‘Sad facts about happy pills’ – not so many facts!

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Posted 23 August 2011; updated 17 December 2011


Edition 10 of a local magazine ‘Health Intelligence’ has on its cover a headline: ‘Antidepressant dangers exposed – The sad facts about happy pills’ – an article written by Morné Malan who has a PhD in English.

(The original article being deconstructed can be read here:
Sad Facts About Happy Pills – Health Intelligence Edition 10 page14)

UPDATE (17 December 2011)

Comment 8 of the comments section below contains the following statement by Brent Murphy the editor of Health Intelligence magazine: “Therefore we will be publishing the following statement in edition 12 (edition 11 is already in circulation so it can’t appear in that)”. (emphasis added) This is followed by the promised  “CLARIFICATION” which reads:

In an article Sad Facts about Happy Pills featured in Health Intelligence 10,  it was reported as “FACTS” that antidepressants cause death, brain damage and cancer.  Whilst we believe it is correct that the research referred to in the article raises concerns that antidepressants may be associated with cardiac-related mortality, brain nerve damage, and ovarian and breast cancer, this research is preliminary, mostly performed on animals, and needs confirmation with larger human based data.  Therefore these effects should not have been reported as “FACTS” implying certainty, but rather “CONCERNS” implying possibility.  The writer also suggested that people who suffer from mood disturbances should consider stopping accepting prescriptions for antidepressants based on this evidence.  The editorial board of Health Intelligence does not believe that people who are taking antidepressants should discontinue their therapy based on the possibilities mentioned in this article.  Furthermore, should antidepressant therapy be discontinued or changed it should be done so under medical supervision and over a gradual weaning-off time period. It is also the opinion of our board, based on current evidence, that the risk vs. benefit ratio favours treatment of people who suffer from severe depression (as opposed to mild/moderate depression), with antidepressant medication.”

Did Mr Murphy keep his word? Here is a copy of what was actually published in Health Intelligence magazine edition 12 on page 11:

 

Access the text of the Update by Brent Murphy – Editor of Health Intelligence here.

Not quite the same is it? In ‘fact’ it is rather watered down, leaves out a couple of important statements that were in the original ‘clarification’, and adds an invalid ‘excuse’ (in this context) for unethically using animal studies to present inaccurate,  misleading and unproven FACTS about antidepressants to the public.

It is worth repeating that in severe major depression, antidepressants save lives because people with severe major depression are such a high suicide risk. I wonder why the opinion of the magazine’s editorial board that people with severe depression should be treated with antidepressants is no longer reflected in published update. Was this the actual opinion of the editorial board – or is the editorial board perhaps only a token body?

Here is the rest of the original critique of the article (first posted 23 August 2011) referred to on the cover as ‘Antidepressant dangers exposed – The sad facts about happy pills’ in Health Intelligence Edition 10 page 14:

The headline inaccurately refers to all antidepressants, whereas the article deals only with one class of antidepressants – the ‘selective serotonin reuptake inhibitors’ or SSRIs.

On the contents page the article has a subtitle: ‘Side effects include brain damage, cancer and heart attacks’. Again this is inaccurate in that it refers to all antidepressants. It is only when reading the article (on page 14) that a different subtitle ‘New study results highlight how SSRI antidepressants work by damaging the brain’. SSRIs work by increasing the amount of serotonin in the brain. Serotonin is believed to ‘assist the innate healing power of the body’ in overcoming depression.

Malan does not distinguish between ‘mild’ depression and ‘moderate to severe’ depression in the magazine article which is one of its ‘fatal flaws’. The article implies that people taking antidepressants are likely to be harmed (damaged) more than they would benefit from the medication. At the end of the article a list of alternative substances as part of a completely unproven ‘Natural Antidepressant Protocol’ is recommended. The dangers of a person with moderate to severe depression who may read the magazine article and suddenly stop taking their prescribed medication to change to the ‘protocol’ promoted in the magazine are very serious, particularly as no acceptable evidence exists that the ‘natural protocol’ is any better than prescription antidepressants for moderate to severe depression. The ‘protocol’ may even result in the depression getting worse. We can’t be sure, and what’s even more serious is that the promoters of this ‘protocol’ cannot be sure either.

