Discussing medical ethics and vaccines with Vera Sharav of the AHRP

This post begins with a local tragedy.  A few miles away from my office in Waltham sits the site of the Fernald State School, founded in 1848 as the “Massachusetts School for the Feeble-Minded.”  Fernald, at its peak, housed 2,500 people, and it operated until 2014.  For at least part of its life its mission was explicitly eugenicist – to separate those considered inferior from the larger population.  The fact that many of its inmates were merely poor and not actually intellectually disabled has been one of the scandals of the school’s history.

Disabled or not, during the 1940s and 1950s some of the school’s inmates were used as subjects for a nutrition experiment conducted by MIT, with support from Quaker Oats.  To recruit children for the experiment, MIT researchers established a “science club” for the children, in order to create a context for feeding them radioactive food.  The radioactive markers in the food were designed to allow the researchers to monitor absorption of nutrients such as calcium and iron from oatmeal.  This research was one of a large number of dubiously ethical radiation studies conducted in the United States during the postwar period.

A 1986 report by then-US Rep. Edward Markey of Massachusetts described many of these studies, and after that report the US Department of Energy’s Advisory Committee on Human Radiation Experiments (ACHRE) investigated these testing programs.  Their report, issued in 1993, had a chapter on the experiments at Fernald in addition to their description of other studies and the larger context.

I first became aware of this research scandal in 1998, when I was a graduate student at MIT.  In January of that year MIT and Quaker Oats settled lawsuits related to the unethical research for 1.85 million dollars, a settlement that made national and local news.

I decided that these events would make an interesting post for the Waltham Review, with the idea being that they might provide some context for understanding the distrust of the scientific establishment that appears to be intensifying recently along a number of dimensions – and that appears to be having a variety of potentially devastating consequences. In that sense, this piece is a companion to an earlier Waltham Review piece on starvation experiments that were conducted on conscientious objectors at the University of Minnesota during World War Two.

As I dug into the events at Fernald, I quickly discovered that I was not the first person to have the inspiration to write a blog post about that situation.  In December of 2014, a group called the Alliance for Human Research Protection wrote a piece on Fernald; the AHRP also reposted a 2015 blog post about these events from the Priceonomics blog.

The AHRP and Priceonomics blog posts give great descriptions of the events at Fernald, and the only thing specifically about Fernald that I would have added to those posts would have been to highlight the contrast between the high ethical stakes involved and the apparently low academic impact for the problematic research.  The results of the research program can still be accessed online.  These significant ethical transgressions led to papers that have now been cited between 9 and 88 cites over 60 years. By way of comparison, my own most widely-cited work has more than 1600 citations in 10 years. What great damage was done in order to facilitate research that appears to be getting read a handful of times a year!

As I learned more, I realized that the truly important story was not Fernald but the AHRP itself, and that organization’s battle to publicize and combat what it describes as unethical or questionable behavior in medical research and treatment.  The AHRP is led by the energetic Vera Sharav, and her work on this front has been often heroic, in particular when it comes to publicizing the too-frequent deviations from the established rules that govern medical research and treatment.  The AHRP maintains on its website a useful list of unethical behaviors – some recent – by individuals and groups within the medical and scientific community.

Sharav was the focus of a recent profile in the new online magazine Stat, published by Boston Globe Media. The article mentions her background – she is a Holocaust survivor – and the impact that her early experiences had on her outlook and on her determination to fight against unethical medical practices.

As the Stat article mentions in a surprisingly passing way, Sharav and AHRP also gave an award last year to the polarizing British anti-vaccine crusader Andrew Wakefield, honoring him for his work.  I believe that the coverage of Sharav’s vaccine skepticism in Stat probably falls short of capturing the impact that vaccine skepticism is having on the world right now.

Skepticism – healthy or otherwise – is at the heart of the philosophy and approach of the Waltham Review. Although I don’t try to touch on the taboo merely for the sake of provocation or offense, I do try very hard not to reflexively or thoughtlessly avoid topics that are considered inappropriate to discuss in our society.

But I now arrive at what may be the limit of my automatic skepticism. Vaccines are the point where, as Editor-in-Chief, my official position boils down to this: while we are busy being skeptical, let’s try not to get so skeptical that we give our kids and their friends measles or whooping cough.

I realized that talking to – and necessarily humanizing – an influential vaccine skeptic felt more taboo for me than it would have felt to talk white supremacy with a hundred raving Trump supporters.  But please read my interview with Ms. Sharav, and see what you think.  At what point, if at all, do you get off the train she’s conducting?  I – a skeptic’s skeptic – remained on her train for a long, long time, and I am grateful to her for most of her work.  But I get off the skepticism train at some point before it gets to measles.

I think that there are a number of thoughts to keep in mind while reading the interview with her. First of all, in a different context, the economist Paul Samuelson remarked that “it takes a theory to beat a theory.” We have an existing approach to medical research and human subject experimentation that involves obtaining consent, safety review boards, institutional oversight – a variety of features constructed by thoughtful people in order to direct a process that is necessary.  This approach is obviously failing at times – for example the Fernald case and a terrible recent case at the University of Minnesota that Ms. Sharav describes in the interview, as well as the well-known and atrocious Tuskeegee Syphilis Experiment, which arguably led to the establishment of our current set of ethical guidelines for medical research.  But if this system of laws, norms, and guidelines needs to be further reformed, what would a reform look like?  Do the terrible violations highlighted by the AHRP violations of the established norms and guidelines, or do they represent problems with the norms and guidelines themselves?

Finally, one can construct a taxonomy of people and institutions based on their attitudes toward change.  Conservatives resist change; reformers want to change an existing system without discarding it; revolutionaries want to discard the existing system in favor of something new; and reactionaries want to discard the current system in favor of some actual or mythical past.  There is fuzziness around the edges of these categories, an each of us probably has elements of all four types.  But it is worth keeping this taxonomy in mind as we think about how we react to violations of ethical norms in medicine.  Are we conservatives?  Are we reformers?  Are we revolutionaries?  Or are we reactionaries?

The interview with Vera Sharav is below.

