There has been a growing trend for drug companies to outsource clinical trials; the human studies that determine the safety and efficacy of medicines.
Now, as reported in the New York Times, an article about the globalization of clinical trials is raising questions about the ethics and the science of increasingly conducting studies outside the US, when the studies are meant to gather evidence for new drugs to gain approval in this country.
The article, “Ethical and Scientific Implications of the Globalization of Clinical Research,” by several Duke University researchers, suggests an ethical quagmire when drugs intended for wealthy nations are tested on people in developing countries. The authors suggest that human volunteers in foreign countries may be unduly influenced by the promise of financial compensation or free medical care to participate in clinical trials.
The report also asks whether drug research conducted in developing countries is relevant to the treatment of American patients. The authors write that drug research in developing countries, where certain populations may metabolize medications differently because of environmental factors or genetic mutations, might not be relevant for American patients.
Some critics say the authors used overly simplistic data mining to raise an alarm, without presenting hard evidence of widespread ethical or scientific problems. I also have a few observations of my own; some in agreement and some in disagreement with the Duke authors' statements.
The Duke authors are warranted in their worries about volunteers from developing nations being unduly influenced by financial compensation and free medical care. Many of these nations are poor, and the volunteers may be viewed as particularly vulnerable. However, the Declaration of Helsinki, recognizes the need for special protection in vulnerable populations; this protection comes in the source of the clinical trial protocol.
The protocol must include, among other things, information regarding potential conflicts of interest, incentives for volunteers, and provisions for treating and/or compensating volunteers who are harmed as a consequence of participation in the research study. This protocol must be reviewed and approved by an independent research ethics committee before the study can even begin. If the volunteers' health and rights would be subjected to malbeneficience or injustice in any way, then the protocol would be rejected.
Protocol reviewers must take into account the risks involved with the study and weigh those risks against the benefits. If the only benefits for the volunteer are monetary, then researchers are conducting an unethical trial. Participation in risky trials warrants a greater monetary compensation, and volunteers outside the US may be vulnerable because they will accept less money than an American would expect; however, how can one put a monetary value on someone's life?
Medical research involving a disadvantaged or vulnerable population is only justified if the research is responsive to the health needs and priorities of this population and if there is a reasonable likelihood that this population stands to benefit from the results of the research.
I also agree that volunteers may be unduly influenced by free medical treatment. It may be enticing to participate if the volunteer is offered free medical treatment; especially for patients who would never have received treatment at all. However, do the risks of the trial outweigh the benefits of a check up or treatment?
Duke authors also brought up the topic of relevance. Relevance may be a factor when studying safety and efficacy in different age groups, but I feel that, in many instances, relevance is a non-factor because we are all humans. However, populations that are underrepresented in medical research should be provided appropriate access to participation in research.
For example, in many clinical studies based in the US, the majority of participants are Caucasian. However, aren't there many other races/ethnicities represented in the US population? What if the Duke authors are correct, and a drug may have a different effect on African Americans because of mutations such as Sickle Cell Anemia? Wouldn't it prove to be beneficial to go outside the US and enroll subjects of that race/ethnicity?
The authors also questioned the relevance of testing outside the US because they feel that certain populations may metabolize medications differently because of environmental factors. If we are to believe this statement, then should we perform separate clinical trials within the US for Americans in Hawaii (tropical rainforest climate) as well as for Americans in Alaska (subarctic/tundra climate)? Where does it end?
The authors also seem to treat all foreign countries alike. Research conducted in some places outside the United States, like Canada and Sweden, might be perfectly relevant to American patients. For example, a clinical trial of the Merck drug Gardasil, a vaccine against the human papilloma virus, was conducted in Costa Rica, where there is a high incidence of the disease.
Whatever the interpretations, the use of offshore clinical trials is growing, and physicians must be conscious of the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards; and no national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects.
Thursday, February 26, 2009
Wednesday, February 25, 2009
Stay tuned for another episode of “The Microwave Generation – We Don’t Work for Anything”
I know I’ve said this before, but this subject is definitely one close to my heart. The article, “A Boy’s Obesity Led His Mother to Send Him For Stomach Surgery,” tells the tale of a mother who researched the Internet to find a surgeon to perform stomach surgery on her 15-year-old son after she could not find a gastric bypass surgeon to perform the procedure due to his age. The boy, Andrew, who was 5-foot-4 and weighed 260 pounds told his mother, “There were times when I felt I just couldn't go on.” According to the article, after being rejected by the gastric bypass surgeon and, “already a veteran of numerous failed diets, exercise programs and summer “fat” camp, Andrew became convinced that weight-loss surgery, which had transformed the physique of a family friend, was his only hope.” Andrew reported that his teacher walked past him in the lunchroom and said loudly, “‘Are you sure you should have gotten doubles?’”
