I am in the middle of preparing a presentation on the innovative ('ethical') pharmaceutical industry. After just a few hours on the net, searching for misdeed, I stumbled about incident after incident after incident. Here's a bullet point list of some of the stuff I found:
Merck: VIOXX – withheld information about health risks from patients and regulators
Pfizer: Trovan – law suits by victims and Nigerian government pending
Bayer: Guilty of defrauding MedicAid in the USA
Pfizer: Neurontin – fraudulently promotes drug for unrelated uses
GSK: Paxil – lied about effectiveness and safety
GSK: Guilty of defrauding MedicAid
IMClone: Insider trading
TAP: Guilty of defrauding government by bribing doctors into prescribing its drugs instead of cheaper but equally efficient alternatives
GSK: Omitted to tell patients and doctors voluntarily that its diabetes drug Avandia results into a 43% higher likelihood of heart attacks
Schering-Plough: Criminal investigation – sold misbranded and unapproved drugs, bribed MCO & doctors to use its drugs
Showing posts with label drug research and development. Show all posts
Showing posts with label drug research and development. Show all posts
Thursday, June 21, 2007
Friday, June 08, 2007
The people of Nigeria vs Pfizer Inc
Nigeria's federal government seeks $7 billion from Pfizer over drug study
By: BASHIR ADIGUN - Associated Press
ABUJA, Nigeria -- The Nigerian government filed a lawsuit Monday
against Pfizer Inc., asking for $7 billion in damages over allegations
the pharmaceutical company conducted a drug experiment that led to
deaths and disabilities among children more than a decade ago, court
papers showed.
The civil case filed in the capital, Abuja, is separate from a legal
challenge launched in the northern state of Kano that seeks $2 billion
from Pfizer, although all the cases stem from the same mid-1990s drug
study.
Pfizer has denied the charges in the Kano case, which are
substantively similar to those in the Abuja-based suit.
In the civil suit filed in Kano, authorities allege Pfizer illegally
conducted a drug experiment on 200 children during a meningitis
epidemic in the state's main city, also called Kano, in 1996,
resulting in deaths, brain damage, paralysis and slurred speech in
many of the children.
Pfizer treated 100 meningitis-infected children with an experimental
antibiotic, Trovan. Another 100 children, who were control patients in
the study, received an approved antibiotic, ceftriaxone -- but the
dose was lower than recommended, the families' lawyers alleged.
Up to 11 children in the study died, while others suffered physical
disabilities and brain damage.
Pfizer has insisted its records show none of the deaths was linked to
Trovan or substandard treatment. That civil suit is asking the judge
to award Kano state $2 billion. Both that case and a related criminal
action against Pfizer officers were both postponed Monday after the
plaintiff's counsel failed to show up for the initial court hearing.
The judge hearing the case said criminal proceedings lodged against
company officers would now begin July 4, while a related civil case
seeking the monetary damages was to begin July 9.
State and company officials were not immediately available for
comment. Nigeria's government is in disarray after the May 29
inauguration of new governors, state assemblies and elected federal
officers, including a new president.
In the Abuja civil case, the government is asking for $500 million for
treatment, compensation and support for the victims of the drug test
and their families. Another $450 million is earmarked for damages
related to money spent to overcome societal misgivings related to the
test, and $1 billion is sought to pay for health programs. The federal
government is also seeking $5 billion as general damages.
New York-based Pfizer, the world's largest drug maker, has denied any
wrongdoing. A federal court in Manhattan dismissed a 2001 lawsuit by
disabled Nigerians who allegedly took part in the study, but the case
is under appeal.
Authorities in Kano state are blaming the Pfizer controversy for
widespread suspicion of government public health policies,
particularly the global effort to vaccinate children against polio,
which has met strong resistance in northern Nigeria.
Islamic leaders in largely Muslim Kano had seized on the Pfizer
controversy as evidence of a U.S.-led conspiracy. Rumors that polio
vaccines spread AIDS or infertility spurred Kano and another heavily
Muslim state, Zamfara, to boycott a long-term campaign to vaccinate
millions.
Vaccination programs restarted in Nigeria in 2004, after an 11-month
boycott. But the delay set back global eradication -- the boycott was
blamed for causing an outbreak that spread the disease across Africa
and into the Middle East.
-- Associated Press Writer Salisu Rabiu contributed to this report
from Kano, Nigeria.
By: BASHIR ADIGUN - Associated Press
ABUJA, Nigeria -- The Nigerian government filed a lawsuit Monday
against Pfizer Inc., asking for $7 billion in damages over allegations
the pharmaceutical company conducted a drug experiment that led to
deaths and disabilities among children more than a decade ago, court
papers showed.
The civil case filed in the capital, Abuja, is separate from a legal
challenge launched in the northern state of Kano that seeks $2 billion
from Pfizer, although all the cases stem from the same mid-1990s drug
study.
Pfizer has denied the charges in the Kano case, which are
substantively similar to those in the Abuja-based suit.
In the civil suit filed in Kano, authorities allege Pfizer illegally
conducted a drug experiment on 200 children during a meningitis
epidemic in the state's main city, also called Kano, in 1996,
resulting in deaths, brain damage, paralysis and slurred speech in
many of the children.
Pfizer treated 100 meningitis-infected children with an experimental
antibiotic, Trovan. Another 100 children, who were control patients in
the study, received an approved antibiotic, ceftriaxone -- but the
dose was lower than recommended, the families' lawyers alleged.
Up to 11 children in the study died, while others suffered physical
disabilities and brain damage.
Pfizer has insisted its records show none of the deaths was linked to
Trovan or substandard treatment. That civil suit is asking the judge
to award Kano state $2 billion. Both that case and a related criminal
action against Pfizer officers were both postponed Monday after the
plaintiff's counsel failed to show up for the initial court hearing.
The judge hearing the case said criminal proceedings lodged against
company officers would now begin July 4, while a related civil case
seeking the monetary damages was to begin July 9.
State and company officials were not immediately available for
comment. Nigeria's government is in disarray after the May 29
inauguration of new governors, state assemblies and elected federal
officers, including a new president.
In the Abuja civil case, the government is asking for $500 million for
treatment, compensation and support for the victims of the drug test
and their families. Another $450 million is earmarked for damages
related to money spent to overcome societal misgivings related to the
test, and $1 billion is sought to pay for health programs. The federal
government is also seeking $5 billion as general damages.
New York-based Pfizer, the world's largest drug maker, has denied any
wrongdoing. A federal court in Manhattan dismissed a 2001 lawsuit by
disabled Nigerians who allegedly took part in the study, but the case
is under appeal.
Authorities in Kano state are blaming the Pfizer controversy for
widespread suspicion of government public health policies,
particularly the global effort to vaccinate children against polio,
which has met strong resistance in northern Nigeria.
Islamic leaders in largely Muslim Kano had seized on the Pfizer
controversy as evidence of a U.S.-led conspiracy. Rumors that polio
vaccines spread AIDS or infertility spurred Kano and another heavily
Muslim state, Zamfara, to boycott a long-term campaign to vaccinate
millions.
Vaccination programs restarted in Nigeria in 2004, after an 11-month
boycott. But the delay set back global eradication -- the boycott was
blamed for causing an outbreak that spread the disease across Africa
and into the Middle East.
-- Associated Press Writer Salisu Rabiu contributed to this report
from Kano, Nigeria.
Friday, May 25, 2007
Patients allegedly undersupplied with cutting edge medication
A study published by the German federation of the innovative (ie research active) pharmaceutical industry alleges that up to 74% of patients suffering from dementia, and up to 69% of patients suffering from rheumathoid arthritis are denied access to innovative drugs due to cost considerations. Basically insurance companies put pressure on doctors to prescribe cheaper, generic drugs, many of which, according to the research active industry, are plain suboptimal.
Now, one should not be too surprised that the pharmaceutical industry and its for-hire academic researcher (a professor doctor doctor med type guy in Bochum) come to this conclusion.
Assuming that the claims made by the good professor, and the industry that finances him, are correct, one might still wonder whether this isn't further proof that our reliance on market mechanisms to ensure medical innovation is misguided. It seems as if not only the poor in developing countries are unable to access life preserving medication but also your average citizen in a country as rich as Germany. Surely there is something odd about our health care systems' continuing reliance on profit driven drug companies to deliver the needed drugs affordably. I am not suggesting, by the way, that there is something inherently bad about the companies going about their business in terms of maximising returns for their shareholders. What is problematic is that we as a society have shifted most drug R&D responsibility their way. Now we depend on them and find that while this was convenient for awhile, we (as in more and more of us) can't afford their goods anylonger.
