Despite existing strict safeguards, drugs with unknown side effects still manage to get through current well- established screening programs.
By: Ringo Bones and Vanessa Uy
It’s quite ironic that a drug formulated to relieve pain became known as: “the cure worse than the disease.” The drug Bextra –also known by it’s generic name as valdecoxib- that is marketed by the drug firm G.D. Searle and Company, was a popular pain reliever often used to treat the symptoms (i.e. pain) of rheumatoid arthritis and osteo arthritis in adults. The drug was recalled once it was linked to life threatening side effects including the autoimmune disorder Stevens Johnson syndrome, heart attacks, and strokes. Bextra was recalled from market circulation, however, the action came too late for the thousands of Bextra users who were harmed by the drug.
Drugs that manage to enter the market before their serious side effects are fully known is by no means a recent phenomenon. Back in 1960, thalidomide was this supposedly über-harmless sedative which was later found out to be a serious teratogen i.e. affects fetal development. Physicians in the then West Germany began noticing a spike in the occurrence of birth defects of one particular type. The babies are affected with phocomelia (from the Greek words: phoke, a seal, and melos, a limb). Toward the end of 1961 a persistent German pediatrician, Dr. Widukind Lenz tracked down thalidomide as the agent responsible in the case of the seal babies. Thalidomide usage had then spread from Germany to other European countries as well as to Canada, South America, Japan, and the Near East. In November 1961 the German manufacturer of thalidomide halted production, but the total number of thalidomide affected babies ultimately exceeded 5,000 in Germany and at least 1,000 in other countries.
At the time, American mothers were spared of the “full brunt” of the “thalidomide disaster” through the diligence of Frances Kelsey, a doctor then working for the US Food and Drug Administration. An American drug company had then applied for permission from the FDA to distribute the drug in the US, but Dr. Kelsey repeatedly refused to approve the application until she had conclusive evidence of thalidomide’s safety. When the news of the “thalidomide disaster” in Germany spread, the manufacturers withdrew their application to market thalidomide. Meanwhile, however, the drug companies had already sent out some thousands of free samples to physicians. Fortunately only a few of those got taken by pregnant women: American thalidomide babies numbered less than ten, and most of them were caused by pills brought in from Europe.
Recently, the drug firm involved with the marketing of Bextra is now resolving personal injury tort claims of the thousands of affected users via structured settlement. Is the Bextra incident a sign of increasing complacency of the established consumer product “watchdog” arm of the FDA? If so, then we the taxpayers deserve something better to get our money’s worth. Isn’t it what our taxes are for in the first place?
Showing posts with label Pharmacology. Show all posts
Showing posts with label Pharmacology. Show all posts
Thursday, January 3, 2008
Vioxx: Beyond Pain Relief?
Is it due to the current profit driven health care system/industry that drugs with undesirable side effects still manage to enter the market?
By: Ringo Bones and Vanessa Uy
Ever since the discovery of aspirin over a hundred years ago, medical science had been busy searching / designing for a substitute drug that’s just as effective in managing pain without aspirin’s broad-spectrum somewhat undesirable side effects. One of these drugs is Vioxx whose generic name is rofecoxib. Vioxx / rofecoxib is a non steroidal anti-inflamatory drug (NSAID for short) developed by the drug firm Merck and Company to treat osteoarthritis, acute pain conditions, and dismenorrhoea. Rofecoxib was approved as safe and effective by the US Food and Drug Administration (FDA) on May 20, 1999 and was subsequently marketed under the brand name Vioxx, Ceoxx, and Ceeoxx.
Ever since FDA approval, rofecoxib gained widespread acceptance. Over 80 million people were prescribed rofecoxib at some time. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risks of heart attack and stroke associated with long term high-dosage use of the drug. Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. Vioxx was Merck’s “Golden Goose” because it made them US$ 2.5 billion.
Merck’s withdrawal of Vioxx from the market is by no means an open and shut case. There’s the New England Journal of Medicine (NEJM) “controversy” on the Vioxx trial where certain data submitted to the FDA were not published in the NEJM article about the evaluation of Vioxx. The risks of prescribing rofecoxib to patients with pre existing cardiovascular disorders was found during the 2000 – 2001 Merck studies to find out if rofecoxib slows down the onset of Alzheimer’s disease or if the drug is a potential cure.
