![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 38. This is the beginning of the thread.
Posted by jrbecker on August 7, 2003, at 9:47:43
looks like the mass media is going to grab a hold on this one again due to the latest paxil concerns in children
Posted by Dinah on August 7, 2003, at 10:10:05
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
They ought to just admit that SSRI's cause akasthesia (sp?) (and I'm not sure that's the right word anyway) in some small percentage of people. And that that can lead to suicide in those who might not otherwise kill themselves, even in a depression. And warn doctors to agressively watch for signs of this problem.
It's not such a horrible admission. It's probably not that huge a percentage.
Posted by Susan J on August 7, 2003, at 10:38:28
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
Well, I'm 36, and just spent a year on Paxil. It was the first time in my life, and I've been fighting depression for over 20 years, that I actually felt truly suicidal. I'm on Wellbutrin now, and haven't felt this good in years.
I guess Paxil does and will continue to help many people, but it was a HORRIBLE choice for me. It was also the first time I've tried medication to help with depression, so I really didn't know what to expect, or even know if it was working. I just hope therapists and MDs are truly aware that these drugs can have unforseen, and seemingly illogical, side effects.
Susan
Posted by Dinah on August 7, 2003, at 10:49:53
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by Susan J on August 7, 2003, at 10:38:28
And different for everyone! It was Wellbutrin that made me suicidal. And the doctors kept telling me to wait out the side effects.
Posted by Susan J on August 7, 2003, at 10:52:41
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues » Susan J, posted by Dinah on August 7, 2003, at 10:49:53
Oh, that's horrible! My therapist said figuring out which drug is best for you is trial and error. And since the drugs I've tried may take up to six weeks before they are actually working properly, that's a long time to continue feeling horrible.
Posted by lori lu on August 7, 2003, at 11:41:20
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
My six-year old takes liquid Paxil. I'm more concerned that he has started to have accidents at night(he never had any before) because Paxil makes him so tired he can't wake up to go to the bathroom (I do get up and carry him to the bathroom while he is sleeping but he has been having several in one night). He used to not have to go to the bathroom at night but Paxil makes him so thirsty during the day he is always drinking water. Now he is starting to get a loose stools this week and not make it to the bathroom. With school starting in a couple weeks I CAN"T have this happening at school.Paxil AND a year of therapy have turned his OCD and anxiety around and he is a totally different kid. He is so happy. I hated going through the withdrawls of Paxil myself, but I don't know what to do. I'll call his pdoc. Any ideas?
Posted by Larry Hoover on August 7, 2003, at 11:43:31
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
> looks like the mass media is going to grab a hold on this one again due to the latest paxil concerns in children
>
> http://www.nytimes.com/2003/08/07/health/07DEPR.html?hpI'd like to add some context to this debate. What's being identified in this article, and similar pieces, is a short-term risk of suicidality which occurs early in treatment. That risk is not unique to Paxil, nor to SSRIs as a class. It has long been recognized as a risk of antidepressant therapy, in general.
I'm going to post a couple abstracts, with my comments.
J Affect Disord. 1996 Nov 4;41(1):1-8.
Epidemiological data suggest antidepressants reduce suicide risk among depressives.Isacsson G, Bergman U, Rich CL.
Department of Clinical Neuroscience and Family Medicine, Division of Psychiatry, Karolinska Institute, Huddinge University Hospital, Sweden. goran.isacsson.@cnsf.ki.se
In spite of the availability of antidepressant medication for several decades, it has not been shown that such medication lowers the risk for suicide in depressed patients. This report explores this apparent paradox by means of pharmacoepidemiological methods. Data on the prevalence of depression in the population and among suicides as well as data on the prevalence of antidepressant medication in depressed suicides were obtained from a review of the literature. Data on the prevalence of antidepressant medication in the population in 1990-1991 were obtained from the statistics of the Swedish National Corporation of Pharmacies. It was found that only one in five depressed individuals with major depression were treated with antidepressants in Sweden. The calculated risk for suicide among depressed patients who were treated with antidepressants was 141 per 100,000 person years and, among the untreated, 259 per 100,000 person years (i.e., 1.8 times higher among the untreated). This supports the hypothesis that antidepressant medication decreases the risk for suicide in depressed patients. The reason this has not been obvious in the general suicide statistics seems to be that so few depressed people are treated with antidepressants. Effective suicide prevention strategies should include intensive efforts to recognize and treat more depressed people.
