Subjecting Yourself to Experimental Meds

ghostlibrary writes "Even while NIH is getting new ethics regs, patientINFORM is being evangelized as a way for ordinary citizens to look up experimental treatment online, in essence circumventing their doctor, and the FDA long ago tacitly approved this. /. debated Wikis in hospital. RSI fans track risky or untested procedures from the Typing Injury FAQ and Health-Hack covers IT-related self-help medicine. Laser-eye stuff is now mainstream and doesn't need a check beyond google. Any other sites out there for those willing to dictate their own medical course? Does this mean Internet users will become test subjects more than the usual college students and elderly?"

Comments

If nobody voulnteers no cures will be found

[guildsolutions]

Its pretty obvious... If nobody vols for these medications, then the results will never be determined. Once we leave the earth we goto a better place above anyway, or so a lot of people tell me. Its a good thing to test experimental drugs...

Just not on me.

Re:If nobody voulnteers no cures will be found

[Austerity Empowers]

Provided the volunteers are informed of the risks of their choice by an independent medical expert. New-age/prayer treatments, or radical new drug treatments tend to sound attractive when argued by their supporters, but aren't always good choices.

If I had a terminal condition I'd ideally like my doctor to lay out all my options, and explain them fully. This includes the conventional (but probably not so effective or pleasant), and the unconventional (and not have to worry that I or my family will sue him later). The reality is that traditional doctors can be a bit CYA, while the research doctors may be inclined to not tell me what I need to know. The laws and our social behavior are set up in such a way as to continue this situation.

The next best option is to do my own research and run it by a couple conventional doctors and see how their answers disagree. It's not perfect but it's a step towards the ideal. This facility would seem to offer that, provided people who use it consult with an actual medical expert.

Bottom line, if I am dying from a particularly untreatable form of cancer, I may be inclined to try something new. I just need to know what the options are, and what the odds are. Only I should be allowed to gamble with my life.

sentence 1: wtf

[Bootle]

Does that even remotely make any sense? Sure as hell doesn't to me...

Be careful

[thewiz]

My life was saved by an experiemntal drug. The doctors couldn't get my heart restarted after my third open-heart surgery via defibrillation or other methods. The anaesthesist was one of the doctors evaluating a new medication that showed promise for restarting hearts and used it on me. As you can tell, it worked.

I've also been on the bad side of experimental drugs and have suffered thru some major side-effects. It's not a great feeling when the medication you are taking to eliminate pre-ventricular contractions makes you feel like you're living underwater.

As for people volutarily subjecting themselves to experimental medications and treatment: TALK WITH YOUR DOCTOR FIRST! He knows your particular case better than any other doctor and can help you evaluate if you are a good candidate for the experimental treatment. It's a good thing that it's becoming easier to find out about available experimental treatments, but don't think it's going to be the "magic-bullet" cure until you find out more and talk with your doctor.

Re:Be careful

[Rude Turnip]

"As you can tell, it worked."

That, or you're a zombie.

WTF on the challenges?

[PornMaster]

I'm as cynical as the next guy, but how the fuck can someone challenge the publishing of information as violating the Freedom of Information Act?

Day Job: Lab Rat

[RobertB-DC]

Moderately Off-Topic Anecdote time!

One of my favorite unknown alt.country singers, Slaid Cleaves, tells the story of his day job: lab rat for experimental medicines at a center in Austin, Texas.

I take drugs for a living. I'm a human guinea pig. A lab rat. A medical research volunteer. Pharmaco International pays me to stay in their facility for about $100 a day. Some studies only last a couple of days. Some are comprised of several weekend stays. Right now I'm in the middle of a long term study. 22 days. We are in the facility for the entire time, except for a few 20 minute walks around the building for fresh air. No visitors. No outside food. Hospital type meals are provided, along with newspapers, movies, pay phones and a clip board that tells us where to be and when for certain "procedures."

The rest of the story (including the lab's phone number, if you're interested) can be found at Slaid Cleaves' web site.

/. abbreviation

[kevin_conaway]

...and the FDA long ago the tacitly approved this. /. debated...

Can we please refrain from starting sentences with the /. abbreviation?

