In an interesting study by D. E. Barnes et al developed a late-life dementia risk index that can accurately stratify older adults into those with a low, moderate, or high risk of developing dementia within 6 years. The authors studied 3,375 participants without evidence of dementia at baseline. They used logistic regression to identify those factors most predictive of developing incident dementia within 6 years and developed a point system based on the logistic regression coefficients.
These subjects had a mean age of 76 years at baseline; 59% were women and 15% were African American. Fourteen percent (n = 480) developed dementia within 6 years.
The final late-life dementia risk index included older age (1–2 points), poor cognitive test performance (2–4 points), body mass index <18.5 style="font-weight: bold;">Conclusions of the authors were that:
The late-life dementia risk index accurately stratified older adults into those with low, moderate, and high risk of developing dementia.
This tool could be used in clinical or research settings to target prevention and intervention strategies toward high-risk individuals.
Neurology 2009, doi:10.1212/WNL.0b013e3181a81636
Friday, June 12, 2009
Thursday, June 11, 2009
POOR COMMUNICATION IN HOSPITAL READMISSIONS
Discharging and readmitting physicians communicated on only about half the patients who returned within 2 weeks.
When patients who are discharged from a hospital are readmitted, do the discharging and readmitting medical teams communicate with each other? To examine this issue, researchers at two Boston teaching hospitals surveyed residents and attending physicians about patients who required short-term readmission after being discharged from general medicine services.
Of 432 consecutive patients who were discharged and readmitted within the next 14 days, 123 had common providers on both teams, and 84 had planned readmissions; thus, 225 cases were analyzed. Discharging teams were aware that their patients had been readmitted in only 49% of cases, and communication occurred between teams in only 44% of cases. When communication did not occur, 61% of respondents believed that communication would have been beneficial.
Comment by Allan S. Brett, MD: These results won’t surprise physicians who work in systems in which hospitalist or resident-attending teams rotate every few weeks.
Better communication likely would enhance quality of care: In caring for hospitalized patients, we learn valuable medical and psychosocial information that doesn’t always appear in discharge summaries. Failure to communicate also results in lost learning opportunities: We surely learn valuable lessons when we see what happens to our patients shortly after hospital discharge. Creating systems to ensure communication between discharging physicians and readmitting physicians simply makes good sense.
Other articles on Hospital readmissions: physician awareness and communication practices.
Roy CL et al J Gen Intern Med. 2009 Mar;24(3):374-80. Epub 2008 Nov 4.Physicians are frequently unaware of patient readmissions and often do not communicate when readmissions occur. This communication is often desired and frequently results in the exchange of important patient information. Further work is needed to design systems to address this potential discontinuity of care.
Inform Prim Care. 2008;16(2):147-55.Design and implementation of a web-based patient portal linked to an electronic health record designed to improve medication safety: the Patient Gateway medications module.
Schnipper JL et al. This module allows patients to view and modify the list of medications and allergies from the EHR, report non-adherence, side effects and other medication-related problems and easily communicate this information to providers, who can verify the information and update the EHR as needed. Usage and satisfaction data indicate that patients found the module easy to use, felt that it led to their providers having more accurate information about them and enabled them to feel more prepared for their forthcoming visits.
J Gen Intern Med. 2008 Sep;23(9):1414-22. Epub 2008 Jun 19.Classifying and predicting errors of inpatient medication reconciliation.
Pippins JR et al.
Unintentional medication discrepancies are common and more often due to errors taking an accurate medication history than errors reconciling this history with patient orders. Focusing on accurate medication histories, on potential medication errors at discharge, and on identifying high-risk patients for more intensive interventions may improve medication safety during and after hospitalization.
J Am Med Inform Assoc. 2008 Jul-Aug;15(4):424-9. Epub 2008 Apr 24 A randomized trial of electronic clinical reminders to improve medication laboratory monitoring.
Matheny ME They identified high rates of inappropriate laboratory monitoring. Electronic reminders did not significantly improve these monitoring rates. Future studies should focus on settings with lower baseline adherence rates and alternate drug-laboratory combinations.
When patients who are discharged from a hospital are readmitted, do the discharging and readmitting medical teams communicate with each other? To examine this issue, researchers at two Boston teaching hospitals surveyed residents and attending physicians about patients who required short-term readmission after being discharged from general medicine services.
Of 432 consecutive patients who were discharged and readmitted within the next 14 days, 123 had common providers on both teams, and 84 had planned readmissions; thus, 225 cases were analyzed. Discharging teams were aware that their patients had been readmitted in only 49% of cases, and communication occurred between teams in only 44% of cases. When communication did not occur, 61% of respondents believed that communication would have been beneficial.
Comment by Allan S. Brett, MD: These results won’t surprise physicians who work in systems in which hospitalist or resident-attending teams rotate every few weeks.
Better communication likely would enhance quality of care: In caring for hospitalized patients, we learn valuable medical and psychosocial information that doesn’t always appear in discharge summaries. Failure to communicate also results in lost learning opportunities: We surely learn valuable lessons when we see what happens to our patients shortly after hospital discharge. Creating systems to ensure communication between discharging physicians and readmitting physicians simply makes good sense.
Other articles on Hospital readmissions: physician awareness and communication practices.
Roy CL et al J Gen Intern Med. 2009 Mar;24(3):374-80. Epub 2008 Nov 4.Physicians are frequently unaware of patient readmissions and often do not communicate when readmissions occur. This communication is often desired and frequently results in the exchange of important patient information. Further work is needed to design systems to address this potential discontinuity of care.
