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Posted on 07/25/2007 4:04:34 PM PDT by neverdem
Print Edition
Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?
Ten years ago, doctors drilled a hole into John Gotschall's skull, inserted two catheters, and pumped a poison into his brain. Using a child's morphine pump, the team of neurosurgeons pushed diphtheria toxin into Gotschall's temporal parietal lobe over a period of four days. Eight weeks later, they did it again, reusing the same cavity and pumping in a slow stream of tissue-killing fluid.
Gotschall was not well. Shortly before he invited a team of surgeons to experiment with his cerebral tissue, the 44-year-old municipal worker had plowed his car into a snow bank on a Baltimore street. When he woke up at the hospital, doctors told him he'd had a seizure at the wheel. An MRI revealed the cause of that seizure: a tumor deeply embedded in his brain tissue. There are different grades of brain tumor, many of them slow-growing. Gotschall had glioblastula multiforma (GBM), brain cancer in its most aggressive and deadly form, and he likely had only months to live.
(Excerpt) Read more at reason.com ...
Ping
... "A court makes up a right," snarked the Washington Post editorial page.
Imagine, we can find a right to abortion, but can find a consitutional right to seek drugs that might save you from certain death due to a disease untreatable by existing drugs.
Once again, Judge Rogers expresses clarity and reasonablity, and once again the WP demonstrates its consistent hatred of common sense and human decency. While I have no problem with Roberts, it is amazing that Bush would have picked Hariett over Rogers. Absolutely amazing.
No, terminal patients and every other kind of patients have a right to whatever treatment they want, whether it's an untested pharmaceutical product or a ditzy New Age "healer" arranging crystals around them. It's called FREEDOM.
The Abigail Alliance argues that it also protects the right of terminally ill patients, acting on a doctor's advice, to obtain potentially lifesaving medication when all other alternatives have been exhausted.
No, terminally ill and every other kind of patients have the right to purchase any medication they want, regardless of what any doctor thinks and regardless of whether any other alternatives have been tried.
To sift the pharmaceutical gold from this vast bed of chemical silt, drug companies need some type of trial system, and for trials they will need patients. Trials are typically randomized, meaning that some patients will receive the treatment and others will not. If patients could simply obtain the medicines they wanted, they would have little incentive to enter the clinical testing lottery.
Oh dear, that pesky FREEDOM thing could interfere with what "drug companies need" (though the underlying reality here is that the whole scheme is what government needs, not what drug companies need).
Mindful of medicine's dependence on test subjects, the alliance isn't asking that all patients get access to development drugs. It's asking that patients already denied admission to trials . . . be able to buy the drugs they're denied. And even this concession, argue their opponents, would dismantle the clinical trial system.
If the clinical trial system is incompatible with FREEDOM, it needs to be discarded forthwith. In reality, there are lots of ways to reasonably establish the effectiveness of a medication or treatment, without these hyper-regulated clinical trials. The only obstacle to employing such ways is a mountain of government regulations.
under current FDA regulations, patients cannot waive liability for negligence. Whether they want it or not, patients must have the right to sue, which means they may never be given the chance to take a risk.
No, patients do not have to have a right to sue if they don't want it, and they do have a right to take risks if they want to.
There is a serious argument to be made that the entire clinical trial system is antiquated, that it is time to stop counting piles of bodies and to start using more sophisticated measures of drug efficacy.
Ya think?
Arthur Caplan, one of the world's most prominent bioethicists . . . argued that terminally ill patients are desperate and therefore may be more in need of the FDA's paternalism than other classes of patients.
Oh goody, a "bioethicist" chanting the old dogma "You don't need FREEDOM, because the government is here to help you".
In the heavily risk-averse culture of the FDA bureaucracy, talk of rapid, radical change isn't even countered. It's just ignored.
It's high time the FDA be placed on the "to be ignored" list by citizens exercising their FREEDOM. Politicians who interfere should be voted out of office.
The right to self-medicate is considered so absurd that incoherence passes for analysis in respected medical journals, while opposition is treated as hysteria.
We are under no obligation to "respect" medical journals in which "incoherence passes for analysis".
GBM is a relatively rare disease, and TransMID has a tiny prospective market. Celtic Pharma's Rossi estimates testing has cost more than $600 million so far.
And people wonder why the pharmaceutical companies charge such exorbitant prices for drugs. They are forced to charge exorbitant prices because they are forced waste colossal amounts of money complying with government regulatory schemes. And how does the government get away with this? Because the sheeple have been conditioned incrementally, over many decades now, not to recognize tyranny even when it's killing them and their loved ones.
Every time you go to a doctor to get a "prescription", you are submitting to tyranny. If doctors can't figure out how to make a living without government giving them an artificial monopoly, they don't deserve to make a living as doctors. Too many imagine themselves to be "practicing medicine" when actually they are functioning as little more than glorified toll collectors.
My uncle died of a brain tumor last year. He went in for a headache, and the MRI showed a tumor. He was dead less than 6 months later. I don’t know what kind it was.
If someone is dying, thrown the darn regulations out the window. More people in broader trials give more people a chance to possibly live. If someone said, “the standard drugs aren’t working, and this drug works in the lab but you don’t meet the trial standards, so you don’t get it”, then the result is probably manslaughter. You’re sending people into the desert without water, knowing they will probably die.
Body Reveals Its Inflammation 'Off Switch'
Math as a Civil Right: Voting rights advocate calls for mathematics literacy It's too bad the subject wants a politicized solution.
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The situation is even worse, my FRiends. Doctors will even refuse to try APPROVED drugs on patients if they deem them too old or too far along in their disease. My father died because we couldn’t find a doctor who would agree to treat him. We pleaded and pleaded with all of them. Finally, two doctors stepped in, but by then it was too late.
Thanks, that is very interesting. I’m pinging IslandJeff to decide if this should be on the diabetes ping list. It’s pretty tangential though.
For almost half of those years I have not had adequate medical insurance and paid for all my medicine cash. These medical trials nade a real difference in my quality of life. It was also my informed choice to participate.
There is no way for a new drug to progress to commercial viability without these trials. Yes, I am a guinea pig but I know I make a difference. My personal tests have been used in at least three presentations describing the research conducted. Yes, I was Patient "A"!
If ANY terminally ill patient wants into a stage 1 trial, then the FDA needs a streamlined procedure to allow such testing in the US, under study conditions. Stage 1 trials are often NOT fully safe, and we discover that the review drug is not useful due to these tests.
And yes, sometimes the drugs (or placebos) will be harmful to the test subjects.
I once blew out at 24% of lung capacity after a couple of months of placebo. Not a pleasant way to drive oneself to the doctor. Also not very smart on my part.
I “guinea-pigged” for a study for a new diabetes drug when my insurance was woefully inadequate. The price of test-strips, for instance, is just outrageous.
All the injectable drug did was cause heartburn, but my cholesterol levels dropped drastically.
It’s now on the market specifically for that purpose.
Anyone in a situation like that should take full advantage of it: it’s essentially free medical care.
Not to mention the Silky Ponies of the netherworlds. Get rid of punitive damages and Big Bad Pharm could probably cure obesity and cancer. You're spot on - people need to think for themselves.
I hate getting rid of or capping punitive damages. Every case is different, and some actions are basically criminal. Why not move to a loser pays system instead for tort reform?
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