Perceptions of probity

I found this picture interesting.

Take a look at look at the two images from your seat. Note which face is angry, and which is calm (Mr Left or Mr Right). Now get up and move back at least 10 feet.

I had the same feeling when speaking about ghostwriting and scientific misconduct at recent meetings of the International Society of Medical Publication Professionals (ISMPP). Different people, apparently looking at the same world, do not see the same thing.

Although "ghostwriters" are ostensibly the key enemy, I had a different view after these meetings. Most honestly believe that what they do is important and good. Most are very nice people, well intended, and with genuine concerns about integrity. Most are shocked when shown examples of what has happened - and the consequences.

This is in contrast to academic medical leadership who have acquiesced with deception, and have passed their sense of integrity to the next generation. Medical writers do facilitate deception, but are not generally responsible for it. Some ghostwriters have however been participants in outright scientific fraud.

There are problems with overemphasising only one facet of a very large problem, and pretending that it is the whole problem.

Work of Phillippe G. Schyns and Aude Oliva at MIT

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Memory Hole (24 October): Everyone is fooled

Scientific Misconduct Blog Memory Hole: Events of October the 24th

81 years ago today: Houdini's last performance

On 24 October 1926 Harry Houdini the famous escapologist gave his last performance
(at the Garrick Theatre in Detroit).

His escapes relied on trickery and misdirection.

Not unlike the nimble evasions and circumlocutions, and the Houdini-like scientific escapes discussed here.
It is about those scientific fraudsters and fakers who slip through the loopholes. Everyone is fooled.

He was also a genius.

The picture is a detail from his 1 March 1921 patent application for a diving suit.

#1370316 signed "H Houdini, Inventor".

Serious science and engineering underlying the tomfoolery.

78 years ago today: Stock market crash

24 October 1929 was the "Black Thursday" crash on the New York Stock Exchange. I am interested in the functioning and malfunctioning of government and "regulators" (including drug "regulators") in a supposed free market - hence this entry.

60 years ago today: Walt Disney and the "communists"

On 24 October 1949 Walt Disney testified to the House Un-American Activities Committee naming Disney employees he believed to be communists. Ditto above.

5 years ago today: Imperial College London and the mystery publication

On 24 October 2002 a mysterious paper appeared in the New England Journal of Medicine about hypertrophic cardiomyopathy (W. Shamin et al. NEJM. 347, 1326 1333, 2002)

There were eight authors. The signatures of all eight appeared on the original submission and the three revised versions. Over the weeks following publication it emerged that several of these signatures were forgeries. Indeed most "authors" had never seen the manuscript, nor the original data.

Six "authors" had affiliations with Imperial College. Two authors, Waqar Shamin and Mohammed Yousufuddin appear to have chosen six other authors at random to lend prestige to their paper. One author stated "The first thing I knew of it was when Yousufuddin rang me two days before its publication to congratulate me, and to ask me about the method involved in case journalists questioned him".

Having said that, authors in the NEJM and elsewhere are often not authors at all.

This is a good quote about the importance of authorship:

"the integrity of a body of literature is our society’s ultimate temporal forum for negotiating life and death, suffering and wellness... the medical well-being of the society it serves is dependent on the question of who stands behind the word."
-Fr. Mark Gruber, 1999 (cited in ref)

Source for main story: "Paper Retracted as Co-Author Admits Forgery," Nature 421: 77.

3 years ago today: Bullying of doctors in the USA for raising patient welfare concerns

On 24 October 2004 the Association of American Physicians and Surgeons passed a resolution to investigate what they describe as "bad faith" peer review (basically use of hospital "peer review" proceedings to bully doctors who advocate too loudly or too persistently for better patient care).

