Migraine With Aura Linked To Increased Risk Of Dying From Cardiovascular Disease.
Bloomberg News (8/25, Kay) reports that individuals who experience migraines with aura may be "more likely to die from stroke or heart disease, according to a study in the British Medical Journal."
The UK's Press Association (8/25) reports that investigators "examined data from 18,725 men and women born between 1907 and 1935 and living in Iceland."
The UK's Telegraph (8/25, Adams) reports that the researchers "found that those who had migraine with aura were 27 per cent more likely than those without migraines to die from cardiovascular disease, which includes both heart disease and strokes." The investigators also found that "suffering from normal migraine also increased the risk of mortality compared to those who did not suffer at all from them, but by a lesser degree." The UK's Daily Mail (8/25, Hope), WebMD (8/24, Doheny), and MedPage Today (8/24, Walsh) also covered the story.
Tuesday, August 31, 2010
Monday, August 16, 2010
Nexagon Gel Approved for Serious Eye Injuries
I must have been out to lunch on the Orphan Drug approval for chronic epithelial defects, especially those caused by chemical burns.
New Gel May Help Speed Healing Of Chronic Wounds, Serious Eye Injuries.
The AP (8/12, Cheng) reported that scientists have developed a new gel called Nexagon. Although it "has only been tested on about 100 people so far, experts say if it proves successful, the gel could have a major impact on treating chronic wounds, like leg or diabetes ulcers, and even common scrapes or injuries from accidents." It "works by interrupting how cells communicate and prevents the production of a protein that blocks healing," essentially allowing "cells to move faster to the wound to begin healing it." The gel has already "been granted approval by the Food and Drug Administration for serious eye injuries."
Company preparing to initiate Phase 2 clinical trial
May 11. 2009 - CoDa Therapeutics, Inc. today announced that its lead drug product candidate, Nexagon® , has received Orphan Drug Designation from the U.S Food and Drug Administration for the treatment of persistent corneal epithelial defects. The Company initiated a Phase 2 clinical trial for this indication in April 2009.
Persistent Epithelial Defect (PED) is a condition where the epithelium (thin layer of surface cells) covering the cornea of the eye fails to re-grow over a defect within the expected time period. PED is extremely difficult to treat and a common occurrence after traumatic abrasions and chemical injury. If unresolved the outcome for patients can lead to severe visual impairment or even blindness in the affected eye.
"Receiving orphan drug designation for Nexagon® for the treatment of PED is an important milestone for CoDa and provides meaningful benefits as we move our lead program through clinical development" commented Bradford J. Duft, President and Chief Executive Officer of CoDa.
"In acute eye injury from chemical burns a successful outcome for patients is often challenging. In recent cases of PED from ocular burns, where we received compassionate use approval from New Zealand regulatory authorities, we have seen dramatic improvement in epithelial re-growth and a positive result for patients following treatment with Nexagon® "commented Professor Charles McGhee, Director of the New Zealand National Eye Centre, University of Auckland. "This designation will assist CoDa’s clinical advancement of Nexagon® which has the potential to significantly improve clinical outcomes in patients with PED."
Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan Drug Designation entitles CoDa to seven years of market exclusivity in the treatment of PED patients in the event of market approval for this indication. Additional incentives for orphan drug development include tax credits related to development expenses, reduction in FDA user fees, and FDA assistance in clinical trial design.
New Gel May Help Speed Healing Of Chronic Wounds, Serious Eye Injuries.
The AP (8/12, Cheng) reported that scientists have developed a new gel called Nexagon. Although it "has only been tested on about 100 people so far, experts say if it proves successful, the gel could have a major impact on treating chronic wounds, like leg or diabetes ulcers, and even common scrapes or injuries from accidents." It "works by interrupting how cells communicate and prevents the production of a protein that blocks healing," essentially allowing "cells to move faster to the wound to begin healing it." The gel has already "been granted approval by the Food and Drug Administration for serious eye injuries."
Company preparing to initiate Phase 2 clinical trial
May 11. 2009 - CoDa Therapeutics, Inc. today announced that its lead drug product candidate, Nexagon® , has received Orphan Drug Designation from the U.S Food and Drug Administration for the treatment of persistent corneal epithelial defects. The Company initiated a Phase 2 clinical trial for this indication in April 2009.