No doubt it is time to reconsider how drug R&D is currently being financed.
Now, one should not be too surprised that the pharmaceutical industry and its for-hire academic researcher (a professor doctor doctor med type guy in Bochum) come to this conclusion.
Assuming that the claims made by the good professor, and the industry that finances him, are correct, one might still wonder whether this isn't further proof that our reliance on market mechanisms to ensure medical innovation is misguided. It seems as if not only the poor in developing countries are unable to access life preserving medication but also your average citizen in a country as rich as Germany. Surely there is something odd about our health care systems' continuing reliance on profit driven drug companies to deliver the needed drugs affordably. I am not suggesting, by the way, that there is something inherently bad about the companies going about their business in terms of maximising returns for their shareholders. What is problematic is that we as a society have shifted most drug R&D responsibility their way. Now we depend on them and find that while this was convenient for awhile, we (as in more and more of us) can't afford their goods anylonger.
No doubt it is time to reconsider how drug R&D is currently being financed.
Sunday, March 25, 2007
Access to Essential Drugs
By way of promoting a book I co-edited, here's a review of said product in this week's medical journal THE LANCET.The Lancet 2007 24 March
Book Review
Access to essential drugs and the pendulum of power
The Power of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing
Jillian Clare Cohen, Patricia Illingworth and Udo Schuklenk, eds.
Pluto Press, 2006, ISBN 0-745-32402-9.
Pp 320. £19·99, US$35·00
Many factors have influenced my commitment to campaign for access to essential medicines, but two immediately leap out. When I was working in Bangladesh I witnessed a certain drug company promote the virtues of a sugar-coated vitamin pill as the most important factor in helping children grow and stay healthy. Families spent a day's wages on these useless tablets when they could have been buying bananas, spinach, and dahl instead. As I watched parents make sacrifices to pay for these pills, I realised that I was obliged to do something about this profoundly unjust situation:
I knew what was going on, doing nothing would make me complicit in the drug company's actions.
Years later, in my role as a medical editor, I accepted an invitation to lunch with the Association of the British Pharmaceutical Industry. It was just after the South African Government had won their landmark court case against the pharmaceutical industry, in April, 2001, and I wanted
to hear the association's view of the outcome. It was in London's Grosvenor Hotel and everyone apart from me was tucking into a three-course meal under the chandeliers. I felt alone in my disapproval of drug companies' evangelical zeal to uphold patents, and uncomfortable about the way those present were talking about African people. After I said my piece, I left the dining room and a Brazilian waiter came running after me to thank me for what I had said.
And here lies the problem. The activities of drug companies that put patents before public health—encouraged by the World Trade Organisation's rule on Trade-Related Intellectual Property Rights (TRIPS)—places the pharmaceutical industry and campaigners on different sides of an impasse that is so wide there seems to be no possibility of meeting in the middle. In the real world, the outcome of this polarised debate depends on who has the most power, which unfortunately for now is the drug companies. But if there is any hope of making progress, there has to be some mutual recognition and acknowledgement of each other's point of view. Will I find any thought-provoking reasoning in The Power of Pills to help me appreciate the
position of drug companies?
The Power of Pills explains the social, ethical, and legal issues involved in drug development, marketing, and pricing and has contributions from an eclectic mix of academics, activists, economists, ethicists, health-care professionals, lawyers, and philosophers. There is one contributor from the pharmaceutical industry. Most of the essays are beautiful examples
of moral, philosophical, and economic reasoning at its best. For example, Michael Selgelid and Eline Sepers argue that drug companies should be "incentivised" to research diseases in developing countries. The need for governments in the south to implement a comprehensive public-private policy that sets the agenda is the focus of Joao Carapinha's essay. Steve Miles suggests that the socioeconomic gap between rich and poor countries is likely to grow unless
developing countries establish their own research capacity that prioritises the health needs of their populations. The case for abolishing the patent system is made convincingly by Adam Mannan and Alan Story. And Brook Baker argues that access to essential medicines is a human right and proposes that the international community should put it firmly on the human rights agenda.