[Note: there are two versions of this interview presented here.  The second version is a transcript of the conversation with Ms. Sharav.  The first version is a version with edits that Ms. Sharav sent after reading the transcript version that I sent to her.]


[Version edited by Ms. Sharav]

WR: I am thrilled you are taking the time to talk to the Waltham Review.  The context for my questions is in thinking about the legacy of the really terrible human subject experimentation that happened at the Fernald School.  But before we go into that, could you give us some background.  What is the Alliance for Human Research Protection, and how was it formed?  

VS: Well, I am sure that you must have looked at the website, and have an idea.  Our primary focus really is on human experimentation.  You know, it’s evolved to be a bit broader because medical experiments often are presented as medical treatment, access to related treatment and so forth, and so it’s kind of all of medicine that is involved.  Often the same doctors who both treat and do research.

How did I get into it?  Well, there is sort of a nice little profile of me in Stat, I don’t know if you saw that.

WR: Yes.

VS: So then you know my background.  Well, then human experiments, especially unethical ones, you know, it triggers something in me because I know where that can lead, and has led.

And that is always a threat.  And as much as American medicine has tried for many decades to completely disavow and distance itself from any sort of connection to, in fact, the mentors, I mean German medicine was historically and for many of the older doctors certainly, they got a lot of their education there.  They went there for their postdocs and all that sort of thing.  To learn the ways of doing research.  So the culture is a bit intertwined and both German doctors and the American medical community for practically five decades didn’t talk about it at all.

WR: Are there places where you can trace out these links explicitly?

VS: [for example, Wikipedia:The term internal medicine originates from the German term Innere Medizin, popularized in Germany in the late 19th century to describe physicians who combined the science of the laboratory with the care of patients. Many early-20th century American physicians studied medicine in Germany and brought this medical field to the United States. Thus, the name “internal medicine” was adopted in imitation of the existing German term.]

 I mean right now there is a book that just came out – I mean I can’t keep up, frankly – some people ask me “why are you spending so much time on the Holocaust, it was so long ago.”  No it’s not!  Its tentacles continue and unless measures are taken such that such things never ever happen again, there is no reason to believe that they won’t.  Particularly since in America now, medicine has become very much a government-controlled sort of thing.  You’ve got mandates by government officials requiring medicines, particularly vaccines, without really the backup data to justify it.

WR: I want to come back to that in a little bit.  But I want to ask first a question: you’ve posted on your website a number of articles and links related to what I think is the atrocious treatment of human subjects at the Waltham, Massachusetts Fernald School.  That was the situation where MIT researchers working for Quaker Oats fed radioactive oatmeal to unsuspecting disabled kids.  Where does this Fernald School experimentation fit within a larger pattern of unethical research?

VS: Of course it does!  It very much does.  First of all, it’s an example of government funding, this was during the Cold War, when American medicine did turn greatly in the direction of what I just talked about.  That was part of that mentoring.  We’ve got Paperclip, with some 1600 Nazi scientists being invited to the United States, and they were all over, and their influence was tremendous.  In the radiation experiments, in lots of experiments you have Nazi doctors and scientists being placed in many universities to be mentors, they were the leaders, they had the most experience.  So a lot those things were not right in that way.

And that Waltham experiment, that one is there, MIT, and you know, we have had many different experiments like that during the same period.  Children are very vulnerable, and especially if they are in an institution, you always have to expect that they need a great deal of protection from exploiters.  And that’s what they did there.  At first, you know, MIT didn’t admit anything.  Nobody admitted anything.  The only one who sort of got hammered was Post Cereal, now really, they weren’t the ones to conduct the thing, it was their cereal simply that was being poisoned with radioactive material, but they really had nothing to do with it.

WR: Aside from the financial settlements by MIT and Quaker Oats, were any researchers’ careers negatively affected?

VS: I don’t think that any American researchers’ careers have been negatively affected from having been caught doing either unethical, fraudulent, whatever kind of research that is not acceptable and that you would think would not be publishable.  And yet a lot of these experiments have been published, and they have never really been retracted.

WR: What would you say is the single most egregious historical case of unethical experimentation in the United States that you’re aware of.  If you had to pick one case as the emblematic case.

VS: Well, there is a case at the University of Minnesota.  It involved psychiatry, psychiatry has always been kind of a cesspool in terms of both treatment and research.  And it goes together because those who come into the hands of psychiatry are regarded as damaged goods, so lots of different things have been done on them.

This particular case, the reason I bring it up, is it involves a major university, it involves a major drug company.

WR: Can you name the drug company?

VS: Yeah…I have so many.  I will get this to you. [Editor’s note: the drug company was AstraZeneca, and the drug was Seroquel. **[Comment: I would not always rely on the NYT when it comes to unethical research…I would link instead to the full story in Mother Jones, 2015 & ForbesSee NYT article from last year here.]

WR: OK.

VS: It involves an experiment in which a subject who was floridly psychotic, who was declared by a judge to be incapable, he was corralled into the clinical trial.  That clinical trial has been totally discredited because it’s one of these, they call them “seeding” – you know, just a matter of marketing.  They weren’t about finding out anything important.

WR: Marketing on behalf of…

VS: The drug company.  A lot of the drug trials that the companies do are  primarily ways of obtaining positive findings for marketing claims.  They’ve done a trial, it showed great effects, nobody got hurt, everything is wonderful.  Therefore, they encourage doctors you can prescribe this to anybody and everybody, even if they have a headache.  Whatever.  That’s the kind of use they get from such a trial.

Now this guy, as I said, had been corralled by the principal investigator, actually the chairman was involved.  He was floridly psychotic and he was getting worse and worse.  His mother was desperate, trying to get him out of the trial, because she saw him deteriorate very, very greatly. She was afraid that he was going to hurt somebody or hurt himself.

She left messages to the people involved, the staff that was involved in the trial.  They wouldn’t let him go, because as it turned out, this was a multi-site trial.  The University of Minnesota was cautioned by AstraZeneca that it wasn’t meeting its quota.  And so they got a little desperate, and so they forced people into the trial.

