Princess Health and NIH Update: Resistance Against New Conflict of Interest Rules Continues. Princessiccia

Princess Health and NIH Update: Resistance Against New Conflict of Interest Rules Continues. Princessiccia

conflicts of interest NIH

Gusty 13:35 Add Comment

The New England Journal of Medicine this week has a good summary by Robert Steinbrook of the latest developments at the NIH. In particular, it has a clear table of the new, more stringent regulations temporarily put in place by Director Zerhouni.
These included:

• Prohibition of employment with pharmaceutical and biotechnology companies, research institutions that receive NIH grants and contracts, health care providers and insurers, and related trade, professional, or similar associations
• Prohibition of compensated teaching or writing for these organizations
• Prohibition of self-employed business activity involving sale or promotion of products or services of a pharmaceutical or biotechnology company or a health care provider or insurer
• Prohibition of holding stock in biotechnology or pharmaceutical companies for employees who must file financial disclosure reports, a $15,000 limit in holdings in any one company for other employees
• Prohibition for senior employees only of the receipt of most awards worth more than $200, and a similar prohibition for all employees of such awards from an organization which is involved with the employees work
• In general, outside teaching, clinical, scientific writing, and scientific editing activities are permitted as long as they comply with other standards.

It also includes a narrative of how Zerhouni changed his mind about the need for such regulations. Much of its contents has already appeared on Health Care Renewal, but it does have some important new items.
One is that the new regulations at the NIH parallel those already in place at regulatory agencies, such as the Food and Drug Administration and the Securities and Exchange Commission. This was in part driven by the realization that NIH decisions can have "increasingly powerful influence ... on financial markets." Moreover, Zerhouni felt the regulations were in response to activities by high NIH officials that "really were purely and imply what you would call product-endorsement activities, speaking for a company on behalf of a product to entice physicians to prescribe that product at greater levels."

The article also mentions the opposition to these new regulations that Zerhouni has encountered. Furthermore, yesterday, the Washington Post reported that apparently a physician recently nominated to head the National Institute of Environmental Health Sciences now has "serious concerns about taking the job under the new rules." "His primary concenr is that he would be unable to recruit or retain top talent."

The NIH is, as Steinbrook stated, is "regarded as the world's premier biomedical research institution." So, it amazes me that some people don't think the could manage to work in full-time leadership positions at the NIH because they no longer could also work for certain outside organizations, or simultaneously pursue self-employed business activity involving the products of such organization. Are NIH salaries really so low that its high level employees need second jobs to get along economically? Or do people now feel so entitled to lucrative side-employment with industry that the notion of loyal service to the public means nothing? But maybe such people are not those who should be working at "the world's premier biomedical research institution."

Princess Health and NIH Update: Resistance Against New Conflict of Interest Rules Continues.Princessiccia

Princess Health and NIH Update: Resistance Against New Conflict of Interest Rules Continues.Princessiccia

conflicts of interest NIH

Gusty 13:35 Add Comment

The New England Journal of Medicine this week has a good summary by Robert Steinbrook of the latest developments at the NIH. In particular, it has a clear table of the new, more stringent regulations temporarily put in place by Director Zerhouni.
These included:

• Prohibition of employment with pharmaceutical and biotechnology companies, research institutions that receive NIH grants and contracts, health care providers and insurers, and related trade, professional, or similar associations
• Prohibition of compensated teaching or writing for these organizations
• Prohibition of self-employed business activity involving sale or promotion of products or services of a pharmaceutical or biotechnology company or a health care provider or insurer
• Prohibition of holding stock in biotechnology or pharmaceutical companies for employees who must file financial disclosure reports, a $15,000 limit in holdings in any one company for other employees
• Prohibition for senior employees only of the receipt of most awards worth more than $200, and a similar prohibition for all employees of such awards from an organization which is involved with the employees work
• In general, outside teaching, clinical, scientific writing, and scientific editing activities are permitted as long as they comply with other standards.

It also includes a narrative of how Zerhouni changed his mind about the need for such regulations. Much of its contents has already appeared on Health Care Renewal, but it does have some important new items.
One is that the new regulations at the NIH parallel those already in place at regulatory agencies, such as the Food and Drug Administration and the Securities and Exchange Commission. This was in part driven by the realization that NIH decisions can have "increasingly powerful influence ... on financial markets." Moreover, Zerhouni felt the regulations were in response to activities by high NIH officials that "really were purely and imply what you would call product-endorsement activities, speaking for a company on behalf of a product to entice physicians to prescribe that product at greater levels."

