As the first step of that single patient IND process for emergency or compassionate use, a physcian must request permission from the manufacturer. Without that permission generally the drug will not be made available.

I do not work at the FDA but can assure you having worked with numerous drug companies, that they are NOT in the business of granting approval for a single patient IND for drugs that just entered a Phase 1 trial. While most companies do not make their formal “Compassionate Use” policies public, those that do (Pfizer is one) note that its generaly considered around the beginning of Phase 3.

I hope that this treatment is successful for Fred Baron, but I know that it he would have a greater chance of successful outcome if he, his family and his doctors did not have to go through hoops to gain access to what his doctors and pharmacist believe may help him.

The pharmas are the bad guys and will remain so in the public’s eye until they stop paying their CEO’s unacceptable amounts of money, with the research mafia close behind accepting money for delivering shabby and biased research results. When people are placed at the top of the prioity list, private jets may disappear and the world will be a healthier place.

Oh, do I sound cynical? I learned it all trying to get GDNF from Amgen for Parkinson’s patients.

I think you and others are missing a point here.

By creating this “noise” about accessing this drug, I hope more patients are now more aware of its existence.

Each of the high profile people who called on Mr. Baron’s behalf to plead his case and get access have been generous to cancer patients in many ways.

It is by shinning a light into the dark corners that Pharma would like to remain dark - sometimes, that we can be of benefit to people.

As for me, I can personally state that I spend a great deal of time advocating, working and caring for cancer patients. Providing input on issues as important as this one, is also key to helping patients.

But you are right, this is a wasteful and mostly dysfunctional health care system.

Stay healthy!

By exposing the good, the bad and the dysfunction of a system where the medical advice and counsel of politicians and celebrities means more than a treating physician’s recommendation, Ed Silverman and Pharmalot likely helped Mr. Baron’s physicians close this deal.

I look at all of the resources that have been expended to help Mr. Baron gain (hopefully prompt) access to treatment and I can’t help but think that they would be better spent on actually providing treating physician recomended therapies and services to cancer and other patients.

All of us have had the time to post about this topic. With the exception of Ed, would our time be better spent volunteering to help a cancer (or other) patient rather than posting about it? It probably would be, but unfortunately in a wasteful and dysfuntional system like the US Health system, things don’t work that way.

There are some prominent cases of ordinary folks petitioning drug companies and it has worked. These were for drugs in phase I and Phase II

What I disagreed with was the reason Biogen used to deny access.

That being said, I concur with Nathan and the others who suggested that anyone need access to the drug, then petition all the people who helped Mr. Barton.

I personally do not think the Pharma world is an evil empire. I think some of the decisions they make, along with the FDA are “crazy” and not well thought out. However, sometimes, and unfortunately, those times are rare, they do get it right.

Patients should beware though, if there is too much commotion made and many people are clamoring for the drug, well, the price will no doubt go up.

How can this crazy system be fixed? We shouldn’t be putting the lives of fellow human beings at the mercy of for profit businesses. But, since that is unlikely to change, this is what we get.

With regards to the comments on the constitution, if one were quite savy in the art of debate, one might find that health issues could, COULD, be covered under the 14th amendment - (hmm, it could also provide insight for preemption)

“No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.”

One could argue that blocking access to potentially life saving drugs and devices, ensuring certain death, might not be in keeping with the spirit of the 14th amendment.

Not anti pharma, just wishing they would get it right more often.
Snap, thanks for your comments.

Thanks for your professional comments. Nice to see objective handling rather than one presenting what they think is right or should be.

By the way, the Constitution does not extend to the FDA as a separate entity. Equal rights does not mean equal health benefits. If there was “equality” across the board, our country would make a nice communist regime. We are where we are because of the democratic system helped by competition or can I say, capitalism!

FDA employee