Don't Rule Out Off-Label Calcineurin Inhibitor Use, Says Expert

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PALM BEACH, ARUBA – Calcineurin inhibitors – used largely off-label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It's a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

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PALM BEACH, ARUBA – Calcineurin inhibitors – used largely off-label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It's a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

PALM BEACH, ARUBA – Calcineurin inhibitors – used largely off-label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It's a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

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Despite Concerns, Calcineurin Inhibitors Remain Useful

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ARUBA, DUTCH CARIBBEAN – Calcineurin inhibitors – used largely off label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It’s a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

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ARUBA, DUTCH CARIBBEAN – Calcineurin inhibitors – used largely off label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It’s a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

ARUBA, DUTCH CARIBBEAN – Calcineurin inhibitors – used largely off label for dermatologic conditions – should become a better-known part of the armamentarium, said Dr. Charles Ellis.

Calcineurin inhibitors work by preventing T-cell activation by blocking calcineurin through its inhibitor immunophilin, said Dr. Ellis, of the University of Michigan, Ann Arbor. Among the drugs in this class are cyclosporine, pimecrolimus, tacrolimus, and a therapy in development, voclosporin. Only pimecrolimus and tacrolimus are available in topical forms.

In the United States, oral cyclosporine is approved for psoriasis but is generally not marketed for the indication, he said. All of the other therapies are used off label, although oral tacrolimus and oral pimecrolimus have been shown to be effective against psoriasis in small studies. The drugs have proved useful for atopic dermatitis, pyoderma gangrenosum, lichen planus, and alopecia areata.

Cyclosporine should not be used for longer than 1 year because it can cause kidney dysfunction, so it is not recommended for psoriasis. And in alopecia, it usually stops working, so he said he generally will not start patients on the drug for this condition.

Voclosporin is being developed for psoriasis by the Canadian company Isotechnika. A phase III trial showed about a 50% improvement in Psoriasis Area and Severity Index (PASI-75) score by week 12; the effect continued through week 24 (Lancet 2008;371:1337-42).

However, patients taking voclosporin had double the rate of headache and gastrointestinal problems as did those on placebo, said Dr. Ellis.

The drug was to be reviewed by a Food and Drug Administration advisory panel in 2010, but the agency cancelled the meeting. In the United States, Isotechnika is seeking approval to treat infectious uveitis; the psoriasis indication is being pursued in Canada. The drug is also in development for prevention of kidney transplant rejection.

Topical calcineurin inhibitors offer a distinct advantage because they do not have the same systemic side effects seen with the oral formulations, said Dr. Ellis.

Pimecrolimus cream and tacrolimus ointment are approved as second-line therapies for short-term chronic treatment of moderate to severe dermatitis in nonimmunocompromised adults and children. They can be used in a standard regimen, with applications up to a week after clearing, or in a proactive regimen, using the topicals until there is clearance, and then applying twice weekly to all affected areas for a year.

Topical calcineurin inhibitors were initially embraced as a potentially safe alternative to topical steroids. But animal data has linked high exposure to lymphoma.

There are no human data to support this as a potential risk, but the FDA, in 2006, added a boxed warning for rare cases of malignancy, he said. "It’s a theoretical problem," but has nonetheless dampened enthusiasm for the drugs, said Dr. Ellis.

Even so, he said, in his practice, topical calcineurin inhibitors are not considered anathema. He uses them off label for psoriasis of the face, groin, and genitals; seborrheic dermatitis; pyoderma gangrenosum; mucosal lichen planus; and vitiligo, among other conditions.

When considering use, weigh the potency, the cost, and how long it takes to discuss the potential risks with patients, said Dr. Ellis.

Astellas Pharma, which markets tacrolimus ointment (Protopic) in the United States, is conducting a very long-term safety study of the therapy in children with atopic dermatitis, which might provide answers on the cancer risk, he said.

He disclosed serving as a consultant to Allergan and Ferndale Laboratories.

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AAD: Cancer Patients With Skin Conditions Not Being Referred

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NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

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NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

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Skin Conditions Can Have Severe Impact in Cancer Patients

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NEW ORLEANS – Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients’ quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient’s ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it’s imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

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NEW ORLEANS – Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients’ quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient’s ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it’s imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

NEW ORLEANS – Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients’ quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient’s ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it’s imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

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Food Allergy Often Inappropriately Diagnosed

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NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

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NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

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AAD: Food Intolerance Misdiagnosed as Allergy in Many

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NEW ORLEANS - Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin.

