Court sees no right to unapproved medicines

Reuters ^ | 8 August 2007 | Lisa Richwine

[Turret Gunner A20]

By Lisa Richwine

WASHINGTON (Reuters) - Terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators, a U.S. appeals court ruled on Tuesday.

The U.S. Food and Drug Administration requires a wide battery of research, ranging from animal and laboratory tests to advanced trials with people, before it will consider approving a new drug. Manufacturers say the process can take up to 10 years.

[Turret Gunner A20]

UNAPPROVED MEDICINES  A U.S. appeals court ruled that terminally ill patients do not have the right to experimental drugs ... those would be drugs that are not approved by the government. How would you like to be on your death bed .. suffering from some terminal illness .. knowing that the government that you supported throughout your working life; the government that you served in uniform through several wars; the government that you pledged allegiance to time after time ... that very same government was using every means at its disposal to prevent you from gaining access to a drug, though experimental, that might actually prolong your life while doing absolutely no harm whatsoever to someone else. Nice feeling, isn't it? You might have one year, maybe six months, to draw breath. You know that it will be about 10 years for the experimental drug that might help you to become approved. You're going to die sooner than you otherwise would ... because of a government regulatory agency. The lawsuit was brought by The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation. The claim was that patients should at least have "more access" to experimental drugs. The government (FDA) is thrilled with the ruling because it gets to keep control over access to treatments that only it deems appropriate. Government and control; what a wonderful combination.

Yes .. there was a dissent. One judge that didn't go along with the majority opinion said: "There is no logic to be found ... in the conclusion that the right to save one's life is unprotected" by the Constitution. Neal Boortz

[P-40]

Guess the terminally ill will just have to hold off on dying then...

[Still Thinking]

Well, and not just the right to save one’s own life, but the more fundamental question of when the government has sufficient interest to be able to tell us what we’re allowed to ingest.

The obvious response to that is that [some] recreational drugs are illegal, but I think that has at least some justification in the direct and indirect effects on society of those drugs. In this case, I hardly see the potential for such effects, so the question comes back to which aspects of our lives government may properly assert control over.

[E. Pluribus Unum]

The War on Drugs has adversely impacted the cost, quality and freedom of health care in fundamental ways that the general public can't even imagine.

It is the War on Drugs that has given the federal government a monopoly on health care, starting with the Harrison Narcotics Act of 1914.

[Phantom Patriot]

so the question comes back to which aspects of our lives government may properly assert control over.

They are soooo interested in running our individual lives that they can’t even repair the infrastructure to keep us safe on the way home from work. ( Bridges )But the court will hold governments personal control. Time to replace them all including the courts.

[ladtx]

This is exactly where I find myself. I have a condition (gastric varices) that have bled twice in a 6 month period, luckily it has stopped on it’s own. Next time I may not be so lucky. A drug used in Canada, Europe and even the Middle East is not approved here. It can be administered in a rather simple outpatient procedure. It looks as if I may have to go to Canada while my own government sits on its hands.

[4CJ]

Hmmm, they are DYING. What's the worst that can happen if they take the experimental drugs?

And where does the Constitution delegate any power to the federal government over healthcare?

The Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States; but all Duties, Imposts and Excises shall be uniform throughout the United States;

Nope.

To borrow money on the credit of the United States;

Nope.

To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes;

Nope.

To establish an uniform Rule of Naturalization, and uniform Laws on the subject of Bankruptcies throughout the United States;

Nope.

To coin Money, regulate the Value thereof, and of foreign Coin, and fix the Standard of Weights and Measures;

Nope.

To provide for the Punishment of counterfeiting the Securities and current Coin of the United States;

Nope.

To establish Post Offices and Post Roads;

Nope.

To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;

Nope.

To constitute Tribunals inferior to the supreme Court;

Nope.

To define and punish Piracies and Felonies committed on the high Seas, and Offenses against the Law of Nations;

Nope.

To declare War, grant Letters of Marque and Reprisal, and make Rules concerning Captures on Land and Water;

Nope.

