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FDA proposes to regulate e-cigarettes, cigars
The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.
And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.
"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.
Under the proposed rule, makers of tobacco products would have to:
• Register with the FDA and report product and ingredient listings.
• Only market new tobacco products after FDA review.
• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
• Not distribute free samples.
FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.
Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.
The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.
There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.
Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."
The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."
Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."
A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.
The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.
He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.
FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.
On Twitter @aliciaault
The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.
And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.
"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.
Under the proposed rule, makers of tobacco products would have to:
• Register with the FDA and report product and ingredient listings.
• Only market new tobacco products after FDA review.
• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
• Not distribute free samples.
FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.
Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.
The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.
There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.
Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."
The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."
Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."
A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.
The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.
He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.
FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.
On Twitter @aliciaault
The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.
And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.
"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.
Under the proposed rule, makers of tobacco products would have to:
• Register with the FDA and report product and ingredient listings.
• Only market new tobacco products after FDA review.
• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
• Not distribute free samples.
FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.
Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.
The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.
There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.
Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."
The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."
Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."
A handful of Democratic senators and a House member who issued a recent report on the apparently concerted effort to market e-cigarettes to teenagers expressed dismay with the FDA proposal. The joint statement said: "Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," they said. "As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction," they added.
The American Cancer Society Cancer Action Network’s chief executive, John R. Seffrin, Ph.D., said that while the FDA’s action was an important step, it was still giving manufacturers a chance to skirt oversight, especially when it came to marketing to children. The companies are using tactics that include "marketing small flavored cigars that look like cigarettes, entering the e-cig market with promotions that could dramatically increase use among children and creating several new types of smokeless products," said Dr. Seffrin, in a statement.
He urged the agency to move quickly. "It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products," he said.
FDA Commissioner Hamburg said that the agency would move quickly. "We are eager to see this process move forward," she said.
On Twitter @aliciaault
E&M codes could soon require more rigor
ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.
The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.
If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.
If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.
The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.
A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."
Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.
The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.
Detail your decision making
According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.
The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."
Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."
If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.
It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."
Note the basics
Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.
That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.
"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."
On Twitter @aliciaault
ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.
The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.
If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.
If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.
The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.
A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."
Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.
The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.
Detail your decision making
According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.
The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."
Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."
If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.
It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."
Note the basics
Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.
That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.
"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."
On Twitter @aliciaault
ORLANDO – With Medicare seeing a sharp spike in payments for evaluation and management services, a proposed overhaul of Current Procedural Terminology E&M codes could force physicians to provide substantially more documentation of their medical decision making.
The American Medical Association’s CPT editorial panel is scheduled to vote in mid-May on a recommendation to make such changes to E&M codes.
If the CPT panel’s changes are substantial enough, it’s even possible that the Centers for Medicare and Medicaid Services may embark on a revaluation of all the E&M codes, said Dr. Glenn Littenberg, a past member of the CPT editorial panel and a current CPT adviser to the American Society for Gastrointestinal Endoscopy.
If CMS decided to do so, revaluation potentially could be a good thing – if it results in a higher valuation for decision making, said Dr. Robert Wergin, president-elect of the American Academy of Family Physicians. But "if the motivation is to put up a barrier to code appropriately for the level of complexity of visits, it’s another step to undervalue the cognitive area," he said.
The federal government has been taking a closer look at coding, with the concern that electronic health records are making it easier to upcode.
A report in 2012 by the U.S. Department of Health & Human Services (HHS) inspector general found that between 2001 and 2010, physicians had increased their billing for higher-level E&M codes. Medicare payments for E&M services increased by 48% during the same period, from $22.7 billion to $33.5 billion. The Office of Inspector General labeled E&M services as "vulnerable to fraud and abuse."
Coding is a physician’s lifeblood, said Dr. Wergin. The AAFP is waiting to get more details on the CPT panel’s recommendations before it can say whether it supports the changes, he said.
The American College of Physicians said its officials could not comment, citing confidentiality agreements for ACP members who are on the CPT panel.
Detail your decision making
According to Dr. Littenberg, the CPT panel is proposing much more detailed documentation of decision making, including describing the number and complexity of problems. Medical decision making will be one of the two requirements to qualify for moderate to extensive E&M services for an office visit, an established patient, or follow-up hospital care.