Persistent Epithelial Defect (PED) is a condition where the epithelium (thin layer of surface cells) covering the cornea of the eye fails to re-grow over a defect within the expected time period. PED is extremely difficult to treat and a common occurrence after traumatic abrasions and chemical injury. If unresolved the outcome for patients can lead to severe visual impairment or even blindness in the affected eye.
"Receiving orphan drug designation for Nexagon® for the treatment of PED is an important milestone for CoDa and provides meaningful benefits as we move our lead program through clinical development" commented Bradford J. Duft, President and Chief Executive Officer of CoDa.
"In acute eye injury from chemical burns a successful outcome for patients is often challenging. In recent cases of PED from ocular burns, where we received compassionate use approval from New Zealand regulatory authorities, we have seen dramatic improvement in epithelial re-growth and a positive result for patients following treatment with Nexagon® "commented Professor Charles McGhee, Director of the New Zealand National Eye Centre, University of Auckland. "This designation will assist CoDa’s clinical advancement of Nexagon® which has the potential to significantly improve clinical outcomes in patients with PED."
Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan Drug Designation entitles CoDa to seven years of market exclusivity in the treatment of PED patients in the event of market approval for this indication. Additional incentives for orphan drug development include tax credits related to development expenses, reduction in FDA user fees, and FDA assistance in clinical trial design.
Tuesday, August 10, 2010
What's Coming in EHR's
Don't hold your breath but, one day..........
Newly Developed Program Automatically Sifts Through Patient Charts To Provide Diagnosis, Treatment Suggestions.
The Milwaukee Journal Sentinel (8/9, Ghose) reports "University of Wisconsin-Milwaukee researchers have developed a program that reads patient charts, then automatically sifts through thousands of medical studies and condenses the key findings to suggest diagnoses and treatment." In most cases, "the system, called AskHermes, does as well as doctors," according to the study, published online in the Journal of Biomedical Informatics. "Doctors could one day use the program to cross-check their conclusions, identify rare diseases or optimize their treatment regimens," the paper adds.
Newly Developed Program Automatically Sifts Through Patient Charts To Provide Diagnosis, Treatment Suggestions.
The Milwaukee Journal Sentinel (8/9, Ghose) reports "University of Wisconsin-Milwaukee researchers have developed a program that reads patient charts, then automatically sifts through thousands of medical studies and condenses the key findings to suggest diagnoses and treatment." In most cases, "the system, called AskHermes, does as well as doctors," according to the study, published online in the Journal of Biomedical Informatics. "Doctors could one day use the program to cross-check their conclusions, identify rare diseases or optimize their treatment regimens," the paper adds.
Who Knew?!
Some Open-Angle Glaucoma Patients May Benefit From Reduction Of Pressure Within The Eyeball.
HealthDay (8/9, Preidt) reported that, according to a study published online Aug. 9 in the Archives of Ophthalmology, "patients with glaucoma who have more rapid visual field change than other patients may benefit from a reduction of pressure within the eyeball." During "the study, 216 patients with open-angle glaucoma were given standard treatment for controlling intraocular pressure...and were followed up with re-examination every four months." The study authors found that "reducing intraocular pressure appeared to slow the rate at which some...patients experienced declines in visual field."
All I can say is WTF!
HealthDay (8/9, Preidt) reported that, according to a study published online Aug. 9 in the Archives of Ophthalmology, "patients with glaucoma who have more rapid visual field change than other patients may benefit from a reduction of pressure within the eyeball." During "the study, 216 patients with open-angle glaucoma were given standard treatment for controlling intraocular pressure...and were followed up with re-examination every four months." The study authors found that "reducing intraocular pressure appeared to slow the rate at which some...patients experienced declines in visual field."
All I can say is WTF!
Tuesday, August 3, 2010
Is "Touch" on your Checklist?"
Other than an handshake are you "hand's on" with your physical exam?
Not on the Doctor’s Checklist, but Touch Matters
By DANIELLE OFRI, M.D.
A new patient comes to my office, a healthy middle-aged woman. The medical assistant has already documented her normal blood pressure. Of our allotted 15 minutes, I spend more than two-thirds talking with her.
