Pray that you don't get terminal cancer anytime soon, because, according to the Court - you ain't got a right to try any unapproved treatments. Even if "conventional" treatment isn't working and you consent to experimental drugs.

http://www.washingtonpost.com/wp-dyn/content/article/2008/01/14/AR2008011401709.html

Quote :

"Supreme Court Lets Stand Experimental-Drug Ruling By Robert Barnes Washington Post Staff Writer Tuesday, January 15, 2008; A02 The Supreme Court yesterday declined to consider whether dying patients have a right to be treated with experimental drugs not yet approved by the Food and Drug Administration. The court, without comment or recorded dissent, let stand a ruling by the U.S. Court of Appeals for the D.C. Circuit, which said the terminally ill have no constitutional right to drugs the agency considers safe enough only for additional testing. The challenge was brought by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs. The alliance is headed by Frank Burroughs of Fredericksburg and named in honor of his daughter, Abigail Burroughs, who was diagnosed at 19 and died at 21 of a form of cancer rare in someone her age. The young woman died in 2001, and the drug she was seeking was later approved. Steve Walker, co-founder of the alliance, called the court's decision not to hear the case "a tragedy." "We have now had all three branches of government abandon our constituents, which now number in the thousands," Walker said. The groups' petition told the court that "a terminally ill patient with no approved treatment options has a right to decide for himself, in consultation with his own doctor, whether to take a drug that the FDA concedes is safe and promising enough to be tested in substantial numbers of human subjects." Too many patients, they contend, cannot get into trials of the drugs "because they are too young, too sick, cannot qualify for the trial protocol, cannot travel, or because the trial is simply too small." Walker said another lawsuit is a possibility, and the alliance is also asking Congress to change the law. The groups lost in the lower courts last summer when, after a pair of conflicting rulings, the full D.C. Circuit ruled 8 to 2 that "there is no fundamental right deeply rooted in this nation's history and tradition of access to experimental drugs for the terminally ill." The Bush administration, representing the FDA, asked the Supreme Court not to hear the case. "On the one hand, when existing treatments have been tried and have proven ineffective, patients who are suffering from serious diseases have an understandable interest in trying potentially effective investigational drugs, particularly when the patient's illness is life-threatening," Solicitor General Paul D. Clement said in a brief filed with the court. "On the other hand, allowing patients to obtain and use unproven drugs carries a host of risks and potential detriments for the public health." Clement said FDA studies have shown that "preliminary expectations of safety and efficacy often prove to be unfounded, and drugs that initially appear promising are frequently found ineffective or even affirmatively dangerous to life and health.""

But seriously - "risks to the public health?" Like what, exactly? They're dying. I don't think there's any greater danger than "inevitable death."

Then again, this would assume one actually owns their own body, and as this government has made abundantly clear - one does not.

1/17/2008 6:25:20 PM

Quote :

""preliminary expectations of safety and efficacy often prove to be unfounded, and drugs that initially appear promising are frequently found ineffective or even affirmatively dangerous to life and health."""

why the hell does a terminally ill patient care about an experimental drug's efficacy or whether it is dangerous to their life and health.

1/17/2008 6:39:59 PM

I guess it's pretty clear that you do not own your own body in today's America.

1/17/2008 10:55:05 PM

^

*cough* abortion

1/17/2008 11:13:10 PM

I wonder which groups filed briefs to oppose this.

1/17/2008 11:27:39 PM

god damn it

this is a great opportunity to have tests for drugs if the patient consents and increases our overall knowledge of medicine

the court needs to get its head out of its ass

1/17/2008 11:35:43 PM

Quote :

"I wonder which groups filed briefs to oppose this."

Well, the Bush Administration, for one...

Of course, I don't even see how this would be against the interests of the pharmaceutical companies. Assuming they don't have to count these people in their case studies, they effectively have nothing to lose by these people volunteering for experimental treatments - sign a liability waiver and it should in theory be all they need, no? So there's not even a compelling "business interest" here - just a regulatory (see: governmental power) angle.