The proposal is more prescriptive than current requirements, "and harder to grasp and keep in mind during an encounter," said Dr. Littenberg, who is also a gastroenterologist in Pasadena, Calif. He said he is "concerned about the impact of this," adding, "there are things about this proposal I don’t like, and I’ve said as much at CPT."
Decision making "is critical at arriving at a diagnosis and treatment plan," Dr. Wergin said, but the AAFP believes that it needs to be better defined by the CPT. "Let’s define medical decision making in a more meaningful way that makes sense to people like me," said Dr. Wergin, who added, "I have a lot of complicated patients."
If the focus is only on the presenting problem, it tends to undervalue the decision making that goes into evaluating a patient who may have multiple comorbidities and perhaps social issues as well, Dr. Wergin explained. To truly evaluate a patient, decision making should look at that individual as a whole, not as one issue, he said.
It appears that the panel is moving in that direction, Dr. Littenberg observed, but it will also require clear documentation that "reflects our thought process."
Note the basics
Physicians should be thinking more in terms of what would be required in documentation to defend an audit, he cautioned. The history, physical, and what led to decisions about diagnosis and treatment – the basic thinking behind what happened on that particular day – need to be within the notes.
That kind of documentation "is actually not that complicated, and yet we fail to do it a large percentage of the time," said Dr. Littenberg.
"It can’t just be a recap of a problem list and continue the same therapy and ‘See you next year,’ " he said. "That’s not ever going to pass a high-level audit."
On Twitter @aliciaault
AT ACP INTERNAL MEDICINE 2014
ABIM will add nonphysicians to certification boards
ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.
The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.
*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.
Why the new structure?
One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.
Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.
"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."
By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.
The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.
The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.
The council has up to 18 members, and will:
• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.
• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.
• Set and integrate operational policies and procedures across the specialty boards.
• Evaluate proposals for new specialties/focused practice areas.
Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.
Overhaul of subspecialty boards
The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.
The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.
In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.
Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.
The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.
The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.
Other specialties will be addressed in the near future.
Acceptance slow
So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.
And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.
But it will have an impact. And the addition of nonphysicians may not be wholly embraced.
Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.
"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.
This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.
On Twitter @aliciaault
*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated.
Thirty years ago, passing a board examination in internal medicine or one of its subspecialties was a rite of passage. The successful examinee had proven that they had mastered the complexities of their chosen medical discipline. One understood that there was more to clinical practice than medical knowledge, but the public demonstration of sufficient medical knowledge was a core requisite of that practice.
As a profession, we grudgingly accepted first recertification, and then the mysterious Maintenance of Certification process, as proof of our continued intellectual competency. We assented without much complaint to the increased costs and the constantly changing specifics of the certification process.
Now we learn that others, such as community physicians, health care executives, and consumer advocates, will have a place on the ABIM to pass judgment on the professional, knowledge-based, assessment of experts in internal medicine and its subspecialties. Instead of just "taking our boards," it may well be time to speak up and take them back!
Thirty years ago, passing a board examination in internal medicine or one of its subspecialties was a rite of passage. The successful examinee had proven that they had mastered the complexities of their chosen medical discipline. One understood that there was more to clinical practice than medical knowledge, but the public demonstration of sufficient medical knowledge was a core requisite of that practice.
As a profession, we grudgingly accepted first recertification, and then the mysterious Maintenance of Certification process, as proof of our continued intellectual competency. We assented without much complaint to the increased costs and the constantly changing specifics of the certification process.
Now we learn that others, such as community physicians, health care executives, and consumer advocates, will have a place on the ABIM to pass judgment on the professional, knowledge-based, assessment of experts in internal medicine and its subspecialties. Instead of just "taking our boards," it may well be time to speak up and take them back!
Thirty years ago, passing a board examination in internal medicine or one of its subspecialties was a rite of passage. The successful examinee had proven that they had mastered the complexities of their chosen medical discipline. One understood that there was more to clinical practice than medical knowledge, but the public demonstration of sufficient medical knowledge was a core requisite of that practice.
As a profession, we grudgingly accepted first recertification, and then the mysterious Maintenance of Certification process, as proof of our continued intellectual competency. We assented without much complaint to the increased costs and the constantly changing specifics of the certification process.
Now we learn that others, such as community physicians, health care executives, and consumer advocates, will have a place on the ABIM to pass judgment on the professional, knowledge-based, assessment of experts in internal medicine and its subspecialties. Instead of just "taking our boards," it may well be time to speak up and take them back!
ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.
The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.
*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.
Why the new structure?
One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.
Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.
"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."
By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.
The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.
The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.
The council has up to 18 members, and will:
• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.
• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.
• Set and integrate operational policies and procedures across the specialty boards.
• Evaluate proposals for new specialties/focused practice areas.
Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.
Overhaul of subspecialty boards
The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.
The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.
In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.
Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.
The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.
The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.
Other specialties will be addressed in the near future.
Acceptance slow
So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.
And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.
But it will have an impact. And the addition of nonphysicians may not be wholly embraced.
Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.
"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.
This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.
On Twitter @aliciaault
*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated.
ORLANDO – The American Board of Internal Medicine is taking a potentially controversial step into the future by adding nonphysicians to both its main board and its subspecialty boards, a move that would give them a say in what defines being a good doctor.
The ABIM began the change in its governance process about 3 years ago, and took the first steps last July when it broke up its 29-member board of directors into two smaller panels: the board of directors and the ABIM council. The board will focus on governance issues, and the council will hone in on the assessment process itself. A few weeks ago, the board approved the addition of two new "public" members, including a health care executive and an official with a consumer organization.
*The subspecialty boards will remain the same, but add non-physician members. The boards will create exam committees, but those will be made up entirely of physicians.
Why the new structure?
One of the ABIM’s core roles is "to offer a professionally sanctioned definition of what a good doctor is," said Dr. Richard J. Baron, president and chief executive officer of the ABIM, in an interview. Physicians have always defined what that means, he said. But the world has changed, and "the definition doesn’t just belong to doctors," said Dr. Baron, who is also a past chair of the ABIM board.
Physicians now have to answer to payers that want to reward performance and measure quality. They also have to answer to patients. "I think there’s an increasingly clear recognition that medicine is a service profession," said Dr. Baron.
"It’s hard for us to say whether we are meeting the needs of our patients if we don’t find ways to ask them if we are. That’s a pretty important evolutionary transformation in assessing how well we do what we do," he said. "Having patients around the table as we think about the standards that we generate will help us have some assurance that we’re actually doing that."
By the same token, as physicians start working more with health care teams, having a team member help define what makes a good doctor also makes sense, said Dr. Baron.
The ABIM will soon announce the names of the nonphysicians who were confirmed in April by the ABIM Board. One is a health care executive who has experience heading a Medicaid managed care company and has also been a senior official with the Department of Health & Human Services. The second is the leader of a widely respected consumer organization, said Dr. Baron.
The main board now has 12 directors, with a maximum of 15. Up to 20% of the board’s membership can be made up of noninternists.
The council has up to 18 members, and will:
• Determine the requirements for certification and maintenance of certification across all the internal medicine disciplines.
• Harmonize ABIM standards with those of other recognized physician education and assessment initiatives.
• Set and integrate operational policies and procedures across the specialty boards.
• Evaluate proposals for new specialties/focused practice areas.
Some subspecialty board members migrated to the council. And the council has some at-large members who have expertise in performance improvement, quality measures, or health information technology. The council also will add members who can offer the patient and caregiver perspective and the health care team perspective.
Overhaul of subspecialty boards
The ABIM also decided it was time to reorganize the subspecialty boards, in part so they could more effectively design quality improvement and performance assessment modules for the MOC (maintenance of certification) process.
The role of the subspecialty boards is to define, refine, and set standards in certification and MOC in the discipline; perform oversight/review of performance assessments in the discipline; and build partnerships with societies and other organizational stakeholders in support of ABIM work.
In the past, the subspecialty boards were mainly charged with developing the exam for each specialty. But as the certification and MOC processes have evolved, the subspecialty board members have not been equipped to flesh out the exam, said Dr. Baron.
Each new exam committee will have from six to eight members, with physicians from the particular specialty. But the committees also will have at least one community physician in nonacademic practice and two public, nonphysician members. This will include, for example, a nurse practitioner who’s part of a patient-centered medical home, or a diabetes educator. And it also will include someone who can give the patient or caregiver perspective, said Dr. Baron.
The ABIM has selected exam committee members for internal medicine, critical care medicine, endocrinology, diabetes and metabolism, gastroenterology, geriatric medicine, hematology, infectious disease, medical oncology, nephrology, pulmonary disease, and rheumatology. Members of the committees will be announced in July.
