Rapid Responses to:

EDITOR'S CHOICE:
Kamran Abbasi
A tough nut to crack
BMJ 2005; 330: 0-h [Full text]
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Rapid Responses published:

[Read Rapid Response] Judgment is reserved, for now.
Hilary Butler   (28 January 2005)
[Read Rapid Response] BRAVO
DR RUCHIRA SINGH, dr sanjay singh   (28 January 2005)
[Read Rapid Response] Tough
Ian C Reid   (29 January 2005)
[Read Rapid Response] Protecting Editorial Integrity through Responsibility and Resolve
Stefan P. Kruszewski   (5 February 2005)
[Read Rapid Response] Re: Protecting Editorial Integrity through Responsibility and Resolve
Kathleen (Katie) M. Hill   (7 February 2005)
[Read Rapid Response] Merck's missing mercury memo
Stevie M Gamble   (10 February 2005)
[Read Rapid Response] Re: Merck's missing mercury memo
John Stone   (12 February 2005)
[Read Rapid Response] No One To Trust
Paul Shapiro   (13 February 2005)

Judgment is reserved, for now. 28 January 2005
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Hilary Butler,
freelance jounalist
home, 1892, New Zealand.

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Re: Judgment is reserved, for now.

Dear Sir,

Those of us who have watched the BMJ for a long time, saw the hand of a Richard Smith, who is no longer, as the stabilizing force. Or perhaps, as you might have it.. the nutcracker.

Recent changes of both nutcracker and policies, have caused a minor hiccup in my breathing.

I can no longer say with surity, that the BMJ will continue to be a hard nut to crack. How do I know that the new broom isn't some cheaper version that might occasionally crack at the handle base, on a particularly difficult, and troublesome task.

Pharmaceuticals may have been right, that the BMJ was once upon a time, a hard nut to crack, but the odds are back to zero/zero once again. Trust is earned, not handed down as a legacy.

Only history will tell, if the new editors have the intestinal fortitude of the past editors.

Already, regarding one study you mention (the Copenhagen study), I have growing doubts. People who know epidemiology flaws better than I do, are huddled in furious discussion. So, its a bit early to state that papers in this issue, or any future issue, will turn out to be as exemplary as you would have us think.

Reputation is only built on what went before, under different management.

Lets just wait and see, on all points, shall we?

Hilary Butler.

Competing interests: None declared

BRAVO 28 January 2005
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DR RUCHIRA SINGH,
clinical fellow obs & gynae
barnet general hospital barnet,
dr sanjay singh

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Re: BRAVO

We enjoyed reading your article.The puzzle of medicine is really a tough nut to crack. A lot of money is spent to unreveil the mysteries of medicine, trials undertaken to give the best possible evidence to the world

BMJ is a medium which we think is the best medium for doctors to express themself. Keep up the good work.

Competing interests: None declared

Tough 29 January 2005
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Ian C Reid,
Professor of Mental Health
University of Aberdeen AB25 2 ZD

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Re: Tough

In view of the "tough nuts" striding around, seems a little disingenuous not to mention the "correction and apology" to a pharmaceutical company (this issue)in the editorial...

Competing interests: Have received grants and honoraria from most companies making psychopharmaceuticals - including Eli Lilly

Protecting Editorial Integrity through Responsibility and Resolve 5 February 2005
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Stefan P. Kruszewski,
Psychiatrist
Harrisburg, Pennsylvania USA

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Re: Protecting Editorial Integrity through Responsibility and Resolve

The BMJ must be steadfast in its resolve as a ‘tough nut to crack.’(1) The reasons are simple and timeless. The products, treatments, therapies and pharmaceuticals derived from research and its applications are only as safe and effective as their honest and reproducible scientific discipline.

Research science can be corrupted at any step of the research process. It is the very reason behind the passion that drives the arguments for full disclosure and transparency. Since this is not a theoretical exercise, but one from which human lives are held in the balance, the stages of the process are worth reiterating: If basic science is corrupted, clinical protocols can not accurately proceed. If the results of an early clinical trial are misreported, the basis for larger trials is skewed. If negative data or adverse effects are hidden, the risk -benefit questions cannot be addressed. If the positive conclusions are embellished, the marketing and advertisement are at risk. If the regulatory bodies do not perform their tasks in an independent and unbiased manner, the approval process is corrupted. (2) If any facet of the pharmaceutical ‘diamond’ is not etched carefully or any person who chooses to make decisions about the process is not scrupulously clear about the reasons and responsibilities that they have undertaken, the entire process suffers as a result. The consequences for that interruption of the scientific process violate the Hippocratic Oath, our common welfare and can harm an uninformed public.

That said, kudos to Kamran Abbasi for having the courage and opportunity to assert and defend his positions, as he writes in his recent Editor’s Choice remarks. (1) What he does must be the mainstay of responsible editing, not the exception.

He and his editorial staff must expose published studies whose conclusions are not corroborated by the research results; where statistical analysis is simply a means to achieve a positive result rather than a meaningful analysis of benefit and reward; and when sloppy and uncontrolled clinical research designs merit neither statistical analysis nor publication.

