Monday, November 15, 2010
putting a voice on patients: understanding the doctor-patient relationship
listen to the voices of patients suffering from/accepting a wide range of serious medical conditions. Doctor -patient relationships involve deeply personal patient experiences and these qualities are important to be mindful of when analyzing ethical quandries arising in this context. http://www.nytimes.com/interactive/2009/09/10/health/Patient_Voices.html
NEW IVF Technique: Is it ethically acceptable to use this technology?
New screening technique may boost IVF success rates
15 November 2010
By Kyrillos Georgiadis
Appeared in BioNews 584
UK-based researchers have developed a new screening technique which could double or triple IVF success rates. The new test allows for any chromosomal abnormalities to be detected in embryos before they are implanted into the mother.
The new technique allows viability of embryos to be tested without risking damage. Dr Simon Fishel, director of CARE fertility clinic in Nottingham, spoke of how the new test is a significant improvement on current methods saying it will make a 'stupendous difference'. Current PGD (preimplantation genetic diagnosis) techniques involve comparative genomic hybridization arrays, the accuracy of which has been questioned, and in utero (in the womb) prenatal screening, which can carry a risk of miscarriage.
'Before we would look down a microscope and see five, six, maybe 10 embryos knowing that half are chromosomally abnormal but there's no way of testing it. We now we have an objective test that is related to the health of the pregnancy', Dr Fishel told the BBC. At around day five of embryo development, the blastocyst has two distinct parts - a group of cells called the embryoblast which will later develop into the body of the fetus, and a group of surrounding cells, the blastocoele, which fuses with the inner membrane of the uterus to form the placenta.
'At this stage we can do a tiny biopsy of those placental cells. So we don't even touch the cells that are going to become the baby itself', Dr Fishel explained. Subsequent chromosomal analysis would show any abnormalities before the embryo is implanted.Chromosomal abnormalities are the largest cause of miscarriages, accounting for over 50 percent of embryos that abort spontaneously in the first trimester, both in IVF and natural conception.
One in 200 newborns has multiple congenital abnormalities because of a chromosomal abnormality. Trials of the new technique, held by fertility specialists at CARE Fertility in Manchester, include three women in their late 30s who having undergone the new procedure will give birth in late December.
15 November 2010
By Kyrillos Georgiadis
Appeared in BioNews 584
UK-based researchers have developed a new screening technique which could double or triple IVF success rates. The new test allows for any chromosomal abnormalities to be detected in embryos before they are implanted into the mother.
The new technique allows viability of embryos to be tested without risking damage. Dr Simon Fishel, director of CARE fertility clinic in Nottingham, spoke of how the new test is a significant improvement on current methods saying it will make a 'stupendous difference'. Current PGD (preimplantation genetic diagnosis) techniques involve comparative genomic hybridization arrays, the accuracy of which has been questioned, and in utero (in the womb) prenatal screening, which can carry a risk of miscarriage.
'Before we would look down a microscope and see five, six, maybe 10 embryos knowing that half are chromosomally abnormal but there's no way of testing it. We now we have an objective test that is related to the health of the pregnancy', Dr Fishel told the BBC. At around day five of embryo development, the blastocyst has two distinct parts - a group of cells called the embryoblast which will later develop into the body of the fetus, and a group of surrounding cells, the blastocoele, which fuses with the inner membrane of the uterus to form the placenta.
'At this stage we can do a tiny biopsy of those placental cells. So we don't even touch the cells that are going to become the baby itself', Dr Fishel explained. Subsequent chromosomal analysis would show any abnormalities before the embryo is implanted.Chromosomal abnormalities are the largest cause of miscarriages, accounting for over 50 percent of embryos that abort spontaneously in the first trimester, both in IVF and natural conception.
One in 200 newborns has multiple congenital abnormalities because of a chromosomal abnormality. Trials of the new technique, held by fertility specialists at CARE Fertility in Manchester, include three women in their late 30s who having undergone the new procedure will give birth in late December.
Wednesday, November 10, 2010
Director of The Hastings Center Poses Ethical ? about Synthentic Biology
Serendipity: A prominent ethicist is also thinking about synthetic biology at this moment.
Thomas Murray: Dir., The Hastings Center
Risk, Reward, Regulation and Synthetic Biology: The Ethical Questions
Environmental clean-up, medications with fewer side effects, improved food supplies-do the theoretical benefits of synthetic biology suggest we forge ahead on the basis of promise?
Or, do we focus on risks, such as unintended contamination or intentional weaponization, and hold back in the face of uncertainty?
And how do we navigate regulation between these different perspectives and mind-sets?
Thomas Murray: Dir., The Hastings Center
Risk, Reward, Regulation and Synthetic Biology: The Ethical Questions
Environmental clean-up, medications with fewer side effects, improved food supplies-do the theoretical benefits of synthetic biology suggest we forge ahead on the basis of promise?
Or, do we focus on risks, such as unintended contamination or intentional weaponization, and hold back in the face of uncertainty?
And how do we navigate regulation between these different perspectives and mind-sets?
Tuesday, November 9, 2010
Is there a moral line to draw in the world of synthetic biology: ethically acceptable and unethical?
The Rea[ Promise of Synthetic Biotogy
Scientists are closing in on the abilityto make life from scratch, with potential consequences both good and bad
BY LAWRENCE M. KRAUSS
I have seen the future, and it is now.
Those words came to mind again as I recently
listened to Craig Venter, one of those leading
the new areas of synthetic genomics and synthetic
biology. Every time I hear a talk on this
subject, it seems a new rhreshold in the artificial
manipulation and, ultimately, creation of life l-ras been passed.
Consider just some of the progress associated rvith the J. Craig
Venter Institute. In 2003 its researchers cleated a synthetic version
of the bacteriophage phiX174. ln 2007 they successfully
transformed one species of bacteria to another by genome transplantation.
Most recently, they deveioped methods for the coinplete
synthetic assembly of tl.re genome of the bacterium
My c op I a s m a ge n it a Ii um.
