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#1 joseph1951

joseph1951

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Inviato 27 febbraio 2008 - 20:48:23

Dal letto dell'opsedal, posto le ultime notizie dal mondo anglo americano
Sono avvenimenti importanti che si succedono ad effeto cascata

estratti dal'The One click Group di oggi:
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Latest News On One Click
Scroll down the website to read much more news on One Click or go to the News Archives

* Fantastic One Click Judicial Review News!This latest news of the progress of the One Click Judicial Review of the CFS/ME NICE Guidelines is simply fantastic. What One Click has achieved here is a monumental success and what an amazing coup to have Dr Bruce Carruthers' expert witness testimony to support us! This is surely the strongest of bases to bring a Judicial Review. I would like to say a big Thank You again to Jane and Ben for their perseverance with this action and for working so selflessly to uphold the rights and interests of hundreds of thousands of ME/CFS labelled patients.
Lara, Health Advocate

* Hepatitis B Vaccine And Multiple Sclerosis In Children
In line with our Freedom of Information policy, One Click publishes today this stellar paper by Dr Marc Girard, MSc, MD that concerns Hepatitis B vaccination and the risk of multiple sclerosis in children posed by this vaccine. GlaxoSmithKline and Sanofi Pasteur are currently being sued for manslaughter and aggravated fraud following allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998. The issue of research bias amounting to scientific fraud is also exposed in Dr Girard's paper that has been submitted to the Archives of Pediatrics & Adolescent Medicine. This paper is a must read. The truth will out.
Dr Marc Girard, MSc, MD/The One Click Group

* FDA Slammed For Useless SSRIs Approval Process
The conundrum for industry and psychiatry is lack scientific evidence to support the safety and effectiveness of these drugs: First, the exceedingly high placebo effect (80%) demonstrated in controlled clinical trial data submitted to the FDA and second, severe adverse effects - including a twofold increased risk of suicidal behavior - now acknowledged on the drugs' label. These negative facts have led psychiatrists whose career is invested in the drugs to turn to epidemiological data.
Vera Hassner Sharav, AHRP

* Full Text - US Government Vaccine-Autism Case
The US government has conceded the Vaccine-Autism link in the Court of Federal Claims. One Click now publishes the full text of this case of a CHILD, a minor, by her Parents and Natural Guardians, MOM & DAD, Petitioners versus SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
The United States Court Of Federal Claims, Office Of Special Masters

* Wyeth Hopes For HRT Cancer Inducing Comeback
Since Hormone Replacement Therapy (HRT) was found by the Women's Health Initiative in 2002 to cause a 26 percent increased risk of breast cancer, 29 percent increased risk of heart attack, 41 percent increased risk of stroke and 100 percent increased risk of blood clots, a study in the January issue of Cancer Epidemiology, Biomarkers and Prevention found the cancers also move quickly. Selling a product that causes cancer isn't easy, but with help from a U.S endocrinologist group, Wyeth is again obscuring the truth about HRT despite enduring 5,000 lawsuits over this issue.
Martha Rosenberg, AlterNet

* BADA-UK Lyme Borreliosis Charity Announcement
BADA-UK will be launching its revised and more comprehensive website this week. In place of the "Tick Talk" forum, we will be providing a blog which will be managed by BADA-UK administrators. We are happy to receive material for possible inclusion.
"Tick Talk" Administrator, BADA-UK

* SSRIs Uncontrolled Mass Medical Experiment Finished
A group of experts led by Professor Irving Kirsch from the Department of Psychology at the University of Hull, analysed 47 clinical trials using data released under Freedom of Information rules by the US Food and Drug Administration (FDA). The research shows that anti-depressants work no better than dummy pills. The pharmaceutical industry's hugely lucrative uncontrolled SSRIs mass medical experiment on the most vulnerable in our society has now come to a close.
The Press Association, BBC News, Daily Telegraph, The Independent etc. etc.

* The UK MMR Vaccine Demonstration (2)
The General Medical Council Hearing of Dr Andrew Wakefield, Professor Simon Murch and Professor John Walker-Smith resumes on Tuesday, 25 March 2008 when the case for the Defence will be presented. A crowd of supportive parents of autistic children will be demonstrating against the process of charging doctors without a single patient complaining. Beginning at 8am, it's time to make a stand for children's rights to a healthy future without risking vaccine damage and its life-long consequences of care.
Allison Edwards, CryShame

* US Government Concedes Vaccine-Autism Link
After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD), the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims. The government's concession raises more questions than it answers. The Federal Government's Vaccine Court defense strategy is now in jeopardy.
David Kirby, The Huffington Post

Scroll down the website to read much more news on One Click or go to the News Archives

The One Click Group">

* SSRIs Uncontrolled Mass Medical Experiment Finished
A group of experts led by Professor Irving Kirsch from the Department of Psychology at the University of Hull, analysed 47 clinical trials using data released under Freedom of Information rules by the US Food and Drug Administration (FDA). The research shows that anti-depressants work no better than dummy pills. The pharmaceutical industry's hugely lucrative uncontrolled SSRIs mass medical experiment on the most vulnerable in our society has now come to a close.
The Press Association, BBC News, Daily Telegraph, The Independent etc. etc.

