Snappy title. I decided that it was all humorous, so I've posted the press release, in full.
I was discussing the concept of Chomsky's foregrounded elements with one of my colleagues, recently. Very briefly, this term refers to a turn of phrase that signals the lie behind a given statement. I would like to bring to your attention "relating to the company's U.S. pharmaceuticals business," and suggest that this is such a foregrounded element: the suggestion being that in other parts of the world Squibb is going to carry on doing just what it's been doing. Or, perhaps, it means that it is only in the US that Squibb has been paying doctors to prescribe its drugs. Who knows?
Anyway, I'm going to send this to Laura Hortas (email at the bottom of the press release) and the One of the Four, in order that Squibb can fully understand the extent to which it, and others, have undermined any trust that might have been invested in the Worshipful Company. And the extent to which it (the Worshipful Company) is now regarded with almost complete contempt. To the extent that it gives a shit, of course.
NEW YORK, Sept. 28 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that it has finalized a civil settlement agreement with the United States Department of Justice ("DOJ") and the Office of the United States Attorney for the District of Massachusetts resolving the previously disclosed investigations that began several years ago involving the company's drug pricing, and sales and marketing activities. The company announced in December 2006 that an agreement in principle had been reached. In connection with the settlement, the company has entered into a five-year corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services ("OIG") that provides for, among other obligations, the continued development and maintenance of the company's compliance programs relating to the company's U.S. pharmaceuticals business.
As previously announced, the agreement provides for a civil resolution and payment of $499 million, the full amount of which has been reserved. There are no criminal charges against the company. The agreement will not affect the company's ongoing business with any customers, including the government.
Bristol-Myers Squibb is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
SOURCE: Bristol-Myers Squibb Company
CONTACT: Media, Jeff Macdonald, Communications, +1-212-546-4824,
jeffrey.macdonald@bms.com, or Laura Hortas, Communications, +1-609-252-4587,
laura.hortas@bms.com, or Investors, John Elicker, Investor Relations,
+1-212-546-3775, all of Bristol-Myers Squibb Company
Web site: http://www.bms.com/
Sunday, 30 September 2007
Bristol-Myers Squibb to pay $515 million for doctor kickback scheme
Bob Fiddaman's got a piece on Seroxat Sufferers, just now, which is taken from the Boston Globe. It concerns a settlement by Squibb over a civil action that dealt with a bunch of stuff, including promotion of off-label prescription of drugs to quacks:
http://fiddaman.blogspot.com/2007/09/will-gsk-be-next.html
In a statement posted on its website, the company said the settlement agreement will not affect the company's ongoing business with any customers, including the government.
"Bristol-Myers Squibb is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life,'' the company said.
"From the past"? [Derisive laughter] Yeah, right. Guys, this activity forms part of your business plan, along with suppression of data, dodgy regulatory assessment of licence applications and conflicted academia writing positive stuff about your snake oil remedies. I'm going to have a read of Squibb's statement and I'll make comment, if I find something sufficiently amusing.
Matt
http://fiddaman.blogspot.com/2007/09/will-gsk-be-next.html
In a statement posted on its website, the company said the settlement agreement will not affect the company's ongoing business with any customers, including the government.
"Bristol-Myers Squibb is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life,'' the company said.
"From the past"? [Derisive laughter] Yeah, right. Guys, this activity forms part of your business plan, along with suppression of data, dodgy regulatory assessment of licence applications and conflicted academia writing positive stuff about your snake oil remedies. I'm going to have a read of Squibb's statement and I'll make comment, if I find something sufficiently amusing.
Matt
Delighted to engage GSK shareholders - Part II
Welcome back gentle readers. I am pleased to report that the One of the Four dropped me a line, via his secretary, today. Apparently he mislaid my last reply amidst the chaos that is his busy desk... Anyway, I replied, copied to Gordon Brown (texture like sun), Johnson and Vara:
Dear [redacted],
You are very kind to apologize: I am regrettably well-acquainted with complete ignorance, as Mr Vara will attest.
As it happens, I was not desperate for the MHRA to pursue GSK through the criminal justice system, on the issue of the Russian vaccines, although I do think it would be more appropriate for the relationship between regulator and regulated to be rather more "edgy" than it is. I regret that the MHRA has already demonstrated its incompetence to me and my colleagues on other matters and, as such, there is precious little likelihood of it scrutinizing this incident, when apparently it is unable to see the significance of the Worshipful Company withholding negative data from a scientific perspective, let alone a regulatory one. I was greatly amused by its failure to have even the most basic information about efficacy, which is hardly surprising, given the seemingly routine suppression of negative data.
In any case, I have made all these points and more to Brown, and have been deafened by the ensuing silence. I will draw my own inferences, as is the fashion these days, I believe.
Best regards
Matthew Holford
**************************************
Subject:
Date: Sat, 29 Sep 2007 16:46:28 +0100
From: [the.one's.secretary]@parliament.uk
To: [audit.committee]@hotmail.co.uk
Dear Mr Holford,
Thank you for your further e-mail of 26 July. I must first of all apologise for not having responded sooner but I am afraid it was overlooked on my desk.
I understand the points that you raise. It seems to me, however, that in terms of my frontbench role as Shadow [something-or-other] the legal issues are fairly clear. I can see no possiblility of a criminal investigation from this country. So far as your concern that the MHRA is not investigating the activities of GSK whether it is endangering patients or others by its activities in this country, then this is a matter which should be raised through your local constituency MP as it is outside my departmental remit.
Yours sincerely,
[redacted]
Shadow [something-or-other]
Dear [redacted],
You are very kind to apologize: I am regrettably well-acquainted with complete ignorance, as Mr Vara will attest.
As it happens, I was not desperate for the MHRA to pursue GSK through the criminal justice system, on the issue of the Russian vaccines, although I do think it would be more appropriate for the relationship between regulator and regulated to be rather more "edgy" than it is. I regret that the MHRA has already demonstrated its incompetence to me and my colleagues on other matters and, as such, there is precious little likelihood of it scrutinizing this incident, when apparently it is unable to see the significance of the Worshipful Company withholding negative data from a scientific perspective, let alone a regulatory one. I was greatly amused by its failure to have even the most basic information about efficacy, which is hardly surprising, given the seemingly routine suppression of negative data.
In any case, I have made all these points and more to Brown, and have been deafened by the ensuing silence. I will draw my own inferences, as is the fashion these days, I believe.
Best regards
Matthew Holford
**************************************
Subject:
Date: Sat, 29 Sep 2007 16:46:28 +0100
From: [the.one's.secretary]@parliament.uk
To: [audit.committee]@hotmail.co.uk
Dear Mr Holford,
Thank you for your further e-mail of 26 July. I must first of all apologise for not having responded sooner but I am afraid it was overlooked on my desk.
I understand the points that you raise. It seems to me, however, that in terms of my frontbench role as Shadow [something-or-other] the legal issues are fairly clear. I can see no possiblility of a criminal investigation from this country. So far as your concern that the MHRA is not investigating the activities of GSK whether it is endangering patients or others by its activities in this country, then this is a matter which should be raised through your local constituency MP as it is outside my departmental remit.
Yours sincerely,
[redacted]
Shadow [something-or-other]
Tuesday, 25 September 2007
Experts Question Study on Youth Suicide Rates
Goodness me, I am slow on the uptake! The story that I have for you, today, my most excellent friends, (Stop it. Ed.), has been doing the rounds for some time, now, but I have neglected to contribute my "hit" in any relevant Google search.
This has been covered in some detail by many others, blogs and mainstream press, alike, so I'll keep my synopsis as brief as possible, and link you to a bunch of other sources, at the bottom of the post. It seems that a team of academics scrutinized data on suicides in children and adolescents in the US, and found that there was a significant rise in 2004. On 15 October, 2004, the FDA installed a black box warning on SSRIs.
The "inevitable" conclusion was that the warning had led to a decrease in prescriptions for these drugs, which had led to the increase in suicides. These "findings" were published in the American Journal of Psychiatry, and also featured in the BMJ. However, the more numerate amongst you will have noted that only a month and a half of 2004 remained when the warning was announced. Indeed, a New York Times article, which ran a couple of weeks ago, pointed out that prescriptions didn't change much in 2004: that came in 2005, when preliminary figures suggest a fall in suicides.
However, despite the apparent quality of the conclusions reached [sorry, at this point I have to insert a favourite quotation from my Legal History professor, Dr Anton Schutz, who once observed that one of his students' reasoning amounted to "an athletic intellectual bound"] the AJP and BMJ have yet to respond with any kind of modification to the plangent whailings of the authors, Gibbons, Mann, et al:
SSRI prescriptions for children and adolescents decreased after U.S. and European regulatory agencies issued warnings about a possible suicide risk with antidepressant use in pediatric patients, and these decreases were associated with increases in suicide rates in children and adolescents
Ooh, yes, nearly forgot, the lead authors have lots of links with quite a few of our friends in the Worshipful Company.
See also:
http://www.nytimes.com/2007/09/14/us/14suicide.html
http://www.furiousseasons.com/
http://www.pharmalot.com/
http://seroxatsecrets.wordpress.com/
This has been covered in some detail by many others, blogs and mainstream press, alike, so I'll keep my synopsis as brief as possible, and link you to a bunch of other sources, at the bottom of the post. It seems that a team of academics scrutinized data on suicides in children and adolescents in the US, and found that there was a significant rise in 2004. On 15 October, 2004, the FDA installed a black box warning on SSRIs.
The "inevitable" conclusion was that the warning had led to a decrease in prescriptions for these drugs, which had led to the increase in suicides. These "findings" were published in the American Journal of Psychiatry, and also featured in the BMJ. However, the more numerate amongst you will have noted that only a month and a half of 2004 remained when the warning was announced. Indeed, a New York Times article, which ran a couple of weeks ago, pointed out that prescriptions didn't change much in 2004: that came in 2005, when preliminary figures suggest a fall in suicides.
However, despite the apparent quality of the conclusions reached [sorry, at this point I have to insert a favourite quotation from my Legal History professor, Dr Anton Schutz, who once observed that one of his students' reasoning amounted to "an athletic intellectual bound"] the AJP and BMJ have yet to respond with any kind of modification to the plangent whailings of the authors, Gibbons, Mann, et al:
SSRI prescriptions for children and adolescents decreased after U.S. and European regulatory agencies issued warnings about a possible suicide risk with antidepressant use in pediatric patients, and these decreases were associated with increases in suicide rates in children and adolescents
Ooh, yes, nearly forgot, the lead authors have lots of links with quite a few of our friends in the Worshipful Company.
See also:
http://www.nytimes.com/2007/09/14/us/14suicide.html
http://www.furiousseasons.com/
http://www.pharmalot.com/
http://seroxatsecrets.wordpress.com/
Monday, 24 September 2007
State plans lawsuit against drug firms
Welcome back, gentle reader (I give up. Ed.). Just the other day, I came across something, which has been picked up on by Pharmalot and Furious Seasons (and, no doubt, others). There's additional comment on both those blogs (links on the right of the page), if you would care to read on. It seems that there are more lawsuits heading the way of the Worshipful Company, this time in Arkansas. This from the Arkansas Democrat Gazette (http://www.nwanews.com/adg/News/202128/ for the full story):
"...A letter [Arkansas Attorney General Dustin] McDaniel wrote to the [Legislative] council says “substantial evidence” exists to support a claim by the state for “improper and unlawful marketing” of anti-psychiotic drugs by Eli Lilly & Co. of Indianapolis; Janssen Pharmaceutica of Titusville, N. J.; and Astra Zeneca, an international company formed by the union of a United Kingdom firm and a Swedish firm.
The drugs in question are Zyprexa, Risperdal and Seroquel.
Officials with those companies didn’t return telephone messages left by the Arkansas Democrat-Gazette.
McDaniel told reporters after the meeting that researchers have known since the 1950s that anti-psychotic drugs had serious side effects, including weight gain, hypoglycemia and Type II diabetes..."
"Improper and unlawful marketing." Oh, well, I suppose it's something. I do wonder, now, every time I see Eli's name, just how the drug came to be developed. Particularly given that reference to the 1950s. That's what secrecy does for you, I guess.
Incidentally, I note that the lovely Anne Milgram is considering joining a bunch of other states in bringing a similar action. Anne Milgram. She would be the Attorney General of New Jersey, where most of our friends in the Worshipful Company are based. Ouch! The very possibility of a home defeat! It warms the cockles of your heart!