The techniques now developed make the feat of
sequencing the human genome in 2001 seem
prehistoric. Not only have rhe cost and speed - of sequencing evolved faster than those of fcomputer
chips, but the ability to use both '' I -)
chemistry and biology to synthesize new
complex organisms has undergone a revolution
in the past five years. Instructions
embedded in synthetic gene sequences
can now be implanted in foreign cells
and thereby cause those cells to express
proteins; those proteins, in turn, build
nerv functioning copies of the life-forms
whose instruction manual is in the embedded
sequences. Venter calls this cycle "softrvare that creates its own
hardware." I expect to hear news soon of the successful creation
of the first completelv artificial life-form, built from scratch and
not alive until the scientists assembled it.
Semiconductor nanotechnologv has been heralded for more
than a decade, but I believe it ri'iil pale beside the ability of biotechnology
to transform life and society. Imagine the impact of
piggybacking on nature's majesty and designing living systems
that can perform tasks not found in nature, from microbes that
make gasoline or eat carbon dioxide to create nonbiodegradable
plastic building materials to organisms designed to surgically and
strategically operate on cancer cells. I expect that within 50 vears
the world's economy will be driven not by computer-generated information
but by biologically generated softrvare.
Of course, as Spiderman would sa,v, rvith great power comes
great responsibility. Hackers now create software viruses that periodically
disable huge computer networks. \7ith the ability to
make DNA sequences to order has risen the specter of garagebased
DNA hackers who might terrorize the world-intentionally
or accidentally-by re-creating the Ebola virus or the 1918 fl:.
Each of those disease organisms has a genetic code far smaller
than that of the recently s.'nthesized M. genitaliunu. One could
also imagine producing, again perhaps r"rnwittingly, viruses that
are immune to existing vaccines.
Some may fear the existence of new life-forms that might attack
a11 life on earth or at least human life. This fear is probably
misplaced. Life has sr-rrvived for more than three billion years because
it is robust, and almost no mutations can easill'outrvit the
defense mechanisms built up through eons of exposure to
potential pathogens. Venter's argument that new naturally
emerging diseases are a far greater threat than new artifi
cial diseases seems relatively compelling.
Nevertheless, there have been, until fairly recently,
few checks on the unfettered reproduction
of generic information. As the abilitl'to
' synthesize more complex biological systems
has increased, however, the research
community has put in place a voluntary system
of restrictions, for example, on the fulfillment
of commercial orders for genetic sequences
that correspond to portions of potentially
lethal organisms. At present, the
technological know-how associated with developing
synthetic biolcQy laboratories with
malice aforetl.rought is probably beyond the means of even sophisticated
terrorist networks. Moreover, it is important not to let misplaced
t-ears of Armageddon unduly restrict scientific work with
great potential to benefit humankind.
I have alrvays felt that, aside from research that violates universal
human mores, when it comes to technological applications,
that which can be done will be done. What we need to do is rigorouslv
attempt to anticipate what may be possible so that rve can
minimize the risks and maximize rhe benefits. 'We need to walk
into the future, no matter how unnerving, with open eyes if society
is to keep pace with technology. r
Lawrence M. Krauss; a theoretical physicist, commentLttor
and book awtbor, is Foundation Professor and director
of the Origins Initiatiue at Arizon;t State Uniuersity
( h ttp : // kraLt s s.faculty. a su. e du).
-
I
=
Ii
32 scteHrtnc AMERTcAN February 2010
Scientists are closing in on the abilityto make life from scratch, with potential consequences both good and bad
BY LAWRENCE M. KRAUSS
I have seen the future, and it is now.
Those words came to mind again as I recently
listened to Craig Venter, one of those leading
the new areas of synthetic genomics and synthetic
biology. Every time I hear a talk on this
subject, it seems a new rhreshold in the artificial
manipulation and, ultimately, creation of life l-ras been passed.
Consider just some of the progress associated rvith the J. Craig
Venter Institute. In 2003 its researchers cleated a synthetic version
of the bacteriophage phiX174. ln 2007 they successfully
transformed one species of bacteria to another by genome transplantation.
Most recently, they deveioped methods for the coinplete
synthetic assembly of tl.re genome of the bacterium
My c op I a s m a ge n it a Ii um.
The techniques now developed make the feat of
sequencing the human genome in 2001 seem
prehistoric. Not only have rhe cost and speed - of sequencing evolved faster than those of fcomputer
chips, but the ability to use both '' I -)
chemistry and biology to synthesize new
complex organisms has undergone a revolution
in the past five years. Instructions
embedded in synthetic gene sequences
can now be implanted in foreign cells
and thereby cause those cells to express
proteins; those proteins, in turn, build
nerv functioning copies of the life-forms
whose instruction manual is in the embedded
sequences. Venter calls this cycle "softrvare that creates its own
hardware." I expect to hear news soon of the successful creation
of the first completelv artificial life-form, built from scratch and
not alive until the scientists assembled it.
Semiconductor nanotechnologv has been heralded for more
than a decade, but I believe it ri'iil pale beside the ability of biotechnology
to transform life and society. Imagine the impact of
piggybacking on nature's majesty and designing living systems
that can perform tasks not found in nature, from microbes that
make gasoline or eat carbon dioxide to create nonbiodegradable
plastic building materials to organisms designed to surgically and
strategically operate on cancer cells. I expect that within 50 vears
the world's economy will be driven not by computer-generated information
but by biologically generated softrvare.
Of course, as Spiderman would sa,v, rvith great power comes
great responsibility. Hackers now create software viruses that periodically
disable huge computer networks. \7ith the ability to
make DNA sequences to order has risen the specter of garagebased
DNA hackers who might terrorize the world-intentionally
or accidentally-by re-creating the Ebola virus or the 1918 fl:.
Each of those disease organisms has a genetic code far smaller
than that of the recently s.'nthesized M. genitaliunu. One could
also imagine producing, again perhaps r"rnwittingly, viruses that
are immune to existing vaccines.
Some may fear the existence of new life-forms that might attack
a11 life on earth or at least human life. This fear is probably
misplaced. Life has sr-rrvived for more than three billion years because
it is robust, and almost no mutations can easill'outrvit the
defense mechanisms built up through eons of exposure to
potential pathogens. Venter's argument that new naturally
emerging diseases are a far greater threat than new artifi
cial diseases seems relatively compelling.