I ask about her personal medical history, her family medical history. I inquire about her lifestyle: what kind of work she does, whether she smokes, how much she exercises, whether she eats five servings of fruits and vegetables each day. I review her “health maintenance”: whether she’s up to date with her mammogram, Pap smear, vaccinations.
I press into the remaining minutes, counseling about calcium, sunscreen, seat belts. I screen for depression, domestic violence. I remind her about flu shots and colonoscopies. I pull out brochures about healthy diet and exercise, and we talk about ways to squeeze in exercise during her sedentary job.
And then I compliment myself on a job well done. I’ve covered all the relevant screening topics. I’ve touched all the bases of preventative medicine for a healthy woman. And I’ve even managed to finish on time, so I won’t have to keep the next patient waiting.
But my patient has a quizzical look on her face. Is that all there is, she seems to be asking.
In fact, through our extensive discussion (and the initial blood pressure check), we have fulfilled all of the medical interventions that scientific evidence has validated as helpful for a healthy patient. But my patient is clearly dissatisfied. A doctor’s visit is not a doctor’s visit until a stethoscope has probed the inner rhythms of the heart, and a set of medical hands has palpated the belly. Research has shown that patients expect a physical exam.
But is there any research to show that a physical exam — in a healthy person — is of any benefit? Despite a long and storied tradition, a physical exam is more a habit than a clinically proven method of picking up disease in asymptomatic people. There is scant evidence to suggest that routinely listening to every healthy person’s lungs, or pressing on every normal person’s liver, will find a disease that wasn’t suggested by the patient’s history. For a healthy person, an “abnormal finding” on physical exam is more likely to be a false positive than a real sign of illness.
Moreover, a normal physical exam cannot reassure a patient that there is no disease lurking in the shadows.
But does the physical exam serve any other purpose? The doctor-patient relationship is fundamentally different from, say, the accountant-client relationship. The laying on of hands sets medical practitioners apart from their counterparts in the business world. Despite the inroads of evidence-based medicine, M.R.I.s, angiograms and PET scanners, there is clearly something special, perhaps even healing, about touch. There is a warmth of connection that supersedes anything intellectual, and that connection goes both ways in the doctor-patient relationship.
We only have a few minutes left to our visit, but I gesture her up to the exam table. I place my hand on her shoulder and slide my stethoscope over her ribs. As I listen to the thrum of airflow that I’m 99.9 percent sure is perfectly normal, I feel both of our bodies relax ever so slightly.
I ease the bell of the stethoscope around to her heart, and though I know that there is only a small chance that I will hear anything to indicate serious illness, the familiar rhythms are comforting to my ear. As I examine her abdomen, we continue to talk, but there is a perceptible shift in the tenor of our interaction.
The polite but businesslike nature of our initial conversation has melted. No matter how we’ve come to this room, to these postures, to this connection, we are now more intimate. Even if our initial conversation had been marked by frustration or anger, the timbre of our interaction would have softened. It is almost impossible to be annoyed or curt when skin is touching skin.
Perhaps that is the crux. Touch is inherently humanizing, and for a doctor-patient relationship to have meaning beyond that of a business interaction, there needs to be trust — on both ends. As has been proved in newborn nurseries, and intuited by most doctors, nurses and patients, one of the most basic ways to establish trust is to touch.
I cringe whenever our hospital administration refers to the doctors and nurses as “health care providers.” That term always makes me feel like a soft-drink dispenser at Burger King. I’m not a “provider”; I’m a person, a doctor. And my patient is not a “customer” or a “client.” We are not transacting business.
Which is why a doctor’s visit never feels complete without a physical exam. It is a crucial part of the doctor-patient relationship that cannot be underestimated. One doesn’t need a scientific study to prove that.
Dr. Danielle Ofri is an internist in New York City. Her newest book is “Medicine in Translation: Journeys With My Patients.”
Not on the Doctor’s Checklist, but Touch Matters
By DANIELLE OFRI, M.D.
A new patient comes to my office, a healthy middle-aged woman. The medical assistant has already documented her normal blood pressure. Of our allotted 15 minutes, I spend more than two-thirds talking with her.
