The following letter to the president of Brown University requests that she writes to the editor of the Journal of the American Academy of Child & Adolescent Psychiatry supporting our request for retraction of a journal article that misrepresented the efficacy and safety of paroxetine for depressed adolescents. The letter was written by Healthy Skepticism members Jon Jureidini and Leemon McHenry and signed by additional Healthy Skepticism members and others. Jon and Leemon's campaign for retraction of the misleading article has been endorsed as a Healthy Skepticism campaign by the Healthy Skepticism international management group.
4 October 2011
President Ruth J. Simmons
Office of the President
Brown University
1 Prospect Street
Campus Box 1860
Providence, Rhode Island 02912
Dear President Simmons,
Study 329: A multi-center, double blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression
We write to you about our ongoing concerns regarding a journal article that originated at the Department of Psychiatry and Human Behavior, under the leadership of Dr. Martin Keller.
Between 1993 and 1998, SmithKline Beecham (subsequently GlaxoSmithKline) provided $800,000 to Brown University for its participation in the above study.
[1] The results were published in 2001 by Keller et al. in a journal article, 'Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial',
[2] in the
Journal of the American Academy of Child & Adolescent Psychiatry
.
The article was ghostwritten by agents of the manufacturer, and seriously misrepresented both the effectiveness and the safety of paroxetine in treating adolescent depression.
While problems with study 329 and the Keller et al paper have been thoroughly exposed in legal actions,
[3] the bioethical and medical literature,
[4] a book,
[5] and a BBC Panorama documentary
[6], the paper continues to be cited uncritically in the medical literature as evidence of the efficacy of paroxetine for treatment of adolescent depression.
[7],
[8] Our main concern is that adolescents are being harmed because well-intentioned physicians have been misled.
Moreover, the misrepresentation has been compounded by the following:
1) The
Journal
was asked by two of the undersigned, Drs. Jureidini and McHenry, to retract the article, but has refused to do so.
2) In a letter of May 13, 2008, from Pamela D. Ring to Dr. David Egilman, Brown University refused to release information about its internal investigation into Dr. Keller's conflicts of interest and scientific misconduct.
Study 329 reveals the pervasive influence of GlaxoSmithKline's marketing objectives on the preparation and publication of a 'scientific' manuscript and peer-reviewed journal article. GlaxoSmithKline's own internal documents disclosed in litigation show that company staff were aware that the study 329 did not support a claim of efficacy but decided that it would be "unacceptable commercially" to reveal that.
[9]
The data were therefore selectively reported in Keller
et al
.'s article, in order to "effectively manage the dissemination of these data in order to minimise any potential negative commercial impact".9 As it turns out, the Keller
et al
. article was used by GlaxoSmithKline's to ward off potential damage to the profile of paroxetine and it was used to promote off-label prescriptions of Paxil® and Seroxat® to children and adolescents, some of whom became suicidal and self-harmed as a result.
[10]
The unretracted article is a stain on Brown University's reputation for academic excellence. The University cannot claim to be a leader in scientific research and moral integrity while failing to act to redress this article that negligently misrepresents scientific findings.
In its accreditation document for the New England Association of Schools and Colleges (NEASC), Brown University claims in relation to 'Standard Eleven: Integrity' that 'The institution manages its academic, research and service programs, administrative operations, responsibilities for students and interactions with prospective students with honesty and integrity', that it 'expects that members of its community, including the board, administration, faculty, staff, and students, will act responsibly and with integrity', and that 'Truthfulness, clarity, and fairness characterize the institution's relations with all internal and external constituencies'.
[11] The University's inaction in relation to study 329 casts doubt on the validity of these claims.
We ask that you write to the editor, Dr. Andres Martin,
Journal of the American Academy of Child & Adolescent Psychiatry
supporting our request for retraction of the journal article.
We are making this letter available to interested parties and it will be posted on the Healthy Skepticism website (
www.healthyskepticism.org).
