Alicia Ault

The Food and Drug Administration has approved peginterferon alfa-2b for adjuvant treatment of melanoma in patients with "microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy."

The drug, to be marketed as Sylatron by Schering Corp., a Merck & Co. subsidiary, is the second melanoma drug to receive FDA approval this year. The first, ipilimumab (Yervoy), was the first drug ever to improve survival of metastatic melanoma in a clinical trial.

Dr. Eric Rubin, Merck's vice president of clinical oncology, said in a statement that the company was "pleased to offer patients with node-positive melanoma this new option [Sylatron] to treat the disease." He pointed out that Sylatron "is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years."

The FDA based its approval on a single study, EORTC (European Organisation for the Research and Treatment of Cancer) trial 18991, "Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation Alone in Resected Stage III Melanoma," the final results of which were published in 2008 in the Lancet (2008:372;117-26).

Peginterferon alfa-2b was shown to prolong relapse-free survival in this study, which enrolled 1,256 patients with resected stage III melanoma, but investigators saw no difference in overall survival. The median relapse-free survival was 34.8 months with peginterferon alfa-2b vs. 25.5 months with observation.

Peginterferon alfa-2b is given subcutaneously, and can be self-injected by melanoma patients. The recommended dose starts at 6 mcg/kg per week for eight doses, and then tapers to 3 mcg/kg per week for up to 5 years. Premedication with acetaminophen is advised when patients start treatment.

A safety analysis in 608 patients who were treated with peginterferon alfa-2b found the most serious adverse events to be fatigue, increased ALT, increased AST, and pyrexia.

Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, and also in those with autoimmune hepatitis or with hepatic decompensation, according to Merck. There is also a boxed warning on the increased risk of depression, suicidal ideation, suicide, and other neuropsychiatric disorders, which is consistent with all interferons.

Prescribing information can be found on the FDA Web site.

The Food and Drug Administration has approved peginterferon alfa-2b for adjuvant treatment of melanoma in patients with "microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy."

The drug, to be marketed as Sylatron by Schering Corp., a Merck & Co. subsidiary, is the second melanoma drug to receive FDA approval this year. The first, ipilimumab (Yervoy), was the first drug ever to improve survival of metastatic melanoma in a clinical trial.

Dr. Eric Rubin, Merck's vice president of clinical oncology, said in a statement that the company was "pleased to offer patients with node-positive melanoma this new option [Sylatron] to treat the disease." He pointed out that Sylatron "is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years."

The FDA based its approval on a single study, EORTC (European Organisation for the Research and Treatment of Cancer) trial 18991, "Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation Alone in Resected Stage III Melanoma," the final results of which were published in 2008 in the Lancet (2008:372;117-26).

Peginterferon alfa-2b was shown to prolong relapse-free survival in this study, which enrolled 1,256 patients with resected stage III melanoma, but investigators saw no difference in overall survival. The median relapse-free survival was 34.8 months with peginterferon alfa-2b vs. 25.5 months with observation.

Peginterferon alfa-2b is given subcutaneously, and can be self-injected by melanoma patients. The recommended dose starts at 6 mcg/kg per week for eight doses, and then tapers to 3 mcg/kg per week for up to 5 years. Premedication with acetaminophen is advised when patients start treatment.

A safety analysis in 608 patients who were treated with peginterferon alfa-2b found the most serious adverse events to be fatigue, increased ALT, increased AST, and pyrexia.

Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, and also in those with autoimmune hepatitis or with hepatic decompensation, according to Merck. There is also a boxed warning on the increased risk of depression, suicidal ideation, suicide, and other neuropsychiatric disorders, which is consistent with all interferons.

Prescribing information can be found on the FDA Web site.

The Food and Drug Administration has approved peginterferon alfa-2b for adjuvant treatment of melanoma in patients with "microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy."

The drug, to be marketed as Sylatron by Schering Corp., a Merck & Co. subsidiary, is the second melanoma drug to receive FDA approval this year. The first, ipilimumab (Yervoy), was the first drug ever to improve survival of metastatic melanoma in a clinical trial.

Dr. Eric Rubin, Merck's vice president of clinical oncology, said in a statement that the company was "pleased to offer patients with node-positive melanoma this new option [Sylatron] to treat the disease." He pointed out that Sylatron "is the first such therapy approved for the adjuvant treatment of melanoma by the FDA in more than 15 years."

