Aubrey Blumsohn is currently running a jolly little tale, which should comfort all those who are concerned that the UK is just as corrupt as everywhere else, but is better at hiding/ignoring it:
Why there is no scientific fraud in Britain
It's official: we don't do corruption. OK? And no amount of subtle (and not-so-subtle) inuendo on my part is going to change that. Do you understand?
Dear Sir or Madam,
Many thanks. Must just be in the US, then.
As it happens, I am aware of the legal requirement. I am also aware that there are allegations of suppressing this type of data. I am aware that companies have used euphemistic language to disguise severe side effects (witness "emotional liability" for "suicidality"), and that there are allegations that the same side effect has been reported under several different head, in order to disguise the incidence of that side effect. And I am aware that the MHRA does not routinely require companies to submit original data, with marketing authorization applications. Nor does it require companies to submit any kind of data, either original or statistical analysis, when a trial fails (at least, that's what the MHRA told me).
How would the MHRA know that a company was, or was not, suppressing side effect data, in the circumstances? In short, there is a problem here. That the MHRA chooses not to acknowledge it, for whatever reasons that it may have, is neither here, nor there.
Best regards
Matthew Holford
************************************
Subject: FW: FOI 07/292 - FW: Eli Lilly; Janssen Pharmaceutica; and Astra Zeneca
Date: Fri, 26 Oct 2007 13:01:51 +0100
From: info@mhra.gsi.gov.uk
To: m.holford@hotmail.co.uk
Dear Mr Holford
Re: Marketing Irregularities Our Ref: FOI 07/292
Thank you for your enquiry to the Medicines and Healthcare products Regulatory Agency (MHRA).
1. There are no current investigations at the MHRA as described in your email.
2. The legal requirement to report suspected side effects is in the following legislation:
European legislation: EC Directive 2001/83 Title IX Article 104 requirements for reporting suspected adverse reactions. Article 103 requires a marketing authorisation holder (MAH) to have the services of a qualified person responsible for pharmacovigilance
UK legislation: SI 1994 No.3144 Section 7 is the relevant one which requires a MAH to comply with the EU legislation and Schedule 3 to this SI provides the offences and penalties.
Yours sincerely
Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
************************************
From: Matthew Holford [mailto:m.holford@hotmail.co.uk]
Sent: 02 October 2007 01:56
To: MHRA Information Centre
Cc: johnsona@parliament.uk; Shailesh Vara
Subject: Eli Lilly; Janssen Pharmaceutica; and Astra Zeneca
Dear Sir or Madam,
Are the abovecaptioned companies being investigated in the UK for marketing irregularities, with respect to their drugs Zyprexa, Risperdal and Seroquel? That is to say, are they being investigated for intentially hiding side effects and downplaying the efficacy of alternatives? Does the MHRA regard such activities as unlawful?
Best regards
Matthew Holford
Saturday, 27 October 2007
Tuesday, 23 October 2007
Norton settles price fixing claim
I see that the Worshipful Company has been lining up to settle with Jim Gee. I haven't found anything more recent than this offering, from the Beeb, and assume that the remaining cases are proceeding towards court:
Norton settles price fixing claim
Naturally, the settlements have been made on a no liability basis (as far as the Worshipful Company was concerned, anyway), although Gee appears to have his own views as to the reason for the prospective defendants' reluctance to have their day in court:
The remaining defendant companies should recognise our resolve to press on with the continuing civil proceedings against all of those allegedly concerned in the price fixing arrangements.
I think the SFO was also taking an interest in this - I haven't found anything to suggest that it was pursued beyond curiosity, though. Incidentally, as of January, 2007, Gee no longer works at the DoH. Perhaps he was too good at his job:
NHS OVER £800MILLION BETTER OFF THANKS TO THE WAR ON FRAUD
NHS fraud supremo moves on after eight years
Presumably, he left his role as Director General of the European Healthcare Fraud and Corruption Network, at the same time? Anyway, I'm sure KPMG will benefit enormously from his talents.