Comment: Note the confounding influence of the generally low rate of treatment of depression, which serves to obscure (by dilution) the benefit accruing from pharmacological treatment. Moreover, as this study does not distinguish in any way the group of suicides arising *from* treatment (they are included in the group statistic), there is a net benefit from pharmacological treatment, in the context of suicide.
Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):525-30.Antidepressant medication and suicide in Sweden.
Carlsten A, Waern M, Ekedahl A, Ranstam J.
Department of Social Medicine, University of Goteborg, Sweden. anders.carlsten@telia.com
OBJECTIVE: To explore a possible temporal association between changes in antidepressant sales and suicide rates in different age groups. METHODS: A time series analysis using a two-slope model to compare suicide rates in Sweden before and after introduction of the selective serotonin reuptake inhibitors, SSRIs. RESULTS: Antidepressant sales increased between 1977-1979 and 1995-1997 in men from 4.2 defined daily doses per 1000 inhabitants and day (DDD/t.i.d) to 21.8 and in women from 8.8 to 42.4. Antidepressant sales were twice as high in the elderly as in the 25-44-year-olds and eight times that in the 15-24-year-olds. During the same time period suicide rates decreased in men from 48.2 to 33.3 per 10,000 inhabitants/year and in women from 20.3 to 13.4. There was significant change in the slope in suicide rates after the introduction of the SSRI, for both men and women, which corresponds to approximately 348 fewer suicides during 1990-1997. Half of these 'saved lives' occurred among young adults. CONCLUSION: We demonstrate a statistically significant change in slope in suicide rates in men and women that coincided with the introduction of the SSRI antidepressants in Sweden. This change preceded the exponential increase in antidepressant sales.
Comment: A temporal association is literally coincidence. That said, coincidence does not mean "no relationship". There is a significant relationship between the introduction of SSRI medication and the change in the rate of suicide. That significant relationship is revealed by what they describe as a "significant change in slope" of the rate of suicide plot. This, from a statistical perspective, requires the introduction or removal of an independent variable, as the dependent variable plots to a different regression line (i.e. change in slope). The only change they identify is the introduction of SSRI medication (a new independent variable). So, even if SSRIs do lead to a short-term enhancement in the risk of suicide, the long-term risk (which embeds the short-term increase within it) is reduced.
What I find to be compelling about the latter study is that the subjects are the inhabitants of an entire nation. Unlike clinical trials, in which subjects do not have comorbid diseases, and are selected for disease severity and other things, the population under study (everybody in Sweden) includes substance abusers, people with comorbid conditions, people prescribed the meds off-label, people of all ages, those who stopped taking the meds or who didn't take it as prescribed, and so on. The entire gamut of human experience. All they're saying is, that at the same time SSRIs were added to the mix, suicide rates declined significantly.
What I wish to emphasize is that people need adequate supervision when initiating pharmacological treatment for depression. To blame the drugs is a little bit short-sighted. The issue is how the patients are managed, under care.
Lar
Posted by Susan J on August 7, 2003, at 12:15:28
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues » jrbecker, posted by Larry Hoover on August 7, 2003, at 11:43:31
As Larry said >>To blame the drugs is a little bit short-sighted. The issue is how the patients are managed, under care.
<<I agree with this completely. However, I was getting biweekly therapy sessions, had eliminated as many stress factors in my life as possible, and my therapist swears up and down that I'm emotionally "healthy" (e.g. healthy habits), but chemically depressed.
I never felt any suicidal urges until I starting taking Paxil. While this is anecdotal evidence only, I really believe that it was the drug, which gave me almost every side effect in the book and which never subsided, that caused me to fall into such despair as to want to kill myself.
I don't think there is any sole factor that causes depression, but I do think it's very difficult to pin down exactly what is not working or even hurting you. My therapist touted Paxil as the Miracle Drug. I truly hope for some people it is. It wasn't for me.
