Alicia Ault

More Data Sought on Vytorin

It's the controversy that won't die. The House Energy and Commerce Committee and its Oversight and Investigations subcommittee are seeking more information on why the Data Safety Monitoring Board asked two other DSMBs to unblind data for their major Vytorin trials before their conclusion. In a letter to the chief executives of Merck and Schering-Plough, Committee Chairman Henry Waxman (D-Calif.) and Subcommittee Chairman Bart Stupak (D-Mich.) requested “all minutes, records, communications, and other documents” related to the DSMBs for the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), SHARP (Study of Heart and Renal Protection), and IMPROVE-IT (Examining Outcomes in Subjects with Acute Coronary Syndrome: Vytorin vs. Simvastatin) trials. A Schering-Plough spokesman says that the company is “aware of the current letter from the Energy and Commerce Committee, and will cooperate with the request for information.”

MRI Blood Flow Coverage Sought

The American College of Radiology, American College of Cardiology, North American Society for Cardiovascular Imaging, and the Society for Cardiovascular Magnetic Resonance have asked the Centers for Medicare and Medicaid Services to cover the measurement of blood flow by magnetic resonance imaging. The current CMS policy—established in 1985—states that blood flow measurement, imaging of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications are not reasonable or necessary. The groups asked the CMS to specifically consider national coverage of the blood flow indication. The comment period closed on Feb. 19. The CMS expects to issue a proposed decision in late July and take final action by mid-October.

EMS Delays for Women?

Women may be getting the short end of the stick when it comes to rapid response for cardiac conditions. A study in the January issue of Circulation: Cardiovascular Quality and Outcomes finds that women complaining of cardiac symptoms to 911 dispatchers were 52% more likely than were men to experience delays in care from emergency medical services. Researchers reviewed data on 5,887 calls made in 2004 for suspected cardiac symptoms to 911 for Dallas County, Tex. Half of the patients were women and half were white. The median time in EMS care—which included at the scene and transport to the hospital—was 34 minutes; times of 49 minutes or longer were considered to be a delay. The researchers found no serious delays in getting to the scene, but women had 52% higher odds of being delayed. They could not speculate on the reasons for the delays, but in an accompanying editorial, Dr. Joseph Ornato of Virginia Commonwealth University, Richmond, said possible explanations included a need for extra time to place 12-lead ECGs in an effort to preserve a woman's modesty. But, he said, the study provides insufficient data to assess whether a gender bias exists. “Nevertheless, it is a critical issue and deserves follow-up study,” said Dr. Ornato.

FDA Device Enforcement Lax

A nonprofit watchdog group says that the Food and Drug Administration is not properly enforcing its own rules on monitoring manufacturers' testing of medical devices. The Project on Government Oversight reviewed FDA enforcement of quality assurance standards for medical devices such as implantable cardiac defibrillators, pacemakers, aortic valves, and stents. Device makers have to satisfy requirements for good laboratory practices before a product can be tested in humans. The Project, known as POGO, said that agency inspections have been dropping—from 33 labs in 2005 to just 1 in 2008—and that there is a laissez-faire culture at the FDA's Center for Devices and Radiological Health. The group said that internal FDA documents show that many CDRH scientists have challenged management on its lack of enforcement, but that they have been rebuffed. POGO called on Congress to investigate what it alleges is a deliberate decision not to enforce FDA rules by CDRH senior management.

FDA on High-Risk List

The FDA faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said, adding the agency to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

More Data Sought on Vytorin

It's the controversy that won't die. The House Energy and Commerce Committee and its Oversight and Investigations subcommittee are seeking more information on why the Data Safety Monitoring Board asked two other DSMBs to unblind data for their major Vytorin trials before their conclusion. In a letter to the chief executives of Merck and Schering-Plough, Committee Chairman Henry Waxman (D-Calif.) and Subcommittee Chairman Bart Stupak (D-Mich.) requested “all minutes, records, communications, and other documents” related to the DSMBs for the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), SHARP (Study of Heart and Renal Protection), and IMPROVE-IT (Examining Outcomes in Subjects with Acute Coronary Syndrome: Vytorin vs. Simvastatin) trials. A Schering-Plough spokesman says that the company is “aware of the current letter from the Energy and Commerce Committee, and will cooperate with the request for information.”

MRI Blood Flow Coverage Sought

The American College of Radiology, American College of Cardiology, North American Society for Cardiovascular Imaging, and the Society for Cardiovascular Magnetic Resonance have asked the Centers for Medicare and Medicaid Services to cover the measurement of blood flow by magnetic resonance imaging. The current CMS policy—established in 1985—states that blood flow measurement, imaging of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications are not reasonable or necessary. The groups asked the CMS to specifically consider national coverage of the blood flow indication. The comment period closed on Feb. 19. The CMS expects to issue a proposed decision in late July and take final action by mid-October.

EMS Delays for Women?

Women may be getting the short end of the stick when it comes to rapid response for cardiac conditions. A study in the January issue of Circulation: Cardiovascular Quality and Outcomes finds that women complaining of cardiac symptoms to 911 dispatchers were 52% more likely than were men to experience delays in care from emergency medical services. Researchers reviewed data on 5,887 calls made in 2004 for suspected cardiac symptoms to 911 for Dallas County, Tex. Half of the patients were women and half were white. The median time in EMS care—which included at the scene and transport to the hospital—was 34 minutes; times of 49 minutes or longer were considered to be a delay. The researchers found no serious delays in getting to the scene, but women had 52% higher odds of being delayed. They could not speculate on the reasons for the delays, but in an accompanying editorial, Dr. Joseph Ornato of Virginia Commonwealth University, Richmond, said possible explanations included a need for extra time to place 12-lead ECGs in an effort to preserve a woman's modesty. But, he said, the study provides insufficient data to assess whether a gender bias exists. “Nevertheless, it is a critical issue and deserves follow-up study,” said Dr. Ornato.

