To all those still infatuated with Managed Care:
June 16, 2005
Canadian Health Care A Contradiction in Terms
By Steve Chapman
To critics of the American health care system, Shangri-La is not a fantasy but a shimmering reality, though it goes by another name: Canada. Any debate on health care eventually arrives at the point where one participant says, "We should have what Canadians have. Free care, universal access and low cost -- who could ask for more?"
Well, plenty of people could ask for more -- starting with the Supreme Court of Canada. Last week, ruling on a challenge to the health care in the province of Quebec, the court sent a clear message south: Don't believe the hype.
The program, said the court, has such serious flaws that it is violating constitutional rights and must be fundamentally changed. And the flaws, far from being unique to Quebec, are part of the basic structure of Canada's health care policy.
No one doubts that the American model has serious defects, particularly rising costs and lack of access to medical insurance. But anyone who thinks the Canadians have come up with a magical solution is doomed to disappointment.
The dirty secret of the system is that universal access is no guarantee of treatment. Sick Canadians spend months and even years on waiting lists for surgery and other procedures. In 1993, the average wait to see a specialist after getting a doctor's referral was nine weeks. Since then, according to the Fraser Institute of Vancouver, it's increased to 18 weeks.
The typical patient needing orthopedic surgery has time to get pregnant and deliver a baby before being called. The Supreme Court cited the testimony of one orthopedic surgeon that 95 percent of patients in Canada waited over a year for knee replacements -- with many of them in limbo for two years.
In some cases, the delay lasts longer than the person enduring it. Or as the Supreme Court put it: "Patients die as a result of waiting lists for public health care."
Not only does the government subject its citizens to painful and even fatal delays in the public system, it bars them from seeking alternatives in the private market. You see, it's illegal for private insurers to pay for services covered by the public system.
That policy is what forced the Supreme Court to order changes. "The prohibition on obtaining private health insurance," it declared, "is not constitutional where the public system fails to deliver reasonable services."
The program has created a gap between supply and demand that is wider than Hudson Bay. Its failings, however, go beyond that. The single-payer approach, for example, is often held up as the only way to simultaneously control costs and deliver quality care.
In fact, Canada has somehow managed to do neither.
After adjusting for the age of the population, the Fraser Institute compared 27 countries in the Organisation for Economic Co-operation and Development that guarantee universal access to health care. By some mysterious alchemy, Canada has proportionately fewer physicians than most of these nations but spends more on health care than any except Iceland.
It would be a dubious feat to control costs only by depriving people of treatment. But to forcibly deprive people of treatment while letting costs surge is no achievement at all.
Admirers of our good neighbor to the north say the United States pours money into all sorts of fancy equipment but doesn't get better results by such measures as life expectancy. But life expectancy is affected by multiple factors, including education, crime rates and diet -- with health care playing only a modest role. In those areas where modern medicine can make a big difference, the United States does very well.
Take breast cancer. In Britain, which is famous for its socialized system, close to half of all victims die of the disease, according to a recent Cato Institute study by John Goodman, head of the National Center for Policy Analysis. In Germany and France, almost one-third do. In Canada, the figure is 28 percent -- and here, it's 25 percent. Our mortality rate for prostate cancer is 67 percent lower than Britain's and 24 percent lower than Canada's.
The usual story we hear is that the health care system next door provides first-rate care to all, at low cost. The realities -- dangerous delays, bloated expenditures and mediocre results -- are not so appealing. American liberals may not welcome evidence that the single-payer model works far better in theory than in practice. But for that, they can blame Canada.
Thursday, June 16, 2005
Dispute at the American Society of Hypertension Over Industry Involvement
The Boston Globe reported that a dispute has broken out at the American Society of Hypertension over the influence of pharmaceutical companies and conflicts of interest. Things have gotten pretty messy, so it's not easy for an outsider to tell what are at its roots.
There are two factions, one who "expresses wariness about industry participation and a newer faction that embraces it," according to the Globe.
In the first faction is Dr. John H. Laragh, a society cofounder and editor of the American Journal of Hypertension. In an email to the Society's membership, he charged that "the lines separating marketing from education have been fractured." Prof. Curt Furberg, former member of the Society's executive council, agreed that "the society is seen as a marketing tool by industry. There is a lot of money to go around."
Furthermore, Laragh said that industry involvement has increased at the society's annual meeting. This year, industry-sponsored sessions, instead of being isolated as "satellites," were "intertwined with the rest of the program." He noted that one society member, who also is a founding partner of a company that administers clinical trials under contract with the pharmaceutical industry, chaired a meeting to discuss the results of a trial that his company administered.
In the second faction is the President of the Society, Dr. Thomas Giles. He said that industry involvement is "part of a 'partnership' between physicians, corporations, and government and can be managed with appropriate disclosure rules, " according to the Globe. He noted that unrestricted educational grants from pharmaceutical companies, notably Novartis, AstraZeneca, and Pfizer, financed about $1.5 million of the Society's $4.4 million budget. He said, "we will not put ourselves in the position where were [sic] are going to function as the marketing arm for anyone."
Laragh has also acquired "enemies," who questioned his editorial salary ($229,000 in 2003), and whether he "engineered" his wife's new position as President-Elect of the Society.
Not a pretty picture, but I guess that more open discussion about the role of industry in scientific and clinical societies may do some good.
There are two factions, one who "expresses wariness about industry participation and a newer faction that embraces it," according to the Globe.
In the first faction is Dr. John H. Laragh, a society cofounder and editor of the American Journal of Hypertension. In an email to the Society's membership, he charged that "the lines separating marketing from education have been fractured." Prof. Curt Furberg, former member of the Society's executive council, agreed that "the society is seen as a marketing tool by industry. There is a lot of money to go around."
Furthermore, Laragh said that industry involvement has increased at the society's annual meeting. This year, industry-sponsored sessions, instead of being isolated as "satellites," were "intertwined with the rest of the program." He noted that one society member, who also is a founding partner of a company that administers clinical trials under contract with the pharmaceutical industry, chaired a meeting to discuss the results of a trial that his company administered.
In the second faction is the President of the Society, Dr. Thomas Giles. He said that industry involvement is "part of a 'partnership' between physicians, corporations, and government and can be managed with appropriate disclosure rules, " according to the Globe. He noted that unrestricted educational grants from pharmaceutical companies, notably Novartis, AstraZeneca, and Pfizer, financed about $1.5 million of the Society's $4.4 million budget. He said, "we will not put ourselves in the position where were [sic] are going to function as the marketing arm for anyone."
Laragh has also acquired "enemies," who questioned his editorial salary ($229,000 in 2003), and whether he "engineered" his wife's new position as President-Elect of the Society.
Not a pretty picture, but I guess that more open discussion about the role of industry in scientific and clinical societies may do some good.