Inform Prim Care. 2008;16(2):147-55.Design and implementation of a web-based patient portal linked to an electronic health record designed to improve medication safety: the Patient Gateway medications module.
Schnipper JL et al. This module allows patients to view and modify the list of medications and allergies from the EHR, report non-adherence, side effects and other medication-related problems and easily communicate this information to providers, who can verify the information and update the EHR as needed. Usage and satisfaction data indicate that patients found the module easy to use, felt that it led to their providers having more accurate information about them and enabled them to feel more prepared for their forthcoming visits.
J Gen Intern Med. 2008 Sep;23(9):1414-22. Epub 2008 Jun 19.Classifying and predicting errors of inpatient medication reconciliation.
Pippins JR et al.
Unintentional medication discrepancies are common and more often due to errors taking an accurate medication history than errors reconciling this history with patient orders. Focusing on accurate medication histories, on potential medication errors at discharge, and on identifying high-risk patients for more intensive interventions may improve medication safety during and after hospitalization.
J Am Med Inform Assoc. 2008 Jul-Aug;15(4):424-9. Epub 2008 Apr 24 A randomized trial of electronic clinical reminders to improve medication laboratory monitoring.
Matheny ME They identified high rates of inappropriate laboratory monitoring. Electronic reminders did not significantly improve these monitoring rates. Future studies should focus on settings with lower baseline adherence rates and alternate drug-laboratory combinations.
Wednesday, June 10, 2009
DOES ALCOHOL MAKE YOU FLUSH?
The Flushing Questionnaire
The flushing questionnaire consists of two questions:
(A) Do you have a tendency to develop facial flushing immediately after drinking a glass (about 180 ml) of beer?
(B) Did you have a tendency to develop facial flushing immediately after drinking a glass of beer in the first one or two years after you started drinking? For both questions, the choice of answers are: yes, no, or unknown.
If an individual answers yes to either question A or B, they are considered to be ALDH-2 deficient. The addition of question B is important because some individuals can become tolerant to the facial flushing effect.
The alcohol flushing response is a biomarker for ALDH2 deficiency. ALDH2-deficient patients have an increased risk for esophageal cancer if they drink even moderate amounts of alcohol. Because of the intensity of the symptoms, most people who have the alcohol flushing response are aware of it. Therefore clinicians can determine ALDH2 deficiency simply by asking about previous episodes of alcohol-induced flushing.
ALDH2-deficient patients can then be counseled to reduce alcohol consumption, and high-risk patients can be assessed for endoscopic cancer screening. The authors estimate that there are at least 540 million ALDH2-deficient individuals in the world, representing approximately 8% of the population. In a population of this size, even a small reduction in the incidence of esophageal cancer could result in a substantial reduction in esophageal cancer deaths worldwide.
Philip J. Brooks e al has documented that approximately 36% of East Asians (Japanese, Chinese, and Koreans) show a characteristic physiological response to drinking alcohol that includes facial flushing nausea, and tachycardia,
This so-called alcohol flushing response is predominantly due to an inherited deficiency in the enzyme aldehyde dehydrogenase 2 (ALDH2) found mostly in Asia but also present in the West.
Few are aware of the accumulating evidence that ALDH2-deficient individuals are at much higher risk of esophageal cancer (specifically squamous cell carcinoma) from alcohol consumption than individuals with fully active ALDH2.
Esophageal cancer is one of the deadliest cancers worldwide, with five-year survival rates of 15.6% in the United States, 12.3% in Europe, and 31.6% in Japan.
When detected early, esophageal cancer can be treated by endoscopic mucosectomy, a standard and relatively non-invasive procedure. However, once the cancer has grown large enough to penetrate the submucosal layer, the likelihood of lymph node metastasis increases significantly. Only about 20% of esophageal cancer patients survive three years after diagnosis, emphasizing the importance of disease prevention.
In view of the approximately 540 million ALDH2-deficient individuals in the world, many of whom now live in Western societies, even a small percent reduction in esophageal cancers due to a reduction in alcohol drinking would save many lives. Increasing evidence also points to the metabolism of ethanol by microorganisms in the oral cavity as an important source of acetaldehyde in saliva and, by extension, in the esophagus. Acetaldehyde levels in saliva are 10–20 times higher than in blood, due to the local formation of acetaldehyde by oral microorganisms. Importantly, ALDH2 heterozygotes have two to three times the acetaldehyde levels in their saliva compared to fully active ALDH2 individuals after a moderate dose of oral ethanol.
For patients at high risk of esophageal cancer, doctors should also consider endoscopy for early cancer detection.
Using a version of the health risk assessment that includes the flushing questionnaire as a major component, it has been estimated that approximately 58% of esophageal cancers in the population could be detected by screening.
Philip J. Brooks et al. The Alcohol Flushing Response: An Unrecognized Risk Factor for Esophageal Cancer from Alcohol Consumption. PLoS Med 6(3): e1000050. doi:10.1371/journal.pmed.1000050
The flushing questionnaire consists of two questions:
(A) Do you have a tendency to develop facial flushing immediately after drinking a glass (about 180 ml) of beer?
(B) Did you have a tendency to develop facial flushing immediately after drinking a glass of beer in the first one or two years after you started drinking? For both questions, the choice of answers are: yes, no, or unknown.
