Round 3: schrodingers dog v maria_stardust: Naive Guinea Pigs, page 1

I'd like to welcome my very good friend and respected opponent maria_stardust, our gracious host MemoryShock, and our judges to this debate.

The topic for this debate is ”Given The Chasm Of Scientific Comprehension Between The Public And The Scientific Community Is So Vast, There Is No Such Thing As "Voluntary and Informed Consent" When Planning Human Trials/Experiments."

I will be arguing the PRO position.

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The constitution only gives people the right to pursue happiness, you have to catch it yourself.

Benjamin Franklin

Personal responsibility is one of the cornerstones of American society. As such, whether it comes to politics, one's occupation, personal relationships, and especially as to whether or not to participate in a human clinical trial, the responsibility rests with the participant to get all available information in order to make an informed choice on when deciding whether or not to grant his/her consent.

The American public has many available sources of information:

1. The information provided by those who are conducting the trial.
2. The internet and all it's resources.
3. Their physician.
4. Their Government.
5. The guidelines of "The Declaration of Helsinki" which outlines the ethical standards for human experimentation.
6. The guideline of the NIH defining "informed consent" as:

Informed consent is a continuing process that helps you decide whether to enroll in a trial. During the first meeting and in follow-up meetings the research team will tell you about

tests or treatments that you may get if you are assigned to the treatment group
possible risks and benefits of these tests or treatments
standard tests and treatments available now
what you need to do, such as take medications at a certain time.
NIH

It seems that a plethora of information and protections are readily available and that the responsibility to avail ones self of it rests clearly with the participant.

So what is the problem?

No doubt there are many clinical trials which follow ethical and reputable methods and standards. I will also concede that without those, we would not be benefiting from many of the valuable and life saving treatments and products we use today.

However:

Over the course of this debate I will put before you all the different factors which preclude many participants from making an informed consent. These include but are not limited to, the conductors of the trials:

1. Use of coercive methods.
2. Withholding information.
3. Abusing and taking advantage of the participants' desperation with regards to their medical condition.
4. Conducting knowingly dangerous trials in third world countries which have neither standards nor enforcement.
5. Taking advantage of participants' financial woes.
6. Taking advantage of an FDA which favors business interest above patients' welfare
7. Putting profit before patients.
8. Researchers' desperation to come up with treatments.

There are many other factors which contribute to the deception of participants who grant a consent which is as informed as a reasonable person would expect, but which is in fact often based on lies and deception, leading to serious long term affects and sometimes death for the participants.

Our courtrooms and law journals are littered with such examples of horrific abuse by the conductors of clinical trials. The shocking stories of these clinical trials are regular visitors to front page news. And we are all too familiar with the recurring nature of pharmaceutical recalls such as Vioxx.

These are all well known and documented facts which I believe cannot be contested by my opponent.
And for as long as clinical trials abuses continue in some cases, they will undermine the credibility and validity of all clinical trials.

Informed consent can only be established if everyone involved has done everything they can to make the information available and have acted ethically and with the participants' best interest at hand. Especially when health, life, and death are at stake. Otherwise, consent is worthless. The courts have validated this premise time and again.

Otherwise there would be no need for this:

In an article titled: Regulating Dr. Frankenstein: Money, Lax Ethics, & Clinical Trials, several guidelines are suggested:

In a powerful speech to the NIH (Aug. 16, 2000), Dr. Marcia Angell, the former editor of the New England Journal of Medicine, outlined six things that should be done to remedy the problems typified by the Gelsinger case. In brief, Dr. Angell suggested the adoption of the following guidelines: (1) medical “investigators who receive grant support from industry should have no other financial ties to those companies” (e.g., equity stakes in those companies); (2) “institutions should not accept grants with strings attached. Investigators should design and analyze their own studies, write their own papers and decide about publication”; (3) “consultancy arrangements need to be carefully limited”; (4) “institutions should not become outposts for industry by allowing investor-owned companies to set up teaching or research centers in their hospitals and giving them access to the students, house officers and patients”; (5) “institutions and the senior officials should not have investments in any health care industry”; and (6) “institutions need to get together on this issue and develop a common policy.”
cspinet

[edit on 25-9-2008 by MemoryShock]

I see that it didn't take long for deflection to appear as part of my opponent's strategy:

My opponent will undoubtedly attempt to paint the entire scientific community as rife with manipulation and abuse in regards to the planning and implementation of human clinical trials and experiments.

Will I?

I believe I said the following in my opening statement:

No doubt there are many clinical trials which follow ethical and reputable methods and standards. I will also concede that without those, we would not be benefiting from many of the valuable and life saving treatments and products we use today.

And like I also said in my opening statement, there are just as many examples of unethical all the way to criminal abuses within the clinical trial industry.


I also see, that once again I have drawn an opponent who is willing to stake her position on the entire debate on the definition and semantics within the the thread title. I, as per usual, welcome that.

My opponent wishes to emphasize the part of the title which says "there is no such thing." Very well, I remember a previous opponent doing the same with the word "completely."

So how do we get from what I conceded above, which is to say that only part of the industry is unethical, to the concept that "there is no such thing" as "voluntary and informed consent?"

Well let me put it like this:

Have you seriously considered taking, or ever taken part in a clinical trial?

That is to say, how many of us would ever take that chance unless we were desperate for either money or a cure to a disease that is afflicting us?

And why is that? There is plenty of money to be made.

Ever been so strapped for cash that you'd swallow pesticide for $460? That's what dozens of college-age Nebraskans did in 1998 after reading a school-newspaper ad urging students to "earn extra money." They called 402-474-PAYS, signed a seven-page consent form and popped a pill loaded with the active ingredient in Raid roach spray. Dow AgroSciences commissioned the trial to vouch for the safety of one of its top-selling bug killers, chlorpyrifos.

continued...

