 |
Fraudulent trial of antidepressant medication
(See the English translation of this newsletter below the Danish newsletter)
Svindel med forsøg med antidepressiv medicin
Tilbage i nullerne blev der udført et stort amerikansk forsøg for at undersøge effekten af antidepressiv medicin. Det var det såkaldte “Sequenced Treatment Alternatives to Relieve Depression” (STAR*D) forsøg, hvor det blev konkluderet, at antidepressiv medicin kunne afhjælpe depression hos 67% af patienterne. Forsøget var det hidtil største forsøg med behandling af depression, og forsøgets resultater blev citeret i mange nyhedsmedier, og i stor udstrækning brugt til markedsføring af antidepressiv medicin.
Men efterfølgende blev der fundet alvorlige fejl og manipulation af data i forsøget, så effekten af antidepressiv medicin blev stærkt overdrevet. I virkeligheden var det kun 35% af patienterne, der fik afhjulpet deres depression med antidepressiv medicin. De 35% var det kumulative antal i løbet af hele forsøget, der var inddelt i 4 faser. Men ved forsøgets afslutning var det kun sølle 3% af de oprindelige 4041 deltagere, der var kommet af med deres depression og forblevet raske, og som var forblevet i forsøget helt til afslutningen.
Da svindlen blev afsløret, afslog forsøgets forskere at svare på kritikken.
Den undersøgende journalist Roger Whitaker har gravet videre i forsøgets vildledende konklusioner, og i september sidste år offentliggjorde han en længere redegørelse for, hvordan forsøgets resultater blev manipuleret til fordel for medicinalindustrien.
En af de måder forsøgets resultater blev forvrænget på var, at patienter, der ikke tålte den antidepressive medicin, udgik af forsøget uden at blive talt med i statistikken. Disse patienter skulle selvfølgelig medregnes i antallet af patienter, der ikke fik deres depression afhjulpet med antidepressiv medicin.
Nogle af patienterne var ved forsøgets start ikke tilstrækkeligt deprimerede til at indgå i forsøget. Men nogle af disse patienter blev senere talt med i gruppen af patienter, der fik deres depression afhjulpet med antidepressiv medicin.
606 patienter, der udgik af forsøget undervejs, blev fejlagtigt medregnet som patienter, der havde fået deres depression afhjulpet af antidepressiv medicin.
Det primære antidepressive middel anvendt i forsøget var citalopram, der blev udviklet af Lundbeck i Danmark. Hvis citalopram ikke hjalp patienterne, kunne de komme i behandling med andre antidepressive midler i forsøgets senere faser. I USA blev citalopram markedsført af Forest Laboratories, der var Lundbecks samarbejdspartner. 8 af de 12 forskere i STAR*D forsøget havde økonomiske forbindelser til Forest Laboratories, og alle 12 forskere havde økonomiske forbindelser til mindst et medicinalfirma.
Ref.: “The STAR*D Scandal: Scientific Misconduct on a Grand Scale” af Roger Whitaker
Et godt alternativ til antidepressiv medicin er fysisk aktivitet/motion. Forskning har vist, at fysisk aktivitet medfører signifikant reduktion af depression.
Ref.: Association Between Physical Activity and Risk of Depression
Der findes adskillige andre gode alternativer til antidepressiv medicin som beskrevet i vores tidligere nyhedsbrev “Depression skyldes ikke kemisk ubalance“. Samme nyhedsbrev omtaler også de mange alvorlige bivirkninger ved antidepressiv medicin.
Ansvarsfraskrivelse: Intet i dette nyhedsbrev er et forsøg på at afholde dig fra nødvendig lægebehandling. Nedtrapning af medicin eller behandling bør ske i samråd med en kvalificeret læge. Vælger du at ophøre med lægeordineret medicin eller behandling bærer du selv det fulde ansvar.
Newletter in English
Fraudulent trial of antidepressant medication
About 20 years ago a large american trial was done to investigate the effect of antidepressant medication. It was the socalled “Sequenced Treatment Alternatives to Relieve Depression” (STAR*D) trial, which concluded that antidepressant medication resulted in remission of depression in 67% of the patients. The trial was the largest trial at that time for treating depression, and the results were cited in numerous news media and were used extensively for the marketing of antidepressant medication.
But afterwards serious errors and manipulation of data in the trial were discovered, so that the effect of the antidepressant medication was wildly exaggerated. In reality, only 35% of the patients experienced remission of their depression. The 35% were the cumulative number of patients experiencing remission at some point during the entire trial, which was divided into 4 phases. But at the end of the trial, only 3% of the 4041 original participants had experienced remission and remained well all the way to the end of the trial.
When the fraud was revealed, the researchers in the trial declined to answer the criticism.
The investigative journalist Roger Whitaker dug into the misleading conclusions of the trial, and in September 2023, he published his findings.
One of the ways the results of the trial were manipulated was to not include patients, who dropped out of the trial because they did not tolerate the medication. Those patients should of course have been included in the number of patients, who did not experience remission of their depression.
Some patients were at beginning of the trial not sufficiently depressed to take part in the trial per the protocol of the trial. But some of those patients were later counted in the group of patients, who experienced remission of their depression.
606 patients, who dropped out before the trial was finished, were erroneously counted as patients, who experienced remission of their depression.
The primary antidepressant drug used in the trial was citalopram, which was developed by Lundbeck in Denmark. If citalopram did not help the patients, they could be treated with other antidepressant drugs in the later phases of the trial. In the USA citalopram was marketed by Forest Laboratories, who collaborated with Lundbeck. 8 out of the 12 researchers in the STAR*D trial had financial ties to Forest Laboratories, and all 12 researchers had financial ties to at least one pharmaceutical company.
Ref.: “The STAR*D Scandal: Scientific Misconduct on a Grand Scale” by Roger Whitaker
A good alternative to antidepressant medication is physical activity. Research has shown, that physical activity results in a significant reduction of depression.
Ref.: Association Between Physical Activity and Risk of Depression
There are numerous other good alternatives to antidepressant medication as described in our newsletter “Depression skyldes ikke kemisk ubalance“. That same newsletter also contains information about the many severe side effects from antidepressant medication.
Disclaimer of liability: Nothing in this newsletter is an attempt to prevent you from getting necessary medical treatment. Withdrawal from medication or treatment should be done in concert with a qualified physician. If you choose to withdraw from prescribed medication or treatment, you carry the full responsibility.