Deferred Prosecution for Bristol Myers Squibb for Fraud Charges
The NY Times reported that federal prosecutors will defer prosecution of Bristol Myers Squibb for alleged manipulation of inventory designed to artificially inflate sales. The company will return $300 million to stockholders; set up an endowed chair of business ethics at Seton Hall University Law School; remove its CEO, Peter R. Dolan, from his additional position as chairman of board; and allow a retired federal judge to continue monitoring company operations, and appoint an additional board member acceptable to him. If the company complies with all obligations to the government, the prosecutors will dismiss criminal complaints already filed without further prosecution.
Two former Bristol Myers Squibb executives, former chief financial officer Frederick S. Schiff, and Richard J. Lane, former head of worldwide medicines, were indicted on charges of conspiracy and securities fraud. Lawyers for both men declared their innocence.
The prosecutors stated that these events resulted from a "corporate culture at Bristol-Myers at the time that emphasized higher sales at all costs...." according to the Times.
Two former Bristol Myers Squibb executives, former chief financial officer Frederick S. Schiff, and Richard J. Lane, former head of worldwide medicines, were indicted on charges of conspiracy and securities fraud. Lawyers for both men declared their innocence.
The prosecutors stated that these events resulted from a "corporate culture at Bristol-Myers at the time that emphasized higher sales at all costs...." according to the Times.
Wednesday, June 15, 2005
A Not-For-Profit Hospital Sues a Former Donor
The Boston Globe reported that the not-for-profit Massachusetts Eye & Ear Infirmary has sued a foundation for failure to deliver a pledged contribution. However, the pledge was apparently made to support a specific research program run by a doctor who has left the hospital, taking his research program with him. The Casey Foundation, run by Washington philanthropist Betty Brown Casey, had been funding work done by Dr. Steven Zeitels. After Zeitels and four other members of his team moved to Massachusetts General Hospital, the foundation asked Massachusetts Eye & Ear Infirmary to return any funds remaining in the grant. The hospital responded by suing the foundation for about half of the $2 million grant which it had not yet received, saying that the money was meant for the institution, not any particular researcher. Zeitels, however, said that the foundation had not meant to provide general funding for the hospital, but "was funding a specific program with unique investigators that was delineated both in the original proposal ... as well as scientific reports."
Suing a former donor seems to be a heavy-handed approach for a not-for-profit institution that presumably wants to receive money from other donors in the future. But it fits in with current US congressional concerns that some not-for-profit hospitals act more like for-profit corporations. (See our previous post here.)
Suing a former donor seems to be a heavy-handed approach for a not-for-profit institution that presumably wants to receive money from other donors in the future. But it fits in with current US congressional concerns that some not-for-profit hospitals act more like for-profit corporations. (See our previous post here.)
No Federal Standards for Reporting Flawed Medical Devices
The NY Times reported about recent recalls of implanted cardiac devices. One important point the reporter made was that so far the US Food and Drug Administration (FDA) has no uniform standards for notification of physicians when problems are found with implantable devices. Currently, it is up to the device manufacturer to decide when to report problems. Apparently, it is acceptable for the manufacturer to "consider potential loss of business to competitors and legal liability" when making such decisions.
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."
Monday, June 13, 2005
Big Conflicts of Interest Alleged at Small Massachusetts Hospital
The Boston Globe reported on the travails of tiny Hubbard Regional Hospital in Webster, MA, allegedly brought on by mismanagement.
The 76-year old, 24-bed hospital was run for over 10 years by Quorum Helath Resources, which says it "provides management support services, consulting, education and training programs to independent hospitals and health systems nationwide." Quorum billed the hospital $500,000 a year for its services. The hospital lost money in nine of the last 10 years.
The Globe article suggests that the hospital's management during this time suffered from important conflicts of interest:
One former Hubbard nurse, who was born in the hospital, called the events "a slap in the face." A member of the Hubbard Regional Hospital Guild, an auxiliary fund-raising organization, was more graphic, "The hospital was gradually being raped by various entitities."
Even small community hospitals in the US are not safe from leadership by the inept and the conflicted.
The 76-year old, 24-bed hospital was run for over 10 years by Quorum Helath Resources, which says it "provides management support services, consulting, education and training programs to independent hospitals and health systems nationwide." Quorum billed the hospital $500,000 a year for its services. The hospital lost money in nine of the last 10 years.
The Globe article suggests that the hospital's management during this time suffered from important conflicts of interest:
- In 2003, the hospital sold a medical office building for $450,000 to a real-estate company owned by three directors of Hometown Bank. The Bank was a major creditor of the hospital. The bank's CEO, Matthew S. Sosik, was on the hospital's board of directors. The hospital leased back space in the building, but allegedly paid $3250/month for 3000 square feet while it was only using 1200.
- In 2004, the hospital sold a house for $250,000 to a real estate trust controlled by Daniel B. Flynn, a real estate developer, who was also a borrower from Hometown Bank. Legal work for Flynn was handled by Michael L. Jalbert's law firm. Jalbert was the hospital's board chairman. Again, the hospital leased back the property at $1700/month.
- In 2001, Flynn had leased land from the hospital for $2000/month, and built a building on it in which the hospital rented space for $7500/month. The firm that surveyed this property was owned by Jalbert's father.
- Jalbert's law firm also handled legal work for the hospital, at the same time he handled legal work for Hometown Savings, and another hospital creditor.
One former Hubbard nurse, who was born in the hospital, called the events "a slap in the face." A member of the Hubbard Regional Hospital Guild, an auxiliary fund-raising organization, was more graphic, "The hospital was gradually being raped by various entitities."
Even small community hospitals in the US are not safe from leadership by the inept and the conflicted.
Not Very Slick Management: Administrators Alleged to Ignore Surgical Instruments "Disinfected" with Used Hydraulic Fluid
From the Associated Press, via the Charlotte Observer, came the story that a mix-up at Duke Health Raleigh and Durham Regional hospitals, both run by the Duke University Health System, caused surgical instruments used for operations on 3800 patients to be "disinfected" by immersion in hydraulic fluid drained from a hospital elevator system, rather than detergent.
According to the version reported in the Raleigh News and Observer, operating room staff complained to administration that their instruments were covered with oil. Sometimes, the staff had to wipe down tools because they were too slick to be usable. However, according to a Center for Medicare and Medicaid Services (CMS) report, "Administrative staff failed to heed the multiple complaints of staff sterilizing and using the instruments, thus delaying the discovery of the error and needlessly exposing patients to these instruments over a longer time period." So far, Duke has refused to reveal results of analyses of the content of the used hydraulic fluid. Duke officials declined interviews, but insisted that the surgical infection rate has not increased since the mix-up. A patient who suffered various maladies after surgery with the oily instruments requested information about the exposure from Duke, but received a letter from its risk-management department stating, they were "not in a position to respond at this time."
Not such slick managerial work on this one... Sorry, I couldn't help making these terrible puns, but sometimes we try to laugh to keep from crying. This story is so bizarre that it sounds like an urban legend. What kind of hospital manager would ignore repeated reports that surgical instruments came out of the sterilizer coated with oil? But with 422 related posts on Google News by June 14, this story appears all too real.