* The UK MMR Vaccine Demonstration (2)
The General Medical Council Hearing of Dr Andrew Wakefield, Professor Simon Murch and Professor John Walker-Smith resumes on Tuesday, 25 March 2008 when the case for the Defence will be presented. A crowd of supportive parents of autistic children will be demonstrating against the process of charging doctors without a single patient complaining. Beginning at 8am, it's time to make a stand for children's rights to a healthy future without risking vaccine damage and its life-long consequences of care.
Allison Edwards, CryShame

* US Government Concedes Vaccine-Autism Link
After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD), the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims. The government's concession raises more questions than it answers. The Federal Government's Vaccine Court defense strategy is now in jeopardy.
David Kirby, The Huffington Post

* One Click NICE Judicial Review - Campaign Update 4
I write to you today on a subject very dear to the hearts of hundreds of thousands of people around the world - the One Click Judicial Review of the appalling CFS/ME Guidelines produced by the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. It is my happy duty to announce to you today that thanks to the formidable representation carried out by our excellent lawyers Saunders Solicitors LLP and the work of One Click conjoined to help ME/CFS labelled patients, we have very good news to impart.

Jane Bryant, Director, The One Click Group
* Patient Activism Starting To Shape Healthcare Systems
HSC News International, issue 41, February 2008, ‘Winds of change: the patient as activist’, now published. Spurred on by heightened public concerns about lifestyles and chronic disease, patients are turning into activists. Delays and deficiencies in healthcare services have hardened their perspectives. It may not be a role that patients welcome, but they are driven to take action when their child lies sick, or a loved one is in pain and care and treatment falls short of expectations. Patient activists are driving the winds of change.
HSC News International, Issue 41, February 2008

* MMR and the doctors - taking us all for dummies
Vested interests links of UK doctors and politicians with the pharmaceutical industry propagandising the benefits of the MMR vaccine exposed. The 2005 Commons Select Committee on Health report, The Influence of the Pharmaceutical Industry warned: "Public relations is particularly important during times of bad publicity, especially when the safety of brands is called into question. Considerable resources are invested into building long-term, sustainable relationships with stakeholders and 'key opinion leaders' and journalists." Precisely this is occurring whilst the UK government looks on, rearranging the vaccine/autism-induced deckchairs on the pharmaceutical industry Titanic.
John Stone, parent

Scroll down the website to read much more news on One Click or go to the News Archives

The One Click Group


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Fantastic One Click Judicial Review News!
From Lara, Health Advocate

This latest news of the progress of the One Click Judicial Review of the CFS/ME NICE Guidelines is simply fantastic and gives a sense of liberation to those of us who for a long time now have felt that no one in authority was prepared to listen to the facts or to take patients' needs or rights seriously.

It is just and proper that ME/CFS-labelled patients, ignored and marginalised for so long now, should be allowed to have their case heard in a high court. Several thousand research papers not to mention the vast clinical experience that has grown up in the last 20 years shows that these patients are suffering with diseases every bit as `physical' as cancer, heart disease and AIDS. When properly tested, the patients have abnormal immune, endocrine, neurological, nutritional, cardiac, gastrointestinal and mitochondrial dysfunctions. The presence of one or more toxins and/or serious viral, bacterial, fungal or other infections has been confirmed in study after study. There is not a shadow of doubt that these patients have something very physical wrong with them and that primary stress and depression are no more prevalent in their cases than in the rest of the general population.
The CFS/ME NICE guidelines in their current form, allow for `exclusionary' testing that can only be described as totally pathetic. It is entirely possible that such a panel of tests could be completely normal while more in-depth scans, blood testing and proper physical examination would show up the true nature of the patient's health. However, these guidelines are the perfect tool if the intention is to dismiss patients as suffering from a Somatisation Disorder. Indeed, according to Professor Simon Wessely, the only reason that a patient is not given this diagnosis outright in the first place, is that in his view they are too psychologically weak to cope and must instead be labelled with a `euphemism'. This is based entirely on he (and his cronies) subjective and unproven opinions. The views of this group of psychiatrists have done untold damage to ME/CFS-labelled patients who instead of getting the thorough and appropriate healthcare they needed, have either been coerced into inappropriate GET/CBT therapies or left to rot in their homes, suffering terrible pain and symptoms, often in isolation or with their desperate families and carers. This appalling situation amounts to hundreds of thousands of UK patients (and millions globally) undergoing a form of passive, remote torture caused by the deliberate withholding of appropriate medical treatments.

The psychiatric lobby have shown no compassion to these patients and have instead deliberately misled government, media, the medical profession and the public into thinking that ME/CFS labelled patients are simply neurotic, symptom focussing, enjoying secondary gain from family members and wrongful financial gain from the state and that their `crash and burn' aberrant personalities are to blame for their symptoms. This should never have been allowed to happen in a modern day society and how the Wessely School were ever allowed to get away with it beggars belief. Perhaps our government was persuaded that CBT/GET approaches would work and that they would save money on healthcare and benefits?

Well, now is the time to carefully reconsider, because the growing epidemic of ME/CFS and neurological illness is not going to be halted by such baseless, useless, junk pseudo-medicine. The financial, human and societal costs will just keep on rising until proper research and healthcare is provided.

For these reasons I am cheering loudly for the One Click Judicial Review to go full steam ahead! What One Click has achieved here to date amounts in my view to a monumental success and what an amazing coup to have Dr Bruce Carruthers' expert witness testimony to support us! This is surely the strongest of bases to bring a Judicial Review! I would like to say a big Thank You again to Jane and Ben for their perseverance with this action and for working so selflessly to uphold the rights and interests of hundreds of thousands of ME/CFS labelled patients. With you on our side we may look to the future with hope and pride.

BW
Lara

********************

For Further Information:

One Click NICE Judicial Review
Campaign Update 4

Very Simply We Did It

Health Advocacy Pressure Group
Launches NICE High Court Action Today

The One Click Group Response
CFS/ME NICE Guidelines

********************


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Hepatitis B Vaccine And Multiple Sclerosis In Children
One Click Note: In line with our Freedom of Information policy, One Click publishes today this stellar paper by Dr Marc Girard, MSc, MD that concerns Hepatitis B vaccination and the risk of multiple sclerosis in children posed by this vaccine.

