Anti-Depression Drugs and Alzheimer's - A Deadly Fraud
- Published on Sunday, 15 June 2008 22:49
- Written by Stanton O. Berg
- Welcome to the World of VooDoo Medicine -
Note: I do not make specific or individual recommendations on treatments nor drug usage in any specific case. If you find the contents of this page applicable to your situation or your loved ones situation, make your decision based on a discussion with your own doctor or a competent doctor in the field of Geriatrics and Internal Medicine!
The U. S. Food and Drug Administration (FDA) has not approved any drugs for the treatment of behavioral and psychiatric symptoms in the persons with Alzheimer’s or other dementia. Further, No Drugs have been approved for the treatment of Depression in persons who have Alzheimer’s or some other dementia. This fact has apparently had no affect on the medical profession.
The seven (7) more commonly or widely prescribed anti-depressant drugs on the market are:
1. Sertraline (Zoloft).
2. Paroxetine (Paxil)
3. Fluoxetine (Prozac).
4. Citalopram (Celexa).
5. Veniafaxine (Effexor)
6. Nefazodone (Serzone)
7. Escitalopram (Lexapro).
*Note: there are 20 or more Antidepression drugs on the market.
University of Connecticut, (Storrs, Conn.) in a News Release dated August 13, 1998 states: “Antidepressant drugs effective mainly as a placebo effect of treatment.”
“The effectiveness of antidepressants is mainly in the placebo effect of treatment, not in the medication itself, according to a new study by a university of Connecticut psychologist. Seventy five percent of the response to medication for depression was a result of the patient being in treatment, while at the most 25 percent of the response was a true drug affect, asserts, the study by UConn psychologist Irvin Kirsch and former UConn graduate student Guy Sapirstein. (PhD, now a psychologist at Westwood Lodge Hospital in Needham, Mass.) This means that for a typical patient, 75 percent of the benefit obtained from the active drug would also have been obtained from an inactive placebo, Kirsch says. Whether the remaining 25 percent of the drug response is a true effect of the drug or a psychologically triggered response to side effects alone cannot yet be determined.”...”Kirsch and Sapirstein analyzed the changes in 2,318 patients whose primary diagnosis was depression and who had been randomly assigned to either antidepressant medication or placebo in 19 double-blind clinical trials.” “The study was a meta-analysis, a way of mathematically combining results from different studies with different measures. This analysis included 19 studies in which 858 participants received placebos and 1,460 participants received medication.”
Irving Kirsch and Thomas Moore did a second larger analysis in 2002 that was reported in USA TODAY on 7/7/2002 in their Health and Science Section.
“Through a Freedom of Information Act request, two psychologists obtained 47 studies used by the FDA for approval of the six antidepressants prescribed most widely between 1987-99.” “Overall antidepressant pills worked 18% better than placebos, a statistically significant difference but not meaningful for people in clinical settings, says university of Connecticut psychologist Irvin Kirsch. He and co-author Thomas Moore will release their findings July 15 in Prevention and Treatment, an e-journal of the American Psychological Association. More than half of the 47 studies found that patients on antidepressants improved no more than those on placebos, kirsch says.“ (Included in the study were all of the above listed 6 most popular antidepressants.)
The Harvard Health Letter of December 1st 2005 states: “Which antidepressant was shown in recent tests to be no more effective than a placebo. (Surprise – it was Zoloft).”
2010 – January – Journal of the American Medical Association reports on new study-analysis of Antidepressants. Headlines: ABC News – 6 January 2010 “Study Antidepressants, Placebos Near Equally Effective – Commonly Prescribed Antidepressants Had “Negligible” effect on Patients with Mild, Moderate, Even Severe Depression. Headline: Newsweek:29 January 2010 - “The Depressing News About Antidepressants – Studies suggest that the popular drugs are no more effective than a placebo, In fact, they may be worse.” The story by Sharon Begley…:
“But ever since a seminal study in 1998, whose findings were reinforced by landmark research in the JAMA last month, that evidence has come with a big asterisk. Yes, the drugs are effective, in that they lift depression in most patients. But that benefit is hardly more than what patients get when they, unknowingly and as part of a study, take a dummy pill – a placebo As more and more scientists who study depression and the drugs that treat it are concluding, that suggests that antidepressants are basically expensive Tic Tacs”.
“Hence the moral dilemma. The placebo effect – that is, a medical benefit you get from an inert pill or other sham treatment – rests on the holy trinity of belief, expectation, and hope. But telling someone with depression who is being helped by antidepressants, or who hopes to be helped, threatens to topple the whole house of cards. Explain that it’ all in their heads, that the reason they’re benefiting is the same reason why Disney’s Dumbo cold initially fly only with a feather clutched in his trunk – believing makes it so – and the magic dissipates like fairy dust in a windstorm.”