To raise and support Armies, but no Appropriation of Money to that Use shall be for a longer Term than two Years;

Nope.

To provide and maintain a Navy;

Nope.

To make Rules for the Government and Regulation of the land and naval Forces;

Nope.

To provide for calling forth the Militia to execute the Laws of the Union, suppress Insurrections and repel Invasions;

Nope.

To provide for organizing, arming, and disciplining the Militia, and for governing such Part of them as may be employed in the Service of the United States, reserving to the States respectively, the Appointment of the Officers, and the Authority of training the Militia according to the discipline prescribed by Congress;

Nope.

To exercise exclusive Legislation in all Cases whatsoever, over such District (not exceeding ten Miles square) as may, by Cession of particular States, and the acceptance of Congress, become the Seat of the Government of the United States, and to exercise like Authority over all Places purchased by the Consent of the Legislature of the State in which the Same shall be, for the Erection of Forts, Magazines, Arsenals, dock-Yards, and other needful Buildings; And

Nope.

To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof.

Nope.

[Phantom Patriot]

This is exactly where I find myself. I have a condition (gastric varices) that have bled twice in a 6 month period, luckily it has stopped on it’s own. Next time I may not be so lucky. A drug used in Canada, Europe and even the Middle East is not approved here. It can be administered in a rather simple outpatient procedure. It looks as if I may have to go to Canada while my own government sits on its hands.

Then it should be your choice to try something else. The limit on government control should stop at making sure you are informed of all of the risks involved. Not whether it should be administered. That’s up to your Medical professional. And you.

[metmom]

Terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators, a U.S. appeals court ruled on Tuesday.

They won't approve drugs that could help terminally ill people because it MIGHT hurt them, but they also won't do anything about some substances (like cigarettes) that are KNOWN to be harmful.

The hypocrisy is staggering, but following the money trail explains it all.

[trisham]

This is a bad decision. Our country is moving in the wrong direction with this kind of thinking.

[sure_fine]

“Guess the terminally ill will just have to hold off on dying then...”

or get to Mexico or Europe

[Lexington Green]

We must build more prisons for the terminally ill.

[<1/1,000,000th%]

If someone wants to be a guinea pig, call the company doing the development and become part of the clinical trials.

You can’t force companies to sell drugs that create nothing but liabilities for them. Unless your aim is to get rid of all medicinal drugs.

I’m sure the recreational drugs will always be around.

[ClaireSolt]

This whole FDA is a major driver in drug costs. Rather than talking about drug reimportation, Congress should be reforming the FDA, but I am beginning to doubt its ability to reform itself.

[RightWhale]

Somewhat interesting. Further evidence that the state in fact if not de jure owns its citizens and has the power of life and death.

[goodnesswins]

Congress is also currently in process of limiting the use of bio-identical hormones also......things that the Pharm Co’s cannot patent.....We need to regain/retain OUR freedoms regarding our bodies/lives.....

[P-40]

The hypocrisy is staggering

That it is. If I were terminally ill, I would like it to be *my* choice to try the experimental drug. If it did not help me, it might help someone else.

[beltfed308]

Terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators, a U.S. appeals court ruled on Tuesday.

Just great! Now they have removed any vestige of hope that terminal patient could have. If the FDA had existed during WW2 penicillin would never have been discovered or even available.

[metmom]

One of the problems with new drug development is that at some point, it has to be tested on real, live human beings. If someone wants to volunteer, knowing all the risks and being thoroughly informed about it, I don’t see that it shouldn’t be their choice.

I’m getting so sick of the government *protecting* us from ourselves. I don’t like the regulation and they’re treating the populace like children who aren’t smart enough to know any better, yet they are just as human and fallible as the man on the street. There’s nothing about them that makes them more qualified to make those decisions than me.

[secretagent]

The Federal Government doesn’t have an enumerated power in the Constitution to say boo about drugs.

More important, no government has a legitimate role in dictating what people do to their own bodies.

All laws restricting drugs violate the most fundamental of human rights - the right to live your own life as you wish, provided you respect the right of others to live their life as they choose.