AP reporter M. Marchione writes that ten years ago the government set out to test herbal and other alternative health remedies to find the ones that do work. After spending $2.5 billion, the disappointing answer seems to be that almost none of them do. And the government is still spending the money.Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis. Black cohosh for menopausal hot flashes. Saw palmetto for prostate problems. Shark cartilage for cancer; have all proved no better than dummy pills in big studies funded by the National Center for Complementary and Alternative Medicine. The lone exception: ginger capsules may help chemotherapy nausea.
Critics also say the federal center's research agenda is shaped by an advisory board loaded with alternative medicine practitioners. They account for at least nine of the board's 18 members, as required by its government charter. Many studies they approve for funding are done by alternative therapy providers; grants have gone to board members, too. "It's the fox guarding the chicken coop," said a previous director of the Office of Alternative Medicine, a smaller federal agency that preceded the center's creation. "This is not science, it's ideology on the part of the advocates." The center was handed a flawed mission, many scientists say.
Congress created it after several powerful members claimed health benefits from their own use of alternative medicine and persuaded others that this enormously popular field needed more study. The new center was given $50 million in 1999 (its budget was $122 million last year) and ordered to research unconventional therapies and nostrums that Americans were using to see which ones had merit. That is opposite how other National Institutes of Health agencies work, where scientific evidence or at least plausibility is required to justify studies, and treatments go into wide use after there is evidence they work - not before.
"There's very little basic science behind these things. Most of it begins with a tradition, or personal testimony and people's beliefs, even as a fad. And then pressure comes: 'It's being popular, it's being used, it should be studied.' It turns things upside down," said a senior editor who reviews alternative medicine research submitted to the New England Journal of Medicine.
Yet to be politically correct the government continues to fund studies of purported energy fields, distance healing and other approaches that have little if any biological plausibility or scientific evidence. Taxpayers are bankrolling studies of whether pressing various spots on your head can help with weight loss, whether brain waves emitted from a special "master" can help break cocaine addiction, and whether wearing magnets can help the painful wrist problem, carpal tunnel syndrome.
An acupressure weight-loss technique won a $2 million grant even though a small trial of it on 60 people found no statistically significant benefit - only a trend that could have occurred by chance. The researcher says the pilot study was just to see if the technique was feasible.
Some say "It's become politically correct to investigate nonsense." Many scientists say that unconventional treatments hold promise and deserve serious study, but that the federal center needs to be more skeptical and selective. Many of the studies that have been funded I would not have funded because they seem irrational and foolish - studies on distant healing by prayer and energy healing, studies that are based on precepts and ideas that are contrary to what is known in terms of human physiology and disease.
Critics say that unlike private companies that face bottom-line pressure to abandon a drug that flops, the federal center is reluctant to admit a supplement may lack merit - despite a strategic plan pledging not to equivocate in the face of negative findings.
Echinacea is an example. After a large study by a top virologist found it didn't help colds, its fans said the wrong one of the plant's nine species had been tested. Federal officials agreed that more research was needed, even though they had approved the type used in the study.
Herbal Supplements
That reasoning was used to justify the $2 million weight-loss study, approved in 2007. It will test Tapas acupressure, devised by Tapas Fleming, a California acupuncturist.
Use of her trademarked method requires employing people she certifies, and the study needs eight. It involves pressing on specific points on the face and head - the inner corners of the eyes are two - while focusing on a problem.
In a federally funded pilot study, 30 dieters who were taught acupressure regained only half a pound six months later, compared with over three pounds for a comparison group of 30 others. However, the study widely missed a key scientific standard for showing that results were not a statistical fluke. The pilot trial was just to see if the technique was feasible. The results were good enough for the federal center to grant $2.1 million for a bigger study in 500 people that is under way now.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Part III of IV, Believing in Treatments that don't work- HOMEOPATHIC REMEDIES
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
SUMMER SALE - SPECIAL OFFER - ONLY TILL LABOR DAY 2009 ALL PRICES SLASHED 50% + FREE SHIPPING & HANDLING
Thursday, July 2, 2009
Wednesday, July 1, 2009
PART I OF III Believing in Medical Treatments That Don’t Work
Dr. David H. Newman writes* about how medical ideology often gets in the way of evidence-based medicine." Dr. Newman contends that "the practice of medicine contains countless examples of elegant medical theories that belie the best available evidence." For instance, despite "recent press reports detailing the dangers of cough syrup for children" that "have noted that cough syrup doesn't work," the use of these cough remedies "is common." Dr. Newman claimed that although "treatment based on ideology is alluring," the "uncomfortable truth is that many expensive, invasive interventions are of little or no benefit."
Another example is in the early throes of a heart attack, caused by an abruptly clotted artery, the stunned heart often beats quickly and forcefully. For decades doctors have administered “beta-blockers” as a remedy, to reduce consumption of limited oxygen supplies by calming and slowing the straining heart. Giving these drugs in the early stages of a heart attack represents elegant medical ideology.
But it doesn’t work.
Studies show that the early administration of beta-blockers to heart attack victims does not save lives, and occasionally causes dangerous heart failure. While two studies support the use of beta-blockers after heart attack, there are 26 studies that found no survival benefit to administering beta-blockers early on. Moreover, in 2005, the largest, best study of the drugs showed that beta-blockers in the vulnerable, early hours of heart attacks did not save lives, but did cause a definite increase in heart failure.
Remarkably, the medical community has continued to strongly recommend immediate beta-blocker treatment. Why? Because according to the theory of the straining heart, the treatment makes sense. It should work, even though it doesn’t. Ideology trumps evidence.
The practice of medicine contains countless examples of elegant medical theories that belie the best available evidence.
He noted that "the administration's plan for reform includes identifying healthcare measures that work, and those that don't," but "to place evidence above ideology, researchers and analysts must be trained in critical analysis, have no conflicts of interest and be a diverse group." And, "perhaps most importantly, we as doctors and patients must be open to evidence," he concluded.
ADDITIONAL EXAMPLES
• Patients with ear infections are more likely to be harmed by antibiotics than helped. While the pills may cause a small decrease in symptoms (for which ear drops work better), the infections typically recede within days regardless of treatment. The same is true for bronchitis, sinusitis, and sore throats. Unnecessary antibiotics are still given to more than one in seven Americans each year for these conditions alone, at a cost of more than $2 billion and tens of thousands of serious adverse medication effects requiring treatment.
• Back surgeries to relieve pain are, in the majority of cases, no better than nonsurgical treatment. Yet doctors perform 600,000 of these surgeries each year, at a cost of over $20 billion.