Matt
"...A letter [Arkansas Attorney General Dustin] McDaniel wrote to the [Legislative] council says “substantial evidence” exists to support a claim by the state for “improper and unlawful marketing” of anti-psychiotic drugs by Eli Lilly & Co. of Indianapolis; Janssen Pharmaceutica of Titusville, N. J.; and Astra Zeneca, an international company formed by the union of a United Kingdom firm and a Swedish firm.
The drugs in question are Zyprexa, Risperdal and Seroquel.
Officials with those companies didn’t return telephone messages left by the Arkansas Democrat-Gazette.
McDaniel told reporters after the meeting that researchers have known since the 1950s that anti-psychotic drugs had serious side effects, including weight gain, hypoglycemia and Type II diabetes..."
"Improper and unlawful marketing." Oh, well, I suppose it's something. I do wonder, now, every time I see Eli's name, just how the drug came to be developed. Particularly given that reference to the 1950s. That's what secrecy does for you, I guess.
Incidentally, I note that the lovely Anne Milgram is considering joining a bunch of other states in bringing a similar action. Anne Milgram. She would be the Attorney General of New Jersey, where most of our friends in the Worshipful Company are based. Ouch! The very possibility of a home defeat! It warms the cockles of your heart!
Matt
Request for victims to testify about their secret settlement in Congressional hearing
Bob Fiddaman's got an appeal running on Seroxat Sufferers, just now:
http://fiddaman.blogspot.com/2007/09/request-for-victims-to-testify-about.html
A Congressional committee is looking for victims of defective products who settled, but had to keep the product details secret due to a secrecy clause in their settlement (i.e. Ford/Firestone, prescription drugs, medical device victims). Ideally, the defendant corporation settled previous cases in secrecy and did not resolve the product defect...
...please contact Christine Zinner in the Public Affairs Department at (202)-944-2853 or christine.zinner@justice.org. Since the hearing is coming up very soon, we would appreciate any information as soon as possible.
It would be interesting to understand what the objective of this hearing is... We'll have to wait and see, won't we?
Matt
http://fiddaman.blogspot.com/2007/09/request-for-victims-to-testify-about.html
A Congressional committee is looking for victims of defective products who settled, but had to keep the product details secret due to a secrecy clause in their settlement (i.e. Ford/Firestone, prescription drugs, medical device victims). Ideally, the defendant corporation settled previous cases in secrecy and did not resolve the product defect...
...please contact Christine Zinner in the Public Affairs Department at (202)-944-2853 or christine.zinner@justice.org. Since the hearing is coming up very soon, we would appreciate any information as soon as possible.
It would be interesting to understand what the objective of this hearing is... We'll have to wait and see, won't we?
Matt
Saturday, 22 September 2007
Re: Government response to petition "SeroxatGSK"
Brown's office responded to Sally Milsom's petition, which closed in August. It was a shoddy piece of literature, in all respects:
http://www.pm.gov.uk/output/Page13265.asp
I felt compelled to respond to Brown in person:
Dear Brown,
Good Lord, man! Couldn't you think of anything original? You know, we went to all that trouble to establish for ourselves that the MHRA is incompetent (and from its own lips) - ie, that it has an assessment process that is apparently designed to not scrutinize drug licensing applications; nor can it provide even the most basic information (ie, about efficacy) and that that it does provide it refuses to expand on; that it stonewalls those who would attempt to scrutinize it; we identify any number of inconsistencies in the claims made by these charlatans and you come out with that pap. Pap that's several years old, I would point out.
Very disappointing. Quite insulting, actually, because it suggests to me that you have a very low opinion of our intelligence, such that you believe we would be satisfied with this. It also suggests that you don't consider us worthy of the time taken to compose something original that actually addresses the issues raised.
Have a nice day.
Matthew Holford
> From: number10@petitions.pm.gov.uk
> To: number10@petitions.pm.gov.uk
> Subject: Government response to petition 'SeroxatGSK'
> Date: Fri, 21 Sep 2007 15:09:15 +0000
>
> You recently signed a petition asking the Prime Minister to "carry out a
> thorough investigation into the drug trials regarding
> Paroxetine/Seroxat/Paxil."
>
> The Prime Minister's Office has responded to that petition and you can view
> it here:
>
> http://www.pm.gov.uk/output/Page13265.asp
http://www.pm.gov.uk/output/Page13265.asp
I felt compelled to respond to Brown in person:
Dear Brown,
Good Lord, man! Couldn't you think of anything original? You know, we went to all that trouble to establish for ourselves that the MHRA is incompetent (and from its own lips) - ie, that it has an assessment process that is apparently designed to not scrutinize drug licensing applications; nor can it provide even the most basic information (ie, about efficacy) and that that it does provide it refuses to expand on; that it stonewalls those who would attempt to scrutinize it; we identify any number of inconsistencies in the claims made by these charlatans and you come out with that pap. Pap that's several years old, I would point out.
Very disappointing. Quite insulting, actually, because it suggests to me that you have a very low opinion of our intelligence, such that you believe we would be satisfied with this. It also suggests that you don't consider us worthy of the time taken to compose something original that actually addresses the issues raised.
Have a nice day.
Matthew Holford
> From: number10@petitions.pm.gov.uk
> To: number10@petitions.pm.gov.uk
> Subject: Government response to petition 'SeroxatGSK'
> Date: Fri, 21 Sep 2007 15:09:15 +0000
>
> You recently signed a petition asking the Prime Minister to "carry out a
> thorough investigation into the drug trials regarding
> Paroxetine/Seroxat/Paxil."
>
> The Prime Minister's Office has responded to that petition and you can view
> it here:
>
> http://www.pm.gov.uk/output/Page13265.asp
Monday, 17 September 2007
Declassified
Welcome back, gentle reader (that's enough Aesop. Ed.). Today, we will be speculating on the extent of operation MKULTRA (that's the one that Eli provided the LSD for, if you remember). I'm delighted to have found a site that has a bunch of documents from this rather dubious episode in the ill-named CIA's murky history (most of the documentation was destroyed by the CIA in 1972, but that that remains is chilling enough, for my tastes):
http://www.michael-robinett.com/declass/c000.htm
I'm going to read this in more depth, because I find it an interesting insight into the absolutely staggering psychosis affecting those who would pretend to protect us. However, let me give you a little snippet from pages 020-21:
8. The next phase of the MKULTRA program involves physicians, toxicologists and other experts in mental, narcotics, and general hospitals and in prisons, who are provided with the products and findings of the basic research projects and proceed with intensive testing on human subjects. [my emphasis] These specialists are also recipients for testing purposes of the flow of new products from pharmaceutical laboratories. [my emphasis] Materials and procedures with intelligence potential [sic] may be identified through this relationship. The testing programs are conducted under accepted scientific procedures including the use of control populations, the employment of placebos, and the detailed observation, measurement, recording, analysis and publication [oh, yeah? Where?] of findings. Where health permits, test subjects are voluntary participants in the program... [my emphasis - what the fuck does that mean?]
...10. The final phase of testing of MKULTRA materials involves their application to unwitting subjects in normal life settings. It was noted earlier that the capabilities of MKULTRA substances to produce disabling or discrediting effects or to increase the effectiveness of interrogation of hostile subjects cannot be established solely through testing on volunteer populations... [my emphasis]
Just how far did this go, Mr Bush? And what could possibly have possessed your impossibly diseased minds to believe that this was OK?
Incidentally, I strongly recommend that the gentle reader should read on. The author has helpfully summarized the content of each page in the title of that page. Page 024 makes the mind boggle just to read that title, but the notion that "close working relations" are maintained with Plod the Fucking Sod, in order to suppress "compromising situations" just sends me completely fucking incandescent.
You bunch of fucking untrustworthy cunts.
http://www.michael-robinett.com/declass/c000.htm
I'm going to read this in more depth, because I find it an interesting insight into the absolutely staggering psychosis affecting those who would pretend to protect us. However, let me give you a little snippet from pages 020-21:
8. The next phase of the MKULTRA program involves physicians, toxicologists and other experts in mental, narcotics, and general hospitals and in prisons, who are provided with the products and findings of the basic research projects and proceed with intensive testing on human subjects. [my emphasis] These specialists are also recipients for testing purposes of the flow of new products from pharmaceutical laboratories. [my emphasis] Materials and procedures with intelligence potential [sic] may be identified through this relationship. The testing programs are conducted under accepted scientific procedures including the use of control populations, the employment of placebos, and the detailed observation, measurement, recording, analysis and publication [oh, yeah? Where?] of findings. Where health permits, test subjects are voluntary participants in the program... [my emphasis - what the fuck does that mean?]
...10. The final phase of testing of MKULTRA materials involves their application to unwitting subjects in normal life settings. It was noted earlier that the capabilities of MKULTRA substances to produce disabling or discrediting effects or to increase the effectiveness of interrogation of hostile subjects cannot be established solely through testing on volunteer populations... [my emphasis]
Just how far did this go, Mr Bush? And what could possibly have possessed your impossibly diseased minds to believe that this was OK?
Incidentally, I strongly recommend that the gentle reader should read on. The author has helpfully summarized the content of each page in the title of that page. Page 024 makes the mind boggle just to read that title, but the notion that "close working relations" are maintained with Plod the Fucking Sod, in order to suppress "compromising situations" just sends me completely fucking incandescent.
You bunch of fucking untrustworthy cunts.
Sunday, 16 September 2007
Those Lifton "Thought Reform" methods, in full
So, if one chooses to use largely overt, physical abuse (like the CIA), one can, nevertheless, affect a person's neurology, it would seem. One will, most likely, turn them into a nervous wreck.
However, is it possible to "change a person's mind" using solely a methodology that is "without proof", ie that could be achieved by secretly denying access to information, and so on? And consider this, what would happen if one did precisely the opposite? Well, Robert Jay Lifton certainly believed that mind control (in an apparently negative sense) was possible. Let's look at this particular brand of insanity, shall we:
http://changingminds.org/techniques/conversion/lifton_thought_reform.htm
Milieu control
All communication with outside world is limited, either being strictly filtered or completely cut off. Whether it is a monastery or a behind-closed-doors cult, isolation from the ideas, examples and distractions of the outside world turns the individuals attention to the only remaining form of stimulation, which is the ideology that is being inculcated in them.
This even works at the intrapersonal level, and individuals are discouraged from thinking incorrect thoughts, which may be termed evil, selfish, immoral and so on.
Mystical manipulation
A part of the teaching is that the group has a higher purpose than others outside the group. This may be altruistic, such as saving the world or helping people in need. It may also be selfish, for example that group members will be saved when others outside the group will perish.
All things are then attributed and linked to this higher purpose. Coincidences (which actually may be deliberately engineered) are portrayed as symbolic events. Attention is given to the problems of out-group people and attributed to their not being in the group. Revelations are attributed to spiritual causes.
This association of events is used as evidence that the group truly is special and exclusive.
Confession
Individuals are encouraged to confess past 'sins' (as defined by the group). This creates a tension between the person's actions and their stated belief that the action is bad, particularly if the statement is made publicly. The consistency principle thus leads the person to fully adopt the belief that the sin is bad and to distance themselves from repeating it.
Discussion of inner fears and anxieties, as well as confessing sins is exposing vulnerabilities and requires the person to place trust in the group and hence bond with them. When we bond with others, they become our friends, and we will tend to adopt their beliefs more easily.
This effect may be exaggerated with intense sessions where deep thoughts and feelings are regularly surfaced. This also has the effect of exhausting people, making them more open to suggestion.
Self-sanctification through purity Individuals are encouraged to constantly push towards an ultimate and unattainable perfection. This may be rewarded with promotion within the group to higher levels, for example by giving them a new status name (acolyte, traveller, master, etc.) or by giving them new authority within the group.
The unattainability of the ultimate perfection is used to induce guilt and show the person to be sinful and hence sustain the requirement for confession and obedience to those higher than them in the groups order of perfection.
Not being perfect may be seen as deserving of punishment, which may be meted out by the higher members of the group or even by the person themselves, who are taught that such atonement and self-flagellation is a valuable method of reaching higher levels of perfection.
Aura of sacred scienceThe beliefs and regulations of the group are framed as perfect, absolute and non-negotiable. The dogma of the group is presented as scientifically correct or otherwise unquestionable.
Rules and processes are therefore to be followed without question, and any transgression is a sin and hence requires atonement or other forms of punishment, as does consideration of any alternative viewpoints.
Loaded language New words and language are created to explain the new and profound meanings that have been discovered. Existing words are also hijacked and given new and different meaning.
