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.
“Heartburn pills taken by thousands of women ‘raise risk of hip fractures by up to 50 per cent’,” the Daily Mail reported today. The headline is based on a large new study of drugs called proton pump inhibitors (PPIs), which are commonly used to treat heartburn, acid reflux and ulcers.
The study found that post-menopausal women who regularly took PPIs for at least two years were 35% more likely to suffer hip fracture than non-users, a figure that increases to 50% for women who were current or former smokers. However, although this increase in risk is large, the overall risk of fractures remains small.
This was a large, well conducted study that suggests that long-term use of PPIs is associated with a small increase in risk of hip fracture, although the researchers point out that the risk seems to be confined to women with a history of smoking. Unlike previous research, this study took careful account of other factors that might affect risk such as body weight and calcium intake.
Women who are concerned about their use of PPIs are advised to consult their GP.
Where did the story come from?
The study was carried out by researchers from Massachusetts General Hospital, Boston University and Harvard Medical School and was funded by the US National Institutes of Health. The study was published in the
peer-reviewed British Medical Journal.
Although the Mail’s headline is technically correct, it gives the impression that these drugs carry a very large increase in the risk of hip fracture. In fact, the study found that, in absolute terms, the increase in risk for regular users was small. Researchers found that among the women in the study who regularly used PPIs, about two in every 1,000 fractured a hip each year. In non-users, this figure was about 1.5 in every 1,000. This is a increase of about five fractures a year in every 10,000 women taking PPIs.
The Mail did point out this “absolute difference” towards the end of its story. Both the Mail and the BBC included comments from independent experts.
What kind of research was this?
The researchers point out that PPIs are among the most commonly used drugs worldwide. In the US they are available over the counter, but in the UK are available only on prescription. They are used for symptoms of heartburn, gastro-oesophageal reflux disease (GORD) and stomach ulcers. PPIs are thought to work by reducing acid production in the stomach. Concern has grown over a potential association between long-term use of these drugs and bone fractures, although the researchers say that previous studies have had conflicting results and many did not take other factors (called
confounders) that might affect the risk of fracture into account.
In their
cohort study of nearly 80,000 post-menopausal women, the researchers set out to examine the association between long-term use of PPIs and the risk of hip fracture. Unlike a
randomised controlled trial, a cohort study cannot prove cause and effect. However, cohort studies enable researchers to follow large groups of people for long periods and they are useful for looking at potential long-term risks and benefits of treatments. The study was
prospective, which means it followed participants in time, rather than collecting information retrospectively. This makes it more reliable.
What did the research involve?
This study took its data from a large ongoing US study called the Nurses Health Study, which began in 1976 and which sent health questionnaires every two years to 121,700 female nurses aged 30-55.
From 1982 participants were asked to report all previous hip fractures and in each biennial questionnaire, women were asked if they had sustained a hip fracture over the previous two years. Those who reported a hip fracture were sent a follow-up questionnaire asking for more details. Fractures from bad accidents, such as falling down a flight of stairs, were excluded from the study. A review of medical records for 30 of the women validated all self-reported fractures.
From 2000 to 2006 the women were asked if they had regularly used a PPI in the previous two years. In earlier questionnaires (1994, 1996, 1998 and 2000), the women were also asked if they had regularly used other drugs for acid reflux, called H2 blockers.
The biennial questionnaires also included questions on other factors including menopausal status, body weight, leisure activities, smoking and alcohol use, use of hormone replacement therapy (HRT) and other medicines. Researchers used a validated food frequency questionnaire to calculate the women’s total intake of calcium and vitamin D.
They then analysed the data for any association between regular use of PPIs and hip fracture, adjusting their findings for key confounders such as body weight, physical activity, smoking and alcohol and calcium intake. They also took into account whether the reasons for using a PPI might have affected the results.
Finally, they carried out a systematic review combining their results with 10 previous studies on the risk of hip fracture and the long-term use of PPIs.
What were the basic results?
The researchers documented 893 hip fractures during the period of the study. They also found that, in 2000, 6.7% of women regularly used a PPI – a figure that had risen to 18.9% by 2008.
