Project Veritas has recently gone viral with another undercover video that people from both sides of the debate are exaggerating in both directions. Dr. Robert Malone, who many establishment figures claim has credibility problems, claims the researcher exposed in this video, Jordon Trishton Walker, "has no moral compass," which may be at least partly true, and, if so, it may apply to many other researchers and a large portion of the for-profit pharmaceutical industry. I'm not convinced that Dr. Robert Malone has credibility problems just because the establishment media claims he's a fringe researcher, but I'm not ruling it out either, and there's no doubt that James O'Keefe has serious credibility problems; however, a significant portion of the claims in this video can be partially confirmed from other sources that are much more reliable. Even though the video raises some legitimate concerns it would help to understand the fundamental basics of medical ethics, which most people don't, and to consider, although some of the conclusions from the video can be confirmed, I'm not sure all of it can, and some of it, which is getting the most attention is being exaggerated and misrepresented. For example, one of the claims that some people have made is that they were intentionally making viruses more dangerous so they could increase profits from selling vaccines; however, even if they weren't doing this, the profit motive has often turned out to be more important than providing the best medical care for the majority of the public, especially those that can't afford it, sometimes even if they volunteer to serve as research subjects.
When JTW was confronted about the disclosures in this video he acted with outrage demanding that they couldn't do this to him; however, he was a beneficiary of a system that gives the majority of financial benefits to a small percentage of the public; and, in the medical research industry they routinely use people and animals for research often doing much more harm to them than what was being done to him, not that I'm a fan of James O'Keefe. In recent decades medical research is supposedly applying much better standards to protect human research subjects than they used to; however, animals are still being abused much worse, decades ago poor people and before the civil war slaves were abused much worse, and there's good reason to suspect when modern ethics protected research subjects in wealthy countries, that they may have moved a lot of research to third world countries where they weren't protected, so they may still be abusing people in other parts of the world much worse than anything JTW put up with. And during the video he even admitted that the revolving door with drug companies and the government might benefit them but it's bad for the public!
The way this has been presented to the public has divided people into two opposing sides, with most people on both sides more concerned with proving their side is right and the other is wrong, even though both sides are flawed. On the right are many religious people that may not be familiar with science in most cases, including many "pro-life" people who aren't concerned with protecting the environment, providing health care, childcare, educational services, and other policies that do as much, if not much more, to protect life than banning abortion. On the left are people that are supposedly much more concerned with good science that often do want to provide these services, but they're often so outraged by right wingers that are trying to ban abortion and they hate James O'Keefe for some of his past activities, that they refuse to consider the possibility that he might be partly right on this subject, and sort through the good science to figure out which part might be right. This is very similar to a sting he did about eight years ago on Planned Parenthood which I covered in Both sides of Planned Parenthood controversy ignore or misrepresent human research experiments. There's only a small fraction of the public that even seems to be trying to sort through the facts, just as they did eight years ago after his expose on Planned Parenthood, and many of those are better informed about the actual research, whether they're involved in it or they just read up on academic work not covered in traditional media, which is what I did.
Traditional media almost never discusses medical ethics of research, although it's discussed much more in the academic world, and it would be much easier to sort out the exaggerations if the majority of the public was aware of the basic ethical principles of medical research. And there's one important factor that is almost never mentioned, although it is hinted at by some of the better ethicists, and, occasionally some of the worst. The people controlling the research are all from the upper middle class or wealthier people, and more often than not, the vast majority of those used as research subjects are from lower classes with less financial options or educational background, so they may often not recognize the complete risks of the research in many cases. The benefits of the research is also controlled by the upper classes, and even though a lot of research is done by upper middle class college educated people, they work for large institutions controlled by wealthier people, and, under our current economic system, their top priority is to maximize profits for investors, not necessarily to benefit all people equally and fairly, as they often say or imply. Other wealthy countries with Universal health care and price controls on patented drugs are much more likely to share the benefits of modern research than in the United States, or third world countries with poor medical institutions, that often attract more funding for research purposes than to treat the public, especially poor people.
The evidence to support these conclusions, and more, isn't secret, and can be confirmed with public information, some which is easily available to everyone, and more which I'll cover below from some researchers on the subject. However, MSM never discusses it in this manner and repeats false propaganda about benefits of research being shared by all equally without question, over and over, which is a very convincing propaganda tactic for those not considering opposing views. They understand "A lie repeated often enough becomes the truth," or at least it seems to, especially if it's not challenged in a high profile manner, and since well over 90% of national speech is controlled by six corporations, and a fraction of 1% of the wealthiest people in the country they can ensure that opposing views on many subjects are relegated to the fringes where few people hear it.
Our medical and research institutions are controlled by a political system and economic ideology that violates many ethical standards, making it virtually impossible to impose good ethical practices in research, yet traditional media, the political establishment and some so-called ethicists, including Ezekiel Emanuel, who helped design the Affordable Care Act, have been unwilling or unable to point out many of these flaws. There has been wide support for some form of Universal Health care for decades, yet the political establishment refuses to implement this, even though all other wealthy countries already have it. And 22 studies agree: 'Medicare for All' saves money 02/24/2020, the most conservative of these studies admit that it will save at least a few billion dollars per year, and the total will probably be even higher as most of the studies indicate. And even though many of these studies didn't review how many if any lives it would save some of them did including one reported in Medicare for All Would Save $450 Billion and 68,000 Lives: Study 02/18/2020. Furthermore even a quick look at Wikipedia's List of countries by life expectancy shows that all the wealthy countries with Universal Health care, and some much poorer countries without as good a health care system, have longer life expectancy, while all the countries with lower life expectancy don't have as good a health care system and are much poorer, and in many cases they have much less stable governments. There's an overwhelming amount of evidence showing that Universal Health Care, like all other wealthy countries already have, will save an enormous amount of money and lives at the same time, but our political system isn't even trying to implement it, and they even have "ethicists" like Ezekiel Emanuel trying to justify the current system, which he helped develop, and at best is only slightly better than the previous system before 2009. This system keeps control of health care in private hands so they can try to maximize profits, and, as I'll demonstrate below, it doesn't conform with some of the ethics Ezekiel Emanuel claims to defend.
They certainly aren't preserving this system because the public likes it; as I pointed out several times including a recent article Conclusive Proof Showing Democracy In The USA Is A Lie! which shows dozens of polls, including one showing strong support for Medicare for All demonstrating that a large majority of the public support it and a large majority are also on the same side of many other issues involving rigging the economy in favor of the rich, yet campaign donors are on the other side, and the political establishment virtually always takes the side of their donors at the expense of the public, with a few possible exceptions where issues like abortion or same sex marriage doesn't impact their wealth or issues like infrastructure, where it's also in their own best interests to repair roads or other services helping them make profits. One source that get's right to the point when it comes to the wealthy controlling the legal system is Randall Sheldon who wrote "Controlling the Dangerous Classes" where he says "On any given day, in courtrooms all over the country, we have essentially one class passing judgment on another class. Our system is fundamentally a system influenced by class (and race)." I went into this in more detail, including more excerpts from his book in We Have A Lawless Oligarchy; Not A Democracy! He doesn't actually provide a source for this claim; however it wasn't hard to think it through and realize that judges, lawyers, lawmakers and other powerful people are college educated, and much more likely to come from wealthy families, and a quick Google search finds many sources saying that the vast majority of people in criminal court are from low income people.
The same basic principle applies for any other given subject, and if you look for evidence in research on any given subject, including medical research, you may find that wealthy people control powerful institutions, and they use their control to ensure that they receive most of the benefits. There are numerous researchers, including Harriet Washington, author of "Medical Apartheid," "Deadly Monopolies," and at least one more good book, Marcia Angell, author of "The Truth About Drug Companies," Laura Stark author of "Behind Closed Doors," Rebecca Dresser author of "Silent Partners," Wendy Orent, author of "Plague," several authors of research on MKULTRA, including John Marks and Gordon Thomas, and many other researchers, including even Ezekiel Emanuel even though he doesn't always abide by his own ethical views, showing how medical research is rigged in favor of the wealthy and confirming some of the claims made by Jordon Trishton Walker, but not necessarily some exaggerations, in the following excerpts:
Did Project Veritas Show Pfizer Mutating COVID-19?! 01/28/2023
PV: Pfizer ultimately is thinking about mutating COVID?
JTW: Well, that is not what we say to the public. No.
JTW: Don’t tell anyone this by the way, you have to promise you won’t tell anyone.
JTW: We’re exploring like – you know how the virus keeps mutating?
JTW: Well one of the things we’re exploring is like, why don’t we just mutate it ourselves so we could- we could create preemptively develop new vaccines, right? So we have to do that. If we’re gonna do that though, there’s a risk of like, as you could imagine, no one wants to be having a pharma company mutating fucking viruses.
JTW: You have to be like very controlled to make sure that this virus that you mutate doesn’t create something like, you know, goes everywhere.
JTW: Which, I suspect is the way that the virus started in Wuhan, to be honest. Like, it makes no sense that this virus popped out of nowhere.
PV: Yeah, I know.
JTW: It’s bullshit.
PV: It [mutating COVID] sounds like Gain-of-Function to me.
JTW: I don’t know, it’s a little bit different. I think it’s different. It’s like, this, it’s definitely not Gain-of-Function.
PV: It sounds like it is, I mean, it’s okay.
JTW: No no no, but directed evolution is very different.
JTW: Well you’re not supposed to do Gain-of-Function research with the viruses.
JTW: They’d rather we not, but we do these selected structure mutations to try to see if we can make them more potent.
JTW: So, there is research ongoing about that. I don’t know how that’s going to work.
JTW: There better not be any more outbreaks cause, like, Jesus Christ.
JTW: It is a revolving door for all government officials.
JTW: It’s pretty good for the industry to be honest. It’s bad for everyone else in America.
PV: Why is it bad for everyone else [in America]?
JTW: Because if the regulators, who review our drugs, you know that once they stop being a regulator, they want to go work for the company, they are not going to be as harsh on the company where they’re getting their job. ......
JTW: So, the way it would work is like we put them in – the virus in these monkeys. And then we successively, like, cause them to keep infecting each other.
JTW: And we collect serial samples from them, and then, the ones that are more infectious, to like, the virus we’ll put them in another monkey and you just constantly actively mutate it. That’s one way. .......
JTW: Who knows? I mean, either way, it’s going to be a cash cow. COVID will probably be a cash cow for us for a while going forward. Like, obviously, like .....
PV: Well I think the whole, you know, research of the viruses and mutating it [them], like, would be the ultimate cash cow.
JTW: Yeah, it’d be perfect.
JTW: It [Pfizer] is a revolving door for all government officials.
PV: Wow!
JTW: Yeah, for any industry though. So, in the pharma industry, all the government officials who, you know, review our drugs eventually, come work for pharma companies.
JTW: And the military – all the army and defense government officials eventually go work for the defense companies afterwards.
PV: How do you feel about that revolving door?
JTW: It’s pretty good for the industry to be honest. It’s bad for everyone else in America.
PV: Why is it bad for everyone else [in America]?
JTW: Because if the regulators, who review our drugs, you know that once they stop being a regulator, they want to go work for the company, they are not going to be as harsh on the company where they’re getting their job. Complete article
PV: Pfizer ultimately is thinking about mutating COVID?
JTW: Well, that is not what we say to the public. No.
JTW: Don’t tell anyone this by the way, you have to promise you won’t tell anyone.
JTW: We’re exploring like – you know how the virus keeps mutating?
JTW: Well one of the things we’re exploring is like, why don’t we just mutate it ourselves so we could- we could create preemptively develop new vaccines, right? So we have to do that. If we’re gonna do that though, there’s a risk of like, as you could imagine, no one wants to be having a pharma company mutating fucking viruses.
JTW: You have to be like very controlled to make sure that this virus that you mutate doesn’t create something like, you know, goes everywhere.
JTW: Which, I suspect is the way that the virus started in Wuhan, to be honest. Like, it makes no sense that this virus popped out of nowhere.
PV: Yeah, I know.
JTW: It’s bullshit.
PV: It [mutating COVID] sounds like Gain-of-Function to me.
JTW: I don’t know, it’s a little bit different. I think it’s different. It’s like, this, it’s definitely not Gain-of-Function.
PV: It sounds like it is, I mean, it’s okay.
JTW: No no no, but directed evolution is very different.
JTW: Well you’re not supposed to do Gain-of-Function research with the viruses.
JTW: They’d rather we not, but we do these selected structure mutations to try to see if we can make them more potent.
JTW: So, there is research ongoing about that. I don’t know how that’s going to work.
JTW: There better not be any more outbreaks cause, like, Jesus Christ.
JTW: It is a revolving door for all government officials.
JTW: It’s pretty good for the industry to be honest. It’s bad for everyone else in America.
PV: Why is it bad for everyone else [in America]?
JTW: Because if the regulators, who review our drugs, you know that once they stop being a regulator, they want to go work for the company, they are not going to be as harsh on the company where they’re getting their job. ......