The most extreme consequence of severe depression is suicide. The magazine article is an example of irresponsible health information as it does not include any warnings about the important process medical doctors refer to as ‘weaning off’ antidepressants, and doing so under medical care. Self-treatment of moderate to severe depression is not recommended. 

NB: The normal variation in human emotions of ‘feeling sad’ is not depression and should not be treated with antidepressants.

 

The evidence behind the ‘facts’ quoted in the article.

 

The article states: ‘a recent study reported that anti-inflammatory medication reduces SSRIs’ effectiveness by as much as 14%’. This statement is not made by the authors and does not apply to human beings. The information comes from a study done in mice with data from humans added on – not controlled human clinical study data. To quote from the Discussion section of this article:

 

Because the clinical analyses were conducted as post hoc analyses, it would be informative to evaluate the effects of NSAIDs [Non-Steroidal Anti-Inflammatory Drugs] and other analgesics on SSRI antidepressant response in a prospective, double-blind, randomized clinical study. Specifically, it will be important to standardize medications to better evaluate their role in determining treatment outcome. In the present study, no adjustments were made for multiple comparisons in the analyses.

In other words the authors themselves indicate the need for further research!

Fact: The statement about anti-inflammatory medications is not supported by the evidence.

 

The magazine article then states:

“FACT 1: THEY [Antidepressants] CAUSE BRAIN DAMAGE”

The evidence (three references) for this statement is based mainly on animal studies (rodents and primates) and some human studies (including post-mortem brain studies). The only human component that has any real bearing on this claim is stated as follows:

These results, together with . . . the increased BDNF [brain-derived neurotrophic factor] levels in patients treated with antidepressants, suggest a central role for this neurotrophin and its receptor in the molecular mechanisms of antidepressive therapy.(emphasis added)

In other words this is still an hypothesis about the mechanisms of action of antidepressive therapy. These 3 references cannot be used to support the claim of ‘brain damage’ stated in the magazine article and further investigation is needed.

 

Fact: Fact 1 is not supported by the evidence provided.

 

The next ‘fact’ is:

FACT 2: THEY [Antidepressants] CAUSE CANCER

The evidence (one reference) has the following conclusion in the abstract of the report:

 

Both the pre-clinical and clinical data are mixed in terms of showing an association between AD [antidepressant] use and breast and ovarian cancer. The possibility that ADs may exhibit a bi-phasic effect, whereby short-term use and/or low dose antidepressants may increase the risk of breast and ovarian cancer, warrants further investigation. Industry affiliations were significantly associated with negative conclusions regarding cancer risk. The findings have implications in light of the 2009 USPSTF guidelines for breast cancer screening and for the informed consent process.(emphases added)

In other words, again, this is not a fact but needs further investigation.

Fact: Fact 2 is not supported by the evidence provided.

The last ‘fact’ is:  

FACT 3: THEY [Antidepressants] CAUSE DEATH

 

This statement seems intended to induce fear in readers, and is frankly irresponsible. Two references are used in making this statement. The first reference has the following conclusion:

In this cohort of women without baseline CHD [coronary heart disease], depressive symptoms were associated with fatal CHD, and a measure of clinical depression including antidepressant use was specifically associated with SCD [sudden cardiac death]. Although antidepressant use might be a marker of worse depression, its specific association with SCD merits further study.(emphasis added)

In other words – this is not yet a fact! The second reference has the following conclusion:

In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality. Antidepressants were not associated with risk of CHD. Tricyclic antidepressants and SSRIs may be associated with increased risk of mortality, and SSRIs with increased risk of hemorrhagic and fatal stroke, although absolute event risks are low. These findings must be weighed against quality of life and established risks of cardiovascular disease and mortality associated with untreated depression.(emphases added)

The authors of this latter reference commented on the research in the first reference quoted above that ‘the possibility of residual confounding by depression cannot be ruled out.’ In other words, the possibility of the depression in some women still being a factor in developing the cardiovascular effects cannot be excluded. The authors also emphasise the crucial point about the risks of untreated depression.

The fact is neither of these studies can be used as evidence that antidepressants are the reason for sudden cardiac deaths. The subtitle on the contents page which includes ‘heart attacks’ is actually contradicted by the authors who stated that antidepressants were not associated with risk of coronary heart disease. (Not all sudden cardiac death is necessarily due to coronary heart disease.)