[Edited on January 17, 2008 at 11:38 PM. Reason : Vested interests]

1/17/2008 11:36:58 PM

Yeah, I think Bush and the Supreme Court are wrong on this one. And let's face it, the Supreme Court has blown it a lot in recent years with poor holdings on eminent domain, medical marijuana, and now this.

It's a pity.

1/18/2008 2:06:59 AM

^ and ^^. I have to agree. This ruling or lack of one really is strange. What is the motivation for pushing for such a ruling? I don't see it either.

Maybe this is more about indirect implications of letting people be free to seek medical care outside the officially sanctioned FDA-route. Maybe this is actually about keeping the lid on alternative medicine in the US. Afterall, couldn't you consider alternative medicines experimental? And if that is the case then I can see why the drug companies would work to get the ruling that came down. Natural remedies are kinda hard to patent... no big $$ from cancer cure.

I really don't know, just speculating.

1/18/2008 2:25:09 AM

Well, the case in question was about treatments being developed by pharmaceutical companies in pre-public trials (Phase II testing). In other words, very tightly controlled experimental trials - the FDA has to approve anyone who has access to the treatment. So, unlikely that this is alternative medicine - these are drugs / treatments that just haven't been approved for public use, yet.

But I mean, therein lies the "gotcha." Ted Olson (the solicitor general, representing Bush, and by proxy, the FDA) argued that this is about "public health," given that these are "unproven" and "potentially unsafe" treatments. But again - these people are dying. I fail to see why the FDA should get to play gatekeeper even in the most drastic and dire circumstances such as this, especially if the patient operates off of informed consent.

I mean, what, they might die? This was happening anyways.

1/18/2008 2:38:04 AM

How in the blue fuck did the body who's only real purpose is to define what is and is not Constitutional arrive at this conclusion?

The very existance of the FDA isn't really Constitutional, in my opinion (whether or not it is a good instution is another debate, but if we want to have it, there are provisions for adapting our laws to legally accomodate it). I guess if we're comfortable enough with shitcanning the Constitution whenever the government deems fit, it's not really a stretch to do it some more in an instance like this.

[Edited on January 18, 2008 at 2:44 AM. Reason : asdfads]

1/18/2008 2:44:02 AM

public health >> individual health

according to the govt. we've had this discussion before.

1/18/2008 8:29:04 AM

Quote :

"The very existance of the FDA isn't really Constitutional, in my opinion"

I agree, the FDA simply shouldn't exist

it is too powerful, corrupt, and inefficient and it constantly provides poor and biased regulation

a loose network of private companies, competing for efficacy, would do a better job, and with no federal corruption

Quote :

"I guess it's pretty clear that you do not own your own body in today's America"

this ruling is both sad and outrageous

how did america get so far down the wrong path? can we turn it around in our lifetimes? (without spilling a ton of blood)


oh, and the

Quote :

"public health >> individual health"

argument is weak sauce

1/18/2008 9:20:54 AM

You guys have completely missed the argument here.

When a treatment is in the trial stage, what they need are lots of sick people who will voluntarily enter trials. In a trial, half the people are given the new treatment and half are given nothing as a control group in a double-blind study. So, even if the drug works perfectly, half the trial patients are condemned to death anyway. If you can simply demand the treatment and get it then what idiot would sign up for the trial and only a 50/50 chance of getting treated?

Those in power are worried that no one would, and therefore treatments would necessarily remain experimental for lack of trials and if the drug does more harm than good we would never know.

1/18/2008 9:44:02 AM

Quote :

"You guys have completely missed the argument here"

not true

the argument is weak sauce

Quote :

"If you can simply demand the treatment and get it then what idiot would sign up for the trial and only a 50/50 chance of getting treated?"

a benevolent, generative, responsible and caring "idiot"?*

(also, the 50/50 bet would surely be the cheaper option, therefore more appealing)

(*snark, let's not forget that libertarianism requires good and responsible people; don't sell us short)

Quote :

"Those in power are worried that no one would, and therefore treatments would necessarily remain experimental for lack of trials and if the drug does more harm than good we would never know."

translation:

"the PARTICULAR drug safety procedures we currently employ are more important than human life
and
not reforming the PARTICULAR drug safety procedures we currently employ is more important than human life"


get rid of the FDA

plain and simple

get rid of the FDA

1/18/2008 10:19:21 AM

Quote :

"public health >> individual health"

You mean The Group >> The Individual?