It’s quite unfortunate that Vioxx / rofecoxib was riddled with controversy like the other NSAID type drug Bextra / valdecoxib were the extent of the effects on the human cardiovascular system was not immediately known during the drug’s evaluation process. The rationale behind major drug companies producing and developing these kinds of drugs is sound because the medical community had always been searching for a substitute drug for aspirin in applications where it’s broad- spectrum of physiological effects would make it an undesirable choice. Lets not forget that if aspirin were to go through the stringency of current FDA standards of evaluation, it would never be approved for human use due to its broad –spectrum of physiological effects. Aspirin is primarily used as an analgesic and pain reliever but it also works as a mild anti-coagulant which it is used as a heart attack “preventive” for patients who are at risk for this. But aspirin’s use for this purpose requires a doctor’s supervision.
Despite of a number of drugs with attendant controversies, the medical community can’t immediately rule out their possible future potential applications. Studies have shown that Vioxx / rofecoxib is a potential Alzheimer’s disease preventive and / or possible cure. There was an article in Nature about how the teratogenic effects of thalidomide was “overlooked” because the drug doesn’t affect significantly the developing embryos of rabbits – the standard lab animal then in use back in the 1950’s - while the teratogenic nature of thalidomide was clearly evident in higher primates. Despite of thalidomide’s dangerous side effects, it has been recently used once again but this time it’s in the treatment of heart failure patients. Back in 2005, a BBC World documentary titled “Kill or Cure” featured recent trials of thalidomide being used as treatment of heart failure patients. This caused howls of protests from various thalidomide victims’ organizations around Europe criticizing the medical communities’ “failure to learn from history.”
When it comes to developing new and better drugs, the recent realities of the uneasy “marriage” between the drug industry and the medical community will always result in a “convoluted” path in drug evaluation and marketing. This is due to the results of trying to balance the demands of making a profit while staying true to the “Hippocratic Oath.”
By: Ringo Bones and Vanessa Uy
Ever since the discovery of aspirin over a hundred years ago, medical science had been busy searching / designing for a substitute drug that’s just as effective in managing pain without aspirin’s broad-spectrum somewhat undesirable side effects. One of these drugs is Vioxx whose generic name is rofecoxib. Vioxx / rofecoxib is a non steroidal anti-inflamatory drug (NSAID for short) developed by the drug firm Merck and Company to treat osteoarthritis, acute pain conditions, and dismenorrhoea. Rofecoxib was approved as safe and effective by the US Food and Drug Administration (FDA) on May 20, 1999 and was subsequently marketed under the brand name Vioxx, Ceoxx, and Ceeoxx.
Ever since FDA approval, rofecoxib gained widespread acceptance. Over 80 million people were prescribed rofecoxib at some time. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risks of heart attack and stroke associated with long term high-dosage use of the drug. Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. Vioxx was Merck’s “Golden Goose” because it made them US$ 2.5 billion.
Merck’s withdrawal of Vioxx from the market is by no means an open and shut case. There’s the New England Journal of Medicine (NEJM) “controversy” on the Vioxx trial where certain data submitted to the FDA were not published in the NEJM article about the evaluation of Vioxx. The risks of prescribing rofecoxib to patients with pre existing cardiovascular disorders was found during the 2000 – 2001 Merck studies to find out if rofecoxib slows down the onset of Alzheimer’s disease or if the drug is a potential cure.
It’s quite unfortunate that Vioxx / rofecoxib was riddled with controversy like the other NSAID type drug Bextra / valdecoxib were the extent of the effects on the human cardiovascular system was not immediately known during the drug’s evaluation process. The rationale behind major drug companies producing and developing these kinds of drugs is sound because the medical community had always been searching for a substitute drug for aspirin in applications where it’s broad- spectrum of physiological effects would make it an undesirable choice. Lets not forget that if aspirin were to go through the stringency of current FDA standards of evaluation, it would never be approved for human use due to its broad –spectrum of physiological effects. Aspirin is primarily used as an analgesic and pain reliever but it also works as a mild anti-coagulant which it is used as a heart attack “preventive” for patients who are at risk for this. But aspirin’s use for this purpose requires a doctor’s supervision.
