Validity of medical research financed by the pharmaceutical industry

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Ken Fox
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#1: Post by Ken Fox »

Another reason for doubting this sort of publication is the sponsorship by a commercial company, in this case Nestle. When research is paid for by a company, the company itself decides whether or not to allow it to be published, and these decisions are controlled by the determination of the sponsoring company as to whether or not publication serves their corporate interests. For this study I have no idea what the benefits would be to Nestle one way or the other.

To take another, more easily understood example, a very large proportion of the medical research done nowadays is paid for by pharmaceutical and medical device companies, and these companies have to give the researchers permission to publish their results. If the results are not favorable as to a particular drug or device, the manufacturers don't give permission and the study is not published. The result of this is that only positive studies get published, which gives the impression to those who rely upon the medical literature that a drug or device is more effective than it really is.

This phenomenon led a former editor of a major medical journal (I forget whether it was JAMA, Journal of the American Medical Ass'n, or NEJM, the New England Medical Journal) to recently comment that he no longer trusted the medical literature. Consider THAT the next time your physician recommends that you have a brain transplant or take a new medicine, and cites medical articles to buttress his recommendation!

ken


...split from Relationship between Coffee and Dose by moderator...
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Alfred E. Neuman, 1955

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#2: Post by GC7 »

Ken

Your last post is simply a gross oversimplification that is totally misleading as to the great majority of academic research. While there very well may be examples of research funds whose results and ultimate publication are controlled by a company the vast majority of research grants or collaborations (at least those known to me) are free of such ties. I have a current study using a pre-approval drug of a major pharm company and we are free to publish our results whatever they may be. We do of course provide the company our results before publication. Within a company itself they of course may do what they want with their research. However, publication standards that get the material out into the public domain remain the same for academic and corporate data as do government approval mechanisms.

Your statement about the large proportion of medical research funded by pharm and medical device companies is also way off the mark. By far the largest investment in research comes from The National Institutes of Health. Without this research investment by the government the drug companies would have no technologies or basic foundation from which to use for directed drug discovery. Clinical trials by definition are run through public access since companies have no access to patients or patient care without their collaborators. Those data are not company controlled when it comes to ANYTHING that ultimately becomes approved for human use and for sale.

Basic medical, genetic and translational research is far and away in a better position to cure and to manage disease then at any time in the past. It is quite amazing what we can do these days and the future is brighter without the past administration hindering all sorts of breakthrough ideas that could translate into cures.

While there is a glut of poor research publications that will never translate into new drugs, cures or basic insights into disease to state that there should be little trust in the medical literature is MALPRACTICE. Whomever made that statement (former editor :roll: ) is WACKO with a chip on his/her shoulder and a misinformed background of information.

Please show us the articles he/she cites to "buttress his recommendation"

End of rant.

Ken Fox (original poster)
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#3: Post by Ken Fox (original poster) »

I don't retract a single word of what I posted and do not doubt for a second its validity as regards the clinical practice of medicine. I used to practice medicine and I remain in touch with friends who still do, including my own internist, who has been a friend for more than 20 years. He doesn't believe anything a drug detail man tells him nor much of what he reads.

This impact of unpublished negative drug studies has been written up a number of times in publications written for intelligent laymen, such as the Wall St. Journal.

I am not addressing basic research being done on molecules that haven't reached phase 3 testing, where the stakes are much lower for the drug companies who are developing them.

I also sincerely doubt the idea that the US Gov't funded MEDICAL research approaches in any way the amount of money that "big pharma" puts into their phase 3 trials. For those who are unfamiliar with the term, "phase 3" refers to studies that are done to try to get approval from the FDA (US Food and Drug Administration) for a drug to be marketed in the USA for a particular indication. If the study does not produce the results that the drug company wants, they have NO obligation whatsoever to publish it and in fact they prohibit the publication of such articles in most instances. Medical researchers who accept funding from the drug companies to perform this type of research sign agreements with the drug companies giving the drug companies the right to refuse publication. This has been extensively documented and this is what the former medical journal editor was referring to.

Added on top of this is the fact that drug companies don't want to risk money on risky propositions, so they channel their resources into funding research on drugs that are very little different than their current "blockbuster" drugs that are about to go off patent (e.g. to become subject to generic competition). One needs to look no further than PPI drugs such as Nexium, Aciphex, ad nauseum. They change a carbon or hydrogen atom somewhere and then do repetitive testing on 20 possible uses for the drug, knowing that to meet the 5% statistical confidence level all they have to do is test enough things and by chance alone they will appear to have a better result. That's how Nexium became the new blockbuster after its predecessor.

