A lot of nutritionists say that in order to shed off those unwanted pounds, it's really not about eating less, but exercising more. Although this is absolutely true, this doesn't mean that people can eat whatever they like so long as they work out. In fact, studies show that some meals, especially those bought from fast-food chains, could actually have more calories than one could burn in a 30-minute workout. Thus, the need to watch what one eats. Below are the greasiest and most calorie-packed meals of some of the most popular fast-food chains in the world.
KFC
KFC's chicken is definitely finger lickin' good. No one can contest this and surely, KFC serves one of, if not the best fast-food chicken in the world. And the best (or the worst rather) in terms of calorie count is the KFC Famous Bowl with rice and gravy. It also comes with an order of Caesar Side Salad and a medium raspberry iced tea. This meal alone packs an amazing 1,457 calories, 59 g of fat (13 g saturated fat), and 3,560 mf of Sodium. Next time at KFC, be sure to try and avoid this meal and instead, go for the crispy strips and green beans combo that has much less calories at 475.
McDonald's
McDonald's boasts of serving billions of customers worldwide. However, this fast-food chain is also responsible for adding trillions of calories to their customers' bodies. McDonald's burgers are world-famous and few are up to par with the quality and the succulence of their delicious burgers.
Just try to veer away from the Chicken Selects Premium Breast Strips (5 pc) with Creamy Ranch Sauce. This combo meal also comes with an order of large fries and a large Coke. All in all, the total calorie count for this meal amounts to 1,670 calories. It also contains 87 g of fat (13 g saturated fat) and 2,370 g of sodium. This meal contains so much calories that even the Quarter Pounder without cheese (combined with side salad and a large iced tea) does not even come close as it only packs a total of 470 calories, 22 g of fat (7 g saturated fat, 1 g trans fat) and 1,490 ms of Sodium.
Burger King
Burger King is one of the best fast-food restaurants in the world and the burgers they serve are absolutely sumptuous. The problem is, most of them are packed with so much calories that even after a workout, some calories would still be left unburned. The pick of the bunch is the infamous Triple Whopper with Cheese. The meal comes with large fries and a medium Coke.
This meal alone contains a whopping of 2,040 calories, 113g of fat (38 g saturated fat), 3.5 g of trans fats and 2,650 mg of Sodium. That is of course if the order does not include extra toppings of bacon. Just imagine how much more calories it would have once this is added. As an alternative, one can opt for the Whopper Jr. (without Mayo), with Garden Salad and bottled water. At 490 g of calories, this meal has only one fourth of the calorie content of the Triple Whopper.
by: Jamie Hanson
Tuesday, June 30, 2009
How to Cure Type 2 Diabetes - A Simple Plan of Exercise and Dieting
How to cure type 2 diabetes is a question on about 1 in 3 Americans' minds. Can you believe that so many people are diabetic or pre-diabetic?
Yet, the American Diabetic Association (ADA) still states that there is no cure for diabetes. And even yet, thousands of people will cure diabetes this year. Who is telling the truth? In this article, you will learn the basics of how to cure type 2 diabetes with exercise and dieting.
Why Curing Diabetes Works
Have you seen the popular show, The Biggest Loser? Recently, one of the overweight contestants lost pounds of fat and changed her life. I was impressed to hear how she naturally cured her high blood pressure and cured her diabetes in a matter of 10 weeks.
How did she do it? Exercise and dieting.
And research study after research study shows that the best way to become healthier and cure common diseases like gout, high blood pressure, and diabetes is good old fashion exercise and dieting. Here are some tips to help you make your diet simpler, your exercise program simpler and cure type 2 diabetes.
Cure Type 2 Diabetes Naturally
Simpler is better. These tips may be considered simple but they will reverse diabetes in a matter of weeks. Just try them!
1. Drinking water should be an important habit throughout the day. Water can help you lose weight and also keep your body flushed. It also makes healthier cells which will eventually accept insulin. You should drink at least 2 cups of water for every 2 hours you are awake. Do the math and make a goal today.
2. Avoid sugar and avoiding carbohydrates is extremely important to start your diet. Sugar is obviously a no-no for diabetics. Carbohydrates and starches are also important to avoid because they are converted to glucose once it mixes with saliva. In other words, carbohydrates are like eating tablespoons of sugar.
Once you reverse or cure diabetes, you will be able to reintroduce carbohydrates to your body through whole grains.
You should avoid breads, pastas, cereals, crackers, potatoes and chips for a few weeks while your blood sugar normalizes.
3. Exercising is also important for making new cells that accept insulin and normalizing blood sugar. Try to exercise once a day for at least 30 minutes (you can go longer). Exercising has been shown to help in the cure of diabetes.
Exercise is beneficial because it will reduce insulin resistance, ward off diabetes complications, help you lose weight, make you feel and look better and help you maintain a steady blood sugar level for life.
If you live an inactive lifestyle, start by exercising only a little each day. Gradually work your way up to exercising more which will reduce the chance of burning out. And find something you enjoy like biking, hiking or swimming.
Cure Diabetes in 4 Weeks
Your body creates about 60,000 new cells by the time it takes you to read one sentence. Imagine if your body was healthy enough to create cells that accept insulin and start reversing diabetes. Imagine curing diabetes in 4 weeks with a 100% guaranteed, step by step plan.
by: Joe Barton
Yet, the American Diabetic Association (ADA) still states that there is no cure for diabetes. And even yet, thousands of people will cure diabetes this year. Who is telling the truth? In this article, you will learn the basics of how to cure type 2 diabetes with exercise and dieting.
Why Curing Diabetes Works
Have you seen the popular show, The Biggest Loser? Recently, one of the overweight contestants lost pounds of fat and changed her life. I was impressed to hear how she naturally cured her high blood pressure and cured her diabetes in a matter of 10 weeks.
How did she do it? Exercise and dieting.
And research study after research study shows that the best way to become healthier and cure common diseases like gout, high blood pressure, and diabetes is good old fashion exercise and dieting. Here are some tips to help you make your diet simpler, your exercise program simpler and cure type 2 diabetes.
Cure Type 2 Diabetes Naturally
Simpler is better. These tips may be considered simple but they will reverse diabetes in a matter of weeks. Just try them!
1. Drinking water should be an important habit throughout the day. Water can help you lose weight and also keep your body flushed. It also makes healthier cells which will eventually accept insulin. You should drink at least 2 cups of water for every 2 hours you are awake. Do the math and make a goal today.
2. Avoid sugar and avoiding carbohydrates is extremely important to start your diet. Sugar is obviously a no-no for diabetics. Carbohydrates and starches are also important to avoid because they are converted to glucose once it mixes with saliva. In other words, carbohydrates are like eating tablespoons of sugar.
Once you reverse or cure diabetes, you will be able to reintroduce carbohydrates to your body through whole grains.
You should avoid breads, pastas, cereals, crackers, potatoes and chips for a few weeks while your blood sugar normalizes.
3. Exercising is also important for making new cells that accept insulin and normalizing blood sugar. Try to exercise once a day for at least 30 minutes (you can go longer). Exercising has been shown to help in the cure of diabetes.
Exercise is beneficial because it will reduce insulin resistance, ward off diabetes complications, help you lose weight, make you feel and look better and help you maintain a steady blood sugar level for life.
If you live an inactive lifestyle, start by exercising only a little each day. Gradually work your way up to exercising more which will reduce the chance of burning out. And find something you enjoy like biking, hiking or swimming.
Cure Diabetes in 4 Weeks
Your body creates about 60,000 new cells by the time it takes you to read one sentence. Imagine if your body was healthy enough to create cells that accept insulin and start reversing diabetes. Imagine curing diabetes in 4 weeks with a 100% guaranteed, step by step plan.
by: Joe Barton
Americans Hit the Web for Health Info
A new report from the PEW Internet Project shows that 61% of American adults go online for health information. These "e-patients" are seeking information about health for themselves or for friends or relatives. And 2/3 of them talk to someone else about what they find online, most often a friend or spouse.Certainly young physicians and health administrators are aware of this sea change , but I
Monday, June 29, 2009
Tips on Feeling Better during Cold and Flu
The flu, which is a nickname for the influenza virus, starts suddenly and hits hard. Your fever may go as high as 40C (105F). You'll probably feel weak and tired, and have a dry cough, a runny nose, chills, muscle aches, severe headache and a sore throat. The fever may last for three to five days. After the flu goes away, you may still feel weak and tired or keep coughing for up to three weeks...>>
The flu is most common in winter and early spring. It often occurs in outbreaks. The flu virus changes often. About every 10 years it undergoes major changes, so that more severe outbreaks occur.
Feel better By Doing:
1.Stay home and rest, especially while you have a fever.
2. Stop smoking and avoid secondhand smoke, which can make cold symptoms worse.
3. Drink plenty of fluids like water, fruit juices and clear soups. Fluids help loosen mucus. Fluids are also important if you have a fever because fever can dry up your body's fluids, which can lead to dehydration.
Don't drink alcohol.
4. Gargle with warm salt water a few times a day to relieve a sore throat. Throat sprays or lozenges may also help relieve the pain.
5. Use saline (salt water) nose drops to help loosen mucus and moisten the tender skin in your nose.
6. Wash your hands frequently. This is often your best defense. Wash the entire hand using warm water and soap. Don't forget to clean under fingernails. Wash for about 10 seconds.
7. Avoid putting your hands near your eyes, nose or mouth, unless you have washed. Most bacteria and germs are spread from a surface to your hands to your face. Few germs are transmitted through the air.
8. Clean your 'shared spaces' more often than other times of the year. Remember phones, keyboards, steering wheels, office equipment and other items used by several people during the day.
9. Get a flu shot. Flu shots are especially beneficial for those with wekened immune systems, the elderly or those who come in contact with a lot of people. Check with Health Services for more information.
10. Get enough sleep. During sleep, your body's immune system goes into high gear to protect you from illness. Lack of sleep can reduce immune functioning making you susceptible to sickness.
11. Drink more water. In the fall and winter, it is easy to overlook your thirst and get dehydrated. Make sure you consume 8 glasses a day.
Continue a moderate exercise program. Try to maintain a 3-4 day a week exercise routine. Consistency is key.
12. Eat healthily. A good rule is to eat 10-15 calories per pound of "desired body weight." If your ideal weight is 170 lbs, then consume 1700-2550 calories a day (1700 for sedentary individuals and 2550 for extremely active types.)
13. Limit alcohol intake. Alcohol can be dehydrating which, in turn, may decrease your resistence to bacteria.
14. Finally, listen to your body. If you are less than 100% you will feel better and recover faster if you let yourself rest.
by: Barbara Camie
The flu is most common in winter and early spring. It often occurs in outbreaks. The flu virus changes often. About every 10 years it undergoes major changes, so that more severe outbreaks occur.
Feel better By Doing:
1.Stay home and rest, especially while you have a fever.
2. Stop smoking and avoid secondhand smoke, which can make cold symptoms worse.
3. Drink plenty of fluids like water, fruit juices and clear soups. Fluids help loosen mucus. Fluids are also important if you have a fever because fever can dry up your body's fluids, which can lead to dehydration.
Don't drink alcohol.
4. Gargle with warm salt water a few times a day to relieve a sore throat. Throat sprays or lozenges may also help relieve the pain.
5. Use saline (salt water) nose drops to help loosen mucus and moisten the tender skin in your nose.
6. Wash your hands frequently. This is often your best defense. Wash the entire hand using warm water and soap. Don't forget to clean under fingernails. Wash for about 10 seconds.
7. Avoid putting your hands near your eyes, nose or mouth, unless you have washed. Most bacteria and germs are spread from a surface to your hands to your face. Few germs are transmitted through the air.
8. Clean your 'shared spaces' more often than other times of the year. Remember phones, keyboards, steering wheels, office equipment and other items used by several people during the day.
9. Get a flu shot. Flu shots are especially beneficial for those with wekened immune systems, the elderly or those who come in contact with a lot of people. Check with Health Services for more information.
10. Get enough sleep. During sleep, your body's immune system goes into high gear to protect you from illness. Lack of sleep can reduce immune functioning making you susceptible to sickness.
11. Drink more water. In the fall and winter, it is easy to overlook your thirst and get dehydrated. Make sure you consume 8 glasses a day.
Continue a moderate exercise program. Try to maintain a 3-4 day a week exercise routine. Consistency is key.
12. Eat healthily. A good rule is to eat 10-15 calories per pound of "desired body weight." If your ideal weight is 170 lbs, then consume 1700-2550 calories a day (1700 for sedentary individuals and 2550 for extremely active types.)
