TRUTH WILL TRIUMPH.
Posted by bmhegde on 1
When I first conceived the clinical pharmacology unit for Kasturba Medical College, Mangalore, where I was the Dean in the early 90s, the original concept was to do ethical and scientific drug research to help the Indian pharma companies to help the Indian populace. I got one of my very good friends, Prof. Gopi Menon, who had been teaching clinical pharmacology in Holland for twenty years by then to go over here to train junior researchers. He came on his own and stayed here for three weeks training some of my colleagues in the field to start the first department. We had chosen one of my very good students, Prabha Adhikari, to be in charge. For nearly a decade before that I was myself directing the drug trials in Wenlock Hospital, our clinical teaching set up, for Ranbaxy and Cipla and other companies. However, I was not happy with the setting and we wanted to have training facilities for training juniors to have regular drug trials of very high standards. I think it was one of the first such centres in India then. Gopi Menon did help other centres in India as well later.
Looking back I now feel that the whole pattern of drug trials has taken a bad turn in that the multinational drug companies have maneuvered to get hold of this area to their advantage. I have been writing about it but my “friends” in India think I am only a muckraker. Now we have a fascinating book by an American pathologist by training and the former Editor-in-Chief of the much coveted medical weekly, the New England Journal of Medicine, Marcia Angell, who has proved my convictions beyond a shadow of any doubt. . She published a new book through Random House in New York with the title: The Truth About the Drug Companies: How They Deceive Us and What To Do About It. In a recent interview on her book tour she candidly answered the press reporters’ questions. One answer is very pertinent here.
“As a journal editor, I witnessed a disturbing trend in pharmaceutical research. Twenty years ago, most drug trials were conducted at academic medical centers and the pharmaceutical companies tended to stand back during the testing period. However, in recent years, the companies have succeeded in attaching strings to research contracts, often designing the studies themselves, keeping the data in-house and deciding whether or not to publish the results. They also began to contract with private research companies for testing. Moreover, the medical schools and even individual researchers began to enter into entrepreneurial arrangements with the drug companies. While all this was occurring, I began to see bias creep into medical research. And I saw a lot of it. The most obvious example were studies comparing a new drug to a placebo. That may be enough to get a drug F.D.A. approval, but it should not be enough for The New England Journal of Medicine. Doctors don't want to know whether a drug is better than nothing. They want to know if it's better than what they are already using.”
Those readers who are familiar with my earlier writings, during the last forty years, would realize that Marcia is verbalizing my earlier thoughts! Pharmaceutical companies have done a lot in the past to introduce life saving drugs but, now they are only interested in making money. The laudable motto of service is given a go by with their greed for money and proclivity for comfort. Let us review one class of drug scenario-the antibiotics. Time was when penicillin was discovered in the early 40s. Although Sir Alexander Fleming did notice that a fungus, Penicillium Notatum, could destroy colonies of Staphylococcus Aureus, he did precious little beyond that except getting all the credit for a new find and getting Knighted by the King. He had forgotten all about the whole thing since the prevailing wisdom at that time was that any drug given internally to kill germs would kill man as well! Long before Alexander Fleming’s serendipitous discovery of funguses killing bacteria, two others had noticed the same happening with Penicillium Glucuon, but they are now forgotten.
Ultimately when Howard Florey, an Australian born pathologist, while heading the Dunn School of Pathology in Oxford was working in his institute with a biochemist Ernest Chain, a Jew thrown out of Germany by Hitler, discovered penicillin from the same fungus. Both Florey and Chain came to know about the forgotten find about fungi killing germs and they went ahead to show that the drug is safe in animals. To mass produce penicillin Florey did not have the facilities. He took the help of two agricultural scientists from the US who helped him with their facilities. Even then Howard Florey was very shy of publicity for two reasons. He thought he could not meet the huge demand of the army in the middle of the Second World War where the wound gangrene casualties outnumbered those that died with the bullet! The other burning guilt was that he avoided drafting during the First World War fearing death. He wanted to do something for the dying soldiers. In the meantime the greedy American agricultural scientists had patented penicillin and eventually Florey had to purchase his own discovery from them. This is how money entered science in a big way. With all this happening in Oxford Sir Alexander Fleming managed to convince the world and the Swedish Academy that he is the real discoverer of penicillin and bagged Nobel Prize alone. That much for scientific honesty.
