Paraphrased from an ad on the radio this morning. This is not an exact quote.
As if ads that got patients to ask their doctors if drug X was right for them with no indication of what drug X did, now we have this shit. It went on an on and the message was that clinical trials were where the good stuff was, and that this company was now giving great opportunities for everyone to get in on the action. The ad seemed to imply that it was better because not only because it was new but because it was not yet proven.
Somehow I heard this conversation in my head:
Ignorance peddling predators glossing over the risks and preying on the sick and the desperate, taking advantage of ignorance and increasing it, may all involved in developing this ad come down with cancer and lose their insurance.
You have no idea how clinical trials work, particularly for cancer.
Briefly, in a clinical trial, a patient will not be denied standard of care. If cancer X has been shown to be treatable by treatment Y, then that treatment will still be provided, and the trial will add the additional treatment.
The only scenario where this is not the case is if the patient has already not responded to treatment Y (hormone refractory prostate cancer, for example). In that case, you are testing your additional treatment for the therapy of patients who have already not responded to traditional therapies, and will hopefully get FDA approval for that indication.
If the rules on clinical trials were relaxed a bit, diseases would be getting treated much faster.
Without more information on who’s offering the trial, for what cancer and what drug(s) are involved, it’s hard to know just what’s at stake here.
Advertising directly to the public for cancer patients to take part in a clinical trial is not standard practice - so maybe lee is concerned about the ethics of a drug company trying to move its product through FDA approval faster by creating a stampede to fill the quota for a trial.
I remember reading once (can’t remember where or vouch for its accuracy) that a pitfall of participating in clinical trials, for some, is that they find themselves responding positively to the medication, but at the end of the trial are not allowed to continue taking it—and in some cases the drug is not approved or marketed afterward. So they end up experiencing a drug they know they respond to, but which they can’t get.
Anyone heard of this shit or have or have any fuckin’ first-hand experience?*
*Query gratuitously profanitized after I noticed this was a Pit thread.
I don’t understand the funding for some clinical trials. For new pharmaceuticals, the company usually pays. But what about new procedures? We are trying to get my wife into an adult stem cell transplant study, but it is funded by the patient’s own insurance; if your insurance won’t pay, then you can’t participate. We have Blue Cross/Blue Shield, who claims they never pay for experimental procedures. So how can they conduct a clinical trial if many of the prospective subjects are excluded by their insurance company? The study coordinators are scratching their heads now, as if it never occurred to them that the insurance companies would decline to pay for their study. How does this happen? They have spent $20 million of an NIH grant, only to suddenly find out they don’t have any eligible subjects? The mind reels.
Well, that is what one would hope is the case, but goes contrary to what this ad seems to be promising. I have noticed more and more propaganda in the last few years that seem to tout clinical trials as the be all and end all of advanced treatment, advocating for them to be made widely available to all comers, and hinting that those not in a clinical trial as somehow getting shafted. This is in sharp contrast to what I would expect for an ethical presentation of a clinical trial, which is a way to study the effects of new drugs and procedures where consenting informed individuals realize that they are as likely to be in a control group as a group which is receiving the proposed treatment, and that the proposed treatment is not without risks.
They’d like to get as many potential people in as possible to have a pool of eligibles. But there will VERY strict criteria set ahead of time, and anybody who is not a candidate will not be put on the clinical trial; all comers are welcome, but not all would be enrolled.
Depends on how the trial is being conducted, and that would be spelled out in the consent form. For cases like cancer, as someone mentioned above, the trial would almost certainly be <proven treatment> versus <proven treatment plus new study drug>. For non life-and-death ailments, it might be something like that, or it might be <study drug> versus placebo, with the doctor able to give doses of a known medication to any patient who doesn’t show enough improvement within a certain time period after the trial starts. There is a lot of variation in how trials can be set up. Ask the study doctor why a certain setup is being done if you don’t understand.
Some are “open label” trials which means that the doctor and subject both know what’s being taken - this is usually later in the drug development. Some are “double blind” where neither knows. And some studies are a mix - perhaps one doctor at the study site knows (like the one who administered the treatment), perhaps the subject knows too, but the doctor doing the followup doesn’t. This can be unavoidable - if certain drugs have unmistakeable known side effects (for example, headache immediately after being given) then that’s hard to hide.
Vinyl Turnip - this could indeed happen, yes. Some drugs do not reliably show enough of a difference to be worth using, so perhaps some subjects were very much helped by the drug but a whole ton more were not, to the point where it’s hard to tell the difference between that and placebo. Sometimes a subject shows improvement on placebo and assumes it must be the drug. Some drugs work but have unacceptably high rates of bad side effects.
Also, lee, a reputable institution would not make wild claims about a study drug’s efficacy. I know that hospitals and universities have to have their study’s advertising, if any, approved by a review board which supervises research in general, to ensure it’s not making promises or being coercive in any fashion.
That is exactly the case. And you are entirely correct regarding the likelihood of being a control versus case.
Any company/institution hoping to have its product tested in the field needs to have every document - the trial protocol, consent forms, advertising (print/radio/tv) approved by a certified Institutional Review Board, made up of scientists and non-scientists alike. The IRB reviews the ethical and scientific merits of the study to ensure that all participants’ rights are protected as much as possible. Promising a hoped-for benefit is coercive and should not have been approved by an IRB.
Nevertheless an advertisement very like the one I heard was on the radio this morning. I don’t know that it is trying to drum up volunteers for approved study or if it is a bunch of con artists preying on the sick, or simply propaganda to help change general attitudes. I have so far had no luck finding out who paid for the spot. I will be listening for it in the future to find out more.
Also, I am not as confident in the process that approves studies as you seem to be. There have been several studies in recent years which made news which were at best questionable ethically. Also companies and institutions are increasingly using spin offs and shell companies to limit liability for testing so that they don’t have to put their full assets and reputations on the line when conducting tests. The TGN1412 study comes to mind. The company that conducted that was spin off from a medical school and is now bankrupt while the med school is going fine. Too bad the subjects are not doing well.
If the non-scientists in your IRB all have attitudes influenced by propaganda like that I heard this morning, and the scientist are eager to run the trials, it doesn’t leave the subjects’ interests well protected.
Sorry - didn’t mean to imply that you didn’t hear what you said you did. I meant that whoever approved that ad, based on what you posted, should have their ass in a sling.
Nor do I think that every clinical trial that’s been approved by an IRB has been approved properly, or is being run properly. Any system is bound to have its flaws, as well as have those within the system who are willing to either exploit said flaws or try to get around the regs in the first place. That being said, what’s in place now is a lot better than what was in place 20 years ago, and will be even better 20 years from now. There have indeed been several studies in recent years that made the news. There’ve also been several more that haven’t made the news…because nothing went wrong. If there’s no controversy, it’s a rather poor headline.
Members of the boards are required to take human-subjects research training and learn all about the ethics and regulatory aspects of clinical trials, as well as declare a conflict of interest and absent themselves from the room when trials in which they are involved are reviewed. Further, every potential member has to be approved by the Office of Human Research Protections before they can serve. Every one I know is fiercely dedicated to the protection of human subjects and would be just as offended by that ad as you were. Just because they’re scientists doesn’t mean they don’t care about the subjects. And just because they’re non-scientists doesn’t mean they’re going to follow the scientists’ lead in every review.