Thursday, November 08, 2007

Memory Hole (3 November): Forgetfulnesss

Scientific Misconduct Blog Memory Hole: Events of November 3rd

Quote of the day

A gift of God bestowed in compensation for destitution of conscience.

48 years ago today: Thalidomide saga - the Voss question

On 3 November 1959 a written report was received by Chemie Grunenthal from neurologist Dr Ralf Voss of Dusseldorf reporting more adverse effects. Voss asked if Thalidomide could cause damage to the peripheral nervous system. Chemie Grunenthal replied that such effects had never been observed before. At the trial this proved to have been a lie.

8 years ago today: Hidden deaths, hidden science and uninformed consent in gene trials

On 3 November 1999 it was reported that deaths in clinical trials involving gene therapy were being hidden on demand from companies who were worried that it would "have an impact on their business". The Washington post reports:

"Scientists and drug companies have failed to notify the National Institutes of Health about six deaths that occurred in gene therapy experiments in the past 19 months".

"The researchers said they reported the deaths to the Food and Drug Administration, which keeps such information secret". "they are filing reports with demands for confidentiality or maintaining that they don't have to file them with the NIH at all".

Researcher Ronald Crystal "cited concerns about the impact on his business if the death were made public". "Schering-Plough also had demanded confidentiality for three recently filed reports of serious patient illness during gene therapy trials. The lead scientists in two of those studies determined that the complications "probably" were caused by the gene therapy; Schering-Plough officials had downgraded those assessments, saying they were "possibly related" to the therapy".

My oh my. Confidential science, confidential deaths, and information-free "informed" consent. No learning from the experience. Collusion by regulators. Is this science? Is it ethical? Did participants know that even their deaths would not contribute to knowledge? Would they have consented to take part had they known this?

Persons and companies named: Schering-Plough, Ronald Crystal of Cornell, Jeffrey Isner of Tufts, Carol Goodrich of Parke-Davis

But, two weeks later on 21 November 1999 the Washington post provided further details about one death - the totally unnecessary death of 18 year old Jesse Gelsinger at the University of Pennsylvania following a gene therapy experiment. It is reported that:

"it wasn't the first time the researchers had seen it. Unbeknown to Gelsinger, .... that monkeys the Penn team had similarly treated had succumbed in very much the same way". "The original [Gelsinger] consent form, reviewed by the NIH, clearly notified prospective participants that monkeys had died from a related treatment, but the final version given to patients eliminated any mention of the deaths." The NIH committee members say they also never got word of a significant change in the consent form. Neither the FDA nor the Penn team can explain today why the reference to monkey deaths was dropped.

"all four rhesus monkeys that had been given high doses of the first-generation virus had died in previous experiments".

Bit it wasn't only monkey data that had been hidden: Schering-Plough Corporation and the University of California had done preliminary trials in dying cancer patients, but "lowered the dose when two early participants experienced serious drops in blood pressure. But even at that lower dose – which was lower than the total dose eventually given to Gelsinger – two patients suffered serious stroke-like attacks". Wilson (the researcher) said he was only vaguely aware of those studies, none of which had been published in peer-reviewed journals until after Gelsinger's death. "But neither did Wilson reveal in his [own] written report at the meeting that one [earlier] patient had suffered an especially serious reaction to the treatment. Gelsinger was not informed of any of this.

Wilson, the researcher said: "If a mistake was made, we've got to own up to it and learn from it. Ultimately, the tragedy of Jesse's death would be if we don't learn anything." So let's think a little here - what have we learned over 8 years Dr Wilson?


3 years ago today: WHO is wagging WHO

On 3 November 2004 the World Health Organization was accused of hiding a report on food advertising "after pressure from the food industry". Yet more irrelevant paperwork perhaps, but is hiding things a proper part of the remit of the WHO.

A censor is a man who knows more than he thinks you ought to.
Granville Hicks (1901-1982)

Source: "WHO buried report to please food industry" The Guardian, Nov 3 2004

2 years ago today: USA is the sickest

On 3 November 2005 a report published in Health Affairs (Schoen C et al. Health Affairs 2005) showed that the USA lagged far behind other countries in several indicators of healthcare despite far greater expenditure. The US doesn't rank at all on mortality statistics either (nor for that matter does the UK). Other studies show that even the wealthiest in the US are worse off. Technology is not necessarily the same as good science.

2 years ago today: Ethics for sale

On 3 November 2005 Bloomberg News reported on commercial (for profit) IRBs (ethics committees) and their rubber stamping of ethical approval of clinical studies for industry. I will highlight just one quotation:

Angela Bowen, who runs Western IRB and founded this ethics company, the largest commercial IRB in the US, had overseen clinical trials "for which doctors were criminally charged and jailed for lying to the FDA and endangering the lives of trial participants." But no action was taken against Western IRB. Angela Bowen told Bloomberg reporters that she "didn't see human safety issues in those trials."

So, lies in clinical research are apparently not a safety issue according to the owner of an ethics board?? Neither is hiding of unwanted results that are derived from the risk undertaken by human research participants.

In 2000, Angela Bowen reported that her company was receiving 1400 protocols per year, and charged about $550 per protocol. Business is going "straight up" she said. In April 2007 private equity firm Boston Ventures bought a majority stake in Western IRB for an undisclosed amount.

How did we reach this point?

See also: Slate, Ethics for Sale, by Carl Elliott and Trudo Lemmens and Annals of Internal Medicine (2000) 132 (6) 513-6

2 years ago today: Guidant sued for misrepresenting cardiac device

On 3 November 2005 New York Attorney General Eliot Spitzer sued Guidant Corporation (now Boston Scientific) for alleged fraud in connection with its sales of implantable cardiac defibrillators. Guidant had admitted that it failed to disclose information about defects in the device to doctors and patients. The device is expensive ($25,000). Doctors and patients might have chosen not to implant them had they realized that the benefit and risk were different from those conveyed.

The product was a faulty product, not because it sometimes failed, but because the combination package of product+science was not based on truthful conveying of that science. A later review concluded that (NYT 21/3/2006) Guidant had indeed been guilty of such misrepresentation.

In January 2006 "Guidant agreed to be acquired by Boston Scientific for $27 billion. Executives of Boston Scientific said they were considering changing the name of Guidant's heart device as part of a plan to rebuild physician confidence in its products (NYT)". Hmmmmm.

Perhaps confidence results from honest and transparent science - not linguistic manipulation. Did anyone go to prison here - after all patients likely died?

Parexel bonus

1 years ago today: Reward for bad science a £1 million bonus (TGN1412)

On 3 November 2006 Lawyers on behalf of six men who almost died in a medical trials criticised the US research company for awarding its boss a bonus of £920,000. The boss is Parexel chief executive Josef von Rickenbach. The trial was the TGN1412 study.

This disaster was caused in part by non-application of brainpower by the UK drug regulator (the MHRA). The MHRA then exonerated themselves (of something). See also the Hoofnagle trial discussed in the 23 October and 29 October memory holes. Learning = zero.

Source: BBC, Parexel chief gets a million £ bonus, 3 Nov 2006

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1 comment:

Srihari Yamanoor said...

This is so bad to be coincidental. I had just posted about something that smells almost this fishy on my medical devices blog. Going to update it with this post as an addendum..