[Cz-biology] [Cz-health-sci] Merck proposal is NOT A GOOD IDEA

[Anthony Sebastian]

Oliver Hauss writes: "We have to deal with the quality of each and everyone's work, and not just with that of the Merck Manual's editorial team."

Regarding the Merck Manual, can articles on medical subjects for everyone in the country to read admit of high quality, including credibilty, if the source of the evidence behind assertions does not appear in the articles for anyone to study for herself?  Perhaps some formulations have not yet caught up with the latest evidence.  One cannot qualify the articles as scientific, since they lack reference to the primary data that supports conclusions.

And I agree with the generality of Oliver's statement in the quote above.

Oliver also writes: "If we say that we shouldn't use the Merck information because it doesn't cite peer-reviewed literature, I can certainly support that."

I feel one can always cite a Merck Manual article, so long as we comment on the issue that the authors write as authorities but do not cite the sources of their information or recommended pertinent further reading sources.  Indeed, as a "Signed Articles" subpage, CZ could reproduce a Merck Manual article, with their permission and signed by the authoring editorial team, and also with the understanding that CZ might comment on the article.  Merck might buy that as we would link to the original Merck page with the information that the Merck Manual also has related articles.  They primarily wanted the links.

Anthony.Sebastian  
  ----- Original Message ----- 
  From: Oliver Hauss<mailto:ohauss at arcor.de> 
  To: Biology Workgroup List cz-health-sci at voltaire.citizendium.org<mailto:cz-health-sci at voltaire.citizendium.org> 
  Sent: Thursday, November 01, 2007 7:08 AM
  Subject: Re: [Cz-biology] [Cz-health-sci] Merck proposal is NOT A GOOD IDEA


  Badgett, Robert G schrieb:
  >
  > Thanks for the opportunity to discuss this. I would not touch this
  > offer either.
  >
  > Aside from the Viox incident in which Merck is alleged to have
  > withheld negative data from the NEJM (See Failing the Public Health —
  > Rofecoxib, Merck, and the FDA - http://pmid.us/15470193<http://pmid.us/15470193>) (See
  > Expression of Concern - http://pmid.us/16339408<http://pmid.us/16339408>) and publishing a
  > deceptive meta-analysis (http://pmid.us/14564311<http://pmid.us/14564311>), there are numerous
  > studies of the hazards of conflicts of interest.
  >
  Bob, do you consider bringing up "alleged" misconduct as a good
  demonstration of your own impartiality?  The conduct of NEJM itself in
  this affair was far from stellar. The hazards of conflicts of interest
  exist totally independently of whether someone works for a company or not.

  > In the CZ evidence-based medicine article, I started a summary of
  > empiric studies on the problems with conflict of interest in
  > medicine(http://en.citizendium.org/wiki/Evidence-based_medicine#Conflict_of_interest<http://en.citizendium.org/wiki/Evidence-based_medicine#Conflict_of_interest>).
  >
  ...sorry, but we're neither talking about clinical trials of drugs nor
  about "the industry" in general. Statistical evidence says only
  something about likelihood in individual cases, but is no evidence for
  the individual case, and we're talking about one individual company
  here. To use these studies in the discussion here is an abuse of statistics.

  > Perhaps a worse problem is that our relating with a conflicted entity
  > may induce /bad behavior on our part/. See the start of a summary of
  > this at
  > http://en.citizendium.org/wiki/Medical_ethics#Effect_on_the_conduct_of_research_and_publishing<http://en.citizendium.org/wiki/Medical_ethics#Effect_on_the_conduct_of_research_and_publishing>.
  > Most disturbing is the Stelfox NEJM study (http://pmid.us/9420342<http://pmid.us/9420342>)
  > listed at the preceding link.
  >
  With the first line, you basically destroy your own argumentation. Your
  suggestion here that such bias would only be introduced by our
  association with Merck is intenable. It very likely already exists with
  numerous authors -the only logical consequence would be to fold our
  things and go if this risk is totally unacceptable.