If an individual answers yes to either question A or B, they are considered to be ALDH-2 deficient. The addition of question B is important because some individuals can become tolerant to the facial flushing effect.
The alcohol flushing response is a biomarker for ALDH2 deficiency. ALDH2-deficient patients have an increased risk for esophageal cancer if they drink even moderate amounts of alcohol. Because of the intensity of the symptoms, most people who have the alcohol flushing response are aware of it. Therefore clinicians can determine ALDH2 deficiency simply by asking about previous episodes of alcohol-induced flushing.
ALDH2-deficient patients can then be counseled to reduce alcohol consumption, and high-risk patients can be assessed for endoscopic cancer screening. The authors estimate that there are at least 540 million ALDH2-deficient individuals in the world, representing approximately 8% of the population. In a population of this size, even a small reduction in the incidence of esophageal cancer could result in a substantial reduction in esophageal cancer deaths worldwide.
Philip J. Brooks e al has documented that approximately 36% of East Asians (Japanese, Chinese, and Koreans) show a characteristic physiological response to drinking alcohol that includes facial flushing nausea, and tachycardia,
This so-called alcohol flushing response is predominantly due to an inherited deficiency in the enzyme aldehyde dehydrogenase 2 (ALDH2) found mostly in Asia but also present in the West.
Few are aware of the accumulating evidence that ALDH2-deficient individuals are at much higher risk of esophageal cancer (specifically squamous cell carcinoma) from alcohol consumption than individuals with fully active ALDH2.
Esophageal cancer is one of the deadliest cancers worldwide, with five-year survival rates of 15.6% in the United States, 12.3% in Europe, and 31.6% in Japan.
When detected early, esophageal cancer can be treated by endoscopic mucosectomy, a standard and relatively non-invasive procedure. However, once the cancer has grown large enough to penetrate the submucosal layer, the likelihood of lymph node metastasis increases significantly. Only about 20% of esophageal cancer patients survive three years after diagnosis, emphasizing the importance of disease prevention.
In view of the approximately 540 million ALDH2-deficient individuals in the world, many of whom now live in Western societies, even a small percent reduction in esophageal cancers due to a reduction in alcohol drinking would save many lives. Increasing evidence also points to the metabolism of ethanol by microorganisms in the oral cavity as an important source of acetaldehyde in saliva and, by extension, in the esophagus. Acetaldehyde levels in saliva are 10–20 times higher than in blood, due to the local formation of acetaldehyde by oral microorganisms. Importantly, ALDH2 heterozygotes have two to three times the acetaldehyde levels in their saliva compared to fully active ALDH2 individuals after a moderate dose of oral ethanol.
For patients at high risk of esophageal cancer, doctors should also consider endoscopy for early cancer detection.
Using a version of the health risk assessment that includes the flushing questionnaire as a major component, it has been estimated that approximately 58% of esophageal cancers in the population could be detected by screening.
Philip J. Brooks et al. The Alcohol Flushing Response: An Unrecognized Risk Factor for Esophageal Cancer from Alcohol Consumption. PLoS Med 6(3): e1000050. doi:10.1371/journal.pmed.1000050
Tuesday, June 9, 2009
NEW MEDICAL CONFLICT OF INTEREST GUIDELINES
In 2007, nearly half of the $2.54 billion in income for CME providers accredited by the Accreditation Council for Continuing Medical Education (ACCME) was from commercial support (companies with a product in the marketplace); over the past decade, commercial support has quadrupled. The committee found that CME "has become far too reliant on industry funding" and that this funding "tends to promote a narrow focus on products," not "a broader education on alternative strategies for managing health conditions. It concluded "that the current system of funding is unacceptable and should not continue."
In March 2009, despite increasing pressures for reform the ACCME,announced that it would "not be taking any action to end the commercial support" of accredited CME and affirmed its systems and standards for keeping CME "free of commercial bias."
As if in response in late April 2009, the Institute of Medicine (IOM) issued a report on conflicts of interest that is notable for its breadth — it covers many aspects of medical research, education, and practice as well as both individual and institutional financial relationships.
The IOM defined a conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." Secondary interests "may include not only financial gain but also the desire for professional advancement, recognition for personal achievement, and favors to friends and family or to students and colleagues."
Overview of IOM Recommendations about Conflict of Interest in Medicine.
• Institutions engaged in medical research and education, clinical care, and the development of clinical practice guidelines should "adopt and implement conflict of interest policies" and "strengthen disclosure policies."
• Congress "should create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities." Until Congress acts, "companies should voluntarily adopt such reporting."
• Academic medical centers, research institutions, and medical researchers should "restrict participation of researchers with conflicts of interest in research with human participants." Exceptions "should be made public."
• Academic medical centers, teaching hospitals, faculty members, students, residents, and fellows should "reform relationships with industry in medical education"; these institutions and professional societies should "provide education on conflict of interest."
• The organizations that created the accrediting program for continuing medical education and other interested groups should reform the financing system so that it is "free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education."
• Physicians, professional societies, hospitals, and other health care providers should reform physicians' financial relationships with industry; the same standards should apply to community physicians, medical school faculty, and trainees. Physicians should forgo all gifts and other "items of material value" from pharmaceutical, medical-device, and biotechnology companies, accepting only "payment at fair market value for a legitimate service" in specified situations. Physicians should "not make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged." Physicians should "not meet with pharmaceutical and medical device sales representatives except by documented appointment and at the physician's express invitation" and should "not accept drug samples except in certain situations for patients who lack financial access to medications." Until institutions change their policies, physicians and trainees "should voluntarily adopt" these recommendations "as standards for their own conduct."