And what ever came of Dow's experiments on chlorpyrifos, the killer ingredient used in Raid and hundreds of other bug sprays and lawn-care products? The EPA ended up banning household use of the insecticide, a nerve-gas derivative found to cause brain damage in fetal rats and weakness and vomiting in children.
TIME

Or maybe you have taken part in a clinical trial that you haven't consented to, and you don't even know it.

That will be the case for these 340 soon to be babies:

ABSTRACT

Background Young infants and pregnant women are at increased risk for serious consequences of influenza infection. Inactivated influenza vaccine is recommended for pregnant women but is not licensed for infants younger than 6 months of age. We assessed the clinical effectiveness of inactivated influenza vaccine administered during pregnancy in Bangladesh.

Methods In this randomized study, we assigned 340 mothers to receive either inactivated influenza vaccine (influenza-vaccine group) or the 23-valent pneumococcal polysaccharide vaccine (control group). Mothers were interviewed weekly to assess illnesses until 24 weeks after birth. Subjects with febrile respiratory illness were assessed clinically, and ill infants were tested for influenza antigens. We estimated the incidence of illness, incidence rate ratios, and vaccine effectiveness.
NEJM

Now, this would be the part of the debate where I would insert the countless horrific human consequences that came about as a result of some clinical trials.

As I said at the top of this post, I will not spend the entire debate listing these. I will only mention one, for the record:

Human medical experiments go terribly wrong in "nightmare" TGN1412 drug trial

The scene was a living medical hell, say witnesses. After being injected with the anti-inflammatory drug TGN1412, patients began tearing their shirts off, screaming that their heads were going to explode. One patient's head swelled to triple its normal size, and patients were soon passing out, vomiting, or screaming in sheer terror.

Within minutes after the injections, patients were suffering from severe breathing attacks, convulsions and excruciating pain. And now, after the incident, they are fighting for their lives after having their organs permanently damaged. Only the two who were given placebos escaped the horrors. (It gives new credence to the safety of mind/body medicine, homeopathy and the placebo effect, doesn't it? Take a placebo, and you probably won't die.)

continued...

Drug companies around the world, of course, are now concerned they won't be able to sign up more human guinea pigs for their own experimental drug trials. The drug industry relies heavily on exploiting the poor as human guinea pigs (see Human medical experimentation in modern times: How immigrants, poor people, minorities and children are modern-day guinea pigs for Big Pharma ), for without poor people to run experiments on, there can be no official declaration that the drugs are safe enough for everyone else to take.
NN

Exploitation indeed. And though many my voluntarily sign "informed consent" forms, it seems that most do it at the end of an emotional and psychological gun. It also seems that poverty and desperation are the foundation of the clinical trial industry.

So I now ask my opponent, when are YOU signing up for a clinical trial?
I'm sure they will tell you all you need to know.

What have we here…

It is apparent that my opponent has decided to run fast and loose with the debate rules.

Specifically, this part:

Each individual post may contain up to 10 sentences of external source material, totaled from all external sources.

My opponent has managed to use nearly 25 sentences of external source material in his previous post. One can only assume he will tread more carefully regarding the rules in his subsequent posts.

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The Art of Deflection

Originally posted by schrodingers dog
I see that it didn't take long for deflection to appear as part of my opponent's strategy:

My opponent will undoubtedly attempt to paint the entire scientific community as rife with manipulation and abuse in regards to the planning and implementation of human clinical trials and experiments.

Ah, the subtle – or in my adversary’s case, not-so-subtle – art of deflection.

Truth be told, my opponent is attempting to paint the entire scientific community as rife with manipulation and abuse in regards to all things relating to human clinical trials. It is the only way his argument will work.

As I have conceded in my opening statement, there are indeed instances of such misdeeds. But that is certainly a far cry from the reality of industry norms. Especially in regards to the issue of “informed and voluntary consent.”

Which brings us to what is ultimately the heart of this debate.

Autonomy: Our Most Precious Asset

The central premise of “informed and voluntary consent” resides in the issue of autonomy, the basic human principle concerning self-determination, ergo the ultimate control over one’s physical body.

The concept of “informed and voluntary consent” arose out of the medical research atrocities commited involuntarily during World War II against concentration camp prisoners by Nazi physicians. These horrific events came to light during the Nuremberg trials, where many of these doctors were tried for their crimes against humanity.

The Nuremberg Code, which emerged from the trials, abandons the earlier paternalistic perspective of medicine and research and replaces it with the centrality of patient self-determination by asserting that the voluntary consent of the human subject is necessary under all circumstances of medical research.

Source 1: Informed Consent

As one can clearly see, the right to autonomy and the precept of “informed and voluntary consent” are principles not to be taken lightly.

The Noble Pursuit

It is true that the scientific research community asks a great deal of the general public when soliciting volunteers and patients to participate in human clinical trials and experiments. No doubt, that pre-clinical testing is undertaken on laboratory animals, but animal testing has its limits. Once research has advanced beyond the initial stages, there comes a point when it becomes necessary to consider planning human clinical trials.

As my opponent so eloquently conceded in his opening remarks:

origininally posted by schrodingers dog
No doubt there are many clinical trials which follow ethical and reputable methods and standards. I will also concede that without those, we would not be benefiting from many of the valuable and life saving treatments and products we use today.

In short, the participation of volunteers in clinical trials is nothing short of a noble pursuit that ultimately benefits humanity.

The Clinical Trial Process

Before we go any further, let us take a moment to examine the how the clinical trial process unfolds.

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Source 2: Clinical Trial

Phase I usually consists of 20 to 80 healthy volunteers to measure the drug strictly for safety. Once the drug’s safety has been established it advances to the next phase.

Phase II generally consists of 20 to 300 volunteers and patients with the ailment the drug is targeting. This phase tests for both drug safety and efficacy. Drugs which fail usually do so within this phase.

Phase III, the test group of volunteer patients can range anywhere from 300 to 3,000+. It is this last phase of the clinical trial that confirms both the risks and benefits associated with the new drug.

After completion of the first three phased clinical trials, the pharmaceutical manufacturer may elect to submit the clinical research results to the FDA for approval.