This is particularly effective due to the way we think a lot though language. The consequence of this is that the person who controls the meaning of words also controls how people think. In this way, black-and-white thinking is embedded in the language, such that wrong-doers are framed as terrible and evil, whilst those who do right (as defined by the group) are perfect and marvellous.
The meaning of words are kept hidden both from the outside world, giving a sense of exclusivity. The meaning of special words may also be revealed in careful illuminatory rituals, where people who are being elevated within the order are given the power of understanding this new language.
Doctrine over person The importance of the group is elevated over the importance of the individual in all ways. Along with this comes the importance of the the group's ideas and rules over personal beliefs and values.
Past experiences, beliefs and values can all thus be cast as being invalid if they conflict with group rules. In fact this conflict can be used as a reason for confession of sins. Likewise, the beliefs, values and words of those outside the group are equally invalid.
Dispensed existence There is a very sharp line between the group and the outside world. Insiders are to be saved and elevated, whilst outsiders are doomed to failure and loss (which may be eternal).
Who is an outsider or insider is chosen by the group. Thus, any person within the group may be damned at any time. There are no rights of membership except, perhaps, for the leader.
People who leave the group are singled out as particularly evil, weak, lost or otherwise to be despised or pitied. Rather than being ignored or hidden, they are used as examples of how anyone who leaves will be looked down upon and publicly denigrated.
People thus have a constant fear of being cast out, and consequently work hard to be accepted and not be ejected from the group. Outsiders who try to persuade the person to leave are doubly feared.
Dispensation also goes into all aspects of living within the group. Any and all aspects of existence within the group is subject to scrutiny and control. There is no privacy and, ultimately, no free will.
Further to my previous post, you may wish to read up on the CIA's "Operation Midnight Climax," which involved extensive use of LSD:
http://en.wikipedia.org/wiki/Operation_Midnight_Climax
Goodness me, these people are desperately unsophisticated, aren't they?
Matt
However, is it possible to "change a person's mind" using solely a methodology that is "without proof", ie that could be achieved by secretly denying access to information, and so on? And consider this, what would happen if one did precisely the opposite? Well, Robert Jay Lifton certainly believed that mind control (in an apparently negative sense) was possible. Let's look at this particular brand of insanity, shall we:
http://changingminds.org/techniques/conversion/lifton_thought_reform.htm
Milieu control
All communication with outside world is limited, either being strictly filtered or completely cut off. Whether it is a monastery or a behind-closed-doors cult, isolation from the ideas, examples and distractions of the outside world turns the individuals attention to the only remaining form of stimulation, which is the ideology that is being inculcated in them.
This even works at the intrapersonal level, and individuals are discouraged from thinking incorrect thoughts, which may be termed evil, selfish, immoral and so on.
Mystical manipulation
A part of the teaching is that the group has a higher purpose than others outside the group. This may be altruistic, such as saving the world or helping people in need. It may also be selfish, for example that group members will be saved when others outside the group will perish.
All things are then attributed and linked to this higher purpose. Coincidences (which actually may be deliberately engineered) are portrayed as symbolic events. Attention is given to the problems of out-group people and attributed to their not being in the group. Revelations are attributed to spiritual causes.
This association of events is used as evidence that the group truly is special and exclusive.
Confession
Individuals are encouraged to confess past 'sins' (as defined by the group). This creates a tension between the person's actions and their stated belief that the action is bad, particularly if the statement is made publicly. The consistency principle thus leads the person to fully adopt the belief that the sin is bad and to distance themselves from repeating it.
Discussion of inner fears and anxieties, as well as confessing sins is exposing vulnerabilities and requires the person to place trust in the group and hence bond with them. When we bond with others, they become our friends, and we will tend to adopt their beliefs more easily.
This effect may be exaggerated with intense sessions where deep thoughts and feelings are regularly surfaced. This also has the effect of exhausting people, making them more open to suggestion.
Self-sanctification through purity Individuals are encouraged to constantly push towards an ultimate and unattainable perfection. This may be rewarded with promotion within the group to higher levels, for example by giving them a new status name (acolyte, traveller, master, etc.) or by giving them new authority within the group.
The unattainability of the ultimate perfection is used to induce guilt and show the person to be sinful and hence sustain the requirement for confession and obedience to those higher than them in the groups order of perfection.
Not being perfect may be seen as deserving of punishment, which may be meted out by the higher members of the group or even by the person themselves, who are taught that such atonement and self-flagellation is a valuable method of reaching higher levels of perfection.
Aura of sacred scienceThe beliefs and regulations of the group are framed as perfect, absolute and non-negotiable. The dogma of the group is presented as scientifically correct or otherwise unquestionable.
Rules and processes are therefore to be followed without question, and any transgression is a sin and hence requires atonement or other forms of punishment, as does consideration of any alternative viewpoints.
Loaded language New words and language are created to explain the new and profound meanings that have been discovered. Existing words are also hijacked and given new and different meaning.
This is particularly effective due to the way we think a lot though language. The consequence of this is that the person who controls the meaning of words also controls how people think. In this way, black-and-white thinking is embedded in the language, such that wrong-doers are framed as terrible and evil, whilst those who do right (as defined by the group) are perfect and marvellous.
The meaning of words are kept hidden both from the outside world, giving a sense of exclusivity. The meaning of special words may also be revealed in careful illuminatory rituals, where people who are being elevated within the order are given the power of understanding this new language.
Doctrine over person The importance of the group is elevated over the importance of the individual in all ways. Along with this comes the importance of the the group's ideas and rules over personal beliefs and values.
Past experiences, beliefs and values can all thus be cast as being invalid if they conflict with group rules. In fact this conflict can be used as a reason for confession of sins. Likewise, the beliefs, values and words of those outside the group are equally invalid.
Dispensed existence There is a very sharp line between the group and the outside world. Insiders are to be saved and elevated, whilst outsiders are doomed to failure and loss (which may be eternal).
Who is an outsider or insider is chosen by the group. Thus, any person within the group may be damned at any time. There are no rights of membership except, perhaps, for the leader.
People who leave the group are singled out as particularly evil, weak, lost or otherwise to be despised or pitied. Rather than being ignored or hidden, they are used as examples of how anyone who leaves will be looked down upon and publicly denigrated.
People thus have a constant fear of being cast out, and consequently work hard to be accepted and not be ejected from the group. Outsiders who try to persuade the person to leave are doubly feared.
Dispensation also goes into all aspects of living within the group. Any and all aspects of existence within the group is subject to scrutiny and control. There is no privacy and, ultimately, no free will.
Further to my previous post, you may wish to read up on the CIA's "Operation Midnight Climax," which involved extensive use of LSD:
http://en.wikipedia.org/wiki/Operation_Midnight_Climax
Goodness me, these people are desperately unsophisticated, aren't they?
Matt
Thursday, 13 September 2007
Eli Lilly, Zyprexa and the Bush family
I came across the name of Wesbecker, just recently, and in an odd moment, I thought I'd read up on this interesting little snippet of pharmaceutical history. I found this piece, by Bruce Levine, which told me all that I needed to know (thanks Bruce, at least somebody did):
http://www.antidepressantsfacts.com/Bush-Lilly-CIA-serotonin.htm
And here's a little exerpt, which might just get you wondering what front page-holding events were kicking off at around that time to prevent the Fourth Estate from getting their thumbs out of their arses:
"In the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be prejudicial and Judge John Potter initially agreed that the jury shouldn't hear it. However, when Lilly attorneys used witnesses to make a case for Eli Lilly's superb system of collecting and analyzing side effects, Judge Potter said that Lilly had opened the door to evidence to the contrary and ruled that the Oraflex information would now be permitted. To Judge Potter's amazement, victims' attorneys never presented the Oraflex evidence and Eli Lilly won the case. Later, it was discovered that-in a manipulation Cornwell described as "unprecedented in any Western court"-Eli Lilly cut a secret deal with victims' attorneys to pay them and their clients not to introduce the Oraflex evidence. However, Judge Potter smelled a rat and fought for an investigation. In 1997, Eli Lilly quietly agreed to the verdict being changed from a Lilly victory to "dismissed as settled.""
But Levine excels himself with this beauty, which, if I hadn't been caused to wish a large number of people ill, I would have laughed at:
"There is one Eli Lilly piece of history so bizarre that if told to many psychiatrists, one just might get diagnosed as paranoid schizophrenic and medicated with Zyprexa. Former State Department officer John Marks in The Search for the "Manchurian Candidate": The CIA and Mind Control, The Secret History of the Behavioral Sciences (1979)-along with the Washington Post (1985) and the New York Times (1988)-reported an amazing story about the CIA and psychiatry. A lead player was psychiatrist D. Ewen Cameron, president of the American Psychiatric Association in 1953. Cameron was curious to discover more powerful ways to break down patient resistance. Using electroshock, LSD, and sensory deprivation, he was able to produce severe delirium. Patients often lost their sense of identity, forgetting their own names and even how to eat. The CIA, eager to learn more about Cameron's brainwashing techniques, funded him under a project code-named MKULTRA. According to Marks, Cameron was part of a small army of the CIA's LSD-experimenting psychiatrists. Where did the CIA get its LSD? Marks reports that the CIA had been previously supplied by the Swiss pharmaceutical corporation Sandoz, but was uncomfortable relying on a foreign company and so, in 1953, the CIA asked Eli Lilly to make them up a batch of LSD, which Lilly subsequently donated to the CIA."
Eli and mind control. You shouldn't have done that, guys.
Matt
http://www.antidepressantsfacts.com/Bush-Lilly-CIA-serotonin.htm
And here's a little exerpt, which might just get you wondering what front page-holding events were kicking off at around that time to prevent the Fourth Estate from getting their thumbs out of their arses:
"In the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be prejudicial and Judge John Potter initially agreed that the jury shouldn't hear it. However, when Lilly attorneys used witnesses to make a case for Eli Lilly's superb system of collecting and analyzing side effects, Judge Potter said that Lilly had opened the door to evidence to the contrary and ruled that the Oraflex information would now be permitted. To Judge Potter's amazement, victims' attorneys never presented the Oraflex evidence and Eli Lilly won the case. Later, it was discovered that-in a manipulation Cornwell described as "unprecedented in any Western court"-Eli Lilly cut a secret deal with victims' attorneys to pay them and their clients not to introduce the Oraflex evidence. However, Judge Potter smelled a rat and fought for an investigation. In 1997, Eli Lilly quietly agreed to the verdict being changed from a Lilly victory to "dismissed as settled.""
But Levine excels himself with this beauty, which, if I hadn't been caused to wish a large number of people ill, I would have laughed at:
"There is one Eli Lilly piece of history so bizarre that if told to many psychiatrists, one just might get diagnosed as paranoid schizophrenic and medicated with Zyprexa. Former State Department officer John Marks in The Search for the "Manchurian Candidate": The CIA and Mind Control, The Secret History of the Behavioral Sciences (1979)-along with the Washington Post (1985) and the New York Times (1988)-reported an amazing story about the CIA and psychiatry. A lead player was psychiatrist D. Ewen Cameron, president of the American Psychiatric Association in 1953. Cameron was curious to discover more powerful ways to break down patient resistance. Using electroshock, LSD, and sensory deprivation, he was able to produce severe delirium. Patients often lost their sense of identity, forgetting their own names and even how to eat. The CIA, eager to learn more about Cameron's brainwashing techniques, funded him under a project code-named MKULTRA. According to Marks, Cameron was part of a small army of the CIA's LSD-experimenting psychiatrists. Where did the CIA get its LSD? Marks reports that the CIA had been previously supplied by the Swiss pharmaceutical corporation Sandoz, but was uncomfortable relying on a foreign company and so, in 1953, the CIA asked Eli Lilly to make them up a batch of LSD, which Lilly subsequently donated to the CIA."
Eli and mind control. You shouldn't have done that, guys.
Matt
Wednesday, 12 September 2007
Re: Matthew Holford - Final Report - Part II
Incidentally, should it ever come to pass that you are writhing on your dining room floor, in the midst of your latest anxiety attack, before feverishly pacing to and fro, trying to escape a predator that won't reveal itself, and then trying every source that one can find in order to establish what's happening to you, only to be informed by those who have any interest in engaging with you, obliquely or otherwise, that it is your problem, then you will have the right to call me vexatious.
Until that time, you would do better to keep your own counsel when it comes to throwing around that word. Do you understand?
Best regards
Matthew Holford
Until that time, you would do better to keep your own counsel when it comes to throwing around that word. Do you understand?