FDA Device Enforcement Lax

A nonprofit watchdog group says that the Food and Drug Administration is not properly enforcing its own rules on monitoring manufacturers' testing of medical devices. The Project on Government Oversight reviewed FDA enforcement of quality assurance standards for medical devices such as implantable cardiac defibrillators, pacemakers, aortic valves, and stents. Device makers have to satisfy requirements for good laboratory practices before a product can be tested in humans. The Project, known as POGO, said that agency inspections have been dropping—from 33 labs in 2005 to just 1 in 2008—and that there is a laissez-faire culture at the FDA's Center for Devices and Radiological Health. The group said that internal FDA documents show that many CDRH scientists have challenged management on its lack of enforcement, but that they have been rebuffed. POGO called on Congress to investigate what it alleges is a deliberate decision not to enforce FDA rules by CDRH senior management.

FDA on High-Risk List

The FDA faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said, adding the agency to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

More Data Sought on Vytorin

It's the controversy that won't die. The House Energy and Commerce Committee and its Oversight and Investigations subcommittee are seeking more information on why the Data Safety Monitoring Board asked two other DSMBs to unblind data for their major Vytorin trials before their conclusion. In a letter to the chief executives of Merck and Schering-Plough, Committee Chairman Henry Waxman (D-Calif.) and Subcommittee Chairman Bart Stupak (D-Mich.) requested “all minutes, records, communications, and other documents” related to the DSMBs for the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), SHARP (Study of Heart and Renal Protection), and IMPROVE-IT (Examining Outcomes in Subjects with Acute Coronary Syndrome: Vytorin vs. Simvastatin) trials. A Schering-Plough spokesman says that the company is “aware of the current letter from the Energy and Commerce Committee, and will cooperate with the request for information.”

MRI Blood Flow Coverage Sought

The American College of Radiology, American College of Cardiology, North American Society for Cardiovascular Imaging, and the Society for Cardiovascular Magnetic Resonance have asked the Centers for Medicare and Medicaid Services to cover the measurement of blood flow by magnetic resonance imaging. The current CMS policy—established in 1985—states that blood flow measurement, imaging of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications are not reasonable or necessary. The groups asked the CMS to specifically consider national coverage of the blood flow indication. The comment period closed on Feb. 19. The CMS expects to issue a proposed decision in late July and take final action by mid-October.

EMS Delays for Women?

Women may be getting the short end of the stick when it comes to rapid response for cardiac conditions. A study in the January issue of Circulation: Cardiovascular Quality and Outcomes finds that women complaining of cardiac symptoms to 911 dispatchers were 52% more likely than were men to experience delays in care from emergency medical services. Researchers reviewed data on 5,887 calls made in 2004 for suspected cardiac symptoms to 911 for Dallas County, Tex. Half of the patients were women and half were white. The median time in EMS care—which included at the scene and transport to the hospital—was 34 minutes; times of 49 minutes or longer were considered to be a delay. The researchers found no serious delays in getting to the scene, but women had 52% higher odds of being delayed. They could not speculate on the reasons for the delays, but in an accompanying editorial, Dr. Joseph Ornato of Virginia Commonwealth University, Richmond, said possible explanations included a need for extra time to place 12-lead ECGs in an effort to preserve a woman's modesty. But, he said, the study provides insufficient data to assess whether a gender bias exists. “Nevertheless, it is a critical issue and deserves follow-up study,” said Dr. Ornato.

FDA Device Enforcement Lax

A nonprofit watchdog group says that the Food and Drug Administration is not properly enforcing its own rules on monitoring manufacturers' testing of medical devices. The Project on Government Oversight reviewed FDA enforcement of quality assurance standards for medical devices such as implantable cardiac defibrillators, pacemakers, aortic valves, and stents. Device makers have to satisfy requirements for good laboratory practices before a product can be tested in humans. The Project, known as POGO, said that agency inspections have been dropping—from 33 labs in 2005 to just 1 in 2008—and that there is a laissez-faire culture at the FDA's Center for Devices and Radiological Health. The group said that internal FDA documents show that many CDRH scientists have challenged management on its lack of enforcement, but that they have been rebuffed. POGO called on Congress to investigate what it alleges is a deliberate decision not to enforce FDA rules by CDRH senior management.

FDA on High-Risk List

The FDA faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said, adding the agency to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address internal mismanagement. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also have said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” said the agency.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. The agency did not elaborate but did say that, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a proton pump inhibitor or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

French researchers found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363–75). Another study found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354–62).

A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel also was less effective (Lancet 2009;373:309–17).

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also have said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” said the agency.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. The agency did not elaborate but did say that, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a proton pump inhibitor or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

French researchers found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363–75). Another study found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354–62).

A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel also was less effective (Lancet 2009;373:309–17).

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also have said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” said the agency.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. The agency did not elaborate but did say that, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a proton pump inhibitor or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

French researchers found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363–75). Another study found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354–62).

A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel also was less effective (Lancet 2009;373:309–17).

The Centers for Medicare and Medicaid Services has proposed to refuse coverage of computed tomography colonography for colorectal cancer screening.

“The evidence is inadequate to conclude that CT colonography (CTC) is an appropriate colorectal cancer screening test,” the agency said in a posting to its Web site.

The proposal followed a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting in which a majority of committee members expressed moderate confidence in the technology's ability to determine with adequate specificity and sensitivity the presence of polyps greater than 10 mm, but less confidence in detecting smaller polyps. Committee members expressed even less confidence in the technology's ability to increase overall cancer screening rates. Additionally, they said that it did not appear that CTC had a similar ratio of cost per life-years saved, compared with optical colonoscopy.

At that meeting, representatives of the U.S. Preventive Services Task Force reiterated its position that there is insufficient evidence to assess the benefits and harms of CTC.

When the Centers for Medicare and Medicaid Services (CMS) began its process of considering coverage of the technology in May 2008, it received 100 comments, 79 of which favored adding CTC as a Medicare-covered benefit.

Among those commenting in support of coverage for asymptomatic, average-risk patients over age 50 years were the American Cancer Society, American College of Radiology, American Gastroenterological Association, and the Medical Device Manufacturers Association.

In its comments, the AGA said that it would support coverage only if CMS required providers to meet technology, training, and reporting standards. CTC also should only be covered as part of Medicare's Coverage with Evidence Development process, said the AGA. At the November MEDCAC meeting, AGA reiterated its position.