The cardiology committee will contain a handful of tertiary specialties, including adult congenital heart disease, advanced heart failure and transplant cardiology, cardiovascular disease, clinical cardiac electrophysiology, and interventional cardiology.
Other specialties will be addressed in the near future.
Acceptance slow
So far, the ABIM’s governance and structural shifts seem to have largely gone unnoticed by internists, said Dr. Baron. In part, it’s because governance is a bit of sausage making that may not be of interest to outsiders. But it’s also because of the understandable focus on the changes to the MOC process, he observed.
And, the changes to the ABIM board and its subspecialty boards aren’t likely to have an impact on certification or recertification exams in the near future, Dr. Baron said.
But it will have an impact. And the addition of nonphysicians may not be wholly embraced.
Dr. Baron recalled that while giving a talk about the governance changes at the American College of Cardiology’s annual meeting in March, an ACC physician member stood up and said that he could not imagine why the ABIM thought it made sense to have a patient on the board.
"[He] congratulated me with great sarcasm on my political correctness," Dr. Baron said. " ‘What do [patients] know about being a cardiologist?’ " the physician asked.
This is "a view that many members of our physician community have," Dr. Baron noted, but he believes others will see the merits of bringing in other stakeholders.
On Twitter @aliciaault
*Correction 4/24/14: A previous version of this story misstated that the ABIM would rename the subspecialty boards. The story has been updated.
FROM ACP 2014
FDA approves ofatumumab for chronic lymphocytic leukemia
The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.
Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.
That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.
Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.
The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.
In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.
For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.
Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.
That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.
Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.
The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.
In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.
For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved ofatumumab (Arzerra injection, for intravenous infusion) in combination with chlorambucil, for previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.
Ofatumumab, an anti-CD20-directed monoclonal antibody, manufactured by GlaxoSmithKline, was originally given an accelerated approval in 2009. As a condition of that approval, the company was required to conduct further studies. The trial used as the basis of the April 17 approval fulfilled that postmarketing requirement, and accelerated approval was converted to regular approval, said the FDA.
That multicenter, randomized, open-label trial compared ofatumumab in combination with chlorambucil to chlorambucil alone. Patients received an intravenous infusion of ofatumumab on the following schedule: 300 mg on cycle 1, day 1; 1,000 mg on cycle 1, day 8; and 1,000 mg on day 1 of all subsequent 28-day cycles. In both arms, chlorambucil was given at a dose of 10 mg/meter orally on days 1 to 7, every 28 days. Ofatumumab patients were premedicated with acetaminophen, an antihistamine, and a glucocorticoid.
Median progression-free survival was 22.4 months for patients receiving the combination, compared with 13.1 months for those who were given chlorambucil alone. Progression-free survival was assessed by a blinded independent review committee using the 2008 International Workshop on Chronic Lymphocytic Leukemia update of the National Cancer Institute Working Group guidelines.
The most common adverse reactions of the ofatumumab-chlorambucil combination were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia, and upper abdominal pain. Sixty-seven percent of patients who received ofatumumab experienced one or more symptoms of infusion reaction; 10% experienced a grade 3 or greater infusion reaction.
In September, the FDA added a black box warning to ofatumumab’s label on the risk of reactivation of hepatitis B virus infection in patients with prior infection.
For previously untreated chronic lymphocytic leukemia, the recommended dose and schedule is 300 mg on day 1; followed 1 week later by 1,000 mg on day 8; followed by 1,000 mg on day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles, according to the FDA.
On Twitter @aliciaault
FDA approves GLP-1 receptor agonist albiglutide for type 2 diabetes
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
FDA approves Grastek, second oral allergy therapy
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
On Twitter @aliciaault
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
On Twitter @aliciaault
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
On Twitter @aliciaault
Inpatient safety efforts yield mixed results
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
On Twitter @aliciaault
Block marketing of e-cigs to kids, senators urge FDA
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
ACP gives primary care and specialists tools for better referrals
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
Dr. Molly Cooke,
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
Dr. Molly Cooke,
Dr. Molly Cooke,
AT ACP INTERNAL MEDICINE 2014
ACP: Physicians must address gun violence
ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:AT ACP INTERNAL MEDICINE 2014