I ask about her personal medical history, her family medical history. I inquire about her lifestyle: what kind of work she does, whether she smokes, how much she exercises, whether she eats five servings of fruits and vegetables each day. I review her “health maintenance”: whether she’s up to date with her mammogram, Pap smear, vaccinations.
I press into the remaining minutes, counseling about calcium, sunscreen, seat belts. I screen for depression, domestic violence. I remind her about flu shots and colonoscopies. I pull out brochures about healthy diet and exercise, and we talk about ways to squeeze in exercise during her sedentary job.
And then I compliment myself on a job well done. I’ve covered all the relevant screening topics. I’ve touched all the bases of preventative medicine for a healthy woman. And I’ve even managed to finish on time, so I won’t have to keep the next patient waiting.
But my patient has a quizzical look on her face. Is that all there is, she seems to be asking.
In fact, through our extensive discussion (and the initial blood pressure check), we have fulfilled all of the medical interventions that scientific evidence has validated as helpful for a healthy patient. But my patient is clearly dissatisfied. A doctor’s visit is not a doctor’s visit until a stethoscope has probed the inner rhythms of the heart, and a set of medical hands has palpated the belly. Research has shown that patients expect a physical exam.
But is there any research to show that a physical exam — in a healthy person — is of any benefit? Despite a long and storied tradition, a physical exam is more a habit than a clinically proven method of picking up disease in asymptomatic people. There is scant evidence to suggest that routinely listening to every healthy person’s lungs, or pressing on every normal person’s liver, will find a disease that wasn’t suggested by the patient’s history. For a healthy person, an “abnormal finding” on physical exam is more likely to be a false positive than a real sign of illness.
Moreover, a normal physical exam cannot reassure a patient that there is no disease lurking in the shadows.
But does the physical exam serve any other purpose? The doctor-patient relationship is fundamentally different from, say, the accountant-client relationship. The laying on of hands sets medical practitioners apart from their counterparts in the business world. Despite the inroads of evidence-based medicine, M.R.I.s, angiograms and PET scanners, there is clearly something special, perhaps even healing, about touch. There is a warmth of connection that supersedes anything intellectual, and that connection goes both ways in the doctor-patient relationship.
We only have a few minutes left to our visit, but I gesture her up to the exam table. I place my hand on her shoulder and slide my stethoscope over her ribs. As I listen to the thrum of airflow that I’m 99.9 percent sure is perfectly normal, I feel both of our bodies relax ever so slightly.
I ease the bell of the stethoscope around to her heart, and though I know that there is only a small chance that I will hear anything to indicate serious illness, the familiar rhythms are comforting to my ear. As I examine her abdomen, we continue to talk, but there is a perceptible shift in the tenor of our interaction.
The polite but businesslike nature of our initial conversation has melted. No matter how we’ve come to this room, to these postures, to this connection, we are now more intimate. Even if our initial conversation had been marked by frustration or anger, the timbre of our interaction would have softened. It is almost impossible to be annoyed or curt when skin is touching skin.
Perhaps that is the crux. Touch is inherently humanizing, and for a doctor-patient relationship to have meaning beyond that of a business interaction, there needs to be trust — on both ends. As has been proved in newborn nurseries, and intuited by most doctors, nurses and patients, one of the most basic ways to establish trust is to touch.
I cringe whenever our hospital administration refers to the doctors and nurses as “health care providers.” That term always makes me feel like a soft-drink dispenser at Burger King. I’m not a “provider”; I’m a person, a doctor. And my patient is not a “customer” or a “client.” We are not transacting business.
Which is why a doctor’s visit never feels complete without a physical exam. It is a crucial part of the doctor-patient relationship that cannot be underestimated. One doesn’t need a scientific study to prove that.
Dr. Danielle Ofri is an internist in New York City. Her newest book is “Medicine in Translation: Journeys With My Patients.”
Monday, August 2, 2010
Autologous Stem Cell Treatment Restores Vision In Patients With Severe Eye Damage From Burns.
Autologous Stem Cell Treatment Restores Vision In Patients With Severe Eye Damage From Burns.
ABC World News (6/23, story 11, 2:00, Sawyer) reported, "This is big medical news. We learned today that doctors have restored sight to some people blinded by accidents" by "harvesting stem cells from their own eyes to grow new corneas."
