Arzneimittelprüfer Sawicki erhält keinen neuen Vertrag

Liebe Leser,

sie haben sicherlich auch schon davon gehört, dass der Leiter des IQWiG, Peter Sawitzki, keien neuen vertrag bekommt und im August gehen muss. Es ist viel die rede von politischer Einflußnahme durch die Politiker der FDP, die ihrer Klientel eien lästigen Kritiker vom Hals schaffen will. Da stellt sich nach dem Skandal der Steuererleichterungen für die Hoteliers und der Spende eines prominenten Hotelunternehmers die Frage, wieviel die Pharmaindustrie wohl der FDP gespendet hat?

Wie ist eure Meinung dazu? Lesen sie dazu den folgenden Bericht aus Stern.de (http://www.stern.de/gesundheit/iqwig-chef-sawicki-ein-opfer-der-pharmalobby-1537740.html)



Ein Opfer der Pharmalobby

Er ist der Schrecken der Pharmaindustrie: Peter Sawicki, Leiter des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Heute hat der Stiftungsrat beschlossen, dass er Ende August seinen Hut nehmen muss. Ein Lehrstück in Sachen Lobbyismus. Von Lea Wolz, Lutz Kinkel und Nina Bublitz.





Als Pharmakritiker hat er viele Feinde. Nun ist er offiziell über eine "Dienstwagenaffäre" gestolpert: Peter Sawicki, der Leiter des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Iqwig), muss gehen. Der Vertrag des 52-jährigen Wissenschaftlers laufe zum 31. August aus, teilten Vorstand und Stiftungsrat des Instituts am Freitag in Berlin mit. Er hätte zwar gerne noch weitergemacht, höre aber zum 31. August auf, sagte Sawicki.





Für den Verbraucherschutz ist das eine deutliche Niederlage, die Pharmaindustrie dürfte dagegen jubeln. Sawicki, der das Iqwig seit 2004 leitet, war wegen seiner pharmakritischen Haltung bei den Arzneimittelherstellern von Anfang an heftig umstritten. Auch in der industrienahen schwarz-gelben Koalition hatte er wenig Freunde. Schon im Koalitionsvertrag sprachen sich die Fraktionen von Union und FDP dafür aus, die Arbeit des Instituts zu überprüfen - und es industriefreundlicher auszurichten. Künftig soll es stärker die Interessen der Pharmaindustrie und die Erfahrung der Ärzte in den Krankenhäusern berücksichtigen. Kurz gesagt: Es scheint so, als habe die schwarz-gelbe Regierung mit dem Fall Sawicki ein weiteres Lehrstück ihrer Klientelpolitik gegeben. Nutznießer dieses Krimis um einen der letzten unbestechlichen Kritiker der Arzneimittelindustrie ist eben diese.


Ein Dorn im Auge der Pharmaindustrie
Den Arzneimittelherstellern ist das Iqwig schon seit seiner Gründung im Zuge der Gesundheitsreform 2004 ein Dorn im Auge. Denn mit Pseudoinnovationen, die das Budget der Krankenkassen belasten, dem Patienten aber wenig bringen, lässt sich viel Geld aus dem Gesundheitssystem ziehen. Um dem entgegenzutreten, prüft das Iqwig Studien zu Arzneimitteln und untersucht als "Medikamenten-TÜV", ob Therapien und die oft teuren Medikamente auch nützlich sind. Andernfalls können sie aus dem Leistungskatalog der Krankenkassen gestrichen werden. Für einen Hersteller kann das Verluste in mehrstelliger Millionenhöhe bedeuten.
So machte sich das Institut bei der Pharmaindustrie wenig beliebt, als es entschied, dass Analoginsuline nicht besser sind als herkömmliches Humaninsulin. Stattdessen warnten die Medikamentenprüfer immer wieder vor Nebenwirkungen. Im Juni 2009 stellte das Iqwig fest, dass ein künstliches Insulin bei Diabetikern sogar Krebs auslösen könnte. Auch das Medikament Memamtin, das bei Alzheimer verordnet wird, fand nicht den Segen der Arzneimittelprüfer. Ein Beleg für den Nutzen fehle, hieß es aus dem Iqwig. Wer so handelt, macht sich viele Feinde - und sollte sich daher besser nach allen Seiten absichern.
Mächtigster Pharmakritiker stürzt über Benzin für den Rasenmäher
Offiziell ist der 52-jährige Sawicki mit den grau gewellten Haaren und den feinen Gesichtszügen nun allerdings über sein Auslagengebaren gestolpert. Unter anderem hat sich der harte Pharmakritiker durch den Abschluss von zwei Leasing-Verträgen für Dienstwagen angreifbar gemacht, da er zuvor den Vorstand nicht informiert hatte. Sawicki wies die Vorwürfe zurück. Ein von ihm in Auftrag gegebenes Rechtsgutachten kommt ebenfalls zu dem Schluss, dass er mit den geleasten Fahrzeugen - einem Audi Q7 und einem Audi Q5 - nicht gegen seinen Dienstvertrag verstoßen habe. Sawickis Dienstwagen hätten stets ordnungsgemäß im Haushaltsplan des Iqwig gestanden. Die Vorstandsmitglieder und der Stiftungsrat waren mithin darüber informiert.
Daneben wird dem Leiter des Iqwig vorgeworfen, sich auch bei einzelnen privaten Abrechnungen in einer Höhe von insgesamt knapp 1200 Euro - unter anderem für Rasenmäher-Benzin, Maut- und Parkgebühren - regelwidrig verhalten zu haben. 2007 stand Sawicki bereits in der Kritik, da er als Chef des Iqwig an das private Institut seiner Frau einen Auftrag vergeben hatte. Allerdings gab es auch Beschwerden, das Iqwig sei nicht effizient und arbeite wissenschaftlich ungenau.