- Amongst women who had regularly taken a PPI at any time, there were 2.02 hip fractures per 1,000 person years, compared with 1.51 fractures per 1,000 person years among non-users.
- Women who regularly used PPIs for at least two years had a 35% higher risk of hip fracture than non-users (age adjusted hazard ratio (HR) 1.35; 95%
confidence interval (CI) 1.13 to 1.62), with longer use associated with increasing risk. Adjustment for risk factors, including body mass index, physical activity and intake of calcium did not alter this association (HR 1.36; CI 1.13 to 1.63).
The increased risk did not change when researchers also took into account the reasons for PPI use:
- Current and former smokers who regularly used PPIs were 51% more likely to have a hip fracture than non-users (HR 1.51; (CI) 1.20 to 1.91).
- Among women who never smoked there was no association between PPI use and hip fracture (HR 1.06; (CI) 0.77 to 1.46).
- In a meta-analysis of these results with 10 previous studies, the risk of hip fracture in users of PPI was higher compared to non–users of PPIs (pooled odds ratio 1.30; CI 1.25 to 1.36).
The researchers also found that two years after women stopped taking PPIs, their risk of hip fracture returned to a similar level to that in women who had never taken them. Also, women taking H2 blockers had a “modest” increased risk of hip fracture but the risk was higher in women who took PPIs.
How did the researchers interpret the results?
The researchers conclude that their results provide “compelling evidence” of a risk between PPI use and hip fracture. They say the findings suggest that the need for long-term, continuous use of PPIs should be carefully evaluated, particularly among people who have smoked or are still smokers.
They suggest that PPIs may increase the risk of fracture by impairing the absorption of calcium, although in this study the risk of fracture was not affected by dietary calcium intake. The finding that the risk was confined to women with a history of smoking (an established risk factor for fracture) indicates that smoking and PPIs may act together (have a “synergistic effect”) on fracture risk.
Conclusion
This large study had several strengths. Unlike some previous studies, it collected information on and took into account other key risk factors for fracture, including body weight, smoking, alcohol use and physical activity. It also looked at the women’s use of PPIs every two years (rather than just asking them once) and took into account variations in use during this time in their analysis.
However, as the authors note, it also had some limitations:
- It did not ask about the brands of PPI used, nor the doses of PPI the women took, both of which could affect risk of fracture.
- The information about hip fracture was self-reported and not confirmed by medical records (although a smaller study has found self-reporting of hip fracture to be reliable).
- Also, the study did not record the women’s bone mineral density (BMD). Low[?] BMD is an important risk factor for fracture and adding a measure of this could have strengthened the study.
Finally, because this was a cohort study, other factors both measured and unmeasured may have affected the results, even though researchers took many of these into account in their analysis. Socio-economic status and education, for example, were not established. Because this was a study of registered nurses, the applicability of the results to other socio-economic groups might be limited.
This study found that the long-term, regular use of these drugs is associated with a small increased risk in hip fracture among older women, a risk that seems to be confined to past or current smokers. Women who regularly take PPIs and who are concerned about these findings are advised to talk to their GP. Whether any change in use of this commonly prescribed drug is needed requires further study.
Links To The Headlines
Indigestion drugs taken by millions linked to hip fractures. The Daily Telegraph, February 1 2012
Heartburn pills taken by thousands of women 'raise risk of hip fractures by up to 50 per cent'. Daily Mail, February 1 2012
Ulcer drugs 'link to fractures'. BBC News, February 1 2012
Links To Science
Khalili H, Huang ES, Jacobsen BC, et al.
Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study. British Medical Journal. Published online January 31 2012
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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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
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Qualification Requirements/Preferences:Education Certifications/Licensure Experience Physical AbilitiesA. Experience:Clinical Expert aka Clinical Nurse IV aka Registered Nurse IV: The Clinical Expert aka Clinical Nurse IV aka Registered Nurse IV is an expert clinician who demonstrates high level knowledge and expertise in specialty as well as general nursing resource to nursing and health care team and is a leader. At least five years of experience in their specialty upon hire. Additionally they must have a Bachelors of Science in nursing degree.B. Education - Graduate from an accredited School of Nursing (BSN is required).C. License, Certification, or Registration Required -- Current Registered Nurse licensure in the State of California. Current BLS for healthcare providers through the American Heart Association.D. National Specialty Certifications preferredE. Language Skills a€“ English Language Proficiency required. Ability to effectively present information and respond to questions from patients, families and the general public in a positive manner.F. Mathematical Skills a€“ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.G. Reasoning Ability a€“ Ability to define problems collects data, establish facts, and draw conclusions. Ability to interpret an extensive variety of technical/clinical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Follows the nursing plan of care and initiate changes, need critical thinking skills.H. Special Qualifications a€“ Able to function effectively in a busy, fast-paced environment. Must be capable of making decisions under pressure and managing anger, fear, hostility and violence of others appropriately.I. Must possess minimum computer competency comprised of a working knowledge of Windows or comparable system specifically including keyboarding and mouse skills and applicable to individual job duties and expectations, employee must demonstrate competency in use of the applications indicated on the competency checklist.Work Environment:-Must be able to perform assigned duties in a demanding work environment.Physical Requirements:-The physical ability and perceptive acuity to satisfactorily perform all direct and indirect patient care functions.All External hires must successfully pass background check, drug screen, and pre-employment physical.
Stade spoke first in a spirited debate between former FDA and current consultant Philip J. Phillips, Esq., President, Phillips Consulting Group, LLC, Professor Ralph F. Hall, Professor of Practice, University of Minnesota Law School, and Partner, Lauren R. Silvis, Esq., Sidley Austin LLP. Section 513 of the Food, Drug, and Cosmetic Act ("FD&C Act") mandates that, prior to marketing, FDA must classify all medical devices into one of three classes depending on the intended use, indications for use, and level of control necessary to ensure the safety and effectiveness of the device. Class I requires the least control, followed by class II, and class III requires the most control. Section 513(i) of the FD&C Act essentially states that if a new device is substantially equivalent to an already-marketed device or "predicate" device, the new device is given the same classification as the device already in the market and may be submitted as a "510(k)" submission, which is based on section 510(k) of the FD&C Act. If the new device is not substantially equivalent to any such device, the new device is placed in class III and requires a premarket approval application ("PMA") under Section 515 of the FD&C Act.
Over the years, the 510(k) process has become the most common and controversial pathway for bringing medical devices to market. FDA's definition of medical device includes products ranging from simple tongue depressors to pacemakers to laser surgical devices. Under the current 510(k) process, device manufacturers must notify FDA of their intent to market a medical device at least 90 days prior to launch. If FDA determines that the device is substantially equivalent to an existing 510(k) cleared device or other device that was on the market when the Medical Device Amendments were enacted in 1976, then it may proceed to market. If not, it must undergo pre-market approval as a premarket approval application ("PMA").
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.
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
His attorneys argued in a motion filed last week that the arrangement protects him from criminal prosecution in Maryland because Brigham administered drugs that killed the fetuses while the patients were in New Jersey
Dr. Steven Chase Brigham speaks with one of his attorneys in this 2010 file photo. Brigham of Voorhees, faces charges of performing illegal abortions at an abortion clinic on East High Street in Elkton, Md.
WASHINGTON — Lawyers for an abortion doctor charged with murder in Maryland for the deaths of five fetuses have asked a judge to dismiss the charges, arguing that prosecutors lack jurisdiction because the deaths occurred in New Jersey.
Dr. Steven Brigham, 55, of Voorhees, N.J., lost his New Jersey medical license in 2010 after regulators discovered an arrangement under which he would begin second- and third-trimester abortions in New Jersey, and then have the patients drive themselves to Maryland the next day to complete the procedures.
His attorneys argued in a motion filed last week that the arrangement protects him from criminal prosecution in Maryland because Brigham administered drugs that killed the fetuses while the patients were in New Jersey. He then extracted the fetuses at his clinic in Elkton, Md., a small town in the northeast corner of the state.