The drug industry is represented by Robert Freeman, a pharma veteran. He offers a predictable defence arguing for "strong intellectual property rights, a stable regulatory, pricing and reimbursement environment, and the recognition that pharmaceutical innovation is a major contribution to the health of nations." We are back at the impasse. I am not convinced.
Another prime example of pharma dogma is in the 2005 report from the Millennium Project Working Group on Access to Essential Medicines, one of the Millennium Development Goal targets, which discusses the way forward.
The report's authors come up with similar solutions to those outlined in The Power of Pills, such as fair pricing of essential medicines and innovative methods of research and development that are not led by the pharmaceutical industry. However, at the back of the report is a statement of dissent by representatives of the research-based pharmaceutical industry and signed by
Eli Lilly, Merck, and Pfizer. Although representatives for the industry were part of the working group they refused to sign the report, "because of the enormous visionary gap between ourselves and the working group in identifying root causes of the access challenge". Their reasons are so important in understanding why there is a stand-off position when it comes
to access to essential medicines that I think their response is worth quoting. They state, "We do not believe that the main problem in barring medicines to the poor is patent protection, nor do we accept that individual pricing practises are fundamental to explaining why one-third of
the world's poor lack access to basic, low cost essential medicines." They conclude, "In short, the report fails to provide the balanced and accurate perspective necessary to stimulate fresh policy approaches that could make a real difference to the lives of the poor. To allow these inaccuracies and misinterpretations to become accepted truth and as the basis of moving policies forward does no one any service, least of all patients who rely most on the commitments we have made. It would significantly diminish our ability to fulfil commitments to current and future partnerships—most importantly—our capacity to produce new drugs, diagnostics, and vaccines."
I am left wondering how much more evidence and reasoning it will take for the drug industry to meet somewhere along the impasse. Is there any way forward? A WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property may offer some hope. The group's aim is to help devise a global strategy to boost research and development for neglected diseases, including looking at new ideas such as patent pooling, to address the barriers posed by patents for individual drugs. But experience to date shows that drug companies will do everything they can to cling on the status quo where they hold all of the power. The pendulum of power will need to swing to the other side before there is any reasonable progress.
So imagine this: after deciding to diversify and invest in its own research and development, a former Indian generic drug company has come up with a new compound that could be of major benefit to people with lung cancer—the leading cause of death from cancer in rich countries. The company has tested its drug in clinical trials, it has been approved for use, and as is within the company's rights, according to TRIPS, the company patents it and charges a premium so that the cost for treating one patient for 1 year with the new drug is £50?000. Can you imagine the response to this situation, including the tabloid headlines? Now why should the response to access to life-saving treatment, such as antiretroviral therapy, for people in developing
countries be any different? Is it because they are poor? Is it because they are powerless? Or is it because, on the whole, the international community just does not care? The power is not with the pills. It is with the pill makers.
nathan ford < nathan.ford@london.msf.org >
Jillian Clare Cohen, Patricia Illingworth and Udo Schuklenk, eds.
Pluto Press, 2006, ISBN 0-745-32402-9.
Pp 320. £19·99, US$35·00
Many factors have influenced my commitment to campaign for access to essential medicines, but two immediately leap out. When I was working in Bangladesh I witnessed a certain drug company promote the virtues of a sugar-coated vitamin pill as the most important factor in helping children grow and stay healthy. Families spent a day's wages on these useless tablets when they could have been buying bananas, spinach, and dahl instead. As I watched parents make sacrifices to pay for these pills, I realised that I was obliged to do something about this profoundly unjust situation:
I knew what was going on, doing nothing would make me complicit in the drug company's actions.
Years later, in my role as a medical editor, I accepted an invitation to lunch with the Association of the British Pharmaceutical Industry. It was just after the South African Government had won their landmark court case against the pharmaceutical industry, in April, 2001, and I wanted
to hear the association's view of the outcome. It was in London's Grosvenor Hotel and everyone apart from me was tucking into a three-course meal under the chandeliers. I felt alone in my disapproval of drug companies' evangelical zeal to uphold patents, and uncomfortable about the way those present were talking about African people. After I said my piece, I left the dining room and a Brazilian waiter came running after me to thank me for what I had said.