Despite of a number of drugs with attendant controversies, the medical community can’t immediately rule out their possible future potential applications. Studies have shown that Vioxx / rofecoxib is a potential Alzheimer’s disease preventive and / or possible cure. There was an article in Nature about how the teratogenic effects of thalidomide was “overlooked” because the drug doesn’t affect significantly the developing embryos of rabbits – the standard lab animal then in use back in the 1950’s - while the teratogenic nature of thalidomide was clearly evident in higher primates. Despite of thalidomide’s dangerous side effects, it has been recently used once again but this time it’s in the treatment of heart failure patients. Back in 2005, a BBC World documentary titled “Kill or Cure” featured recent trials of thalidomide being used as treatment of heart failure patients. This caused howls of protests from various thalidomide victims’ organizations around Europe criticizing the medical communities’ “failure to learn from history.”
When it comes to developing new and better drugs, the recent realities of the uneasy “marriage” between the drug industry and the medical community will always result in a “convoluted” path in drug evaluation and marketing. This is due to the results of trying to balance the demands of making a profit while staying true to the “Hippocratic Oath.”
RNAi Therapy: Hope or Hype?
Touted as the latest cutting-edge therapy to turn the tide of battle against the AIDS pandemic, will RNA interference (RNAi) therapy succeed where protease inhibitor based drugs failed?
By: Ringo Bones
Growing up during the 1980’s, one can’t seem to ignore the doomsayer’s predictions on how humanity will be wiped out by the relentless spread of HIV infection or AIDS. Since at the time the existing therapeutic regimen are next to useless compared to the drugs set to replace them in the coming years. In the 1990’s came protease inhibitor based drugs that proved very promising – albeit very expensive – in saving the lives of AIDS sufferers in the early stages of the disease. Due to the high cost of the therapeutic regimen (Did it used to cost US$30,000 a year per patient?), only the extremely rich like NBA basketball star Magic Johnson can afford the expense. A decade or so later, the cost of the drugs came down dramatically that philanthropic institutions - like the Bill and Melinda Gates Foundation could provide the same therapy to parts of Africa seriously affected by AIDS at a cost of less than a dollar a day for every patient.
Though somewhat still awaiting field trials, RNA interference or RNAi therapy is the latest cutting edge therapy that has the necessary fighting chance to cure AIDS. RNAi therapy has the capability of switching off the pathogen that causes disease. If successful, RNAi therapy could not only cure AIDS but also hepatitis-C infections and further research could make RNAi therapy as a cure for cancer.
RNAi therapy was pioneered by an Australian biotech company called BENITEC. On July 2007, BENITEC was about to start dosing patients in the first human trials of their RNAi therapy, which attacks HIV infections on three separate fronts. Dr John Rossi from the Beckman Research Institute, City of Hope, California, outlined BENITEC’s RNA interference (RNAi) therapy – which he has collaborated on – and said that the first patient in the Phase I clinical trial will be dosed sometime by the end of July 2007.
Although the virus that causes HIV / AIDS can built up resistance to existing protease inhibitor based drugs alarmingly quickly, Dr John Rossi explained that attacking the virus on three separate fronts could enable the RNAi based drug to fend resistance for longer. It’s easy for the AIDS virus to mutate around one thing but much more difficult if there are three factors to contend with. Also, the mutated viruses that he has observed so far are much weaker that their previous “generation” as observed by Dr Rossi. But later, the virus reverted back to its original sequence.
Dr Rossi explained that the RNAi based drug uses a lentivirus vector to deliver the genes that encode for the three different forms of RNA to battle the virus. RNAi in the form of short hairpin RNA (shRNA), that targets an exon in the transactivator or transcription (Tat) and Regulator of Virion (Rev) gene (ShI). A decoy for the HIV TAT – reactive element (TAR) and a ribozyme that targets the host cell CCR5 chemokine receptor (CCR5RZ).
The scientists at BENITEC are using two different techniques to introduce the DNA into the body. The first one is where they remove the patient’s own bone marrow progenitor cells, genetically modifying them using the virus and then reinfuse them into the patient during a bone marrow transplant. BENITEC claims that – if successful – the new treatment could allow patients’ bodies to produce HIV-resistant white blood cells indefinitely.
BENITEC and City of Hope are also using a similar approach, only with T cells instead of stem cells explained Rossi. He went on to explain that the anti-CCR5 ribozyme may prevent the virus from entering the cell but if it does get in and starts to produce RNA’s, the drug will capture that RNA and also move the Tat away from the virus.
Not only does the drug attempt to knock back virus levels, Rossi said it also aims to destroy the lymphoma that develops in many HIV-positive patients. The trial itself will be treating five patients in this subgroup, with the results expected within a year.