Told that he would have to wait 3 years until he turned 18-years old to have the surgery, “he pleaded with his mother for help.” So, his mother, instead of taking every step she could to help him lose weight, like cooking and eating healthier, taking him on walks or to the gym, and encouraging him to make a lifestyle change, because she was “worried about his (her son’s) increasing girth, high blood pressure and severe sleep apnea, Cheryl Burrill said she didn’t think her son could wait three years. Scouring the Internet, she found Reston surgeon Eric Pinnar, who specializes in “lap-band” surgery.”
So, the “microwave generation” filled with kids and teenagers who want everything in life to come easy for them without ever having to work hard for it have found a way to eat whatever they want, get as fat as they want, and then beg their parents for stomach surgery to lose weight. I not only find fault here with the parents and the teenagers requesting this surgery, I also have an issue with the doctors who are performing these surgeries. According to the article, “Although a handful of doctors have operated on children and teenagers, some weighing more than 700 pounds, bariatric surgery has been regarded by many doctors as too risky and drastic for patients under 18. A 2007 study estimated that 2,744 teens underwent weight-loss surgery between 1996 and 2003, a number that more than tripled between 2000 and 2003. Many pediatricians and pediatric surgeons have been leery of the procedures, which have not been studied in children, require lifetime adherence to a strict dietary regimen, and can cause hazardous nutritional deficiencies and, in rare cases, death.”
Now that this phenomenon is gaining popularity, gastric bypass surgery studies are being conducted by the NIH and the FDA, reporting that this surgery may decrease the numbers of obese adults by early intervention through encouraging gastric bypass in teenagers. The article goes on to say that “‘We know that the vast majority of morbidly obese adolescents become morbidly obese adults, and that medical and behavioral therapy doesn't work for them,’ said Evan Nadler, director of New York University's minimally invasive pediatric surgery program who is involved in the FDA lap-band study. ‘These kids are sick. This is truly a disease, a problem we can treat with the best means we know how. [Surgery] is the only known mechanism for sustained and significant weight loss.’”
The article then reports that “Two other factors are fueling the reevaluation of weight-loss surgery: the relentless increase in childhood obesity and the dismal results of behavioral treatment, consisting of some combination of diet, talk therapy and exercise. Behavioral treatment has a long-term failure rate estimated at roughly 95 percent.”
If we start at home teaching our kids how to live health lifestyles from birth, we would not have these problems. Instead, we allow our children to eat whatever and whenever they want because we want to avoid confrontations. What happened to the days when you actually did what your parents told you to do? What happened to the times when your mother and father ran the household and not the child? I know that when I was growing up, there was no such thing as weight loss surgery. You got outside and you ran around and played all day. You did not sit around the house, watching TV, playing video games, texting your friends, and listening to your iPod while munching on all the sweets you wanted to eat. You ate home-cooked meals every day, and there was NO WAY my parents would even entertain the thought of spending thousands of dollars on surgery because somebody at school teased me about my weight, whether it was the teacher or a student.
Have we become so jaded and superficial that appearances are more important than teaching our kids life principles, like putting down the Snicker’s bar and instead eating a piece of fruit, or getting up off the couch and run some laps around the neighborhood? I am sorry, but I know about healthy eating because I have had to make the sacrifice to lose weight for my own health problems. Yes, it is hard, but it can be done with dedication and commitment, and lots and lots of patience. You did not get fat overnight, so you will not lose weight over night or even over one year. It may take 2 or 3 years. Are our precious children to privileged to wait a reasonable amount of time before they start seeing results?
In the end of the article, one of the teenagers who received weight loss surgery brags on how great she is sticking to a diet and playing sports. Why could she have not done that before the surgery to lose the weight? Would it not be less expensive to just change the grocery list and buy a treadmill? And what about the doctors? Are they so desperate to increase their wallets that they will risk the lives of teenagers to decrease theirs? Now that this is gaining more popularity, when will it stop? We better get ready, because soon we will be signing-up our 4 and 5 year olds because they are a little too chunky. And that will be sad. Because I love babies with fat cheeks. Hey, I was one.