"Kritische Arzneimittelbewertung wird geschwächt"
"Die Entscheidung, Sawicki zu entlassen, ist eindeutig politisch motiviert", sagt der Herausgeber des pharmakritischen "Arznei-Telegramms", Wolfgang Becker-Brüser zu stern.de. Die kritische Arzneimittelbeurteilung werde dadurch entscheidend geschwächt. "Sawicki hat sich bei seiner Beurteilung von Medikamenten immer auf wissenschaftliche Studien gestützt und sich nicht auf einen Handel mit den Pharmafirmen eingelassen", meint der Pharmazeut und Arzt. Bei der sogenannten evidenzbasierten Medizin muss ein Medikament in randomisierten und kontrollierten klinischen Studien beweisen, dass es besser ist als die bereits erhältlichen. Nun werde wohl ein industriefreundlicherer Kandidat den Posten erhalten, befürchtet Becker-Brüser. Zum Schaden der Verbraucher: "Langfristig treibt das die Krankenkassenbeiträge wieder hoch."





Auch international findet der Fall Sawicki Beachtung. Das renommierte Wissenschaftsmagazin "Science" berichtet in der aktuellen Ausgabe über die Entscheidung, die zu Druckschluss noch nicht gefallen war. Zu Wort kommt Gerd Antes, Direktor des deutschen Cochrane-Zentrums, der meint, dass Sawickis Ausscheiden die Arbeit des Iqwig untergraben würde. Es sei Teil einer politischen Strategie, die strengen Verfahren bei neuen Medikamenten und Medizinprodukten zu lockern.

Vorwürfe "lächerlich" und "vorgeschoben"
Auch SPD, Grüne und Linke warnen, durch die Ablösung solle der Einfluss der Pharmaindustrie wachsen. Die Vorwürfe an Sawicki hinsichtlich der Amtsführung seien "lächerlich" und "vorgeschoben", sagte der SPD-Gesundheitsexperte Karl Lauterbach zu stern.de. Es sei von Anfang an klar gewesen, dass Union und FDP dass Institut nicht nach den Regeln der evidenzbasierten Medizin laufen lassen wollten. "Sawicki war für die Neuausrichtung des Instituts der falsche Mann. Deswegen musste er entsorgt werden", kritisiert Lauterbach.
Bei den Grünen sieht man das ähnlich: "Es ist schäbig, Sawicki über die Spesenabrechnung loswerden zu wollen. Weil es klar ist, dass der Hintergrund ein anderer ist, nämlich ein politischer: Man will einen Pharmakritiker kaltstellen", sagte Birgitt Bender, gesundheitspolitische Sprecherin der Grünen, zu stern.de. "Wenn durch diese Personalentscheidung die Arbeit des Instituts weichgespült werden soll, werden das die Versicherten teuer bezahlen. Denn dann würden Mondpreise für Medikamente mit wenig Nutzen verlangt und die falschen Anreize für die Pharmaindustrie gesetzt." Die gesundheitspolitische Sprecherin der Linksfraktion, Martina Bunge, erklärte, mit der Entscheidung würden "alle enttäuscht, die sich ein unabhängiges Gegengewicht zur Übermacht der Pharmakonzerne wünschen".
Vorwürfen, die Arzneiprüfungen lockern zu wollen ist die Bundesregierung bereits entgegengetreten. Das Iqwig leiste eine notwendige und gute Arbeit, sagte Gesundheitsstaatssekretär Stefan Kapferer. "Eine Lockerung der Prüfregeln soll es nicht geben." Für den Posten als neuer Chef des Iqwig ist stern.de-Informationen zufolge unter anderem Leo Hansen von der Kassenärztlichen Vereinigung Nordrhein im Gespräch.