In its evaluation, CMS said none of the available evidence focuses on “a population more representative of the Medicare population.” A younger population likely has a lower polyp prevalence, lower positive rates, and lower rates of referral to optical colonoscopy, the agency said. Further, since Medicare already covers screening tests known to lead to positive health outcomes, a new test should show evidence of increasing overall screening, according to the proposed decision. A new test should not lead to duplicative testing or switching from one test to another, and so far, there's nothing to say that CTC would lead to either of these scenarios, which would increase resource use, said CMS.

Finally, there are no data showing that screening with CTC leads to less cancer, the agency said.

CMS is accepting comments on this proposed decision until mid-March, but it is unlikely to change its direction by the time it makes its final decision shortly thereafter.

To view the proposal or to comment, go to http://tinyurl.com/dmpcok

The Centers for Medicare and Medicaid Services has proposed to refuse coverage of computed tomography colonography for colorectal cancer screening.

“The evidence is inadequate to conclude that CT colonography (CTC) is an appropriate colorectal cancer screening test,” the agency said in a posting to its Web site.

The proposal followed a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting in which a majority of committee members expressed moderate confidence in the technology's ability to determine with adequate specificity and sensitivity the presence of polyps greater than 10 mm, but less confidence in detecting smaller polyps. Committee members expressed even less confidence in the technology's ability to increase overall cancer screening rates. Additionally, they said that it did not appear that CTC had a similar ratio of cost per life-years saved, compared with optical colonoscopy.

At that meeting, representatives of the U.S. Preventive Services Task Force reiterated its position that there is insufficient evidence to assess the benefits and harms of CTC.

When the Centers for Medicare and Medicaid Services (CMS) began its process of considering coverage of the technology in May 2008, it received 100 comments, 79 of which favored adding CTC as a Medicare-covered benefit.

Among those commenting in support of coverage for asymptomatic, average-risk patients over age 50 years were the American Cancer Society, American College of Radiology, American Gastroenterological Association, and the Medical Device Manufacturers Association.

In its comments, the AGA said that it would support coverage only if CMS required providers to meet technology, training, and reporting standards. CTC also should only be covered as part of Medicare's Coverage with Evidence Development process, said the AGA. At the November MEDCAC meeting, AGA reiterated its position.

In its evaluation, CMS said none of the available evidence focuses on “a population more representative of the Medicare population.” A younger population likely has a lower polyp prevalence, lower positive rates, and lower rates of referral to optical colonoscopy, the agency said. Further, since Medicare already covers screening tests known to lead to positive health outcomes, a new test should show evidence of increasing overall screening, according to the proposed decision. A new test should not lead to duplicative testing or switching from one test to another, and so far, there's nothing to say that CTC would lead to either of these scenarios, which would increase resource use, said CMS.

Finally, there are no data showing that screening with CTC leads to less cancer, the agency said.

CMS is accepting comments on this proposed decision until mid-March, but it is unlikely to change its direction by the time it makes its final decision shortly thereafter.

To view the proposal or to comment, go to http://tinyurl.com/dmpcok

The Centers for Medicare and Medicaid Services has proposed to refuse coverage of computed tomography colonography for colorectal cancer screening.

“The evidence is inadequate to conclude that CT colonography (CTC) is an appropriate colorectal cancer screening test,” the agency said in a posting to its Web site.

The proposal followed a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting in which a majority of committee members expressed moderate confidence in the technology's ability to determine with adequate specificity and sensitivity the presence of polyps greater than 10 mm, but less confidence in detecting smaller polyps. Committee members expressed even less confidence in the technology's ability to increase overall cancer screening rates. Additionally, they said that it did not appear that CTC had a similar ratio of cost per life-years saved, compared with optical colonoscopy.

At that meeting, representatives of the U.S. Preventive Services Task Force reiterated its position that there is insufficient evidence to assess the benefits and harms of CTC.

When the Centers for Medicare and Medicaid Services (CMS) began its process of considering coverage of the technology in May 2008, it received 100 comments, 79 of which favored adding CTC as a Medicare-covered benefit.

Among those commenting in support of coverage for asymptomatic, average-risk patients over age 50 years were the American Cancer Society, American College of Radiology, American Gastroenterological Association, and the Medical Device Manufacturers Association.

In its comments, the AGA said that it would support coverage only if CMS required providers to meet technology, training, and reporting standards. CTC also should only be covered as part of Medicare's Coverage with Evidence Development process, said the AGA. At the November MEDCAC meeting, AGA reiterated its position.

In its evaluation, CMS said none of the available evidence focuses on “a population more representative of the Medicare population.” A younger population likely has a lower polyp prevalence, lower positive rates, and lower rates of referral to optical colonoscopy, the agency said. Further, since Medicare already covers screening tests known to lead to positive health outcomes, a new test should show evidence of increasing overall screening, according to the proposed decision. A new test should not lead to duplicative testing or switching from one test to another, and so far, there's nothing to say that CTC would lead to either of these scenarios, which would increase resource use, said CMS.

Finally, there are no data showing that screening with CTC leads to less cancer, the agency said.

CMS is accepting comments on this proposed decision until mid-March, but it is unlikely to change its direction by the time it makes its final decision shortly thereafter.

To view the proposal or to comment, go to http://tinyurl.com/dmpcok

NIMH's Stimulus Plans

Few federal agencies have yet decided or said what they will do with the cash infusion from the recently passed stimulus package. But the National Institute of Mental Health has already made plans. The agency said that it will use the $350 million it is receiving to support basic and clinical R01 grants, supplements to existing grants, and grants funded through a new 2-year R01 program, the National Institutes of Health Challenge Grants in Health and Science. According to the agency, the Challenge Grants fund studies that will rapidly generate outcomes. The money has to be spent within 2 years, “requiring NIH and NIMH to establish an unusually quick turnaround for high-impact, short-term projects,” an agency statement said.

