AIDS, PrEP, and the Nuremberg Code

A human rights disaster in the making

Given that July 16 was the eleventh anniversary of the FDA approval of PrEP for “HIV prevention,” I thought it would be interesting to examine just how ethical the widespread use of PrEP is; in particular, whether patients have truly been given the information needed to make the best decision possible for their health. Or is it the case that patients are being deceived into thinking that this is a mild drug, with manageable side effects, and near perfect efficacy?

With that in mind, I will consider each of the ten tenets of the Nuremberg Code and assess whether the use of PrEP in its intended population actually violates any of these tenets.

The voluntary consent of the human subject is absolutely essential.
This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

I argue that true informed consent is not available for any anti-HIV drug. Clinical trials are fast tracked and their success or failure depends exclusively on the surrogate endpoints of viral load and CD4+ T cell levels. Regarding PrEP, there is even more cause for concern. As I have mentioned before, no clinical trial data exist supporting the claim in the media and by the CDC that PrEP is “>99% effective” at preventing the acquisition of HIV positivity, yet we are somehow supposed to believe that in the real world, the results are dramatically better than the results of any clinical trial. This is virtually unheard of in medicine—typically, medications “in the wild” behave no better and often quite a bit worse than they did in trials. It is very telling that the very advertisements whose purpose is to promote these drugs never claim any effectiveness at all, let alone “>99% effectiveness.” The perfect picture painted by the media is a huge red flag, indicating either sloppy (or no) data collection and analysis, or straight up deception. There is no other possibility.

The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

This is interesting to me, and the point I will try to make is rather subtle. Whoever came up with the notion of pre-exposure prophylaxis presumably believes that the risk of seroconversion is greater than the risk of serious adverse events. I don’t have (much) issue with the design of the trials for PrEP that I’ve seen; the problem occurs when the trial is over and the potential consumers of PrEP are lied to about its true efficacy in preventing seroconversion. How is deception valid “for the good of society”?

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.

Well this one is a giveaway. There is no way to test PrEP’s “effectiveness” in animals. Some anti HIV drugs have been studied in mice, but since there is no animal model for AIDS or even “HIV disease,” its prevention cannot possibly be studied in animals.

The lack of an animal model for AIDS reminds me of the fact that HIV AIDS dogmatists have also abandoned Koch’s postulates, as well. The standards of research are so low, you could trip over them if you’re not careful; yet we are expected to believe that “HIV science” is so perfect as to be beyond criticism, despite the fact that its record of prediction is dismal, and we still have neither a vaccine nor a cure, which was promised to be available by 1986.

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

I’ll just refer the reader, again, to the Truvada disaster and to the constant failures and dangers of anti HIV drugs.

No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

Drugs used for PrEP are not new. They are drugs used to treat “HIV infection,” recycled as HIV vaccines. The dangers of these drugs are legion and were known long before the concept of PrEP came along, yet they are routinely given to patients with no trace of HIV genetic material as prophylactics.

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

This is a tricky one, because on the one side we have the HIV dogmatists, that insist that HIV positivity is a disaster and to be avoided at all costs (despite it also being a “chronic manageable condition”); in their minds, it is acceptable collateral damage to experience kidney failure, cardiovascular conditions, broken bones, and legion other adverse effects, so long as seroconversion is avoided. (Or, if seroconversion has already occurred, the holy grail is getting to and staying “undetectable.”)

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

The multiple lawsuits for anti-HIV drugs, including drugs used in PrEP, are plenty of indication that this tenet has been violated and continues to be violated.

The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

No comment. (Okay, one: What determines “scientific qualification” for human experimentation using toxic drugs?)

During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.

As far as I know, patients can quit PrEP at any time. Of course, this is technically true, but there is a great deal of psychological coercion involved in keeping patients “retained in care.”

During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

This is another problem. Who is in charge of this massive real time clinical trial of PrEP? Who is following these people “in the wild” to see how this intervention works out long term? Is anyone in charge? Are any data being collected and examined to support “>99% effectiveness”? If such data exist, I have yet to find them. The best I’ve seen are case studies of “rare PrEP failures.” If any of my readers is aware of the availability of such data, I’d love it if you’d let me know.

To summarize—the problems with informed consent are not restricted to PrEP; they apply to all anti-HIV treatment, across the board. The history of AIDS is replete with instances of “miracle drugs” being lauded and then falling dramatically short of expectations; indeed, causing many life threatening conditions. (AZT. HAART. PrEP. The complete failure in producing a vaccine for HIV.) Perhaps the reason that, after forty years, these therapies fall far short of the cure we were promised by 1986, is that we are chasing the wrong suspect, and HIV (whatever that is) has nothing to do with AIDS. All the signs point in that direction. Why is the scientific community not following the signs?

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