One year earlier in October 2003, the same newspaper, the Pittsburg Post Gazette published an excellent series of articles over four days dealing with the abuse of doctors who had voiced concerns over patient welfare in the United states. Some of the articles in this "Cost of Courage" series are below:

Part 1: How the tables turn on doctors
Part 2: When right can be wrong
Doctors who spoke out: part A
Doctors who spoke out: part B
Doctors who spoke out: part C
Doctors who spoke out: part D
Extra: Rules of fair play don't always apply
Extra: Centre County hospital critics soon unwanted
Extra: Doctors pay for reporting suspicions

Source main story: Medical groups look into 'bad faith' peer reviews, Pittsburg Post Gazette, Oct 24, 2004

2 years ago today: Cylert discontinuation

On 24 October 2005 the FDA announced that "the overall risk of liver toxicity" from Cylert (Pemoline, an ADHD drug) "outweighs the benefits of this drug". It was linked with 21 cases of liver failure, of which 13 resulted in liver transplantation or death (incidence 10 to 25 times greater than the general population). Abbott Laboratories had already discontinued production.
Source: FDA Alert: Cylert

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Memory Hole (21 October): Vioxx and a quacking duck

8 years ago today: A story of ducks and a single death in a Vioxx clinical trial

On 21 October 1999 a 73-year-old woman died. That death and our response to it tells volumes about the health of our profession.

In medicine we sell our wares under the banner of science. The technique of science (the "scientific method") consists of a number of steps. For a double blind randomized clinical drug trial those steps might be:

1. State a meaningful hypothesis
2. Design a study and statistical methods to test it
3. Do the study in a double blind randomized way
4. Unblind the study AFTER deciding what happened to each patient and locking the database
5. Study authors analyze the results
6. Share the results with everyone

That is the usual way of science. This method is not used by the practitioners of any system of quackery.

So that takes us to the Merck Advantage trial of Vioxx, and a single 73-year-old female participant in that trial who died on this day - Oct. 21, 1999. She died a few minutes after calling her son to tell him she felt short of breath.

The Advantage trial was a very short (12-week) clinical trial in 5,500 patients. If you want to avoid showing up long term side effects, you keep your clinical trials short and scientifically irrelevant (that's about the meaningful hypothesis part).

Now eight people taking Vioxx suffered heart attacks or sudden cardiac death in the Advantage trial, compared with just one taking naproxen, according to data released by the F.D.A. in 2005. The difference was statistically significant, but Merck never showed the data that way.

In the published study, Dr. Lisse (University of Arizona) reported that five patients taking Vioxx had suffered heart attacks during the trial, compared with one taking naproxen, a difference that did not reach statistical significance. But the paper never mentioned the other cardiac deaths of patients taking Vioxx, including the 73-year-old woman.

Dr. Lisse said that while he was listed as the paper's first author, Merck actually wrote the report (that's the authoring bit). "Merck designed the trial, paid for the trial, ran the trial," Dr. Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."

Now, the other thing in usual science is not to allow company technocrats with a vested interest to decide themselves what happened to individual 73 year old women after the study is unblinded.

Neither patients nor their doctors were aware whether patients were receiving Vioxx or naproxen. Results from the trials were also supposed to be blinded when they were examined, so that Merck researchers could not bias the results. After examining the case, Dr. Eliav Barr, a Merck employee judged that the woman had probably died of a heart attack."

"Common things being common, the clinical scenario is likely to be MI (heart attack)" Dr. Barr wrote in an E-mail message in November 2000 to Dr. Reicin, the Merck clinical research executive.

Dr. Reicin quickly shot back: "I think this should be called an unknown cause of death." A few hours later, she wrote, "I would prefer unknown cause of death so we don't raise concerns."

"A fatal event not being treated as objectively as possible surprises me," said Dr. Myerburg, a prominent cardiologist. "It looks like they're playing around with this death."

In November 2001, an F.D.A. reviewer who had examined all the company's data concluded in a report to other agency officials that Merck had misclassified the death. But the F.D.A. never told anyone either.

Dr. Lisse, the study "author" said he had never heard of the case of the woman who died, until told of it by a reporter.