Dan Markingson wound up committing suicide in a most violent way, he practically decapitated himself.  Just think about how psychotic he was to do that  with a package opener.  I mean, it’s the most gruesome case.

The case has one hero, and that’s Carl Elliot.  He is both a trained psychiatrist and a genuine ethicist, he’s kind of a major figure.  He’s one of our heroes –a bioethicist at the University of Minnesota who has taken this on.  This is extremely unusual that a faculty member, an academic, puts his own career on the line.

And that’s an example of what is going on.  There are petitions to the governor. Complaints to to the FDA, the medical board, University of Minnesota, everybody, everybody has covered-up.  Nobody, nobody got a slap on the wrist.  The only one who got slapped on the wrist actually was the drug company, in separate lawsuits.  AstraZeneca settled Seroquel lawsuits for $647 million.  You know the zeros in millions of dollars in Pharma settlements keep getting added and it means nothing.

WR: When did this happen?

VS: When did this happen?  In 2004…I don’t remember the exact date.  But if you look up Dan Markingson and Carl Elliot, because Carl has written a lot about it, and he has had some twenty-eight faculty members sign petitions, saying that the university should convene an independent investigation.  And But the administration refuses; nothing has been done, nothing.  They thumb their nose.

WR: What is the most egregious ongoing case of violations in human subject experimentation?

VS: Well, let’s go back to government.  Because when government does things, it’s on a major scale.  So there is, there are a couple of experiments, there is a new research paradigm that they are pushing.  The paradigm is to compare, they call it “comparison effectiveness research.”  To compare two methods of treatment, they want to totally waive informed consent for these trials because, they argue, these are treatments that have already been approved.  But that’s dishonest.  There is a big difference between treatment and clinical trial.In a controlled clinical trial treatment conforms according to a protocol, you’re held to a predetermined regimen that includes dose of the intervention, nothing is individualized.

Now they are doing these experiments on critically ill patients fighting for their lives.  So any little thing can put them at risk.  But of course they can then say “these subjects were so sick anyway.”  Now, there are two examples in particular.  One was with adults, it’s called ARDS—Acute Respiratory Disease and was conducted by the ARDS Network which is an NIH-funded network of 14 medical centers.  That experiment was done at intensive care units with lung-injured patients.  There was no informed consent at practically none of the institutions –despite all of the IRBs—federal ethics research regulations were violated.

WR: But if these patients are critically ill, is there a way to get informed consent?

VS: Families, next of kin, were not asked if it was all right!  If you are in a condition that you  can’t respond, does that mean you are now a free specimen?  That is the Nazi mentality: that we have an available specimen and you can do whatever experiment you want.

Now the second experiment was performed with extremely premature babies in which, oxygen intake was tested.  One of the major issues in these trials is, they are comparing two extreme arms.  In other words, in most of these kinds of treatments in particular you really can’t say “one size fits all” but they are looking for that magic number, that particular dose.  When you are talking about critically ill persons, there are many concomitant conditions that may be present in this or that individual.  They are not all just lung-injured.  And the degree to which some can breathe a bit, some can’t.  You need to be very careful in adjusting treatment, to monitor them, and to make professional judgments that consider their condition and their best interest.  That is not done in these clinical trials.  In these clinical trials critically ill patients are arbitrarily assigned to either a high dose or a low dose.

And of course more die, but they always have the rejoinder “oh, well, these were critically ill patients who were at risk of dying.   Nobody has ever admitted that patients die because of the treatment in the clinical trial.  It’s never, never done.   They never admit wrongdoing, even in major lawsuits – oh they’ll pay billions of dollars in settlement fees but admit no fault.

Now with the babies: the experiment is called SUPPORT (Surfactant Positive Pressure & Oxygenation Randomized Trial) a randomized trial involving over a thousand very premature babies whose lives were at risk. The consent form deceived parents about the risks of randomization. The researchers even fudged what’s called – the oximeter which measures the amount of oxygen that the baby’s lungs have. The oximeter is supposed to guide the clinician as to whether to increase or not increase the amount of oxygen intake.  It’s so delicate, every clinical decision about the dose of oxygen requires great care and professional judgment. When I think of these very, very premature babies, they are fighting for their lives.  And instead of making clinical decisions to help them survive, they are being used much as animals are in (what amounts to) a physiological experiment.

The reason they fudged the oximeter was so that the clinicians in the neonatal ICU and the nurses wouldn’t know the true amount of oxygen the baby was getting — So that they would be blinded too. I don’t think you’ve ever heard something as ethically egregious as this experiment. The end result was that 23 babies that might have lived were sacrificed.

[Editor’s note: see description of this study in NYT here.] **suggest also, Science Mag.

It’s very hard.  I get emotional about this because it is really so horrific.  Now, OHRP (Office of Human Subject Research Protection)  held a hearing in 2013 attended by a lot of people with opposing views. NIH officials and the New England Journal of Medicine protects and promotes these kind of experiments, arguing “science is so important.”

As a matter of fact they didn’t learn anything in these trials –neither ARDS nor SUPPORT — because the best treatment for survival requires individualized treatment, so what have you found out?

This research paradigm is major NIH stuff.  You’ll find the controversy about SUPPORT discussed not just on our website but also elsewhere.  Now I have to explain to you too, and I want this upfront.  I am not a doctor, which you know.  But I think, now I work with doctors, for example on these kind of very technical trials.  Oh my God, it’s so technical that even seasoned reporters don’t want to touch these complex trials because they really don’t quite understand the medical-scientific issues involved. They do understand and have written about the informed consent violations.

I work with mentors who are critical care doctors.  Including at NIH [Editor’s note: Ms. Sharav proposed the revision – I mean, that’s big-time Deep Throat. from the transcript of our call,  which I belief is a revision which changes the meaning of the passage significantly.  The revision is therefore noted.] So I am not shooting from the hip.  But I can tell you that this stuff is extremely complicated.  Because the treatment modality is complicated, because these are all human beings!   They are not widgets.  You know, they are treating them like animals in physiology experiments.  That’s what they are doing.  They want to see how much the lung can take.  I mean, that is not humane research.