Meth Costs Staggering

In the first study to assess the methamphetamine problem in the United States, the RAND Corp. estimates use of the drug cost the nation $23.4 billion in 2005. That figure includes the burden of addiction, premature death, and drug treatment, among other costs. Two-thirds of the costs were attributable to the burden of addiction, which RAND measured by quantifying the impact of a lower quality of life. The second-largest expense category was crime and criminal justice expenses. RAND cautions that the estimates are preliminary, since they are based on “an emerging understanding” of meth and the harm it causes. Use may not be common nationally, but some localities are particularly hard-hit, said RAND. In 2004, meth was the primary drug of abuse in 59% of treatment admissions in Hawaii, for instance. The study was sponsored by the Meth Project Foundation and the National Institute on Drug Abuse and can be found online at

www.rand.org/pubs/monographs/MG829/

Abbott Warned on Depakote

The Food and Drug Administration warned Abbott Laboratories that a promotional campaign for its products Depakote and Depakote ER was false and misleading and omitted important safety information. The campaign consisted of a flashcard sent to health care providers. The card was misleading because it did not include the risks–including a boxed warning about hepatotoxicity–in the main body, FDAsaid. It also implied that the ER formulation was indicated for use in a broader group of patients than the conventional formulation, but that is not the case. The agency asked Abbott to immediately cease distribution of the card. The drugs are prescribed for seizure disorders, migraine, and bipolar disorder.

'Truth' Campaign Effective

The American Legacy Foundation's “truth” campaign about youth smoking has not only been very effective in stopping teens from starting, it also has been cost effective, according to three new studies. The campaign was started in 2000 by ALF, which was created out of the tobacco industry settlement in 1998. A study published in the April issue of the American Journal of Preventive Medicine found that from 2000 to 2004, the campaign prevented 450,000 youths from starting to smoke. Another study in the same issue reported that the program paid for itself in the first 2 years and has saved $2-$5 billion in health expenditures. A third study, published in the February issue of Ethnicity and Health, found that the “truth” campaign has led to increased antitobacco beliefs and attitudes among youths of all ethnicities.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court for the Northern District of California, alleges that until at least 1976, the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy A. Lazarus, AMA board member, said in a statement.

NIMH's Stimulus Plans

Few federal agencies have yet decided or said what they will do with the cash infusion from the recently passed stimulus package. But the National Institute of Mental Health has already made plans. The agency said that it will use the $350 million it is receiving to support basic and clinical R01 grants, supplements to existing grants, and grants funded through a new 2-year R01 program, the National Institutes of Health Challenge Grants in Health and Science. According to the agency, the Challenge Grants fund studies that will rapidly generate outcomes. The money has to be spent within 2 years, “requiring NIH and NIMH to establish an unusually quick turnaround for high-impact, short-term projects,” an agency statement said.

Meth Costs Staggering

In the first study to assess the methamphetamine problem in the United States, the RAND Corp. estimates use of the drug cost the nation $23.4 billion in 2005. That figure includes the burden of addiction, premature death, and drug treatment, among other costs. Two-thirds of the costs were attributable to the burden of addiction, which RAND measured by quantifying the impact of a lower quality of life. The second-largest expense category was crime and criminal justice expenses. RAND cautions that the estimates are preliminary, since they are based on “an emerging understanding” of meth and the harm it causes. Use may not be common nationally, but some localities are particularly hard-hit, said RAND. In 2004, meth was the primary drug of abuse in 59% of treatment admissions in Hawaii, for instance. The study was sponsored by the Meth Project Foundation and the National Institute on Drug Abuse and can be found online at

www.rand.org/pubs/monographs/MG829/

Abbott Warned on Depakote

The Food and Drug Administration warned Abbott Laboratories that a promotional campaign for its products Depakote and Depakote ER was false and misleading and omitted important safety information. The campaign consisted of a flashcard sent to health care providers. The card was misleading because it did not include the risks–including a boxed warning about hepatotoxicity–in the main body, FDAsaid. It also implied that the ER formulation was indicated for use in a broader group of patients than the conventional formulation, but that is not the case. The agency asked Abbott to immediately cease distribution of the card. The drugs are prescribed for seizure disorders, migraine, and bipolar disorder.

'Truth' Campaign Effective

The American Legacy Foundation's “truth” campaign about youth smoking has not only been very effective in stopping teens from starting, it also has been cost effective, according to three new studies. The campaign was started in 2000 by ALF, which was created out of the tobacco industry settlement in 1998. A study published in the April issue of the American Journal of Preventive Medicine found that from 2000 to 2004, the campaign prevented 450,000 youths from starting to smoke. Another study in the same issue reported that the program paid for itself in the first 2 years and has saved $2-$5 billion in health expenditures. A third study, published in the February issue of Ethnicity and Health, found that the “truth” campaign has led to increased antitobacco beliefs and attitudes among youths of all ethnicities.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court for the Northern District of California, alleges that until at least 1976, the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy A. Lazarus, AMA board member, said in a statement.

NIMH's Stimulus Plans

Few federal agencies have yet decided or said what they will do with the cash infusion from the recently passed stimulus package. But the National Institute of Mental Health has already made plans. The agency said that it will use the $350 million it is receiving to support basic and clinical R01 grants, supplements to existing grants, and grants funded through a new 2-year R01 program, the National Institutes of Health Challenge Grants in Health and Science. According to the agency, the Challenge Grants fund studies that will rapidly generate outcomes. The money has to be spent within 2 years, “requiring NIH and NIMH to establish an unusually quick turnaround for high-impact, short-term projects,” an agency statement said.

Meth Costs Staggering

In the first study to assess the methamphetamine problem in the United States, the RAND Corp. estimates use of the drug cost the nation $23.4 billion in 2005. That figure includes the burden of addiction, premature death, and drug treatment, among other costs. Two-thirds of the costs were attributable to the burden of addiction, which RAND measured by quantifying the impact of a lower quality of life. The second-largest expense category was crime and criminal justice expenses. RAND cautions that the estimates are preliminary, since they are based on “an emerging understanding” of meth and the harm it causes. Use may not be common nationally, but some localities are particularly hard-hit, said RAND. In 2004, meth was the primary drug of abuse in 59% of treatment admissions in Hawaii, for instance. The study was sponsored by the Meth Project Foundation and the National Institute on Drug Abuse and can be found online at

www.rand.org/pubs/monographs/MG829/

Abbott Warned on Depakote

The Food and Drug Administration warned Abbott Laboratories that a promotional campaign for its products Depakote and Depakote ER was false and misleading and omitted important safety information. The campaign consisted of a flashcard sent to health care providers. The card was misleading because it did not include the risks–including a boxed warning about hepatotoxicity–in the main body, FDAsaid. It also implied that the ER formulation was indicated for use in a broader group of patients than the conventional formulation, but that is not the case. The agency asked Abbott to immediately cease distribution of the card. The drugs are prescribed for seizure disorders, migraine, and bipolar disorder.

