24 December 2011

The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences

RebornHammer accused me of not reading the meta-study "The Financing of Drug Trials by Pharmaceutical Companies and its Consequences" (Schott et al, 2010) (I referred to the authors as Lieb et al in the discussion). I disagree as I did read it and I think my understanding of the meta-study is better than RebornHammer's.

tinyurl com/6qjmgb4 PROZAC is so great!! A study on trials of SSRIs revealed that those with significant results were more likely to be published, sometimes more than once, whereas trials with non- significant results or findings unfavorable to the drug under investigation (intention-to-treat analyses versus per-protocol analyses) were not published
1) This article is not a criticism of peer review or science, it's a criticism of pharmaceutical companies and how they try to thwart the science that exposes inefficacy or side-effects of their products. Lieb et al are encouraging government to take steps to see that this doesn't happen and that science continues to hold pharmaceutical companies accountable for evidence.

2) This in no way is evidence supporting Homeopathy.
@wstevenschneider thats evidence for a bias against homeopathy and any research or peer review that might prove it to work..

@wstevenschneider And that is why every time you ask for peer review proving homeopathy you are asking for something that is unlikely to ever exist under the current political/ medical situation on the planet earth.

@wstevenschneider hello? can you read? what this is is a criticism of peer review that is used by the medical community to choose treatments for their patients. The point is that the pharmaceutical industry is out of control, and owns(through contributions and donations) most of the most highly respected peer review for medicine out there. This means that if it's not a pharmaceutical drug it does not get the light of day. Homeopathy is not a pharmaceutical drug.
Let's read "The Financing of Drug Trials by Pharmaceutical Companies and its Consequences" (Schott et al, 2010) together.


Fifty-seven independent studies looked at various trials that were funded by pharmaceutical companies. These studies were then organized into a meta-study to get a more comprehensive view of what is going on when pharmaceutical companies fund research.


Incomplete registration
With the aim of facilitating public access to clinical trial data and preventing pharmaceutical companies from influencing the publication of results, in 2004 the International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in any of the 11 leading medical journals (7): new trials had to be registered by 1 July 2005; those already under way, by 13 September 2005. Meanwhile several reg- isters fulfill the ICMJE standards.

In January 2005 major pharmaceutical organi- zations, among them the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Inter- national Federation of Pharmaceutical Manufacturers and Associations (IFPMA), implemented guidelines that obliged their members to enter trials prospectively in publicly accessible registers (8, 9).

Despite this, two of the 57 studies included in the present investigation contain data suggesting that phar- maceutical companies are still not registering important information on clinical drug trials.
Evidence that some pharmaceuticals are not disclosing their funding of drug-trials.
Concealment of adverse drug reactions
Seven of the studies investigated concerned themselves with adverse drug reactions (ADRs) in industrially sup- ported drug trials (Table).
Evidence that some pharmaceuticals are repressing the publication of self-funded trials that reflect negatively on their product.
Publication bias
Of the 57 studies included in this investigation, 14 ana- lyzed the connection between the type of funding of a trial and publication bias.
Evidence that some pharmaceuticals only present the self-funded trials that reflect positively on their product to the FDA.
Rights over trial data and restricted publication rights
Two investigations on this topic were identified. Both an analysis of the protocols of all studies initiated and published by pharmaceutical companies in a particular region of Denmark in 1994 and 1995 (e28) and a ques- tionnaire survey of medical specialists in Australia (e29) indicated that in some trials pharmaceutical companies secure the rights over the data and place constraints on publication rights.
Evidence that some pharmaceuticals consider the methodology, results and data from the drug trials on their product to be propriety information, particularly if they are funding the trial.
Ghostwriters and guest authors
A case study on rofecoxib (e5) and an investigation into the above-mentioned studies in Denmark both found evidence of frequent resort to ghostwriters and guest authors in industry-funded publications. The Denmark investigation showed that statisticians employed by pharmaceutical companies are frequently not men- tioned in the published articles (e4).
Evidence that some pharmaceuticals attempt (and succeed in some cases) to control the direction of and what is said in the report of a trail they are funding.