Peter Rost Gets A Little Help From The Government

This Blog is from Ed Silvermann from Pharmalot.

For those who may not remember, Peter Rost is the controversial gadfly and former Pfizer exec who is locked in a whistleblower lawsuit with the big drugmaker over his allegations that Genotropin, a human growth hormone, was marketed for unapproved uses, such as combating aging in adults and treating short stature in children. Rost worked for Pharmacia, which was bought by Pfizer.

Although the US Justice Department failed to join his lawsuit, Rost is pressing on and his case is being closely watched. Last year, he cited numerous instances in Indiana and Kentucky in which Genotropin marketing may have violated the False Claims Act. Providing such detail was needed for the case to proceed and his efforts may serve as a template for other whistleblowers who are stymied by federal judges seeking details that are very hard to come by.

Rost showed that is possible to clear rule 9b of the False Claims Act, which refers to fraud claims with “sufficient specificity,” another way of saying a whistleblower must provide very specific info about false claims a drugmaker submitted to the government for payment. This may include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing, a level of detail that can be very hard to obtain, given patient privacy laws such as HIPAA.

Pfizer has repeatedly moved to dismiss the case, but yesterday the Justice Department filed an amicus brief, stating it “remains a real party interest” in the litigation, even though it chose not to intervene. The reason for its brief was, essentially, to shoot down Pfizer’s interpretation of the Medicaid Act and the False Claims Act. “The United States has a keen interest in the development of the law in this area and in the correct application of the law in this, and similar, cases,” the DOJ writes. In doing so, the government gave Rost a lift, even with a caveat that no position was taken on the merits of his claims (here is the brief).

In explaining its views, the DOJ argues that “summary judgment should not be granted simply because someone other than the defendant submitted the false claims, a prior authorization scheme existed, or physicians deny that they were influenced by kickbacks.” The DOJ also contends that circumstantial evidence is sufficient to prove that the False Claims Act can be violated.

The DOJ rejects several Pfizer arguments. For instance, the DOJ writes that “…the fact that Pharmacia may have caused false claims to be submitted through the actions of pharmacists is irrelevant. As long as the submission of the false claims was the foreseeable result of its illegal kickbacks, it has caused the submission of false claims and is liable under the FCA.”

Pfizer has been arguing that Rost’s lawsuit should be tossed because the drugmaker itself had not submitted any claims to Medicaid that could be construed as false and Genotropin was already listed under state prior authorization programs, among other things.

 

For those who may not remember, Peter Rost is the controversial gadfly and former Pfizer exec who is locked in a whistleblower lawsuit with the big drugmaker over his allegations that Genotropin, a human growth hormone, was marketed for unapproved uses, such as combating aging in adults and treating short stature in children. Rost worked for Pharmacia, which was bought by Pfizer.

Although the US Justice Department failed to join his lawsuit, Rost is pressing on and his case is being closely watched. Last year, he cited numerous instances in Indiana and Kentucky in which Genotropin marketing may have violated the False Claims Act. Providing such detail was needed for the case to proceed and his efforts may serve as a template for other whistleblowers who are stymied by federal judges seeking details that are very hard to come by.

Rost showed that is possible to clear rule 9b of the False Claims Act, which refers to fraud claims with “sufficient specificity,” another way of saying a whistleblower must provide very specific info about false claims a drugmaker submitted to the government for payment. This may include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing, a level of detail that can be very hard to obtain, given patient privacy laws such as HIPAA.

Pfizer has repeatedly moved to dismiss the case, but yesterday the Justice Department filed an amicus brief, stating it “remains a real party interest” in the litigation, even though it chose not to intervene. The reason for its brief was, essentially, to shoot down Pfizer’s interpretation of the Medicaid Act and the False Claims Act. “The United States has a keen interest in the development of the law in this area and in the correct application of the law in this, and similar, cases,” the DOJ writes. In doing so, the government gave Rost a lift, even with a caveat that no position was taken on the merits of his claims (here is the brief).

