Some organizations are demanding a change in the process to permit terminally ill people to gain speedier access to possible cures. Their demands have so far been rebuffed by regulators. Here I argue the case for liberalizing the approval process. Terminally ill patients are still capable of rational assessment of their alternative choices. FULL ARTICLE
Source link: http://archive.mises.org/5366/the-terminally-ill-and-their-right-to-drugs/
The Terminally Ill and Their Right to Drugs
Previous post: Advice from me, re: academic publishing
Next post: Cantor Week
{ 13 comments }
The only flaw in your argument that I see is the tendancy to see all new drugs as positive. The purpose of testing a new drug is to evaluate it’s safety (that is does in harm or kill more or less than it benefits). While everyone has the right to determine what risks they are taking without any data that risk is unknown. Drug companies, like all sellers of a product tend to emphasise the positive and downplay the negatives (witness the COX2 drugs). The FDA is at least theoretically neutral (although increasingly subject to political pressure). I personally think everyone should be allowed to take any drug they wish (except antibiotics as that affects the rest of us). Then some enterprising company could set themselves up to replace the FDA and sell objective information about drugs, reward patients for participating etc. Until then, there is a certain danger in allowing very dangerous drugs (as all drugs for terminally ill patients tend to be) on the market without testing.
OK lets see Terminally Ill,please see the definition of the word terminal. There are very vew drugs that actually cure anything,if this were not true we would have an extremely large population of people over 100.
As for the aspect and need to make a rational choice to become a lab rat is a whole different set of circumstances…And to those who actually pay attention to trends in medicine via reported news stories. We see too many cases of experimentation in the name of science,simply again out of self need to the “what if: aspect of life.
If I may use as an example,the Aids drug testing performed…May I also add prior to continueing the docotors credo; Cause no harm.
The trial that most recently came to light was the use of abandonded babies in a catholic orphanage/hospital in New York. Through the Freedom of Information Act those reports are available to see the collected data from these experiments…..I was appalled by the eye witness reports of staff who saw the end results un-fold as the tests were conducted.
I realise that many will simply accept such mode of operation civil,since these babies would die any how,have been abandonded,and their sacrifice will serve the greater good….
As for the aspect of not gaining any profit from this type of work you are very wrong for that data will be used to only justify the desire to place upon the market another product either similar to another firms product.Or one that can be advertised as exclusive to one company that holds patent to it.
We shall not cheat death,we all shall one day die.But living by knee jerk reactions to it simply reflects how little we truly are alive in this world…and only going through the motions of living it.
Many of the health problems we see today have been brought about by the very same acts of “plowing ahead”,no thought of the other “what ifs” no care or concern of others,this fueled by the thought or desire of profit,or desire for ones own prominence in the books,simply driven out of self.
We aslo have numerous examples of the road ahead often forgotten,and I be so bold as to say Prozac….Suicidal Increase….See what I am getting at ? Any one recall Tuskeegee…? Or in a more abstract notion…Kinsey..?
Mindless desperation will accomplish nothing,we must make the most of each day for our lives will all be truly measured by a “-” between two dates on a tombstone in the end.
There needs to be separation of State and medicine. We have had many terminally ill citizens who (with help) have travelled to clinics in Mexico and elsewhere to gain access to drugs and treatments that are not allowed in the USA (or in socialist-medicine Canada). In some cases, the terminally ill patient needed an organ transplant (available at overseas clinics) in order to live.
Less government involvement with drugs and medical care may go a long way to improve the health of the population (and prolong the lives of the terminally ill).
The only flaw in your argument that I see is the tendancy to see all new drugs as positive.
There is no such implication – Lisa’s argument is that the matter should be decided between the patient and the drug company.
The purpose of testing a new drug is to evaluate it’s (sic) safety (that is does in harm or kill more or less than it benefits).
Maybe, but do not forget that a drug company will prefer many LIVING customers than dead ones.
While everyone has the right to determine what risks they are taking[,] without any data that risk is unknown. Drug companies, like all sellers of a product tend to emphasise the positive and downplay the negatives (witness the COX2 drugs).
First, nothing in life is certain. Second, all new products need to be tested SOMETIME – if a lack of data is to serve as justification for heavy regulation, then why stop at drugs? Why not any other new product that tests the market, like can openers?