13. Limit alcohol intake. Alcohol can be dehydrating which, in turn, may decrease your resistence to bacteria.
14. Finally, listen to your body. If you are less than 100% you will feel better and recover faster if you let yourself rest.
by: Barbara Camie
Sleeping Aids and Insomnia
Fighting Insomnia with Sleeping Aids...
Due to many people around the world suffering from insomnia, there has been a great deal of research and studies. There are different forms of sleeping problems that affect people but there are now numerous aids that can help them. A certain amount of people suffer from short term insomnia whereas a number of individuals suffer from what is known as chronic insomnia.
Consider how you feel if you wake up early or without having a full nights sleep. It is very common to feel cranky or uncomfortable and the feeling can last all day. For most people, this is not a lasting occurrence and is usually rectified by a sound sleep at night. Some people are not so lucky though. Many people are experiencing this situation each and every day of their life.
Knowing that you are never able to get enough sleep that your body craves or desires can start to have an extremely negative affect on a person. They will always be feeling lethargic or not up to their best. They will dread trying to get to sleep every night and this anxiety will only make matters worse. A problem for many people with insomnia is that a cyclical effect can occur where worrying about a lack of sleep can further cause a person to be awake all night. Suffering from insomnia is an extremely uncomfortable ailment to experience.
Both types of insomnia can have a massive impact on how a person is able to function throughout their normal life. Research on Insomnia and Sleeping Aids has shown that people need seven or eight hours of sleep each day on a regular basis to be at their optimum level. This is why there is an increasing market for sleeping aids and there are a great number of commercial products looking to take advantage of this situation.
When a person is unable to get to sleep, quite often it is to due to an imbalance in the chemicals that are active within their body. If a person has more awake chemicals than sleep chemicals active, they can find difficulty in sleeping but there are numerous aids available to make life more bearable. Using any one of the sleeping products available can ensure a person gets proper nights sleep and that they are fully charged and ready for whatever life may throw at them in the following day.
Although possibly not seen as one of the more dangerous ailments a person can suffer from, insomnia is able to change a person’s mood or happiness in a very short span of time. Having problems with sleeping can cause great difficulty for a person and this is why so many people are looking for cures or aids to alleviate the difficulties they face. A lack of proper sleep can reduce a person’s ability to concentrate or focus, making problem solving and decision making a far harder task than what it should be. Sleeping is considered to be the body’s natural way of recharging; therefore it is advisable to seek aids or assistance to ensure a proper night’s sleep. Many doctors or pharmacists would be happy to offer advice to people having difficulty with this matter.
Another problem in recognizing insomnia as a major hazard to people’s health is that a great majority of people do not consider it to be a serious ailment. Quite commonly, people may pass it off as a symptom of some other health issue they are experiencing as opposed to being a serious issue within its own right. There is a growing need for people to accept that lack of sleeping is a major issue and they require medical advice and aids to ensure they are able to overcome difficulties caused by this situation.
Many products to aid sleeping can be purchased freely over the counter and this has led to a boon in this burgeoning industry. With a lack of sleep being a major concern for a great number of individuals having a quick solution at hand has been a boon for many sufferers. With this form of medication being available over a counter, many users may consider it to be risk free. Whilst there may not be a risk level that is associated with many other more serious forms of medication, it should be noted that this medication can still cause problems.
Given that insomnia sufferers are likely to be desperate to get some sleep, they may consider an increase in dosage to be a good idea. Increasing the recommended dose levels is never a sensible idea as it can quickly lead to addiction. Addiction to over the counter forms of medication is rising sharply and catches many people unaware. There needs to be a greater level of awareness of dangers that all medicine can cause if used improperly.
Medication to cure or reduce insomnia can have an extremely positive impact on users but caution needs to be applied to its use. No matter whether it is taken in a tablet, liquid or capsule form, all forms of medication can cause addiction and if a user has any doubt they should always seek the opinion of their doctor or pharmacist.
As more and more people become aware of disadvantages in lack of sleeping and the negative impact it has on quality of life, expect this market for aids to cure insomnia to thrive. As with all ailments, if you are suffering from insomnia the same should be informed to your doctor or local medical facility. It should be their decision whether you need medication to increase your chances of falling asleep.
by: Mike Argiro
Due to many people around the world suffering from insomnia, there has been a great deal of research and studies. There are different forms of sleeping problems that affect people but there are now numerous aids that can help them. A certain amount of people suffer from short term insomnia whereas a number of individuals suffer from what is known as chronic insomnia.
Consider how you feel if you wake up early or without having a full nights sleep. It is very common to feel cranky or uncomfortable and the feeling can last all day. For most people, this is not a lasting occurrence and is usually rectified by a sound sleep at night. Some people are not so lucky though. Many people are experiencing this situation each and every day of their life.
Knowing that you are never able to get enough sleep that your body craves or desires can start to have an extremely negative affect on a person. They will always be feeling lethargic or not up to their best. They will dread trying to get to sleep every night and this anxiety will only make matters worse. A problem for many people with insomnia is that a cyclical effect can occur where worrying about a lack of sleep can further cause a person to be awake all night. Suffering from insomnia is an extremely uncomfortable ailment to experience.
Both types of insomnia can have a massive impact on how a person is able to function throughout their normal life. Research on Insomnia and Sleeping Aids has shown that people need seven or eight hours of sleep each day on a regular basis to be at their optimum level. This is why there is an increasing market for sleeping aids and there are a great number of commercial products looking to take advantage of this situation.
When a person is unable to get to sleep, quite often it is to due to an imbalance in the chemicals that are active within their body. If a person has more awake chemicals than sleep chemicals active, they can find difficulty in sleeping but there are numerous aids available to make life more bearable. Using any one of the sleeping products available can ensure a person gets proper nights sleep and that they are fully charged and ready for whatever life may throw at them in the following day.
Although possibly not seen as one of the more dangerous ailments a person can suffer from, insomnia is able to change a person’s mood or happiness in a very short span of time. Having problems with sleeping can cause great difficulty for a person and this is why so many people are looking for cures or aids to alleviate the difficulties they face. A lack of proper sleep can reduce a person’s ability to concentrate or focus, making problem solving and decision making a far harder task than what it should be. Sleeping is considered to be the body’s natural way of recharging; therefore it is advisable to seek aids or assistance to ensure a proper night’s sleep. Many doctors or pharmacists would be happy to offer advice to people having difficulty with this matter.
Another problem in recognizing insomnia as a major hazard to people’s health is that a great majority of people do not consider it to be a serious ailment. Quite commonly, people may pass it off as a symptom of some other health issue they are experiencing as opposed to being a serious issue within its own right. There is a growing need for people to accept that lack of sleeping is a major issue and they require medical advice and aids to ensure they are able to overcome difficulties caused by this situation.
Many products to aid sleeping can be purchased freely over the counter and this has led to a boon in this burgeoning industry. With a lack of sleep being a major concern for a great number of individuals having a quick solution at hand has been a boon for many sufferers. With this form of medication being available over a counter, many users may consider it to be risk free. Whilst there may not be a risk level that is associated with many other more serious forms of medication, it should be noted that this medication can still cause problems.
Given that insomnia sufferers are likely to be desperate to get some sleep, they may consider an increase in dosage to be a good idea. Increasing the recommended dose levels is never a sensible idea as it can quickly lead to addiction. Addiction to over the counter forms of medication is rising sharply and catches many people unaware. There needs to be a greater level of awareness of dangers that all medicine can cause if used improperly.
Medication to cure or reduce insomnia can have an extremely positive impact on users but caution needs to be applied to its use. No matter whether it is taken in a tablet, liquid or capsule form, all forms of medication can cause addiction and if a user has any doubt they should always seek the opinion of their doctor or pharmacist.
As more and more people become aware of disadvantages in lack of sleeping and the negative impact it has on quality of life, expect this market for aids to cure insomnia to thrive. As with all ailments, if you are suffering from insomnia the same should be informed to your doctor or local medical facility. It should be their decision whether you need medication to increase your chances of falling asleep.
by: Mike Argiro
UK's National Programme for IT in the NHS Known Doomed at Outset?
It would seem likely.
In May 2009 at "The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians" I wrote:
I (and many like minded colleagues) don't find healthcare information technology issues a laughing matter, however.
-- SS
In May 2009 at "The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians" I wrote:
... I can add that if this initiative [the U.S. multibillion dollar ARRA push towards national healthcare IT by 2014] blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system.
The UK situation is much worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "16 key points in Gateway Reviews on NHS IT scheme" and the secretive Gateway Reviews themselves upon which the preceding article was based, released under UK Freedom Of Information laws. From ComputerWeekly.com author Tony Collins on Gateway Reviews:
Highlights of the secretive health IT program reviews, now made public:
How many of these findings apply in the U.S. Health IT program in 2009?
Finally, about the aforementioned May 2009 post, Matthew Holt of the Healthcare Blog wrote that I had "gone loopy", i.e., crazy (see footnote to the above-linked May 2009 post). The Chairman of CCHIT Mark Leavitt wrote that concerns about health IT are expressed by "fearmongers" and should be "laughed off."
These cavalier attitudes are a major part of what has gone wrong in HIT, as well as our society more generally.
... Gateway reviews are mini-audits at critical stages in projects. The reports in question gave a red, amber or green status at each stage to help the project’s senior responsible owner decide whether to move to the next phase.
The government’s policy on Gateway reviews is to keep them confidential. All copies of a review are shredded, with the supporting material, to ensure only two reports remain – one for the Treasury’s Office of Government Commerce (OGC) and the other for the project’s senior responsible owner.
Highlights of the secretive health IT program reviews, now made public:
- the NPfIT was probably doomed from the start, in Spring 2002. As one Gateway Review put it, many dedicated people were working hard on building the components for a car that hadn't been designed. To some extent that's still true today.
- people didn't really know what they were doing in the first critical months in 2002
- the initial plan was for new IT - not for changes to the way people work. So the preoccupation was with IT and not patients. It was hoped that new IT would drive change. But that rarely if ever succeeds.
- that the costs and complexity were initially underestimated - by about £7bn - because nobody had an understanding of what was needed.
- that speed was unduly important. One gateway review suggested that key staff didn't have time to take action on recommendations or learn lessons.
- the programme as a whole, according to one Gateway Review, was not assessed against a list of Common Causes of Failure, as published by the National Audit Office. Only individual projects were assessed against the list.
How many of these findings apply in the U.S. Health IT program in 2009?
Finally, about the aforementioned May 2009 post, Matthew Holt of the Healthcare Blog wrote that I had "gone loopy", i.e., crazy (see footnote to the above-linked May 2009 post). The Chairman of CCHIT Mark Leavitt wrote that concerns about health IT are expressed by "fearmongers" and should be "laughed off."
These cavalier attitudes are a major part of what has gone wrong in HIT, as well as our society more generally.
Not to draw a specific comparison with these individuals, but our society is crumbling, and it's in no small part due to clowns in leadership roles, rather than as performers in Ringling Bros. and Barnum and Bailey's Greatest Show on Earth.
According to Matthew Holt and Mark Leavitt, Health IT concerns are a laughing matter, expressed by crazy people.
I (and many like minded colleagues) don't find healthcare information technology issues a laughing matter, however.
-- SS
Sunday, June 28, 2009
Primary Care and Extra Services
Anyone who follows medical economics or medical blogs knows that primary care physicians are becoming few and far between. The number of young doctors who chose any specialty OTHER than primary care (family medicine or general internal medicine) continues to rise. So it is no surprise that I just read an article about adding "Ancillary Services in Primary Care".It is kind of sad that taking
Saturday, June 27, 2009
Why do Celebreties Have Bad Doctors?
Michael Jackson's mysterious death that involved his personal physician at his side when he died, brings up so many questions and speculations. The 911 phone call states that the physician was there when he "collapsed" in bed and was "pumping" (presumably performing CPR) him as the call was made. Further details are impossible as the doctor has disappeared and the toxicology portion of the
Toxic Cleanup in Montana
With all the emphasis on the economy and health care reform, we don't hear as much about toxic clean-up anymore or the critical work of the U.S. Environmental Protection Agency (EPA).The towns of Libby and Troy, in Northwest Montana are depending upon the EPA to clean up a vermiculite mine (opened in 1923) that was contaminated with toxic asbestos. The population of Libby was largely unaware
Friday, June 26, 2009
Michael Jackson - Man In The Mirror
"If you want to make the world a better place, just look at yourself and make a change."
Why Did US Physicians Give Up Their Ability to Enforce Their Own Professional Standards?
In his recent review of Dr Ezekiel Emanuel's book, (Healthcare, Guaranteed: A Simple, Secure Solution for America,) Dr Arnold Relman, Editor-Emeritus of the New England Journal of Medicine, discussed the history of the deprofessionalization of American physicians.
Writing about the decline of physicians' professionalism in 2007 [ Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here) ], Dr Relman had briefly alluded to the effect of the 1975 Supreme Court decision, (see our post here):
It seems to me that Dr Relman has elucidated one of the "missing links" that help explain the current sorry state of physicians' core values, and the broader continuing health care crisis. I am amazed that this bit of history seems to have been so thoroughly forgotten. Dr Relman did write about it before 2007, but in publications that few physicians and other health care professionals were likely to see. Other than Dr Relman, almost no one writing in the medical and health care literature seems to have interest in this issue. (It has been discussed in the Journal of Health Politics, Policy and Law, and the Stanford Law Review by M. Gregg Bloche, but these unfortunately also could have easily been missed by nearly all physicians and health care professionals.) So we have another example of the anechoic effect.
Yet in my humble opinion, every physician and health care professional ought to know that the profession once foreswore the commercialization of medical practice, but gave up on its ability to police its own conflicts of interest after the US Supreme Court decided that professionals are subject to anti-trust law.
But knowing this important bit of history raises more questions than it answers:
Inquiring minds want to know.... And answering these questions might bring us back on the path of true medical professionalism.
Hat tip to Merrill Goozner in the GoozNews blog.
References (from Relman)
1. Goldfarb v. Virginia State Bar, 421 U.S. 773 (1975).
2. Kenneth J. Arrow, "Uncertainty and the Welfare Economics of Medical Care," The American Economic Review, Vol. 53, No. 5 (December 1963).
The behavior of US physicians has been changed by the commercialization of medical care, and this too has increased costs. US medical practice has traditionally relied on fee-for-service, which has always given it some of the attributes and incentives of a business. However, the American Medical Association (AMA) maintained for many years that medical practice was a profession, not a business. The AMA's ethical guidelines therefore advised physicians to limit their income to reasonable earnings from the care of patients, and to refrain from advertising and from entering financial arrangements with drug and device manufacturers. Those restrictions were lifted after the US Supreme Court decided in 1975 that lawyers, and by extension members of other professions, including physicians, are engaged in interstate commerce and therefore must be subject to antitrust law (from which they had largely been exempt).(1)
This decision had an enormous effect on the medical profession, but its consequences have received relatively little public attention. Although the courts did not initiate the commercialization of medicine, they certainly accelerated it and gave it legal justification. In 1980, after medical organizations lost some costly antitrust trials, in which they were accused of such offenses as limiting doctor fees or denying staff privileges, the AMA changed its ethical guidelines, declaring medicine to be both a business and a profession. This lowered the AMA's barriers to the commercialization of medical practice, allowing physicians to participate in any legal profit-making business arrangement that did not harm patients.
Nearly a half-century ago, Stanford economics professor Kenneth Arrow, later a Nobel laureate, convincingly argued that medical care cannot conform to market laws because patients are not ordinary consumers and doctors are not ordinary vendors. He said that sick or injured patients must rely on physicians in ways fundamentally different from the price-driven relation between buyers and sellers in an ordinary market. This argument implied that, contrary to the assumptions of antitrust law, market competition among physicians cannot be expected to lower medical prices. And since physicians influence decisions to use medical services far more than patients do, the volume and types of services provided to patients—and hence total health costs—need to be controlled by forces other than the market, such as professional standards and government regulation. But Arrow's argument was largely ignored in the rush to exploit health care for commercial purposes that ensued after the passage of Medicare and Medicaid in 1965.(2)
Writing about the decline of physicians' professionalism in 2007 [ Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here) ], Dr Relman had briefly alluded to the effect of the 1975 Supreme Court decision, (see our post here):
The law also has played a major role in the decline of medical professionalism. The 1975 Supreme Court ruling that the professions were not protected from anti-trust law undermined the traditional restraint that medical professional societies had always placed on the commercial behavior of physicians, such as advertising and investing in the products they prescribe or facilities they recommend. Having lost some initial legal battles and fearing the financial costs of losing more, organized medicine now hesitates to require physicians to behave differently from business people. It asks only that physicians' business activities should be legal, disclosed to patients, and not inconsistent with patients' interests. Until forced by anti-trust concerns to change its ethical code in 1980, the American Medical Association had held that 'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients' and that 'the practice of medicine should not be commercialized, nor treated as a commodity in trade.' These sentiments reflecting the spirit of professionalism are now gone.
It seems to me that Dr Relman has elucidated one of the "missing links" that help explain the current sorry state of physicians' core values, and the broader continuing health care crisis. I am amazed that this bit of history seems to have been so thoroughly forgotten. Dr Relman did write about it before 2007, but in publications that few physicians and other health care professionals were likely to see. Other than Dr Relman, almost no one writing in the medical and health care literature seems to have interest in this issue. (It has been discussed in the Journal of Health Politics, Policy and Law, and the Stanford Law Review by M. Gregg Bloche, but these unfortunately also could have easily been missed by nearly all physicians and health care professionals.) So we have another example of the anechoic effect.
Yet in my humble opinion, every physician and health care professional ought to know that the profession once foreswore the commercialization of medical practice, but gave up on its ability to police its own conflicts of interest after the US Supreme Court decided that professionals are subject to anti-trust law.
But knowing this important bit of history raises more questions than it answers:
- The Supreme Court decision apparently involved interpretation of law, not the constitution. Therefore, why didn't organized medicine pursue a change in the law that would allow physicians to continue to enforce their traditional professional values?
- The Supreme Court decision was primarily directed at lawyers, not physicians. Since the decision, to my knowledge, the law profession has maintained strict rules about conflicts of interest. (For example, no legal CME is sponsored by corporations whose products they seek to have the attendees favor.) Why did the decision wreck physicians' but not lawyers' abilities to regulate their own conflicts of interest?
- The Supreme Court decision only affects US law. Why have physicians in other countries also abandoned their traditional values about commercial entanglements?
- Why did this application of US antitrust law have such significant effects during an era when antitrust enforcement in health care was generally declining? (Insurance companies and hospitals that dominate local markets have not feared antitrust enforcement.)
- Why did only Dr Relman and Prof Bloche seem to care about this up to now?
Inquiring minds want to know.... And answering these questions might bring us back on the path of true medical professionalism.
Hat tip to Merrill Goozner in the GoozNews blog.
References (from Relman)
1. Goldfarb v. Virginia State Bar, 421 U.S. 773 (1975).
2. Kenneth J. Arrow, "Uncertainty and the Welfare Economics of Medical Care," The American Economic Review, Vol. 53, No. 5 (December 1963).
Thursday, June 25, 2009
108 Days
Imagine your 44 year old husband suffers electrocution and severe burns at work. He is rushed to one of the best hospitals in the country and you anticipate a few days in the hospital while he recovers and receives compassionate care. Instead , the care is erratic, the professionals are rude and arrogant, and one complication after another spirals him into septic shock and coma. That is the
Contamination & Cleaning
How long can influenza virus remain viable on objects (such as books and doorknobs)?
Studies have shown that influenza virus can survive on environmental surfaces and can infect a person for up to 2-8 hours after being deposited on the surface.
What kills influenza virus?
Technorati Profile
Influenza virus is destroyed by heat (167-212°F [75-100°C]). In addition, several chemical germicides, including chlorine, hydrogen peroxide, detergents (soap), iodophors (iodine-based antiseptics), and alcohols are effective against human influenza viruses if used in proper concentration for a sufficient length of time. For example, wipes or gels with alcohol in them can be used to clean hands. The gels should be rubbed into hands until they are dry.
What surfaces are most likely to be sources of contamination?
Germs can be spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth. Droplets from a cough or sneeze of an infected person move through the air. Germs can be spread when a person touches respiratory droplets from another person on a surface like a desk, for example, and then touches their own eyes, mouth or nose before washing their hands.
How should waste disposal be handled to prevent the spread of influenza virus?
To prevent the spread of influenza virus, it is recommended that tissues and other disposable items used by an infected person be thrown in the trash. Additionally, persons should wash their hands with soap and water after touching used tissues and similar waste.
Photo of cleaning suppliesWhat household cleaning should be done to prevent the spread of influenza virus?
To prevent the spread of influenza virus it is important to keep surfaces (especially bedside tables, surfaces in the bathroom, kitchen counters and toys for children) clean by wiping them down with a household disinfectant according to directions on the product label.
How should linens, eating utensils and dishes of persons infected with influenza virus be handled?
Linens, eating utensils, and dishes belonging to those who are sick do not need to be cleaned separately, but importantly these items should not be shared without washing thoroughly first.
Linens (such as bed sheets and towels) should be washed by using household laundry soap and tumbled dry on a hot setting. Individuals should avoid “hugging” laundry prior to washing it to prevent contaminating themselves. Individuals should wash their hands with soap and water or alcohol-based hand rub immediately after handling dirty laundry.
Eating utensils should be washed either in a dishwasher or by hand with water and soap.
Response & Investigation
What is CDC doing in response to the outbreak?
The agency’s goals are to reduce transmission and illness severity, and provide information to help health care providers, public health officials and the public address the challenges posed by the new virus. CDC is working with state and local health departments to enhance surveillance in the United States and to collect and analyze data to assess the impact of the virus and determine the groups at increased risk of complications. In addition, CDC continues to issue new and updated interim guidance for clinicians, public health professionals and the public for the prevention and treatment of this new virus.
To expand the national and international laboratory capacity for detecting novel H1N1 influenza, CDC has developed and distributed new influenza diagnostic kits and reagents to more than 350 laboratories, including laboratories in 131 countries. CDC’s Division of the Strategic National Stockpile (SNS) continues to send antiviral drugs, personal protective equipment, and respiratory protection devices to all 50 states and U.S. territories to help them respond to the outbreak.
The U.S. Government also is aggressively taking early steps in the process to manufacture a novel H1N1 influenza vaccine, working closely with manufacturing. CDC has isolated the new H1N1 virus, made a candidate vaccine virus that can be used to create vaccine, and has provided this virus to industry so they can begin scaling up for production of a vaccine, if necessary.
What epidemiological investigations are taking place in response to the recent outbreak?
CDC works very closely with state and local officials in areas where human cases of new H1N1 flu infections have been identified. CDC has deployed staff to several states to assist with the investigation of the impact of the novel H1N1 influenza, including the assessment of the severity of illness, how easily the virus spreads, and the amount of time people may be infectious. In states where EpiAid teams have been deployed, many epidemiological activities are taking place or planned including:
* Active surveillance in the counties where infections in humans have been identified;
* Studies of health care workers who were exposed to patients infected with the virus to see if they became infected;
* Studies of households and other contacts of people who were confirmed to have been infected to see if they became infected; and
* Study to see how long a person with the virus infection sheds the virus.
Who is in charge of medicine in the Strategic National Stockpile (SNS) once it is deployed?
Local health officials have full control of SNS medicine once supplies are deployed to a city, state, or territory. Federal, state, and local community planners are working together to ensure that SNS medicines will be delivered to the affected area as soon as possible. Many cities, states, and territories have already received SNS supplies. After CDC sends medicine to a state or city, control and distribution of the supply is at the discretion of that state or local health department. Most states and cities also have their own medicines that they can access to treat infected persons.
*Note: Much of the information in this document is based on studies and past experience with seasonal (human) influenza. CDC believes the information applies to novel H1N1 (swine) viruses as well, but studies on this virus are ongoing to learn more about its characteristics. This document will be updated as new information becomes available.
For general information about influenza in pigs (not novel H1N1 flu) see Background Information on Influenza in Pigs.
http://www.cdc.gov/h1n1flu/qa.htm
Studies have shown that influenza virus can survive on environmental surfaces and can infect a person for up to 2-8 hours after being deposited on the surface.
What kills influenza virus?
Technorati Profile
Influenza virus is destroyed by heat (167-212°F [75-100°C]). In addition, several chemical germicides, including chlorine, hydrogen peroxide, detergents (soap), iodophors (iodine-based antiseptics), and alcohols are effective against human influenza viruses if used in proper concentration for a sufficient length of time. For example, wipes or gels with alcohol in them can be used to clean hands. The gels should be rubbed into hands until they are dry.
What surfaces are most likely to be sources of contamination?
Germs can be spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth. Droplets from a cough or sneeze of an infected person move through the air. Germs can be spread when a person touches respiratory droplets from another person on a surface like a desk, for example, and then touches their own eyes, mouth or nose before washing their hands.
How should waste disposal be handled to prevent the spread of influenza virus?
To prevent the spread of influenza virus, it is recommended that tissues and other disposable items used by an infected person be thrown in the trash. Additionally, persons should wash their hands with soap and water after touching used tissues and similar waste.
Photo of cleaning suppliesWhat household cleaning should be done to prevent the spread of influenza virus?
To prevent the spread of influenza virus it is important to keep surfaces (especially bedside tables, surfaces in the bathroom, kitchen counters and toys for children) clean by wiping them down with a household disinfectant according to directions on the product label.
How should linens, eating utensils and dishes of persons infected with influenza virus be handled?
Linens, eating utensils, and dishes belonging to those who are sick do not need to be cleaned separately, but importantly these items should not be shared without washing thoroughly first.
Linens (such as bed sheets and towels) should be washed by using household laundry soap and tumbled dry on a hot setting. Individuals should avoid “hugging” laundry prior to washing it to prevent contaminating themselves. Individuals should wash their hands with soap and water or alcohol-based hand rub immediately after handling dirty laundry.
Eating utensils should be washed either in a dishwasher or by hand with water and soap.
Response & Investigation
What is CDC doing in response to the outbreak?
The agency’s goals are to reduce transmission and illness severity, and provide information to help health care providers, public health officials and the public address the challenges posed by the new virus. CDC is working with state and local health departments to enhance surveillance in the United States and to collect and analyze data to assess the impact of the virus and determine the groups at increased risk of complications. In addition, CDC continues to issue new and updated interim guidance for clinicians, public health professionals and the public for the prevention and treatment of this new virus.
To expand the national and international laboratory capacity for detecting novel H1N1 influenza, CDC has developed and distributed new influenza diagnostic kits and reagents to more than 350 laboratories, including laboratories in 131 countries. CDC’s Division of the Strategic National Stockpile (SNS) continues to send antiviral drugs, personal protective equipment, and respiratory protection devices to all 50 states and U.S. territories to help them respond to the outbreak.
The U.S. Government also is aggressively taking early steps in the process to manufacture a novel H1N1 influenza vaccine, working closely with manufacturing. CDC has isolated the new H1N1 virus, made a candidate vaccine virus that can be used to create vaccine, and has provided this virus to industry so they can begin scaling up for production of a vaccine, if necessary.
What epidemiological investigations are taking place in response to the recent outbreak?
CDC works very closely with state and local officials in areas where human cases of new H1N1 flu infections have been identified. CDC has deployed staff to several states to assist with the investigation of the impact of the novel H1N1 influenza, including the assessment of the severity of illness, how easily the virus spreads, and the amount of time people may be infectious. In states where EpiAid teams have been deployed, many epidemiological activities are taking place or planned including:
* Active surveillance in the counties where infections in humans have been identified;
* Studies of health care workers who were exposed to patients infected with the virus to see if they became infected;
* Studies of households and other contacts of people who were confirmed to have been infected to see if they became infected; and
* Study to see how long a person with the virus infection sheds the virus.
Who is in charge of medicine in the Strategic National Stockpile (SNS) once it is deployed?
Local health officials have full control of SNS medicine once supplies are deployed to a city, state, or territory. Federal, state, and local community planners are working together to ensure that SNS medicines will be delivered to the affected area as soon as possible. Many cities, states, and territories have already received SNS supplies. After CDC sends medicine to a state or city, control and distribution of the supply is at the discretion of that state or local health department. Most states and cities also have their own medicines that they can access to treat infected persons.
*Note: Much of the information in this document is based on studies and past experience with seasonal (human) influenza. CDC believes the information applies to novel H1N1 (swine) viruses as well, but studies on this virus are ongoing to learn more about its characteristics. This document will be updated as new information becomes available.
For general information about influenza in pigs (not novel H1N1 flu) see Background Information on Influenza in Pigs.
http://www.cdc.gov/h1n1flu/qa.htm
Cardiac Arrest Symptoms and Causes
Singer Michael Jackson died on June 25, 2009, after being rushed to a hospital suffering from cardiac arrest.
Cardiac arrest is the sudden loss of cardiac function, when the heart abruptly stops beating. A person whose heart has stopped will lose consciousness and stop normal breathing, and their pulse and blood pressure will be absent. Unless resuscitative efforts are begun immediately, cardiac arrest leads to death within a few minutes. This is often referred to by doctors as "sudden death" or "sudden cardiac death (SCD)."
Ventricular fibrillation is the most common cause of cardiac arrest. Ventricular fibrillation occurs when the normal, regular, electrical activation of heart muscle contraction is replaced by chaotic electrical activity that causes the heart to stop beating and pumping blood to the brain and other parts of the body. Permanent brain damage and death can occur unless the flow of blood to the brain is restored within five minutes. Heart attack is the most common cause of ventricular fibrillation. Less common causes of cardiac arrest include respiratory arrest (loss of breathing function), choking, trauma, electrocution, and drowning.
Early cardiopulmonary resuscitation (CPR) and defibrillation (electrical impulses delivered to the chest to restore normal heart rhythm) are the only way to reverse a cardiac arrest. These lifesaving measures must be instituted within a few minutes after cardiac arrest in order to have any chance of success. For every minute that passes without defibrillation, a person's chances of survival decrease by 7% to 10%. In areas where emergency medical services are able to provide defibrillation within five to seven minutes, the survival rate for cardiac arrest has been reported to be as high as 49%. It is rare for a resuscitation to be successful if more than ten minutes have elapsed following a cardiac arrest.
While having coronary artery disease or having a heart attack can increase a person's risk for having cardiac arrest, a heart attack is not the same thing as cardiac arrest. A heart attack (myocardial infarction) occurs when a portion of the heart muscle dies due to lack of blood flow and oxygen to a specific area of the heart. Symptoms of a heart attack typically include chest or other upper body discomfort and shortness of breath. A heart attack can precipitate sudden onset of ventricular fibrillation and cardiac arrest. Heart attack victim that develops ventricular fibrillation will lose consciousness.
Cardiac arrest is obviously a serious medical emergency. The mortality (death rate) from cardiac arrest can be decreased by providing immediate CPR and prompt defibrillation. Many public places are now equipped with automated external defibrillators (AEDs) that allow lay persons to provide emergency defibrillation in case of cardiac arrest.
By.Melissa Conrad Stoppler, MD
Cardiac arrest is the sudden loss of cardiac function, when the heart abruptly stops beating. A person whose heart has stopped will lose consciousness and stop normal breathing, and their pulse and blood pressure will be absent. Unless resuscitative efforts are begun immediately, cardiac arrest leads to death within a few minutes. This is often referred to by doctors as "sudden death" or "sudden cardiac death (SCD)."
Ventricular fibrillation is the most common cause of cardiac arrest. Ventricular fibrillation occurs when the normal, regular, electrical activation of heart muscle contraction is replaced by chaotic electrical activity that causes the heart to stop beating and pumping blood to the brain and other parts of the body. Permanent brain damage and death can occur unless the flow of blood to the brain is restored within five minutes. Heart attack is the most common cause of ventricular fibrillation. Less common causes of cardiac arrest include respiratory arrest (loss of breathing function), choking, trauma, electrocution, and drowning.
Early cardiopulmonary resuscitation (CPR) and defibrillation (electrical impulses delivered to the chest to restore normal heart rhythm) are the only way to reverse a cardiac arrest. These lifesaving measures must be instituted within a few minutes after cardiac arrest in order to have any chance of success. For every minute that passes without defibrillation, a person's chances of survival decrease by 7% to 10%. In areas where emergency medical services are able to provide defibrillation within five to seven minutes, the survival rate for cardiac arrest has been reported to be as high as 49%. It is rare for a resuscitation to be successful if more than ten minutes have elapsed following a cardiac arrest.
While having coronary artery disease or having a heart attack can increase a person's risk for having cardiac arrest, a heart attack is not the same thing as cardiac arrest. A heart attack (myocardial infarction) occurs when a portion of the heart muscle dies due to lack of blood flow and oxygen to a specific area of the heart. Symptoms of a heart attack typically include chest or other upper body discomfort and shortness of breath. A heart attack can precipitate sudden onset of ventricular fibrillation and cardiac arrest. Heart attack victim that develops ventricular fibrillation will lose consciousness.
Cardiac arrest is obviously a serious medical emergency. The mortality (death rate) from cardiac arrest can be decreased by providing immediate CPR and prompt defibrillation. Many public places are now equipped with automated external defibrillators (AEDs) that allow lay persons to provide emergency defibrillation in case of cardiac arrest.
By.Melissa Conrad Stoppler, MD
The science of sudden cardiac arrest.
Journalists and politicians across the country were in shock Friday afternoon at news that Tim Russert, the prominent and beloved NBC correspondent, had collapsed and died suddenly of a heart attack in the network's Washington office. Russert had previously been been diagnosed with several risk factors for a sudden heart attack, including coronary artery disease and diabetes. But his death is still a sad reminder that cardiac arrest can strike anyone without warning—and that when it does, it is often fatal.
Sudden cardiac arrest accounts for 310,000 deaths in America every year, or 850 a day—more than those caused by breast cancer, lung cancer, stroke, and AIDS combined. But despite how common the condition is, doctors know little about what predisposes one person to it and not another. The National Institutes of Health is currently mounting a major study at 60 trial sites across the country to try and identify risk factors related to both genes and lifestyle, and will begin enrolling patients this week. For now, says Jeffrey Olgin, a cardiologist at the University of California, San Francisco, assessing risk is "a very, very difficult thing. I can't look at you and say you have a 10 percent chance of dying from this."
Doctors do know that a previous history of heart attacks is the most important risk factor. Vice President Dick Cheney, who has suffered four heart attacks, wears a pacemaker to ward off sudden arrest. Age and gender also play roles, and as a 58-year-old male, Russert was in high-risk groups; the average age for suffering sudden cardiac death is between 58 and 62. Other factors involved in all forms of cardiovascular disease—family history, smoking, diabetes, and obesity—can come into play. Russert had some of these too; he had been previously diagnosed with diabetes and and coronary artery disease, and his autopsy on Friday showed an enlarged heart. But doctors do not know which of these factors is most important in causing a sudden heart attack, or why. They also do not know if stress plays a role at all; the data is unclear. "Most of us do not think it is terribly relevant," says Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic and a past president of the American College of Cardiology. After all, he notes, "many people in this world have stressful jobs," and they don't all die of of heart attacks.
What is clear is that there are ways to lower one's risk of sudden cardiac death: eat healthy, exercise, don't smoke, and take aspirin or statins. The trouble, though, is that patients often don't think they're at serious risk until they are actually experiencing an attack. In about a third of all sudden deaths due to coronary disease, death is the first sign that anything major is wrong. Russert himself was exercising and taking medication for his coronary artery disease, which was asymptomatic. He performed well in a stress test two months ago.
A sudden cardiac arrest is, of course, unexpected, but the process that causes it may begin many years before. "In middle-aged men, it's virtually always caused by degeneration in the wall of a coronary artery," says Dr. Thomas Risser, a cardiologist at Cambridge Health Alliance. "It starts with fat deposits and inflammation, and these plaques just lie there silently." They can do so for decades until one of them fractures, at which point the body tries to plug the hole with a blood clot—and ends up blocking off the whole blood vessel. This condition is known as a coronary thrombosis, and it is extremely dangerous. The heart muscle, now starved for oxygen-rich blood, falls out of rhythm; it quivers but doesn't pump. "In the final stage, the ventricle looks like a bag of worms. It's chaotically beating very fast and therefore is completely inefficient at pumping blood," says Olgin. "Soon, there's no blood flow anywhere, including the brain, and people just suddenly collapse."
Once a patient's heart has gotten out of a normal rhythm, it can't get back on beat on its own. But a defibrillator—either an internally implanted one such as Cheney's, or an external one with electrical paddles—can get the heart beating steadily again, provided it is used in time. "If people get there with an external defibrillator within three minutes of a collapse, the survival rate for the kind of thing Russert may have had can be as high as 50 percent," says Robert J. Myerburg, a cardiologist at the University of Miami Miller School of Medicine. "But time is the whole issue. If you rely on fire/rescue teams to bring one, the chance of survival drops seven to ten percent" with every minute that passes after a collapse. It's unclear whether Russert had access to a defibrillator. His internist said on Friday that "resuscitation" had begun immediately after the collapse and continued at the hospital, to no avail.
http://www.newsweek.com/id/141450
Sudden cardiac arrest accounts for 310,000 deaths in America every year, or 850 a day—more than those caused by breast cancer, lung cancer, stroke, and AIDS combined. But despite how common the condition is, doctors know little about what predisposes one person to it and not another. The National Institutes of Health is currently mounting a major study at 60 trial sites across the country to try and identify risk factors related to both genes and lifestyle, and will begin enrolling patients this week. For now, says Jeffrey Olgin, a cardiologist at the University of California, San Francisco, assessing risk is "a very, very difficult thing. I can't look at you and say you have a 10 percent chance of dying from this."
