Number of US Citizens at Risk to SSRI Antidepressants

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> SSRI-Research

> Fri, 20 Aug 2004 23:27:01 -0400

 

> [sSRI-Research] Number of US Citizens at

> Risk to SSRI Antidepressants

>

> 27 April 2004

>

> Representative, U.S. The Honorable Mr. Joe Barton,

> United States House of Representatives.

> Washington DC.

>

> Representative, U.S. The Honorable Mr. James

> Greenwood,

> United States House of Representatives,

> Washington DC.

>

> Number of US Citizens at Risk to SSRIs

> http://www.ahrp.org/risks/aldred0404.html

> This letter is to advise you that there is a new and

> accurate method for calculating the number of

> patients that have taken SSRIs in the US since

> introduction of these drugs. Neither the FDA, nor

> Pharma have been able to make this calculation. This

> method enables the extent of the harm, induced

> suicide and dependency caused by SSRIs in the US

> since 1988 to be quantified in both human and

> financial terms.

>

> Dear Mr. Barton and Mr. Greenwood,

>

> I have read your public letter to the FDA (24 March

> 2004) regarding your concerns over the regulation of

> SSRIs with great interest. I am encouraged that

> serious questions are now being asked by the US

> Govt. about the adequacy of FDA's process of safety

> regulation of SSRIs and the FDA's long intimacy with

> Pharma and its extended network of funding and

> influence.

>

> I have an important contribution to make to the

> investigation of SSRI induced harm caused by the

> massive prescription of Prozac, Paxil, Zoloft and

> the other SSRIs to both adults and children without

> any explicit warnings of the known potential of

> these drugs to induce suicide or dependency.

>

> The FDA, MHRA (UK equiv.of FDA) and PI admit that

> they have no idea how many patients are taking or

> have taken SSRIs. I have designed a computer model

> or simulation that provides a very accurate method

> for converting the known medication consumed (pills)

> into the actual number of patients who took them.

> The method relies on published clinical usage

> profiles and eliminates all the guesswork and

> ambiguity involving prescriptions, visits to doctor

> etc. It is a logical process that does not use

> statistics and so it can be easily understood

> without special mathematical skills. The model runs

> from the year of introduction of the drug, it

> quantifies and accumulates the growing cohort of

> long term and new patients from the annual quantity

> of pills consumed. Some more details are given in

> Appendix 1.

>

> The model logic, arithmetic, assumptions and

> implementation have been challenged in an extensive

> series of stress and sensitivity tests, designed to

> expose errors, to detect benign assumptions, and to

> measure model response to variation of all input

> parameters. Independent assessments have been made

> at two UK Universities and it has been presented

> twice to the MHRA for critical review. No flaws in

> the logic and methodology of the IMR patient flow

> model system have been found.

>

> It has been known by Pharma since1985 and now sadly

> by many thousands of victims, that every person,

> healthy or depressed, adult or child, who starts an

> SSRI, faces a finite risk of drug induced suicide

> and other harm in the first weeks of use. (Teicher

> and Cole, 1993)

>

> Since 1988, 68 million Americans have used Paxil,

> Prozac and Zoloft. Using a most conservative excess

> suicide rate, at least 21 thousand avoidable

> suicides may have been induced, without any warnings

> to the victims or their families.

>

> Table 1 (below): Use of Paroxetine (Paxil) in USA

> 1993 ­2002 showing patient growth.

> Paroxetine (Paxil) in USA 1993 - 2002.

> Year New Patients starting in current year

> Long Term Patients at start of current year Total

> Patients treated in current year Patients dropping

> out in current year

> 1993 850,205 0 850,205 536,447

> 1994 1,467,859 170,041 1,781,617 1,080,082

>

> 1995 1,289,065 453,410 1,990,600 1,098,270

>

> 1996 1,653,982 674,428 2,546,312 1,326,963

>

> 1997 2,106,261 939,762 3,325,610 1,701,480

>

> 1998 2,037,645 1,268,091 3,661,774

> 1,768,610

> 1999 1,861,142 1,548,724 3,754,306 1,680,144

> 2000 2,330,549 1,759,557 4,404,711 1,973,904

> 2001 1,887,306 2,036,854 4,318,112 1,801,226

> 2002 3,046,058 2,197,859 5,562,945 2,482,068

>

> Totals 18,530,071 15,449,195

>

> Total of Paxil medication for each year has been

> used to produce this image of patient growth. A

> total of 5.8 billion Paxil tablets (of all dose

> values) have been consumed in various quantities by

> 18.5 million US citizens during the last 10 years.