“But the question of whether antidepressants – which in 2008 had sales of $9.6 billion in the U.S. ,reported that consulting firm IMS Health – have any effect other than through patients’ belief in them was too important to scare researchers off. Proponents of the drugs have found themselves making weaker and weaker claims. Their last stand is that antidepressants are more effective than a placebo in patients suffering the most severe depression. So concluded the JAMA study in January. In an analysis of six large experiments in which as usual, depressed patients received either a placebo or an active drug, the true drug effect – that is, in addition to the placebo effect – was “nonexistent to negligible” in patients with mild, moderate and even severe depression. Only in patients with very severe symptoms (scoring 23 or above on the standard scale) was there a statically significant drug benefit. Such patients account for about 13 percent of people with depression. “Most people don’t need an active drug”, says Vanderbilts Hollon, a coauthor of the study. “For a lot of folks, you’re going to do as well on a sugar pill or on conversations with your physicians as you will on medication. It doesn’t matter what you do; it’s just the fact that you’re doing something.”…Why that should be remains a mystery, admits coauthor Robert DeRubeis of the University of Pennsylvania.”
“The Week” 29 July 2011 – “The Case Against Antidepressants” – “A growing chorus of critics is challenging the widespread use of antidepressants. Why?”
“What evidence do critics have?” “They point to numerous studies – including many done by Big Pharma itself – that found that SSRIs are little more effective at relieving depression and anxiety than placebos, or dummy pills. The Emperor’s New Drugs, psychologist Irwin Kirsch revealed that more than half of the clinical trials sponsored by drug companies for the Food and Drug Administration between 1987 and 1999 found that SSRIs alleviated depression no better than placebos A more recent study published in JAMA, the Journal of the American Medical Association in January 2010 found that for mild to moderate depression, the difference between placebos and antidepressants was “nonexistent to negligible…The medications proved significantly more effective in only the most severe cases, about 13% of the patients.”…”If Prozac and its chemical cousins are barely more effective than placebos, how did the drug companies get the government to approve them? To approve a drug, the FDA requires pharmaceutical companies to provide just two positive trials showing that it’s more effective than a placebo. But the FDA does not set a limit on the number of negative trials a company can carry out before coming up with two positives. Theoretically a drug company could carry out hundreds of failed trials before finally ending up with two successful ones…Kirsch says, “Adverse data are suppressed. It’s as if the fox has been hired to guard the hen house.”…”Is depression caused by a chemical imbalance? There’s actually little evidence supporting this widespread belief, which was heavily promoted by the drug companies. In fact, studies shave found that the levels of serotonin in depressed people’s brains are the same as they are in those of non-depressed people. “The serotonin theory of depression, ”says Irish psychiatrist and author David Healy ...”is comparable to the masturbatory theory of insanity.”
AMDA’s publication “Caring for the Ages”, December 2011 headlined an article: “Antidepressants Showed No Benefit in Alzheimer’s”.
“Sertraline (Zoloft) and Mirtazapine (Remeron), two commonly prescribed antidepressants shown to carry risks of adverse events in dementia patients, had no more clinical benefit than placebo in people with possible or probable Alzheimer’s disease, a multicenter trial in the United Kingdom found. Researchers …of the Institute of Psychiatry, Kings College, London reported their results from a …double blind, randomized trial in the Lancet (2011).
The team recruited more than 300 patients from geriatric psychiatry service in nine centers. Eligibility criteria were probable or possible Alzheimer’s disease, depression lasting 4 weeks or longer and dementia related depression score of 8 or higher on the Cornell Scale for Depression in Dementia.
“Our trial has negative findings...important clinical implications...Analysis of the data suggests clearly that antidepressants, given with normal care, are not clinically effective when compared with placebo for the treatment of clinically significant depression in dementia.”…”Placebo reduced depression more than antidepressants did in dementia.”
In a commentary published with the study report, Henry Brodaty, MD, a dementia researcher at the School of Psychiatry at University of New South Wales, Australia, called the results important because the study is the largest trial of antidepressants in dementia ever. Also, depression affects about 20% of the 36 million people with dementia worldwide.”
What Does This All Mean?
