Pharmacosis is the fourth leading cause of death - Dr. David Healey

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CBEC Conference on Emerging Ethical Issues

Pharmacosis is the fourth leading
cause of death - Dr. David Healey

Ghost written clinical trials, RCTs are published in the prestigious
medical journals which are then used for preparation of
Guidelines to promote drug sales

Doctors used to treat diseases but now they treat risk factors
Pharma industry is now behaving more ethically as they follow protocols

By Shaukat Ali Jawaid

KARACHI: Pharmacosis is now the fourth leading cause of death. In the past doctors used to treat diseases but now they treat risk factors and we have many new diseases. Ghost written clinical trials are published in prestigious medical journals which are then used to prepare Guidelines. Randomized Clinical Trials may also benefit but they do hide serious adverse drug reactions. Medicine is no more confined to treatment of diseases but it has progressed to Mediculture. The pharmaceutical industry is now behaving a bit more ethically as they follow some protocols. These views were expressed by Dr. David Healey a world renowned British Psychiatrist who has authored numerous books and had contributed a great deal to the medical literature in the form of original scientific research. He was one of the invited guest speakers at the recently held CBEC International Conference on Emerging Ethical Issues held from December 6-7th 2013. He was the first speaker in the first session on December 6th and the title of his presentation was “Pharmaceuticalizaiton of Medicine”.

Dr. David Healy

This was an excellent presentation on the topic heard by the jam-packed audience with pin drop silence and Dr.David Healey highlighted in detail the unethical practices indulged in by the pharmaceutical industry while conducting clinical trials, Randomized Clinical Trials and how the Ghost written trials publication in prestigious medical journals is then maneuvered and all this was supplemented with hard facts and references. He started with depicting a picture wherein an acutely ill child was lying in the bed and a physician sitting with him is looking at the child. This physician, Dr. David Healey remarked is not doing any intervention, not giving any medications but just try to look at the patient to understand his disease and the patient. He then quoted Phillip Pinil who had remarked that “When to omit or suspend medications is a great art”.

He showed slides of Snake Oil preparation advertisement which used to make all sort of claims promising cure of innumerable diseases. Advertisements with such exaggerated claims had been a routine in those days. Pharma industry developed many new safe and effective drugs which proved life saving. Previously patients with diphtheria used to die having miserable time but when its treatment was discovered, it saved many lives and death from diphtheria dropped significantly. When many companies came up with similar molecules, companies started to brand their preparations in 1886. Bayer discovered Aspirin but it was never sold by its scientific name but it was branded as Aspirin. Snake oil and Beecham’s Pill which also contained some dangerous things continued to make exaggerated claims for cure of almost every disease if one looks at the advertisements in those days. It was in 1905 that an agency was established in United States which later became known as Food and Drugs Administration (FDA) of USA to regulate the industry. Then we saw the development of many new drugs which were considered as great medical breakthrough in the treatment of diseases.

Continuing Dr. David Healey said that it was in 1947 that National Health Service was introduced in Britain to provide antibiotics, anti-hypertensive’s, Anti-psychotics and many other drugs to the patients free so that the population will be healthy and will help enhanced productivity as compared to other European countries. In 2007, the Pharma market was estimated to be 663 Billion US dollars and the major drug market consisted of oncologics, lipid regulators, respiratory agents and antidiabetic preparations etc. From 1980-2008 the pharmaceutical industry had increased its advertising budget manifold and we saw them providing free lunches, dinners, pens and sponsoring medical conferences all over the world. When we had this Thalidomide tragedy and many pregnant women gave birth to babies without limbs, it was decided to have Randomized Clinical Trials of drugs to ensure their safety and efficacy. All drugs had to go through this procedure. Patenting of drugs started in 1960s and we had laws for patent protection so that the industry can recover its cost on development of new drugs. Pharma industry introduced an antipsychotic promoting to have anti-manic effect within four days. Sodium Valporate was discovered in 1961. Another pharmaceutical company did some modifications to this molecule/compound and came up with another drug branded it and started marketing it. Now what the Pharma industry does, it markets diseases first and then sells drugs to treat these diseases. An existing psychotropic was then promoted as a mood stabilizer in 1995 saying that it was a fast and effective mood stabilizer. Then we saw over one hundred new articles on mood disorders published in medical journals between 1985-2005. The number of publications on mood disorders later increased further every year. The number of articles on manic disorders, depression available on Medline increased manifold between 1960-2007. Later the industry added Bipolar disorders to the list of diseases for which these drugs were effective. Once this was done, there were more than five hundred articles appearing on bipolar disorders every year.

Group photograph taken during CBEC Int. conf. from (L to R) shows
Dr. Rana Muzaffar, Prof. Farhat Moazam, Sandhya Srinivasan, Standing
from (L to R) Dr. Amir Jafarey, Marisa De Andrade, Natasha Anwar,
Mariam Hassan and David Healy.