Don't get me wrong; I'm a major league capitalist, and if that is what the drug companies want to do to buttress their bottom lines, then more power to them. It does however behoove practicing physicians to regard all published literature as suspect until repeatedly proven in additional studies, and by their own observations when it comes to commonly used drugs for common diseases.

ken

Slight addendum: I easily found articles on the subject I address above (suppressed medical research results) by googling. I used the search terms "wall street journal medical research negative studies not published" which pulled up pages and pages of links, many of which are not relevant but some of which are (typical of google searches). At the top was an article I remember reading a year ago on antidepressants.

Because I subscribe to the online edition of the WSJ, any link I would post here might not work for non subscribers (WSJ online is a paid service) but if you use the right search terms in google you can get free access to individual articles. I am reluctant to paste in the article content here as that would violate the WSJ's copyright and in addition might get Dan's lawyers all upset. If you search with google using the search terms I gave above, you will find the article for yourself and be able to read it (plus others) for free.

The link from the google search for the "top of page" article was: online.wsj.com/public/article_print/SB120051950205895415.html

I hope the link will work for you.
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Alfred E. Neuman, 1955

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#4: Post by GC7 »

Well I lost two long responses and I don't have time to repeat that so the short version.

Ken you are simply wrong in your conclusions. You base your view on criminal conduct within a company or companies that if true is still minor in proportion to the VAST majority of ethical work and conduct within the academic and company/private sector research community.

You are also way off the mark in your thoughts on costs of phase 3 trials. Add up cost of all trials phase 1, 2 and 3 and they are dwarfed by the NIH yearly budget. Look it up yourself.

You seem to be a former disgruntled physician. I don't know why but with the exception of tight funding the research community is in a far far better position to help people then ever.

This of course does not change the fact that publications funded by conferences (the topic of this thread that we should get back to) are generally published as is without any peer review and need to be read with caution as to quality and conclusions

Ken Fox (original poster)
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#5: Post by Ken Fox (original poster) »

Disgruntled? It is because of my career in medicine that I was able to retire early and enjoy life even more :mrgreen:

Those who are interested in this (non-coffee related topic) can peruse a few of the below articles pulled up in a quick google search:

http://blogs.wsj.com/health/2008/12/12/ ... published/

http://theoncologist.alphamedpress.org/ ... l/13/9/923

http://www.mindfully.org/Health/2008/An ... 6jan08.htm

http://generalmedicine.suite101.com/art ... n_hurt_you

http://www.cmaj.ca/cgi/content/full/170/4/481

http://www.ahrp.org/infomail/04/06/05.php

http://online.wsj.com/article/SB122342420313813411.html

http://www.medicalnewstoday.com/articles/94267.php

http://news.bbc.co.uk/1/hi/health/3652185.stm

http://www.scienceblog.com/cms/clinical ... 18271.html

http://jnci.oxfordjournals.org/cgi/content/full/djn495

If I had had another half hour, I could have pasted in another 100 of these articles.

Bottom line: if your physician relies almost entirely on published drug study information and does not have a healthy degree of skepticism towards it, then it might be a good time to find another one.

ken
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Alfred E. Neuman, 1955

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#6: Post by GC7 »

Ken

I will reply once here only. You seem to be impugning the ethics and integrity of an entire community of scientists working in academia and industry when you are really talking about salesman and marketing gurus pushing drugs. Or perhaps you are talking about the scientists themselves?

You are wrong about budgets. However, I ask you what you think of the Nobel winning research of Brown and Goldstein who dissected the biosynthetic pathway leading to cholesterol synthesis and the resulting inhibitors? Those cholesterol lowering drugs are used by millions and saving and prolonging hundreds of thousands or millions of lives. New genetic research leading to personalized medicine (with proper legislation to protect an individuals rights to insurance etc) will allow us to predict who medicines will help and who will have averse reactions and thus leading to more effective treatment. Do you support such efforts? Should we not do medical research and use the money for something else?

I could go on and on with success stories as well but I'll stop and ask those reading to choose your doctors carefully and ask questions. I'll also ask you to believe that researchers in industry and academia are doing great things that will have immense positive consequences in lifespan and quality of life. We are not the greedy unethical criminals that Ken would have us believe.

edit - in skimming one of your articles I can say you misread either on purpose or because you don't understand. If only a small number of trials get published or extended to larger patient populations that is not necessarily a bad thing. Only a tiny fraction of drugs get approved or help people. That this is realized quickly and aborted is GOOD. The clinical trials protocol is very involved and there to ensure that a treatment protocol will work and better then existing treatments. As you progress from 1 to 3 the endpoint is harder to reach and achieve, That too is good.

