Thursday, December 22, 2011

Why Are Westerners So In Love With Circumcision For Africans?


Daniel J Ncayiyana, the editor of the South African Medical Journal, presents a rarely heard view in a professional medical journal: he is critical of mass male circumcision campaigns that make claims to reduce HIV transmission, by widely varying amounts. In fact, it is rare to hear someone in such a position criticizing anything to do with theory (and hence programming) relating to HIV in Africa.

Despite the often vast claims of Western proponents of voluntary (so they say, anyhow) male circumcision, Ncayiyana opposes this as a strategy, finding the evidence mixed, sometimes exaggerated and never completely convincing. Perhaps the claim that "'Male circumcision is the most powerful intervention we have at this point in time" should be interpreted as reflecting the lack of success in other areas of HIV prevention, rather than the effectiveness of circumcision?

Enthusiasts of circumcision seem to forget that if they diminish the potential effectiveness of other prevention strategies, people may get the impression that circumcision on its own is effective, which it is not. All trials of male circumcision consisted of a combination of prevention strategies, including condom use. If circumcision results in a reduction in use of other prevention strategies, sexual transmission of HIV from females to males could increase.

Of course, male to female transmission, which is far more common in African countries, will not be reduced by male circumcision; it may even be increased. This operation, which is ostensibly aimed at couples who tend not to use condoms (and other groups), sounds like it will fail to reduce transmission in the very contexts where reduction is most needed. So far, the various pronouncements about circumcision seem to have produced little but confusion.

Ncayiyana mentions the fact that prison services in South Africa report a "near-stampede" by inmates demanding circumcision (though this may be another exaggeration), who seem to think the operation will protect them against non-heterosexual, perhaps even non-sexual HIV transmission. There is simply no evidence that circumcision protects against male to male transmission, or even male to female transmission where anal sex is involved.

One of the most puzzling things about female to male sexual transmission of HIV is that it occurs so much in African countries. Counterintuitive as it may seem for a virus that is claimed to be almost entirely sexually transmitted, female to male transmission hardly ever occurs in most Western countries. The bulk of transmission is from men having sex with men and intravenous drug use. Even the percentage of female to male transmission estimated in Western countries may fail to exclude cases where people were not altogether frank about the risks they have faced, or where health professionals failed to report all the risks.

While criticizm of circumcision is not often cited, there is some published criticizm, some of which Ncayiyana alludes to. He even alludes to the lack of certainty about the relative contribution of heterosexual transmission, as opposed to other sexual and non-sexual modes of transmission. And he notes that arguments for adult male circumcision have been used as arguments for new-born babies, which is simply ridiculous.

Van Howe and Storms put it succinctly: "It is not hard to see that circumcision is either inadequate (otherwise there would be no need for the continued use of condoms) or redundant (as condoms provide nearly complete protection)." It is not hard to see, but the calls for tens of millions of men (and perhaps even more babies) to be circumcised to reduce HIV keep coming in. Even Bill Gates has forked out $50 million for circumcision.

One of Ncayiyana's main worries is that all this attention for circumcision will take attention away from HIV prevention strategies that work, at least to some extent, such as condom use. If sexual behavior needs to change, circumcision is unlikely to have much long term impact on this. If men's attitudes towards women need to change, as we are so often told they do, circumcision is not going to bring this kind of change about. And the list goes on.

I don't have as much faith as Ncayiyana seems to have in condom use, however combined with partner reduction and the like. I think they may all be useful when it comes to reducing sexual transmission or HIV, but this will not shed light on non-sexual transmission. Non-sexual transmission through unsafe healthcare, cosmetic practices, traditional medicine, tattooing, scarification and oathing may be rare, as UNAIDS claims. But UNAIDS may be wrong, they haven't checked yet. However, circumcision seems like more of an unwise leap of faith than a genuine HIV transmission prevention strategy.

allvoices

23 comments:

Joseph said...

"Male circumcision is the most powerful intervention we have at this point in time..."

This is claim is horrific and a disservice to the fight against HIV, as, even if the research were infallible (which it is actually horrendously flawed), condoms, not circumcision are the most powerful intervention.