According to the version reported in the Raleigh News and Observer, operating room staff complained to administration that their instruments were covered with oil. Sometimes, the staff had to wipe down tools because they were too slick to be usable. However, according to a Center for Medicare and Medicaid Services (CMS) report, "Administrative staff failed to heed the multiple complaints of staff sterilizing and using the instruments, thus delaying the discovery of the error and needlessly exposing patients to these instruments over a longer time period." So far, Duke has refused to reveal results of analyses of the content of the used hydraulic fluid. Duke officials declined interviews, but insisted that the surgical infection rate has not increased since the mix-up. A patient who suffered various maladies after surgery with the oily instruments requested information about the exposure from Duke, but received a letter from its risk-management department stating, they were "not in a position to respond at this time."
Not such slick managerial work on this one... Sorry, I couldn't help making these terrible puns, but sometimes we try to laugh to keep from crying. This story is so bizarre that it sounds like an urban legend. What kind of hospital manager would ignore repeated reports that surgical instruments came out of the sterilizer coated with oil? But with 422 related posts on Google News by June 14, this story appears all too real.
MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising
Fellow health care blogger Robert Centor MD (of MedRants) published an op-ed in USA Today advocating that direct to consumer (DTC) advertisements for pharmaceuticals should be banned.
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?
Saturday, June 11, 2005
How Johnson & Johnson Marketed Propulsid
The NY Times reported on the events leading up to Johnson & Johnson's withdrawal of Propulsid, based on documents made available by related lawsuits. Propulsid was withdrawn from the market after its use was related to serious cardiac rhythm disturbances.
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren’t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren’t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "
Friday, June 10, 2005
The AMA may be "getting it"
AMA pursues doctor hiring reform
Miami Herald
June 10, 2005
In a move that could have widespread effects on the nation's healthcare industry, the American Medical Association's Board of Trustees is recommending the development of proposed legislation that would forbid corporations and hospitals from directly employing physicians.
-- SS
Miami Herald
June 10, 2005
In a move that could have widespread effects on the nation's healthcare industry, the American Medical Association's Board of Trustees is recommending the development of proposed legislation that would forbid corporations and hospitals from directly employing physicians.
-- SS
Government officials who "get it"
I heard Department of Health and Human Services Secretary Michael Leavitt speak at the AHRQ Annual Patient Safety and Health Information Technology conference this week. The linked article summarizes his plans for spearheading standardization on electronic medical records data.
It is with great pleasure that I can report this government official seems to know the issues, challenges and benefits of such an initiative quite well.
It is with great pleasure that I can report this government official seems to know the issues, challenges and benefits of such an initiative quite well.
The last paragraph was particularly interesting:US moves to spur digital health records nationwide
By Lisa Richwine
Mon Jun 6, 5:11 PM ET
The U.S. government is taking steps to help spawn a nationwide network of electronic medical records that are easily accessible but protect patient privacy, Health and Human Services Secretary Michael Leavitt said on Monday.
A new advisory panel will make recommendations aimed at prodding the private sector to establish standards so medical records can be shared throughout the health-care system, Leavitt said.
"In order for health IT (information technology) to move forward, we have to have interoperable standards ... creating a system where information is digital, privacy protected and interchangeable," Leavitt said in an interview ... the new panel, announced by Leavitt at a health IT meeting in New York, will have 17 government and private sector members, plus Leavitt as chairman. The group will give recommendations on how to make health records compatible among varying computer systems while keeping patient information secure. The panel will exist for at least two years and possibly as long as five years ... President Bush has set a goal for most Americans to have electronic health records by 2014.
Then there's this from the New York Times:Leavitt said the technology also would be a boost to the Food and Drug Administration's efforts to monitor drug side effects because reports from throughout the country could be gathered quickly for analysis.
Drug Safety System Is Broken, a Top F.D.A. Official Says
By Gardiner HarrisWASHINGTON, June 8 - A top federal drug official told a medical advisory board on Wednesday that the nation's drug safety system had "pretty much broken down" and that there was room for "a lot of improvement" in the government's approach to uncovering dangers in drugs already on the market.
The official, Dr. Janet Woodcock, deputy commissioner of operations at the Food and Drug Administration, made her remarks before a committee of experts at the Institute of Medicine, who had been asked by the agency to suggest safety improvements after a year of well-publicized troubles, including the withdrawal of two big-selling painkillers.
... She said the drug agency had long known that it needed to improve systems for learning about problems with drugs on the market. One way to do that, she said, is to take advantage of electronic health records from managed-care organizations.
As I wrote here, I agree with these assessments. Unfortunately, based on my experiences in pharma (where my experience in EMR and views on its use for drug safety surveillance were quite completely ignored, or perhaps I should say discarded), I predict there will be significant initial opposition by pharma to use of data collected on adverse drug events from EMR's. It is not data from a RCT, after all, and will invariably cause major headaches after the rollout of new drugs.
-- SS
Thursday, June 09, 2005
"Scientists Behaving Badly" and "Unreasonable Managerial Demands"
An article in Nature reports on "Scientists Behaving Badly."(1) This was a broadly based anonymous survey, with a 52% response rate, and a sample size of 3247. Of note, the numbers of respondents who reported engaging in the following behaviors in the last three years were:
This assertion was probably written before the publication in the New England Journal of Medicine of an article that showed what a large proportion of medical schools and academic medical centers are willing to sign away faculty members' control of their research to research sponsors (see our previous post here.) That article showed that about 2/3 of schools and medical centers were willing to sign away their faculty members' ability to alter research methods specified by the sponsor, and about 1/2 were willing to let the sponsor write up the research reports, which faculty could comment on, but not change, even though they were likely to be listed as principle authors. The data in the NEJM article is certainly compatible with the proportion of respondents to the Nature study who noted "pressure from a funding source." Thus, the "managerial" demands that researchers face may often go beyond merely being difficult, or even unreasonable.
This is just another reminder of the spectre of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
How much more evidence will be needed before something is done about how such organizations are lead?
Reference
1. Martinson BC, Anderson MS, deVries R. Scientists behaving badly. Nature 2005; 435: 737-8.
- Falsifying or "cooking" research data - 0.3%
- Ignoring major aspects of human-subject requirements - 0.3%
- Failing to present data that contradicts one's own previous research - 6.0%
- Improperly assigning authorship credit - 10.0%
- Changing the design, methodology, or results of a study in response to pressure from a funding source - 15.5%
This assertion was probably written before the publication in the New England Journal of Medicine of an article that showed what a large proportion of medical schools and academic medical centers are willing to sign away faculty members' control of their research to research sponsors (see our previous post here.) That article showed that about 2/3 of schools and medical centers were willing to sign away their faculty members' ability to alter research methods specified by the sponsor, and about 1/2 were willing to let the sponsor write up the research reports, which faculty could comment on, but not change, even though they were likely to be listed as principle authors. The data in the NEJM article is certainly compatible with the proportion of respondents to the Nature study who noted "pressure from a funding source." Thus, the "managerial" demands that researchers face may often go beyond merely being difficult, or even unreasonable.
This is just another reminder of the spectre of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
How much more evidence will be needed before something is done about how such organizations are lead?
Reference
1. Martinson BC, Anderson MS, deVries R. Scientists behaving badly. Nature 2005; 435: 737-8.
Pfizer Dissident Unplugged
The New York Times reported that Dr. Peter Rost, a Pfizer executive who publicly spoke out in favor of importation of low cost drugs, lost his company email and cell-phone service after he appeared on "60 Minutes," again speaking in favor of drug importation.
A Pfizer spokesman, Paul Fitzhenry, implied that Dr. Rost's communication problems were technical, "there have been cases, through a change of vendor, where some employees have lost service for a period of time." However, Rost also claimed that he no longer has employees who report to him, a secretary, or an identified supervisor, and he now works out an isolated office next to the company security department.
After Rost first publicly came out in favor of drug importation, a Pfizer spokesperson had said, "Dr. Rost has no qualifications to speak on importation."
Rost formerly worked for Pharmacia until it was acquired by Pfizer. He was in charge of the marketing of genotropin.
Rost must have thought he was on the faculty of a university, and thus had free speech and academic freedom (but then again, a look at the FIRE web-site might suggest that university faculty may not always be so privileged either.)
A Pfizer spokesman, Paul Fitzhenry, implied that Dr. Rost's communication problems were technical, "there have been cases, through a change of vendor, where some employees have lost service for a period of time." However, Rost also claimed that he no longer has employees who report to him, a secretary, or an identified supervisor, and he now works out an isolated office next to the company security department.
After Rost first publicly came out in favor of drug importation, a Pfizer spokesperson had said, "Dr. Rost has no qualifications to speak on importation."
Rost formerly worked for Pharmacia until it was acquired by Pfizer. He was in charge of the marketing of genotropin.
Rost must have thought he was on the faculty of a university, and thus had free speech and academic freedom (but then again, a look at the FIRE web-site might suggest that university faculty may not always be so privileged either.)
Canadian Ban on Private Health Insurance Struck Down
The Globe and Mail reported that the Canadian Supreme Court has just struck down as unconstitutional a law in Quebec that makes private health care insurance illegal. Dr. Albert Schumacher, the President of the Canadian Medical Association, said, "this is indeed a historic ruling that could substantially change the very foundation of medicare as we know it."
The court found "in sum, the prohibition on obtaining private health insurance is not constitutional where the public system fails to deliver reasonable services."
Health Care Renewal has frequently discussed the excesses of the for-profit and private not-for-profit organizations that comprise a major chunk of the US health care system, so Canada's impending leap into a multi-centric health care system may not be an unalloyed success. However, throwing caution about commenting about another nation's politics aside, I can't help but think that putting a little more control of health care into the hands of individual Canadians may not be entirely a bad thing. Maybe some of our friends north of here will comment more knowledgeably.
The court found "in sum, the prohibition on obtaining private health insurance is not constitutional where the public system fails to deliver reasonable services."
Health Care Renewal has frequently discussed the excesses of the for-profit and private not-for-profit organizations that comprise a major chunk of the US health care system, so Canada's impending leap into a multi-centric health care system may not be an unalloyed success. However, throwing caution about commenting about another nation's politics aside, I can't help but think that putting a little more control of health care into the hands of individual Canadians may not be entirely a bad thing. Maybe some of our friends north of here will comment more knowledgeably.
More Exaggerated Hospital List Prices
The Opinion Journal (the on-line opinion site of the Wall Street Journal) has a long article about one family's experience in the UK and US health care systems. Of note, the author noted that the charges for 10 physical therapy sessions at Cornell University Hospital in New York City were $27,000. As the author said, "there is something seriously out of whack about 10 therapy sessions that cost more than month's worth of hospital bills in England."
These prices are comparable to the list prices that a Tenet hospital was charging for physical therapy in Florida, but are more than an order of magnitude (i.e., ten times) higher than prices quoted as reasonable by a leader of the American Physical Therapy Association (see previous post here).
So everybody still thinks the reason for rising US health care costs is a mystery?
These prices are comparable to the list prices that a Tenet hospital was charging for physical therapy in Florida, but are more than an order of magnitude (i.e., ten times) higher than prices quoted as reasonable by a leader of the American Physical Therapy Association (see previous post here).
So everybody still thinks the reason for rising US health care costs is a mystery?
Wednesday, June 08, 2005
Local "Naturopathic Doctor" Shut Down
Our own Providence Journal reported that the RI Health Department shut down the office of a "naturopathic doctor," John E. Curran, after federal agents raided two of his offices. Before reading the news article, it's instructive to look at Curran's web-site, which was still up, at least through today.
On it he:
Curran's practice is listed on a this web-site which has links to a variety of New England based "holistic" practitioners. Some make claims to treat real diseases that seem far from evidence based, for example:
At a time when health care is derided for its rising costs, declining accessibility to patients, and stagnant quality, I wonder why do there is so little concern about the costs incurred by these so-called complementary and alternative medicine practitioners, and so little skepticism about the expansive claims they make about the tests and treatments they provide?
On it he:
- claims he can treat "catastrophic" or "unusual or rare" diseases;
- implies that his treatments are harmless, and, in comparison to standard medicine, "Treatments are more natural, gentler, and more easily accepted by our bodies;"
- implies he is a licensed ND, naturopathic doctor;
- claims that his version of naturopathy is "evidence-based;" and
- provides a testimonial of a patient who seems to say that Curran put his Stage 4 head and neck cancer into remission.
Curran's practice is listed on a this web-site which has links to a variety of New England based "holistic" practitioners. Some make claims to treat real diseases that seem far from evidence based, for example:
- "The Way to Balance," whose practitioners claim they can treat arthritis, seizures, and asthma
- "The Circle of the Light Studio, " whose practitioners claim that therapeutic touch can treat asthma and cardiac problems, and relieve AIDS symptoms
At a time when health care is derided for its rising costs, declining accessibility to patients, and stagnant quality, I wonder why do there is so little concern about the costs incurred by these so-called complementary and alternative medicine practitioners, and so little skepticism about the expansive claims they make about the tests and treatments they provide?
Monday, June 06, 2005
Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx
The Philadelphia Inquirer reported a series of allegations that a top Merck executive threatened and intimidated physicians who questioned the safety of its Cox-2 inhibitor drug Vioxx, now off the market.
Louis M. Sherwood, who retired as a Senior Vice President of Medical and Scientific Affairs for Merck, had been known as "the epitome of an upstanding guy, smart and well-respected." The Inquirer reported that "Sherwood earned accolades from both worlds [academia and industry]. At retirement in March 2002, he was given two lifetime achievement awards, one from industry physicians and one from medical-schol professors."
Nonetheless, evidence discovered in one of the cases against Merck revealed:
Unfortunately, if these allegations are true, they will become just another entry in the sorry catalog of threats to free speech and academic freedom in medicine, (which may relate to the many threats to free speech and academic freedom in colleges and universities, such as those that have been documented by FIRE.)