Doctors do know that a previous history of heart attacks is the most important risk factor. Vice President Dick Cheney, who has suffered four heart attacks, wears a pacemaker to ward off sudden arrest. Age and gender also play roles, and as a 58-year-old male, Russert was in high-risk groups; the average age for suffering sudden cardiac death is between 58 and 62. Other factors involved in all forms of cardiovascular disease—family history, smoking, diabetes, and obesity—can come into play. Russert had some of these too; he had been previously diagnosed with diabetes and and coronary artery disease, and his autopsy on Friday showed an enlarged heart. But doctors do not know which of these factors is most important in causing a sudden heart attack, or why. They also do not know if stress plays a role at all; the data is unclear. "Most of us do not think it is terribly relevant," says Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic and a past president of the American College of Cardiology. After all, he notes, "many people in this world have stressful jobs," and they don't all die of of heart attacks.
What is clear is that there are ways to lower one's risk of sudden cardiac death: eat healthy, exercise, don't smoke, and take aspirin or statins. The trouble, though, is that patients often don't think they're at serious risk until they are actually experiencing an attack. In about a third of all sudden deaths due to coronary disease, death is the first sign that anything major is wrong. Russert himself was exercising and taking medication for his coronary artery disease, which was asymptomatic. He performed well in a stress test two months ago.
A sudden cardiac arrest is, of course, unexpected, but the process that causes it may begin many years before. "In middle-aged men, it's virtually always caused by degeneration in the wall of a coronary artery," says Dr. Thomas Risser, a cardiologist at Cambridge Health Alliance. "It starts with fat deposits and inflammation, and these plaques just lie there silently." They can do so for decades until one of them fractures, at which point the body tries to plug the hole with a blood clot—and ends up blocking off the whole blood vessel. This condition is known as a coronary thrombosis, and it is extremely dangerous. The heart muscle, now starved for oxygen-rich blood, falls out of rhythm; it quivers but doesn't pump. "In the final stage, the ventricle looks like a bag of worms. It's chaotically beating very fast and therefore is completely inefficient at pumping blood," says Olgin. "Soon, there's no blood flow anywhere, including the brain, and people just suddenly collapse."
Once a patient's heart has gotten out of a normal rhythm, it can't get back on beat on its own. But a defibrillator—either an internally implanted one such as Cheney's, or an external one with electrical paddles—can get the heart beating steadily again, provided it is used in time. "If people get there with an external defibrillator within three minutes of a collapse, the survival rate for the kind of thing Russert may have had can be as high as 50 percent," says Robert J. Myerburg, a cardiologist at the University of Miami Miller School of Medicine. "But time is the whole issue. If you rely on fire/rescue teams to bring one, the chance of survival drops seven to ten percent" with every minute that passes after a collapse. It's unclear whether Russert had access to a defibrillator. His internist said on Friday that "resuscitation" had begun immediately after the collapse and continued at the hospital, to no avail.
http://www.newsweek.com/id/141450
Omega-3 And Sudden Cardiac Arrest
Not just like Michael jackson.....Sudden Cardiac Death (SCD) is responsible for numerous deaths in the U.S. and other countries around the world. It is not the same as a heart attack. A heart attack normally occurs when advanced atherosclerosis (clogging of the arteries) slowly starves the heart causing irreversible damage. The heart finally cannot function properly and stops. Sudden cardiac death occurs when the electrical impulses that control heart function become erratic resulting in an irregular heartbeat (arrhythmia). When the arrhythmia is severe enough the heart suddenly stops, starving the brain of needed blood. Death often follows quickly unless emergency care is administered immediately. Often sudden cardiac death occurs when no other heart disease is detected.
It has long been understood that eating fish can reduce the likelihood of heart attack and other cardiovascular diseases. The reason? Fish, especially cold-water fatty fish, is high in two omega-3 polyunsaturated fatty acids (PUFA). These two fatty acids are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omega-3 has been shown to reduce the build-up of artery clogging atherosclerosis and keep blood platelets from sticking together thus reducing the risk of heart attack and stroke.
But more recent studies suggest that omega-3 fatty acids also have an effect on the dangerous arrhythmias that can cause sudden cardiac death by regulating the impulses that control heart rhythm.
One study involved the use of mycocytes (cells that beat independently). By adding the free fatty acids to these cells arrhythmias were aborted. When the fatty acids were extracted from the mycocytes the arrhythmias would reoccur thus indicating that omega-3 fatty acids have a stabilizing effect on heart rhythm. The apparent mechanism for controlling rhythm involved cell ion channels, proteins that control the movement of sodium, calcium and potassium ions across the membrane of the cell.
Another study, conducted by Danish researchers, examined the relationship between heart rate variability and omega-3 fatty acids in healthy subjects. It had already been determined that heart arrhythmias could be positively impacted in patients who were recent heart attack victims. These researchers wanted to determine if people otherwise free of heart disease could gain the same arrhythmia controlling benefits from omega-3 fatty acids.
Sixty healthy adults were randomly divided into three groups. The first group received daily supplements containing 6.6 g of omega-3 (containing 3.0g EPA and 2.9g DHA). Group two received 2.0g of omega-3 (containing 0.9g EPA and 0.8g DHA). The remaining group received only an olive oil placebo. The supplements were given for 12 weeks. Before and after the supplements were consumed heart rate variability and blood cell fatty acids were measured. It was found that heart rate variability was favorably influenced by the amount of omega-3 consumed. In other words, the more omega-3 one consumed the higher the heart rate variability, especially in men with low heart rate variability before supplementing.
The researchers concluded that omega-3 fatty acids positively affected heart rate variability thus having a protective effect on heart function. These finding were similar to those of earlier studies showing that omega-3 positively affects heart rhythm in patients who had suffered a previous heart attack. Since sudden cardiac death is the result of erratic heart rhythm, omega-3’s heart protective qualities show great promise in the fight against sudden cardiac arrest. The mechanical studies completed by these and other researchers seemed to confirm other studies that the oral ingestion of fish and fish oils provide prophylaxis for the prevention of fatal cardiac arrhythmias when taken regularly in small amounts. In simple terms, consuming fish and fish oil supplements can save lives.
by: Greg Post
It has long been understood that eating fish can reduce the likelihood of heart attack and other cardiovascular diseases. The reason? Fish, especially cold-water fatty fish, is high in two omega-3 polyunsaturated fatty acids (PUFA). These two fatty acids are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omega-3 has been shown to reduce the build-up of artery clogging atherosclerosis and keep blood platelets from sticking together thus reducing the risk of heart attack and stroke.
But more recent studies suggest that omega-3 fatty acids also have an effect on the dangerous arrhythmias that can cause sudden cardiac death by regulating the impulses that control heart rhythm.
One study involved the use of mycocytes (cells that beat independently). By adding the free fatty acids to these cells arrhythmias were aborted. When the fatty acids were extracted from the mycocytes the arrhythmias would reoccur thus indicating that omega-3 fatty acids have a stabilizing effect on heart rhythm. The apparent mechanism for controlling rhythm involved cell ion channels, proteins that control the movement of sodium, calcium and potassium ions across the membrane of the cell.
Another study, conducted by Danish researchers, examined the relationship between heart rate variability and omega-3 fatty acids in healthy subjects. It had already been determined that heart arrhythmias could be positively impacted in patients who were recent heart attack victims. These researchers wanted to determine if people otherwise free of heart disease could gain the same arrhythmia controlling benefits from omega-3 fatty acids.
Sixty healthy adults were randomly divided into three groups. The first group received daily supplements containing 6.6 g of omega-3 (containing 3.0g EPA and 2.9g DHA). Group two received 2.0g of omega-3 (containing 0.9g EPA and 0.8g DHA). The remaining group received only an olive oil placebo. The supplements were given for 12 weeks. Before and after the supplements were consumed heart rate variability and blood cell fatty acids were measured. It was found that heart rate variability was favorably influenced by the amount of omega-3 consumed. In other words, the more omega-3 one consumed the higher the heart rate variability, especially in men with low heart rate variability before supplementing.
The researchers concluded that omega-3 fatty acids positively affected heart rate variability thus having a protective effect on heart function. These finding were similar to those of earlier studies showing that omega-3 positively affects heart rhythm in patients who had suffered a previous heart attack. Since sudden cardiac death is the result of erratic heart rhythm, omega-3’s heart protective qualities show great promise in the fight against sudden cardiac arrest. The mechanical studies completed by these and other researchers seemed to confirm other studies that the oral ingestion of fish and fish oils provide prophylaxis for the prevention of fatal cardiac arrhythmias when taken regularly in small amounts. In simple terms, consuming fish and fish oil supplements can save lives.
by: Greg Post
The RUCkus Continues: Former Medicare Administrator Calls the "RUC Process" "Incredibly Flawed," and the AMA Chair Says He's "Inaccurate"
We have posted frequently about the role of the RBRVS Update Committee (RUC) in fixing the rates at which Medicare pays physicians. These payment rates have been much more generous for procedures than for "cognitive" services, (that is, services including interviewing and examining patients, making diagnoses, forecasting prognoses, recommending tests or treatments, and counseling patients.) Several authors have suggested that how the RUC fixes payment rates is a major cause of the decline of primary care. (See our previous posts on this here, here, here, here, here, here, and here and important articles by Bodenheimer et al,[1] and Goodson.[2])
An Interview with a former Medicare administrator
Health Affairs just published an interview(3) with Kerry Weems, a recent administrator of the US Center for Medicare and Medicaid Services (CMS) under the Bush administration, who had some remarkable criticism for the RUC.
There are a number of important points here.
First, a former CMS administrator charged that the RUC has a substantial role in the decline of primary care in the US. Such charges have been made by well-reputed academics who have analyzed the role of the RUC from the outside. But as we have said before, aspects of what the RUC does are obscure, especially because the proceedings of RUC meetings are not made public. But now someone more directly involved has made the same charges.
Second, a former CMS administrator has called the "RUC process ... incredibly flawed." Even the second Bush administration felt these flaws were sufficient to have "a number of discussions," but found "it's a hard nut to crack." Hence he said that although there is something fundamentally wrong with the "RUC process," the government could not easily fix it.
Yet RUC leadership has repeatedly said that the RUC is merely a private advisory committee which gives recommendations to CMS using its rights to free speech and to petition the government. (Note also that above, Inglehart first said that the RUC was formed as "an expert panel" to make "recommendations." But then he said the committee "determines ... how much doctors will earn.") If the RUC is simply an advisory committee, and CMS did not like the advice the RUC was giving, why couldn't CMS leaders simply ignore the RUC?
Weems' remarks do not make sense if the RUC is merely an outside private group providing advice. But they do make sense if the RUC is acting like a government agency.
So this interview once again raises the question: why does CMS rely exclusively on the RUC to update the RBRVS system, apparently making the RUC de facto a government agency, yet without any accountability to CMS, or the government at large?
A response by the Chair of the Board of the AMA
Within days of this interview, Dr Rebecca Patchin, the Chair of the Board of Trustees of the American Medical Association (AMA), wrote a response to the Weems interview. (Amazingly, the response appeared as a blog post on the Health Affairs Blog.)
First, she implied that a former CMS administrator did not know what he was talking about when it came to the RUC.
Now I feel like I am in good company. The leaders of the RUC have charged that I made inaccurate statements about the RUC as well (see post here).
However, Dr Patchin failed to identify any particular statements by Kerry Weems or his interviewer as inaccurate, much less provide any evidence to that effect. Note that while the RUC leaders also charged me with making inaccurate statements, they did not specify any particular statements as inaccurate, much less produce evidence in support of their contentions.
Next, Dr Patchin wrote:
This may be so, but it ignores an important issue. While the RUC may have made some recommendations to increase payments for cognitive services, it has made many more recommendations to increase payments for procedural services. Furthermore, while payments for individual procedures went up, and the volume of procedures also went up, the global budget for physicians' services, called the Sustainable Growth Rate (SGR), resulted in across the board cuts. Since raises for procedures were larger and more frequent than raises for cognitive services, the net effect was that payments for procedures increased relative to cognitive services.
Even more important, it begs that question: what has the RUC done at times when no one asked it "to review payments for E&M ... codes?" After all, the RUC leadership has argued again and again that it is only a private advisory committee (and see below for another such argument). As such, it should be able to choose how often it deals with payments for cognitive services. It should not have to wait to be asked to review them. So why wasn't the RUC reviewing these payments more frequently?
