I found an opinion piece by a couple of prominent bio"ethicists" telling why cures for the suffering and dying must be delayed. The sick and dying cannot have access to cures that rats and mice can get now. It is important really to let us suffer. Yes, very, very important. See if researchers who found cures for our diseases in lab animals were allowed to use them immediately on the sick who are begging for them, well then there might not be enough volunteers for the 'careful' clinical trials that make armies of clinical trial workers fortunes.
I stopped counting at 22 lab animal out and out cures or treatment as good as cures for autoimmune disease like my son is crippled with and have so limited my life as well. Yes 22 things a mouse can have that you I and my son cannot because those clinical trials need 'fresh meat' for their trials.
It would be different if the multi-billion dollar clinical trial industry allowed every patient in that asked to be in. But the dirty little secret of the clinical trial billion dollar industry is that they exclude tens of thousands of critically ill patients who have the illnesses they are testing for but who do not have the right inclusionary or exclusionary criteria (too young, too old, too long with the disease, too short a time with the disease, not every one of the symptoms, or having an additional disease as well as the tested disease, which is all too common for autoimmune patients, or you live too far away, or, or, or, etc.).
I know because my son has happened twice been rejected for clinical trials. Even though he had the right condition and we lived close by the testing center, and he was the right age, he did not have a lesion quite large enough for the study. There were dozens of other trials I did not even apply to because the inclusionary/exclusionary criteria were so specific, so tightly written that he had no chance.
But when the medication is approved by the FDA, everyone has access not just the ones who have those narrow inclusionary and exclusionary criteria. So why not test everyone?
Our bio"ethics" friends do not see the tens of thousands turned away. Nor do they care about their suffering and deaths. They see it as "ethical" to let the suffering continue because, hey, we have to have thousands of human lab rats so that the clinical trial folks can pick a few dozen lucky ones to get a chance at the new meds or treatment.
For thousands of years civilizations and cultures found treatments and cures for illnesses the old fashion way trial and error. Some folks died. True. But many more were saved when the right treatment and dosage was established. I would be proud to volunteer and if need be die, just for the chance that my son could get a cure a day earlier. Why should he live in misery when there are so many ways that might allow his immune system to function normally?
What does society gain by spending one billion dollars and ten years on each and every new medication that comes out? Nothing. The only ones who gain are the folks who work in the multi billion dollar clinical trial industry.
Every one else loses.
The patients lose a chance at years of healthy lives or living at all. Big Pharma loses billions on the trials which means obscenely high costs for new meds.
The last bill for my son's seven vials of Remicade was 7K!!! He has an infusion every six weeks. My retirement age wife must keep working, so we have insurance which pays ever lesser amounts--now about 3/4ths of the cost which is pretty much my entire disability retirement. Could the meds be cheaper if clinical trial costs were less? Of course!
No one gains anything from the current immoral system except those employed in the clinical trial industry.
In ten minutes you and I could put together a much faster and more ethical system that would still be safer than the age old trial and error method of the curanderos, witch doctors, and forest herbalists.
Simply designate an institution as the National Testing Center. Free the Center of all FDA slowdowns and all risk of lawsuits or liability. Only patients who signed extensive informed waivers allowed in. The place funded half by government, half by Big Pharma. The rights to profits from the cures divided into three. One part to the government, one part to the person(s) whose idea it was, one part to Big Pharma based on the percentage they contribute to the National Testing Center. All patients who volunteer, every one of them, allowed to participate in trials.
The only goal of the National Testing Center is a cure as fast as possible. No other agenda. Only cures. Safety is not as important as cures. Money is not as important as cures. Delays for playing double blind games not allowed (of course we must have some good tests to keep track of disease progression--perhaps T reg competence?) Nothing gets in the way of cures as fast as possible.
At this Center everything is tried. All the cures for the mice. Every idea tested. Also all patients encouraged to keep an open access online journal of what is happening to him/her--treatment symptoms, problems, discomforts, successes. Anyone, especially potential patients, allowed to read what is written on the on line blogs. Those who died have their name memorialized on a Wall of Heroes that is the first thing seen when entering. Everyone would understand the risks. But we would also understand the incredible heroism of those who were freely willing to die to find that ultimate cure.
There would have to be an adjudication court to decide what percentage of profits the various "idea folks" contributed to the cures, yet even here there are easy solutions and models to choose from.
So why don't we do this simple quick thing to end suffering and death? Incidentally it would likely make the United States the center for cures for the world. It would bring unprecedented wealth to our country. No more Great Recession, no more trillions in debt to the Chinese. Who could be against this idea of fast cures now?