Phase IV clinical trials are “post-approval” studies that continue after a drug has hit the market.
[2]

At any rate, human clinical trials are long and costly undertakings. As such, it is imperative that researchers be able to enroll an adequate number of volunteer participants to quantify the studies.

Which begs the question: Is there such a thing as “informed and voluntary consent” in regards to human clinical trials and experiments?

Yes. “Informed and voluntary consent” is the cornerstone of all clinical research.

Speaking of which…

How About Those Cases

My opponent cherry-picked three cases he felt would shed light on the abuses he believes are inherent within the clinical trial realm. His aim with this particular tactic is both hit and miss.

Case 1: College students were paid to pop a pesticide-laced pill. Hit and Miss

There are some clinical trials where volunteers are paid a nominal fee for participation, plus miscellaneous expenses such as travel, and are considered a “recruitment incentive.”

Financial incentives are most often used when health benefits to subjects are remote or nonexistent.

Source 3: FDA – Clinical Trails

As my opponent has noted, the volunteers involved with this case signed a seven-page consent form and were paid a nominal fee for their participation in the trial.

Case 2: Pregnant women involved in an influenza vaccine clinical trial. Miss

I wonder if my opponent took the time to fully understand the nuances of this clinical trial? It would appear not.

As quoted directly from his post:

Background Young infants and pregnant women are at increased risk for serious consequences of influenza infection. Inactivated influenza vaccine is recommended for pregnant women but is not licensed for infants younger than 6 months of age. We assessed the clinical effectiveness of inactivated influenza vaccine administered during pregnancy in Bangladesh.

In essence, the vaccine is already recommended for pregnant women, the trial was just checking the effectiveness of the recommendation.

It seems to me that my opponent was aiming for a bit of sensationalism via the tried-and-true route of exploitation of poor pregnant women. In this case, it is simply not true.

Moving on.

Case 3: The TGN1412 Clinical Trial Hit and Miss

This most unfortunate case occurred in London during a Phase I clinical trial. The pre-clinical trials showed the drug TGN1412 safe in laboratory animals.

In its first human clinical trials, in March 2006, it caused catastrophic systemic organ failure in the subjects, despite being administered at a supposed sub-clinical dose of 0.1 mg per kg, some 500 times lower than the dose found safe in animals, resulting in the hospitalization of six volunteers on 13 March 2006.

Source 4: TGN1412

As with all clinical trials, there are risks that can be incurred by participating volunteers. In this case, the trial produced wholly unanticipated effects in humans.

The following holds true in regards to the risks of clinical trials in general:

Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don't always know what the side effects will be.

[3]

It is mainly for this reason that “informed and voluntary consent” is an imperative when participating in human clinical trials or experiments.

Socratic Questions

Question 1: Do you think human clinical trials and experiments should be conducted at all?

Question 2: Do you think that halting human clinical trials and experiments would prove to be detrimental to society as a whole?

Question 3: Do you believe that the concept of “informed and voluntary consent” should be discontinued?

Question 4: Do you believe that there is a better alternative to human clinical trials and experiments in regards to scientific research?

As my honorable opponent as correctly pointed out. I seem to have misunderstood the rules of the debate. I was under the impression that the limit was 10 sentences per cited source as opposed to 10 sentences total. This really doesn't change anything within my argument other than to make it clearer. I am not sure what the consequences of this breach are, thought I am happy to keep the total cited material to under 30 to include my three middle posts. I will, unless told otherwise, continue under this premise.
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Now to address some of my opponents erroneous and/or inaccurate statements.

Truth be told, my opponent is attempting to paint the entire scientific community as rife with manipulation and abuse in regards to all things relating to human clinical trials. It is the only way his argument will work.

I seem to have to keep answering this erroneous description of my position. I will not continue to do so, thus I refer you to my answer at the top of my previous post and let you decide.

The fact is I don't have or need to, as my opponent states, paint the entire scientific community in my opponent's terms.
Though I thank my opponent for attempting to tell me what I "have" to do to win the debate, I will kindly remind her that I am quite capable of deciding that for myself. I am sure my opponent would love to dictate and frame this debate on her terms, it is simply not going to happen.


Let's go back to the three examples I have given and which my opponent chooses to refute.

Case 1.

My opponents response:

There are some clinical trials where volunteers are paid a nominal fee for participation, plus miscellaneous expenses such as travel, and are considered a “recruitment incentive.”

Financial incentives are most often used when health benefits to subjects are remote or nonexistent.

Thank you for reinforcing exactly what have I been saying..
Which is that clinical trials take advantage of their subjects financial or physical desperation due to their illness. All you have done is to say that when the subjects are sick, why bother also paying them. This hardly puts the people you are defending in a better light.

Case 2.

My opponent's response:

In essence, the vaccine is already recommended for pregnant women, the trial was just checking the effectiveness of the recommendation.

Well here my opponent has clearly missed the point I was trying to convey. This case was used as an example of involuntary consent.
Not for the pregnant women used in the study, but for their unborn children!
Where did they sign away their consent?

Case 3.

My opponent's answer to this one is incredibly disingenuous. Her own citation of a wikipedia article includes all the criticism and controversy associated with this clinical trial.
Did my opponent think we would not read her own citation?
Or perhaps my opponent is hanging her hat on the MHRA (European version of the FDA) findings of this clinical trials. They are of little comfort to the participants, and I don't see why the neutrality and findings of the MHRA shouldn't be considered just as historically suspect as those of the FDA. This example does nothing but reinforce this belief.


My opponent had some questions which I am more than happy to answer.

Answer to question 1:

Do you think human clinical trials and experiments should be conducted at all?

Yes, but at the very minimum under the improved guidelines cited in my opening statement, which are:

(1) Medical “investigators who receive grant support from industry should have no other financial ties to those companies” (e.g., equity stakes in those companies).
(2) Institutions should not accept grants with strings attached. Investigators should design and analyze their own studies, write their own papers and decide about publication.
(3) Consultancy arrangements need to be carefully limited.
(4) Institutions should not become outposts for industry by allowing investor-owned companies to set up teaching or research centers in their hospitals and giving them access to the students, house officers and patients.
(5) Institutions and the senior officials should not have investments in any health care industry”; and (6) “institutions need to get together on this issue and develop a common policy.