There is some research that should not be done.  If you can’t do it ethically, then you’ll have to find an alternative way to find the information that you’re looking for.  And my God, today, with all the virtual this and virtual that, there are all kinds of technologies that could be used.  But they prefer to have cheap human beings.

WR:  But, and I am enormously sympathetic to what you’re describing in terms of the ethical shortsightedness.  But I do want to push you from the other side for a second.  The position of not doing experimentation of some kind can fall apart when you look at it from the perspective that any time you’re giving a substance to somebody you’re performing an experiment.

VS: Well, but there is a big difference.  If you are a physician, and you are giving treatment, you are supposed to monitor the effects, and change whatever needs to be changed as you see reason to change things.  In an experiment, in the controlled experiment, you don’t do that.  You’re blind.  And the fact is, look, there is a lot of literature by now questioning this whole so-called “gold standard” because it isn’t a gold standard, it’s been bastardized.  And it’s really become a kind of a marketing tool, and you want to push this or that treatment, you do a trial to show this particular drug or device or dose is the right one.

In other words, they are getting the results they want to begin with.  That’s not science.  That’s not science.  Initially clinical trials were supposed to be designed to disprove that something was effective.  Not to prove that it was effective.

WR: And so the sense is that because the environment is – there is a larger context of corporate control –

VS: It’s a partnership.  It’s a very, very unholy partnership.

WR: You touched on something a few minutes ago and I want to come back to it.  You mentioned vaccines and vaccine research.  Thinking about vaccines, what is your perspective and the perspective of the AHRP on vaccines and vaccine mandates?

VS: We don’t have a firm “this or that” position.  But our position is “open the data and start doing real clinical trials.”  Comparison trials.  They don’t do that.  It’s so secretive because, again, what’s insane here is that the data are secretive, the trials are not designed as has been requested for God knows how many years: to compare children who are vaccinated to children who are not vaccinated and see what happens.  Because we’ve got all kinds of flare-ups of diseases that had been dormant, and they are appearing in vaccinated children just as in non-vaccinated.  So there is something wrong here.

Now, there are a couple of lawsuits against Merck by former Merck scientists who say that they’ve been fudging the data.  So as far as vaccines, the point there is everybody is immune [Editor’s note: VS is talking about immunity from lawsuits, not disease].  Unlike any other industry, you know – car malfunctions, the car manufacturer is responsible. Not so with vaccines.  They have a government free immunity.  And then

WR: I have to admit that I am not sure what you mean, when you say everybody is immune?

VS: I mean that if a vaccine is found to be harmful, whether it is a particular batch or the combined viruses in a vaccine.  No one is held responsible.  A parent cannot sue.

WR: So there is a freedom from liability.

VS: But total.   This is the greatest business model ever.  The pharmaceutical industry is known to be pretty corrupt – the same industry.  So they have immunity, and they get the government to mandate every darned vaccine.  American children simply are being forced to take far, far more vaccines than Europeans?  I mean, what is the difference between an American and a French kid?

I didn’t even want to get into vaccines because for a long time I was very focused on psychiatric stuff, and as I said, I called it the cesspool.  And then, you know, willy nilly, you get involved in more, depending on what area needs some attention.  So that is how I wound up with vaccines.  But not anti-vaccine, blanket like that – that’s nonsense.  But one needs to have some independent evaluation.  You know, the flu vaccine is being pushed on everybody – the elderly, children, and it’s found to be worthless.

WR: So if the universities are embedded with the corporations, and the corporations are in bed with the corporations, and the government with the corporations….

VS: And the government is in bed with the universities, and universities get grants both ways

WR: Who would you trust to do this kind of independent investigation that you’re describing?

VS: Well….you know, there are some people. There are scientists who are demanding, first of all, they want access to all clinical trials data.  It’s becoming a groundswell, and it’s kind of international.  It’s being promoted also by the BMJ and the Cochrane Institute.  There are serious scientists who realize that without the data, nothing is believable.  Some very astute scientists have said that between 75 and 90 percent – nobody knows exactly – of published research reports are false; the claims are false.  They are not backed by real data.

WR: If you had to decide, or if you are giving advice to somebody like me – I have small children, a 5 year old and an 8 year old – would you advise me to vaccinate my loved ones against the common childhood illnesses?

VS:   I would not say one way or the other.  I would say you have to investigate more.  I think that’s the only thing I can really say.  You need to investigate the issues about that vaccine and what the – is it given in all the Western countries?  You know, it’s pretty easy to check things now.

WR: But for somebody who has to….

VS: I don’t think there is one.  You can check also VAERS – the vaccine adverse effect database that the FDA maintains but doesn’t look at much – but others are looking at.  You can see which vaccine has a lot of serious – we’re talking about serious side effects, not the little red spots.

WR: The last question about vaccines.  You recently named the British vaccine researcher Andrew Wakefield to you honor roll of exemplary professionals.  Can you walk me through your perspective on the controversy?

VS: Well, the only way I could really broach it is what I wound up having to do, and I spent a lot of time on it.  If you look at the AHRP website, I looked through a lot of research to see what was validated, what wasn’t, and it’s – propaganda is one thing, but the real scientific data, not from vaccinologists, but from researchers who – top neuroscientists who are looking at the various ingredients, you know.  Testing things on that level.  They are saying that it’s – what he said about that multiple, the MMR is so.

OK – I know how he was trashed.  Everybody called him: fraudster and all that.  Never mind that the high court in England absolved his colleague who was the one who chose – you know, selected the children and did the clinical stuff.  He didn’t do the clinical stuff.  But he was accused of fraudulently doctoring the data.  He didn’t do that.

As I said, the body of evidence – the fact is that this connection with the gut, with the intestinal disease – that’s all been replicated all over the world.  Look, since I am not beholden at all to anyone – I checked it with my board, gave them the scientific information that I had gathered, and nobody objected.  Oh, I’ve been hammered, by friends, you know – scientist friends, because they didn’t look at the actual scientific data!  Look at what’s been written in peer reviewed journals.  Because the stuff that replicates Wakefield’s reported findings is written in obscure journals.  Because the New England Journal of Medicine is not going to publish something that confirms Wakefield’s claims, it’s just not going to happen.  Neither will the BMJ.  They all have financial conflicts of interest with Glaxo-SmithKline and Merck, the manufacturers.