The article also mentions the opposition to these new regulations that Zerhouni has encountered. Furthermore, yesterday, the Washington Post reported that apparently a physician recently nominated to head the National Institute of Environmental Health Sciences now has "serious concerns about taking the job under the new rules." "His primary concenr is that he would be unable to recruit or retain top talent."

The NIH is, as Steinbrook stated, is "regarded as the world's premier biomedical research institution." So, it amazes me that some people don't think the could manage to work in full-time leadership positions at the NIH because they no longer could also work for certain outside organizations, or simultaneously pursue self-employed business activity involving the products of such organization. Are NIH salaries really so low that its high level employees need second jobs to get along economically? Or do people now feel so entitled to lucrative side-employment with industry that the notion of loyal service to the public means nothing? But maybe such people are not those who should be working at "the world's premier biomedical research institution."

Princess Health and HCA leads campaign to curb doctor-owned hospitals. Princessiccia

Princess Health and HCA leads campaign to curb doctor-owned hospitals. Princessiccia

HCA

Gusty 05:53 Add Comment

An interesting article on the competition between physicians opening specialty hospitals owned by themselves and corporate medicine. Big-business medicine whines that physician-owned specialty centers gives physicians an "unfair advantage." I would classify this story under the heading "The World's Smallest Violin."

Big-business medicine claims physicians "cherry-pick" the best-insured patients for their centers. However, managed care and for-profits tend to try exactly the same thing to minimize care delivery, maximize corporate profit and shareholder value, and minimize physician income in the bargain to add insult to injury.

Businessmen need to realize that in essence, clinicians are the true owners of hospitals. As I've often said, in a somewhat tongue-in-cheek example, even if hospitals all burned to the ground in some hypothetical apocalypse, clinicians could still take care of patients to a good extent in tents using primitive equipment. They are enablers of healthcare; everyone else is a facilitator. (If only clinicians would become more politically astute and use this realization more aggressively.)

Dear HCA, welcome to the true marketplace of competition from those who actually know what they're doing in medicine, its practitioners.

-- SS

HCA leads campaign to curb doctor-owned hospitals (excerpts)
By TODD PACK
Staff Writer, Tennesean.com

Before many of its heart surgeons left to become owners in a nearby specialty hospital, Oklahoma University Medical Center admitted 150 heart patients a month. Soon afterthe doctor's hospital opened, OU's cardiovascular admissions fell to zero.I t was a drop in business that has cost OU nearly $12 million since 2002 and threatened its ability to care for Oklahoma's most critically injured patients, OU's chief medical officer said. ''Simply put, these facilities drain essential resources from full-service community hospitals,'' said Dr. Andy Sullivan, chief medical officer of the OU Medical Center, a teaching hospital that operates under a joint agreement between the school, the state and Nashville-based HCA Inc.

HCA, which runs 190 hospitals in the United States and overseas, has become one of the leaders in the campaign to curb expansion of physician-owned specialty
hospitals across the country. ''This is a hugely important issue,'' HCA Senior Vice President Victor Campbell said.

What makes it important to companies such as HCA is that doctors are allowed to refer patients to facilities the doctors also own.Critics such as the American Hospital Association say this ''self-referral'' gives doctors an unfair advantage because they refer patients to their own hospitals and take the best-insured patients.

... But proponents of the hospitals dismiss such arguments as self-serving.''They bring competition to the community and bring a new way of thinking of health care,'' said Jim Grant, president of the American Surgical Hospital Association and a Nashville resident. ''They should be promoted.''

... Speaking recently before a House subcommittee looking at the issue of specialty hospitals, one AMA trustee said simply, ''Competition works.'' ''In the hospital industry, the addition of specialty hospitals to the mix gives patients more choice, forcing existing hospitals to innovate to keep patients coming to them,'' said the trustee, William Plested, a Santa Monica, Calif., heart surgeon who isn't affiliated with a specialty hospital.

