process).
This applies for new drugs as well as for off-label or re-approval of an existing medication for cancer.
When CEO’s make the decision not to share drugs that show some promise with terminal cancer patients they are protecting their future options to submit these drugs as part of formal trials with controlled patient groups. Giving out the drug to terminal patients who request it, have no other options and are happy to experiment with anything that may offer hope can in the future prevent or disrupt their data resulting in problems conducting formal FDA trials. So some would say the CEO’s are doing their fiscal or moral responsibility to run the drug through the proper process that would enable it’s approval as a treatment for millions of patients rather then just the one patient showing the urgent need at that time.
(I would disagree with this, but the case could be made)
At the same time, the approach that doctors took to fighting the AIDS virus which was a series of experimental cocktails created outside of the FDA trial system created a number of treatment protocols that have made huge improvements in the life of afflicted patients. This type of process is not possible in Cancer research since even if you are participating in the FDA trial of an experimental treatment you are forbidden from combining it with other experimental treatments which would pollute their studies.
This approach to approving drugs has led to a slow down in innovation of one the front lines treatment protocols as drug companies are hesitant to led their drugs be combined & experimented on by doctors & patients who have no other hope and are more then willing to combine treatments to attempt a cocktail based treatment protocol.
Many leading cancer researchers have begun to push for a change in this process which would allow them more flexibility in combining different experimental treatments with terminal patients – but the costs & risks to the drug companies under the current FDA process is too great.
This is part of the reason why some of the best treatment protocols are being developed and advanced in Europe & around the world. Anti-angiogensis, Cox-2 inhibitors and a number of other treatment options (in the case of colorectal cancer which I was involved in researching for my brother) were all medications that had better options in Europe then in the United States and Canada.
The incremental, prove of efficacy approach of the FDA may seem like a good idea to create good data for proof of efficacy – but I would argue in the war against cancer, which continues to be a elusive and complicated disease we need to have the option to pull out all the stops and throw everything we have at it to be able to create more data about off label use of drugs, cocktails and experimental therapies in combination with the standard chemo treatments.
This is an FDA problem more so then the CEO of the drug company. They’ve created this environment and there are millions of terminal patients who are every year left in the same hopeless situation of having to beg for access to something that has shown some results in labs – but not yet made it through the arduous FDA approval process for treatment in Cancer.
This is by far the best explanation of what’s going on that I’ve read on this thread. Thank you.
Extremely interesting post. Sad situation. There are many factors to consider here:
1 — Tysabri is a monoclonal antigen-produced medication created to treat multiple sclerosis. Only multiple sclerosis. It is available to any licensed physician in the US.
2 — Physicians in this situation probably declined to use it because the patient suffers from another disease. “Monoclonal antibodies” meds work [or not] on only one “target” disease. Using them for another disease is reckless at this time.
3 — If the doctors say, ok, we will give a try, “off label”, the chances of the patient dying are very high. Then, the doctors would be sued for millions, their lives and careers ruined by the lawyers who are already soliciting family members. Arrington is a lawyer so he understands this very well.
4 — There was really no need to call Clinton, Harkin, Armstrong, etc.
Of course, there is much more about this situation.
Holly Wagner MD
Holly, tysarbi is in clinical trials for myeloma now… so using it here isn’t really “reckless”as you say…otherwise the FDA wouldn’t allow the trials.
Tysabri has also been FDA approved for Crohn’s Disease.
This is a tough ethics case because from an emotional stand point you feel for the family in the situation and would like to see the best ending possible and for him to receive the drugs. At the same point he is using his fame and celebrity status of his connections to pressure to bend the rules, something that clearly would never even come up to the average person. There will definitely be mixed emotions for this as I’m sure there are average day people in this situation who don’t stand a chance. Interesting story and I’m surprised this is the first we are hearing of it.
Craig
http://www.budgetpulse.com
I’m sure anyone in his situation would try to bend the rules if they could
I (we?) must be missing something. The doctor doesn’t need approval from the FDA to administer an approved drug for off-label indications. I don’t understand why they would bother rallying friends to petition the FDA. And what kind of ‘approval’ did they receive from the FDA? Not marketable approval for a new medical indication. My guess is that the CEO took a stand against the grass roots efforts to influence the FDA because — well because he runs a big pharma company and that’s not the way you get drugs approved. There are official processes and protocols. The last point is… don’t mistake the CEO’s posture as wishing the patient ill. That’s going too far.