And then, when you think of the other things involved in that particular case one, I can’t understand.  Originally, there was a separate vaccine for measles.  They took it away!  Gone!  They don’t want to sell a vaccine against one virus, because they make so much more money if they sell three in one.  And just, common sense tells you – do you have to bombard the child all at once with a whole bunch of viruses and irritants that might trigger an autoimmune response– vaccines contain all kinds of irritants.

For example, I was having a problem with the computer.  I don’t have the university to sort of do the servicing.  One thing I was told: when you have a bunch of software updates, a tech support person said “don’t download all of them at once.  Do one at a time!  Do one, and do your work, and maybe the next day, if nothing happens, download the second one.”

Yet, they refuse to do that safety measure with vaccines, it’s crazy!  Especially after all this really comes down to, I mean my God, it’s such a vindictive dogfight of the worst kind.  And yet, nobody has been willing to accommodate the small number of children who are likely to be at risk. Government could very easily say to the vaccine manufacturers “you know, why don’t you bring back the measles vaccine, let’s separate them.”

WR: I have to say as an economist, I would say that you have to worry about compliance.  If you separate it out into three vaccines, there is a greater chance that people don’t show up, just realistically, people miss appointments.  You could end up missing more kids if you separate out into three.  I see what you are saying, but I can also see another side to it.  Realistically reaching as many kids as possible, there is some value to making the implementation as easy as possible.

VS: I tell you why I reject that.  Because it would not be doctors who would be saying that, that’s an economic consideration implemented by government dictate.  A government dictate.  That is what is a big red flag.  In all my readings of actually what happened to German medicine when it became part of the government.  That was the big slippery slope. Look at what’s happening,  you have all kinds of people in government creating these mandates, and it has nothing to do with the medical, scientific evidence. It’s the economic interests that call the shots.

Having been in a couple of committees, advisory committees, whatever, I have witnessed the attitude of the government bureaucrats toward actual treating physicians in the trenches they denigrate them as if they who are academics they know better.  Nonsense.  Medicine was a healing profession when good doctors used to be very, very meticulous observers of each individual.  Doctors took copious notes so that they could reasonably prescribe treatments that they thought would be the best for the patient.  Now they don’t do that anymore!  Everything is done by guideline.  Practice guidelines.  And those practice guidelines – God forbid if a doctor does not adhere to it, then he is open to lawsuits.  Nobody will protect a doctor who veers from guideline dictates. him.  But it’s nonsense.  Because those guidelines are dictated by corporations and government for economic, not clinical goals.

From my dealing with doctors in critical care, and internal medicine a lot of doctors are leaving the profession now because they don’t like the huge bureaucracy that they now have to deal with.  They are being pushed actually into practices that are hospital-based.  That’s part of the reason that – that the costs skyrocketed.  Because hospitals take a cut too, you know –they don’t give office space for nothing.

WR: There is one last question that I want to ask you.  And it’s a….

VS: At the end you have to tell me what you are really doing!

WR: I will.   You are describing an unholy alliance between corporations, the government, and the academic sector, when it comes to medical research and experimentation and the influence of pharmaceutical companies.  Is there any thing – any single development – where you look at the academic/business/government unholy alliance, and say “you know, even though the alliance was unholy, I am pretty glad that it led to the development of X.” – that could be computers, space travel, anything.  Is there any development for which we can – not contesting your assertion that it is an unholy alliance – is there anything where we can say “gee – I am glad that the unholy alliance gave us this.”

VS: I don’t know!  It used to be the opening of borders by the internet, now it’s also being used for nefarious purposes…so I can’t really say that.  I, really, I mean, the Internet and the cell phones were enthusiastically embraced, you know, God’s gift and all over the world.  But look what it’s actually also helping to foment!

WR: OK.  Well, I appreciate your time very much. 

[Editor’s note: I then described the nature of and context for my interest to Ms. Sharav.]

 

 


[Unedited version of the interview]

WR: I am thrilled you are taking the time to talk to the Waltham Review.  The context for my questions is in thinking about the legacy of the really terrible human subject experimentation that happened at the Fernald School.  But before we go into that, could you give us some background.  What is the Alliance for Human Research Protection, and how was it formed?  

VS: Well, I am sure that you must have looked at the website, and have an idea.  Our primary focus really is on human experimentation.  You know, it’s evolved to be a bit broader because medical experiments often are presented as medical treatment, access to related treatment and so forth, and so it’s kind of all of medicine that is involved.  Often the same doctors who both treat and do research.

How did I get into it?  Well, there is sort of a nice little profile of me in Stat, I don’t know if you saw that.

WR: Yes.

VS: So then you know my background.  Well, then human experiments, especially unethical ones, you know, it triggers something in me because I know where that can lead, and has led.

And that is always a threat.  And as much as American medicine has tried for many decades to completely disavow and distance itself from any sort of connection to, in fact, the mentors, I mean German medicine was historically and for many of the older doctors certainly, they got a lot of their education there.  They went there for their postdocs and all that sort of thing.  To learn the ways of doing research.  So the culture is a bit intertwined and both German doctors and the American medical community for practically five decades didn’t talk about it at all.

WR: Are there places where you can trace out these links explicitly?

VS: I mean right now there is a book that just came out – I mean I can’t keep up, frankly – some people ask me “why are you spending so much time on the Holocaust, it was so long ago.”  No it’s not!  Its tentacles continue and unless measures are taken such that such things never ever happen again, there is no reason to believe that they won’t.  Particularly since in America now, medicine has become very much a government-controlled sort of thing.  You’ve got mandates by government officials requiring medicines, particularly vaccines, without really the backup data to justify it.

WR: I want to come back to that in a little bit.  But I want to ask first a question: you’ve posted on your website a number of articles and links related to what I think is the atrocious treatment of human subjects at the Waltham, Massachusetts Fernald School.  That was the situation where MIT researchers working for Quaker Oats fed radioactive oatmeal to unsuspecting disabled kids.  Where does this Fernald School experimentation fit within a larger pattern of unethical research?