I'm sorry, I thought the whole idea of starting our own country was to escape the tyranny of the gov't over the individual.

So if a bunch of people don't want you to try and save your own life...you just should die?

Quote :

"If you can simply demand the treatment and get it then what idiot would sign up for the trial and only a 50/50 chance of getting treated? "

Save that Altruistic stuff for someone else. If I'm dying, I don't want to be forced to be sacrificed as part of a trial experiment to save society. I want to be cured with whatever is available at the time. If I want to take a desperate chance on a iffy treatment, what's it to you?

1/18/2008 10:36:06 AM

Obviously, someone has not seen I Am Legend, for if they had, they would understand.

1/18/2008 11:29:02 AM

Quote :

"LoneSnark: You guys have completely missed the argument here. When a treatment is in the trial stage, what they need are lots of sick people who will voluntarily enter trials. In a trial, half the people are given the new treatment and half are given nothing as a control group in a double-blind study. So, even if the drug works perfectly, half the trial patients are condemned to death anyway. If you can simply demand the treatment and get it then what idiot would sign up for the trial and only a 50/50 chance of getting treated? Those in power are worried that no one would, and therefore treatments would necessarily remain experimental for lack of trials and if the drug does more harm than good we would never know."

From what I understand, however - this is generally the procedure for non-terminal conditions. Doing a test like this on a terminal condition and giving nothing would violate all kinds of medical ethics rules, I am almost certain.

I'm not medical researcher, but from everything I gather, couldn't they use a different, well-researched drug as their control group to establish a baseline correlation? i.e., "We know how well drug X performs, and we know its effects. How does new drug Y perform in comparison?" For example, Drug X would be the "standard" treatment (which, while not being effective "enough," would have well-quantified effects).

Obviously, a placebo is preferable in a non-terminal condition - but I can't see how an IRB would actually approve a human test where 50% of patients are guaranteed to die. There's no way that would pass medical ethics muster.

Meanwhile, I dug this up on Bloomberg:

http://www.bloomberg.com/apps/news?pid=20601103&sid=atnVIGEgRQt4&refer=us

Quote :

"The government also said wider disbursement of investigational medicines might undermine clinical testing. That would especially be the case if drugmakers could sell those products at a profit -- something they currently can't do -- because companies would have less incentive to pursue regulatory approval, the U.S. said."

Except this again seems like a really, really weak argument. Pharma companies are going to try and circumvent the FDA by going directly to terminal patients, and never finish going through with trials? Erm... somehow, I don't think that logic actually stands up to scrutiny...

1/18/2008 12:43:46 PM

Quote :

"You guys have completely missed the argument here. When a treatment is in the trial stage, what they need are lots of sick people who will voluntarily enter trials. In a trial, half the people are given the new treatment and half are given nothing as a control group in a double-blind study. So, even if the drug works perfectly, half the trial patients are condemned to death anyway. If you can simply demand the treatment and get it then what idiot would sign up for the trial and only a 50/50 chance of getting treated? Those in power are worried that no one would, and therefore treatments would necessarily remain experimental for lack of trials and if the drug does more harm than good we would never know."

Presumably, your insurance won't cover experimental treatments and even if it would, you would still have to exhaust all known good treatments first, so for some people the 50/50 split will be an economic and expedient decision.

1/18/2008 12:49:38 PM

I like it. now I don't have the right to get fucking treated. great.

1/18/2008 4:07:40 PM

Quote :

"there is no fundamental right deeply rooted in this nation's history and tradition of access to experimental drugs for the terminally ill"

But I can still smoke cigarettes legally...because those are going to help me get better.

Sweet Christ, what is this country coming to?

