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.:: MEDICAL ARTICLES ::.
Newest ArticleCategory: Drug Evaluation Experimenting With Heterodox* Therapeutic Methods
Iwan Darmansjah, MD What is Clinical Pharmacology? Clinical Pharmacology is an outbranching of Pharmacology that was developed after The Harris Kefauver Amendment Act, (USA,1962) came into effect. It was a reaction to the presence of unsafe and inefficacious drugs on the American Market. The main trigger was a drug that when taken by some 30% of pregnant mothers to prevent vomiting, gave birth to babies without extremities. The assessment of premarketed drugs at that time was done through testimonials of doctors in their respective fields and only subjective evaluation were applied, although efficacy outcome may some times have been correct. But even when the drug was effective, no dose-finding studies were performed and therefore drugs such as ephedrine, codeine, or theophylline were used at wrong doses until this date. But, most importantly was, that the above Act had changed the drug registration system and had developed a Drug Evaluation Committee, now common worldwide. Indonesia was not far away from applying such procedure, and in 1971, at a time when foreign drug companies began to invest in Indonesia and needed such a Committee was just timely. As Chairman of that Committee, without any experience, I wrote to the US FDA and requested them to send us their Guidelines for the Evaluation of all Groups of Drugs, that made a pile of documents of about half a meter. We were very thankful for that and read them all, one by one, matching the drug class that we needed to evaluate. It has to be mentioned that the documents were very well written for our understanding, scientific and objective, and our self-learning process went very well. No wonder, that our findings were mostly identical as that of the US. Indonesia’s Drug and Food Control became the leader in Asia, and most other (Asian) countries relied on our decisions. Clinical trial reports were the most important documents, but also the most difficult to assess and to verify, fraud has to be detected, and soon we were masters in doing that. We organized Courses in Drug Evaluation in the Region and personally gave presentations abroad, among others, at the Japanese Food and Drug Agency. Clinical Pharmacology - What is in a name? Cl. Ph. is closely involved with the design , coordination and execution of Clinical Trials and thus are forming important links with Clinical Departments in Clinical Therapeutics and Research. ‘Clinical’ is used as an adjective and therefore describes what part it is from Pharmacology. It has to do with the clinical part applied to what Pharmacology does - which originally was done on animals. So we may have other parts of science that applies that clinical part in Pharmacy, Microbiology, or Pathology, or even Economics (Clinical Economics, Jeffry Sachs, used in the text of his book: ‘The End of Poverty’) Sachs is an Economist who has a Pediatrician wife, and learned by observing her work that Economics , in fact, should be applied like how his wife handled her patients by taking anamnesis first, then examination, diagnosis and planning a treatment schedule, follow up, etc. not like how Economists make decisions rather haphazardly. The main thing in Cl. Ph. is applying all knowledge of Pharmacology in the clinical setting, thus: on patients. Therefore a Clinical Pharmacologist should also be a practicing doctor, who is legally apt to examine patients. Sachs is only borrowing the word ‘Clinical’ to go more systematically in taking Economic Decisions Three Case-studies follow hereunder: 1. Challenges towards Heterodox Therapeutic Methods The therapeutic decision process in medicine has long been established since the medical profession existed following the above hierarchical model. Nothing has changed since then. However, the global environment had changed since the last decades: disease patterns, improved technology and diagnostic tools, availability of more drugs, increased health care cost and limitation of funds. The presence of Clinical Pharmacology has without doubt improved the therapeutic decision tools, and should be well nurtured. The result of Clinical trials, including epidemiological drug studies are producing outcome results that would aid difficult evaluation whether to treat or not to treat or how to treat. Although GCP has produced ICH Guidelines, other new unorthodox approaches may be experimented The strategy in Indonesia of not to treat a patient with a positive Widal test or a patient with stroke, while there is no drug for it, except good patient care, should be applied in Indonesia and other Asian countries. The Widal test is not meant to diagnose the disease, because the rise of the titer is merely the result of people eating food contaminated with Salmonella Typhi, which just elicit a small titer without (prolonged) fever, while diagnosis of typhoid is done clinically, by following up the fever pattern and clinical variables and finding Salmonella typhi bacteria in a blood sample cultured. More than 70% of a rise in titer can be found on healthy people in developing countries without a closed sewage system. 