>

> Table 2 (below) gives the number of suicides that

> may have been induced in this population of 18.5

> million Americans at risk after Paxil was

> introduced. It does not include the additional

> suicides that may have been induced when patients

> attempted to withdraw after long use A range of net

> rates between 32 and 104 induced suicides per 100K

> patients starting Paxil has been used to calculate a

> range of total deaths. These rates have been derived

> from clinical data recently released by GSK.(Glaxo

> Smith Klein) These rates are very conservative and

> are far lower than the net rates measured in earlier

> randomised clinical trials (RCTs), (1990, 1991) and

> in epidemiological studies, typically 180-200/100K

> in excess of placebo.

>

> From table 2, in 2002 over 3 million Americans

> became new users of Paxil and therefore faced a net

> risk of induced suicide that is unlikely to be lower

> than 32/100K and quite probably is higher than

> 104/100K. Thus somewhere between 987 and 3168 excess

> suicides may have occurred due to Paxil. But

> whatever the total, it was not zero, several hundred

> Americans died who were not warned of the possible

> outcome that has been known and denied by the

> manufacturer for so long.

>

> Table 2 (below): Induced Suicides in USA 1993 ­2002

> at different possible rates

>

> Net Induced Suicides (Starting On Drug)

> Year Patients Starting at Risk Net Rate per

> 100K Net Rate per 100K Net Rate per 100K Net Rate

> per 100K Net Rate per 100K Net Rate per 100K

> 104 90 75 61 47 32

>

> 1993 850,205 884 762 641 519 397 275

> 1994 1,467,859 1527 1316 1106 896 686 476

> 1995 1,289,065 1341 1156 971 787 602 418

> 1996 1,653,982 1720 1483 1246 1010 773 536

> 1997 2,106,261 2191 1889 1587 1286 984 682

> 1998 2,037,645 2119 1827 1536 1244 952 660

> 1999 1,861,142 1936 1669 1403 1136 870 603

> 2000 2,330,549 2424 2090 1756 1423 1089 755

> 2001 1,887,306 1963 1693 1422 1152 882 611

> 2002 3,046,058 3168 2732 2296 1859 1423 987

>

> Totals 18,530,071 19271 16618 13964 11311

> 8657 6004

>

> There is a simple analogy with another industry that

> demands two questions. Assuming the lowest rate

> (32/100K) would the FAA support an airworthiness

> certificate for a certain aircraft type, that for 10

> years consistently crashed and killed 300 to 1000

> passengers per year and injured many others? How

> would the FAA react if the aircraft manufacturer

> consistently blamed the crashes on the passengers

> but not the aircraft?

>

> The Crisis in Medical Regulation

> The movement to expose these same fundamental

> regulatory failures in the UK is ahead of that in

> the US and is now beginning to show results. During

> 2003 the MHRA has been progressively shamed and

> forced into a succession of most serious admissions

> of their failure to protect patients. These failures

> include cover up of evidence of harm since 1991,

> failure to challenge pharma, failure to seek out

> reports of harm from the use of SSRIs, ignorance of

> the numbers of patients at risk etc, and general

> denial of any possibility that these drugs can

> induce suicide, attempted suicide or long term

> dependency, despite overwhelming evidence to the

> contrary.

>

> The evidence comes not only from the Industry's

> hidden Healthy Volunteer trials 1988 (Ref. Tobin v

> GSK 2001, Wyoming) and from RCTs with manipulated

> results (SKB, UK Licence Application.1990, 91) but

> also from the abundant and growing evidence from the

> victims themselves and the bereaved families. (e.g.

> Panorama investigations in the UK and Washington,

> Feb 2004)

>

> There are many parallels between the Pharma biased

> behaviour of both regulatory bodies (FDA and MHRA)

> during the last 15 years that are themselves very

> significant. What is required now in both countries

> is a full, open and independent enquiry, focussed on

> SSRIs, mandated to discover whether Medical

> Regulation is fundamentally flawed, and, if it is,

> to measure what harm has been done and who is

> responsible.

>

> The fundamental requirement for such an enquiry is a

> detailed and accurate analysis of the total number

> of patients involved and their period of unwarned

> risk on these drugs if they survived.