• Medical companies and their foundations should reform interactions with physicians — for example, by instituting "policies and practices against providing physicians with gifts, meals, drug samples (except for use by patients who lack financial access to medications), or other similar items of material value and against asking physicians to be authors of ghostwritten materials." Consulting arrangements "should be for necessary services, documented in written contracts, and paid for at fair market value." Companies "should not involve physicians and patients in marketing projects that are presented as clinical research."
• Groups that develop clinical practice guidelines should restrict industry funding and conflicts of panel members. Various entities, including accrediting and certification bodies, formulary committees, health insurers, and public agencies should "create incentives for reducing conflicts in clinical practice guideline development."
• The governing bodies of institutions engaged in medical research, medical education, patient care, or guideline development "should establish their own standing committees on institutional conflicts of interest" that "have no members who themselves have conflicts of interest relevant to the activities of the institution."
• The National Institutes of Health should revise federal regulations to require research institutions to have policies on institutional conflicts of interest, including "the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts."
• Oversight bodies and other groups should "provide additional incentives for institutions to adopt and implement" conflict-of-interest policies, such as by publicizing the names of institutions that have instituted the recommended policies and those that have not.
• The Department of Health and Human Services and its agencies should develop and fund research agendas on conflict of interest.
Adapted from Steinbrook R. NEJM 360;21:2160
COMMENT:
On Clinical practice guidelines.
Perhaps the most dangerous of these comments are that with regard to clinical practice guidelines the IOM found that "the risk of undue industry influence . . . is significant."
Specific recommendations were made for strengthening conflict-of-interest policies.
These include a general exclusion of panel members with conflicts of interest, a prohibition on direct funding for guideline development from industry or industry-controlled foundations, and complete disclosure of any remaining financial associations or industry funding.
In exceptional circumstances "in which avoidance of panel members with conflicts of interest is impossible because of the critical need for their expertise," groups should take measures such as publicly documenting that they had made good-faith efforts to find experts without conflicts, for example, by advertising for members, appointing a chair without a conflict of interest, limiting members with conflicts to "a distinct minority," excluding participants with conflicts from "deliberating, drafting, or voting on specific recommendations," and publicly disclosing the "relevant conflicts of interest of panel members."
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
In March 2009, despite increasing pressures for reform the ACCME,announced that it would "not be taking any action to end the commercial support" of accredited CME and affirmed its systems and standards for keeping CME "free of commercial bias."
As if in response in late April 2009, the Institute of Medicine (IOM) issued a report on conflicts of interest that is notable for its breadth — it covers many aspects of medical research, education, and practice as well as both individual and institutional financial relationships.
The IOM defined a conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." Secondary interests "may include not only financial gain but also the desire for professional advancement, recognition for personal achievement, and favors to friends and family or to students and colleagues."
Overview of IOM Recommendations about Conflict of Interest in Medicine.
• Institutions engaged in medical research and education, clinical care, and the development of clinical practice guidelines should "adopt and implement conflict of interest policies" and "strengthen disclosure policies."
• Congress "should create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities." Until Congress acts, "companies should voluntarily adopt such reporting."
• Academic medical centers, research institutions, and medical researchers should "restrict participation of researchers with conflicts of interest in research with human participants." Exceptions "should be made public."
• Academic medical centers, teaching hospitals, faculty members, students, residents, and fellows should "reform relationships with industry in medical education"; these institutions and professional societies should "provide education on conflict of interest."
• The organizations that created the accrediting program for continuing medical education and other interested groups should reform the financing system so that it is "free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education."
• Physicians, professional societies, hospitals, and other health care providers should reform physicians' financial relationships with industry; the same standards should apply to community physicians, medical school faculty, and trainees. Physicians should forgo all gifts and other "items of material value" from pharmaceutical, medical-device, and biotechnology companies, accepting only "payment at fair market value for a legitimate service" in specified situations. Physicians should "not make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged." Physicians should "not meet with pharmaceutical and medical device sales representatives except by documented appointment and at the physician's express invitation" and should "not accept drug samples except in certain situations for patients who lack financial access to medications." Until institutions change their policies, physicians and trainees "should voluntarily adopt" these recommendations "as standards for their own conduct."
• Medical companies and their foundations should reform interactions with physicians — for example, by instituting "policies and practices against providing physicians with gifts, meals, drug samples (except for use by patients who lack financial access to medications), or other similar items of material value and against asking physicians to be authors of ghostwritten materials." Consulting arrangements "should be for necessary services, documented in written contracts, and paid for at fair market value." Companies "should not involve physicians and patients in marketing projects that are presented as clinical research."
• Groups that develop clinical practice guidelines should restrict industry funding and conflicts of panel members. Various entities, including accrediting and certification bodies, formulary committees, health insurers, and public agencies should "create incentives for reducing conflicts in clinical practice guideline development."
• The governing bodies of institutions engaged in medical research, medical education, patient care, or guideline development "should establish their own standing committees on institutional conflicts of interest" that "have no members who themselves have conflicts of interest relevant to the activities of the institution."
• The National Institutes of Health should revise federal regulations to require research institutions to have policies on institutional conflicts of interest, including "the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts."
• Oversight bodies and other groups should "provide additional incentives for institutions to adopt and implement" conflict-of-interest policies, such as by publicizing the names of institutions that have instituted the recommended policies and those that have not.