Physicians and scientists must learn how to defend themselves against such threats, or science, and worse, patients will suffer.
Louis M. Sherwood, who retired as a Senior Vice President of Medical and Scientific Affairs for Merck, had been known as "the epitome of an upstanding guy, smart and well-respected." The Inquirer reported that "Sherwood earned accolades from both worlds [academia and industry]. At retirement in March 2002, he was given two lifetime achievement awards, one from industry physicians and one from medical-schol professors."
Nonetheless, evidence discovered in one of the cases against Merck revealed:
- Lee Simon, a former Harvard faculty member, after lecturing about the risks of Vioxx, said he was threatened by Sherwood: "he would hurt my career if I continued to lecture." Sherwood also charged that Simon was biased against Vioxx. However, the Inquirer reported that Simon's "boss at Harvard, Steven Weinberger, now a Vice-President at the American College of Physicians in Philadelphia, confirmed getting Sherwood's call but said it had 'nothing to do' with Simon's promotion." Weinberger stated, "Lou Sherwood was not at all threatening me." Yet, John Yates, Sherwood's successor at Merck, contacted Simon, and said, according to him, that Sherwood's behavior "would never happen again, that it was unnecessary, that it was not the behavior of Merck." [Note that Dr. Weinberger has appeared in Health Care Renewal posts in the past, here, here, and here, on the subject of declining interest in primary care, which he has suggested is due more to shortcomings in how medical schools promote the field to students and due to inadequate current "chronic care models" than to pressures faced by practicing physicians, including external threats to their core values.]
- M. Thomas Stillman, from the University of Minnesota Medical School, also questioned the safety of Vioxx. A Merck "sales executive" described him as a "vocal adversary of Merck and Vioxx" in an email. A memo documented that Sherwood had "complained to Stillman's boss." Yates also called Stillman to apologize.
- Gurkirpal Singh, from Stanford University, questioned whether data about Vioxx was being hidden. A memo by Sherwood described Singh as "perceived as an advocate for Searle," which was then the manufacturer of the competing drug, Celebrex. The Inquirer reported that Sherwood called Singh's supervisor, Professor James F. Fries, at home, labeled Singh "anti-Vioxx," suggested Singh would "flame out," and threatened Fries with "consequences for myself and for Stanford," according to Fries. Fries wrote Merck to complain, noting all the above cases and those of two other researchers. Fries then got a call from David Anstice, President of the Human Health-Americas division of Merck, saying that Sherwood's behavior was "not the norm," and promising to take action.
Unfortunately, if these allegations are true, they will become just another entry in the sorry catalog of threats to free speech and academic freedom in medicine, (which may relate to the many threats to free speech and academic freedom in colleges and universities, such as those that have been documented by FIRE.)
Physicians and scientists must learn how to defend themselves against such threats, or science, and worse, patients will suffer.
Bristol-Myers-Squibb Settling Case of Inflated Sales Figures
The NY Times reported that Bristol-Myers-Squibb will soon be paying about $300 million in exchange for the US Department of Justice deferring prosecution of its alleged criminal conduct. The allegations were that the company inflated sales figures that it reported to investors. The company's current CEO, Peter R. Dolan, has acknowledged that the company inflated revenue by about $2.5 billion from 1999 to 2002. (See this Forbes article for more on Dolan's record.)
More on the Alliance Between the University of Pennsylvania and the Tai Sophia Institute
The Associated Press has done a follow-up of the new relationship between the University of Pennsylvania Medical School and the Tai Sophia Institute, "an alternative medicine school." (See our previous post here.)
The new article quoted the leader of Tai Sophia, "the goal is that the Penn medical school graduates will be highly able to speak with patients about how to guide these things [acupuncture, herbalism] in overall care."
Furthermore, Dr. Alfred P Fishman, "co-director of the collaboration," noted, "today, we're moving away from being completely focused on preventing disease and toward looking at what it takes to [achieve and maintain] wellness... I think patient care will improve enormously."
In particular, the article reported that "cardiologists at Penn's Presbyterian Medical Center are working with Tai Sophia to integrate alternative therapies into traditional care for heart patients. The idea is to teach the cardiology staff how to develop personalized therapy plans - including everything from meditation and message to reflexology and aromatherapy - to decrease patient stress, pain and anxiety."
However, the article also included a riposte by Steven Barrett, who runs Quackwatch. Barrett charged that alternative medicine is not being accepted into medical schools because of good evidence that it works, but because "skeptical voices are squelched and 'administrators see it as a way to jump on the bandwagon and get grant money.'"
I wonder what sort of data exists on the benefits of reflexology or aromatherapy for patients with heart disease? I would bet not much. Quick PubMed searches did not reveal anything convincing. For Quackwatch's take, see their page on reflexology, and their page on aromatherapy.
I am still waiting for any rationale for the University of Pennsylvania's embrace of the Tai Sophia Institute that fits with the University's scientific mission.
The new article quoted the leader of Tai Sophia, "the goal is that the Penn medical school graduates will be highly able to speak with patients about how to guide these things [acupuncture, herbalism] in overall care."
Furthermore, Dr. Alfred P Fishman, "co-director of the collaboration," noted, "today, we're moving away from being completely focused on preventing disease and toward looking at what it takes to [achieve and maintain] wellness... I think patient care will improve enormously."
In particular, the article reported that "cardiologists at Penn's Presbyterian Medical Center are working with Tai Sophia to integrate alternative therapies into traditional care for heart patients. The idea is to teach the cardiology staff how to develop personalized therapy plans - including everything from meditation and message to reflexology and aromatherapy - to decrease patient stress, pain and anxiety."
However, the article also included a riposte by Steven Barrett, who runs Quackwatch. Barrett charged that alternative medicine is not being accepted into medical schools because of good evidence that it works, but because "skeptical voices are squelched and 'administrators see it as a way to jump on the bandwagon and get grant money.'"
I wonder what sort of data exists on the benefits of reflexology or aromatherapy for patients with heart disease? I would bet not much. Quick PubMed searches did not reveal anything convincing. For Quackwatch's take, see their page on reflexology, and their page on aromatherapy.
I am still waiting for any rationale for the University of Pennsylvania's embrace of the Tai Sophia Institute that fits with the University's scientific mission.
Georgia State Senator, Charged with Defrauding Hospital and Medical School, Convicted
The Atlanta Journal-Constitution reported that Georgia State Senator Charles W Walker was convicted of 127 counts in a 137 count indictment. We had previously posted about the scope of the indictment, which included charges that Walker had defrauded both Grady Memorial Hospital, Georgia' largest public hospital, and the Medical College of Georgia in schemes to get these institutions to use personnel from Walker's temporary employment agency.
Opinions About the Regulating the Pharmaceutical Industry
Two major newspapers have published opinion pieces condemning current pharmaceutical industry practices, and calling for better regulation of the industry.
The Atlanta Journal-Constitution noted how pharmaceutical companies promised to supply clinical trial data to a government sponsored web-site, but often provided data too limited to be meaningful. The editorial suggested "given the results so far, the next step would be to convert the voluntary government Web site to a national registry and threaten stiff financial penalties for companies that fail to comply."