And here lies the problem. The activities of drug companies that put patents before public health—encouraged by the World Trade Organisation's rule on Trade-Related Intellectual Property Rights (TRIPS)—places the pharmaceutical industry and campaigners on different sides of an impasse that is so wide there seems to be no possibility of meeting in the middle. In the real world, the outcome of this polarised debate depends on who has the most power, which unfortunately for now is the drug companies. But if there is any hope of making progress, there has to be some mutual recognition and acknowledgement of each other's point of view. Will I find any thought-provoking reasoning in The Power of Pills to help me appreciate the
position of drug companies?
The Power of Pills explains the social, ethical, and legal issues involved in drug development, marketing, and pricing and has contributions from an eclectic mix of academics, activists, economists, ethicists, health-care professionals, lawyers, and philosophers. There is one contributor from the pharmaceutical industry. Most of the essays are beautiful examples
of moral, philosophical, and economic reasoning at its best. For example, Michael Selgelid and Eline Sepers argue that drug companies should be "incentivised" to research diseases in developing countries. The need for governments in the south to implement a comprehensive public-private policy that sets the agenda is the focus of Joao Carapinha's essay. Steve Miles suggests that the socioeconomic gap between rich and poor countries is likely to grow unless
developing countries establish their own research capacity that prioritises the health needs of their populations. The case for abolishing the patent system is made convincingly by Adam Mannan and Alan Story. And Brook Baker argues that access to essential medicines is a human right and proposes that the international community should put it firmly on the human rights agenda.
The drug industry is represented by Robert Freeman, a pharma veteran. He offers a predictable defence arguing for "strong intellectual property rights, a stable regulatory, pricing and reimbursement environment, and the recognition that pharmaceutical innovation is a major contribution to the health of nations." We are back at the impasse. I am not convinced.
Another prime example of pharma dogma is in the 2005 report from the Millennium Project Working Group on Access to Essential Medicines, one of the Millennium Development Goal targets, which discusses the way forward.
The report's authors come up with similar solutions to those outlined in The Power of Pills, such as fair pricing of essential medicines and innovative methods of research and development that are not led by the pharmaceutical industry. However, at the back of the report is a statement of dissent by representatives of the research-based pharmaceutical industry and signed by
Eli Lilly, Merck, and Pfizer. Although representatives for the industry were part of the working group they refused to sign the report, "because of the enormous visionary gap between ourselves and the working group in identifying root causes of the access challenge". Their reasons are so important in understanding why there is a stand-off position when it comes
to access to essential medicines that I think their response is worth quoting. They state, "We do not believe that the main problem in barring medicines to the poor is patent protection, nor do we accept that individual pricing practises are fundamental to explaining why one-third of
the world's poor lack access to basic, low cost essential medicines." They conclude, "In short, the report fails to provide the balanced and accurate perspective necessary to stimulate fresh policy approaches that could make a real difference to the lives of the poor. To allow these inaccuracies and misinterpretations to become accepted truth and as the basis of moving policies forward does no one any service, least of all patients who rely most on the commitments we have made. It would significantly diminish our ability to fulfil commitments to current and future partnerships—most importantly—our capacity to produce new drugs, diagnostics, and vaccines."
I am left wondering how much more evidence and reasoning it will take for the drug industry to meet somewhere along the impasse. Is there any way forward? A WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property may offer some hope. The group's aim is to help devise a global strategy to boost research and development for neglected diseases, including looking at new ideas such as patent pooling, to address the barriers posed by patents for individual drugs. But experience to date shows that drug companies will do everything they can to cling on the status quo where they hold all of the power. The pendulum of power will need to swing to the other side before there is any reasonable progress.
So imagine this: after deciding to diversify and invest in its own research and development, a former Indian generic drug company has come up with a new compound that could be of major benefit to people with lung cancer—the leading cause of death from cancer in rich countries. The company has tested its drug in clinical trials, it has been approved for use, and as is within the company's rights, according to TRIPS, the company patents it and charges a premium so that the cost for treating one patient for 1 year with the new drug is £50?000. Can you imagine the response to this situation, including the tabloid headlines? Now why should the response to access to life-saving treatment, such as antiretroviral therapy, for people in developing
countries be any different? Is it because they are poor? Is it because they are powerless? Or is it because, on the whole, the international community just does not care? The power is not with the pills. It is with the pill makers.
nathan ford < nathan.ford@london.msf.org >
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