Bioethics Panel Told No Guarantee Against Unethical Research

ATLANTA — Experts say that the kind of unethical medical studies that occurred half a century ago could still happen again despite more than 1,000 rules and regulations that should prevent such abuses.

Bioethicists and researchers spoke Tuesday before a presidential panel in Washington. The meeting was triggered by the government's apology last fall for federal doctors infecting prisoners and mental patients in Guatemala with syphilis 65 years ago.

President Barack Obama ordered his Commission for the Study of Bioethical Issues to explore whether such a study could ever happen again.

Speakers noted that over the last several decades, as many as 1,000 rules, regulations and guidelines have been enacted worldwide to ensure the ethical conduct of medical research. In the United States, there are rules to protect people in every study done by federal scientists, funded by federal agencies or those testing a product requiring federal approval to be sold.

But that oversight is inconsistent – ethical rules can vary among federal agencies. What's more, if federal funding or review is not involved, an unethical study could be done and no one in authority would ever know about it.

"We have a leaky system," said Eric Meslin, director of the Indiana University Center for Bioethics.

Dr. Robert Califf, Duke University's vice chancellor for clinical research, agreed there are weaknesses.

"It's night and day and what you could do in the 'good old days' with no one knowing about it. But there's no 100 percent guarantee. There still will be bad things that will happen," he said.

The commission, ordered to report to the president by September, was given two tasks:

_Examine federally funded international studies to make sure research is being done ethically. The commission named a 14-member international panel of experts to study the question.

_Take a more intensive look at the Guatemala study. More than a dozen commission investigators have already started poring through hundreds of boxes of old government documents.

What they will turn up is unknown, but there are doubtless more unethical studies from the past that have never been publicly reported, said Susan Lederer, a medical historian at the University of Wisconsin.

On Sunday, The Associated Press reported on dozens of studies from the past – most of them between 40 and 80 years ago – involving researchers deliberately infecting people to study the effects of diseases or to see if an experimental treatment might work.

The AP investigation itself was triggered by the Guatemala study.

At Tuesday's commission meeting, Lederer was the most pessimistic of five guest speakers about whether that kind of research could happen again.

"I don't think you should look to historians for optimism," she said.

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Online:

The Commission Web site: http://www.bioethics.gov/

Comments

[JOHNSPEAKS]

09:01 AM on 03/07/2011

What is unethical research and why is the highly educated willing to experiment with?
-Antipsychotic Drugs- is a crap shoot with mentally ill people too see how they will respond?
-Electroshock Therapy- uses electrical shock treatment to destroy parts of the brain?
-Deep Brain Stimulation- uses electrodes to probe the brain and see what happens?
-Deep Sleep Therapy- many types of shock treatments are done at the same time?
-Lobotomy- makes human beings into -Zombies- by destroying parts of the brain?
-Infants and Children and Young Adults- they the supposed mental health professionals are now brain washing the general public into believing that we should expertiment with infants and children as young as -Three Months Old-? Think twice before -You- get involved with these supposed human beings who want to experiment on your child? Please research the mental health industry for the last hundred years and -You- will see how they played -God- with innocent human lives with never ending experimentation?

[Catlovesyourmom19]

06:56 PM on 03/05/2011

Why not make it legal to do such testing on felons convicted (and proven guilty beyond a reasonable doubt) of heinous crimes (rape, child molestation, torture, murder, etc.)? Better them than the innocent people and animals being tested on now.

[jeremyspeaks]

11:41 PM on 03/05/2011

That sounds like you are advocating cruel and unusual punishment, forbidden in the 8th amendment to the US constitution. Why do you hate the U.S. constitution?

Like Tam below, I'm wondering why the public comments in session 10 of the conference have gotten no mention whatsoever in the press coverage of this event. Fortunately, the video of the comments is on the public record, available at the bioethics.gov video archives, and it's not going away.

[healthanalyst]

05:53 PM on 03/07/2011

IRBs take the harshest line on using prisoners as they have coercion to be in the study. Participants are there on their own free will, without coercion, though the drug study trials that pay participants are another story to look at.

[Tam Borine]

01:03 PM on 03/05/2011

I have to question why the media is not reporting about the 20 victims of current unethical research projects who were in attendance and spoke during session 10 of the meeting on March 1, 2011. Is there any valid reason for this omission? We deserve to be heard and we deserve to be vindicated for the hell we've been put through by criminals in these fields. The people conducting research on humans today without their consent do not even get a slap on the wrist. They should be prosecuted and held to account for the hideous things they are doing to other human beings.

[John Richard Smith]

12:59 AM on 03/05/2011

More on "Corporate" Responsibility

Early days yet and this case has yet to be tested under a formal judicial process.

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Millions of surgery patients at risk in drug research fraud scandal

Millions of NHS patients have been treated with controversial drugs on the basis of "fraudulent research" by one of the world's leading anaesthetists, The Daily Telegraph can disclose.

http://www.telegraph.co.uk/health/8360667/Millions-of-surgery-patients-at-risk-in-drug-research-fraud-scandal.html

Joachim Boldt is at the centre of a criminal investigation amid allegations that he may have forged up to 90 crucial studies on the treatment. He has been stripped of his professorship and sacked from a German hospital following allegations about his research into drugs known as colloids.

He published dozens of papers "proving" their benefits and contradicting studies which suggested they could increase the risk of death in surgery and cause kidney failure, severe blood loss and heart failure.

German medical authorities are scrutinising 92 of his key publications and a criminal investigation is under way into allegations that he forged documents, tested drugs on patients without their consent and fraudulently claimed payments for operations he had never performed.

Mr Boldt received funding from manufacturers of hydroxyethyl starch (HES) – the colloid he most strongly advocated – including B. Braun, Baxter and Fresenius Kabi.

He was frequently paid to speak at international medical conferences where he hailed HES as "the holy grail" of fluid drugs.

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Is there a shared responsibility ?

[Peter Aleff]

04:26 AM on 03/04/2011

What good are a thousand new rules and regulations against unethical clinical research when they are routinely ignored?

In the SUPPORT study published last May, researchers at 16 US hospitals reduced the oxygen breathing help for premature babies although they knew that this greatly increased the risk of death for those gasping babies.

These researchers wanted to find out whether reducing the oxygen would reduce the combined rate of death and blinding, as if these two outcomes had the same importance for the babies, and as if intact eyes were of any use to a dead child. Even before the now touted thousand new regulations, the medical ethics rules have long insisted that the importance of the objective outweigh the risks and burdens to the research subjects.

Yet, this knowingly baby-asphyxiating study preventably killed 23 extra preemies in the low-oxygen group, and all the medical grant givers and Institutional Review Boards had approved this cold-blooded baby-killing experiment.

Moreover, no one appears to have told the parents what the doctors were doing to their children: the National Institutes of Health could not find any records of the Informed Consent Forms that patients or their parents are supposed to sign before any medical experiment on any human subject can begin. Since preemies cannot complain those researchers apparently considered it OK to treat them behind their parents’ backs as disposable guinea pigs.

For details, see retinopathyofprematurity.org/BioethicsSUPPORT.htm.

Peter Aleff

[healthanalyst]

05:50 PM on 03/07/2011

The IRB should not have approved this, studies with children and babies are pretty much verboten. And yes, I have read and have to apply to an IRB for research. Its not a necessary evil, it can catch errors in the statistical analysis as well at ethics.

[John Richard Smith]

05:21 AM on 03/03/2011

The Walker-Smith , Wakefield example is an extremely poor one concerning ethics as

1. The findings are currently under appeal at the High Court of the UK

2. The team quite reasonably believed that they were covered by official documentation provided by two separate Ethics Committees at two differing institutions.

3. The Employer at that time the Royal Free Hospital should have taken full responsibilities if those alleged ethics breaches happened whilst that research team was under their direct supervision.

4. There is clear evidence the patients were receiving the necessary clinical diagnosis and treatment and that any research was drawn from those clinical findings and treatment..

5. There is clear evidence that patients benefited from treatment regimes even those these were in their very infancy and was only made after the professionalism of a team of eminent gastroenterologists.

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Point number 3 is the most interesting one because it focusses on what responsibility
organisations could and should undertake in ensuring research is conducted properly.

They had at any time the ability to stop that particular "research" in its tracks ...they chose not to do so.

There are two conclusions that could be drawn

a) They did not feel there was a need to stop the clinical work / research.

b) They did not undertake their responsibilities as medical organisation in regards to duty of care to patients.

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Far to often the higher up the ladder we go the less responsibility is taken by organisational management structures.

[Sheldon101]

10:31 AM on 03/03/2011

1. Is Walker-Smith contesting the findings or merely the sanction? Findings against Walker-Smith were made using a criminal standard of proof. In his appeal, what errors does Walker-Smith allege were made.

2.Using a criminal standard of proof, the panel rejected the lies of the doctors regarding ethical approval.

3. How did the failings of their employer excuse the doctors from their violations of Good Medical Practice?

4. The panel, using a criminal standard of proof, found that children had undergone medical procedures that were not clinically indicated and that the doctors acted against the clinical interests of the children.

5. The GI problem the kids had was constipation. More attention was paid to this problem after their stay at the hospital. The preparation for a colonoscopy, whether needed or not, uses a very, very effective laxative that relieved the constipation.,

[John Richard Smith]

11:35 PM on 03/03/2011

sheldon101 obviously the sophistication of the argument presented here in regards to "corporate" responsibility escapes you.

Please try to discuss the core issue of ethics and responsibility.

[Kim CureTalk]

02:55 PM on 03/02/2011

What's the deal? Can we please publish a negative article about clinical research when it is actually merited? Bad things that MIGHT be uncovered is just more fuel that adds to the proverbial fire that burns in the name of "evil clinical research".

Did you know that Clinical Research or Clinical Trials are the ONLY way we (AKA the human race) have come up with to move the edge of medicine forward. Drugs like aspirin that your grandma takes, mass produced insulin that your cousin Phil takes, Lipitor that uncle Ray takes for his blood pressure, "the pill" that your sister takes, the Tamoxifen that your mother takes, and the Zoladex your father takes were all designed, refined and eventually put on the market through the clinical trials process.

Read more of my thoughts here (http://bit.ly/fpYt7w). Taking ethics seriously is important, and yes, serious breaches still do occur, but bashing research as a whole because of what might happen is also unethical. Clinical Research helps make us feel better and live longer and this process will continue to improve along the way.

[acads]

10:10 AM on 03/07/2011

Non consenting unethical research, what does your post have to do with this. Those drugs were tested in studies where the participants signed off that they knew the risks and the benefits. The participants(if you want to call them that) of the topic of this panel in most cases were not not given that oppurtunity or were given false information, they were just used as guinue pigs. Clinical research has nothing to do with this.

[onionboy]

01:24 PM on 03/02/2011

Unfortunately, I don't see outrage among the public and MSM when it comes to unethical research. Here are two high profile examples:

Dr. Heimlich (of "Heimlich Maneuver" fame) was once a media darling. He had a theory of malarial infection to cure HIV and just about anything. He moved forward with such experiments overseas while UCLA faculty. He and UCLA subsequently and swiftly dissolved that relationship once those experiments were discovered. We had international tribunals about such things after WW2, but I barely saw a story in any major media outlet headlining Dr. Heimlich's unethical breach.

When that Andrew Wakefield report came out, the debate became about whether or not his research was "right". There was little discussion about how he had carried out much of his research without ethics board approval (a legal requirement at the time), administered a substance to a child solely for experimental purposes also without ethics board notification or approval (again a legal requirement). He did his research ignoring all of the oversight mechanisms that are in place to protect the rights of research subjects, in his case those subjects being children. To my knowledge, he doesn't even dispute these issues. Yet, no one even brings these issues up in the MSM.

The rights of human subjects in research must be protected. There are international codes and individual country regulations to do this. But when those ethics are breached, we must loudly expose the offenders to serve as a lesson for the next.

[AnthropologistAmongApes]

01:30 PM on 03/02/2011

Well said. Ethics have intentionally been confused for personal morality, particularly by the right. That has essentially eliminated the requirement that morality be vetted for its efficacy and harm. So instead of a refined set of ethics we get the projections of a populace who is ethically illiterate but morally aggressive.

[onionboy]

02:08 PM on 03/02/2011

Interesting observation. One of the responsibilities in my job, one is to investigate allegations of research misconduct, human subject protection violations, and other compliance issues. The majority are non-malicious. People do things wrong unknowingly or to cut corners to make a deadline or to focus on the medical care of an individual patient. The few that actively ignore the regs and ethics never have just a single issue. They have a broken sense of morality in general. They lie about everything. The only thing that could keep them in place is fear of getting caught.

One person had some small issues with initials on a consent form. This led to an attempt to identify all subjects affected. This led to an observation that the # of subjects in the database didn't match reported enrollment to ethics committee. This led to further noticing they didn't match numbers publication. This led to them not matching raw data and an inability to locate original raw data. This led to an orchestration of forging laboratory notebooks and re-labeling samples by an entire lab. Why would they all blindly follow and risk their careers? This person often ordered the whole lab to sell internet products for weeks at a time. It was a side business, and was why there was no time to obtain actual results to publish.

Lies on top of lies these sociopathic-types tell. I'm sure they're in more than just science. Government too I would guess.

[jody grind]

05:20 AM on 03/03/2011

11/10/05, "Dr. Henry Heimlich's latest maneuver, a controversial AIDS cure, has many medical ethicists gagging" by Thomas Francis, Radar Magazine: http://winston7.true.ws/

6/8/07, "Dr. Heimlich's New 'Maneuver': Cure AIDS With Malaria" by Brian Ross, ABC 20/20: http://blogs.abcnews.com/theblotter/2007/06/dr_heimlichs_ne.html

7/3/08, "Democratic Congressional Candidate's Ties to Bizarre AIDS Research" by Joseph Rhee, ABC News: http://abcnews.go.com/Blotter/story?id=5301370&page=1

10/31/07, "Dr. Heimlich says “malariotherapy” moving forward," Cincinnati Beacon: http://bit.ly/dylI7I

[onionboy]

11:57 AM on 03/03/2011

I do remember the 20/20 story which was the biggest of those. But do the test. Ask people. People my age (40s) will remember when we were kids and he was on EVERY talk show imaginable. Everyone knew his name and his maneuver (which now has its own controversy according to his son). When I people now about his malaria malarkey, I've yet to see anyone not look surprised. I know faculty at UCLA who hadn't heard anything about it.