1/18/2008 6:22:34 PM

in this day and age, you can't have people dying while taking new drugs, especially unapproved ones.

let's say a drug company is developing a new drug that can essentially treat leukemia better than any other drug currently on the market. this drug is in the latest stages of development and is currently in the process of achieving FDA approval and could be officially on the market within a year.

now let's say there's this very sick old lady with leukemia and she thinks her absolute last chance is to take this drug. let's also say that for some reason the FDA says--"sure, we'll let you into a clinical trial." (even though she's technically too sick to be considered). while being part of the trial this person receives the new treatment...but because her leukemia is so far along and her health is so poor, she does in fact die during the clinical trial.

the first thing that will happen will be that her family will question whether or not this drug killed killed their grandmother, they will hire a lawyer (a la John Edwards) and he will sue the drug company for killing the poor, old, helpless grandmother. the drug company will spend a lot of time and millions of dollars to defend themselves from a lawsuit and, in the end, may or may not, pay the family of the deceased millions of dollars.

the second thing that will happen is that the new drug will have the public perception of killing somebody in a clinic trial, even though the drug had no impact in her death. competing drug companies will hype up their current drugs for leukemia and claim that they don't kill people. this new leukemia treatment that would have been a miracle drug for a lot of people with leukemia will be taken off the market, either by the drug company or by the FDA. 10+ years of research, development, and production down the drain. billions of dollars wasted. millions of man-hours by all the scientists and engineers all for nothing. the reputation of the drug company ruined. all because this very sick old lady died during a drug trial she had no business being in.

this is why the FDA regulates drugs and regulates how and why people are screened for clinical trials. the potential profit lost by the drug company affects not only the company, but the entire industry, and the economy. the role of the government is make sure that economy stays stable, people have jobs, industries stay profitable...and for what? so that the drug industry can continue to employ americans, so the drug industry can continue to create better drugs for americans, and so that america is allowed to work harder to keep america safe and healthy.

[Edited on January 18, 2008 at 7:08 PM. Reason : asdfghjk]

1/18/2008 7:00:32 PM

^ Nobody needs the FDA. For any reason. The government shouldn't protect us from ourselves.

Drug companies should be able to choose who gets to enter clinical trials.

1/18/2008 7:50:50 PM

no drug company will ever let someone on the verge of death into their clinical trial to prove that their drug is successful, safe and better than every other drug out there...

Quote :

"Nobody needs the FDA. For any reason."

tell that to all the people who died in the early 20th century after pharmacists put antifreeze in cough syrup because it made the active ingredient stay in solution better. tell that to the people who died from early vaccines that people made without really knowing what was being put into these so called vaccines.

without the FDA, Thalidomide could have been distributed to pregnant women in this country...

so yes, lets deregulated drugs and let "drug makers" put the cheapest, least safe materials (especially the rare new compunds that no one quite knows what they could do to you) into drugs. lets not hold them accountable. lets not try and do things that actually help people....



[Edited on January 18, 2008 at 8:33 PM. Reason : asdfghj]

1/18/2008 8:09:33 PM

Quote :

"the first thing that will happen will be that her family will question whether or not this drug killed killed their grandmother, they will hire a lawyer (a la John Edwards) and he will sue the drug company for killing the poor, old, helpless grandmother. the drug company will spend a lot of time and millions of dollars to defend themselves from a lawsuit and, in the end, may or may not, pay the family of the deceased millions of dollars."

Except that your very long scenario is foiled by one simply thing: the liability release waiver, which would be almost certain to be signed as a condition of receiving an experimental treatment. This would exempt the company from any kind of lawsuit such as you describe.

Second, this person wouldn't be part of the clinical trial. They'd be receiving an experimental treatment - this does not automatically make them part of the clinical group. So, no trashing the clinical trial numbers either.

1/18/2008 8:27:00 PM

Quote :

"FDA isn't really Constitutional"

it comes between the Commerce Clause and the ability of the legislature and executive to set up quasi-executive/legislative bodies such as the FDA and the FCC


so yes, it is constitutional. you may not agree with the decisions they make, but their existence is relatively justified.