JTW: So, the way it would work is like we put them in – the virus in these monkeys. And then we successively, like, cause them to keep infecting each other.
JTW: And we collect serial samples from them, and then, the ones that are more infectious, to like, the virus we’ll put them in another monkey and you just constantly actively mutate it. That’s one way. .......
JTW: Who knows? I mean, either way, it’s going to be a cash cow. COVID will probably be a cash cow for us for a while going forward. Like, obviously, like .....
PV: Well I think the whole, you know, research of the viruses and mutating it [them], like, would be the ultimate cash cow.
JTW: Yeah, it’d be perfect.
JTW: It [Pfizer] is a revolving door for all government officials.
PV: Wow!
JTW: Yeah, for any industry though. So, in the pharma industry, all the government officials who, you know, review our drugs eventually, come work for pharma companies.
JTW: And the military – all the army and defense government officials eventually go work for the defense companies afterwards.
PV: How do you feel about that revolving door?
JTW: It’s pretty good for the industry to be honest. It’s bad for everyone else in America.
PV: Why is it bad for everyone else [in America]?
JTW: Because if the regulators, who review our drugs, you know that once they stop being a regulator, they want to go work for the company, they are not going to be as harsh on the company where they’re getting their job. Complete article
Many of the authors I mentioned above discussed financial conflicts of interests which JTW also mentions, and confirm that this is typical and he is describing it accurately, although mainstream media almost never discusses it anymore. However there may be some doubt about whether or not he's confirming that they're involved in "Gain-of-function research" or "Directed evolution," which many conspiracy theorists are making a big deal out of, but he specifically says he's not doing Gain-of-function research and that "directed evolution is very different." It's hard to imagine that most people even know what this is, including myself, since I only know what I found by looking it up on Wikipedia articles on each, Wikipedia: Gain-of-function research and Wikipedia: Directed evolution, which indicates there might be something to be concerned about, even if you dismiss JTW's claims. The Wikipedia articles clearly indicate there's some of this research going on even if JTW isn't involved in it, but it's getting no attention from the majority of the public, until now, and, as I said most people don't understand it, so it can easily be exaggerated either way.
However, Robert Malone clearly indicated he thinks that JTW really is discussing Gain-of-Function Research as he wrote in Project Veritas has broken Pfizer's Gain-of-Function Research Program Wide Open. 01/26/2023, where he says:
You're gaining function, you're creating a new function in virus one by adding elements from virus two, infecting one monkey and then another monkey. That's called serial passage. That appears to have been one of the technologies deployed in the Wuhan Institute of Virology with the humanized mouse strains that I believe were obtained from EcoHealth Alliance. That's an example of directed evolution.
The gentleman seems to have absolutely no moral compass at all about what he's doing. The hubris and arrogance and immaturity. If this is the quality of individuals within Pfizer that are making these huge decisions that risk global public health with such a casual disregard for the human toll, it's profoundly corrupt in terms of would it be feasible for Pfizer to circumvent international or national law? I think that is undeniable.
And the gentleman in your investigative work has clearly indicated that Pfizer believes that it has successfully captured the regulatory apparatus of the United States government and presumably worldwide. Pfizer has completed regulatory capture, is quite proud of it.
Furthermore, even if you don't accept Dr. Malone's claims that it's Gain-of-function research, there's no doubt that they routinely use animals for research which often involves infecting them with diseases, and at times they even do this with humans with the least amount of political power, as some of the researchers I mentioned exposed.
Like many other subjects, the Mainstream Media virtually never mentions some of the most basic principles of medical ethics, like does medical treatment or research do more harm than good and who benefits the most from research or who pays the highest price for the research. The reason for this may be that if they discussed it adequately they might find that the majority, especially if you include the animal kingdom, might pay the highest price, but the vast majority of the benefits go to the wealthy, which is indefensible from an ethical point of view. As I said, even some ethicists, like Ezekiel Emanuel, partly discus this, as I'll explain in one or two of his articles below, and makes false assumptions about how medical treatment benefits us all. In all fairness, there has been a fair amount of research that has benefited the majority and improved the quality of heath care over the past hundred years or so, of course, but most of the best research improving the quality of health care for all in the United States, not just the rich, is decades old, before business interests consolidated their control over the health care industry, and put profits ahead of the best interests of the patient.
There are several Memes claiming that the Health Maintenance Organization Act of 1973 first allowed for profit corporations to control the health care system enabling them to put profits ahead of health, which by most reasonable standards is partly true; however, several fact checkers including Politifact and Snopes focus on a few details to claim it's false, which gives a more biased impression than the meme, but even their denials include some admission of the truth, which is that this is part of a long series of laws encouraging corporate control of health care, putting profit ahead of health care. This goes back at least to the FDR administration if not much sooner, and there are more reliable researchers than either Politifact of Snopes. One good source that sheds a little light on it is Lisbeth Schorr author of "Within Our Reach" 1988 who writes "As the price for passage of the Medicare legislation, (during the Johnson administration in the 1960s) doctors, hospitals, and the insurance industry extracted a promise that government-sponsored insurance for the aged would not be used as an entering wedge for governmental reform of reimbursement arrangements. .... The concession was enshrined on the first page of the law: 'Nothing in this title shall be construed to authorize any federal officer ... to excersise any supervision or control over the compensation of any institution ... or person providing health services.'" (p.113) When I Googled the quote from the law I found that the same, or very similar language was also used in the Social Security Act in the 1930s, and perhaps numerous other laws, possibly showing a pattern of behavior to protect corporate control and profits from private industries including health care.
Lisbeth Schorr focused most of her research on programs solving many social problems, including reduction of violence, and health care was a modest part of what she wrote about; but other went into more detail into the history of our health insurance system including The Neoliberal Turn in American Health Care 04/15/2014 and many more articles from Physicians for a National Health Program including Managed cost, mismanaged care 02/13/2013 which says:
Nixon’s true motives, however, might best be revealed by his infamous White House tapes. A recording from February 17, 1971 captured a conversation between President Nixon and John Ehrlichman, the president’s chief domestic advisor. On the tape, which has been transcribed by the Presidential Recordings Program at the University of Virginia, Ehrlichman brought up the idea of incentivizing the creation of HMOs as a model for reform. Nixon was initially hesitant (“You know I’m not too keen on any of these damn medical programs”), but Ehrlichman argued, “This is a private enterprise one .... Edgar Kaiser is running his Permanente deal for profit, and the reason that he can do it. .... All the incentives are toward less medical care, because the less care they give them, the more money they make.” Nixon’s response: “Well, that appeals to me .... Not bad.” He announced his HMO plan the next day.
Now, of course, no politician would say that he wanted to help corporations increase profits by denying health care, even Nixon, but he, of course had a better explanation to give to the public in a high profile manner, and this only leaked out to the public because of the Watergate scandal, and most of the attention by the media was focused on Watergate, so this hardly got any attention, but it shows his true intentions. One of the "fact checkers" claimed that Kaiser couldn't get approval as an HMO until four years later, but he did eventually get it, and Nixon clearly indicated that was his objective.
Most research volunteers are told that research helps everyone, and the media often tells that to the majority of the public as well, implying that supporting science is in all of our best interests, which would be true if we didn't have a rigged economic system, including health care. In all fairness, there have been some examples where researchers have used some wealthy people for research, or shared the benefits with the majority, but this is getting rarer than it used to be. Rebecca Dresser mentions in her book that some researchers from the nineteenth century felt they shouldn't use others for research unless they were willing to take the risks themselves, but this almost certainly wasn't for the riskiest research; and Harriet Washington reported that in many cases slaves were used for research and treated as property, often torturing them for the benefit of the research, assuming there were benefits from the research. The CIA also used each other for research into LSD in the 1950s according to several credible sources, partly because they thought they could trust each other to tell the truth about their experiences, and keep quit about it, but they also thought there was little risk in it. This changed when Frank Olson died and they had to cover up the circumstances behind it. And one of the most famous example where a good researcher was more concerned with helping the public was Jonas Salk who declined to patent his vaccine, and showed he trusted it so much that he vaccinated his own kids first. He famously answered Ed Murrow's question, "Who owns this patent?" by saying "Well, the people I would say. There is no patent. Could you patent the sun?"
Other examples are questionnaires that are very popular for sociology research where some of the most common people filling them out are college students, who are often upper middle class, but when they need views from diverse classes, they seek them out; however there's no risk in these. Some experiments, like the Obedience to Authority or Stanford Prison Experiments have little or no physical risk, but they found out they do have psychological risks, and many of those subjects were college students. But even when this happens, as I pointed out in several previous articles including We're Using Children For Research, Without Accepting The Benefits! when people volunteer for many research projects and they learn how to reduce violence or solve other social problems, and often save money at the same time, they refuse to base political decisions on this research, often because it contradicts the interests of the wealthy, so even when they learn from good research the benefits are often not realized.
Also one common fact, at least within the research community, is that the vast majority of research done doesn't provide much if any benefit for society at all, although there is often some cost to the reserch subjects, especially animals, who aren't granted any rights at all in our society. The hope is that the few cases where there are advances in science it can be shared with a much larger percentage of people, or at least that's what they claim, although profits are often as important if not more important than that. The basic ethical principal behind this was often expressed by Mr. Spock on Star Trek when he repeatedly said "The good of the many outweigh the good of the one, or the few," which seems logical, and if research is done well it may turn out to be true, but if profits is a higher priority, as it often is, that's not always the case.
Furthermore, a good ethical guideline certainly wouldn't sound good if we said, "Those without political power shall be sacrificed so those with political power can control and receive most of the benefits," yet, at least to some degree, that's what our system often does with research and many other activities.
This is, of course, very difficult to measure for certain whether or not the majority are receiving more benefits from research than the losses experienced by the research subjects. But there should be no doubt for anyone acting in good faith that animals worldwide are paying a much higher price for research and many other human activities than they receive benefits, when you consider the fact that their environments are being destroyed all over the world and they're routinely used for factory farming, research or other purposes, without consideration for their best interests. Single examples without comparing how it applies to our entire society will be inadequate; however, they could be a good start since this is a complicated issue no matter how we start. One good example might be considering this excerpt from "Intimate violence" by Richared Gelles and Murray Straus 1988 Complete Book PDF:
Walker's theory of learned helplessness has its roots in the research of the experimental psychologist, Martin Seligman. Seligman and his associates placed dogs in cages and administered electrical shocks at random and varied intervals. The dogs learned quickly that no matter how they responded, they could not control the shocks. At the beginning, the dogs tried to escape. When they found that they could not stop the shocks, they stopped searching for an escape and became passive and submissive. At this point the researchers altered the experiment. They first tried to teach the dogs to cross to the other side of the cage and escape. The dogs remained passive. The researchers then left the cage doors open and showed the dogs the way out. The dogs were still passive, made no attempt to get out, and made no attempt to avoid the shocks. Only by repeated attempts to physically drag the dogs out of the cage were the dogs motivated to overcome their learned helplessness and attempt to escape. Seligman's group and other experimental psychologists have repeated these experiments with cats, fish, rats, birds, primates, and even humans with the same results. p.142
Basically they tortured the dogs for the sake of research, and it's unclear what they expected to gain from this research or how, before it was done, and it may be equally hard to tell whether there was a benefit to make it worthwhile. Furthermore, it should also be considered whether anything that might have been learned from this experiment could have been learned by other more ethical means. When it comes to research books that teach how to reduce violence, I've read dozens of them and this is the only book that cites this as part of the research that helps them draw their conclusions, and if you read their book, or at least the seventh chapter, it clearly seems as if they thought it helped to some degree, but they also found that it had limitations. But could they have learned the same things with research that was done in a more ethical manner? When it comes to learning how to prevent violence, they almost certainly could have. There's no chance that this experiment could possibly have provided more benefits for the animals used for research, and there's serious doubt that it could have provided adequate benefit for people, assuming you believe that animals should be sacrificed for the benefit of people, especially when you consider the fact that the educational opportunities weren't passed on to the majority of people or used to make important decisions or government policy as I pointed out previously in We're Using Children For Research, Without Accepting The Benefits! which explains that even when we develop overwhelming evidence about how to solve many social problems, including reducing violence, the research that could save lives is routinely ignored, in favor of the interests of campaign donors.
Perhaps one of the most brazen violations of reasonable ethics, assuming people think animals should have rights, was described by Peter Singer almost fifty years ago, when he wrote the first edition of Animal Liberation which describes, among other things how animals are used for research to develop cosmetics, where animals often sacrifice their lives, and often undergo testing that should be considered equivalent to torture, so people can wear cosmetics and corporations can profit from them. He goes into much more than that, including use of animals for research that helps develop medical treatment, which many people may consider worthwhile, and the abuse of factory farms which is on a much larger scale, which meat eaters tolerate, even if they admit it's at least partly wrong. When it comes to research for medical purposes, then ethical values should involve a greater benefit than there is harm, and there's no way that can be the case, especially when you consider we're well into the Sixth Extinction. The Sixth Extinction, which the media and most people pay little attention to has already caused hundreds of extinctions, if not much more by reliable estimates. Other issues threatening the planet, of course include Climate Change, the fact that we're using resources faster than the Earth can reproduce them, and various other environmental threats, including availability of clean water or other necessities, which could easily combine with war and other social problems to threaten life as we know it at one point or another, although most scientists admit they don't know exactly when.
