FDA warning on SSRIs

[Anonymous]

You say you read " the original" regarding Freud.  What are you talking about.  He wrote volumes.  The original is in German.  Wow I give you a lot of credit for reading that.  I am giving people including teens and children another alternative from meds and being told how to think.   Psychoanalysis or Psychotherapy for 4-6 years is a very viable therapy and your bashing it is really too bad.
    I am reading a book about selected papers by Frieda Fromm Reichmann who had as a teacher, Freud. She did analysis with schizophrenics and manic-depressives.  Very good reading

[Anonymous]

Mourning and depression are a lot alike.  We don't medicate mourning.

[Anonymous]

Ginger, what you seem to be missing is that everything must be coded in the brain somehow.

For argument's sake (and to *way* oversimplify), let's say sadness = low serotonin and depression = extremely low serotonin.

Now, you could be born with fewer serotonin receptors, which would make you naturally sadder than other people.  You could experience the early deaths of your parents, which would lower your serotonin environmentally.  And a million other combinations could occur.

The point is, it doesn't matter if the cause of low serotonin is "natural" (ie death of loved one", artificial (ie, produced by the wearing off of drugs like cocaine) or genetic (ie, produced by pre-existing factors) or some combo thereof.

You can get at it several ways:  talk about it, use light therapy, use antidepressants.  If any of those work, your serotonin will go up.

it doesn't matter the initial cause.  so it doesn't matter how you treat it either.

All is preference, basically and there is no "natural."

[Anonymous]

re:  Freud fan.  I didn't read the original German, but I did read translations.  It still didn't impress me. It's still pseudoscience.

If you are interested in having your views challenged, check out "Therapy's Delusions" by Ofshe and Watters.

[Anonymous]

Oh... and one more reply to Ginger.

Re:  being skeptical about research and methods.  

i 100% agree with you.

But critiquing research doesn't mean throwing the baby away with the bathwater.  

it means:

understanding sample size and statistical significance

understanding sample selection and randomization

understanding diff between controlled research (AKA experimental) and observational data

understanding the importance of replication and peer review and good journals v. not so good.

understanding what factors were "controlled for" and how

using common sense

checking funding sources etc. but not using that as your only point of analysis

noting converging lines of evidence.

so, if there are multiple controlled studies published in good journals with large sample sizes  by a variety of researchers, you can pretty much believe it.

as opposed to one observational study published in an iffy journal with 2 subjects.

[Deborah]

http://www.drugawareness.org/Archives/1 ... rozac.html

Psychiatric Association to investigate Brown University

PROVIDENCE, R.I. (AP) - The American Psychiatric Association plans to investigate a report that the head of Brown University's psychiatric
department failed to disclose more than $500,000 in consulting fees, most from pharmaceutical companies whose health benefits he praised in journals and at conferences.

Dr. Martin Keller, a noted researcher on depression, could be banned from APA-sponsored conferences if he did not follow the group's policies for financial disclosures, association spokeswoman Lynn Writsel said Wednesday.

The Globe reported that Keller received consulting fees from companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly - all of which market antidepressants he praised in a series of medical research reports.

The school said Keller followed the school's rules to the letter. It requires annual conflict-of-interest reports for researchers who make more
than $10,000 or 10 percent in equity. The reports are reviewed by a misconduct committee and the dean of the graduate school.

"The fundamental basis of scientific research is that there is an open and honest presentation of the data that is not cooked, not slanted," Sasich
said.

[Anonymous]

On 2003-11-24 16:15:00, Deborah wrote:

"http://www.drugawareness.org/Archives/1stQtr_2001/010699Prozac.html



Psychiatric Association to investigate Brown University



PROVIDENCE, R.I. (AP) - The American Psychiatric Association plans to investigate a report that the head of Brown University's psychiatric

department failed to disclose more than $500,000 in consulting fees, most from pharmaceutical companies whose health benefits he praised in journals and at conferences.



Dr. Martin Keller, a noted researcher on depression, could be banned from APA-sponsored conferences if he did not follow the group's policies for financial disclosures, association spokeswoman Lynn Writsel said Wednesday.



The Globe reported that Keller received consulting fees from companies such as Pfizer Inc., Bristol-Myers Squibb, Wyeth-Ayerst, and Eli Lilly - all of which market antidepressants he praised in a series of medical research reports.