Matt
Norton settles price fixing claim
Naturally, the settlements have been made on a no liability basis (as far as the Worshipful Company was concerned, anyway), although Gee appears to have his own views as to the reason for the prospective defendants' reluctance to have their day in court:
The remaining defendant companies should recognise our resolve to press on with the continuing civil proceedings against all of those allegedly concerned in the price fixing arrangements.
I think the SFO was also taking an interest in this - I haven't found anything to suggest that it was pursued beyond curiosity, though. Incidentally, as of January, 2007, Gee no longer works at the DoH. Perhaps he was too good at his job:
NHS OVER £800MILLION BETTER OFF THANKS TO THE WAR ON FRAUD
NHS fraud supremo moves on after eight years
Presumably, he left his role as Director General of the European Healthcare Fraud and Corruption Network, at the same time? Anyway, I'm sure KPMG will benefit enormously from his talents.
Matt
German prosecutors probe again into bribes by drug companies
I was trawling through a Google search, when I came across a couple of little gems from the back catalogue of the BMJ. I was actually following up on the reference to German investigations, that I posted, yesterday, and came across this:
German prosecutors probe again into bribes by drug companies
[Anton Winkler, spokesman for the Munich state prosecutor, noted] that an investigation opened against SmithKline Beecham in Germany in 1999 by the Munich state prosecutor, who started investigations into the activities of 4000 doctors accused of accepting bribes from SmithKline Beecham across the whole country. This was concluded this week. Seventy one doctors in the city and dozens of employees of SmithKline Beecham have been accused of bribery.
The main feature of the story, however, covers a second investigation, featuring some "seven to nine" drug companies, none of which featured the Bedford Massive. The story is of particular concern to the Germans, because it is reported that, of the known bribery cases in Germany, one third occur in the health sector. Nice.
The second story, which popped up unexpectedly concerns price fixing. I probably would have made the suggestion myself, but it seems that there is a concern that while this activity is present in the UK, there is a suspicion that it affects other countries in the EU. That pesky Worshipful Company, eh?
Drugs companies are defrauding healthcare systems, conference hears
Professor Peter Schonhofer of the Institute of Pharmacology, Bremen, said the fraud included not being able to view data from clinical trials submitted to the German regulatory body, the Federal Institute of Drugs and Medicinal Products.
"If they have information they don't tell us it," he told the BMJ. "We don't have access to relevant data."
That could mean therapeutic decisions were inappropriate—but because the relevant data were covered by a commercial confidentiality clause, those outside the institute could never know how appropriate the treatment was.
He also cited what is euphemistically called a "drug use study," whereby a doctor is paid anything from EUR200 (GBP140; $250) to EUR500 for transferring a patient from one drug to another and then filling in a form to say what they have done.
"We know that the pharmaceutical industry in German has spent EUR1bn a year for such drug use studies. And it is not just in Germany. In Italy, GSK [GlaxoSmithKline] spent EUR28m over a 12 year period just for doctors to provide a signature."
Smooth. And this business of "drug use studies" fits in nicely with the previous piece. But there's more:
Jim Gee, chief executive of the Department of Health's NHS Counter Fraud and Security Management Service, said they had evidence to suggest the existence of a price fixing cartel. Six pharmaceutical companies are allegedly involved in fixing the price of warfarin, costing the NHS GBP28m; seven are allegedly involved in keeping the price of penicillin high, costing the NHS GBP30m...
"Clearly these companies operate in the other countries too," Mr Gee said, suggesting that other European countries might also have been similarly defrauded.
Altogether now (to the tune of "Always look on the bright side," or the Archers' theme tune (use your imagination, I know it doesn't scan)):
Extend and enhance life by
Living longer and feeling better
Do more by being
Committed to helping people improve their health
Let's find new ideas that are inspired by life
And respect people's integrity and excellence
We can all ease suffering and enhance the quality of life, and
Always look on the bright side of life...(rpt)
And when you've finished puking, you may award yourself a cookie for every Worshipful Company tagline you spotted (in order to replace the ones you tossed)! Clue: I've "trimmed" them, in order to have them make vague sense.
