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NEW YORK – Conflicts of interest, whether reported or unreported, are just one component of a broken system that has misaligned incentives with meaningful advances in breast cancer research, agreed a panel of experts who participated in an evening program sponsored by SHARE, a breast cancer patient advocacy group.
“The issue of disclosures, while it is important, is not really the key issue. The key issue for me is about the amazing amount of money that is changing hands,” said Fran Visco, president of the National Breast Cancer Coalition, Washington. She contended not enough money in breast cancer research is being applied to save women’s lives rather than driving profits for institutions, physicians, and the pharmaceutical industry.
The other two participants in this panel, called Conflicts of Interest in Research and Treatment: What Breast Cancer Patients Should Know, largely agreed. In turn, they each explained that major sums of money in play for physicians and institutions collaborating with industry are earmarked for generating income much more than improving outcomes.
“Most of where this money is going is for these little tiny improvements and there is no association between the outcome increment that you get and what you pay for that outcome increment,” said Robert Cook-Deegan, MD, a bioethicist and a professor at the School for Innovation in Society, Arizona State University, Tempe.
Leaving aside whether physician-scientists working at nonprofit research institutions can avoid conflicts of interest when money is funneled to them from start-up investment opportunities, pharmaceutical board memberships, and direct compensation deals for consultancies and other services, Dr. Cook-Deegan was referring to the bigger problem of misaligned incentives. Large financial rewards are available for any drug with market potential instead of being limited to those that save lives, he said.
Tracing the current system to the Bayh-Dole Act in 1980, which permitted researchers to claim patents for intellectual property developed with federal funding, Dr. Cook-Deegan described a system of minnows, fish, and sharks. Researchers, who are the minnows, seek potential new therapeutics to be developed by for-profit startups or other commercial entities, which are the fish. If the drug continues to show promise, it brings investors, who are the sharks.
Once the new therapy reaches the sharks, the excitement about a new and more effective treatment has been overshadowed by the excitement about profits, which are essential to pay for the large investment required for the clinical development that brings new drugs to market. If the drug is marketable, it is considered a success even when the clinical benefits barely register.
“There have been about 20 new [cancer] drugs approved by the [Food and Drug Administration] in the last 2 years. The increased median disease-free survival is usually about 3 months,” said Otis W. Brawley, MD, who recently joined the Kimmel Cancer Center at Johns Hopkins University after resigning his position as chief medical officer at the American Cancer Society (ACS).
Dr. Brawley joined the others in declaring: “The system is broken.” The flow of money is not the only incentive for researchers to participate in clinical development programs focused on minor advances rather than blockbuster discoveries. Unrestricted research grants are now much harder to obtain, according to Dr. Brawley, making collaboration with industry essential not just for research funding but career advancement. Research at major cancer centers is still being conducted at the highest level, but there are unavoidable interdependent relationships for nonprofit institutions and for-profit enterprises.
“The doc who prescribes the drug to the average patient probably does not have this conflict of interest,” he said. “However, they are influenced by people who have these conflicts.”
The SHARE panel on conflicts of interest was convened after a series of articles co-reported by ProPublica and the New York Times described the failure of the chief medical officer at Memorial Sloan Kettering Cancer Center, José Baselga, MD, to disclose his financial conflicts of interest in publications, such as the New England Journal of Medicine, where they are required. Dr. Baselga resigned his position.
However, the failure to disclose financial relationships with industry was a minor topic during the SHARE panel. Robert Bazell, PhD, an adjunct professor in the division of molecular, cellular, and developmental biology at Yale University, New Haven, Conn., moderated the panel. He said in his opening remarks that the issues “go much deeper.”
While the articles did not reveal “anything illegal, it opened a lot of peoples’ eyes as to how much money there was in the system,” said Dr. Bazell, who was for many years the chief science and health correspondent for NBC News.
Specifically, it has heightened concern about whether profit motives are subverting the goals of science, according to Dr. Bazell. “This money bomb has fallen on a lot of science but it has particularly fallen on oncology,” he said.
Not everyone, including the bioethicist, agreed that profits by themselves are the problem. Big rewards may be a reasonable price for discoveries that save lives, but all agreed that the system does not necessarily reserve big rewards for life-saving advances.