• More than a half million Americans per year undergo arthroscopic surgery to correct osteoarthritis of the knee, at a cost of $3 billion. Despite this, studies show the surgery to be no better than sham knee surgery, in which surgeons “pretend” to do surgery while the patient is under light anesthesia. It is also no better than much cheaper, and much less invasive, physical therapy.
Treatment based on ideology is alluring. Surgeries to repair the knee should work. A syrup to reduce cough should help. Calming the straining heart should save lives. But the uncomfortable truth is that many expensive, invasive interventions are of little or no benefit and cause potentially uncomfortable, costly, and dangerous side effects and complications.
The critical question that looms for health care reform, asks Dr. Newman, is whether patients, doctors and experts are prepared to set aside ideology in the face of data.
Can we abide by the evidence when it tells us that antibiotics don’t clear ear infections or help strep throats?
Can we stop asking for, and writing, these prescriptions?
Can we stop performing, and asking for, knee and back surgeries?
Can we handle what the evidence reveals?
Are we ready for the truth?
Somewhere along the line, theory trumped reality. Administering a medicine or performing a surgery became more important than its effect.
New York Times (4/2/09) Well blog
Caveat:
Evidence-based medicine is an important advance, although it can be a double-edged sword. When the evidence base applies, we should use it, and it reasonable for Medicare and other payers to insist on it. It is critical, however, to appreciate that there will always be patients for whom there is no evidence. They may so differ demographically from study participants from which the guidelines derive that it is doubtful as to whether guidelines are relevant. Or they may have conditions, such as rare diseases, for which there is no evidence band likely never will be. We must avoid the trap of those patients being shut out of care for lack of evidence.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Part II of IV, Believing in Treatments that don't work
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
SUMMER SALE - SPECIAL OFFER - ONLY TILL LABOR DAY 2009 ALL PRICES SLASHED 50% + FREE SHIPPING & HANDLING
Another example is in the early throes of a heart attack, caused by an abruptly clotted artery, the stunned heart often beats quickly and forcefully. For decades doctors have administered “beta-blockers” as a remedy, to reduce consumption of limited oxygen supplies by calming and slowing the straining heart. Giving these drugs in the early stages of a heart attack represents elegant medical ideology.
But it doesn’t work.
Studies show that the early administration of beta-blockers to heart attack victims does not save lives, and occasionally causes dangerous heart failure. While two studies support the use of beta-blockers after heart attack, there are 26 studies that found no survival benefit to administering beta-blockers early on. Moreover, in 2005, the largest, best study of the drugs showed that beta-blockers in the vulnerable, early hours of heart attacks did not save lives, but did cause a definite increase in heart failure.
Remarkably, the medical community has continued to strongly recommend immediate beta-blocker treatment. Why? Because according to the theory of the straining heart, the treatment makes sense. It should work, even though it doesn’t. Ideology trumps evidence.
The practice of medicine contains countless examples of elegant medical theories that belie the best available evidence.
He noted that "the administration's plan for reform includes identifying healthcare measures that work, and those that don't," but "to place evidence above ideology, researchers and analysts must be trained in critical analysis, have no conflicts of interest and be a diverse group." And, "perhaps most importantly, we as doctors and patients must be open to evidence," he concluded.
ADDITIONAL EXAMPLES
• Patients with ear infections are more likely to be harmed by antibiotics than helped. While the pills may cause a small decrease in symptoms (for which ear drops work better), the infections typically recede within days regardless of treatment. The same is true for bronchitis, sinusitis, and sore throats. Unnecessary antibiotics are still given to more than one in seven Americans each year for these conditions alone, at a cost of more than $2 billion and tens of thousands of serious adverse medication effects requiring treatment.
• Back surgeries to relieve pain are, in the majority of cases, no better than nonsurgical treatment. Yet doctors perform 600,000 of these surgeries each year, at a cost of over $20 billion.
• More than a half million Americans per year undergo arthroscopic surgery to correct osteoarthritis of the knee, at a cost of $3 billion. Despite this, studies show the surgery to be no better than sham knee surgery, in which surgeons “pretend” to do surgery while the patient is under light anesthesia. It is also no better than much cheaper, and much less invasive, physical therapy.
Treatment based on ideology is alluring. Surgeries to repair the knee should work. A syrup to reduce cough should help. Calming the straining heart should save lives. But the uncomfortable truth is that many expensive, invasive interventions are of little or no benefit and cause potentially uncomfortable, costly, and dangerous side effects and complications.
The critical question that looms for health care reform, asks Dr. Newman, is whether patients, doctors and experts are prepared to set aside ideology in the face of data.
Can we abide by the evidence when it tells us that antibiotics don’t clear ear infections or help strep throats?
Can we stop asking for, and writing, these prescriptions?
Can we stop performing, and asking for, knee and back surgeries?
Can we handle what the evidence reveals?
Are we ready for the truth?
Somewhere along the line, theory trumped reality. Administering a medicine or performing a surgery became more important than its effect.
New York Times (4/2/09) Well blog
Caveat:
Evidence-based medicine is an important advance, although it can be a double-edged sword. When the evidence base applies, we should use it, and it reasonable for Medicare and other payers to insist on it. It is critical, however, to appreciate that there will always be patients for whom there is no evidence. They may so differ demographically from study participants from which the guidelines derive that it is doubtful as to whether guidelines are relevant. Or they may have conditions, such as rare diseases, for which there is no evidence band likely never will be. We must avoid the trap of those patients being shut out of care for lack of evidence.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Part II of IV, Believing in Treatments that don't work
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
SUMMER SALE - SPECIAL OFFER - ONLY TILL LABOR DAY 2009 ALL PRICES SLASHED 50% + FREE SHIPPING & HANDLING
Tuesday, June 30, 2009
Circumcision Prevents Sexual Transmitted Diseases (STDs)
Is there a reason why Catholic nuns and Jewish women have a decreased incidence of cervical cancer and the opposite applies to groups such as blacks and Hispanics, where rates of HIV, herpes, and cervical cancer are disproportionately high?
Johns Hopkins scientists, along with researchers in Uganda, are saying that "circumcision significantly reduces the risk of contracting herpes (HSV-2) and human papillomavirus (HPV)," contributing more hard data to a pool of "growing scientific evidence that the procedure helps stem the spread of some sexually transmitted diseases." A little "over half of male newborns in the US get circumcised, according to research published earlier this year in the American Journal of Public Health." It’s ironic that apparently, that "percentage has declined over the past decade, in part because the American Academy of Pediatrics said in 1999 that the evidence is 'not sufficient to recommend routine neonatal circumcision.'" But, pathologist and Hopkins' team member Aaron Tobian, MD, PhD, said, "The scientific evidence for the public-health benefits of male circumcision is overwhelming now."