Yours sincerely
Jon Jureidini
Child Psychiatrist
Clinical Professor, University of Adelaide
Leemon McHenry
Department of Philosophy, California State University, Northridge
Jerome Biollaz
Professor Emeritus of Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne
Alain Braillon
Stephen Bezruchka
Senior Lecturer, School of Public Health, University of Washington
Ruud Coolen van Brakel, director
Sandra van Nuland, consultant
Martine van Eijk, MD PhD
Instituut voor Verantwoord Medicijngebruik (
Dutch Institute for Rational Use of Medicine)
Marc-Andre Gagnon,
Research Fellow, Edmond J. Safra Center for Ethics, Harvard University
Ken Harvey
Adjunct Senior Lecturer, School of Public Health, La Trobe University, Melbourne
David Healy
Professor in Psychological Medicine, Cardiff University School of Medicine
Andrew Herxheimer,
Emeritus Fellow, UK Cochrane Centre, Oxford
Jerome Hoffman
Professor of Emergency Medicine, University of Southern California
Joel Lexchin
Professor, School of Health Policy and Management, York University, Toronto, Canada
Melissa Raven
Adjunct Lecturer, Discipline of Public Health, Flinders University, Australia
Dee Mangin
Associate Professor, Director Primary Care Research Unit, Christchurch School of Medicine
Peter Mansfield
Director, Healthy Skepticism
Dan Mayer
Professor of Emergency Medicine, Albany Medical College, New York
David Menkes
Associate Professor of Psychiatry, University of Auckland
Robert Purssey
Senior Lecturer, University of Queensland
Nicholas Rosenlicht
Clinical Professor of Health Sciences, University of California, San Francisco
Jorg Schaaber
President, International Society of Drug Bulletins (ISDB)
Arthur Schafer
Director, Centre for Professional and Applied Ethics, University of Manitoba
Michael Wilkes
Professor of Medicine, University of California, Davis
Jim Wright
Co-Managing Director, Therapeutics Initiative
Liliya E. Ziganshina
Head, Professor, Department of Basic and Clinical Pharmacology, Kazan Federal University, Russian Federation
[1] Keller M. (2011). Martin B. Keller, MD. Providence, RI: Brown University; 2011.
http://research.brown.edu/pdf/1100924449.pdf
[2] Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial.
J Am Acad Child Adolesc Psychiatry
. 2001 Jul;40(7):762-72.
[3]
The People of the State of New York vs. SmithKline Beecham
Corp.
(Case No. 04-CV-5304 MGC),
Beverly Smith vs. SmithKline Beecham Corp.
(Case No. 04 CC 00590),
Engh vs. SmithKline Beecham
Corp
. (Case No. PI 04-012879),
Teri Hoormann vs. SmithKline Beecham
Corp.
(Case No. 04-L-715) and
Julie Goldenberg and
Universal Care vs. SmithKline Beecham Corp.
(Case No. 04 CC 00653)
[4] Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329.
Int J Risk Saf Med
2008;20:73-81.
http://www.pharmalot.com/wp-content/uploads/2008/04/329-study-paxil.pdf
[5] Bass A. Side effects: A prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill, NC: Algonquin Books; 2008.
[6] BBC. Seroxat – Secrets of the Drugs Trials. Panorama. BBC one; 2007 Jan 29.
http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm
[7]
http://scholar.google.com.au/scholar?hl=en&lr=&cites=7589903240306694483
[8] Jureidini J, McHenry L. Conflicted medical journals and the failure of trust. Accountability in Research 18:45-54.
[9] SmithKline Beecham, Seroxat/Paxil adolescent depression position piece on the Phase III clinical studies, October 1998, PAR003019178;
http://www.healthyskepticism.org/documents/documents/19981014PositionPiece.pdf
[10] Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry. 2006 Mar;63(3):332-9
[11] Brown University. Standard Eleven: Integrity. NEASC Accreditation; 2008.
http://www.brown.edu/Project/NEASC/Standards/integrity_11.php
Earlier this month, celebrity chef Paula Deen announced that she has adult-onset or type 2 diabetes, then accepted a multimillion dollar deal to promote Novo Nordisk’s type 2 diabetes drug, Victoza. Before there was Paula Deen, there was figure skater
Dorothy Hamill and actor
Wilford Brimley. Indeed, there has been a long line of celebrity spokespeople for pharmaceutical companies, and their track record thus far has been quite poor in terms of honesty, openness, and promoting the public’s health.
Middle-aged arthritis sufferers flocked to their doctors demanding Vioxx for pain relief after watching Hamill figure skate in TV ads touting the drug shortly into the new millennium. We now have
evidence that Vioxx caused as many as 140,000 extra cases of serious heart disease in the United States during the years that its maker concealed evidence of its risks, and it was withdrawn from the US market in 2004.