Nevertheless, there have been, until fairly recently,
few checks on the unfettered reproduction
of generic information. As the abilitl'to
' synthesize more complex biological systems
has increased, however, the research
community has put in place a voluntary system
of restrictions, for example, on the fulfillment
of commercial orders for genetic sequences
that correspond to portions of potentially
lethal organisms. At present, the
technological know-how associated with developing
synthetic biolcQy laboratories with
malice aforetl.rought is probably beyond the means of even sophisticated
terrorist networks. Moreover, it is important not to let misplaced
t-ears of Armageddon unduly restrict scientific work with
great potential to benefit humankind.
I have alrvays felt that, aside from research that violates universal
human mores, when it comes to technological applications,
that which can be done will be done. What we need to do is rigorouslv
attempt to anticipate what may be possible so that rve can
minimize the risks and maximize rhe benefits. 'We need to walk
into the future, no matter how unnerving, with open eyes if society
is to keep pace with technology. r
Lawrence M. Krauss; a theoretical physicist, commentLttor
and book awtbor, is Foundation Professor and director
of the Origins Initiatiue at Arizon;t State Uniuersity
( h ttp : // kraLt s s.faculty. a su. e du).
-
I
=
Ii
32 scteHrtnc AMERTcAN February 2010
Thursday, November 4, 2010
2nd of 2 articles on doctors and drug company payments
Drug firms' payments to doctors raise ethical concerns for many
By Colleen O'Connor
The Denver Post
Posted: 10/31/2010 01:00:00 AM
Following the money from seven pharmaceutical companies to Colorado's medical experts — payments for things such as lectures, consulting, travel, meals and patient-education programs — shows that over the past two years, nearly $4.9 million has been disbursed around the state.
It's gone to doctors at National Jewish Health, the Rocky Mountain Cancer Center and the Heart Center of the Rockies; to a family dermatology practice in Westminster, a nurse practitioner in Fruita; and a bone-research center in Lakewood.
A database compiled by the national investigative news service ProPublica analyzed the financial ties between doctors and the seven drug companies in the U.S. that currently disclose the figures. The seven make up 36 percent of the sales market.
These payments are legal, but controversial, and there is a national effort by state lawmakers, Congress and academic medical institutions to shine light on the financial relationships between doctors and the pharmaceutical industry.
Proponents say that these paid speeches fill an educational gap, especially in rural places where primary-care doctors have a hard time keeping up with the latest treatments.
But critics say that travel, meals and other expenses paid by drug companies add to the cost of medications for everyone. They also say paid lectures amount to bribery by the drug companies, because the doctors talking about how to better recognize a condition may also recommend medications to treat it.
Patients uneasy about pay
Patients also are critical, according to the second annual prescription drug survey released this summer by Consumer Reports.
Fifty-eight percent said they were concerned by drug companies' buying meals for doctors and their staffs, while 72 percent were not happy with payments made by pharmaceutical companies to doctors for testimonials or for serving as a company spokesperson for a given drug.
"These financial relationships present a conflict of interest in which the physicians might be tempted to put their own interests ahead of their patients," said Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, in an e-mail interview with The Denver Post.
In Colorado, two of the top earners of payments from the seven drug firms work for National Jewish Health.
Ronald Balkissoon, a pulmonologist, received more than $220,000 for speaking and consulting, while Joseph Spahn, a pediatric allergist, received more than $155,000.
Education vs. appearances
National Jewish Health has a conflict-of-interest policy that requires doctors each year to report if they received more than $10,000 from any private company in the past year. The department chair and chief compliance officer then decide whether there is a potential conflict of interest, said spokesman William Alstetter.
None was found in either case, he said.
Most of these doctors' talks were given to other doctors, especially in rural outposts, educating them about diseases and the companies' drug treatments, he said.
Alstetter declined to make either Balkissoon or Spahn available for interview.
Although both doctors commonly prescribe medications by GlaxoSmithKline and AstraZeneca, which paid their speaking fees, "we like to believe that education is the dominant part of the talks, understanding better how to manage and diagnose the disease," Alstetter said. "There are diseases that are poorly managed, or not even diagnosed, and this can do a lot in getting doctors to understand and recognize them."
John Tucker Hardy, a child and adolescent psychiatrist based in Pueblo, is another top earner in Colorado, receiving more than $167,000 from the seven companies.
He declined requests to speak about his fees.
The national movement for increased transparency also affected the health care reform bill, which requires that by 2013, all pharmaceutical companies must disclose payments to physicians to the federal government, which will post the information on a website. More than 70 drug companies operate in the U.S.
On the state level, Gov. Bill Ritter this summer signed legislation that will require the Colorado Department of Regulatory Agencies to post this information on its website.
"Right now, this is an area of intense discussion across the board, at institutions and at the government level," said Heather Pierce , senior director of science policy and regulatory counsel at the Association for American Medical Colleges. "There have been a lot of specific incidents that brought this to the forefront."
A central incident was the 2008 congressional investigation into how a renowned child psychiatrist at Harvard failed to disclose to the school that he received $1.6 million in consulting fees over a two-year period from a drug company that made the anti-psychotic that he'd been prescribing.
"The interest is exponentially more now than it was five years ago, which was exponentially more than it was five years before that," said Richard Krugman, who has served as dean of the University of Colorado School of Medicine for 20 years.
"Overall, there's a lot more public scrutiny of physicians and public employees in a world where money is now tight, and people want to know what their money is being spent on," he said, especially in "the health care industry, which is 16 percent of the gross domestic product — trillions of dollars."
It's a delicate balance, especially for medical schools.
Walking a fine line of trust
Pharmaceutical companies frequently collaborate with physician investigators and scientists at these institutions to create medical breakthroughs and perform clinical trials to determine the safety of promising new therapies.
"To maintain the public trust, it is imperative that these relationships not be or appear to be influenced by factors other than the pursuit of knowledge or the best interests of the patient," according to the disclosure policy of the Feinberg School of Medicine at Northwestern University, which requires its faculty to report all externally compensated professional activities, no matter how small the amount. The disclosures are then posted on the school's public website.
Institutions such as the Stanford University School of Medicine and Harvard Medical School have banned their doctors from participating as paid consultants and lecturers in the drug companies' speakers' bureau.
CU med school guidelines
In Colorado, physicians at the CU School of Medicine are allowed to participate in speakers' bureaus, but industry representatives are not allowed to select speakers or topics and cannot preapprove the content of educational programs.