Also, clinicians are often responsive to parents insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin, of Oregon Health and Science University in Portland, said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish.

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.



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NEW ORLEANS - Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin.

Also, clinicians are often responsive to parents insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin, of Oregon Health and Science University in Portland, said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish.

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.



NEW ORLEANS - Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin.

Also, clinicians are often responsive to parents insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin, of Oregon Health and Science University in Portland, said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish.

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.



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Food Allergy Often Inappropriately Diagnosed

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Food Allergy Often Inappropriately Diagnosed

NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

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NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

NEW ORLEANS – Food allergy continues to be misdiagnosed, in part because of clinician reliance on patch tests and food avoidance tests rather than on overt clinical signs of food allergy, according to Dr. Jon Hanifin of Oregon Health and Science University in Portland.

Photo credit: © Julián Rovagnati/Fotolia.com
    Peanuts, milk and eggs are among the most popular food allergens. 

Also, clinicians are often responsive to parents’ insistence that their children have food allergies. About 75% of what parents suspect to be food allergies are really just food intolerance, Dr. Hanifin said at the annual meeting of the American Academy of Dermatology.

Food allergies typically have a rapid-onset reaction, usually consisting of urticaria, swelling, and respiratory or gastrointestinal symptoms, he said. The most common food allergens are egg, milk, peanut, soy, wheat, and fish

In 2010, the National Institute of Allergy and Infectious Diseases issued new guidelines for the diagnosis and treatment of food allergies. The result of evaluations by a 25-member expert panel, which included three dermatologists, the guidelines were based on a systematic review of the available evidence from the Rand Corp. (JAMA 2010;303:1848-56).

The report concluded that food allergies affect at least 1%-2% – but fewer than 10% – of the United States population, and that most testing is not sufficient to diagnose the condition. Furthermore, food allergy has been misdiagnosed as a result of inadequate diagnostic criteria and the limited sensitivity and specificity of IgE testing.

In the guidelines, food allergy is now defined as an adverse health effect arising from a specific immune response that occurs upon exposure to a given food, said Dr. Hanifin.

Despite the publication of those guidelines, the nature of food allergies continues to be misunderstood, and clinicians continue to struggle to diagnose food allergies, he said. The costs of these misunderstandings include unnecessary visits to physicians and alternative practitioners, expensive test panels, and the expense of special foods. Some children even end up with impaired nutrition or poor growth as a result of dietary changes that were made in the belief that they would alleviate the allergy.

Dr. Hanifin reported no conflicts relevant to this talk.

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FROM THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF DERMATOLOGY

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CMS Proposes Value-Based Purchasing

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A new rule proposed by the Centers for Medicare and Medicaid Services that aims to reward hospitals for quality – above all else – could be a boon for hospitalists, predicted Dr. Patrick Torcson, chair of the Society of Hospital Medicine’s Performance and Standard Committee.

The so-called value-based purchasing program was required under the Affordable Care Act (ACA) and includes proposals for performance standards, a scoring scheme, and suggestions for how the scores could be translated into incentive payments that would first be rewarded to hospitals in the fiscal year beginning Oct. 1, 2012.

It’s unclear exactly how the payments will affect hospital physicians just yet, but "there’s no group better-positioned than hospitalists to help hospitals be successful" under the program, said Dr. Torcson, who practices at the St. Tammany Parish Hospital in Covington, La.

As Dr. Torcson sees it, this program offers "an exciting opportunity for hospitalists to become champions of the hospital-level agenda." The program could give hospitalists leverage in contracting situations. The offer of a team to help the hospital become successful "becomes a leverage point," just as the ability to influence length of stay was a leverage point in the 1990s, he said.

Hospitalists should pay particular attention to how the CMS calculates a bonus payment to the hospital: That payment could end up being the same as – or less or more than –the subsidy a practice receives from the hospital. Hospitals will not balk at the subsidy if the hospitalist physicians can demonstrate how much they contributed to securing the bonus payment, Dr. Torcson said.

"This is now real pay-for-performance," he said, noting that the program is basically an extension of the Hospital Inpatient Quality Reporting program.

CMS Administrator Donald Berwick agreed. "The hospital value-based purchasing program proposal expands upon CMS’ long-standing pay-for-reporting program to reward hospitals not just for reporting data, but for the results of that data," he said.

Hospital quality data have been reported publicly since 2005 at a CMS Web site (www.hospitalcompare.hhs.gov). The quality measures reported for that initiative will be the same under the value-based purchasing program, so every hospitalist will be familiar with these measures, said Dr. Torcson.