GlaxoSmithKline and Sanofi Pasteur are being investigated by the French authorities following allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998. The drug companies are currently being sued for manslaughter and aggravated fraud. 10 million children were potentially put at risk by this vaccine.

The issue of research bias amounting to scientific fraud is also exposed in this paper.

Dr Girard has submitted this paper to the Archives of Pediatrics & Adolescent Medicine. It will be most interesting to see if they publish. In the interim, the Editor has been placed on to the One Click News Alerts distribution list.

The truth will out.

See About Dr Girard


*************************

26 February 2008


Hepatitis B vaccination and the risk of multiple sclerosis in children

Dr Marc Girard, MSc, MD


“Tell me who are your friends…”

With an extensive training against biased research gained through thousands of hours spent in medical reports1,2 ordered in the setting of the criminal inquiry which recently led the manufacturers of hepatitis B vaccines to face charges of manslaughter and aggravated fraud3, I could not help reading the paper by Mikaeloff et al (2007)4 with a high degree of suspicion. And it is fair to note that in the medias as well as the “experts” – esp. those regularly neglecting to declare their conflicts of interest with the vaccine manufacturers5 –, those most prone to hype this problematic study were the same as those which used to be harshly involved in promoting communication that French prosecutors tend now to charge as “aggravated fraud”: tell me who are your friends, says an old French proverb, and I will tell you who you are…

Whereas in pharmacoepidemiology, the case/control design is normally used as a cheap recourse to rapidly get reliable data in case of a health alert, the first surprise here lies in the formidable time lag required to have these results: they should have been available some 15 years before, in the interval between the modification in the international sheet of Engerix B pointing out a risk of post-vaccinal multiple sclerosis (MS) in 1993 and the irresponsible launch of a pediatric campaign of vaccination in Sept. 1994. Still in 2004, during a private meeting, the Director of AFSSAPS told me that the KIDMUS cohort was consistent with a frightening threat on public health and that carrying a formal case/control study was therefore a sheer emergency: in spite of this, 3 additional years have been needed, while in the meantime the investigators stubbornly refused to release any piece of information when asked by French colleagues, in an atmosphere more evocative of a plot than of any sound pediatric research regarding a critical and urgent health issue in our country…

Needless to say: in the meantime, the French authority did not take the elementary precaution to withhold any incitation to vaccine pediatric subjects against such a “terrible” disease as hepatitis B – with a spontaneous resolution in 98-99% of cases and about which I recently compelled one “expert” to confess that no more than some 60 cases did occur in this age group in France, most of them in migrants.5

Suspicion about undue delays grows even more acutely as the design of the study was needlessly hampered by the selection of no less than 10 controls per case, when the accepted wisdom is that there is no clear advantage in using a maximum of 3-4 controls per case. Yet, the Hernan et al study6 (which, quite suggestively, appears as the main foil of the authors) also included the same number of controls: but as they confirmed once asked on this point (personal communication), unlike the French authors the US researchers used automated data, so that there was no penalty in cost nor in delay in selecting more than 4 controls per case. Thus, as there can be no methodological justification to the subsequent waste of time and money in Mikaeloff et al’s study4, it suffices to consider its media coverage5 to retrospectively grasp the trick: presenting this study as a definite refutation of Hernan et al’s investigation6 while substantiating that the former was “as big” as the latter and making a terrible racket on this numerical equivalence devoid of any statistical significance…

This childish inflation of the number of controls is all the more suspect as, in the same time, the number of included cases underwent a dramatic – and yet unexplained – reduction. When the study was announced, everybody (I included) understood that the cases would be the 472 children of the KIDMUS cohort – a frightening sample size, incidentally, regarding a disease such as MS which is in no way a pediatric condition in a country of 60 million of inhabitants. Yet, it would be interesting to know why of these 472 children, Mikaeloff et al retained only one third: as recently as in 28 Aug. 2007 (whereas the paper was already accepted for publication), in her response to a MP question about the benefit/risk ratio of hepatitis B vaccine in infants, the French Ministry of Health announced7 Mikaeloff et al’s publication claiming that the cohort included “467 children” and, as it happens, insisting over the fact that no less than… twelve controls would be matched to every case (an argument more likely to impress the average MP than any professional equipped with a minimum of epidemiological or statistical culture)… Beyond the obvious promotional trick, it is still as difficult to see any scientific rationality in the methodological choice of decimating the sample of cases while inflating that of controls.

Another high index of suspicion is related to the companion paper by the same team,8 also duly mentioned by the French Ministry of health, and which pertains to the longstanding strategy of mystification adopted by the French Agency from the very beginning of the story, in 1994: shifting the real problem (is there any risk, for a healthy person, to develop a MS after hepatitis B vaccination?) – which concerned some 60 million of French citizen in a perspective of an “universal” immunization – to something without genuine connection (is there a risk, for subjects already affected by MS, to experience relapse after vaccination?) – which concerned about 25 000 persons at that time. Likewise, whereas any reasonable physician in this country was concerned by the risk of triggering MS in exposing some 10 million of pediatric subjects to hepatitis B vaccination, Mikaeloff et al – with the obvious support of their Ministry – were apparently very happy to claim that out of the… 33 children with pre-existing MS and then exposed to this vaccine, there was no evidence of any risk of relapse:8 how nice and reassuring!...

