Dear Friends and Colleagues:
Attached an interesting article from a recent edition of BusinessWeek reporting the emergence of cognition enhancers as the next financial goldmine for pharmaceutical companies seeking new applications for existing drugs.
I am categorically opposed to permit the expansion of the clinical application for these medications and look forward to your comments and response.
Happy Holidays, Merry Christmas, Happy Hanukkah.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
DRUGS December 18, 2008, 5:00PM EST
A Boom in Memory-Enhancing Drugs?
Some scientists predict boomers and college grads alike will fuel a boom in so-called cognition drugs. But at what risk?
By Ellen Gibson
Facing an important job interview, the college graduate searches her closet for the perfect outfit, then rifles through her medicine cabinet for just the right cognitive-enhancement pill. Adderall, perhaps, to help her concentrate. Or Provigil, for alertness...or maybe a beta blocker to combat jitters?
Doctors in the U.S. who track drug trends say scenarios like this could play out in a thousand variations as college students who grew up using prescription drugs as study aids enter the workforce. Many high-powered professionals are already popping such pills in secret. Within a few years they could be joined by millions of older adults, including baby boomers who decide there's nothing wrong with using "smart drugs" to ward off senior moments. The drug industry will benefit mightily if public opinion swings this way.
Many healthy people have trepidations about tinkering with the brain using addictive or otherwise risky pharmaceuticals. But those reservations are eroding for several reasons. A whole generation has come of age using attention-deficit drugs such as Adderall and Ritalin, a category valued at nearly $4.7 billion in 2007. A lot of teenagers have used them casually as study aids, often buying them on the Internet. And now, overworked professionals are seeing the appeal. "From assembly-line workers to surgeons, many different kinds of employee may benefit from enhancement and want access to it," wrote Martha J. Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania, in a recent commentary in the science journal Nature. In the controversial essay, she and her co-authors, including Stanford Law School Professor Henry T. Greely, declared it's time for people to overcome their squeamishness: "Mentally competent adults should be able to engage in cognitive enhancement using drugs."
Cognition drugs are already a big market. Adderall XR, the extended-release version of the ADHD drug, brings Shire Pharmaceuticals (SHPGY) $1 billion a year. Pfizer's (PFE) Alzheimer's drug Aricept had U.S. sales of $1.6 billion in 2007—and it may give a boost to healthy people as well. In a small study, airline pilots on the drug showed some improvement in short-term memory. Then there's Provigil, a narcolepsy treatment that pulls in $840 million for Cephalon CEPH). Analysts say a fair portion of that comes from healthy people who use it to stay awake.
A half-dozen companies now have memory drugs in their research pipelines that the U.S. Food & Drug Administration will review initially as treatments for Alzheimer's or age-related dementia. But Steven Ferris, a neurologist and former committee member at the FDA, says there is huge potential for a memory treatment aimed at still-healthy baby boomers—and predicts that the FDA will ultimately condone such uses. "The first evidence-based memory treatment could be a $20 billion drug," predicts Ferris, who now runs an aging and dementia research center at New York University School of Medicine.
At the FDA, cognitive enhancement is barely on the radar right now. The majority of medicines the agency oversees are designed to treat diseases. Drug companies believe this could present a problem for smart drugs—a worry that may be inhibiting research spending in this area. "Regulators would have a hard time approving [cognition drugs] if they're not intended for a medical condition," in part because they have known health risks, says Shire spokesperson Matthew Cabrey.
Indeed, ADHD medications carry so-called black box warnings on their labels. Potential side effects of Adderall range from insomnia to cardiac events. Medical ethicists have a separate set of concerns. They worry poor people don't have the same access to these drugs as the wealthy.
What's more, if social concerns about smart drugs were to vanish, pressure to use them in the workplace might become irresistible. Under certain circumstances, "it is totally understandable for a manager to encourage people to change their work performance through drugs," Martha Farah said in an interview.
Her colleague Dr. Anjan Chatterjee, a neurologist at the University of Pennsylvania Hospital, raises another red flag. Creative insights often arise when the mind is allowed to wander, he says. If drugs that sharpen concentration become widespread in the workplace, they may nurture "a bunch of automatons that are very good at implementing things but have nothing to implement."
Chatterjee has thought deeply about this new class of drugs. In a famous 2004 research paper, he coined the term "cosmetic neurology," and he compares the current state of cognitive enhancement to the advent of cosmetic surgery. That specialty evolved as doctors struggled to help disfigured soldiers returning from World War I. It then morphed into a form of "elective self-improvement," he says. The same could happen with smart drugs. After all, the FDA currently regulates treatments for wrinkles, hair loss, and sexual dysfunction, which are not strictly medical in nature. Cognition drugs are the next obvious frontier. Says Chatterjee: "This is inevitable."
Gibson is an editorial assistant with BusinessWeek.
Monday, December 22, 2008
Saturday, December 6, 2008
Baclofen for the Treatment of Alcoholism?
Dear Friends and Colleagues:
A recent BBC news report highlighted a book written by a French cardiologist describing his " cure from alcoholism" utilizing Baclofen.
Attached you find the news report and a reference to a SMALL double-blind randomized trial suggesting a beneficial effect of Baclofen for the treatment of alcoholism.
Looking forward to your comments.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
======================================================================================
BBC NEWS
France abuzz over alcoholic 'cure'
By Hugh Schofield
Paris
An eminent French cardiologist has triggered an impassioned debate in the medical world over his claim to have discovered a cure for alcoholism.
Dr Olivier Ameisen, 55, one of France's top heart specialists, says he overcame his own addiction to alcohol by self-administering doses of a muscle-relaxant called baclofen.
He has now written a book about his experience - Le Dernier Verre (The Last Glass) - in which he calls for clinical trials to test his theory that baclofen suppresses the craving for drink.
Widespread media coverage of his book in France has led to a rush of demands from alcoholics for similar treatment, and some doctors have reported unexpected successes after prescribing it.
But many other specialists are sceptical, warning of the dangers of so-called miracle cures.
'Needed alcohol'
Dr Ameisen was associate professor of cardiology at New York's Cornell University, and in 1994 he opened a profitable private practice in Manhattan.
But, stricken by an overwhelming feeling of inadequacy - he says he felt like "an impostor waiting to be unmasked" - he found relief in large quantities of whisky and gin.
"I detested the taste of alcohol. But I needed its effects to exist in society," he says in Le Dernier Verre, which comes out in English next month.
Dr Ameisen says he tried every known remedy to end his dependence. Between 1997 and 1999 he spent a total of nine months confined in clinics - but nothing worked.
Fearing for his own patients, he gave up his practice and returned to Paris. Then, in 2000, he read an article about an American man who was treated with baclofen for muscle spasms and found that it eased his addiction to cocaine.
Further investigation uncovered research showing that the drug worked on rats to cut addiction to alcohol or cocaine.
But, strangely, Dr Ameisen found that baclofen was unknown to specialists on dependence.
In March 2002 he began treating himself with daily doses of five milligrams.
"The first effects were a magical muscular relaxation and baby-like sleep," he says. Almost immediately he also detected a lessening in his desire for drink.
Gradually, he increased the daily dosage to a maximum of 270mg, and found that he was "cured". Today he continues to take 30 to 50mg a day.
"Mine is the first case in which a course of medicine has completely suppressed alcohol addiction," he says.
"Now I can have a glass and it has no effect. Above all, I no longer have that irrepressible need to drink."
Not licensed
With its eye-catching message, Le Dernier Verre has been an autumn best-seller - prompting thousands of recovering alcoholics to ask to be prescribed with baclofen.
Some doctors have decided to ignore the fact that the drug is not authorised for treating alcoholism, and report exciting results.
"I prescribed it to two alcoholics who were really at the end of the road. To be honest, it was pretty miraculous," says Dr Renaud de Beaurepaire of the Paul-Guiraud hospital at Villejuif near Paris.
In Geneva, Dr Pascal Garche put 12 patients on baclofen, of whom seven came through reporting marked improvements.
"I have never had reactions like this before. We cannot ignore findings such as this - the book is going to set the cat among the pigeons," he said.
However, many specialists fear that media excitement over Dr Ameisen's theory is obscuring the complex nature of alcoholism.
"Encouraging people to think that there is a miracle molecule is to completely misunderstand the nature of alcoholism, and is extremely irresponsible, " says Dr Michel Reynaud of Paul-Brousse hospital in Paris.
"We need comprehensive tests to determine how this drug acts, if it is effective and at what dosage, and if it is genuinely harmless in the longer term, " says Alain Rigaud, president of the National Association for the Prevention of Alcoholism and Addiction.
"But even if it turns out to work, that does not mean a drug alone is the solution."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/7768141.stm
Published: 2008/12/06 16:44:46 GMT
======================================================================================
PROCEEDINGS OF A SYMPOSIUM ENTITLED: 'GABAB RECEPTORS: A TARGET OF NEW TREATMENTS FOR ALCOHOLISM AND DRUG ABUSE'
BACLOFEN EFFICACY IN REDUCING ALCOHOL CRAVING AND INTAKE: A PRELIMINARY DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY
Giovanni Addolorato*, Fabio Caputo2, Esmeralda Capristo, Marco Domenicali2, Mauro Bernardi2, Luigi Janiri1, Roberta Agabio3, Giancarlo Colombo4, Gian Luigi Gessa3,4,5 and Giovanni Gasbarrini
Institute of Internal Medicine and
1 Institute of Psychiatry, Catholic University of Rome, Rome,
2 ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna,
3 ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari,
4 C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and
5 Neuroscienze S.c.a r.l., Cagliari, Italy
Received 15 March 2002; first review notified 19 April 2002; accepted 22 April 2002
ABSTRACT
— Aims: The {gamma}-aminobutyric acid (GABAB) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated.
Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse.
Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.
=======================================================================================
Baclofen Use in the Treatment of Alcohol Delirium Tremens
We read with great interest the recent meta-analysis by Mayo-Smith et al1 about the management of alcohol withdrawal delirium (AWD). The authors included new clinical data on the management of AWD, ranging from a single case report to a prospective randomized trial from 1966 to 2001. Since the time considered, among the possible new drugs useful in the management of AWD, the authors did not mention the possible utility of the {gamma}-aminobutyric acid {beta}(GABA receptor agonist baclofen. Baclofen is able to suppress alcohol withdrawal symptoms both in animals2 and in humans3 and may be effective in reducing voluntary alcohol intake in alcohol-preferring rats2 and alcohol craving and intake in alcoholic individuals.4 We recently described a patient in whom AWD was rapidly and completely suppressed by baclofen administration.5 We believe that prior clinical data suggest that baclofen could be a useful new drug in the treatment of AWD, although future controlled clinical trials are needed to confirm its safety and effectiveness.
AUTHOR INFORMATION
Correspondence: Dr Addolorato, Institute of Internal Medicine, Catholic University, Gemelli Hospital, L.go A. Gemelli 8, 00168-Rome, Italy (g.addolorato@rm.unicatt.it).