For example, "landmark studies from three African countries, including Uganda, previously found circumcision lowered men's chance of catching the AIDS virus by up to 60 percent. The new work "stems from the Uganda research and looked at protection against three other STDs" -- herpes, HPV, and syphilis.
The research teams set up two parallel, but independent, trials comprised of "a total of 5,534 uncircumcised men between the ages of 15 and 49 who were negative for the AIDS virus. Then, "1,684 of the 3,393 men who tested negative for herpes were circumcised immediately, and the others received a medical circumcision after 24 months." In addition, "352 men in the circumcised group and 345 in the delayed circumcision group were evaluated for HPV at the start of the trial and at 24 months."
Two years later, investigators noted that "circumcised volunteers were one-fourth less likely to have genital herpes and one-third less apt to carry a type of HPV that causes cervical cancer, compared with the still-uncircumcised males." Even "when all HPV types were assessed, including those causing genital warts, the circumcised volunteers were still nearly one-third less likely to carry one of the types.”
COMMENT:
There are "several reasons that removing the foreskin of the penis might help reduce transmission of certain infections. The foreskin, has two different sides," with the outside being very much like "regular skin cells," but "the inside is mucosal, similar to a woman's vagina." And, "during intercourse, the skin side is pulled back and the mucosal side is open and exposed." One researcher opines that "it's likely that there are viral receptors on that mucosal side that make it easier for a virus to get into the cells." Moreover, "if a woman has passed along viral cells, they're now trapped inside the foreskin, in a moist environment that's conducive for the virus to replicate."
The study authors say their findings "should guide public health policies for neonatal, adolescent, and adult male circumcision programs," according to MedPage Today (3/25/09, Smith), particularly since "circumcision rates in the US are falling, especially among groups such as blacks and Hispanics, where rates of HIV, herpes, and cervical cancer are 'disproportionately high.'"
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Part I of IV, Believing in Treatments that don't work
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
Johns Hopkins scientists, along with researchers in Uganda, are saying that "circumcision significantly reduces the risk of contracting herpes (HSV-2) and human papillomavirus (HPV)," contributing more hard data to a pool of "growing scientific evidence that the procedure helps stem the spread of some sexually transmitted diseases." A little "over half of male newborns in the US get circumcised, according to research published earlier this year in the American Journal of Public Health." It’s ironic that apparently, that "percentage has declined over the past decade, in part because the American Academy of Pediatrics said in 1999 that the evidence is 'not sufficient to recommend routine neonatal circumcision.'" But, pathologist and Hopkins' team member Aaron Tobian, MD, PhD, said, "The scientific evidence for the public-health benefits of male circumcision is overwhelming now."
For example, "landmark studies from three African countries, including Uganda, previously found circumcision lowered men's chance of catching the AIDS virus by up to 60 percent. The new work "stems from the Uganda research and looked at protection against three other STDs" -- herpes, HPV, and syphilis.
The research teams set up two parallel, but independent, trials comprised of "a total of 5,534 uncircumcised men between the ages of 15 and 49 who were negative for the AIDS virus. Then, "1,684 of the 3,393 men who tested negative for herpes were circumcised immediately, and the others received a medical circumcision after 24 months." In addition, "352 men in the circumcised group and 345 in the delayed circumcision group were evaluated for HPV at the start of the trial and at 24 months."
Two years later, investigators noted that "circumcised volunteers were one-fourth less likely to have genital herpes and one-third less apt to carry a type of HPV that causes cervical cancer, compared with the still-uncircumcised males." Even "when all HPV types were assessed, including those causing genital warts, the circumcised volunteers were still nearly one-third less likely to carry one of the types.”
COMMENT:
There are "several reasons that removing the foreskin of the penis might help reduce transmission of certain infections. The foreskin, has two different sides," with the outside being very much like "regular skin cells," but "the inside is mucosal, similar to a woman's vagina." And, "during intercourse, the skin side is pulled back and the mucosal side is open and exposed." One researcher opines that "it's likely that there are viral receptors on that mucosal side that make it easier for a virus to get into the cells." Moreover, "if a woman has passed along viral cells, they're now trapped inside the foreskin, in a moist environment that's conducive for the virus to replicate."
The study authors say their findings "should guide public health policies for neonatal, adolescent, and adult male circumcision programs," according to MedPage Today (3/25/09, Smith), particularly since "circumcision rates in the US are falling, especially among groups such as blacks and Hispanics, where rates of HIV, herpes, and cervical cancer are 'disproportionately high.'"
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Part I of IV, Believing in Treatments that don't work
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
Monday, June 29, 2009
MICHAEL JACKSON—A PERFECT STORM
“This time media overkill and sudden death have come together to create a perfect storm, a storybook ending to public fascination: The end of one entertainer’s lifelong struggles and a never-ending media chase all in the same scene. It is, however, still not safe to go back to the news.”
No. I’m not referring to Michael Jackson.
This was the heading of a new story about Anna Nicole Smith’s death who died suddenly at a hotel in Florida. This was also the way Marilyn Monroe, died of drugs and barbiturates. The medical examiner in the Smith case said the cause of death was "combined drug intoxication" with the sleeping medications as the major factor in combination with therapeutic levels of other drugs used to treat pain. Drug associated sudden death was also the way Smith’s son died five months earlier.
Smith was taking a lengthy list of other medications, including methadone for pain, Valium, anti-anxiety and anti-depression drugs. She had also recently taken longevity medications, B12 and growth hormone.
Bacterial infection from injecting drugs into her buttocks were contributory causes in her death. Some of the medications Smith was taking were prescribed to her, some to other aliases she used or to other people, but all of the drugs she was on were intended for her."Miss Smith had a long history of prescription drug use and over-self medicating. It can become very toxic if you mix it with any other central nervous system depressant drugs. You could get profound sedation leading up to coma and respiratory arrest."
There was no evidence of suicide. There was no suicide note. Smith also suffered stress from the various lawsuits she was involved in.
Does all this sound familiar?
Michael Jackson, age 50, was pronounced at the UCLA Medical Center, after being found unconscious and without respiration at a rented home in Los Angeles.
At approximately 1:14 p.m., a team of doctors including emergency physicians and cardiologists attempted to resuscitate him for a period of more than one hour, and they were unsuccessful," Jackson's brother Jermaine Jackson said during a Thursday press conference. A cadiologist at Indiana University in Indianapolis, opined that cardiac arrest was "the first thing that came to mind" after hearing of the singer's sudden death, and also pointed out that 30% to 50% of such events occur in people with no preceding history.