So can we really believe anything at all, and how to distinguish this from the worst type of quackery? As the old saying goes, ...If it looks like a duck, and it quacks like a duck...it's a bloody duck.

What is even more amazing is that the leadership of medicine says nothing -- nothing at all. Medical students learn none of this in any of their pseudo-ethics training.

Sources:

1. Correspondence in the Annals of Internal Medicine on the problem: Deeply disturbing evidence of medicine run amok
2. New York Times, April 24, 2005: "Evidence in Vioxx Suits Shows Intervention by Merck Officials"

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It was Dr Purple in the Library - and things go bump in the night

The attempts by the good Dr Purple at Procter and Gamble to alter a scientific meeting abstract appears to be causing some hilarity across the blogsphere (See P&G Pharmaceuticals: how to deal with a public relations disaster [Link])

Pharmagossip [Link] posted the wonderful Deep Purple Smoke on the Water as a tribute to the good Dr Purple.


No matter what we get out of this
I know we'll never forget
Smoke on the water,
fire in the sky

Several other blog entries discussed the Waddington game Clue (Cluedo for those in the UK).
"it was Dr Purple in the library with the poison" [Link]
Ghosts on the sly: [Link]
Other stuff [Link]
For the good Dr Purple: [Link]
CL Psych posted an excellent discussion about Purple Haze [Link] and
Roy Poses over at the excellent Health Care Renewal included an old Scottish poem that tells it all (See : Actonel, Procter and Gamble, and Things That Go Bump in the Night)

From ghoulies and ghosties
And long-leggedy beasties
And things that go bump in the night
Good Lord, deliver us!

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P&G Pharmaceuticals: how to deal with a public relations disaster

Patients get damaged by misrepresented pharmaceutical research. “Ghost-writing” has been repeatedly criticized - but this diverts attention from the more important problem – “ghost science”, of which “ghost-writing” is only a small part. Ghosts work behind the scenes at every level of the pharmaceutical scientific process. Sometimes these ghosts make mistakes and get startled by the headlamps - as Procter and Gamble discovered this week.

The steps P&G have taken to suppress concerns about their research procedures involving the drug Actonel seem to have derived from a Monty Python script. For the backstory read press reports, collated postings on this blog, report in AAAS, or Slate.

Last year, Procter and Gamble released previously hidden raw data underlying one published paper, several meeting abstracts, and two draft publications (with myself as first author). Work by independent statisticians has confirmed that the data does not provide credible support for P&G's reporting of a convenient "plateau" for Actonel in any of the three ghosted publications.

A declaration of Mea Culpa would have served Procter and Gamble far better than the endless attempts to collude with other script writers (like the editors of the Journal of Bone and Mineral Research). Instead P&G have now stepped further into the mud:

1. They refused to allow me to place the data they eventually provided (underlying three publications) into the public domain. This did not serve to enhance their credibility.
2. They refused to allow me as author to submit raw data directly to a journal editor requesting such data.
3. They declined to provide a copy of the consent form patients would have signed upon agreeing to participate in this research. Did patients consent to have the measurements I performed? Did participants realize that data derived from their risk would not be open to scrutiny by authors of the publications, or that it could be misrepresented?
4. But wait .... whatever next .... the Python team would be impressed by P&G's new attempt to act behind the scenes to have a perfectly valid conflict of interest declaration removed from the first of several scientifically correct meeting abstracts submitted about this research.

Read what happened and laugh (or cry):

Step 1: The abstract below (authored by myself and an independent statistician) was submitted on 22 January for presentation at The International Bone and Mineral Society Meeting (to be held in Montreal). The statistical aspects have been redacted pending publication. The electronic submission was accompanied by a declaration of funding leading to the footer as shown - "Study funded by Procter & Gamble Pharmaceuticals".

