“No seriously ill person should have to die merely because the FDA stamp of approval on a drug is years away.” - The Abigail Alliance
The Abigail Alliance’s mission is to expand the availability of experimental drug treatments for “patients that have run out of conventional treatment options.” The Abigail Alliance was founded in 2001, after the death of Abigail Burroughs who died of cancer at the age of 21. An experimental drug named Erbitux showed promising results, but unfortunately she was ineligible to participate in the clinical trial.
According to the Abigail
- many people die while waiting for experimental drug treatments to receive approval.
- the FDA imposes many restrictive participant requirements for drug clinical trials, leaving out the most ill patients.
- many clinical studies involve the use of placebos to treat life-threatening diseases.
What the Abigail Alliances seeks to do:
- allow seriously ill patients to receive experimental drug therapies, if they have run out of all other options.
- ban the use of placebos in clinical studies.
- give patients and doctors more control over their treatment options and eliminate policies that place decisions on the FDA.
- make it more affordable for smaller biotech companies to conduct clinical studies.
The fight for earlier access to effective, new treatments is a slow but steady one. The FDA is very resistant to change, but the Abigail Alliance has had many accomplishments. Some of these include introducing the ACCESS Act (Access, Compassion, Care, and Ethics for Seriously Ill Patients) to Congress and expanding certain drugs to many seriously ill patients. Some of these drugs include Abraxane (breast & prostate cancer), Alimta (lung cancer), Avastin and many others. Despite these many accomplishments, however, their work is far from over.
By Max Flores
References:
Kovach, S. (2007). The Abigail Alliance: Motivated by the tragic circumstances, families battle an uncaring bureaucracy. Life Extension. 25-30.
Links:
http://abigail-alliance.org/ - The Abigail Alliance for Better Access to Developmental Drugs
http://www.clinicaltrials.gov/ - Registry of Federal and private clinical trials
It would be good if people would support this. The process for approving drugs is too long. It seems that if you are rich you can access drugs that have already been approved in other countries but are still being held up in our country. We should at least have the choice...it is our life!
You're right, You want to believe that everyone is wanting to do the right thing, but with drug companies...I'm not so sure.
I understand that someone who is desperate for a treatment would not want to take the placebo, but isn't it important to the integrity of the study to chose whether or not they want to include a placebo? What are the benefits and disadvantages to using a placebo in a study?
I can see where you are coming from. It is necessary to exhaust all treatment options before giving up, but there are guidelines for participating in clinical trials for a reason. I am sure that the FDA is aware of just how many people potentially depend on the success of this drug. Perhaps they will not be so strict on who is allowed to receive the treatment.
So many issues and interesting questions and things to consider. It is not a black and white type of thing. We all know the resources that have gone into fighting cancer over the past 50 years, but what we have is a history of new drugs that may slow down the death process if you are lucky. It is so difficult to get a drug to market that once one is on the market the drug companies fight anything new someone else comes up with because they are trying to recoup their expenses in bringing their existing drug to market.
If someone came up with a real verified cure the drug companies would fight it also for this reason. If the “cure” turned out to be a so called “natural” remedy, it couldn’t be patented and so the drug companies are never interested in testing these types of treatments and no one else has the money to go through the process the FDA requires, especially if no one can make a buck off of it.
As far as the placebo thing goes, well folks are kind of nuts and some people will think themselves well, but so what? By the time a drug is in human trials hasn’t it been tested in a laboratory setting on animals? Even with the placebo in trials to compare the actual drug to, many drugs are approved that have a high placebo rate as well.
From: Abigail Alliance for Better Access to Developmental Drugs
Frank Burroughs, President
This is great that there is such an excellent discussion going here on this blog. Let me add and clarify a few things from the extensive comments.
As regards safety, what the Abigail Alliance and the bill in Congress, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act S.3046 H.R.6270), are talking about are drugs and vaccines for cancer and other serious life-threatening illnesses that are showing significant efficacy in clinical trials. Also it is important to keep in mind that drugs and vaccines in clinical trials are very closely monitored for safety. Another important point is that the decision to take an investigational drug by a person who has run out of FDA approved options and cannot get into a clinical trial, should be the patient’s in consultation with their doctor.
Here is what is profound (from www.abigail-alliance.org):
"Every drug for cancer and other serious life-threatening illnesses that the Abigail Alliance has pushed for earlier access to in our eight-year history is now approved by the FDA! There is not one drug that we pushed for earlier access to that did not make it through the clinical trial process. Many lives could have been saved or extended, if there had been earlier access to these drugs!"
As of early 2009 the count is 16 drugs! EVEN the FDA's own Science and Technology Board in their late 2007 report recommended there be a provisional approval mechanism for promising developmental drugs.
Speaking of the FDA Science and Technology Board, they and for a long time the Critical Path Initiative (www.c-path.org) have been pushing the FDA to use more modern scientific and statistical tools in clinical trial design, drug data, drug review, and approval. The ACCESS Act covers many early access issues, including jump starting the FDA using more modern tools.
By the FDA using more modern scientific and statistical tools, the use of placeboes would be greatly reduced. There are a significant number of patients who opt not to enroll in clinical trials, because they don’t want to take the risk of getting a placebo. Therefore the ACCESS Act would actually help speed up clinical trial enrollment.
One last note for now is that data outside a clinical trial can add to the knowledge about a new therapy.
Thank you all for your input.
Frank Burroughs, Abigail Alliance
Max,
I have been meaning to post this for some time.
Thank you very much for your good words and encouragement. Abigail’s inspiration, the people we have helped so far, and the people we continue to try and help brings me a good life.
Thank you for your good work with the blog.
Frank Burroughs
President, Abigail Alliance for Better Access to Developmental Drugs