All right, you say, Hamill was paid to shill for a dangerous drug. But what could be wrong with Brimley telling diabetics to check their blood sugar?
There is one group of patients with type 2 diabetes, the most common form of the disease, who need to check their sugar levels frequently and who really need those cute little machines. Those are also those (apparently including Brimley) who take insulin shots. But the majority of type 2 diabetes folks take only oral medicines or use diet and exercise to regulate their blood sugar. From those ubiquitous TV ads in the late 1990s and early 2000s, however, you’d guess that scientific studies show great health advantages to religiously using home glucose monitors.
Funny thing, though. The available research shows overwhelmingly that there’s no known health benefit to home glucose monitoring for people not on insulin. A number of
large studies on improving outcomes and death rates in diabetes show consistently that tight blood sugar control is not where the action is. Rather, type 2 diabetes tends to strike through severe complications like heart attacks, strokes, kidney failure, and other diseases that basically are caused by diabetes’ effects on both large and small blood vessels. Doing things to protect yourself from those diseases—diet, exercise, stopping smoking, controlling blood pressure, and so on—improves and lengthens life in diabetics. Lowering blood sugar by itself hardly helps at all.
Don’t hold your breath waiting for highly-paid celebrity spokespersons to tell you these important medical facts on TV. And the reason they won’t is part of why the whole system of celebrities touting drugs and medical devices is unfortunate for public health. These ads don’t just sell us products. They sell us ways to think about disease. And the industry wants to be sure that the way we think about a disease is whatever way is best for pushing their sales and profits.
Physician and historian
Jeremy Greene wrote about this a few years ago. He showed how the pharmaceutical industry jumped onto the preventive medicine bandwagon to convince both doctors and the rest of us to “prescribe by the numbers”—not to ask what drugs actually lengthened life or improved quality, but simply to be happy when a lab test result, such as blood sugar or cholesterol, was high and a drug made it go lower. It turns out that it’s much easier to discover and market a drug that makes your lab values look prettier than it is to find drugs that really save lives and prevent heart attacks. But most of us simply assume that lower lab numbers mean less risk and a healthier future—a connection that medical research informs us is often missing. (A great book on this frequent lack of connection is
Overdiagnosed by W. Gilbert Welch.)
Now, at this point I have to add the usual disclaimer, and then a disclaimer on the disclaimer. The disclaimer is that you should treat your medical condition based on your doctor’s advice and not what you read on a blog or news outlet. If you have diabetes, for instance, find a physician that you trust and follow that physician’s advice, though you should also ask questions and feel free to do your own research.
But here’s disclaimer squared: when a drug or device company markets products to you with a celebrity spokesperson, you can be sure that the same marketing, probably on steroids, is going on behind the scenes in doctors’ offices and hospital corridors. When at least 84 percent of American doctors regularly rely on industry salespeople for critical information about drugs, the “prescribe by the numbers” message is
just as ingrained in their thinking as it is in the general public’s. (The celebrities that drug companies use to brainwash doctors are not the Wilford Brimleys of the world, but rather distinguished medical school faculty physicians who happily take company money to serve on their speakers’ bureaus and to push the company marketing message.)
So, bottom line: is there something especially bad about any single celebrity deciding to shill for a particular drug or medical device, like Paula Deen telling us to eat cheeseburgers and also take good care of our diabetes? Maybe yes, maybe no. Is there a problem with how these products are marketed in the United States today? Absolutely.
Howard Brody is a family physician and medical ethicist and directs the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. He maintains
a blog on the ethics of the relationship between the medical profession and the pharmaceutical industry.
Ritalin and Adderall, a combination of dextroamphetamine and
amphetamine, are stimulants. So why do they appear to calm children down? Some experts argued that because the brains of children with attention problems were different, the drugs had a mysterious paradoxical effect on them.
However, there really was no paradox. Versions of these drugs had been given to World War II radar operators to help them stay awake and focus on boring, repetitive tasks. And when we reviewed the literature on attention-deficit drugs again in 1990 we found that all children, whether they had attention problems or not, responded to stimulant drugs the same way. Moreover, while the drugs helped children settle down in class, they actually increased activity in the playground. Stimulants generally have the same effects for all children and adults. They enhance the ability to concentrate, especially on tasks that are not inherently interesting or when one is fatigued or bored, but they don’t improve broader learning abilities.