Control/Tracking: 07-A-464-IBMS Current Date/Time: 1/22/2007 3:53:26PM
Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response?
Authors: A. Blumsohn(1), J. L. Hutton(2)
1 Sheffield Teaching Hospitals, Sheffield, UNITED KINGDOM,
2 Department of Statistics, University of Warwick, Coventry, UNITED KINGDOM.
Understanding the determinants of bisphosphonate induced change in fracture risk is a prerequisite to rational prescribing and therapeutic monitoring. A previous abstract (Blumsohn, Barton, Chines, Eastell. JBMR 2003;18 S2:S89), and draft publications failed to shed light on the true relationship between change in bone resorption (uNTX/Cr) and fracture risk in the HIP study. The study included 938 women (FN T score <-3, age 74 SD 3) who received Ca and either 5mg risedronate/day, 2.5mg or placebo for 3 years. Randomization and event codes were supplied to authors in 2006. Data did not provide evidence to support previous conclusions.
Previous reports on these data suggested risk of incident vertebral fracture (V#) was non-decreasing when NTX decreases beyond -30% (%?NTX < -30%), and the relationship was "non linear" with "little further improvement in fracture benefit below a decrease of 30 to 35%". It further suggested that another marker (%?PINP) was significantly predictive of V#.
We used several statistical models as well as visual inspection to evaluate a potential "plateau" effect at a putative threshold -30% or -40%.
--- --- -------- ---------- ------ ---- ----, ---- ---------- -- ---- --- ----, --- --- --------------- -- ---: ----- --- ---------- --- -------- --- ------- -- ---- --------- ------ ----- --- ----- --- ---------, --- ---- ------ --- --------- ---------- ----------- ---- ----------- --- ---- --- --- ------, ---- -- ------- --------- -- ---- -- --- ---------- ------- -----
------ ---------- ------ -- -------- -- - ------- ---- --- -------- ---------- ---- --- ----------- ---- ------ -------- -- -------- ---- ------ -- --- ------ --- -------- ---- --------- ------- ----- ---- -- --- ------ -- -------- ---- ----- - ---- --------- -- ----- --- ---- --- ----------- ----- ----- -- ---- ----- --------- -- ------- -- --- --------- ------- --- -- -------- -- --- --- ----- - -----
---------- ------ ------ -- -------- --- - ------- -- ------ ---------, --- ----------- -------- -- -- ------- ---- - - ------ --- ---- --- --- --- ----- --- ---- -- -- --------- ------------- ---- ------- --- ---------- ---------- ------ ------ ----------- ---------- --- -------- -- ----- -- --- ------- ------- ------ --- - --- --------- ---- -------, ------ ------- -- - ---- --------- --------, ------ -------- -- ----------- ------------ ------- ------ --- -- --- ----- -- ---------- -- ------- -- ---------- ------ ---- - -------
In conclusion, this study provides no evidence to support a plateau relationship between NTX change and fracture risk with threshold near -30% in patients taking risedronate.
Author Disclosure Block: Study funded by Procter & Gamble Pharmaceuticals.

Step 2: On the 6th of March a fascinating E-mail was sent from the meeting organizers to mysterious Dr C Purple at Procter and Gamble. Unfortunately for Dr Purple the E-mail was also copied to my own E-mail address which had accompanied the abstract submission, together with Dr Purple's earlier secret E-mail to the meeting organizers. Dr Purple had asked for my declaration of interests and funding to be removed from the abstract. The meeting organizers had complied with this request.

Subject: RE: Abstract Change
Date: Mon, 5 Mar 2007 17:33:59 -0500
From: "Paterson, Anne"
To: purple.cr@pg.com
CC: Aubrey Blumsohn

Dear Dr. Purple,

I have adjusted the disclosure so it does not include the below disclosure for P&G. There is currently no disclosure. If there is to be, please let me know and I’ll make the appropriate change.

Thank you for your patience and please do not hesitate to let me know if you have additional questions or concerns.

