Saturday, December 20, 2008

Dr. Ken show wrap up

Frank Burroughs and I were on the Dr. Ken Kronhaus Good Day Health program this morning as a part of the Doug Stephan Good Day show.

It went pretty well. Frank was awesome. I was a bit too rehearsed. There was so much I wanted to say and so little time. It is also surprisingly difficult to talk in quick accurate sound bites. Communicating on the radio is far harder than I imagined it would be.

Here are my followup emails to the various participants thanking them for their time. I hope many of you have a change to thank the participants as well for bringing the problem of the lack of access to life changing and life saving medications to the attention of an American radio audience.

Dear Frank
You were great! I am so glad you agreed to be on the show.

I think I am just too emotional. I spend hours preparing. I have stacks of flash cards with notes. So much to say so little time. Believe it or not I actually practiced what I wanted to say. Maybe too much.

How does a person get years of frustration, anger and sadness at the system and the delays into short coherent sentences? The delays have cost Paul so much.

I thought Doug Stephan was very helpful as well. He was pro-getting drugs to market. Dr. Ken less so. The thalidomide precedent has so affected our culture of getting new drugs to market.Everyone involved is terrified that they will get the blame for letting the next thalidomide on the market. Physicians, FDA bureaucrats and big pharma are too frightened of that one mistake that could cost them everything. The laws really need to be changed to give them protection so they can be more courageous.

Thank you again for your wonderful work. You remain our family's hero. The one shining hope in the midst of the constant stream of hurdles and barriers put up between my son and the help he needs.

I wish we could have brought up Jacob Gunvalson's lost of injunctive relief for access to PTC 124 by the third district court of appeals. I followed the case in the news. Poor Cheri.

Sometimes, I think there is a book here--a compelling book of patients and their loved ones desperately seeking game changing medication and therapies that are locked away in a research lab. In the case of my son, the med he needs, Ustekinumab, is in clinical trials here in San Diego County less than thirty miles away sitting in refrigerators but denied to him. He did not qualify for trials--too sick. It is a kind of terrible mental torture knowing that the medication is so close.

Most Americans have no idea of the type of revolutionary cures available in research labs and clinical trials. And they certainly have no idea that these meds are denied to the very sickest Americans who need them most.


Dear Dr. Kronhaus,

Thank you so much for having Frank Burroughs and I on your show this morning.

Changes in FDA clinical trial rules and lack of access to medication for the sickest Americans in a subject that most Americans are unaware of until they or a family member is denied life changing and life saving treatment—too late to do anything about the problem.

It is outrageous that our family has to consider traveling thousands of miles to Canada to get a medication that sits in a refrigerator less than thirty miles away from us in San Diego. Our son could not get passed the exclusionary criteria for that San Diego clinical trial. He had the right condition that was being tested, psoriatic arthritis but also has the related condition ankylosing spondylitis. He was too sick with autoimmune disease to qualify. A trip to Canada would be excruciating for our son. He is in constant pain. He uses almost thirty ice compresses a day. He is frozen up. I am not sure he could survive the trip. Is this what medicine has come to in America?

As to your expressed concerns about unexpected side effects, we are aware of that possibility but the disease effects must have equal consideration. His current life is no picnic.

Inclusionary and exclusionary criteria have been narrowed by pharmas companies in an attempt to protect the results of clinical trial from having any unexpected adverse problems. This narrowing has resulted in shortages of qualified volunteers. If trials were open up to more patients, cures would come faster not slower. Lack of qualified volunteers is now a limiting factor in trials. Yet thousands want access. Can we not find a way to solve both problems?

No one wants to get rid of safeguards in scientific process of testing drugs, we just ask that the process be streamlined and be a little compassionate for the very sick.

Peter Welch

Dear Doug

Thank you so much for giving Frank and me air time to discuss the unbelievable problem of access for sick patients to revolutionary new medication and therapies. People I tell about the problem just cannot believe it's true. They think there has to be a way to get these meds. But they are wrong. Compassionate use is a cruel hoax and access to clinical trials is denied for the sickest patients by exclusionary criteria put in place by Pharma companies.

The number one goal of the company is profit. Profit comes from the quickest possible approval of a new med not from helping sick Americans have greater access. Letting sick patients in or allowing compassionate use might result in some adverse event that slows down the already too slow approval process. I do not blame the pharma companies they are playing the game by the rules that are in place. Hopefully tom Daschle, Obama's appointee for Secretary of Health and Human Services will be a rule changer

I do blame the FDA for its antiquated rules and procedures. I especially blame the current FDA commissioner Andrew C. von Eschenbach. He has done nothing to improve access. Henry Waxman's House Oversight Committee wrote a letter to him a year and a half ago complaining about this very problem among others. Von Eschenbach forgot that it was his mandate and the mission of the FDA to improve the health of Americans first and foremost. He seemed to think that protecting FDA bureaucracy and big pharma company exclusive hold on these new cures were his number one and only job. Those considerations should have been his last priority. For the last six or eight months he seems to be just riding out his job, going through the motions waiting for the next commissioner to be appointed. Very sad.

Thank you again for bringing this the matter of access to the air.

I had practiced what I was going to say--over and over. Maybe too much I wanted to say so much more. I had flash cards and notes but saying it quickly and well is a lot harder than I thought it would be. That is why you have a radio talk show and I do not.

Peter Welch

No comments: