I'm the first to admire the strengths and virtues of the free-enterprise model as it applies to drug development and sales. This model encourages drug companies to employ talented people and to take risks in developing new drugs for serious medical problems. But let's face it, current practices also produce undesirable effects.
1. When their drug that was wonderful last month is suddenly no good.
It's been entertaining to watch the drug companies suddenly come up with new, patentable variations of their drugs just when their old patents are expiring. For example, since the 1970s, the Abbott company has been doing a dance with different formulations of valproic acid (used for seizures, migraines and bipolar disorder). At first, the brand name was Depakene, but when that patent ran out, Depakene was suddenly no good any more, and Depakote (just barely different enough to be patentable) was the only drug one should think of. Then when Depakote's patent ran out, suddenly it wasn't any good, either. Now Depakote ER (extended release) is the only way to fly.
This approach of reworking the old drug into longer-acting formats has worked for other drug companies, too. For example, GlaxoSmithKline has gone through the same dance with their formulations of bupropion for depression, evolving from Wellbutrin to Wellbutrin SR (sustained release) to Wellbutrin XL (extended release). Wyeth, seeing a good thing, followed the same path with venlafaxine antidepressant, going from Effexor to Effexor XR (extended release). It's just an amazing coincidence how these new, suddenly-better drugs emerge just when the old drugs expire and face generic competition.
2. When they make us forget that the older drugs work just fine.
Since 1954 we've had effective anti-psychotic drugs to treat schizophrenia, but beginning in the 1990s a series of new anti-psychotics emerged, now called the "atypical" or "novel" anti-psychotics. Suddenly, the older drugs -- all generic and therefore reasonably priced -- were no good. Only the new, patented anti-psychotics were any good and one might even be guilty of malpractice if one prescribed an older drug (or continued prescribing one to a patient who seemed to be doing fine). Indeed, a generation of new psychiatrists cycled through training programs with this concept in mind, rarely writing a prescription for an older drug.
The alleged superiority of the newer drugs was tested in the recently completed CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) study and found to be absent. The study compared four newer drugs to an older drug, perphenazine, and the differences in outcome were minimal to none.
3. When they draw attention away from non-medication treatments.
Drug companies sell drugs. Therefore, when it comes to marketing their products, they have no interest in promoting -- or even mentioning -- non-drug treatments. There are no salespeople making the rounds of doctors' offices to remind physicians of the rigorously proved benefits of stress management training for migraine and tension-type headaches, or of cognitive-behavioral counseling for depression.
4. When they hook us on samples.
Doctors' offices receive samples of patented (high mark-up) drugs and not of unpatented (low mark-up) drugs. Therefore, patients are steered toward the expensive drugs by means of these "loss-leaders."
5. When they shape medical practice.
Drug companies aggressively court the thought-leaders, like faculty members at medical schools, with financial perks such as impressive fees for speaking engagements. They also subsidize medical publications. The effects of these marketing activities on medical practice are not necessarily beneficial to patients.
For example, tissue plasminogen activator (tPA) is an expensive clot-dissolving drug approved for use in stroke patients. Its benefits are modest and its risks are real (brain hemorrhage and death). Thoughtful clinicians might reasonably conclude that the benefits of administering tPA do not outweigh the risks. But this is not the message that comes from many thought-leaders and publications. Instead, the implication is that administering this drug is a standard of care, and omitting it constitutes malpractice.
6. When the sales reps push unapproved uses.
Recently, a Pfizer sales rep told me that his company's drug, pregabalin, is effective in preventing migraine. He shouldn't have said that. Pregabalin is FDA-approved for treatment of epilepsy and nerve-pain, but not migraine. Although physicians in the U.S. are allowed to prescribe drugs for "off-label" uses, drug companies are prohibited from advertising their drugs for non-approved uses. In fact, Pfizer got in trouble for pushing another drug, gabapentin, for unapproved uses.
7. When doctors don't think critically about what they're doing.
This, strictly speaking, isn't a deficiency of the drug companies. But because the only salespeople that doctors see are for expensive, branded drugs, the names of less expensive (or more effective) alternatives may not come to mind when prescriptions are written.