The school said Keller followed the school's rules to the letter. It requires annual conflict-of-interest reports for researchers who make more

than $10,000 or 10 percent in equity. The reports are reviewed by a misconduct committee and the dean of the graduate school.



"The fundamental basis of scientific research is that there is an open and honest presentation of the data that is not cooked, not slanted," Sasich

said.

"

Deborah, there are unscrupulous prostitutes who will roll a client for his money and not have sex with him.  There have been a *lot* of anecdotal accounts of said unscrupulous prostitutes over the years.

Just because those anecdotes and *many* of them unquestionably exist, doesn't mean that if you go to a whore and pay her her fee you're not going to get laid.  People do it all the time.

You can come up with all the anecdotes in the world of bad whores, or bad cops, or bad soldiers,  or bad scientists, but that methodology of yours will *never* prove that *all* whores, cops, soldiers, or scientists are bad at their jobs.

[Antigen]

On 2003-11-24 17:13:00, Anonymous wrote:


On 2003-11-24 16:15:00, Deborah wrote:

You can come up with all the anecdotes in the world of bad whores, or bad cops, or bad soldiers, or bad scientists, but that methodology of yours will *never* prove that *all* whores, cops, soldiers, or scientists are bad at their jobs.

Can you find a strong advocate for your position who is not somehow affiliated with the pharms and who does not have a conflict of interest as regards their advocacy for SSRIs?

The only maxim of a free government ought to be to trust no man living with power to endanger the public liberty.
-- John Adams, (1772)

[Deborah]

http://www.drugawareness.org/Archives/4 ... d0035.html

Insight Magazine?s interview with Dr. Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, shows that FDA was caught off guard when Dr. Arif Khan independently analyzed FDA?s data revealing that the new psychotropic drugs?including antidepressants (SSRIs) and antipsychotics? substantially INCREASED the rate of suicide in patients who participated in clinical trials testing the drugs? safety and efficacy between 1985-2000. (See: Clinical Psychiatry News

A recent study conducted by Arif Khan, medical director of the Northwest Clinical Research Center in Bellevue, Wash., and adjunct professor of psychiatry at Duke University School of Medicine, has revealed startling numbers of suicides committed and suicides attempted in the clinical trials for the new SSRI antidepressants ? numbers that for years had been hidden from both prescribing physicians and the public.

Kahn has examined the official clinical drug-trial data for all SSRIs approved by the Food and Drug Administration (FDA) between 1985 and 2000, in which 71,604 participants in the clinical trials were treated with antipsychotics, all SSRIs and anticonvulsants. The rate of suicides in the general public is 11 in 100,000, which means an incidence rate for those participating in the SSRI clinical trials of nearly 68 percent ? that?s 718 suicides for every 100,000. Kahn?s research further revealed that nearly 4 percent of SSRI drug-trial participants attempted suicide within the following year.

Asked what the FDA considers an acceptable number of deaths in clinical trials, Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, tells Insight, ?Your question is not particularly pertinent because these trials are not designed to influence suicide. If you look at any one individual trial it is very unlikely you will find a suicide in the trial, and generally we don?t.?

You see, says Laughren, ?It?s only if you accumulate data across a large number of trials that you even have enough data to look at. What you do see in individual trials is that patients who get drugs improve more than patients who get placebo. That?s what we see. When you do a meta-analysis across a large number of trials and you look at the other outcomes of suicide and attempted suicide, you don?t see any particular benefit from being assigned the drug compared to placebo.?

Which, of course, is the point. And Laughren further announced that ?the drug is not approved for the treatment of suicide. They are approved for the treatment of depression. Dr. Khan?s findings and our findings suggest that these drugs that we?re studying and approving for depression don?t appear to have a benefit on the outcome of suicide. That is not to say that they don?t have a benefit in treating depression.?

The drugs don?t have a ?benefit? on the outcome of suicide, which they in fact increase dramatically, but they do have a ?benefit? for depression. How is this possible when in fact the clinical trials for SSRIs show the suicide rate increased by 68 percent?