“The focus isn’t really on drugs that will save lives, its just on more drugs,” said Ms. Visco, echoing the incentive system described by Dr. Cook-Deegan. She believes the current system handsomely rewards scientists and physicians for developing drugs with little or no significant clinical benefit. When a drug shows a progression-free survival benefit relative to a previous standard, even of modest statistical or clinical significance, it will be prescribed and profits will be generated.
Early in her tenure at the National Breast Cancer Coalition, Ms. Visco, who was a practicing lawyer prior to taking the helm of the coalition, considered fund raising for research the primary goal. She hoped that the coalition could help the breast cancer research community identify and fund priorities, but her perspective has changed.
“I used to think that we should be collaborators but now I am coming to the conclusion that we should be in charge. Educated, trained patient advocates with a constituency should be in charge, because our only agenda is to save lives and end breast cancer,” Ms. Visco said. She no longer believes in simply increasing funding even at research centers such as the National Cancer Institute without a fundamental reorganization of priorities.
Many leaders in medicine are aware of the problem, according to Dr. Brawley, who cited a recent statement by the American Society of Clinical Oncology that expressed concern about the plethora of cancer trials showing very small gains. He did agree with the others, however, that incentives are now misaligned.
“We are designing clinical trials not to look for big gains,” Dr. Brawley agreed. But he also cautioned that the system is complex. One reason that drugs offering modest or little gain over a previous standard are highly marketable is that patients themselves demand them. Direct-to-consumer marketing supports drugs with little or even nothing to offer.
“I see patients who want drugs that they should not get,” said Dr. Brawley, who indicated that clinicians are under pressure to offer something to desperate patients even when options are expensive and not shown to provide any change in outcome.
Overall, in the shake-up at Memorial Sloan Kettering, it was the failure to disclose significant financial relationships rather than the financial relationships themselves that represented an important breach in ethics, according to Dr. Brawley, who indicated that researcher relationships with industry are not inherently wrong. In an article published in November 2018, the New York Times reported that Dr. Brawley left his post at the ACS because of “his dismay” over some partnerships the ACS had formed with industry, but Dr. Brawley would not confirm or deny this report.
Relative to conflicts of interest at major research institutions, Dr. Cook-Deegan was more circumspect about whether disclosure is enough. Although he agreed with the premise that close collaboration with industry might be clinically valuable, which one investigator at Memorial Sloan Kettering claimed when speaking with the New York Times, he questioned whether there is a line over which the relationship is too intertwined.
“Do you really need to serve on the board? Do you really need the types of financial ties that have the potential to influence clinical decisions?” he asked.
Although Dr. Cook-Deegan agreed with the others that he does not know exactly how best to fix the system, he believes a fix may be coming.
“I think we are at an inflection point,” he said. “The symptoms of a system that has been running off the rails for a while are getting severe enough that we are starting to pay attention,” he said. One sign of movement is that both political parties have “introduced bills to address pricing, which is directly related to the problems we are talking about.”
NEW YORK – Conflicts of interest, whether reported or unreported, are just one component of a broken system that has misaligned incentives with meaningful advances in breast cancer research, agreed a panel of experts who participated in an evening program sponsored by SHARE, a breast cancer patient advocacy group.
“The issue of disclosures, while it is important, is not really the key issue. The key issue for me is about the amazing amount of money that is changing hands,” said Fran Visco, president of the National Breast Cancer Coalition, Washington. She contended not enough money in breast cancer research is being applied to save women’s lives rather than driving profits for institutions, physicians, and the pharmaceutical industry.
The other two participants in this panel, called Conflicts of Interest in Research and Treatment: What Breast Cancer Patients Should Know, largely agreed. In turn, they each explained that major sums of money in play for physicians and institutions collaborating with industry are earmarked for generating income much more than improving outcomes.
“Most of where this money is going is for these little tiny improvements and there is no association between the outcome increment that you get and what you pay for that outcome increment,” said Robert Cook-Deegan, MD, a bioethicist and a professor at the School for Innovation in Society, Arizona State University, Tempe.
Leaving aside whether physician-scientists working at nonprofit research institutions can avoid conflicts of interest when money is funneled to them from start-up investment opportunities, pharmaceutical board memberships, and direct compensation deals for consultancies and other services, Dr. Cook-Deegan was referring to the bigger problem of misaligned incentives. Large financial rewards are available for any drug with market potential instead of being limited to those that save lives, he said.
