July 12, 1998
Placebo1

PLACEBOS WHAT ARE THEY?

A Placebo is a "fake pill" a "sugar pill", a pill made up to look exactly like the Medication to be tested against!

I have never used placebos more than about 3 times in my practice of Medicine in 50 years. I have never been able to believe that a sugar pill could cause 17% of normal (so-called) people to get headaches from them.

I wonder who started them, and who and how they thought of the double blind study.

If in my treatment of 4000+ narcoleptics (1945 to 1965) and recording the effects of the medications &/or lack of effects, is not entirely equal to something much better than placebos or double blind studies. Some of my patients have had up to 10 different medications, and they have had differing effects. How would I have been able to have accomplished double blind studies on all of them, or how would I have been able to persuade all those patients to take fake pills just to prove that the "good" pills worked?

I had a patient with Narcolepsy whose son at 7 years had blackouts, and an abnormal EEG, as well as being very hyperactive. I asked her to take him to a hospital, to their Hyperactive Clinic. She did so and he was placed on Ritalin eventually at 20mg tid. The doctor was asked by the inquiring regulator to do a double blind study to see if the Ritalin "was the appropriate treatment" or some such other requirement that I have no knowledge of. They did a triple blind study using Tofranil, Ritalin, and placebo for about 2 weeks at a time each. They had reports from the mother, the father, the school teacher, the school nurse, the janitor, and any other person they could think of. Isn't it interesting that these reports are by word of mouth (are these anecdotal reports?).

The decision was that the Ritalin worked, and the boy was able to do his school work much better. Then the inquiring regulator asked the doctor at the clinic why the boy had such a large dose of the Ritalin. The doctor at the clinic said he needed it, and the inquiring regulator doctor believed him, and stopped the investigation. Why did the regulating doctor believe him and never believe me?

December 18, 2000

Placebos!

A few additional thoughts!

If the doctor told the patient that the placebo would help, is that not a deliberate lie? And if so how does this make the situation scientific?

If the doctor gets an "informed consent from the patient to use placeboes in the treatment of some illness, does this means that this is half a lie? And if so how does this make the situation any more scientific, or is it half-scientific and half lie? I just talked today to a man who said he had been in a test survey where he had consented to be tried on a drug or a placebo. He stated he never found out which one he had been given so he could relate to the effects of lack of same, and he thought this was reprehensible that he was not informed afterwards. He also agreed with this being half a lie. Could we add the lack of information after as being another lie?

It is interesting that the word anecdote is anathema to the peer reviewers. Well how about all the reports of the above mentioned people who described this 7-year old boy’s reactions to the three different pills? Are these not anecdotes? These ones insisting on scientific accuracy, can’t have their cake and eat it too!

Isn’t it interesting that the boy had 6 pills a day. They must have been able to do arithmetic at that time as this meant that the boy took 2190 pills a year and they were not so impressed with the number over 1000 a year, as they seem to be today. More than one of my patients have called me in the last two months telling me that some doctor cannot prescribe their pills any more (e.g. Ritalin, Dexedrine, Valium etc) because he was prescribing more than 1000 of the pills per year. Have the regulators suddenly forgotten their multiplication tables.

There was a report some years ago that the teachers in a high school discovered that the students did not know their multiplication (times) tables. So they took a whole day and taught them their times tables, and toward the end of the afternoon the teacher gave the young adults questions to answer using these times tables. After they finished they gave them calculators to check their work. The calculators were designed to give the wrong answers. And the young adults believed the calculators!

Does this mean that we need to give calculators to the regulators so they can improve their thinking and make it more logical, and possible more sensible! After all they blackmail and regulate the doctors’ prescribing rights on the basis of the numbers over 1000 per year, and have never as far as I know ever asked the patient if the pills he/she were taking helped.

On one of my visits by two inspectors who wanted me to sign off prescribing Benzodiazepenes (they had made a 15 minute appointment expecting me to do this without any warning as to why they were seeing me) and I explained a lot of things about those pills for about 1 hour, and then said that I insisted that they ask the patients concerned if those pills helped them to relieve their suffering. They said, "they would do what was necessary"!.

SPYING!

What was necessary? After a hiatus of about 2 weeks I began to get phone calls from male and female patients each Friday or Saturday nights for about 4 weeks, who told me that I had prescribed Valium for them, and they were going away and needed a months supply tid. I go sucked in on the first two, and on Monday tried to find their files in my office. There were no files, and when I was called the following week ends, I asked them to call me Monday afternoon so I could find their files in my office. None ever called on the Mondays.

I concluded that the regulators were putting the persons up to this, and felt that they spying on me!

I also have felt that they have sent fake patients to my office, whom I saw and took their histories (anecdotes), advised them of what their treatment should be, and what investigation should be done before the treatment if necessary. Two or three, after giving them appointments for EEG’s or further appointment in my office cancelled the appointment, and gave no reason. It is interesting that one, a young lady nurse who did not look sick, I had video taped the interview. I would like to ask the regulators if they had sent her.

Shortly after this 3 young men came into my office, one of whom was all bent over, and complained of severe back pain and needed a perscription for Heroin. I unfortunately did not get their OHIP numbers or names, and at that time (1981) I was not photographing every patient, and I threw them out. After some months thinking about this, I concluded that the RCMP had sent them as spies, and that this was likely due to the Ont. College of Physicians & Surgeons.

There was a report in the CMAJ that in one of the provinces where the regulators had a number of doctors agree to see fake patients who would give them a history of hypertension, to see just what the doctors would suggest for their treatment. Apparently the regulators were going to believe everything that these fake patients reported to the regulators (more anecdotal information, obviously very scientific). The concluded that some of the doctors did not suggest the correct treatment, and probably decided the doctors needed to read & use more guidelines!

