Thursday, November 22, 2007

Memory Hole (11 November): What else happened?

Scientific Misconduct Blog Memory Hole: Events of November 11th

9 years ago today: New laws and missing raw data

On 11 November 1998 new congressional laws were enacted to deal with access to raw scientific data. This followed refusal by Harvard to release raw data based on a spurious excuse of participant "confidentiality".

"When tax dollars pay for a scientific study, should the public be allowed to see the results? Of course. And now it can, thanks to a provision in the new federal budget law". Read on....

That's good law, but why should it apply only to publicly funded research? Withholding of raw data means that the work is not science in any conventional sense, and should not be published or publicized as science. Science that cannot be scrutinized is not science at all.

3 years ago today: The MHRA: "Shake-up" vs "inaction and cover-up"

On 11 November 2004 the following item appeared on BBC News about the UK drug "regulator". It is reproduced in full.

BBC NEWS: [Link] Shake-up for drug licensing body, November 11, 2004

A reform of the way drugs are regulated has been outlined by ministers to make the system more independent. A new code of conduct has been drawn up for the Medicines and Healthcare products Regulatory Authority (MHRA) body responsible for licensing. It proposes not allowing the members of the body, the Commission for the Safety of Medicines (CSM), to hold interests in the pharmaceutical industry. It also calls for more patient involvement in the process. Two lay representatives will sit on the CSM, the new name for the Committee for the Safety of Medicines, as well as patient representatives on every expert advisory group under the plans. The MHRA has also written to pharmaceutical companies to demand more action on their agreement to publish their clinical trial data. The move comes after heavy criticism at the way the MHRA operates. On Wednesday in a Westminster Hall debate Dr Ian Gibson, chairman of the Commons science and technology select committee, said the MHRA had an image problem. He said it was "gaining a reputation for not giving out information". "I think it is time the culture of secrecy was addressed.

"The damage done by the public believing they have been lied to or defrauded is difficult to repair. "It is the only regulatory agency that is fully industry funded. "It is a difficult task to convince people that a regulatory body entirely funded by the industry is impartial." Last month BBC's Panorama programme criticised the MHRA over its handling of anti-depressant drug Seroxat. The Panorama investigation claimed vital information relating to Seroxat was overlooked.

It suggested the drug could be addictive and increase suicidal feelings in young adults. Health Minister Lord Warner said it was important the MHRA was "open and transparent". He said the changes meant that "everyone can be confident in the impartial and independent expert advice given on the safety of medicines". Professor Sir Alasdair Breckenridge said: "Proposals for the new commission incorporating strengthening of patient and lay involvement, tightening of the rules of interest and increased transparency will move the MHRA forward in its aims of improving public health." And Harry Cayton, the government's patients tzar, welcomed the increased involvement of patients, saying it would increase the agency's "expertise and strengthen its ability to take account of the public interest". "I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions."

No shake-up ever took place. See also:
The MHRA : Why is the government not acting?
1463 days to nothing - the GlaxoSmithKline Criminal Investigation

1 year ago today: Medical Leadership in action

On 11 November 2006 Elizabeth Paice, Chair of the medical forum charged with delivering MMC (Modernising Medical Careers) in the UK stated "MMC is going to be really, really good". (From BMA News 11 Nov 2006)
Medical Leadership
And it was good, really good.

Read on:

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