Fact: Fact 3 is not supported by the evidence provided.

The main facts we should be worrying about are that selective use and misinterpretation of scientific references is unacceptable and irresponsible; and that the promotion of unproven remedies which have not been independently evaluated for their quality, their safety or whether or not they work can be considered immoral and unethical.

 

Antidepressants are not just ‘happy pills’: in moderate to severe depression they are life-saving when used correctly.

 

The magazine article then concludes with a potentially thoroughly dangerous, irresponsible and untested statement that: ‘perhaps its time for all those suffering from mood disturbances beyond their control to stop accepting prescriptions for dangerous medicine, and to turn to safer, more natural alternatives’.

This is followed by a heading:

‘Natural Antidepressant Protocol’

 

The following substances are listed:

5-HTP (100mg three times per day)

SAMe (400mg once or twice daily)

Tyrosine (1,000mg twice daily)

Phosphatidylserine (100mg two to three times per day)

Magnesium glycinate (400mg twice daily).

 

No information is given about this ‘protocol’ or how to implement it. The ‘protocol’ appears to have been tagged on to the article as an afterthought. There is no evidence that this combination of substances in the recommended dosages has been tested or been proven to be effective.  According to the website associated with the publisher and the editorial director of Health Intelligence, when 5-HTP is combined with Vitamin B6, it is said to increase the amount of serotonin in the brain by 60% when compared to taking 5-HTP alone. No evidence for this statement is provided and if correct, it is highly likely to have come from animal studies. [This statement remains on 17 Dec 2011 – RJ]

It would be interesting to find out if anti-inflammatories interfere with the ‘effectiveness’ of the serotonin produced by 5-HTP as is claimed happens with SSRIs. Perhaps the company is planning to do research to disprove this possibility? Of course, as the magazine article points out for ‘Fact’ 2 above, where financial ties with researchers appeared to influence the results, the company would have to ensure that completely independent researchers carry out such studies. (It should also be noted that the magazine contains advertising for the company associated with the publisher [Colin Levin] and the editorial director [Brent Murphy], who must be considered fully accountable for the content of the magazine. The magazine can even be purchased directly from the company’s website.) [This link is still operative on 17 Dec 2011 and stocks are still available – RJ] 

The ‘natural protocol’ includes SAMe which is the abbreviation for S-adenosylmethionine. It would seem from the article that all the substances in this protocol should be purchased and taken together. However on the website for 5-HTP under the heading ‘Interactions’ the following statement is made: ‘[t]he use of 5-HTP together with the following products may result in adverse effects, and concomitant use should be avoided’(emphasis added) followed by a list of antidepressant medications. Under a sub-heading ‘Herbs and supplements’ of substances to be avoided, SAMe is listed! So while the magazine article seems to recommend using 5-HTP and SAMe together – the website of the company associated with the magazine recommends against it. [This statement contradicting the presumptive advice in the natural antidepressant protocol in the magazine article remains on the website on 17 Dec 2011 – RJ]

The ‘antidepressant dangers exposed’ in the magazine article are not factual, but misleading and irresponsible information which could have serious consequences for a person suffering from moderate to severe depression.

 

[Copies of references available on request. It should be noted that the editors and reviewers of the different articles would ‘de facto’ be in agreement with the conclusions quoted.]

This analysis was prepared by Professor Roy Jobson. Professor Jobson is a medical doctor and Associate Professor of Pharmacology in the Faculty of Pharmacy at Rhodes University. He has previously served as a Council member of the Medicines Control Council (MCC), was the inaugural Chairperson of the MCC’s Pharmacovigilance Committee, and a member of its Clinical Trials and Complementary Medicines Committees. He is an Associate of the College of Clinical Pharmacologists of the Colleges of Medicine of South Africa. He is a Council member of the Allied Health Professions Council of South Africa as a community representative. His analysis of this article does not reflect an official viewpoint of any of these institutions.

 

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9 Responses to ‘Sad facts about happy pills’ – not so many facts!