Even if the "research" was 100% accurate, circumcision couldn't hold a candle to the almighty condom. Condoms protect over 95% of the time, every time, whereas circumcision would only protect 60% of the time for a period of 18 months.

The authors of these so-called "studies" themselves cannot stress the fact that a circumcised male still has to use a condom.

The claim that "male circumcision is the most powerful intervention we have at this point in time" is categorically false, and organizers who make it ought to be fined.

Ian Samson's Blog said...

So, just what is Daniel J going to do about telling the less-than-honourable Minister of Health about the dangers of his roll-out plans of mass circumcision of 2.5 million SA men by 2015? And all the others who are so determined to proceed with their "precautionary" programs? It's a load of junk! It's about time the Minister of Health vetoed the decisions and placed a moratorium on all circumcisions in the country.

Simon said...

Hi Joseph
I agree with you but the circumcision enthusiasts insist that people don't/can't use condoms here, which I think is more of a prejudice than a research finding. Still, any published criticism of circumcision, especially from the establishment, is welcome.

Hi Ian
He doesn't go far enough, but it's a start and I hope more Africans will take up the baton and do their own thinking, particularly if Western donors are cutting funding or threatening to add even more conditions to continued funding.

Regards and thank you both for your responses.
Simon

Anonymous said...

I am appalled that my fellow Americans, well those who have money to spend, encourage amputation of healthy, necessary body parts to prevent disease. The thing is circumcision creates a lack of feeling over the years due to keratinization which discourages condom use because as condoms also affect sensation. In addition, no foreskin means easier access to the urethra in general for negative bacterias and viruses. My husband's urologist has confirmed this. While I am against infant circumcision, and for the right of a grown man to choose, I do believe that my tax dollars should not be aiding in the misinformation being given to those in Africa nor should it help sad excuses for Americans to lie to our African friends and say circumcision works. It does not work, condoms and monogamy as well as education and testing do.

cosmopolite said...

The African randomised clinical trials can be criticised far more harshly than you people seem to appreciate:
http://xa.yimg.com/kq/groups/23477339/1441224426/name/JLM_boyle_hill.pdf

The authors of this article have been intactivist medical scientists for over a decade.

Joseph said...

@Simon
The circumcision enthusiasts insist that Africans are too stupid to learn how to use condoms properly, so "off with their heads" it is. At the same time, we're expected to believe that circumcision is to be part of a so-called "comprehensive package" that both circumcises them and instructs them to use condoms consistently. How on EARTH are African men expected to use condoms, when, at the same time, we're giving them an alternative, one that, even if the "science" is accurate, is worlds less effective?

The so-called "studies" are full of holes, but even if they were 100% correct, this would still only be a "60% reduction," and only in female to male transmission; little is talked about the Wawer study which showed that women were 50% more likely to get sexually transmitted HIV from a circumcised partner. Promoting circumcision not only provides less to men; it leaves women 100% exposed to the viral load in semen. Not to mention that the promotion of circumcision tacitly endorses the discrimination of non-circumcising men by circumcising ethnic groups (IE, the Luo by the Kikuyus) and the forced circumcision of children and infants. So much for "voluntary."

The promotion of circumcision is an impertinent travesty that smart African scholars need to openly reject and criticize the WHO for endorsing.

For scholarly critiques of the much famed African "studies," I provide the following links:

You already mention Storms and Van Howe:
http://www.publichealthinafrica.org/index.php/jphia/article/viewArticle/jphia.2011.e4/html_9

Here is another criticism by Darby and Van Howe. The paper specifically addresses using circumcision in Australia, but does a good job of demolishing the much hyped African "trials":
http://www.publichealthinafrica.org/index.php/jphia/article/viewArticle/jphia.2011.e4/html_9

Gregory Boyle and George Hill have recently published a paper in Australia's Journal of Law and Medicine this month:
http://xa.yimg.com/kq/groups/23477339/1441224426/name/JLM_boyle_hill.pdf

I'm telling you there's something funny going on up at the WHO. They're either engaged in sabotage, smoking crack, or they're seriously that incompetent.