The AP (6/24, Chang) reports, that, according to a study published online June 23 in the New England Journal of Medicine and reported last week at a meeting of the International Society for Stem Cell Research, "dozens of people who were blinded or otherwise suffered severe eye damage when they were splashed with caustic chemicals had their sight restored with transplants of their own stem cells -- a stunning success for the burgeoning cell-therapy field." In fact, Italian researchers say that "the treatment worked completely in 82 of 107 eyes and partially in 14 others, with benefits lasting up to a decade so far."
The Time (6/23, O'Callaghan) "Wellness" blog reported, "In a study of 106 patients treated between 1998 and 2007, researchers were able to extract adult stem cells from healthy eye tissue, grow additional stem cells in the lab, and secure them over the damaged eye tissue." But, "the treatment technique is limited to people who still have some healthy eye tissue and at least partial vision, as it requires extracting some living stem cells to cultivate new ones." Vision for many of the patients "was restored within mere months of treatment."
"Interestingly, the procedure was successful in some patients who had been burned years before entering the study," HealthDay (6/23, Dotinga) reported. "Patients 22, 26 and 46, for example, were nearly blind in one of their eyes, with completely opaque corneas, after suffering alkali burns; they had undergone unsuccessful surgery, respectively, 13, 30, and three years before admission to the study. The researchers were able to restore a stable corneal covering to all three, with patients 22 and 46 regaining complete visual acuity, the study reported." Reuters (6/23, Emery), MedPage Today (6/23, Phend), and WebMD (6/23, Boyles) also covered the story.
Steep Regulatory Requirements Must Be Overcome Before Technique Can Be Tried In US, Expert Says. The Modesto Bee (6/24) reports, "Despite recent successes in Italy, it's likely to be years before American doctors again try to restore people's eyesight with stem cell transplants, said Dr. Ivan Schwab, a UC-Davis ophthalmology professor who has done similar transplants in the past." Schwab pointed out that "there are steep regulatory and financial requirements for doing stem cell corneal transplants." He added, "I just don't think that these techniques are going to be available to patients in the United States for a bit...maybe a decade."
ABC World News (6/23, story 11, 2:00, Sawyer) reported, "This is big medical news. We learned today that doctors have restored sight to some people blinded by accidents" by "harvesting stem cells from their own eyes to grow new corneas."
The AP (6/24, Chang) reports, that, according to a study published online June 23 in the New England Journal of Medicine and reported last week at a meeting of the International Society for Stem Cell Research, "dozens of people who were blinded or otherwise suffered severe eye damage when they were splashed with caustic chemicals had their sight restored with transplants of their own stem cells -- a stunning success for the burgeoning cell-therapy field." In fact, Italian researchers say that "the treatment worked completely in 82 of 107 eyes and partially in 14 others, with benefits lasting up to a decade so far."
The Time (6/23, O'Callaghan) "Wellness" blog reported, "In a study of 106 patients treated between 1998 and 2007, researchers were able to extract adult stem cells from healthy eye tissue, grow additional stem cells in the lab, and secure them over the damaged eye tissue." But, "the treatment technique is limited to people who still have some healthy eye tissue and at least partial vision, as it requires extracting some living stem cells to cultivate new ones." Vision for many of the patients "was restored within mere months of treatment."
"Interestingly, the procedure was successful in some patients who had been burned years before entering the study," HealthDay (6/23, Dotinga) reported. "Patients 22, 26 and 46, for example, were nearly blind in one of their eyes, with completely opaque corneas, after suffering alkali burns; they had undergone unsuccessful surgery, respectively, 13, 30, and three years before admission to the study. The researchers were able to restore a stable corneal covering to all three, with patients 22 and 46 regaining complete visual acuity, the study reported." Reuters (6/23, Emery), MedPage Today (6/23, Phend), and WebMD (6/23, Boyles) also covered the story.
Steep Regulatory Requirements Must Be Overcome Before Technique Can Be Tried In US, Expert Says. The Modesto Bee (6/24) reports, "Despite recent successes in Italy, it's likely to be years before American doctors again try to restore people's eyesight with stem cell transplants, said Dr. Ivan Schwab, a UC-Davis ophthalmology professor who has done similar transplants in the past." Schwab pointed out that "there are steep regulatory and financial requirements for doing stem cell corneal transplants." He added, "I just don't think that these techniques are going to be available to patients in the United States for a bit...maybe a decade."