Trust in Medical Professionals

[lukewarmfusion]

Doctors are like help desk technicians - you come to them with a problem, they have tests they can perform, and in the end they try to help you fix whatever's ailing you. But also like a tech, doctors are not always perfect - they have to make educated guesses about the problem and can definitely make mistakes. (The analogy continues, but it's important to realize the difference in necessary education before a person becomes a doctor. The risks of a PC crash are nothing compared to an allergic reaction that results in death.)

Now just like calling a computer tech, your visit to the doctor may not be that fruitful. It is possible that you will discover something your physician doesn't - after all, it's your body. In many cases, the doctor may not be willing to spend hours of research time finding a possible treatment for you. It's not surprising that you're willing to spend those hours on Google or other resources.

What I'd suggest is that you do your research and present your findings to your doctor. Work with him or her to approach these findings from an objective (try) standpoint and leave your emotions at the door. If your doctor will not work with you and you believe that one of these treatments may be successful, find another doctor who will be more receptive.

A few months ago, I went to the doctor with what I feared to be bronchitis or pneumonia. He told me I had the flu and prescribed a couple of things. I was skeptical of his anti-viral Rx, and when I went to get them filled the pharmacist told me that these drugs were only supposed to be prescribed on the first or second day of symptoms (I was in my fourth). I felt like the doctor (not my regular, but someone filling in) just gave me something to get me to leave. I did some research, and sure enough, there was no reason he should have prescribed those pills other than to mollify me.

Like telling a user "run a defrag."

All medications are experimental forever

[G4from128k]

All medications are experimental for three fundamental reasons:

1. Clinic research is not statistically adequate: testing a medication on 10,000 people will not catch adverse side effects that kill 1-in-20,000 (e.g., kill 1,500 per year when 30 million peapl take the drug). Aspirin given to millions of children for more than 100 years before discovering Reyes syndrome.
2. Genetic variations: People aren't genetically uniform. A drug that tests safe and effective on Chinese patients may kill Caucasians (and the Chinese and Caucasians are hardly genetically uniform). For childhood leukimia, there are currently 3 different drugs and they use genetic testing to determine which one to use (the wrong one is lethal).
3. Environmental factors: The other substances that you ingest affect drug behavior. Two different drugs may be metabolized via that same pathway and thus if you take both, it slows the the processing of the drug (may increase or decrease the drug's effects). Foods also affect the results. For example., grapefruit deactivates certain digestive enzymes that otherwise limit absorption of some drugs (e.g., you get a higher dose of the medicine if you take it with grapefruit juice).

The point is that there's rarely enough data and too many genetic and environmental variations to judge all the effects. No medicine is ever proven safe. At best, you can create statistical confidence estimates on the likelihood of adverse reactions, but the genetic and environmental factors make these hard to do.

What is a doctor?

[qualico]

Next time your in a doctor's office, ask to see their drug indications guide.
You should be given a thick manual with pages of fine print on all the available drugs and the interactions/warnings of each.

The scary part is that it will be choked full of advertising.
For example; notice the thick tabbed glossy insert for "Viagra".

This may not be as fraudulent as this:
http://www.whistleblowerfirm.com/pharmaceutical-fr aud/

However, it does beg the question, "What is a doctor?"
If they are being swayed by advertising and free samples, than they are nothing more than a sales agent.

That be said, there are no doubt a class of doctors who see beyond this garbage and choose to educate themselves to offer an unbiased and professional service for their clients.

Good on ya, if you have found the later, otherwise you might as well just subject yourself to experimental meds.

Re:Its your life

[stanleypane]

No medicinal value? Cocaine was once used as a local anesthetic. What do you think helped spur the creation of synthetic drugs such as novacaine or lidocaine?

Ditto for PCP. It was originally procuded as an anesthetic for humans later used by veterinarians. Now, neither uses them because of their potential for abuse. Ever heard of Ketamine? Another popular anesthetic used by vets. It is in the same family of drugs as PCP.

patient directed medicine

[Anonymous Coward]

[ Disclaimer: I come from a family of MDs, so am probably unusually sympathetic to doctors ]

There is a general problem with medicine in the US, and this story is part of it. The medical system considers us "patients" who are to be taken care of. But the insurance system considers us "customers", who have to manage our own health care, and figure out how it will be paid for.