This systematic review clearly shows that clinical trials with the involvement of pharmaceutical companies often present the therapeutic benefit of a drug in too positive a light and also fail to mention risks. Clinical studies are increasingly being funded by pharmaceuti- cal companies (e32­e35). Professional medical bodies construct evidence-based guidelines on the basis of published trial results, so their recommendations may be flawed. This contributes to excessive prescription of expensive new drugs whose efficacy is overestimated and risks underestimated. Moreover, because the evi- dence is distorted patients do not receive adequate in- formation (14).

In the past few years measures have been taken worldwide to deal with the problems described here. Laws have been enacted, for example, with the inten- tion of securing public access to research data (15­18). In the USA, for instance, a law of 27 September 2008 prescribes the registration and publication of the results of clinical trials in a register accessible on the internet (15, 19). In the European Union, directive 2001/20/EC requires registration of all clinical studies (16). A guideline implemented in 2008 lays down what classes of information from the EudraCT database-- accessible only to governmental authorities--should be made available in the publicly accessible EudraPharm drug database, which thus remains incomplete (17, 18).

Pharmaceutical organizations have implemented recommendations that are intended to ensure compre- hensive publication of research findings, whether posi- tive or negative (9, 12, 20). This initiative on the part of the pharmaceutical industry is welcome; however, the present investigation shows that negative results are still not being published in timely fashion and control mechanisms have failed.

Official regulatory measures to guarantee public access to study protocols and results and prevent the withholding of information about dangerous ADRs are urgently required. This would also give independent drug bulletins and bodies representing physicians, e.g., the Drug Commission of the German Medical Associ- ation, the opportunity to obtain detailed, unbiased in- formation about new drugs. Furthermore, it should be obligatory to prove that a new drug provides additional benefit compared with existing pharmacological and non-pharmacological forms of treatment. More public funding should be made available for independent studies (21, 22).

Measures must be taken at many levels to ensure that commercial interests do not undermine the knowledge of scientifically correct study planning, study execu- tion, and publication (4, 5, e15, 15, 23­25, e36, e37). A large number of physicians are involved in the planning and conduct of drug trials. For the benefit of their pa- tients, they should assume greater responsibility and work to counteract the economic self-interest of pharmaceutical companies in research and clinical practice.
This meta-study is not an indication of the corruption of peer review though it does indicate that some pharmaceutical companies attempt to subvert the peer review process in pursuit of profits. What the meta-study does show, albeit indirectly, is the self-correcting nature of peer review at work. Science is always questioning things, even its own conclusions. Peer review is also subject to this scrutiny.

Here we see scientists taking a look at a particular portion of peer review, in this case drug-trials, and finding evidence of pharmaceutical companies trying to subvert the peer review process. This meta-study serves to alert researchers, journal editors, medical doctors and policy makers of these subversion attempts.

Furthermore, the meta-study acknowledges that, while progress has been made countering some of these threats to peer review, more effort is required as more pharmaceutical companies are starting to fund research. Schott et al calls for several things:
  • Official regulation of drug-trails to guarantee public access to studies and provide disclosure of adverse drug reactions.
  • New drugs should provide benefits beyond that provided by old regimes.
  • Increase public funding for more independent studies.
  • Improved measures to prevent commercial interests from subverting the research and the peer-review process.
  • Doctors to be proactive in countering the commercialization of medical science.
It does not follow that because there are pharmaceutical companies that attempt to subvert research and peer review that the peer review process is unreliable.

In fact, much of the message that comes from this meta-study is that the reader should be wary of pharmaceutical-funded clinical trials. As usual, the trials to go to are the publicly-funded, independent third-party studies that have no vested interest in the success of the drug being reviewed.

Far from being evidence that peer review and medical science are corrupt and unreliable, this meta-study shows us that peer review allows scientists to verify attempts to corrupt the process and to suggest corrections. It also demonstrates that science is out to protect the well-being of the general public and that pharmaceutical companies must continue to be held accountable.