If the doctors will not administer the drug, why does Andrew not do it himself? If he and a doctor are in one room, nobody knows who gave his Dad the medicine.
Wow……. who cares about side effects or liability….. he is going to die………. no way back from there ….. let them do anything they can to save him…….
To the Baron Family – My thoughts are with you.
To All – Regarding the statements: “FDA head Andrew von Eschenbach ok’d it, and the drug was moved to Baron’s hospital. But then things get crazy. The CEO of Biogen Idec, James Mullen, has apparently refused to approve the experimental use of the drug for Baron, despite personal telephone calls from all of the individuals above. What is he thinking.”
Let’s get the facts before jumping to conclusions. The CEO has a fiduciary duty to the company’s shareholders. First, if he approves for this use, everyone will demand the drug before its adequately tested. However, if it works, why not demand it? The issue is likely liability. Even though the FDA approved it the company can be liable. The FDA has approved many drugs that were later found to have side effects and the drug company was exposed to liability.
As an analogy, remember the EPA approved the use of MTBE as a fuel additive and than Congress passed a law requiring it be used. Later, it was discovered to be a cancer agent and EVERYONE in the MTBE chain (from manufacturers to gas station owners) is now exposed to strict liability.
http://edition....e.ap/index.html
That said, I’d recommend company’s work closer with volunteer patients to develop a solid waiver so untested treatments can move forward more quickly.
I’d note that the Trail Lawyers Association has always been solidly behind President Bill Clinton, Senator John Kerry, Senator Tom Harkin and Senator Ted Kennedy. I’d ask them to join the fight to limit liability as well.
I just called Ohio’s Senator Voinivich, explained the situation to one of his aides and asked to please share this time sensitive info with other politicians ASAP. Please do the same.
The only reason for caring is feeling connected to the rest of humanity, even when typing to anonymous people, from the computer. Your view, ianubis, is your view, and as long as it is not promoting hate and violence, far be it for me not to respect it.
Does the CEO of Biogen deserve automatic reverence because it is a drug company? That’s rhetorical. I think that the CEO does need to offer an explanation for his action, if for no other reason that it is the decent thing to do in this case. I do not have a life threatening illness and am on at least two drugs that are FDA approved for other illnesses. The potential side effects are probably the same as when the research on these drugs was done for other illnesses. Is special treatment being requested? Yes. Health care is a very timely topic worth discussing and attempting to fix, but it’s a debate for another day. Might the results of the Tysabri help both Andrew’s dad and later the greater population? That’s the hope. In summary, no explanation has been put forth, many leaders of our country have interceded, and Biogen’s CEO is still refusing. I can’t help wonder if the man is ego tripping, to be the one that turned down Clinton, Armstrong, Kennedy, Kerry, Harkin, yeah, that’s a real coup in itself. Excuse me, I have a couple calls to make.
To use your same analogy, does a sufferer deserve more “reverence” because of who he knows?
Also, your point about the CEO not saying anything – perhaps if Michael Harrington has emailed/called for a statement first before publishing his point of view, it may have been forthcoming.
As it is, the CEO has been painted the bad guy without all the facts being known, due to (arguably) lazy journalism.
Sorry – meant Arrington.
Whats more important, money, or possibly life? Fiduciary responsibility to shareholders or moral responsibility as a human being?
For a drug company, fiduciary responsability.
Sorry for the post. I don’t know what am talking about.
I did not write the comment “Sorry for the post. I don’t know what I am talking about.” Are the comments attributed to others legitimate? Just wondering.
I hate to imply that I’d let this man die without trying, give him the freekin meds already, but give Biogen an exemtion on trials. If letting terminal patients in on trials botches the results more than just one person is at risk.
This is a complicated story.
Tysabri was approved in 2004, and voluntarily withdrawn by manufacturer Biogen in 2005 when patients developed deadly brain infections during trials. Tysabri was approved again in January 2008, but only for Crohn’s disease, and only as part of a strict program limiting risk of developing progressive multifocal leukoencephalopathy (PML), the deadly brain infection.