Posted by Bill L on August 7, 2003, at 13:16:45
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by lori lu on August 7, 2003, at 11:41:20
I have never heard of Paxil causing thirst. Maybe you just need to force him not to drink too much at night.
As for the loose stolls, maybe it's not the Paxil. I know that where I live (in Baltimore)there is a lot of virus going around. Even if it it is the Paxil, it might go away on its own.
After hearing how well your child is doing, I would hate to think of him having to discontinue the Paxil.
Posted by Susan J on August 7, 2003, at 13:24:41
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by lori lu on August 7, 2003, at 11:41:20
Hi, When does your son take the Paxil? My doc told me to take it at night so the sleepiness wouldn't affect daytime activities. Maybe your son could try the opposite, taking it upon waking or early afternoon so that the sedating effects wear off a bit before bedtime?
Good luck!
Posted by Janelle on August 7, 2003, at 13:27:44
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues » lori lu, posted by Susan J on August 7, 2003, at 13:24:41
have to register at that site or what? Thanks.
Posted by Susan J on August 7, 2003, at 13:39:24
In reply to How do you get to the article? I couldn't! Do you, posted by Janelle on August 7, 2003, at 13:27:44
You mean the New York Times article? I didn't have any trouble accessing it, but I "do" think I registered at the NY Times website several months ago. (Can't remember, and my computer would just sign me in automatically if I did).
Try registering at the NY Times website....
Susan
Posted by Janelle on August 7, 2003, at 13:55:12
In reply to Re: How do you get to the article? I couldn't! Do you » Janelle, posted by Susan J on August 7, 2003, at 13:39:24
Posted by jrbecker on August 7, 2003, at 16:31:01
In reply to How do you get to the article? I couldn't! Do you, posted by Janelle on August 7, 2003, at 13:27:44
Sorry, I usually paste the article as well. I think I'm just getting lazier.
>>>
Debate Resumes on the Safety of Depression's Wonder Drugs
By GARDINER HARRIS
Warnings by drug regulators about the safety of Paxil, one of the world's most prescribed antidepressants, are reopening seemingly settled questions about a whole class of drugs that also includes Prozac and Zoloft.Doctors are just beginning to react to the finding — reported first by British drug authorities in June and then endorsed the next week by the Food and Drug Administration — that unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide.
Because the studies also found that Paxil was no more effective than a placebo in treating young people's depression, the regulators recommended that doctors write no new Paxil prescriptions for patients under 18. Experts say that the suicide risk is highest in the first few weeks young patients are on the drug.
The concern that Paxil and drugs like it could cause suicide had been weighed, and rejected, by regulators a dozen years ago, amid early concerns about the group of antidepressants known as selective serotonin reuptake inhibitors, or S.S.R.I.'s. In the meantime, millions of people have taken the drugs, and many experts say that they have prevented far more suicides by teenagers and children than any reading of the new findings suggests they could have caused.
Almost no one suggests that Prozac, Zoloft, Paxil and their cousins are not safe for the vast majority of adults, although studies have shown them to be only modestly effective.
Still, the warnings have the early critics saying they feel vindicated. Plaintiffs' lawyers who have uncovered evidence that they say shows drug makers withheld evidence of the S.S.R.I.'s suicide risk from regulators say the warnings give fresh urgency to their claims.
And the findings have unsettled some of the very experts who absolved S.S.R.I.'s of a link to suicide a dozen years ago. Of the 10 American specialists who, as members of an ad hoc F.D.A. panel, formally cleared the drugs of a link to suicide in 1991, seven now say that the new information would prompt them to reconsider that decision, if they were asked.
"In 1991, we said there wasn't sufficient evidence to support a link between these drugs and suicide," said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina and a member of the panel. "Now there is evidence, at least in children, and I wouldn't rule out that it's in adults, too."
British health authorities have promised to "urgently" examine the implications of their findings for adults. The F.D.A. is considering whether to impose new restrictions on the use of the antidepressants. The agency's warning emphasized that younger patients "should not discontinue use of Paxil without first consulting their physicians," adding, "it is important that Paxil not be abruptly discontinued."
While the regulators' warnings address only Paxil, many of the experts on the 1991 panel said all S.S.R.I.'s act similarly in the body, so concerns about one could apply to all.