Simon said...

Cosmopolite, thank you for the article.

Joseph, thank you for the articles. I'm still not clear why WHO, UNAIDS and the rest are pushing ahead with circumcision despite the evident problems. What has the HIV industry got to gain from adding the relatively small amount of HIV money they are happy to flush down the toilet for circumcision along with the massive amounts of money that is being spent on other ineffective strategies?

Simon

Joseph said...

The way I see it, this isn't at all about HIV prevention, but about the vindication, popularization, and, if possible, medical requirement of circumcision for adults and children. The circumcision promoters don't give a damn about actual HIV promotion, but about making sure they can make it look like circumcision, the circumcision of infants in particular, is medically useful. Notice how the "studies" in Africa were all conducted on adults, but now it automatically translates to circumcising children.

You've got to look at the history behind circumcision, its advocates, and other disease circumcision was supposed to "prevent" in the past. For this, I recommend the books "Marked in Your Flesh" by anthropologist Leonard Glick. As a Jew himself, he gives insights on the importance of circumcision to adherents of Judaism, as well as how circumcision became important in the west. Another recommended book is "A Surgical Temptation" by medical historian Robert Darby.

Joseph said...

So why is the WHO, UNAIDS and the rest are pushing ahead with circumcision despite the evident problems? What has the HIV industry got to gain from adding the relatively small amount of HIV money they are happy to flush down the toilet for circumcision along with the massive amounts of money that is being spent on other ineffective strategies?

To answer these questions, you've got to take a look at the motives for why people would support circumcision in the first place.

I've summed it up to four top reasons why anyone advocates for circumcision.

1. Religion.
Circumcision is an important ritual in Judaism, Islam, and many tribal traditions. Particularly in the case of Judaism, Jews have been defending it since the 2nd century. One of the things that are celebrated at Hanukkah is particularly the fact that they have been carrying out circumcision in the face of the governments of the countries where they have lived, who had banned the practice. "Religious freedom," however, has lost its validity as a rationale for genital cutting, as this can be exemplified with female circumcision. Because "it's my religious right" no longer works, you'll notice that Jews have to fall back on the "study, after study" to insist that male circumcision has "benefits." (Though these should be of no importance to somebody who says this is a practice that their god ordained.) It is no surprise, then, that many of the "researchers" of circumcision throughout history have been Jewish. In the past, Abraham Wolbarst invented the idea that circumcision prevented penile cancer. Abraham Ravich tried to argue that circumcision "reduced prostate cancer in circumcised men." Aaron J. Fink invented the idea that circumcision might prevent AIDS purely out of thin air; he is the one who started the circumcision/HIV wild goose chase. You'll find that the quest for medical legitimization by "researchers" with a conflict of interest continue today. Look at all of the literature concerning circumcision and HIV, and you'll notice that there is a familiar group of "researchers," among them who just happen to be Jewish. Moses, Weiss and Halperin in particular. (Halperin's grandfather was a mohel, and he is on record saying that he feels it may be his destiny to carry out his grandfather's legacy.) Why is Israel actively promoting circumcision via Operation Abraham? The inventors of the PrePex device just happen to be Israeli. Are these people truly interested in HIV prevention? Or is it still the same old quest to vindicate a religious practice which has come ever under scrutiny? (See the proposed ban in San Francisco.) Let the reader do his own research and decide.

Joseph said...

Reason 2: Financial Incentive
Much money might be going into circumcising the whole of Africa at the moment, but the way I see it, this is nothing but an investment from which stockholders expect a return.

As I've already pointed out, there may be reasons other than actual HIV prevention driving the knives of circumcision advocates. One of these reasons is, for me, without a doubt, financial.

In the US alone, an estimated 1.3 million baby boys are circumcised every year. Circumcisions aren't free. At a dollar a head, that's already 1.3 million dollars. Consider that circumcisions can cost anywhere from a hundred to 3,000 dollars, depending on who performs it and where. And that's not counting the amount of money that goes into the manufacturing of circumcision-specific supplies, including the circumstraint board, the various clamps used in the procedure, circumcision kits, anesthesia, labor, etc. In America and countries where circumcision is performed, circumcision is a business. Because this is money usually reaped at the expense of unwitting individuals, doctors who profit from the procedure strive for a scientific alibi, if but a pseudo-medical one.