Best regards
Matthew Holford
Re: Matthew Holford - Final Report
Oooh, and that does sound final, doesn't it? Anyway, Sean Fletcher (or somebody) has been busy at his keyboard, and had this to say:
Dear Mr Fletcher,
Many thanks for this. As it happens, you have satisfied my enquiries completely: I had only one, in fact. At the risk of posing questions, which the MHRA has no realistic capacity to satisfy, and thus being confirmed as vexatious, I would ask just how much control the MHRA actually has over its members - to which end, how capable is it of safeguarding the public? Please don't concern yourself with a reply.
The MHRA certainly did have the capacity to satisfy my enquiries. It just chose not to, that's all.
Best regards
Matthew Holford
***************************
From: "MHRA Information Centre"
To: "Matthew Holford"
Subject: Matthew Holford Review - Final Report
Date: Wed, 12 Sep 2007 10:48:32 +0100
<>
Dear Mr Holford,
Please find attached the outcome of our internal review into your recent Freedom of Information Act requests.
Please contact me 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
Attachment (I've only included the Conclusions and Recommendations on the ground that it's the only relevant bit:
Conclusions and Recommendations
65. Those questions which have not been answered under FOI requests 07/066 (see paragraphs 11, 32 and 33) and 07/088 (see paragraphs 13, 34 and 35) should now be considered and appropriate responses sent to Mr Holford.
66. In respect of FOI requests 07/140 and 07/142, the MHRA correctly applied the principles of aggregation in terms of S12(4) of the FOI Act. I do not think, however, that the aggregation caused the costs of dealing with Mr Holford’s requests to exceed the appropriate limit of £600.
Rather than relying on S12, the Agency should have invoked Section 14 of the FOI Act.
67. The Agency was justified in applying Section 14 of the FOI Act to Mr Holford’s requests in late May and early June.
Subsequent requests from Mr Holford on Seroxat and matters relating to Seroxat can, likewise, be deemed vexatious and the Agency would be justified in refusing such requests.
Dear Mr Fletcher,
Many thanks for this. As it happens, you have satisfied my enquiries completely: I had only one, in fact. At the risk of posing questions, which the MHRA has no realistic capacity to satisfy, and thus being confirmed as vexatious, I would ask just how much control the MHRA actually has over its members - to which end, how capable is it of safeguarding the public? Please don't concern yourself with a reply.
The MHRA certainly did have the capacity to satisfy my enquiries. It just chose not to, that's all.
Best regards
Matthew Holford
***************************
From: "MHRA Information Centre"
To: "Matthew Holford"
Subject: Matthew Holford Review - Final Report
Date: Wed, 12 Sep 2007 10:48:32 +0100
<
Dear Mr Holford,
Please find attached the outcome of our internal review into your recent Freedom of Information Act requests.
Please contact me 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
Attachment (I've only included the Conclusions and Recommendations on the ground that it's the only relevant bit:
Conclusions and Recommendations
65. Those questions which have not been answered under FOI requests 07/066 (see paragraphs 11, 32 and 33) and 07/088 (see paragraphs 13, 34 and 35) should now be considered and appropriate responses sent to Mr Holford.
66. In respect of FOI requests 07/140 and 07/142, the MHRA correctly applied the principles of aggregation in terms of S12(4) of the FOI Act. I do not think, however, that the aggregation caused the costs of dealing with Mr Holford’s requests to exceed the appropriate limit of £600.
Rather than relying on S12, the Agency should have invoked Section 14 of the FOI Act.
67. The Agency was justified in applying Section 14 of the FOI Act to Mr Holford’s requests in late May and early June.
Subsequent requests from Mr Holford on Seroxat and matters relating to Seroxat can, likewise, be deemed vexatious and the Agency would be justified in refusing such requests.
Delphi Centre, GSK and TGA
Bob Fiddaman, over at Seroxat Sufferers, has been a-surfing the web, just recently. It seems that one of those patient groups that the Worshipful Company is so keen on supporting is breaching Australian advertising laws (link to the full story below). The TGA (that's the Aussie version of the FDA/MHRA) doesn't seem to want to talk to us about it, though. I wonder why?
Anyway, having made it aware of our initial concerns, I thought I'd write to it again. This to the TGA and Delphi, copied to Bicknell, Johnson, Vara and the MHRA:
Dear Sirs,
We have contacted you recently on the subject of an apparent breach of Australian (and possibly EU) drug advertising laws:
http://fiddaman.blogspot.com/2007/09/delphi-centre-gsk-and-tga.html
To date, we have received no response from the TGA. We are concerned at this apparent unwillingness to a) enforce the Law, and b) engage with patients and consumers, as you may imagine.
I have copied Mr Simon Bicknell, GSK's Head of Corporate Governance, here in the UK, and I have no doubt that, as a lawyer, he will be keen to ensure that GSK is not in transgression of the relevant laws. Similarly, should he decide that it is, he will no doubt instruct the Delphi Centre to pull the offending Aropax logo from Delphi's sponsors' page. Or you could it yourself.
Best regards
Matthew Holford
Anyway, having made it aware of our initial concerns, I thought I'd write to it again. This to the TGA and Delphi, copied to Bicknell, Johnson, Vara and the MHRA:
Dear Sirs,
We have contacted you recently on the subject of an apparent breach of Australian (and possibly EU) drug advertising laws:
http://fiddaman.blogspot.com/2007/09/delphi-centre-gsk-and-tga.html
To date, we have received no response from the TGA. We are concerned at this apparent unwillingness to a) enforce the Law, and b) engage with patients and consumers, as you may imagine.
I have copied Mr Simon Bicknell, GSK's Head of Corporate Governance, here in the UK, and I have no doubt that, as a lawyer, he will be keen to ensure that GSK is not in transgression of the relevant laws. Similarly, should he decide that it is, he will no doubt instruct the Delphi Centre to pull the offending Aropax logo from Delphi's sponsors' page. Or you could it yourself.
Best regards
Matthew Holford
Tuesday, 11 September 2007
More opaque than an opaque thing... Part VI
I just thought I'd let Johnson know what the position was...
Dear Mr Johnson,
I'm reasonably confident that you're not going to do anything about this, but I have to prove that you're not going to do anything, don't I? I can't just say that, can I?
Shame on you: people are having to put up with incompetent performance and fraudulent marketing because people like you are protecting interests that do not deserve to be protected. Pharmaceuticals are not appropriate for the treatment of mental health issues (and they're probably not much good for anything else, either). The Chemical Imbalance theory, the very pillar on which all these shite drugs are balanced, is bollox. And you know it, as does the FDA, even if the MHRA hasn't acknowledged it, yet.
Best regards
Matthew Holford
Dear Mr Johnson,
I'm reasonably confident that you're not going to do anything about this, but I have to prove that you're not going to do anything, don't I? I can't just say that, can I?
Shame on you: people are having to put up with incompetent performance and fraudulent marketing because people like you are protecting interests that do not deserve to be protected. Pharmaceuticals are not appropriate for the treatment of mental health issues (and they're probably not much good for anything else, either). The Chemical Imbalance theory, the very pillar on which all these shite drugs are balanced, is bollox. And you know it, as does the FDA, even if the MHRA hasn't acknowledged it, yet.
Best regards
Matthew Holford
More opaque than an opaque thing... Part V
STOP PRESS:
The AG's office replied, but I can't be bothered to post the email. The upshot is that the AG's office knows nothing, and doesn't know who does.
Dated: Wednesday, 12 September, 2007
I thought I'd try the AG's office. Just for a laugh, you know. Copied to Deats, Johnson, Vara, CPS:
Dear Sir or Madam,
I'm very keen to understand the position, on this question. Perhaps the Attorney General's Office is able to clarify, or direct me to somebody more appropriate?
The issue at stake is what conduct constitutes an offence under Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). It is my contention that the suppressing of negative trials data (ie, data that does not demonstrate safety/efficacy of a drug), which may or may not be widespread (although the suppression of original data most certainly is widespread, on the ground that it is "proprietary information") causes the provision of "false or misleading" data, when only positive data is presented to the regulator at the time of the marketing authorization application.
The above is my understanding of the process - I have tried to clarify with the MHRA, but regrettably it felt unable to discuss its assessment process with me. As such, I apologize for any material inaccuracies.
Best regards
(redacted)
******************************
Dear (redacted),
Perhaps you will never have to consider the question. However, please do not concern yourself, as the Head of the Intelligence and Enforcement Unit, at the MHRA, is currently considering the matter, and I have no doubt that the Secretary of State is similarly occupied, given the seriousness of the implications, and the role of the DoH in promoting the Worshipful Company.
Best regards
(redacted)
**************************
From: "Freedom of Information Unit"
To: (redacted)
Subject: Freedom of Information Act Request (Ref 1025)
Date: Tue, 11 Sep 2007 16:04:17 +0100
FREEDOM OF INFORMATION ACT REQUEST
Dear (redacted),
I refer to your request under the above legislation for information about guidance held by the CPS concerning Medicines for Human Use (Clinical Trials) Regulations 2004, and in particular the contravention of Regulation 50.
I am writing to advise you that the Crown Prosecution Service does not hold the information requested. The CPS does not hold any guidance concerning this topic.
If you are unhappy with the decisions made in relation to your request from the Crown Prosecution Service you may ask for an internal review. You should contact the Freedom of Information Unit (Appeals), 50 Ludgate Hill, London, EC4M 7EX, if you wish to complain.
If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Crown Prosecution Service. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours Sincerely,
(Redacted)
Information Management Unit
[Crown Prosecution Service]
The AG's office replied, but I can't be bothered to post the email. The upshot is that the AG's office knows nothing, and doesn't know who does.
Dated: Wednesday, 12 September, 2007
I thought I'd try the AG's office. Just for a laugh, you know. Copied to Deats, Johnson, Vara, CPS:
Dear Sir or Madam,
I'm very keen to understand the position, on this question. Perhaps the Attorney General's Office is able to clarify, or direct me to somebody more appropriate?
The issue at stake is what conduct constitutes an offence under Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). It is my contention that the suppressing of negative trials data (ie, data that does not demonstrate safety/efficacy of a drug), which may or may not be widespread (although the suppression of original data most certainly is widespread, on the ground that it is "proprietary information") causes the provision of "false or misleading" data, when only positive data is presented to the regulator at the time of the marketing authorization application.
The above is my understanding of the process - I have tried to clarify with the MHRA, but regrettably it felt unable to discuss its assessment process with me. As such, I apologize for any material inaccuracies.
Best regards
(redacted)
******************************
Dear (redacted),
Perhaps you will never have to consider the question. However, please do not concern yourself, as the Head of the Intelligence and Enforcement Unit, at the MHRA, is currently considering the matter, and I have no doubt that the Secretary of State is similarly occupied, given the seriousness of the implications, and the role of the DoH in promoting the Worshipful Company.
Best regards
(redacted)
**************************
From: "Freedom of Information Unit"
To: (redacted)
Subject: Freedom of Information Act Request (Ref 1025)
Date: Tue, 11 Sep 2007 16:04:17 +0100
FREEDOM OF INFORMATION ACT REQUEST
Dear (redacted),
I refer to your request under the above legislation for information about guidance held by the CPS concerning Medicines for Human Use (Clinical Trials) Regulations 2004, and in particular the contravention of Regulation 50.
I am writing to advise you that the Crown Prosecution Service does not hold the information requested. The CPS does not hold any guidance concerning this topic.
If you are unhappy with the decisions made in relation to your request from the Crown Prosecution Service you may ask for an internal review. You should contact the Freedom of Information Unit (Appeals), 50 Ludgate Hill, London, EC4M 7EX, if you wish to complain.
If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Crown Prosecution Service. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours Sincerely,
(Redacted)
Information Management Unit
[Crown Prosecution Service]
More opaque than an opaque thing... Part IV
I thought I might as well go through all the hoops and mail the Head of the absurdly-named Intelligence and Enforcement Unit, at the MHRA. This to Michael Deats, copied to Woods, Breckenridge, Vara, Johnson and the CPS:
Dear Mr Deats,
I am currently engaged in a discussion with Professors Woods and Breckenridge and the CPS (please see below) on a question over the application of Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).
Would it be your position, as Head of the Intelligence and Enforcement Unit at the MHRA, that where trials have been carried out on a drug, and those trials have produced negative results, and that there are also trials of that same drug that have yielded results that are interpreted as positive, and it is subsequently only the positive results that are submitted in support of a marketing authorization application, that the presentation of only the positive data (owing to the suppression of the negative data) amounts to the provision of "false or misleading" information, under Regulation 50?
Best regards
Matthew Holford
Dear Mr Deats,
I am currently engaged in a discussion with Professors Woods and Breckenridge and the CPS (please see below) on a question over the application of Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).
