Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, March 07, 2008

GSK statement on MHRA investigation

Good old Alistair Benbow is in fine form again - basically denying any wrong doing.

Basically, I see this whole hiding of data as a relationship between two people.

Call it a marriage if you will.

The husband is loyal, honest and caring and he assumes his wife is as well.

A few years into their marriage, she has an affair, she does not tell her husband... he finds out through a third party. He is obviously devasted and feels he can't trust her anymore. She assures him that it was a 'one off' and she will never do it again.

But the wife is of the opinion that if she does not lie to her husband then she is doing no wrong. She convinces herself that she is not lying because he hasn't asked her.

So, she, in her own warped mind, can have another affair. To her she is doing no wrong. She can even disguise her lies later on. Her husband may ask her 'Are you seeing someone else?' Her conscience won't be pricked because she has already decided that she isn't seeing another man (he is seeing her!) therefore when she replies to her husband 'No, I am not seeing anyone else', she feels vindicated. Her husband may ask her, 'Are you sleeping with someone?' Again she can disguise her lie to keep him from the truth, 'No, I'm not sleeping with someone.' In reality she is having sex with someone but because her husband asked her if she was sleeping with someone she only needs to answer whether or not she has been sleeping with him.

It's a classic case of the liar convincing not only themselves, but others too that they are doing no wrong.

Here, GSK were asked 'Have you been hiding data from us?'

Of course we all know that they did but they could answer 'No' because the data that they only had to provide (by law) was the positive data. So they were perfectly within the letter of the law to answer 'We are not hiding data from anyone'.

However, where GSK slipped up was when they submitted evidence to the MHRA to support a licensing application for Seroxat use in children. Once again, they did this on the basis of only having to provide the data they wanted to.

If we can go back to the husband and wife scenario, it can become clearer.

The wife tells the husband she is going away on holiday with a friend.

On her return she shows him some photographs that she has taken whilst away on some exotic island. The photographs look innocent enough, there are no indications that she is having an affair. She feels vindicated. Although she did go on holiday, she didn't quite tell her husband the whole truth (because a, she didn't have to and b, he never asked)

Sometime down the line, the husband asks her why there are only 33 photo's when the camera could take a maximum of 48 photo's? 'Oh, they were just boring photo's of the airport darling', she replies. Once again she is not actually lying, they were photo's taken at the airport but they included her lover. Her husband never asked her a direct question like 'Do the other photo's contain your lover?' Why would he, he had no inkling.

Where the MHRA investigation lets us all down is quite simple really.

They knew the questions to ask but they never asked them. They could have asked, 'the information that you never gave us contained bad results did it?' Of course GSK could have answered 'No'... and again in a perverse kind of way, they would have been telling the truth. They could vindicate themselves by answering 'No' because not ALL the information they kept from the regulator was bad... just some of it. Therefore, in their eyes, they have not lied. But the MHRA had evidence. Dr David Healy, the World's leading SSRi Expert had sent it to Dr June Raine of the MHRA nearly 8 years ago. Why didn't the MHRA (the husband) confront GSK (the wife) with this evidence?

It's akin to President Clinton and Monica Lewinsky. 'I did not have sexual relations with that woman'. He obviously knew that he did, but he vindicated himself because he had convinced himself that oral sex did not fall under the 'sexual relations' label. Once convinced, he was free from any form of guilt or conscience.

Ladies and gentlemen, I give you Alistair Benbow's take on the recent MHRA investigation:

Statement here

GlaxoSmithKline (GSK) notes the conclusions announced today by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding its investigation into disclosure of paediatric trial data for the anti-depressant medicine Seroxat (paroxetine).

“The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients. We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18,” said Dr Alastair Benbow, Medical Director for GSK Europe.

“Whilst there are substantive and rigorous requirements in place regarding disclosure of clinical trial data, it is clear that there is a need and benefit to strengthen the confidence of decision-makers and the general public that all pharmaceutical industry clinical trial data are disclosed promptly and transparently. GSK is committed to working with the Government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area,” he added.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7



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