What this story failed to mention is that prior to testing in humans, new potential drugs go through many layers of “preclinical” tests in animals. Many, no, most, drugs are rejected for further study because of observations seen in these animal studies. A small fraction of drugs graduate to the clinical testing phase. Then the first testing in humans is done on a very small population. Just looking for safety--no immediate adverse effects. As more confidence is gained, trials become bigger so the benefits--if they are real and statistically significant---can be quantified. And there’s a lengthy process of informed consent. Anyone can withdraw for any reason.
This story fell flat for me. I wish there was more background. To echo another comment, the “tee up” for human trials is long and, despite that the idea of the “human lab rat” is provoking, most of human trials aren’t done willy-nilly in a strip mall. This piece could have been strengthened by a background on the fraught history of drug trials, the protections put in place in the last decade, and role of major academic medical centers in getting drugs tested and marketed. (In other words, yeah, phase I trials for cancer treatments are tested on consenting cancer patients in strict settings and not on randos who don’t have cancer.)
I wish there had been a discussion of what types of trials the Lab Rats are enrolling in, if they also donate bodily fluids (like plasma) for money, and questions of the like. Even a more interesting vignette of Lab Rat’s typical month would have helped drive it home. Darn it, now I have more questions than answers!
I work in research and there are many, many safeguards to make sure there is not undue coercion in recruiting subjects. There are people who participate in research for selfless reasons but not enough. Providing some incentive to compensate people for their time and willingness to take risks seems fair and morally sound to me.
I was waiting for the part of the article where we hear what awful things happen when a side effect is found, but it never came. If some people do this more or less full-time, are we to assume it's relatively safe?
Also very interested in why overweight candidates are disqualified, since presumably plenty of overweight people would take the treatment.
I must be a libertarian because I don’t really see the problem with this. For coerced uncompensated prisoners, absolutely awful. For people willing to subject themselves and get compensated in the process? They seem to like the camaraderie and are otherwise unemployable? As long as they are consenting adults, cool. Go for it.
"Phlebotomists who don’t know how to draw blood are just part of the deal." This sentence does not describe a phlebotomist, i.e. a person specially trained to draw blood samples. You might encounter a phlebotomist in a hospital, where the volume of testing requires them to move from ward to ward drawing blood samples as ordered by attending physicians. In the typical medical office, this task is handled by the medical assistant, who learned the process as part of a medical assistant course or on the job training.
As a general medic in a USAF hospital in the late 1960s I learned how to draw blood by first observing, then doing it. It was not particularly hard to learn to do properly; without harm or pain to the patient or danger of blood contamination to yourself. As our patient population included dependents (spouses and children) I also learned to insert scalp vein needles on tiny babies for intravenous infusion. The most common size needles used for routine blood draws and venipuncture is 21 gauge . The gauge is small enough that it does not cause any significant pain or discomfort during use.
Ironically, the person you generally do not want to draw your blood or give you injections is the physician; because they rarely do it and due to that lack of experience do not do it well.
Viox killed as many as the Vietnam war, and yet people still line up to take controversial medicine. I’m not one who thinks all Parma is bad, but I can’t believe people voluntarily do this kind of stuff.
Interesting article but it ended so abruptly. A deeper piece might be nice. I’ve got so many questions. How many of these people die? What about complications? What happens if the drug ruins their body? Etc
I think this is far to sensational and not accurate which is disappointing since it may leave the reader with the wrong perception- and these days perception is everything.
First actual lab rats have no choice in the decision- the rodents used are treated without any input. Phase I patients are fully informed of what they are participating in and the study is cleared by both the Food and Drug Administration and a institutional review board (ethics) who look closely at the safety data from all prior studies in lab animals as well as prior human studies of this agent and any related agents.
The process is more akin to a test pilot. When Chuck Yeager climbed into the X1 he made a voluntarily decision to do this and knew the risks. When a patient enters a phase I study they have to read a long and detailed informed consent that outlines all the known and anticipated risks as well as the potential risks as well as time commitment. The must also consent to this and meet the background criteria to ensure it is safe for them to participate. Investigational therapies are them ost regulated form of medicine in the USA.
The likelihood of dying from a phase I trial drug is very low. Some have likened it to well below the risk of dying from a bread toaster fire in the USA (there are statistics on this), yet we do not attempt highly regulate the use of toasters.
We are living in a golden age of new drug development, all medicines must go through this process to determine safety as we need to treat serious illnesses with better and safe drugs.
My guess is over time, AI will improve to where these studies will be truncated into minimal in vivo testing. Since COVID, I've begun to believe many pharmaceuticals are interfering with natural human immune processes. We may see a homeopathic revolution in the next century that will make more sense for human sustainability.
Once you've tried a new drug isn't there a chance it could effect the outcome of the next trial? This seems a little sloppy.
Great article, btw.
After reading recent articles about the Vax, I feel like we're all lab rats.
