Mrs. Linda McAvan,
member of the European parliament (MEP),
Labour party, Yorkshire, United Kingdom of Great Britain and Northern Ireland,
rapporteur in (or to) the said parliament
on the new European Union (EU) proposal of directive
on pharmaco-vigilance on human medication
(and another report by Mrs McAvan on pharmaco-vigilance directive 2001/83/EEC)
made this week, on Tuesday 21 September 2010 or so, a speech in or to the said parliament.

The video of the speech is available here (1):
New law to report adverse effects of medicines
21 September 2010
http://news.bbc.co.uk/democracylive/hi/europe/newsid_9016000/9016588.stm

Here’s my transcript of the gist of the speech. Please don’t interpret this transcript as accurate. I have transcribed to the least bad of my inabilities, but I cannot guarantee anything. If my transcript is however not too bad, please feel free to draw my attention to its main errors. Yes, in a couple of days the EU should have the text in the Official Journal or so.

My comments should follow in another post in a couple of days. Basic imbecilities are however already pointed in this transcript between [ & ] 
Of course when I point between [ & ] to an inadequacy of my understanding of the English language, this refers to my own imbecility – thalidomide-induced brain damage.

Now that I’m here, here’s an existing comment of mine:
http://www.tampabay.com/opinion/editorials/dr-frances-oldham-kelsey-shows-the-good-that-government-can-do/1123407#comments
This week, the European Union (EU) introduced legislation, a so-called pharmaco-vigilance directive, to prevent another thalidomide scandal, i.e., the intentional creation by guv’mint of thalidomide monsters like myself.
Pharmaco-vigilance, that’s vigilance against guv’mints intentionally allowing harmful drugs on the market.
The EU parliament argues that we need protection against unsafe drugs and concludes that only guv’mint can provide this protection. The parliament does not show how guv’mint could possibly provide this protection.
Here’s the BBC:
New law to report adverse effects of medicines
21 September 2010
http://news.bbc.co.uk/democracylive/hi/europe/newsid_9016000/9016588.stm
SNIP
MEPs {Members of European Parliament] have given their backing to a tougher rules to increase the amount of information about side effects of medicines.
The so-called Pharmacovigilance directive has already been agreed by the Council of Ministers and the European Parliament’s Public Health Committee.

Here goes McAvan:

Thank You, Mr. President,

I am sure everybody in this room has taken or is taking pharmaceutical products at some time or other.

The safety of those products is of paramount importance for public health.

THALIDOMIDE

Last week, at a meeting of “experts” to talk about this new legislation, we were reminded that 2010 marks the 50th anniversary of thalidomide [Ivo: that’s not true. Thalidomide was marketed since 1957.]

Anybody my age will certainly remember what thalidomide meant. The IMAGES [Ivo’s emphasis] of children born with no limbs.
[Ivo: McAvan was thus at least 14 years old fifty years ago when those images appeared. So now she’s at least (14 + 50 =) 64 years old. She does not look like that.)

Lessons were learnt from that experience (the thalidomide experience) and over the years, governments developed pharmaco-vigilant systems to monitor the safety of medicines because it became clear that clinical trials alone would never be enough to ensure that once we put medicines out there into the public domain, we would know all the side-effects in advance.

Improvements have been made and last week, "experts" told us that with the improvements we have already made, it would have taken only a handful cases of thalidomide to actually identify the problem.

In the 1960-ies, it took 2000 cases before the problem was picked up. {Ivo: Where did she get that information? From the "experts"?]

In recent years in Europe, we have been working at European level to develop a coherent system between member-states and the European Medicines Agency in London on pharmaco-vigilance.

It is very clear that we need to work together, because with a pool of 500 million people, it is much easier and quicker to pick up an adverse reaction than when working alone at national level.

The creation of a medicines agency, a network of agencies in each country, underpinned by EU law, have helped us to make such progress and the practical tools we created, like the EU database, Eudravigilance, the biggest in the world, helps us to reduce the amount of time to identify adverse reactions.