For perverse as it was, this displacement translates also in a direct argument against the latest investigation by Mikaeloff et al.4 Actually, the main focus in the communication by the French Agency since 1994 was about the potential contra-indications of the vaccine in the tiny subpopulation of people with a familial or personal history of MS. Yet, if one considers Table 1, it appears that the risk of MS history was 2.6 times higher in the cases than in the controls: in other terms and according to the abovementioned recommendations by the French Agency, this means that the probability of being vaccinated was significantly lower in the cases as compared with the controls – an interesting bias in a study such this one…

Although my previous remarks should be sufficient to crack the credibility of this study, there is another methodological objection regarding the exposure ascertainment. In fact, the vaccination campaign in French schools occurred in an atrocious mess and improvisation: indeed, mess and improvisation were precisely the pretexts taken by the late Health Ministry B. Kouchner to suspend the pediatric campaign in Oct. 1998. Therefore, the vaccination certificate (“carnet de santé”) was by far be the poorest document of relevance to assess exposure regarding hepatitis B vaccine: although doubts exist regarding the long-term efficacy of the vaccine, the only way of comparing exposure between the cases and the controls should have been serum antibodies, and this is a sheer scandal to publish a study bypassing such an elementary checking. Therefore, the assessment of exposure in this study was severely flawed and this justifies considering its conclusions with the highest degree of suspicion.

The Archives of Pediatrics & Adolescent Medicine deserve a final criticism. Although this is not politically correct to say, the medical journals share a huge responsibility in the too lamented “publication bias” due to their severely flawed process of selection leading to the publication of incredibly poorly designed investigations,9 reviews intolerably prejudiced in their references,10-12 or even studies explicitly suspected of fraud13 by regulatory agencies14. As documented above, there were a number of reasons to develop a high degree of suspicion against the current study by Mikaeloff et al4: besides of publishing this problematic investigation – and in free access –, was it necessary to publish an accompanying editorial15 to celebrate it under the fallacious pretext of “Science”? Completely unjustified in a scientific journal, this hype reminds us the same procedure16 used by the New England Journal of Medicine once the Ascherio et al17 and Confavreux et al18 investigations – both of them favorable to the hepatitis B vaccination – were published, in spite of their obvious weaknesses: in the meantime, the same journal failed to publish any similar celebration of the paper by Hernan et al6 – by far the best study in the field – and, up till now, remained regrettably silent on the reasons for its refusal to publish this remarkable investigation… This is a worrying bias to consider that data favorable to vaccines are “scientific” by essence19 as exemplified by comparing the promotion of vaccine against hepatitis B on the one hand, against HPV on the other: at some 15-20 years of interval, that both vaccines could be, each, “the first” immunization against a cancer is closest of “aggravated fraud” than of “Science” and I am now reasonably confident that this will be published by the Archives with the same epistemological zeal as that used to celebrate the study by Mikaeloff et al4…

To conclude, Mikaeloff et al’s investigation4 failed to answer to the question which triggered its planning and performance, and was perfectly summarized by Tardieu – one of its co-authors – in 200420: why, in a period where the main change in environment was vaccination against hepatitis B, did the 90ties show a burst of pediatric MS, a disease extremely rare in that age group and whose overall epidemiology, anyway, is normally quite stable. To be more precise, why, further to this vaccination campaign, the KIDMUS cohort showed a 25-fold increase in the frequency of pediatric MS as compared to previous records?2 A question strangely consistent with a more general one: why, as compared to the latest record prior to the vaccination campaign, the widely accepted estimations of MS frequency in the French population showed an increase from about 25,000 at baseline to 80,000-90,000 today?2 To say nothing about this second interesting question: whatever its real cause, why such alarming situation did not trigger, from the French authority, any investigation more appropriate than that of Mikaeloff et al4 who, in spite of these dramatic – and yet unexplained – figures concerning our children, keep holding that tout va très bien, Madame La Marquise (“All is well, Madam the Marquise”).21

Marc Girard, MSc MD
76 route de Paris, 78760 Jouars-Pontchartrain (France)
tel : 33 (0)1 34 89 42 29
fax : 33 (0)1 34 89 76 08
e-mail : agosgirard@free.fr

Conflicts of interest: Dr. Girard works as an independent consultant for the pharmaceutical industry, including (at least until recently) vaccine manufacturers and a number of their competitors

References

1. Reuters Medical News. Reports criticizes French Hepatitis Vaccination Campaign. Medscape, Nov 2002

2. Girard M. When evidence-based medicine (EBM) fuels confusion: multiple sclerosis after hepatitis B vaccine as a case in point. Medical Veritas 2007; 4:1436-51

3. Anon. Manslaughter charges are laid in two French drug cases. Scrip 2008; (3334):5

4. Mikaeloff Y, Caridade G, Rossier M et al. Hepatitis B vaccination and the risk of childhood-onset multiple sclerosis. Arch Pediatr Adolesc Med 2007; 161:1176-82

5. France 5. fr, C dans l’air. Le « procès » des vaccins dangereux, 8 Feb, 2008, (partial transcription of a French TV program, latest access 24 Feb. 2008)

6. Hernan M, Jick S, Olek M, Jick H. Recombinant hepatitis B vaccine and the risk of multiple sclerosis. A prospective study. Neurology 2004; 63:838-42.

7. Santé (vaccinations, hépatite B, pertinence). Question 3556, 28 Aug. 2007. Assemblée nationale, 16 Oct. 2007 : 6386

8. Mikaeloff Y, Caridade G, Assi S, Tardieu M, Suissa S. Hepatitis B vaccine and risk of relapse after a first childhood episode of CNS inflammatory demyelination. Brain 2007; 130 (Pt 4):1105-10

9. Sadovnick AD, Scheifele DW. School-based hepatitis B vaccination programme and adolescent multiple sclerosis [letter]. Lancet 2000; 355(9203):549-50

10. Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune disease: what is the evidence? Lancet 2003; 362(9396):1659-66

11. Pollard AJ. Hepatitis B vaccination. BMJ: BMJ 2007; 335(7627):950

12. Girard M. Being or not being an idiot, British Medical Journal (latest access 24 Feb. 2008)

13. Zipp F, Weil JG, Einhaupl KM. No increase in demyelinating diseases after hepatitis B vaccination. Nat Med 1999; 5(9):964-5

14. Commission Nationale de Pharmacovigilance. Vaccination anti hépatite B – Mise à jour des données et des études de pharmacovigilance. Communiqué de février 2000

15. Rivara FP, Christakis DA. The march of Science. Arch Pediatr Adolesc Med. 2007;161(12):1214-1215

16. Gellin BG, Schaffner W. The risk of vaccination - The importance of "negative'' studies. N Engl J Med 2001; 344(5):372-3

17. Ascherio A, Zhang SM, Hernan MA et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med 2001; 344(5):327-32

18. Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S. Vaccinations and the risk of relapse in multiple sclerosis. N Engl J Med 2001; 344(5):319-26.