And just as in the many dieters who have used and abandoned similar drugs to lose weight, the effects of stimulants on children with attention problems fade after prolonged use. Some experts have argued that children with
A.D.D. wouldn’t develop such tolerance because their brains were somehow different. But in fact, the
loss of appetite and
sleeplessness in children first prescribed attention-deficit drugs do fade, and, as we now know, so do the effects on behavior. They apparently develop a tolerance to the drug, and thus its efficacy disappears. Many parents who take their children off the drugs find that behavior worsens, which most likely confirms their belief that the drugs work. But the behavior worsens because the children’s bodies have become adapted to the drug. Adults may have similar reactions if they suddenly cut back on coffee, or stop smoking.
TO date, no study has found any long-term benefit of attention-deficit medication on academic performance, peer relationships or behavior problems, the very things we would most want to improve. Until recently, most studies of these drugs had not been properly randomized, and some of them had other methodological flaws.
But in 2009, findings were published from a well-controlled study that had been going on for more than a decade, and the results were very clear. The study randomly assigned almost 600 children with attention problems to four treatment conditions. Some received medication alone, some cognitive-behavior therapy alone, some medication plus therapy, and some were in a community-care control group that received no systematic treatment. At first this study suggested that medication, or medication plus therapy, produced the best results. However, after three years, these effects had faded, and by eight years there was no evidence that medication produced any academic or behavioral benefits.
It isn't often that a prescription product repurposed on the street then returns to the clinic. But that's just what's happening with ketamine, sold as a generic and by Pfizer (
$PFE) under the brand names Ketalar and Ketaject (and illegally as Special K). Studies testing the injectable against depression are yielding some dramatic results, described by patients in language familiar to recreational users.
Researchers from the National Institute for Mental Health and from Houston's Ben Taub General Hospital have administered ketamine to severely depressed patients with almost instantaneous results, NPR reports. Yale scientists have pinpointed a potential explanation: Ketamine appears to affect glutamate in the brain, triggering new connections among brain cells.
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"I feel that something's lifted or feel that I've never been depressed in my life," was how NIMH researcher Carlos Zarate described his ketamine patients' reactions. "And it was a different experience from feeling high. This was feeling that something has been removed." One Ben Taub study patient, who believes she got ketamine, not placebo, said she went home feeling "no more fogginess, no more heaviness." Both of them reactions that
LA Weekly
deemed obvious. "Any raver could have told you this," the paper said.
Ketamine has serious potential side effects, including hallucinations during its infusion--and, not insignificantly, addiction. But unlike drugs already approved as antidepressants, the injectable appears to work quickly, a big advantage for patients in crisis. Further study is on the way; the Ben Taub researchers say that if their trial shows that ketamine outperforms a placebo, they plan to conduct a longer-term study to determine whether its effects could be long-lasting.
- see the blog
post at NPR
- get
more, also from NPR
- see the
LA Weekly
post
Related Articles:
Researchers study 'Special K' drug as potential tonic for depression
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Details of a major new collaboration involving many of the world's most recognisable pharmaceutical firms were announced at the end of January 2012.
Working alongside governments and a number of prominent global health agencies, they'll be donating both drugs and insight in a bid to manage or eradicate 10 tropical diseases over the next eight years.
The tie-up represents the largest ever measure taken against the likes of sleeping sickness, Guinea worm disease and leprosy, all of which come under the NTDs (Neglected Tropical Diseases) tag. Sleeping sickness is spread by the tsetse fly while another type of insect causes Chagas disease infections in humans.
Neglected Tropical Disease Drugs
Come 2020, 14 billion individual doses will have been supplied to the Neglected Tropical Disease drugs cause. 13 drugs firm are involved in all, including GlaxoSmithKline and Novartis while, on the political side, the British, US and UAE governments are leading the initiative.
"With the boost to this momentum being made today, I am confident almost all of these diseases can be eliminated or controlled by the end of this decade", Margaret Chan - the Director-General of the World Health Organization - stated.
Neglected Tropical Diseases are rife within the world's poorest nations. According to the best guesses of medical experts, they affect in excess of one billion people, with children making up more than half of affected cases.