Some of the blockbuster drugs doing enormous business, he mentioned included Zantac (1985), Prozac (1991) and Lipitor (1997). Then it was decided to ensure that drugs should be made available on prescription only but this did not mean that drugs won’t be available without prescription in many countries of the world where their availability without prescription continues even today. When Thalidomide was introduced as a sleeping pill, its adverse effects were not mentioned and were not known. They became known only when many babies without limbs were born to pregnant women who had been taking this drug. However, now Dr. David Healey remarked, the Pharma industry was behaving more ethically as they follow certain protocols.

Speaking about the Clinical Research Organizations (CROs) and how they function, Dr.David Healey remarked that these CROs have an annual budget of thirty to forty billion US Dollars. They conduct clinical trials in India, South Africa, China and other Asian less developed countries where monitoring and regulations are not so strong. Pharma industry finds recruiting patients for the trials much more difficult in the developed countries and conducting trials in the West is also much more expensive. Most of these trials are in fact marketing trials. The companies withhold data and promote Ghost writers. They write these trials with ghost authors from all over the globe and then get them published in not so obscure but prestigious medical journals. These articles help the Pharma industry achieve their objectives. He showed some examples of Medical Trial Writers who had prepared the manuscripts based on these trials to be submitted to some of the world’s leading medical journals and at the place of authors the words written were “TBD” which means that the names of the authors are “To Be Determined”. In UK we have NICE Guidelines for the treatment of various diseases and these are also based on the Randomized Clinical Trails and publications in leading well reputed medical journals. He then showed convincing material wherein one of the multinational pharmaceutical companies sponsored four clinical trials and then got one hundred thirty seven articles published from those trials in various medical journals promoting that their antipsychotic olanzapine was the best for the treatment of schizophrenia. Then an article was also published in American Journal of Child and Adolescent Psychiatry, a best reputed medical journal with very high Impact Factor saying that an antidepressant was effective in treatment of depression in children but what this article did not mention was the this drug also promotes suicidal tendencies in children. All such things happen with the close collaboration of marketing people and the Ghost Writers who create such medical literature. It was many years later that then the industry came up with some precautions regarding the use of such antidepressants in children.

Dr.David Healy opined that we now have many new diseases. Doctors used to treat illnesses but now they treat risk factors. He pointed out that if a survey was done in New Zealand almost 94% of its population will be found with lipid abnormalities but does it mean that everyone there should be put on lipid lowering drugs?. The industry promotes osteoporosis and to increase their sales, they also provide bone scan measurement facilities. The industry sells more tools to the profession with the result that now doctors have started giving more problems to the patients than treatment. When a patient goes to see a physician, he or she asks, have you been screened for your lipid profile and bone scan? He then showed headline from a leading newspaper which contained the statement “American Psychiatric Association believes that Anti-depressants saves Lives”. He termed it as the “Professional Suicide Note”. It is not the antidepressants but “Psychiatrists” which saves lives, Dr.David Healy remarked.
Continuing Dr. David Healy said that in the past we used to notice “Absenteeism” at work due to sickness but now we see “Presenteeism” which means that people are present but they do not or cannot work as they have taken the drugs. Dr. David Healey further stated that we need guidelines for treating people. We need to reduce mortality rate and reduce the number of people going to the hospitals. Doctors and Patients both should be vigilant and carefully monitor and note adverse drug reactions which are often hided by those with vested interests.

His presentation was followed by lively discussion. Responding to various questions Dr.David Healey remarked that “Let us not give Pills in Good Faith”. The Adverse Drug Reactions are often hided. It is the Hair Dressers and the women who know the ADRs better than the doctors in many cases because it was the hair dressers who looked at the hairs more carefully. We need to have literature and ADR data which should not be in the control of the Pharma industry. Questions were asked how one can find out the Ghost Writers. It was also pointed out that now we see terms like “Pre-Hypertension” and “Pre-Diabetic stage” which it appears are all meant to increase the sale of respective drugs. Dr. David Healy remarked that good medicines are welcome with information what good it does and what it does not? Controls should be taken away from the Pharma industry and we need to look into the patients. With close monitoring of drugs and patients, one gets more information. Motivated women physicians will look at these issues more carefully. Responding to another question Dr. David Healy said that when FDA was established it had little regulatory powers which remained with the professional specialty organizations like American College of Physicians, American Psychiatric Association etc. They should have more say in regulations. Many a times the FDA has not seen the data. Hence it is extremely important the regulators should work in close collaboration with the professional bodies, listen to doctors and not the FDA and doctors should be an important part of regulatory affairs, he concluded.