19. Girard M. Misconceptions about misconceptions, British Medical Journal.

20. Cognat Ch. Une étude inquiétante. Le Progrès, 15 Nov. 2004

21. Ventura R et al. Tout va très bien Madame la Marquise: an English translation.

About WAVE
The World Association for Vaccine Education (WAVE) is globally focused, non-profit, educational institution advocating reformation of the mass vaccination systems. To this effect, WAVE provides an avenue for a public exchange of non-medical vaccine information, ideas and a continuously updated database of documents that concern vaccine risk and uselessness. It’s intent is to redress the balance of information available to parents on vaccination issues, acknowledge people who experience vaccine reactions, and adamantly advocate and maintain freedom of choice.

*******************

For Further Information:
Vaccine Companies Sued For Manslaughter
Reuters

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FDA Slammed For Useless SSRIs Approval Process
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FDA Data: Antidepressants Produce NO Clinically Significant Improvement in Depressed Patients

FYI

Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration by Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria, Thomas J. Moore, Blair T. Johnson, has just been published in PLoS (Public Library of Science)

The study addresses the clinical question: is the risk / benefit ratio of antidepressants favorable for patient use?

The conclusion: "compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression."

This new study by expands the authors' previous analysis, The Emperor's New Drugs (2006) [1] as well an earlier analysis by the principle author (2005).[2]

The just released study utilizes additional -- decades old data -- released to the authors by the FDA.

The authors note:

"Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials."

"Conventional meta-analyses are often limited to published data. In the case of antidepressant medication, this limitation has been found to result in considerable reporting bias characterized by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. To avoid publication bias, we evaluated a dataset that includes the complete data from all trials of the medications, whether or not they were published. Specifically, we analyzed the data submitted to the FDA for the licensing of four new-generation antidepressants for which full data, published and unpublished, were available. As part of the licensing process, the FDA requires drug companies to report ''all controlled studies related to each proposed indication'' (emphasis in original). Thus, there should be no reporting bias in the dataset we analyze."

We challenge the FDA on two points:

1. If independent analyses of data submitted to the FDA conclude that the drugs failed to demonstrate clinical improvement and the drugs' safety profile shows serious risks of harm -- including increased suicides and suicide attempts -- one has to question the FDA approval process.

What was the safety and efficacy standard used by the FDA to justify approval of the new generation antidepressant and antipsychotic drugs?

The question undercuts current legal arguments deferring all drug safety issues to the FDA: the preemption arguments presuppose a scrupulous, rigorous scientific FDA standard for approval and drug labeling. That presumption is not credible in light of the evidence demonstrating FDA's failure to analyze SSRI safety and efficacy data for more than 15 years.

2. Despite wide acknowledgement that published clinical drug trial reports are biased and unrepresentative of the data, what justification is there for FDA's recent Proposed Guidance for Industry that would legalize the illegal marketing / promotion of drugs for off-label uses? See: DRAFT GUIDANCE

Underscoring the significance of the PLos study findings, the government sponsored STAR*D naturalistic uncontrolled observational study confirmed the lack of antidepressant efficacy. See: Separating the Facts from the Propaganda_Latest Findings of Depression Study

The conundrum for industry and psychiatry is lack scientific evidence to support the safety and effectiveness of these drugs: First, the exceedingly high placebo effect (80%) demonstrated in controlled clinical trial data submitted to the FDA [1] [2]; and second, severe adverse effects - including a twofold increased risk of suicidal behavior-now acknowledged on the drugs' label. These negative facts have led psychiatrists whose career is invested in the drugs to turn to epidemiological data [5] [6].

References:

1. Irving Kirsch, Thomas J. Moore, Alan Scoboria, and Sarah S. Nicholls The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration, Prevention & Treatment Volume Five July 15, 2002. Target article with 9 commentaries.

2. Joanna Moncrieff and Irving Kirsch Efficacy of Antidepressants in Adults, BMJ, 2005;331:155-157.


Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org


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Full Text - US Government Vaccine-Autism Case
See US Government Concedes Vaccine-Autism Link
David Kirby
The Huffigton Post


************
FULL TEXT: AUTISM VACCINE CASE

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS

CHILD, a minor, by her Parents and Natural Guardians, MOM & DAD,
Petitioners,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

RESPONDENT’S RULE 4© REPORT
In accordance with RCFC, Appendix B, Vaccine Rule 4©, the Secretary of Health and Human Services submits the following response to the petition for compensation filed in this case.

FACTS
CHILD (“CHILD”) was born on December --, 1998, and weighed eight pounds, ten ounces. Petitioners’ Exhibit (“Pet. Ex.”) 54 at 13. The pregnancy was complicated by gestational diabetes. Id. at 13. CHILD received her first Hepatitis B immunization on December 27, 1998. Pet. Ex. 31 at 2.