Here's my latest example: I have good reason to suspect I have high LP-a, a condition that can be detected with a simple, inexpensive blood test. The results are easy to interpret, but the test is not standard procedure, especially for someone my age (young).

The local hospital does the test for $30. My insurance won't cover this test, so it is going to be out of pocket for me. BUT, the hospital won't do the test without a doctor's prescription (read: permission). They say this is so that it gets "billed to your insurance" correctly (even when I say that I am paying out of pocket).

I can go find some doctor (I don't have a regular doctor), pay a few hundred dollars (insurance won't cover this visit), and explain in gory detail why I want this specific test, hope that they don't think I am kook and give me the prescription. Then I pay the $30.

The kicker is that the hospital still won't give me the results. Instead, they will only send them to the doctor, requiring a second visit, and more money I don't have.

So how does this make sense:
- A test is being done on me
- But doctor must consent (no mention anywhere of my own consent, by the way)
- The results, in medical file, are kept hidden from me
- And I am expected to pay for the whole thing
- Yet can not influence any of the process

Its not circumventing, it is working with your doc

[rvaniwaa]

I have a rare form of cancer for which I am about 30 years younger than the average person with this cancer. I don't expect my doctor to know much about carcinoid because there are so few of us (he has only treated about half a dozen people with carcinoid).
Therefore, I feel it is my job to research as much as possible, find experts in carcinoid with which to consult and the latest paper to forward on to my current doc. Medicine should be a cooperative venture between doctor and patient, never just one or the other.
--Ron

Experimental drugs vs. tried and true alternatives

[vorpal22]

Drug law and the pharmaceutical industry both baffle me completely, in a theoretical sense and from personal experience.

There seems to be a whole branch of the pharmaceutical industry that is interested in deriving new medications to substitute for older tried-and-true medications, because the older meds often demonstrate "positive side effects" that we somehow view as undesirable.

What we're ignoring is that while the newer medications may eliminate the positive side effects (which may be addictive, or encourage abuse of medications, etc), these are not just vanishing; they're often being replaced by negative and potentially dangerous side effects.

From my own dealings with the medical industry, I present several examples:

• In 1996, still a teenager, I was cursed with some terrible, painful, and scarring cystic acne. I went to my doctor at the time and requested tetracycline. He instead gave me Accutane as he was hesitant to prescribe antibiotics for this condition. Several months later, for no situational reason, I became suicidal and tried to kill myself. Suicidal tendencies are now a well-known side effect of Accutane.
• In 1999, I developed a debilitating case of Generalized Anxiety Disorder. My doctor did not want to prescribe me benzodiazepines (very effective anxiolytics), instead preferring to give me paroxetine (Paxil). Result? It induced, within hours, panic attacks in me. Prior to that point, I had never had a panic attack before. It was determined that I was one of approximately 7% of caucasians deficient in the CYP450 family of liver enzymes, explaining why the medication demonstrated effects within hours instead of within days. This resulted in me also developing Panic Anxiety Disorder. My doctor then wanted to give me imipramine, which had a whole host of negative side effects, including instant death in a small percentage of users. I finally went to see another doctor, who was happy to prescribe me the benzodiazepine alprazolam (Xanax), which worked brilliantly and allowed me to live my life and engage in a cognitive behavioural therapy treatment program to learn long-term anxiety management skills. Note that in dealing with long term users of Paxil, I've noticed that many report that Paxil withdrawal is far worse than benzodiazepine withdrawal despite the fact that Paxil is supposed to be "non-addictive".
• I pulled a muscle in my lower back in late 2000. The doctor I went to see did not want to give me muscle relaxants for it as he thought they were too addictive, so instead, he provided me with celecoxib (Celebrex). I was in so much pain and so unable to do anything from the stiffness that I was unable to protest, and while it worked, during the treatment I discovered that Celebrex was so new a medication that it had only undergone a couple of clinical trials and had rushed to be released. I felt thoroughly like a guinea pig, particularly in light of the fact that several years later, Celebrex has largely been yanked from the market as it can cause possible heart problems.