The FDA based its approval on a single study, EORTC (European Organisation for the Research and Treatment of Cancer) trial 18991, "Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation Alone in Resected Stage III Melanoma," the final results of which were published in 2008 in the Lancet (2008:372;117-26).

Peginterferon alfa-2b was shown to prolong relapse-free survival in this study, which enrolled 1,256 patients with resected stage III melanoma, but investigators saw no difference in overall survival. The median relapse-free survival was 34.8 months with peginterferon alfa-2b vs. 25.5 months with observation.

Peginterferon alfa-2b is given subcutaneously, and can be self-injected by melanoma patients. The recommended dose starts at 6 mcg/kg per week for eight doses, and then tapers to 3 mcg/kg per week for up to 5 years. Premedication with acetaminophen is advised when patients start treatment.

A safety analysis in 608 patients who were treated with peginterferon alfa-2b found the most serious adverse events to be fatigue, increased ALT, increased AST, and pyrexia.

Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, and also in those with autoimmune hepatitis or with hepatic decompensation, according to Merck. There is also a boxed warning on the increased risk of depression, suicidal ideation, suicide, and other neuropsychiatric disorders, which is consistent with all interferons.

Prescribing information can be found on the FDA Web site.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

WASHINGTON – Republicans and Democrats found little consensus on reforming the medical malpractice system during an April 6 House hearing on legislation to institute a federal torts policy.

The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2011 (H.R. 5) was introduced in January by Rep. Phil Gingrey (R-Ga.), who is a physician. It has 122 cosponsors so far, as well as the backing of most major medical professional societies.

But at the hearing, Democrats said they could not support the bill for a number of reasons. "This is a bill we’ve heard before, a bill on which we’ve disagreed before," said Rep. Lois Capps (D-Calif.). She said that Democrats support the Republicans’ goal of overhauling the malpractice system, but that "it is also clear that differences in our [approaches] remain."

Rep. Frank Pallone (D-N.J.), the subcommittee’s ranking minority member, said, "I can’t support and never have supported H.R. 5." He agreed that the malpractice issue needed attention, but said he objected to the bill’s extension to cover drug and device companies, and also to the bill’s cap on noneconomic damages. Rep. Pallone said it would be more important to control malpractice premiums directly.

Democrats also said the bill would preempt the states’ ability to make policy and regulate the insurance business. Rep. Henry Waxman (D-Calif.) released an April 4 letter from the National Conference of State Legislatures that was sent to the subcommittee expressing its opposition to H.R. 5. It is the NCSL malpractice policy that federalism "contemplates diversity among the states in establishing rules," said the letter. "The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5 and other related measures would undermine that diversity and disregard factors unique to each particular state."

Republicans, however, said that H.R. 5 is modeled on what they deemed successful state models in California and Texas. "I do not believe we need to study this anymore," said Rep. Michael Burgess (R-Tex.)."In Texas, we know what works," he said, citing gains in the number of new physicians practicing in the state and reductions in malpractice litigation since a reform model was put into place in 2003.

Physicians who testified at the hearing said that the threat of malpractice suits drove up the cost of care by encouraging defensive medicine. And they testified that the litigious climate had contributed to increases in malpractice insurance premiums.

The environment is causing many ob.gyns. to change how they practice, testified Dr. Lisa Hollier of the University of Texas, Houston, who testified on behalf of the American Congress of Obstetricians and Gynecologists (ACOG).

She said that on average, ob.gyns. are sued 2.7 times over the course of their career. A third are decreasing the number of high-risk patients they take, and an almost equal number are increasing cesarean deliveries or ceasing to offer vaginal birth after a cesarean, said Dr. Hollier.

Dr. Troy Tippett, a Florida neurosurgeon who spoke on behalf of the Health Coalition on Liability and Access, said that the group "believes there can be no real health care reform without meaningful medical liability reform."

H.R. 5 would limit lawsuits to within 3 years after an injury, cap noneconomic damages at $250,000, limit attorneys’ fees, and eliminate the concept of joint and several liability, which means that the plaintiff could not sue all the potential parties responsible for the injury. The bill would extend the protections to drug and device manufacturers, nursing homes, and other health care providers.

Rep. Waxman and several other Democrats said that the insurance industry was to blame for much of the malpractice climate.