Tracing the current system to the Bayh-Dole Act in 1980, which permitted researchers to claim patents for intellectual property developed with federal funding, Dr. Cook-Deegan described a system of minnows, fish, and sharks. Researchers, who are the minnows, seek potential new therapeutics to be developed by for-profit startups or other commercial entities, which are the fish. If the drug continues to show promise, it brings investors, who are the sharks.
Once the new therapy reaches the sharks, the excitement about a new and more effective treatment has been overshadowed by the excitement about profits, which are essential to pay for the large investment required for the clinical development that brings new drugs to market. If the drug is marketable, it is considered a success even when the clinical benefits barely register.
“There have been about 20 new [cancer] drugs approved by the [Food and Drug Administration] in the last 2 years. The increased median disease-free survival is usually about 3 months,” said Otis W. Brawley, MD, who recently joined the Kimmel Cancer Center at Johns Hopkins University after resigning his position as chief medical officer at the American Cancer Society (ACS).
Dr. Brawley joined the others in declaring: “The system is broken.” The flow of money is not the only incentive for researchers to participate in clinical development programs focused on minor advances rather than blockbuster discoveries. Unrestricted research grants are now much harder to obtain, according to Dr. Brawley, making collaboration with industry essential not just for research funding but career advancement. Research at major cancer centers is still being conducted at the highest level, but there are unavoidable interdependent relationships for nonprofit institutions and for-profit enterprises.
“The doc who prescribes the drug to the average patient probably does not have this conflict of interest,” he said. “However, they are influenced by people who have these conflicts.”
The SHARE panel on conflicts of interest was convened after a series of articles co-reported by ProPublica and the New York Times described the failure of the chief medical officer at Memorial Sloan Kettering Cancer Center, José Baselga, MD, to disclose his financial conflicts of interest in publications, such as the New England Journal of Medicine, where they are required. Dr. Baselga resigned his position.
However, the failure to disclose financial relationships with industry was a minor topic during the SHARE panel. Robert Bazell, PhD, an adjunct professor in the division of molecular, cellular, and developmental biology at Yale University, New Haven, Conn., moderated the panel. He said in his opening remarks that the issues “go much deeper.”
While the articles did not reveal “anything illegal, it opened a lot of peoples’ eyes as to how much money there was in the system,” said Dr. Bazell, who was for many years the chief science and health correspondent for NBC News.
Specifically, it has heightened concern about whether profit motives are subverting the goals of science, according to Dr. Bazell. “This money bomb has fallen on a lot of science but it has particularly fallen on oncology,” he said.
Not everyone, including the bioethicist, agreed that profits by themselves are the problem. Big rewards may be a reasonable price for discoveries that save lives, but all agreed that the system does not necessarily reserve big rewards for life-saving advances.
“The focus isn’t really on drugs that will save lives, its just on more drugs,” said Ms. Visco, echoing the incentive system described by Dr. Cook-Deegan. She believes the current system handsomely rewards scientists and physicians for developing drugs with little or no significant clinical benefit. When a drug shows a progression-free survival benefit relative to a previous standard, even of modest statistical or clinical significance, it will be prescribed and profits will be generated.
Early in her tenure at the National Breast Cancer Coalition, Ms. Visco, who was a practicing lawyer prior to taking the helm of the coalition, considered fund raising for research the primary goal. She hoped that the coalition could help the breast cancer research community identify and fund priorities, but her perspective has changed.
“I used to think that we should be collaborators but now I am coming to the conclusion that we should be in charge. Educated, trained patient advocates with a constituency should be in charge, because our only agenda is to save lives and end breast cancer,” Ms. Visco said. She no longer believes in simply increasing funding even at research centers such as the National Cancer Institute without a fundamental reorganization of priorities.
Many leaders in medicine are aware of the problem, according to Dr. Brawley, who cited a recent statement by the American Society of Clinical Oncology that expressed concern about the plethora of cancer trials showing very small gains. He did agree with the others, however, that incentives are now misaligned.
“We are designing clinical trials not to look for big gains,” Dr. Brawley agreed. But he also cautioned that the system is complex. One reason that drugs offering modest or little gain over a previous standard are highly marketable is that patients themselves demand them. Direct-to-consumer marketing supports drugs with little or even nothing to offer.