1/18/2008 8:30:19 PM

^^fine, throw out the lawsuit

the scenario still stands (even as extreme as i've summarized the consequences to be)

a drug company will lose a lot more money from losing a heavily developed drug right before approval than they would from a lawsuit. and without that profit, then they won't be compensated for the many drugs that never get past the research stage and they won't be able to fund research and development for new potential drugs....

and even still, having someone die while using an "experimental" treatment is not good PR for a comapny trying to develop that "experimental" drug into an FDA approved drug that they can potentially sell and make a profit from. the potential risk does not out weigh the potential gains.

[Edited on January 18, 2008 at 8:45 PM. Reason : asdfghjkl]

1/18/2008 8:40:28 PM

^ Still, all these issues are the companys responsibility to handle. Not the governments.

1/18/2008 8:51:23 PM

and its our government's responsibility to serve, protect and support its people

when people die because of low quality products produced in the country, the government should do something about it

1/18/2008 8:57:13 PM

Quote :

"To prevent patients from choosing their own risks is to prevent the rational, contextual judgments that their lives require--which often means to condemn them to suffering and death. The history of the FDA is filled with bans or delays of drugs like Interleukin-2, TPa, and various beta-blockers that many would have benefited from had they been free to take them. The death toll from such bans is, according to conservative estimates, in the hundreds of thousands. "

And banning drugs doesn't cause deaths?

1/18/2008 9:05:02 PM

Interleukin-2 and TPa are approved...

the harsh truth is that the FDA wants to ensure that things are safe before approving them. They want to approve safe, effective drugs. Convincing them that drugs are safe takes time and a lot of red tape. The red tape is necessary to ensure accountability.

The FDA may be annoying, but they're not evil.

1/18/2008 9:15:48 PM

Quote :

"Another example of keeping drugs off the market is FDA's denial of approval of a vaccine to prevent meningitis C. This is a bacteria that infects thousands of Americans and kills hundreds each year. No conjugated vaccine (one comprised of linked components) is approved for use in the United States. Three such products are available in Canada and Europe, where 20 million doses of the vaccine have already been administered. As a turf-protecting measure, our FDA refuses to recognize foreign drug approvals. So what's the story? Is the FDA out to deliberately kill Americans? No, but the end result is the same. "

Killing people, one way or another, is evil.

1/18/2008 9:20:09 PM

Quote :

"without the FDA, Thalidomide could have been distributed to pregnant women in this country..."

Also without the FDA and its 10 year delay of approving the heart medication Propanolol, approximately 100,000 people might've lived if they could've legally accessed this life-saving drug.

The FDA is a political organization. Politics rules it actions. Currently abortion is in. So the FDA approves the French abortion pill RU-486 despite the fact that it increases the risk of breast cancer.

The FDA shouldn't get the last word on what you're willing to risk to stay alive.

1/18/2008 9:24:37 PM

Quote :

"our FDA refuses to recognize foreign drug approvals."

foreign regulatory agencies don't always recognize FDA approvals either...obviously...

^it is political. but it goes both ways. for controversal therapies to be approved by the FDA, the drug company that manufactures the therapy has to work hard to either prove that it is safe, or persuade the FDA that the need and desire for a treatment heavily outweighs its risks.

if you really want to get down to the nitty gritty, you could debate the ethics and exploitation tactics (of sick, dying people) used by drug companies to get their drugs approved...

[Edited on January 18, 2008 at 9:36 PM. Reason : asdfghjkl]

1/18/2008 9:24:46 PM

Quote :

"a drug company will lose a lot more money from losing a heavily developed drug right before approval than they would from a lawsuit. and without that profit, then they won't be compensated for the many drugs that never get past the research stage and they won't be able to fund research and development for new potential drugs...."

Except again, this wouldn't be part of a clinical trial process. This would be allowing a person who is terminal to have access to a drug which shows promise in clinical trials. A little different.

Quote :

"and even still, having someone die while using an "experimental" treatment is not good PR for a comapny trying to develop that "experimental" drug into an FDA approved drug that they can potentially sell and make a profit from. the potential risk does not out weigh the potential gains."