NTD Drug Doses
In its first report on the state of these diseases released in 2010, WHO highlighted the draining impact they have on economies but stressed how they tended to be ignored, since there's not too much money to be made from developing and distributing the NTD drugs that would be used to treat them.
"We fully support the WHO's bold vision and we are committed to playing our part in helping to achieve universal coverage of intervention programmes for diseases that can be controlled or eliminated by existing treatments, and to spur R&D into new treatments for diseases where none currently exist", GSK's Chief Executive Officer, Sir Andrew Witty, stated in a company release.
"Through this new partnership, we have both the means and the energy to strike a decisive blow against disease in the world's poorest countries."
Image copyright Geoffrey M. Attardo - Courtesy Wikimedia Commons
Kader Arif, the lead Acta negotiator in the European Parliament, says Acta potentially cuts access to lifesaving generic drugs and restricts online freedom
The French MEP who resigned his position in charge of negotiating the international Anti-Counterfeiting Trade Agreement (Acta) has said it "goes too far" by potentially cutting access to lifesaving generic drugs and restricting internet freedom.
In an exclusive interview with the Guardian, Kader Arif – a member of the European parliament's international trade group, who was the lead negotiator over Acta – said that despite talks over the agreement having begun in 2007, "the European parliament, which represents the rights of the people, had no access to this mandate, neither had it information of the position defended by the commission or the demands of the other parties to the agreement".
Arif resigned in protest on 26 January as the EU signed the treaty, saying that he wished to "denounce in the strongest manner the process that led to the signing of this agreement: no association of civil society [and] lack of transparency from the beginning".
He said that it now threatens online freedom, access to the use of generic versions of drugs for treating illnesses, and could potentially mean that someone crossing a border who has a single song or film on their computer could face criminal charges.
Asked what he thought European citizens should do, Mr Arif said: "Showing that there is interest and concern about this agreement is the best way of creating a real public debate, which was never possible until now because of the lack of transparency on this dossier. Especially if the timeframe is short, raising awareness of members of parliament will be crucial. And because Acta is a mixed agreement, it will have to be ratified both by the European parliament and by every member state of the union, so there is also an opportunity to organise debates at the national level."
He says that it is now impossible to renegotiate the agreement because the 11 key parties to it concluded their discussions on 1 October 2011: "the European commission negotiated it on behalf of the EU, on the basis of a mandate given by the member states in 2007."
That means, he says, that "at this stage one can only accept or reject the agreement – no change of the text is possible. If the right wing of the European parliament had not imposed such a tight calendar, the members of the European parliament could have drafted an interim report, which would have put conditionalities to the ratification of the agreement, by giving recommendations to the commission and member states on how to implement it. But this is no longer a feasible option."
"The title of this agreement is misleading, because it's not only about counterfeiting, it's about the violation of intellectual property rights," he told the Guardian. "There is a major difference between these two concepts."
Acta
has triggered public protests in a number of European and other countries, as well as online attacks by the hacking collective Anonymous. The US, EU member states, Australia, New Zealand, Canada, Japan and a number of other countries have signed it, although none has yet ratified it in national legislation.
The agreement would create an international framework and set of standards for a voluntary legal regime to enforce intellectual property rights across national boundaries.
Arif said one example illustrates this difference particularly well – the case of generic medicines. "Generic medicines are not counterfeited medicines; they are not the fake version of a drug; they are a generic version of a drug, produced either because the patent on the original drug has expired, or because a country has to put in place public health policies," he said.
A number of countries such as India and African nations have sought to use generic versions of drugs for infections such as HIV, which has often been resisted by pharmaceutical companies. Under Acta, Arif fears such countries would not have the same freedom to determine their own actions.
"There are international agreements,
such as the Trips agreement, which foresees this last possibility," he said. "They're particularly important for developing countries which cannot afford to pay for patented HIV drugs, for example.
"The problem with Acta is that, by focusing on the fight against violation of intellectual property rights in general, it treats a generic drug just as a counterfeited drug. This means the patent holder can stop the shipping of the drugs to a developing country, seize the cargo and even order the destruction of the drugs as a preventive measure."
He thinks that is a key flaw: "Acta also limits the flexibilities listed in the Trips agreements to support developing countries in need of generic drugs. When the question of finding the right equilibrium between protection of intellectual property rights and protection of final users is so crucial, Acta appears to be very unbalanced in favour of patent holders. This is one of the major problems with the agreement."
Internet freedoms could also be under threat if Acta is ratified in its present form, he says. "The chapter on internet is particularly worrying as some experts consider it reintroduces the concept of liability of internet providers, which is clearly excluded in the European legislation." That could make ISPs, who provide internet access, liable for users' illicit file-sharing.
Arif also expressed concern that there could be more intrusive checks at borders to fight counterfeiting.
"I see a great risk concerning checks at borders, and the agreement foresees criminal sanctions against people using counterfeited products as a commercial activity," he said.
"This is relevant for the trade of fake shoes or bags for example, but what about data downloaded from the internet? If a customs officer considers that you may set up a commercial activity just by having one movie or one song on your computer, which is true in theory, you could face criminal sanctions.
"I don't want people to have their laptops or MP3 players searched at borders, there needs to be a clearer distinction between normal citizens and counterfeiters which trade fake products as a commercial activity. Acta goes too far."
The
text of the finalised treaty (PDF) has now been made public, and the European commission has begun to try to explain how Acta would work. It has also published a document called
10 Myths about Acta, asserting that the public was informed "since the launch of the negotiations"; that it is drafted "in very flexible terms" and that "safeguards and exceptions under EU law or under the Trips agreement remain fully preserved".
It also insists that "Acta is about tackling large-scale illegal activity … there is a provision on Acta specifically exempting travellers from checks if the infringing goods are of a non-commercial nature and not part of large-scale trafficking".
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Johnny Carson once said that if you want to clear your system out, sit on a piece of cheese and swallow a mouse. Many would claim that a homeopath's prescription for colonic purging would be about as helpful. In the UK activists have devised a colourful way to make their point.
The Guardian reports on a series of unusual protests outside pharmacies in the UK. On Saturday, January 30, hundreds of self-proclaimed skeptics gathered to denounce the Boots chain's hawking of homeopathic remedies, treatments that are unregulated and have little or no scientific basis. At precisely 10:23am local time protesters staged a series of mass overdoses in several cities, downing entire bottles of pills and potions to emphasize their worthlessness as medicine.
CanadaPharmacyNews, no one seems to have braved the cold to have at it with Canuck homeopathy.
Skeptics argue that theories behind homeopathy – which relies on the extreme dilution of animal, plant, mineral as well as synthetic substances so that remedies do not contain a molecule of the original substance – are utter nonsense. Most scientists agree that the only possible impact of such remedies is as a placebo. The
10:23 Campaign, which organized the demonstrations in Britain, has created an interesting website, with a provocative collection of
videos. Richard Dawkins is entertaining as he demolishes homeopathic theory in less than ten minutes.
As predicted, no ill effects were reported from consuming massive amounts of homeopathic remedies. Anti-homeopathy groups have targeted Boots because they believe its nationwide status as a long-established pharmacy retailer gives the public false confidence in such products. The sale of homeopathic pills and potions in drugstores – along with potato chips, candy and soft drinks – sends a mixed message.
The anti-homeopathy lobby believes that by diverting people with genuine complaints away from conventional medicine homeopaths can put lives at risk. They cite cases of patients who have been been warned away from vaccinations, given homeopathic preparations for serious diseases like malaria, or advised to stop taking medication for cardiac disease.
The Canadian Pharmacists Association (CPhA) has not changed its position on homeopathy since 1998, when it issued a
brief on herbal and homeopathic products, making several recommendations that generally revolved around ensuring that such preparations are regulated, that their claims of efficacy are substantiated by available clinical data, and that the safety of the Canadian public is protected.
The
Natural Health Products Regulations require all homeopathic medicines to have a licence before being sold in Canada. Licence holders are issued a product number which must appear on the label of their product. The Natural Health Products Directorate (NHPD), which is responsible for issuing product licences for all natural health products, uses evidence submitted by applicants to critically assess the safety, efficacy and quality of NHPs before approving them for sale in Canada.
In addition to a product licence, all businesses in Canada which manufacture, package, label and/or import homeopathic medicines for sale must also have a site licence as of January 1, 2006. For more information on
Canadian regulation of natural and homeopathic products, see the Health Canada website. Despite these detailed rules, Canada's pharmacies are full of products of questionable pedigree.
Caveat emptor
.
Photo credits:
flickr photo by
TW Collins
flickr photo by
ten23campaign
statement. The Gates Foundation announced a five-year, $363 million commitment to support NTD product and operational research. Gates also announced last Thursday that the foundation would be donating $750 million to help fight AIDS through the Global Fund to Fight Aids program. The World Health Organization (WHO) unveiled a new strategy to fight NTDs, including a roadmap for implementation that sets targets for what can be achieved by the end of the decade. "The efforts of WHO, researchers, partners, and the contributions of industry have changed the face of NTDs. These ancient diseases are now being brought to their knees with stunning speed," Dr. Margaret Chan, Director-General of the WHO, said in a press release. "With the boost to this momentum being made today, I am confident almost all of these diseases can be eliminated or controlled by the end of this decade." In the largest coordinated effort yet to fight diseases like Guinea worm disease, leprosy and sleeping sickness, the group promised to give an average of 1.4 billion treatments each year to those in need. Experts say that a billion people are affected by NTDs around the world, including over 500 million children. The WHO said in a 2010 report on NTDs that while the diseases cost billions of dollars in lost productivity, they are often ignored because they affect mainly poor people and do not offer a profitable market for drug makers. Andrew Witty, CEO of GlaxoSmithKline, said speaking on behalf of the CEOs of the 13 pharmaceutical companies: "Many companies and organizations have worked for decades to fight these horrific diseases. But no one company or organization can do it alone." --- On the Net:
http://philanthropy.com/article/How-Wealthy-Donors-Can-Get/125815/
January 9, 2011
For Better Results, Wealthy Donors Need to Meddle Less and Collaborate More
Enlarge Image
Michael J. Fox, featured in an advertisement for Parkinson's Progression Markers Campaign.
When it comes to philanthropy, ambition is not in short supply. Great fortunes come from entrepreneurs, investors, and celebrities who have taken risks in their careers and enjoyed odds-beating success. And a growing number expect nothing less dramatic from their personal philanthropy: to end poverty or reverse climate change or cure cancer.
Philanthropists will always support their favorite causes with a portion of their wealth, but simply writing checks to organizations that do great work won’t create these ambitious changes.
Donations from foundations and the ultra-wealthy account for only 6 percent of the total revenue that America’s nonprofits receive in a year. So ambitious philanthropists need an approach that creates many dollars’ worth of results for each dollar invested. Yet all too often, they limit themselves by focusing almost exclusively on the results they hope to see in solving a problem or focusing on a cause.
What’s the missing link?
Donors tend to fall in love with a “program model”—an idea (say, charter schools) that they believe will deliver results. They don’t pay nearly enough attention to defining their “investment model”—what it takes to create change.
That means thinking about what that will take (such as expanding the reach of high-performing nonprofits or designing effective social-media campaigns). It also means thinking about how they as philanthropists can best support those efforts (through the roles they play, the resources they assemble, and the relationships they develop).
Even sophisticated donors can fall into this trap. Many donors meddle excessively in the design of programs. They don’t know how to help grantees deal with tough organizational challenges, or they pressure nonprofits to develop programs that don’t have much to do with their missions.
It’s a scenario as hopeless as a venture-capital firm working to create a compound with a biotech company that lacks the skills to help navigate approval from the Food and Drug Administration, hire a sales force, raise the next round of funds, or negotiate with a pharmaceutical business to manufacture and distribute a new drug.
As a result, these donors often add little value to their grantees and, sometimes they even impose a high cost on nonprofits as the organizations try to fulfill the donors’ unrealistic expectations. What should philanthropists do?
Effective philanthropists merge smart program ideas with the pragmatic techniques it takes to make change happen—and learn to identify and support grantees in both dimensions.
First, philanthropists need to find a suitable way to accomplish their goals. The four most common methods of change:
Building great nonprofit organizations. Some problems require strong nonprofits that can effectively deliver services to large numbers of people.
In supporting fledgling social entrepreneurs, the Draper Richards Foundation, in San Francisco, offers a powerful illustration of how to do this well.
Draper Richards identifies nonprofit leaders with the greatest potential to create large-scale change, regardless of what type of cause—improving health, protecting the environment, or promoting culture—or what approach. Then it focuses on organizational needs like building boards, identifying key people to hire, devising ways to measure results, and attracting additional support.