Wednesday, November 7, 2007
Tuesday, November 6, 2007
Botox: A Promising Therapy Against Neuromuscular Disorders
Botox is widely known therapy for treatment of strabismus, blepharospasm, cervical dystonia, severe primary axillary hyperhidrosis and glabellar lines.
Botox® is in fact, a popular brand name owned by Irvine, California based American company Allergan, Inc. Allergan is a globally known and esteemed pharmaceutical company that produces eye care, skin care and neuromuscular treatment products. The pharma actually sells the potent neurotoxin, Botulinum toxin type A, under the brand name Botox.
Botox and Botrox Cosmetic got the U.S. FDA’s nod for treatment of strabismus, blepharospasm, cervical dystonia, severe primary axillary hyperhidrosis and glabellar lines respectively in 1989.
Botrox Cosmetic has shown brilliant success against moderate to severe glabellar lines associated with corrugators and/or procures muscle activity in adult patients. Glabellar lines are the frown lines between the eyebrows appeared to soften following treatment for eye muscle disorders.
Botox has had a great success as an effective treatment for Cervical Dystonia, Strabismus, Blepharospasm and Severe Axillary Hyperhidrosis.
Cervical Dystonia (CD) is the neuromuscular disorder that belongs to disorders known as focal dystonias. The CD in its severe form can cause abnormal head position and severe neck pain. It’s also known as spasmodic torticollis.
Strabismus is the disorder of crossed eyes. It is a neuromuscular disorder that causes a deviation in alignment of one eye from the other. It can occur gradually or rapidly in adults. Esotropia and Exotropia are two forms of Strabismus. The Esotropia (convergent strabismus) causes the eyes to turn towards the nose and Exotropia (divergent strabismus) causes the eyes to turn away from the nose. The eyes may also turn up and down.
Blepharospasm in simple words is an uncontrollable blinking. It is a neuromuscular disorder related to dystonia including essential blepharospasm or VII nerve disorder in patients 12 years of age and above. It affects the muscles that control eyelid movement and causes uncontrollable blinking. Its severe form can cause functional blindness.
Severe Axillary Hyperhidrosis in simple words is the severe underarm sweating. The condition involves hyperactive sweat glands that cause over-sweating.
In the beginning the botox therapy was used in the treatment of certain ophthalmic movement disorders, but presently it’s been used quite commonly against many therapeutic neuromuscular disorders, pain related to cosmetic facial aesthetics. Its use in the treatment of migraine headaches (chronic headache and chronic musculoskeletal pain) has considerably increased.
The researchers reckon that ‘botulinum toxin type A', can potentially be used to treat urinary incontinence, anal fissure, spastic disorders associated with injury or disease of the central nervous system including trauma, stroke, multiple sclerosis, or cerebral palsy and focal dystonias affecting the limbs, face, jaw, or vocal cords. There’re also evidences that botrox can help in weight loss by increasing the gastric emptying time, but the FDA hasn’t given green signal yet.
Botox® is in fact, a popular brand name owned by Irvine, California based American company Allergan, Inc. Allergan is a globally known and esteemed pharmaceutical company that produces eye care, skin care and neuromuscular treatment products. The pharma actually sells the potent neurotoxin, Botulinum toxin type A, under the brand name Botox.
Botox and Botrox Cosmetic got the U.S. FDA’s nod for treatment of strabismus, blepharospasm, cervical dystonia, severe primary axillary hyperhidrosis and glabellar lines respectively in 1989.
Botrox Cosmetic has shown brilliant success against moderate to severe glabellar lines associated with corrugators and/or procures muscle activity in adult patients. Glabellar lines are the frown lines between the eyebrows appeared to soften following treatment for eye muscle disorders.
Botox has had a great success as an effective treatment for Cervical Dystonia, Strabismus, Blepharospasm and Severe Axillary Hyperhidrosis.
Cervical Dystonia (CD) is the neuromuscular disorder that belongs to disorders known as focal dystonias. The CD in its severe form can cause abnormal head position and severe neck pain. It’s also known as spasmodic torticollis.