In this case also drugs, prescription and otherwise- and even some heroin use probably played a major role. There was also a lot of morphine. A lot of different drugs, say British newspapers including The Sun and the Times of London, citing an anonymous hospital worker and another source, who reported that Jackson received an injection of meperidine (Demerol) shortly before collapsing in his home. Jackson's health appeared to be worsening in recent years. In 2005,Jackson just like his predecessor Anna Nicole Smith was also hospitalized due to "dehydration with the flu."
Jackson himself had admitted to a painkiller addiction in 1993. He claimed that his addiction stemmed from an injury he sustained in 1984, when a special effects explosion during the filming for a Pepsi commercial badly burned his head. He also claimed that the mental stress of child-molestation allegations fueled his need for medication.
Jackson also reportedly suffered from back pain -- a condition that took the spotlight during his much-publicized trial in 2005 for allegedly molesting a young boy. Jackson failed to show up for a court appointment, ostensibly because his back pain became so severe that he had to go to the hospital instead The chief suspected cause of Jackson's death continues to be cardiac arrest.
Is there anyone left that does not know that cardiac arrest or sudden death is the chief manifestation of drug abuse?
I doubt it.
We’re going to be faced with months of reporting on this—about drugs—about who will take care of his children—about his debts and most of all his accruing income to his estate ala’ Elvis. I have a request. Let’s stop the news cycle now and just remember Jackson as we do Elvis as great and innovative entertainers who gave us a lot of pleasure during the years we were lucky to know them.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
No. I’m not referring to Michael Jackson.
This was the heading of a new story about Anna Nicole Smith’s death who died suddenly at a hotel in Florida. This was also the way Marilyn Monroe, died of drugs and barbiturates. The medical examiner in the Smith case said the cause of death was "combined drug intoxication" with the sleeping medications as the major factor in combination with therapeutic levels of other drugs used to treat pain. Drug associated sudden death was also the way Smith’s son died five months earlier.
Smith was taking a lengthy list of other medications, including methadone for pain, Valium, anti-anxiety and anti-depression drugs. She had also recently taken longevity medications, B12 and growth hormone.
Bacterial infection from injecting drugs into her buttocks were contributory causes in her death. Some of the medications Smith was taking were prescribed to her, some to other aliases she used or to other people, but all of the drugs she was on were intended for her."Miss Smith had a long history of prescription drug use and over-self medicating. It can become very toxic if you mix it with any other central nervous system depressant drugs. You could get profound sedation leading up to coma and respiratory arrest."
There was no evidence of suicide. There was no suicide note. Smith also suffered stress from the various lawsuits she was involved in.
Does all this sound familiar?
Michael Jackson, age 50, was pronounced at the UCLA Medical Center, after being found unconscious and without respiration at a rented home in Los Angeles.
At approximately 1:14 p.m., a team of doctors including emergency physicians and cardiologists attempted to resuscitate him for a period of more than one hour, and they were unsuccessful," Jackson's brother Jermaine Jackson said during a Thursday press conference. A cadiologist at Indiana University in Indianapolis, opined that cardiac arrest was "the first thing that came to mind" after hearing of the singer's sudden death, and also pointed out that 30% to 50% of such events occur in people with no preceding history.
In this case also drugs, prescription and otherwise- and even some heroin use probably played a major role. There was also a lot of morphine. A lot of different drugs, say British newspapers including The Sun and the Times of London, citing an anonymous hospital worker and another source, who reported that Jackson received an injection of meperidine (Demerol) shortly before collapsing in his home. Jackson's health appeared to be worsening in recent years. In 2005,Jackson just like his predecessor Anna Nicole Smith was also hospitalized due to "dehydration with the flu."
Jackson himself had admitted to a painkiller addiction in 1993. He claimed that his addiction stemmed from an injury he sustained in 1984, when a special effects explosion during the filming for a Pepsi commercial badly burned his head. He also claimed that the mental stress of child-molestation allegations fueled his need for medication.
Jackson also reportedly suffered from back pain -- a condition that took the spotlight during his much-publicized trial in 2005 for allegedly molesting a young boy. Jackson failed to show up for a court appointment, ostensibly because his back pain became so severe that he had to go to the hospital instead The chief suspected cause of Jackson's death continues to be cardiac arrest.
Is there anyone left that does not know that cardiac arrest or sudden death is the chief manifestation of drug abuse?
I doubt it.
We’re going to be faced with months of reporting on this—about drugs—about who will take care of his children—about his debts and most of all his accruing income to his estate ala’ Elvis. I have a request. Let’s stop the news cycle now and just remember Jackson as we do Elvis as great and innovative entertainers who gave us a lot of pleasure during the years we were lucky to know them.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
TOP 10 Laws and Rules Every Physician Should Know
The following information is being provided as a resource to remind you of important laws and rules that affect your medical practice, but is not all inclusive. Although this applies to my state of Florida it is still your responsibility to read and become familiar with the laws and rules of your state.
Florida Law and/or Rule
1. You must update your Practitioner Profile within 15 days
Description
s. 456.042, F.S. This includes changes in –
• Address
• Staff privileges
• Medical malpractice history
• Financial responsibility
• Board certification
• Education
• Disciplinary/criminal history
Florida Law and/or Rule
2. Before you move to a new practice, notify the Board
Description
s. 456.035, F.S.; s. 458.319(3), F.S.; s. 458.327(2)(e), F.S. No current address on file? Here is what can happen:
• crisis at renewal time
• late renewal may mean practicing on an inactive license
• practice on inactive license = criminal offense
Florida Law and/or Rule
3. Do not pre-sign prescriptions
Description
s. 458.331(1)(aa), F.S. Board of Medicine Disciplinary Guidelines provide a maximum penalty of -
• Reprimand
• $5,000 fine
• 2 years probation
Florida Law and/or Rule
4. At license renewal, read the fine print before you renew
Description
s. 458.319, F.S. • It is your license on the line, not your office manager’s!
• CME and Financial Responsibility requirements are audited
• Maintain copies of your CME certificates for at least 2 biennium
• DIDN’T RECEIVE YOUR RENEWAL POSTCARD? Call (850) 488-0595 extension #3
• RENEW ONLINE at https://ww2.doh.state.fl.us/mqaservices/login.asp
• The Preventing of Medical Errors course has specific requirements including a study of root cause analysis, error reduction, prevention and patient safety, and the 5 most mis-diagnosed medical conditions which are:
• cancer
• cardiac
• acute abdomen
• timely diagnosis of surgical complications
• stroke and related cranial conditions
• CME providers may be located on the Internet by typing “continuing medical education” in the search field, or by contacting the American Medical Association at (312) 464-4952.
