Hello Again,
Just read this interesting articel from the BBC, http://www.bbc.co.uk/news/health-14572284
Basically it says that scientist have found away to use ecstasy to essentially cure cancer in people. The article is a bit confusing because it says that ecstasy has been proven to cure certain types of cancer in humans, but then goes on to say that at this point it has only been done in a test tube. Either way, it does appear on the surface that they might be onto something.
So, here is the debate. The article said that even if the drug looks promising it won’t be available for at least 10 years as it has to go through FDA type approval, clinical trial and the meeting to come up with a really cool name for it. My question is, the drug is aimed at helping people who have a terminal disease that at this time might have a treatment, but no cure. They will die, no if’s about it. Why then does agencies like the FDA even bother with this bullshit of clinical trials and allow paitents to opt into being test subjects, in essence using them as the clinical trial? It seems to me that if you are dying of cancer what do you have to lose? If the new drug kills you, you were a gonner anyway, why not take a chance that this might be the thing that could save you?
I can certainly understand holding a drug from the market for testing for conditions that aren’t fatal. I mean, that new toe fungus drug would be nice, but if it doesn’t get here soon nasty toe person is going to live. What is wrong with letting those with nothing to lose make the choice to try promising treatments?
You don’t know what clinical trials are, do you? It means you’re testing the drug on people. So for the most part, they are exactly what you are asking about. The very earliest clinical trials are usually on healthy people and not sick people (to make sure the drug is not so dangerous it harms people without existing problems), but after that, the drug is tested on people who have the disease it’s supposed to treat.
I couldn’t agree more with your post, with this minor quibble. I see no reason for the FDA to not “bother with [the] bullshit of clinical trials”. I say do both: continue with the clinical trials and allow people who are clearly terminal to give the drug a chance. Or, more to the point, give themselves a chance.
But aren’t there some drugs that are NOT used on humans, that seem promising? I seem to recall that some people go to other countries to get treated with certain drugs that the U.S> won’t allow doctors to use. No?
Occasionally, an experimental drug will be released to people with terminal diseases, but on the whole, the FDA has a record of lengthy testing required before a drug is approved.
Just watching a little bit of daytime TV will expose you to all the law firms looking to make a buck on “bad drugs” that have been pulled from the market because the side effects outweigh any benefit.
And the government has a long memory of thalidomide and its unexpected results.
~VOW
Right, I was going to come back and say this - my original answer was a little short (and might’ve come off as snippy). The FDA has some programs that allow patients with untreatable or terminal to get access to drugs that look like they could help even if those drugs have not been offically approved. The bigger problem in my experience is that it can be hard to get patients to sign up for a clinical trial. A lot of people who are already sick don’t want to be guinea pigs or they don’t want to take the chance they’ll be treated with something that doesn’t work. It’s a hard situation to deal with.
Thalidomide is back on the market, actually. And there are plenty of more recent drugs with unexpected side effects or PR disasters.
This gives me bad memories of the Reiki thread. There are drugs that are approved in other countries that aren’t approved in the U.S. and vice versa, sure. And there are always drugs that are being developed but aren’t approved yet.
Yes, I know exactly what clinical trials are. I also now that at any given time there might be a few hundred thousand people who are facing death from cancer and the clinical trial might include a couple of thousand. The point I am making is when you are facing death and there are no other options why shouldn’t you have the ability to opt in and take a chance on a promising, but as yet unproven medication?
I concided that point in my origional post, and it is valid for thousands of conditions including my example of toe fungus. But, toe fungus isn’t going to KILL me in a matter of months. If I am dying I don’t have the luxury of waiting to see if the drug might harm me. If I knew that there was no other option for treatment for a cure and death was the only sure thing, I think I would take a chance on a promising treatment even if there was a possiblity of it doing harm to me. What do I have to lose? I am dead anyway, but just maybe this exerimental drug will work. Not everyone in need is included in a clinical trial. So, the thought is, dispense with the traditional clinical trial in situations like these, let the patients willing to be used as test subjects be used and get your information from them.
Yes, it does sound like the same process of clinical trials, with the exception of letting all those who might benifit from the treatment be involved if they want to, instead of the “lucky few” who are chosen for traditional trials.
I am not sure what you meant by saying “harms people without existing problems”, as the only people that would want to take a chance on an experimental drug would already have an existing problem, hence the reason for wanting to take the drug.