Over three years, the average Draper Richards grantee grows from a budget of $160,000 per year to $1.6-million per year. The foundation’s portfolio has included highly regarded organizations such as Education Pioneers, Global Citizen Year, Kiva, and Room to Read.
Changing public will and government. Some problems require changing public beliefs or government policies.
The conservative businessman John M. Olin exemplified this ambition. Alarmed by the political events of the 1960s, and convinced that the very existence of America’s free-enterprise system was at stake, Olin supported the creation of legal associations and law schools specifically to promote his conservative philosophy and financed conservative think tanks engaged in scholarly and legal advocacy.
As a result, the Olin Foundation—with only a handful of staff members and an endowment that never exceeded $118-million—is widely recognized as a key player in institutionalizing the conservative movement in the United States over the past 30 years. This, five years after it formally shut its doors.
Establishing new “intermediary” organizations. Some problems require influencing the actions of many institutions in a system. In such cases, a donor may establish an organization to build coalitions to work toward a shared goal.
As an example, ConnectEd, created by the James Irvine Foundation, seeks to improve education in California by leading pilot projects; promoting collaboration among education, labor, and industry; advising policy makers; and calling attention to important concerns through research and advocacy. Over time, ConnectEd has built a coalition of more than 60 organizations to promote its approach to improving education.
Researching and developing solutions. Sometimes an innovation is needed. The Michael J. Fox Foundation for Parkinson’s Research invests nearly $50-million per year but knows these resources are vastly insufficient to cure Parkinson’s disease. So it focuses on influencing researchers around the world to improve their performance, which not only helps scientists get closer to discovering a cure but also lowers the investment risk for others interested in developing Parkinson’s drugs.
It has assembled a blue-chip scientific advisory panel, a team of in-house scientists with the technical savvy to vet ideas and ask tough investment questions, a patient council that represents the voice of the beneficiaries in the priority-setting process, and an executive team with deep strategic planning expertise.
The National Institutes of Health and venture capitalists, among others, now consult with the foundation as they assess proposals and allocate research dollars—a powerful testament to the foundation’s value.
Second, after philanthropists get clear about the appropriate methods of change, they need to organize their approach accordingly. Three particularly important elements:
Defining the right role. The best role is the one that matches the philanthropist’s capabilities with the grantee’s needs. Money is the most obvious need, but other roles can draw on the philanthropist’s time and influence.
In the case of the Michael J. Fox Foundation, the founder brought not only money but also a unique public persona that attracted supporters.
Assembling the right resources. Some philanthropists worry that they can’t carve out a distinct role because they are not big enough. And it’s true that some philanthropists “build” their own staffs. But it doesn’t take a foundation with 100 staff members or a billion-dollar endowment to create results. Smart philanthropists flexibly “buy” capacity by investing in their grantees and “borrow” expertise from contractors.
Forging the right relationships. The inherent power dynamic between donors and grantees makes it hard to get honest feedback about what adds value and creates costs. And while it’s exciting for donors to dream big with nonprofit leaders, philanthropists must understand the cost of capital they are imposing.
Focusing on what it takes to deliver change can increase the odds of honest conversations about grantees’ real concerns and ensure that expectations of donor and nonprofit match. The key is keeping the cost of capital proportionate to the value of the benefits created, for the grantee and for society.
Most traditional foundations don’t hire employees or finance projects with an eye on what it takes to bring about real change.
But every philanthropist can do a better job of reaching his or her goals by understanding what is needed beyond a great program or idea. Paying attention to that issue does not have to be complicated or expensive, just deliberate—and it necessarily evolves as philanthropists learn from their investment experiences and get better over time.
No external force will make philanthropists forge the missing link, only their own relentless drive for results.
Cannabis female flowers. Photo: Acdx (CC)
I have a right to ingest/smoke whatever I want and to explore the contents of “my own mind” in the process, so long as I am not hurting anyone
else
, even if it kills
me
. This is a human right, albeit one that few people think of.
Imagine if you had the right to have a shed in your backyard but you didn’t have a right to explore the contents of that shed. That would be a little insulting, wouldn’t it?
Those who want to limit our mental exploration are to be held highly suspect. Those same people, for instance, often advocate that perfectly normal and healthy individuals go on 7 psychotropic pharmaceuticals at the same time. Limiting access to information is usually a form of domination.
We don’t truly have access to our own minds right now. Some of us do, but there is a huge effort…
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