Stating that drugs are different is missing the point: they are different in that they serve a certain market. The issue is the JUSTIFICATION for regulatory bodies like the FDA, and not what they regulate. The problem is one of consistency.
The FDA is at least theoretically neutral (although increasingly subject to political pressure).
The FDA is not neutral, not even in theory, since its function is to regulate. A neutral body would only advise, not regulate.
Until then, there is a certain danger in allowing very dangerous drugs (as all drugs for terminally ill patients tend to be) on the market without testing.
The idea that without a regulatory body, dangerous drugs would be sold without restriction, making people drop like flies, is pure fantasy. Again, it is in the best interests of drug companies to have as many LIVING customers as possible, not dead or maimed.
As for the aspect and need to make a rational choice to become a lab rat is a whole different set of circumstances…
Why would it be so? Why assume that people can make rationa choices about EVERYTHING else EXCEPT becoming “lab rats”? Are people selectively stupid? Is that your contention?
I realise that many will simply accept such mode of operation civil,since these babies would die any how,have been abandonded,and their sacrifice will serve the greater good….
Indeed it may not, but how do you know if these alledged experimentations are not the direct result of government regulation via the FDA? Consider just how many years it takes to test a new drug following the FDA’s guidelines. How would you know if testing could be made under much more ethical standards if the FDA did not restrict experimentation so much?
As for the aspect of not gaining any profit from this type of work you are very wrong for that data will be used to only justify the desire to place upon the market another product either similar to another firms product.
So the problem here is the profit motive…
Many of the health problems we see today have been brought about by the very same acts of “plowing ahead”,no thought of the other “what ifs” no care or concern of others,this fueled by the thought or desire of profit,or desire for ones own prominence in the books,simply driven out of self.
I do not think so. I do not think germs and genetic maladies really care if you are one of those “good souls”, with solidarity in your heart, or a rich miser.
Digg front page
This is a simple issue of private property. If an individual owns themself then they and their advisors should be able to assume the risk of a new or untested drug.
If the individual does not own themself, as is the case with the FDA, then the life of this individual is not their own to save. That makes it especially bad for individuals in desperate situations. The FDA establishese the level of risk that the user can take, I am sure out of love, then they take away that individuals most fundamental right to life.
Therefore the FDA is fundamentally evil.
“By allowing free access to drugs that have not gone through trials, the argument goes, we undercut the incentives for individuals who want the drugs to participate in trials.”
The reason why some people make this claim is that if you take part in a (third phase) clinical trial you have no way of telling if you’re actually going to get the drug or if you are going to be given a placebo instead. A few years ago the father of a friend of mine was diagnosed with stage IV lung cancer, completely incurable. Soon afterwards his family heard about a new therapy being developed in the United States and applied for him to take part in the trials. They were ready to pay a very large sum of money for a trip to the US, even though they knew their father could end up in the control group. Obviously if the medication had been available without taking part in the trial, they would have bought it. The answer to this argument is that not everyone will be able to afford the medication, so there will always be people who will volunteer to take part in clinical trials.
By the way, David Friedman wrote about the human costs of FDA regulation in chapter 21 (“It’s my life”) of his book, The Machinery of Freedom.
Here is where I think Milton Friedman laid out a good case for a total free market in all of medicine (in his 1960s book Capitalism and Freedom). No FDA, no medical licensing, nothing, just get rid of it all. Now, of course, this will never happen in America the land of the un-free, but I think Milton did have a good description of how it would work without government force.
For example, instead of license, there would be certification. That seems to work pretty well for electrical products, which as far as I know are certified by UL and are safe and reliable. And after all, electricity is pretty dangerous stuff.
Milton also believes that the market’s tools, such as brand names, would allow companies, such as Sears, to have certified doctors. 40 years ago, I recall opticians having a booth at Sears where I could get glasses repaired w/o a prescription.
With drugs, we have the problem of patents, which is forced monopolies. I’ve concluded that all patent law should be repealed. I believe there would still be innovation, and companies could use other methods of protection, such as trade secrets etc.
And finally, I guess it comes as no surprise that I feel that since a human being owns their own body they should be the one making all the decisions about what should or should not go into their body. Naturally they should be able to hire anyone to be their advisor. Instead of an FDA, brand names, and department stores (like Sears) that guarantee their product would serve us all better than any forms of government regulation.