VS: Of course it does!  It very much does.  First of all, it’s an example of government funding, this was during the Cold War, when American medicine did turn greatly in the direction of what I just talked about.  That was part of that mentoring.  We’ve got Paperclip, with some 1600 Nazi scientists being invited to the United States, and they were all over, and their influence was tremendous.  In the radiation experiments, in lots of experiments you have, they wound up being placed in many universities.  And they were the mentors, they were the leaders, they had the most experience.  So a lot those things were not right in that way.

And that Waltham experiment, that one is there, MIT, and you know, we have had many different experiments like that during the same period.  Children are very vulnerable, and especially if they are in an institution, you always have to expect that they need a great deal of protection from exploiters.  And that’s what they did there.  At first, you know, MIT didn’t admit anything.  Nobody admitted anything.  The only one who sort of got hammered was Post Cereal, now really, they weren’t the ones to conduct the thing, it was their cereal simply that was being poisoned with radioactive material, but they really had nothing to do with it.

WR: Aside from the financial settlements by MIT and Quaker Oats, were any researchers’ careers negatively affected?

VS: I don’t think that any American researchers’ careers have been negatively affected from having been caught doing either unethical, fraudulent, whatever kind of research that is not acceptable and that you would think would not be publishable.  And yet a lot of these experiments have been published, and they have never really been retracted.

WR: What would you say is the single most egregious historical case of unethical experimentation in the United States that you’re aware of.  If you had to pick one case as the emblematic case.

VS: Well, there is a case at the University of Minnesota.  It involved psychiatry, psychiatry has always been kind of a cesspool in terms of both treatment and research.  And it goes together because those who come into the hands of psychiatry are regarded as damaged goods, so lots of different things have been done on them.

This particular case, the reason I bring it up, is it involves a major university, it involves a major drug company.

WR: Can you name the drug company?

VS: Yeah…I have so many.  I will get this to you. [Editor’s note: the drug company was AstraZeneca, and the drug was Seroquel. See NYT article from last year here.]

WR: OK.

VS: It involves an experiment in which a subject who was floridly psychotic, who was declared by a judge to be incapable, he was corralled into the clinical trial.  That clinical trial has been totally discredited because it’s one of these, they call them “seeding” – you know, just a matter of marketing.  They weren’t about finding out anything important.

WR: Marketing on behalf of…

VS: The drug company.  A lot of the drug trials the companies do.  There are parallel tracks going on.  The ones that companies do are primarily ways of obtaining good marketing claims.  They’ve done a trial, it showed great things, nobody got hurt, everything is wonderful.  Therefore, doctors you can prescribe this to anybody and everybody.  You know, if they have a headache.  Whatever.  That’s the kind of trial.

Now this guy, as I said, had been corralled by the, actually the chairman was involved.  He was floridly psychotic and he was getting worse and worse.  His mother was desperate, trying to get him out of the trial, because she saw him deteriorate very, very greatly. She was afraid that he was going to hurt somebody or hurt himself.

She left messages to the people involved, the staff that was involved in the trial.  They wouldn’t let him go, because as it turned out, this was a multi-site trial.  The University of Minnesota thought it wasn’t meeting its quota.  And so they got a little desperate, and so they forced people into the trial.

This went on he wound up committing suicide in such a violent way, he practically decapitated himself.  Just think about how psychotic he was.  With a, what do you call it, a package opener.  I mean, it’s the most gruesome case.

The case has one hero, and that’s Carl Elliot.  He is both a trained psychiatrist but he’s kind of a major figure.  He’s one of our heroes.  A bioethicist who has taken this on.  He is at the University of Minnesota.  This is extremely unusual that a faculty member, an academic, puts his own career on the line.

And that’s what is going on.  There are petitions, the governor.  I mean everybody, the FDA, the medical board, Minnesota, everybody, everybody covers up.  Nobody, nobody got a slap on the wrist.  The only one who got slapped on the wrist actually was the drug company, in separate lawsuits.  They wound up paying something like two – I remember, two hundred million – you know the zeros keep getting added and it means nothing.

WR: When did this happen?

VS: When did this happen?  In the…I don’t remember the exact date.  But if you look up Dan Markingson.  And Carl Elliot.  Because Carl has written a lot about it, and he has had some twenty-eight faculty members sign petitions and things, saying that the university should do something.  And nothing, nothing.  They thumb their nose.

WR: What is the most egregious ongoing case of violations in human subject experimentation?

VS: Well, let’s go back to government.  Because government, when government does things, it’s on a major scale.  So there is, there are a couple of experiments, there is a new paradigm that they are pushing.  The paradigm is to compare, they call it “comparison effectiveness research.”  To compare two methods of treatment, and they want to totally waive informed consent for these trials because, they argue, these are treatments that have already been approved.  No sir.  In a controlled clinical trial – there is a big difference between treatment and clinical trial –  according to a protocol, you’re held, nothing is individualized.

Now they are doing these on critically ill patients fighting for their lives.  So any little thing can, you know.  But of course they can then say “you know, they were so sick anyway.”  Now, there are two examples in particular.  One was with adults, it’s called ARDS network, which is an NIH-funded multi- it’s like 14 campuses.  That was done at intensive care units with lung-injured patients.  No informed consent.  Practically none of the institutions.  With all of the IRBs, and all of that, nothing.

WR: But if these patients are critically ill, is there a way to get informed consent?

VS: Families!  You know, if you can’t respond.  Does that mean you are now a free specimen?  That is the Nazi mentality.  That we have an available specimen and you can do what you want.

Now the second one was with extremely premature babies, testing oxygen intake.  Now, one of the major issues in these trials is, they are comparing two extreme arms.  In other words, in most of these kinds of treatments in particular, but in many, you really can’t say “one size fits all” but they are looking for that magic number, that particular dose.  You know, that sort of thing.  When you are talking about critically ill, there are many concomitant conditions that may be present in this or that individual.  They are not all just lung-injured.  And the degree to which some can breathe a bit, some can’t.  You need to be very, to monitor them and to make professional judgments that consider their condition and their best interest.  That is not done in these clinical trials.  These clinical trials are arbitrarily assigned to either a high dose or a low dose.  OK?