Then, Dr Patchin reiterated:
and again,
This, once more, begs the questions. Why didn't the RUC make more recommendations to improve payments for cognitive services? Why doesn't CMS get recommendations about payments to physicians from sources other than the RUC? Why doesn't CMS make the process for setting physicians' payments, and updating and revising the RBRVS system more broad-based and transparent? Why did the administrator of CMS feel unable to change or ignore the "RUC process?"
I don't have the capacity to find out the answers to these questions. Answering them might take some investigative reporting, or even a Congressional investigation. Given that physicians' payments are key incentives driving the health care system, and that payments favoring procedures are likely to be a major cause for rising volume and costs of procedures, which, in turn, is likely to be a major reason our health care system is so expensive, why do we know so little about how these payment rates are set?
References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Iglehart JK. Doing more with less: a conversation with Kerry Weems. Health Aff 2009; http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1
An Interview with a former Medicare administrator
Health Affairs just published an interview(3) with Kerry Weems, a recent administrator of the US Center for Medicare and Medicaid Services (CMS) under the Bush administration, who had some remarkable criticism for the RUC.
Iglehart: The last question I wanted to ask you relates to the Specialty Society Relative Value Scale Update Committee [RUC] of the American Medical Association. The AMA formed the RUC to act as an expert panel in developing relative value recommendations to CMS. The twenty-nine-member committee essentially determines, through the relative values it establishes for the codes that form the basis of Medicare payments, how much doctors will earn from providing services to beneficiaries. In recent years the RUC has come under criticism based on the view that its specialty- dominated composition undervalues primary care services and, in some instances, overvalues specialty services. I have two questions, Kerry, regarding the RUC. You have been in government for twenty-six years; have you ever heard of an administration that has seriously questioned the RUC process, and whether CMS ought to somehow internalize it or delegate it to another body?
Weems: I think there is a general consensus that the RUC has contributed to the poor state of primary care in the United States. In many ways the supposition behind the RUC process, behind the whole relative value scale, is incredibly flawed. It's an input measurement system, so it asks, What's the cost of my inputs, and that's how I'm going to price my outputs. It has no relationship to perhaps the market value of what you might buy. So because it's highly procedure based, it's prejudiced against just standard primary care evaluation and management [E&M] visits, because in an E&M visit it's hard to document what happens in the same way that it is when you remove a mole, or perform some other procedure.
So the process itself is flawed. I don't think that we can make a change without a statutory change giving us the ability to do that. But it's something that is drastically needed. You know, it's funny that we talk about better coordination of care and creating the medical home. Well, the place where this can occur is in an E&M visit, which has been highly undervalued by the RUC.
Iglehart: You say that the RUC process is seriously flawed and needs to be overhauled. Was there ever any discussion during the eight years of the George W. Bush administration about doing that?
Weems: There were a number of discussions, but it's a hard nut to crack. Those discussions never ripened to the point where we could say we've got something better.
Iglehart: But you'd anticipate under the Obama administration that those discussions will continue?
Weems: Sure. And, you know, you can even see the early attempts at trying to crack that. Representative [Pete] Stark [D-CA] introduced last year the so-called CHAMP [Children's Health and Medicare Protection Act] bill, in which he proposed to develop a new payment approach that would have provided more money to primary care physicians. He split it up into several different categories. This probably wasn't the right approach, but again, he was trying to work through the problem, trying to provide more money for primary care. His heart was in the right place.
There are a number of important points here.
First, a former CMS administrator charged that the RUC has a substantial role in the decline of primary care in the US. Such charges have been made by well-reputed academics who have analyzed the role of the RUC from the outside. But as we have said before, aspects of what the RUC does are obscure, especially because the proceedings of RUC meetings are not made public. But now someone more directly involved has made the same charges.
Second, a former CMS administrator has called the "RUC process ... incredibly flawed." Even the second Bush administration felt these flaws were sufficient to have "a number of discussions," but found "it's a hard nut to crack." Hence he said that although there is something fundamentally wrong with the "RUC process," the government could not easily fix it.
Yet RUC leadership has repeatedly said that the RUC is merely a private advisory committee which gives recommendations to CMS using its rights to free speech and to petition the government. (Note also that above, Inglehart first said that the RUC was formed as "an expert panel" to make "recommendations." But then he said the committee "determines ... how much doctors will earn.") If the RUC is simply an advisory committee, and CMS did not like the advice the RUC was giving, why couldn't CMS leaders simply ignore the RUC?
Weems' remarks do not make sense if the RUC is merely an outside private group providing advice. But they do make sense if the RUC is acting like a government agency.
So this interview once again raises the question: why does CMS rely exclusively on the RUC to update the RBRVS system, apparently making the RUC de facto a government agency, yet without any accountability to CMS, or the government at large?
A response by the Chair of the Board of the AMA
Within days of this interview, Dr Rebecca Patchin, the Chair of the Board of Trustees of the American Medical Association (AMA), wrote a response to the Weems interview. (Amazingly, the response appeared as a blog post on the Health Affairs Blog.)
First, she implied that a former CMS administrator did not know what he was talking about when it came to the RUC.
In the interview, inaccurate statements were made about the role of the AMA/Specialty Society RVS Update Committee (RUC), which advises CMS regarding the relative levels of reimbursement for different medical procedures performed by physicians.
Now I feel like I am in good company. The leaders of the RUC have charged that I made inaccurate statements about the RUC as well (see post here).
However, Dr Patchin failed to identify any particular statements by Kerry Weems or his interviewer as inaccurate, much less provide any evidence to that effect. Note that while the RUC leaders also charged me with making inaccurate statements, they did not specify any particular statements as inaccurate, much less produce evidence in support of their contentions.
Next, Dr Patchin wrote:
Every time the RUC has been asked to review payments for E&M (evaluation and management) codes, the RUC has sent CMS recommendations that would lead to higher payments.
This may be so, but it ignores an important issue. While the RUC may have made some recommendations to increase payments for cognitive services, it has made many more recommendations to increase payments for procedural services. Furthermore, while payments for individual procedures went up, and the volume of procedures also went up, the global budget for physicians' services, called the Sustainable Growth Rate (SGR), resulted in across the board cuts. Since raises for procedures were larger and more frequent than raises for cognitive services, the net effect was that payments for procedures increased relative to cognitive services.
Even more important, it begs that question: what has the RUC done at times when no one asked it "to review payments for E&M ... codes?" After all, the RUC leadership has argued again and again that it is only a private advisory committee (and see below for another such argument). As such, it should be able to choose how often it deals with payments for cognitive services. It should not have to wait to be asked to review them. So why wasn't the RUC reviewing these payments more frequently?
Then, Dr Patchin reiterated:
To clarify: The RUC makes recommendations to CMS, and then CMS makes its payment decisions.
and again,
Bottom line: the RUC makes recommendations, CMS makes payment decisions.
This, once more, begs the questions. Why didn't the RUC make more recommendations to improve payments for cognitive services? Why doesn't CMS get recommendations about payments to physicians from sources other than the RUC? Why doesn't CMS make the process for setting physicians' payments, and updating and revising the RBRVS system more broad-based and transparent? Why did the administrator of CMS feel unable to change or ignore the "RUC process?"
I don't have the capacity to find out the answers to these questions. Answering them might take some investigative reporting, or even a Congressional investigation. Given that physicians' payments are key incentives driving the health care system, and that payments favoring procedures are likely to be a major cause for rising volume and costs of procedures, which, in turn, is likely to be a major reason our health care system is so expensive, why do we know so little about how these payment rates are set?
References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Iglehart JK. Doing more with less: a conversation with Kerry Weems. Health Aff 2009; http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1
Tuesday, June 23, 2009
Doctors Who Don't See Patients
I wish someone would do a study on how many doctors complete medical school but never go into any type of patient care practice. I suspect the number is higher than we think.I was at an upscale art party last weekend, filled with beautiful art and beautiful young people. I sat next to an attractive "early thirty-something" woman, confident and well dressed. She mentioned that her business
The Pregnancy Glow and Other Myths of Motherhood
It happened during the ninth month of my first pregnancy. I was going through a department store check-out lane where a teenage girl was ringing up my purchases. She looked shyly at my burgeoning belly with an expression that could only be described as reverent.
With eyes full of dreams of future motherhood she asked, “Is pregnancy really as bad as everyone says?”
Without the slightest guilt, I replied, “No. It’s worse.”
The Deception
When my husband and I announced the birth of our blessed expectation some months prior, along with endless congratulations, I received the good news of the many wonderful changes I could expect.
"You’ll positively glow.”
“Your hair and nails will look fabulous.”
“You’ll feel absolutely beautiful.”
According to family and friends, as a gestating woman, I would feel nothing short of a precious vessel, glowing with health and radiance given only to those experiencing the miracle of growing a child.
About a week later, wearing the pallor of death, I was running away from the smell of my husband’s lunchtime tuna fish sandwich knowing I’d never been so violently ill my entire life.
The Reality
Although it’s rumored there are actually women who sail through pregnancy untouched by any ills or discomfort, I was not one of them. If I’d ever experienced a pregnancy glow, I’m certain I could only have been radioactive.
I was told to expect a little morning sickness. I didn’t anticipate 24/7 progesterone poisoning, body aches, or never ending fatigue. And in all the happy tales of pregnancy recounted to me, I'm certain I'd have remembered hearing if pure, unadulterated misery were mentioned as a symptom of gestation.
Sitting in my obstetrician’s office near the end of the first trimester, she asked how I was feeling. “Sick.”
“Good.” She replied.
Seeing my defeated look, she offered a small respite. “You’ll start to feel better after week 12 or 13.”
I crossed the days off my calendar waiting for magical week 13. It came and went. My never ending nausea did not. I was sick, tired, and sick of being both.
I'd been told how sharing a child together would make my marital relationship more intimate. I, on the other hand, hated my husband. No matter he and I had joyfully consented to make this child together, or that he worried and did the best he could to make me feel more comfortable. Somewhere in the back of my mind, as I watched him lie peacefully asleep at night while I was awake fending off nausea, all I could think was, “this is your fault.”
And so it went for the entire duration of nine months. I knew beyond any shadow of a doubt, if I ever survived this go-round on the pregnancy rollercoaster, there would be no more children in my future, ever. Motherhood just wasn’t all that it was cracked up to be.
The Grand Debut
Jacob Lyle arrived in early fall that year, bearing 10 perfect fingers and toes, a head full of brown hair and big blue eyes. He was bruised and battered from birth, yet, to my eyes, perfection unlike the world had ever seen before.
Suddenly, my entire life made sense. At 23-years old, I wasn’t yet sure what I wanted to be when I grew up, or what my future held outside of being a wife to my husband. With the arrival of Jacob, I knew exactly why I was here—to be the mother of this beautiful child. Having Jacob filled my life with a sense of awe and wonder I had never known. I was a mother, and that was enough.
Altered Expectations
While I had expected sleepless nights with my newborn, what I hadn’t expected was how much I would enjoy them. I gladly gave up sleep to have the chance just to hold my tiny son in my arms and look at his sweet face.
I expected life to change. I never expected the very foundations of my world to be rocked. It came as a total shock that the simple act of becoming a mother—wasn’t simple.
Previous to motherhood, tragedy in the world was sad. After the birth of my son, it was heart-wrenching. No longer could I watch a movie or read a news report depicting harm to a child without emotion. Every child became my child. What if it were Jacob who was sick? What if it were Jacob who was injured?
Issues I’d previously given no thought suddenly became of substantial importance. Was there truly a difference between breastfeeding and formula feeding? Should we circumcise? If I vaccinated my child, he could have a serious adverse reaction. If I chose not to vaccinate, he could become very ill.
I became an information addict and read every book on childcare I could get my hands on and spent endless hours researching my concerns and second guessing my decisions. The rest of my waking hours were spent staring at Jacob as he slept, assuring myself he was still breathing and would only continue to do so thorough my conscious willing of it. Fortunately, he survived my new mother paranoia and came out relatively unscathed-- or at least, I will assume so until I’m presented with a bill for therapy.
Personal Truths
I had gone into motherhood with the words of many fostering my belief I’d have a baby, but life would eventually go back to normal again by the magical six-week check-up (at which point I'd also have lost all my baby weight). What I didn’t know when I gave birth was normal was gone forever, along with any peace of mind, my figure, and any hope of a good night’s sleep, but that I’d never trade a moment of my new life to have it back again.
Motherhood, I’ve come to find, is a journey rather than a destination. And while we may endeavor to share experiences with a new mom-to-be, the truths of motherhood remain personal and hers alone to find. The only certainty is the journey is well worth traveling.