I've reported on this numerous times, and so have many other sources that were peer reviewed, some of which I've cited in the past and more that will be posted below; but there hasn't been any consideration of this within the research community that I know of. There should be no doubt that we're currently on an unsustainable path with our industrial, economic and political system, so this should be taken into consideration when it comes to research or medical ethics. If the vast majority of research provides little if any benefit and the research that does provide benefits takes decades if not longer to provide more benefits than the harm caused by both the good and bad research, then it's reasonable to assume we won't get those benefits unless we reverse our destructive environmental practices.
Therefore, there's a compelling argument to call a complete halt to all research that puts people at risk for any reason, since there's major doubt about whether we'll actually receive benefits at all. And, of course, if there are any benefits, without providing access to health care for those who can't afford it, who also happen to be those most likely to be put at risk, we're essentially maintaining a system where one poorer class of people makes almost all the sacrifices and a wealthier class of people get all the benefits, and the losses for the poor are greater than the gains by the rich, especially when environmental destruction is added, which, for now, impacts the poor much more, although it will eventually, at some time in the future, possibly decades, even destroy the environment for the rich, which is why our current economic and political system is so insane.
G. Owen Schaefer and Ezekiel Emanuel, who wrote a paper mentioned below claim we actually need millions more people to participate in research than we already have; but they don't discuss the fact that a large portion of current research is being done for "me-too" drugs which may not add much to benefit patients, but enable increased profits and extensions of patents so they can gouge consumers even more. Nor do they discuss that a large portion of people currently being used for research do so because they need the money to survive or they can't afford health care, and in many cases research subjects have been coerced one way or another, often because they're in the military and required to follow orders, which occasionally includes participating in research which they may not have known when they signed up, or people in prisons, or other poor people that are coerced into participating one way or another, even though the bulk of the benefits go to the wealthy.
Also, as I already pointed out above, if we provided universal health care for all, and provided more preventive actions, including treating health care problems before they escalate, reducing pollution, increase safety practices at work or home, including those that would have prevented the Ohio rail crash a few weeks ago, and other rational activities that should be non-controversial, this would save far more lives and do more to improve the quality of life for all than research projects that are much more controversial, or would be much more controversial, if people knew about them. Ending lies or a rigged economy creating mass incarceration, and wars based on lies, as well as a rigged economy would all do much more to save lives and improve the quality of life for all, and shouldn't be controversial either.
If we did all these things many lives and billions of dollars would be saved; but what would it do to the available supply of research subjects that Schaefer and Emanuel say we need?
It would of course make it much more difficult for them to get, reducing the supply of willing research subjects. However, we would be saving many more lives than the research would help save, especially since current research is far more concerned with profits than helping the majority anyway. This will, of course, be difficult if not impossible to impose with our current power structure; however, with escalating environmental destruction and the potential for war and other social problems to partly or completely destroy or current society, the current power structure could collapse. The problem is how much damage it will do to the majority, which may be forced to pay a higher price before the wealthy rigging the system are removed from power.
Don't get me wrong, I'm not opposed to scientific research, assuming it's used to solve problems and improve the quality of life for all, but it's not doing that at all, and current scientific advances may be used to serve the interests of the wealthy while doing far more damage to the majority than good, especially when it comes to environmental destruction. If we were able to implement major reforms and do the best with the research we already have to improve the lives of all, not just the wealthy, and do so without sacrificing the poor for the benefit of the wealth, and review ethical practices, teaching the public about it, not just college educated people, then reasonable research with the benefit of helping people could resume. This should not, however, include "me-too" drugs with little benefits, or research on cosmetics that Peter Singer criticized, and the benefits would be shared with all, not just the wealthy.
With our current system a large percentage of the benefits for research from the past few decades is being wasted, and instead of using it to reverse environmental destruction the political establishment is covering up and escalating environmental destruction, ensuring we may not be able to benefit from this research in the future anyway. To refuse to reverse this, as our current establishment is doing, is insane!
As I said several good researchers have provided academic work to support my claims including Harriet Washington, author of "Medical Apartheid" and "Deadly Monopolies" and Marcia Angell, author of "The Truth About Drug Companies." These books explain how race is a major factor in research where minorities are much more likely to be used for research, while wealthy people get almost all the benefits, and how almost all medical research is financed by the government, yet they give patents to drug companies anyway. The justification for these patents, enabling them to gouge us with absurd prices, is supposedly because they risk a lot of money on research, which isn't true, since the government pays for it, and they risk liability, which for the most part is also false, since the government also shields them from almost all liability, just like they shield many companies creating massive amount of pollution, which I've gone into in numerous past articles, and the Ohio Rail crash can now be added to that.
Until now I haven't gone into much of the research from Laura Stark and Rebecca Dresser, who are both also very good researchers and ethicists as well as Ezekiel Emanuel, who does come up with some good ethical recommendations, as well as some biased ones, but doesn't always abide by his own ethics, including support for the Affordable Care Act, which can't be considered nearly as ethical as a Single Payer system, like Medicare for All. Below are some excerpts from these three and a review of them starting with Laura Stark "Behind Closed Doors." 2012 (Which can be read free in it's entirety on the Internet Archive, there are links to the pages of excerpts below, but unless you create an account and check it out, you won't be able to read more than 20 pages in a 24 hour period.) Many of these ethical principles sound much better if you don't look too closely at how research subjects are chosen, what their incentives are, and who receives the bulk of benefits from the research, which is rarely disclosed and requires a closer look at the entire system to share educational benefits and health care opportunities, which as I already indicated isn't done nearly as well as many people assume.
There are three moral principles ... The commissioners decided that the three principles would come into play in three corollary practices: making sure that the people being studied were not chosen in discriminatory ways; ensuring that participants had adequate information when they agreed to be studied; and ensuring that the risk to participants (whether physical, social, or legal) were appropriate in the light of the potential benefits of the study, either for the participants or for others. Stark BCD 2012 p.11
This is one of numerous times where ethicists now claim that subjects should be random, which for the most part wasn't a concern more than fifty years ago, and even more so when blacks were considered property, as Harriet Washington pointed out in "Medical Apartheid," and there were few major improvements until the outrage over the Tuskegee Experiments, and as additional excerpts will show many researchers resisted those reforms. Furthermore, research subjects often don't have the educational background to understand all the risks, and as other excerpts will show often jump to false conclusions, and of course, most of the benefits are only shared with those that can afford it.
To signal their disagreement, board members in a few instances abstained from voting altogether. It was the most damning act of resistance they mustered. .... The work of achieving unanimity happened before the vote ..... Stark BCD 2012 p.22
The point of an Institutional Review Board (IRB) seems to be to get opposing views; however, they're all hired by institutions that ultimately want to approve research programs, although they want to avoid lawsuits or other problems later. This certainly is better than no oversight at all,but they have an incentive to come to a consensus. This includes one member who's supposedly a "community" representative, although even that member is paid by research institutions. They, of course, don't want to go to too much of an extreme that might risk a lawsuit, but what is rarely said is that poor research subjects can rarely afford to sue unless it's an extreme case and they can get a lawyer who works on a contingency fee, which means they get a large portion of any settlement. As I pointed out in We're Using Children For Research, Without Accepting The Benefits! Carl E. Schneider, author of "The Censor's Hand" argued that the threat of lawsuits may be as effective, if not more effective than IRBs, which he claims prevents research projects from doing more research that might save more lives; however, if he doesn't know how weak a threat this is since most victims can't afford a lawyer and courts are heavily biased in favor of wealthy institutions, it's because he doesn't want to know. I previously pointed out that he clearly seems to serve the interests of research institutions that want to avoid accountability, although they wouldn't want to be associated with his research since it would harm their reputation.
Most of the time board members were not confrontational. Their discussions of research proposals were brief, and their demeanor toward each other was civil. Occasionally, though, they got red-faced. Witness this exchange about reporting suspected child abuse, which unfolded during a late-autumn meeting at Greenly State: Stark BCD 2012 p.21
The exchange at Greenly State recounted at the beginning of this chapter was part of a review of a study on how parents discipline their children. By state law, investigators have to report children whom they suspect may have been abused, a provision that makes research on parenting practices quite delicate. In this case, the investigator planned to ask mothers and fathers to report, in detail, how they punished their children. The investigator made it clear when she spoke with the board that there were no circumstances in which her team would report parents to legal authorities as possible child abusers. Many board members were ambivalent about the study. On the one hand, it seemed to them that at some point the investigator would have to report abuse to stay within the bounds of state law. 18 On the other hand, board members agreed with the investigator that her otherwise very useful and important data would be invalidated (“shaped” or “sanitized”) if she trumpeted to parents in advance that she might report them for child abuse. After the investigator left, board members brainstormed ways in which the investigator could collect less detailed data so that she would not be able to even suspect child abuse while still collecting some data on discipline practices, for example, by changing questions about frequency of hitting children with different items (hand, belt, brush, etc.) into dichotomous variables (e.g., whether parents ever hit their child with a belt). Stark BCD 2012 p.29
In this case, the board did not merely require that the investigator change his measures or report abuse; .... The IRB tabled the decision and referred the protocol to university legal offices. After several months with no decision, the investigator abandoned her research plan and withdrew the project from consideration. Stark BCD 2012 p.29-30
This issue is not unprecedented; the Glueck's study on juvenile delinquency also encountered this problem, and they resolved it by trying to avoid questions that might uncover abuse which they would feel obligated to report; and in both occasions they solved their "ethical problems" by avoiding finding out about the abuse, which avoided the uncomfortable need to do something about it. In this case the research project was abandoned, at least temporarily, but it raises at least two major problems, which could have been avoided, assuming they consulted with other researchers, who probably weren't available to the Gluecks, who did their research between 1938 and 1950, before some of the best research was available. One possible solution was provided by several researchers including Lisbeth Schorr, author of "Within Our Reach," 1988 which includes discussions about home visitor programs for at risk parents. Professor James Garbarino and Dr. Robert John Zagar also came up with similar recommendations. Instead of abandoning the research projects, they could have prepared to offer any parents that might have used abusive parenting practices with counseling without the threat of prosecution. Some details would, of course, have to be worked out, but by now there are plenty of people with experience in these successful programs that could have advised on how to approach at risk parents in a manner that would reduce the risk to children without necessarily damaging the potential research, possibly even helping it. This certainly seems more ethical than intentionally depriving themselves of information about child abuse so they wouldn't have to choose between either reporting it or damaging the reliability of their research
A second potential problem which Laura Stark didn't discuss was the possibility that the research institution might shop for a different location to conduct their research so that they wouldn't have to report the abuse, assuming they found it, or do anything else to help. if the research institution wanted to do their research even though their lawyers warned them against doing so in that state, they could have simply done it in another state, which for all I or Laura Stark knows they just might have, without consideration for ethical problems that could have been solved as I explained above. This potential is there for almost all research projects, and deserves much more attention than I can provide here, in an article that's already getting long; furthermore, I can't help but wonder why it hasn't received much more attention elsewhere, since it's so obvious. Part of the reason for that is simply that most people don't think about it and those involved in research might have a bias against discussing it.
It's virtually guaranteed that many researchers go to third world countries where citizens aren't protected from abuse, which Robert F. Kennedy discussed a little in "The Real Anthony Fauci" where he points out that a lot of research is done in third world countries that don't protect their citizens as well as wealthy countries. RFK Jr. has become very controversial, however, I found that despite some flaws in his speeches and smears by MSM his research in this book is much more credible, and this includes his discussion about using people in third world countries for research. Both Laura Stark and Rebecca Dresser also provide some research showing this is a problem, although they might not get to the point as well. I also pointed out another example where researchers could shop around for IRBs as well in We're Using Children For Research, Without Accepting The Benefits! where I discussed Gregory D. Kutz who wrote "Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation," where he testified before Congress about how easy it was to create a fake IRB and unethical researchers could either do this themselves, or shop around for an IRB that will approve their research project. In all fairness, it's important to point out that independent IRBs like the one that Gregory Kutz created to find out if it can be faked are a minority of IRBs, but if a research institution wanted to do something unethical they could rely on a subsidiary that takes advantage of unethical IRBs to avoid liability, which could be set up so a larger more profitable corporation could get the profits while minimizing liability. Clearly the research institutions need to do much more to prevent shopping for locations where they don't protect subjects or shopping for unreliable independent IRBs that only provide the illusion of ethical treatment.
... If a black man has been in prison, he is less than half as likely to be considered for a job than an ex-offender whose skin color happens to be white.
This is an important research finding. .... Yet despite potential positive outcomes of this research, one could argue that the research methods were deceptive and unfair to the people being studied. The research involved sending fake job candidates–one white man and one black man–to apply in person for jobs advertised in a local newspaper. … The employers were under study, but they had never agreed to be the focus of the researcher’s gaze, and they wasted time and money screening bogus applicants.