The drugs' manufacturers, which sell billions of dollars of S.S.R.I.'s every year, have treaded carefully in responding to the warnings. Without criticizing the regulators, they maintain that there is no proof that their drugs have a link to suicidal thinking in young patients — and they point out that the F.D.A. in the past found no merit in such claims.
"We're trying right now to look at this issue with the F.D.A. and come up with an understanding together of what the data mean," said Dr. Philip Perera, a medical director of GlaxoSmithKline, the British company that makes Paxil. Pfizer, the maker of Zoloft, said that its drug was different from Paxil and had passed all F.D.A. safety evaluations, including one as recently as June 12. Eli Lilly & Company said that Prozac does not cause suicides.
So far, there is little evidence that the warnings have affected doctors' prescribing practices. Teenagers and children account for about 5 percent of S.S.R.I. prescriptions, and companies that track the industry have detected no falloff in sales.
"I can hardly imagine working without these drugs," said Dr. William Schreiber, a Louisville, Ky., internist. "These are good drugs, and I think they're safe drugs."
But the warnings are beginning to seep into doctors' awareness. Connecticut officials, for example, last month dropped Paxil from their list of approved medications for foster children. And even doctors who do not believe there is a link between S.S.R.I.'s and an increased risk of suicide are emphasizing that patients need to be closely monitored in their first weeks on the drugs.
"See them every day, if you need to," Dr. Perera of GlaxoSmithKline said.
The drugs are widely prescribed by general practitioners, who do not have the same training in depression and treatment as psychiatrists.
With S.S.R.I.'s now the most prescribed drugs for depression, it is easy to forget how high passions ran when the F.D.A. convened an expert panel in 1991 to weigh claims that Prozac and other S.S.R.I.'s may cause some patients to become suicidal. The panel's hearing in Bethesda, Md., was mobbed; its chairman wore a bulletproof vest.Dozens of people told stories like the one related by Melinda Harris. Blaming Prozac, she described how her father came into the kitchen one morning, picked up a 12-inch butcher knife and stabbed himself repeatedly in the stomach.
Just as emotionally, advocates for the mentally ill pleaded with the panel to reassure patients that they could take Prozac with confidence. Representatives of Eli Lilly cited studies finding no connection between suicide and the drug, which had been on the market for almost four years.
Despite the sharp conflict, the panel voted unanimously in Prozac's favor, and the controversy died down. To this day, the panel's findings are cited to rebut claims that the drugs can be harmful.
But some of the early critics say the warnings demonstrate their prescience. "I feel vindicated," said Joseph Glenmullen, author of "Prozac Backlash," a fierce critique of antidepressants. "These companies have vehemently denied this side effect for over a decade, and now their own data indicate there's a significant risk."
The British regulators said that their analysis of the nine studies of Paxil found 3.2 times the likelihood of suicidal thoughts or suicide attempts among teens and children given the drug as among patients given a placebo. They also said that Paxil has not proved effective against depression in children and teenagers.
Some experts suspect that in the first few weeks of therapy, drugs like Paxil can shove a small number of patients toward a mental precipice, perhaps because they can cause a severe form of restlessness known as akathisia. Patients who make it through the first weeks of drug therapy uneventfully do fine on the medication on the long term, these experts say.
Teenagers and children seem particularly vulnerable, said Dr. Mark A. Riddle, director of the division of child and adolescent psychiatry at the Johns Hopkins Children's Center.
"Kids tend to get quite activated, especially on adult doses of S.S.R.I.'s," said Dr. Riddle, who in 1991 conducted one of the first studies of the drugs in younger patients. "We had a lot of cases of kids who became so disinhibited they did reckless things," he said, describing those early findings.
In recent years, most debate among doctors and researchers about the S.S.R.I.'s has focused on whether they are effective, rather than whether they are safe.
Dr. David Shaffer, a researcher at Columbia University, noted that teenage suicides have fallen significantly in every country where Prozac and its cousins are in widespread use.
"This amazing, undreamt of and unhoped for reduction in suicide rates is probably the result of more liberal treatment of young people with S.S.R.I.'s, and it's suggestive that these drugs may be responsible for saving a lot of lives," Dr. Shaffer said. "The introduction of S.S.R.I.'s has been a revolution."