I have to say maybe I am a bit biased her since I recently watched my mother in law die from lung cancer. I can assure you that somewhere in the world, there is a clinical trial going on with a drug targeted for lung cancer. I can also assure you that she would have taken the risk of trying that unproven drug. Would she still be alive today if she had the ability to make that decision? Who knows, but I am positive she would have given anything for the chance.
I can certainly see your point, I would think that if terminal patients were allowed to take untested drugs that liability waivers would have to be in place. I am certainly not advocating that they be allowed to do so and if it doesn’t work out be allowed to sue (with the exception of gross negligence). My thought is that it would be a risk in which they would assume all liability.
Also, thanks to a few of the posters who commented that the FDA allows terminal patients in some circumstances the ability to try unapproved drugs. I didn’t know that this option was out there, and it possibly makes my question moot. I was under the impression that the FDA will not under any circumstances allow a terminal patient to try unrpoven treatments. Hence my “bullshit” comment. (Of course I hope all of you realize that I am not advocating the release of all unproven drugs on the market. My question is limited to those with terminal conditions, that have no other option)
And as has been explained to you, programs exist that do exactly that. However, even in those cases, the FDA has an obligation to make sure that there’s something more to the treatment than wishes and claims. There has to be something to back it up, and that’s what the trials are for. When an experimental drug looks like it’s doing really well, and it can potentially save or improve lives, there are procedures in place to get it out to those who need it as quickly as is safe. But testing is not a bad thing. It needs to be done.
And if you scrolled down and read my last two post I thanked those who pointed it out. Even went as far to say that I was unaware that the FDA made exceptions and that my question is moot.
Then I apologize if I jumped to conclusions. In the OP it sounded like you were asking why patients can’t volunteer for clinical trials when that’s exactly what they do. You’re actually asking if some of the restrictions on studies can be loosened so more people can just choose to opt in. So my answer to that is that when you’re talking about people who are severely ill or terminal, I agree the process should be sped up. I don’t want untested drugs getting out there, but you don’t want people to die waiting.
I do wonder if your proposal would make it harder to get valid data from the clinical trials. Studies are carefully randomized to try to make sure the patients who get the experimental drug are about as healthy as the patients who are getting the placebo or the older drug or both. So it seems possible to me - and I’m not a statistician - that the patients may live longer or not, but you won’t get good data that way.
As you’ve probably seen firsthand, it’s not always as simple as hope or no hope. There’s usually some treatment option even if it’s not a great one, and everybody hopes they’ll beat the odds.
Patients aren’t just chosen for trials. They volunteer. Consent is extremely important; otherwise you’re experimenting on people without telling them.
I was describing the first part of the trial process, which usually involve testing the drug on a small number of people who are healthy. Those studies aren’t supposed to show that the drug works on the disease. They just show that it does something within the body (hopefully the thing it’s supposed to do) and that it doesn’t hurt people. If a drug makes healthy people sick, you may not want to give it to people who are already very sick.
I’m sorry for your loss, and yes, I’m there are lung cancer drugs being tested. The clinical trial system is complicated and it’s not just because of the safety issues - doctors and patients often just don’t know what studies are being done or who is a good fit - and it can be very frustrating for those of us who have someone who is dealing with a rare or untreated cancer.
If you’re interested in that ecstasy thing, we had one or two threads about it. It sounds exciting but this is not something that’s ready for testing on people. Knowing that it works on cells is great, but there’s the whole matter of getting into a person’s body in the most effective and least harmful way.
No, that’s absolutely not true. There’s no rule against testing drugs on terminal patients. A rule like that would make it impossible to test drugs for a lot of diseases, and some patients only sign up for a clinical trial after they’ve tried the normal treatment and found it didn’t work for them.
Thankyou for taking the time to respond and clarify. It does seem that I was ignorant on the subject as a whole, which is why I posted the question in the first place.
I am not personally interested in this study, just frustated (even though I have been proved wrong on this issue) in seeing potential treatments delayed. The whole medical drug issue however is at times frustrating for me. As I have mentioned in another thread about medical marijuana being legalized, it is hard for those of us looking for an answer to understand and accept what we see as uneccassary delays, although valid reasons were raised here.
*Full disclosure. Currently I am taking an obscene amount of narcotic pain killers a day, hence my comment about legalization of medical cannabis. Hell, my assumptions about the pain fighting abilities of pot might be based completely on mis-placed hope. But when your only other choice is to gobble morphine daily your view gets a bit skewed. And then when I see comments in stories about a possible drug to help will take decades to come to light it gets frustrating. I realize that they are two totally different subjects, but the approval process and legality issues seem to run together.