Physicians are not allowed to accept meals or other hospitality from drug companies.
"We have a lot of national and international experts in their fields, and pharmaceutical companies are one of many different groups that may be interested in their opinion," Krugman said. "There's nothing inherently wrong with having a contract with a company. It depends on what the work is for and whether it fits into place with our policies."
As with most medical schools in the country, the main watchdog of enforcement is a physician's integrity.
"The guidelines and professional behavior assumes that you will act professionally, and it's on the honor system," Krugman said. "Generally speaking, that works. There are times when information comes to us that suggests there may be a problem, and then we look into it."
Colleen O'Connor: 303-954-1083 or coconnor@denverpost.com
Read more: Drug firms' payments to doctors raise ethical concerns for many - The Denver Post http://www.denverpost.com/news/ci_16480972#ixzz14KHw0ik6
By Colleen O'Connor
The Denver Post
Posted: 10/31/2010 01:00:00 AM
Following the money from seven pharmaceutical companies to Colorado's medical experts — payments for things such as lectures, consulting, travel, meals and patient-education programs — shows that over the past two years, nearly $4.9 million has been disbursed around the state.
It's gone to doctors at National Jewish Health, the Rocky Mountain Cancer Center and the Heart Center of the Rockies; to a family dermatology practice in Westminster, a nurse practitioner in Fruita; and a bone-research center in Lakewood.
A database compiled by the national investigative news service ProPublica analyzed the financial ties between doctors and the seven drug companies in the U.S. that currently disclose the figures. The seven make up 36 percent of the sales market.
These payments are legal, but controversial, and there is a national effort by state lawmakers, Congress and academic medical institutions to shine light on the financial relationships between doctors and the pharmaceutical industry.
Proponents say that these paid speeches fill an educational gap, especially in rural places where primary-care doctors have a hard time keeping up with the latest treatments.
But critics say that travel, meals and other expenses paid by drug companies add to the cost of medications for everyone. They also say paid lectures amount to bribery by the drug companies, because the doctors talking about how to better recognize a condition may also recommend medications to treat it.
Patients uneasy about pay
Patients also are critical, according to the second annual prescription drug survey released this summer by Consumer Reports.
Fifty-eight percent said they were concerned by drug companies' buying meals for doctors and their staffs, while 72 percent were not happy with payments made by pharmaceutical companies to doctors for testimonials or for serving as a company spokesperson for a given drug.
"These financial relationships present a conflict of interest in which the physicians might be tempted to put their own interests ahead of their patients," said Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, in an e-mail interview with The Denver Post.
In Colorado, two of the top earners of payments from the seven drug firms work for National Jewish Health.
Ronald Balkissoon, a pulmonologist, received more than $220,000 for speaking and consulting, while Joseph Spahn, a pediatric allergist, received more than $155,000.
Education vs. appearances
National Jewish Health has a conflict-of-interest policy that requires doctors each year to report if they received more than $10,000 from any private company in the past year. The department chair and chief compliance officer then decide whether there is a potential conflict of interest, said spokesman William Alstetter.
None was found in either case, he said.
Most of these doctors' talks were given to other doctors, especially in rural outposts, educating them about diseases and the companies' drug treatments, he said.
Alstetter declined to make either Balkissoon or Spahn available for interview.
Although both doctors commonly prescribe medications by GlaxoSmithKline and AstraZeneca, which paid their speaking fees, "we like to believe that education is the dominant part of the talks, understanding better how to manage and diagnose the disease," Alstetter said. "There are diseases that are poorly managed, or not even diagnosed, and this can do a lot in getting doctors to understand and recognize them."
John Tucker Hardy, a child and adolescent psychiatrist based in Pueblo, is another top earner in Colorado, receiving more than $167,000 from the seven companies.
He declined requests to speak about his fees.
The national movement for increased transparency also affected the health care reform bill, which requires that by 2013, all pharmaceutical companies must disclose payments to physicians to the federal government, which will post the information on a website. More than 70 drug companies operate in the U.S.
On the state level, Gov. Bill Ritter this summer signed legislation that will require the Colorado Department of Regulatory Agencies to post this information on its website.
"Right now, this is an area of intense discussion across the board, at institutions and at the government level," said Heather Pierce , senior director of science policy and regulatory counsel at the Association for American Medical Colleges. "There have been a lot of specific incidents that brought this to the forefront."
A central incident was the 2008 congressional investigation into how a renowned child psychiatrist at Harvard failed to disclose to the school that he received $1.6 million in consulting fees over a two-year period from a drug company that made the anti-psychotic that he'd been prescribing.
"The interest is exponentially more now than it was five years ago, which was exponentially more than it was five years before that," said Richard Krugman, who has served as dean of the University of Colorado School of Medicine for 20 years.
"Overall, there's a lot more public scrutiny of physicians and public employees in a world where money is now tight, and people want to know what their money is being spent on," he said, especially in "the health care industry, which is 16 percent of the gross domestic product — trillions of dollars."
It's a delicate balance, especially for medical schools.
Walking a fine line of trust
Pharmaceutical companies frequently collaborate with physician investigators and scientists at these institutions to create medical breakthroughs and perform clinical trials to determine the safety of promising new therapies.
"To maintain the public trust, it is imperative that these relationships not be or appear to be influenced by factors other than the pursuit of knowledge or the best interests of the patient," according to the disclosure policy of the Feinberg School of Medicine at Northwestern University, which requires its faculty to report all externally compensated professional activities, no matter how small the amount. The disclosures are then posted on the school's public website.
Institutions such as the Stanford University School of Medicine and Harvard Medical School have banned their doctors from participating as paid consultants and lecturers in the drug companies' speakers' bureau.
CU med school guidelines
In Colorado, physicians at the CU School of Medicine are allowed to participate in speakers' bureaus, but industry representatives are not allowed to select speakers or topics and cannot preapprove the content of educational programs.
Physicians are not allowed to accept meals or other hospitality from drug companies.
"We have a lot of national and international experts in their fields, and pharmaceutical companies are one of many different groups that may be interested in their opinion," Krugman said. "There's nothing inherently wrong with having a contract with a company. It depends on what the work is for and whether it fits into place with our policies."
As with most medical schools in the country, the main watchdog of enforcement is a physician's integrity.