We need further improvements and since thalidomide in the 1960-ies we have seen problems with drugs like Vioxx and very recently, with the diabetes drug Avandia.

I believe that the package of laws that MEPs and the council have agreed, have negotiated in their first reading, put to this house tomorrow is a very good package which will further improve pharmaco-vigilance in the European Union.

THE PRAC

The creation of the PRAC, the Pharmaco-Vigilance Risk Assessment Committee, is one of the key changes of the legislation.
The PRAC will include “experts”, not just of national governments, but also of patients and healthcare professionals.
It is thus a beefed-up committee which settles [and here, in this sentence, which in fact includes also the two previous sentences, Ivo’s English is not good enough to understand McAvan completely] or takes medicine-safety decisions on the basis of the approval of the medicines by its  “experts”.

We’ll be improving information to patients.

Patients will be able to report to national authorities.
There will be a notice on the patient-information leaflet encouraging people to report any adverse reaction.

There will also be a black symbol on new products.

At the moment, healthcare professionals know, when they, as healthcare professionals, give you, as a patient, a new product, that this product has adverse reactions.
You as a patient do not know the adverse reaction.
The healthcare professionals knows [the kind of adverse reactions the patient] should be looking for, but you as a patient do not know.

BETTER PUBLIC INFORMATION

One-stop web portal on medicines bringing together all the different information about medicine safety.

The patient-information leaflet will contain the kind of information you’ve got, at the moment, to spend hours and hours putting together.

For the drug companies, the gains will be in terms of streamlining procedures, cutting duplication of reporting, and the freeing-up of resources for more important research work. [Ivo: The costs for drug companies do not matter for the eurocrats]

These are changes, which, I believe, Mr. President, will vastly improve the whole system of pharmaco- vigilance in Europe.

And finally, I want to thank [some eurocrat colleagues who have enabled to produce this shXX -   blahblahblah]

Transcribed at Siquijor, on 24 September 2010

Ivo Cerckel
honestmoney@maktoob.com

Ivo’s note:

(1)
other press reports, which however do not include the speech, are

EU verschärft die Arzneimittelüberwachung
 22.09.10 | 14:01 Uhr
http://www.ad-hoc-news.de/eu-verschaerft-die-arzneimittelueberwachung–/de/News/21618314
 
Effets secondaires des médicaments: l’UE crée un système d’alerte renforcé
AFP / 22 septembre 2010 12h51
http://www.romandie.com/infos/news2/100922105122.d68ug94k.asp

EU beefs up medicine surveillance rules`
Published: 23 September 2010  The EU is to strengthen its drug monitoring systems and force high-risk medicines to carry a black symbol on their packaging as part of tough new rules passed by MEPs yesterday (22 September)
http://www.euractiv.com/en/health/eu-beefs-medicine-surveillance-rules-news-498049

McAvan own website contains some reference to some only of the drafts of the proposal in this post:
Linda Helps Patients Win New Rights to Information from EU Pharma Deal
22nd September 2010
http://www.lindamcavanmep.org.uk/news/2010/09/22

The Public’s Quiet Savior From Harmful Medicines

By GARDINER HARRIS

Published: September 13, 2010

http://www.nytimes.com/2010/09/14/health/14kelsey.html

SNIP

Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as midwife to modern pharmaceutical regulation.

On Wednesday, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, will honor Dr. Kelsey with the first Kelsey award. It will be given to a F.D.A. staff member annually. The award will come 50 years after Dr. Kelsey, then a new medical officer at the agency, first sat down to consider an application from the William S. Merrell Company of Cincinnati to sell a sedative named Kevadon, which was widely prescribed in Europe for morning sickness in pregnancy.

 

Physician to be honored for historic decision on thalidomide

By Lyndsey Layton

Washington Post Staff Writer

Monday, September 13, 2010; 9:17 PM

http://www.washingtonpost.com/wp-dyn/content/article/2010/09/13/AR2010091306279.html

SNIP

To mark the 50th anniversary of Kelsey’s action, FDA Commissioner Margaret A. Hamburg will present her with the first Kelsey Award on Wednesday, an honor that will be given regularly to an FDA employee to “celebrate courage and scientific decision-making.”