The 17 clinical processes of care measures proposed for fiscal 2013 center around acute MI, heart failure, pneumonia, hospital-related infections, and surgical care improvement. Facilities will also be measured on patient satisfaction via the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems Survey).

For fiscal year 2014, the CMS is proposing to incorporate measures on 30-day mortality; hospital-acquired conditions such as falls, pressure ulcers, and catheter-associated infections; and a variety of patient safety measures.

The program will be funded by a reduction in base operating diagnosis-related group (DRG) payments for each discharge. In fiscal 2013, that reduction will be 1%. At 3 months before the Oct. 1, 2012, start of that fiscal year, the CMS will notify hospitals of the estimated amount they will receive as an incentive payment. On Nov. 1, 2012, they’ll get notice of the exact payment amount.

The CMS will take comments on the proposal until March 8.

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A new rule proposed by the Centers for Medicare and Medicaid Services that aims to reward hospitals for quality – above all else – could be a boon for hospitalists, predicted Dr. Patrick Torcson, chair of the Society of Hospital Medicine’s Performance and Standard Committee.

The so-called value-based purchasing program was required under the Affordable Care Act (ACA) and includes proposals for performance standards, a scoring scheme, and suggestions for how the scores could be translated into incentive payments that would first be rewarded to hospitals in the fiscal year beginning Oct. 1, 2012.

It’s unclear exactly how the payments will affect hospital physicians just yet, but "there’s no group better-positioned than hospitalists to help hospitals be successful" under the program, said Dr. Torcson, who practices at the St. Tammany Parish Hospital in Covington, La.

As Dr. Torcson sees it, this program offers "an exciting opportunity for hospitalists to become champions of the hospital-level agenda." The program could give hospitalists leverage in contracting situations. The offer of a team to help the hospital become successful "becomes a leverage point," just as the ability to influence length of stay was a leverage point in the 1990s, he said.

Hospitalists should pay particular attention to how the CMS calculates a bonus payment to the hospital: That payment could end up being the same as – or less or more than –the subsidy a practice receives from the hospital. Hospitals will not balk at the subsidy if the hospitalist physicians can demonstrate how much they contributed to securing the bonus payment, Dr. Torcson said.

"This is now real pay-for-performance," he said, noting that the program is basically an extension of the Hospital Inpatient Quality Reporting program.

CMS Administrator Donald Berwick agreed. "The hospital value-based purchasing program proposal expands upon CMS’ long-standing pay-for-reporting program to reward hospitals not just for reporting data, but for the results of that data," he said.

Hospital quality data have been reported publicly since 2005 at a CMS Web site (www.hospitalcompare.hhs.gov). The quality measures reported for that initiative will be the same under the value-based purchasing program, so every hospitalist will be familiar with these measures, said Dr. Torcson.

The 17 clinical processes of care measures proposed for fiscal 2013 center around acute MI, heart failure, pneumonia, hospital-related infections, and surgical care improvement. Facilities will also be measured on patient satisfaction via the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems Survey).

For fiscal year 2014, the CMS is proposing to incorporate measures on 30-day mortality; hospital-acquired conditions such as falls, pressure ulcers, and catheter-associated infections; and a variety of patient safety measures.

The program will be funded by a reduction in base operating diagnosis-related group (DRG) payments for each discharge. In fiscal 2013, that reduction will be 1%. At 3 months before the Oct. 1, 2012, start of that fiscal year, the CMS will notify hospitals of the estimated amount they will receive as an incentive payment. On Nov. 1, 2012, they’ll get notice of the exact payment amount.

The CMS will take comments on the proposal until March 8.

A new rule proposed by the Centers for Medicare and Medicaid Services that aims to reward hospitals for quality – above all else – could be a boon for hospitalists, predicted Dr. Patrick Torcson, chair of the Society of Hospital Medicine’s Performance and Standard Committee.

The so-called value-based purchasing program was required under the Affordable Care Act (ACA) and includes proposals for performance standards, a scoring scheme, and suggestions for how the scores could be translated into incentive payments that would first be rewarded to hospitals in the fiscal year beginning Oct. 1, 2012.

It’s unclear exactly how the payments will affect hospital physicians just yet, but "there’s no group better-positioned than hospitalists to help hospitals be successful" under the program, said Dr. Torcson, who practices at the St. Tammany Parish Hospital in Covington, La.