But as Milton once said, the problem is getting from here to where we want to be and I think this is like trying to modify a trillion line COBOL computer program that has been patched to death for 50 years. Sometimes your only choice is really to start from scratch, like the founding fathers did. But that was clearly a miracle that we are not going to see repeated.
FDA should be abolished, period.
The government has no business interferring with judgement of both patient and his doctor about what would be in the patient’s best interest.
It is not, like, the FDA has a God-like omniscience to tell what will work in each particular case.
And for anyone who have had visited a drugstore in another country it is painfully obvious that FDA both deprives people from use of drugs which are well-known and proven in efficiency by decades of clinical use, _and_ drives drug prices up, sometimes as much as by an order of magnitude.
FDA is nothing more than a bunch of murderers. They keep killing people who had a chance to get well but couldn’t because a compound which would work for them is not on an “approved” list, or simply because they could not afford it because of the FDA-facilitated monopolism.
To get a drug through FDA trials costs more than ANY company in Australia or most of the rest of the World will invest. The only hope, if you have developed a new drug, is to sell or licence it to a large pharma. Should they decide to run with it they’ll have the necessary US$500 million to get it certified and allowed by FDA. At that stage making and packing the drug is a trivial cost (most drugs costs very little to manufacture). Tough luck for the public though. You guys get to pay and pay and pay. What an excellent rort!
Sione
Of course there is no “right” to drugs, and more than there is a right to food or water.
For those who claim that there is – give your money to the poor now (after all there are plenty of people dying of hunger and thrist in the world) – not going to do it (or saying “it is the government’s job”)well clearly you do not believe in these rights to food and water.
There has long been confusion between the virtue of justice (not aggressing against the body or goods of others) and the principle of charity (helping others).
“Rights” are a matter of natural law (not aggressing against people and keeping contracts unless these contracts involve such aggression). “Charity” (so often sneared at) is a much more difficult thing – it means helping people without hope of payment.
Only in the case of going to help someone who is being attacked (or hunting down the attacker), without hope of payment, do the virtues of justice and that of charity cross.
A man may be perfectly just (i.e. not violate anyone’s rights in any way) without ever helping anyone – even not going to their aid if he sees them being attacked.
Justice is not the only virtue.
However, of course if someone wants to give drugs to a terminally ill person (either out of charity, or to test the drug – or for a bit of both of these reasons) they should be allowed to do so if that is want the terminally ill person wants.
Talk of “risks”, when someone is dying anyway, is absurd.
However, I would go further. Say there is a 99% chance that a new drug will kill someone, and a 1% chance that the new drug will cure his baldness (or say that the percentage chances are totally known) a person should still be able to buy and use the drug (if someone wishes to sell it to him).
In a society where suicide is legal there is no logical case for people not being allowed to buy any drug they wish to. Even very risky drugs (or drugs where the risks are unknown) and whose only benefits are small.
Of course the normal principle of fraud applies, anyone who claims that their drug is “totally safe”, or whatever, lays themseleves open to civil action or to criminal action.
Such things as the F.D.A. or doctor licensing (whatever the intentions of the people who created such things) increase the costs of medical care and restrict some forms of medical care so that many people die without having a chance to access them.
As was pointed out above, if A.M.A. doctors are really better at medical care than people the A.M.A. does not want licenced, then nothing should stop A.M.A. doctors advertising “A.M.A. approved, do not go to people the A.M.A. does not approve of”.
Of course, historically, doctor licensing (like the lawyer licensing) was actually a way of (for example) restricting training (by closing down some institutions – with dishonest claims of lack quality) and increasing the price of services.
If the author of this article wishes to address the issue of the right to drugs, I think there is an additional factor that needs to be considered: U.S. trade and industrial policy.
The FDA has a number of objectives. Some of these are obvious, and some not. One of the not-so-obvious objectives of the FDA is to coordinate and pursue an Intellectual Property strategy on behalf of the Federal Government. It does this primarily by channeling research money to quasi-government agencies like University Medical Centers.
The objective is to make sure that the Fed has a IP stake in newly developed drugs whenever possible. So the question of which experimental drugs will get produced (or made available) often hinges on who owns the IP, and how it affects U.S. industrial policy.
Comments on this entry are closed.