Florida Law and/or Rule
5. You must keep charts on the family, employees and friends that you treat
Description
s. 458.331(1)(r), F.S. and s. 458.331(1)(m), F.S. • A prescription creates the physician/patient relationship
• Records are required even for family
• Spouses/friends may become adverse parties
• Cannot self-prescribe controlled substances
Florida Law and/or Rule
6. Patient Boundaries
Description
S. 458.329, F.S. and s. 458.331(1)(j), F.S. State Boards of Medicine should have a zero tolerance policy on physician/patient sexual misconduct
• Typical penalty is suspension/revocation
• Remember: A prescription creates a physician/patient relationship
Florida Law and/or Rule
7. Pause before you make the incision on the correct site of the correct patient
Description
s. 458.331(1)(t), F.S.; s. 456.072, F.S.; and Rule 64B8-9.007, F.A.C. • The “pause” before the procedure must be in the patient chart
• If you make the mistake, inform the patient and/or the patient’s representative and document it or the Board will increase the penalty.
• Read the rule at 64B8-9.007 Standards of Practice.
Florida Law and/or Rule
8. Internet Prescribing
Description
s. 458.331(1)(t), F.S. and Rule 64B8-9.014, FAC • Prescribing without a history and physical is both a standard of care violation and a violation of Board rule
• Physician have been disciplined for this with penalties ranging from revocation to suspension, reprimands and fines
• DO NOT JEOPARDIZE YOUR LICENSE – DON’T PRESCRIBE BASED ON INTERNET & QUESTIONNAIRES!
Florida Law and/or Rule
9. Relocating Practice?
Description
Rule 64B8-10.002, FAC You are responsible to:
• hold patient records for 5 years
• notify patients in letters or by sign as to where to pick up records
• place a notice in newspapers and notify the Board of Medicine 30 days before you move
• complete your hospital charts if leaving the area!
Florida Law and/or Rule
10. Help for impaired practitioners
Description
s. 456.076, F.S. Do you know a colleague with drug, alcohol, or psychiatric problems?
• You can get them help without subjecting them to disciplinary action
• Most state Boards have an excellent evaluation and rehabilitation programs that is a phone call away: Call your state’s Professional Resource Network
• For most practitioners, this is and remains a confidential process that offers help to those willing to change
• This program was recently expanded to include medical students as well
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Circumcision Prevents Sexual Transmitted Diseases (STDs)
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
Florida Law and/or Rule
1. You must update your Practitioner Profile within 15 days
Description
s. 456.042, F.S. This includes changes in –
• Address
• Staff privileges
• Medical malpractice history
• Financial responsibility
• Board certification
• Education
• Disciplinary/criminal history
Florida Law and/or Rule
2. Before you move to a new practice, notify the Board
Description
s. 456.035, F.S.; s. 458.319(3), F.S.; s. 458.327(2)(e), F.S. No current address on file? Here is what can happen:
• crisis at renewal time
• late renewal may mean practicing on an inactive license
• practice on inactive license = criminal offense
Florida Law and/or Rule
3. Do not pre-sign prescriptions
Description
s. 458.331(1)(aa), F.S. Board of Medicine Disciplinary Guidelines provide a maximum penalty of -
• Reprimand
• $5,000 fine
• 2 years probation
Florida Law and/or Rule
4. At license renewal, read the fine print before you renew
Description
s. 458.319, F.S. • It is your license on the line, not your office manager’s!
• CME and Financial Responsibility requirements are audited
• Maintain copies of your CME certificates for at least 2 biennium
• DIDN’T RECEIVE YOUR RENEWAL POSTCARD? Call (850) 488-0595 extension #3
• RENEW ONLINE at https://ww2.doh.state.fl.us/mqaservices/login.asp
• The Preventing of Medical Errors course has specific requirements including a study of root cause analysis, error reduction, prevention and patient safety, and the 5 most mis-diagnosed medical conditions which are:
• cancer
• cardiac
• acute abdomen
• timely diagnosis of surgical complications
• stroke and related cranial conditions
• CME providers may be located on the Internet by typing “continuing medical education” in the search field, or by contacting the American Medical Association at (312) 464-4952.
Florida Law and/or Rule
5. You must keep charts on the family, employees and friends that you treat
Description
s. 458.331(1)(r), F.S. and s. 458.331(1)(m), F.S. • A prescription creates the physician/patient relationship
• Records are required even for family
• Spouses/friends may become adverse parties
• Cannot self-prescribe controlled substances
Florida Law and/or Rule
6. Patient Boundaries
Description
S. 458.329, F.S. and s. 458.331(1)(j), F.S. State Boards of Medicine should have a zero tolerance policy on physician/patient sexual misconduct
• Typical penalty is suspension/revocation
• Remember: A prescription creates a physician/patient relationship
Florida Law and/or Rule
7. Pause before you make the incision on the correct site of the correct patient
Description
s. 458.331(1)(t), F.S.; s. 456.072, F.S.; and Rule 64B8-9.007, F.A.C. • The “pause” before the procedure must be in the patient chart
• If you make the mistake, inform the patient and/or the patient’s representative and document it or the Board will increase the penalty.
• Read the rule at 64B8-9.007 Standards of Practice.
Florida Law and/or Rule
8. Internet Prescribing
Description
s. 458.331(1)(t), F.S. and Rule 64B8-9.014, FAC • Prescribing without a history and physical is both a standard of care violation and a violation of Board rule
• Physician have been disciplined for this with penalties ranging from revocation to suspension, reprimands and fines
• DO NOT JEOPARDIZE YOUR LICENSE – DON’T PRESCRIBE BASED ON INTERNET & QUESTIONNAIRES!
Florida Law and/or Rule
9. Relocating Practice?
Description
Rule 64B8-10.002, FAC You are responsible to:
• hold patient records for 5 years
• notify patients in letters or by sign as to where to pick up records
• place a notice in newspapers and notify the Board of Medicine 30 days before you move
• complete your hospital charts if leaving the area!
Florida Law and/or Rule
10. Help for impaired practitioners
Description
s. 456.076, F.S. Do you know a colleague with drug, alcohol, or psychiatric problems?