German prosecutors probe again into bribes by drug companies
[Anton Winkler, spokesman for the Munich state prosecutor, noted] that an investigation opened against SmithKline Beecham in Germany in 1999 by the Munich state prosecutor, who started investigations into the activities of 4000 doctors accused of accepting bribes from SmithKline Beecham across the whole country. This was concluded this week. Seventy one doctors in the city and dozens of employees of SmithKline Beecham have been accused of bribery.
The main feature of the story, however, covers a second investigation, featuring some "seven to nine" drug companies, none of which featured the Bedford Massive. The story is of particular concern to the Germans, because it is reported that, of the known bribery cases in Germany, one third occur in the health sector. Nice.
The second story, which popped up unexpectedly concerns price fixing. I probably would have made the suggestion myself, but it seems that there is a concern that while this activity is present in the UK, there is a suspicion that it affects other countries in the EU. That pesky Worshipful Company, eh?
Drugs companies are defrauding healthcare systems, conference hears
Professor Peter Schonhofer of the Institute of Pharmacology, Bremen, said the fraud included not being able to view data from clinical trials submitted to the German regulatory body, the Federal Institute of Drugs and Medicinal Products.
"If they have information they don't tell us it," he told the BMJ. "We don't have access to relevant data."
That could mean therapeutic decisions were inappropriate—but because the relevant data were covered by a commercial confidentiality clause, those outside the institute could never know how appropriate the treatment was.
He also cited what is euphemistically called a "drug use study," whereby a doctor is paid anything from EUR200 (GBP140; $250) to EUR500 for transferring a patient from one drug to another and then filling in a form to say what they have done.
"We know that the pharmaceutical industry in German has spent EUR1bn a year for such drug use studies. And it is not just in Germany. In Italy, GSK [GlaxoSmithKline] spent EUR28m over a 12 year period just for doctors to provide a signature."
Smooth. And this business of "drug use studies" fits in nicely with the previous piece. But there's more:
Jim Gee, chief executive of the Department of Health's NHS Counter Fraud and Security Management Service, said they had evidence to suggest the existence of a price fixing cartel. Six pharmaceutical companies are allegedly involved in fixing the price of warfarin, costing the NHS GBP28m; seven are allegedly involved in keeping the price of penicillin high, costing the NHS GBP30m...
"Clearly these companies operate in the other countries too," Mr Gee said, suggesting that other European countries might also have been similarly defrauded.
Altogether now (to the tune of "Always look on the bright side," or the Archers' theme tune (use your imagination, I know it doesn't scan)):
Extend and enhance life by
Living longer and feeling better
Do more by being
Committed to helping people improve their health
Let's find new ideas that are inspired by life
And respect people's integrity and excellence
We can all ease suffering and enhance the quality of life, and
Always look on the bright side of life...(rpt)
And when you've finished puking, you may award yourself a cookie for every Worshipful Company tagline you spotted (in order to replace the ones you tossed)! Clue: I've "trimmed" them, in order to have them make vague sense.
Sunday, 21 October 2007
Executives arrested at drug firm
Following my posts concerning Trim Bossy Quibblers (anagram), I thought I might have a scout round, just to make sure that no such activities were being pursued in the UK (ie, the bribing of quacks, in order to have them prescribe a certain manufacturer's snake oil remedies). I see that Italy has a bit of an issue with this kind of thing, with an incident involving our good friends at GSK, back in 2003, which I was quick to bring to the MHRA's attention (no doubt the incident was of little concern to it, being outside its jurisdiction):
Italian police investigate GSK Italy for bribery
I see from a SOMO report, dated in late 2004, that the language being used is still of allegations and "accusations," so we shouldn't jump to conclusions. However, I see that SOMO mentions German allegations, too (see p18). More recently, Milanese police have had cause to investigate eight companies, in 2006, including giants Recordati, Pfizer, GlaxoSmithKline, AstraZeneca and Novartis:
Executives arrested at drug firm
I see that Le Monde notes the silence of the media, with respect to the GSK case. Jeez, they must have some powerful friends, because I'd cut their fucking hearts out with a spoon, if it were me (figuratively speaking, obviously). Should I look further? I don't think I've got the stomach for it. Thanks all the same.