Circumcising doctors have two dilemmas that they have to address; 1, the lack of medical rationale for the procedures they carry out on healthy, non-consenting individuals, and 2, a decline in the practice that is both leaving them stark naked in the garden of medical ethics, and that is also cutting into their pocketbooks. Thus, they must invest in "research" and programs that bolster circumcision.

You'll notice that much of the money that funds the "research" and circumcision promotion campaigns in Africa comes from American institutions, such as the National Institutes of Health, Johns Hopkins Bloomberg School of Public Health and others. I see this as nothing more than the American medical industry seeking to justify a procedure from which many of its members profit from.

Perhaps they believe that if they can establish that circumcision "prevents HIV," and that "many men are lining up for the procedure," then they can bolster popularity for this procedure which is has been steadily declining (according to the CDC, infant circumcision has fallen from its 90% prevalence in the 1980s, to 56% today).

And this is not even getting into circumcision related business. Recently the PrePex manufacturers have been running ads on the BBC and other news outlets, boasting how they're going to facilitate the circumcision of millions with their device. Their device isn't free; PrePex is cashing in on the circumcision/HIV gravy train. And so are other devices. Who is David R. Tomlinson? He is the inventor of the AccuCirc device, and he has "improved" other devices like the Gomco and the Mogen circumcision devices, which, surprise, surprise, are being used on male INFANT circumcision campaigns in Africa. He also just so happens to be the "chief expert on circumcision" at the World Health Organization.

Not to mention that there are industries that profit from the harvesting of foreskins, particularly infant foreskins, for the manufacture of their product, SkinMedica, Advanced Tissue Sciences (ATS), Organogenesis, BioSurface Technology, Genzyme, Ortec International, LifeCell Corporation (Nasdaq:LIFC), and others.

And let's not forget that "researchers" get hefty grants for their "work." It is a conflict of interest when people's lack of health becomes your financial well-being.

In the words of Upton Sinclair:

"It is difficult to get a man to understand something when his salary depends upon his not understanding it."

Is this about HIV prevention? Or is this about vindicating a procedure that makes millions, if not billions?

Joseph said...

3. Personal Vendetta (AKA "researcher bias")
A fable often attributed to Aesop is "The Fox Without a Tail." This is the story of the fox who lost his tail to a trap, and who then tried convincing his colleagues that the tail gives nothing but problems, and that other would be wise to part their own.

Another fable that comes to mind is "The Fox and the Grapes." In this story, the fox tries very hard to attain some grapes that caught his fancy, but were suspended way up high, too high for the poor fox to get his paws on. Giving up, he concluded that "the grapes must be sour anyway."

In this way, I think that a lot of the "researchers" who are involved in the work must come from circumcising cultures, where the researchers are male and circumcised from birth (IE, they will never know what it is like to have a foreskin), they are married to circumcised husbands (and they come from the same circumcising culture where everyone is circumcised, so they do not know what a normal penis looks or works like), and/or they are parents to circumcised children (a decision that they cannot take back).

Could it be that these "researchers" and the people who back them are simply trying to wrong a right? Feeling uncomfortable with their cognitive dissonance, they feel they must somehow justify the circumcised penis to make themselves feel better for engaging in the practice?

Again, look at where all the circumcision/HIV "researchers" and investors come from. They're either from cultures that circumcise, or they belong to religions where circumcision is seen as a divine commandment. Who is Robert Bailey? Stephen Moses? Daniel Halperin? Maria Wawer? Ronald Gray? Brian Morris? Bill Gates? If I'm not mistaken, all of the "researchers" are American, Jewish, or they hearken from a time in their lives where circumcision was the norm. Could it be these "researchers" are just out to justify themselves at the expense of African men, and children?

I think their reasons for being so gung-ho about circumcision run deeper than just wanting to prevent HIV.

