Guest guest Posted March 7, 2004 Report Share Posted March 7, 2004 drugawareness atracyphd2 Sun, 7 Mar 2004 14:29:36 EST [drugawareness] ELI LILLY FINALLY AGREES WITH DR. TRACY ON WITHDRAWAL?!!! A March 5 Associated Press article reports: " Eli Lilly and Co. has doubled the time used to wean people off an experimental antidepressant an Indiana college student had been testing before she committed suicide. " Lilly also decided to extend from four days to eight the period allowed for participants to withdraw from the drug. Study participants take the drug in gradually increasing dosages over 20 days. Their dosages then are gradually reduced until they come off the drug. " _____________________________ So after 20 days on the drug patients are now given almost half that amount of time to withdraw - exactly what I have stated over and over and over again for years now to be the safest method for withdrawal from these antidepressants given their strong steroid effect! So why do these companies not put out pills that are 1 mg, 2 mg, 3 mg, and so on in order for the patients to be able to more easily go through a safe withdrawal - especially with the time release pills that are so hard to decrease in dose? Could it be because they are STILL in denial? And why are doctors be made more aware of the necessity of these extended withdrawal periods so that they better understand how to safely withdraw patients from these drugs? _______________________________ " Hayes said that in duloxetine testing on 8,500 people, Lilly has not seen evidence of suicide as a withdrawal symptom. " We don't have reasons to believe at this time that duloxetine is dangerous to people in terms of precipitating some suicidal event, either in its taking or its discontinuation, " Hayes said. ________________________________ The only reason they have not seen suicide during use of these drugs or the withdrawal is that they still have blinders on and refuse to see it. Nothing has ever changed when it comes to that. These companies continue to protect profits over the patient's health. After all, if they do not protect those profits the company may fold and then they would not have a job. You see, if a company were to admit to doctors how serious a withdrawal their patients would suffer and that it would jeopardize their own practice as their patients suffer from the addiction and withdrawal from these drugs, how many of them would prescribe them? Despite the manufacturers' continual denial of the role of the withdrawal of these antidepressants in producing both homicide and suicide, it is very real and there is solid scientific data to prove that in a court of law. [Refer to my book Prozac: Panacea or Pandora? to find that evidence.] That is precisely why these companies continue to settle out of court so that " gag " orders can be placed on victims and their families. And as much as I respect Dr. Glenmullin and his work and appreciate his support in sounding an alarm about these antidepressants, I must disagree that only " some " of these antidepressants produce an increase in suicidal thoughts within 10 days. EVERY ONE of them have the potential to do this! What is confusing to so many about SSRI withdrawal is that in withdrawal from some of these antidepressants suicidal thoughts can show up within 10 days. But with others the most serious period of withdrawal can hit ONE MONTH, TWO MONTHS or MANY MONTHS later. It all depends on many things: the length of time the patient has been on antidepressants, the accumulation rate of the drug within brain tissue, the patient's liver function, the patient's thyroid function, the patient's pancreatic function, etc. The plain truth is that Traci Johnson's death is evidence that over a decade and a half AFTER the SSRIs have been on the market we still have no idea what the dangerous potential of these drugs are. Yet we continue to use them six years after Dr. Candace Pert, the discoverer of the serotonin binding process which made them all possible, called them " monsters. " She went on to say that she is alarmed to admit she had anything to do with their development and to witness their widespread use when we know so little about them long-term effects. How much longer and how many more deaths will it take for the whole truth to come out? Will Traci Johnson be the last? As always I urge all of you to get this information to those who need it so that the deaths of all of these individuals will at least save the lives of others and not be in vain. Ann Blake Tracy, PhD Executive Director, International Coalition For Drug Awareness Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape or CD on safe withdrawal: " Help! I Can't Get Off My Antidepressant! " (800-280-0730) Website: www.drugawareness.org http://www.zwire.com/site/news.cfm?newsid=11079213 & BRD=2212 & PAG=461 & dept_id=465812 & rfi=6\\ Lilly alters procedure in drug trial The Associated Press March 05, 2004 Eli Lilly and Co. has doubled the time used to wean people off an experimental antidepressant an Indiana college student had been testing before she committed suicide. Lilly made the change after some participants in the same study complained that they were sleepless, anxious or nervous during their withdrawal from the drug, duloxetine, The Indianapolis Star reported Friday. Some participants in the study made the comments in mental health evaluations required after the suicide last month of 19-year-old Traci Johnson. No other participants reported any symptoms that indicated a risk of suicide, according to a new consent form that Lilly issued Feb. 24. " I don't want to have that interpreted as being I was afraid that the drug was a problem. If I thought it had been, I would have stopped the study, " said John Hayes, a clinical psychiatrist who leads Lilly's development team for duloxetine. Johnson, a Bensalem, Pa., resident who had attended Indiana Bible College last semester, hanged herself Feb. 7 at Lilly's hotel-like research lab at the Indiana University Medical Center at IUPUI. She had been participating in a study of the effects of high doses of duloxetine, an ingredient in Cymbalta, a drug for depression and incontinence that Lilly hopes to bring to market this summer. The U.S. Food and Drug Administration is reviewing her death. A Marion County coroner's report released this week did not cite the drug as a factor in her suicide. A board that reviews all Lilly drug trials at IUPUI said Wednesday that it was satisfied with the changes Lilly made in response to Johnson's death, which included questioning test subjects about their mental health daily for two weeks after their last dose and having a psychiatrist evaluate each subject after the last dose. Lilly also decided to extend from four days to eight the period allowed for participants to withdraw from the drug. Study participants take the drug in gradually increasing dosages over 20 days. Their dosages then are gradually reduced until they come off the drug. Hayes said that in duloxetine testing on 8,500 people, Lilly has not seen evidence of suicide as a withdrawal symptom. " We don't have reasons to believe at this time that duloxetine is dangerous to people in terms of precipitating some suicidal event, either in its taking or its discontinuation, " Hayes said. Dr. Joe Glenmullen, a psychiatrist at Harvard Medical School, suggested that Lilly's tried to wean people off the drug too quickly. Glenmullen, who wrote a book criticizing the use of antidepressants, said suicidal thoughts can increase within 10 days after the last dose when someone suddenly stops taking some antidepressants. Side effects of antidepressants, particularly in children, have drawn increasing scrutiny in recent months. Effexor maker Wyeth Pharmaceuticals wrote doctors in August to warn that while a cause-and-effect is not certain, its studies show more suicide-related thinking in children taking the drug than those given dummy pills, including a 2 percent incidence of hostility. Shortly after Johnson's suicide, Lilly disclosed that four participants who were depressed committed suicide during previous trials of the drug, a number the company said was below the level of those who were not taking the medicine and lower than suicide rates for another class of antidepressants, which includes Paxil, Zoloft and Prozac. Dr. Fred Cohen, president of Crownstone, a pharmaceutical investment research firm in Pennsylvania, said it was not uncommon for a manufacturer to change the protocol in a drug trial. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.