From what I learned so far from virus physiology, using the “reproductive” phase of the pathogenic virus to “kill” it or render the virus impotent is a good way to tackle fast mutating RNA based viruses like HIV / AIDS. But a part of me that’s been reading (and watching) far too many science fiction stories find this technology rife for abuse. Especially further on when the science behind RNA interference therapy can be made to make one’s own immune system attack ones own body or make each and every cell in one’s body into a bunch of malignant tumors. As with any scientific “tool”, it’s up to the global community to police its applications.
By: Ringo Bones
Growing up during the 1980’s, one can’t seem to ignore the doomsayer’s predictions on how humanity will be wiped out by the relentless spread of HIV infection or AIDS. Since at the time the existing therapeutic regimen are next to useless compared to the drugs set to replace them in the coming years. In the 1990’s came protease inhibitor based drugs that proved very promising – albeit very expensive – in saving the lives of AIDS sufferers in the early stages of the disease. Due to the high cost of the therapeutic regimen (Did it used to cost US$30,000 a year per patient?), only the extremely rich like NBA basketball star Magic Johnson can afford the expense. A decade or so later, the cost of the drugs came down dramatically that philanthropic institutions - like the Bill and Melinda Gates Foundation could provide the same therapy to parts of Africa seriously affected by AIDS at a cost of less than a dollar a day for every patient.
Though somewhat still awaiting field trials, RNA interference or RNAi therapy is the latest cutting edge therapy that has the necessary fighting chance to cure AIDS. RNAi therapy has the capability of switching off the pathogen that causes disease. If successful, RNAi therapy could not only cure AIDS but also hepatitis-C infections and further research could make RNAi therapy as a cure for cancer.
RNAi therapy was pioneered by an Australian biotech company called BENITEC. On July 2007, BENITEC was about to start dosing patients in the first human trials of their RNAi therapy, which attacks HIV infections on three separate fronts. Dr John Rossi from the Beckman Research Institute, City of Hope, California, outlined BENITEC’s RNA interference (RNAi) therapy – which he has collaborated on – and said that the first patient in the Phase I clinical trial will be dosed sometime by the end of July 2007.
Although the virus that causes HIV / AIDS can built up resistance to existing protease inhibitor based drugs alarmingly quickly, Dr John Rossi explained that attacking the virus on three separate fronts could enable the RNAi based drug to fend resistance for longer. It’s easy for the AIDS virus to mutate around one thing but much more difficult if there are three factors to contend with. Also, the mutated viruses that he has observed so far are much weaker that their previous “generation” as observed by Dr Rossi. But later, the virus reverted back to its original sequence.
Dr Rossi explained that the RNAi based drug uses a lentivirus vector to deliver the genes that encode for the three different forms of RNA to battle the virus. RNAi in the form of short hairpin RNA (shRNA), that targets an exon in the transactivator or transcription (Tat) and Regulator of Virion (Rev) gene (ShI). A decoy for the HIV TAT – reactive element (TAR) and a ribozyme that targets the host cell CCR5 chemokine receptor (CCR5RZ).
The scientists at BENITEC are using two different techniques to introduce the DNA into the body. The first one is where they remove the patient’s own bone marrow progenitor cells, genetically modifying them using the virus and then reinfuse them into the patient during a bone marrow transplant. BENITEC claims that – if successful – the new treatment could allow patients’ bodies to produce HIV-resistant white blood cells indefinitely.
BENITEC and City of Hope are also using a similar approach, only with T cells instead of stem cells explained Rossi. He went on to explain that the anti-CCR5 ribozyme may prevent the virus from entering the cell but if it does get in and starts to produce RNA’s, the drug will capture that RNA and also move the Tat away from the virus.
Not only does the drug attempt to knock back virus levels, Rossi said it also aims to destroy the lymphoma that develops in many HIV-positive patients. The trial itself will be treating five patients in this subgroup, with the results expected within a year.
From what I learned so far from virus physiology, using the “reproductive” phase of the pathogenic virus to “kill” it or render the virus impotent is a good way to tackle fast mutating RNA based viruses like HIV / AIDS. But a part of me that’s been reading (and watching) far too many science fiction stories find this technology rife for abuse. Especially further on when the science behind RNA interference therapy can be made to make one’s own immune system attack ones own body or make each and every cell in one’s body into a bunch of malignant tumors. As with any scientific “tool”, it’s up to the global community to police its applications.