Would it be your position, as Head of the Intelligence and Enforcement Unit at the MHRA, that where trials have been carried out on a drug, and those trials have produced negative results, and that there are also trials of that same drug that have yielded results that are interpreted as positive, and it is subsequently only the positive results that are submitted in support of a marketing authorization application, that the presentation of only the positive data (owing to the suppression of the negative data) amounts to the provision of "false or misleading" information, under Regulation 50?
Best regards
Matthew Holford
Monday, 10 September 2007
Corruption: it's a big problem in Namibia (and elsewhere)
Apparently, Namibia has a Zero Tolerance for Corruption campaign, which you have to be impressed by, seeing as there doesn't appear to be the slightest concern in the western democracies that this might be an issue:
http://www.anticorruption.info/corr_def_alt.htm
Apparently, if you're a public official, if you're in doubt as to the nature of your actions, you should ask yourself a) “Are my actions legal?”; b) “Am I being fair and honest?”; c) “How will it look in the newspaper?”; and d) “Would I like my child, my mother or my friends to know what I have done?”
They've certainly nailed the key issues, to be sure. There are even a series of definitions of corruption, from a variety of sources, just so that one knows what it is, when one sees it, I suppose. This is a taster:
In broad terms, corruption is the abuse of public office for private gain. It encompasses unilateral abuses by government officials such as embezzlement and nepotism, as well as abuses linking public and private actors such as bribery, extortion, influence peddling, and fraud [my emphasis]. Corruption arises in both political and bureaucratic offices and can be petty or grand, organized or unorganized. Though corruption often facilitates criminal activities such as drug trafficking, money laundering, and prostitution, it is not restricted to these activities. For purposes of understanding the problem and devising remedies, it is important to keep crime and corruption analytically distinct.
Handbook on fighting corruption, the Centre for Democracy and Governance
Thank goodness we don't have to concern ourselves about this kind of thing in the UK, because the definition, above, clearly clearly doesn't apply to any Politically Exposed Person (PEP) that I know of. Can you imagine if this sort of thing was going on in the pharmaceutical sector? It'd be a nightmare, wouldn't it?
Matt
http://www.anticorruption.info/corr_def_alt.htm
Apparently, if you're a public official, if you're in doubt as to the nature of your actions, you should ask yourself a) “Are my actions legal?”; b) “Am I being fair and honest?”; c) “How will it look in the newspaper?”; and d) “Would I like my child, my mother or my friends to know what I have done?”
They've certainly nailed the key issues, to be sure. There are even a series of definitions of corruption, from a variety of sources, just so that one knows what it is, when one sees it, I suppose. This is a taster:
In broad terms, corruption is the abuse of public office for private gain. It encompasses unilateral abuses by government officials such as embezzlement and nepotism, as well as abuses linking public and private actors such as bribery, extortion, influence peddling, and fraud [my emphasis]. Corruption arises in both political and bureaucratic offices and can be petty or grand, organized or unorganized. Though corruption often facilitates criminal activities such as drug trafficking, money laundering, and prostitution, it is not restricted to these activities. For purposes of understanding the problem and devising remedies, it is important to keep crime and corruption analytically distinct.
Handbook on fighting corruption, the Centre for Democracy and Governance
Thank goodness we don't have to concern ourselves about this kind of thing in the UK, because the definition, above, clearly clearly doesn't apply to any Politically Exposed Person (PEP) that I know of. Can you imagine if this sort of thing was going on in the pharmaceutical sector? It'd be a nightmare, wouldn't it?
Matt
The MHRA - taking patient reporting seriously - Part IV
Well, I feel properly satisfied with the outcome of this. Thank goodness my experience isn't a trivial matter for those who have an interest in the drugs I take:
Dear (redacted),
Many thanks for this. I believe it answers my questions satisfactorily, and I consider the complaint dealt with.
The issue, then, lies elsewhere: the manufacturers are not responsible, because the risk of suicidal ideation was noted on the PIL; my GP was not responsible, even though he was responsible for my care, because he brought the side effect to my attention, when he prescribed the drug (and then, when I experienced the side effect, told me that it wasn't the drug); the MHRA is not responsible, because it is not required to be responsible.
May I ask who is responsible - and this is not a rhetorical question, I would like an answer? Could you seek guidance from the Secretary of State on this one, please, because I am keen to understand whether it is believed that I should be responsible for my reaction to chemicals that, with the greatest of respect to the MHRA, are not controlled particularly effectively, judging by the less than scientific approach that is taken to licensing (both by manufacturers and regulators)?
I have to be honest, rarely have I experienced such a sorry catalogue of failure and incompetence as this. There are so many gaps in this system that it is a wonder to me that anybody survives it. More to the point, when a flaw is identified, the MHRA (and others) appear determined to argue that everything is just hunky dory, and that a complainant is somehow deranged to even suggest that anything is wrong. In short, full defensive mode is initiated. And yet, the MHRA is characterized as a world leader?
Best regards
(redacted)
********************************
From: "Pharmacovigilance,"
To: (redacted)
Subject: Yellow Card Complaint
Date: Mon, 10 Sep 2007 10:36:39 +0100
Dear (redacted)
You raised a formal complaint that your Yellow Card report was not subject to follow-up. This complaint has been investigated by the Signal Management Group and I will address your concerns below.
Further to your Freedom of Information (FOI) request FOI 07-246 on the 15th August 2007 concerning the Yellow Card Scheme, a response was sent to you on 30 August 2007 explaining what a ‘follow-up’ is and detailing the process by which it is determined whether it is necessary for a Yellow Card report to be followed-up. Please refer to this communication for further explanations of the process of ‘follow-up’. In summary I will reiterate that the term follow-up refers to the communication with the reporter to request further information regarding their Yellow Card report.
The following up of a report is at the discretion of our pharmacovigilance scientists and assessors at the MHRA and is in no way a compulsory part of the Yellow Card Scheme. As stated in the FOI 07-246 response the request for further information or ‘following up’ of a report does not necessarily signify these reports are of greater importance or interest.
With regards to your Yellow Card report, I can confirm it was determined a request for further information from yourself was not necessary at that time for two main reasons:
Firstly the report you completed was adequately filled in to provide enough information to be entered onto our database for rapid analysis and assessment by our physicians, pharmacists and scientists.
Secondly the suspected adverse reaction reported by yourself was suicidal ideation. As you are well aware, Suicidal ideation is listed as a potential side effect in the Patient Information Leaflet (PIL) for fluoxetine. Whilst we are not in any way dismissing the seriousness of this reaction, this in itself does not necessarily warrant a Yellow Card report being followed up.
The risk of suicidal ideation and suicide with SSRIs are continually monitored by the MHRA. In May 2003, in response to continuing public concerns about the safety of SSRIs, an Expert Working Group of the Committee on Safety of Medicines (CSM) was convened to investigate ongoing safety concerns with these medicines, in particular around suicidal behaviour and withdrawal reactions/dependence. I believe you are already aware of this ‘Report of the CSM Expert Working Group on the Safety of SSRI’s’ and your questions regarding its contents and conclusions have already been satisfactorily addressed.
With regards to provision of the manufacturer’s details of the generic fluoxetine you were prescribed, I am unable to provide you with this information. Currently there are approximately 32 marketing authorisation holders for generic brands of fluoxetine in the UK and therefore I am not able to inform you which of these MAHs provided the fluoxetine you were prescribed by your practitioner. However the MAHs name would clearly have been stated on the packaging and also on the Patient Information Leaflet provided with the pack as a legal requirement.
I hope you feel this letter addresses your complaint in all respects. If you remain dissatisfied, you can make representations to the Central Complaints Officer:
(redacted)
MHRA
16-107 Market Towers
1 Nine Elms Lane
Vauxhall
SW8 5NQ
Dear (redacted),
Many thanks for this. I believe it answers my questions satisfactorily, and I consider the complaint dealt with.
The issue, then, lies elsewhere: the manufacturers are not responsible, because the risk of suicidal ideation was noted on the PIL; my GP was not responsible, even though he was responsible for my care, because he brought the side effect to my attention, when he prescribed the drug (and then, when I experienced the side effect, told me that it wasn't the drug); the MHRA is not responsible, because it is not required to be responsible.
May I ask who is responsible - and this is not a rhetorical question, I would like an answer? Could you seek guidance from the Secretary of State on this one, please, because I am keen to understand whether it is believed that I should be responsible for my reaction to chemicals that, with the greatest of respect to the MHRA, are not controlled particularly effectively, judging by the less than scientific approach that is taken to licensing (both by manufacturers and regulators)?
I have to be honest, rarely have I experienced such a sorry catalogue of failure and incompetence as this. There are so many gaps in this system that it is a wonder to me that anybody survives it. More to the point, when a flaw is identified, the MHRA (and others) appear determined to argue that everything is just hunky dory, and that a complainant is somehow deranged to even suggest that anything is wrong. In short, full defensive mode is initiated. And yet, the MHRA is characterized as a world leader?
Best regards
(redacted)
********************************
From: "Pharmacovigilance,"
To: (redacted)
Subject: Yellow Card Complaint
Date: Mon, 10 Sep 2007 10:36:39 +0100
Dear (redacted)
You raised a formal complaint that your Yellow Card report was not subject to follow-up. This complaint has been investigated by the Signal Management Group and I will address your concerns below.
Further to your Freedom of Information (FOI) request FOI 07-246 on the 15th August 2007 concerning the Yellow Card Scheme, a response was sent to you on 30 August 2007 explaining what a ‘follow-up’ is and detailing the process by which it is determined whether it is necessary for a Yellow Card report to be followed-up. Please refer to this communication for further explanations of the process of ‘follow-up’. In summary I will reiterate that the term follow-up refers to the communication with the reporter to request further information regarding their Yellow Card report.
The following up of a report is at the discretion of our pharmacovigilance scientists and assessors at the MHRA and is in no way a compulsory part of the Yellow Card Scheme. As stated in the FOI 07-246 response the request for further information or ‘following up’ of a report does not necessarily signify these reports are of greater importance or interest.
With regards to your Yellow Card report, I can confirm it was determined a request for further information from yourself was not necessary at that time for two main reasons:
Firstly the report you completed was adequately filled in to provide enough information to be entered onto our database for rapid analysis and assessment by our physicians, pharmacists and scientists.
Secondly the suspected adverse reaction reported by yourself was suicidal ideation. As you are well aware, Suicidal ideation is listed as a potential side effect in the Patient Information Leaflet (PIL) for fluoxetine. Whilst we are not in any way dismissing the seriousness of this reaction, this in itself does not necessarily warrant a Yellow Card report being followed up.
The risk of suicidal ideation and suicide with SSRIs are continually monitored by the MHRA. In May 2003, in response to continuing public concerns about the safety of SSRIs, an Expert Working Group of the Committee on Safety of Medicines (CSM) was convened to investigate ongoing safety concerns with these medicines, in particular around suicidal behaviour and withdrawal reactions/dependence. I believe you are already aware of this ‘Report of the CSM Expert Working Group on the Safety of SSRI’s’ and your questions regarding its contents and conclusions have already been satisfactorily addressed.
With regards to provision of the manufacturer’s details of the generic fluoxetine you were prescribed, I am unable to provide you with this information. Currently there are approximately 32 marketing authorisation holders for generic brands of fluoxetine in the UK and therefore I am not able to inform you which of these MAHs provided the fluoxetine you were prescribed by your practitioner. However the MAHs name would clearly have been stated on the packaging and also on the Patient Information Leaflet provided with the pack as a legal requirement.
I hope you feel this letter addresses your complaint in all respects. If you remain dissatisfied, you can make representations to the Central Complaints Officer:
(redacted)
MHRA
16-107 Market Towers
1 Nine Elms Lane
Vauxhall
SW8 5NQ
Democracy (the myth of trust)
As is my wont, I'm generally keen to understand the etymology of the words, particularly the key words, that I use. I think I may as well give you a quick definition of what the word "democracy" actually means, because for most people, I imagine, the concept of democracy is inevitably connected with the political system under which we (those in the western "liberal democracies") live. There's nothing liberal or democratic about them, of course, and there will no doubt be those who would argue that everybody understands that, and what am I moaning about?
Well, perhaps I'm just a pedant, or perhaps there's something more to this laziness with language. That is, while our own lives have no real connection with democratic principles, it's important that we can kid ourselves that they do. More importantly, it's valuable for those in power to pretend that we have some sort of control over our lives, when key decisions impacting our wellbeing are made without any reference to us. If that is the case, and it most certainly is, because I don't remember the last time any cunt of a politician asked me my opinion (on the contrary, as you will discover shortly), then whose interests are those decisions being made in?