"The guidelines and professional behavior assumes that you will act professionally, and it's on the honor system," Krugman said. "Generally speaking, that works. There are times when information comes to us that suggests there may be a problem, and then we look into it."
Colleen O'Connor: 303-954-1083 or coconnor@denverpost.com
Read more: Drug firms' payments to doctors raise ethical concerns for many - The Denver Post http://www.denverpost.com/news/ci_16480972#ixzz14KHw0ik6
Is there an ethical problem with doctors receiving $ from drug companies? first of two articles
Genentech Offers Secret Rebates for Eye Drug
Genentech has begun offering secret rebates to eye doctors as an apparent inducement to get them to use more of the company’s expensive drug Lucentis rather than a less costly alternative.
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Madalyn Ruggiero for The New York Times
Dr. Greg Rosenthal, a retina specialist, said the rebates on Lucentis amounted to bribery.
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Madalyn Ruggiero for The New York Times
Barbara Glassner gets an injection of Avastin, another drug made by Genentech.
Under the program, which started on Oct. 1, medical practices can earn up to tens of thousands of dollars in rebates each quarter if they use a lot of Lucentis and if their usage increases from the previous quarter, according to a confidential document outlining the program that was obtained by The New York Times.
Lucentis, approved in 2006, is mainly used to treat age-related macular degeneration, the leading cause of blindness in the elderly. It costs about $2,000 for each injection, with an injection into the eye needed as often as once a month.
The competition comes from Avastin, another Genentech drug that has the same mode of action. While Avastin is approved only to treat cancer, many retina specialists say it works just as well in the eye as Lucentis. So they are using it off-label because each injection costs only $20 to $50.
Using Avastin instead of Lucentis saves Medicare — and costs Genentech — hundreds of millions of dollars a year.
The rebates are considered a form of volume discount, and have been offered for some other drugs. They are legal if they adhere to certain guidelines.
Still, some doctors said they had ethical concerns about the arrangement.
“There’s no way to look at that without calling it bribery,” said Dr. Greg Rosenthal, a retina specialist in Toledo, Ohio, who has been critical of attempts by Genentech to get doctors to use Lucentis. He is not a participant in the rebate program.
Genentech, which is owned by the Swiss company Roche, said in a statement, “Rebate and discount programs are a common business practice across the industry, including in the field of ophthalmology.” The company said it had such programs for other drugs and that they “help reduce the cost of our medicines for hospitals, pharmacies and doctors.”
Senator Herb Kohl, chairman of the Special Committee on Aging, who has investigated efforts to curtail the use of Avastin in the past, criticized the Lucentis incentives.
“This rebate program appears to be an attempt to reverse the trend of significantly reduced reimbursements that Genentech has been receiving from Medicare for Lucentis,” Mr. Kohl, a Democrat from Wisconsin, said in a statement. “I am highly doubtful that Medicare will benefit in any way from the rebates being offered to doctors.”
Since both Lucentis and Avastin are administered in the doctor’s office, doctors buy the drugs and are then reimbursed by Medicare or private insurers.
Medicare reimburses at 6 percent above the average selling price of a drug, so that doctors can profit from use of a drug. For Lucentis, that 6 percent would translate to roughly $120 a dose. That potential profit increases if the doctors get a bigger discount when they purchase the drug, or a rebate later. Rebates are counted by Medicare in calculating the average selling price of a drug, so the new Lucentis rebates might help slightly lower the amount Medicare pays per injection in future quarters.
The issue of doctors profiting from drugs is fairly new to ophthalmology. Cancer doctors, however, have long made money on the chemotherapy drugs they administer in their offices, though such profits have been sharply reduced in recent years because they were perceived to be giving doctors an incentive to overtreat.
In 2008, Amgen stopped offering rebates to oncologists using its anemia drug Aranesp. Critics, including Senator Charles E. Grassley, Republican of Iowa, said the rebates might have been increasing usage even as studies were showing that high doses of the drug might be harmful.
Genentech suggested that it started the Lucentis rebate program now to spur doctors to try the drug to treat retinal vein occlusion. Lucentis was recently approved to treat that condition.
Some doctors said they thought the company might be worried about the results, expected next spring, of a clinical trial comparing Avastin and Lucentis in treating macular degeneration. If the drugs are proven equivalent, the rebates might help slow the defection to the cheaper alternative.
The rebates might also encourage doctors to give Lucentis off-label for other eye diseases or give more frequent injections.
Many doctors inject the drug less frequently than once every four weeks, the interval specified in the drug’s label.
Several retina specialists who were contacted did not know about the rebate program because it is being offered only to practices that use a certain amount of Lucentis. And doctors who have signed up for the rebates are not allowed to acknowledge even the existence of the program, let alone to talk about the specific terms.
“The existence of this agreement is confidential,” says the contract that medical practices are asked to sign.
(Page 2 of 2)
One retina specialist who is not in the program but heard about it from a colleague said that his Genentech sales representative declined to talk about it, instead handing him a slip of paper containing a number to call at Genentech.
This doctor, who spoke on condition of anonymity because he did not want to offend the company, said he was told when he called the number that the rebates were being offered only to the top 300 Lucentis-using practices. But he said that might still represent most use of Lucentis.
The program offers rebates based both on volume and on increases in use. For the volume part, the rebates range from 0.25 percent to 1.5 percent of the wholesale cost. One example provided in the document was that a practice using 600 vials a quarter would get a rebate of $8,775.
The rebate based on increased usage ranges from 1 percent to 1.5 percent. Growth in usage of only 0.01 percent qualifies for the 1 percent rebate, while growth of 10 percent or more qualifies for the top rebate. The example provided in the document was of a rebate of $9,652.50.
A practice meeting the minimum requirements for the largest rebates in both categories would receive more than $58,000 in the quarter, according to a calculation done by The New York Times.
Dr. David W. Parke II, chief executive of the American Academy of Ophthalmology, said the society was looking into the new program. “The issue is really does this constitute a financial inducement that in some way alters delivery of care in a way that is not in the patient’s best interest?” he said.
Dr. Parke said that Genentech obviously believed the rebates would sway physician practice. But he said he doubted a rebate of $20 or $30 an injection would be that influential.