>

> In the UK, US, Canada, Australia etc. there are many

> who now believe that the greatest medical scandal of

> all time is about to be exposed, the proper outcome

> of which must fundamentally change all national

> processes of drug regulation in favour of the safety

> and wellbeing of patients not massive commercial

> profit regardless of harm done.

>

> This tragedy has many causes, here are three of the

> most fundamental:

>

> 1) All Governments have delegated the responsibility

> for medical regulation and funding to various

> agencies without close oversight. This has resulted

> in the equivalent of the Police Dept. being funded

> and part staffed by the Mafia.

>

> 2) Culture in Pharma consistently values commercial

> profit above patient safety. FDA and MHRA meekly

> allow assertions of market vulnerability and

> commercial confidentiality by Pharma to justify all

> manner of secrecy, non-disclosure and inaction. Drug

> safety is not a continuous process of investigation

> and validation, one dubious licence issued 15 years

> ago lasts indefinitely without review whilst the

> drug applicability is continually extended in

> addition to the lucretive unvalidated uncontrolled

> off label use (eg Paxil for the under fives )

>

> 3) Doctors claim the independence and freedom to

> override/ignore any FDA regulation and are not

> compelled to report any suspected adverse drug

> effects to the FDA, thus the most vital safety feed

> back is continually lost. By comparison, in

> Aviation, human safety is paramount. Pilots, of

> similar status to doctors, must obey air traffic

> control instructions implicitly and must report all

> suspected defects that could affect safety. There is

> no place in modern hi tech aviation for uncontrolled

> barn storming pilots, so why should modern hi tech

> medicine be any different especially when there are

> many more patients at risk from complex ill

> validated drugs than passengers in complex well

> validated aircraft?

>

> Robust investigation of medical regulation is

> inevitable. The purpose of this letter is to inform

> that there is a viable and accurate method for

> quantifying the harm done by SSRIs that will assist

> any enquiry. In addition to offer to explain the

> function and implementation of the IMR Model in

> sufficient detail to demonstrate that the results

> are scientifically credible and worthy of serious

> consideration by the US Government.

>

> Yours sincerely,

>

> Graham Aldred.

>

>

>

> Appendix 1

> Principle of the IMR Model System.

> The clinical study of SSRI use indicates

> characteristic patterns of usage or tolerance, from

> the early weeks through to several years. The total

> quantity of medication that has been issued from the

> pharmacies is known in annual or quarterly

> increments. A very accurate method has been devised

> for converting consumption of medication, moderated

> by characteristic patient usage, into actual numbers

> of patients.

>

> The phasing of patients in starting or leaving the

> drug in the short term or finding themselves

> dependant for many years, is handled with

> flexibility and without artificial constraint in the

> model. The model starts running from the year of

> introduction of the drug. It generates an image of

> the patient flow that is progressively updated,

> giving all the accumulating totals of those joining

> or leaving the drug as the years go by for the

> entire and growing national cohort.

>

> Annual cohorts can be characterised individually

> within the model, with a different usage profile,

> drop out rate and suicide rate, (e.g. patients in

> 2001 did behave differently to those in 1994). The

> IMR model will also calculate the number of long

> term patients (LTP) dependant at any time and will

> give breakdowns of how many patients have been on

> drug for a given number of years, including costs.

>

> There is considerable evidence that the danger of

> induced suicide or suicidal acts occurs at any dose

> transition with SSRIs, particularly in the first

> weeks of starting the drug, when changing dose mid

> treatment, or when trying to stop after long use.

> The IMR model uses a range of suicide rates from

> clinical data to calculate the total suicides

> induced in various combinations of depressed and

> anxious patients both when they start the drug and

> when they attempt to withdraw.

>

> In summary, IMR will calculate any subtotals for any

> year and for the whole term: new patients, total

> patients treated, current long term patients, drop

> out patients (both short and long term), new long

> term patients, start drug suicides, withdrawal

> suicides, total and specific costs etc.

>

> IMR has been used to model the patient flow

> resulting from the use of paroxetine (Paxil),

> fluoxetine (Prozac) and sertraline (Zoloft) since

> introduction in several countries including the US.

> The IMR patient flow model has general applicability

> beyond SSRIs and could be used to investigate any

> drug for which there is a known usage profile.

>

> Graham Aldred

>

>

>

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