Investigate who these people are and how much time they've dedicated themselves to circumcision as opposed to anything else in their field. It should be obvious to anyone where their true interests lie.

Focusing on preserving a procedure, one that is age old and steeped in controversy, in lieu of preserving the human body, and finding less invasive, more effective solutions, should immediately smack of quackery. "Science" that seeks to find a problem to a solution, and not a solution to a problem is inherently flawed. You'll find the same devotion doesn't exist to finding the "benefits" of female circumcision, breast ironing, feet binding and head trephination as it does with circumcision.

Joseph said...

4. Circumfetishism
A reason for circumcision that is sicker than the rest is that of circumfetishism.

What is circumfetishism? It is a sexual fixation for the circumcised penis, and/or derives sexual gratification from the act of circumcision itself. Circumfetishism often involves fantasies of power and control, which may be ritualistically acted out. As such, it inevitably includes fantasies of children. Inflicting circumcision on a boy provides some circumcisers and onlookers with a sexual thrill. Groups such as the Acorn Society, the Gilgal Society, and the Cutting Club openly admit to a morbid fascination with circumcision to the point of sado-masochistic fetish. These groups advertise that doctors are among their members. There are those on the internet who discuss the erotic stimulation they experience by watching other males being circumcised, swap fiction about it, and trade in videotapes of actual circumcisions. Furthermore, there are anecdotal accounts of doctors becoming sexually aroused when circumcising boys. Circumcision certainly provides an opportunity not only to handle boys' and mens' penises without the condemnation that a sexual assault (in the sense that phrase is normally used) would attract, but also the opportunity to exercise power over another human being, to alter the penis and to control it and a man's future sexual life.

The ironic thing is that circumcison advocates often accuse intactivists of having some sort of "foreskin fetishism." There is probably no greater example of projection.

Joseph said...

"That some people get off on circumcision might be true," some might ask, "but how is this related to circumcision research?"

One would hope that researchers have integrity and that they keep their research and their own personal interests separate. One would think that even if a researcher had these interests, that they would do their best to hide them. But what are these "researchers" doing brazenly engaging in exchange with organizations that can be equated to NAMBLA? (The North American Man-Boy Love Association?)

The Gilgal Society has published a book containing stories eroticizing the circumcision of minors. One can Google them to find more about them. "Sure," some might say, "OK, so there is a group that gets off on circumcision, and they've established an organization and openly exchange this stuff. So what?" Well first, this is basically child porn. That should be the first concern. But secondly, why do the names of authors of the most recent pro-circumcision papers published in various medical journals, appear on Gilgal Society publications? Why can one find Bertran Auvert, Robert C. Bailey, Stefan Bailis, Daniel Halperin, Brian J. Morris, Edgar J. Schoen, Jake H. Waskett, Helen Weiss and Thomas E. Wiswell, seemingly endorsing the publication?

What is CircList? Who are they? What do they do? Circlist is a website and discussion group for men who sexually fantasize about performing and receiving circumcisions, often on small children. And yet, some top known circumcision advocates in the scientific field endorse and "recommend" it as an informative site on circumcision. Why? Notable characters that recommend, and/or link to CircList on their websites include Brian J. Morris, Edgar J. Schoen, and researcher Daniel T. Halperin. Some of these "researchers" are on record as actually having exchanges with the CircList group. Why?

Joseph said...

It should worry people that people like Brian J. Morris are teaming up with characters from CircList to publish their "research."

In recent times, Brian Morris has used his prestige at the University of Sidney to publish "studies" with one Jake Waskett, and recently one Chris Eley who are both prominent members of CircList. Why?

Intactivists have been keeping an eye on Jake Waskett for a few years now, and we know him to be a circumfetishist who got himself circumcised an adulthood to fulfill a childhood fantasy. He has since latched onto the idea that circumcision of healthy individuals, both infant and adult, can be justified using scientific research. Intactivists have visual records of him exchanging on CircList. He is also known to lurk on parenting forums trying to convince parents to circumcise their children, citing all the usual "research," when we know for a fact that his interests lie elsewhere.