From January 26, 1999 through June 28, 1999, CHILD visited the Pediatric Center, in Catonsville, Maryland, for well-child examinations and minor complaints, including fever and eczema. Pet. Ex. 31 at 5-10, 19. During this time period, she received the following pediatric vaccinations, without incident:

Vaccine Dates Administered
Hep B 12/27/98; 1/26/99
IPV 3/12/99; 4/27/99
Hib 3/12/99; 4/27/99; 6/28/99
DTaP 3/12/99; 4/27/99; 6/28/99

Id. at 2.

At seven months of age, CHILD was diagnosed with bilateral otitis media. Pet. Ex. 31 at 20. In the subsequent months between July 1999 and January 2000, she had frequent bouts of otitis media, which doctors treated with multiple antibiotics. Pet. Ex. 2 at 4. On December 3,1999, CHILD was seen by Karl Diehn, M.D., at Ear, Nose, and Throat Associates of the Greater Baltimore Medical Center (“ENT Associates”). Pet. Ex. 31 at 44. Dr. Diehn recommend that CHILD receive PE tubes for her “recurrent otitis media and serious otitis.” Id. CHILD received PE tubes in January 2000. Pet. Ex. 24 at 7. Due to CHILD’s otitis media, her mother did not allow CHILD to receive the standard 12 and 15 month childhood immunizations. Pet. Ex. 2 at 4.

According to the medical records, CHILD consistently met her developmental milestones during the first eighteen months of her life. The record of an October 5, 1999 visit to the Pediatric Center notes that CHILD was mimicking sounds, crawling, and sitting. Pet. Ex. 31 at 9. The record of her 12-month pediatric examination notes that she was using the words “Mom” and “Dad,” pulling herself up, and cruising. Id. at 10.

At a July 19, 2000 pediatric visit, the pediatrician observed that CHILD “spoke well” and was “alert and active.” Pet. Ex. 31 at 11. CHILD’s mother reported that CHILD had regular bowel movements and slept through the night. Id. At the July 19, 2000 examination, CHILD received five vaccinations – DTaP, Hib, MMR, Varivax, and IPV. Id. at 2, 11.

According to her mother’s affidavit, CHILD developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent, high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was having a normal reaction to her immunizations. Id. According to CHILD’s mother, this behavior continued over the next ten days, and CHILD also began to arch her back when she cried. Id.

On July 31, 2000, CHILD presented to the Pediatric Center with a 101-102 degree temperature, a diminished appetite, and small red dots on her chest. Pet. Ex. 31 at 28. The nurse practitioner recorded that CHILD was extremely irritable and inconsolable. Id. She was diagnosed with a post-varicella vaccination rash. Id. at 29.

Two months later, on September 26, 2000, CHILD returned to the Pediatric Center with a temperature of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and pulling at her left ear. Id. at 29. Two days later, on September 28, 2000, CHILD was again seen at the Pediatric Center because her diarrhea continued, she was congested, and her mother reported that CHILD was crying during urination. Id. at 32. On November 1, 2000, CHILD received bilateral PE tubes. Id. at 38. On November 13, 2000, a physician at ENT Associates noted that CHILD was “obviously hearing better” and her audiogram was normal. Id. at 38. On November 27, 2000, CHILD was seen at the Pediatric Center with complaints of diarrhea, vomiting, diminished energy, fever, and a rash on her cheek. Id. at 33. At a follow-up visit, on December 14, 2000, the doctor noted that CHILD had a possible speech delay. Id.

CHILD was evaluated at the Howard County Infants and Toddlers Program, on November 17, 2000, and November 28, 2000, due to concerns about her language development. Pet. Ex. 19 at 2, 7. The assessment team observed deficits in CHILD’s communication and social development. Id. at 6. CHILD’s mother reported that CHILD had become less responsive to verbal direction in the previous four months and had lost some language skills. Id. At 2.

On December 21, 2000, CHILD returned to ENT Associates because of an obstruction in her right ear and fussiness. Pet. Ex. 31 at 39. Dr. Grace Matesic identified a middle ear effusion and recorded that CHILD was having some balance issues and not progressing with her speech. Id. On December 27, 2000, CHILD visited ENT Associates, where Dr. Grace Matesic observed that CHILD’s left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The tube was replaced on January 17, 2001. Id.

Dr. Andrew Zimmerman, a pediatric neurologist, evaluated CHILD at the Kennedy Krieger Children’s Hospital Neurology Clinic (“Krieger Institute”), on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after CHILD’s immunizations of July 19, 2000, an “encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness.” Id. He noted a disruption in CHILD’s sleep patterns, persistent screaming and arching, the development of pica to foreign objects, and loose stools. Id. Dr. Zimmerman observed that CHILD watched the fluorescent lights repeatedly during the examination and would not make eye contact. Id. He diagnosed CHILD with “regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development.” Id. At 2. Dr. Zimmerman ordered genetic testing, a magnetic resonance imaging test (“MRI”), and an electroencephalogram (“EEG”). Id.

Dr. Zimmerman referred CHILD to the Krieger Institute’s Occupational Therapy Clinic and the Center for Autism and Related Disorders (“CARDS”). Pet. Ex. 25 at 40. She was evaluated at the Occupational Therapy Clinic by Stacey Merenstein, OTR/L, on February 23, 2001. Id. The evaluation report summarized that CHILD had deficits in “many areas of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a result.” Id. at 45. CHILD was evaluated by Alice Kau and Kelley Duff, on May 16, 2001, at CARDS. Pet. Ex. 25 at 17. The clinicians concluded that CHILD was developmentally delayed and demonstrated features of autistic disorder. Id. at 22.

CHILD returned to Dr. Zimmerman, on May 17, 2001, for a follow-up consultation. Pet. Ex. 25 at 4. An overnight EEG, performed on April 6, 2001, showed no seizure discharges. Id. at 16. An MRI, performed on March 14, 2001, was normal. Pet. Ex. 24 at 16. A G-band test revealed a normal karyotype. Pet. Ex. 25 at 16. Laboratory studies, however, strongly indicated an underlying mitochondrial disorder. Id. at 4.