Yet most studies — including those recently reviewed by British and American health regulators — have found that S.S.R.I.'s are no more effective in fighting teenage depression than sugar pills.
Even in adults, S.S.R.I.'s have been found to offer only modest benefits. In about half of all adult tests, the drugs prove no more effective than placebos. On average, they reduce symptoms of depression by about 41 percent on a widely used scale, versus a 31 percent reduction among those taking placebos, according to a survey in 2000 of studies used by the F.D.A. in approving the drugs.
Researchers, moreover, have not been able to analyze much of the data on the drugs, because they have not been made public.
GlaxoSmithKline, for instance, has acknowledged that just one of its nine studies of Paxil in children and adolescents has been published — a study that made only passing mention of suicide and concluded that the drug was effective against depression. According to the F.D.A., the combined results of all nine trials show that the drug is not effective against depression in patients under 18. Of the S.S.R.I.'s, only Prozac is approved by the F.D.A. to treat depression in children and teenagers, although doctors also widely prescribe the others.
Unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide.
Dr. Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center who was a researcher in four of GlaxoSmithKline's studies of Paxil, said he suspected that the other studies went unpublished at least in part because the results were unfavorable."Some of these studies were finished a couple of years ago," Dr. Emslie said. "But negative trials tend not to get published."
Dr. Perera, the GlaxoSmithKline official, said that publishing studies "takes time." He declined to say if the company would seek to publish the eight Paxil studies that have not appeared in journals.
According to Dr. Emslie, other companies have withheld negative studies of S.S.R.I.'s. "I know of at least a half-dozen other studies of antidepressant treatments in children and adolescents that have been completed but as yet have not been published," he said. "More than enough time has passed for these to be published at least in abstract form." He refused to identify the companies or the drugs involved because he, like other researchers involved in similar research, has signed contracts promising secrecy.
With negative results not disclosed, researchers and physicians often believe that drugs are more effective and safer than they actually are, according to Dr. Marcia Angell, a former editor of The New England Journal of Medicine. "It changes the way medicine is practiced," Dr. Angell said.
Back in 1991, in their presentation to the blue-ribbon committee reviewing Prozac, Lilly scientists made much of the fact that studies analyzing Zoloft and Paxil failed to show any link between those drugs and an increase in suicides.
"There is simply no scientific evidence whatsoever, no placebo-controlled double-blind study, that has established a cause-and-effect relationship between antidepressant pharmacotherapy of any class and suicidal acts or ideation," said Dr. Charles B. Nemeroff, a professor of psychiatry at Emory University who worked as a consultant and spoke on behalf of Lilly.
In an interview, Dr. Nemeroff said he believed that his statement was accurate then and remains so, since he has not seen any published study to contradict it.
The British and American regulators have reached a different conclusion. And experts hired by lawyers suing the manufacturers over claims that the drugs led to suicides question whether the F.D.A. received a full picture of the available research in 1991.
For instance, F.D.A. procedures required Lilly to inform the agency of any concerns about Prozac raised by other national health authorities. But court records show that Lilly never told the F.D.A. or the expert panel that German regulators initially refused to approve Prozac's sale in 1985 because of concerns over a link with suicide.
In their analysis of Lilly's data, the German authorities said that Prozac seemed to have caused a substantial increase in suicide among users, according to court records. Ultimately, the Germans approved Prozac with a warning that physicians should consider using sedatives for patients at risk of suicide.
No such warning is included in Prozac's label in the United States, although the risk of suicidal thinking is listed among the drug's side effects.
Gary Tollefson, a Lilly executive who spoke before the 1991 panel, was asked in a deposition why he did not tell the experts about the German concerns.
"That was not a question I was asked," he said, according to court records, "so I did not answer that question."
Documents brought to light in other cases suggest that Lilly struggled for years to reconcile suicidal events among patients taking Prozac in its trials. One memo shows that a top Lilly executive asked the company's own researchers to record suicide attempts as "overdose" and thoughts of suicide as "depression."