The freedom and responsibility to speak out are the cornerstones of obligatory medical reporting since it that duty that protects the integrity of scientific debate. Editor Abbasi must not only remain impervious to retreat from those essential endeavors, but must continue to safeguard his editorial and investigative reporters: Susan Mayor, Ray Moynihan, Lynn Eaton, Owen Dyer, Tony Sheldon and Jeanne Lenzer, and so many others----who brilliantly share that burden and exemplify that responsibility. (3, 4, 5, 6)

I’m going to be corny, but I believe what I’m saying to my soul. The current day courageous medical editors and writers are not unlike other freedom fighters who fought for lofty ideals: Lech Walesa’s pro-democratic Solidarity efforts in the Gdansk shipyards prior to the collapse of the Soviet Union; Nelson Mandela’s struggles and sacrifice against apartheid in South Africa; and, Rosa Park’s refusal to sit at the back of the bus in a segregated 1955 Montgomery, Alabama. Like them, freedom fighters for ethical and honest medical reporting must be protected and nurtured. The search for scientific truth can be precarious, but the goal is keen.

1. Abbasi, K. A Tough Nut to Crack. BMJ 2005; 330: 7485.O-h (29 January)

2. Spiers, Alexander. Save the FDA.BMJ 2005; 330:308 (5 February), doi:10.1136/bmj.330.7486.308

3. Mayor, S. Rofecoxib caused excess heart disease. BMJ 2005; 330: 212 (29 January)

4. Dyer, O. Surgeon is struck off for failing to mention disciplinary action. BMJ 2005;330:274 (5 February), doi:10.1136/bmj.330.7486.274-a

5. Sheldon, T. Pfizer found guilty of breaching code. BMJ.2005;330:162 (22 January), doi:10.1136/bmj.330.7484.162-b

6. Lenzer, J. Public interest group accuses FDA of trying to discredit whistleblower. BMJ 2004; 329: 1255( 27 November)

Competing interests: None declared

Re: Protecting Editorial Integrity through Responsibility and Resolve 7 February 2005
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Kathleen (Katie) M. Hill,
Welfare Recipient
L8L 2P2

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Re: Re: Protecting Editorial Integrity through Responsibility and Resolve

I feel acute despair that any perseverance is futile in the wake of products, treatments, therapies and pharmaceuticals derived from research based on the corruption of reproducible science that is biopsychiatry, but I'm still an advocate for ephemeral hope. Without an honest investigation into the foundational knowledge that has been buried by psychiatry for two centuries, “the passion that drives the arguments for full disclosure and transparency” will be corrupted into the service of sales for false hope cloaking the stick of displaced fears, masking lies of our shallowness, stuck on tremendous power, but empty of creativity. A war on reality, the true basis for psychiatric theory, practice and research into “mental illness” can only result in the criminalization and repression of the “mentally ill.” In her article Hope at Midnight Rebecca Solnit wrote, “(t)hose with a stake in the status quo are there to protect the center not just from assault, but from imagination and transformation. But change will come anyway … And besides which, if you give up, you'll hate yourself in the morning.”

Competing interests: Psychiatric Consumer-Survivor X-Patient Self-Advocate

Merck's missing mercury memo 10 February 2005
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Stevie M Gamble,
retired HMIT
EC2Y 8BL

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Re: Merck's missing mercury memo

The BMJ will, I hope, continue to call it as it sees it, but may I suggest some caution when it comes to covering Myron Levin's report in today's LA Times

'91 Memo Warned of Mercury in Shots

http://www.latimes.com/news/printedition/la-fi- vaccine8feb08,1,1695027.story

Something along the lines of

'By a total coincidence, the 1991 memo, which said inter alia that 6- month-old children who received their shots on schedule would get a mercury dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish, was entirely accidentally omitted from the documents originally disclosed'

would do. After all, it's not as if Merck would ever withhold safety information on any of its products, would it?

On second thoughts...

Stevie M Gamble

Competing interests: None declared

Re: Merck's missing mercury memo 12 February 2005
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John Stone,
none
London N22

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Re: Re: Merck's missing mercury memo

It may have been optimistic to believe that BMJ were going to call it at all. News management?

Competing interests: Parent of an autistic child

No One To Trust 13 February 2005
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Paul Shapiro,
Grandpa
Retired Engineer, Great Neck, New York, 11021, USA

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Re: No One To Trust

The politicians, researchers, medical professionals and those working for the US Government medical and pharmaceutical development oversight and approval agencies remain cozy with the Pharma Companies and seem to find genuine concern only when their immediate world has been rocked when the problem of conflicts of interest are exposed..

The public is fed up with the corporate buying of lawmakers with obscene donations to their political campaigns and the salarying researchers to advise the government while having a vested interest in the outcome. These cozy relationships and old boy networks have shut out the funding of honest independent researchers and have tainted many of the decisions being made that affect our medical and drug delivery system. The public has lost faith in both the politicians and researchers because of feelings that decisions are no longer made based on what is best for the public they are supposed to serve but are made based upon what serves their selfish interests best.

I have lost trust and respect for the oversight agencies such as the Center For Disease Control (CDC),Food and Drug Administration (FDA), Institute of Medicine (IOM), and any other US Government health related oversight agencies. The entire regulatory system has lost it’s moral compass and has let itself be corrupted at every level.

I feel that I’m out here on my own, without guidance that I can trust!!!!

Competing interests: Grandpa to a vaccine permanently damaged beautiful little boy. He received the 22 Government mandated vaccinations and at 18 months he faded from the real world. Apparently these vaccines were not tested to a standard of, "DO NO HARM".