Again - this is not a clinical trial. This is in regards to terminal patients - read, people who are already dying. If a company has a drug which proves promising in early human trials, and a person is dying with conventional therapy proving ineffective, this would have allowed them access to medicines which would otherwise be forbidden to them.

Further, if a company is so callous and risk-averse that they would still refuse to sell experimental medicines to a terminal patient, no one is making them. Right now though, they can't - even if this person is dying.

1/18/2008 9:54:01 PM

^Doesn't that make the FDA callous and risk-averse if they're denying these drugs to dying people?

1/18/2008 10:09:32 PM

I assumed that point was somewhat implicit.

1/18/2008 10:25:32 PM

I hate this country. I hate this god damned country.

Quote :

"I guess it's pretty clear that you do not own your own body in today's America."

Quote :

"^ *cough* abortion "

Abortion has nothing to do with your body, just the body inside you. Stupid dumb shit Americans.

1/19/2008 1:50:19 AM

Abortion has plenty to do with your body.

Quote :

"Anti-abortionists often claim that the fetus is a human being and, although within and part of the mother, it has individual rights. A consistent application of this view essentially makes the act of abortion an act of murder. This view of the unborn fetus fails to make two vital distinctions-the metaphysical difference between the actual and the potential and between an entity and its parts. The anti-abortionist position also fails to recognize that human beings are granted rights qua man's status as a rational animal, not qua animal. In reality, the potential is not the actual, nor is an entity's parts the same as the entity itself and rights can only be granted to actual rational entities. The potential of my financial success and making billions of dollars does not create the actuality of my purchase of Microsoft today. Likewise, the possession of a gun and an index finger to pull its trigger with which to potentially shoot my neighbor does not actually make me a murderer. The relationship between mother and fetus is not that of two distinct human entities, but rather that of an independent human being (the mother) with rights and a dependent physical appendage, something that is physically within and part of the mother and therefore cannot have individual rights."

1/19/2008 9:51:54 AM

Re the FDA, I see no reason why we can't let the FDA exist solely to review/approve drugs for informational purposes while leaving the final decision of use between doctors and patients.

A friend of mine, who has worked at the FDA for 15 yrs now, said the approval process has become corrupt and politicized. The time it takes for approval has been rising steadily since the '60s, with the average now at 15 yrs. This puts enormous pressure on drug prices (it has been estimated that FDA regulation increases the required break-even return on a drug by about 200 percent).

1/19/2008 10:42:56 AM

Quote :

"The relationship between mother and fetus is not that of two distinct human entities, but rather that of an independent human being (the mother) with rights and a dependent physical appendage, something that is physically within and part of the mother and therefore cannot have individual rights.""

Not to derail, but this only holds currently if the mother is the one doing the killing. Push a pregnant woman down a flight of stairs and you'll be charged for two murders.

1/19/2008 12:48:32 PM

If I want to stick magnesium perchlorate into my body at any time--let alone when I'm nearing death, that's my right.

SCOTUS be damned.

1/20/2008 1:59:22 PM

Drugs are bad, mmk.

1/21/2008 8:40:36 AM

While I am ready to go for the kneejerk reaction of "let us decide what to put in our own bodies," this seems like it's overreaching for a reason. What if the experimental medication involves live cultures, genetic modification, bacteria, or some sort of altered virus that could mutate within a human host and spread? I'm not saying that's likely, but it DOES provide a sensible reason to not allow experimental agents to be used, even by dying people.

Now, the question is whether the one outweighs the other... and whether that's why the supreme court has made this decision.

1/21/2008 10:52:01 AM

Well the article said things that this was something that was pending that later got approved. It seems like anything that would have the ability to mutate or cause some kind of pandemic wouldn't even make it to the pending stage if there were any danger of something like that happening.

1/21/2008 11:00:44 AM

Quote :

"If I want to stick magnesium perchloratelive cultures, genetic modification, bacteria, or some sort of altered virus that could mutate within a human host and spread into my body at any time--let alone when I'm nearing death, that's my right."

1/22/2008 4:59:10 PM

Yeah, not even remotely the same.

Try again.

1/22/2008 6:10:38 PM