• The Department of Health and Human Services and its agencies should develop and fund research agendas on conflict of interest.
Adapted from Steinbrook R. NEJM 360;21:2160
COMMENT:
On Clinical practice guidelines.
Perhaps the most dangerous of these comments are that with regard to clinical practice guidelines the IOM found that "the risk of undue industry influence . . . is significant."
Specific recommendations were made for strengthening conflict-of-interest policies.
These include a general exclusion of panel members with conflicts of interest, a prohibition on direct funding for guideline development from industry or industry-controlled foundations, and complete disclosure of any remaining financial associations or industry funding.
In exceptional circumstances "in which avoidance of panel members with conflicts of interest is impossible because of the critical need for their expertise," groups should take measures such as publicly documenting that they had made good-faith efforts to find experts without conflicts, for example, by advertising for members, appointing a chair without a conflict of interest, limiting members with conflicts to "a distinct minority," excluding participants with conflicts from "deliberating, drafting, or voting on specific recommendations," and publicly disclosing the "relevant conflicts of interest of panel members."
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
Monday, June 8, 2009
FOLIC ACID AND PREGNANCY
Recent evidence suggested that folic acid might decrease the birth prevalence of congenital heart defects, the most common of all birth defects.
Believe it or not, the existing evidence for an association between folic acid and congenital heart defects, however, was still inconclusive in 2007—even though doctors have been prescribing it for a long time. This lack of solid evidence even necessitated a statement from the American Heart Association Council which emphasized the importance of this possible association and the need for corroborative evidence from population based studies.
Canadian researchers examined rates of severe congenital heart defects during the 9 years before folic acid fortification of grains was implemented (1990–1998) and during the 7 years afterward (1999–2005).
They found that while the heart defect rate remained stable before fortification, it dropped an average of 6% per year in the period after.
The authors conclude that the data "support the hypothesis that folic acid has a preventive effect on heart defects.”
SUMMARY:
What is already known on this topic
Animal studies show that folic acid might prevent congenital heart defects. Evidence from one randomized controlled trial and several case-control studies is supportive but not conclusive because prior to this study evidence was lacking from from population based studies.
What this study adds
The birth prevalence of severe congenital heart defects in Quebec, Canada, decreased after the implementation of a public health policy to increase the folic acid intake at the population level. This population based study supports previous evidence that intake of folic acid around conception has a preventive effect on congenital heart defects
BMJ 2009;338:b1673
COMMENT: The evidence now is irrefutable. Folic acid must be part of the nutritional supplements taken in pregnancy.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
Believe it or not, the existing evidence for an association between folic acid and congenital heart defects, however, was still inconclusive in 2007—even though doctors have been prescribing it for a long time. This lack of solid evidence even necessitated a statement from the American Heart Association Council which emphasized the importance of this possible association and the need for corroborative evidence from population based studies.
Canadian researchers examined rates of severe congenital heart defects during the 9 years before folic acid fortification of grains was implemented (1990–1998) and during the 7 years afterward (1999–2005).
They found that while the heart defect rate remained stable before fortification, it dropped an average of 6% per year in the period after.
The authors conclude that the data "support the hypothesis that folic acid has a preventive effect on heart defects.”
SUMMARY:
What is already known on this topic
Animal studies show that folic acid might prevent congenital heart defects. Evidence from one randomized controlled trial and several case-control studies is supportive but not conclusive because prior to this study evidence was lacking from from population based studies.
What this study adds
The birth prevalence of severe congenital heart defects in Quebec, Canada, decreased after the implementation of a public health policy to increase the folic acid intake at the population level. This population based study supports previous evidence that intake of folic acid around conception has a preventive effect on congenital heart defects
BMJ 2009;338:b1673
COMMENT: The evidence now is irrefutable. Folic acid must be part of the nutritional supplements taken in pregnancy.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
Sunday, June 7, 2009
“QUALITY METRICS” IS NOW BECOMING THE STANDARD OF MEDICAL CARE
The Obama administration is working with Congress to mandate that all Medicare payments be tied to "quality metrics." But an analysis of this drive for better health care reveals a fundamental flaw in how quality is defined and metrics applied. In too many cases, the quality measures have been hastily adopted, only to be proven wrong and even detrimental to the patient.
In Massachusetts, there are not only carrots but also sticks to adhere to quality metrics. Physicians who fail to comply with quality guidelines from certain state-based insurers are publicly discredited and their patients required to pay up to three times as much out of pocket to see them. Unfortunately, many states are considering the Massachusetts model for their local insurance.
A colleague who works in an ICU in a medical center in our state told us how his care of the critically ill is closely monitored. If his patients have blood sugars that rise above the metric, he must attend what he calls "re-education sessions" where he is pointedly lectured on the need to adhere to the rule. If he does not strictly comply, his hospital will be downgraded on its quality rating and risks financial loss. His status on the faculty is also at risk should he be seen as delivering low-quality care.
But this coercive approach was turned on its head last month when the New England Journal of Medicine published a randomized study, by the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group, of more than 6,000 critically ill patients in the ICU. Half of the patients received insulin to tightly maintain their sugar in the normal range, and the other half were on a more flexible protocol, allowing higher sugar levels. More patients died in the tightly regulated group than those cared for with the flexible protocol.
Similarly, maintaining normal blood sugar in ambulatory diabetics with vascular problems has been a key quality metric in assessing physician performance. Yet largely due to two extensive studies published in the June 2008 issue of the New England Journal of Medicine, this is now in serious doubt.