In another memo, a Lilly employee objected to those instructions, making reference to the German health authority, known by its initials as the B.G.A. "I do not think I could explain to the B.G.A., a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation," he wrote.
In a recent statement, Lilly said: "There is no credible scientific evidence that establishes a causal connection between Prozac and violent or suicidal behavior. To the contrary, scientific evidence shows that Prozac and other antidepressant medications appear to reduce these behaviors."
Lilly representatives told the 1991 panel that the company had put together a series of proposed studies to examine the suicide issue and said one of the studies had already been started. According to plaintiffs' lawyers, Lilly never completed the study; Lilly declined to comment.
Were the F.D.A. to reconstitute the 1991 panel, its members would again be presented with a confusing mix of data on the issue — despite the passage of 16 years since Prozac's introduction and the use by tens of millions of people of it and other S.S.R.I.'s.
Under the circumstances, one member of the panel, Dr. Keh-Ming Lin, a professor of psychiatry at the University of California at Los Angeles, said the new information unearthed by regulators might lead him to change his vote absolving S.S.R.I.'s of suicide risk.
"If you have data that's worrisome, you tend to be conservative," Dr. Lin said, "even when the question isn't resolved."
Posted by BekkaH on August 7, 2003, at 17:32:46
In reply to How do you get to the article? I couldn't! Do you, posted by Janelle on August 7, 2003, at 13:27:44
Hi Janelle,
Yes, you do have to register for the NEW YORK TIMES site, but it's free. It looks as if jrbecker has now posted the article in its entirety, but I think it's worth your while to register for the site so you can read future articles. By the way, every Tuesday, the NY TIMES has a "Science and Health Times" section, and nearly every week there is at least one article devoted to mental health.
Posted by Janelle on August 7, 2003, at 18:21:00
In reply to Re: How do you get to the article? - Janelle, posted by BekkaH on August 7, 2003, at 17:32:46
Posted by jay on August 7, 2003, at 22:44:13
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
I would be one of the first to admit the SSRI's, as well as tricyclics, made life pretty bad at times in the first couple of months of their use for me. But, I eventually used some simple common sense and a couple of ways to 'ease' onto the meds, which included starting with a lower dose (I partially blame the drug companies for only doling out one initial dose for everyone at a time!), and simply using a good dose of a benzodiazepine. And I also partially blame the drug companies for going around and touting these meds as "first-line" treatment for anxiety, because it is that out-of-control anxiety at first that I think causes these problems! So, most of the actual *logic* goes against what the drug companies have promoted aggressively (i.e. first line, standard dose for all..etc..) If you think about it, and the "regulation" model of neurons that SSRI's supposedly partially work by, yes it could at first very well cause problems in a brain that has an 'excess' number of neurons caused by stress and altered neurochemicals, and that "regulation" could likely take that 3 or so month period, and possibly even longer in some. This means you have a *lot* of neurons being flooded by mostly serotonin, and ya that will cause some agitating and possibly suicidal effects until the neurons are "regulated". (And of course, this also affects regulation of many other neurotransmitters.) That's why having an educated pdoc who is up on every shred of research, and even takes into account various hypotheses, is important, but unfortunately a large number of pdocs are not like this. All of this can be controlled if only people and companies come "out of the closet", and lay all of their research on the table!
I just have to use Prozac as an example. The first time I tried it in 1991-92, for only a few days at 20mg's, I felt horrible and like I was going to explode! Now, just over ten years later, I am on 40 mg's a day of the drug, and it has greatly helped me overcome some of the basic hurdles in life that exacerbated my anxiety and depression in the past. I don't even think I now could blame the drug for causing any current "agitation", especially *not* "suicidal thoughts", as after weaning onto it properly and using benzos at the time, my day's are FAR much more smoother and way less stressful than most of the times I can remember in my life.
Jay...
Posted by Dinah on August 8, 2003, at 7:59:22
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by jay on August 7, 2003, at 22:44:13
I thought the best part of the article was the advice to physicians to closely monitor people during the opening stages, every day if necessary.