These and other ethical guidelines would help start restoring the public trust in clinical trials, which should NEVER be controlled, financially or otherwise, by pharmaceutical companies.

Answer to question 2:

Do you think that halting human clinical trials and experiments would prove to be detrimental to society as a whole?

Well, if it was up to me, I would not allow another clinical trial to go forward until minimum standards, such as the ones stated in my previous answer were instituted worldwide. Or if human trials were conducted by neutral and impartial organizations. Until then, as long as arbitrary and inadequate standards are the norm, and trial continue to be conducted by those who's self interest lies with the approval process, we will continue to see case after horrible case of clinical trial abuses.

Answer to question 3:

Do you believe that the concept of “informed and voluntary consent” should be discontinued?

Nice try.
The concept of “informed and voluntary consent" would be a nice one to continue if the clinical trial and pharmaceutical industries had not through their actions made a complete mockery out of it. Thus my answer to your question is: I believe that that as soon as the concept of “informed and voluntary consent” is established as the legitimate norm for the clinical trial industry, and is no longer just a concept, then yes I would like it to continue. Sadly, it seems that the industry isn't rushing.

Answer to question 4:

Do you believe that there is a better alternative to human clinical trials and experiments in regards to scientific research?

No. Human trials are a necessary part of the evolution of any drug and many products. But as I now have stated numerous times, not under the current inadequate standards which encourage dishonesty and corruption.


It is interesting that when my opponent cited this external source for Source 1: Informed Consent, she only mentions autonomy. As it happens her very source cites two principles which precede the concept of autonomy:

1. Preconditions: Includes competence (to understand and decide) and voluntariness (in deciding).
2. Information elements: Includes disclosure (of risks/benefits); recommendation (plan); and understanding (of information and plan).

Now why would my opponent choose two skip two essential principles within her own citation that precede autonomy and without which autonomy becomes moot?

Clearly it is because they do not suit her position in this debate.
That is understandable as they also do not suit the conductors of clinical trials or the pharmaceutical companies behind them.
And within these two premises which my opponent has chosen to "skip" on her way to autonomy, lies the principal reason why "voluntary and informed consent" is impossible to establish within the current state of the industry.

I will address the concept of "competence" and its inextricable relationship with the concept of "due process" in due course.

I would like to focus on the second premise of "information elements."

The entire clinical trial industry is one primarily defined by massive conflicts of interest. Pharmaceutical companies run the very clinical trials which determine whether or not a drug in which they have invested millions of dollars in R&D hits the market. Not to mention their responsibilities to their stock owners. The scientists who make these drugs have reputations and careers to protect. The FDA has consistently and erroneously sided on the side of big pharma including many documented cases of corruption. The idea that any of these people will give a clinical trial participant ALL available information to establish informed consent is not only incomprehensibly naive but also extremely dangerous.

The fact is, if one chooses to undertake a clinical trial, they are essentially rolling the dice on whether they have been told either part or the whole truth about the substances they are testing.

And that is precisely why they pray on the poor and desperately ill.

I have a couple questions for our opponent:

Question 1:

With the lack of any enforceable global standard for information dissemination to clinical trial subjects by the conductors, are they to trust in their good faith and altruistic nature to determine their safety?

Question 2:

Are we to trust the FDA, which has consistently failed the public, to have oversight of clinical trials?

Question 3:

Without an outside neutral and impartial agency armed with scientific understanding and enforceable global standards, and dedicated to the oversight of clinical trials, how can anyone trust that subjects are protected and that full disclosure is the norm?

What is “Informed and Voluntary Consent” ?

My opponent seems to be of the opinion that I am not being completely upfront about what constitutes “informed and voluntary consent” and the role autonomy plays in this principle.

Now why would my opponent choose two skip two essential principles within her own citation that precede autonomy and without which autonomy becomes moot?

Clearly it is because they do not suit her position in this debate.

This contention could not be further from the truth. What he construes as “skipping” I maintain as simply a lack of posting space. Posting constraints only allow 10,000 characters per post.

Therefore, let’s delve into what constitutes “informed and voluntary consent” as it is a crucial part of this debate and my stance.

… For informed consent to be legally recognized in medical practice, the following steps need to be clearly articulated:
1. Preconditions: Includes competence (to understand and decide) and voluntariness (in deciding).
2. Information elements: Includes disclosure (of risks/benefits); recommendation (plan); and understanding (of information and plan).
3. Consent elements: Includes authorization (based on patient autonomy).

Source 1: Informed Consent

Emphasis is mine. Every single one of these elements are essential to ensure that a person’s consent is both “informed” and “voluntary.” I honestly don’t think it can be explained any more clearly than that.

Most importantly, though, is the element that constitutes consent: autonomy.

As I have stated previously, autonomy is the central premise of any type of consent. It is one of our most basic human rights. It is what defines who we are. Without autonomy we are essentially prisoners.

I would like to focus on the second premise of "information elements."

The entire clinical trial industry is one primarily defined by massive conflicts of interest. Pharmaceutical companies run the very clinical trials which determine whether or not a drug in which they have invested millions of dollars in R&D hits the market. Not to mention their responsibilities to their stock owners. The scientists who make these drugs have reputations and careers to protect. The FDA has consistently and erroneously sided on the side of big pharma including many documented cases of corruption.

My opponent is making quite a claim here. However, he has yet to present any evidence to substantiate these charges. Are we to connect these dots based strictly on his word?

Keeping It Honest a.k.a. Cutting Through the Spin

My opponent must be incredibly myopic considering he refuses to acknowledge the full picture in regards to the cases he cited in his first reply and continued to spin in his second reply.

Let us review these cases (again), and bring things back into perspective.