Kindly,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)
Washington, DC 20036

From: purple.cr@pg.com [mailto:purple.cr@pg.com]
Sent: Tuesday, February 27, 2007 10:47 AM
To: IBMS - Paterson, Anne
Subject: Abstract Change

Dear Anne:

Last Thursday we spoke about changing an abstract, here are the details;

Please check the abstract submitted by Blumsohn and Hutton (Title: Relationship of fracture risk to change in bone resorption with risedronate in the HIP study - is there a plateau response) for a statement in the disclosure block indicating that the study was funded by Procter & Gamble Pharmaceuticals. Would you please let me know if is this disclosure is still attached to the abstract. If it remains associated with the abstract, please tell me what is the process for having it removed from the abstract?

Thank you for your help with this.

Christopher Purple, Ph.D.
Medical & Technical Affairs
Procter & Gamble Pharmaceuticals
513.622.0516
purple.cr@pg.com

Step 3: Professor Hutton and I responded with some consternation. We were informed that the meeting organizers had been duped (misled) by Procter and Gamble.

From: Aubrey Blumsohn
Sent: Monday, March 05, 2007 5:59 PM
To: Paterson, Anne
Subject: RE: Abstract Change


Dear Ms Paterson

Kindly let me know the basis upon which you altered the abstract submitted by myself (removing the conflicts of interest/disclosure section). Please also state precisely who gave you permission to do so.

This is extremely strange. Dr Purple's rather unusual E-mail below your own appears to have derived from a commercial company.

I would appreciate your urgent response. I would also appreciate it if you would send be a copy of the IBMS conflicts of interest and disclosure policy as it applies to this meeting and to IBMS
activities in general.

The abstract as submitted is attached.

Yours Sincerely

Dr Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), MRCPath

Subject: RE: Abstract Change
Date: Mon, 5 Mar 2007 18:11:17 -0500
From: "IBMS - Paterson, Anne"
To: "Aubrey Blumsohn"

Dear Dr. Blumsohn,

I apologize for this misunderstanding as I was under the impression you knew about the conflict. I have reentered the disclosure in the abstract as indicated in your attached pdf.

Please let me know if you have any further questions. I will contact you if anything else comes up regarding this conflict.

Regards,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)
2025 M Street NW, Suite 800
Washington, DC 20036

Subject: RE: Abstract Change
Date: Tue, 6 Mar 2007 09:19:10 -0500
From: "IBMS - Paterson, Anne"
To: "Professor Jane Hutton"

Dear Dr. Hutton,

Thank you for your concern. It is not our policy and I take responsibility for the misunderstanding. I was misled and can assure you that as soon as I realized that the authors were not notified, I alerted the submitter and immediately returned it to its original form.

I am not sure how Dr. Purple viewed the abstract.

Please do let me know if you have any additional concerns.

Kind regards,
Anne

Anne Paterson
International Bone and Mineral Society (IBMS)

Well thank you Anne Paterson and the IBMS for behaving properly so far. Award of an oral presentation to to 07-A-464-IBMS may help restore a little of the lost credibility in skeletal pharmaceutical research.

And to Dr Purple of P&G: Please watch the Monty Python Parrot sketch below. Perhaps the PR staff at P&G should assist with research into soap and sanitary products like the Rely Tampon until you get some training from a proper pharmaceutical company - like Eli Lilly or Merck. Please invite me to give a seminar to your staff about the obligations of a doctor and how to deal with ethical problems in a more plausible way. I would be happy to do so any time.



You might also want to read some excellent blogs about pseudoevidence based medicine, a more effective public relations gambit, Conflicts of interest and other troubles with research. You are not alone.

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A journal editor does at least one right thing - well done Professor John A Eisman

I posted previously about the attempt by the Editor of the Journal of Bone and Mineral Research (JBMR) to inhibit discussion about scientific misconduct and false declarations by authors of a published paper in JBMR (Richard Eastell et al. 2003 J.Bone.Miner.Res. 18:1051-6) as well as two draft publications and several meeting abstracts purportedly written by myself. That previous posting is reproduced below.