Jake Waskett is but a layman who is no authority to be making value judgements on circumcision whatsoever. He is neither a surgeon, nor a urologist, nor a pediatrician, nor an epidemiologist, he has not the least bit to do with medicine (he's nothing but a computer programmer). And yet, other circumcision "researchers" are beginning to include him on scientific papers as if he were any kind of authority. Why is this? Methinks he parrots pro-circumcision rhetoric so well that he has become a favorite among the pro-circumcision "researcher" crowd. It's ironic that some circumcision advocates have the nerve to dismiss opponents of circumcision as "laymen outside of the field." Well, what is Jake Waskett?

What is Brian Morris too, now that we're on the subject? Brian is a professor of molecular sciences, and he holds no medical degree of any kind. He too is neither a surgeon, urologist, pediatrician or even an epidemiologist. And yet, somehow, he can get away with writing books for parents, trying to convince them to circumcise their children, hosting a website that tries to act as an information resource for circumcision, and publishing papers on the matter. He too is nothing but a pro-circumcision lackey whose enthusiasm for the practice has garnered the favor of the pro-circumcision "researchers" club. He also happens to be an active member of the Gilgal Society.

Joseph said...

So what drives the interest of some of these circumcision "researchers" and promoters? Is it a true concern for the prevention of HIV? Or is it something that runs a little bit deeper than that?

Why aren't they careful that they might be employing types with outwardly despicable interests in circumcision? Are they concerned about their strength in numbers? Or could it be that an erotic fixation for circumcision is something they all actually share?

So why are WHO, UNAIDS and the rest pushing ahead with circumcision despite the evident problems? What has the HIV industry got to gain from adding the relatively small amount of HIV money they are happy to flush down the toilet for circumcision along with the massive amounts of money that is being spent on other ineffective strategies?

To answer these questions, I think it is necessary to analyze researchers' potential conflicts of interest. In my opinion, it can be summarized to these four. It's researchers trying to buttress their cherished beliefs with "science." It's doctors and manufacturers that have money to lose if circumcision falls out of favor. It's "researchers" who have a personal vendetta to legitimize the irreversible state of their organs, or organs of their spouses and children. It's "researchers" who would like nothing more than to preserve a procedure that produces the object of sexual desire.

It behooves the scientific community to launch an investigation as to the motives of all of this circumcision "research," what the motives of the authors are, who is funding them, and who stands to gain from the proliferation of the practice of circumcision.

It is my firm belief that this circumcision hullabaloo has absolutely nothing to do with HIV prevention, and more to do with the self-serving purposes I've outlined above.

Simon said...

Thank you for your comments, Joseph, I'll keep a look out for good research on the subject.

Joseph said...

Thanks for your time.

There is something wrong when people are more concerned about necessitating a "solution," rather than getting rid of the problem.

There are two words I have reserved for these knife-happy mutilators; opportunistic charlatans.

It gives me hope that there is a voice of reason coming from within Africa itself.

Thank you for your blog, and for asking the questions that need to be asked. It's about time someone has.

~Joseph

Thomas said...

I'd just like to second what Joseph says about Jake Waskett. I wasn't really familiar with any of the controversy surrounding these issues until he posted a comment on an article on circumcision I happened to be reading claiming that a paper (Exposé of misleading claims that male circumcision will increase HIV infections in Africa), of which he was a co-author, refuted the claims in the article (which were based on Van Howe & Storms paper, How the circumcision solution in Africa will increase HIV infections).

Out of curiosity I decided to read it to see if it really did refute the claims in the article, but instead what I found was a basic ignorance of the paper that they were supposed to be critiquing. I challenged Jake Waskett on this, and his response was that of someone who didn't seem to be familiar with the paper they co-authored or the basic arithmetic that was the point of contention. The mistake made in Waskett's paper is so appalling that I find it hard to believe that it went through any kind of peer review, it was the sort of thing that an undergradaute would notice immediately.