• You can get them help without subjecting them to disciplinary action
• Most state Boards have an excellent evaluation and rehabilitation programs that is a phone call away: Call your state’s Professional Resource Network
• For most practitioners, this is and remains a confidential process that offers help to those willing to change
• This program was recently expanded to include medical students as well
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for Circumcision Prevents Sexual Transmitted Diseases (STDs)
Deepen your understanding of How to Be an Effective Medical Expert www.MedMalBook.com
Sunday, June 28, 2009
IN DEFENSE OF DEFENSIVE MEDICINE?
I was surfing through some medical blogs the other day and found this Emergency Physicians Monthly - White Coats Call Room – A blog from inside the emergency department http://www.epmonthly.com:80
The doctor writes that “During a recent ED shift, just for the heck of it, I started taking notes as I went from room to room treating patients. I wanted to try to show myself whether or not “defensive medicine” was a figment of my imagination. It isn’t a figment of my imagination.”The ED doctor gives these examples which do not serve his purpose of showing up “defensive medicine as bad.” In fact if f I were judging by this doctor’s examples I would defend the indefensible. I would defend defensive medicine.
See if you agree.
His Example 1.
A patient in her 60s fell and hit her head 5 days ago. She was having a headache. I couldn’t find a mark on her and was inclined to send her home with pain medications. But she was on Coumadin which put her at risk of bleeding. So I did a CT scan of her head to “make sure” that she didn’t have a bleed. She didn’t.
But she could have! Couldn’t she? Remember the late Catherine Graham owner of the Washington Post who died post fall cerebral bleed. And how about the beautiful actress daughter of the famous Redgrave clan - Natasha Richardson--mother of 2 children who also died post a skiing accident of a subdural hematoma—even without Coumadin to precipitate and prolong the bleeding inside her head.. The only way to help these patients is early diagnosis by x-ray. When clinical findings occur it’s usually too late-- which this doctor, seems to disregard.
Example 2 given by this ED doctor as defensive medicine.
An out of town patient in her 40’s who had a long history of smoking and a history of COPD came in for coughing and shortness of breath. She was at a baby shower and had forgotten her albuterol inhaler. Her oxygen saturation was 92% on room air. Her heart rate was 105. She got a couple of treatments and steroids and was marginally improved. Her symptoms were most likely explained by her underlying COPD. I was inclined to discharge her with a prescription for steroids and another inhaler. Instead, I did a CT scan of her chest to “make sure” that she didn’t have a pulmonary embolism. She didn’t. She went home on steroids and an inhaler. We made sure to recommend that she stop smoking so that we wouldn’t get dinged by CMS for failing to meet a “quality indicator.”
This patient could very well have a pulmonary embolus kicking in a bout of SOB.
His third Example.
A patient dropped a TV on his foot. There was only a little red mark on the back of his foot, but the patient stated that he could not bear weight on his foot. I was inclined to wrap him up and send him home with pain medication and crutches, but I did an x-ray of his foot to “make sure” that there was no fracture. There wasn’t.
Only a little red mark of his foot-but he could not bear weight on his foot? Sounds like an x-ray certainly is indicated here.
Example 4.
A 94 year old demented lady was brought in because she was not “acting right.” Her daughter tried to wake her from sleep and had a more difficult time than usual waking the patient up. The daughter stated that the patient was “acting different,” even though nurses who had seen the patient before and the nursing home staff stated that the patient was not acting different. The patient got a bunch of labs and a head CT just to “make sure” that the allegedly incremental increase in her dementia wasn’t caused by a metabolic problem or a spontaneous bleed in her brain. It wasn’t. She was discharged back to the nursing home to finish her nap.
The most common causes of sudden dementia or worsening of dementia in the elderly are medication problems, metabolic causes and infections. This lady certainly deserved these “defensive medical tests.”
Example 5.
Then there was the suicidal patient. She was drinking, became upset with her boyfriend, and used a piece of broken glass to cut her wrists. Her alcohol level was in the mid-200s. She was drunk and she “was going to f***ing die.” But no psychiatric institution would accept her in transfer until she had a complete laboratory and toxicological workup, including an EKG and a urinalysis just to “make sure” that a whacked out chloride level or a raging UTI wasn’t really behind her suicidal tendencies.
That’s right. How many “psychiatric” patients die in the psychiatric unit not from psychiatric but because of drugs and metabolic causes? Too many.
This particular ED doctor obvious from his remarks, thought that he had to do all the “extra” studies because of “defensive medicine.”
“Why,” he asks, “was I ordering all of these things when my clinical judgment led me to believe that they would “probably” not lead to any changes in the patient’s management?
Hello! Clinical judgment is great where indicated. These examples however do not prove this doctor’s point. In fact the opposite.
The answer, he gives is that “because in our culture, “probably” doesn’t cut the mustard any more. Clinical medical judgment has been supplanted, he says, by the demand that physicians disprove the improbable. Society has made it so that physicians are more concerned with proving that unlikely diagnoses with the possibility of a “bad outcome” don’t exist and with maintaining good Press - Ganey scores. Many physicians are afraid to practice rational medicine based upon clinical judgment and physical examination skills. No one wants to face the liability. For those who would assert that I was practicing inappropriate medicine for ordering all of the “unnecessary tests” above, tell me which conditions that it would have been acceptable to “fail to diagnose” on the possibility that my clinical examination alone missed an unlikely disease process. That, my friends, is defensive medicine at work.”
Doctor, your case would be better made with better examples.
And doctor, I would further reply ---how about this case?
40 yr old indigent street guppy shows up to the ER with altered level of consciousness. Blood alcohol was .3 (almost 4 times the normal intoxication limit 0.08). ER Doc runs CBC, metabolic panel that shows only elevated liver enzymes, no surprise for chronic alcoholism. ER Doc decides to wait it out, and discharges patient after almost a full shift, alert and oriented. (No discharge blood alcohol done). Said patient returns 1 hr later, again altered LOC. Being a bounce back, this time he gets the full work-up. Blood alcohol 0.12, CT shows subdural hematoma.
What really is defensive medicine? Defensive medicine eludes easy definition
Definitions include:
“Medical practices designed to avert the future possibility of malpractice suits.”
“ In defensive medicine, responses are undertaken primarily to avoid liability rather than to benefit the patient.”
“Doctors order tests, procedures, or visits, or avoid high-risk patients or procedures primarily (but not necessarily solely) to reduce their exposure to malpractice liability.”
“Medical practices designed to avert the future possibility of malpractice suits.”
Some defensive medicine, however, presumably helps patients. Some paradoxically puts the patients in harm's way (the more you do, the more you are likely to "break something.")