  1. Sophia van Rooyen 23 August, 2011 at 5:31 pm #

    Prof Robson
    Thanks for this wonderful analysis of the article. As a family physician I find this helpful to explain the inaccuracies in this article. I am forwarding this to my patient.
    Sophia

  2. Kevin Charleston 23 August, 2011 at 6:48 pm #

    Seems like an an oxymoron then "Health Intelligence".
    Thanks for the info Professor.  

  3. Brent Murphy 24 August, 2011 at 10:47 am #

    Dear All

    I am the editor of Health Intelligence magazine and a director of SOLAL Technologies,a company that manufactures natural medicines.

    Roy's commentary is not factual. 

    Firstly the risks of antidepressants are not limited to the SSRI class only  (see below).

    Secondly the author (Morne Malan) of the Health Intelligence article DID specifiy that he was referring to SSRI's; he did not simply refer to all antidepressants as Roy suggests.

    Thirdly, Roy implies that there is no evidence that natural medcinces are effective for depression.  This is untrue.  a simple search of pubmed will show there are natural medicines that are effective.

    Most importantly I would like to draw readers attention to this research, not to discourage them from taking antidepressants, but so that they can be fully informed, because without information, one cannot give informed consent:
     
    ANTIDEPRESSANTS AND CANCER:
    Antidepressants and Breast and Ovarian Cancer Risk: A Review of the Literature and Researchers' Financial Associations with Industry
    http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0018210
    "Both the pre-clinical and clinical data are mixed in terms of showing an association between AD use and breast and ovarian cancer. The possibility that ADs may exhibit a bi-phasic effect, whereby short-term use and/or low dose antidepressants may increase the risk of breast and ovarian cancer, warrants further investigation."
    "Previous studies in a variety of biomedical fields have found that financial ties to drug companies are associated with favorable study conclusions."
    " Industry affiliations were significantly associated with negative conclusions regarding cancer risk."
     
    …and financial ties bias
    http://www.pharmalot.com/2011/04/antidepressants-breast-cancer-industry-studies/
    A new meta-analysis of 61 trials identified a connection in nearly 33 percent of the epidemiological and pre-clinical studies conducted between 1965 and 2010 found an association between cancer and antidepressants. And the link was stronger among women using selective serotonin reuptake inhibitors, or SSRIs.
     
    Moreover, the study found researchers with industry ties were significantly less likely than researchers without those affiliations to conclude antidepressants increase the risk of breast or ovarian cancer. The authors of the meta-analysis, which was published this week in PLoS Medicine, suggest the findings raise public health and policy issues, “because there is increasing evidence that financial ties among industry, investigators, and academic institutions can affect the research process.”
     
     
    ANTIDEPRESSANTS INCREASE ALL CAUSE MORTALITY AND STROKE:
    http://www.medscape.com/viewarticle/714216
    "Postmenopausal women taking either a tricyclic antidepressant (TCA) or a selective serotonin-reuptake inhibitor (SSRI) appear to be at increased risk for all-cause mortality, and SSRI users seem to be at increased risk for hemorrhagic and fatal stroke, although the absolute event risks are low, according to an analysis from the Women's Health Initiative (WHI) study."
     
    ANTIDEPRESSANTS: NO EVIDENCE OF EFFECTIVENESS:
    Moncrieff J, Cohen D (2006)
    Do Antidepressants Cure or Create Abnormal Brain States?
    PLoS Med 3(7): e240. http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0030240
    "Drug-induced effects of antidepressants vary widely according to their chemical class—from sedation and cognitive impairment to mild stimulation and occasionally frank agitation"
    "No evidence shows that antidepressants or any other drugs produce long-term elevation of mood or other effects that are particularly useful in treating depression."
     
    Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration
    http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045
    "Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance."
     
    ANTIDEPRESSANTS AND WEIGHT GAIN/DIABETES
    http://www.medscape.com/viewarticle/590844
    Taking moderate to high daily doses of antidepressants for more than 2 years is associated with an 84% increased risk for diabetes, according to a large observational study.
    The increased risk was particularly notable for the selective serotonin-reuptake inhibitor (SSRI) paroxetine and the tricyclic antidepressant amitriptyline.
    Weight gain might explain much of the relation between antidepressant use and diabetes, according to the study authors.
     