What does this all mean? It means an overall fraud against the public on a grand scale. It also suggests that there is no real benefit to the person with Alzheimer’s or other dementia when they do not possess the mental capacity to receive placebo benefits. The Alzheimer’s or other dementia victims have lost the ability to remember, rationalize, reason or think. The placebo effect is all psychological. As all the studies from 1998, 2002, 2005, 2010 and now 2011 point out, the value of the drugs are negligible or non existent and the benefit is no more than that of a placebo (in some cases less then a placebo) for mild, moderate and severe depression. The last study talks of the placebo effect and that it is based on the trinity of belief, the expectation and the hope of benefit. The Alzheimer's patients in middle and late stages, lack the mental ability to form the necessary trinity of belief, expectation or hope of benefit to produce the placebo effect. Alzheimer's patients in the early stages may well experience the placebo effect as they still retain the mental capacity for the so called "Holy trinity" required for the placebo effect - belief, expectation and hope.
Editorial Note: Most treatment for depression when qualified doctors as psychiatrists are the attending doctors, consists of two phases. (1.) Psychotherapy and (2.) drugs. Many times credit for an improvement is given to the effect of the drugs when it is really a part of the pyychotherapy or the "talk" therapy phase of the treatment. This "truth" is recognized in the reviews of most recent studies reported in 2010. An interesting quote from the 210 studies review: "It's all well and good to point out that psychotherapy is more effective than either pills or placebos, with dramatically lower relapse rates. But there's the little matter of reality. In the U.S. most patients with depression are treated by primary-care doctors, not psychiatrists."
Drug companies tend to publish only the studies that support their drug for approval and ignore the negative studies that show it of little value. I recall a lecturer at an Alzheimer's conference, who indicated in the question and answer session that the negative studies usually are never a matter of publication. He indicated that the readers are not interested in the negative studies. They are interested only in the positive studies. The FDA only requires that the drug companies provide 2 clinical trials showing the drug will provide benefits greater than a placebo effect and of a statisitcally significant amount. It makes little difference that there are a half dozen more trials that show the drug to be of no benefit. The negative trials are ignored and usually never published.
Note: The lack of publication of negative studies is verified in an article appearing in the Wall Street Journal on 12 December 2008 by Robert Lee Hotz. The article sub title reads: "Untold numbers of Clincal Trial Results Go Unpublished; Those that are made Public can't Always be Believed." "Among 90 FDA approved drugs betweeen 1998 and 2000 included in a statistical analysis there were: 909 clinical trials - 394 Published in peer-reviewed medical journals. - 515 unpublished." "researchers who reviewed the FDA's regulatory paperwork for dozens of recently approved drugs found that in some clinical trials submitted for publication, conclusions had been changed, statistics revised, and outcomes altered to make treatments look more effective. Among 43 outcomes reported in the FDA filings that did not favor a drug, 20 were never published. In four out of five instances in which the statistical significance of findings was changed from the FDA filing, the published version was more favorable."
Article in the Minneapolis Star-Tribune (Ira Rosofsky - Psychologist) 27 March 2009 entitled: "Enough With The Drugging of Old People." Sub title reads: "We spend billions on this practice. Does it make living with dementia any easier? for us, maybe, Not for them."
"A survey released in 2002 by the Kaiser Foundation found that the staffs in a typical nursing home spend about two hours and 20 minutes a day with each resident. For the remaining 21 hours and 40 minutes, residents are left to their own (mostly medicated) devices. Where is the comfort in that? Dementia sufferers in nursing homes are not only taking donepezil and memantine but other similarly questionable drugs for depression, anxiety, psychosis or simply being ornery. It is easier to medicate than to engage. And when the chemical restraints don't work, nursing homes use physical restraints...why not admit the failure of medication and instead spend some of that money on more staff to hold the hands of both patients and their families?" Beyond nurturance, the savings could be deiverted to research that might yield not only statistically significant but meaninful and large improvements. Or maybe even a cure."
Editorial Note: The Criminal Negligence (Involuntary Manslaughter) trial of Michael Jackson’s personal physician Conrad Murray revealed the coroner’s finding that Jackson died of “acute Propofol (hospital anesthetic) intoxication aggravated by the effects of Lorazepam (Ativan).an anti-anxiety drug. (3 November 2011) It should be noted that the drug Lorazepam is frequently prescribed for Alzheimer’s patients despite the fact that it is not approved for such use by the FDA. Below are the listed side effects of this drug. The last side effect one needs in the care of Alzheimer's is cognitive impairment and memory impairment.
Ativan is noted for the side effects of "addiction, depression, and cognitive impairment;.."Lorazepam (Ativan) appears to have more profound adverse effects on memory than other benzodiazepines; Lorazepam (Ativan) impairs both explicit memory and implicit memory. In the elderly, falls may occur as a result of benzodiazepines. Adverse effects are more common in the elderly, and they appear at lower doses than in younger patients. Benzodiazepines can also cause or worsen depression.