Was it worth it? I would say yes, but others would disagree. .... When I asked this question to IRB chairs from large universities across the United States, almost all thought their board would have required changes to the study, if they had let it go ahead at all. Stark BCD 2012 p.41
It is not ... That said, federal regulations do allow IRBs to waive consent for an investigator doing some types of research if the study cannot be carried out in any other way and if the study poses risks that are no greater than what the research subject would experience in his everyday life. 7 Stark BCD 2012 p.43
They did require one change, though. Devah Pager had planned to debrief employers after the study, in keeping with a more conservative reading of the regulations. The board members asked her not to debrief her research subjects. There was little risk of harm to participants, they reasoned. And if employers never knew they were in the study, they would never be able to sue. Stark BCD 2012 p.55
Personally, I would agree that this research project would be worth it, especially since it helps exposing possible racism against the least powerful people that have fewer educational and economic opportunities, and that racism has been a massive problem for hundreds of years, causing many social problems. It certainly seems reasonable that we should hold more powerful people accountable or learn how to correct mistakes. If there is a problem with racism they could use it for research with no threat of legal action to potential employers that might be exposed, and they could easily have agreed not to name them, and advise them on possible improvements. This might have been one of the exceptional cases where I might agree that an appeal was appropriate if another IRB had rejected it, showing that perhaps not all shopping for IRBs might be bad, although reasonable discretion should be advised, and like the original researchers I agree that they should have been willing to debrief the employers, and perhaps offer them a modest amount of compensation for their time, along with a confidentiality agreement, which I almost always disagree with, since confidentiality agreements are often used to cover up corruption. This could have deterred the threat of a lawsuit if they informed them, along with the obvious possibility that if the employers rejected the modest compensation offered they would potentially also lose their confidentiality agreement, and wind up exposed for racist behavior.
Furthermore, undercover research operations stings like this are also very common among police and the media, right or wrong, and in some cases I suspect it might be right, like this one, but as I've pointed out in a previous article Anti-violence social experiments could be part of a slippery slope many similar research projects have much more ethical problems, and they could be used to study how to manipulate or shame people for the wrong reasons. In that article I discussed an elevator video to see how people reacted when a man was abusing his girlfriend, which was actually an act to study how people react to it, and compared it to experiments like the "Obedience to Authority Experiment," and the "Stanford Prison Experiment" which I covered in several other articles as well, and showed they may have been financed by the CIA to study indoctrination of recruits to teach blind obedience in boot camp, among other things. I also compared these experiments with the reality show "What Would You Do?" where John Quiñones routinely uses members of the public as research subjects and for entertainment purposes without asking their permission, and he doesn't seem to consult with an IRB at all. Frankly, this is done with a profit motive that is more concerned with making money and entertaining the public than it is with ethics, and I would be highly skeptical of their motives or the possibility that they're more concerned with grandstanding or profit than a benefit to society, and, as my previous article indicated, to shame or manipulate the public, which is why even though this one experiment reported by Laura Stark may be worthwhile, I think each additional one should be considered carefully, and people shouldn't be used for national entertainment without permission or under pressure, which is why I think that show never should have been aired, any more than Chris Hansen's "To Catch a Predator," should have been aired, since it's far more concerned with entertainment than prevention of violence and there are much more effective ways to reduce violence which the media refuses to report, although they're willing to use violence for entertainment.
Yet he simultaneously insisted that the investigator should not be asked to change study procedures because it might jeopardize his professional standing outside of the IRB. Kevin was not appeased until Nancy reminded Kevin, “The minutes don’t record you personally.”Stark BCD 2012 p.65
This should raise major alarms, since a possibly dissenting view was essentially convinced to change his views when assured he would remain anonymous and not held accountable of the ethics of this research was questioned later.
Yet the features of institutional life in which prisoners, soldiers, and wards of the state lived were part of their value. Researchers demanded a good deal of long-term, physical control over healthy subjects for drug screening, control trials, and baseline studies. The level of social engineering that was possible within these institutions was, in part, what made their residents coveted research material. Every aspect of their carnal experiences could be controlled: food, exercise, sleep, and sex. All of that, and the “clinical materials” (as the people were called) were low-cost and in large supply. Stark BCD 2012 p.86
As I indicated above, prisoners, soldiers and wards of the state were much more likely to be used for research with little or no legal protection. If you read these books and other sources, you may find, as I did, that there were reforms after several exposes, in the 1970s or periodically since then, that supposedly increased protection or ethical guidelines; but there are also occasional stories, which rarely get much attention, showing these reforms haven't always worked, and in some cases, the research may have been relocated where there was no scrutiny or oversight.
... Patients would be considered objects of study first and last. “Work based only on the fact that the patient needs it for the improvement of his health would not be authorized.” ... 1951 ... Stark BCD 2012 p.88
... The aim of medical intervention could be the greater good of science, not the improvement of a person’s health, whether sick or healthy. Stark BCD 2012 p.110
At at least one point in her books, Harriet Washington said that ethical practices require researchers to give research subjects the best medical treatment available, which certainly sounds good, and most of us would agree with it, but she also points out that many researchers don't meet this requirement. However, in all fairness, when doing medical research it means that they don't know which medical treatment is the best, and the research is supposed to enable them to learn so they could do so for other patients in the future. An example of a reasonable compromise that Washington might agree with might be giving one patient the best known drug to treat a condition, and another one the experimental drug, after it's tested on animals to minimize risks, with no placebo groups, but this is rarely done. Both Laura Stark and Rebecca Dresser, as well as other researchers acknowledge that Washington't recommendations, which are good, aren't put in practice in modern research and past research over fifty years ago may have been much worse, and there's a possibility that when they want to take greater risks now, they may do so in third world countries where subjects may not be protected as well. To this day, the majority of benefits go to one class of wealthier people, while the majority of sacrifices are made by poorer people with less political power. There's no way to make this sound ethical, so in most cases, they avoid discussing it at all, or when they can't avoid it they often confuse the issue, and spin it to make it sound ethical even though this is false.
We continue to have a system where the good of the many, who happen to be poor, is routinely sacrificed for the good of the few, who are rich, the opposite of ethical recommendations by the logical Mr. Spock from Star Trek.
Inside the hospital wards, men were also infected with malaria so that researchers could compare new drugs developed to treat disease. 40 Malaria was debilitating Allied troops (as well as residents of the American South). ... Stark BCD 2012 p.93
In 1964 members of a new profession, science journalism, reported on a case in which two physicians had injected twenty-two patients at New York’s Jewish Chronic Disease Hospital with cancer cells without first getting their consent. 20 Within a community that included many Holocaust survivors, it was particularly upsetting to learn that clinical researchers had injected the patients as part of a study supported in part through NIH’s National Cancer Institute. ... NIH lawyers successfully explained that researchers funded through the Extramural Program were not bound by the Clinical Center’s local policy. 22 Stark BCD 2012 p.145
This clearly indicates that infecting monkeys with a contagious virus as the video above of JTW shows is far from unprecedented, and I'm sure there are many more examples of this, especially with animals, but information is generally shared only among researchers, not the general public. This research was done during World War II, and there have supposedly been reforms since then, but they resisted those reforms as excerpts below will show, and occasionally get caught trying to get around them, so, once again, I wouldn't rule out the possibility that this kind of research is still going on in third world countries with people, as JTW indicated they might, although he didn't claim direct knowledge of it.
Given their interests, NIH leaders encouraged the heroic slant. One of Carl’s contemporaries, a twenty-six-year-old farmer from Idaho, consented to have his left thigh opened up and a piece of muscle removed for lab study.
For the .... church leaders, one of the harsh lessons of the previous program was that coordinating placements was costly for the organizations and serving without pay left men destitute. The only compensation the men received for their work during World War II was the pleasure of not being imprisoned for draft-dodging.Stark BCD 2012 p.96 Under the political scrutiny of the early 1950s, NIH leaders felt it was crucial to figure out how to achieve their primary and pragmatic goal, which was to build a bulwark against legal action. In the words of clinical directors from 1952, research guidelines would serve “as a counter-balance and check to protect not only the patient but the Institute involved and the Clinical Center as a whole.” Stark BCD 2012 p.102 ... At NIH, for example, it was the pinnacle of research ethics to state that studies followed the Nuremberg Code’s precept that no experiment should be done in which the researchers believed subjects could die or be disabled–unless, that is, “the experimentalist physicians also serves as subject.” 78 Hand-waving aside, researchers generally regarded the Nuremberg Code as a set of principles appropriate for moral monsters, not for democratically minded American physicians. 79 Stark BCD 2012 p.104
These are just a few of many examples showing that the research subjects come from poorer classes, and researchers fro wealthier classes that often though they were better than others, and didn't think rules applied to them, and more quotes below show how they resisted changes to protect the vulnerable. They were more likely to admit this openly over fifty years ago.
NIH Researchers against Signed Forms
Researchers, however, were often reluctant to use signed forms. In contrast to lawyers, such as Rourke, researchers resisted patient-generated documentation even as the 1962 FDA Drug Amendments demanded that they start collecting signed forms for studies on “investigational new drugs.” Research on these drugs accounted for a good deal of the work done at the Clinical Center, especially on Normals, but researchers reasoned that it was not productive–legally or scientifically–to collect signed forms.Their reasoning continued to reverberate in a legal atmosphere that was becoming less sympathetic to the claimed needs of researchers by the early 1960s. Stark BCD 2012 p.125
An important premise that shaped researchers’ day-to-day work in the Clinical Center was that patients were not fully rational. It was an age-old notion that sick patients were poor decision makers because they were uneducated, deluded by their disease, or just silly. Stark BCD 2012 p.125-6
To NIH researchers, the church volunteers were by definition deviant: “It is also truth that in our culture a normal young person is more likely to pursue an uninterrupted course of educational or gainful occupational self-advancement, than to dedicate a year or two of his or her life to community service.” In addition, NIH administrators felt that the church sent “their most normal and effective volunteers ... into the field to positions of independent responsibility, while ‘placement problems’ [were] assigned to NIH.” 39 By 1965, the proportion of Normals who had to be discharged or turned into sick patients because of psychiatric problems was so uncannily high that NIH scientists began to suspect that psychotic people from all of their sending organizations were intentionally trying to get a foot in the door at the Clinical Center. Once in, they would take advantage of its excellent care. Stark BCD 2012 p.130-1
Although American doctors and scientists knew of the Nuremberg Code at the time, historians have established that its principles did little to change the day-to-day practice of medical research. 4 In 1964 the World Medical Association endorsed a set of recommendations for medical research practices that updated the Nuremberg Code. Contemporary researchers felt that the code was overly restrictive for researchers working with the advances of postwar medicine and, they said, too limiting for clinicians trained in democratic countries who knew right from wrong, even if they had to do unsavory things at times.
American researchers were dismayed to read a draft of the World Medical Association’s recommendations written in the early 1960s, which included heavy restrictions on the use of prisoners in medical studies. The British Medical Journal published an early draft of the recommendations in 1962, and they were also circulated informally among Americans. Given the memories of the Holocaust in Europe, restrictions on prisoner research would seem unsurprising. And yet in the United States, prisoners fueled research on new drugs at federal penitentiaries and inside hospitals, such as the Clinical Center. 5 Stark BCD 2012 p.139
... Projecting a shortfall in the number of Normals coming to the Clinical Center from historic peace churches, Dr. Clifton K. Himmelsbach had suggested that federal prisoners might fill the gap. During the 1930s, Himmelsbach had directed the prisoner research program at Leavenworth, Kansas. From there he moved to the NIH addiction research hospital in Lexington Kentucky, where he trained under Dr. Harold Isbell, whose LSD research on prisoners most directly implicated the NIH in the CIA research scandal hearings in 1977. 11 Himmelsbach studied drug withdrawal, and the Lexington hospital was a satellite research facility of the NIH Intramural Program, which housed federal prisoners addicted to drugs or alcohol. Because of his extensive experience with prisoner programs in Lexington and Leavenworth, Himmelsbach was brought into the Clinical Center in 1959 to set up a prisoner program on the main campus. By the 1950s, Himmelsbach had a strong network of contacts within the Bureau of Prisons. He and the Bureau of Prisons director James V. Bennett were close friends, for example. Himmelsbach plugged Vernon Knight into his network, and selected the first federal prisoners from a penitentiary in Pennsylvania. ... Stark BCD 2012 p.140
Many of these researchers don't seem able to recognize their own obvious bias, which may be because they all came from the same wealthy class that taught one generation after another to believe they're better than most other people and to feel entitled to use people for their own purposes without accountability, which was much more common in previous centuries, implying they may have only learned to hide it better in recent decades. They certainly don't seem interested in research that shows that one of the biggest reasons why it may seem as if there's more crime in lower classes is because they're victims of a rigged economy, so they may feel justified in taking the rights away from prisoners, without acknowledged the possibility that they never had rights to begin with because they were often born into lower classes without educational or economic resources that forced them into desperation, although details vary for many prisoners, as well as those that didn't resort to crime, but were victims of a rigged economy.