“The dollars involved for the average practice are not likely to massively change a physician’s prescribing practices,” he said. Dr. Susan Malinowksi, a retina specialist in Southfield, Mich., disagreed, saying that with doctors’ income already facing cuts because of health care reform, the rebates would be welcome. Just on Wednesday, Medicare proposed cutting the separate fee, apart from the drug cost, that it pays doctors for giving injections into the eye. “$18,000 a quarter, $19,000, why would that not incentivize you?” said Dr. Malinowski, who was not offered the rebates.
The clinical trial that will directly compare Avastin and Lucentis is being sponsored by the National Eye Institute and will be closely watched.
“If Avastin is as good as or better than Lucentis, it’s obviously going to win,” said Dr. Lawrence J. Singerman, a retina specialist in Cleveland. He said the trial results would have more influence on doctors than the rebate.
Practices seem split now, with some using mostly Lucentis and others mostly Avastin, and some using Lucentis for well-insured patients and Avastin for others.
In 2008, Medicare paid for about 480,000 injections of Avastin to treat macular degeneration, compared with only 337,000 injections of Lucentis, according to Dr. Philip J. Rosenfeld of the University of Miami, who studied the records with Medicare officials. Yet the fewer Lucentis injections cost Medicare $537 million while the Avastin injections cost only $20 million.
Sales of Lucentis in the United States rose 29 percent in the first nine months of this year, to 1.08 billion Swiss francs, or about $1.1 billion, according to Roche’s financial report.
http://www.nytimes.com/2010/11/04/business/04eye.html?pagewanted=1&_r=3&hp
Genentech has begun offering secret rebates to eye doctors as an apparent inducement to get them to use more of the company’s expensive drug Lucentis rather than a less costly alternative.
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Madalyn Ruggiero for The New York Times
Dr. Greg Rosenthal, a retina specialist, said the rebates on Lucentis amounted to bribery.
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Barbara Glassner gets an injection of Avastin, another drug made by Genentech.
Under the program, which started on Oct. 1, medical practices can earn up to tens of thousands of dollars in rebates each quarter if they use a lot of Lucentis and if their usage increases from the previous quarter, according to a confidential document outlining the program that was obtained by The New York Times.
Lucentis, approved in 2006, is mainly used to treat age-related macular degeneration, the leading cause of blindness in the elderly. It costs about $2,000 for each injection, with an injection into the eye needed as often as once a month.
The competition comes from Avastin, another Genentech drug that has the same mode of action. While Avastin is approved only to treat cancer, many retina specialists say it works just as well in the eye as Lucentis. So they are using it off-label because each injection costs only $20 to $50.
Using Avastin instead of Lucentis saves Medicare — and costs Genentech — hundreds of millions of dollars a year.
The rebates are considered a form of volume discount, and have been offered for some other drugs. They are legal if they adhere to certain guidelines.
Still, some doctors said they had ethical concerns about the arrangement.
“There’s no way to look at that without calling it bribery,” said Dr. Greg Rosenthal, a retina specialist in Toledo, Ohio, who has been critical of attempts by Genentech to get doctors to use Lucentis. He is not a participant in the rebate program.
Genentech, which is owned by the Swiss company Roche, said in a statement, “Rebate and discount programs are a common business practice across the industry, including in the field of ophthalmology.” The company said it had such programs for other drugs and that they “help reduce the cost of our medicines for hospitals, pharmacies and doctors.”
Senator Herb Kohl, chairman of the Special Committee on Aging, who has investigated efforts to curtail the use of Avastin in the past, criticized the Lucentis incentives.
“This rebate program appears to be an attempt to reverse the trend of significantly reduced reimbursements that Genentech has been receiving from Medicare for Lucentis,” Mr. Kohl, a Democrat from Wisconsin, said in a statement. “I am highly doubtful that Medicare will benefit in any way from the rebates being offered to doctors.”
Since both Lucentis and Avastin are administered in the doctor’s office, doctors buy the drugs and are then reimbursed by Medicare or private insurers.
Medicare reimburses at 6 percent above the average selling price of a drug, so that doctors can profit from use of a drug. For Lucentis, that 6 percent would translate to roughly $120 a dose. That potential profit increases if the doctors get a bigger discount when they purchase the drug, or a rebate later. Rebates are counted by Medicare in calculating the average selling price of a drug, so the new Lucentis rebates might help slightly lower the amount Medicare pays per injection in future quarters.
The issue of doctors profiting from drugs is fairly new to ophthalmology. Cancer doctors, however, have long made money on the chemotherapy drugs they administer in their offices, though such profits have been sharply reduced in recent years because they were perceived to be giving doctors an incentive to overtreat.
In 2008, Amgen stopped offering rebates to oncologists using its anemia drug Aranesp. Critics, including Senator Charles E. Grassley, Republican of Iowa, said the rebates might have been increasing usage even as studies were showing that high doses of the drug might be harmful.
Genentech suggested that it started the Lucentis rebate program now to spur doctors to try the drug to treat retinal vein occlusion. Lucentis was recently approved to treat that condition.
Some doctors said they thought the company might be worried about the results, expected next spring, of a clinical trial comparing Avastin and Lucentis in treating macular degeneration. If the drugs are proven equivalent, the rebates might help slow the defection to the cheaper alternative.
The rebates might also encourage doctors to give Lucentis off-label for other eye diseases or give more frequent injections.
Many doctors inject the drug less frequently than once every four weeks, the interval specified in the drug’s label.
Several retina specialists who were contacted did not know about the rebate program because it is being offered only to practices that use a certain amount of Lucentis. And doctors who have signed up for the rebates are not allowed to acknowledge even the existence of the program, let alone to talk about the specific terms.
“The existence of this agreement is confidential,” says the contract that medical practices are asked to sign.
(Page 2 of 2)
One retina specialist who is not in the program but heard about it from a colleague said that his Genentech sales representative declined to talk about it, instead handing him a slip of paper containing a number to call at Genentech.
This doctor, who spoke on condition of anonymity because he did not want to offend the company, said he was told when he called the number that the rebates were being offered only to the top 300 Lucentis-using practices. But he said that might still represent most use of Lucentis.
The program offers rebates based both on volume and on increases in use. For the volume part, the rebates range from 0.25 percent to 1.5 percent of the wholesale cost. One example provided in the document was that a practice using 600 vials a quarter would get a rebate of $8,775.