And of course more die, but they always have the “oh, well, you know.”  Nobody has ever admitted that patients die because of the treatment in the clinical trial.  It’s never, never.  That’s just not, you know, they never, even in these major lawsuits – oh they’ll pay billions of dollars but admit no fault.

No with the babies it’s called “support,” and it was really, they even fudged what’s called – the monitor – which is considered, just like a thermometer, only it’s a dial that measures the amount of oxygen that the baby’s lungs have.  And that is supposed to guide the clinician as to whether to increase or not increase.  It’s so delicate, I can’t even.  When I think of these very, very premature babies, they are fighting for their lives.  And they instead, the reason they fudged the thing was so – I don’t think you’ve ever heard something like this – so that the clinicians in the neonatal ICU and the nurses wouldn’t know the true amount the baby was getting.  So they would be blinded too.

[Editor’s note: see description of this study in NYT here.]

No, OK.  I don’t know.  It’s very hard.  I get emotional about this because it is really so horrific.  Now, NIH had a hearing last year, and a lot of people, and you’ve got the New England Journal of Medicine protecting and promoting these kind of, “oh, science is so important.”

Now of course, by the way, they didn’t learn anything in these trials because the best treatment requires individualized treatment, so what have you found out?

This is major NIH stuff.  You’ll find not just on our website but also elsewhere.  Now I have to explain to you too, and I want this upfront.  I am not a doctor, which you know.  But I think, now I work with doctors, for example on these kind of very technical.  Oh my God, it’s so technical that even you now, If they gave a report, they don’t want to touch these things because they really don’t quite understand it.

Do you see?  Now, I work with, you know, mentors who are critical care doctors.  Including at NIH – I mean, that’s big-time Deep Throat.  So I am not shooting from the hip.  But I can tell you that this stuff is extremely complicated.  Because the treatment modality is complicated, because these are all human beings!   They are not widgets.  You know, they are treating them like animals in physiology experiments.  That’s what they are doing.  They want to see how much the lung can take.  I mean, that is not humane research.

There is some research that should not be done.  If you can’t do it ethically, then you’ll have to find an alternative way to find the information that you’re looking for.  And my God, today, with all the virtual this and virtual that, there are all kinds of technologies that could be used.  But they prefer to have cheap human beings.

WR:  But, and I am enormously sympathetic to what you’re describing in terms of the ethical shortsightedness.  But I do want to push you from the other side for a second.  The position of not doing experimentation of some kind can fall apart when you look at it from the perspective that any time you’re giving a substance to somebody you’re performing an experiment.

VS: Well, but there is a big difference.  If you are a physician, and you are giving treatment, you are supposed to monitor the effects, and change whatever needs to be changed as you see reason to change things.  In an experiment, in the controlled experiment, you don’t do that.  You’re blind.  And the fact is, look, there is a lot of literature by now questioning this whole so-called “gold standard” because it isn’t a gold standard, it’s been bastardized.  And it’s really become a kind of a marketing tool, and you want to push this or that treatment, you do a trial to show this is the right one.

In other words, they are getting the results they want to begin with.  That’s not science.  That’s not science.  Initially clinical trials were supposed to be designed to disprove that something was effective.  Not to prove that it was effective.

WR: And so the sense is that because the environment is – there is a larger context of corporate control –

VS: It’s a partnership.  It’s a very, very unholy partnership.

WR: You touched on something a few minutes ago and I want to come back to it.  You mentioned vaccines and vaccine research.  Thinking about vaccines, what is your perspective and the perspective of the AHRP on vaccines and vaccine mandates?

VS: We don’t have a firm “this or that” position.  But our position is “open the data and start doing real clinical trials.”  Comparison.  They don’t do that.  It’s so secretive because, again, what’s insane here is that the data are secretive, the trials are not designed as has been requested for God knows how many years: to compare children who are vaccinated to children who are not vaccinated and see what happens.  Because we’ve got all kinds of flare-ups of diseases that had been dormant, and they are appearing in vaccinated children just as in non-vaccinated.  So there is something wrong here.

Now, there are a couple of lawsuits against Merck by former Merck scientists who say that they’ve been fudging the data.  So as far as vaccines, the point there is everybody is immune [Editor’s note: VS is talking about immunity from lawsuits, not disease].  Unlike any other industry, you know – car malfunctions, the car manufacturer is responsible. Not so with vaccines.  They have a government free immunity.  And then

WR: I have to admit that I am not sure what you mean, when you say everybody is immune?

VS: I mean that if a vaccine is found to be harmful, whether it is a batch that, these things are manufactured quite differently from other pharmaceuticals.  Noone is held responsible.  A parent cannot sue.

WR: So there is a freedom from liability.

VS: But total.  So, wait, this is the greatest business model ever.  So they have immunity.  The pharmaceutical industry is known to be pretty corrupt – the same industry.  And, they get the government to mandate every darned vaccine.  American children simply are being forced to take far, far more vaccines than Europeans?  I mean, what is the difference between a French kid?

That – I didn’t even want to get into vaccines because for a long time I was very focused on psychiatric stuff, and as I said, I called it the cesspool.  And then, you know, willy nilly, you get involved in more, depending on what area needs some attention.  So that is how I wound up with vaccines.  But not anti-vaccine, blanket like that – that’s nonsense.  But one needs to have some independent evaluation.  And, you know, the flu vaccine is being pushed on everybody – the elderly, children, and it’s found to be worthless.

WR: So if the universities are embedded with the corporations, and the corporations are in bed with the corporations, and the government with the corporations….

VS: And the government is in bed with the universities, and universities get grants both ways

WR: Who would you trust to do this kind of independent investigation that you’re describing?

VS: Well….you know, there are some people.  There are some people.  There are scientists who are demanding, first of all, they want access to all clinical trials data.  It’s becoming a groundswell, and it’s kind of international.  It’s being promoted also by the BMJ.  The Cochrane Institute.  There’s serious scientists who realize that without the data, nothing is believable.  Some very astute scientists have said the between 75 and 90 percent – nobody knows exactly – of published research reports are false.  Claims are false.  They are not backed by real data.