Strabismus is the disorder of crossed eyes. It is a neuromuscular disorder that causes a deviation in alignment of one eye from the other. It can occur gradually or rapidly in adults. Esotropia and Exotropia are two forms of Strabismus. The Esotropia (convergent strabismus) causes the eyes to turn towards the nose and Exotropia (divergent strabismus) causes the eyes to turn away from the nose. The eyes may also turn up and down.
Blepharospasm in simple words is an uncontrollable blinking. It is a neuromuscular disorder related to dystonia including essential blepharospasm or VII nerve disorder in patients 12 years of age and above. It affects the muscles that control eyelid movement and causes uncontrollable blinking. Its severe form can cause functional blindness.
Severe Axillary Hyperhidrosis in simple words is the severe underarm sweating. The condition involves hyperactive sweat glands that cause over-sweating.
In the beginning the botox therapy was used in the treatment of certain ophthalmic movement disorders, but presently it’s been used quite commonly against many therapeutic neuromuscular disorders, pain related to cosmetic facial aesthetics. Its use in the treatment of migraine headaches (chronic headache and chronic musculoskeletal pain) has considerably increased.
The researchers reckon that ‘botulinum toxin type A', can potentially be used to treat urinary incontinence, anal fissure, spastic disorders associated with injury or disease of the central nervous system including trauma, stroke, multiple sclerosis, or cerebral palsy and focal dystonias affecting the limbs, face, jaw, or vocal cords. There’re also evidences that botrox can help in weight loss by increasing the gastric emptying time, but the FDA hasn’t given green signal yet.
Sunday, November 4, 2007
Forget The Cure For Cancer, Heart Disease, Alzheimer, Or Diabetes. Unless...
If you want a cure for cancer, heart disease, Alzheimer, or diabetes, don't count on the academia, the National Institute of Health (NIH), or the biotech/pharmaceutical industry. With all the money they have spent on researching these diseases, they have very little to show for it.
In 1971, during the State of the Union address, President Nixon declared the war on cancer proposing "an intensive campaign to find a cure for cancer." Since 1971, Americans spent, through taxes, donations, and private R&D, about $200 billion in inflation-adjusted dollars. This money produced 1.56 million papers on cancer. Yet, today we are no closer to a cure than we were in 1971. Why?
Consider what Dr. Almog said in his paper: Drug Industry in "depression" (Almog, D. Drug industry in "depression". Med Sci Monit. 2005 Jan;11(1):SR1-4, I would urge you to read his paper, it's an eye opener on relationship between academic research and commercial drug discovery): "When the basic science/biology of disease is not available, no new drugs come to market." With the billion of dollars spent by the NIH on basic science, and the millions of papers published on the topic, the question is, "Why isn’t the basic science/biology of disease available? Individual discoveries in the biology of human disease are cornerstone in new treatments. However, in drug discovery, these basic science/biology discoveries are seemingly unrelated dots. To connect the dots you need a theory. The Blind Men and the Elephant is a famous story about six blind men encountering an elephant for the first time. Each man, seizing on the single feature of the animal, which he appeared to have touched first, and being incapable of seeing it whole, loudly maintained his limited opinion on the nature of the beast. The elephant was considered a wall, a spear, a snake, a tree, a fan or a rope, depending on whether the blind men had first grasped the creature’s side, tusk, trunk, knee, ear or tail. The story epitomizes the problem of the reductionist approach in biology. A recent book Microcompetition with Foreign DNA and the Origin of Chronic Disease, by Hanan Polansky [11], presents an alternative. The book identifies the disruption that causes atherosclerosis, cancer, obesity, osteoarthritis, type II diabetes, alopecia, type I diabetes, multiple sclerosis, asthma, lupus, thyroiditis, inflammatory bowel disease, rheumatoid arthritis, psoriasis, atopic dermatitis, graft versus host disease, and other chronic diseases, and describes the sequence of events that leads from the disruption to the molecular, cellular, and clinical effects."