Dr. Zimmerman referred CHILD for a neurogenetics consultation to evaluate her abnormal metabolic test results. Pet. Ex. 25 at 8. CHILD met with Dr. Richard Kelley, a specialist in neurogenetics, on May 22, 2001, at the Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILD’s history and lab results were consistent with “an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression.” Id. at 7. He continued to note that children with biochemical profiles similar to CHILD’s develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress. Id. Dr. Kelley described this condition as “mitochondrial PPD.” Id.

On October 4, 2001, Dr. John Schoffner, at Horizon Molecular Medicine in Norcross, Georgia, examined CHILD to assess whether her clinical manifestations were related to a defect in cellular energetics. Pet. Ex. 16 at 26. After reviewing her history, Dr. Schoffner agreed that the previous metabolic testing was “suggestive of a defect in cellular energetics.” Id. Dr. Schoffner recommended a muscle biopsy, genetic testing, metabolic testing, and cell culture based testing. Id. at 36. A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation. Id. at 22. A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three. Id. at 3. The most prominent findings were scattered atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected myofibers, and occasional myofiber with reduced cytochrome c oxidase activity. Id. at 7. After reviewing these laboratory results, Dr. Schoffner diagnosed CHILD with oxidative phosphorylation disease. Id. at 3. In February 2004, a mitochondrial DNA (“mtDNA”) point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C). Id. at 11.

CHILD returned to the Krieger Institute, on July 7, 2004, for a follow-up evaluation with Dr. Zimmerman. Pet. Ex. 57 at 9. He reported CHILD “had done very well” with treatment for a mitochondrial dysfunction. Dr. Zimmerman concluded that CHILD would continue to require services in speech, occupational, physical, and behavioral therapy. Id.

On April 14, 2006, CHILD was brought by ambulance to Athens Regional Hospital and developed a tonic seizure en route. Pet. Ex. 10 at 38. An EEG showed diffuse slowing. Id. At 40. She was diagnosed with having experienced a prolonged complex partial seizure and transferred to Scottish Rite Hospital. Id. at 39, 44. She experienced no more seizures while at Scottish Rite Hospital and was discharged on the medications Trileptal and Diastal. Id. at 44. A follow-up MRI of the brain, on June 16, 2006, was normal with evidence of a left mastoiditis manifested by distortion of the air cells. Id. at 36. An EEG, performed on August 15, 2006, showed “rhythmic epileptiform discharges in the right temporal region and then focal slowing during a witnessed clinical seizure.” Id. At 37. CHILD continues to suffer from a seizure disorder.

ANALYSIS
Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits. After a thorough review, DVIC has concluded that compensation is appropriate in this case.

In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11©(1)©(ii).

DVIC has concluded that CHILD’s complex partial seizure disorder, with an onset of almost six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury.

Respectfully submitted,

PETER D. KEISLER
Assistant Attorney General

TIMOTHY P. GARREN
Director
Torts Branch, Civil Division

MARK W. ROGERS
Deputy Director
Torts Branch, Civil Division

VINCENT J. MATANOSKI
Assistant Director
Torts Branch, Civil Division

s/ Linda S. Renzi by s/ Lynn E. Ricciardella
LINDA S. RENZI
Senior Trial Counsel
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044
(202) 616-4133
DATE: November 9, 2007


UK Web Hosting by 3DPixel.net Wed, February 27th, 2008. 03:21 pm



Wyeth Hopes For HRT Cancer Inducing Comeback
AlterNet
Despite 5,000 Lawsuits, Wyeth Hopes For Hormone Replacement Therapy Comeback
By Martha Rosenberg
February 26, 2008

Selling a product that causes cancer isn't easy, but with help from a U.S. endocrinologist group, Wyeth is again obscuring the truth about HRT.

A reduction in a jury award from $134 million to $58 million for a drug that caused cancer would not normally be cause to rejoice. But it has not been a normal year for hormone maker Wyeth.

The Madison, NJ-based drug company faces 5,300 Prempro- and Premarin-related law suits in addition to the one it just lost -- but with damages reduced -- in Reno, NV brought by three women with breast cancer.

Wyeth had asked Washoe District Judge Robert Perry for a mistrial.

Selling a product that causes cancer isn't easy for Wyeth. In January, the drug giant announced it was selling the one million square-foot Rouses Point, NY plant, where it made its horse-urine derived drugs, and cut fully 10 percent of its work force.

Nor is the Food and Drug Administration (FDA) rubber stamping new drugs from the company which made fenfluramine/phentermine and some say has a "safety second" culture.

Last year it rejected Wyeth's osteoporosis drug, bazedoxifene, because of stroke and blood clot problems, its schizophrenia drug, bifeprunox, because it was not as effective as other drugs on the market and its menopause drug, Pristiq, because of serious heart or liver complications experienced by trial participants.

The FDA is "establishing monopolies" by rejecting drugs just because they're inferior to existing ones, growled outgoing Wyeth CEO Bob Essner when bifeprunox was not approved. After all, the public liked Vioxx and Vytorin just fine, and they weren't better than their predecessors.

No wonder Wyeth lawyers have been browbeating the FDA, successfully it turns out, to regulate pharmacy compounded bioidentical hormones that have unseated its products in many women's medicine chests.

Wyeth is not alone in hoping for an HRT comeback.

Since HRT was found by the Women's Health Initiative in 2002 to cause a 26 percent increased risk of breast cancer, 29 percent increased risk of heart attack, 41 percent increased risk of stroke and 100 percent increased risk of blood clots, a study in the January issue of Cancer Epidemiology, Biomarkers and Prevention found the cancers also move quickly.