Brigham's lawyers also argue that he is immune from prosecution under Maryland's fetal homicide law, which was intended to apply to people who kill or do physical harm to pregnant women, causing fetal death. The law includes exemptions for physicians administering lawful medical care, and Brigham's attorneys say using it against an abortion doctor interferes with a woman's constitutional right to terminate a pregnancy.
"By bringing these charges, the state has placed a chilling effect on doctors who perform abortions and thus will inhibit women from finding doctors who perform abortions even if the procedure is necessary to protect the life or health of the woman," attorneys Nancy Forster and C. Thomas Brown argue in their motion.
Cecil County State's Attorney Ellis Rollins declined to comment Monday.
Prosecutors have made few public statements about their rationale for the charges, although Rollins has acknowledged they are in uncharted territory. Experts on both sides of the abortion debate say it is highly unusual, if not unprecedented, to charge an abortion doctor with murder under a fetal homicide law. Thirty-eight states have such statutes.
At a bail review hearing earlier this month in Cecil County Circuit Court for Brigham's co-defendant, Dr. Nicola Riley, Deputy State's Attorney Kerwin Miller suggested that prosecutors believe any death of a viable fetus to be homicide, regardless of the circumstances.
"The law is clear that it is unlawful, as a matter of fact it is homicide, when you kill a viable fetus," Miller said, according to a transcript of the proceeding. "So an abortion on a viable fetus is not a lawful procedure, is not lawful medical care."
In their motion, Brigham's attorneys also take issue with prosecutors' characterization of the fetuses as viable, arguing that the state has no right to interfere with a doctor's judgment about the need for an abortion.
Maryland's fetal homicide law, the attorneys argue, "leaves the determination of viability to the 'best medical judgment of the attending physician.' If a doctor determines that the fetus is not viable, for whatever reason, and the state disagrees with that determination, under their theory, the doctor can be charged with fetal homicide."
Doctors generally consider fetuses to be viable outside the womb starting around 23 weeks. Prosecutors have not detailed how they determined the viability of the five fetuses Brigham is accused of killing. One of them was known to have been aborted at 21 weeks.
Riley, Brigham's former colleague, also has been charged with murder in the death of that 21-week-old fetus. Her attorneys also have argued that she is immune from prosecution under the fetal homicide law. Both Brigham and Riley, of Salt Lake City, Utah, are free on bond.
In the case that led to charges against both Brigham and Riley, the patient suffered serious injuries, and Riley drove her to a nearby hospital rather than call 911. That case alerted medical regulators to Brigham's unusual arrangement, which authorities described as an effort to take advantage of Maryland's more permissive abortion laws. Brigham was not licensed to perform abortions after the first trimester in New Jersey.
In Maryland, licensed physicians can perform abortions before the fetus is deemed capable of surviving outside the womb, and abortions of viable fetuses are permitted to protect the life or health of the mother or if the fetus has serious genetic abnormalities.
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Speciality: Medical/Surgical
Shift: 12hr
Hours: 7:00PM to 7:30AM
Days: Monday - Friday
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Qualification Requirements/Preferences:Education Certifications/Licensure Experience Physical AbilitiesA. Experience:Clinical Nurse II aka Registered Nurse II: the Registered Nurse II is a competent clinician who provides nursing care in a skilled and effective manner. One year clinical experience a minimum of 1 year acute care experience.B. Education -- Graduate from an accredited School of Nursing (BSN preferred).C. License, Certification, or Registration Required -- Current Registered Nurse licensure in the State of California. Current BLS for healthcare providers through the American Heart Association.D. National Specialty Certifications preferred.E. Language Skills a€“ English Language Proficiency required. Ability to effectively present information and respond to questions from patients, families and the general public in a positive manner.F. Mathematical Skills a€“ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.G. Reasoning Ability a€“ Ability to define problems collects data, establish facts, and draw conclusions. Ability to interpret an extensive variety of technical/clinical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Follows the nursing plan of care and initiate changes, need critical thinking skills.H. Special Qualifications a€“ Able to function effectively in a busy, fast-paced environment. Must be capable of making decisions under pressure and managing anger, fear, hostility and violence of others appropriately.I. Must possess minimum computer competency comprised of a working knowledge of Windows or comparable system specifically including keyboarding and mouse skills and applicable to individual job duties and expectations, employee must demonstrate competency in use of the applications indicated on the competency checklist.Work Environment:-Must be able to perform assigned duties in a demanding work environment.Physical Requirements:-The physical ability and perceptive acuity to satisfactorily perform all direct and indirect patient care functions.All External hires must successfully pass background check, drug screen, and pre-employment physical.