'Truth' Campaign Effective

The American Legacy Foundation's “truth” campaign about youth smoking has not only been very effective in stopping teens from starting, it also has been cost effective, according to three new studies. The campaign was started in 2000 by ALF, which was created out of the tobacco industry settlement in 1998. A study published in the April issue of the American Journal of Preventive Medicine found that from 2000 to 2004, the campaign prevented 450,000 youths from starting to smoke. Another study in the same issue reported that the program paid for itself in the first 2 years and has saved $2-$5 billion in health expenditures. A third study, published in the February issue of Ethnicity and Health, found that the “truth” campaign has led to increased antitobacco beliefs and attitudes among youths of all ethnicities.

Veterans Sue Over Experiments

The Vietnam Veterans of America and six individual veterans are suing the Defense Department, the Central Intelligence Agency, and the U.S. Army for failing to care for them after they helped test toxic chemical and biologic substances starting in the 1950s. The lawsuit, which was filed last month in the U.S. District Court for the Northern District of California, alleges that until at least 1976, the government used troops to test nerve gas, psychoactive chemicals such as LSD, and toxic substances without proper informed consent. The plaintiffs are not seeking monetary damages but want medical treatment for such veterans in the future. The lawsuit also calls on the government to disclose all medical information about tests performed on the plaintiffs. The complaint is available in full online at

www.edgewoodtestvets.org

Court Shields Billing Records

An appeals court has ruled against the release of Medicare billing records, which was sought by the group Consumers' Checkbook so that it could grade physicians on quality. The nonprofit had filed a Freedom of Information Act request for all 2004 Medicare claims from physicians in several locations, and the group won in a lower court in 2007. But the Department of Health and Human Services, joined by the American Medical Association, appealed, and the U.S. Circuit Court of Appeals for the District of Columbia ruled that HHS does not have to release the information. Disclosure of the requested data would constitute an invasion of physicians' privacy, the appeals court said. The AMA praised the decision. “The court clearly found that the release of personal physician payment data does not meet the standard of the Freedom of Information Act, which is to provide the public with information on how the government operates,” Dr. Jeremy A. Lazarus, AMA board member, said in a statement.

Botox Sales Decline

Sales of Botox declined almost 3% worldwide in the fourth quarter of 2008—from $339 million to $329 million, reported Allergan Inc., and the company predicted a further decline. For all of last year, Botox (botulinum toxin type A) sales rose $99 million to $1.3 billion. But in the upcoming year, Allergan is forecasting sales of just $1.15 billion to $1.19 billion. Meanwhile, the first full year of sales of Allergan's eyelash-enhancing therapy Latisse (bimatoprost ophthalmic solution) should hit $30 million to $50 million, according to the company. Because overall sales of its products declined in 2008, Allergan announced that it would lay off 5% (460) of its employees. Cuts primarily will come from personnel in sales and marketing of urology products in the United States and Europe.

FDA Turns Down Skin Antibiotic

The Food and Drug Administration has notified Arpida Ltd. that its antibiotic iclaprim is not approvable without more clinical data. The agency said that the Switzerland-based company's new drug application didn't demonstrate that, against complicated skin and skin-structure infections, iclaprim was as effective as comparable products. "After the negative recommendation of the advisory committee of last November, the FDA opinion comes as no surprise," Arpida CEO Jurgen Raths said in a statement. The company will now "develop a viable road map to approval in close consultation with the FDA," Dr. Raths said.

Phase III Eczema Study Starts

The first phase III study of a therapy for chronic hand eczema has begun enrolling patients. Basilea Pharmaceutica AG, also Swiss based, said that its HANDEL (hand eczema research of alitretinoin) study will randomize 600 patients to oral alitretinoin or placebo for up to 24 weeks. There is currently no FDA-approved therapy for severe chronic hand eczema that's refractory to topical steroids. Alitretinoin is a vitamin A derivative and thus is a teratogen. In a statement, National Eczema Association CEO Vicki Kalabokes called the study's start "very exciting news."

Copayments Limit Phototherapy

Ninety percent of dermatologists surveyed by the National Psoriasis Foundation report that copayments for phototherapy are preventing or limiting patients from seeking the treatment. The foundation said that 192 dermatologists responded to its e-mail and fax survey, 61% of whom were in solo or group practices. Most reported seeing about 100 psoriasis patients a year. About 43% said they had seen a decrease in the number of psoriasis patients treated with phototherapy over the past 5 years. The most common reasons for discontinuing therapy included cost to the patient (31%), inconvenience (25%), and availability of a new treatment in a clinical trial (16%). Almost half of the doctors surveyed said they had problems getting reimbursed for phototherapy.

Thermage's New Look

Thermage Inc. has had a makeover to become Solta Medical. Having fully absorbed Reliant Technologies, the manufacturer of aesthetic medical devices began trading on the NASDAQ exchange as Solta in mid-January. The company makes radiofrequency devices and lasers for skin treatments. Soon after Solta's debut, CEO Stephen Fanning told the Wall Street Journal that the company would be shopping for other deals as the economy continues to decline. Included on his list of target product lines: wrinkle fillers.

Psoriasis Chats Are Helpful

A new study in the January Archives of Dermatology finds that on-line communities provide valuable education as well as psychological and social support to psoriasis patients. Researchers at Harvard Medical School, Boston, surveyed users of five frequently used psoriasis support sites sponsored by the National Psoriasis Foundation, the Psoriasis Help Organisation, the Google psoriasis group, the MSN Psoriasis Group, and the Psoriasis Philippine Online Community. Responses came from 260 people over age 18 years. The mean age was 40 years, and 75% were white, 60% were female, 44% were married, and 84% were college educated. The most popular activity on the sites was posting messages, which usually asked for or provided information to. Users were more than twice as likely as the general psoriasis population to have severe psoriasis, said the researchers. Most survey respondents said that the online groups had an improved quality of life, a lessened disease severity, and a widened support network.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 new molecular entities and 2 biologics in 2007. Four of the 2008 approvals came in December. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits. Many of the delays were attributable to resource constraints, the agency explained. FDA analyst Ira Loss of the firm Washington Analysis said the agency has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009.