While no one disputes peer review is not without its flaws, it is the only thing preventing pharmaceuticals from corporately raping the public. This meta-study serves as a call-to-arms to protect the integrity of peer review from being subverted by pharmaceuticals whose main interest is producing profit for their share-holders.

So, RebornHammer I'm curious as how you got, "The point is that the pharmaceutical industry is out of control, and owns(through contributions and donations) most of the most highly respected peer review for medicine out there," from Schott et al when this is clearly not what the meta-study says. I get the impression that you read the abstract and drew your own conclusions without bothering to find out what the meta-study actually said.

22 December 2011

Examining Peer-Review

RebornHammer's Campaign

Our good friend RebornHammer dislikes the fact that his detractors call for peer reviewed evidence in support of his claims of Homeopathy. RebornHammer dislikes the fact so much that he has begun to wage a campaign to discredit peer review.

tinyurl com/735c5v9

Richard Smith, also a past editor of the British Medical Journal, recently summed up his view of journal peer review as follows:2

“We have little evidence on the effectiveness of peer review, but we have considerable evidence on its defects. In addition to being poor at detecting gross defects and almost useless for detecting fraud it is slow, expensive, profligate of academic time, highly subjective, something of a lottery, prone to bias, and easily abused.”
RebornHammer - Quote-Mining Richard Smith"

RebornHammer: (in response to the claim that the previous article doesn't discredit peer review or the research that demonstrates Homeopathy doesn't work)
tinyurl com/73x23m3 Where to now for health-related journal peer review?: Excerpt from JLM, June 2011 "despite 25 years of effort, journal peer review processes are themselves not “evidence-based”. This is not to suggest that we should become cynical about peer review, but rather that systems of peer review be recognised as generally not being based upon firm scientific data and that they are as much about politics and ethics as about “evidence”."
RebornHammer - Not Understanding the JLM Article.

Measured Response

Dear RebornHammer, nobody ever said that peer review is the end-all and be-all of scientific evidence.
  • Is peer review slow? Yes.
  • Are erroneous articles found in journals? Yes.
  • Do many laypersons and some scientists uncritically accept the validity of peer reviewed articles that appear in a journal? Yes.
  • Do journals reflect the biases and sometimes ideologies of their editors? Yes.
  • Could we have something better than peer review? Sure, but we don't have that yet and need to use the best tool available which is peer review (perhaps it might be you, RebornHammer, who discovers/develops a better tool).
  • Do flaws in peer review invalidate science? Certainly not.
Why then do we prefer peer reviewed evidence over some random article found on "teh Intrawebs" you may wonder? The main thing peer reviewed journals provide for us is a body of evidence that has a guarantee that most of the articles will be free of basic errors.

Your next question, RebornHammer, should be "How does this body of evidence work?"

As scientists perform their research their results are submitted for peer review. Assuming there are no basic errors in the paper the paper gets accepted for publishing. Sometimes a journal's editorial staff do not practice sufficient oversight and a researcher may have to try to get their paper published in different journals before it finally gets accepted.

Regardless, if the scientists' results are verifiable then the conclusions and results of their paper will be used by other scientists when they explain the results of their own particular papers. Over time the number of papers using these results will constitute a body of evidence that confirms the correctness of the results of the original paper.

On the other hand, if the scientists' results are not verifiable then the conclusions and results of their paper will not be used by many other scientists to explain the results in their own particular papers. This will result in a dearth of evidence for the results of the original paper.

What this means, RebornHammer, is that the articles you quote do not invalidate peer review. These articles warn the people who use peer review, be they scientists or laypeople, to maintain a modicum of skepticism even when citing peer reviewed literature!

Now, you may maintain that I and others accept peer reviewed literature uncritically but tear-apart your non-peer reviewed literature. It is true that we are more likely tear apart your non-peer reviewed literature than any peer reviewed evidence you may cite. It is not true however, that I, at least (though I'm sure the others are the same, but I don't wish to speak their minds for them), don't view the peer reviewed evidence we use as our evidence without skepticism.