Case 1: College students were paid to pop a pesticide-laced pill.

… clinical trials take advantage of their subjects financial or physical desperation due to their illness.

As I have stated previously, these students were paid a nominal fee for their participation in this particular trial. “Nominal” being the key word here. The fees paid are generally small and token in nature. This is to prevent potential volunteers from feeling coerced into participation by any major financial gain.

In other words, there is very little to be gained financially by participating in a clinical trial.

In fact, any and all payments made to volunteeers are overseen by the Institutional Review Board assigned to that particular clinical trial. Again, this is to prevent any undue coersion to participate in a clinical trial.
Source 2: Clinical Trial

As for the “physical desperation” angle my opponent is alluding to, there are indeed times when patients who have exhausted all other means of treatment are allowed to participate in clinical trials.

Compassionate use trials: provide experimental therapeutics prior to final FDA approval to patients whose options with other remedies have been unsuccessful. Usually, case by case approval must be granted by the FDA for such exceptions.

[2]

The patients who participate in these types of trials, choose to do so voluntarily via informed consent. Once again, it comes back to the self-determination aspect of autonomy.

This is not shocking new evidence, and there is no smoking gun.

Case 2: Pregnant women involved in an influenza vaccine clinical trial.

Well here my opponent has clearly missed the point I was trying to convey. This case was used as an example of involuntary consent.
Not for the pregnant women used in the study, but for their unborn children!
Where did they sign away their consent?

Is my opponent serious?!?! No, really…

The reason I ask, you see, is because last time I checked unborn children are not full fledged individuals (or even technically individuals) capable of consent in the first place. (Much less “signing” anything.) The reason for this being, and I’ll explain it in layman’s terms, is that an unborn baby resides in their mother’s tummy. As a result, fetuses do not have autonomy.

It appears that my opponent is suggesting that women be stripped of their autonomy when pregnant, and should only be allowed autonomy when they are not.

Partial autonomy?!?

This is, of course, to protect the “right” of “informed and voluntary consent” of a fetus over a mother’s right to autonomy.

Otherwise, why the outrage? Hmmmm…

By extension of my opponent’s twisted logic, sexually active women of child bearing age should also be stripped of their autonomy between menstrual cycles, as they could potentially be pregnant.

Dare I ask, is this a path we are even willing to consider?

Autonomy is a basic human right that cannot be toggled on and off at whim.

Case 3: The TGN1412 Clinical Trial

My opponent's answer to this one is incredibly disingenuous. Her own citation of a wikipedia article includes all the criticism and controversy associated with this clinical trial.
Did my opponent think we would not read her own citation?

What does this have to do with “informed and voluntary consent”? Nothing.

There are risks inherent in all clinical trials, including the risk of death. That is why all clinical trials require “informed and voluntary consent.” Volunteers are made aware of the risks before consenting to participate. Also, volunteers are free to leave the clinical trial at any time.

There is a reason clinical trials are held in the first place, and that is to test the safety and efficacy of all new drugs and treatments before they are allowed to enter the marketplace.
[2]

My Opponent’s Answers

Question 1: Do you think human clinical trials and experiments should be conducted at all?

Yes, but at the very minimum under the improved guidelines cited in my opening statement…

Fair enough. I reserve the right to pursue this reasoning in my next reply.

Question 2: Do you think that halting human clinical trials and experiments would prove to be detrimental to society as a whole?

Well, if it was up to me, I would not allow another clinical trial to go forward until minimum standards, such as the ones stated in my previous answer were instituted worldwide.

So, not until a global government is established to ensure global regulation. Interesting.

Question 3: Do you believe that the concept of “informed and voluntary consent” should be discontinued?

I believe that that as soon as the concept of “informed and voluntary consent” is established as the legitimate norm for the clinical trial industry, and is no longer just a concept, then yes I would like it to continue.

“Informed and voluntary consent” is the industry norm. Instances of abuse are exceptions to the norm. My opponent has yet to substantiate this claim.

Question 4: Do you believe that there is a better alternative to human clinical trials and experiments in regards to scientific research?

…not under the current inadequate standards which encourage dishonesty and corruption.

Again, my opponent states that dishonesty and corruption exists, but fails to substantiate such claims.

My Answers

1.With the lack of any enforceable global standard for information dissemination to clinical trial subjects by the conductors, are they to trust in their good faith and altruistic nature to determine their safety?

Short of a global government to regulate a global standard, yes. It’s a matter of personal judgement and self-determination.

2. Are we to trust the FDA, which has consistently failed the public, to have oversight of clinical trials?

Yes. At the present time there is no alternative. Also, you have yet to back your claim.

3. Without an outside neutral and impartial agency armed with scientific understanding and enforceable global standards, and dedicated to the oversight of clinical trials, how can anyone trust that subjects are protected and that full disclosure is the norm?

Simple, potential litigation and bad PR. Short of a global government, it is impossible to enforce any type of global standard.

Socratic Questions

Question 1: Do you think that the implementation of a global standard that is enforceable is realistic and why?

Question 2: Do you think autonomy should be stripped from pregnant women to preserve the right of consent of fetuses?

I will begin by disposing of my opponents questions.

Question 1: Do you think that the implementation of a global standard that is enforceable is realistic and why?

I don't see why not. And it can be done without the silly premise that a "global government" is required. We have a convenient and existing legal mechanisms for this, we call them treaties. They are actually quite common. Believe or not, we even have an existing institution to negotiate and ratify these treaties called the United Nations. So as you can see, should the will be there, it is quite realistic to have these global standards, and we don't need the NWO to do it.

Question 2: Do you think autonomy should be stripped from pregnant women to preserve the right of consent of fetuses?