Matt
Italian police investigate GSK Italy for bribery
I see from a SOMO report, dated in late 2004, that the language being used is still of allegations and "accusations," so we shouldn't jump to conclusions. However, I see that SOMO mentions German allegations, too (see p18). More recently, Milanese police have had cause to investigate eight companies, in 2006, including giants Recordati, Pfizer, GlaxoSmithKline, AstraZeneca and Novartis:
Executives arrested at drug firm
I see that Le Monde notes the silence of the media, with respect to the GSK case. Jeez, they must have some powerful friends, because I'd cut their fucking hearts out with a spoon, if it were me (figuratively speaking, obviously). Should I look further? I don't think I've got the stomach for it. Thanks all the same.
Matt
Friday, 19 October 2007
Freedom of Information: Under-resourced watchdog swamped by complaints
I thought I might just follow the logical course of action and take my complaint to the ICO. I'm not expecting anything to be done about it: the ICO doesn't look like a very powerful body, to my eye:
Dear Sir or Madam,
Further to Robert Verkaik's piece in today's Indy, I would like to make a formal complaint about the MHRA's decision to dismiss my enquiries concerning its regulatory [in]activity. I object to it characterizing my enquiries as concerning Seroxat, specifically, when Seroxat, although a good case in point, was only that: a case study:
Matthew Holford Final Report
It is my contention that the MHRA operates a culture of blind eye, which permits a course of conduct that leads, ultimately, to the licensing of drugs that are both dangerous and inefficacious. Specifically, that it permits drug companies to withhold original data; that it does not insist on data from failed trials being submitted with the licence application portfolio; that it seemingly considers only the drug companies' (positive) opinion of its products, when licensing, thus rendering its own risk:benefit assessment procedures meaningless; that it places undue faith in the opinions of academics who are regularly shown to be conflicted; that its patient reporting system gives little weight to patient experience, which permits it to leave drugs on the market, in spite of the flags being raised; and that it ignores the warning signs that are present in the regular legal actions brought by class action and states, in the US, which allege dubious marketing and suppression of information concerning side effects.
This represents a chain of causation that leads to drugs with dubious risk profiles remaining on the market, I would argue. And you may rest assured that I am incandescent that the MHRA chose to dismiss my complaint, and to brand me vexatious, presumably as a means of avoiding scrutiny of its activities. I would be grateful if the ICO would rule on this, and ultimately order the MHRA to respond to my queries, particularly that concerning the question "what is the benefit of Seroxat?"
Best regards
Matthew Holford
Dear Sir or Madam,
Further to Robert Verkaik's piece in today's Indy, I would like to make a formal complaint about the MHRA's decision to dismiss my enquiries concerning its regulatory [in]activity. I object to it characterizing my enquiries as concerning Seroxat, specifically, when Seroxat, although a good case in point, was only that: a case study:
Matthew Holford Final Report
It is my contention that the MHRA operates a culture of blind eye, which permits a course of conduct that leads, ultimately, to the licensing of drugs that are both dangerous and inefficacious. Specifically, that it permits drug companies to withhold original data; that it does not insist on data from failed trials being submitted with the licence application portfolio; that it seemingly considers only the drug companies' (positive) opinion of its products, when licensing, thus rendering its own risk:benefit assessment procedures meaningless; that it places undue faith in the opinions of academics who are regularly shown to be conflicted; that its patient reporting system gives little weight to patient experience, which permits it to leave drugs on the market, in spite of the flags being raised; and that it ignores the warning signs that are present in the regular legal actions brought by class action and states, in the US, which allege dubious marketing and suppression of information concerning side effects.