Dr. Allen Kachalia, a hospitalist at Brigham and Women’s Hospital in Boston, said that he agreed that the system was rife with problems, especially on the insurance side. Dr. Kachalia, who also has a law degree and studies medicolegal issues, said that recent studies show that almost 60% of malpractice claims contain an error, but that the claims are not properly adjudicated about 25% of the time.

"This means that in about a quarter of the claims in which there is an error, patients may not be receiving payment, and in a quarter of the claims in which there is no error, patients may still receive payment," Dr. Kachalia testified. "This type of inaccuracy can undermine both patient and physician faith in the malpractice system."

He also said that a majority of premium dollars are spent on overhead, whereas only about 46 cents per dollar are paid out to injured patients.

The data are mixed on damage caps, he testified. They may lower the size of claims paid and may translate into lower premiums paid by physicians, but they may not lower the number of claims filed. Caps may also lead to less defensive medicine, "but their effect on the overall quality of care is unknown," said Dr. Kachalia.

The House Judiciary Committee has passed a version of H.R. 5, and the full Energy and Commerce Committee is due to consider the legislation in mid-May. A Senate companion bill (S. 218) has only two cosponsors and is awaiting consideration by the Senate Judiciary Committee.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

The Food and Drug Administration on Apr. 7 announced the approval of an extended-release form of gabapentin for moderate to severe restless legs syndrome.

The drug, known as Horizant (gabapentin enacarbil), is a prodrug of gabapentin. It was developed by XenoPort Inc. of Santa Clara, Calif., and GlaxoSmithKline.

"People with restless legs syndrome can experience considerable distress from their symptoms," said Dr. Russell Katz, director of the FDA’s Division of Neurology Products at the agency’s Center for Drug Evaluation and Research, in a statement. "Horizant provides significant help in treating these symptoms."

According to the National Institute of Neurological Disorders and Stroke, restless legs syndrome (RLS) is a neurologic disorder that is "characterized by unpleasant sensations in the legs and an uncontrollable, and sometimes overwhelming, urge to move them for relief." Mild to moderate cases are treated with lifestyle and behavioral changes. More severe cases warrant therapies such as dopaminergics, benzodiazepines, opioids, and anticonvulsants. Two other drugs were approved for the condition for moderate to severe RLS: Requip (ropinirole) in 2005 and Mirapex (pramipexole) in 2006.

The prevalence and incidence rates of RLS are currently not well known, according to the Restless Legs Syndrome Foundation. There is no cure and symptoms can worsen with age. The manufacturers estimate that 1%-3% of the U.S. population is symptomatic.

RLS remains underrecognized, "and many patients go untreated as a result," said Dr. Atul Pande, senior vice president at GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment" for moderate to severe primary RLS, he said in a statement.

XenoPort CEO Ronald W. Barrett said that Horizant was the "culmination of XenoPort’s efforts to develop a nondopaminergic therapy" for patients with RLS.

Horizant carries a number of risks and contraindications. Even at the once-daily dose of 600 mg, it can cause somnolence and "significant driving impairment," according to GSK and XenoPort. It is an antiepileptic, and that class of drugs has been shown to increase the risk of suicidal thoughts or behaviors. Horizant also increases this risk, and will carry such a warning, said the companies and the FDA. The dosage also needs to be adjusted for patients with renal impairment.

GAITHERSBURG, MD. – The Food and Drug Administration should require that genetic tests sold directly to consumers should in some cases be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during the meeting, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most of the panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition such as Huntington's disease.

“As a patient, if I got a test result like that, I'd take it to my doctor,” said Tiffany House, the panelist's consumer representative. “I'd think they'd probably run to their doctor with this information,” said Ms. House, who is a board member of the International Pompe Association.

After the meeting, FDA officials acknowledged that there was no real consensus on what role physicians should play. “We got lots of diverse advice,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health.

He said that the agency would likely have to review each genetic test to determine whether it should be directly available to a consumer, and if so, whether a physician should order it or receive results directly. With so many opinions expressed, it may take awhile for things to settle out, said Elizabeth Mansfield, Ph.D., director of the personalized medicine staff in that same CDRH office. “We need to digest what came out of this meeting.”

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers.

“Many of these disorders have a spectrum of communication that can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics.

“I would suggest we are not ready yet to put this directly into the consumers' hands,” he said.