Women who took combined estrogen/progestin hormone-replacement therapy for just three years had four times the usual risk of lobular breast cancer, which accounts for about 10 percent of invasive breast cancer.

The effect of millions of HRT users saying, "You want us to take WHAT?" after the WHI study -- 75 percent quit -- was also dramatic. There was an 8.6 percent reduction in overall breast cancer between 2001 and 2004 and 14.7 reduction for estrogen-receptor positive breast cancer.

But "studies" by doctors who don't want to give up the HRT gravy train appear with increasing regularity, promoting results that seek to reverse or spin the WHI findings.

HRT actually protects against heart disease and reduces calcification of the arteries -- two original, disproved HRT selling points -- say the authors of the new crop of "timing hypothesis/therapeutic window of opportunity" analyses, hoping the memory of the American public is as short as their practice's funds without trumped up HRT profits.

Researchers even resuscitated the discredited claim that HRT protects against dementia at a meeting of the American Academy of Neurology last year. And there are rumblings that HRT's ability to lower colon cancer could be of value. (HRT causes breast cancer, heart attack, stroke and blood clots but you might not get colon cancer!)

Of course some doctors have noted the creeping HRT revisionism.

Enthusiasm for the "Yes, but" studies "far exceeds the science" and does not "alter current recommendations that hormone therapy should never be used to prevent heart disease," says Dr. Helen Roberts, senior lecturer in women's health at Auckland University. For one thing, "the risk of stroke was elevated regardless of how many years had elapsed since menopause," she says of the new studies.

But others like the American Association of Clinical Endocrinologists (AACE) have jumped on the HRT bandwagon.

"This is an important and meaningful analysis for women who can benefit from Hormone Replacement Therapy," said Richard Hellman, AACE President about a study which indicated HRT did not elevate cardiovascular disease risk in some women.

And a position paper on the AACE site says, "Given the powerful effects of estrogen therapy in relieving menopausal symptoms, we believe that physicians may safely counsel women to use estrogen for the relief of menopausal symptoms."

Some suggest Wyeth money is behind the AACE position.

After all, Hellman also came out for controversial diabetes drug Avandia when the FDA questioned the drug's safety. "There is still not a good scientific basis for assessing the drug's safety in all patients. But, we can say, if there is an increased risk for a heart attack, it appears to be a relatively small risk," he wrote on the AACE site.

And even though Hellman added the organization has "no financial ties to the company, GlaxoSmithKline that manufactures Avandia," AACE's annual report for 2006-2007 thanks GlaxoSmithKline four times for its financial support.

Wyeth money could help for future court cases.

********************

For Further Information:
HRT: Licensed to Kill and Maim
By Martin J Walker

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UK Web Hosting by 3DPixel.net Wed, February 27th, 2008. 03:18 pm



BADA-UK Lyme Borreliosis Charity Announcement
From BADA-UK

To all "Tick Talk" forum members:

BADA-UK will be launching its revised and more comprehensive website this week.

Unfortunately, due to the sheer volume of spam that we receive, and the ability of spammers to evade the level of forum security that is available to us, we have decided to close the "Tick Talk" forum.

In place of the forum, we will be providing a blog which will be managed by BADA-UK administrators. This will be available as soon as possible from our website www.bada-uk.org. It won't be possible for anyone to post material directly to the blog, but we are happy to receive material for possible inclusion. Additionally, there is a "comment" facility on all the items we post.

We apologise for any inconvenience or disappointment this may cause but the sheer volume of spam has become unmanageable.

We look forward to any of your comments to the blog.

Best wishes

"Tick Talk" Administrator

BADA-UK (Borreliosis & Associated Diseases Awareness UK)
Registered charity No. 1113329 England & Wales
Registered charity No. SC038414 Scotland
Company number 5539748
W: www.bada-uk.org
E: email@bada-uk.org


UK Web Hosting by 3DPixel.net Wed, February 27th, 2008. 03:16 pm



SSRIs Uncontrolled Mass Medical Experiment Finished
See Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration, Irving Kirsch et al, PLoS Med 5(2): e45 doi:10.1371/journal.pmed.0050045

****************

The Press Association
Anti-depressants 'over prescribed'
26 February 2008

Research indicating that new-generation anti-depressants work no better than dummy pills was seized upon as evidence that doctors are over-prescribing.

Mental health campaigners said millions of people with depression were not getting sufficient access to talking therapies due to GPs being over reliant on prescribing drugs such as Prozac.

It follow a review of clinical trials that found that such drugs had no more effect than a placebo for mildly depressed patients and for most people suffering severe depression.

The study showed that even trials suggesting benefit for severely depressed people did not provide evidence of clear clinical benefit, researchers said.

Dr Tim Kendall, deputy director of the Royal College of Psychiatrists Research Unit, said the findings were "fantastically important".

A group of experts, led by Professor Irving Kirsch, from the Department of Psychology at the University of Hull, analysed 47 clinical trials using data released under Freedom of Information rules by the US Food and Drug Administration (FDA).

The researchers looked at four commonly-used anti-depressants and the clinical trials submitted to gain licensing approval.

They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).

They found little evidence of benefit when analysing both unpublished and published data from the drug companies.

Furthermore, the seemingly good results for very severely depressed patients came from the fact a patient's response to the dummy pill decreased rather than any notable increase in their response to antidepressants.

************************

For Further Information:

The Independent - The vested interests that conspire to bury bad news
The Times - Depression drugs don’t work, finds data review
BBC NEWS - Anti-depressants 'of little use'

etc. etc. etc.

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UK Web Hosting by 3DPixel.net Tue, February 26th, 2008. 03:44 pm





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