Princess Health and HCA leads campaign to curb doctor-owned hospitals.Princessiccia

Princess Health and HCA leads campaign to curb doctor-owned hospitals.Princessiccia

HCA

Gusty 05:53 Add Comment

An interesting article on the competition between physicians opening specialty hospitals owned by themselves and corporate medicine. Big-business medicine whines that physician-owned specialty centers gives physicians an "unfair advantage." I would classify this story under the heading "The World's Smallest Violin."

Big-business medicine claims physicians "cherry-pick" the best-insured patients for their centers. However, managed care and for-profits tend to try exactly the same thing to minimize care delivery, maximize corporate profit and shareholder value, and minimize physician income in the bargain to add insult to injury.

Businessmen need to realize that in essence, clinicians are the true owners of hospitals. As I've often said, in a somewhat tongue-in-cheek example, even if hospitals all burned to the ground in some hypothetical apocalypse, clinicians could still take care of patients to a good extent in tents using primitive equipment. They are enablers of healthcare; everyone else is a facilitator. (If only clinicians would become more politically astute and use this realization more aggressively.)

Dear HCA, welcome to the true marketplace of competition from those who actually know what they're doing in medicine, its practitioners.

-- SS

HCA leads campaign to curb doctor-owned hospitals (excerpts)
By TODD PACK
Staff Writer, Tennesean.com

Before many of its heart surgeons left to become owners in a nearby specialty hospital, Oklahoma University Medical Center admitted 150 heart patients a month. Soon afterthe doctor's hospital opened, OU's cardiovascular admissions fell to zero.I t was a drop in business that has cost OU nearly $12 million since 2002 and threatened its ability to care for Oklahoma's most critically injured patients, OU's chief medical officer said. ''Simply put, these facilities drain essential resources from full-service community hospitals,'' said Dr. Andy Sullivan, chief medical officer of the OU Medical Center, a teaching hospital that operates under a joint agreement between the school, the state and Nashville-based HCA Inc.

HCA, which runs 190 hospitals in the United States and overseas, has become one of the leaders in the campaign to curb expansion of physician-owned specialty
hospitals across the country. ''This is a hugely important issue,'' HCA Senior Vice President Victor Campbell said.

What makes it important to companies such as HCA is that doctors are allowed to refer patients to facilities the doctors also own.Critics such as the American Hospital Association say this ''self-referral'' gives doctors an unfair advantage because they refer patients to their own hospitals and take the best-insured patients.

... But proponents of the hospitals dismiss such arguments as self-serving.''They bring competition to the community and bring a new way of thinking of health care,'' said Jim Grant, president of the American Surgical Hospital Association and a Nashville resident. ''They should be promoted.''

... Speaking recently before a House subcommittee looking at the issue of specialty hospitals, one AMA trustee said simply, ''Competition works.'' ''In the hospital industry, the addition of specialty hospitals to the mix gives patients more choice, forcing existing hospitals to innovate to keep patients coming to them,'' said the trustee, William Plested, a Santa Monica, Calif., heart surgeon who isn't affiliated with a specialty hospital.

Princess Health and Health Care Renewal Bloggers to Speak. Princessiccia

Princess Health and Health Care Renewal Bloggers to Speak. Princessiccia

Gusty 13:10 Add Comment

Kim Atwood and Tim Gorski will be speaking at a conference entitled "Curing the Ills of Alternative Medicine and Questionable Mental Health Practices." The date is May 21, 2005, and the location is Amherst, NY. Atwood will be talking about �Naturopathic Medicine: Politics Trumps Science� and Gorski, �They Ain�t Measuring What They�re Measuring.�
Wally Smith and I will be giving a Special Symposium entitled "External Threats to Professionalism in a Chaotic Health Care Environment, Thursday, May 12, 2005 at the Society for General Internal Medicine annual meeting in New Orleans. Note that the meeting theme is Out of Chaos: The Critical Role of Generalists. The meeting dates are May 11-14, 2005.

Princess Health and Health Care Renewal Bloggers to Speak.Princessiccia

Princess Health and Health Care Renewal Bloggers to Speak.Princessiccia

Gusty 13:10 Add Comment

Kim Atwood and Tim Gorski will be speaking at a conference entitled "Curing the Ills of Alternative Medicine and Questionable Mental Health Practices." The date is May 21, 2005, and the location is Amherst, NY. Atwood will be talking about �Naturopathic Medicine: Politics Trumps Science� and Gorski, �They Ain�t Measuring What They�re Measuring.�
Wally Smith and I will be giving a Special Symposium entitled "External Threats to Professionalism in a Chaotic Health Care Environment, Thursday, May 12, 2005 at the Society for General Internal Medicine annual meeting in New Orleans. Note that the meeting theme is Out of Chaos: The Critical Role of Generalists. The meeting dates are May 11-14, 2005.