The editor, Professor John Eisman had agreed to present his case at the 3rd Annual Meeting of the International Society for Medical Publication Professionals (ISMPP, April 23 – 25, 2007, Philadelphia, PA). The meeting program is here. Thank you ISMPP for encouraging honest discussion about scientific procedure and publication ethics.

Update: However I now understand that Professor Eisman was "instructed" by someone not to attend. I have nothing to hide, and avoiding open honest discussion seems quite inappropriate Professor Eisman. Incredible.

Nevertheless Professor Eisman may be willing to read the evidence bundle, the independent statistical reports and the various corrected publications. He might even want to comment on the latest antics of Dr Purple at Procter and Gamble Pharmaceuticals and how that would be viewed by him as an honest editor. I will be detailing the various attempts of several parties to prevent the matter from being raised, and to allow those accused of misconduct (including a pharmaceutical company) to "independently" investigate themselves.

This is a meeting of medical writers (sometimes ghostwriters), perhaps not the most challenging of audiences. However I have always felt that over-emphasis on the problem of ghostwriting diverts attention from the more important problem of ghosted science. Medical writers do have a relevant role under proper circumstances, but under some circumstances they provide an easy conduit for scientific misconduct. The byline of the meeting is "Ensuring Integrity in Medical Publications: Conflicts, Credibility & Collaboration" and I will be reporting on the how the meeting addresses those goals.

"There is a demand today
for men who can make wrong appear right."
- Terence

I have a very old fashioned idea - that Medical Journal Editors should go about their business with as much objectivity and integrity as possible. They should act in the interests of the patients we serve. The Journal of Bone and Mineral Research (JBMR) is seeking a new editor to replace Professor John A. Eisman, MBBS, Ph.D. To apply, see here.

Editors wanting hints as to how to react when approached with concerns about research misconduct involving a major pharmaceutical sponsor and fellow friendly scientists, see the John A. Eisman approach. First try protracted delay. Then try meaningless gibberish, followed by excuses (or exasperation) when asked to reply properly. Then edit a letter of concern to remove all content, and offer to publish it giving a pharmaceutical company the right to respond. Express surprise when the offer is refused. Then decline to review any evidence at all, offering lame excuses. Decline to read statistical reports. Decline to read correspondence relating to denial of access to data. Decine to read anything relating to the concerns raised. Then suggest that those implicated will arrange for the concerns to be addressed. Good trick! It is always a good idea to address concerns that are different from those raised. When the matter reaches the press, write statements so at variance with your previous correspondence that it is hard not to laugh out loud. For collated correspondence and press statements see here. For press see here.

Will the JBMR eventually publish the truth about these three publications and how they came to be? Perhaps not. But then - who cares. Third rate conflicted medical journals that snuggle up to vested interests are steadily losing relevance.

Perhaps the new editor will join me in calling for Procter and Gamble to allow authors (including myself as first author of two of the three intended P&G publications) to make the raw data from the three publications publicly available. So far P&G have declined to allow that. I wonder why that might be?

Alternatively perhaps Professor John A. Eisman would care to perform a teensy tiny statistical analysis himself. He might even consider reading the statistical reports he was offered. Perhaps he would even care to review the evidence with me. Of course there is nothing whatever to hide Professor Eisman - or is there...

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Union of Concerned Scientists Cartoon Competition

A winner has been announced.



Please support the Union of Concerned Scientists

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What have they got to hide? The Famciclovir case

Pending further description of methodology in Sheffield Actonel studies, my attention was drawn to a similar scandal in another parallel scientific universe. It involves the drug Famciclovir (Famvir) and is discussed at Pharmawatch and Healthcare Renewal.

Famvir is used for treatment of herpes zoster, and genital/labial herpes. The case involves a nine year delay before partial publication of findings which had adverse implications for the sponsor. As in the Actonel case, it also involved protracted denial of raw data to academic authors. The study and editorial were finally published a few weeks ago (1,2).