Botox Sales Decline

Sales of Botox declined almost 3% worldwide in the fourth quarter of 2008—from $339 million to $329 million, reported Allergan Inc., and the company predicted a further decline. For all of last year, Botox (botulinum toxin type A) sales rose $99 million to $1.3 billion. But in the upcoming year, Allergan is forecasting sales of just $1.15 billion to $1.19 billion. Meanwhile, the first full year of sales of Allergan's eyelash-enhancing therapy Latisse (bimatoprost ophthalmic solution) should hit $30 million to $50 million, according to the company. Because overall sales of its products declined in 2008, Allergan announced that it would lay off 5% (460) of its employees. Cuts primarily will come from personnel in sales and marketing of urology products in the United States and Europe.

FDA Turns Down Skin Antibiotic

The Food and Drug Administration has notified Arpida Ltd. that its antibiotic iclaprim is not approvable without more clinical data. The agency said that the Switzerland-based company's new drug application didn't demonstrate that, against complicated skin and skin-structure infections, iclaprim was as effective as comparable products. "After the negative recommendation of the advisory committee of last November, the FDA opinion comes as no surprise," Arpida CEO Jurgen Raths said in a statement. The company will now "develop a viable road map to approval in close consultation with the FDA," Dr. Raths said.

Phase III Eczema Study Starts

The first phase III study of a therapy for chronic hand eczema has begun enrolling patients. Basilea Pharmaceutica AG, also Swiss based, said that its HANDEL (hand eczema research of alitretinoin) study will randomize 600 patients to oral alitretinoin or placebo for up to 24 weeks. There is currently no FDA-approved therapy for severe chronic hand eczema that's refractory to topical steroids. Alitretinoin is a vitamin A derivative and thus is a teratogen. In a statement, National Eczema Association CEO Vicki Kalabokes called the study's start "very exciting news."

Copayments Limit Phototherapy

Ninety percent of dermatologists surveyed by the National Psoriasis Foundation report that copayments for phototherapy are preventing or limiting patients from seeking the treatment. The foundation said that 192 dermatologists responded to its e-mail and fax survey, 61% of whom were in solo or group practices. Most reported seeing about 100 psoriasis patients a year. About 43% said they had seen a decrease in the number of psoriasis patients treated with phototherapy over the past 5 years. The most common reasons for discontinuing therapy included cost to the patient (31%), inconvenience (25%), and availability of a new treatment in a clinical trial (16%). Almost half of the doctors surveyed said they had problems getting reimbursed for phototherapy.

Thermage's New Look

Thermage Inc. has had a makeover to become Solta Medical. Having fully absorbed Reliant Technologies, the manufacturer of aesthetic medical devices began trading on the NASDAQ exchange as Solta in mid-January. The company makes radiofrequency devices and lasers for skin treatments. Soon after Solta's debut, CEO Stephen Fanning told the Wall Street Journal that the company would be shopping for other deals as the economy continues to decline. Included on his list of target product lines: wrinkle fillers.

Psoriasis Chats Are Helpful

A new study in the January Archives of Dermatology finds that on-line communities provide valuable education as well as psychological and social support to psoriasis patients. Researchers at Harvard Medical School, Boston, surveyed users of five frequently used psoriasis support sites sponsored by the National Psoriasis Foundation, the Psoriasis Help Organisation, the Google psoriasis group, the MSN Psoriasis Group, and the Psoriasis Philippine Online Community. Responses came from 260 people over age 18 years. The mean age was 40 years, and 75% were white, 60% were female, 44% were married, and 84% were college educated. The most popular activity on the sites was posting messages, which usually asked for or provided information to. Users were more than twice as likely as the general psoriasis population to have severe psoriasis, said the researchers. Most survey respondents said that the online groups had an improved quality of life, a lessened disease severity, and a widened support network.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 new molecular entities and 2 biologics in 2007. Four of the 2008 approvals came in December. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits. Many of the delays were attributable to resource constraints, the agency explained. FDA analyst Ira Loss of the firm Washington Analysis said the agency has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009.

Botox Sales Decline

Sales of Botox declined almost 3% worldwide in the fourth quarter of 2008—from $339 million to $329 million, reported Allergan Inc., and the company predicted a further decline. For all of last year, Botox (botulinum toxin type A) sales rose $99 million to $1.3 billion. But in the upcoming year, Allergan is forecasting sales of just $1.15 billion to $1.19 billion. Meanwhile, the first full year of sales of Allergan's eyelash-enhancing therapy Latisse (bimatoprost ophthalmic solution) should hit $30 million to $50 million, according to the company. Because overall sales of its products declined in 2008, Allergan announced that it would lay off 5% (460) of its employees. Cuts primarily will come from personnel in sales and marketing of urology products in the United States and Europe.

FDA Turns Down Skin Antibiotic

The Food and Drug Administration has notified Arpida Ltd. that its antibiotic iclaprim is not approvable without more clinical data. The agency said that the Switzerland-based company's new drug application didn't demonstrate that, against complicated skin and skin-structure infections, iclaprim was as effective as comparable products. "After the negative recommendation of the advisory committee of last November, the FDA opinion comes as no surprise," Arpida CEO Jurgen Raths said in a statement. The company will now "develop a viable road map to approval in close consultation with the FDA," Dr. Raths said.

Phase III Eczema Study Starts

The first phase III study of a therapy for chronic hand eczema has begun enrolling patients. Basilea Pharmaceutica AG, also Swiss based, said that its HANDEL (hand eczema research of alitretinoin) study will randomize 600 patients to oral alitretinoin or placebo for up to 24 weeks. There is currently no FDA-approved therapy for severe chronic hand eczema that's refractory to topical steroids. Alitretinoin is a vitamin A derivative and thus is a teratogen. In a statement, National Eczema Association CEO Vicki Kalabokes called the study's start "very exciting news."