2. The Story of Theophylline and Aminophylline Aminophylline was the first well-known effective drug for bronchial asthma and bronchitis, it works as a bronchodilator and facilitates expectoration of bronchial mucus. This has been used since the 60s and 80s in a combination with ephedrine (Franol). However, the doses were not correct, aminophylline was used in variable doses of less than 100mg to 2400 mg (oral and/or IV), which was either useless or toxic. Such high variation of the dose of a drug reflects ignorance of the right dose. I did some small personal research, using and observing the reaction of asthmatic and bronchitis patients using a combination of aminophylline and ephedrine since 1960 (aminophylline is better soluble than theophylline). The combination of theophylline with Beta2 agonists are less effective. The use of dexamethasone became popular, because of its consistent anti-asthmatic activity, but the efficacy is offset by its deleterious metabolic side effects in chronic use. In the 1960s bronchial inhalants were very popular and soon isoprenaline and later Orciprenaline were used extensively; side effects of overuse were widespread and many deaths were reported. Since the invention of the more Selective Beta2 agonist like Salbutamol and Terbutaline, these drugs had replaced the previous ones as inhalants and Theophylline was ousted from the market through counter- promotion, because the specific Beta agonists were safer and did not give side effects like theophylline - nausea, stomach upset and tachycardia (mild). But it was less effective and also produced tacchycardia in larger doses. My comparative observation found that aminophylline-ephedrine combination was much better and longer in duration compared to beta agonists, so I continued using it. Realizing the problem of the dose of theophylline, I experimented with small differences in doses, and after some 20 years found that the optimal effective and safe dose for aminophylline was 135- 140 mg plus ephedrine 8 mg as the adult dose, which I still use to date with the constant great effectiveness. This means that I succeeded to finish a long-term Clinical Trial with N=1 and the result was very convincing. Almost all patients reacted unequivocally and if one had complaints (nausea) with 140 mg, I lowered the dose to 125-135 mg, and sometimes less. I also found that nausea and tachycardia occurs mostly with small underweight women (very rare,). No single serious adversity had happened in 40 years with almost 100% efficacy .(Seldom did I gave antibiotics or steroids, unless deem necessary). I noted that a dose of 140 mg Aminophylline was applicable for all adults with different bodyweights and no adaptation to the dose was necessary. This was an important finding to have a one dose policy for all. In the light of the great need of an effective drug for bronchitis in the WORLD this combination is the first choice of an improved therapeutic decision. I hope doctors will try this combination (and doses) on your own patients. (Theophylline dose = 86% of aminophylline). Antibiotics and expectorants are not effective. Also Cold and cough medicines in Indonesia and the world are all of bad composition and wrong doses; they have been criticized by FDA himself and many authors, including myself, but The FDA takes no steps to improve. Legitimacy of my Claim: • Drug Used: A once popular effective established drug in the 1960s-80s until newer drugs replaced the above combination through market forces. Wrong doses (too low or too high) have been used up till now. • Patients Used : from General Practice with keen observation and follow up for some 40 years. • Efficacy and Safety : Consistent good result • No serious adverse effect encountered. • Better and safer than current anti-asthmatics (eg. steroids) and treatment for bronchitis, which does not have another effective drug ( antibiotics and mucolytics don’t work) • An old good drug displaced by false market forces ( no comparative trials) 3. How within 15 minutes I got my kyphosis straight and increased 3-4 cm in length Orthopedic surgery is the usual way of repairing kypho- scoliosis which is a difficult operation, with many failures. I suffered myself from a heavy kypho-scoliosis since my younger years; the hunch-back was clearly evident and I lost some of my height, it also became worse with time. I will certainly not go for an operation and decided to try acupuncture. Two years ago I met a smart acupuncturist who studied in Beijing and applied a new method by Professor Kiiko Matsumoto in Japan, who had developed a novel method to combine Western Diagnosis with the orthodox Chinese Meridians, which resulted in many unexpected cures that Western Medicine could not do. After observing many good results, I tried my first contact with a queer case on myself: I suffered from a rhinitis which was the result of a serious fall on my left temple, which caused a fracture of my zygomaticus and bleeding that went on for 3-4 weeks. After it had stopped I suffered from a runny nose every time I eat. Mucus was flowing from my left nostril, and a bit from the right. It lasted more than 2 years and became unbearable. So I decided to try what acupuncture can do. After consulting one of the Textbooks in English, the Acupuncturist, who had 2 MDs from 2 Medical Schools, she said the diagnosis was “sphenoidal imbalance”, whatever this meant to me. An acupuncture therapy was also suggested in the book. I followed the treatment schedule, and was astonished that after several sessions the runny nose began to diminish and ultimately stopped. I was glad and rather surprised, but the proof was clear. Several other ailments were cured like magic within 15-20 minutes of needling. At last, I asked whether my kyphosis of some 60 years can be improved, and the answer was positive and so the very same day she stuck the needles in my back and arms plus legs and within 15 minutes I stood more erect and my height increased by some 3-4 cm and trusted what this new method of acupuncture could do, that Western Medicine sometimes failed. There is a scientific explanation of the kyphosis case; the front intervertebral muscles were in spasm and by needling these muscles from the back, it can be relaxed instantly, diminishing the kyphosis. Isn’t that an elegant alternative cure after suffering for 60 years?  Print Article  Send Article |
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