Posted by SLS on August 8, 2003, at 10:41:08
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues » jay, posted by Dinah on August 8, 2003, at 7:59:22
Here's a thread that I participated on a few years back:
http://www.dr-bob.org/babble/20000526/msgs/35096.html
- Scott
Posted by lorilu on August 8, 2003, at 16:17:13
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues » lori lu, posted by Susan J on August 7, 2003, at 13:24:41
Thanks. You're right, he does take it at night.We go to see his doc today and I'll ask about switching the time of day.
Posted by lorilu on August 8, 2003, at 16:28:50
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by Bill L on August 7, 2003, at 13:16:45
I've talked to his doctor, I guess Paxil works on your brains "Seritonnin"(sic) and we have a lot more of that in our gut than in our brain. I give him "Pediasure" because he is a picky eater and by default that has kept him "regular". I stopped giving him that these last 2 weeks and he started having accidents. As soon as I started giving him the Pediasure shakes again he seems to be ok. We all want him on his meds too. Hopefully with something as simple as these shakes, it will help. My mom couldn't take Paxil. She had severe loose stools with it. The doc said it can be genetic. Whatever. As for the bed wetting. I'm going to ask today if he can take the med in the am or early afternoon so he won't be so tired. I try to limit eve. drinks and have cut out all cafine(sic)I swear on days he swims he must drink half the pool! :) Thanks for all comments!
Posted by Psychquackery on August 8, 2003, at 22:00:04
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
> looks like the mass media is going to grab a hold on this one again due to the latest paxil concerns in children
>
> http://www.nytimes.com/2003/08/07/health/07DEPR.html?hpThe SSRI-akathisia connection a definite thing. It doesnt occur in all or even most people, but it does occur. You can read right out of Stephen Stahl that SSRIs can cause akathisia and the mechanism is simple. I will read right out of Stahl's "Essential Psychopharmacology of Depression and Bipolar Disorder" book. Chapter 2 page 99:
"Thus, acute stimulation of serotonin 2A and 2C receptors in the projection from raphe to limbic cortex may cause the acute mental agitation, anxiety, or induction of panic attacks that can be observed with early dosing of an SSRI. Acute stimulation of the 2A receptors in the basal ganglia may lead to changes in motor movements due to serotonin's inhibition of dopamine neurotransmission there. Thus, akathisia (restlessness), psychomotor retardation, or even mild parkinsonism and dystonic movements can result."
So there you go, right from one of the top psychopharmacologists in the country...Stephen Stahl.
And if you do the opposite...if you block or antagonize the serotonin 2A receptor instead of stimulate it, you get an anti-akathisia or anti-EPS effect. Thats why antidepressants like Remeron, Serzone and trazodone dont cause akathisia they block the serotonin 2A receptor rather than stimulate it like the SSRIs do.
Some psychiatrists dont even know the above information and dont warn their patients of possible akathisia from SSRIs. And when it happens, patients get scared and think the problem is them when its just their own particular reaction to the drug and stop the SSRI. Or rarely, go off the deep end cause the akathisia shook them up bad and committ suicide. Its rare but it has happened.
One thing about that article that irked me was how Dr. Charles Nemeroff of Emory University totally denies the SSRI-akathisia connection. That guy is so connected to the drug companies, he has too many conflicts of interest to even ask that question to. Ive read some things about that guy that dont impress me, I think he has a bad temper.
Also, a few years ago I had all my psychiatric records copied to me. One of them mentioned that I had experienced akathisia from SSRIs and that "akathisia treatment would be beneficial." That was coming from a Neuropsychiatrist evaluation. Not one of the other psychiatric records mentioned a thing about akathisia. I think thats typical of psychiatry...they pretty much pay pure attention to the behavioral aspects of the diseases we have and they dont know enough about the drugs they prescribe.
Igor
Posted by Sleepy Susan on August 9, 2003, at 8:13:13
In reply to Re: NYTimes:Debate on SSRIs and Suicide risk continues, posted by lori lu on August 7, 2003, at 11:41:20
> My six-year old takes liquid Paxil. (snip)Paxil AND a year of therapy have turned his OCD and anxiety around and he is a totally different kid. He is so happy. I hated going through the withdrawls of Paxil myself, but I don't know what to do. I'll call his pdoc. Any ideas?