This question following your earliest statement on this case, are the most ridiculous thing I have ever been accused of. You are injecting mothers'/women's rights and all the emotional weight these issues bear onto an issue that has nothing to do with these rights. No one, including myself, is disputing any of these rights, and they are not a part of this conversation. We are not talking about a woman's right to choose. In the case I cited, all the women involved already chose to give birth to their fetuses. As such they will become living humans who will have to bear the consequences of their mother's actions. Just as you and I have to live with the fact that our parents immunized us when we were children. In both cases, notwithstanding the mothers' legal standing, the fact remains that the recipient never volunteered their consent.


Now, for the final time, I will go back to the three cases I cited:

Case 1:

As I have stated previously, these students were paid a nominal fee for their participation in this particular trial. “Nominal” being the key word here. The fees paid are generally small and token in nature. This is to prevent potential volunteers from feeling coerced into participation by any major financial gain.

I don't know where my opponent is looking. In the external quote I provided in my first post students were paid $460. In the same article, which I until now assumed my opponent had read, it also says the following:

A year and a half ago, newspapers in California reported that researchers there were paying healthy volunteers $1,000 to complete a six-month regimen of perchlorate, a rocket- fuel component that disrupts thyroid function and may cause retardation in babies.
TIME

Perhaps my opponent was more fortunate than the rest of us with her finances during her college years. That would explain the disconnect.

And as far as taking advantage of the most unfortunate among us, please consider the following article:
Miami Test Center Lures Poor Immigrants as Human Guinea Pigs

Case 2:

It appears that my opponent is suggesting that women be stripped of their autonomy when pregnant, and should only be allowed autonomy when they are not.

This unfortunate and inaccurate interpretation of my position has been addressed by my response to question 2 at the top of this post.

Case 3:

There is nothing to be added by me on this case as my opponent only chose to dispute its relevance. Clearly we disagree on this point. I will let the case itself and my existing comments speak for themselves.



Let me address my opponent's answers to my questions.

1. With the lack of any enforceable global standard for information dissemination to clinical trial subjects by the conductors, are they to trust in their good faith and altruistic nature to determine their safety?

Short of a global government to regulate a global standard, yes. It’s a matter of personal judgement and self-determination.

You have answered a question that was not asked. Hence I will assume that you agree that we should trust in the good faith and altruistic disposition of the pharmaceutical companies and their clinical trial conductors to always provide ALL available information so that one can give their informed consent. A naive and dangerous course of action for anyone considering participation.

2. Are we to trust the FDA, which has consistently failed the public, to have oversight of clinical trials?

Yes. At the present time there is no alternative. Also, you have yet to back your claim.

Let me do that:

Indeed, Dr. Greg Koski, former head of OHRP, the federal agency that is supposed to oversee federally funded clinical trials, and the IRB system, now acknowledges: "It's not really a 'few bad apples' problem. We need to create a system that grows better apples."
ahrp.org

Here's a fascinating, comprehensive, and disturbing paper citing the Journal of the American Medical Association:

The JAMA report provides a basis for evaluating the value and relevance of clinical trial findings for clinical care. It also provides a basis for measuring FDA's performance as gatekeeper in preventing hazardous drugs from reaching the market. They found that clinical trials are underpowered to detect uncommon, but potentially lethal drug reactions. Their design, biased selection, short duration, and accelerated approval process almost ensures that severe risks go undetected during clinical trials.
ahrp.org

I encourage everyone to read the whole paper. I would cite more from it but I, by my count, have reached my 30 sentence limit. As you read, please pay particular attention to the segment addressing the "dirty dozen" practices of corrupt research.

Fact is the news and the web is littered with such examples of corruption within the very institutions who's role it is to protect us.

And this is precisely one, but not the only, reason that it is impossible to establish "Voluntary and Informed Consent"


3. Without an outside neutral and impartial agency armed with scientific understanding and enforceable global standards, and dedicated to the oversight of clinical trials, how can anyone trust that subjects are protected and that full disclosure is the norm?

Simple, potential litigation and bad PR. Short of a global government, it is impossible to enforce any type of global standard.

First of all, litigation and bad PR are of little comfort to the victims of clinical trials and are well within the risk assessments of pharmaceutical companies. Second, the rest of the world does not share America's generous civil legal system. So in essence and for all practical purposes, your answer to my question is insufficient.

My opponent my cite as many altruistic concepts such as "compassionate use" or any other guidelines as she wants. The inescapable fact is that these principles, in the eyes of the clinical trial industry and their government cronies, are not worth the paper they are written on.

The Safety Nets

The reality of the clinical trial process is a far cry from the territory of lawless wilderness my opponent has painted. There is stringent oversight, regulations and safety nets in place to ensure that volunteers and patient participants are adequately protected.

First and foremost among these protections, is “informed and voluntary consent” and the pivotal point of this debate. As I stated in my previous post the elements that constitute informed consent are as follows:

… For informed consent to be legally recognized in medical practice, the following steps need to be clearly articulated:
1. Preconditions: Includes competence (to understand and decide) and voluntariness (in deciding).
2. Information elements: Includes disclosure (of risks/benefits); recommendation (plan); and understanding (of information and plan).
3. Consent elements: Includes authorization (based on patient autonomy).

Source 1: Informed Consent

An integral part of this process involves a high degree of open communication that occurs between potential volunteers and physicians screening the selection process. All possible risks and side effects are discussed, as well as the fact that there is a degree of uncertainty that is inherent in all clinical trials, including the risk of death.

Another point that is emphasized during the screening process is the fact that participants are free to leave a clinical trial at any point. Once again, the role of self-determination via autonomy is a crucial element of consent.

Then there are the Institutional Review Boards who monitor human clinical trials to ensure the welfare of volunteers. These committees work directly with the Food and Drug Administration, Human Health Services, and the Office for Human Resource Protections to perform critical oversight of these trials.

The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. The chief objectives of every IRB protocol review are to assess the scientific merit of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.

Source 2: Institutional Review Boards

All of this is done to allow for increased transparency within the clinical trial process.

Keeping It Honest a.k.a. Cutting Through the Spin: Part II

At the beginning of this debate my opponent chose three clinical trial studies that he felt best exemplified his stance that the system was rife with manipulation and abuse. Needless to say, there has been more than a fair amount of spin in his presentations. We will once again revisit these cases to bring the facts back into alignment.