 

 

human testing – updated 15 Sep 2009

http://bphouse.com/honest_money/human-testing/

SNIP

3.
Thalidomide was definitely known in the year 1938 and [its] defects were noted in Phoenix, AZ (USA) in a medical journal that year. It was known as a cure for {Hansen]’s Disease and made by [Richardson]-Merrill Co. in [Cincinnati], OH (USA). I don’t know what action was taken, but a young female doctor named Frances Oldham Kersey (or Kelsey) recognized its dangers. Theodore, Princeton, WV/USA
(reaction under From The Times April 4, 2008 Thalidomide: 50 years on victims unite to seek more compensation Nigel Hawkes, Health Editor
http://www.timesonline.co.uk/tol/news/uk/health/article3671815.ece

 

Kelsey was the lady who in 1960 only joined the US of A Food and Drugs Administration (FDA).

Once there, she further delayed thalidomide’s approval (thalidomide was marketed since 1957)
and was given a Presidential award by US of A president Kennedy for that delay.

 

Wikipedia says
that Kelsey is credited SINCE NINETEEN THIRTY-EIGHT with her interest in teratogens – that is, drugs that cause congenital malformations,
that 1938 was the date of the creation of the FDA,
and that Kelsey managed to be appointed there in 1960
http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey

 

Thalidomide was marketed since 1957.

Kelsey was only appointed in the FDA in 1960.

How can she get (all) the credit for having ‘saved’ the US of A from it?

 

4.
It would be all about (female, I suppose) intuition.

 

The Thalidomide Disaster
Friday, Aug. 10, 1962
http://www.time.com/time/magazine/article/0,9171,873697,00.html
Thanks to the INTUITION of the Food and Drug Administration’s Dr. Frances Kelsey,* the U.S. has got off lightly because the drug was never licensed for general use
+
Her first major assignment was to pass on the application of Cincinnati’s William S. Merrell Co. for a license to market thalidomide in the U.S. under the trade name Kevadon.* Along with the application came a sheaf of reports on years of animal testing and human use of the drug in Europe. There was no hint that the drug had any undesirable side effects, and Merrell pressed hard for quick approval.
+
Though Dr. Kelsey had kept Kevadon off the U.S. market for more than a year, this did not mean that no U.S. doctors were using the drug

 
Ivo:
Kevadon (thalidomide) was marketed in Europe since 1957
  

Kelsey came only to the FDA after the Aptil-May 1960 Duesseldorf Cocgress
 
Merrell Co. waited so long to file its application in US of A.

 
Merrell Co. OR Richardson-Merrill Co.?
(Merrell is with “e” before the double L. Richardson-Merrill is with “i’ before the double L.)
 
We don’t even know who filed the application in 1960.

 

5.
AS I QUOTED ABOVE
Thalidomide was definitely known in the year 1938 and [its] defects were noted in Phoenix, AZ (USA) in a medical journal that year. It was known as a cure for [Hansen]’s Disease and made by [Richardson]-Merrill Co. in [Cincinnati], OH (USA). I don’t know what action was taken, but a young female doctor named Frances Oldham Kersey (or Kelsey) recognized its dangers. Theodore, Princeton, WV/USA
(reaction under From The Times April 4, 2008 Thalidomide: 50 years on victims unite to seek more compensation Nigel Hawkes, Health Editor
http://www.timesonline.co.uk/tol/news/uk/health/article3671815.ece

 
Right, 1937 was ALSO the Elixir Sulfanilamide disaster
BUT look whose name is appearing:

The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication. The Food and Drug Administration was notified, and an extensive search was conducted to recover the distributed medicine. FRANCES OLDHAM KELSEY assisted on a research project, which verified that the excipient DEG was responsible for the fatal adverse effects. At least 100 deaths were blamed on the medication.
http://en.wikipedia.org/wiki/Elixir_Sulfanilamide

 

6.
Look how Kelsey is lying

 