Lorenzo Leggio, MD; Ludovico Abenavoli, MD; Fabio Caputo, MD; Giovanni Gasbarrini, MD; Giovanni Addolorato, MD
REFERENCES
1. Mayo-Smith MF, Beecher LH, Fisher TL, et al, Working Group on the Management of Alcohol Withdrawal Delirium, Practice Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium: an evidence-based practice guideline. Arch Intern Med. 2004;164:1405-1412. FREE FULL TEXT
2. Colombo G, Agabio R, Carai MAM, et al. Ability of baclofen in reducing alcohol intake and withdrawal severity, I: preclinical evidence. Alcohol Clin Exp Res. 2000;24:58-66. FULL TEXT | ISI | PUBMED
3. Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112:226-229. FULL TEXT | ISI | PUBMED
4. Addolorato G, Caputo F, Capristo E, et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37:504-508. FREE FULL TEXT
5. Addolorato G, Leggio L, Abenavoli L, et al. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003;26:258-262. PUBMED
Arch Intern Med. 2005;165:586.
A recent BBC news report highlighted a book written by a French cardiologist describing his " cure from alcoholism" utilizing Baclofen.
Attached you find the news report and a reference to a SMALL double-blind randomized trial suggesting a beneficial effect of Baclofen for the treatment of alcoholism.
Looking forward to your comments.
Yours
Bernd
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
======================================================================================
BBC NEWS
France abuzz over alcoholic 'cure'
By Hugh Schofield
Paris
An eminent French cardiologist has triggered an impassioned debate in the medical world over his claim to have discovered a cure for alcoholism.
Dr Olivier Ameisen, 55, one of France's top heart specialists, says he overcame his own addiction to alcohol by self-administering doses of a muscle-relaxant called baclofen.
He has now written a book about his experience - Le Dernier Verre (The Last Glass) - in which he calls for clinical trials to test his theory that baclofen suppresses the craving for drink.
Widespread media coverage of his book in France has led to a rush of demands from alcoholics for similar treatment, and some doctors have reported unexpected successes after prescribing it.
But many other specialists are sceptical, warning of the dangers of so-called miracle cures.
'Needed alcohol'
Dr Ameisen was associate professor of cardiology at New York's Cornell University, and in 1994 he opened a profitable private practice in Manhattan.
But, stricken by an overwhelming feeling of inadequacy - he says he felt like "an impostor waiting to be unmasked" - he found relief in large quantities of whisky and gin.
"I detested the taste of alcohol. But I needed its effects to exist in society," he says in Le Dernier Verre, which comes out in English next month.
Dr Ameisen says he tried every known remedy to end his dependence. Between 1997 and 1999 he spent a total of nine months confined in clinics - but nothing worked.
Fearing for his own patients, he gave up his practice and returned to Paris. Then, in 2000, he read an article about an American man who was treated with baclofen for muscle spasms and found that it eased his addiction to cocaine.
Further investigation uncovered research showing that the drug worked on rats to cut addiction to alcohol or cocaine.
But, strangely, Dr Ameisen found that baclofen was unknown to specialists on dependence.
In March 2002 he began treating himself with daily doses of five milligrams.
"The first effects were a magical muscular relaxation and baby-like sleep," he says. Almost immediately he also detected a lessening in his desire for drink.
Gradually, he increased the daily dosage to a maximum of 270mg, and found that he was "cured". Today he continues to take 30 to 50mg a day.
"Mine is the first case in which a course of medicine has completely suppressed alcohol addiction," he says.
"Now I can have a glass and it has no effect. Above all, I no longer have that irrepressible need to drink."
Not licensed
With its eye-catching message, Le Dernier Verre has been an autumn best-seller - prompting thousands of recovering alcoholics to ask to be prescribed with baclofen.
Some doctors have decided to ignore the fact that the drug is not authorised for treating alcoholism, and report exciting results.
"I prescribed it to two alcoholics who were really at the end of the road. To be honest, it was pretty miraculous," says Dr Renaud de Beaurepaire of the Paul-Guiraud hospital at Villejuif near Paris.
In Geneva, Dr Pascal Garche put 12 patients on baclofen, of whom seven came through reporting marked improvements.
"I have never had reactions like this before. We cannot ignore findings such as this - the book is going to set the cat among the pigeons," he said.
However, many specialists fear that media excitement over Dr Ameisen's theory is obscuring the complex nature of alcoholism.