    All the best
     
    Brent Murphy – B.Pharm(Rhodes), MPS
    Editor -Health Intelligence Magazine

  4. Roy 24 August, 2011 at 3:21 pm #

    Thanks for your comments Brent.

    Please note that my critique was confined to the specific Health Intelligence article: "Antidepressant dangers exposed – The sad facts about happy pills" and it was not a general review of antidepressants. I was concerned that what your magazine was presenting as sensationalist "fact" to the public was not (yet?) fact – if it can or ever will be shown to be accurate. My point was that by using the very words of the authors in the references quoted by Morné Malan, it could be shown that what was being presented as factual was in fact (sic) inaccurate.  As you well know, I do not accept non-human studies as appropriate evidence for humans.

    If you carefully read what I wrote again, you will see that I clearly pointed out that Health Intelligence referred generally to antidepressants (i.e. "all" antidepressants) on its cover and its contents page. I also clearly pointed out that the article on page 14 was about SSRIs.

    I did not say there was no evidence for natural medicines. I said there was no evidence for the "Natural Antidepressant Protocol" recommended in the article. I would be very interested in being provided with evidence for the efficacy of this protocol in moderate to severe depression.

    I think it is extraordinarily irresponsible to publish an article to be read by the general public that essentially only says: "Facts: anti-inflammatories reduce the efficacy of SSRIs; SSRIs cause brain damage; SSRIs cause cancer; and SSRIs cause death; and by the way, sponsored research can't be trusted" when these "facts" are not definitive. One of the advantages of a strong regulatory authority is that medicines which cause brain damage or cause cancer (without overriding benefits); or cause death, can be "banned".

    How did you as editorial director of Health Intelligence (and a pharmacist!) permit this highly flawed article to be published?

  5. Brent Murphy 26 August, 2011 at 3:37 pm #

    Hi Roy
     
    1.
    With regards Health Intelligence's (edition 10) article Sad Facts on Happy Pills, the article was reviewed by a pharmacist (not myself).  I have spoken to a few members of our board, who (myself included) agree with your points that the research should not have been reported as "FACTS", but rather possibilities.  We agree that the article should not discourage the use of antidepressants in severely depressed patients.  In future we will have more than one member of our board review articles.  I will also become more actively involved in review myself.  
    Therefore we will be publishing the following statement in edition 12 (edition 11 is already in circulation so it can't appear in that):
     
    —————————————————
    "CLARIFICATION: 
    In an article Sad Facts about Happy Pills featured in Health Intelligence 10,  it was reported as “FACTS” that antidepressants cause death, brain damage and cancer.  Whilst we believe it is correct that the research referred to in the article raises concerns that antidepressants may be associated with cardiac-related mortality, brain nerve damage, and ovarian and breast cancer, this research is preliminary, mostly performed on animals, and needs confirmation with larger human based data.  Therefore these effects should not have been reported as “FACTS” implying certainty, but rather “CONCERNS” implying possibility.  The writer also suggested that people who suffer from mood disturbances should consider stopping accepting prescriptions for antidepressants based on this evidence.  The editorial board of Health Intelligence does not believe that people who are taking antidepressants should discontinue their therapy based on the possibilities mentioned in this article.  Furthermore, should antidepressant therapy be discontinued or changed it should be done so under medical supervision and over a gradual weaning-off time period. It is also the opinion of our board, based on current evidence, that the risk vs. benefit ratio favours treatment of people who suffer from severe depression (as opposed to mild/moderate depression), with antidepressant medication."
     
    —————————————————-
     
    2.
    With regards the "hyperbolic" 🙂 claims by poster on this blog that there is NO evidence of effectiveness for these of the generic CAMS recommended in the antidepressant protocol listed in Health Intelligence, I disagree.  There is evidence. Using the amino acid S-adenosyl methionine (SAMe) mentioned in the protocol, by way of example:
     
    http://www.ncbi.nlm.nih.gov/pubmed/7941964?dopt=Abstract
    S-adenosyl-l-methionine (SAMe) as antidepressant: meta-analysis of clinical studies;
    Acta Neurol Scand Suppl. 1994;154:7-14.
     