The rebate based on increased usage ranges from 1 percent to 1.5 percent. Growth in usage of only 0.01 percent qualifies for the 1 percent rebate, while growth of 10 percent or more qualifies for the top rebate. The example provided in the document was of a rebate of $9,652.50.
A practice meeting the minimum requirements for the largest rebates in both categories would receive more than $58,000 in the quarter, according to a calculation done by The New York Times.
Dr. David W. Parke II, chief executive of the American Academy of Ophthalmology, said the society was looking into the new program. “The issue is really does this constitute a financial inducement that in some way alters delivery of care in a way that is not in the patient’s best interest?” he said.
Dr. Parke said that Genentech obviously believed the rebates would sway physician practice. But he said he doubted a rebate of $20 or $30 an injection would be that influential.
“The dollars involved for the average practice are not likely to massively change a physician’s prescribing practices,” he said. Dr. Susan Malinowksi, a retina specialist in Southfield, Mich., disagreed, saying that with doctors’ income already facing cuts because of health care reform, the rebates would be welcome. Just on Wednesday, Medicare proposed cutting the separate fee, apart from the drug cost, that it pays doctors for giving injections into the eye. “$18,000 a quarter, $19,000, why would that not incentivize you?” said Dr. Malinowski, who was not offered the rebates.
The clinical trial that will directly compare Avastin and Lucentis is being sponsored by the National Eye Institute and will be closely watched.
“If Avastin is as good as or better than Lucentis, it’s obviously going to win,” said Dr. Lawrence J. Singerman, a retina specialist in Cleveland. He said the trial results would have more influence on doctors than the rebate.
Practices seem split now, with some using mostly Lucentis and others mostly Avastin, and some using Lucentis for well-insured patients and Avastin for others.
In 2008, Medicare paid for about 480,000 injections of Avastin to treat macular degeneration, compared with only 337,000 injections of Lucentis, according to Dr. Philip J. Rosenfeld of the University of Miami, who studied the records with Medicare officials. Yet the fewer Lucentis injections cost Medicare $537 million while the Avastin injections cost only $20 million.
Sales of Lucentis in the United States rose 29 percent in the first nine months of this year, to 1.08 billion Swiss francs, or about $1.1 billion, according to Roche’s financial report.
http://www.nytimes.com/2010/11/04/business/04eye.html?pagewanted=1&_r=3&hp
Monday, November 1, 2010
what is the ethical dilemma here? what principles are in conflict?
Losing Touch With the Patient
By PAULINE W. CHEN, M.D.
Published: October 21, 2010
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Several years ago I helped care for a man who had been hospitalized with a severe infection of the abdominal wall. When his primary doctors discovered that the bacteria responsible was resistant to most antibiotics, they quickly isolated him, moving him into a single room with a sign on the door proclaiming “Contact Precautions” and directing visitors to put on gloves, mask and gown before entering.
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But garbing up in all those items was not a straightforward exercise. The gowns, vast swaths of baby-yellow polyester, added an insulating and sweat-inducing layer. The masks were either so flimsy they fell off easily or so unyielding they muffled voices and steamed up eyeglasses. And the gloves had such generous finger pockets that the excess latex inevitably got tangled in the loops and ties of the gowns and masks or in the dressing materials and bedding of the patient.
None of these precautions made it easy to examine or even visit him. Most of us were loath to go through the process of gearing up more than we had to; and even his wife of more than 20 years occasionally groaned as she dutifully swathed herself in the protective coverings each day. As the weeks wore on, we clinicians found ourselves minimizing our interactions, designating one team member to suit up and complete the work needed or shouting out updates and questions to the patient from the sterile safety of the doorway.
Increasingly isolated in these ways, he began to withdraw from everyone except his wife. His once daily declarations that he was going to “beat this infection” became less vocal, dimming to whispers, then disappearing altogether. He stopped turning to face us when we called out to him, choosing instead to continue staring blankly at the ceiling.
As his lungs, heart and then kidneys began to fail, his room became crammed with life-support machines and metal poles and pumps metering out intravenous medications. The small space in which he was confined eventually became a space-age pastiche of beeping machines, plastic tubes and wires, and shrouded, faceless, hovering yellow figures.
When he finally died, from cardiac arrest, more than two months later, it was hard not to remember the weeks leading up to his death and to wonder about one thing. In trying so hard to contain the infection, had we lost sight of the person?
For nearly half a century, infectious disease experts and hospital epidemiologists have relied on various methods of contact precautions to contain increasingly widespread and often virulent multi-drug-resistant bacteria. These methods of infection control — hand washing, alcohol foams, physical isolation, gowns, gloves and sometimes masks and eye protection — are now a routine part of clinical life in hospitals across the country; up to a quarter of all hospitalized patients at any time are placed under such restrictions. But while contact precautions are generally not just accepted but expected by doctors and patients alike, what has not been acknowledged until more recently are the unintended consequences of such strict limitations.
In the current issue of The Annals of Family Medicine, Dr. Leif Hass, a family practice physician working as a hospitalist at the Alta Bates Summit Medical Center in Oakland, Calif., eloquently describes some of these repercussions. After he and his daughter recuperate from mysterious arm and leg infections caused by the drug-resistant MRSA bacteria, Dr. Hass suddenly finds himself reaching for gloves every time he sees a patient in the hospital. He is torn between his sense of duty to reach out, gloveless, to “the people most in need of touch” and a gripping and not entirely irrational fear that “hospital wards that had been so familiar now seemed like uncontrollable pools of pathogens.”
Such fear of contagion among physicians, studies have shown, can compromise the quality of care delivered. When compared with patients not in isolation, those individuals on contact precautions have fewer interactions with clinicians, more delays in care, decreased satisfaction and greater incidences of depression and anxiety. These differences translate into more noninfectious complications like falls and pressure ulcers and an increase of as much at 100 percent in the overall incidence of adverse events.
“There is a misperception that infections are the single worst adverse event that can happen in a hospital,” said Dr. Daniel J. Morgan, lead author of a recent review of these studies and an assistant professor of epidemiology and public health at the University of Maryland in Baltimore. “In getting overly focused on preventing one type of infection, we fail to see the overall picture for patients.”