Copayments Limit Phototherapy

Ninety percent of dermatologists surveyed by the National Psoriasis Foundation report that copayments for phototherapy are preventing or limiting patients from seeking the treatment. The foundation said that 192 dermatologists responded to its e-mail and fax survey, 61% of whom were in solo or group practices. Most reported seeing about 100 psoriasis patients a year. About 43% said they had seen a decrease in the number of psoriasis patients treated with phototherapy over the past 5 years. The most common reasons for discontinuing therapy included cost to the patient (31%), inconvenience (25%), and availability of a new treatment in a clinical trial (16%). Almost half of the doctors surveyed said they had problems getting reimbursed for phototherapy.

Thermage's New Look

Thermage Inc. has had a makeover to become Solta Medical. Having fully absorbed Reliant Technologies, the manufacturer of aesthetic medical devices began trading on the NASDAQ exchange as Solta in mid-January. The company makes radiofrequency devices and lasers for skin treatments. Soon after Solta's debut, CEO Stephen Fanning told the Wall Street Journal that the company would be shopping for other deals as the economy continues to decline. Included on his list of target product lines: wrinkle fillers.

Psoriasis Chats Are Helpful

A new study in the January Archives of Dermatology finds that on-line communities provide valuable education as well as psychological and social support to psoriasis patients. Researchers at Harvard Medical School, Boston, surveyed users of five frequently used psoriasis support sites sponsored by the National Psoriasis Foundation, the Psoriasis Help Organisation, the Google psoriasis group, the MSN Psoriasis Group, and the Psoriasis Philippine Online Community. Responses came from 260 people over age 18 years. The mean age was 40 years, and 75% were white, 60% were female, 44% were married, and 84% were college educated. The most popular activity on the sites was posting messages, which usually asked for or provided information to. Users were more than twice as likely as the general psoriasis population to have severe psoriasis, said the researchers. Most survey respondents said that the online groups had an improved quality of life, a lessened disease severity, and a widened support network.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 new molecular entities and 2 biologics in 2007. Four of the 2008 approvals came in December. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits. Many of the delays were attributable to resource constraints, the agency explained. FDA analyst Ira Loss of the firm Washington Analysis said the agency has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they "never" had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti. Medicare fees are about 80% of private pay fees.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. "Primary care is in a huge state of crisis," said Ms. Kane. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. "That may not be fast enough," she said, adding that the demonstration is a "drop in the pond. We need to move a whole ocean."

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that "we're talking about a significant amount of time, still." He said he expected that interim data might support quicker action.

The panel also voted unanimously to again include its June 2008 recommendation that Congress establish a budget-neutral payment adjustment.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron-emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, said Mr. Winter. The money could be reallocated to physician services, if the recommendation is adopted.

MedPAC commissioners also voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

They agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would "negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians," said AHA Vice President for Policy Don May in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they "never" had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti. Medicare fees are about 80% of private pay fees.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. "Primary care is in a huge state of crisis," said Ms. Kane. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. "That may not be fast enough," she said, adding that the demonstration is a "drop in the pond. We need to move a whole ocean."

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that "we're talking about a significant amount of time, still." He said he expected that interim data might support quicker action.

The panel also voted unanimously to again include its June 2008 recommendation that Congress establish a budget-neutral payment adjustment.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron-emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, said Mr. Winter. The money could be reallocated to physician services, if the recommendation is adopted.

MedPAC commissioners also voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

They agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would "negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians," said AHA Vice President for Policy Don May in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise.

WASHINGTON — Medicare advisers unanimously voted to recommend increasing physician fees by 1.1% next year, while expressing dismay that their June 2008 recommendation to boost primary care pay has not yet been acted upon.

The Medicare Payment Advisory Commission—better known as MedPAC—is charged with advising Congress on setting payment rates for physicians, hospitals, and other health care providers.

Under current law, Medicare physician fees are due to be reduced by 21% in 2010. MedPAC initially considered recommending that physician fees be updated by the projected change in input prices, minus an overall productivity goal that was established by the U.S. Bureau of Labor Statistics. The formula translated into a 1.1% increase, but many MedPAC commissioners were uncomfortable with the language and the possibility that it could be used to reduce fees.

Some even suggested that the panel should be considering a larger increase than 1.1%, but Chairman Glenn Hackbarth said he would not vote to approve a higher number, partly because Medicare has a statutory obligation to keep beneficiaries' Part B premiums for physician services in check. As fees rise, so do Part B premiums. And even small increases in physician fees can translate into billions more in Medicare spending, at a time when Congress is struggling to revive the faltering U.S. economy.

There seems to be no indication that Medicare reimbursement policy is leading to access problems for beneficiaries, according to reports from MedPAC staff members. A survey conducted in the early fall of 2008 found that 76% of beneficiaries said they "never" had a delay in getting an appointment for routine care, and 84% never had a delay when seeking an illness-related appointment. This is better than what has been reported by privately insured patients, said MedPAC staff member Cristina Boccuti. Medicare fees are about 80% of private pay fees.

Commissioner Nancy Kane, an associate dean of education at the Harvard School of Public Health in Boston, said that the 1.1% increase in fees would not be enough for primary care. "Primary care is in a huge state of crisis," said Ms. Kane. She asked about the progress of the federal medical home demonstration project, and expressed concern that it could be 7–10 years before Medicare rewarded physicians for participation in medical homes. "That may not be fast enough," she said, adding that the demonstration is a "drop in the pond. We need to move a whole ocean."

Mr. Hackbarth pointed out that MedPAC had recommended the pilot project to help move the process along, but acknowledged that "we're talking about a significant amount of time, still." He said he expected that interim data might support quicker action.

The panel also voted unanimously to again include its June 2008 recommendation that Congress establish a budget-neutral payment adjustment.

Primary care could get another boost if Congress follows MedPAC's recommendation to change the equipment use rate for imaging machines that cost more than $1 million. Currently, CMS pays physicians based on an estimate that magnetic resonance imaging, computed tomography, and positron-emission tomography are used an average 25 hours per week, but data suggest that 45 hours per week is a more accurate and better target, said MedPAC staff member Ariel Winter. The goal is to push physicians to be more efficient with use of the devices. Adopting the new rate would reduce the practice expense relative value unit by almost 8%.

That change would provide a savings of about $900 million annually, said Mr. Winter. The money could be reallocated to physician services, if the recommendation is adopted.

MedPAC commissioners also voted to increase hospital payments by the projected increase in the market basket, and to reward high-quality, high-performing facilities with a larger, unspecified increase.