In explaining its views, the DOJ argues that “summary judgment should not be granted simply because someone other than the defendant submitted the false claims, a prior authorization scheme existed, or physicians deny that they were influenced by kickbacks.” The DOJ also contends that circumstantial evidence is sufficient to prove that the False Claims Act can be violated.

The DOJ rejects several Pfizer arguments. For instance, the DOJ writes that “…the fact that Pharmacia may have caused false claims to be submitted through the actions of pharmacists is irrelevant. As long as the submission of the false claims was the foreseeable result of its illegal kickbacks, it has caused the submission of false claims and is liable under the FCA.”

Pfizer has been arguing that Rost’s lawsuit should be tossed because the drugmaker itself had not submitted any claims to Medicaid that could be construed as false and Genotropin was already listed under state prior authorization programs, among other things.

 

Codes R not us.

• December 25th, 2009
• 5:10 pm
• Link to this comment

American way of life is something else, that includes your justice system and everything else. That is why things change so slowely and with such pain. Look at Obama’s noble goal to give everyone health care in the richest country in the world, how dificult the process is. Here we have a company Pfizer that already paid $2.300.000.000.00 in fines for doing all kinds of illegal stuff for years, including offlabel promo (their routine way to make extra $$) and the DOJ is not going after them on this one. They did it for sure so what is the problem? We all hope Peter wins. Yes he deserves it as much as the other successful WBers.

Pfizer und das FBI

Liebe Leser,

wenn sie mehr über die Ermittlungen des FBI gegen Pfizer wegen der illegalen Vermarktung von Bextra und Celebrex erfahren wollen und die 2,3 Mrd. Strafzahlung an die US Regierung, so sollten sie hier mal nachschauen :http://www.fbi.gov/page2/sept09/pfizer_settlement_090209.html

http://www.fbi.gov/inside/archive/inside090309.htm

Pfizers secret Files , Risk of SUICIDE was evident when Zoloft was registered in Germany

 

Dear Mr. Herxheimer,

you may remember that  3 years ago you accompanied me and Prof. Müller-Oerlinghausen when we visited the Europeam Medical Agency EMEA to read some documents on SSRI antidepressants.

After more than three years I succeeded to get access to the files regarding the registration of Zoloft in Germany at the german regulatory agency BfArM.

My lawyer, Prof. Müller-Oerlinghausen from the Drug Commission of the German Medical Association and I have looked into the files of the german medical authorities and have found documents proving my claim, that the increased risk of suicide was evident when ZOLOFT was registered in Germany in 1996. The data from all clinical trials show that the rate of suicide among the patients taking sertraline was statistically significant higher than among the patients getting placebos or a different antidepressant. Also the death rate in the sertraline group was significantly higher. But the german expert ignored the data and claimed instead that sertraline even reduces the risk of suicide.

I hesitated for some time to give the documents to the press and to the public because the german authorites did not allow me to give them to anybody. But the public has a right to know the facts! The crucial pages are page 50 to 53 of the expert report (page 1-3 of the file Gutachten_1995_03.pdf) and the tables of the listing of all deaths. They show that until 1.sept. 1993  16940 patients taking part in medical studies took sertraline and 0.09% (=15 patients) were suicidal. In the control group of 9016 patients only 0.02% were suicidal (=2 patients). This diffenence ist statistically significant with more than 99 percent probability!

The tables show that among the 46 deaths of all clinical trials 34 patients had taken sertraline and among them 10 committed suicide (9 official suicides and one patients poisioned himself with carbon-monoxide). In the control group only one patient committed suicide.

All these data were ignored by the german expert, a very prominent german psychiatrist, who has written the report. Instead he claimed that Zoloft even reduces the risk of suicide. This report was the medical basis for the german medical agency to approve Zoloft in germany in 1996.