What this story failed to mention is that prior to testing in humans, new potential drugs go through many layers of “preclinical” tests in animals. Many, no, most, drugs are rejected for further study because of observations seen in these animal studies. A small fraction of drugs graduate to the clinical testing phase. Then the first testing in humans is done on a very small population. Just looking for safety--no immediate adverse effects. As more confidence is gained, trials become bigger so the benefits--if they are real and statistically significant---can be quantified. And there’s a lengthy process of informed consent. Anyone can withdraw for any reason.
Great writing, fascinating subject, lab rats in need of counseling.
This story fell flat for me. I wish there was more background. To echo another comment, the “tee up” for human trials is long and, despite that the idea of the “human lab rat” is provoking, most of human trials aren’t done willy-nilly in a strip mall. This piece could have been strengthened by a background on the fraught history of drug trials, the protections put in place in the last decade, and role of major academic medical centers in getting drugs tested and marketed. (In other words, yeah, phase I trials for cancer treatments are tested on consenting cancer patients in strict settings and not on randos who don’t have cancer.)
I wish there had been a discussion of what types of trials the Lab Rats are enrolling in, if they also donate bodily fluids (like plasma) for money, and questions of the like. Even a more interesting vignette of Lab Rat’s typical month would have helped drive it home. Darn it, now I have more questions than answers!
I work in research and there are many, many safeguards to make sure there is not undue coercion in recruiting subjects. There are people who participate in research for selfless reasons but not enough. Providing some incentive to compensate people for their time and willingness to take risks seems fair and morally sound to me.
So here’s the conundrum--- People will scream, “didn’t they test this for safety??!!” while others scream, “look how they test it for safety!!”.
I was waiting for the part of the article where we hear what awful things happen when a side effect is found, but it never came. If some people do this more or less full-time, are we to assume it's relatively safe?
Also very interested in why overweight candidates are disqualified, since presumably plenty of overweight people would take the treatment.
I must be a libertarian because I don’t really see the problem with this. For coerced uncompensated prisoners, absolutely awful. For people willing to subject themselves and get compensated in the process? They seem to like the camaraderie and are otherwise unemployable? As long as they are consenting adults, cool. Go for it.
"Phlebotomists who don’t know how to draw blood are just part of the deal." This sentence does not describe a phlebotomist, i.e. a person specially trained to draw blood samples. You might encounter a phlebotomist in a hospital, where the volume of testing requires them to move from ward to ward drawing blood samples as ordered by attending physicians. In the typical medical office, this task is handled by the medical assistant, who learned the process as part of a medical assistant course or on the job training.
As a general medic in a USAF hospital in the late 1960s I learned how to draw blood by first observing, then doing it. It was not particularly hard to learn to do properly; without harm or pain to the patient or danger of blood contamination to yourself. As our patient population included dependents (spouses and children) I also learned to insert scalp vein needles on tiny babies for intravenous infusion. The most common size needles used for routine blood draws and venipuncture is 21 gauge . The gauge is small enough that it does not cause any significant pain or discomfort during use.
Ironically, the person you generally do not want to draw your blood or give you injections is the physician; because they rarely do it and due to that lack of experience do not do it well.
Viox killed as many as the Vietnam war, and yet people still line up to take controversial medicine. I’m not one who thinks all Parma is bad, but I can’t believe people voluntarily do this kind of stuff.
Interesting article but it ended so abruptly. A deeper piece might be nice. I’ve got so many questions. How many of these people die? What about complications? What happens if the drug ruins their body? Etc
I think this is far to sensational and not accurate which is disappointing since it may leave the reader with the wrong perception- and these days perception is everything.
First actual lab rats have no choice in the decision- the rodents used are treated without any input. Phase I patients are fully informed of what they are participating in and the study is cleared by both the Food and Drug Administration and a institutional review board (ethics) who look closely at the safety data from all prior studies in lab animals as well as prior human studies of this agent and any related agents.
The process is more akin to a test pilot. When Chuck Yeager climbed into the X1 he made a voluntarily decision to do this and knew the risks. When a patient enters a phase I study they have to read a long and detailed informed consent that outlines all the known and anticipated risks as well as the potential risks as well as time commitment. The must also consent to this and meet the background criteria to ensure it is safe for them to participate. Investigational therapies are them ost regulated form of medicine in the USA.
The likelihood of dying from a phase I trial drug is very low. Some have likened it to well below the risk of dying from a bread toaster fire in the USA (there are statistics on this), yet we do not attempt highly regulate the use of toasters.
We are living in a golden age of new drug development, all medicines must go through this process to determine safety as we need to treat serious illnesses with better and safe drugs.
What alternative do you propose?
I didn't like the rat images. They seemed absurdly manipulative. And on my they seemed to have the opposite effect I think was intended.
My guess is over time, AI will improve to where these studies will be truncated into minimal in vivo testing. Since COVID, I've begun to believe many pharmaceuticals are interfering with natural human immune processes. We may see a homeopathic revolution in the next century that will make more sense for human sustainability.