  > Focusing now just on the quality of the Merck manual, there must be
  > something good going on as it is in its 18th edition. However, in
  > 1992, Antman showed the inaccuracies of traditionally edited textbooks
  > that rely on the unaided expert (http://pmid.us/1535110<http://pmid.us/1535110>). Since then,
  > medical texts have improved their methods to include things such as
  > peer review, disclosing authors' conflicts of interest, attributing
  > source evidence, frequent updating with literature searches supplied
  > to authors from a central editorial office. The Merck Manuel does none
  > of these and does not have an adequately transparent process.
  >
  Sorry, but from personal experience, I seriously doubt this. Our own
  article on iron deficiency anemia, until I went over it the other day,
  had simply taken over from Wikipedia markers for iron deficiency that
  are plain and simply useless in the event of chronic kidney disease (and
  some even in general) and was completely lacking markers that are openly
  advocated in the respective guidelines (which themselves are more
  instruments of policy and politics than evicence-based medicine). You
  yourself simply included references in the article, without a hint of
  verifying whether the references are outdated or not. Despite the fact
  that you noted that the article still has disputable statements, you
  chose to give it more credibility by simply tacking some sources onto
  it. You used a source from 1990 -more than 15 years old!- to support a
  claim which YOU introduced that ferritin was the most sensitive test for
  iron deficiency anemia (
  http://en.citizendium.org/wiki?title=Iron_deficiency_anemia&diff=100190016&oldid=100126447<http://en.citizendium.org/wiki?title=Iron_deficiency_anemia&diff=100190016&oldid=100126447>
  ) . I should consider this an insult, since you imply the diagnostics
  industry has not done any R&D in hematology in 20 years. But frankly,
  given the development of life sciences over the last 20 years, anyone
  should pause and ask himself what he is doing here before citing papers
  this old. While ferritin is still included in the KDOQI guidelines, it
  is used there only and exclusively in combination with TSAT or
  reticulocyte hemoglobin content. The same holds true for other
  guidelines. And in fact, some studies have shown that contrary to the
  claims you introduced, the sensitivity of ferritin can be abysmal:
  http://cjasn.asnjournals.org/cgi/content/full/1/Supplement_1/S4/T1<http://cjasn.asnjournals.org/cgi/content/full/1/Supplement_1/S4/T1>

  If you believe it is better to do so, I will revert my changes since my
  employer sells instruments with which you can measure some, but not all
  of the parameters at issue. However, the paper I cited was actually done
  on a competition instrument. So it's your choice: Do you want to spread
  outdated information that seriously threatens the health of people for
  the sake of a fig leaf against bias or are you interested in the
  information being accurate? Do you want Citizendium to make false claims
  because YOU introduced them and not someone from the diagnostics
  industry who, for the very reason that he works in the field, is
  familiar with pertinent literature?

  > So, there is theoretical risk that the Merck Manual is compromised and
  > maybe biased. Let's look:
  >
  > 1. It is interesting that if you search rofexocib in the Merck manual
  > you get 0 hits.
  >
  Why is it interesting? Rofexocib has been withdrawn. It is not an
  available drug in this context and as such, there is no reason to
  mention it. If you look into the article on pain
  (http://www.merck.com/mmpe/sec16/ch209/ch209a.html<http://www.merck.com/mmpe/sec16/ch209/ch209a.html>) , it goes into COX-2
  inhibitors at length: "NSAIDs include nonselective COX (COX-1 and COX-2)
  inhibitors and selective COX-2 inhibitors (coxibs); all are effective
  analgesics. Aspirin is the least expensive but has prolonged
  antiplatelet effects. Coxibs have lowest risk of ulcer formation and GI
  upset. However, when a coxib is used with low-dose aspirin, it may have
  no GI benefit over other NSAIDs. Recent studies suggest that inhibition
  of COX-2, which occurs with both nonselective COX inhibitors and coxibs,
  is associated with a prothrombotic effect that can increase risk of MI,
  stroke, and claudication. This effect appears to be drug-related, as
  well as dose- and duration-related. Although there is some evidence that
  the risk is very low with some of the nonselective COX inhibitors (eg,
  ibuprofen, naproxen) and coxibs (celecoxib), it is prudent to consider
  the potential for prothrombotic effects as a risk of all NSAID therapy."