They agreed to reduce the indirect medical education (IME) payment by 1%, which would put it at 4.5% per 10% increment in the resident:bed ratio. MedPAC staff said that the IME payment was a roughly $3 billion subsidy with little required accountability in return. The staff also said that the current rate was set at more than twice the impact of teaching on hospital costs, allowing academic centers to reap higher profits than do nonteaching facilities.

The American Hospital Association said it was happy with the vote to increase payments overall. But the IME reduction would "negatively affect the education, clinical care and research missions of teaching hospitals, including their ability to train high-quality physicians," said AHA Vice President for Policy Don May in a statement.

Payment increases to ambulatory surgery centers (ASC) have been frozen since 2003, but an increase is required by law in 2010. Although the centers are generally seen by Medicare as more efficient and less costly than hospital inpatient or outpatient departments, spending per beneficiary and the number of procedures per beneficiary continue to rise.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education, said Dr. Pittelkow.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow. The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

Currently, DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions for all the terms.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The American Academy of Dermatology is launching an online dictionary of common terms that it hopes will aid dermatologists, primary care physicians, and other practitioners in communicating, securing reimbursement, and reporting adverse events.

DermLex grew out of a 5-year grant issued by the National Institute of Arthritis and Muscoloskeletal and Skin Diseases in 2001 to Dr. Art Papier and Dr. Lowell Goldsmith at the University of Rochester (N.Y.) dermatology department to develop a universal dermatology lexicon. Five years later, the AAD took over the project, and the initial version 1.0 was expected to be live on its Web site (www.aad.org/research/lexicon

Dr. Mark Pittelkow, chairman of the AAD's Medical Informatics Committee, said that the most important goal of DermLex is to create a common language among dermatologists but also between specialties. It should help make coding more accurate, he said in an interview. DermLex will also contribute to better patient care and improve provider education.

“Hopefully, it will be facilitating documentation, as well,” he said, noting that the push for electronic health records is likely to accelerate in the Obama administration.

Eventually, DermLex should have online tools so it seamlessly integrates into an electronic medical record, said Dr. Pittelkow.

The compendium is similar to SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms), which was developed by the College of American Pathologists and is owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark.

Dr. Pittelkow said that hopefully, DermLex will be used as a companion to SNOMED-CT.

DermLex is primarily a compendium of terms organized in a hierarchical fashion, he said. The Medical Informatics Committee still is working on formal definitions.

The database will be open to the public, but AAD members will likely get additional tools that will not be available to nonmembers, Dr. Pittelkow said.

The AAD is providing the technical and financial support for the project, although it has been a largely volunteer effort up until this point. The need for ongoing support will be great, he said.

“Some may view (DermLex) as a sort of stamp collecting, but it's supposed to be very alive and dynamic,” said Dr. Pittelkow. He made no disclosures.

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

The Food and Drug Administration said that Sanofi-Aventis and Bristol-Myers Squibb Co. have agreed to conduct studies to better characterize the effectiveness of clopidogrel (Plavix) in patients with certain genetic factors. The two manufacturers also said they will lead clinical trials to assess what effects other therapies, such as proton pump inhibitors, might have on clopidogrel's efficacy.

Several recent studies have raised doubts about the anticlotting agent's effectiveness in patients with certain genetic profiles. “The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said.

According to the FDA's posting on its Web site, the two drug makers have agreed to complete the studies within a certain time frame. However, “it could take several months to complete the studies and analyze the results.”

In the meantime, physicians should continue to prescribe clopidogrel, said the agency. Patients should not stop taking the drug but should talk with their physicians if they are currently taking a PPI or considering starting on one, including the over-the-counter omeprazole (Prilosec).

The agency cited six published reports looking at the effects of PPIs or certain polymorphisms on clopidogrel. Most were published in 2008. Missing from the FDA's reference list were three studies published at the end of December and in early January.

One found that acute myocardial infarction patients with a CYP2C19 loss-of-function allele who took clopidogrel had a higher rate of cardiovascular events (N. Engl. J. Med. 2009;360:363-75). Another found that patients with acute coronary syndromes who had the same polymorphism had lower levels of the active clopidogrel metabolite and thus a higher rate of cardiovascular events (N. Eng. J. Med. 2009;360:354-62). A third study found that, in patients under age 45 years with the same polymorphism, clopidogrel was less effective (Lancet 2009;373:309-17).

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.

FDA Posts Guidance on Handouts

The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article should not be highlighted, otherwise marked up, or attached to promotional materials.

Device Makers Update Ethics Code

The Advanced Medical Technology Association (AdvaMed) has revised its ethics code covering equipment manufacturers' dealings with health care professionals. New rules explicitly prohibit manufacturers from providing entertainment, recreation, or gifts of any type to physicians. The document also describes acceptable royalty arrangements between companies and providers. The update is the first since 2005.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 a vial and set a similar price when it launched NeoProfen in July 2006, according to the FTC. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Clinic Discloses Industry Ties

The Cleveland Clinic has begun public disclosure of the business relationships its staff physicians and scientists have with drug and medical device makers. The organization said its Web site will list the names of companies with which each staff professional has collaborations. It also will identify whether a physician or scientist owns equity or has the right to royalties, a fiduciary position, or a consulting relationship that pays $5,000 or more per year. “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations,” said Dr. Joseph Hahn, Cleveland Clinic chief of staff. He added that to the best of his knowledge, Cleveland Clinic is the first academic medical center in the United States to disclose these ties.

Lawmaker Asks for Heparin Review

Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp. recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used “all of the tools available” to investigate the deaths.

GAO Slams FDA on Device Reviews

The FDA is allowing too many high-risk medical devices to go through its least stringent approval process, called 510(k), the GAO reported in January. After Department of Health and Human Services officials read the report, they agreed. Class III devices include pacemakers and heart valves. Under 510(k), the manufacturer simply proves that the device is substantially equivalent to one already on the market. A 1990 law gave the FDA 5 years to determine which class III devices should require premarket approval applications, which are stricter than 510(k) clearances, but the agency hasn't done so, the GAO reported. The FDA approved 228 of 342 applications for class III devices submitted through the 510(k) process during fiscal years 2003–2007.