Princess Health and How Academic Health Centers' Advertising Put Their Interests Ahead of Those of Patients. Princessiccia

Princess Health and How Academic Health Centers' Advertising Put Their Interests Ahead of Those of Patients. Princessiccia

academic medical centers deception marketing

Gusty 08:48 Add Comment

An important article was just published in the Archives of Internal Medicine on the use of advertising by academic health centers (AHCs). [Larson RJ et al. Advertising by academic medical centers. Arch Intern Med 2005; 165: 645-651.] (For a typical media report on it, go here.)
The authors surveyed marketing departments of 17 top rated (by US News and World Report) AHCs to assess the process used to construct advertisements. They then searched for print advertisements placed by the AHCs in local newspapers, and did a structured assessment of each ad.
Let me quote from their results section (with italics added for emphasis). First, the process of development and approval of the ads was almost never supervised by physicians:

• "About two thirds of the marketing department representatives were familiar with their institutional review board's process for assuring fair, balanced, and straightforward content in advertising to attract research participants. None of the marketing departments had a similar process for reviewing ads to attract patients for health services."
• "Only 1 center had a mechanism in place for obtaining medical approval from a person outside the department being advertised."

Now, re the ads themselves:

• The ads promoted dubious services, "Of the 21 ads for single [clinical] services,.... 19 single-service advertisements were for procedures considered cosmetic ..., having limited (or no) efficacy data, ... or lacking consensus."
• The ads played on patients' emotions, "Most of the institutions' slogans emphasized cutting-edge care and institution status.... The remaining slogans tended to use emotional themes." "Advertising headlines ... commonly mentioned symptoms or diseases or used strategies that might appeal to patients' emotions or fears."
• The ads exaggerated benefits while avoiding mention of harms, "While more than three quarters of the single-service ads highlighted potential benefits of the services promoted... none quantified their positive claims. Only 1 ad mentioned or implied potential harms of the service...."

And their summary included:

• "Given the prestige of academic medical centers ... consumers may have great confidence in the quality , accuracy, and underlying altruistic motivations of any information with which the institutions are associated. Because of this trust, consumers may not recognize the different between information intended to inform the public and advertising designed to generate revenue."
• "Second, many of the ads seemed to foster the perception that more and higher-technology medicine is always better." "As a result, patients may be given false hopes and unrealistic expectations."

Finally, they concluded with this:

• "If academic medical centers are to continue with advertising to attract patients, we believe they must be more sensitive to the conflict of interest between public health and making money."

Their abstract's conclusion was even more blunt:

• "Many of the ads seem to place the interests of the medical center before the interests of the patients."

This is a terrific article, providing new awareness of yet another way in which important medical organizations are straying from their mission, with patients as the biggest losers.

Princess Health and How Academic Health Centers' Advertising Put Their Interests Ahead of Those of Patients.Princessiccia

Princess Health and How Academic Health Centers' Advertising Put Their Interests Ahead of Those of Patients.Princessiccia

academic medical centers deception marketing

Gusty 08:48 Add Comment

An important article was just published in the Archives of Internal Medicine on the use of advertising by academic health centers (AHCs). [Larson RJ et al. Advertising by academic medical centers. Arch Intern Med 2005; 165: 645-651.] (For a typical media report on it, go here.)
The authors surveyed marketing departments of 17 top rated (by US News and World Report) AHCs to assess the process used to construct advertisements. They then searched for print advertisements placed by the AHCs in local newspapers, and did a structured assessment of each ad.
Let me quote from their results section (with italics added for emphasis). First, the process of development and approval of the ads was almost never supervised by physicians:

• "About two thirds of the marketing department representatives were familiar with their institutional review board's process for assuring fair, balanced, and straightforward content in advertising to attract research participants. None of the marketing departments had a similar process for reviewing ads to attract patients for health services."
• "Only 1 center had a mechanism in place for obtaining medical approval from a person outside the department being advertised."