Essentially Waskett and his co-authors appear to be incapable of understanding a very simple calculation in Van Howe & Storms paper, in which Van Howe & Storms subtract the incidence of HIV in the group who report no sexual contact from the incidence in the sexually active group. Using this, Van Howe & Storms then calculate the number of cases of sexually transmitted HIV, but Waskett and his co-authors claim to be completely mystified by how this number is reached, and Waskett didn't understand when I explained the calculation to him.

Simon said...

Thank you Thomas, I'll have a look at that Morris paper. I'd also like to draw your attention to another site where I have posted about circumcision in Rwanda, where they plan to circumcise 2 million men using PrePex, a piece of plastic with an elastic band. Yet, the evidence in Rwanda is clearly against circumcision, which would involve massive expenditure for little or no gain and possible some considerable disbenefits, such as those mentioned by those opposed to circumcision.

http://dontgetstuck.wordpress.com/2012/01/10/prepex-in-rwanda-male-circumcision-associated-with-higher-hiv-transmission-and-higher-profits/

Joseph said...

This radioblog session is very, VERY relevant. Those interested in this issue need to listen.

http://www.blogtalkradio.com/avoiceformen/2012/01/06/circumcising-africa

Simon said...

Thanks Joseph.

KOTFrank said...

1. http://tinyurl.com/yks9apv 1in 5 HIV Infections Caused by Medical Staff (5million/yr,Africa,09) papers backed by Royal Society of Medicine

2. Stopping clinical trials early often exaggerates treatment effects (Mayo Clinic study 2010)
Stopping clinical trials early often exaggerates treatment effects

Date: March 24, 2010
Source: Mayo Clinic
Summary: An international study of nearly 100 clinical trials that were stopped early due to positive treatment effects has found that many of those effects were exaggerated.
---------------------------------------------------------------------------------------

An international study of nearly 100 clinical trials that were stopped early due to positive treatment effects has found that many of those effects were exaggerated. The authors of the study -- published in the current issue of the Journal of the American Medical Association -- recommend that researchers resist pressures to end clinical trials early and continue trials for longer periods before even considering premature termination.

"Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects. These misleading estimates are likely to result in misguided decisions about the trade-off between risks and benefits of a therapy," says Victor Montori, M.D., Mayo Clinic endocrinologist and corresponding author of the study. "On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials. Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent."

The clinical trials that Dr. Montori and colleagues studied were ended early because of a convincing -- and usually large -- apparent difference between an experimental treatment and an existing standard therapy. The studies were ended so participants taking a placebo or less effective medications could also take the studied drug. It usually also allows physicians to prescribe the therapy sooner because it will reach the market earlier. Dr. Montori says almost everyone involved benefits from a trial ending early -- doctors, researchers, funding sources, pharmaceutical firms, scientific journals, even reporters -- everyone except the patient, who may end up receiving a therapy on the basis of misleading information about its benefits.


The researchers examined 63 medical questions regarding 91 truncated trials and compared them to 424 comparable trials that were not stopped early. Results showed that the studies that were stopped -- especially smaller trials of a few hundred participants -- had exaggerated or misleading treatment effects. Those misleading findings are often compounded downstream because researchers are less likely to return to the topic after what is perceived as a significant successful finding.


The authors recommend that researchers use restraint and truncate clinical trials only near the end of a study and then only with "a very good reason." Otherwise, says Dr. Montori, patients and physicians will be making treatment choices based on inaccurate information, or worse, opting for one treatment when another may be more appropriate.


The study was supported by the Medical Research Council of the U.K. Other authors include Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all of McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

Story Source:

The above story is based on materials provided by Mayo Clinic. Note: Materials may be edited for content and length.

Mayo Clinic. "Stopping clinical trials early often exaggerates treatment effects." ScienceDaily. ScienceDaily, 24 March 2010. .

Simon said...

Thanks for your comment Frank, yes, a lot of flawed studies have been used over the years, and a lot of self-serving interpretations have been made. Billions of dollars has been spent on 'expert' opinion rather than evidence, because a lot of 'experts' know that that's how to attract the funding. People who know absolutely nothing about development, such as Bill Gates, Bob Geldof, Tony Blair, Bill Clinton and others, are credited with being 'experts', and their maunderings sway public opinion and often decide how donor money gets spent.