?What this [increased suicide rate] would tell us,? says Laughren, ?is that this is a serious condition, not a trivial condition. Depression is a serious condition. If you look at individual trials there are so few suicides that you wouldn?t be able to make sense of it all. It?s only after you look across multiple development programs over a very long period of time that you have enough events that you can get this kind of analysis.?

So, does this mean that FDA should wait longer periods of time before approving such drugs? ?No,? says Laughren, ?because the data are very clearly showing that these drugs benefit patients. What this tells us is that it is very difficult to exclude patients that are suicidal. As hard as you try you really are not able to predict who is suicidal and who is not. It [the trial data] does not tell us that being in clinical trials puts you at risk of suicide. It is not surprising to see a few suicides when you look at a fairly large number of patients, many of whom are followed for months or years.?

But the data show the suicide rate is elevated 68 percent when comparing SSRI participants to those given placebo and to the general population. So the question isn?t whether being in a clinical trial puts a person at risk, but whether a particular drug puts a participant in a clinical trial at risk. Besides, what good does it do to be declared officially less depressed if it means you are 68 percent more likely to kill yourself?

Whitaker says, ?You shouldn?t be seeing four to five times the suicide rate in drug-treatment groups, especially when these drugs are supposed to prevent this. It?s terrible that the FDA approved drugs with these high suicide rates. Naturally they do expect some suicides, but the question is whether there is something the drug is doing that is increasing that rate, and here it looks like it may be. A further question that has to be asked is why it has taken 15 years to find out about this data. Why are we learning about these increased suicides in clinical trials 15 years after the drugs were approved??


http://www.insightmag.com/global_user_e ... yid=285737

And the numbers in those trials:
http://www.drugawareness.org/Archives/3 ... d0002.html
Here are the suicide rates. Keep in mind as you read through these that the rate of 11 out of 100,000 persons per year is the suicide rate for the population at large.

*752 per 100,000 for those treated with atypical antipsychotics?risperidone (Risperdal), olanzapine (Zyprexa), and quetiapine (Seroquel)

*718 per 100, 000 for those treated with the SSRIs ? Selective Serotonin Reuptake Inhibitors (Prozac, Zoloft, Paxil, Luvox, Celexa)

*425 per 100, 000 for those treated for ?social anxiety disorder? with nefazodone (Serzone), mirtazapine (Remeron), and bupropion (Wellbutrin/Zyban)

*136 per 100,000 for those treated for panic disorder?with benzodiazepine alprazolam (Xanax)

*105 per 100, 000 persons for those treated for obsessive-compulsive disorder with anticonvulsant valproate (Depakote).

These figures clearly speak for themselves. The massive numbers of wrongful death suits will obviously follow. At least loved ones will know why they have lost those who meant so much to them via such tragic circumstances.

Keep in mind as you read through this data that the new antipsychotics listed here are basically a combination of the older antipsychotics and the SSRIs. They too have a STRONG effect upon serotonin levels. Also the most likely reason researchers saw an even higher rate of suicide in placebo with the antipsychotics is that these patients were likely being abruptly discontinued from their older antipsychotics for the clinical trials. This abrupt withdrawal causes suicide.


[ This Message was edited by: Deborah on 2003-11-24 18:41 ]

[Deborah]

http://www.drugawareness.org/Archives/2 ... d0015.html

Treatment guidelines for psychiatrists "call unequivocally for medication," says Robert DeRubeis, chairman of the psychology department at the University of Pennsylvania in Philadelphia.

But in the largest and longest-running study to pit medication against psychotherapy, Dr. DeRubeis and colleagues have found cognitive therapy -- which basically teaches patients to think about their thoughts differently -- is at least as effective as standard drugs in treating severe depression. The results of the study, which was funded by the National Institute of Mental Health and GlaxoSmithKline PLC, maker of the antidepressant Paxil, were presented at the annual meeting of the American Psychiatric Association in Philadelphia Thursday.

The findings have shocked hard-core "pharmaceuticals first" psychiatrists like Jay Amsterdam, a research psychiatrist at Penn and a co-author of the study. "I was a skeptic," he says. "I didn't think that in people with real, biochemically based depression, cognitive therapy would be effective. But I told Rob [DeRubeis], 'if you can fix my patients, I'll be a believer.' When I saw the result, I told him he had a highly effective treatment for depression, and that if he could bottle it he'd have a billion-dollar drug."

