ACP IM 2012

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

NEW ORLEANS – The American College of Physicians has issued a policy paper containing at least a dozen recommendations to help reform the Medicare program, including support for having wealthier beneficiaries pay higher premiums and for giving the federal government the ability to negotiate drug prices.

The time to act is now, as the Medicare Trust Fund is due to run out of money in 2024, said ACP President Dr. Virginia Hood at the organization’s annual meeting. But the ACP will not advocate for any reform that would threaten beneficiaries’ access to, or quality of, care, she said.

Alicia Ault/IMNG Medical Media

"Difficult choices must be made to ensure the program’s solvency, but not at the expense of patients’ health," said Dr. Hood at a press briefing.

Robert Doherty, the ACP’s senior vice president of governmental affairs and public policy, said that Medicare had become a political football. "Republicans and Democrats alike are engaging in a war of words about Medicare, trying to scare voters into believing that the other party will destroy the program," he said at the briefing.

But neither party is facing up to the facts, said Mr. Doherty. Given rising health costs, an aging population, and increased cost-shifting to beneficiaries, the program "can’t continue as it is," he said. "Change is coming, change is necessary," Mr. Doherty said.

He and Dr. Hood said that the ACP’s recommendations for reform could help find cost savings, improve value, and protect access to care.

The ACP recommended finding ways to accelerate adoption of the patient-centered medical home concept. But it expressed concern about proposals to transform Medicare from a defined benefit to a defined contribution program. Also known as "premium support," this concept has been advanced by Rep. Paul Ryan (R-Wisc.) and has the backing of many of his GOP colleagues in the House of Representatives.

But, said Dr. Hood, "too little is known today about the impact of a Medicare premium support program on patient access to care." She added, "It’s concerning that with such little information that risky decisions would be made to transition away from the current guaranteed benefit structure."

Instead, the ACP proposes testing such a system. The College also said that the Medicare eligibility age should not be raised unless affordable, comprehensive insurance is made available to those who would now have to wait.

"Advancing the Medicare eligibility age could result in tens of millions of seniors having no access to affordable coverage from age 65 to 67, adding to the ranks of the uninsured," Mr. Doherty said.

The organization recommended that Congress instead give Medicare the authority to redesign benefits, coverage, and cost-sharing so that high-value services are rewarded and lower-value services – which might be not only inappropriate but also harmful – be given less coverage or lower reimbursement.

The ACP waded into somewhat controversial waters by urging Medicare to cover advance planning for patients with terminal illnesses. Payment for the voluntary discussions was included in the Affordable Care Act, but after Republicans said that such counseling might lead to rationing of care – or "death panels" – the Obama administration retracted a rule defining the benefit.

"Voluntary advance care planning should be covered and reimbursed by Medicare to encourage patient-physician engagement and ensure that patients are informed of their palliative and hospice care options," Mr. Doherty said.

Finally, the ACP urged an overhaul of the authority of the Independent Payment Advisory Board. Congress should have the right to approve or disapprove of the IPAB’s recommendations "by a simple majority," according to the policy paper.

Overall, "I do believe that the politicians have to show some leadership," said Mr. Doherty. Both parties need to talk responsibly "about the challenges to sustaining Medicare," and not just talk of "ending Medicare as we know it," he added. Because, he said, "Medicare as we know it is not sustainable. It’s going to have to change."

NEW ORLEANS – The American College of Physicians has issued a policy paper containing at least a dozen recommendations to help reform the Medicare program, including support for having wealthier beneficiaries pay higher premiums and for giving the federal government the ability to negotiate drug prices.

The time to act is now, as the Medicare Trust Fund is due to run out of money in 2024, said ACP President Dr. Virginia Hood at the organization’s annual meeting. But the ACP will not advocate for any reform that would threaten beneficiaries’ access to, or quality of, care, she said.

Alicia Ault/IMNG Medical Media

"Difficult choices must be made to ensure the program’s solvency, but not at the expense of patients’ health," said Dr. Hood at a press briefing.

Robert Doherty, the ACP’s senior vice president of governmental affairs and public policy, said that Medicare had become a political football. "Republicans and Democrats alike are engaging in a war of words about Medicare, trying to scare voters into believing that the other party will destroy the program," he said at the briefing.

But neither party is facing up to the facts, said Mr. Doherty. Given rising health costs, an aging population, and increased cost-shifting to beneficiaries, the program "can’t continue as it is," he said. "Change is coming, change is necessary," Mr. Doherty said.

He and Dr. Hood said that the ACP’s recommendations for reform could help find cost savings, improve value, and protect access to care.

The ACP recommended finding ways to accelerate adoption of the patient-centered medical home concept. But it expressed concern about proposals to transform Medicare from a defined benefit to a defined contribution program. Also known as "premium support," this concept has been advanced by Rep. Paul Ryan (R-Wisc.) and has the backing of many of his GOP colleagues in the House of Representatives.