I only wish I could talk to that teenager one more time.
by: Barbara A. Eastom Bates
With eyes full of dreams of future motherhood she asked, “Is pregnancy really as bad as everyone says?”
Without the slightest guilt, I replied, “No. It’s worse.”
The Deception
When my husband and I announced the birth of our blessed expectation some months prior, along with endless congratulations, I received the good news of the many wonderful changes I could expect.
"You’ll positively glow.”
“Your hair and nails will look fabulous.”
“You’ll feel absolutely beautiful.”
According to family and friends, as a gestating woman, I would feel nothing short of a precious vessel, glowing with health and radiance given only to those experiencing the miracle of growing a child.
About a week later, wearing the pallor of death, I was running away from the smell of my husband’s lunchtime tuna fish sandwich knowing I’d never been so violently ill my entire life.
The Reality
Although it’s rumored there are actually women who sail through pregnancy untouched by any ills or discomfort, I was not one of them. If I’d ever experienced a pregnancy glow, I’m certain I could only have been radioactive.
I was told to expect a little morning sickness. I didn’t anticipate 24/7 progesterone poisoning, body aches, or never ending fatigue. And in all the happy tales of pregnancy recounted to me, I'm certain I'd have remembered hearing if pure, unadulterated misery were mentioned as a symptom of gestation.
Sitting in my obstetrician’s office near the end of the first trimester, she asked how I was feeling. “Sick.”
“Good.” She replied.
Seeing my defeated look, she offered a small respite. “You’ll start to feel better after week 12 or 13.”
I crossed the days off my calendar waiting for magical week 13. It came and went. My never ending nausea did not. I was sick, tired, and sick of being both.
I'd been told how sharing a child together would make my marital relationship more intimate. I, on the other hand, hated my husband. No matter he and I had joyfully consented to make this child together, or that he worried and did the best he could to make me feel more comfortable. Somewhere in the back of my mind, as I watched him lie peacefully asleep at night while I was awake fending off nausea, all I could think was, “this is your fault.”
And so it went for the entire duration of nine months. I knew beyond any shadow of a doubt, if I ever survived this go-round on the pregnancy rollercoaster, there would be no more children in my future, ever. Motherhood just wasn’t all that it was cracked up to be.
The Grand Debut
Jacob Lyle arrived in early fall that year, bearing 10 perfect fingers and toes, a head full of brown hair and big blue eyes. He was bruised and battered from birth, yet, to my eyes, perfection unlike the world had ever seen before.
Suddenly, my entire life made sense. At 23-years old, I wasn’t yet sure what I wanted to be when I grew up, or what my future held outside of being a wife to my husband. With the arrival of Jacob, I knew exactly why I was here—to be the mother of this beautiful child. Having Jacob filled my life with a sense of awe and wonder I had never known. I was a mother, and that was enough.
Altered Expectations
While I had expected sleepless nights with my newborn, what I hadn’t expected was how much I would enjoy them. I gladly gave up sleep to have the chance just to hold my tiny son in my arms and look at his sweet face.
I expected life to change. I never expected the very foundations of my world to be rocked. It came as a total shock that the simple act of becoming a mother—wasn’t simple.
Previous to motherhood, tragedy in the world was sad. After the birth of my son, it was heart-wrenching. No longer could I watch a movie or read a news report depicting harm to a child without emotion. Every child became my child. What if it were Jacob who was sick? What if it were Jacob who was injured?
Issues I’d previously given no thought suddenly became of substantial importance. Was there truly a difference between breastfeeding and formula feeding? Should we circumcise? If I vaccinated my child, he could have a serious adverse reaction. If I chose not to vaccinate, he could become very ill.
I became an information addict and read every book on childcare I could get my hands on and spent endless hours researching my concerns and second guessing my decisions. The rest of my waking hours were spent staring at Jacob as he slept, assuring myself he was still breathing and would only continue to do so thorough my conscious willing of it. Fortunately, he survived my new mother paranoia and came out relatively unscathed-- or at least, I will assume so until I’m presented with a bill for therapy.
Personal Truths
I had gone into motherhood with the words of many fostering my belief I’d have a baby, but life would eventually go back to normal again by the magical six-week check-up (at which point I'd also have lost all my baby weight). What I didn’t know when I gave birth was normal was gone forever, along with any peace of mind, my figure, and any hope of a good night’s sleep, but that I’d never trade a moment of my new life to have it back again.
Motherhood, I’ve come to find, is a journey rather than a destination. And while we may endeavor to share experiences with a new mom-to-be, the truths of motherhood remain personal and hers alone to find. The only certainty is the journey is well worth traveling.
I only wish I could talk to that teenager one more time.
by: Barbara A. Eastom Bates
Pregnancy Exercise And Diet Tips - Sensible Advice For Expectant Mothers
Mothers-to-be have many questions about pregnancy nutrition and exercise. The tips and advice below will help you get started on a healthy pregnancy.
A diet containing the essential nutrients and vitamins are vital to the development of both mother and child. Vitamins are imperative to the health of a developing baby and the well being of the mother. Choosing foods that are rich in vitamins and other nutrients are a critical part of a healthy pregnancy nutrition plan and supplemental vitamins are necessary as well.
Follow a well-planned pregnancy diet to help avoid complications such as morning sickness, fatigue, anemia, and constipation. Your healthy diet must continue after pregnancy if you plan to breastfeed your baby.
Pregnancy food recommendations
* Your pregnancy diet should include plenty of complex and unrefined carbohydrates as they contain important B vitamins, trace minerals, and fiber that are essential to a fit, healthy pregnancy.
* Appropriate quantities of yellow and green leafy vegetables are vital for the growth of the baby and the health of the mother.
* Dairy products contain calcium that will assist in the developing baby's teeth and bones. If your diet is lacking calcium your body will draw calcium from your bones to meet it's increased need.
* Avoid excessive amounts of fat must be avoided during pregnancy, as it will only serve to add excess pounds, which will be hard to lose after the birth of your baby.
* Vitamin C in generous amounts is crucial to a healthy pregnancy, bone growth, and various metabolic processes. Including berries, citrus fruits, raw broccoli and cabbage can help provide you with the Vitamin C that you need.
Ideally, your pregnancy diet should include 3-4 servings of protein and meat, 2-4 servings of fruit, 6-11 servings of grains, 4-6 servings of dairy products, and 6-8 glasses of water, milk, and juice. A pregnant mother must follow a healthy diet that will benefit the developing baby but that will also maintain her general health as well.
Exercise recommendations during pregnancy
Exercise during pregnancy will promote strength, muscle tone, and endurance. Regular activity during your pregnancy will help alleviate swelling, fatigue, and backache. If you expect to remain fit during your pregnancy you will need to work your heart and major muscle groups. The type of exercise you do during your pregnancy will depend on your fitness level prior to pregnancy. Walking, pregnancy yoga videos, and swimming are excellent pregnancy exercises combined with stretching and other low-impact activities.
Exercises that involve a risk of falling or injury should be avoided such as bicycling, racket sports, horseback riding, and skiing. You will need to alter your exercise routine from trimester to trimester to accommodate your growing body. Avoiding over-exertion is necessary to avoid complications such as faintness, dizziness, vaginal bleeding, and premature contractions. Also, make sure you drink plenty of water before, during, and after exercising to reduce the risk of dehydration, which can raise your body temperature and cause harm to yourself and/or your baby.
A regular exercise program is beneficial to both mother and child, but check with your health care provider to make sure you have no conditions or risks that will prevent you from participating in a regular exercise routine or could cause potential harm to yourself or your child.
by: Tina Titas
A diet containing the essential nutrients and vitamins are vital to the development of both mother and child. Vitamins are imperative to the health of a developing baby and the well being of the mother. Choosing foods that are rich in vitamins and other nutrients are a critical part of a healthy pregnancy nutrition plan and supplemental vitamins are necessary as well.
Follow a well-planned pregnancy diet to help avoid complications such as morning sickness, fatigue, anemia, and constipation. Your healthy diet must continue after pregnancy if you plan to breastfeed your baby.
Pregnancy food recommendations
* Your pregnancy diet should include plenty of complex and unrefined carbohydrates as they contain important B vitamins, trace minerals, and fiber that are essential to a fit, healthy pregnancy.
* Appropriate quantities of yellow and green leafy vegetables are vital for the growth of the baby and the health of the mother.
* Dairy products contain calcium that will assist in the developing baby's teeth and bones. If your diet is lacking calcium your body will draw calcium from your bones to meet it's increased need.
* Avoid excessive amounts of fat must be avoided during pregnancy, as it will only serve to add excess pounds, which will be hard to lose after the birth of your baby.
* Vitamin C in generous amounts is crucial to a healthy pregnancy, bone growth, and various metabolic processes. Including berries, citrus fruits, raw broccoli and cabbage can help provide you with the Vitamin C that you need.
Ideally, your pregnancy diet should include 3-4 servings of protein and meat, 2-4 servings of fruit, 6-11 servings of grains, 4-6 servings of dairy products, and 6-8 glasses of water, milk, and juice. A pregnant mother must follow a healthy diet that will benefit the developing baby but that will also maintain her general health as well.
Exercise recommendations during pregnancy
Exercise during pregnancy will promote strength, muscle tone, and endurance. Regular activity during your pregnancy will help alleviate swelling, fatigue, and backache. If you expect to remain fit during your pregnancy you will need to work your heart and major muscle groups. The type of exercise you do during your pregnancy will depend on your fitness level prior to pregnancy. Walking, pregnancy yoga videos, and swimming are excellent pregnancy exercises combined with stretching and other low-impact activities.
Exercises that involve a risk of falling or injury should be avoided such as bicycling, racket sports, horseback riding, and skiing. You will need to alter your exercise routine from trimester to trimester to accommodate your growing body. Avoiding over-exertion is necessary to avoid complications such as faintness, dizziness, vaginal bleeding, and premature contractions. Also, make sure you drink plenty of water before, during, and after exercising to reduce the risk of dehydration, which can raise your body temperature and cause harm to yourself and/or your baby.
A regular exercise program is beneficial to both mother and child, but check with your health care provider to make sure you have no conditions or risks that will prevent you from participating in a regular exercise routine or could cause potential harm to yourself or your child.
by: Tina Titas
Breastfeeding And Diabetes
If you are a diabetic and have a baby, there are certain things to keep in mind while you are breastfeeding. Firstly, studies have proven that breastfeeding a baby can help to prevent type 1 diabetes development. Babies who breastfeed until at least six months will be at a lower risk for type 1 diabetes. Doctors generally recommend that mothers breastfeed their children until nine to twelve months.
Doctors are unsure if the positive effects of nursing come from special nutrients in the colostrum (the special milk from mothers) or if it because babies who are breastfed often grow at a more regular pace than those who are fed from cow’s milk. Babies weaned on cow’s milk often experience growth spurts rather than the steady growth associated with mother’s milk. If you are a diabetic, consider breastfeeding to help lower your child’s chances of diabetes due to genetic predisposition.
Breastfeeding is not only positive for the babies, but also for the mothers. Breastfeeding can help maternal weight loss, and it is particularly important for diabetic women to maintain a healthy weight. Some breastfeeding mothers find it easier for them to manage their diabetes because their glucose levels stay more constant and they have a remission of some symptoms while breastfeeding.
Just like during pregnancy, breastfeeding requires much blood sugar level monitoring from the mother. You will probably find that your need for insulin is lower than before your pregnancy. Insulin will not enter your baby’s body because it is too large to be carried on the breast milk. However, if you have type 2 diabetes and are taking diabetes medication, talk with your doctor to make sure that you are on a type of medication that will be healthiest for both you and for your baby.
Breastfeeding means that you have to be extra careful of your nutrition, so be sure to see your doctor or dietitian to create a meal plan that will work for you. It is important to eat regular snacks when you are breastfeeding because you want to keep your blood glucose levels constant. You will need to increase your caloric intake by about 500 calories a day to meet your baby’s nutritional needs. You can do this simply by drinking a glass of milk each time you breastfeed, which will keep you both hydrated and full of vitamins.
In order to maintain a balanced diet, experts suggest that mothers eat 20% of calories from protein, 40-60% from carbohydrates, and 30-40% from fruits and vegetables. Keeping up with all of these food groups will ensure that your body has the nutrients to provide for the baby.
As a breastfeeding mother, low blood sugar is an increased risk. However, by eating a healthy diet full of legumes, whole grains, other healthy foods, you will be able to keep low blood sugar at bay. Drinking lots of fluids is also an important part of having a healthy blood sugar level. Most importantly, monitor your blood glucose levels and record the results frequently. Having a newborn baby around will mean that you are very busy, but it is also the time when it is most important to take care of yourself so that you will be able to care for your baby.