"Encouraging people to think that there is a miracle molecule is to completely misunderstand the nature of alcoholism, and is extremely irresponsible, " says Dr Michel Reynaud of Paul-Brousse hospital in Paris.
"We need comprehensive tests to determine how this drug acts, if it is effective and at what dosage, and if it is genuinely harmless in the longer term, " says Alain Rigaud, president of the National Association for the Prevention of Alcoholism and Addiction.
"But even if it turns out to work, that does not mean a drug alone is the solution."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/7768141.stm
Published: 2008/12/06 16:44:46 GMT
======================================================================================
PROCEEDINGS OF A SYMPOSIUM ENTITLED: 'GABAB RECEPTORS: A TARGET OF NEW TREATMENTS FOR ALCOHOLISM AND DRUG ABUSE'
BACLOFEN EFFICACY IN REDUCING ALCOHOL CRAVING AND INTAKE: A PRELIMINARY DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY
Giovanni Addolorato*, Fabio Caputo2, Esmeralda Capristo, Marco Domenicali2, Mauro Bernardi2, Luigi Janiri1, Roberta Agabio3, Giancarlo Colombo4, Gian Luigi Gessa3,4,5 and Giovanni Gasbarrini
Institute of Internal Medicine and
1 Institute of Psychiatry, Catholic University of Rome, Rome,
2 ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna,
3 ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari,
4 C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and
5 Neuroscienze S.c.a r.l., Cagliari, Italy
Received 15 March 2002; first review notified 19 April 2002; accepted 22 April 2002
ABSTRACT
— Aims: The {gamma}-aminobutyric acid (GABAB) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated.
Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse.
Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.
=======================================================================================
Baclofen Use in the Treatment of Alcohol Delirium Tremens
We read with great interest the recent meta-analysis by Mayo-Smith et al1 about the management of alcohol withdrawal delirium (AWD). The authors included new clinical data on the management of AWD, ranging from a single case report to a prospective randomized trial from 1966 to 2001. Since the time considered, among the possible new drugs useful in the management of AWD, the authors did not mention the possible utility of the {gamma}-aminobutyric acid {beta}(GABA receptor agonist baclofen. Baclofen is able to suppress alcohol withdrawal symptoms both in animals2 and in humans3 and may be effective in reducing voluntary alcohol intake in alcohol-preferring rats2 and alcohol craving and intake in alcoholic individuals.4 We recently described a patient in whom AWD was rapidly and completely suppressed by baclofen administration.5 We believe that prior clinical data suggest that baclofen could be a useful new drug in the treatment of AWD, although future controlled clinical trials are needed to confirm its safety and effectiveness.
AUTHOR INFORMATION
Correspondence: Dr Addolorato, Institute of Internal Medicine, Catholic University, Gemelli Hospital, L.go A. Gemelli 8, 00168-Rome, Italy (g.addolorato@rm.unicatt.it).
Lorenzo Leggio, MD; Ludovico Abenavoli, MD; Fabio Caputo, MD; Giovanni Gasbarrini, MD; Giovanni Addolorato, MD
REFERENCES
1. Mayo-Smith MF, Beecher LH, Fisher TL, et al, Working Group on the Management of Alcohol Withdrawal Delirium, Practice Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium: an evidence-based practice guideline. Arch Intern Med. 2004;164:1405-1412. FREE FULL TEXT
2. Colombo G, Agabio R, Carai MAM, et al. Ability of baclofen in reducing alcohol intake and withdrawal severity, I: preclinical evidence. Alcohol Clin Exp Res. 2000;24:58-66. FULL TEXT | ISI | PUBMED
3. Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112:226-229. FULL TEXT | ISI | PUBMED
4. Addolorato G, Caputo F, Capristo E, et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37:504-508. FREE FULL TEXT
5. Addolorato G, Leggio L, Abenavoli L, et al. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003;26:258-262. PUBMED
Arch Intern Med. 2005;165:586.
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