But, said Dr. Hood, "too little is known today about the impact of a Medicare premium support program on patient access to care." She added, "It’s concerning that with such little information that risky decisions would be made to transition away from the current guaranteed benefit structure."

Instead, the ACP proposes testing such a system. The College also said that the Medicare eligibility age should not be raised unless affordable, comprehensive insurance is made available to those who would now have to wait.

"Advancing the Medicare eligibility age could result in tens of millions of seniors having no access to affordable coverage from age 65 to 67, adding to the ranks of the uninsured," Mr. Doherty said.

The organization recommended that Congress instead give Medicare the authority to redesign benefits, coverage, and cost-sharing so that high-value services are rewarded and lower-value services – which might be not only inappropriate but also harmful – be given less coverage or lower reimbursement.

The ACP waded into somewhat controversial waters by urging Medicare to cover advance planning for patients with terminal illnesses. Payment for the voluntary discussions was included in the Affordable Care Act, but after Republicans said that such counseling might lead to rationing of care – or "death panels" – the Obama administration retracted a rule defining the benefit.

"Voluntary advance care planning should be covered and reimbursed by Medicare to encourage patient-physician engagement and ensure that patients are informed of their palliative and hospice care options," Mr. Doherty said.

Finally, the ACP urged an overhaul of the authority of the Independent Payment Advisory Board. Congress should have the right to approve or disapprove of the IPAB’s recommendations "by a simple majority," according to the policy paper.

Overall, "I do believe that the politicians have to show some leadership," said Mr. Doherty. Both parties need to talk responsibly "about the challenges to sustaining Medicare," and not just talk of "ending Medicare as we know it," he added. Because, he said, "Medicare as we know it is not sustainable. It’s going to have to change."

NEW ORLEANS – The American College of Physicians has issued a policy paper containing at least a dozen recommendations to help reform the Medicare program, including support for having wealthier beneficiaries pay higher premiums and for giving the federal government the ability to negotiate drug prices.

The time to act is now, as the Medicare Trust Fund is due to run out of money in 2024, said ACP President Dr. Virginia Hood at the organization’s annual meeting. But the ACP will not advocate for any reform that would threaten beneficiaries’ access to, or quality of, care, she said.

Alicia Ault/IMNG Medical Media

"Difficult choices must be made to ensure the program’s solvency, but not at the expense of patients’ health," said Dr. Hood at a press briefing.

Robert Doherty, the ACP’s senior vice president of governmental affairs and public policy, said that Medicare had become a political football. "Republicans and Democrats alike are engaging in a war of words about Medicare, trying to scare voters into believing that the other party will destroy the program," he said at the briefing.

But neither party is facing up to the facts, said Mr. Doherty. Given rising health costs, an aging population, and increased cost-shifting to beneficiaries, the program "can’t continue as it is," he said. "Change is coming, change is necessary," Mr. Doherty said.

He and Dr. Hood said that the ACP’s recommendations for reform could help find cost savings, improve value, and protect access to care.

The ACP recommended finding ways to accelerate adoption of the patient-centered medical home concept. But it expressed concern about proposals to transform Medicare from a defined benefit to a defined contribution program. Also known as "premium support," this concept has been advanced by Rep. Paul Ryan (R-Wisc.) and has the backing of many of his GOP colleagues in the House of Representatives.

But, said Dr. Hood, "too little is known today about the impact of a Medicare premium support program on patient access to care." She added, "It’s concerning that with such little information that risky decisions would be made to transition away from the current guaranteed benefit structure."

Instead, the ACP proposes testing such a system. The College also said that the Medicare eligibility age should not be raised unless affordable, comprehensive insurance is made available to those who would now have to wait.

"Advancing the Medicare eligibility age could result in tens of millions of seniors having no access to affordable coverage from age 65 to 67, adding to the ranks of the uninsured," Mr. Doherty said.

The organization recommended that Congress instead give Medicare the authority to redesign benefits, coverage, and cost-sharing so that high-value services are rewarded and lower-value services – which might be not only inappropriate but also harmful – be given less coverage or lower reimbursement.

The ACP waded into somewhat controversial waters by urging Medicare to cover advance planning for patients with terminal illnesses. Payment for the voluntary discussions was included in the Affordable Care Act, but after Republicans said that such counseling might lead to rationing of care – or "death panels" – the Obama administration retracted a rule defining the benefit.

"Voluntary advance care planning should be covered and reimbursed by Medicare to encourage patient-physician engagement and ensure that patients are informed of their palliative and hospice care options," Mr. Doherty said.

Finally, the ACP urged an overhaul of the authority of the Independent Payment Advisory Board. Congress should have the right to approve or disapprove of the IPAB’s recommendations "by a simple majority," according to the policy paper.

Overall, "I do believe that the politicians have to show some leadership," said Mr. Doherty. Both parties need to talk responsibly "about the challenges to sustaining Medicare," and not just talk of "ending Medicare as we know it," he added. Because, he said, "Medicare as we know it is not sustainable. It’s going to have to change."

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.