“I see patients who want drugs that they should not get,” said Dr. Brawley, who indicated that clinicians are under pressure to offer something to desperate patients even when options are expensive and not shown to provide any change in outcome.
Overall, in the shake-up at Memorial Sloan Kettering, it was the failure to disclose significant financial relationships rather than the financial relationships themselves that represented an important breach in ethics, according to Dr. Brawley, who indicated that researcher relationships with industry are not inherently wrong. In an article published in November 2018, the New York Times reported that Dr. Brawley left his post at the ACS because of “his dismay” over some partnerships the ACS had formed with industry, but Dr. Brawley would not confirm or deny this report.
Relative to conflicts of interest at major research institutions, Dr. Cook-Deegan was more circumspect about whether disclosure is enough. Although he agreed with the premise that close collaboration with industry might be clinically valuable, which one investigator at Memorial Sloan Kettering claimed when speaking with the New York Times, he questioned whether there is a line over which the relationship is too intertwined.
“Do you really need to serve on the board? Do you really need the types of financial ties that have the potential to influence clinical decisions?” he asked.
Although Dr. Cook-Deegan agreed with the others that he does not know exactly how best to fix the system, he believes a fix may be coming.
“I think we are at an inflection point,” he said. “The symptoms of a system that has been running off the rails for a while are getting severe enough that we are starting to pay attention,” he said. One sign of movement is that both political parties have “introduced bills to address pricing, which is directly related to the problems we are talking about.”
NEW YORK – Conflicts of interest, whether reported or unreported, are just one component of a broken system that has misaligned incentives with meaningful advances in breast cancer research, agreed a panel of experts who participated in an evening program sponsored by SHARE, a breast cancer patient advocacy group.
“The issue of disclosures, while it is important, is not really the key issue. The key issue for me is about the amazing amount of money that is changing hands,” said Fran Visco, president of the National Breast Cancer Coalition, Washington. She contended not enough money in breast cancer research is being applied to save women’s lives rather than driving profits for institutions, physicians, and the pharmaceutical industry.
The other two participants in this panel, called Conflicts of Interest in Research and Treatment: What Breast Cancer Patients Should Know, largely agreed. In turn, they each explained that major sums of money in play for physicians and institutions collaborating with industry are earmarked for generating income much more than improving outcomes.
“Most of where this money is going is for these little tiny improvements and there is no association between the outcome increment that you get and what you pay for that outcome increment,” said Robert Cook-Deegan, MD, a bioethicist and a professor at the School for Innovation in Society, Arizona State University, Tempe.
Leaving aside whether physician-scientists working at nonprofit research institutions can avoid conflicts of interest when money is funneled to them from start-up investment opportunities, pharmaceutical board memberships, and direct compensation deals for consultancies and other services, Dr. Cook-Deegan was referring to the bigger problem of misaligned incentives. Large financial rewards are available for any drug with market potential instead of being limited to those that save lives, he said.
Tracing the current system to the Bayh-Dole Act in 1980, which permitted researchers to claim patents for intellectual property developed with federal funding, Dr. Cook-Deegan described a system of minnows, fish, and sharks. Researchers, who are the minnows, seek potential new therapeutics to be developed by for-profit startups or other commercial entities, which are the fish. If the drug continues to show promise, it brings investors, who are the sharks.
Once the new therapy reaches the sharks, the excitement about a new and more effective treatment has been overshadowed by the excitement about profits, which are essential to pay for the large investment required for the clinical development that brings new drugs to market. If the drug is marketable, it is considered a success even when the clinical benefits barely register.
“There have been about 20 new [cancer] drugs approved by the [Food and Drug Administration] in the last 2 years. The increased median disease-free survival is usually about 3 months,” said Otis W. Brawley, MD, who recently joined the Kimmel Cancer Center at Johns Hopkins University after resigning his position as chief medical officer at the American Cancer Society (ACS).
Dr. Brawley joined the others in declaring: “The system is broken.” The flow of money is not the only incentive for researchers to participate in clinical development programs focused on minor advances rather than blockbuster discoveries. Unrestricted research grants are now much harder to obtain, according to Dr. Brawley, making collaboration with industry essential not just for research funding but career advancement. Research at major cancer centers is still being conducted at the highest level, but there are unavoidable interdependent relationships for nonprofit institutions and for-profit enterprises.