Former FDA official Mary Pendergast, who now works as a food and drug consultant and adviser to some companies that seek to market genetic tests, said that the panel was being paternalistic in its insistence on looking for a way to keep the tests from being sold directly to consumers.

“There is an alternative to this highly paternalistic approach; that information in and of itself is not harmful,” said Ms. Pendergast.

A government-sponsored study that was presented at the meeting seemed to back her assertion. The National Human Genome Research Institute's Multiplex Initiative found that people who underwent tests for eight common diseases were highly satisfied with the results – regardless of what those results showed – and that they felt as if they understood the implications and limitations of the tests.

The 266 people who took the tests tended to have more positive than negative emotions in the wake of receiving results, said Colleen McBride, Ph.D., the study's designer and a senior investigator at the institute's Social and Behavioral Research Branch.

GAITHERSBURG, MD. – The Food and Drug Administration should require that genetic tests sold directly to consumers should in some cases be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during the meeting, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most of the panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition such as Huntington's disease.

“As a patient, if I got a test result like that, I'd take it to my doctor,” said Tiffany House, the panelist's consumer representative. “I'd think they'd probably run to their doctor with this information,” said Ms. House, who is a board member of the International Pompe Association.

After the meeting, FDA officials acknowledged that there was no real consensus on what role physicians should play. “We got lots of diverse advice,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health.

He said that the agency would likely have to review each genetic test to determine whether it should be directly available to a consumer, and if so, whether a physician should order it or receive results directly. With so many opinions expressed, it may take awhile for things to settle out, said Elizabeth Mansfield, Ph.D., director of the personalized medicine staff in that same CDRH office. “We need to digest what came out of this meeting.”

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers.

“Many of these disorders have a spectrum of communication that can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics.

“I would suggest we are not ready yet to put this directly into the consumers' hands,” he said.

Former FDA official Mary Pendergast, who now works as a food and drug consultant and adviser to some companies that seek to market genetic tests, said that the panel was being paternalistic in its insistence on looking for a way to keep the tests from being sold directly to consumers.

“There is an alternative to this highly paternalistic approach; that information in and of itself is not harmful,” said Ms. Pendergast.

A government-sponsored study that was presented at the meeting seemed to back her assertion. The National Human Genome Research Institute's Multiplex Initiative found that people who underwent tests for eight common diseases were highly satisfied with the results – regardless of what those results showed – and that they felt as if they understood the implications and limitations of the tests.

The 266 people who took the tests tended to have more positive than negative emotions in the wake of receiving results, said Colleen McBride, Ph.D., the study's designer and a senior investigator at the institute's Social and Behavioral Research Branch.

GAITHERSBURG, MD. – The Food and Drug Administration should require that genetic tests sold directly to consumers should in some cases be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during the meeting, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most of the panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition such as Huntington's disease.

“As a patient, if I got a test result like that, I'd take it to my doctor,” said Tiffany House, the panelist's consumer representative. “I'd think they'd probably run to their doctor with this information,” said Ms. House, who is a board member of the International Pompe Association.

After the meeting, FDA officials acknowledged that there was no real consensus on what role physicians should play. “We got lots of diverse advice,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health.

He said that the agency would likely have to review each genetic test to determine whether it should be directly available to a consumer, and if so, whether a physician should order it or receive results directly. With so many opinions expressed, it may take awhile for things to settle out, said Elizabeth Mansfield, Ph.D., director of the personalized medicine staff in that same CDRH office. “We need to digest what came out of this meeting.”

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers.

“Many of these disorders have a spectrum of communication that can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics.

“I would suggest we are not ready yet to put this directly into the consumers' hands,” he said.

Former FDA official Mary Pendergast, who now works as a food and drug consultant and adviser to some companies that seek to market genetic tests, said that the panel was being paternalistic in its insistence on looking for a way to keep the tests from being sold directly to consumers.

“There is an alternative to this highly paternalistic approach; that information in and of itself is not harmful,” said Ms. Pendergast.

A government-sponsored study that was presented at the meeting seemed to back her assertion. The National Human Genome Research Institute's Multiplex Initiative found that people who underwent tests for eight common diseases were highly satisfied with the results – regardless of what those results showed – and that they felt as if they understood the implications and limitations of the tests.

The 266 people who took the tests tended to have more positive than negative emotions in the wake of receiving results, said Colleen McBride, Ph.D., the study's designer and a senior investigator at the institute's Social and Behavioral Research Branch.