The paper also published a response by Peter S Kim, President of Merck Research Laboratories, who said "given its track record of publishing data, the implication that Merck has hidden data is both unfair and inaccurate." He didn't address specific charges that Merck has hidden or manipulated data (for links to posts on these charges, see this.)
Meanwhile, an op-ed in the Denver Post stated "drug-making has become a very competitive industry, which may be putting profits before our health." Furthermore, it suggested that the US Food and Drug Administration is "too outdated, inadequate, and riddled with conflicts of interest to regulate the business of medical drugs." Instead, it proposed a new regulatory structure to ensure "that medical drugs would have to be safe for their intended use, that full information about potential harmful effects would be given to consumers and the medical community, and that harmed consumers would have the right to redress under exisiting product liability laws."
Clearly, there seems to be increasing sentiment for a renewal of the regulatory structure for the pharmaceutical industry. It may also be reasonable to suggest that other health care sectors, especially hospitals/ academic medical centers, and managed care organizations/ insurers, may be called upon to quickly clean up their acts, or also be subject to new and more rigorous regulation.
The Atlanta Journal-Constitution noted how pharmaceutical companies promised to supply clinical trial data to a government sponsored web-site, but often provided data too limited to be meaningful. The editorial suggested "given the results so far, the next step would be to convert the voluntary government Web site to a national registry and threaten stiff financial penalties for companies that fail to comply."
The paper also published a response by Peter S Kim, President of Merck Research Laboratories, who said "given its track record of publishing data, the implication that Merck has hidden data is both unfair and inaccurate." He didn't address specific charges that Merck has hidden or manipulated data (for links to posts on these charges, see this.)
Meanwhile, an op-ed in the Denver Post stated "drug-making has become a very competitive industry, which may be putting profits before our health." Furthermore, it suggested that the US Food and Drug Administration is "too outdated, inadequate, and riddled with conflicts of interest to regulate the business of medical drugs." Instead, it proposed a new regulatory structure to ensure "that medical drugs would have to be safe for their intended use, that full information about potential harmful effects would be given to consumers and the medical community, and that harmed consumers would have the right to redress under exisiting product liability laws."
Clearly, there seems to be increasing sentiment for a renewal of the regulatory structure for the pharmaceutical industry. It may also be reasonable to suggest that other health care sectors, especially hospitals/ academic medical centers, and managed care organizations/ insurers, may be called upon to quickly clean up their acts, or also be subject to new and more rigorous regulation.
Secrecy
I'm trying to catch up after a busy weekend, and there is a lot to catch up on...
Last week in the Hartford Courant, an op-ed article entitled "Medically Unnecessary" offered an ear, nose and throat surgeon's heart-felt complaints about the brave new world of practice dominated by managed care.
In particular, he recounted how his practice tried to negotiate with a prominent insurance company. As a prerequesite to negotiating, the company sent the doctors a "confidentiality contract," which included penalties up to $100,000 per person for any "breach of confidentiality, [decided] solely at the insurer's discretion." The doctors refused to sign.
Here is another example of the secrecy rampant in US health care. Earlier, we had posted about how hospitals keep their often stratospheric "list prices" secret, even from patients who may later be liable to pay these prices if they have no health insurer who can negotiate discounts. We also had posted about how medical schools and academic medical centers are often willing to negotiate research contracts with sponsors whose provisions are kept confidential, perhaps to hide provisions that give the corporate sponsor, not the ostensibly academic investigators control of most aspects of the research.
There are some instances in which secrecy in health care is justifiable. Keeping patients' personal data confidential is a a core value for most physicians. It also seems reasonable for companies that manufacture products used in health care to be able to maintain trade secrets about their manufacturing processes.
However, for the most part, we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.
It is time to end this secrecy.
Last week in the Hartford Courant, an op-ed article entitled "Medically Unnecessary" offered an ear, nose and throat surgeon's heart-felt complaints about the brave new world of practice dominated by managed care.
In particular, he recounted how his practice tried to negotiate with a prominent insurance company. As a prerequesite to negotiating, the company sent the doctors a "confidentiality contract," which included penalties up to $100,000 per person for any "breach of confidentiality, [decided] solely at the insurer's discretion." The doctors refused to sign.
Here is another example of the secrecy rampant in US health care. Earlier, we had posted about how hospitals keep their often stratospheric "list prices" secret, even from patients who may later be liable to pay these prices if they have no health insurer who can negotiate discounts. We also had posted about how medical schools and academic medical centers are often willing to negotiate research contracts with sponsors whose provisions are kept confidential, perhaps to hide provisions that give the corporate sponsor, not the ostensibly academic investigators control of most aspects of the research.
There are some instances in which secrecy in health care is justifiable. Keeping patients' personal data confidential is a a core value for most physicians. It also seems reasonable for companies that manufacture products used in health care to be able to maintain trade secrets about their manufacturing processes.
However, for the most part, we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.
It is time to end this secrecy.
Friday, June 03, 2005
New Marketing Campaign "To Build Emotional Ties Between Merck and Consumers"
The NY Times reported that Merck is embarking on a big $20 million marketing campaign to "help burnish its corporate brand rather than sell its products."
Len Taconi, executive director for corporate communication for Merck, said, "It's an important time for people to know who Merck is and what we stand for as a company."
Robert Passikoff, President of Brand Keys, described by the Times as "a brand and customer-loyalty consultant," said "Merck would be wise to make sure it has more friends than disgruntled patients. Ultimately, you're better off having a tighter emotional bond to your customer base." The Times also reported that the "campaign will try in several ways to build emotional ties between Merck and consumers."
Of course, Merck is a firm that has been around for a long time, and has produced many important products that we physicians have been happy to use> Merck certainly seemed, at least through the start of the 1990's, to be one of the great American companies.
However, in the last year, Merck has come under substantial fire for putting marketing before science, and in particular for manipulating scientific evidence about its formerly hot selling drug Vioxx, now withdrawn from the market.
For example, we have posted about how Merck tried to "neutralize" Vioxx opponents; about how Merck tried to downplay negative results of studies about Vioxx; about how Merck had a New England Journal article reporting a key trial of Vioxx ghost-written; and about how Merck marketed Vioxx as a general-purpose pain reliever in the absence of evidence that it any better in this role than a variety of cheaper drugs, while again down-playing data about its adverse effects.
So perhaps rather than trying to "build emotional ties," in my humble opinion, if Merck wants to regain the profession's and the public's trust, it should rededicate itself to doing valid, honest research about its products, and then presenting its results clearly and honestly. Merck should promote evidence-based health care, rather than spending $20 million on emotion-based marketing.
Len Taconi, executive director for corporate communication for Merck, said, "It's an important time for people to know who Merck is and what we stand for as a company."