“This treatment regimen is able to clear blood clots rapidly and safely, restoring blood flow in the veins of the lower leg, and the results are durable,” said lead author Richard Chang, M.D., chief of the interventional radiology section of the Department of Radiology, Clinical Center, National Institutes of Health (NIH), Bethesda, Md.
DVT is a common and serious health problem in which a blood clot, or thrombus, form in the deep veins, particularly in the lower leg or thigh. Complications occur when the clot breaks off and travels to the lungs, resulting in pulmonary embolism, a potentially fatal condition.
Most patients with DVT are treated solely with anticoagulation therapy (blood thinners) and compression stockings. However, studies have shown that one-third of these patients will suffer from post-thrombotic syndrome, characterized by pain, swelling, or in severe cases by changes in skin color or skin ulceration. Another third are likely to have another clot or pulmonary embolism within five years of their initial DVT.
Treatments with thrombolytic (clot-dissolving) therapy could potentially protect against these occurrences, but can pose a bleeding risk. Therefore, Dr. Chang and colleagues sought to develop a safe, effective and affordable thrombolytic treatment regimen for DVT.
Twenty patients with acute DVT were treated with direct intraclot lacing of the thrombus with a clot-dissolving agent called alteplase and full systemic anticoagulation. Alteplase binds to the clot, so the procedure does not require continuous infusion of the drug, as do some thrombolytic therapies. With this treatment, after lacing one vein segment with alteplase, the interventional radiologist can immediately direct catheters to treat other vein segments to ensure that the entire clot has been adequately treated.
The results of the study showed that blood flow was restored throughout the deep venous system in 16 (80 percent) of the 20 patients during therapy with complete resolution of symptoms in 18 patients (90 percent) after six months of anticoagulation. Alteplase was cleared from the patients’ circulatory system within two hours of treatment, reducing the risk of subsequent bleeding.
There were no serious complications or bleeding during the treatment, and no cases of post-thrombotic syndrome or recurrent clotting during follow-up of 3.4 years.
“With this therapy, pain and swelling resolve rapidly, and, in most cases, the patient is able to resume all normal activity within a week,” said the study’s co-author, McDonald K. Horne III, M.D., from the hematology section of the Department of Lab Medicine, Clinical Center, NIH.
The authors caution that larger clinical trials are required to further support the efficacy of this promising treatment.
Chemotherapy is poison that happens to kill cancer cells faster than it kills healthy cells; that it wreaks havoc on the bodies of patients is unsurprising. But chemo may also affect their unborn children. According to a new study in
PNAS
,
the offspring of mice treated with chemotherapy have higher rates of mutation, even though the offspring themselves were never exposed to the drugs.
The results suggest that these mutations arise from genome destabilization caused by exposure to chemo, rather than just mutated sperm from the treated father. Male mice in the study were exposed to one of three common anticancer drugs—cyclophosphamide, mitomycin C, or procarbazine—and then allowed to mate with untreated females. After sequencing a small piece of DNA from the offspring, the researchers found that mice with treated fathers had mutation rates up to twice that of mice with untreated fathers. Notably, these mutations were present in DNA inherited from both the treated father
and
untreated mother.
What this likely means, according to the researchers, is that chemotherapy induces
epigenetic changes in the sperm. Epigenetic changes don’t affect the underlying DNA sequence, but they alter chemical tags that control how genes are expressed. This ...
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