The fact that they often seemed to think they had higher morals shows they're closed minded about previous support for Eugenetics, which was very popular before WWII and the Nazis also supported this, which created the need for the ethics codes they didn't think applied to them. Furthermore, racist support for Eugenetics, or other bigoted practices never went completely away and many people supported it for decades after WWII, with some people still supporting it today. They recognized irrational beliefs from some religious people, but not that they had similar flawed beliefs.
In this political setting, Director James Shannon, who by this point had become legendary for his administrative cunning, hatched another savvy legal move to protect his agency. To deflect legal liability away from the agency itself and toward the institutions NIH funded, Shannon forced research institutions across the United States to reproduce the expert-review model that he had helped create for the Clinical Center before it opened in 1953. Stark BCD 2012 p.161
The politics behind the development of ethical practices have never been adequately explained to the public, and a large portion of it indicates that those making the laws were far more concerned with creating the illusion of ethics for public relations purposes than they are with the best interests or the public. What the public gets is mostly propaganda that makes them feel good about how research is supposed to help us all equally, even though this isn't remotely true.
Rebecca Dresser is a good academic who had first hand experience after serving as a research subject after being diagnosed with cancer, and she went on to write "Silent Partners" 2017, based on these experiences and additional research, confirming many of the points made by Laura Stark, Harriet Washington and other researchers and adding additional evidence about how the system is rigged by the wealthy, although she doesn't always phrase it quite that way. Her book isn't on the Internet Archive, but if you don't have access to a print copy most of these excerpts can be found on Google Books with additional excerpts, by cut and pasting the quotes in the Google Books search engine, or one chapter was available as a separate paper, which is linked below, but there may be some differences between the original article and the chapter published with the book later. She specifically writes, "Many studies are initiated and financed by wealthy countries but conducted in low income countries." p.18 which is a similar point made by RFK Jr. in "The Real Anthony Fauci" but since he's being demonized by the media and scientific community few people pay attention to him. After reading it there's no doubt in my mind that a large portion of it, at least, is far more credible than the establishment indicates, including one good point which doesn't require expertise, access to clean food and water in parts of Africa, often being used for researching vaccines, as he points out in the following excerpt:
Magical vaccines are Gates’s preeminent cookie-cutter solution for the ills of poverty, famine, drought, and disease. The absurdity of expensive shots as a remedy for indigence, a salve for malnutrition, or the dearth of potable water is obvious when one considers that three billion people live on less than two dollars per day. Eight hundred and forty million people don’t have enough to eat. One billion lack clean water, or access to sanitation. One billion are illiterate. About a quarter of children in poor countries do not finish primary school.122 Poverty is a target-rich environment, but the data suggest that Gates’s vaccines miss the target altogether. Sociologist Linsey McGoey quotes a young health researcher based at the University of Cape Coast, on western Ghana: “From my point of view, it’s more like [the Gates Foundation] are selling technology than solving problems. Most of their calls have to do with developing some new technology or vaccines.” 123
This should be a no brainer, not only in Africa but in the United States. Even if RFK Jr.'s skepticism about vaccines is unjustified there's no doubt that sanitation including clean water helps improve health, yet to the best of my knowledge the Gates Foundation is doing little or nothing about improving infrastructure in Africa, while supporting an enormous amount of research to benefit Pharmaceutical companies, using Africans for research. The same goes in our country where cities like Flint Michigan, Jackson Mississippi and many other places around the country where they're not providing safe drinking water, even though the medical costs after lead poisoning or other forms of pollution are far more expensive. Even when we know how to save lives and money it's rarely done to help the poor, especially minorities. Rebecca Dresser also points out the hypocrisy of some researchers that accidentally tell the truth from time to time, including this excerpt:
That was the case with Chester Southam, a US physician who led the infamous Jewish Chronic Disease Hospital study. In the aftermath of the study, Southam was asked why he failed to expose himself to the same live cancer cells his team had interjected into uninformed and debilitated elderly patients. Though Southam insisted the experiment was safe, he revealed his true thoughts when he told an interviewer, “there are relatively few skilled cancer researchers, and it seemed stupid to take even the little risk.” 28 (Dresser SP 2017 p.34-5)
This is the same research project mentioned above by Laura Stark and if you go to Chester Southam' Wikipedia page it provides additional details, including the fact that "the Regents of the University of the State of New York ... found him guilty of fraud, deceit, and unprofessional conduct, and in the end he was placed on probation for a year," and "he went on to be president of the American Association for Cancer Research," and he maintained several prominent positions until his career ended in 1979. They also provide half a dozen sources about his research, including at least one showing that he infected his patients with West Nile virus, confirming some of the extreme activities JTW said might be going on in China, and possibly adding to evidence that some of the research that was banned over fifty years ago in the United States might still be going on in third world countries, possibly including China, where many people, including JTW, claim COVID was created in a lab.
Members of the research community are unusually well informed about how research works. They also tend to be relatively healthy, well educated, and affluent. As a result, research professionals might not experience the same pressures, risks, burdens, and inconveniences as other subjects. (Dresser SP 2017 p.38)
These researchers also have different motives than most research subjects, on the few occasions when they also serve as subjects. As Chester Southam clearly indicated they may be reluctant to volunteer if they think there is any chance of harming themselves, but willing to risk harming others for the sake of their research, and, on some occasions, there are of course adverse reactions, sometimes even deaths, although that's rare, and as will become clear they're reluctant to discuss the cases that go wrong, as more of her excerpts show.
There is also a dearth of information about the views of patients whose conditions deteriorate during and after study participation. The reasons for this scarcity are unclear, but it may stem from a reluctance to bother patients dealing with worsening health problems. (One team reported that an ethics committee refused to allow interviews with cancer patients whose condition failed to improve despite receiving treatment in a trial. 7) (Dresser SP 2017 p.46)
Few volunteers interviewed after the unexpected death of a healthy subject worried about their safety. Most thought, without any supporting evidence, that the subject must have contributed to what happened by failing to ask enough questions or to follow study requirements. 42
Some volunteers admit that the prospect of compensation trumps their reservations about study risks. One volunteer explained, “You become addicted to the easy money, you don’t want to do anything else.” 43 Another volunteer said, “If there were a study where they cut off your leg and sewed it back on and you got twenty thousand dollars, people would be fighting to get into that study.” 44
According to existing ethics guidelines, payment to volunteers should reflect the time and inconvenience a study involves, rather than the level of risk. 45 But many subjects think higher risk justifies higher payment. 46 For example, women participating in an imaging study agreed that study time and inconvenience should determine payment amounts. But most women thought payment should reflect the unknown risks of research interventions too. One woman said: “If the product is experimental, the reimbursement should be more. .... Because you’re basically a guinea pig, so you’re putting yourself at risk for something.” 47 When a different group of experienced subjects was asked about compensation, 65 percent said the level of risk should affect the amount of payment. 48 (Dresser SP 2017 p.52)
I'm not aware of any study showing how many research subjects suffer bad health effects as a result of the research, and in some cases, even die, nor am I aware of how much if any compensation they get in most cases, but these excerpts clearly shows there's some of this, and if there's any effort to figure out whether research provides more benefits than the damage done, it's not presented to the majority of the public. Furthermore, the responses from some of these research subjects show's they agree to participate because they're desperate for money, confirming some of my claims above that poor people make the sacrifices, while rich people get the benefits. This also adds to evidence that if we provided health care, fair wages for people's work among other things, the supply of research subjects making these sacrifices would be greatly reduced, yet fairness in the economy would provide far more benefits than most research could potentially provide.
... But patients often refuse to participate in placebo-controlled trials. Some who do agree to participate drop out if they think they are in the placebo group. (For more discussion on this phenomenon, see chapter 4.) These patients find it difficult to accept that assignment to a placebo group might actually turn out to be best for them. 69 (Dresser SP 2017 p.57)
This also indicates that many subjects aren't fully aware of what they might be agreeing to; if they were, they would know that their own best interests aren't the top priority of the research, although one group or another might actually come close to getting the best treatment, but the reason they have to do the research is they don't know which group that is. Furthermore, if they did come as close as they could to providing the best treatment available, as Harriet Washington and other advocates for human rights recommend, the decision would probably be between either the best medication previously known or the new drug that is unknown, and the placebo group would be eliminated, unless, perhaps, there's little or no potential for negligence.
There is also evidence that patient-subjects care about the commercial aspects of research. In interviews, experienced subjects criticized trials conducted primarily to generate profits, such as trials of “me-too” drugs or those aimed at extending a drug’s patent protection. One subject put it this way: “I assume it is on the up and up and not so that [the pharmaceutical company] can make a million dollars marketing the drug. [I]f I am in the guinea pig group, I want to make sure ... I am not sacrificing my body for someone’s bottom line.” 85
The experienced subjects in that interview study also wanted to know more about the compensation investigators receive for conducting research. A brief mention that researchers are compensated wasn’t enough for at least some subjects—they wanted to know how much the researchers would earn. One subject said: “[W]hen there is something like that statement in the consent form—’the researcher is getting compensated’—I would think it was like $10—not anything big. It wouldn’t occur to me. The way it is written it’s like they want you to gloss over it.” 86 Researchers ought to disclose these details, another subject said, as “a matter of respect” for the individuals taking part in the study. 87
These experienced subjects also criticized researchers who failed to inform them of the study results. As the interview team reported, many subjects “were disappointed that they had not been re-contacted and informed about study results as was promised or anticipated when enrolling.” This research omission, subjects said, reduced their interest in participating in future studies. 88 Similarly, a large survey of experienced subjects found that 72 percent considered information on research results a “very important” factor in their willingness to join future studies. 89 (Dresser SP 2017 p.60-1)
... Some patients believe that research is governed by concern for their individual best interests, when it is in fact governed by the need to gather accurate and useful data to guide the care of future patients. 92 ... (Dresser SP 2017 p.61-2)
For example, in a questionnaire and interview study of adults in college classes, about half said they were “loathe [sic] to accept that a doctor might genuinely not know what treatment is best.” About half also said it was unacceptable for a doctor to propose using randomization as a way to decide among treatments. They “assumed that just as much knowledge would be gained about which treatment is better if patients and doctors chose their treatment, rather than if treatments were allocated at random.” (Dresser SP 2017 p.80)
Clearly some of these subjects know more about the profit motive for the drug industry than the majority of the public is aware of, but are all research subjects as well informed? Rebecca Dresser provides more information on this than most researchers, but it's still unclear, and she probably doesn't even know. My best guess is that a large percentage of research subjects aren't nearly as well informed. the vast majority of the public certainly isn't aware of "me-too" drugs, which as Harriet Washington and Marcia Angell explain in their books are mostly about increasing profits by creating more patented drugs even though they're not much if any better than older drugs. This also adds to the evidence that researchers want to avoid disclosing how much money they get paid, which is almost certainly much more than the research subjects; this, along with excerpts below add to the evidence of a double standard and the fact that a lot of the financial motives is only disclosed in a low profile manner, if it's disclosed at all, and the media practically never reports on this so voters can make informed Democratic decisions and demand the same from their representatives.
Research sponsors typically don’t pay patients for participation in later-phase trials. The customary view is that potential health benefits to patients substitute for the financial rewards offered to healthy volunteers. This view is changing, however, and some trials now offer relatively large payments to patient-subjects. Like healthy volunteers, patient-subjects who are focused on financial rewards sometimes falsify information related to their trial eligibility and conceal this deception after they are admitted. 27 (Dresser SP 2017 p.93)
Ethical recommendations about not paying patients so they'll help for altruistic reasons or lack of other opportunities for health care are quite common, but these ethical recommendations rarely ever apply to corporations more concerned with profits than health, unless you listen to critics of the establishment often portrayed as radicals.
Subjects concealing or fabricating information about their medical histories and prior trial experiences put themselves at risk too. Certain medical conditions and past drug exposures can increase a person’s susceptibility to harm from trial interventions. In a few documented cases, concealing this information proved deadly to subjects. 52 (Dresser SP 2017 p.99)
Patients entering studies with fixed plans to withdraw if they are assigned to an unwanted treatment group or if their condition doesn’t improve also fail to meet their ethical responsibilities. (Dresser SP 2017 p.100)
We often hear .... These subjects present a different and less egalitarian vision of human research. In this vision these subjects’ interests and contributions are devalued. They are treated with disrespect and discourtesy, regarded more as servants than as research partners. In turn, they feel little allegiance to the research mission.
Subjects .... Repeat trial volunteers complain about substandard conditions in some research units. They tell tales of poorly organized trials, inattentive staff, and silly rules like mandatory bedtimes in on-site studies. (Dresser SP 2017 p.101)
Helm's grades ..... Some subjects—including a well-known US bioethicist— report being told they were not allowed to withdraw from studies, a clear violation of the federal research regulations. 65 ....