I will keep you informed.

best regards,

Lothar Schröder

Frontal21 German TV-Documentary: Big Pharma SSRI Marketing Push

On Tuesday, December 9, German TV ZDF will broadcast a hard hitting documentary about corrupt pharmaceutical company practices.One issue that will be addressed for the first time is: Why did the German drug regulatory agency (BGA) approve Prozac in 1991 after denying Eli Lilly the license to market the drug in Germany in 1984 without explicit label warnings about the increased suicide risk the drug poses ? May 25, 1984 Internal memorandum from Eli Lilly regarding the company's efforts to obtain a marketing license for Prozac in Germany states: "During the treatment with the preparation [fluoxetine] 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sence (sic) of an deterioration of the clinical condition, which reached its lowest point." [PZ281]Furthermore, Lilly's own documents reveal that a 1988 review of clinical trials found that 38% of patients taking Prozac compared to 19% of patients on placebo experienced "activation," which is linked by the FDA in current labeling to violent and suicidal behavior. [PZ-477] . See: Eli Lilly internal documents: What do They Reveal? [http://www.ahrp.org/infomail/05/01/27.php]BZ281: Lilly Memo, Keitz; Bad Homburg to Corporate Headquarters, May 25, 1984, with Comment on Clinical Documentation Fluoxetine from BGA (Germany) rejecting Prozac for marketing.PZ-477: Lilly Memo. Activation and Sedation in Fluoxetine Clinical Trials, 1988See: Lenzer, J. FDA to Review "Missing" Drug Company Documents, BMJ (formerly British Medical Journal), January 1, 2005. [http://bmj.bmjjournals.com/cgi/content/full/330/7481/7]
























From: Lothar Schröder
Sent: Saturday, December 06, 2008 6:32
AMTo: Veracare

Subject: German TV-Documentary on SSRI and psychotopic Drugs

Dear Vera,

Since the death of my wife I am trying to inform the German public about the risk and dangers of SSRI-antidepressants. My wife took ZOLOFT 3 years ago for only 11 days. Two days before her death the medication was stopped abruptly. A few months after her death the European Commission made it mandatory for European license holder of SSRI- antidepressants to include a warning about the risk of suicide for children and adolescents in the product information and package insert. Before it, the risk of suicide was not even listed in the product information and package insert.I have tried to press criminal charges against Pfizer but the German courts have put it down. I have also informed the media about it. Now next Tuesday (09. December 2008, 21:00 hour German time on ZDF) the German TV ZDF will broadcast a documentary about the criminal practices by the big pharmacy companies to press the SSRI antidepressant to the European market. The German regulatory agency BGA (Bundesgesundheitsamt) knew about the risk of suicide of the SSRI Prozac and refused to admit it to the German market: first in 1985 and then 3 years later in 1988. But finally Prozac was admitted to the German market in 1991. Zoloft and the other SSRI antidepressants followed. Last Tuesday, Frontal 21 has broadcast a 6-minute long report about Prozac and Zoloft (see: [http://frontal21.zdf.de/ZDFde/inhalt/19/0,1872,7486227,00.html] ). I hope that this report and the documentary will put real pressure on our politicians and on our regulatory agency. Why was Prozac approved in 1991 although the german BGA knew about the risk of suicide since 1984? Maybe you want to inform the readers of your infomail - I am one of them for many years- and in your blog about the documentary. It will be seen in all German speaking countries in Europe. Thank you very much.

Best regards,

Lothar Schröder

Prozac and the BGA - how a killer drug was registered in Germany

The story of the SSRI antidepressants began in the eighties with the new "wonder drug" Prozac. It was aggressively marketed as more effective and safer than the old antidepressants. Prominent people like Woody Allen praised it and books were published telling the readers about its positive effects.
Soon after Prozac was registered in 1987 it was a blockbuster selling like mad. But only a few years later some doctors and scientists reported strange side effects: some patients became violent or suicidal after taking Prozac. One of the first scientific articles was by Teicher (1991). But despite these early reports Prozac was admitted by the regulatory agencies in other countries too. This is well known by now. But what is not known or some people in high places don’t want to hear is that at least in some countries the regulatory agencies had serious doubts right from the beginning. They were not convinced about the efficacy of the drug Prozac and had concerns about the side effects, especially the risk of suicide.
One case in point is Germany and the German regulatory agency, the Bundesgesundheitsamt (or BGA for short). When Eli Lilly applied for registration of Prozac in the early eighties the BGA had doubts about the efficacy of Prozac ( german name: Fluctin) and was concerned about the suicide risk. In a fax from 25th May 1984 to the headquarter in Indianapolis the BGA expressed the following concerns
(see http://www.baumhedlundlaw.com/01.pdf ) :

“…The frequency of side-effects was very high (partly more than 90%) and the side-effects resulted nearly in each study in dropouts. The frequency of side-effects depended on dose, the age and the duration of therapy. Deciding for the clinical significance of side-effects is not only the frequency of their occurrence but also their severity…”

“… In 15-20% of cases side-effects occur, which involve the central nervous system. As most of them resemble the clinical picture of the underlying disease, even from theoretical reasons one has to expect an intensification and not improvement of symptoms…”

“… During the treatment with the preparation 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sense of a deterioration of the clinical condition, which reached its lowest point….