Anyway, on that note, let's just define democracy for ourselves. According to etymonline, democracy is derived from an Ancient Greek word "demokratia", which was created by the joining of demos "common people," (originally "district"), and kratos "rule, strength". "The strength of the common people"? It may be debateable as to whether democracy ever existed in Ancient Greece, particularly as that empire practised slavery, but are you beginning to see where my grievance lies? Perhaps the knowledge that I am PNG, as far as my MP is concerned provides a clue. It seems that unless I am willing to discuss issues affecting me in party political terms, then I have no right to be anything other disenfranchised. Politicians, or political parties, then, if we are to extrapolate from my experience, are only interested in discussing their own realities - like most people, I suppose. In short, my MP no more represents my interests in Westminster than he flies in the air unaided.
So, if we don't have democracy, in its truest (ie, original) sense, then what do we have? Perhaps we should look at the alternatives, and then perhaps we can establish what our experience indicates.
It seems that Aristotle and Plato thought about this question quite closely. Briefly, the alternatives are "autocracy" (rule by a single person); "oligarchy" (rule by the few); and "aristrocracy" (rule by the best (LMFAO)). While oligarchy and aristocracy might look superficially similar, the distinction that one would make is that aristocracy appears to boil down to rule by the moneyed class, whereas oligarchy appears to concern those who interested in acquiring money, and thus power/influence (control over others, in other words). Indeed, there is a word for this system, too: "plutocracy".
I leave it to the gentle reader (that's enough Aesop. Ed.) to consider which of those possibilities best fits what is actually happening, according to his/her experience, and then to consider whose interests the majority of decisions are likely to be made in. I'll leave you with a quotation by Winston Churchill:
"The strongest argument against democracy is a five minute discussion with the average voter."
And the strongest argument against parliamentary democracy that I can think of is that quotation, Mr Churchill. Many thanks for that.
Matt
Well, perhaps I'm just a pedant, or perhaps there's something more to this laziness with language. That is, while our own lives have no real connection with democratic principles, it's important that we can kid ourselves that they do. More importantly, it's valuable for those in power to pretend that we have some sort of control over our lives, when key decisions impacting our wellbeing are made without any reference to us. If that is the case, and it most certainly is, because I don't remember the last time any cunt of a politician asked me my opinion (on the contrary, as you will discover shortly), then whose interests are those decisions being made in?
Anyway, on that note, let's just define democracy for ourselves. According to etymonline, democracy is derived from an Ancient Greek word "demokratia", which was created by the joining of demos "common people," (originally "district"), and kratos "rule, strength". "The strength of the common people"? It may be debateable as to whether democracy ever existed in Ancient Greece, particularly as that empire practised slavery, but are you beginning to see where my grievance lies? Perhaps the knowledge that I am PNG, as far as my MP is concerned provides a clue. It seems that unless I am willing to discuss issues affecting me in party political terms, then I have no right to be anything other disenfranchised. Politicians, or political parties, then, if we are to extrapolate from my experience, are only interested in discussing their own realities - like most people, I suppose. In short, my MP no more represents my interests in Westminster than he flies in the air unaided.
So, if we don't have democracy, in its truest (ie, original) sense, then what do we have? Perhaps we should look at the alternatives, and then perhaps we can establish what our experience indicates.
It seems that Aristotle and Plato thought about this question quite closely. Briefly, the alternatives are "autocracy" (rule by a single person); "oligarchy" (rule by the few); and "aristrocracy" (rule by the best (LMFAO)). While oligarchy and aristocracy might look superficially similar, the distinction that one would make is that aristocracy appears to boil down to rule by the moneyed class, whereas oligarchy appears to concern those who interested in acquiring money, and thus power/influence (control over others, in other words). Indeed, there is a word for this system, too: "plutocracy".
I leave it to the gentle reader (that's enough Aesop. Ed.) to consider which of those possibilities best fits what is actually happening, according to his/her experience, and then to consider whose interests the majority of decisions are likely to be made in. I'll leave you with a quotation by Winston Churchill:
"The strongest argument against democracy is a five minute discussion with the average voter."
And the strongest argument against parliamentary democracy that I can think of is that quotation, Mr Churchill. Many thanks for that.
Matt
Friday, 7 September 2007
More opaque than an opaque thing... Part III
I'm a bit disappointed with the feedback I'm getting from the MHRA, just now, so I thought I'd try a different angle. This was sent to Breckenridge and Woods, copied to Johnson, Vara and the CPS:
Dear Professors Breckenridge and Woods,
My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.
Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?
Best regards
Matthew Holford
*************************
Dear Sir or Madam,
I am currently engaged in a discussion with the MHRA, concerning the application of the Medicines for Human Use (Clinical Trials) Regulations 2004 (please see below). It appears that the MHRA is unable to provide an opinion, for whatever reason that it might have.
Is the CPS positioned such that it may provide definitive guidance as to the nature of conduct that would constitute a contravention of Regulation 50?
Best regards
Matthew Holford
********************************
Dear Professors Breckenridge and Woods,
My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.
Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?
Best regards
Matthew Holford
*************************
Dear Sir or Madam,
I am currently engaged in a discussion with the MHRA, concerning the application of the Medicines for Human Use (Clinical Trials) Regulations 2004 (please see below). It appears that the MHRA is unable to provide an opinion, for whatever reason that it might have.
Is the CPS positioned such that it may provide definitive guidance as to the nature of conduct that would constitute a contravention of Regulation 50?
Best regards
Matthew Holford
********************************
Thursday, 6 September 2007
More opaque than an opaque thing... Part II
I've still got no idea what this is about:
Dear (redacted),
Many thanks for this. I'm not quite sure of the context of the enquiry, given the passage of time, but if I may just clarify:
At the time of the two protocols mentioned, and, indeed, the original trials on the drug, presumably carried out at some point in the late 80s, then, there was no requirement to track any side effects manifesting themselves after treatment stopped (I take it that the Note for Guidance is binding on those trialling drugs?). However, if I understand you correctly, GSK picked up on the discomfort felt by those ceasing to use the drug, anyway, and monitored it? Prior to the EWG's report, it was presumably held (by whom, or what?) that the side effect being monitored was not a matter of "addiction," but was "withdrawal".
As such, repeated denials that Seroxat was addictive were entirely justified. The EWG's findings/conclusions then validated that holding. At what point did GSK/the MHRA come to the conclusion that the discomfort being experienced was withdrawal, and was this communicated to patients/doctors prior to the publication of the EWG's Report?
On the subject of trials 329/377, I have a couple of outstanding queries, in process. As it stands, I am struggling to understand how it is that the MHRA is investigating the withholding of trials data, when there is no specific criminal offence of that nature, to my knowledge? In any event, the pertinent legislation (the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended)), succeeds any action that GSK may have taken - given the bar on retrospective legislation, generally, there is nothing to investigate, I should have thought?
As such, even if one chose to investigate an offence under Regulation 50 (provision of false or misleading information), the legislation would have come into force after any suspected "providing" took place, and would not apply. Are you able to clarify that point, for me?
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: FOI 07/066 Seroxat
Date: Thu, 6 Sep 2007 11:17:46 +0100
Dear (redacted),
Thank you for your e-mail that has only recently been forwarded to me to deal with. I have been requested to address your first query in paragraph 1 below and my response is attached. I regret that your question in the second paragraph of your e-mail is outside the MHRA’s jurisdiction, therefore, the MHRA will not be able to respond to this query.
Kind regards
(redacted)
Licensing Division
MHRA
Tel 0207 084 2391
Fax 0207 084 2323
Attachment:
FOI 07/066
Dear (redacted),
Regarding you enquiry back in 26 February 2007, I regret that this was not addressed at the time, however I am able to address the second part of your query which was as follows:
“Was GSK required to assess side effects outside the treatment period? I understand that some patients, I think GSK finally accepted 25% as the figure, were impacted by withdrawal symptoms, which GSK initially denied to be a factor. I have seen analysis and GSK internal documentation, concerning Trials 329 and 377, which were conducted when GSK was attempting to get a label change, at the end of the 90s. Would you be able to point me in the direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990?”
GSK would only be required to assess effects outside of a treatment period if that was a requirement of the trial protocol. You may be interested to know that the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression was only finalised in April 2002, see link to this guideline: (HYPERLINK http://www.emea.europa.eu/pdfs/human/ewp/051897en.pdf http://www.emea.europa.eu/pdfs/human/ewp/051897en.pdf)
This guidance clearly recommends the investigation of the effect on stopping medication. Therefore, this guideline was developed some time after the marketing authorisation for Seroxat was granted. However, it is evident from the assessment report that the effect of abrupt withdrawal of paroxetine was followed in a number of patients and described in the original application.
With regard to trials 329 and 377, these clinical trials (and others) are part of an ongoing MHRA investigation and are exempt under section 30 of the FOIA. I understand that you can find a great deal of information about these trials on GSK's website.
You ask to be pointed in the ‘direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990. As already mentioned above, GSK have published a full list of trials conducted on seroxat on its website ( HYPERLINK "http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp" \o "http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp" http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp), summaries of each trial are also provided.
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
(redacted)
MHRA
Licensing Division
MHRA
****************************
From: (redacted)
Sent: 23 February 2007 10:17
To: (redacted)
Subject: RE: FOI 07/066
Dear (redacted),
Thank you, that clarifies considerably.
Was GSK required to assess side effects outside the treatment period? I understand that some patients, I think GSK finally accepted 25% as the figure, were impacted by withdrawal symptoms, which GSK initially denied to be a factor. I have seen analysis and GSK internal documentation, concerning Trials 329 and 377, which were conducted when GSK was attempting to get a label change, at the end of the 90s. Would you be able to point me in the direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990?
Incidentally, while I understand that the MHRA's investigation concerns the possibility of fraudulently withheld information (have I got the gyst of it?), is there likely to be a separate investigation into its activities, in attempting to undermine the democratic process of the House of Commons? Indeed, if it is shown that GSK withheld knowledge of suicidal behaviour, is it likely to be investigated for gross negligence manslaughter?
Best regards
(redacted)
Dear (redacted),
Many thanks for this. I'm not quite sure of the context of the enquiry, given the passage of time, but if I may just clarify:
At the time of the two protocols mentioned, and, indeed, the original trials on the drug, presumably carried out at some point in the late 80s, then, there was no requirement to track any side effects manifesting themselves after treatment stopped (I take it that the Note for Guidance is binding on those trialling drugs?). However, if I understand you correctly, GSK picked up on the discomfort felt by those ceasing to use the drug, anyway, and monitored it? Prior to the EWG's report, it was presumably held (by whom, or what?) that the side effect being monitored was not a matter of "addiction," but was "withdrawal".
As such, repeated denials that Seroxat was addictive were entirely justified. The EWG's findings/conclusions then validated that holding. At what point did GSK/the MHRA come to the conclusion that the discomfort being experienced was withdrawal, and was this communicated to patients/doctors prior to the publication of the EWG's Report?
On the subject of trials 329/377, I have a couple of outstanding queries, in process. As it stands, I am struggling to understand how it is that the MHRA is investigating the withholding of trials data, when there is no specific criminal offence of that nature, to my knowledge? In any event, the pertinent legislation (the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended)), succeeds any action that GSK may have taken - given the bar on retrospective legislation, generally, there is nothing to investigate, I should have thought?
As such, even if one chose to investigate an offence under Regulation 50 (provision of false or misleading information), the legislation would have come into force after any suspected "providing" took place, and would not apply. Are you able to clarify that point, for me?
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: FOI 07/066 Seroxat
Date: Thu, 6 Sep 2007 11:17:46 +0100
Dear (redacted),
Thank you for your e-mail that has only recently been forwarded to me to deal with. I have been requested to address your first query in paragraph 1 below and my response is attached. I regret that your question in the second paragraph of your e-mail is outside the MHRA’s jurisdiction, therefore, the MHRA will not be able to respond to this query.
Kind regards
(redacted)
Licensing Division
MHRA
Tel 0207 084 2391
Fax 0207 084 2323
Attachment:
FOI 07/066
Dear (redacted),
Regarding you enquiry back in 26 February 2007, I regret that this was not addressed at the time, however I am able to address the second part of your query which was as follows:
“Was GSK required to assess side effects outside the treatment period? I understand that some patients, I think GSK finally accepted 25% as the figure, were impacted by withdrawal symptoms, which GSK initially denied to be a factor. I have seen analysis and GSK internal documentation, concerning Trials 329 and 377, which were conducted when GSK was attempting to get a label change, at the end of the 90s. Would you be able to point me in the direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990?”