Subjects complain that researchers are sometimes dishonest too. A website offering tips to volunteers reported that staff members at some research units inflated the number of subjects needed for trials, misleading individuals about their odds of being accepted. This strategy allows the staff to be highly selective about who is actually chosen, wasting the time of the other people who show up. Staff members also tell would-be volunteers that they have been admitted to trials when they are actually alternates who will be included only if others fail to show up. 66
When subjects experience disrespectful treatment like this, relationships with researchers become adversarial. (Dresser SP 2017 p.102)
There is, of course, good reason to consider ethical practices for research subjects as well as the researchers; however, there's no doubt that the researchers have far more control of how the research is conducted, and when they don't abide by reasonable ethical guidelines, it's not surprising that the research subjects don't feel as obligated to do so as well. Rebecca Dresser indicated that she understands this as well, possibly partly due to the fact that she served as a research subject. One of her sources about ethical obligations for research subjects is a paper written by G. Owen Schaefer, Ezekiel Emanuel, and Alan Wertheimer which I go into more below; however, I'm less convinced they're as concerned with ethical practices by researcher, and, since Ezekiel Emanuel went on to help write the Affordable Care Act without pushing much more for Medicare for All, and a few other reasons, my impression is he's much more biased, in favor of wealthy elites, although you can read his articles which are listed below and judge for yourself.
Rebbecca Dresser is right to point out that in order to obtain ethical behavior from the subjects, which at times is in their own best interests, it's important to treat them with more respect, not to decieve them about their right to withdraw from research, especially if they suffer ill health as a result, tell them the truth and share the benefits of the research with them, which despite claims to the contrary, doesn't always happen.
Years ago, the philosopher Hans Jonas considered a fundamental question in human research: Under what conditions is it acceptable to put some individuals at risk for the benefit of others? According to Jonas, a human study is most acceptable when it involves subjects who fully identify with and understand the purpose of the research. Jonas argued that “the appeal for volunteers should seek this free and generous endorsement, the appropriation of the research purpose into the person’s own scheme of ends.” 106 (Dresser SP 2017 p.110)
Like other ..... Consistent with this purpose, the traditional recipients of study results have been scientists and physicians. In the past,researchers felt no obligation to give genetic study subjects information about either a study’s overall results or the subjects’ individual results. (Dresser SP 2017 p.134)
Money is at the heart of a third set of ethical issues relating to genetic research subjects. Should people contributing DNA samples and health information be paid? When their materials are used to develop a commercially valuable cell line or other product, should they receive a portion of the profits? Traditionally, few contributors to genetic research received payment in any form, and courts have rejected research contributors’ claims to a share of the profits from commercially lucrative research.
Many researchers .... Payment opponents say that assigning monetary value to genetic samples and information would dampen the altruism that often underlies the choice to contribute. (Dresser SP 2017 p.138-9)
Moreover, the economist observed ..... And in what way would “such a system be less fair to patients than the current system, under which all revenues from tissue lines .... accrue to the medical community?” 57 (Dresser SP 2017 p.142)
Rebecca Dresser and Hans Jonas are a couple of the rare researchers that actually discuss the most fundamental ethics of research, and obviously argue that those serving as research subjects should benefit from the research; and there is, of course, a lot of rhetoric about how all of society should benefit from it, and claims that everyone does, but a closer look clearly shows this isn't always the case, and the wealthy, including upper middle class or wealthy researchers, get more benefits than the rest of us, since they control the research and how health care is distributed. The evidence to support this conclusion is almost never in traditional media, but the closer you look at good research like this the more obvious it is, especially without universal health care.
As you can see Dresser clearly points out that researchers are concerned about altruistic motives from research subjects or DNA sample donors, but don't seem concerned about the altruistic motives of corporations, which if anything should be considered far more important! Clearly there are many people that think ethical values should apply only to the majority, not the wealthy controlling powerful institutions profiting by depriving people of health care unless they can gouge them for absurdly high prices. The only way they can justify this to the public is to minimize the discussion about it so few people pay attention to it; otherwise many more people would be outraged by how badly the system is rigged.
Rebecca Dresser's chapter on “The ‘Right to try’ Investigational Drugs: Science and Stories in the Access Debate,” Texas Law Review 93 (2015) PDF was originally published as an article that is available free to everyone, with a few changes in the book, so I'll quote that instead, page numbers from this are from the PDF, not the book:
“The ‘Right to try’ Investigational Drugs" Rebecca Dresser 2015
According to liberal-access advocates, physician opinion and minimal safety testing are an adequate scientific basis for allowing terminally ill patients to try investigational drugs. But scientific and other experts dispute this claim. Right-to-try laws would do more harm than good, experts say, by exposing patients to risky and ineffective agents. The laws would also pose an unacceptable threat to the larger group of patients who benefit from receiving drugs that have undergone thorough human testing. Experts predict that if terminally ill patients can easily obtain investigational drugs, fewer patients will be willing to participate in the clinical trials that determine which drugs can actually help patients live longer and better lives. p.3
B. Individual Versus Societal Interests
Besides disagreeing on the proper balance of liberty and protection in access policy, access advocates and critics disagree on the proper balance of individual and societal interests. A rigorous clinical-trial system is essential to determining whether investigational drugs are sufficiently safe and effective to be approved for the general patient population. Making drugs easily available outside trials could threaten that system. Because relatively few patients enroll in trials, it often takes many years to determine the quality of investigational drugs.98 If more patients can obtain drugs outside trials, it will become even harder to conduct the studies that reveal which investigational drugs actually help patients.99
Under existing FDA regulations, officials may approve treatment access only if it “will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use.” 100 But access advocates say that excluding trial-eligible patients is an unethical sacrifice of their interests to promote the greater good. 101 According to access advocates, a rule that “forces people to go into clinical trials if they want access to the only possibly lifesaving drugs” is unacceptably coercive. 102
Experts supporting access restrictions see the situation quite differently. They argue that the individual terminally ill patient’s desire to try investigational drugs is insufficient to outweigh the public’s interest in preserving the integrity of the drug-review system. 103 If access decisions are left to patients and their doctors, they say many more patients will be harmed. 104 Because it will become harder to conduct clinical trials, the drug-review process will be extended.105 This will in turn deprive physicians of the information they need to make evidence-based treatment recommendations to their seriously ill patients.106 p.15-6
....
Experts also point out that the FDA’s regulatory requirements have not prevented drug companies from providing investigational drugs to many patients. 113 When companies say no to patient requests, FDA access regulations are not the reason. Because the drug sponsors’ overriding goal is to gain FDA approval of their drugs, sponsors prefer to devote their limited resources to conducting the clinical trials that will make approval possible. 114 p.17
Experts doubt that right-to-try laws will do much to change this situation. They also warn that the FDA could challenge unauthorized investigational drug distribution as a violation of the Food, Drug and Cosmetic Act.116 Companies distributing investigational drugs without FDA permission could damage their efforts to win FDA approval of those drugs. It isn’t surprising that the Pharmaceutical Research and Manufacturers of America trade group has “serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process.”117 Drug companies would be acting against their self-interest if they provided drugs outside the agency’s access program.118 p.18
Despite rigorous requirements for information disclosure and informed consent in clinical trials, study after study shows that many trial subjects overestimate the possibility of medical benefit and underestimate the possibility of harm from investigational-drug exposure. Some patients join trials without understanding that the trials’ primary purpose is to generate knowledge about investigational drugs, not to provide the best treatment to individual trial participants.176 ... p.25 Complete article
According to liberal-access advocates, physician opinion and minimal safety testing are an adequate scientific basis for allowing terminally ill patients to try investigational drugs. But scientific and other experts dispute this claim. Right-to-try laws would do more harm than good, experts say, by exposing patients to risky and ineffective agents. The laws would also pose an unacceptable threat to the larger group of patients who benefit from receiving drugs that have undergone thorough human testing. Experts predict that if terminally ill patients can easily obtain investigational drugs, fewer patients will be willing to participate in the clinical trials that determine which drugs can actually help patients live longer and better lives. p.3
B. Individual Versus Societal Interests
Besides disagreeing on the proper balance of liberty and protection in access policy, access advocates and critics disagree on the proper balance of individual and societal interests. A rigorous clinical-trial system is essential to determining whether investigational drugs are sufficiently safe and effective to be approved for the general patient population. Making drugs easily available outside trials could threaten that system. Because relatively few patients enroll in trials, it often takes many years to determine the quality of investigational drugs.98 If more patients can obtain drugs outside trials, it will become even harder to conduct the studies that reveal which investigational drugs actually help patients.99
Under existing FDA regulations, officials may approve treatment access only if it “will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use.” 100 But access advocates say that excluding trial-eligible patients is an unethical sacrifice of their interests to promote the greater good. 101 According to access advocates, a rule that “forces people to go into clinical trials if they want access to the only possibly lifesaving drugs” is unacceptably coercive. 102
Experts supporting access restrictions see the situation quite differently. They argue that the individual terminally ill patient’s desire to try investigational drugs is insufficient to outweigh the public’s interest in preserving the integrity of the drug-review system. 103 If access decisions are left to patients and their doctors, they say many more patients will be harmed. 104 Because it will become harder to conduct clinical trials, the drug-review process will be extended.105 This will in turn deprive physicians of the information they need to make evidence-based treatment recommendations to their seriously ill patients.106 p.15-6
....
Experts also point out that the FDA’s regulatory requirements have not prevented drug companies from providing investigational drugs to many patients. 113 When companies say no to patient requests, FDA access regulations are not the reason. Because the drug sponsors’ overriding goal is to gain FDA approval of their drugs, sponsors prefer to devote their limited resources to conducting the clinical trials that will make approval possible. 114 p.17
Experts doubt that right-to-try laws will do much to change this situation. They also warn that the FDA could challenge unauthorized investigational drug distribution as a violation of the Food, Drug and Cosmetic Act.116 Companies distributing investigational drugs without FDA permission could damage their efforts to win FDA approval of those drugs. It isn’t surprising that the Pharmaceutical Research and Manufacturers of America trade group has “serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process.”117 Drug companies would be acting against their self-interest if they provided drugs outside the agency’s access program.118 p.18
Despite rigorous requirements for information disclosure and informed consent in clinical trials, study after study shows that many trial subjects overestimate the possibility of medical benefit and underestimate the possibility of harm from investigational-drug exposure. Some patients join trials without understanding that the trials’ primary purpose is to generate knowledge about investigational drugs, not to provide the best treatment to individual trial participants.176 ... p.25 Complete article
This paper raises some legitimate concerns about the probability, according to most scientific sources, that untested drugs will do more harm than good, and the patients should be advised of this whether they grant them the "right to try" or not. She clearly indicates that in most cases terminally ill patients won't benefit from this anyway; however, when they express more concern about access to these patients as research subjects than the best treatment of the patient that should raise major ethical questions, especially if there are some exceptions where experimental drugs might actually have a chance of being better than known drugs, no matter how rare this is.
By using the argument that people should be deprived of the "right to try" because it would make research subjects harder to find and delay research it clearly shows their priorities, even though it may not be in the patients best interests to take this drug. Clearly patients should be allowed to receive the best treatment available for themselves and they should be able to choose their own medical care. Personally, I think it would be best to allow doctors to treat patients to the best of their ability and share the results with researchers, even if it's not part of a rigid protocol that researchers think would provide the best research results. I have no doubt that some educational material might be obtained without sacrificing the best interests of the patient, even though it might not be as much as a rigid research protocol comparing patients with clearly different treatments at random, and the researchers shouldn't be entitled to use certain patients for research, especially since most research doesn't provide a large benefit for society anyway. However, in all fairness, since untested drugs are rarely in the best interests of the patient, and on the rare occasions where they might be, they can't be sure, this isn't the worst example where withholding choices are done for research purposes, especially for the poor.
The issues faced by the planners of the Ebola vaccine trials are not unusual in global health research. Much of this research is financially supported and initiated by people from wealthy countries but carried out in developing countries, where local residents serve as research subjects. In this context, factors like mistrust, poverty, and low literacy can have major impacts on the conduct of health research. (Dresser SP 2017 p.190)
Social scientists describing these problems believe that ethicists have been insufficiently attentive to empirical data describing local perspectives on research. Two social scientists with years of experience observing health studies in Africa put it this way:
Ethics debates tend to be dominated by the views of scientists and advocates from high-income countries who have little opportunity to engage in the actual conduct of the studies. The perceptions and priorities of the diverse communities who are the subjects of research, of the local researchers and research assistants who are primarily responsible for implementing “ethically appropriate” practices, and of the health workers, managers and policy makers who are so often expected to put research findings into practice, are therefore rarely heard. 12
To correct the situation social scientists urge ethicists to develop an “embedded ethics” that takes into account the views of research participants and others who live in the community. 13 (Dresser SP 2017 p.192-3)
One team found ... The survey asked people in these groups about the benefits that researchers conducting an HIV vaccine trial should provide to the community. Nearly half of all survey respondents thought that researchers should provide healthcare services as post-trial benefits. Other popular choices were clinics, clean water, money, and the trial vaccine (if it proved to be effective). Eighty percent of all respondents opposed limiting post-trial benefits to vaccine trial participants. Instead, they thought that benefits should go to everyone in the local community. Many also thought that benefits other than the vaccine were most important, because of the “tangible, pressing needs in their community.” 49 (Dresser SP 2017 p.203)
Another reasonable-availability survey showed similar divisions. Experienced research participants, investigators and ethics committee chairs in eleven countries (several of which were developing countries) responded to the survey. Eighty-three percent of the experienced participants believed that “every HIV-infected person should receive the study drug if beneficial.” In contrast, just 42 percent of investigators and 29 percent of the ethics committee chairs took this position. 52 (Dresser SP 2017 p.204-5)
Dresser is one of the rare researchers that discuss many inequities which are very common, yet never mentioned in mainstream media. Obviously everyone would want researchers and doctors to be well educated; but when the only people with access to a good education are from wealthy families it creates an obvious class conflict, and some effort should be made to give people from a lower income educational opportunities, and participate in the decision making, as Rebecca Dresser at least partly indicates. Harriet Washington also addressed this disparity in her book "Medical Apartheid," where she begins early in her book by debunking some conspiracy theories, but then goes on to show that even though there have been many exaggerations, or outright lies, there are many real disparities and not all conspiracy theories are false, which she goes on to prove, including the claims that black people are much more likely to be used for research while wealthy white people get most of the benefits. The two social scientists cited by Dresser clearly make similar points which should be considered by the majority, not just wealthy people within the research community.