My 12 year old has been on Paxil for a year for her social anxiety and upped the dose 6 months ago for PMDD and it worked well. We just did the taper and she was pretty miserable, so plan it for a time when you can keep the environment calm-may be difficult with the start of school so soon-we are about to move so that was rough. She has just started Zoloft and about 4 hours after her first dose, she was feeling calm inside again-she was real agitated the during the day. Her worst time is right around ovulation, so I waited till we got her through that to start the taper, as it was 7 days 12.5 PaxilCR and then 7 days of the 25mg Zoloft and she should be at the 50 mg Zoloft for a week by the time she ovulates again.
I wish you luck, it is amazing how well they have calmed her agitation,
Susan
Posted by BobS. on August 9, 2003, at 18:50:41
In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43
The most important issues raised in this article are as follows. I know because I work in human clinical trial arena....
"Even in adults, S.S.R.I.'s have been found to offer only modest benefits. In about half of all adult tests, the drugs prove no more effective than placebos. On average, they reduce symptoms of depression by about 41 percent on a widely used scale, versus a 31 percent reduction among those taking placebos, according to a survey in 2000 of studies used by the F.D.A. in approving the drugs.
Researchers, moreover, have not been able to analyze much of the data on the drugs, because they have not been made public.
GlaxoSmithKline, for instance, has acknowledged that just one of its nine studies of Paxil in children and adolescents has been published — a study that made only passing mention of suicide and concluded that the drug was effective against depression. According to the F.D.A., the combined results of all nine trials show that the drug is not effective against depression in patients under 18. Of the S.S.R.I.'s, only Prozac is approved by the F.D.A. to treat depression in children and teenagers, although doctors also widely prescribe the others."
Posted by Larry Hoover on August 10, 2003, at 7:57:42
In reply to Unpublished (suppressed) studies and 41% efficacy, posted by BobS. on August 9, 2003, at 18:50:41
> The most important issues raised in this article are as follows. I know because I work in human clinical trial arena....
I'm not meaning to sound contrary, but it needs to be said that clinical trials are an exceedingly artificial environment. The very act of controlling variables makes that so.
> "Even in adults, S.S.R.I.'s have been found to offer only modest benefits. In about half of all adult tests, the drugs prove no more effective than placebos. On average, they reduce symptoms of depression by about 41 percent on a widely used scale, versus a 31 percent reduction among those taking placebos, according to a survey in 2000 of studies used by the F.D.A. in approving the drugs.For one such in-depth meta-analysis, go to:
http://www.psychiatrictimes.com/p000429.html which was written by Dr. Khan, an expert in the field.
It's important to emphasize that subjects receiving placebo pills in antidepressant trials are *not* untreated.
From the referenced article:
"The less-than-impressive results in these and other studies also calls to mind the fact that patients assigned to placebo treatment in clinical trials are not "getting nothing." The capsule they receive is pharmacologically inert but hardly inert with respect to its symbolic value and its power as a conditioned stimulus. In addition, placebo-treated patients receive all of the commonly employed treatment techniques: a thorough evaluation; an explanation for their distress; an expert healer; a plausible treatment; expectation of improvement; a healer's commitment, enthusiasm and positive regard; and an opportunity to verbalize their distress. "He goes on to include a very important warning about the interpretation of the data arising from antidepressant clinical trials. Note particularly the concluding statement.
"A cautionary note is indicated about the generalization of these data to the clinical management of depressed patients. The less-than-impressive difference between drug and placebo in this and other studies of clinical trials does not speak directly to the effectiveness of antidepressants in clinical practice. Participants in antidepressant clinical trials are a highly select group and are not representative of the general population of depressed patients. They are not actively suicidal, they are almost always outpatients who are moderately rather than severely or mildly depressed, and they are free of comorbid physical or psychiatric illness. They are likely to have a higher placebo response rate than more severely ill depressed patients. "
"Furthermore, the primary aim of these studies is not to assess the optimal effect of antidepressants, but rather to rapidly assess efficacy of new drugs so they can be brought to the market. Therefore, dose, duration and diagnosis in clinical trials are not necessarily ideally suited to identify the optimal effects of antidepressants. Accordingly, clinical trials may identify the lower bound of the effect size compared to placebo. "
Lar
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