Best of luck.

Mayo might be a good clinic, but that outfit has been overrun by special interest. Evidence: They have been running trial for Ty in MM for months, yet they keep it a secret. Maybe only the rich and famous would be previlegd to know.

If Fred gets Ty due to FDA’s special permission, how about Joe the plumber???

Anyway good luck and good health Fred.

Please explain how you now tell potential patients in the Phase 2 trial that they may not receive study drug but if your friends are well known and famous enough we can make an exception.

To argue that compassionate use is commonplace with drugs in phase 1 trials is just plain false. I’m happy for Mr Baron’s family but still sad for what this means to others if that makes sense. I also find it sad that doctors have provided Mr Baron’s son with “every expectation of positive results” with a drug that has barley made it in to human testing, yet in MS, patients had to fight, plead, and beg to get the drug back on the market despite plenty of data showing how effective it was as a treatment. Some world we live in.

” no effect on any future study or use” do you have any evidence to support that? I’ve never heard of a study that excludes relevant information when available …

BTW, you assuring them you won’t sue them is cute – I am enough of a cynic to assume you’d use whatever information that you do gain if Fred uses the drug and pass it on to one of your partners and have them sue Biogen…

One must ask, is this payback?

No – it isn’t payback – it is the system you trial attorney have pushed for over the last 25 years. No risks, no informed consent, if something bad happens sue. If the only way Biogen feels safe in this case is to say no … look in the mirror.

Meanwhile, Baron was well-connected enough to employ an army of Democratic politicans intent on regulating if not prohibiting off label use of drugs (e.g. off label use is specifically prohibited with Tysabri) to plea his case. Too bad 99.9% of patients don’t have the money or connections that would allow their doctor to do what was done for Mr. Baron, and it appears Mr. Lanier’s offer not to sue this company this one time for this product is just a one time offer. Gee, thanks

I do wish Mr. Baron a speedy recovery. While it may be a long shot, it is amazing what American comapnies and doctors can do if allowed to practice medicine without second guessing from trial lawyers.

Two months!

But Andrew stated his father has only a few days to live. Yet, he openly solicited help from the influential Democrates so that they could pressure Biogen in OKing Tysabri. Therefore if the plead is successful and the patient gets kill instantly, he could blame Ty and Biogen for negligence. It will be lawsuit city and wealth will be transferred from the shareholders to Baron’s family again. This is a setup to milking BIG bucks from the drug company.

Also I believe he might be associated with certain hedge funds that shorted Biogen/Elan and try to create negative news to crash these companies.

I have little faith in lawyers.

http://dembot.com/

I wouldn’t trust any of them further than I could throw them. Their assurances aren’t worth the bulk value of the paper they’re not printed on. Political winds change at the snap of a finger and if anything, anything went wrong to give them even one bullet of ammunition against the large, profitable corporate, they’d use it, no matter what they’d promised.

I won’t say I agree with Biogen. But I can see why they’re doing what they’re doing.

Maybe this decision is not only about one man with friends in the right places. Where were all of these friends in high places during the AdCom to put this drug back on the market for patients where there already was extensive data on its efficacy and safety?

Despite FDA’s approval of compassionate use, are we to assume that if some AE currently unassociated with Tysabri cropped up when given to Mr Well Connected there would be no impact on the trial underway in MM? I would not bet my life on that. Given the regulatory climate if I’m an MS patient I am applauding Biogen’s decision.

Mr Lainer, while they may in fact be out of legal peril to assume there would be no regulatory peril IMO would be naive.

Hopefully all of Mr Baron’s well connected friends will work with groups like Abigail to make real and meaningful policy change that will ulitmately allow for easier access to drugs in cases like this in the future.

He has been suing big pharmas for permitting off-lable use of drugs for all these years.

The company has been given a free pass by EVERYONE in the country who matters, yet they still refuse to help the man out.

That is horrible, and whoever owns stock in the company should consider dumping it.

Clinical trials are set up to yield and identify the most qualified and beneficial patients. Once that is determined, if physicians wish to prescribe outside of the FDA bounds, then they are free to do so. By allowing any one person to enroll, Biogen jeopardizes its ability to continue further research and the cry from others who have MM, have been denied, and are not well connected. Where’s the fairness in that?