The surveys she cites also provide large discrepancies, with people clearly basing their choices on their classes. Keep in mind that when the media does discuss research or some ethicists like G. Owen Schaefer, Ezekiel Emanuel, and Alan Wertheimer, who I cover just below claim that people should have an obligation to serve as research subjects since they get a share of the benefits, yet in this poll even though all the lower income people, including research subjects agree that the benefits should be shared with all only "42 percent of investigators and 29 percent of the ethics committee chairs took this position." What kind of ethics committee chairs don't believe the benefits should be shared with all? Should this raise doubts about ethical values controlled by those with a financial conflict of interest? It's unfortunate that this poll didn't ask all ethicists as well whether they thought the benefits of research should be shared with all the people, which would enable us to know if Research Ethics Committee Chairs are more or less likely to support sharing benefits of research than other ethicists. I don't know for certain but I suspect for profit research organizations are almost certainly the ones choosing Research Ethics Committee Chairs, which could mean they're more likely to support the interests of board members more concerned with profit than the best treatment of patients.
People in developing countries also enroll in research to obtain what is known as “ancillary care.” This is “medical care that the research subjects need but that is not required to make a study scientifically valid, to ensure a study’s safety, or to redress research injuries.” 24 Ancillary care can be a huge motivator for subjects in developing countries. Joining a study allows some people to receive care they wouldn’t otherwise get. It can allow subjects to bypass overcrowded health clinics with long waiting lines. Study participation can open the door to healthcare for family members too. 25 (Dresser SP 2017 p.198)
This clearly shows, in developing countries at least, that declining to provide adequate health care or economic opportunities helps make it easier to recruit research subjects. Rebecca Dresser doesn't go so far as to say that they might have an easier time recruiting research subjects in the United States from people who already have health care insurance, and there are some times, however rare, where there's a chance that experimental drugs or treatments might be in the patients best interests; however, there's an enormous amount of evidence, from her book and many other sources, showing that many research subjects only agree to participate in the research because they need the money, and this may be more likely for people without insurance, which wouldn't be the case in other wealthy countries with Universal health care.
.... Yet the evidence does not show that research decisions are inevitably deficient in developing countries. As one review of research on informed consent stated, to assume that “informed consent is worse in developing countries is a simplification of a complex picture." 53
That review, which covered forty-seven studies that evaluated subject understanding of consent in developed and developing countries, describes numerous complexities. According to the review team, the studies as a whole “do not support a categorical difference between the quality (Dresser SP 2017 p.205)
... Individuals are also chosen to represent specific groups or to supply “typical community views.” 94
The choice of representatives has ethical implications. What gives a person authority to speak on behalf of a particular group? .... (Dresser SP 2017 p.216)
It certainly seems likely that ethical guidelines would be lower in developing countries where protections for the people have always been lower than they are in wealthy countries, and many other researchers have confirmed this including RFK Jr. and even Ezekiel Emanuel who mentions it below, but he goes on to explain why it's now ethical to do this research. My impression is that Dresser, Stark, Washington and Angell are probably more credible than many ethicists employed by for profit corporations, but I'm skeptical that third world subjects are protected as well as those in wealthy countries; and, that's not quite what she wrote, if you look carefully, the review and her statements seem say it's not always worse, but it could still be the case in many cases, and some of these cases where they had inadequate protection have been reported, in one case which I reported on a previous article, based on research from Harriet Washington there were poor families that were used for a study in lead poisoning in Baltimore Maryland. When we can't even apply good ethics in our country being as good as it isn't much to brag about.
The experimental procedure seems to work, and Charlie's progress report becomes insightful and sophisticated. .... In one of many outbursts, Charlie explains his position: “The problem, dear professor, is that you wanted someone who could be made intelligent but still kept in a cage and displayed when necessary to reap the honors you seek. The hitch is that I'm a person." (Excerpt from "Flowers for Algernon" p.247) (Dresser SP 2017 p.235-6)
Research experts .... Ethicist Alexander Capron hit the mark in calling it “wishful thinking to suppose that most of the people on whom research is conducted today in the United States are on a par with—that is, are co-equal participants with—the research the research team and sponsors.” 1 (Dresser SP 2017 p.264)
Fictional authors writing about research subjects have an advantage of being outside of the academic world, where many researchers associate with each other, have common motivations, and might have the same biases. As I said, I consider some, including Dresser more credible than many other academics, but she's still working with the same institutions. The assumption that research subjects "are co-equal participants" is also absurd, as Rebecca Dresser points out throughout her book and there needs to be many improvements; however, researchers trying to create propaganda to hide the class difference, might be inclined to support this false belief, perhaps some of them might even believe it themselves.
As I've said before most of the researchers or ethicists that I've cited are almost certainly much better than the majority working for for-profit health care institutions, including those working directly for or consulting for the government; however, Ezekiel Emanuel hasn't always been one of them. This doesn't mean that all his ethical recommendations are bad, and if you read them I suspect you might agree; however, some of them may be biased, and when he gets things right he may not always abide by them or he may defend institutions that don't abide by good ethical guidelines. The most obvious example is the fact that he was a leading advisor to help develop the Affordable Care Act, which isn't nearly as affordable as the name suggests.
The ACA was created to keep private for profit control over the health care system, despite the political rhetoric, and the more money spent on lobbying advertising or used to pay investors and maximize profits the less they have to spend on health care. As I wrote above there are 22 studies showing that single payer or Medicare for All will save billions of dollars each year, and some of these studies also show it will also save thousands of lives. There's simply no way this can possibly be considered ethical, and no ethicist that helps write this without pointing out it's serious flaws can possibly be credible, confirming the fact that many corporations are far more concerned with the illusion of ethics than the real thing.
Ezekiel Emanuel contributed to at least two papers, (excerpts and links are below) that provide some good recommendations, although others, like exceptions to demands for informed consent, may not be quite as good, but the description of how they're practiced may not be accurate, and the ACA which he later supported may not abide by these principles. In one of his articles with co-author G. Owen Schaefer, he argues that almost all of should feel an "Obligation to Participate in Research,” since we all benefit from research by taking advantage of improvements in health care, but that it shouldn't be required by law. The lack of legal requirements means it's entirely on the honor system, and the fact that only a small fraction of the public have ever even heard this argument, and most of those are probably researchers, means it has little application in the real world.
They imply that "free-riding," which seems to mean taking advantage of advances in research without serving as a research subject should be minimized. Who would these "free-riders" be? If he's referring to the risks involved in serving as a research subject, not money, it seems the free-riders are the ones who take advantage of medical advances after they're proven safe, but never serve as a research subject where there's any potential risk of harm. This would mostly refer to people that have good access to health care an adequate insurance, which is mostly reasonably wealthy people, very rich people, or perhaps some people who manage to get adequate health care through their work, which is how it works in the United States. There might be many more free-riders in other wealthy countries where they provide universal health care. But when it comes to the United States, middle class or poor people are unlikely to be free-riders, unless they get insurance from their employers, and one thing worth considering is that those employers can, and often do, use insurance as a way to discourage strikes or demands for higher pay. Universal Health care eliminates this unfair incentive to discourage workers from standing up for their rights.
They acknowledge that "Wealthy people receive more benefits from biomedical research than poorer people; they are more able to afford new, expensive drugs and interventions," therefore they conclude that "A poorer person does not have an obligation to support an institution that primarily benefits the wealthy." This totally defeats the purpose of the entire article, especially since he went on to support the ACA after this instead of Medicare for All or some other form of Single Payer, which has proven to save more lives, since the vast majority of people serving as research subjects are poor people, and the people getting the best health care are wealthy people. In all fairness, there are some exceptions where most of the research is done and they have reason to believe that new drugs or treatments might be more effective, and patients with certain diseases or conditions might choose them, but these cases are almost certainly very rare, and the fact that they're still experimental means they're still uncertain, and may still do more harm than good. They also consider the possibility that rich people could pay people to serve as subjects on their behalf, but this is clearly an elitist suggestion giving the wealthy more rights than the poor.
Ezekiel Emanuel is also the lead author in another two-part paper, (I assume there are two parts which I found separately, but I can't rule out a third part.) where the second part, What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research Ezekiel J. Emanuel, David Wendler, Jack Killen, Christine Grady 03/01/2004, admits that "Historically, populations that were poor, uneducated, or powerless to defend their own interests were targeted for high-risk research, whereas promising research was preferentially offered to more-privileged individuals [25]." However, there's little indication that this problem has been adequately solved, or that they even come close to trying to solve this problem. Admissions like this are done in a very low profile manner, and a close look at the system he supports shows that even though he acknowledges some of the problems, his ethical recommendations, when they would help solve problems, are often ignored, and little attention is drawn to it. Once again, one of the strongest pieces of evidence is his support for the ACA instead of lobbying for Medicare for All. Additional excerpts from two of his papers and links to the complete papers are below so you can use your own judgement.
____________________ 62. G. Owen Schaefer, Ezekiel Emanuel, and Alan Wertheimer, “The Obligation to Participate in Research,” Journal of the American Medical Association 302 (2009): 67-72, 68. p.117
The Obligation to Participate in Biomedical Research G. Owen Schaefer, B.A., Ezekiel J. Emanuel, M.D. Ph. D, and Alan Wertheimer, Ph. D 2009
Participation in research is a critical way to support that important public good. Consequently, we all have a duty to participate. The current social norm is that people participate only if they have a good reason to do so. The public goods argument implies that people should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making our society significantly healthier and longer-lived. ...
According to another argument, the failure to participate in research is a form of free-riding. 6, 11–14 Free-riding occurs when a person receives a benefit that others pay for and takes advantage of the contributors by refusing to share the burden of obtaining it.
To say that John has a moral obligation to participate in a clinical trial does not mean that John should be legally compelled to do so.
The obligation to participate in research does not undermine the right to withdraw from participation in a trial.31 To say that subjects have a right to withdraw is not to say that they have no prima facie obligation to remain in a study. It is to say that they should not be penalized for withdrawing even if withdrawal is wrong. And we are not proposing that subjects ever be penalized for withdrawal.
In theory, the obligation to participate could be fulfilled by paying someone else to participate. Most U.K. and U.S. citizens discharge their obligation to defend their country by paying for an all-volunteer army through taxes. In principle, we could pay research participants enough so that no one would have to be asked to make any sacrifice by participation. But there are practical and moral limitations to this strategy. It would be in inordinately expensive to increase payment to research subjects enough to attract the millions of participants who are needed above current levels.
.... A shortfall of participants in biomedical research slows the completion of clinical trials more than lack of funding.39, 40 ...
Wealthy people receive more benefits from biomedical research than poorer people; they are more able to afford new, expensive drugs and interventions. A poorer person does not have an obligation to support an institution that primarily benefits the wealthy. 43, 44
The public goods argument maintains that an individual has an obligation to participate in research only if the burden of participation is less than that overall benefit of biomedical research to the individual. It is an open empirical question whether or not wealthy people ultimately get more benefit out of biomedical research than poorer people, but it is likely that the benefit from research to the poor exceeds the burden of participation for the poor as well. There is some evidence that while poor populations lag behind in health improvements compared to the wealthy, the poor populations often manage to catch up as interventions become cheap and widely available.45 This is partially because medical knowledge is a public good; wealthy people’s access to medical knowledge does not preclude poorer people from having access to it. Even if delayed, poorer people still receive benefits from interventions originally targeted at the wealthy. Access to a tuberculosis vaccine or AZT, for example, may be delayed for the less affluent, but they eventually get access and ultimately a greater improvement in their lives from the research since less affluent people are more threatened by diseases such as tuberculosis and HIV/AIDS.
