The clinical treatment system run by the National Cancer Institute has become so burdened with bureaucracy and paperwork that even the Editors of The New York Times are complaining (emphasis mine):
The nation’s most important system for judging the clinical effectiveness of cancer treatments is approaching “a state of crisis.” That is the disturbing verdict of experts assembled by the National Academy of Sciences to review the performance of clinical trials sponsored by the National Cancer Institute....These are the same Editors of The New York Times who want government to regulate all aspects of health care, which is what will happen under Obamacare.
The most shocking deficiency highlighted by the report, issued by the academy’s Institute of Medicine, is that about 40 percent of all advanced clinical trials sponsored by the Cancer Institute are never completed. That is an incredible waste of effort and money, and a huge obstacle at a time when researchers are developing promising new therapies that must be rigorously tested....
So it is especially worrying to hear the experts say that the system — run by the Cancer Institute at the National Institutes of Health — is so mired in cumbersome procedures that it needs to be completely overhauled....
Yet a series of reviews in recent years found that the testing operation is mired in bureaucracy and poorly coordinated. A typical trial must navigate past dozens of overlapping reviews by different boards and agencies that must approve the original concept for the trial and then the protocol that will govern how it is conducted before the investigators can start enrolling any patients.
Under the legislation passed by the Democrats, there will be dozens of new commissions and boards created, and virtually every section of the legislation requires that new regulations be promulgated. The paperwork burden on the health care system will be staggering.
The Institute of Medicine found that a complete overhaul of the clinical trial system was necessary (emphasis mine):
Improved treatments for cancer will be delayed and patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials system improves. The implementation of the report’s collective recommendations will reinvigorate the NCI Clinical Trials Cooperative Group Program and strengthen its position as a critical component of the translational pathway from scientific discovery to improved treatment outcomes for patients with cancer. Modifying any single element of the Program or the clinical trials process will not suffice; changes across the board are urgently needed.I do not dispute the necessity of the National Cancer Institute; it is important to coordinate studies and to inject a measure of scientific neutrality into clinical testing.
But given how government bureaucracy has failed on this small scale, why would we expect any different result when the government regulates the entire health care system?
The problem will be even worse than experienced with the National Cancer Institute because the bureaucracies under Obamacare will be dispersed throughout hundreds of aspects of health care, making it impossible for organizations like the Institute of Medicine to keep track of it all.
We are being set up for failure on a "historic" scale by people who refuse to see the obvious, or who see it but do not care.
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"We are being set up for failure on a 'historic' scale by people who refuse to see the obvious, or who see it but do not care."
ReplyDeleteYes, we are. It is "change" all right. I personally think Obama/Reid/Pelosi fall into the latter category, "see it but do not care", myself.
I have had some experience with the system from the aspect of cardiology. I can assure you that it does not work! The first hurtle that we had to face was the IRB (investigational review board). They require a substantial amount of paper and an oral presentation. If they feel that you might be placing the patient in jeopardy, they shut you down. The problem is that you are experimenting and they are working with old data. Thus, the tendancy is not to allow something to go forward that could be innovative. Then there is the idiotic paper work. If someone some where in the world has a headache or other symptom while taking your medication, then an SAE report is filled out. All investigators around the world must look at the incident with limited information and declare whether the drug was responsible, or possibly responsible, or problably responsible, or liely responsible, etc. In short, the system is broken.
ReplyDeleteThis is why government shouldn't be allowed within one hundred miles of health care and even more evidence that government is the reason for at least half the problems with health care to begin with. I think its time for some old-fashioned civil disobedience myself. See a government regulation? Ignore it.
ReplyDeleteI worked in the pharma industry for 10 years as an information specialist in Regulatory Affairs. THE FDA approves all drugs and oversees the design of clinical trials.
ReplyDeleteFDA is of course run by the government as is the NCI at the National Institutes of Health. Good Grief, they have had difficulties combining their data and establishing good practice and sharing guidelines since 2007. Remember, electronic application submission to the FDA is not even 10 years old. see National Memorandum of Understanding FDA and NCI http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126565.pdf
It is the FDA that shuts down trials - am I right? Well, if the right hand, FDA, does not know what the left hand, National Cancer Institute is doing - well - bad practice can only ensue. Worse, these kinds of clinical trials in the US will continue their decline; clinical trial growth in India will continue its upward spiral - even with the overwhelming shortcomings of that system. http://www.piribo.com/publications/research_development/clinical_trials/booming_clinical_trials_market_india.html
See also overview of the report referenced in the NYT article at the website of the Institute of Medicine of the National Academies http://www.iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx. The report must be purchased if not a member.
This is a very dense swamp we are in when considering new drug approval. It is very difficult for laymen - me included - to understand. Remember - there are lots of stake holders in all of this. For example, the Pharma companies and their trials cannot be as one-sided as the NYT reports because the FDA is in control of what information it wants or needs to see before drug approval. If it wants a comparative study, it gets it. But there are conflicts of interest in this process - doctors from the FDA often end up in industry....
I don't know where the NYT is getting data on percentage of clinical trials shut down but I am not surprised. The percentage of new drugs and/or biologics investigated vs drugs approved is way out of wack - always has been. Very few compounds and biologics get to market that are investigated. I do not have current figures. That is why is is so expensive to bring drugs to market.
How much government is enough government in the clinical trial portion of this process is a question we need answered but this much the FDA does do for us: It weighs both the risk to human health and the efficacy of a drug and that drug must meet both criteria before it can be approved based on the clinical trial data to support both of these aspects. They will not approve a million "me-too" drugs.
In 2005, another report suggested remedies to the NCI's difficulties that obviously have not bee implemented:
http://www.cancer.gov/newscenter/pressreleases/CTWGrecommendations.
Class dismissed - will someone get the lights? TX
I do not dispute the necessity of the National Cancer Institute; it is important to coordinate studies and to inject a measure of scientific neutrality into clinical testing. Professor Jacobson.
ReplyDeleteThey also approve and administer grants to carry out research and clinical trials at universities, etc. The power of the purse. Add to this they provide the loan for the grad student assisting with a clinical trial or research and bingo - a government creature is born.
I personally cannot wait to see all the fools who have wanted Obamacare when it does come to pass. As a disabled veteran that uses the VA system, I laugh at what the government manages to do with it and Champus/Tricare for dependents.
ReplyDeleteAfter suffering severe TBI in Iraq; I wait to see my neurologist in average of 3 weeks if I need an unexpected appointment. For the most part the VA system is choked with WWII, Korea and Vietnam veterans who use it because of the ease of using Medicare benefits with them.
It is unfortunate though, that the VA refuses to prioritize combat injuries over these ailments of age. I do not mean this to sound cruel or to whine, but as I experienced in my own local emergency. The attending doctor had no idea of traumatic brain injury, and is part of the reason why I keep my own paper copies of my medical records.
I only hope that those that wanted healthcare reform get exactly what they wished for when it comes to pass, and they are the ones in need of a doctor. Hopefully, the creature they hoped for gives them just what they deserve.