The Deadly Side Effects of Anti-Depressants!
Archives of Internal Medicine – Vol. 169 No. 22, December 14/28 2009. – “Antidepressant Use and Risk of Incident Cardiovascular Morbidity and Mortality Among Postmenopausal Women in the Women’s Health Initiative Study”. (Sponsored by the National Institute of Health and the National Heart, Lung and Blood Institute.) This study involved 136,293 postmenopausal women. A very large study over a long period of time. .Cardiovascular morbidity and all-cause mortality for women with new antidepressant use at follow up were compared with those characteristics for women taking no antidepressants at follow-up. (Mean follow-up, 5.9 years.). Antidepressant use (both Tricyclic antidepressants ands SSRI antidepressants were involved with no significant differences between the two types.) was associated with increased stroke risk (hemorrhagic stroke and fatal stroke) and all cause mortality. “Psychology Today” commenting on the results of the study (January 4, 2010) referred to the study as a “Firebell in the Night”. They concluded that the large study makes it highly credible. There were 2357 strokes, 445 of which were fatal over the follow up period. That there was not difference between types of antidepressants. (Tricyclic and SSRIs) The use of antidepressants doubled the risk for fatal hemorrhagic stroke and one third higher risk of mortality from all causes. An accompanying commentary found no fault with the study. Dr. William Campbell Douglass II, editor of an Eletter called the “Daily Dose” on 17 December 2010 made the following comments on the study – “Reasons 47 and 48 to avoid antidepressants: They increase your risk of stroke and death...Out of 136,293 women in the Women’s Health Initiative, the ones taking SSRIs like Prozac and Zoloft were 45 percent more likely to have stroke and 32 percent more likely to die, compared to those not taking the drugs…Those are odds I’d rather not take my chances with, especially when the drugs aren’t that effective to begin with…In study after study, placebos routinely outperform antidepressants. In fact, these meds are consistently beaten by just about anything researchers put them up against…I wouldn’t be surprised if a study proved that you could beat depression by going fishing…A study published in the American Journal of Clinical Nutrition found that seniors who had four or more cups of green tea per day were 44 percent less likely to suffer from depression.”
Archives of Internal Medicine – Vol. 169 No. 22, December 14/28 2009. – “Antidepressant Use and Risk of Incident Cardiovascular Morbidity and Mortality Among Postmenopausal Women in the Women’s Health Initiative Study”. (Sponsored by the National Institute of Health and the National Heart, Lung and Blood Institute.)
This study involved 136,293 postmenopausal women. A very large study over a long period of time. .Cardiovascular morbidity and all-cause mortality for women with new antidepressant use at follow up were compared with those characteristics for women taking no antidepressants at follow-up. (Mean follow-up, 5.9 years.).
Antidepressant use (both Tricyclic antidepressants ands SSRI antidepressants were involved with no significant differences between the two types.) was associated with increased stroke risk (hemorrhagic stroke and fatal stroke) and all cause mortality.
“Psychology Today” commenting on the results of the study (January 4, 2010) referred to the study as a “Firebell in the Night”. They concluded that the large study makes it highly credible. There were 2357 strokes, 445 of which were fatal over the follow up period. That there was not difference between types of antidepressants. (Tricyclic and SSRIs) The use of antidepressants doubled the risk for fatal hemorrhagic stroke and one third higher risk of mortality from all causes. An accompanying commentary found no fault with the study.
Dr. William Campbell Douglass II, editor of an Eletter called the “Daily Dose” on 17 December 2010 made the following comments on the study – “Reasons 47 and 48 to avoid antidepressants: They increase your risk of stroke and death...Out of 136,293 women in the Women’s Health Initiative, the ones taking SSRIs like Prozac and Zoloft were 45 percent more likely to have stroke and 32 percent more likely to die, compared to those not taking the drugs…Those are odds I’d rather not take my chances with, especially when the drugs aren’t that effective to begin with…In study after study, placebos routinely outperform antidepressants. In fact, these meds are consistently beaten by just about anything researchers put them up against…I wouldn’t be surprised if a study proved that you could beat depression by going fishing…A study published in the American Journal of Clinical Nutrition found that seniors who had four or more cups of green tea per day were 44 percent less likely to suffer from depression.”
June’s Experience with Lexapro, Zoloft, Remeron and Paxil: (Lexapro, Zoloft and Paxil are SSRI type)
In January 2005, before June went into an Alzheimer's facility, Lexapro was prescribed for her when she was experiencing hallucinations and related symptoms. June was removed from the Lexapro after less then 30 days as her symptoms appeared to be aggravated by the drug.