Told that he would have to wait 3 years until he turned 18-years old to have the surgery, “he pleaded with his mother for help.” So, his mother, instead of taking every step she could to help him lose weight, like cooking and eating healthier, taking him on walks or to the gym, and encouraging him to make a lifestyle change, because she was “worried about his (her son’s) increasing girth, high blood pressure and severe sleep apnea, Cheryl Burrill said she didn’t think her son could wait three years. Scouring the Internet, she found Reston surgeon Eric Pinnar, who specializes in “lap-band” surgery.”
So, the “microwave generation” filled with kids and teenagers who want everything in life to come easy for them without ever having to work hard for it have found a way to eat whatever they want, get as fat as they want, and then beg their parents for stomach surgery to lose weight. I not only find fault here with the parents and the teenagers requesting this surgery, I also have an issue with the doctors who are performing these surgeries. According to the article, “Although a handful of doctors have operated on children and teenagers, some weighing more than 700 pounds, bariatric surgery has been regarded by many doctors as too risky and drastic for patients under 18. A 2007 study estimated that 2,744 teens underwent weight-loss surgery between 1996 and 2003, a number that more than tripled between 2000 and 2003. Many pediatricians and pediatric surgeons have been leery of the procedures, which have not been studied in children, require lifetime adherence to a strict dietary regimen, and can cause hazardous nutritional deficiencies and, in rare cases, death.”
Now that this phenomenon is gaining popularity, gastric bypass surgery studies are being conducted by the NIH and the FDA, reporting that this surgery may decrease the numbers of obese adults by early intervention through encouraging gastric bypass in teenagers. The article goes on to say that “‘We know that the vast majority of morbidly obese adolescents become morbidly obese adults, and that medical and behavioral therapy doesn't work for them,’ said Evan Nadler, director of New York University's minimally invasive pediatric surgery program who is involved in the FDA lap-band study. ‘These kids are sick. This is truly a disease, a problem we can treat with the best means we know how. [Surgery] is the only known mechanism for sustained and significant weight loss.’”
The article then reports that “Two other factors are fueling the reevaluation of weight-loss surgery: the relentless increase in childhood obesity and the dismal results of behavioral treatment, consisting of some combination of diet, talk therapy and exercise. Behavioral treatment has a long-term failure rate estimated at roughly 95 percent.”
If we start at home teaching our kids how to live health lifestyles from birth, we would not have these problems. Instead, we allow our children to eat whatever and whenever they want because we want to avoid confrontations. What happened to the days when you actually did what your parents told you to do? What happened to the times when your mother and father ran the household and not the child? I know that when I was growing up, there was no such thing as weight loss surgery. You got outside and you ran around and played all day. You did not sit around the house, watching TV, playing video games, texting your friends, and listening to your iPod while munching on all the sweets you wanted to eat. You ate home-cooked meals every day, and there was NO WAY my parents would even entertain the thought of spending thousands of dollars on surgery because somebody at school teased me about my weight, whether it was the teacher or a student.
Have we become so jaded and superficial that appearances are more important than teaching our kids life principles, like putting down the Snicker’s bar and instead eating a piece of fruit, or getting up off the couch and run some laps around the neighborhood? I am sorry, but I know about healthy eating because I have had to make the sacrifice to lose weight for my own health problems. Yes, it is hard, but it can be done with dedication and commitment, and lots and lots of patience. You did not get fat overnight, so you will not lose weight over night or even over one year. It may take 2 or 3 years. Are our precious children to privileged to wait a reasonable amount of time before they start seeing results?
In the end of the article, one of the teenagers who received weight loss surgery brags on how great she is sticking to a diet and playing sports. Why could she have not done that before the surgery to lose the weight? Would it not be less expensive to just change the grocery list and buy a treadmill? And what about the doctors? Are they so desperate to increase their wallets that they will risk the lives of teenagers to decrease theirs? Now that this is gaining more popularity, when will it stop? We better get ready, because soon we will be signing-up our 4 and 5 year olds because they are a little too chunky. And that will be sad. Because I love babies with fat cheeks. Hey, I was one.