Case 1: College students were paid to pop a pesticide-laced pill.

My opponent insists that these students were financially coerced into participating in this study. I pointed out that the fee was small and token in nature. He shot back that the same article stated researchers paid volunteers $1,000 to participate in a different six-month clinical trial.

Oh my, $1,000 is alot of money. Or, is it?

A little perspective, please! A breakdown of this figure would indicate that $1,000 over six months equates to $166.66 a month, or $38.46 a week for 26 weeks. This can hardly be construed as financial coercion.

Case 2: Pregnant women involved in an influenza vaccine clinical trial.

This is pulled from my opponent’s original post:

Background Young infants and pregnant women are at increased risk for serious consequences of influenza infection. Inactivated influenza vaccine is recommended for pregnant women but is not licensed for infants younger than 6 months of age. We assessed the clinical effectiveness of inactivated influenza vaccine administered during pregnancy in Bangladesh.

This example was indeed a most foolish choice for my opponent to make on several levels.

First of all, the trial was checking the effectiveness of an already established recommendation that pregnant women be vaccinated for influenza. These women voluntarily consented to medical follow-ups after receiving this recommended vaccine. Additionally, they consented to have their newborns monitored for a period of time after birth. There is nothing amiss.

… notwithstanding the mothers' legal standing, the fact remains that the recipient (child) never volunteered their consent.

His argument that the babies involved in this trial never granted their consent to be monitored after their mothers received a recommended vaccination is one hell of a stretch.

As I have previously stated, the only way for an unborn child to be granted the right to consent, the mother’s autonomy must be cast aside. There is no way around this, as the child resides in her body.

This question following your earliest statement on this case, are the most ridiculous thing I have ever been accused of. You are injecting mothers'/women's rights and all the emotional weight these issues bear onto an issue that has nothing to do with these rights. No one, including myself, is disputing any of these rights, and they are not a part of this conversation. We are not talking about a woman's right to choose.

Emphasis is mine. We are not talking about abortion rights, we are discussing autonomy. In case my opponent has forgotten, autonomy is the central premise of consent.

Babies, born or in utero, do not have the ability to grant consent in any form or fashion. My opponent’s point is moot. He made the original stance, now he needs to stand by it.

Case 3: The TGN1412 Clinical Trial

This was a most unfortunate case in which several volunteers were seriously injured as a result of testing the drug TGN1412. My opponent contends that they were somehow duped into participating in the clinical trial, yet he has failed to substantiate why.

As I have previously stated, there are risks inherent in all clinical trials, including the risk of death.

Going Global

I asked my opponent if he thought that the implementation of a global standard that is enforceable is realistic and to state his reasons why.

His response:

I don't see why not. And it can be done without the silly premise that a "global government" is required. We have a convenient and existing legal mechanisms for this, we call them treaties. They are actually quite common. Believe or not, we even have an existing institution to negotiate and ratify these treaties called the United Nations. So as you can see, should the will be there, it is quite realistic to have these global standards, and we don't need the NWO to do it.

This is a bit over simplistic, wouldn’t you agree. After all, altruistic and neutral organizations such as Amnesty International and the International Red Cross can do very little to prevent human rights violations or deliver humanitarian aid on a global scale. Not all countries are willing to play nice.

The sad truth is a large number of countries routinely disregard treaties put forth by the United Nations and its’ agencies. Realistically, this approach is not feasible short of a global government with the ability to enforce global regulations. To believe otherwise is simply naïve.

For the record, I am not advocating the placement of a new world order. I value my liberty way too much!

All in All…

The precept of “informed and voluntary consent” is a valid and ethical one. While there are instances of manipulation and abuse, it is not rampant, nor does it undermine the clinical trial process.

Socratic Questions

Question 1: Do you still feel that the implementation of a global standard that is enforceable is realistic?

Question 2: Do you still think that international treaties are the solution to enforcing a global standard?

My opponent was a little tardy in her response. However since she was gracious enough to allow me to bend the quotation rules earlier in the debate I am happy to extend to her the same courtesy.
_______________________________________________________________

Question 1: Do you still feel that the implementation of a global standard that is enforceable is realistic?

You tell me. You are the one arguing that the FDA and IRB are doing a bang up job. So what is it going to be? Are we to trust institutions which regulate and enforce clinical trials or are we not?

It is my opinion that an international regulatory agency armed with universal standards would actually work better than national government institutions. First, it would not be tied to "local" corporations. Second, they could oversee trials across international borders. I'm not saying it is easy, I am saying it is necessary.


Question 2: Do you still think that international treaties are the solution to enforcing a global standard?

Same question really. The only thing I will add to my above response is to say yes, an international treaty, enforced by a cooperative effort between the local and international agencies, would be a vast improvement over the present situation.


Other than answering the above questions, I really don't have anything to say as to my opponent's last post. It is mostly a repetition of what she had already stated.


Closing Statement

Ladies and gentlemen,

"There Is No Such Thing As "Voluntary and Informed Consent When Planning Human Trials/Experiments."

What we have here is a massive gap between what ought to be and what is. My opponent has cited all the ethical principles applicable to "informed consent" as it applies to clinical trials, and she has cited the (American) agencies responsible for creating and enforcing them. The tragic fact is that in "real life", these principles are frequently bent or outright ignored. Leading to thousands of preventable injuries and deaths.

The system is fundamentally broken

I direct you to: The Alliance for Human Research Protection

I ask you to to the time to read through their site and all its different sections. They are the repository of all transgressions against the public. They also provide a clear overview of the unacceptable state of the clinical trial industry. My opponent keeps asking for evidence. I have provided as much as is possible within the limits of the debate rules, the rest is all there for all to see. A look at AHRP's news section is enough to turn anyone's stomach.