June was experiencing crying, sadness and other depression type symptoms in the early months of 2005. In June of 2005, June was placed on 50 mgs of Zoloft on the recommendations of the RN who was the Health Care Coordinator ar the Wellstead of Rogers.(an Alzheimer's care facility) This RN assured me that the Zoloft would soon change June's crying and depression like symptoms. This was the same person who days earlier had asked me "Why is June Crying?" My reply was: "because June has Alzheimer's". I had more that I wanted to add to this reply, but did not do so. (And this nurse was the Health Care Coordinator for an Alzheimer's care facility!)
After a few months no appreciable improvement noted. My email to our children on 10/25/2005 reads: “It was an overall bad day for Mom. She cried during most of the noon lunch. She also got angry with me for keeping her from pouring her milk over her food. She said she was going home. She ate only a part of her lunch. After lunch she was taken to the toilet and was upset when she came back. She cried and sat with her head on my shoulder.”
On 10/28/2005 the Zoloft was increased to 75mgs This increase in dosage resulted in my email of 12/1/2005 to the Director of Operations at the Wellstead:
“June has developed severe tremors in her hands. Yesterday noon she could hardly get a spoon to her mouth. She would not let me help her and became angry with me. For an hour following this episode, June did not know me. She said she had no husband and that we were not married.”
(Photo on right is June at the Wellstead November 6, 2005)
In an email to my children dated 12/7/2005 I described June’s symptoms: “Mom has always had sad moods, usually on a daily basis - once or multiple times. In the 9 months that Mom has been at the Wellstead, it has been a rare event for me to see her go all day without a sad period....Now her sad moods are longer with less good time between. What alarms me most is that she now also exhibits anger during the moods. I have never felt that the Zoloft was helping her. After 7 months Mom has shown no signs of improvement and seems to be getting worse.”
When the Zoloft appeared to be having adverse effects on June’s symptoms, she was switched to 15 mgs of Mirtazapine (Remeron) for a few days beginning on 8 December 2005. This decision appeared disasterous. While it removed the tremors from her hands, June had difficulty walking. My daily log for December 11th, 2005 noted that June "seemed to have difficulty walking and her balance was not good." In an email to our children on 12 December 2005 I wrote: "Yesterday I noted that her walking had become more difficult from what I was used to seeing. Today it was so difficult that simply walking her from the dining area to the T Hall (room) seemed to exhaust her and she went for the closest chair. Wally mentioned (another husband caregiver) noting the same last night. I talked with the doctor and the NP will see Mom on Wednesday. However for the time being they are backing off of the use of the new drug Mirtazapine (Remeron)." Almost immediately the walking difficulty disappeared. On December 21st, 2005 June was started on10 mgs of Paxil. No walking difficulties were noted. However over the year 2006 the Paxil also appeared to have no observable affect on the sadness, June was gradually removed from the Paxil and all antidepressants after April 2007.June had then traveled further into the late stages of Alzheimer’s, her responsiveness had decreased and most of the depression type symptoms had also disappeared.
Note: During the year that June was at the Wellstead of Roger's, June fell 8 times. Two of the falls resulted in serious injuries. (fractured pelvis) June's first fall was on 11 August 2005 just 2 months after starting the use of Zoloft.. The other 7 falls took place during the next 5 months and all while on antidepressants. I became educated about this class of drugs too late to be of help to June. I must admit that this first year's experience with nursing home medical staffs resulted in my developing a contempt for the basic knowledge and judgment of most doctors and nurses when it relates to Alzheimer's and dementia related medicine. I soon found that my knowledge and research was superior to theirs! The falls so demoralized June that she no longer had an interest in walking and physical therapy was of no value. I carry a guilt burden concerning the use of the antidepressant drugs and the resulting falls and injuries. I should have done my independent investigation earlier and said "No" to the use of antidepressants.
See the companion essay on the dangerous use of anti-psychotic drugs on Alzheimer's and dementia victims...another class of drugs that has no FDA approval for such usage:
Note: After battling Alzheimer's for almost 11 years, an exhausted June was finally called home by God on October 23rd, 2008. Her funeral notice as published in the Minneapolis Star in October 2008 can be seen on this website under the "In Memoriam" label - or just click on:
For the story of June’s favorite home at 6025 Gardena Lane and the poem I wrote about this home during a day of deep sadness, click on the below link: (This was June’s home for almost 40 years. It was constructed shortly after the previous home was severely damaged in a tornado. 6025 Gardena Lane was the first home the June participated in the selection and purchase of a lot on a small hill, helped with the design of the home and watched it being constructed. 6025 Gardena Lane had a special place in her heart.)