When the baby is born, often it is a good idea to immediately allow the baby to breastfeed, which will prevent low blood sugar. Some hospitals will try to take babies away for observation. You can ask politely, and firmly insist that you baby stays with you for the first feeding and for some initial bonding time. If you are hospitalized after the baby is born, ask to bring your baby with you so that you will still be able to breastfeed. Diabetic mothers are not often hospitalized, but since breastfeeding is even more important for diabetic mothers, it is important to keep this in mind.
Some diabetic mothers may find that their milk comes in late, between two days to two weeks. In the meantime, use a breastpump and speak to your doctor to establish the best solution for you and your baby. Even babies who are too weak to breastfeed can be fed breastmilk that has been pumped.
Breastfeeding is a bonding experience for mothers and babies. Diabetics can breastfeed and gain even more benefits than the emotional closeness, such as lowered diabetes risk for the baby, and improved diabetes control for the mother.
by: Vivian L. Brennan
Doctors are unsure if the positive effects of nursing come from special nutrients in the colostrum (the special milk from mothers) or if it because babies who are breastfed often grow at a more regular pace than those who are fed from cow’s milk. Babies weaned on cow’s milk often experience growth spurts rather than the steady growth associated with mother’s milk. If you are a diabetic, consider breastfeeding to help lower your child’s chances of diabetes due to genetic predisposition.
Breastfeeding is not only positive for the babies, but also for the mothers. Breastfeeding can help maternal weight loss, and it is particularly important for diabetic women to maintain a healthy weight. Some breastfeeding mothers find it easier for them to manage their diabetes because their glucose levels stay more constant and they have a remission of some symptoms while breastfeeding.
Just like during pregnancy, breastfeeding requires much blood sugar level monitoring from the mother. You will probably find that your need for insulin is lower than before your pregnancy. Insulin will not enter your baby’s body because it is too large to be carried on the breast milk. However, if you have type 2 diabetes and are taking diabetes medication, talk with your doctor to make sure that you are on a type of medication that will be healthiest for both you and for your baby.
Breastfeeding means that you have to be extra careful of your nutrition, so be sure to see your doctor or dietitian to create a meal plan that will work for you. It is important to eat regular snacks when you are breastfeeding because you want to keep your blood glucose levels constant. You will need to increase your caloric intake by about 500 calories a day to meet your baby’s nutritional needs. You can do this simply by drinking a glass of milk each time you breastfeed, which will keep you both hydrated and full of vitamins.
In order to maintain a balanced diet, experts suggest that mothers eat 20% of calories from protein, 40-60% from carbohydrates, and 30-40% from fruits and vegetables. Keeping up with all of these food groups will ensure that your body has the nutrients to provide for the baby.
As a breastfeeding mother, low blood sugar is an increased risk. However, by eating a healthy diet full of legumes, whole grains, other healthy foods, you will be able to keep low blood sugar at bay. Drinking lots of fluids is also an important part of having a healthy blood sugar level. Most importantly, monitor your blood glucose levels and record the results frequently. Having a newborn baby around will mean that you are very busy, but it is also the time when it is most important to take care of yourself so that you will be able to care for your baby.
When the baby is born, often it is a good idea to immediately allow the baby to breastfeed, which will prevent low blood sugar. Some hospitals will try to take babies away for observation. You can ask politely, and firmly insist that you baby stays with you for the first feeding and for some initial bonding time. If you are hospitalized after the baby is born, ask to bring your baby with you so that you will still be able to breastfeed. Diabetic mothers are not often hospitalized, but since breastfeeding is even more important for diabetic mothers, it is important to keep this in mind.
Some diabetic mothers may find that their milk comes in late, between two days to two weeks. In the meantime, use a breastpump and speak to your doctor to establish the best solution for you and your baby. Even babies who are too weak to breastfeed can be fed breastmilk that has been pumped.
Breastfeeding is a bonding experience for mothers and babies. Diabetics can breastfeed and gain even more benefits than the emotional closeness, such as lowered diabetes risk for the baby, and improved diabetes control for the mother.
by: Vivian L. Brennan
Breastfeeding Tips for You and Your Baby
Breastfeeding can be termed as the most effective way of creating a perfect bond between a mother and her child. Breast milk helps in the mental and physical growth of your baby. It also increases the baby’s immune system. It can be considered a natural way of protecting your baby.
Breast milk is naturally the most perfect food for your baby. Although it takes time learning how to breastfeed, you will be rewarded if you are persistent. However, it is a fact that some woman simply cannot breastfeed due to medical conditions or the baby not latching on for one reason or another, so don’t be disheartened if you can’t.
When you are breastfeeding, your baby’s mouth should be covering the entire areola; sucking just the nipples will make your nipples sore and your baby will not get sufficient milk. This is one of the most common problems but also the easiest problem to fix that many woman have.
Another reason why woman give up on breastfeeding is pain. Although your nipples might very well scab and crack, this is very normal. Quite often, your nipples will actually bleed. This should cause no alarm because this is fairly common as well. There are many products that are actually made specifically for this reason. Lanolin works remarkably well to repair cracked or sore nipples, which in turn relieves the pain.
In order to ensure your baby grows healthy and strong you will have to take special precautions with what you consume. Medications can pass through your breastmilk as can alcohol and drugs. Always consult your doctor prior to taking any medication and drink alcohol in moderation – none is best. It is better to be safe. Being conscious about your health will have positive effects on your baby as its immune system develops.
When your baby is small, he is totally dependent on you for everything. Breastfeeding is one of those times when you are providing your baby with a necessity as well as sharing a bond that no one else can replace. Enjoy these moments now, as they become far too quickly, memories.
by: Katherine Nagy
Breast milk is naturally the most perfect food for your baby. Although it takes time learning how to breastfeed, you will be rewarded if you are persistent. However, it is a fact that some woman simply cannot breastfeed due to medical conditions or the baby not latching on for one reason or another, so don’t be disheartened if you can’t.
When you are breastfeeding, your baby’s mouth should be covering the entire areola; sucking just the nipples will make your nipples sore and your baby will not get sufficient milk. This is one of the most common problems but also the easiest problem to fix that many woman have.
Another reason why woman give up on breastfeeding is pain. Although your nipples might very well scab and crack, this is very normal. Quite often, your nipples will actually bleed. This should cause no alarm because this is fairly common as well. There are many products that are actually made specifically for this reason. Lanolin works remarkably well to repair cracked or sore nipples, which in turn relieves the pain.
In order to ensure your baby grows healthy and strong you will have to take special precautions with what you consume. Medications can pass through your breastmilk as can alcohol and drugs. Always consult your doctor prior to taking any medication and drink alcohol in moderation – none is best. It is better to be safe. Being conscious about your health will have positive effects on your baby as its immune system develops.
When your baby is small, he is totally dependent on you for everything. Breastfeeding is one of those times when you are providing your baby with a necessity as well as sharing a bond that no one else can replace. Enjoy these moments now, as they become far too quickly, memories.
by: Katherine Nagy
Practicing (Clinical Trials) Medicine Without a License
Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times:
A little Google searching turned up another example on ClinicalTrials.gov of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board.
Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials.
We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See this 2006 vintage post on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis.
In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects.
I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals.
Hat tip to PharmaGossip.
Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.
The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.
The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hospital in his native Ukraine.
Ruth Weber, a 74-year-old Clearwater resident, told the Times in April 2008 that the man who called himself Dr. Martin enrolled her in a study for lower-back pain and adjusted the dosage of her medicine. Only licensed physicians are supposed to conduct such activities. Patients in the study were randomly selected to receive a new Johnson & Johnson painkiller called tapentadol, a placebo or the potent narcotic oxycodone.
Though Dr. Robert Lee Jackson, a Clearwater osteopath, was listed by the FDA as the physician conducting the study, Weber said she never saw Jackson. In weekly visits to Alliance Medical Research Group on Belcher Road, Weber said it was Martin who drew blood, doled out medication and, at one point, doubled her dosage.
Martin also conducted electrocardiograms on Weber, although his techniques were so rusty the electrodes kept slipping off, she said. Weber eventually dropped out of the study when she saw no improvement for her back pain.
A second woman, Ann Reed, told investigators she also responded to an ad for a drug study trial at Alliance Medical Research. Martin took her blood, listened to her heart and gave her medications, Reed said. Martin sometimes had to stick her four times to draw blood, she said.
Like Weber, Reed said she never saw Jackson during her trial, which involved 13 visits between May 2007 and March 2008.
Greg Panico, a spokesman for Johnson & Johnson, said the company audited Alliance Medical after the Times' story and submitted its findings to the FDA. He declined to discuss the nature of the report, but said the drug company is no longer working with Alliance Medical.
Panico also said data collected in the tapentadol study at that site was not submitted to the FDA.
The drugmaker said it reported its findings to the Sterling Institutional Review Board in Atlanta, which had been hired by Johnson & Johnson to oversee patient safety during the trial.
Despite losing the Johnson & Johnson trial, Martin told investigators in July that he was conducting four other drug studies.
A little Google searching turned up another example on ClinicalTrials.gov of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board.
Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials.
We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See this 2006 vintage post on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis.
In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects.
I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals.
Hat tip to PharmaGossip.
Monday, June 22, 2009
Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?
Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:
That is, Bah! to the apostates' narratives --
-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...
Bah!
I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner.
Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest.
First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong.
- Resorting to ad hominem attacks when questioned or criticized.
- Deficient familiarity with the current literature.
- Opining that others' concerns expressed in that literature could be "laughed off."
- Years-behind view of the situation on the ground.
The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in red italic mine):
June 19, 2009 - Perspectives
Health IT Under ARRA: It's Not the Money, It's the Message
by Mark Leavitt
... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having an EHR for every American by 2014.
[Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]
But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver.
[Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]
Some of the early signs have been worrisome. Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place,
[As an information scientist, I'm almost embarrassed to post this link and this link, the results of just a few minutes' work with public resources. Thorough, robust searches in Dialog's suite of databases, Current Contents, Lexis Nexis, SciFinder etc. would show far more - ed.]
that shady conspiracies are operating --
[i.e., HIT industry lobbies - ed.]
make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers
[i.e., those who take due diligence and fiduciary responsibilities seriously - ed.]
are easily affected by fear mongering.
That is, Bah! to the apostates' narratives --
-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...
Bah!I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner.
Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest.
First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong.
I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series here, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint here (PDF). I believe the rush to national EHR by 2014 is premature, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)
Now that we're hopefully past the expected ad hominem, perhaps the real issues can be addressed.
As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.
On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at "Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT" at this link. Both I and another physician, David Kibbe, MD, MBA, Health IT Consultant at American Academy of Family Physicians, were subjected to "nonlinear" commentary.
It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote here, of course - ed.]
Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:
It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote here, of course - ed.]
Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:
1. The article "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop", Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.
There are more than 70 references at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" at this link.
2. This corpus of literature below. These are just examples and not a comprehensive listing:
Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.
National Research Council report. Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009
The National Programme for IT in the NHS: Progress since 2006, Public Accounts Committee, January 2009. Summary points here.
Common Examples of Healthcare IT Difficulties (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology.
Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278
Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1
Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,
IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.
Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512
Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203
Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.
Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423
The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009,
Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).
Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405
Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless? Ford et al., J Am Med Inform Assoc. 2006;13:106-112
Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless, Ford et al., J Am Med Inform Assoc. 2009;16:274-281
High Rates of Adverse Drug Events in a Highly Computerized Hospital, Nebeker at al., Arch Intern Med. 2005;165:1111-1116.
"Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009
“Avoiding EMR meltdown.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006.
"The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006
"Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from A Commonsense Approach to EMRs, July 2006
Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.
Pessimism, Computer Failure, and Information Systems Development in the Public Sector. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007
The literature at my HIT website's "Other Resources" page (link)
The teachings of the field of Social Informatics about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found at this link (MS-Word file). The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (Amazon.com link here) was based on this essay.
3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs).
In the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:
... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.
There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation at this link in PDF) stated:
It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.
Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents [including deaths - ed.] that has been reported to the Swedish National Board of Health and Welfare.
On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a cooperation agreement with our own FDA, under the category of "fearmongers."
Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.
Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.
Health IT Under ARRA: It's Not the Money, It's the Message. Indeed.
And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited.
Finally, to get past the ad hominem and other logical fallacy nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to Chucky, the cob (father) , and Princess, the pen (mother). /sarc
:-)
:-)
The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click this picture from June 1!)
Now that we're hopefully past the expected ad hominem, perhaps the real issues can be addressed.
As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.
Humor and a little humility work much better.
-- SS
-- SS
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