GSK would only be required to assess effects outside of a treatment period if that was a requirement of the trial protocol. You may be interested to know that the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression was only finalised in April 2002, see link to this guideline: (HYPERLINK http://www.emea.europa.eu/pdfs/human/ewp/051897en.pdf http://www.emea.europa.eu/pdfs/human/ewp/051897en.pdf)
This guidance clearly recommends the investigation of the effect on stopping medication. Therefore, this guideline was developed some time after the marketing authorisation for Seroxat was granted. However, it is evident from the assessment report that the effect of abrupt withdrawal of paroxetine was followed in a number of patients and described in the original application.
With regard to trials 329 and 377, these clinical trials (and others) are part of an ongoing MHRA investigation and are exempt under section 30 of the FOIA. I understand that you can find a great deal of information about these trials on GSK's website.
You ask to be pointed in the ‘direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990. As already mentioned above, GSK have published a full list of trials conducted on seroxat on its website ( HYPERLINK "http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp" \o "http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp" http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp), summaries of each trial are also provided.
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
(redacted)
MHRA
Licensing Division
MHRA
****************************
From: (redacted)
Sent: 23 February 2007 10:17
To: (redacted)
Subject: RE: FOI 07/066
Dear (redacted),
Thank you, that clarifies considerably.
Was GSK required to assess side effects outside the treatment period? I understand that some patients, I think GSK finally accepted 25% as the figure, were impacted by withdrawal symptoms, which GSK initially denied to be a factor. I have seen analysis and GSK internal documentation, concerning Trials 329 and 377, which were conducted when GSK was attempting to get a label change, at the end of the 90s. Would you be able to point me in the direction of the original trials' analysis, which secured Seroxat's licence, for adults, c. 1990?
Incidentally, while I understand that the MHRA's investigation concerns the possibility of fraudulently withheld information (have I got the gyst of it?), is there likely to be a separate investigation into its activities, in attempting to undermine the democratic process of the House of Commons? Indeed, if it is shown that GSK withheld knowledge of suicidal behaviour, is it likely to be investigated for gross negligence manslaughter?
Best regards
(redacted)
More opaque than an opaque thing, with a very good reason for being opaque
I'm just engaged in a couple of discussions with the MHRA. I'm not quite sure what they're about, but I'm sure I'll find out eventually. The MHRA's mails are emboldened, as usual:
Dear (redacted),
Many thanks for your prompt reply.
I am (reasonably) familiar with the relevant legislation. However, I wonder if you could confirm that I have understood your previous mail correctly, which I think I've paraphrased (more or less) in the second para of my response, below?
I am surprised that the MHRA is unable to provide a statement of its position, relative to the questions asked in the last para of my mail. I understand that the MHRA has an Intelligence and Enforcement Unit, which would presumably be able to provide the definitive position on what it regards to be a transgression of Regulation 50, given that it is the MHRA that makes decisions as to whether any investigation is initiated? In short, what I am asking for is expert guidance, such that I am able to understand something which, while it looked straight forward enough when I was reading the Regulations, has suddenly become opaque. If I may not ask the MHRA for such a thing, could you direct me to the appropriate body?
As to the question concerning statistical reports: surely that is a matter of fact, not opinion?
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Date: Thu, 6 Sep 2007 13:06:26 +0100
Dear (redacted)
Please find a response attached.
Yours sincerely
(redacted)
Medicines and Healthcare products Regulatory Agency
Room 12-204, Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2487
Fax: 020 7084 2443
Attachment:
Dear (redacted)
Re: FOI 07/118 (FU)
I am responding to your emails of 23rd and 24th August in which you have presented additional questions to my Freedom of Information response to you of 22nd August.
My original response to you indicated what was required under the EU and UK clinical trials legislation and guidance in relation to your initial questions. For further information I would refer you to the UK Statutory Instrument 2004/1031 which can be accessed on the web at the following link: http://www.opsi.gov.uk/si/si2004/20041031.htm and Volume 10 of the European Commission Pharmaceutical Documentation at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm
Beyond this your emails appear to be asking me for views and opinions on certain issues which I believe to be beyond the scope of the FOIA.
Yours sincerely
(redacted)
****************************
From: (redacted)
Sent: 23 August 2007 22:31
To: (redacted)
Cc: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Dear (redacted),
As you may appreciate, I'm not fully conversant with the way in which the various pieces of legislation "mesh". If I understand correctly, then, a clinical trial must be licensed in order to proceed. Upon completion (or presumably early termination) this must be communicated to the MHRA (in the UK), within a certain specified period of time, with failure to do so being a criminal offence. It is also my understanding that the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) provide that information must not be provided that is false or misleading. Regulation 50 provides, if I remember aright.
From your comments, it is apparent that a sponsor may, if it so wishes, not provide the results of trials that have been completed and such completion presumably properly reported. If received wisdom is to be believed, this will be because a trial has "failed". In any event, results data is regarded as proprietary within the industry, and a company may not be compelled to give it up. Indeed, if I understand correctly, trials data is not generally given up, even where a trial is deemed "successful" and used in the marketing authorization application portfolio to demonstrate the "efficacy" of a drug, even where, as is apparently the case with Seroxat, the level of efficacy has not been demonstrated. Instead, a statistical analysis is usually provided. None of this sounds terribly scientific to me, but then I'm a compliance professional, not a drugs regulator.
I would be interested to understand how the MHRA views this withholding of data? We know that certain Seroxat trials "failed", and the results were not made public. Others were held to demonstrate efficacy, and a statistical report based on the successful trials was presumably made available to the MCA/MHRA with the licensing portfolio. This presumably purported to demonstrate efficacy (although not very precisely, as I understand it), safety and quality, or else the product would not have been licensed.
If something similar were to happen today, would this withholding of data be deemed to amount to an offence under Regulation 50 by the MHRA? That is, if a company provides less than all the information about a drug, and the information withheld is negative, then the information that is provided is presumably false, or misleading. Also, does the MHRA endeavour to ensure that it has, at least, a statistical report from all trials conducted on a particular drug, in the event that a marketing authorization is sought for that drug?
I would be interested to read of your views.
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Date: Wed, 22 Aug 2007 17:23:41 +0100
Dear (redacted)
Please find attached a response to your request for information below.
Regards
(redacted)
Medicines and Healthcare products Regulatory Agency
Room 12-204, Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2487
Fax: 020 7084 2443
--------------------------------------------------------------------------------
From: (redacted)
Sent: 12 April 2007 15:51
To: MHRA Information Centre
Cc: (redacted)
Subject: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Dear Sir or Madam,
I was interested to read the article, by your esteemed Chairman and CEO, respectively, Prof Breckenridge and Kent Woods:
http://www.bmj.com/cgi/content/full/331/7520/834
I must confess myself surprised and delighted to discover that the MHRA charges companies, for the purpose of licensing trials. As such, it is presumably aware of any trial, for which it has granted a licence, and for which it does not receive trials results, including details of elements of that trial conducted in other countries? Does the MHRA keep records of any such failure to notifiy, or is its interest limited to collection of the trial fee? If it does, may I ask from what date it began keeping this information? Also, may I ask what percentage of authorized trials do not have the results notified to the MHRA? May I ask what action it takes, in the event that a failure to notify has taken place? Indeed, may I ask what period of grace, after the end of the trial, does the MHRA permit companies, before commencing legal action, under the relevant legislation (The Medicines for Human Use (Clincial Trials) Regulations 2004 (http://www.opsi.gov.uk/si/si2004/20041031.htm#28))?
Finally, I note that the offences, identified under ss49-50, shall be subject to a fine or a maximum period of imprisonment not exceeding two years (ie, they are considered not to be a serious arrestable offences), upon conviction on indictment. The maximum fine, which is defined by statute, is currently £5,000, I believe. To what extent does the MHRA understand these penalties to be an adequate deterrant to non-compliance with the Law?
Best regards
(redacted)
Dear (redacted),
Many thanks for your prompt reply.
I am (reasonably) familiar with the relevant legislation. However, I wonder if you could confirm that I have understood your previous mail correctly, which I think I've paraphrased (more or less) in the second para of my response, below?
I am surprised that the MHRA is unable to provide a statement of its position, relative to the questions asked in the last para of my mail. I understand that the MHRA has an Intelligence and Enforcement Unit, which would presumably be able to provide the definitive position on what it regards to be a transgression of Regulation 50, given that it is the MHRA that makes decisions as to whether any investigation is initiated? In short, what I am asking for is expert guidance, such that I am able to understand something which, while it looked straight forward enough when I was reading the Regulations, has suddenly become opaque. If I may not ask the MHRA for such a thing, could you direct me to the appropriate body?
As to the question concerning statistical reports: surely that is a matter of fact, not opinion?
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Date: Thu, 6 Sep 2007 13:06:26 +0100
Dear (redacted)
Please find a response attached.
Yours sincerely
(redacted)
Medicines and Healthcare products Regulatory Agency
Room 12-204, Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2487
Fax: 020 7084 2443
Attachment:
Dear (redacted)
Re: FOI 07/118 (FU)
I am responding to your emails of 23rd and 24th August in which you have presented additional questions to my Freedom of Information response to you of 22nd August.
My original response to you indicated what was required under the EU and UK clinical trials legislation and guidance in relation to your initial questions. For further information I would refer you to the UK Statutory Instrument 2004/1031 which can be accessed on the web at the following link: http://www.opsi.gov.uk/si/si2004/20041031.htm and Volume 10 of the European Commission Pharmaceutical Documentation at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm
Beyond this your emails appear to be asking me for views and opinions on certain issues which I believe to be beyond the scope of the FOIA.
Yours sincerely
(redacted)
****************************
From: (redacted)
Sent: 23 August 2007 22:31
To: (redacted)
Cc: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Dear (redacted),
As you may appreciate, I'm not fully conversant with the way in which the various pieces of legislation "mesh". If I understand correctly, then, a clinical trial must be licensed in order to proceed. Upon completion (or presumably early termination) this must be communicated to the MHRA (in the UK), within a certain specified period of time, with failure to do so being a criminal offence. It is also my understanding that the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) provide that information must not be provided that is false or misleading. Regulation 50 provides, if I remember aright.
From your comments, it is apparent that a sponsor may, if it so wishes, not provide the results of trials that have been completed and such completion presumably properly reported. If received wisdom is to be believed, this will be because a trial has "failed". In any event, results data is regarded as proprietary within the industry, and a company may not be compelled to give it up. Indeed, if I understand correctly, trials data is not generally given up, even where a trial is deemed "successful" and used in the marketing authorization application portfolio to demonstrate the "efficacy" of a drug, even where, as is apparently the case with Seroxat, the level of efficacy has not been demonstrated. Instead, a statistical analysis is usually provided. None of this sounds terribly scientific to me, but then I'm a compliance professional, not a drugs regulator.
I would be interested to understand how the MHRA views this withholding of data? We know that certain Seroxat trials "failed", and the results were not made public. Others were held to demonstrate efficacy, and a statistical report based on the successful trials was presumably made available to the MCA/MHRA with the licensing portfolio. This presumably purported to demonstrate efficacy (although not very precisely, as I understand it), safety and quality, or else the product would not have been licensed.
If something similar were to happen today, would this withholding of data be deemed to amount to an offence under Regulation 50 by the MHRA? That is, if a company provides less than all the information about a drug, and the information withheld is negative, then the information that is provided is presumably false, or misleading. Also, does the MHRA endeavour to ensure that it has, at least, a statistical report from all trials conducted on a particular drug, in the event that a marketing authorization is sought for that drug?
I would be interested to read of your views.
Best regards
(redacted)
****************************
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: RE: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Date: Wed, 22 Aug 2007 17:23:41 +0100
Dear (redacted)
Please find attached a response to your request for information below.
Regards
(redacted)
Medicines and Healthcare products Regulatory Agency
Room 12-204, Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2487
Fax: 020 7084 2443
--------------------------------------------------------------------------------
From: (redacted)
Sent: 12 April 2007 15:51
To: MHRA Information Centre
Cc: (redacted)
Subject: FOI 07/118 - Medicines regulation and the pharmaceutical industry
Dear Sir or Madam,
I was interested to read the article, by your esteemed Chairman and CEO, respectively, Prof Breckenridge and Kent Woods:
http://www.bmj.com/cgi/content/full/331/7520/834
I must confess myself surprised and delighted to discover that the MHRA charges companies, for the purpose of licensing trials. As such, it is presumably aware of any trial, for which it has granted a licence, and for which it does not receive trials results, including details of elements of that trial conducted in other countries? Does the MHRA keep records of any such failure to notifiy, or is its interest limited to collection of the trial fee? If it does, may I ask from what date it began keeping this information? Also, may I ask what percentage of authorized trials do not have the results notified to the MHRA? May I ask what action it takes, in the event that a failure to notify has taken place? Indeed, may I ask what period of grace, after the end of the trial, does the MHRA permit companies, before commencing legal action, under the relevant legislation (The Medicines for Human Use (Clincial Trials) Regulations 2004 (http://www.opsi.gov.uk/si/si2004/20041031.htm#28))?