Robert Passikoff, President of Brand Keys, described by the Times as "a brand and customer-loyalty consultant," said "Merck would be wise to make sure it has more friends than disgruntled patients. Ultimately, you're better off having a tighter emotional bond to your customer base." The Times also reported that the "campaign will try in several ways to build emotional ties between Merck and consumers."
Of course, Merck is a firm that has been around for a long time, and has produced many important products that we physicians have been happy to use> Merck certainly seemed, at least through the start of the 1990's, to be one of the great American companies.
However, in the last year, Merck has come under substantial fire for putting marketing before science, and in particular for manipulating scientific evidence about its formerly hot selling drug Vioxx, now withdrawn from the market.
For example, we have posted about how Merck tried to "neutralize" Vioxx opponents; about how Merck tried to downplay negative results of studies about Vioxx; about how Merck had a New England Journal article reporting a key trial of Vioxx ghost-written; and about how Merck marketed Vioxx as a general-purpose pain reliever in the absence of evidence that it any better in this role than a variety of cheaper drugs, while again down-playing data about its adverse effects.
So perhaps rather than trying to "build emotional ties," in my humble opinion, if Merck wants to regain the profession's and the public's trust, it should rededicate itself to doing valid, honest research about its products, and then presenting its results clearly and honestly. Merck should promote evidence-based health care, rather than spending $20 million on emotion-based marketing.
Marketing Normal Pressure Hydrocephalus
Joseph Friedman, a neurologist here in Rhode Island, wrote an op-ed in the Providence Journal that documented yet another story about apparently deceptive marketing, this time of devices. He recounted his discovery of a marketing campaign for the device used to shunt fluid for patients with the relatively rare condition of normal pressure hydrocephalus (NPH).
He first saw a segment on a television magazine show on NPH, and then "an avalanche of TV advertisements about the disorder." Then patients with previously diagnosed Parkinson's Disease began to show up in his office, wondering if they didn't have the much more rare condition, NPH. Since the diagnosis of Parkinson's Disease is usually clear-cut, and NPH is very uncommon, these ads may lead to a lot of unnecessary tests. Furthermore, as Dr. Friedman pointed out, "patients suffer twice: first, when they wonder if they've been mistreated for 10 years by their clueless doctor; then, when they're disappointed to learn that they haven't been misdiagnosed."
Dr. Friedman forcefully conceptualized the issues: "what I think: that the dirtbags who run the shunt company, the increasingly politicized U.S. Food and Drug Administration, and the executives who run television are willing to create false hope if it creates a market."
He first saw a segment on a television magazine show on NPH, and then "an avalanche of TV advertisements about the disorder." Then patients with previously diagnosed Parkinson's Disease began to show up in his office, wondering if they didn't have the much more rare condition, NPH. Since the diagnosis of Parkinson's Disease is usually clear-cut, and NPH is very uncommon, these ads may lead to a lot of unnecessary tests. Furthermore, as Dr. Friedman pointed out, "patients suffer twice: first, when they wonder if they've been mistreated for 10 years by their clueless doctor; then, when they're disappointed to learn that they haven't been misdiagnosed."
Dr. Friedman forcefully conceptualized the issues: "what I think: that the dirtbags who run the shunt company, the increasingly politicized U.S. Food and Drug Administration, and the executives who run television are willing to create false hope if it creates a market."
Guidant's Short Circuit, Reloaded
The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.
Thursday, June 02, 2005
CPOE cybernetic miracles not yet achieved
Lest hospital executives believe that computers are going to be a cure-all for all that ails medicine, here's another sobering report on computerized physician order entry (CPOE):
As a medical informaticist, I have always been somewhat skeptical about the "syndrome of inappropriate confidence in computers" and related beliefs in "computational alchemy." While clinical IT progress in undeniable and must proceed, one must temper expectations about the technology to realistic levels. This is especially true for those involved in clinical operations. (Similar issues occur in the pharmaceutical R&D sector, as I have observed). We are still in an era when, paraphrasing Chuck Yeager, who shot down a faster German jet in his propeller-driven P51 Mustang, "it's the [person], not the machine."
This study also suggests that when implementing clinical IT, it best be done right by those with experience in both medicine and computing, because if it's done wrong, even worse problems can result.
Medical errors kill nearly 100,000 American each year, with lethal drug interactions accounting for most of these deaths. Computerization -- which hospitals have been slow to embrace -- was supposed to eliminate most problems, but new research published Wednesday indicates that even the best computer system can’t save you from a doctor’s catastrophic screw-up. Harmful medication-related mishaps cropped up in a quarter of all patients at the Veterans Affairs Medical Center in Salt Lake City, one of the most high-tech hospitals in the country, according to a study published in Archives of Internal Medicine.
"If you were on an airplane and a quarter of the time it crashed, that would be a problem," said study co-author Dr. Jonathan Nebeker, a physician at the VA Medical Center.
Even though the hospital's computers were supposed to protect against dangerous drug interactions, illegible prescriptions and bedside mix-ups, nine of the 937 patients studied died as a result of medication problems, the study found.
As a medical informaticist, I have always been somewhat skeptical about the "syndrome of inappropriate confidence in computers" and related beliefs in "computational alchemy." While clinical IT progress in undeniable and must proceed, one must temper expectations about the technology to realistic levels. This is especially true for those involved in clinical operations. (Similar issues occur in the pharmaceutical R&D sector, as I have observed). We are still in an era when, paraphrasing Chuck Yeager, who shot down a faster German jet in his propeller-driven P51 Mustang, "it's the [person], not the machine."
This study also suggests that when implementing clinical IT, it best be done right by those with experience in both medicine and computing, because if it's done wrong, even worse problems can result.
Wednesday, June 01, 2005
More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care
Intermountain Health Care (IHC, in Utah) is another large health care system that has been accused of employing harsh collection tactics against poor patients who don't pay their bills. Earlier this month it announced kinder, gentler collection processes. It is unclear if these were a response to charges heard in the state legislature last year that the system operates like a for-profit company, and threats that it then should be taxed like one. (See news articles here and here.)
Nonetheless, a state legislative tax force will be investigating IHC, prompted by "recurring perceptions of monopolistic practices, ... of heavy-handed collection practices." (News article here.)
Ironically, a tiny news item appearing early in May suggested that this apparently tough-minded organization could not prevent Ralph Jay Hansen, its former retirement account fund director, from embezzling $2.6 million between 1996 and 2004. (See article here.)
Nonetheless, a state legislative tax force will be investigating IHC, prompted by "recurring perceptions of monopolistic practices, ... of heavy-handed collection practices." (News article here.)
Ironically, a tiny news item appearing early in May suggested that this apparently tough-minded organization could not prevent Ralph Jay Hansen, its former retirement account fund director, from embezzling $2.6 million between 1996 and 2004. (See article here.)
Drug Studies Required by FDA Fast Track Process Never Completed
Help, help, there is so much going on I a can't keep up with it anymore....
The Los Angeles Times just revealed a report by the staff of US Rep. Edward J Markey (D-Mass) about the US Food and Drug Administration (FDA) fast-track drug approval process. This process, created in part as a response to demonstrations by AIDS activists in the late 1980's (see previous post here), allows rapid marketing of drugs after a limited number of studies, contingent on manufacturers' willingness to perform future studies.