Indeed, in one study of more than 10,000 ambulatory diabetics with cardiovascular diseases conducted by a group of Canadian and American researchers (the "ACCORD" study) so many diabetics died in the group where sugar was tightly regulated that the researchers discontinued the trial 17 months before its scheduled end.
And just last month, another clinical trial contradicted the expert consensus guidelines that patients with kidney failure on dialysis should be given statin drugs to prevent heart attack and stroke.
These and other recent examples show why rigid and punitive rules to broadly standardize care for all patients often break down.
Doubts about the relevance of quality metrics to clinical reality are even emerging from the federal pilot programs launched in 2003. An analysis of Medicare pay-for-performance for hip and knee replacement by orthopedic surgeons at 260 hospitals in 38 states published in the most recent March/April issue of Health Affairs showed that conforming to or deviating from expert quality metrics had no relationship to the actual complications or clinical outcomes of the patients.
Similarly, a study led by UCLA researchers of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
In Massachusetts, there are not only carrots but also sticks to adhere to quality metrics. Physicians who fail to comply with quality guidelines from certain state-based insurers are publicly discredited and their patients required to pay up to three times as much out of pocket to see them. Unfortunately, many states are considering the Massachusetts model for their local insurance.
A colleague who works in an ICU in a medical center in our state told us how his care of the critically ill is closely monitored. If his patients have blood sugars that rise above the metric, he must attend what he calls "re-education sessions" where he is pointedly lectured on the need to adhere to the rule. If he does not strictly comply, his hospital will be downgraded on its quality rating and risks financial loss. His status on the faculty is also at risk should he be seen as delivering low-quality care.
But this coercive approach was turned on its head last month when the New England Journal of Medicine published a randomized study, by the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group, of more than 6,000 critically ill patients in the ICU. Half of the patients received insulin to tightly maintain their sugar in the normal range, and the other half were on a more flexible protocol, allowing higher sugar levels. More patients died in the tightly regulated group than those cared for with the flexible protocol.
Similarly, maintaining normal blood sugar in ambulatory diabetics with vascular problems has been a key quality metric in assessing physician performance. Yet largely due to two extensive studies published in the June 2008 issue of the New England Journal of Medicine, this is now in serious doubt.
Indeed, in one study of more than 10,000 ambulatory diabetics with cardiovascular diseases conducted by a group of Canadian and American researchers (the "ACCORD" study) so many diabetics died in the group where sugar was tightly regulated that the researchers discontinued the trial 17 months before its scheduled end.
And just last month, another clinical trial contradicted the expert consensus guidelines that patients with kidney failure on dialysis should be given statin drugs to prevent heart attack and stroke.
These and other recent examples show why rigid and punitive rules to broadly standardize care for all patients often break down.
Doubts about the relevance of quality metrics to clinical reality are even emerging from the federal pilot programs launched in 2003. An analysis of Medicare pay-for-performance for hip and knee replacement by orthopedic surgeons at 260 hospitals in 38 states published in the most recent March/April issue of Health Affairs showed that conforming to or deviating from expert quality metrics had no relationship to the actual complications or clinical outcomes of the patients.
Similarly, a study led by UCLA researchers of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
Saturday, June 6, 2009
The War Of The “Pharmascolds.”
And What Has This To Do With Professors As Impartial Medical Expert Witnesses?
"Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one." - Charles Mackay
Henry Kissinger once said that the reason why fights between academics are so vicious is because the stakes are so low.
But not so in this era. The stakes are pretty high -- in the billions of dollars.
Eric G. Campbell points out in “The Future of Research Funding in Academic Medicine” in the NEJM [April,2009] that” medical schools and teaching hospitals in the United States are essential producers of basic scientific and clinical knowledge that drives our supply of new medicines, devices, and other health care innovations. His points:
• The federal government is the single largest source of financial support for academic life-sciences research in the United States. At the 20 most research-intensive medical schools, an average of 80 to 85% of total research revenues, and about one third of all revenues, come from federal research grants. From 1971 through 2003, the average annual increase in the budget of the National Institutes of Health (NIH) was 9%, or 3.4% with adjustment for inflation. However, in the past 5 years there has been no appreciable growth in this budget — indeed, given the rate of inflation, there was a 13% decrease.
• The second major source of support is industry — makers of medical devices, pharmaceuticals, and biotechnology products, which primarily fund clinical trials and other late-stage clinical research. Although it is difficult to determine the amounts of and trends in industry funding specifically targeted for academic research in the life sciences, the National Science Foundation estimates that the industry's share of support for academic research and development in all fields peaked at 7% in 1999 and decreased to its current level of 5% in 2003. Evidence of this decline can be found in a national survey of medical school researchers conducted in 2008. This has been associated with the growth of contract research organizations and increased focus on international research and the generic drug market.”
• “The future of industry support is uncertain,” says Campbell,” but current trends suggest there will be further decreases.
• Industry-sponsored clinical trials are rapidly moving to poorer countries.
• Reductions in industry funding could make it increasingly difficult for U.S. academic health centers to maintain their clinical and translational research enterprises — and may hit the most productive and senior faculty members hardest, since they are the most reliant on such support.