Excessive burden on the sick
Because much research can be conducted only with those with a particular disease or condition the obligation to participate in biomedical research falls disproportionately on sick individuals who already suffered enough. An obligation for the sick to participate in trials is unreasonably demanding.5
While it is unfortunate that the sick bear a disproportionate burden of participation in research, it is not unfair.
Three-quarters of all biomedical research is actually sponsored by pharmaceutical companies. 41 While there may be an obligation to participate in publicly-funded research, patented biomedical knowledge is not a public good. Hence, participation in industry-sponsored research which may produce patented knowledge is not an obligation.
... Consequently, we can have obligations to help private companies produce public goods. .... Whether a study is publicly or privately financed has little bearing in itself on the obligation to participate in that study.
A negative result that is unpublished and unreleased is not a public good. That is a good reason to encourage the dissemination of the results of all studies. However, negative results which are disseminated to the medical community are indeed a public good. Knowing what does not work can be useful in itself and can contribute to other studies. (Obligation to publish negative results?)
What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research Ezekiel J. Emanuel, David Wendler, Jack Killen, Christine Grady 03/01/2004 Historically, populations that were poor, uneducated, or powerless to defend their own interests were targeted for high-risk research, whereas promising research was preferentially offered to more-privileged individuals [25].
22. ... Ezekiel Emanuel et al., “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,” Journal of Infectious Diseases 189 (2004): 930-37 (Dresser SP 2017 p.220)
Ezekiel Emanuel et al., “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,” Journal of Infectious Diseases 2004
Only if society will gain knowledge, which requires sharing results, whether positive or negative, can exposing human subjects to risk in clinical research be justified. ...
Beyond not wasting resources, researchers should not expose human beings to potential harms without some possible social or scientific benefit.4,30,35,38 p.3
First, fair subject selection requires that the scientific goals of the study, not vulnerability, privilege, or other factors unrelated to the purposes of the research, be the primary basis for determining the groups and individuals that will be recruited and enrolled.3,30,37 In the past, groups sometimes were enrolled, especially for research that entailed risks or offered no potential benefits, because they were “convenient” or compromised in their ability to protect themselves, even though people from less vulnerable groups could have met the scientific requirements of the study.30,37,53,54 ....
Second, it is important to recognize that subject selection can affect the risks and benefits of the study.70 Consistent with the scientific goals, subjects should be selected to minimize risks and enhance benefits to individual subjects and society. p.4
... Indeed, part of the rationale for recent initiatives to include more women, minorities, and children in clinical research is to maximize the benefits and value of the study by ensuring that these groups are enrolled.65-67,72,73 .....
Additionally, fair subject selection requires that, as far as possible, groups and individuals who bear the risks and burdens of research should be in a position to enjoy its benefits,12,13,38,59,74 and those who may benefit should share some of the risks and burdens.75 .... p.5
... Wanting to complete a study quickly may lead to the use of questionable scientific methods or readily available rather than the most appropriate subjects. Independent review by individuals unaffiliated with the clinical research helps minimize the potential impact of such conflicts of interest.86,88 ....
..... To provide informed consent, individuals must be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research; understand this information and its bearing on their own clinical situation; and make a voluntary and uncoerced decision whether to participate.97-99 Each of these elements is necessary to ensure that individuals make rational and free determinations of whether the research trial is consonant with their interests. .... p.6
.... For instance, evidence of an individual’s preferences regarding research may be obtained from a research advance directive rather than the individual’s concurrent informed consent.103 Given the existence of alternative procedures, informed consent requirements can be minimized, and, in some circumstances, consent can even be waived.7,101,103 Research on emergency life-saving interventions for subjects who are unconscious or otherwise not mentally capable of consent and for whom family or proxy consent is not immediately available may be conducted without informed consent.6,107-109 Thus, all requirements need to be satisfied, but they may have to be adjusted and balanced given the circumstances of different types of research. p.7
... In some places, it will be necessary to elicit the consent of elders before individual subjects can be approached for informed consent.115 Similarly, who is considered vulnerable for the purposes of fair subject selection criteria will vary by locale. While in the United States special efforts are necessary to ensure that racial minorities are not just targeted for research with high potential for risks,53,73 in other places fair subject selection may require special focus on religious groups. Similarly, local traditions and economic conditions will influence when financial payments may constitute undue inducements. .... p.8
.... Yet these requirements must all be considered and met to ensure that clinical research— wherever it is practiced—is ethical. p.10
Penn ethicist Zeke Emanuel has another life as a venture capitalist 04/11/2022 [The Trump] administration wanted to “repeal and replace” [Barack Obama’s insurance programs], but they never did come up with the “replace.” And I realized that transformation can come from only one place: the private sector. ... How do you know Oak founder Ann Lamont? She’s married to Connecticut Gov. Ned Lamont, a Democrat.
Guide for Research Ethics Committee Members PDF
.... Undue influence may be financial in nature but would also include, for example, attempts to influence close relatives, or veiled threats to deny access to services to which individuals would otherwise be entitled. In addition, special care is needed in situations where participation in a research project may be the only way to access health care (See also Chapter 9 – Transnational research). ....
Research may also entail some risks and benefits for participants’ families and society at large, but any risk of harm and burden (such as constraints or discomfort) will primarily be borne by the participants. In addition, and depending on the nature of the research, direct benefit for research participants may be limited or absent. p.10
The nature of the risk may not only be physical but also, for example, psychological. The risk for private life has to be taken into account too. Research may also involve social or economic risks. Although the anticipated overall benefits of the research project must clearly be higher than the potential risks, the research may not be considered justified if there is a particularly high risk of serious harm; there comes a point when a certain nature and level of risk will never be deemed acceptable even if the person gives consent to participate in such research. ....
The key question is who ought to receive the benefits of research and bear its risk and burden. In biomedical research involving human beings, this implies that the distribution of risk and burden on the one hand and benefit on the other be fair – a principle known as distributive justice. p.11
Another ethical obligation of the researchers* or of the sponsors of research is to make the conclusions of the research publicly available by means of fair and adequate publication. Sometimes research results, especially ‘negative’ results, are suppressed; such biased under-reporting is not only unscientific and unethical but has also harmed patients, for example when adverse effects of treatments have been concealed. Although several mechanisms are being introduced to aid transparent reporting of research information – e. g. the requirement for pre-registration of any clinical trial on medicinal products in a public database before the trial begins (See Chapter 6 – Independent REC examination of a research project) – RECs can still help by being attentive to this important issue as it pertains to projects completed following their review. p.19-20
It is important for the REC to be aware of previous and concurrent submissions of the research project, and the outcome if known. For example, if another REC has already rejected the proposal, a new REC needs to know this to decide whether the proposal has been changed in response to legitimate concerns, whether the researchers* are merely “shopping around” in the hope of finding another REC that will give a favourable opinion, or if a previous negative opinion was unjustified for whatever reason.
6.C.2 Justification for involving human beings in the research
The applicants must justify why they are proposing to conduct the research in human beings. The REC will need to be satisfied not only that the research holds out the ultimate prospect of improving people’s health (See Chapter 2- Introduction) but also that similar results cannot reasonably be obtained by other means, for example by mathematical modelling or research in animals. It naturally follows that the REC should not countenance invasive research methods if non-invasive methods would be similarly effective. p.30
To obtain reliable evidence, it is often essential to compare the effects of the new method with those of a control method in participants drawn from the same participant population. This is the principle of comparing “like with like”, which is fundamental for achieving unbiased results. The applicants should therefore give their reasons for the presence, and especially the absence, of control groups, together with details of the proposed control method. Participants assigned to a control group should receive a proven effective preventive diagnostic or therapeutic method. Placebo may only be used as the control method under strictly defined conditions (See below). p.31
The overall conclusions of the research should be made available, in a comprehensible form, to any participant who wishes to see them. Although provision of this information has to respect the interests of third parties such as the research sponsor* or researchers* themselves, this should not be used as an excuse to deprive participants of their legitimate right to know the outcome of the research to which they contributed. However a reasonable delay may be acceptable (See below). p.38
6.C.20.2 Making research results available for scientific and healthcare purposes
It is important to make available the results of research, irrespective of whether they substantiate the research hypothesis (“positive”), refute the research hypothesis (“negative”) or are inconclusive. Suppression of results not only distorts the research endeavour if other research groups are unaware of them but also can directly affect patients, who may be recruited needlessly to take part in unnecessarily repetitive research. In addition, systematic accumulation and analysis of research results is essential for developing medical treatments – very seldom will the results of a single research project be so clear cut that they have an immediate impact on clinical practice. Rather, progress depends on new research being carried out and interpreted in the context of systematic reviews* of all other relevant and reliable evidence. If some of this relevant evidence remains unpublished the totality of evidence is biased and therefore unreliable. Patients may then continue to receive treatments that are actually harmful, or conversely not receive treatments that would benefit them. p.39
The term “persons deprived of liberty”* is based on Article 5 of the European Convention on Human Rights. People may be deprived of their liberty not only for security reasons (e.g., for committing an offence under the criminal justice system [prisoners]) but also for health reasons (e.g., for endangering themselves and/or others). The key issue is that they are an especially vulnerable group of potential research participants because of their dependence on others to provide them with food, healthcare, and other amenities of life. Completely denying such people the opportunity to participate in research may harm them by limiting their access to effective and sometimes life-saving therapies. However, in some countries, such research is unlawful. p.45
The most explicit international legal instrument on this subject in Europe is the Council of Europe’s Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, which establishes three specific criteria for such research:
i. research of comparable effectiveness cannot be carried out without the participation of persons deprived of liberty*; p.46
Research projects are often undertaken multinationally, so a REC in one country may be asked to review protocols involving research also taking place in other countries. Sometimes research teams based in different countries collaborate on a single project. On other occasions externally based research organizations fund research to be carried out in a specific country or countries and the researchers* involved may come both from the countries concerned and from the country of the funding organization. For example, research into a tropical disease such as malaria would usually need to be carried out in the countries where it actually occurs but the funding organization may be based elsewhere.
9.A Multinational research: review by different RECs
Every multinational research project must be submitted for ethical review to a REC in each State in which research activity is envisaged (the principle is laid down in Article 9 of the Additional Protocol concerning Biomedical Research). Research must only be carried out in States where the REC has given a favourable opinion. Apart from general protective provisions, the Directive 2001/20/EC also sets out a specific procedural requirement for multicentre clinical trials* that are carried out in more than one Member State by requiring each Member State to give one REC opinion, irrespective of the number of RECs involved within each State. p.49
The legislative framework in this area in Europe is provided by the Council of Europe Convention of Oviedo, 1997, and the Recommendation (2006) 4 on research into biological materials of human origin. The Convention (Article 22) requires participants’ free informed consent for the storage and use of materials for a purpose other than that for which it was removed. It further stipulates (Article 21) that the human body and its parts shall not, as such, give rise to financial gain. This does not of itself preclude the licensing/selling of intellectual property rights arising from research in which the samples are used (i.e. this is the same as for other intellectual property rights) but it does mean that those who donate their materials should be informed if those materials might be used for commercial purposes. It also means that researchers should not sell the materials per se for a profit, and that donors of materials should not be offered financial inducement to donate samples (reimbursement of reasonable expenses would be permissible). p.51
International differences in ethical standards and in the interpretation of legal frameworks 137p.
How Both the EU and the U.S. Are "Stricter" Than Each Other for the Privacy of Government Requests for Information 2017 52p.
Why We Need Stricter Oversight of Research Involving Human Subjects Affected by Conflict June 2022
International Compilation of Human Research Standards 7 PDFs mostly from different regions
Operation Warp Speed Slowly Gets Its Due 01/31/2022 The Trump administration’s Operation Warp Speed delivered three Covid-19 vaccines in record time. Yet liberals are giving the program its due only now, amid President Biden’s Covid-19 stumbles. Some, including former Biden adviser Ezekiel Emanuel, are even calling for another Operation Warp Speed to boost therapies. Operation Warp Speed also delivered the two monoclonal antibody treatments. More such treatments would have been available this winter had the Biden team not abandoned the program.
The following are some additional sources or related articles:
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Allegations of organ harvesting in China persist 06/02/2019
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Cross-Border Quest: The Reality and Legality of Transplant Tourism 05/10/2012
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Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects 2005 by Robert Helms
Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects Issue #8, November 2000 by Robert Helms Text
Israeli doctors experimented on children 05/11/2005
Research scandal forces Israel to tighten up supervision 06/04/2005
Doctor admits Israeli pathologists harvested organs without consent 12/21/2009
Israel harvested organs in ’90s without consent 12/20/2009
Israel harvested organs without permission, officials say 12/21/2009
Israel Became Hub in International Organ Trade Over Past Decade 09/20/2018
‘A cruel harvest of the poor’: Israeli allegedly behind human organ black market arrested in Cyprus 01/08/2018
Ten years of Israel’s organ transplant law: is it on the right track? 03/16/2018
The Big Lie Of Israeli 'Organ Harvesting' Resurfaces As YouTube Video On Haiti Earthquake Goes Global 07/18/2013
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Peter Singer "Animal Liberation" 1975/2015 PDF
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