Comments on: Fred Baron Dies, Despite Being Given Tysabri

By: Discounted Prozac

Discounted Prozac — Thu, 20 Nov 2008 14:06:08 +0000

Great…I like this story.thanks for sharing with us…

By: Anon

Anon — Wed, 19 Nov 2008 18:30:45 +0000

It is not only the concerns about side effects that drives this.

Frequently, there is not enough drug that the company has to even do the studies they want and need to do for approval. This includes the phase III studies, the formulation and stability studies, the drug interaction studies, and even the long term animal carcinogenicity studies. If they don’t even have enough for the patients in the studies then compassionate use must be secondary because if you delay the required studies the submission and approval will be delayed and even more people will die. There’s also the problem if you start opening up compassionate use then no one will enroll in studies where they get placebo. (Hey it worked in phase II why should I take a chance on getting placebo.)

There are tradeoffs. If a company has enough drug on hand and it won’t effect recruitment then compassionate use is appropriate.

I don’t know the details on each drug, but just want to point out that there’s more to it than just worrying about rare side effects, and if you delay submission by opening the flood gates then even more people will die.

By: Fran Harris

Fran Harris — Wed, 19 Nov 2008 17:16:56 +0000

I agree with all that has been said…but more..to the Clinton’s do something about this..with your personal and political clout…let his death be meaningful for others…my son was given a drug not meant for his illness… Gleevac…luckily he had the genetic make-up for this non-traditional use (even though 10% without the make-up had effective and substantive postive results in an Italian study)…luckily he was at a university hospital with their commitment to learning and understanding the latest methods. It worked, but if he had not had the genetic make-up and was not allowed to participate he would be dead. It is about time we took back the rights we have had as Americans and push back torte lawyers and ambulance chasers who have made pharmas and doctors afraid to do the right thing.

By: Mike

Mike — Sat, 01 Nov 2008 21:16:51 +0000

Hey, that’s the system that all of you have built. If a therapy is provided outside of authorized channels, no matter how sympathetic the situation, the manufacturer is at great risk. There is no question about it.

Off-label use…. jumping over a clinical trial? Mr. Baron’s colleagues would have a field day with this if someone else experienced any adverse effects from such use. And what about meds in widespread use where only a couple of people react strongly negatively (Tysabri for MS patients, a few of whom develop PML. Pull the therapy for everyone, even though it is quite efficaceous and everyone knows the risks? People without MS judging the daily life of someone with MS?) It could well come to happen.

I’m sure there was no “legal basis”, other than compassionate authorization. Unfortunately, compassion isn’t written into the procedures, and certainly is not a defense in court.

Sounds cold, and I agree 100% with the sentiment that rules should be waived for dying patients (is there some non-zero probability that the medication going to kill them? or is the lack of medication going to do that with absolute certainty?)

But don’t tsk-tsk the companies. This is the system all have created for them, including Mr. Baron. We have lost our capacity for reasoned judgment. And it is only getting worse.

By: Former pharma Marketing Exec

Former pharma Marketing Exec — Sat, 01 Nov 2008 04:02:51 +0000

Amen Anne,

It is a very sick world in deed when the heads of pharma who are way overpaid, can decide who get access to drugs and who does not.

Shame, Shame,

I feel great sympathy for Mr. Baron’s family.

Rest in peace.

By: Anne PME

Anne PME — Fri, 31 Oct 2008 15:46:30 +0000

It frustrates me to think that Mr. Baron’s family, friends and doctors were forced to spend his last days publicly begging drug company executives and others to gain access to a drug that his doctors felt was medically necessary.

Deepest sympathy to Mr. Baron’s family and friends during this very private time.