While medical research funds are decreasing medical schools across the U.S. have come under fire for not fully disclosing financial ties between researchers, pharmaceutical and medical-device companies. In October, 2009 Senators Charles Grassley, a Republican from Iowa, and Herb Kohl, a Democrat from Wisconsin inquired about links between 22 university professors and device companies. That shot from Washington started an en masse rush towards the exits.
In a hurried response medical schools across the country like Johns Hopkins University’s medical school say [NYT 4/8/09] that they will restrict interactions between doctors and industry representatives. Stanford University School of Medicine, said ON April 1, 2009 that it will require doctors to post industry income and royalty payments on a school Web site. Harvard Medical School also promised that it will review its policies on conflicts of interest in drug research. Columbia University is doing the same thing.
“The outrage comes easily for Grassley — but there are some gray areas” say observers. Medical-school professors get their jobs in the first place because they know their fields. Forbid such educated people to consult with the companies that develop new medicines and you cut off a valuable source of knowledge. What's more, pharma's largesse also flows to the schools themselves in the form of multimillion-dollar endowments. Whether or not the companies are trying to curry favor, they're also building labs and bankrolling scholarships — something that becomes increasingly important as the deteriorating 2009 economy causes philanthropic giving to dry up. No one disagrees that isolating academia from the industry may be ideal, but even many academics concede that the cooperation yields more good than harm.
Though admitting that “working with industry is essential to fulfilling our academic mission, “we have to do it in a way that removes potential bias and preserves the public trust in our institutions,” said Eugene Braunwald, a noted cardiologist. In other words we don’t like the bad publicity. "We don't want our faculty being on the road" as "hired guns," chimed in Dr. Peter Slavin, president of the prestigious Mass. General Hospital who joined the herd rushing to the exits. Slavin maintains that he wants to prohibit physicians from eating meals on a company's tab, including lunches bought for doctors-in-training in the hospital, because it "doesn't promote a positive image of physicians and increases healthcare costs." How does it increase healthcare costs—he doesn’t say.
These new university policies also prohibit gifts like pads, pens and pencils, entertainment or food to underlings like house-staff or even attending physicians— regardless of low value — from drug and medical device companies.
Talk about using a crisis to get what you want — here’s the kicker—donations [if any] from industry will have to be given to the Medical schools themselves rather than individual doctors. This puts the dollars right where the deans and university presidents have always wanted it.
Although Campbell above has shown that industry dollars are dwindling a harsh critic of industry medical school partnerships — Dr. Arnold Relman, a Harvard Medical School professor and former editor of the New England Journal of Medicine, complains that the medical education provisions don't go far enough. "There should be no, zero, industry funding for any particular educational program," he says. "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact."
Critics on the opposite side of the fence like Dr. Thomas Stossel, say restrictions on the interactions between doctors and industry could ultimately hurt patient care. "We have all these tools now for caring for patients, and those tools have come from physicians working with industry." Dr. Stossel, professor of medicine at Harvard, was joined by David A. Shaywitz, a management consultant to add [4/9/09, NYT] that this situation is "largely because of the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds’. They routinely vilify the medical products industry and portray academics working with it as traitors and sellouts."
“Given the vital role of medical products companies and the magnitude of their challenges, one might imagine that this industry would be admired,” they say. “These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit — it's all "corruption" in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities — to demonize the market and portray scientific medicine as an ascetic religion, which it is not.”
Are the problems of the full time salaried academic medical expert who should be impartial in court not solved by these “reforms?”
Not according to Dr. Arnold Relman who complains above that the medical education provisions don't go far enough and that there should be no, zero, industry funding for any particular educational program," ..because "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact." In other words it’s hard for an academician receiving money even indirectly from drug companies to not be biased. It is difficult for a medical expert witness who draws his salary from a medical school and now indirectly from a drug company to be fair about anything involving the company’s drugs —especially if the case involves a patient receiving one of these drugs
That’s it in a nutshell. How is bias removed from a medical expert whose fulltime salary is paid by a fund granted by industry? Does not the expert know which drug company[s] are paying his weekly salary? Does he not know which drugs are being worked on by his medical school —and his colleagues? And does he not know that money coming in to pay his salary depends on the medical school’s relationship with the drug company?
The opposing attorney knows full well that you cannot leap a chasm in two jumps. Removing food and do-dads from medical student lunch boxes and replacing the saved money into the deans coffers offers no consolation to the academic medical expert if his salary is now being paid by the drug company. In fact, where there were only a few academic full timers on a drug company payroll there are now hundreds more who are on the entire medical school full time faculty payroll — feeding from the same trough.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
"Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one." - Charles Mackay
Henry Kissinger once said that the reason why fights between academics are so vicious is because the stakes are so low.
But not so in this era. The stakes are pretty high -- in the billions of dollars.
Eric G. Campbell points out in “The Future of Research Funding in Academic Medicine” in the NEJM [April,2009] that” medical schools and teaching hospitals in the United States are essential producers of basic scientific and clinical knowledge that drives our supply of new medicines, devices, and other health care innovations. His points:
• The federal government is the single largest source of financial support for academic life-sciences research in the United States. At the 20 most research-intensive medical schools, an average of 80 to 85% of total research revenues, and about one third of all revenues, come from federal research grants. From 1971 through 2003, the average annual increase in the budget of the National Institutes of Health (NIH) was 9%, or 3.4% with adjustment for inflation. However, in the past 5 years there has been no appreciable growth in this budget — indeed, given the rate of inflation, there was a 13% decrease.