The results also run counter to those of an earlier study sponsored by the NIMH. In 1989, that three-site trial concluded that although cognitive therapy is as effective as drugs for mild depression, it is much less effective for the moderate-to-severe kind. The NIMH findings remain hugely influential, providing the basis for the drugs-first standard of care. In addition, other research has found that even if cognitive therapy helps initially, therapy patients face a higher risk of relapse than medicated patients.

A key unanswered question is which patients will respond better to drugs and which to talk therapy. Severity doesn't seem to determine that. Chronicity, however, does: The longer a patient has been depressed, the harder it is for cognitive therapy to help. That may reflect the entrenched nature of the depressive thoughts and the difficulty of changing the way the patient views them.

Doctors are reluctant to recommend cognitive therapy instead of drugs for depression not only because of the influence of the earlier NIMH study but also because of concerns about cost and insurance. Despite the widespread belief that long-term psychotherapy is financially impractical, however, in the Penn-Vanderbilt study it cost an average of $2,250 for the four months that patients received it. Treatment with drugs, which patients took for 16 months, cost $2,590. But insurance reimbursement favors drugs, so most primary-care doctors prescribe one of the SSRIs for depressed patients. HMOs, Dr. DeRubeis says, typically cap psychotherapy sessions at four. Many other plans cover half of allowed psychotherapy costs but a much larger percentage of prescription costs.

[Deborah]

http://www.drugawareness.org/Archives/2 ... d0022.html

After thousands of studies, hundreds of millions of prescriptions and billions of dollars in sales, two things are certain about pills that treat depression: Anti-depressants like Prozac, Paxil and Zoloft work. And so do sugar pills.

A new analysis has found that in the majority of trials conducted by drug companies in recent decades, sugar pills have done as well as - or better than - anti-depressants. What?s more, the sugar pills, or placebos, cause profound changes in the same areas of the brain affected by the medicines.

The new research may shed light on findings such as those from a trial last month that compared the herbal remedy St. John?s wort against Zoloft. St. John?s wort fully cured 24 percent of the depressed people who received it, and Zoloft cured 25 percent - but the placebo fully cured 32 percent. The findings do not mean that anti-depressants do not work. But clinicians and researchers say the results do suggest that Americans may be overestimating the power of the drugs and that the medicines? greatest benefits may come from the care and concern shown to patients during a clinical trial - a context that does not exist for millions of patients using the drugs in the real world.

?The drugs work, and I prescribe them, but they are not what they are cracked up to be,? said Wayne Blackmon, a Washington psychiatrist. ?I know from clinical experience the drugs alone don?t do the job.? Still, drugs may have become the reflexive treatment for the vast majority of Americans receiving medical attention for depression: As the number of doctor visits for depression rose from 14 million in 1987 to almost 25 million last year, medications were prescribed for nine in 10 patients Seattle psychiatrist Arif Khan studied the placebo effect in trials submitted to the Food and Drug Administration. His analysis of 96 anti-depressant trials between 1979 and 1996 showed that in 52 percent of them, the effect of the anti-depressant could not be distinguished from that of the placebo.

Khan said the makers of Prozac had to run five trials to obtain two that were positive, and the makers of Paxil and Zoloft had to run even more. ?It speaks to the difficulty we have in classifying and identifying the disorders we deal with,? said Thomas Laughren, who heads the group of scientists at the FDA that evaluates the medicines.

Scientists don?t understand the neural mechanisms of depression - or why medicines like Prozac and Paxil work.

http://www.drugawareness.org/Archives/2 ... oloft.html
A study came out this week indicating that placebo is more effective than Zoloft or St. John?s Wort. I thought, ?So what?s new??

But there seems to be an interest here because not everyone realizes yet that increasing serotonin is the worst thing you could do for someone who is depressed since his or her serotonin levels are already too high. What is low is their ability to metabolize serotonin--exactly what antidepressants lower even further. So one should conclude that ANYTHING that increases serotonin would only make the depression worse after the initial high caused by the shock of the initial serotonin increase.