Tuesday, February 24, 2009
"Which Kid is the Favorite?” is Now a Life and Death Question
It is now reality. We can choose the traits of our children--boy, girl, blond, brunette, blue eyes, green eyes, brown eyes…. Before you get to excited, let us look at it a little closer. Like most things, paradoxically, the closer you get, the less clear things become.
How is it done? A number of eggs are fertilized. By taking a sample from each egg, the doctors identify genetic markers in each egg that will likely result in certain traits. The parents then pick the egg with the combination of traits they like best. The rest of the eggs are likely discarded. Do we want to live in a country where (for instance) the blond haired, blue-eyed boy gets to live while the brown eyed, brown haired girl does not? Let me put it this way: If this technology had been around in the late 1930's and early 1940's, the Nazis would have applied it with gusto.
Besides the moral question of determining who lives based on eye or hair color, there are practical considerations. Our species has been honed over the millennia by evolution (which is not a theory but a fact, period—no debate). Over time, a tapestry of genes and traits was woven that made our species more robust. Genetic mutations and different combinations of genes resulted in a more diverse gene pool (and thus more diverse traits) that made annihilation of the species by one disease or circumstance less likely. Some traits are linked with other traits, so when eye color, hair color or sex are manipulated, other seemingly unrelated traits are manipulated as well, affecting more than just appearance. For contemporary society, research has shown that, as politically correct as it sounds, some traits are more popular than others. What happens when we start to manipulate which genes get passed down and which genes do not? Are we unknowingly manipulating other traits (disease resistance, cancer susceptibility)? I am not a geneticist, but it seems possible.
While there are possible health-related consequences, there are also social consequences. What if boys are more desirable than girls? In many parts of the world (and subcultures within our own country), they are. Will we end up like China, where their 28 year-old policy of one child per family has resulted in female babies being aborted and a CURRENT ratio of 120 men for every 100 women? By one account, 70% of aborted babies in China are female. (http://www.msnbc.msn.com/id/5953508) While females are less “desirable” as a child, they are still desirable as a mate (that is putting it gingerly). Female abductions and trafficking are skyrocketing in China. As a man, I can state unequivocally that the consequences of that giant block of men without mates will cause problems for that society MUCH bigger than just part of its population merely being unfulfilled. As a result, women, and the entire society, will be adversely affected.
I am not saying we should stop or hinder science. It is great that we have this knowledge and ability. However, just because we have the knowledge does not mean we should use it trivially. Our knowledge in these fields is nascent, and we should proceed with extreme caution.
(This blog posting was inspired by this article: http://online.wsj.com/article/SB123439771603075099.html.)
How is it done? A number of eggs are fertilized. By taking a sample from each egg, the doctors identify genetic markers in each egg that will likely result in certain traits. The parents then pick the egg with the combination of traits they like best. The rest of the eggs are likely discarded. Do we want to live in a country where (for instance) the blond haired, blue-eyed boy gets to live while the brown eyed, brown haired girl does not? Let me put it this way: If this technology had been around in the late 1930's and early 1940's, the Nazis would have applied it with gusto.
Besides the moral question of determining who lives based on eye or hair color, there are practical considerations. Our species has been honed over the millennia by evolution (which is not a theory but a fact, period—no debate). Over time, a tapestry of genes and traits was woven that made our species more robust. Genetic mutations and different combinations of genes resulted in a more diverse gene pool (and thus more diverse traits) that made annihilation of the species by one disease or circumstance less likely. Some traits are linked with other traits, so when eye color, hair color or sex are manipulated, other seemingly unrelated traits are manipulated as well, affecting more than just appearance. For contemporary society, research has shown that, as politically correct as it sounds, some traits are more popular than others. What happens when we start to manipulate which genes get passed down and which genes do not? Are we unknowingly manipulating other traits (disease resistance, cancer susceptibility)? I am not a geneticist, but it seems possible.
While there are possible health-related consequences, there are also social consequences. What if boys are more desirable than girls? In many parts of the world (and subcultures within our own country), they are. Will we end up like China, where their 28 year-old policy of one child per family has resulted in female babies being aborted and a CURRENT ratio of 120 men for every 100 women? By one account, 70% of aborted babies in China are female. (http://www.msnbc.msn.com/id/5953508) While females are less “desirable” as a child, they are still desirable as a mate (that is putting it gingerly). Female abductions and trafficking are skyrocketing in China. As a man, I can state unequivocally that the consequences of that giant block of men without mates will cause problems for that society MUCH bigger than just part of its population merely being unfulfilled. As a result, women, and the entire society, will be adversely affected.