The list can go on: Ultram invented for pain in lieu of the opioids (despite the fact that it's still very addictive), Ambien invented for inducing sleep instead of barbiturates and benzodiazepines (because it was, and still is assumed to be safer - ignoring the fact that it can and often does cause dramatic hallucinations at standard prescribed doses).

Personally, when I have severe pain, I want codeine or morphine. When I need to be sedated, give me some Valium. Don't try to haul this new, safer, poorly researched crap on me. Opiates, for example, have been in use for hundreds or thousands of years, and are well understood. I'd be much more likely to put my faith and comfort in them than some experimental drug that's but a couple years old.

OT: A little editorial advice

[hey!]

Y'know, this is an interesting article, but it is classic case of "burying your lead". It starts of almost as if it is about the new NIH regs. I had to read it several times to make positively sure I understood what was going on.

Here is the original article:

ghostlibrary writes "Even while NIH is getting new ethics regs, patientINFORM is being evangelized as a way for ordinary citizens to look up experimental treatment online, in essence circumventing their doctor, and the FDA long ago the tacitly approved this. /. debated Wikis in hospital. RSI fans track risky or untested procedures from the Typing Injury FAQ and Health-Hack covers IT-related self-help medicine. Laser-eye stuff is now mainstream and doesn't need a check beyond google. Any other sites out there for those willing to dictate their own medical course? Does this mean Internet users will become test subjects moreso than the usual college students and elderly?"

Let me suggest this as a better rewrite:

ghostlibrary writes "People who are interested in obtaining information about experimental treatments for health conditions can turn to a new web site called patientINFORM, which is being evangelized by a collective of publishers and medical groups. This site is controversial because it in effect allows patients to circumvent their doctors in the search for unconventional and unapproved therapies. While the FDA has tacitly approved this kind of information service in the past, the NIH is about to issue new regs covering the conflicts of interest this kind of service raises. This site joins other sites that disseminate information about risky or untested procedures, such as the Typing Injury FAQ, which covers RSI (repetitive strain injuries) or Health-Hack, which covers IT-related self-help medicine. Laser-eye stuff is now mainstream and doesn't need a check beyond google, and past Slashdot articles have even discussed the advisability of using wikis in hospitals.

Are there other sites out there for those willing to dictate their own medical course? Does this mean Internet users are joining the usual college students and elderly as experimental subjects for untested therapies?"

I think this is a bit clearer. A general word of advice -- try to put what an article is about in the first clause of the first sentence if possible

Be involved!

[Pedrito]

Whoever described doctors as "techs" was right on. Anyone who isn't actively involved in their own treatment is being absoutely careless. I decided this years ago, but it came crashing home when I got misdiagnosed by 3 doctors who said I had asthma based on very sketchy evidence. I was promptly put on a steroid inhaler for daily treatment and an albuterol inhaler for emergencies.

Now, the reason I went to 3 other doctors (the 4th being the one who correctly diagnosed my problem), is that the albuterol (a stimulant that opens the airways) was making my attacks WORSE, not better. But the second and third doctor said it was all in my head and to stick with it.

It turns out I was actually having panic attacks. So the last thing I really needed was to be sending a stimulant directly into my lungs which is just shy of injecting one right into your veins. I actually stopped taking the albuterol shortly after the second idiot doctor and just kept going back saying the same thing until I finally got a doctor who was willing to actually check if I really had asthma.

Now this is just a single example, but it's also not the first misdiagnosis I've had. I've been prescribed antibiotics for flu. I've been told I had food poisoning when I didn't.

There are some good doctors out there. There are a number of really, really, bad doctors out there. And most doctors, good or bad, are rarely willing to take the time to really investigate their patients' problems these days. You simply can't count on doctors to do the homework on your condition. Someone should be doing the homework. The doctor can run tests, but what if they're not running the right tests? You need to do at least some homework and be willing to make suggestions to your doctor. And if that bugs your doctor, find a new one.

I know we can't all get medical degrees and it should be the doctors' job to figure all this crap out, but the fact is with HMOs and the like, doctors aren't doing their jobs. They're working on a factory line and getting through as many patients as they can as quickly as they can.