Nonetheless, the body of evidence is overwhelmingly against the idea that Homeopathy even works. Too much research has been done on Homeopathy over the past 200 years, too many clinical trials have come back in the 60 odd years since they've been used, to support the notion that Homeopathy works in any way imagined by Homeopaths.

The take home message here is: Despite the flaws and limitations of peer review it is the body of evidence that matters and the body of evidence does not support the Homeopathy hypothesis!

Sourced Articles

The Richard Smith Article

The JLM Article

15 December 2011

Dealing with Anti-scientific Buffoons

I can't believe some of the anti-science crap floating around YouTube. No sooner than you flush some of the excrement out of a forum you're frequenting then some more gets dumped in. What's an honest skeptic to do?

The HomeoTards Past

Mr. Benneth hasn't shown his face in the YouTube forums since the skeptics there spanked him pretty hard over his dishonesty. For now he's sulking and firing potshots from his personal blog.

Mr. Bonking still makes an appearance, mainly to preform a "drive-by" spamming and rarely engages in conversation anymore. Sometimes he'll attempt his Homeopathy apologetics as drhomeopathycures, but even that's weak and infrequent.

The HomeoTards Present

One Homeopath I deal with is only 16 years of age. Old enough to be held accountable, but young enough I still hold out some hope for his eventual return to reality. At this point I'd rather not consider him a HomeoTard, but if the evidence suggests otherwise I may have to change my mind.

This brings me to the main subject of this post, RebornHammer. This "gentleman" (a term I use here, but loosely) came into the forums making claims that James "The Amaz!ing" Randi" had defrauded one Vithoulkas on the $1M Challenge.

A little research into the matter reveals the following:

George Vithoulkas Homeopathy Challege - Starting Anew

After frequent attempts to get RebornHammer to provide some verifiable, peer-reviewed evidence fail, RebornHammer begins posting quotes from scientific laureates in an attempt to convince the skeptics that they're being irrational and unscientific. The skeptics of course understand these quotes and their meanings better than RebornHammer does. It also gets pointed out to reborn hammer that these quotes don't count as evidence in support of Homeopathy's supposed efficacy.

The upshot of this was that I finally lost my temper. Perhaps I was over the top, I don't know. Dealing with deniers of science and cranks all of the time makes me feel cranky. Anyhow, here's an excerpt of the conversation where I blow up.

Cancer is finally cured in Canada but Big Pharma has no interest, watch it 'till the end!

tinyurl com/25lz49u

regarding what it worthy of scientific study, WHERES THE MONEY?. what is worthy of being studied, please watch the YOUTUBE video titled : Cancer is finally cured in Canada but Big Pharma has no interest, watch it 'till the end!
@RebornHammer How is this evidence of the efficacy of Homeopathy?
this is evidence of the inefficacy of the scientific community and the Pharmaceutical industry. There is little interest in cures and medicines that are not patentable. Homeopathic remedies are not patentable. So there would be no interest in proving their efficacy. How about you tell me something that is proven to work(peer review or whatever you think is worthy) that is not patentable? There will be few things you can tell me about. Of course I could be wrong but you go ahead and tell me.
@RebornHammer The puerile pustulence that erupted from this particular post of yours demonstrates what passes for thought in that festering and malodorous mound that you call your brain. None of your technology that you enjoy so much has come about w/o science guiding it. From the car that you drive, to the device that plays your favourite music, to medicine that's protected you from illness, to the building that you live in.

None of these things would have come about without the science, the scientific community and the peer-review process which you so revile. If you dislike these things so much then please turn in your vehicle, give up your music player, stop taking medicine and move into a cave.

You argue against medicine when supporting homeopathy, but you want a "cure for cancer" that hasn't been all the way through trials yet.

In your arguments against science and medicine you try to have it both ways. You want science to approve of the things that you want, but you don't wish to let science take its course and discover how some cure really works, when it works and how well it works.

