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.

My Story in the German News-Magazine Focus 28.02.2008

At the beginning of this year, secret documents are found, that GlaxoSmithKline, the maker of the SSRI PAXIL, have known about the risk of suicide since the late 80ies but have concealed it from the public. Dr. Glenmullen writes: "...GlaxoSmithKline's Paxil data in its earliest reports to the FDA in 1989 show a statistically significant, greater than eight-fold increased risk of suicidal behaviour - suicide and suicide attempts - for patients put on Paxil when compared to patients put on placebo (dummy) pills ...".

I told this and my story to the German news-magazine Focus and they published it on 28th Febuary 2008. I also told them about Mr. John Virapen, an Ex Eli Lilly manager in Sweden. He bribed the swedish expert to write a positive report for the approval of PROZAC, the first SSRI.

But the same must have happend in Germany also.

But what about ZOLOFT and Pfizer? How long did Pfizer know about the risk of suicide of ZOLOFT?

(Reference: http://www.focus.de/gesundheit/news/psycho-medikamente_aid_261754.html )

To be continued ...

Kirsch Study on the Lack of Efficacy of SSRI Antidepressants

A recent study by Kirsch based on the studies submitted to the FDA could not prove that SSRI-antidepressants are effective in treating mild to moderate depression. What the pharma-companies have long claimed has now been proved to be a damn lie! Why are these drugs be given to the patients, if they have severe side effects but almost no positive effects? Why were these SSRI-drugs approved by the FDA in the US, by the BfArM in Germany and in the other countries?

The regulators have to explain that to the public!

(Reference: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0050045)