As the blog complained, many believe that sound clinical judgment has been supplanted by disproving the improbable. Failure to diagnose, no matter how improbable, can, and often does, evolve into a multi-year odyssey narrated by "a plaintiff's attorney telling everyone how the patient's injury is an example of why [the physician] is a bad doctor and why clinical examination alone is simply not good enough." But the problem with the definitions are that defensive” medicine - ie medicine done to avoid the risk of liability, remains undefinable, because you don’t know if your liability is actually reduced by each “unnecessary” test you order.
COMMENT:
If I were judging by this doctor’s examples I would defend the indefensible. I would defend defensive medicine.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for TOP 10 Laws and Rules Every Physician Should Know
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
The doctor writes that “During a recent ED shift, just for the heck of it, I started taking notes as I went from room to room treating patients. I wanted to try to show myself whether or not “defensive medicine” was a figment of my imagination. It isn’t a figment of my imagination.”The ED doctor gives these examples which do not serve his purpose of showing up “defensive medicine as bad.” In fact if f I were judging by this doctor’s examples I would defend the indefensible. I would defend defensive medicine.
See if you agree.
His Example 1.
A patient in her 60s fell and hit her head 5 days ago. She was having a headache. I couldn’t find a mark on her and was inclined to send her home with pain medications. But she was on Coumadin which put her at risk of bleeding. So I did a CT scan of her head to “make sure” that she didn’t have a bleed. She didn’t.
But she could have! Couldn’t she? Remember the late Catherine Graham owner of the Washington Post who died post fall cerebral bleed. And how about the beautiful actress daughter of the famous Redgrave clan - Natasha Richardson--mother of 2 children who also died post a skiing accident of a subdural hematoma—even without Coumadin to precipitate and prolong the bleeding inside her head.. The only way to help these patients is early diagnosis by x-ray. When clinical findings occur it’s usually too late-- which this doctor, seems to disregard.
Example 2 given by this ED doctor as defensive medicine.
An out of town patient in her 40’s who had a long history of smoking and a history of COPD came in for coughing and shortness of breath. She was at a baby shower and had forgotten her albuterol inhaler. Her oxygen saturation was 92% on room air. Her heart rate was 105. She got a couple of treatments and steroids and was marginally improved. Her symptoms were most likely explained by her underlying COPD. I was inclined to discharge her with a prescription for steroids and another inhaler. Instead, I did a CT scan of her chest to “make sure” that she didn’t have a pulmonary embolism. She didn’t. She went home on steroids and an inhaler. We made sure to recommend that she stop smoking so that we wouldn’t get dinged by CMS for failing to meet a “quality indicator.”
This patient could very well have a pulmonary embolus kicking in a bout of SOB.
His third Example.
A patient dropped a TV on his foot. There was only a little red mark on the back of his foot, but the patient stated that he could not bear weight on his foot. I was inclined to wrap him up and send him home with pain medication and crutches, but I did an x-ray of his foot to “make sure” that there was no fracture. There wasn’t.
Only a little red mark of his foot-but he could not bear weight on his foot? Sounds like an x-ray certainly is indicated here.
Example 4.
A 94 year old demented lady was brought in because she was not “acting right.” Her daughter tried to wake her from sleep and had a more difficult time than usual waking the patient up. The daughter stated that the patient was “acting different,” even though nurses who had seen the patient before and the nursing home staff stated that the patient was not acting different. The patient got a bunch of labs and a head CT just to “make sure” that the allegedly incremental increase in her dementia wasn’t caused by a metabolic problem or a spontaneous bleed in her brain. It wasn’t. She was discharged back to the nursing home to finish her nap.
The most common causes of sudden dementia or worsening of dementia in the elderly are medication problems, metabolic causes and infections. This lady certainly deserved these “defensive medical tests.”
Example 5.
Then there was the suicidal patient. She was drinking, became upset with her boyfriend, and used a piece of broken glass to cut her wrists. Her alcohol level was in the mid-200s. She was drunk and she “was going to f***ing die.” But no psychiatric institution would accept her in transfer until she had a complete laboratory and toxicological workup, including an EKG and a urinalysis just to “make sure” that a whacked out chloride level or a raging UTI wasn’t really behind her suicidal tendencies.
That’s right. How many “psychiatric” patients die in the psychiatric unit not from psychiatric but because of drugs and metabolic causes? Too many.
This particular ED doctor obvious from his remarks, thought that he had to do all the “extra” studies because of “defensive medicine.”
“Why,” he asks, “was I ordering all of these things when my clinical judgment led me to believe that they would “probably” not lead to any changes in the patient’s management?
Hello! Clinical judgment is great where indicated. These examples however do not prove this doctor’s point. In fact the opposite.
The answer, he gives is that “because in our culture, “probably” doesn’t cut the mustard any more. Clinical medical judgment has been supplanted, he says, by the demand that physicians disprove the improbable. Society has made it so that physicians are more concerned with proving that unlikely diagnoses with the possibility of a “bad outcome” don’t exist and with maintaining good Press - Ganey scores. Many physicians are afraid to practice rational medicine based upon clinical judgment and physical examination skills. No one wants to face the liability. For those who would assert that I was practicing inappropriate medicine for ordering all of the “unnecessary tests” above, tell me which conditions that it would have been acceptable to “fail to diagnose” on the possibility that my clinical examination alone missed an unlikely disease process. That, my friends, is defensive medicine at work.”
Doctor, your case would be better made with better examples.
And doctor, I would further reply ---how about this case?
40 yr old indigent street guppy shows up to the ER with altered level of consciousness. Blood alcohol was .3 (almost 4 times the normal intoxication limit 0.08). ER Doc runs CBC, metabolic panel that shows only elevated liver enzymes, no surprise for chronic alcoholism. ER Doc decides to wait it out, and discharges patient after almost a full shift, alert and oriented. (No discharge blood alcohol done). Said patient returns 1 hr later, again altered LOC. Being a bounce back, this time he gets the full work-up. Blood alcohol 0.12, CT shows subdural hematoma.
What really is defensive medicine? Defensive medicine eludes easy definition
Definitions include:
“Medical practices designed to avert the future possibility of malpractice suits.”
“ In defensive medicine, responses are undertaken primarily to avoid liability rather than to benefit the patient.”
“Doctors order tests, procedures, or visits, or avoid high-risk patients or procedures primarily (but not necessarily solely) to reduce their exposure to malpractice liability.”
“Medical practices designed to avert the future possibility of malpractice suits.”
Some defensive medicine, however, presumably helps patients. Some paradoxically puts the patients in harm's way (the more you do, the more you are likely to "break something.")