From Tragedy to Triumph:
The Approval of Thalidomide”
by Kristina E. Lutz
http://leda.law.harvard.edu/leda/data/351/Lutz.pdf.
http://72.14.235.132/search?q=cache:mC0RQoulUxYJ:leda.law.harvard.edu/leda/data/351/Lutz.pdf+kevadon+Vick+Chemical&hl=en&ct=clnk&cd=1&gl=uk
SNIP
It was under these auspices that on September 12, 1960, Dr. Kelsey was introduced to Richardson-Merrell’s thalidomide product, Kevadon.
26
At the time of the application’s submission there had not been any reports of problems pertaining to thalidomide.
27
Although it would be later proved that the first thalidomide baby was born on Christmas day, 1956 in Stolberg, Germany,
28
European doctors had yet to make the connection between the horrible birth defects and thalidomide

 

IVO: what about the Duesseldorf 30 April – 1 May 1960 neurological congress?

 

Chronik des Conterganfalls
Tragödie – Katastrophe – Skandal?
http://www.wdr.de/themen/gesundheit/pharmazie/contergan/chronik.jhtml?rubrikenstyle=contergan
30. April/1. Mai 1960:
Auf einem Neurologen-Kongress in Düsseldorf berichtet der Neurologe Ralf Voss über die Nervenschädigungen, die seinen
Beobachtungen zufolge durch Thalidomid verursacht werden. Die Forschungsabteilung von Grünenthal versucht daraufhin, die Nervenschädigungen an Ratten zu reproduzieren – ohne Erfolg. Grünenthal-Forschungsleiter Mückter schließt daraus, dass es sich um besondere Situationen handelt, für die Contergan nur selten als Ursache infrage kommt.

 

Fraus omnia corrumpit, fraud negates everything

 

And in 1997, Kelsey advocated the re-introduction of thalidomide
http://www.berlinonline.de/berliner-zeitung/archiv/.bin/dump.fcgi/1997/0926/none/0016/index.html
Ausgerechnet Frances Kelsey, die vor 37 Jahren das Contergan-Verbot durchsetzte, begründete nun die Wiedereinführung des Produkts in den Vereinigten Staaten.

 
Is this a joke?
 
The first drug [Kelsey] was asked to evaluate [at the FDA] was thalidomide,
http://www.chemistryexplained.com/Hy-Kr/Kelsey-Frances-Kathleen-Oldham.html
In 1960 the Kelseys moved to Washington, D.C., where Frances was offered a job at the Food and Drug Administration (FDA). Her job was to evaluate applications from drug companies that wished to market new drugs. She had sixty days to evaluate each application. The first drug she was asked to evaluate was thalidomide, a sedative prescribed to pregnant women for relief from morning sickness.

 

Ivo Cerckel

honestmoney@maktoob.com

Le quotidien La Dernière Heure annonçait le 1er septembre 2010 que treize monstres softenon, représentés par l’avocat bruxellois Jean-Paul Tieleman, ont assigné l’état belge au tribunal de Bruxelles pour que l’état belge soit condamné à leur verser à chacun un dédommagement de 5 millions d’euro(s) pour le dommage qu’ils subissent toujours suite au fait que leur mère a avalé de la thalidomide, commercialisée en Belgique sous le nom de  « softenon ». (1)

 

Selon ce que La Dernière Heure écrit, la citation se baserait sur deux éléments :

Un, la mise en vente libre du truc sans dispositif de protection de l’utilisateur.

Deux, l’Ennemi, l’état fédéral de Belgique,  n’aurait reconnu sa responsabilité que récemment.

 

Commençons par le second élément.