Again, what we have here is a systemic breakdown

As such, and without the cooperation of the agencies in place to protect us, it is impossible for any potential clinical trial participant to ever know for sure if he/her has even been given all pertinent information to make an informed decision. Though they may do their own research and sign a piece of paper, they are always susceptible to the aforementioned transgressions of the industry. They are at the mercy of the trialists, and their consent is a roll of the dice.

When the institutions responsible to protect "informed consent" are flawed and ineffective, their principles become redundant and illegitimate.

If my opponent was correct in her position, watchdogs such as the AHRP would be unnecessary. Thankfully, we have them to provide us with the information that should be provided to us by the FDA and IRB. Alas, all they can do is record and report past sins. If only they themselves could get enough pre-trial information to warn us.

What chance do the rest of us have?

Anyone need a thousand bucks?

Once again, I would like to thank my esteemed opponent, schrodingers dog, our gracious tournament host, MemoryShock and the mysterious panel of judges who volunteer their time.

---

Closing Statement

It is apparent that “voluntary and informed consent” is a valid and ethical concept that has been developed to protect the rights of both volunteers and patients in regards to participating in clinical trials. Throughout the course of this debate we have overviewed the process of a human clinical trial. We also delved into the concept of “informed and voluntary consent” and reviewed its historical significance and evolution to the present day.

My opponent has attempted to paint the entire scientific community as rife with manipulation and abuse in regards to the planning and implementation of human clinical trials and experiments, with little to no success. While I have conceded that there are indeed instances of such abuse, it is by no means as rampant or scathing as claimed.

Keeping It Honest a.k.a. Cutting Through the Spin: Overview

As these are the three clinical trials my opponent presented as evidence of manipulation and abuse, it is only fair that we take a final look at what he presented, his spin and the reality of what actually occurred. This should have been the smoking gun upon which his argument hinged. But alas, it was not.

Case 1: College students were paid to pop a pesticide-laced pill.

My opponent’s original stance:

There is plenty of money to be made.

The reality is, as I have shown, that any payment made to volunteers participating in a clinical trial are small and token in nature, and usually include miscellaneous expenses such as travel. This is to specifically dissuade the type of financial abuse my opponent is inferring.

He has tried his best to spin this particular case, but it has pretty much stalled on him.

Case 2: Pregnant women involved in an influenza vaccine clinical trial.

My opponent’s original stance:

This case was used as an example of involuntary consent.
Not for the pregnant women used in the study, but for their unborn children!
Where did they sign away their consent?

As it has been shown, these babies were merely monitored after their mothers received a recommended vaccination. That is the long and short of this clinical trial. There was not evil-doing involved on any level, as my opponent has improperly implied.

He was also erroneous in his stance concerning babies, consent and autonomy. Babies, born or in utero, do not have the ability to grant consent in any form or fashion. My opponent’s point was moot from the start.

One has to ask why my opponent decided to choose this particular case to highlight alleged industry abuses. It is obvious he didn’t understand the particular nuances that this clinical trial involved, or the role of the women and newborns who participated.

Could it be that he thought the mere mentioning of clinical trials, pregnant women and unborn children in the same breath would raise indignation and rancor in those reading and/or judging this debate?

There was no exploitation of poor pregnant women or their children in this clinical study.

My opponent failed miserably in his attempt to make a case of manipulation or exploitation in this instance.

Case 3: The TGN1412 Clinical Trial

My opponent’s stance is that somehow the volunteers in this clinical trial were somehow taken advantage of, without really stating why. I’ve read, and re-read his thoughts on this case several times and have yet to see the point he was trying to make.

My opponent only seems to state that what happened with this clinical trial was terrible. However, that doesn’t excuse the fact that he fails to prove (or even attempt to prove, for that matter) what it is about this case that qualifies it to strengthen his stance in this debate.

Yes, what happened in this clinical trial was unfortunate.

As with all clinical trials, there are risks that can be incurred by participating volunteers. In this case, the trial produced wholly unanticipated effects in humans.

As I have stated before, the following holds true in regards to the risks of clinical trials in general:

Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don't always know what the side effects will be.

Source1: FDA – Clinical Trials

It is for this very reason that “informed and voluntary consent” is an imperative when considering participation in human clinical trials or experiments.

It is more than apparent that my opponent’s attempt to use these three cases as prime examples of what he considers to be manipulation and abuse falls painfully short of his intended goal.


Other Shortcomings

My opponent has failed to provide concrete facts as to why there is no such thing as “voluntary and informed consent” in regards to clinical trials.

His modus operandi seems to be: “Hey, I found a great article and/or website with loads and loads of information that will make my argument for me. That being the case, I fail to see why I should take the time to spell out specifics when you can read it all for yourself.”

This is akin to being asked to prepare a book report on War and Peace only to present:
“This Tolstoy guy wrote a really great book that’s full of interesting characters and covers a lot of themes and stuff. You should read it and decide for yourself if it is as great as I claim.”

This method lacks the true spirit of debate.

My opponent should have been able to state his case and present his evidence with references used only as proper attribution and follow-up at the reader’s discretion. Not references used as assigned reading.

A Few Parting Words…

It is true that the scientific community bears the responsibility of protecting those who participate in clinical trials. To this end, there are ample safe guards and oversights in place to protect the rights of those who consider participating in human clinical trials or experiments.

As I have stated more than once, there is an abundance of on-going and open communication that takes place throughout, and in many cases beyond, the duration of a trial. The thorough communication of risks and benefits derived from participation are clearly spelled out, including the possible risk of death. It is also made clear that should a person choose to participate in a trial, they are free to leave the trial at any time. This is more than a standard procedure. It goes to the very heart of what constitutes “informed and voluntary consent.”

This is a delicate balance of yin and yang: as the scientific community is dependent upon volunteers from the general public to further research, and the general public is dependent upon the scientific community to reap the rewards of such research.

Therefore, the precept of “informed and voluntary consent” is more than just a dream. It is the foundation upon which clinical trials are solidly built upon.

In the end, the participation of volunteers in clinical trials is nothing short of a noble pursuit that directly benefits humanity.