Suspect limbal stem cell deficiency in all contact lens wearers
Heck, before today I never even heard of LSCD. Read on...... from Primary Care Optometry News
Suspect limbal stem cell deficiency in all contact lens wearers
The diagnosis tends to be more challenging than the treatment.
For more, see the article on the web:
Suspect limbal stem cell deficiency in all contact lens wearers
The diagnosis tends to be more challenging than the treatment.
For more, see the article on the web:
Time for Management Pays Huge Dividends
Neil Gailmard's recent Tip of the Week, number 440 got me thinking about both Customer Service and what is required of management. Those of you who have been around me for any length of time will hear me say that I believe that providing excellent care to your patients is 50% of the job. The other 50% which provides you with a dynamic and growing practice and a high compensation is managing the practice correctly. You CAN deliver great care and end up with an average or below average income.
The Tip of the Week is worth reading in its entirety -- but so is the last paragraph:
What if you don’t have time?
You simply have to make time for management if you want a successful, fast growth practice. I think it requires the practice owner in addition to a good office manager. The eye care professional/owner has a huge effect on the practice culture, so management and marketing cannot be completely delegated.
Most practices actually see accelerated growth when the ECP schedules more time for management. And that is the best way to correct the hundreds of little flaws that exist in every practice. Schedule time for it. Of course, no practice is ever perfect, but we must keep trying to reach perfection. You may naturally be concerned about reduced productivity if you take a day or two for management. In my experience, most practices are extremely inefficient and if you began a new plan to delegate more and speed up the exam process (without sacrificing quality or stressing out the staff) you could compress all the patients you currently see in five days into three or four days.
If you have unmet patient demand of more than a week or two, hire an associate optometrist to see some of the patients so you can work on management!
One of my favorite quotes is by Zig Ziglar and it sums up this philosophy very well: “You can get anything you want in life if you just help enough other people get what they want.”
The Tip of the Week is worth reading in its entirety -- but so is the last paragraph:
What if you don’t have time?
You simply have to make time for management if you want a successful, fast growth practice. I think it requires the practice owner in addition to a good office manager. The eye care professional/owner has a huge effect on the practice culture, so management and marketing cannot be completely delegated.
Most practices actually see accelerated growth when the ECP schedules more time for management. And that is the best way to correct the hundreds of little flaws that exist in every practice. Schedule time for it. Of course, no practice is ever perfect, but we must keep trying to reach perfection. You may naturally be concerned about reduced productivity if you take a day or two for management. In my experience, most practices are extremely inefficient and if you began a new plan to delegate more and speed up the exam process (without sacrificing quality or stressing out the staff) you could compress all the patients you currently see in five days into three or four days.
If you have unmet patient demand of more than a week or two, hire an associate optometrist to see some of the patients so you can work on management!
One of my favorite quotes is by Zig Ziglar and it sums up this philosophy very well: “You can get anything you want in life if you just help enough other people get what they want.”
Medical Group Praises "Meaningful Use" Rule, Warns Of Challenges In EMR Compliance.
American Medical News (8/2, Silva) reports that the American Medical Association praised the final rule on "meaningful use" of electronic medical records, but warned that some challenges still remain.
"The AMA says physicians still face several challenges in becoming compliant in time. There is no EMR system on the market now that offers the capabilities needed for physicians to become meaningful users. Federal officials expect such systems to become available this fall, which would give practices only a few months to install and test the technology before the Jan. 1, 2011, start date of the incentive program." Also, "Physicians who already have invested in EMRs now must upgrade their systems to meet certification criteria."
American Medical News (8/2, Silva) reports that the American Medical Association praised the final rule on "meaningful use" of electronic medical records, but warned that some challenges still remain.
"The AMA says physicians still face several challenges in becoming compliant in time. There is no EMR system on the market now that offers the capabilities needed for physicians to become meaningful users. Federal officials expect such systems to become available this fall, which would give practices only a few months to install and test the technology before the Jan. 1, 2011, start date of the incentive program." Also, "Physicians who already have invested in EMRs now must upgrade their systems to meet certification criteria."
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