The Clinical Trial billion dollar industry! And the "cover your ass" bureaucrats at the FDA who are terrified to say yes to anything novel or new. No one else. Well except for the two bio "ethicists", Jonathan Kimmelman and Alex John London, writing in the article in blue below.
Please note: I have added bold face to written lines in their opinion piece that I find most ethically challenged. Did you know for instance, that your sick and pained body is a "scare social resource" that must be preserved in pain for the benefit of the clinical trial industry? Or that "providing dying patients access" is not a "true measure of a clinical trials worth"? Translation providing access for the sick and dying makes money for no one under the current byzantine clinical trial system.
Clinical Trials and the Common Good
Testing Innovative Therapies Is More than a Private Affair
By Jonathan Kimmelman and Alex John London | Tuesday, June 1st, 2010
It’s a drama that plays out again and again wherever cutting-edge science meets mortal disease. First, researchers test a therapy that works miracles in animals. Expectant patients flock to those researchers. But then regulatory authorities and ethics committees prevent the researchers from offering the new therapy because of concerns about safety or the science behind the animal study.
Some critics view this as a perversion of medical ethics. What happens between dying patients and their physicians, according to these critics, belongs to them and them alone. They further argue that oversight and ethics are now impeding medical progress. We think these critics are wrong on both counts.
Clinical research is not a private act. It is, instead, a public activity. For one, it is aimed primarily at producing a public good: the knowledge communities require to address their unmet health needs. For another, clinical trials are much larger than private transactions between consenting patients and researchers. The development of new therapies is, in the end, a group endeavor: taxpayers support basic research, companies fund trials, academic medical centers provide the space and equipment, and scientists conduct the research. The true measure of a clinical trial’s worth is not whether it provides dying patients access to unproven medications, but rather, whether it produces a bountiful yield of knowledge that empowers future healthcare providers.
Trials of novel interventions often occur at the vanguard of science, and each stage in the process of translating basic research into clinically useful interventions depends critically on the quality of the information generated at prior stages. As a result, physicians and patients will often have a difficult time distinguishing strong studies from weaker ones. Physicians and patient-volunteers thus lack the ability to reward producers of strong studies by joining their trials and avoiding studies of lesser scientific quality. Oversight structures are necessary to ensure that studies are rigorously designed and that they will pass on valuable knowledge to the next link in the chain of discovery. They also help to ensure that participants, physicians, researchers, and investors can pursue their individual interests without compromising the social mission of the research enterprise.
Clinical trials that are unsafe, or that have a poor scientific justification, pose several threats to the kinds of cooperation needed to transform hard-won advances in basic science into improved care at the bedside. A string of disappointing clinical trials can lead sponsors and scientists to prematurely withdraw support from an otherwise promising area. Unexpected and/or mismanaged safety issues can sully the standing of an entire field and interrupt recruitment of talented researchers and investment from academic research centers.
Poorly justified or unsafe clinical trials also threaten a misallocation of scarce social resources. Patient-volunteers, for instance, are in short supply for many types of research, and fewer than 60 percent of National Cancer Institute-funded clinical trials are able to recruit enough volunteers to complete the study. It is a legitimate ethical concern if scientifically unsound studies draw volunteers away from studies that have greater merit. Another way that trials place demands on scarce resources is through personnel: trials require highly specialized medical expertise. Medical scientists who commit their expertise to weak trials are less able to contribute to other, more worthy research endeavors.
Unfortunately, medical research has a long way to go in terms of strengthening the scientific justification for testing novel therapies like stem cells, vaccines, or approaches involving gene transfer. Animal studies are often poorly designed, executed, and reported. In some cases, interventions are introduced into humans in ways that deviate from what was tested in animals. One recent study showed that preclinical researchers often do not publish all their animal studies, leading to significant overestimates of a drug’s effectiveness. It is not at all clear that oversight bodies and ethics committees, which focus on the willingness of researchers and patient-volunteers to undertake a study, do an adequate job promoting the scientific quality of clinical studies.
Policy proposals that would seek to loosen scientific standards so that patients can more easily access unproven therapies miss the point of research. To preserve the power of clinical research as an engine for scientific advancement, we must recognize that successful scientific innovation requires the sustained cooperation of myriad stakeholders and that the knowledge that results from this extended collaboration represents an important social good.
Jonathan Kimmelman is Associate Professor, Biomedical Ethics Unit and Department of Social Studies and Medicine at McGill University. Alex John London is Associate Professor of Philosophy and Director of the Center for the Advancement of Applied Ethics and Political Philosophy at Carnegie Mellon University