Now, re the ads themselves:

• The ads promoted dubious services, "Of the 21 ads for single [clinical] services,.... 19 single-service advertisements were for procedures considered cosmetic ..., having limited (or no) efficacy data, ... or lacking consensus."
• The ads played on patients' emotions, "Most of the institutions' slogans emphasized cutting-edge care and institution status.... The remaining slogans tended to use emotional themes." "Advertising headlines ... commonly mentioned symptoms or diseases or used strategies that might appeal to patients' emotions or fears."
• The ads exaggerated benefits while avoiding mention of harms, "While more than three quarters of the single-service ads highlighted potential benefits of the services promoted... none quantified their positive claims. Only 1 ad mentioned or implied potential harms of the service...."

And their summary included:

• "Given the prestige of academic medical centers ... consumers may have great confidence in the quality , accuracy, and underlying altruistic motivations of any information with which the institutions are associated. Because of this trust, consumers may not recognize the different between information intended to inform the public and advertising designed to generate revenue."
• "Second, many of the ads seemed to foster the perception that more and higher-technology medicine is always better." "As a result, patients may be given false hopes and unrealistic expectations."

Finally, they concluded with this:

• "If academic medical centers are to continue with advertising to attract patients, we believe they must be more sensitive to the conflict of interest between public health and making money."

Their abstract's conclusion was even more blunt:

• "Many of the ads seem to place the interests of the medical center before the interests of the patients."

This is a terrific article, providing new awareness of yet another way in which important medical organizations are straying from their mission, with patients as the biggest losers.

Princess Health and From Harvard: Bigotry, the Disabled and Slippery Slopes. Princessiccia

Princess Health and From Harvard: Bigotry, the Disabled and Slippery Slopes. Princessiccia

Gusty 04:57 Add Comment

The Philadelphia Inquirer has not replied to me nor, as far as I know, retracted its statement published on two consecutive days that in euthanasia, "Even a normal, healthy person would feel little discomfort after the first few days of thirst."

Perhaps they should read this article from the Harvard Crimson by a student with severe cerebral palsy. I agree with its author that judges, politicians and the mainstream media are driving healthcare down some very slippery slopes.

Of note towards lack of discomfort via starvation is this link cited in the Harvard Crimson article.

-- SS

Princess Health and From Harvard: Bigotry, the Disabled and Slippery Slopes.Princessiccia

Princess Health and From Harvard: Bigotry, the Disabled and Slippery Slopes.Princessiccia

Gusty 04:57 Add Comment

The Philadelphia Inquirer has not replied to me nor, as far as I know, retracted its statement published on two consecutive days that in euthanasia, "Even a normal, healthy person would feel little discomfort after the first few days of thirst."

Perhaps they should read this article from the Harvard Crimson by a student with severe cerebral palsy. I agree with its author that judges, politicians and the mainstream media are driving healthcare down some very slippery slopes.

Of note towards lack of discomfort via starvation is this link cited in the Harvard Crimson article.

-- SS

Princess Health and Pain Management Caught in the Cross-Fire. Princessiccia

Princess Health and Pain Management Caught in the Cross-Fire. Princessiccia

Gusty 12:04 Add Comment

An op-ed in the NY Times about how doctors (and patients) are caught in the cross-fire when the issue is control of pain. Zealous enforcement of the law means doctors whose patients abuse prescribed narcotics are liable to face criminal charges. Meanwhile, advocacy groups have been pushing for more aggressive treatment of pain, and physicians have certainly faced malpractice suits for perceived undertreatment of pain as well. Certainly, physicians should neither over- nor under-treat pain. But also we certainly need a more rational way to set standards for pain treatment that make medical sense and put patients' welfare first.

Princess Health and Pain Management Caught in the Cross-Fire.Princessiccia

Princess Health and Pain Management Caught in the Cross-Fire.Princessiccia

Gusty 12:04 Add Comment

An op-ed in the NY Times about how doctors (and patients) are caught in the cross-fire when the issue is control of pain. Zealous enforcement of the law means doctors whose patients abuse prescribed narcotics are liable to face criminal charges. Meanwhile, advocacy groups have been pushing for more aggressive treatment of pain, and physicians have certainly faced malpractice suits for perceived undertreatment of pain as well. Certainly, physicians should neither over- nor under-treat pain. But also we certainly need a more rational way to set standards for pain treatment that make medical sense and put patients' welfare first.