 

Monsieur l’Avocat Jean-Paul Tieleman était très fier début mars 2010 de pouvoir annoncer à la télévision sur RTL.info que l’état belge reconnaissait sa responsabilité. (2)

 

Dans son commentaire écrit le 2010-03-03 11:38:03 Anonyme 247094 a écrit :

-J. Custers, le ministre belge de la santé (publique), écrivit (Le Soir, 14 juin 1962. p.3 ?) “le peuple [Ivo : non, pas le peuple, mais l'état, belge] a failli à ses devoirs les plus élémentaires. Il n’a plus qu’à s’en aller”. (Ivo : ça veut dire BUITEN, DEHORS) Les sujets belges se demandèrent pourquoi les irresponsables, les ?responsables? pour Janicki, de la santé en Belgique n’avertirent pas aussitôt la population, par tous les moyens de diffusion, presse, radio, télévision, affiches. (Jérôme Janicki ?Le drame de la thalidomide – Un médicament sans frontières – 1956-2009?, Paris, L’Harmattan, 2009, p. 166). Et cinquante ans plus tard que dit Madame Onkelinx ? Elle ne fait que répéter ce que Custers disait : l’état belge est une crapule. Et entretemps, il n’est rien passé, Et Monsieur l’Avocat Tieleman est très fier d’avoir obtenu cette déclaration de Onkelinx qui ne fait que reproduire celle de Custers. Écraser les gouvernements (les politiciens, les fonctionnaires, les allocataires sociaux (et familiaux) et les avocats – sauf mon avocat) ! C’est pour [cela] que j’ai dû fuir l’Europe il y a dix ans. Sinon, je serais mort car ruiné. (3)

 

Maitre Tieleman se moque de qui par son second élément?

 

Par son premier élément, Maître Tieleman reproche à l’Ennemi,

qui obtient ses revenus par l’impôt

alors que le voleur ne revient périodiquement

ni ne prétend voler dans l’intérêt général,

d’avoir mis le truc en vente libre sans dispositif de protection de l’utilisateur.

 

Commençons par les faits.

 

L’Ennemi a autorisé le truc sur “son” marché fin des années 1950.

 

Ainsi que qu’Anonyme 247094 a écrit le 2010-03-03 09:58:55

en réponse à la question de Jappy, écrite le 2010-03-03 09:35:45 :

Juste une question, pourquoi seulement maintenant ?:

 

Jappy, parce [que] cela ne fait que deux ans que je suis au courant du fait que lors d’un congrès de neurologie à Düsseldorf, les 30 avril et 1er mai 1960, le neurologue Ralf Voss sonne l’alarme à la thalidomide. Et qu’en dépit de ce message d’alarme, les fonctionnaires qui avaient autorisé la thalidomide sur les marchés n’en n’ont pas conclu qu’ils devaient la retirer. Il faudra donc que son fabricant, la Chemie Grünenthal GmbH à Stolberg, Aix-la-Chapelle, prenne dix-huit mois plus tard l’initiative de ce retrait le 27 novembre 1961. Je suis né en février 1962. Mon père est médecin, mais la petite Corinne dont les meurtriers se sont fait(s) acquitter à Liège devait naitre en … mai 1962. Et les Belgicains d’applaudir l’acquittement (en 1962). (3, également)

 

Voici la source (4).

 

Le 10 avril 2010, le quotidien Le Monde annonçait que la thalidomide a été retirée du marché en décembre 1961 et que DEUX ANS auparavant, plusieurs médecins allemands signalent des cas de polynévrites (douleurs, sensations de brûlures, troubles vasculaires dans les membres), qu’ils relient à un usage prolongé du Contergan. (5)

 

L’alerte aurait donc déjà été sonnée deux ans avant décembre 1961, c’est-à-dire en décembre 1959.

 

L’Ennemi n’a pas réagi.

 

Les femmes enceintes de Bruxelles et Wallonie n’ont pas compris.

 

Je suis apparemment le seul monstre softenon flamand (survivant).

 

Tout ceci ne fait que confirmer :

Le gouvernement aurait dû mettre mon père Henri Cerckel (*), docteur en médecine, en taule lors de ma naissance en février 1962, c’est-à-dire vingt mois après l’alerte softenon de mai 1960. Mais l’état-providence ne pouvait pas accepter cette mise en taule parce que Corinne devait naître trois mois plus tard, en mai 1962, à Liège et ses meurtriers devaient être acquittés.