Ken Fox (original poster)
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#7: Post by Ken Fox (original poster) »

I don't question science in general nor the ethics of most people who perform scientific research. Nor do I question the advances that have been made in science and medicine, those that will be made in the future, nor the fine people who have made them. I myself have authored or co-authored several studies published in peer-reviewed journals, which thankfully had no economic impact whatsoever and hence never even had the potential for being effected by economic concerns.

I only wish to point out that when private companies sponsor research they seldom do so for "altruistic" reasons.

Nestle was responsible for the article that was cited that started the thread from which this sub-thread was split off. I have no idea what their motivation was in doing so nor any idea how their sponsorship of this research may have effected the outcome and what was published vs. what was not. For purposes of disclosure, I have been a Nestle shareholder several times in the past (although not currently other than that it may be in an index fund ETF I now own). I have had some fine Nestle branded chocolates (ones made in Switzerland, not the USA) and also some of the worst coffee I have ever consumed, also made by them.

My point in citing the example of the effect of drug company sponsorship on published research was that it is a topic with which I have some familiarity and it shows how conflicts of interest can impact the information that ends up in the "public domain." In the case of the clinical practice of medicine, this bias towards publishing mostly those studies that help the drug companies in their marketing has had significant adverse effects on patient care and probably will continue to do so. One can debate who is impugned and for what reasons, one can speak of "a few bad apples" or view the information in any light one chooses. In the end such a conclusion adds little. What is clear is that what is happening with medical research publication bias impacts the value of the medical literature in a profound and negative way.

With regard to coffee I doubt that the impacts can or will be that great.

ken
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Alfred E. Neuman, 1955

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#8: Post by GC7 »

Ken

I mostly agree with you last post.

Minor points

If you see a paper from a conference Nestle or otherwise it should not be taken seriously. Not because Nestle or the company is overtly influencing the publication but the opposite actually. There is NO PEER REVIEW at all for a large number of these conference based articles. They want your cash $$$$$ to attend the conference and the "bonus" is you publish. Most of us avoid this like the plague as we want to save our good work for high impact journals.

You say "What is clear is that what is happening with medical research publication bias impacts the value of the medical literature in a profound and negative way."

I ask what publication bias? Journals are run not by companies but separate entities and controlled by peer review by people who have by their word no conflict of interest or financial stake in the paper.

I don't know where you got your views or information about peer review and publication but it sure is tainted.

Back to coffee please :idea: You will be happy to know I almost always dose at 14 gm.

Ken Fox (original poster)
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#9: Post by Ken Fox (original poster) »

Getting back to coffee:

I bought Nestle (NSRGY) the last time at around $33, then sold it at $39. I had been planning to look back in on it and this thread got me to log onto my brokerage account and I found it was back around $35. All comments about their coffee aside (which truly sucks), they are a very well run company selling near their low for the year and probably about as recession resistant a company as you could find.

On an internal Air France flight a few months ago, they had a Nestle contraption that was wheeled down the aisle to make coffee for people. It made individual cups of horrid coffee as ordered by the passengers, and made a fair amount of noise in doing so. Out of curiosity and in the need for medicinal caffeine, I requested a cup, and it was no better than bad instant coffee, even though it came out of this very impressive looking machine.

My feeling was that any company that could produce a product that bad, and that could succeed in selling it, "deserved" my investment. Shortly thereafter I bought the stock for $33, and later I sold it as above.

I decided to buy it again just now, and maybe this time I'll hold it long term. Just because a company makes some foul products is not a good enough reason not to own it in the right circumstances :mrgreen:

ken
What, me worry?

Alfred E. Neuman, 1955

SL28ave
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#10: Post by SL28ave »

All I know about pharmaceutical research is that I have a very hard working cousin who is a director in an NIH lab who I'd very seriously be very surprised if he twisted even the most harmless data-point, and I'm also very close with someone on Capitol Hill who pointed out politics at NIH. I think especially with coffee there might be a high proportion of "compromise" in research funding, but ultimately some gratitude to companies like Illy should probably be called for. A study that is 100 times more interesting to me than an academically-pure Cornell coffee health study is when Intelligentsia, Counter Culture, Tim Schilling, etc. tasted Rwandan coffee fermented like 100 different ways. Too bad the results weren't published in Nature.

Neither skepticism, intense curiosity nor joy about the research realm should ever be at sleep, imo.

As with most things though... unfortunately... not my area of expertise.
"Few, but ripe." -Carl Friedrich Gauss

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