How much of it is just all in one's head?
FDA Approves Sale of Placebo
http://www.drugawareness.org/Archives/3 ... d0018.html

[ This Message was edited by: Deborah on 2003-11-24 19:11 ]

[ This Message was edited by: Deborah on 2003-11-24 19:29 ]

[Deborah]

http://www.drugawareness.org/Archives/2 ... id_th.html

?Few agencies have a mandate to regulate such a broad swath of American life as the FDA, which oversees products that amount to one quarter of the nation?s consumer economy and 80 percent of the nation?s food supply.?

The New Republic provides the low down about why an the Administration withdrew the leading candidate to head the FDA. Dr. Alistair Wood, a highly regarded pharmacologist, is an eminently qualified drug safety expert(according to all knowledgeable people).

But several of Dr. Wood?s ideas to save lives and money displeased the pharmaceutical industry: for example, a credible system for post-marketing surveillance to catch adverse side effects fast, and switching some drugs to over-the-counter status. Industry prefers to sell drugs by prescription because they can charge more since insurance companies pay for them. Of course, industry doesn?t care about the uninsured who have no money to pay for the higher costs of drugs. These folks are solicited for clinical trials to test new drugs ?without any cost?.

The FDA is currently being run by a former food inspector, Lester Crawford, a veterinarian who is knowledgeable about food safety not drugs. Wouldn?t the public interest be better served if we had two commissioners (or separate agencies), one to oversee food products, the other drugs?

More at the link.

And more on the FDA
http://www.drugawareness.org/Archives/2 ... ng_sa.html
http://www.drugawareness.org/Archives/2 ... ng_sa.html


[ This Message was edited by: Deborah on 2003-11-24 19:20 ]

[Deborah]

Promise, this is the last post.. but couldn't resist. This site is full of interesting summaries of research, etc. No need to spend hours in a research library.

http://www.drugawareness.org/Archives/1 ... d0033.html

Intro to article:

Dan Ferber ([email protected])
 

 
Professional Codes of Ethics?in medicine and accounting?are in need of major revision. The ethics of both professions have been undermined as they came under the inordinate influence of Big Business.

An excellent article in BioMed Central (below) cites several examples of conflict of interest. The first being, John Mendelsohn, M.D., president of the U of Texas MD Anderson Cancer Center, who was a board member of ENRON as well as on the board of ImClone Systems, a biotechnology company that is reported to be under investigation by the US Securities and Exchange Commission for misleading investors about the potential of a new anticancer drug.

Lisa Bero, a pharmacologist and health policy expert at the University of California, San Francisco, notes that beyond individual conflicts of interest, the question that needs to be asked is: "who's driving the whole research agenda and who's planning it"? "Now we have to worry if those people are influenced by a corporate agenda." [See, BioMed Central below]

And in today's Wall Street Journal, Itzhak Sharav, Professor of Accountancy, Columbia University Business School, says, the Financial Accounting Standards Board (FASB) betrayed its mission when it failed to issue rules providing for full corporate financial disclosure. "The slippery slope that got us mired in the Enron swamp had its start in the FASB's initial capitulation to the politicians on the issue of stock options accounting." [See, WSJ below]

Reuters and USA Today report that British and American medical associations have crafted a new code of professional conduct. It "aims to restore public confidence in the medical profession, which has been badly bruised by cases of misconduct, to help doctors cope with ethical problems in the modern world and to reaffirm the profession's commitment to putting the needs of the patient first."

[Anonymous]

I would have no interest in reading anything that is against psychoanalysis.  If you don't believe and know you have an unconscious that drives your thoughts and behaviors, you are not going to understand.  About suicide, since I have felt those wanting to die feelings.  Causes of suicide are either someone told you, you shouldn
't be alive, or your perception was that you shouldn't be.  This is deeply wired into your psyche. Also suicide can also be an extreme rage or hatred, murder directed at yourself.  When we are older and not able to repress those feelings anymore, something triggers these feelings again.  It takes realizing that its something that will shift when talked about enough that helps.  Also when doing research, its funny to me because the persons unconscious is always going to bias the research.  Oh well, have a good day.

[Antigen]

Q: How do you get your teenage girl to lose interest in a boy?

A: Invite him over to dinner and just gush over how much you like the kid.

Psychology; the 2nd oldest profession.

Resentment is like taking poison and waiting for the other person to die
-- Malachy McCourt