(*) Hendrik Cerckel sur http://www.infobel.be depuis que j’ai connaissance de l’alerte softenon de mai 1960. (6)

 

rappel :

Mes parents ont passé leur voyage de noces à bord du yacht, amarré en Méditerranée, de mon grand-père paternel. Ce grand-père y trouva plus tard de la thalidomide. S’il l’a trouvée, c’est probablement qu’elle y avait été cachée, mon père l’ayant administré à ma mère à son insu et ne se rappelant plus ensuite en avoir laissé. (7)

 

Ivo Cerckel

honestmoney@maktoob.com

 

NOTES

 

(1)

Softenon: 13 victimes assignent l’Etat belge(01/09/2010)

http://www.dhnet.be/infos/societe/article/323518/softenon-13-victimes-assignent-l-etat-belge.html

 

(2)

Bébés “softenon”: des victimes veulent être indemnisées par l’Etat belge

 2 mar

http://www.rtlinfo.be/info/archive/310914/bebes–softenon–des-victimes-veulent-etre-indemnisees-par-l-etat-belge/?&archiveYear=2010

 

(3)

RTLinfo – Aperçu des commentaires du 3 Mars 2010

 Bébés “softenon”: des victimes veulent être indemnisées par l’Etat belge

http://www.rtlinfo.be/others/widgets/map/commentaires.php?m=3&y=2010&d=3

 

(4)

Chronik des Contergan-Skandals – Contergan – WDR.de

Chronik des Conterganfalls

Tragödie – Katastrophe – Skandal?

http://www.wdr.de/themen/gesundheit/pharmazie/contergan/chronik.jhtml

EXTRAIT

30. April/1. Mai 1960:

Auf einem Neurologen-Kongress in Düsseldorf berichtet der Neurologe Ralf

Voss über die Nervenschädigungen, die seinen Beobachtungen zufolge durch

Thalidomid verursacht werden. Die Forschungsabteilung von Grünenthal

versucht daraufhin, die Nervenschädigungen an Ratten zu reproduzieren – ohne Erfolg. Grünenthal-Forschungsleiter Mückter schließt daraus, dass es sich um besondere Situationen handelt, für die Contergan nur selten als Ursache infrage kommt.

 

(5)

Un scandale qui a renforcé la pharmacovigilance

09.04.10 | 15h58  •  Mis à jour le 09.04.10 | 15h58
http://www.lemonde.fr/planete/article/2010/04/09/un-scandale-qui-a-renforce-la-pharmacovigilance_1331285_3244.html

http://aujourlejour.midiblogs.com/archive/2010/04/09/thalidomide-un-scandale-qui-a-renforce-la-pharmacovigilance.html

EXTRAITS

En décembre 1961, […] la Chemie Grünenthal, qui commercialisait avec un grand succès depuis 1957 la molécule sous le nom de Contergan, ordonne son retrait […]

Deux ans auparavant, plusieurs médecins allemands signalent des cas de polynévrites (douleurs, sensations de brûlures, troubles vasculaires dans les membres), qu’ils relient à un usage prolongé du Contergan. A l’automne 1961, des obstétriciens et pédiatres allemands s’inquiètent d’une augmentation du nombre d’anomalies des membres – allant de l’absence d’un doigt à une malformation complète du membre – et du tube digestif chez des nouveau-nés.

 

(6)

Het Belgisch goevernement had mijn vader, Henri Cerckel (*), doktoor in de geneeskunde,

in de bak moeten steken toen ik geboren werd in februari 1962, da’s twintig maanden na het softenonalarm van mei 1960. Maar dat mocht niet van de welvaartsstaat omdat Corinne drie maand later, in mei 1962, diende geboren in Luik en haar moordenaars dienden vrijgesproken.

(*) Hendrik Cerckel op  http://www.infobel.be sinds ik weet heb van het softenonalarm van mei 1960

 

(7)

Témoignage thalidomide – Les Monstres de Heidelberg

Originally posted by Ivo Cerckel on September 2nd, 2009

http://bphouse.com/honest_money/etat-belge-assassin-softenon