• The second major source of support is industry — makers of medical devices, pharmaceuticals, and biotechnology products, which primarily fund clinical trials and other late-stage clinical research. Although it is difficult to determine the amounts of and trends in industry funding specifically targeted for academic research in the life sciences, the National Science Foundation estimates that the industry's share of support for academic research and development in all fields peaked at 7% in 1999 and decreased to its current level of 5% in 2003. Evidence of this decline can be found in a national survey of medical school researchers conducted in 2008. This has been associated with the growth of contract research organizations and increased focus on international research and the generic drug market.”
• “The future of industry support is uncertain,” says Campbell,” but current trends suggest there will be further decreases.
• Industry-sponsored clinical trials are rapidly moving to poorer countries.
• Reductions in industry funding could make it increasingly difficult for U.S. academic health centers to maintain their clinical and translational research enterprises — and may hit the most productive and senior faculty members hardest, since they are the most reliant on such support.
While medical research funds are decreasing medical schools across the U.S. have come under fire for not fully disclosing financial ties between researchers, pharmaceutical and medical-device companies. In October, 2009 Senators Charles Grassley, a Republican from Iowa, and Herb Kohl, a Democrat from Wisconsin inquired about links between 22 university professors and device companies. That shot from Washington started an en masse rush towards the exits.
In a hurried response medical schools across the country like Johns Hopkins University’s medical school say [NYT 4/8/09] that they will restrict interactions between doctors and industry representatives. Stanford University School of Medicine, said ON April 1, 2009 that it will require doctors to post industry income and royalty payments on a school Web site. Harvard Medical School also promised that it will review its policies on conflicts of interest in drug research. Columbia University is doing the same thing.
“The outrage comes easily for Grassley — but there are some gray areas” say observers. Medical-school professors get their jobs in the first place because they know their fields. Forbid such educated people to consult with the companies that develop new medicines and you cut off a valuable source of knowledge. What's more, pharma's largesse also flows to the schools themselves in the form of multimillion-dollar endowments. Whether or not the companies are trying to curry favor, they're also building labs and bankrolling scholarships — something that becomes increasingly important as the deteriorating 2009 economy causes philanthropic giving to dry up. No one disagrees that isolating academia from the industry may be ideal, but even many academics concede that the cooperation yields more good than harm.
Though admitting that “working with industry is essential to fulfilling our academic mission, “we have to do it in a way that removes potential bias and preserves the public trust in our institutions,” said Eugene Braunwald, a noted cardiologist. In other words we don’t like the bad publicity. "We don't want our faculty being on the road" as "hired guns," chimed in Dr. Peter Slavin, president of the prestigious Mass. General Hospital who joined the herd rushing to the exits. Slavin maintains that he wants to prohibit physicians from eating meals on a company's tab, including lunches bought for doctors-in-training in the hospital, because it "doesn't promote a positive image of physicians and increases healthcare costs." How does it increase healthcare costs—he doesn’t say.
These new university policies also prohibit gifts like pads, pens and pencils, entertainment or food to underlings like house-staff or even attending physicians— regardless of low value — from drug and medical device companies.
Talk about using a crisis to get what you want — here’s the kicker—donations [if any] from industry will have to be given to the Medical schools themselves rather than individual doctors. This puts the dollars right where the deans and university presidents have always wanted it.
Although Campbell above has shown that industry dollars are dwindling a harsh critic of industry medical school partnerships — Dr. Arnold Relman, a Harvard Medical School professor and former editor of the New England Journal of Medicine, complains that the medical education provisions don't go far enough. "There should be no, zero, industry funding for any particular educational program," he says. "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact."
Critics on the opposite side of the fence like Dr. Thomas Stossel, say restrictions on the interactions between doctors and industry could ultimately hurt patient care. "We have all these tools now for caring for patients, and those tools have come from physicians working with industry." Dr. Stossel, professor of medicine at Harvard, was joined by David A. Shaywitz, a management consultant to add [4/9/09, NYT] that this situation is "largely because of the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds’. They routinely vilify the medical products industry and portray academics working with it as traitors and sellouts."
“Given the vital role of medical products companies and the magnitude of their challenges, one might imagine that this industry would be admired,” they say. “These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit — it's all "corruption" in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities — to demonize the market and portray scientific medicine as an ascetic religion, which it is not.”
Are the problems of the full time salaried academic medical expert who should be impartial in court not solved by these “reforms?”
Not according to Dr. Arnold Relman who complains above that the medical education provisions don't go far enough and that there should be no, zero, industry funding for any particular educational program," ..because "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact." In other words it’s hard for an academician receiving money even indirectly from drug companies to not be biased. It is difficult for a medical expert witness who draws his salary from a medical school and now indirectly from a drug company to be fair about anything involving the company’s drugs —especially if the case involves a patient receiving one of these drugs
That’s it in a nutshell. How is bias removed from a medical expert whose fulltime salary is paid by a fund granted by industry? Does not the expert know which drug company[s] are paying his weekly salary? Does he not know which drugs are being worked on by his medical school —and his colleagues? And does he not know that money coming in to pay his salary depends on the medical school’s relationship with the drug company?
The opposing attorney knows full well that you cannot leap a chasm in two jumps. Removing food and do-dads from medical student lunch boxes and replacing the saved money into the deans coffers offers no consolation to the academic medical expert if his salary is now being paid by the drug company. In fact, where there were only a few academic full timers on a drug company payroll there are now hundreds more who are on the entire medical school full time faculty payroll — feeding from the same trough.
Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com
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