WR: If you had to decide, or if you are giving advice to somebody like me – I have small children, a 5 year old and an 8 year old – would you advise me to vaccinate my loved ones against the common childhood illnesses?

VS: You know, that is just it.  I would not say one way or the other.  I would say you have to investigate more.  I think that’s the only thing I can really say.  You need to investigate the issues about that vaccine and what the – is it given in all the Western countries?  You know, it’s pretty easy to check things now.

WR: But for somebody who has to….

VS: I don’t think there is one.  You can check also VAERS – the vaccine adverse effect database that the FDA maintains but doesn’t look at much – but others are looking at.  You can see which vaccine has a lot of serious – we’re talking about serious side effects, not the little red spots.

WR: The last question about vaccines.  You recently named the British vaccine researcher Andrew Wakefield to you honor roll of exemplary professionals.  Can you walk me through your perspective on the controversy?

VS: Well, the only way I could really broach it is what I wound up having to do, and I spent a lot of time on it.  If you look at the website, I looked through a lot of research to see what was validated, what wasn’t, and it’s – propaganda is one thing, but the real scientific data, not from vaccinologists, but from researchers who – top neuroscientists who are looking at the various ingredients, you know.  Testing things on that level.  They are saying that it’s – what he said about that multiple, the MMR is so.

OK – I know how he was trashed.  Everybody called – he’s the fraudster and all that.  Never mind that the high court in England absolved his colleague who was the one who chose – you know, selected the children and did the clinical stuff.  He didn’t do the clinical stuff.  But he was accused of fraudulently doctoring the data.  He didn’t do that.

As I said, the body of evidence of – the fact is that this connection with the gut, you know, with the intestinal disease – that’s all been replicated all over the world.  So I took – look, since I am not beholden at all to anyone – I checked it with my board, gave them the stuff that I had gathered, and nobody objected.  You know, I mean, that’s what it is.  I can’t – oh, I’ve been hammered, by friends, you know – scientist friends.  Because they don’t look at the actual – look at the data!  Look at what’s written.  Because the stuff that replicates is written in obscure journals.  Because the New England Journal of Medicine is not going to publish something that confirms Wakefield’s claims, it’s just not going to happen.  Neither will the BMJ.  They all have financial conflicts of interest with Glaxo-SmithKline and Merck, the manufacturers.

And then, when you think of the other things involved in that particular one, I can’t understand.  Originally, there was a separate vaccine for measles.  They took it away!  Gone!  They don’t want to sell one, because they make so much more money if they sell three in one.  And just, common sense tells you – do you have to bombard the child all at once with a whole bunch of – there are all kinds of irritants.

You know, it’s like, yes, I was having a problem with the computer.  I don’t have the university to sort of do the servicing.  One thing I got told, when you have a bunch of updates, this was actually for the website software – he said “don’t download all of them at once.  One at a time!  Do one, and do work, and maybe the next day, if nothing happens, do the second one.” And they refuse to do that with vaccines, it’s crazy!  Especially after all this really, I mean my God, it’s such a vindictive and really, a dogfight of the worst kind.  And yet, nobody has – government could very easily say to the vaccine manufacturers “you know, why don’t you bring back the measles vaccine, let’s separate them.”

WR: I have to say as an economist, I would say that you have to worry about compliance.  If you separate it out into three vaccines, there is a greater chance that people don’t show up, just realistically, people miss appointments.  You could end up missing more kids if you separate out into three.  I see what you are saying, but I can also see another side to it.  Realistically reaching as many kids as possible, there is some value to making the implementation as easy as possible.

VS: I tell you why I reject that.  Because it would not be doctors who would be saying that, that’s a government dictate.  A government dictate.  That is what is a big red flag.  In all my readings of actually what happened to German medicine – it became part of the government.  That was the big, big thing.  And we have – look, you’ve got – you also have a lot of incompetence.  You have all kinds of people creating these mandates, and it has nothing to do with the medical, scientific evidence.

I know, even though….having been in a couple of committees, advisory committees, whatever.  Just the attitude toward actual treating physicians in the trenches is so – you know – they denigrate them as if because they are academics they know better.  Nonsense.  Medicine – good doctors used to be very, very meticulous observers of each individual.  Took copious notes so that they could reasonably prescribe treatment that they thought would be the best for the patient.  Now they don’t do that anymore!  Everything is by guideline.  Practice guidelines.  And those practice guidelines – God forbid if a doctor does not adhere to it, then he is open to lawsuits.  Nobody will protect him.  But it’s nonsense.  Because those guidelines are dictated by corporations and government.

From dealing with doctors in critical care, all that.  That’s what – a lot of doctors are leaving the profession now because they don’t like the huge bureaucracy that they now have to deal with.  They are being pushed actually into practices that are hospital-based.  That’s part of the reason that – that the costs skyrocketed.  Because hospitals take a cut, too.  You know –they don’t give office space for nothing.

WR: There is one last question that I want to ask you.  And it’s a….

VS: At the end you have to tell me what you are really doing!

WR: I will.   You are describing an unholy alliance between corporations, the government, and the academic sector, when it comes to medical research and experimentation and the influence of pharmaceutical companies.  Is there any thing – any single development – where you look at the academic/business/government unholy alliance, and say “you know, even though the alliance was unholy, I am pretty glad that it led to the development of X.” – that could be computers, space travel, anything.  Is there any development for which we can – not contesting your assertion that it is an unholy alliance – is there anything where we can say “gee – I am glad that the unholy alliance gave us this.”

VS: I don’t know!  It used to be the internet, now it’s being used…so I can’t really say that.  I, really, I mean, the Internet and the cell phones were, you know, God’s gift and all over the world.  But look what it’s actually helping to foment!

WR: OK.  Well, I appreciate your time very much. 

[Editor’s note: I then described the nature of and context for my interest to Ms. Sharav.]

 


(Artwork: Gustav Klimt (Austrian, 1862-1918) Medicine 1900-1907.)

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