On August 26, 2008, two more cases of PML– the deadly brain infection– were uncovered in European patients using Tysabri to treat multiple sclerosis. The patients are European because use of the drug to treat multiple sclerosis is not allowed in the US.
Earlier, on March 18, 2008, James Mullen said to Reuters that he despite increasing cases of PML, he expected 100,000 people to use the drug by 2010, making it a “$1 billion plus per year drug.”
See further research here: http://www.grou...for-Tysabri-Tre
This information does not make any sense for most people. You seem to believe that you “had to do it” because of what? “journalistic responsibility?”
With all medications that modify/depress the immune system [Tysabri is one of them] it it expected that infections would occur. It could be a manageable skin infection, or a deadly brain infection.
You recklessly imply that Tysabri IS causing the infections and that the company producing it benefits financially from ‘causing’ them?
Your ignorance is stunning.
Allison, MD
Tysabri was reapproved by the FDA for MS back in 2007. There are over 31,000 MS patients currently on drug as of the end of Q208, about half in the US. Following the quarterly report, two cases of PML were announced. It was thought that patient use and uptake would fall dramatically. Biogen and Elan have since stated that there will be positive uptake in Q308, but the degree of uptake is unknown at this point. Biogen will announce the new numbers on its Q3 conference call October 21, 2008.
It is interesting in the sense that this situation reminded me of the “Terri Schiavo” case about three years ago. She had a major stroke, and her doctors knew that more than half of her brain was gone, with no possibility of recovery –However, Jeb Bush [the Florida governor at the time] and members of Congress passed “Terri’s” laws that would keep her on life support, totally ignoring the medical reality and her husband’s wishes.
My point is that politicians are what they are [we all know what] and would jump for any chance of having their names mentioned.
Lance Armstrong? he is doing good work with charities, however, he also likes the shine of the limelight… and he wants his name on the press because [he is bored] he will do the Tour de France again next year…
http://www.cure...mmaryD009101.do
Andrew have the docs mentioned either Thalidomide, Bortezomib or Maxidex?
Curehunter is an artificial intelligence engine that has indexed every known disease against every known drug for all positive clinical outcomes and has routinely passed the Turing Test.
So what? You expect that “Artificial Intelligence” and computers is all we need to successfully treat sick human beings? –Oh! but wait!! It passed the ‘Turing Test’!!!
You are an incredible idiot. Are you 12 years old?
This actually happened to a family friend of ours. The difference is to consider the individual vs greater good. In early uses of an experimental drug, the drug companies collect extensive data on the early patients. Doctors will then use this data in the future to decide whether a drug should or should not be used and for what types of patients. For example, even though a drug works to cure A, if a person also has B, they should not use the drug on such person, because they have B.
If the early patients have a high mortality rate, doctors will not use the drug, because they think the drug is ineffective. Thus, biotech companies carefully screen the early patients to make sure the drug is prescribed correctly, and not randomly. Our family friend was actually a candidate for such an experimental drug, but after this was explained to him, he rejected it. He was close to death anyways, and the drug probably wouldn’t have helped. I don’t know if I would have made the same choice myself, but I will always remember his unselfish deed. Sacrificing himself for the good of others who have a better chance.
It sounds like the patient is on the brink of death, and it is already too late. The drug will probably prove ineffective and puts the drug at risk, sacrificing the lives and well being of future cancer patients. Hard decisions.
thanks for explaining. I guess there was more at play than people realized. Forums are like irrational angry mobs even at techcrunch
I would like to confirm what others have written in the previous comments, you do not need the FDA’s approval or the CEOs approval to use a drug off label.
It’s not unusual at all when 0.5% of a drug’s revenues come from off label usage.
All you need is a doc willing to prescribe it.
I won’t judge on anyone until I hear both sides of the story. We need more information.
To all those who are expressing concern about the moral / ideological / political implications of the lobbying for the drug’s approval: try and put yourselves in the situation of Andrew’s family. Any of us would use every influence available to us to help a loved one. The law of “averages” and what’s right for society as a whole simply doesn’t apply when you’re in this situation.
Dont rush to judgement or any assumptions when the corrupt FDA and its corrupt politcian friends are involved. The ultimate scame here is that drugs often do more harm than good…all for reasons of profit. Wake up people!