What may help clinicians remain focused on the larger picture while still safeguarding patients and themselves from multi-drug-resistant bacteria are less restrictive but equally efficacious precautions. In two separate studies, researchers at the Medical College of Virginia in Richmond found that the rate of infection was identical whether health care workers wore gowns and gloves with only the patients in isolation or whether they wore only gloves with all patients.
“Wearing gloves when examining all patients may become the reality of clinical medicine,” said Dr. Gonzalo Bearman, lead author of both studies and the associate hospital epidemiologist at the Virginia Commonwealth University Medical Center in Richmond.
All of this research points to one eventuality: that some type of contact barrier is in our future as doctors and patients, even though, as Dr. Hass noted when I spoke to him this week, “there are times when an I.C.U. looks like an assembly plant in Silicon Valley.” And while physicians will be forced to rely less on touch and more on other communication skills like listening and acknowledging, the risk remains that the presence of these physical — and technological — barriers will further eclipse some of the most effective ways in which doctors can alleviate the suffering of their patients.
“We just have to make sure,” Dr. Hass said, “that in the age of technology and rapid reforms, some of our best tools for healing — simple things like touching people and telling them you care and making them feel you are there for them — don’t get lost.”
By PAULINE W. CHEN, M.D.
Published: October 21, 2010
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Several years ago I helped care for a man who had been hospitalized with a severe infection of the abdominal wall. When his primary doctors discovered that the bacteria responsible was resistant to most antibiotics, they quickly isolated him, moving him into a single room with a sign on the door proclaiming “Contact Precautions” and directing visitors to put on gloves, mask and gown before entering.
Enlarge This Image
Getty Images
Well
Share your thoughts on this column at the Well blog.
Go to Well »
Related
*
More Doctor and Patient Columns
But garbing up in all those items was not a straightforward exercise. The gowns, vast swaths of baby-yellow polyester, added an insulating and sweat-inducing layer. The masks were either so flimsy they fell off easily or so unyielding they muffled voices and steamed up eyeglasses. And the gloves had such generous finger pockets that the excess latex inevitably got tangled in the loops and ties of the gowns and masks or in the dressing materials and bedding of the patient.
None of these precautions made it easy to examine or even visit him. Most of us were loath to go through the process of gearing up more than we had to; and even his wife of more than 20 years occasionally groaned as she dutifully swathed herself in the protective coverings each day. As the weeks wore on, we clinicians found ourselves minimizing our interactions, designating one team member to suit up and complete the work needed or shouting out updates and questions to the patient from the sterile safety of the doorway.
Increasingly isolated in these ways, he began to withdraw from everyone except his wife. His once daily declarations that he was going to “beat this infection” became less vocal, dimming to whispers, then disappearing altogether. He stopped turning to face us when we called out to him, choosing instead to continue staring blankly at the ceiling.
As his lungs, heart and then kidneys began to fail, his room became crammed with life-support machines and metal poles and pumps metering out intravenous medications. The small space in which he was confined eventually became a space-age pastiche of beeping machines, plastic tubes and wires, and shrouded, faceless, hovering yellow figures.
When he finally died, from cardiac arrest, more than two months later, it was hard not to remember the weeks leading up to his death and to wonder about one thing. In trying so hard to contain the infection, had we lost sight of the person?
For nearly half a century, infectious disease experts and hospital epidemiologists have relied on various methods of contact precautions to contain increasingly widespread and often virulent multi-drug-resistant bacteria. These methods of infection control — hand washing, alcohol foams, physical isolation, gowns, gloves and sometimes masks and eye protection — are now a routine part of clinical life in hospitals across the country; up to a quarter of all hospitalized patients at any time are placed under such restrictions. But while contact precautions are generally not just accepted but expected by doctors and patients alike, what has not been acknowledged until more recently are the unintended consequences of such strict limitations.
In the current issue of The Annals of Family Medicine, Dr. Leif Hass, a family practice physician working as a hospitalist at the Alta Bates Summit Medical Center in Oakland, Calif., eloquently describes some of these repercussions. After he and his daughter recuperate from mysterious arm and leg infections caused by the drug-resistant MRSA bacteria, Dr. Hass suddenly finds himself reaching for gloves every time he sees a patient in the hospital. He is torn between his sense of duty to reach out, gloveless, to “the people most in need of touch” and a gripping and not entirely irrational fear that “hospital wards that had been so familiar now seemed like uncontrollable pools of pathogens.”
Such fear of contagion among physicians, studies have shown, can compromise the quality of care delivered. When compared with patients not in isolation, those individuals on contact precautions have fewer interactions with clinicians, more delays in care, decreased satisfaction and greater incidences of depression and anxiety. These differences translate into more noninfectious complications like falls and pressure ulcers and an increase of as much at 100 percent in the overall incidence of adverse events.
“There is a misperception that infections are the single worst adverse event that can happen in a hospital,” said Dr. Daniel J. Morgan, lead author of a recent review of these studies and an assistant professor of epidemiology and public health at the University of Maryland in Baltimore. “In getting overly focused on preventing one type of infection, we fail to see the overall picture for patients.”
What may help clinicians remain focused on the larger picture while still safeguarding patients and themselves from multi-drug-resistant bacteria are less restrictive but equally efficacious precautions. In two separate studies, researchers at the Medical College of Virginia in Richmond found that the rate of infection was identical whether health care workers wore gowns and gloves with only the patients in isolation or whether they wore only gloves with all patients.
“Wearing gloves when examining all patients may become the reality of clinical medicine,” said Dr. Gonzalo Bearman, lead author of both studies and the associate hospital epidemiologist at the Virginia Commonwealth University Medical Center in Richmond.
All of this research points to one eventuality: that some type of contact barrier is in our future as doctors and patients, even though, as Dr. Hass noted when I spoke to him this week, “there are times when an I.C.U. looks like an assembly plant in Silicon Valley.” And while physicians will be forced to rely less on touch and more on other communication skills like listening and acknowledging, the risk remains that the presence of these physical — and technological — barriers will further eclipse some of the most effective ways in which doctors can alleviate the suffering of their patients.
“We just have to make sure,” Dr. Hass said, “that in the age of technology and rapid reforms, some of our best tools for healing — simple things like touching people and telling them you care and making them feel you are there for them — don’t get lost.”
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