As Dr. Torcson sees it, this program offers "an exciting opportunity for hospitalists to become champions of the hospital-level agenda." The program could give hospitalists leverage in contracting situations. The offer of a team to help the hospital become successful "becomes a leverage point," just as the ability to influence length of stay was a leverage point in the 1990s, he said.

Hospitalists should pay particular attention to how the CMS calculates a bonus payment to the hospital: That payment could end up being the same as – or less or more than –the subsidy a practice receives from the hospital. Hospitals will not balk at the subsidy if the hospitalist physicians can demonstrate how much they contributed to securing the bonus payment, Dr. Torcson said.

"This is now real pay-for-performance," he said, noting that the program is basically an extension of the Hospital Inpatient Quality Reporting program.

CMS Administrator Donald Berwick agreed. "The hospital value-based purchasing program proposal expands upon CMS’ long-standing pay-for-reporting program to reward hospitals not just for reporting data, but for the results of that data," he said.

Hospital quality data have been reported publicly since 2005 at a CMS Web site (www.hospitalcompare.hhs.gov). The quality measures reported for that initiative will be the same under the value-based purchasing program, so every hospitalist will be familiar with these measures, said Dr. Torcson.

The 17 clinical processes of care measures proposed for fiscal 2013 center around acute MI, heart failure, pneumonia, hospital-related infections, and surgical care improvement. Facilities will also be measured on patient satisfaction via the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems Survey).

For fiscal year 2014, the CMS is proposing to incorporate measures on 30-day mortality; hospital-acquired conditions such as falls, pressure ulcers, and catheter-associated infections; and a variety of patient safety measures.

The program will be funded by a reduction in base operating diagnosis-related group (DRG) payments for each discharge. In fiscal 2013, that reduction will be 1%. At 3 months before the Oct. 1, 2012, start of that fiscal year, the CMS will notify hospitals of the estimated amount they will receive as an incentive payment. On Nov. 1, 2012, they’ll get notice of the exact payment amount.

The CMS will take comments on the proposal until March 8.

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Florida Judge Says Affordable Care Act Is Unconstitutional

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A federal judge in Florida ruled on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states; in the last month, another 6 states joined. Two private citizens and the National Federation of Independent Business also joined the suit. The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

Judge Vinson also ruled that the whole law would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement comprised of pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiff's argument that the mandate exceeded Congress' authority, he did not agree with their proposition that the government was overreaching through its proposed Medicaid expansion. The plaintiffs failed to provide ample evidence of its claims, Judge Vinson ruled. As a result, “the states have little recourse to remaining the very junior partner in this partnership,” he wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the Administration would continue implementing health reform while it appeals. During a background briefing, senior administration officials said that Judge Vinson's decision that there was no severability in this case flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Most court watchers expect the case to end up at the Supreme Court.

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A federal judge in Florida ruled on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states; in the last month, another 6 states joined. Two private citizens and the National Federation of Independent Business also joined the suit. The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

Judge Vinson also ruled that the whole law would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement comprised of pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiff's argument that the mandate exceeded Congress' authority, he did not agree with their proposition that the government was overreaching through its proposed Medicaid expansion. The plaintiffs failed to provide ample evidence of its claims, Judge Vinson ruled. As a result, “the states have little recourse to remaining the very junior partner in this partnership,” he wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the Administration would continue implementing health reform while it appeals. During a background briefing, senior administration officials said that Judge Vinson's decision that there was no severability in this case flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Most court watchers expect the case to end up at the Supreme Court.

A federal judge in Florida ruled on Jan. 31 that the Affordable Care Act is unconstitutional.

The ruling and the direction of his opinion were expected.

The suit was filed in March 2010 by 20 states; in the last month, another 6 states joined. Two private citizens and the National Federation of Independent Business also joined the suit. The parties challenged the law's requirement that individuals purchase health insurance and also the ACA's requirement that Medicaid eligibility be expanded to offer insurance to more Americans.

In his 78-page decision, Judge Roger Vinson of the U.S. District Court for the Northern District of Florida in Pensacola said that the individual mandate exceeds Congress' regulatory powers.

Judge Vinson also ruled that the whole law would have to be struck down, as the individual mandate could not be separated out from the ACA, in part because the legislation appeared to be built on a framework that required all the pieces for it to work.

“If…the statute is viewed as a carefully balanced and clockwork-like statutory arrangement comprised of pieces that all work toward one primary legislative goal, and if that goal would be undermined if a central part of the legislation is found to be unconstitutional, then severability is not appropriate,” he wrote.