Apparently, many of these studies are never finished.
Markey's report said that of 91 studies promised since 1992, 42, almost half, were not completed, and 21 were never started.
Markey is calling for new legislation to impose penalties on pharmaceutical companies that do not complete promised studies.
The Los Angeles Times just revealed a report by the staff of US Rep. Edward J Markey (D-Mass) about the US Food and Drug Administration (FDA) fast-track drug approval process. This process, created in part as a response to demonstrations by AIDS activists in the late 1980's (see previous post here), allows rapid marketing of drugs after a limited number of studies, contingent on manufacturers' willingness to perform future studies.
Apparently, many of these studies are never finished.
Markey's report said that of 91 studies promised since 1992, 42, almost half, were not completed, and 21 were never started.
Markey is calling for new legislation to impose penalties on pharmaceutical companies that do not complete promised studies.
Medical Whistleblowers' Roundtable
PLoS Medicine just published a summary of a round-table discussion by notable whistleblowers about pharmaceutical companies' research and marketing practices, with an accompanying editorial. (The on-line journal stepped in as a sponsor 10 days before the conference, after the unnamed journal that originally was going to sponsor the meeting pulled out on its lawyers' advice.)
The conference underlined some of the issues that have appeared on Health Care Renewal. Some notable quotes:
The conference underlined some of the issues that have appeared on Health Care Renewal. Some notable quotes:
- Betrayal of Mission: According to David Graham (who raised concerns about the safety of Vioxx), The US Food and Drug Administration (FDA) is in a "collaborative relationship" with pharmaceutical companies. A senior FDA official told Graham, "industry is our client." The public may be excused for thinking that they are supposed to be the FDA's clients.
- Tactics to Increase Likelihood of Favorable Results: Several participants talked about specific tactics used by some pharmaceutical companies to increase the likelihood that research results will be favorable to their products. An anonymous industry scientist noted that it takes only two positive studies to get FDA approval. But if a study has bad results, "typically a company is not going to publish the study at all." Furthermore, he said "drug companies assiduously avoid acquiring information about side effects." Patients who have increased risks of side-effects "are excluded from studies deliberately, even though, when the drug is approved, these patients will be targeted for sales." He also charged that studies are deliberately designed to be too small, or be over too quickly to detect serious adverse effects.
- Conflicts of Interest: Several participants suggested how drug companies convey money to public officials to influnce state level decisions about drugs. One charged that officials who were responsible for writing state guidelines about psychiatric treatments could access a secret account financed by drug companies. He was told, "Look, drug companies write checks to politicians, they write checks to politicians on both sides of the aisle - back off." He was then advised, "quit being a salmon, swimming against a stream."
- Ghost-Writing: The anonymous industry scientist described the process of ghost-writing, "When studies are published, they are frequently written not by the trained research scientist, who might have designed and analyzed the study, but by a designated medical writer with little if any backgroun in research, but who is trained instead to craft the findings of the study in the best possible way for the company."
More Fall-Out From Start of Congressional Hearings on Not-For-Profit Hospitals
The beginning congressional investigations of not-for-profit hospitals' tax exemptions are raising interest in the business practices of these institutions.
A New York Sun editorial and related news article reported that some of the questions put to the small sample of hospitals being investigated were about compensation perks given to top executives, including country club memberships: and about offshore investments and relationships with for-profit entities. The editorial provided some more information about the generous compensation given to hospital executives: four New York-Presbyterian executives (three of whom are physicians) got more than $1 million in total compensation in 2003, and several others got nearly that much. The hospital also had 3 surgeons who earned more than $1 million.
Newspapers in other states have been prompted to look into the operations of local hospitals named in the investigation. The Cleveland Plain Dealer reported data about high "list prices" charged by the Cleveland Clinic. The San Francisco examiner reported complaints about the dominance of local health care markets by Sutter Health, and allegations about the system's inflated prices and poor quality.
There thus seems to be a growing awareness that some large not-for-profit hospitals have not always been managed in ways compatible with their missions. Again, I hope that these investigations can distinguish between the importance of these institutions' underlying missions and how some current leaders may have veered from their responsibilities to uphold them. Furthermore, I hope the committees' recognize that the hospitals operate within a larger health care system, and are subject to pressures from other large organizations within the system that also have been acting at odds with physicians' core values. Although these pressures should not excuse hospital leaders' failure to uphold their missions, the hospitals (and physicians) must develop defenses against them.
The New York Sun editorial concluded, "the Congress - and the taxpayers footing the bills for the subsidy [effectively provided by not-for-profit status] - are entitled to ask and to rethink the question of whom these institutions exist to serve." Furthermore, "Senator Grassley and Frist and Chairman Thomas of the House Ways and Means Committee will have to be careful not to wreck the crown jewel of the American health-care system. But it's not only Congress that could cripple America's hospitals with clumsy or heavy-handed oversight. The doctors, administrators, and hospital trustees themselves could ruin things by forgetting that, through Medicare, Medicaid, and tax exemptions, the American taxpayers are the ones who are paying."
A New York Sun editorial and related news article reported that some of the questions put to the small sample of hospitals being investigated were about compensation perks given to top executives, including country club memberships: and about offshore investments and relationships with for-profit entities. The editorial provided some more information about the generous compensation given to hospital executives: four New York-Presbyterian executives (three of whom are physicians) got more than $1 million in total compensation in 2003, and several others got nearly that much. The hospital also had 3 surgeons who earned more than $1 million.
Newspapers in other states have been prompted to look into the operations of local hospitals named in the investigation. The Cleveland Plain Dealer reported data about high "list prices" charged by the Cleveland Clinic. The San Francisco examiner reported complaints about the dominance of local health care markets by Sutter Health, and allegations about the system's inflated prices and poor quality.
There thus seems to be a growing awareness that some large not-for-profit hospitals have not always been managed in ways compatible with their missions. Again, I hope that these investigations can distinguish between the importance of these institutions' underlying missions and how some current leaders may have veered from their responsibilities to uphold them. Furthermore, I hope the committees' recognize that the hospitals operate within a larger health care system, and are subject to pressures from other large organizations within the system that also have been acting at odds with physicians' core values. Although these pressures should not excuse hospital leaders' failure to uphold their missions, the hospitals (and physicians) must develop defenses against them.
The New York Sun editorial concluded, "the Congress - and the taxpayers footing the bills for the subsidy [effectively provided by not-for-profit status] - are entitled to ask and to rethink the question of whom these institutions exist to serve." Furthermore, "Senator Grassley and Frist and Chairman Thomas of the House Ways and Means Committee will have to be careful not to wreck the crown jewel of the American health-care system. But it's not only Congress that could cripple America's hospitals with clumsy or heavy-handed oversight. The doctors, administrators, and hospital trustees themselves could ruin things by forgetting that, through Medicare, Medicaid, and tax exemptions, the American taxpayers are the ones who are paying."
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