  > 2. Another example: if you search Merck for "cox", you find this
  > statement in the osteoarthritis chapter
  > (http://www.merck.com/mmpe/sec04/ch034/ch034e.html<http://www.merck.com/mmpe/sec04/ch034/ch034e.html>), "NSAIDs,
  > including cyclooxygenase-2 (COX-2) inhibitors or coxibs, may be
  > considered if patients have refractory pain or signs of inflammation
  > (eg, redness, warmth). NSAIDs may be used simultaneously with other
  > analgesics (eg, tramadol, opioids) to provide better relief of
  > symptoms." Does any MD on this list agree with this clinical
  > recommendation by Merck? The Merck Manual omitted that the Cox-2 drugs
  > might increase myocardial infarctions. It seems the Stelfox bias has
  > occurred.
  >
  It seems there's bias here on your part. First of all, you tear out one
  paragraph from the region of drug therapy and suppress the information
  that it is much more elaborate. Second, you suppress that the article on
  pain lists those risks. Lastly, you suppress that the information is
  included in documentation on the specific drug including in the
  information provided by a drug's manufacturer which the Merck Manual
  explicitly advises to consult before prescribing or administering a drug.

  Lastly, if you actually look at the Osteoarthritis chapter of the HOME
  EDITION
  (http://www.merck.com/mmhe/sec05/ch066/ch066a.html#sec05-ch066-ch066a-328<http://www.merck.com/mmhe/sec05/ch066/ch066a.html#sec05-ch066-ch066a-328>
  ),  you find "However, one of the coxibs, rofecoxib (withdrawn from the
  market), appears to increase the risk of heart attack and stroke after
  long term use. The risk with other coxibs is being studied. Because one
  recent study has shown a 2.5 fold increase in cardiovascular problems
  with another coxib, celecoxib current FDA recommendations are to limit
  use of any coxib to people at high risk of gastrointestinal bleeding,
  who have a history of intolerance to other NSAIDs, or who are not doing
  well on other NSAIDs. Caution should be taken with use of coxibs for
  long periods or by people with risk factors for heart attack and
  stroke." -shattering both your complaint that rofexocib isn't mentioned
  and the failure to point at the risks of Cox-2 inhibitor.

  > So even if we think the Manuel operates with editorial independence
  > from the Merck company, we have to deal with the quality of the Merck
  > Manual.
  >
  > In summary, I believe the Merck Manual's methods are outdated and
  > there is evidence of inconsistent quality of content. Given time, we
  > can write better content. When this happens, it might be hard to
  > jettison the Merck links.
  >
  We have to deal with the quality of each and everyone's work, and not
  just with that of the Merck Manual's editorial team. And the first and
  foremost person with whose quality of work one should be concerned with
  is oneself. The first and foremost hallmark of sound scientific conduct
  is self-skepticism. Before accusing others of outdated methods and
  inconsistent quality, how about assessing your own work critically first?

  If we say that we shouldn't use the Merck information because it doesn't
  cite peer-reviewed literature, I can certainly support that. When
  talking about bias, however, everyone should first and foremost think
  about his own. Suggesting people "flip a switch" when they join the
  industry is just as ridiculous as the assumtion that people not
  officially on the payroll of a company don't have any bias.

  One other thing that I'd like to throw into the discussion is whether
  the home edition of the Merck Manual isn't a better place to link to,
  since it is written for the general reader and as such much more
  accessible for the average reader of CZ. But that's a whole different
  issue. In the meantime, I thank Gareth Lang for his voice of reason.
  Sorry if some of this is sharply-worded, but trying to sell one's own
  biases as adhering to good scientific conduct is using a pretty big
  excavator for the grave of CZ's credibility.

  Oliver Hauss
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