What are the implications of the NIH failure? A decline in the number of new drugs introduced by pharmaceutical companies. Consider what professor Taylor says in his paper: Fewer new drugs from the pharmaceutical industry (Taylor D. Fewer new drugs from the pharmaceutical industry. BMJ. 2003 Feb 22;326(7386):408-9): "In 2002 spending on medicines exceeded $400bn (£248bn; 377bn) worldwide. Optimists in the pharmaceutical industry believe that the global market for their products will go on expanding by around 10% a year, with the United States continuing to lead towards higher per capita outlays. Expenditure on research by the pharmaceutical industry is also increasing worldwide. It is now over $45bn a year---twice the sum recorded at the start of the 1990s---and projected to rise to $55bn by 2005-6. Concerns are growing, however, about the productivity of research being funded by the major pharmaceutical companies. ... Empirical evidence indicates a crisis in productivity in pharmaceutical research. The number of medicines introduced worldwide that contain new active ingredients dropped from an average of over 60 a year in the late 1980s to 52 in 1991 and only 31 in 2001. The overall number of new active substances undergoing regulatory review is still falling."
On the one hand, the expenditure on research is increasing. On the other, the number of new drugs is decreasing. The professionals call this situation the productivity crisis in drug discovery.
In 1971, during the State of the Union address, President Nixon declared the war on cancer proposing "an intensive campaign to find a cure for cancer." Since 1971, Americans spent, through taxes, donations, and private R&D, about $200 billion in inflation-adjusted dollars. This money produced 1.56 million papers on cancer. Yet, today we are no closer to a cure than we were in 1971. Why?
Consider what Dr. Almog said in his paper: Drug Industry in "depression" (Almog, D. Drug industry in "depression". Med Sci Monit. 2005 Jan;11(1):SR1-4, I would urge you to read his paper, it's an eye opener on relationship between academic research and commercial drug discovery): "When the basic science/biology of disease is not available, no new drugs come to market." With the billion of dollars spent by the NIH on basic science, and the millions of papers published on the topic, the question is, "Why isn’t the basic science/biology of disease available? Individual discoveries in the biology of human disease are cornerstone in new treatments. However, in drug discovery, these basic science/biology discoveries are seemingly unrelated dots. To connect the dots you need a theory. The Blind Men and the Elephant is a famous story about six blind men encountering an elephant for the first time. Each man, seizing on the single feature of the animal, which he appeared to have touched first, and being incapable of seeing it whole, loudly maintained his limited opinion on the nature of the beast. The elephant was considered a wall, a spear, a snake, a tree, a fan or a rope, depending on whether the blind men had first grasped the creature’s side, tusk, trunk, knee, ear or tail. The story epitomizes the problem of the reductionist approach in biology. A recent book Microcompetition with Foreign DNA and the Origin of Chronic Disease, by Hanan Polansky [11], presents an alternative. The book identifies the disruption that causes atherosclerosis, cancer, obesity, osteoarthritis, type II diabetes, alopecia, type I diabetes, multiple sclerosis, asthma, lupus, thyroiditis, inflammatory bowel disease, rheumatoid arthritis, psoriasis, atopic dermatitis, graft versus host disease, and other chronic diseases, and describes the sequence of events that leads from the disruption to the molecular, cellular, and clinical effects."
What are the implications of the NIH failure? A decline in the number of new drugs introduced by pharmaceutical companies. Consider what professor Taylor says in his paper: Fewer new drugs from the pharmaceutical industry (Taylor D. Fewer new drugs from the pharmaceutical industry. BMJ. 2003 Feb 22;326(7386):408-9): "In 2002 spending on medicines exceeded $400bn (£248bn; 377bn) worldwide. Optimists in the pharmaceutical industry believe that the global market for their products will go on expanding by around 10% a year, with the United States continuing to lead towards higher per capita outlays. Expenditure on research by the pharmaceutical industry is also increasing worldwide. It is now over $45bn a year---twice the sum recorded at the start of the 1990s---and projected to rise to $55bn by 2005-6. Concerns are growing, however, about the productivity of research being funded by the major pharmaceutical companies. ... Empirical evidence indicates a crisis in productivity in pharmaceutical research. The number of medicines introduced worldwide that contain new active ingredients dropped from an average of over 60 a year in the late 1980s to 52 in 1991 and only 31 in 2001. The overall number of new active substances undergoing regulatory review is still falling."
On the one hand, the expenditure on research is increasing. On the other, the number of new drugs is decreasing. The professionals call this situation the productivity crisis in drug discovery.
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