    "S-adenosyl-l-methionine (SAMe) is a naturally-occurring substance which is a major source of methyl groups in the brain. The efficacy of SAMe in treating depressive syndromes and disorders is superior with that of placebo and comparable to that of standard tricyclic antidepressants. Since SAMe is a naturally occurring compound with relatively few side-effects, it is a potentially important treatment for depression."
     
    —————————–
     
    http://www.ncbi.nlm.nih.gov/pubmed/7941961?dopt=Abstract
    S-adenosylmethionine blood levels in major depression: changes with drug treatment.
    Acta Neurol Scand Suppl. 1994;154:15-8.
     
    "The significant correlation between plasma SAMe levels and the degree of clinical improvement in depressed patients regardless of the type of treatment suggests that SAMe may play an important role in regulating mood."
     
    ——————————-
     
    http://www.ncbi.nlm.nih.gov/pubmed/8441793?dopt=Abstract  
    Double-blind, placebo-controlled study of S-adenosyl-L-methionine in depressed postmenopausal women.
    Psychother Psychosom. 1993;59(1):34-40.
     
    "There was a significantly greater improvement in depressive symptoms in the group treated with SAMe compared to the placebo group from day 10 of the study. Side effects were mild and transient."
     
    —————————
     
    http://www.ncbi.nlm.nih.gov/pubmed/2183633?dopt=Abstract
    Oral S-adenosylmethionine in depression: a randomized, double-blind, placebo-controlled trial.
    Am J Psychiatry. 1990 May;147(5):591-5.
     
    "The results suggest that oral S-adenosylmethionine is a safe, effective antidepressant with few side effects and a rapid onset of action. S-Adenosylmethionine induced mania in a patient with no history of mania. S-Adenosylmethionine may be useful for patients who cannot tolerate tricyclic anti-depressants. These findings support a role for methylation in the pathophysiology of depression."
     
     
    ————————–
     
    http://www.ncbi.nlm.nih.gov/pubmed/12418499?dopt=Abstract
    Efficacy and tolerability of oral and intramuscular S-adenosyl-L-methionine 1,4-butanedisulfonate (SAMe) in the treatment of major depression: comparison with imipramine in 2 multicenter studies.
    Am J Clin Nutr. 2002 Nov;76(5):1172S-6S.
     
    "In both studies, the results of SAMe and imipramine treatment did not differ significantly for any efficacy measure. However, significantly fewer adverse events were observed in the patients treated with SAMe."
     
    ——————
     
    http://www.ncbi.nlm.nih.gov/pubmed/20595412?dopt=Abstract
    S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial.
    Am J Psychiatry. 2010 Aug;167(8):942-8. Epub 2010 Jul 1.
     
    "These preliminary results suggest that SAMe can be an effective, well-tolerated, and safe adjunctive treatment strategy for SRI nonresponders with major depressive disorder and warrant replication."
     
     
    All the best
     
    Brent Murphy – B.Pharm (Rhodes), MPs
    Pharmacist

  6. Roy 27 August, 2011 at 9:37 am #

    @Brent

    Thank you for the undertaking. I do hope that no reader/s have inadvertently been harmed!
     
    As far as the "Natural Antidepressant Protocol' is concerned though, it appeared as follows in the magazine after the "conclusion":
     
    "NATURAL ANTIDEPRESSANT PROTOCOL
     
    5-HTP (100mg three times per day)
    SAMe (400mg once or twice daily)
    Tyrosine (1,000mg twice daily)
    Phosphatidylserine (100mg two to three times per day)
    Magnesium glycinate (400mg twice daily)."
     
    No other information was given at all. My reading of this "protocol" is that it means taking "5-HTP + SAMe + Tyrosine + Phosphatidylserine + Magnesium glycinate" as a treatment "regimen". I still maintain that there is no evidence for this combination; or in the stated doses. If there is, I would love to see it (I would keep any information confidential if necessary.) If the protocol was meant to have an "OR" between each of these substances, that should have been made clear.
     
    You've provided us with abstracts of 6 studies of SAMe use on its own or as adjunctive treatment to SSRIs. Unfortunately I've not had the chance to hunt down the original articles. However the abstracts do not answer the questions about the "Natural Antidepressant Protocol" recommended in the magazine or even about the use of SAMe.
     