As the blog complained, many believe that sound clinical judgment has been supplanted by disproving the improbable. Failure to diagnose, no matter how improbable, can, and often does, evolve into a multi-year odyssey narrated by "a plaintiff's attorney telling everyone how the patient's injury is an example of why [the physician] is a bad doctor and why clinical examination alone is simply not good enough." But the problem with the definitions are that defensive” medicine - ie medicine done to avoid the risk of liability, remains undefinable, because you don’t know if your liability is actually reduced by each “unnecessary” test you order.
COMMENT:
If I were judging by this doctor’s examples I would defend the indefensible. I would defend defensive medicine.
Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.
* Tune in tomorrow for TOP 10 Laws and Rules Every Physician Should Know
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
Saturday, June 27, 2009
HHS says researcher fabricated, falsified data on sleep apnea in severely obese patients
In the Wall Street Journal (4/10/09) Health Blog, Sarah Rubenstein wrote that, according to the Office of Research Integrity at the Health and Human Services Department, "Robert Fogel, a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients." The office said that Fogel "changed or falsified nearly half of the sleep data "so that those data would better conform to his hypothesis." He is also accused of fabricating "about 20 percent of anatomic data that supposedly came from CT scans."
The study, titled "Anatomic and Physiologic Predictors of Apnea Severity in Morbidly Obese Subjects," has since been retracted from the journal Sleep. Commenting on the false data, Fogel said "What I did was obviously horrendously wrong," but that "this was the only paper on which he'd done this." Fogel’s fabrications don’t appear as widespread as those of a Massachusetts doctor who allegedly faked data in 21 published studies. Specifically, PHS found that for the data reported in the Sleep paper, the Respondent:
• Changed/falsified roughly half of the physiologic data
• Fabricated roughly 20% of the anatomic data that were supposedly obtained from Computed Tomography (CT) images
• Changed/falsified 50 to 80 percent of the other anatomic data
• Changed/falsified roughly 40 to 50 percent of the sleep data so that those data would better conform to his hypothesis.
A New Low in Drug Research: 21 Fabricated Studies
We’ve written about plenty of controversies around drug trials, from ghostwriting to keeping quiet about unflattering results.
But the latest news is particularly eye-popping: A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies involving major drugs. Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.
Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica and Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.
“We are left with a large hole in our understanding of this field,” said the editor-in-chief of Anesthesia and Analgesia, which first reported on the retractions. “There are substantial tendrils from this body of work that reach throughout the discipline of postoperative pain management.”Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.
And another horror story:
A medical device company and four of its executives have been indicted on charges of conducting unapproved clinical trials in which three patients died, according to the U.S. Department of Justice.
The company, Norian Corporation, of Cupertino, Calif., faces 52 felony counts, including conspiracy to impede the lawful functions of the FDA, seven counts of making false statements, and 44 counts of shipping an adulterated product. Its parent company, Synthes, of Switzerland and West Chester, Pa., faces 44 misdemeanor counts of shipping an adulterated product
The indictment charges that, from May 2002 to fall 2004, Norian conspired with parent company Synthes and four top executives to use Norian XR and Norian SRS to surgically treat vertebral compression fractures of the spine Norian SRS, in vertebral compression fracture procedures as part of a test market, according to the Department of Justice. Ultimately, 52 surgeons were trained on use of the product in such procedures.
The surgeries were performed despite a warning on the FDA approved label for Norian XR against such use -- preliminary studies had found that the cement reacted chemically with human blood, resulting in clotting. Animal studies had shown that the blood clots became lodged in the lungs, according to the Department of Justice.
Norian conducted three of the training sessions, canceling others after three patients in whom Norian XR was used died on the operating table. The company did not recall the product from the market -- doing so would have required a disclosure about the deaths to the FDA.
Instead, the Department of Justice charges that the company carried out a cover-up in which they lied to the FDA during inspections in May and June 2004.
* Tune in tomorrow for In defense of Defensive medicine.
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
The study, titled "Anatomic and Physiologic Predictors of Apnea Severity in Morbidly Obese Subjects," has since been retracted from the journal Sleep. Commenting on the false data, Fogel said "What I did was obviously horrendously wrong," but that "this was the only paper on which he'd done this." Fogel’s fabrications don’t appear as widespread as those of a Massachusetts doctor who allegedly faked data in 21 published studies. Specifically, PHS found that for the data reported in the Sleep paper, the Respondent:
• Changed/falsified roughly half of the physiologic data
• Fabricated roughly 20% of the anatomic data that were supposedly obtained from Computed Tomography (CT) images
• Changed/falsified 50 to 80 percent of the other anatomic data
• Changed/falsified roughly 40 to 50 percent of the sleep data so that those data would better conform to his hypothesis.
A New Low in Drug Research: 21 Fabricated Studies
We’ve written about plenty of controversies around drug trials, from ghostwriting to keeping quiet about unflattering results.
But the latest news is particularly eye-popping: A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies involving major drugs. Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.
Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica and Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.
“We are left with a large hole in our understanding of this field,” said the editor-in-chief of Anesthesia and Analgesia, which first reported on the retractions. “There are substantial tendrils from this body of work that reach throughout the discipline of postoperative pain management.”Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.
And another horror story:
A medical device company and four of its executives have been indicted on charges of conducting unapproved clinical trials in which three patients died, according to the U.S. Department of Justice.
The company, Norian Corporation, of Cupertino, Calif., faces 52 felony counts, including conspiracy to impede the lawful functions of the FDA, seven counts of making false statements, and 44 counts of shipping an adulterated product. Its parent company, Synthes, of Switzerland and West Chester, Pa., faces 44 misdemeanor counts of shipping an adulterated product
The indictment charges that, from May 2002 to fall 2004, Norian conspired with parent company Synthes and four top executives to use Norian XR and Norian SRS to surgically treat vertebral compression fractures of the spine Norian SRS, in vertebral compression fracture procedures as part of a test market, according to the Department of Justice. Ultimately, 52 surgeons were trained on use of the product in such procedures.
The surgeries were performed despite a warning on the FDA approved label for Norian XR against such use -- preliminary studies had found that the cement reacted chemically with human blood, resulting in clotting. Animal studies had shown that the blood clots became lodged in the lungs, according to the Department of Justice.
Norian conducted three of the training sessions, canceling others after three patients in whom Norian XR was used died on the operating table. The company did not recall the product from the market -- doing so would have required a disclosure about the deaths to the FDA.
Instead, the Department of Justice charges that the company carried out a cover-up in which they lied to the FDA during inspections in May and June 2004.
* Tune in tomorrow for In defense of Defensive medicine.
Deepen your understanding of How to Be an Effective Medical Expert www.medmalbook.com
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