Medical Marijuana: Beyond Reproach?
Is it because of the relentless highly politicized “unscientific” vilification by the Moral Majority on the true nature of cannabis sativa i.e. marijuana during the Reagan Administration that allowed the “drug” to gain it’s unjustly earned “mystique”?
By: Ringo Bones and Vanessa Uy
In July 2007, the British medical journal Lancet published the result of a study that cannabis / pot users are 40% more likely to develop psychological illness like schizophrenia. Even if those conducting this recent study could refine their methods to a level of absolute certainty that’s beyond reproach, the results / data are likely to fall on deaf ears (or blind eyes) because marijuana has gained somewhat of a saint-like status that can be traced back to 1980’s America.
There are an increasing number of people –like us – who compares marijuana to a criminal who got acquitted from a prima facie case due to shoddy police work. Or maybe these are just people who grew up during the 1980’s being endlessly bombarded on the then politically-motivated-scientific-findings on the “brain-damaging” effects of delta-9 tetra hydro cannabinol, the main psychoactive component of marijuana. Back then, a book titled “The Emperor Wears No Clothes” by Jack Herer – which was secretly published in 1985 to the underground “Hemp” community is the only unbiased albeit pro hemp source of information on how marijuana affects a relatively large community. This book also serves as a manifesto that indicted the US Government’s hypocritical stance on marijuana use. During the Reagan Administration, there was an established government conspiracy to suppress findings on how hemp could be used as a viable source of BIOMASS to end America’s dependence on Middle Eastern petroleum. This came to pass despite of a well-known historical knowledge that Betsy Ross made the first US Flag “Old Glory” from hemp fiber. In 1942, the United States Department of Agriculture -with behest from the US Government – produced a 30 minute film titled “Hemp for Victory.” The film promotes the positive aspects of the Hemp Plant from the government’s own mouth.
The legislation that brought about the legalization of marijuana use – albeit for medical purpose – was due to scientific findings on it’s therapeutic effects on glaucoma. Facing relentless public pressure due to suppression of scientific results extolling the positive aspects of marijuana plus the relatively “liberal” political climate of the Clinton Administration, the US Government finally started legal proceedings allowing for the legalization of marijuana for medical use despite the protests of the “conservative” States. Though it’s been legal for a long time in “liberal” territories like the Netherlands, marijuana use – especially in the “coffee shops” of Amsterdam – are viewed as nothing more than recreational drug use by the cynical policymakers around the world. As recently as the 21st of August 2007, when a woman in Germany suffering from multiple sclerosis was prescribed with medical marijuana for pain relief after “conventional” pain medications failed to work caused an- uproar in the “conservative” community.
From the Alternative Medicine standpoint, marijuana –like the “perennially experimental” bee venom therapy for multiple sclerosis – still warrants more definitive research. This is so because the medical community could very much benefit on finding out which chemical components of cannabis sativa i.e. marijuana has genuine medicinal / therapeutic properties that can be separated from those components responsible only for psychoactive and / or narcotic effects.
To the rest of the world (except maybe the Netherlands of course), the legitimacy of medical marijuana will be found wanting due to lack of research and due to the political baggage that the plant endured under “REAGANISM.” While a large majority see “Medical Marijuana” as something really beyond reproach like Al Gore supporters conveniently overlooking Tipper Gore’s circa 1989 PMRC in the name of “Political Correctness.” Maybe Abraham Lincoln said it best “Prohibition will work great injury to the cause of temperance. It is a species of intemperance within itself, for it goes beyond the bounds of reason, in that it attempts to control a man’s appetite by legislation and to make a crime of things that are not crimes. A prohibition law strikes a blow at the very principles upon which our government was founded.” Except that Lincoln’s GOP is a whole different animal compared to the 21st Century “incarnation.”
By: Ringo Bones and Vanessa Uy
In July 2007, the British medical journal Lancet published the result of a study that cannabis / pot users are 40% more likely to develop psychological illness like schizophrenia. Even if those conducting this recent study could refine their methods to a level of absolute certainty that’s beyond reproach, the results / data are likely to fall on deaf ears (or blind eyes) because marijuana has gained somewhat of a saint-like status that can be traced back to 1980’s America.