Some years ago the Medical Post in a front page article stated that Sweden had decided to stop making up medical guidelines as they could not keep them up to date.

This has been one of the reasons that I have said that the guideline for the diagnosis of Narcolepsy is 34 years out of date, and should be changed, as it does not include most of the other 84 listing of sleep disorders. It is my opinion that the list of 83 conditions are part and parcel of the Family of Narcolepsy illnesses, and until this is accepted, the patients will not be treated properly. When I finally got the article "The nature of the Narcoleptic attack":, by Dement et al. from the Journal of Neurology, in 1977, I considered the conclusions reached to be illogical Why? Well they had a table stating that 9 of 11 patients had Sleep Attacks, Cataplexy, and SOREMPS (Sleep Onset Rhythmic Eye Movement Periods), and that these had to be present to make a DEFINITE diagnosis of Narcolepsy. The next sentence after the table mentioned that one man had Sleep Attacks, and SOREMPS, but had no Cataplexy, so they left him out. At the tune I read this in 1977, I had already seen some patients with no Cataplexy and other symptoms of Narcolepsy, and therefore concluded that this criteria was wrong. I might add that I had read Freud’s work for 6 months in 1945, and decided that his thinking was illogical. This did not make me popular with the Toronto psychiatric group, and when I said in the mid 1950's that all Mental illnesses were chemical in the head, I became even less popular. Of course this was only 50 years ahead of some people’s thinking.

The obsession to have all diagnoses perfect and never wrong, and to be proved each time with some method of testing, is only an obsession. Evidence based medicine has been present since the time of Hippocrates, and is not something invented in the last few years, along with cormorbidism. After I graduated from the University of Toronto in Medicine in January 1943, I found out that General Practitioners were considered to make the correct diagnosis 60% of the time and Specialists 80% of the time. This has all changed in the last 15 years or so and the regulators expect all the diagnoses to be correct 100% of the time, and they try to castigate every doctor making wrong diagnosis or would like to.

Why do these regulators not believe anything I send them, re the investigation and treatment of Narcolepsy? Are they suffering from some lack of logic in their thinking? This is the only conclusion I can reach.

Why do all the researchers seem to believe the results of double blind studies, and that anyone else who does not use this method to treat their patients, cannot be believed?

I found that asking my patients whether doctors ever asked them what the effects of their medication was became enlightening. 45% of the General practitioners asked if the effects were good or bad, and 55% of specialists asked. How do the rest know whether the pill worked or not. Perhaps by the fact the patient returns

May 25, 2001

PLACEBOS

The Toronto Star of May 24, 2001 states that "Placebos overrated, study says". They are quoting the current issue of the New England Journal of Medicine. I will get a copy of this article to assess for myself,-to see if I think it is logical today.

It is interesting that they suggested that this was "conventional wisdom, forged in a 1955 article in the Journal of the American Medical Associaton that said placebos helped patients in 35 per cent of cases". Does this article mean that "conventional wisdom" has been faulty for 66 years?

This justifies my opinion of the late 1940's-that the use of placebos did not tell one anything, and that if you believed the good or poor results, you were only fooling yourself.. I, as a result, fail to understand why placebos have been considered for 60+ years as such a wonderful (35%) way to test medications.

In view of this we should examine the ability of those authors, peer reviewers, editors, ethicists, and believers to think logically.

I have decided that when I reach 100 years of age that I will stop thinking logically and then I will be even with all the ones mentioned above

Mar15, 2002

I got an editorial comment from the New England Journal of Medicine of May 24. 2001, and the article still could not agree with the idea that placebos were useless. he wrote with his "tongue in his cheek". I will get the other article from the same journal and comment on it then.

I finally got the original article written from Helsinki, Finland. this author stated that placebos were useless, except in very few circumstances. I sent him an email encouraging him to keep up the good work, and he replied Thanks.

Feb 18/03 Nova on the Public Broadcasting Service had a program be Alvin Alda on placebos. The doctor had investigated this with either the PET Scan or the functional MRI, and concluded that placebos worked because the patient anticipated that s/he would improve. If this is so should we force our patients to anticipate improvement, and we could stop giving medication at all? IF this anticipatory improvement lasts only 3-4 months, then what can we do- give them medication?

Apr21/04

I missed the Nova program on WBEN Mar 17/03, which was on the subject of placeboes. Someone had studed the effect on the PET scan, apparently before during and 6 weeks after the placebo was given. They found that the improvement on the increase in blood circulation was in the same areas of the brain as with the antidepressant medications used. The only thing was that at the time of several months later (3-4) the PET scan with the placebo patients apparently was blank.

Their explanation was that all you needed to get the improvement in symptoms, and on the PET scan was the anticipation of having a medication to improve given to one.

They never tried to give another placebo later to try again.

Does this mean that if one just decides for oneself that one can anticipate improvement then one gets the improvement for 3-4 months. And then should one reanticipate again and again?

Sounds wonderful. I think it sounds like snake oil. As a child of about 7 years I was taken by my family to Picton fair one Saturday night, and there I happened to stop by someone trying to sell bottles of snake oil to the crowd at $100. per botle. He would put some of the contents of a bottle of this substance on a razor strop, and in a very few moments it would appear wet on the opposite side of the strop. The crowd bought up all his bottles rapidly. I had no money and did not at that time and age thought it would go through the skin very easily.

May 9, 2004.

I have learned finally that athe usual placebo is Lactose. What does this do for the lactose sensitive people. How would it help my grandaughter who has lactose sensitivity?

If placebos are so inert, why do they list that 3-24% have headaches, and 2-9% have nausea, along with many other symptoms?