Finally, I note that the offences, identified under ss49-50, shall be subject to a fine or a maximum period of imprisonment not exceeding two years (ie, they are considered not to be a serious arrestable offences), upon conviction on indictment. The maximum fine, which is defined by statute, is currently £5,000, I believe. To what extent does the MHRA understand these penalties to be an adequate deterrant to non-compliance with the Law?
Best regards
(redacted)
Wednesday, 5 September 2007
I see a sign... it is a good omen!
The MHRA was kind enough to follow up on a matter that I raised with it a little while back. I'm not sure that it says anything new, particularly, but it's always good to hear from somebody different. The MHRA's correspondence is emboldened, as usual:
Dear (redacted),
I have had an opportunity to read through your letter, for which, again, many thanks. I have the following comments/questions:
I believe the hypothetical scenario relates to a question that I put regarding the investigation into the GSK vaccine business, in Russia. As far as I know, there have been no decisions made as to GSK's culpability, as yet, and as such I understand that you would not wish to speculate on such a matter. In the event, one of the GSK shareholders in the House was kind enough to refer the matter to the then Secretary of State for Health, Patricia Hewitt. The DoH advised me, via the shareholder, that the MHRA does not concern itself with matters that relate to events in other jurisdictions. As such, I feel that I am as well informed on this matter as I care to be.
As to risk/benefit assessments, I believe that that very precise figure of 83 trials relates to a paper that I had read. If I remember aright, it was a piece by Peter Breggin. I regret that I do not have specific details of the trials to which (I presume) Dr Breggin was referring.
However, while I understand from your comments that the MHRA's risk/benefit analysis is perhaps more subjective than objective, I was rather more interested in the procedure involved? I see that 50 trials were held to demonstrate the efficacy of the drug - did any of these involve a review of the raw data, or were statistical summaries only provided?
Either way, I would be interested to understand how "efficacy" was demonstrated, given that Mr Goldfinch has advised me to the effect that it was not necessary for an applicant to demonstrate the level of efficacy, merely that there was efficacy. I must confess that I am struggling with this one, because if one doesn't have a frame of reference, then it will not be possible to judge whether a drug is efficacious, or not, I should have thought. Indeed, unless placebo and drug's performance are measured against the same scale, then any amount of numbers will be meaningless, irrespective of what the applicant says that the summary demonstrates. Furthermore, one may not say with confidence (nor with the conviction of truth) that a drug is better than placebo, if one does not know what the drug scored, relative to the placebo. Nor will it help if one is unaware as to what the placebo scored.
In summation, then, I am keen to understand the procedure followed in the assessment process, including the risk:benefit analysis, however mercurial the latter element may be?
Best regards
(redacted)
--------------------------------------------------------------------------------
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: FOI 07/088 Seroxat
Date: Wed, 5 Sep 2007 15:56:57 +0100
Dear (redacted),
Please see attached response to your previous query, and please accept my apologies for the considerable delay in responding.
Kind regards
(redacted)
Licensing Division
MHRA
Tel 0207 084 2391
Fax 0207 084 2323
Attachment:
FOI 07/088
Dear (redacted),
Regarding you enquiry back in 9 March 2007, I regret that this was not addressed at the time, however I am able to address your queries which was as follows:
“I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?”
The MHRA is unable to comment on a hypothetical scenario.
“I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.”
Without a list of the 83 trials to which you refer it is not possible to say which of those trials the MHRA has viewed the results of. However, I have been able to ascertain the following information from the original assessment report:
Human Pharmacology: 59 studies were analysed and presented Pharmacokinetic data was obtained from over 60 studies; Drug interaction data was obtained from 30 studies; Efficacy data was supported by over 50 studies (11 Placebo controlled studies; 16 comparator studies; 4 double blind comparator studies, 5 long term efficacy studies; 19 open studies). Safety data will have been obtained from the above mentioned trials.
Regarding the technicalities of the MHRA’s risk analysis. There is no magic formula that can be used to weight the risk/benefit analysis, it is purely a case of considering the benefit(s) that the patients in the trials have experienced against the potential and demonstrated adverse reactions reported in the trials. Obviously the severity and the reversibility of reported adverse reactions need to be carefully balanced against the benefit to the patient of taking the product. The quality of life of the patient if untreated is also a factor that has to be taken into consideration. For some products it may be very easy to establish risk/benefit, however, there are those where the risk/benefit is less clear cut. This is one of the reasons why all new chemical entities (medicinal product) are considered by the Commission on Human Medicines (previously the Committee on the Safety of Medicine) and it subcommittees before a marketing authorisation is granted. It is also the reason why all new drugs have a black triangle for at least 3 years following the initial granting of a licence, to warn prescribers to be vigilant as this is a new product for which there is only limited experience.
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
(redacted)
Licensing Division
MHRA
--------------------------------------------------------------------------------
From: (redacted)
Sent: 09 March 2007 17:21
To: MHRA Information Centre
Cc: The Four
Subject: RE:
Dear Sir or Madam,
Thank you for your kind reply.
I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?
I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.
Best regards
(redacted)
Dear (redacted),
I have had an opportunity to read through your letter, for which, again, many thanks. I have the following comments/questions:
I believe the hypothetical scenario relates to a question that I put regarding the investigation into the GSK vaccine business, in Russia. As far as I know, there have been no decisions made as to GSK's culpability, as yet, and as such I understand that you would not wish to speculate on such a matter. In the event, one of the GSK shareholders in the House was kind enough to refer the matter to the then Secretary of State for Health, Patricia Hewitt. The DoH advised me, via the shareholder, that the MHRA does not concern itself with matters that relate to events in other jurisdictions. As such, I feel that I am as well informed on this matter as I care to be.
As to risk/benefit assessments, I believe that that very precise figure of 83 trials relates to a paper that I had read. If I remember aright, it was a piece by Peter Breggin. I regret that I do not have specific details of the trials to which (I presume) Dr Breggin was referring.
However, while I understand from your comments that the MHRA's risk/benefit analysis is perhaps more subjective than objective, I was rather more interested in the procedure involved? I see that 50 trials were held to demonstrate the efficacy of the drug - did any of these involve a review of the raw data, or were statistical summaries only provided?
Either way, I would be interested to understand how "efficacy" was demonstrated, given that Mr Goldfinch has advised me to the effect that it was not necessary for an applicant to demonstrate the level of efficacy, merely that there was efficacy. I must confess that I am struggling with this one, because if one doesn't have a frame of reference, then it will not be possible to judge whether a drug is efficacious, or not, I should have thought. Indeed, unless placebo and drug's performance are measured against the same scale, then any amount of numbers will be meaningless, irrespective of what the applicant says that the summary demonstrates. Furthermore, one may not say with confidence (nor with the conviction of truth) that a drug is better than placebo, if one does not know what the drug scored, relative to the placebo. Nor will it help if one is unaware as to what the placebo scored.
In summation, then, I am keen to understand the procedure followed in the assessment process, including the risk:benefit analysis, however mercurial the latter element may be?
Best regards
(redacted)
--------------------------------------------------------------------------------
From: (redacted)
To: (redacted)
CC: (redacted)
Subject: FOI 07/088 Seroxat
Date: Wed, 5 Sep 2007 15:56:57 +0100
Dear (redacted),
Please see attached response to your previous query, and please accept my apologies for the considerable delay in responding.
Kind regards
(redacted)
Licensing Division
MHRA
Tel 0207 084 2391
Fax 0207 084 2323
Attachment:
FOI 07/088
Dear (redacted),
Regarding you enquiry back in 9 March 2007, I regret that this was not addressed at the time, however I am able to address your queries which was as follows:
“I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?”
The MHRA is unable to comment on a hypothetical scenario.
“I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.”
Without a list of the 83 trials to which you refer it is not possible to say which of those trials the MHRA has viewed the results of. However, I have been able to ascertain the following information from the original assessment report:
Human Pharmacology: 59 studies were analysed and presented Pharmacokinetic data was obtained from over 60 studies; Drug interaction data was obtained from 30 studies; Efficacy data was supported by over 50 studies (11 Placebo controlled studies; 16 comparator studies; 4 double blind comparator studies, 5 long term efficacy studies; 19 open studies). Safety data will have been obtained from the above mentioned trials.
Regarding the technicalities of the MHRA’s risk analysis. There is no magic formula that can be used to weight the risk/benefit analysis, it is purely a case of considering the benefit(s) that the patients in the trials have experienced against the potential and demonstrated adverse reactions reported in the trials. Obviously the severity and the reversibility of reported adverse reactions need to be carefully balanced against the benefit to the patient of taking the product. The quality of life of the patient if untreated is also a factor that has to be taken into consideration. For some products it may be very easy to establish risk/benefit, however, there are those where the risk/benefit is less clear cut. This is one of the reasons why all new chemical entities (medicinal product) are considered by the Commission on Human Medicines (previously the Committee on the Safety of Medicine) and it subcommittees before a marketing authorisation is granted. It is also the reason why all new drugs have a black triangle for at least 3 years following the initial granting of a licence, to warn prescribers to be vigilant as this is a new product for which there is only limited experience.
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
(redacted)
Licensing Division
MHRA
--------------------------------------------------------------------------------
From: (redacted)
Sent: 09 March 2007 17:21
To: MHRA Information Centre
Cc: The Four
Subject: RE:
Dear Sir or Madam,
Thank you for your kind reply.
I understand that the MHRA may have issues commenting on legal matters, particularly when such matters pertain to a jurisdiction outside its own. What would be its response, in the event that an (unnamed) pharmaceutical company were found to have breached a law in another jurisdiction, which also happened to be a law in the UK?
I am interested to note your comment, concerning risk/benefit assessment. I understand that 83 trials were carried out on Seroxat, during the period 1980-91. What fraction of these did the MCA/MHRA view the results of? Indeed, I would be most interested to understand the technicalities of the MHRA's risk analysis. Perhaps you could advise me, on this point.
Best regards
(redacted)
Monday, 3 September 2007
The letter of the Law (but what of the spirit?)
In the light of the previous post, I thought it might be worth reminding everybody just how excoriating (if one was paying attention) some of the commentary of the Health Select Committee's report into the influence of the pharmaceutical industry was. It's a riveting read, if you're into that sort of thing...
The Report is available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf, if any readers feel inclined to trawl through the 100+ pages for themselves. Pertinent extracts, in support of my last post, follow:
282. The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry, the main exception being Prof Woods, who became chief executive of the MHRA in 2004. Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it. Dr Herxheimer stated:
…when the agency was hived off from the Department of Health…the culture became confirmed that the industry is the client and the client must be looked after: quick service, good service, easy contact, etcetera - so it is a closed community in a sense.
283. Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process. The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate [my emphasis]. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.
284. Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; it should be earned rather than presupposed. The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable, as Sir Iain Chalmers [co-conveners of the James Lind Alliance] commented:
Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.
285. Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem: the December 2004 report of the CSM’s Expert Working Group (EWG) into the safety of SSRI antidepressants. The Group’s main findings pointed to lack of evidence of risk (rather than risk itself) not least because a number of essential studies had never been performed...
The Report is available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf, if any readers feel inclined to trawl through the 100+ pages for themselves. Pertinent extracts, in support of my last post, follow:
282. The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry, the main exception being Prof Woods, who became chief executive of the MHRA in 2004. Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it. Dr Herxheimer stated:
…when the agency was hived off from the Department of Health…the culture became confirmed that the industry is the client and the client must be looked after: quick service, good service, easy contact, etcetera - so it is a closed community in a sense.
283. Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process. The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate [my emphasis]. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.
284. Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; it should be earned rather than presupposed. The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable, as Sir Iain Chalmers [co-conveners of the James Lind Alliance] commented:
Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.
285. Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem: the December 2004 report of the CSM’s Expert Working Group (EWG) into the safety of SSRI antidepressants. The Group’s main findings pointed to lack of evidence of risk (rather than risk itself) not least because a number of essential studies had never been performed...
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