There are an increasing number of people –like us – who compares marijuana to a criminal who got acquitted from a prima facie case due to shoddy police work. Or maybe these are just people who grew up during the 1980’s being endlessly bombarded on the then politically-motivated-scientific-findings on the “brain-damaging” effects of delta-9 tetra hydro cannabinol, the main psychoactive component of marijuana. Back then, a book titled “The Emperor Wears No Clothes” by Jack Herer – which was secretly published in 1985 to the underground “Hemp” community is the only unbiased albeit pro hemp source of information on how marijuana affects a relatively large community. This book also serves as a manifesto that indicted the US Government’s hypocritical stance on marijuana use. During the Reagan Administration, there was an established government conspiracy to suppress findings on how hemp could be used as a viable source of BIOMASS to end America’s dependence on Middle Eastern petroleum. This came to pass despite of a well-known historical knowledge that Betsy Ross made the first US Flag “Old Glory” from hemp fiber. In 1942, the United States Department of Agriculture -with behest from the US Government – produced a 30 minute film titled “Hemp for Victory.” The film promotes the positive aspects of the Hemp Plant from the government’s own mouth.
The legislation that brought about the legalization of marijuana use – albeit for medical purpose – was due to scientific findings on it’s therapeutic effects on glaucoma. Facing relentless public pressure due to suppression of scientific results extolling the positive aspects of marijuana plus the relatively “liberal” political climate of the Clinton Administration, the US Government finally started legal proceedings allowing for the legalization of marijuana for medical use despite the protests of the “conservative” States. Though it’s been legal for a long time in “liberal” territories like the Netherlands, marijuana use – especially in the “coffee shops” of Amsterdam – are viewed as nothing more than recreational drug use by the cynical policymakers around the world. As recently as the 21st of August 2007, when a woman in Germany suffering from multiple sclerosis was prescribed with medical marijuana for pain relief after “conventional” pain medications failed to work caused an- uproar in the “conservative” community.
From the Alternative Medicine standpoint, marijuana –like the “perennially experimental” bee venom therapy for multiple sclerosis – still warrants more definitive research. This is so because the medical community could very much benefit on finding out which chemical components of cannabis sativa i.e. marijuana has genuine medicinal / therapeutic properties that can be separated from those components responsible only for psychoactive and / or narcotic effects.
To the rest of the world (except maybe the Netherlands of course), the legitimacy of medical marijuana will be found wanting due to lack of research and due to the political baggage that the plant endured under “REAGANISM.” While a large majority see “Medical Marijuana” as something really beyond reproach like Al Gore supporters conveniently overlooking Tipper Gore’s circa 1989 PMRC in the name of “Political Correctness.” Maybe Abraham Lincoln said it best “Prohibition will work great injury to the cause of temperance. It is a species of intemperance within itself, for it goes beyond the bounds of reason, in that it attempts to control a man’s appetite by legislation and to make a crime of things that are not crimes. A prohibition law strikes a blow at the very principles upon which our government was founded.” Except that Lincoln’s GOP is a whole different animal compared to the 21st Century “incarnation.”
Innovations in Pharmacology: An Arrested Development?
With the recent controversies surrounding the side - effects of BEXTRA and VIOXX, does this mean that recent advances in pharmacology had reached a dead end?
By: Ringo Bones and Vanessa Uy
The supposedly side – effect free and more effective substitutes for aspirin – BEXTRA and VIOXX- are fast becoming a non-starter for the multi-million dollar pharmaceutical industry. By now, almost all of us are wondering if the “miracles of modern science” has recently abandoned the field of pharmacology. Is this problem truly insurmountable as implied by the latest buzz - words in pharmaceutical / pharmacological publications? Let’s cite some examples.
Before the advent of antibiotics like penicillin, the only cure available for venereal diseases are arsenical compounds (developed during the 19th Century) so toxic that the cure was more likely to kill you than cure you. Now -the problem created by the misuse of our tried-and-true arsenal of antibiotics - are the drug-resistant pathogens engendered by the improper use and administration of antibiotics. That’s why back in the 1990’s arsenicals were re-introduced as a venereal disease cure against multi drug resistant syphilis.
Back in the 1950’s, thalidomide was developed as a much safer substitute for barbiturate-based sleeping pills. It was reported back then that one woman attempted to commit suicide by taking thalidomide based pills and failed to take her own life. Then the teratogenic effects of thalidomide surfaced after the drug was already widely marketed in Europe.