In the summary of the fax, the BGA notes:

“… Considering the benefit and the risk, we think this preparation (Prozac) totally unsuitable for the treatment of depression…”.

In June 1984 the BGA told Eli Lilly which additional data are necessary to decide about the application for registration of Prozac (see: http://www.baumhedlundlaw.com/02.pdf) :

“… As we already explained by our telex to Dr. Zerbe of June 8, 84 we need a careful analysis of suicide and suicide attempts: patient by patient, syptomatology/severity upon entry into the study and week by week until the event occurred, dose of fluoxetine, side-effects, etc.
This is a very serious issue in the opinion of the BGA. It might well be that we will have to recommend concomitant tranquilizer intake for the first 2 or 3 weeks in the package literature…”

Not surprisingly the application for registration was denied by the BGA in 1985. In a letter from Berlin to Eli Lilly in Indianapolis dated 26.02.1985 we can read the reasons (see http://www.baumhedlundlaw.com/04.pdf) :

“… 2. For the drug concerned there is according to their specific profile of adverse effects the justified suspicion, that they have unacceptable damaging effects (§ 25 par. 2 No. 5 AMG).
2.1. The use of the preparation seems objectionable, as the increase in agitation effects occurs earlier than the mood alleviating effect and therefore an increased risk of suicide exist…”

In April 1986 the BGA was still not convinced that Prozac is safe and effective (see: http://www.baumhedlundlaw.com/06.pdf ):

“… Still not resolved is the fact that suicide attempts have been observed more frequently on fluoxetine as compared to imipramine (only epidemiologic data or literature on other antidepressants may help to identify, wether it happened by chance that incidence of suicide attempts was abnormally high on fluoxetine, or abnormally low under comparators)…”


Eli Lilly has written a report in 1986 on all the data on suicide for the BGA (see: http://www.healyprozac.com/Trials/CriticalDocs/badhom030890.htm) and this report was submitted to the BGA in December 1986.

But in 1988 the application for registration of Prozac was rejected a second time by the BGA.

But then mysteriously in 1991 the BGA admitted Prozac for the treatment of depression despite all previous concerns. What has happened? Have critical people at the BGA been intimidated or fired? Or has money been paid to get Prozac registered in Germany?

I have written to our German ministry of health and to the German regulatory agency BfArM about the early doubts of the BGA about Prozac and ask them for an explanation. Why was it approved despite these early health concerns? The ministry has remained silent on that subject and I am still waiting for an answer.

To be continued...

Side Effect Death by John Virapen

This book by the Ex Eli Lilly manger John Virapen is the first time that someone who has worked for the pharmaceutical industry tells the story about Prozac and the other SSRI antidepressants.

It has been published in Germany some weeks ago and will soon be realeased in Sweden.

John Mack (see : http://www.talk.pharma-mkting.com/show038.htm ) writes about this book:

John Virapen is now retired, after working more than 30 years in the pharma industry internationally. He haas worked at the executive level for some major companies such as Eli Lilly and Novo Nordisk. His career started in Sweden where he was Managing Director for Eli Lilly Sweden AB. Virapen now lives in Germany.
Last year Virapen published a fictional novel (written in German) about corruption in the pharma industry, which created some debate. He was urged by the public to tell the true story and has now written a book of memoirs primarily outlining the criminal activities he was involved in during his active years.
The Big Fish here is Eli Lilly. A few months ago Virapen was invited by Andy Vickery, a prominent US attorney, as a fact witness in an ongoing case regarding Prozac. Virapen claims to have "damning evidence" exposing Eli Lilly bribing the regulatory board in Sweden to attain marketing approval for Prozac.

I have read this book already and it is really worth reading. John told me today that he is also going to publish the book in English.

In his book he tells that the same must have happend with Prozac in Germany like in Sweden. Because the Bundesgesundheitsamt (BGA) had great doubts in the late 80ies about the efficiacy of Prozac and was concerned about the suicide risk of Prozac. But then one year later Prozac was suddenly admitted. "Who has dined with the BGA and what did they have for dessert?" ask John Virapen. This I also want to know but not only about Prozac. I asked to the German authorities, why was ZOLOFT admitted, the drug that my wife took and I have asked for access to the files according to the Freedom of Information Act two years ago. I am still wating for the final answer.