Now you conflate a possible medicine that may be used in the future with Homeopathy. DCA has much more effectiveness than any Homeopathic remedy so your sorry attempt to equate the plight of Homeopathy with DCA just marks you as desperate and pathetic.

Homeopathy has already been explored and found wanting. There's nothing new here; in-vitro tests on cancer cells with Homeopathic remedies weren't statistically more significant than the control and quality clinical trials have never shown that Homeopathy is more effective than placebo.

DCA: currently being researched and has efficacy beyond control

@RebornHammer In case you interpret this as an ad hominen note that I am criticizing your continued lack of understanding of how science works, how peer-review works and your insistence that we believe Homeopathy works despite its consistent failure to work in trials or lab tests.

Go and educate yourself on how science and peer-review works instead of concocting conspiracy theories. You're beginning to bore me.
murdocha (Ah, where were you earlier? :-)):
@RebornHammer What is your argument here? Big Pharma makes money so it is bad, therefore homeopathy works? I don't want to put words in your mouth, but that seems to be the essence of your argument. Please, make a request for the financial records of Boiron, Hahnemann Labs, Celletech, OHM Pharma (a Big company), see if they are making a profit. If they are, be prepared to judge them in the same light.
RebornHammer Claims about Cancer Cure
RebornHammer Claims Bad Science and I Blowup
My Blowup Continued

So yes, my head hurts from having to deal with these sorts of people on YouTube. Maybe I will take a break from YouTube for a couple of days, spend time with my wife and kids and get reconnected.

02 December 2011

The Fish of Time Redux

Meeting Two of the Rational Theists

The rational theists of YouTube got together for their second show the other day, The Fish of Time Show, to talk about Creationism. There was some interesting discussion, but there are some things I feel I'd like to address.

The Fish of Time


My Thoughts on Show 2

At 00:38:46 into the show, one of the participants (sorry, I don't know them all by name) mentioned that you have to consider the Genesis story to be allegorical, but the story of Jesus' death and resurrection to be fact. The thing is, how do you decide what to consider allegory and what to consider fact? Is there evidence to support the notion that some parts of the Bible are fact where others aren't? Is there evidence that suggest anything about the Bible is factual at all?

Now, I'm not saying that there is absolutely nothing true or factual in the Bible; you just can't depend on the Bible as a book of facts. For a book purported to be The Word of God this is problematic. How can you count on the Bible to reveal truth if it can't recount facts in a reliable fashion? Even if the Bible turns out to be The Word of God and is Truth, this lack of reliability in terms of facts doesn't lend the Bible much credibility.

So, once you start deciding that some parts of the Bible aren't to be taken literally due to a "fact deficit" what's to stop you from doing the same to ever more and more parts of the Bible? The above is what happened to me. The more I learned the more I realized that the revealed truth of the Bible didn't conform to the observed facts of science.

Listening to The Fish of Time Show I wonder how they can deny one part of the Bible, but accept another part? The truth is, no Christian accepts the entire Bible as literal fact as some amount of interpretation is required. If we were actually to accept the entire Bible as factual and true it would be insane, some parts of the Bible were meant to be allegorical!

I was amused when they laughed at the Koran. Two holy books, which is truer? Good question, is there an answer?


04 Dec 2011

After a conversation with a historian friend of mine (where she pretty much waxed the floor with me regarding evidence in classical studies) I feel it's necessary for me to add the following:
  • Some parts of the Bible's historicity are verifiably true
  • Some parts of the Bible's historicity are verifiably untrue
  • My primary issue is how different sects of Christianity determine what is true and what isn't
  • My secondary issue is how Christians believe the veracity of one set of claims of the miraculous in the Bible over others
  • My tertiary issue is how some Christians' belief in the Bible being inerrant leads them to acts which are technically immoral by any sane reasoning, harmful to the people around them and to trying to restrict basic human rights

Thanks Jo for kicking my ass and keeping me honest.