“The doc who prescribes the drug to the average patient probably does not have this conflict of interest,” he said. “However, they are influenced by people who have these conflicts.”
The SHARE panel on conflicts of interest was convened after a series of articles co-reported by ProPublica and the New York Times described the failure of the chief medical officer at Memorial Sloan Kettering Cancer Center, José Baselga, MD, to disclose his financial conflicts of interest in publications, such as the New England Journal of Medicine, where they are required. Dr. Baselga resigned his position.
However, the failure to disclose financial relationships with industry was a minor topic during the SHARE panel. Robert Bazell, PhD, an adjunct professor in the division of molecular, cellular, and developmental biology at Yale University, New Haven, Conn., moderated the panel. He said in his opening remarks that the issues “go much deeper.”
While the articles did not reveal “anything illegal, it opened a lot of peoples’ eyes as to how much money there was in the system,” said Dr. Bazell, who was for many years the chief science and health correspondent for NBC News.
Specifically, it has heightened concern about whether profit motives are subverting the goals of science, according to Dr. Bazell. “This money bomb has fallen on a lot of science but it has particularly fallen on oncology,” he said.
Not everyone, including the bioethicist, agreed that profits by themselves are the problem. Big rewards may be a reasonable price for discoveries that save lives, but all agreed that the system does not necessarily reserve big rewards for life-saving advances.
“The focus isn’t really on drugs that will save lives, its just on more drugs,” said Ms. Visco, echoing the incentive system described by Dr. Cook-Deegan. She believes the current system handsomely rewards scientists and physicians for developing drugs with little or no significant clinical benefit. When a drug shows a progression-free survival benefit relative to a previous standard, even of modest statistical or clinical significance, it will be prescribed and profits will be generated.
Early in her tenure at the National Breast Cancer Coalition, Ms. Visco, who was a practicing lawyer prior to taking the helm of the coalition, considered fund raising for research the primary goal. She hoped that the coalition could help the breast cancer research community identify and fund priorities, but her perspective has changed.
“I used to think that we should be collaborators but now I am coming to the conclusion that we should be in charge. Educated, trained patient advocates with a constituency should be in charge, because our only agenda is to save lives and end breast cancer,” Ms. Visco said. She no longer believes in simply increasing funding even at research centers such as the National Cancer Institute without a fundamental reorganization of priorities.
Many leaders in medicine are aware of the problem, according to Dr. Brawley, who cited a recent statement by the American Society of Clinical Oncology that expressed concern about the plethora of cancer trials showing very small gains. He did agree with the others, however, that incentives are now misaligned.
“We are designing clinical trials not to look for big gains,” Dr. Brawley agreed. But he also cautioned that the system is complex. One reason that drugs offering modest or little gain over a previous standard are highly marketable is that patients themselves demand them. Direct-to-consumer marketing supports drugs with little or even nothing to offer.
“I see patients who want drugs that they should not get,” said Dr. Brawley, who indicated that clinicians are under pressure to offer something to desperate patients even when options are expensive and not shown to provide any change in outcome.
Overall, in the shake-up at Memorial Sloan Kettering, it was the failure to disclose significant financial relationships rather than the financial relationships themselves that represented an important breach in ethics, according to Dr. Brawley, who indicated that researcher relationships with industry are not inherently wrong. In an article published in November 2018, the New York Times reported that Dr. Brawley left his post at the ACS because of “his dismay” over some partnerships the ACS had formed with industry, but Dr. Brawley would not confirm or deny this report.
Relative to conflicts of interest at major research institutions, Dr. Cook-Deegan was more circumspect about whether disclosure is enough. Although he agreed with the premise that close collaboration with industry might be clinically valuable, which one investigator at Memorial Sloan Kettering claimed when speaking with the New York Times, he questioned whether there is a line over which the relationship is too intertwined.
“Do you really need to serve on the board? Do you really need the types of financial ties that have the potential to influence clinical decisions?” he asked.
Although Dr. Cook-Deegan agreed with the others that he does not know exactly how best to fix the system, he believes a fix may be coming.
“I think we are at an inflection point,” he said. “The symptoms of a system that has been running off the rails for a while are getting severe enough that we are starting to pay attention,” he said. One sign of movement is that both political parties have “introduced bills to address pricing, which is directly related to the problems we are talking about.”