Probably developed during the height of the Cold War i.e. mid to late 1950’s – pyridostigmine bromide – was developed as a substitute for atropine sulfate to counteract the effects of cholinesterase inhibitor based weaponry i.e. nerve gas / nerve agents. Atropine sulfate was known to interfere with the infantry’s physical exertion i.e. dodging bullets upon intramuscular injection. Pyridostigmine bromide was designed to avoid this “inconvenience.” But back in April 1995, pharmacologist Mohamed Abou-Donia, while examining the nature of “Gulf War Syndrome” discovered that pyridostigmine bromide while effective at protecting soldiers against nerve agents by binding to – and shielding – the enzyme that nerve gas attacks. But it also grabs onto enzymes that help break down toxic chemicals thus the probable agent responsible for causing “Gulf War Syndrome.” This is quite the opposite of what atropine sulfate does – by increasing the body’s metabolism so that the nerve agents are flushed out of the body before it can do serious damage.
While a number of pharmaceutical companies choose to wait for unfortunate side – effects to occur before pulling their product off the market. Some – like the ASTRA ZENECA company, choose to voluntarily withdraw their product before a large number of unfortunate side – effects or fatalities could occur. ASTRA ZENECA developed the anticoagulant XIMELAGATRAN as a less toxic replacement for warfarin. XIMELAGATRAN was the first member of direct thrombin inhibitors that can be taken orally. For the benefit of those who do not know what is warfarin, it is the main ingredient in rat poison. Warfarin kills rats by making them bleed to death due to its anti coagulant effects. Also, warfarin makes a good rat poison / rodenticide because in case of accidental poisoning to humans, Vitamin K tablets can be used as a very effective antidote. In 2006, ASTRA ZENECA – the manufacturer of XIMELAGATRAN – announced that it would not attempt to market XIMELAGATRAN after reports of hepatoxicity (liver damage) during trials,and to discontinue it’s distribution in countries where the drug had been approved.
While in the last week of July 2007, the type-2 diabetes maintenance drug AVANDIA – a ROSIGLITAZONE and METFORMINE combination in one convenient pill - has been under scrutiny because recent studies of 7,500 patients have shown that 1 in 50 developed a heart attack. While some, developed fluid retention problems. One-fourth of their test subjects is aged below 50. This report has caused the stock value of GlaxoSmithKlein – AVANDIA’s manufacturer – to fall. Due to lack of a suitable replacement, and since AVANDIA had become ubiquitous with type-2 diabetes sufferers around the world. Majority of the world’s pharmaceutical regulatory bodies has just advised General Practitioners to closely monitor their patients who are presently taking AVANDIA.
This bothersome phenomena where innovations can no longer improve a trusty –but – rusty “workhorse” has finally invaded the world of pharmacology. This “phenomena” had plagued the hi-fi / audio industry for the past 20 –or so – years. It has the effect of rendering the decade –or more- advances in digital recording unable to “out – beauty” the good ol’ analogue sound recording i.e. 30 in/sec magnetic tape recording.
Will the tropanol derivative atropine – despite its negative physiological effects – be the “better” choice in protecting the fighting men and women the world over against cholinesterase inhibitor based weaponry well into the next century for the reason that replacements are proven to do more harm than good? And what about aspirin, are we just fortunate that it was discovered and marketed well before draconian laws to govern the pharmaceutical industry were legislated and enforced? From a pharmacological standpoint, it seems that chemical – based pharmaceuticals are inherently toxic to the human physiology. This is why the major pharmaceutical companies the world over are investing millions in their Research and Development department to develop drugs / agents that work using the principles of the science of genetic engineering like BENITEC’s RNA interference therapy. Presently, it seems the careful management of therapeutic regimens is the only viable option. In retrospect, the progress of the science of pharmacology has always been dependent – or hindered depending your point of view – to the current “politics” that engendered the legislation of draconian laws that regulate the pharmaceutical industry.
By: Ringo Bones and Vanessa Uy
The supposedly side – effect free and more effective substitutes for aspirin – BEXTRA and VIOXX- are fast becoming a non-starter for the multi-million dollar pharmaceutical industry. By now, almost all of us are wondering if the “miracles of modern science” has recently abandoned the field of pharmacology. Is this problem truly insurmountable as implied by the latest buzz - words in pharmaceutical / pharmacological publications? Let’s cite some examples.
Before the advent of antibiotics like penicillin, the only cure available for venereal diseases are arsenical compounds (developed during the 19th Century) so toxic that the cure was more likely to kill you than cure you. Now -the problem created by the misuse of our tried-and-true arsenal of antibiotics - are the drug-resistant pathogens engendered by the improper use and administration of antibiotics. That’s why back in the 1990’s arsenicals were re-introduced as a venereal disease cure against multi drug resistant syphilis.