A report in 1941 showed how 41 out of the 42 patients with staphylococcal bacteriaemia succumbed to the germ. The first post-penicillin report showed the same percentage surviving after penicillin injections! This was announced to the world as the greatest triumph of man over germs. The ill advised euphoria was very short lived. By 1950 it became clear that more than half the strains of Staph. aureus have become resistant to penicillin. Beta lactamase producing staph. could eat penicillin and thrive well on it. Report in 1956 showed that among the severe resistance group 41 out of 42 patients with bacteriaemmia died even with penicillin, the repeat of what used to happen before 1941. We were back to the square one.
It was then that the well meaning drug companies, Glaxo, Smith Kline, Aventis, Roche, Bristol Myers, Squibb, Eli-Lily, Wyeth and Proctor and Gamble, came forward at different times, to test newer molecules and with the emergence of resistance due to beta-lactamase enzyme, drug companies produced methicillin; but soon germs became methicillin resistant. Along with the staphylococcus becoming resistant to penicillin, hospitals were beseeched by gram negative rods. These were the cause of worry but again the industry came up with vancomycin and ciprofloxacin and many other anti-biotics but now they are all reluctant to get into finding a new molecule. There are two reasons. With five hundred molecules in the market, most of them are variants, the chance of a new molecule making lots of money is very remote and the initial funding needed for the discovery could be prohibitive. The risk involved is also not insignificant. With all that no drug company has come forward to go into antibiotic research. This is a very dangerous situation as some “super-bugs” have become resistant to all anti-biotics. The same old drug companies, mentioned earlier, that came forward to help mankind, would now go into other areas where the risk adjusted present value is much higher. While the NPVR for a newer antibiotic is 100, it could be 300 for neurologic drugs, 750 for oncologic drugs and 1750 for musculoskeletal drugs. Naturally, all the companies have gone into those areas. NPVR could be enormous for vitamins and minerals!
This is only one area where the drug companies’ “philanthropic” motives are bared. There are more dangerous areas still to be unraveled. Drug companies sex up research data to suit their convenience. They make the “thought leaders” on their pay role to even manufacture new diseases to sell their drugs, female impotence being one of the new diseases. Even dangerous drugs are being marketed with false claims. Drug prices are hiked up with the US government conniving with them with the false claim that their R&D costs are very high. In fact, most of the recent drugs are only “me too” drugs-the slightly altered form an existing molecule. This ruse is used by companies whose patent rights are elapsing by producing another molecule with a change in a methyl molecule or so. Such drugs are there in plenty. The profit margins could be in the range of 5000% even! The greedy drug companies make modern medicine prohibitively expensive for the common man. With the WTO and GATT etc. even the developing countries are suffering the same fate. If a company outside the US sells a good drug for a cheaper price that drug would be “scientifically” rubbished by the giants in the market making use of some of the doctors who toe their line and sign on the dotted lines. Research data, especially, drug trials are nowadays commercialized by having international entrepreneurial contracts.
I have only given the reader a peep hole view of the dangerous situation created by the drug companies. Marcia’s book bares it all for the lay reader. She is very highly qualified to write this book as she is not only an able editor she is also a senior teacher at the Harvard Medical College. I was only wondering as to why it took her so long g to expose the truth. I have been writing about every aspect what Marcia has shown in her book for the last four decades but medical fraternity in our country chose to ignore it. I have got my recognition elsewhere and people do give weightage to what I write. Better late than never. She is busy selling her book and very soon will become a millionaire. Our books are sold for a pittance in comparison. Dr. Angell has written a remarkable book worth its weight in gold for the future of mankind. Thinking people should ponder over this menace to come up with some answer and see that the medical profession gets its noble status once again. Most of the doctors, if not all, in India would want to see the profession back on its tracks.