CBEC Forum

Dr. David Healy also made a presentation in the CBEC Forum on December 7th 2013. The topic of his presentation was “When Interests Conflict: Physician Pharmaceutical Interaction”. He started his presentation by stating that I am told that the doctors have been corrupted by the pharmaceutical industry in this part of the world but then hastened to add that the situation was no better in the West either. In fact in many cases it may be easy to be a good doctor here than in the developed world. I am not hiding any data from you. We do have access to data but it does not solve our problem, he stated. He then used the term “Medical Partisans” to describe the relationship of the physicians with the Pharma industry and discussed in detail what clinical trials do and what they do not do. It is difficult to distinguish between doctors and those who work in the Pharma industry. He also talked about academic fraud in medicine and gave details how one of his articles was first accepted for publication in BMJ in 2006 but later a week before the publication date he received a communication from the Editor stating that their legal department has advised them to stop its publication. He had similar experience with numerous other well reputed journals which included Lancet, New England Journal of Medicine, Open Mind, Young Mind, Psychiatric Bulletin etc., which from time to time refuse publication of manuscripts from researchers. He then remarked that He was an Irish and it would be interesting to note that many authors of various trials were from Ireland and many of those who won Nobel Prize were also from Ireland. Some of these authors book were banned in Ireland. Government is quite lenient towards the Pharma industry because almost 40% of the new investments in industry come from the pharmaceuticals and the government does not wish to halt this investment. Once he was invited to be a speaker at a CME meeting and later the pharmaceutical company which had sponsored it said that in future if David Healy was invited, they won’t sponsor the programme. It is not only people in the Pharma industry but conflict of interest can be with your colleagues who are used by the Pharma industry. He then gave details how one of his own colleague psychiatrists wrote to the General Medical Council urging to investigate me and to take action against scare mongerers. It was supplemented by a statement in the press stating that Psychiatry was under threat as a discipline. So the conflict at times comes from your own colleagues rather than the Pharma industry. SSRIs are quite useful drugs but there are risk of birth defects and developmental delays if pregnant women are using SSRIs. According to reports at least 15% of pregnant women use anti-depressants and when such side effects are hided, it results in catastrophes that is exactly what had happened when the world witnessed the thalidomide tragedy which was promoted as a sleep inducing pills. It is extremely important that the physicians should know when to use the drugs and when not to use them. NICE guidelines recommend use of olanzapine for treatment of schizophrenia and their recommendations are based on two hundred thirty seven publications from four trials but what these trials do not mention is the possibility of weight gain, emergence of diabetes, lipid levels and suicide rates. Most of these trial papers are usually ghost written papers. And while serving in the NHS if you do not follow these NICE guidelines you are likely to face the music and one has to think all the time how to avoid being sacked, he remarked. It is essential that we all point out the Adverse Drug Reactions instead of Dancing with Pythons. Access to all the data is essential and every effort should be made to ensure that the Pharma industry does not hide data.

Dr. David Healy then showed a slide featuring Pilot and a Doctor and then said, you put your life in the hands of both these persons. When you fly your life is in the hands of the Pilot and when you go to consult a doctor for treatment, you put you life in their hands but here is some difference. If the pilot is careless, he goes down with you which was not the case with the doctor, hence they have to be extra careful, he remarked. Dr. David Healy then narrated how the industry creates demand for drugs and showed the cover of Newsweek which some years ago had a cover story highlighting that millions of children were depressed and the writer in the story had pointed out that antidepressants are quite useful to treat depression in children. He then talked about the story of a 13 Years old boy Miller who was put on antidepressants by the physician and the child was found hanging in the bathroom three weeks after treatment with that antidepressant but later it was said that the child died due to auto erotic asphyxiation and not because of the drug. These things happen because the side effects of suicidal ideation in children on these anti depressants were hided. Cochrane Group as well as NICE guidelines all looks at the published data. In some cases in FDA’s viewpoint almost 50% of the drug trials had negative findings but the Pharma industry have put in place systems whereby all things work to their advantage. The industry can manage ghost writing of studies, non-publication of studies, miscoding and mislocaiton of data, lack of access to data. We are all aware of what happened with Vioxx which later had to be withdrawn because of increased risk of heart attacks and then what happened with Avandia. At times one can find out the differences in results and in the conclusions drawn from the studies and all such things get published in prestigious medical journals.
Drugs discovered in the 1950s, Dr.David Healy remarked were more effective than many newly discovered drugs. Doctors in the past used to see the difference after giving drug to the patient and the information was safe. It was Fisher who introduced Randomization in clinical trials but experience has shown that randomization will hid the problems. He was of the view that RTCs give us weaker drugs, they are the gold standard adverse event hiders and RTCs has converted standard care to Mediculture. Doctors who do not go by the results of clinical trials are likely to be criticized by their own colleagues. We need to educate the patient who should be able to report the Adverse Drug Reactions to the doctors and it is quite likely that some ADRs will take more time to be reported. As regards regulators, no one wants to know that drugs do cause problems. Drugs have political and religious effects as well not only ADRs, Dr. David Healy added.

Note: Dr. David Healy also runs a free independent drug safety website www.Rxisk.org to ensure that medicines are safe for all of us.

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