While the judge agreed with the plaintiff's argument that the mandate exceeded Congress' authority, he did not agree with their proposition that the government was overreaching through its proposed Medicaid expansion. The plaintiffs failed to provide ample evidence of its claims, Judge Vinson ruled. As a result, “the states have little recourse to remaining the very junior partner in this partnership,” he wrote.

The White House characterized the ruling as outside the mainstream of judicial thinking and said that the Administration would continue implementing health reform while it appeals. During a background briefing, senior administration officials said that Judge Vinson's decision that there was no severability in this case flew in the face of legal precedent.

And, on the White House blog, Stephanie Cutter, a senior adviser to President Obama, wrote, “This decision is at odds with decades of established Supreme Court law, which has consistently found that courts have a constitutional obligation to preserve as a much of a statute as can be preserved. As a result, the judge's decision puts all of the new benefits, cost savings, and patient protections that were included in the law at risk.”

After the ruling, House Speaker John Boehner (R-Ohio) said in a statement that the decision “affirms the view, held by most of the states and a majority of the American people, that the federal government should not be in the business of forcing you to buy health insurance and punishing you if you don't.”

Ron Pollack, executive director of Families USA, which filed a brief on behalf of the federal government, said in a statement, “Judge Vinson's decision is radical judicial activism run amok, and it will undoubtedly be reversed on appeal.”

Most court watchers expect the case to end up at the Supreme Court.

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ACP Urges Against Repeal of Health Reform

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WASHINGTON — The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

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WASHINGTON — The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

WASHINGTON — The American College of Physicians came out strongly against any repeal of the Affordable Care Act, and instead is calling on the White House and Congress to come to an agreement on how to tinker with the bill so that it still meets its objectives of covering more Americans, improving access, and reducing the cost of care.

At the ACP's annual State of the Nation's Health Care briefing, President J. Fred Ralston Jr. said that “a highly partisan and polarized debate over health care reform legislation regrettably has taken the country's 'eye off the ball'” of achieving the Affordable Care Act's (ACA's) multiple goals, including “ensuring a sufficient supply of primary care physicians and other specialties facing shortages.”

Dr. Ralston said that the stage is being set for a self-defeating debate that will only lead to a worsening of the nation's health care problems.

“Instead of turning away from the ACA's promise of ensuring access to affordable health insurance to nearly all Americans, the ACP believes that Congress should seek bipartisan common ground on making improvements to it, including giving states more freedom earlier to implement the coverage expansions in a way that best meets their own needs,” he said.

Bob Doherty, the ACP's senior vice president for governmental affairs and public policy, was more blunt about the unfolding political landscape, with Republicans bent on repeal and Democrats intent on preserving every bit of the law intact. Neither side will win, said Mr. Doherty.

“The law won't go away, as most Republicans hope, but restrictions on funding and enforcement could undermine its effectiveness, as many Democrats fear.”

He said it was ironic that Republicans might seek to strip funding from such programs as incentives for establishing electronic medical records, comparative effectiveness, and higher Medicare and Medicaid payments for physicians. Most of these very programs have been championed by Republicans in the past, said Mr. Doherty.

The ACP, in its State of the Nation's Health Care report, urged the White House and Congress to give states more options to cover their residents, and to do it sooner than called for under the ACA. The physicians' group is supporting the bipartisan Empowering States to Innovate Act, a bill cosponsored by Sen. Ron Wyden (D-Ore.) and Sen. Scott Brown (R-Mass.).

The White House and Congress should also find a mutually acceptable replacement for Medicare's Sustainable Growth Rate (SGR), said Mr. Doherty. Instead of eliminating comparative effectiveness programs, Congress should embrace them as a means of reducing health care costs.

A key element of the ACP's wish list for the White House and Congress: a national conversation on “how to conserve and share health care resources effectively, efficiently, judiciously, and fairly, based on the evidence of their clinical effectiveness and value, and in accord with distinctive American values, including individualism,” said Mr. Doherty.

That position is more thoroughly fleshed out in a white paper released by the ACP at the briefing, “How Can Our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently?”

Dr. Ralston said that the ACP believes that “this is the first time a major physician membership society has called for a national consensus on conserving and allocating health care resources and proposed a framework on how to make such decisions.”

But, he added, “to be clear, the ACP is not proposing that care be rationed.”

The idea is that physicians should have access to the best possible evidence on diagnostics and treatments, and that they should be able to share that with patients and make informed decisions about how to proceed.

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