The authors relate that (1):

"....companies are understandably wary of devoting resources to a report that is not in favor of their product. Although we received data tables and listings for this study, we were not able to obtain data tapes to verify the analyses and to conduct what we consider the most clinically relevant analyses"

Dr Wald, the first author, notes in correspondence that:

"We asked for raw data and we were not given it. Initially, we were told that the company has other priorities and that they have not looked at the data. Then company has changed hands and we were told that they no longer had it. But we were given the summary tables and report from which i wrote the paper. The whole process took several years."

Should we as clinicians really be prescribing Famciclovir given this corporate approach to science, and given that we don't really know what was hidden from the authors?

The response of the medical profession and medical ethicists to such problems has been feeble. EBM specialists who collect Clinical Evidence scrupulously fail to document attempts to control, suppress or delay that evidence. It is also puzzling that the drug regulators have no interest in contamination of the scientific literature upon which doctors and patients rely. The malaise is reflected in the recent puzzling assertion in the UK that the drug regulatory body (MHRA) has no remit to investigate or to be concerned about allegations of scientific misconduct or contamination of the scientific literature after a drug is licensed. What then are they for?

We would do well to remind ourselves of the story of Betty Dong and the "thyroid storm" (3, 1996 Editorial in Science, another Editorial)

In 1990, Dong, a researcher at UCSF was funded by Boots to carry out research on a widely use thyroid treatment (Synthroid). She discovered the Boots drug was no more effective than three much cheaper competitors. When she tried to publish, Boots threatened to sue. The publication was withdrawn. She received no institutional support. Company executives attempted successfully to publish an inaccurate version of the findings while excluding Dong and threatening legal action. Nine years later the sordid details were exposed in the press and Dong’s paper was published. In 1999/2000 the company paid $170 million to settle class action lawsuits. However it is estimated that the company made a profit of $3billion in inflated costs during the nine year delay. No company executives were prosecuted. The regulators turned a blind eye.

1. Wald A, Selke S, Warren T et al. Comparative efficacy of famciclovir and valacyclovir for suppression of recurrent genital herpes and viral shedding. Sex Transmitted Dis 2006; 33: 529-533.
2. Fife KH. Are the antiherpes nucleosides really all the same? Sex Transmitted Dis 2006; 33: 534-535
3. Rennie D, "Thyroid storm" JAMA, Apr 1997; 277: 1238 - 1243

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Procter research shenanigans 6: Who stands behind the word?

As of April 2006 the Journal of Bone and Mineral Research has placed an undated "Statement of Concern" on its home page (Not on Pubmed though).

The statement relates to one of the three intended Procter and Gamble publications about change in bone turnover and fractures in patients taking Actonel (Eastell et al. 2003 JBMR 18:1051-6). The other two publications based on overlapping data have only been published in abstract form. The intended first author declined to sign journal declarations while being refused access to underlying raw data.

Medical journals face a crisis of credibility (1-15). Collated correspondence with the JBMR over 2 years provides some insight into the real concerns underlying their "Statement of Concern".

And from (11) a quotation that provides an excellent summary of the crisis facing medicine.

1. 23 August 2006: Why Today's JAMA Editorial Doesn't Go Far Enough
2. PLoS takes a stand
3. NEJM and Vioxx
4. Manipulating a Journal Article: NYT
5. Audio interview with NEJM Editor Drazen -(the call from Hrachovec begins at 44:30)
6. For Science's Gatekeepers, a Credibility Gap
7. Just how much 'new research' can we trust?
8. Incident raises questions of editors' and publishers' corporate connections
9. Why you can't trust medical journals anymore
10. Commercial influence and the content of medical journals
11. Presentation by Gavin Yamey
12. A Story Involving JAMA, Harvard Medical School, Baxter International, Cytyc
13. More on lessons from Neuropsychopharmacology
14. Won't Get Fooled Again, Again, Again
15. About the paper in Am J Psychiatry 163:34A (2006)

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