    Briefly your abstracts indicate that the dosage which appears to show some efficacy is 1600mg per day orally (or 400mg per day by intramuscular injection). Your protocol recommends 400 mg "once or twice" daily (presumably orally – so your maximum dose would be 800 mg daily).
     
    In those abstracts where the duration of treatment is stated, it varies from 4 weeks to 6 weeks. This is not adequate for studies in depression.
     
    The sample size, where it is stated varies from 15 "inpatients" to 147 (presumably) outpatients. No indication is given about how these sample sizes were determined. Perhaps this is explicit in the full articles.
     
    Four of the six abstracts use a tricyclic antidepressant as a comparator and not SSRIs – which is what the article focuses on.
     
    Four studies were published between 1990 and 1994; one in 2002 and one in 2010. Of interest is that the 2010 study was designed to assess the value of SAMe as an *adjunctive* therapy to SSRIs. So if you were to have used this article as a recommendation, it would have had to be in the context of the legitimate use of SSRIs – which the whole article was condemning!
     
    Perhaps Health Intelligence needs to also retract the "Natural Antidepressant Protocol"?

  7. Brent Murphy 27 August, 2011 at 1:15 pm #

    Hi Roy

    My response to your statement “I hope no reader/s have inadvertently been harmed!”:

    MY hope is that no patients taking pharmaceutical SSRI antidepressants for mild to moderate depression (for which there is little to no evidence of effectiveness) have been harmed by the SSRI’s they are using causing breast/ovarian cancer, cardiovascular disease, metabolic syndrome, obesity and diabetes (the research that is coming out suggests this). We are dealing with chemical molecules that humans have never been exposed to ever before, being used chronically. If chronic pathologies are newly identified, even if in animal studies, due to the use of these new chemical moieties, which have not been proven safe long-term, this should be an immediate cause for alarm, and discontinuation of therapy in mild/moderate depression should be considered, until safety can be proven.

    All the best

    Brent.

  8. Roy 29 August, 2011 at 7:50 am #

    @Brent
     
    Irresponsible statements in a publicly available magazine purchased by people who more than likely already believe (or half-believe) the (misleading) statements in it cannot be compared with prescribing decisions of Scheduled medicines made by medical doctors and psychiatrists who are responsible for their patients.
     
    Your response suggests that you yourself actually believe preliminary research and are prepared to make recommendations on it. Long term safety of any medicine cannot be shown unless people are taking the medicines – with all the safeguards and monitoring that have been built in. Unfortunately, healthcare professionals – including pharmacists – are often slack about reporting adverse effects to the National Adverse Drug Event Monitoring Centre. I wonder how many you have reported.
     
    You have not yet provided any evidence for the "Natural Antidepressant Protocol" quoted in the article. It is a combination of substances not found in nature in the particular doses stated, and the combination is one "humans have never been exposed to before" (with the potential for being used chronically in major depression). We're probably exposed to new chemical moieties in the air we breathe every day. The human body is amazing in its ability to deal with some of these, right down to a "cellular level". 
     
    As for "cause for alarm": the international network of regulatory authorities and organisations monitoring medicines safety consider a "signal" to be "one or more reports showing particularly strong evidence of a previously unknown adverse reaction". I assume you recall this from your exposure to pharmacovigilance (as an undergraduate or through CPD information). So just two reports with "particularly strong evidence" from the whole world will be investigated. This is how several medicines / substances have subsequently been removed from the market, including some "natural medicines". These [natural medicines] may also contain chemical moieties that humans have never been exposed to before (which the human body may or may not be able to deal with). 
     

  9. Albert Buhr 16 October, 2012 at 10:02 am #

    While interesting to consider the points and counter-points in these comments, it’s hard to miss the fact that while Brent has showed grace in his retraction and defence, Roy’s relentless attack is characteristic of quackbusters inflamed with their own righteousness. But then, between the witch-hunter and the witch, I’m just the sort who is more inclined to the latter’s company. Many a pitchfork has championed the “truth”. Even if the offending article were grossly over-stated and sensationalist, I would consider it a necessary corrective to the gross over-prescription of anti-depressants, and it’s harm negligible compared to the harm done by the knee-jerk reliance on SSRIs (see Robert Whitaker’s Anatomy of an Epidemic).

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