Back in the 1950’s, thalidomide was developed as a much safer substitute for barbiturate-based sleeping pills. It was reported back then that one woman attempted to commit suicide by taking thalidomide based pills and failed to take her own life. Then the teratogenic effects of thalidomide surfaced after the drug was already widely marketed in Europe.
Probably developed during the height of the Cold War i.e. mid to late 1950’s – pyridostigmine bromide – was developed as a substitute for atropine sulfate to counteract the effects of cholinesterase inhibitor based weaponry i.e. nerve gas / nerve agents. Atropine sulfate was known to interfere with the infantry’s physical exertion i.e. dodging bullets upon intramuscular injection. Pyridostigmine bromide was designed to avoid this “inconvenience.” But back in April 1995, pharmacologist Mohamed Abou-Donia, while examining the nature of “Gulf War Syndrome” discovered that pyridostigmine bromide while effective at protecting soldiers against nerve agents by binding to – and shielding – the enzyme that nerve gas attacks. But it also grabs onto enzymes that help break down toxic chemicals thus the probable agent responsible for causing “Gulf War Syndrome.” This is quite the opposite of what atropine sulfate does – by increasing the body’s metabolism so that the nerve agents are flushed out of the body before it can do serious damage.
While a number of pharmaceutical companies choose to wait for unfortunate side – effects to occur before pulling their product off the market. Some – like the ASTRA ZENECA company, choose to voluntarily withdraw their product before a large number of unfortunate side – effects or fatalities could occur. ASTRA ZENECA developed the anticoagulant XIMELAGATRAN as a less toxic replacement for warfarin. XIMELAGATRAN was the first member of direct thrombin inhibitors that can be taken orally. For the benefit of those who do not know what is warfarin, it is the main ingredient in rat poison. Warfarin kills rats by making them bleed to death due to its anti coagulant effects. Also, warfarin makes a good rat poison / rodenticide because in case of accidental poisoning to humans, Vitamin K tablets can be used as a very effective antidote. In 2006, ASTRA ZENECA – the manufacturer of XIMELAGATRAN – announced that it would not attempt to market XIMELAGATRAN after reports of hepatoxicity (liver damage) during trials,and to discontinue it’s distribution in countries where the drug had been approved.
While in the last week of July 2007, the type-2 diabetes maintenance drug AVANDIA – a ROSIGLITAZONE and METFORMINE combination in one convenient pill - has been under scrutiny because recent studies of 7,500 patients have shown that 1 in 50 developed a heart attack. While some, developed fluid retention problems. One-fourth of their test subjects is aged below 50. This report has caused the stock value of GlaxoSmithKlein – AVANDIA’s manufacturer – to fall. Due to lack of a suitable replacement, and since AVANDIA had become ubiquitous with type-2 diabetes sufferers around the world. Majority of the world’s pharmaceutical regulatory bodies has just advised General Practitioners to closely monitor their patients who are presently taking AVANDIA.
This bothersome phenomena where innovations can no longer improve a trusty –but – rusty “workhorse” has finally invaded the world of pharmacology. This “phenomena” had plagued the hi-fi / audio industry for the past 20 –or so – years. It has the effect of rendering the decade –or more- advances in digital recording unable to “out – beauty” the good ol’ analogue sound recording i.e. 30 in/sec magnetic tape recording.
Will the tropanol derivative atropine – despite its negative physiological effects – be the “better” choice in protecting the fighting men and women the world over against cholinesterase inhibitor based weaponry well into the next century for the reason that replacements are proven to do more harm than good? And what about aspirin, are we just fortunate that it was discovered and marketed well before draconian laws to govern the pharmaceutical industry were legislated and enforced? From a pharmacological standpoint, it seems that chemical – based pharmaceuticals are inherently toxic to the human physiology. This is why the major pharmaceutical companies the world over are investing millions in their Research and Development department to develop drugs / agents that work using the principles of the science of genetic engineering like BENITEC’s RNA interference therapy. Presently, it seems the careful management of therapeutic regimens is the only viable option. In retrospect, the progress of the science of pharmacology has always been dependent – or hindered depending your point of view – to the current “politics” that engendered the legislation of draconian laws that regulate the pharmaceutical industry.
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