There’s more to drug tests than just making sure the patient doesn’t die or grow a third arm or something. They also need to check for dosage levels, long term benefits and drug interactions. Knowing that this or that drug will kill cancer cells in a test tube doesn’t begin to tell you what sort of dosage you need to give an adult male of xxx pounds and yy years who’s also on medication for a thyroid condition, or a heart attack, or any number of things. Until you know all that, you can’t even really set up the factory to make the pills.
While this medicine in your article seems promising, it’s far from the first cancer drug that seemed promising in the test tube phase. Some drugs even make to the human phases before they fall apart.
For example, here’s a NYT opinion piece on a drug, Avastin, which was being tested as a beneficial drug for people whose breast cancer had metastisized. Based on the positive results from the first trial, the drug was granted “accelerated approval”. But once the drug hit a wider audience, follow up tests failed to confirm the original, single, test results and it was deemed that Avastin was actually not helpful in treating cancer. The drug has since been removed from the market.
My reason for mentioning this is twofold: First off, to point out that drugs can get accellerated status if they seem promising and secondly, just because a drug is promising in the early stages doesn’t mean that it will be beneficial once all the results are in.
It’s true that there are many tests going on for cancer-fighting drugs. But just handing them out indiscriminately doesn’t help patients, even terminal patients. The odds are far higher that most of the drugs tested will turn out to be useless, a few of them will be harmful, and none of them a silver bullet.
I don’t mean to sound like I think the research or the tests are useless - far from it. Just that I don’t think the patients in the tests are likely to be the chief beneficiaries.
In fact many of the clinical trials I’ve been associated with would only admit patients that had failed to respond to other therapy and so were at deaths door without other treatment options.
On average it seems there are several media reports a year on the latest drug/treatment that’s going to cure cancer but will need years of study and development.
What we don’t generally hear about are the undramatic followups - drugs that proved way too toxic to treat humans, or were found ineffective in animal or human studies even though they killed tumor cells in tissue culture.
Awhile back it was anti-angiogenesis drugs that were going to revolutionize oncology. It was an extremely logical idea - stop tumors from making new blood vessels and they won’t be able to grow and kill the patient. While the idea is still being pursued and drugs investigated, anti-angiogenesis has not proved to be a magic bullet. One approved drug (Avastin) has uses against some cancers, but recently had its approval to treat advanced breast cancer rescinded by the FDA when it was found to not have significant efficacy, in addition to causing potentially fatal side effects.
I’m unfamiliar with how the ecstasy derivative works, but the idea of attacking cell membranes strikes me as holding potential for major undesirable side effects. Even those anticancer drugs that target specific molecules in malignant cells can have nasty side effects.
If you give the go-ahead to docs to treat patients with any cancer drug outside a controlled setting, then it becomes impossible to definitively evaluate how it did. In any population of patients, a few will live longer than expected and/or have remissions – how do you know if this is by chance or due to the drug? Armed with selective testimonials, makers of these drugs and enthusiastic patients could make a case for widespread usage - and who pays for this? Medicare and everybody’s insurance company?
The idea of tweaking the approval process to speed up trials of drugs that, for example have showed real promise in phase I trials (meant mostly as a test of toxicity and to evaluate early indications of efficacy) sounds good. Just allowing the prescribing of anything and everything sounds like a recipe for confusion, disappointment and wasting of medical resources that are already stretched thin.
You know, another thought just hit me. Why in the world would word of this be published? The poster above who said this is just one of many “cures” we have heard about over the many years, and all and maybe this one haven’t panned out. It seems almost cruel for a news organization to publish stories like this knowing full and well that it is all just speculation at this point. It seems that the only thing accomplished by stories like this, besides motivating me to post at SD, is raising the hopes of some very very sick individuals. The paradox is mind boggling.
Typically things like these are published in medical journals and either the press sees them or the companies/researchers/PR agencies get the press involved. The stories are published because people read stories about these things, and because it really could be significant news. But I agree that touting everything as a possible cure for cancer and Alzheimer’s and such is unfair.
There are drugs that are approved in other countries that aren’t approved in the U.S. and vice versa, sure. And there are always drugs that are being developed but aren’t approved yet.