This represents a chain of causation that leads to drugs with dubious risk profiles remaining on the market, I would argue. And you may rest assured that I am incandescent that the MHRA chose to dismiss my complaint, and to brand me vexatious, presumably as a means of avoiding scrutiny of its activities. I would be grateful if the ICO would rule on this, and ultimately order the MHRA to respond to my queries, particularly that concerning the question "what is the benefit of Seroxat?"
Best regards
Matthew Holford
Friday, 12 October 2007
Trim Bossy Quibblers
I'm not quite sure what publishing my latest exchange with the MHRA is likely to achieve, but I've got nothing to better to do, just at the minute.
Should it be that the gentle reader has any evidence of dodgy payments, you know where to take your concerns:
From: Matthew Holford
Sent: 11 October 2007 13:53
To: MHRA Information Centre
Subject: RE: Bristol-Myers Squibb
Many thanks. I don't have any such evidence, as it happens - must just be in the US, then.
Best regards
Matthew Holford
**************************
Subject: FW: Bristol-Myers Squibb
Date: Tue, 9 Oct 2007 12:42:41 +0100
From: info@mhra.gsi.gov.uk
To: Matthew Holford
Dear Mr Holford,
Thank you for this enquiry.
The Medicines (Advertising) Regulations 1994 prohibit the offer of any gift or inducement to prescribe or supply medicines unless it is inexpensive and relevant to the practice of medicine or pharmacy. The offer of money to doctors to prescribe drugs off-label would therefore be prohibited. The MHRA routinely investigates any complaints received about possible breaches of this legislation.
We are not aware that the above mentioned company is paying doctors to prescribe drugs off-label in the UK but if you have evidence that this is taking place then we would be prepared to investigate it under the legislation on advertising medicines.
Please contact us again if you need further assistance with this, or any other queries.
Kind Regards,
Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
**************************
From: Matthew Holford
Sent: 02 October 2007 01:50
To: MHRA Information Centre
Cc: [Alan Johnson], [Shailesh Vara]
Subject: Bristol-Myers Squibb
Dear Sir or Madam,
Is the MHRA aware as to whether the abovecaptioned company is paying doctors to prescribe drugs off-label, in the UK?
Best regards
Matthew Holford
Should it be that the gentle reader has any evidence of dodgy payments, you know where to take your concerns:
From: Matthew Holford
Sent: 11 October 2007 13:53
To: MHRA Information Centre
Subject: RE: Bristol-Myers Squibb
Many thanks. I don't have any such evidence, as it happens - must just be in the US, then.
Best regards
Matthew Holford
**************************
Subject: FW: Bristol-Myers Squibb
Date: Tue, 9 Oct 2007 12:42:41 +0100
From: info@mhra.gsi.gov.uk
To: Matthew Holford
Dear Mr Holford,
Thank you for this enquiry.
The Medicines (Advertising) Regulations 1994 prohibit the offer of any gift or inducement to prescribe or supply medicines unless it is inexpensive and relevant to the practice of medicine or pharmacy. The offer of money to doctors to prescribe drugs off-label would therefore be prohibited. The MHRA routinely investigates any complaints received about possible breaches of this legislation.
We are not aware that the above mentioned company is paying doctors to prescribe drugs off-label in the UK but if you have evidence that this is taking place then we would be prepared to investigate it under the legislation on advertising medicines.
Please contact us again if you need further assistance with this, or any other queries.
Kind Regards,
Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
**************************
From: Matthew Holford
Sent: 02 October 2007 01:50
To: MHRA Information Centre
Cc: [Alan Johnson], [Shailesh Vara]
Subject: Bristol-Myers Squibb
Dear Sir or Madam,
Is the MHRA aware as to whether the abovecaptioned company is paying doctors to prescribe drugs off-label, in the UK?
Best regards
Matthew Holford
Monday, 1 October 2007
Antidepressants video goes for the jugular
I think I really ought to put in a link to this hard-hitting YouTube video, featured on Pharmalot, Seroxat Secrets, and now, IQAE. It features a bunch of stuff: FDA hearings, expert opinion, and personal experience. Be warned: it's not for the faint-hearted:
Antidepressants video goes for the jugular
Antidepressants video goes for the jugular
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