I am not saying we should stop or hinder science. It is great that we have this knowledge and ability. However, just because we have the knowledge does not mean we should use it trivially. Our knowledge in these fields is nascent, and we should proceed with extreme caution.
(This blog posting was inspired by this article: http://online.wsj.com/article/SB123439771603075099.html.)
Thursday, February 19, 2009
Stem Cells Cause Harm Not Help?
For years, we have been debating the issue of stem cell research and using stem cells to develop cures for diseases. This issue has been a major concern among voters and even influenced who we voted for. My thoughts have always been in favor of stem cell research, and even after reading this article, my opinions remain the same. However, for those who are against stem cell research, I can see how this article may provide more ammunition to sway others to their opinion.
The article (http://www.google.com/hostednews/ap/article/ALeqM5gXPm4dnGNyn2DTR2t_FmA0GW_4JgD96DLTT00) reports that an Israeli child diagnosed with a rare, fatal brain disease, ataxia telangiectasia (A-T), received three injections of neural stem cell from fetuses. After his third injection at age 10, the boy’s brain disease had become severe enough for him to use a wheelchair. But can this be blamed on the neural stem cell injections or is it just a natural progression of his disease?
“But was the boy prone to tumors anyway or were the fetal stem cells to blame? A Tel Aviv University team extensively tested the tumor tissue and concluded it was the fetal cells. Among other evidence, some of the cells were female and had two normal copies of the gene that causes A-T — although that boy’s underlying poor immune function could have allowed the growths to take hold.”
Doctors speculate that the boy’s disease “wasn’t conducive to stem cell therapy in the first place.” So, can we blame the stem cells or the doctors for attempting this procedure without knowing the risks?
“’Patients, please beware,’ said Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania who wasn't involved in the Israeli boy's care but who sees similarly desperate U.S. patients head abroad to clinics that offer unproven stem cell injections. ‘Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time’ to prove how best to pursue the potential therapy, Gearhart said.”
Another doctor urges that better research is needed to “‘maximize the potential benefits of regenerative medicine while minimizing the risks.’”
I am constantly telling my siblings that medicine is experimental, and to develop cures and medications for conditions, sometimes you have to go through the rule-out process before the right one is found. That is the same with stem cell research. We have to understand that there will be risks and there may be failures. But if one failure leads to one success, then in my opinion, it is worth it. If we believe that there are casualties of war and one person dying is better than 200,000, then why don’t we have that same mentality with healthcare and medicine? Can we put death caused by diseases in the same category as war? Aren’t we fighting a war against disease? If we are, then there are bound to be casualties of war, any war, whether it is a war against disease or terrorism, or to protect our freedoms.
The article (http://www.google.com/hostednews/ap/article/ALeqM5gXPm4dnGNyn2DTR2t_FmA0GW_4JgD96DLTT00) reports that an Israeli child diagnosed with a rare, fatal brain disease, ataxia telangiectasia (A-T), received three injections of neural stem cell from fetuses. After his third injection at age 10, the boy’s brain disease had become severe enough for him to use a wheelchair. But can this be blamed on the neural stem cell injections or is it just a natural progression of his disease?
“But was the boy prone to tumors anyway or were the fetal stem cells to blame? A Tel Aviv University team extensively tested the tumor tissue and concluded it was the fetal cells. Among other evidence, some of the cells were female and had two normal copies of the gene that causes A-T — although that boy’s underlying poor immune function could have allowed the growths to take hold.”
Doctors speculate that the boy’s disease “wasn’t conducive to stem cell therapy in the first place.” So, can we blame the stem cells or the doctors for attempting this procedure without knowing the risks?
“’Patients, please beware,’ said Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania who wasn't involved in the Israeli boy's care but who sees similarly desperate U.S. patients head abroad to clinics that offer unproven stem cell injections. ‘Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time’ to prove how best to pursue the potential therapy, Gearhart said.”
Another doctor urges that better research is needed to “‘maximize the potential benefits of regenerative medicine while minimizing the risks.’”
I am constantly telling my siblings that medicine is experimental, and to develop cures and medications for conditions, sometimes you have to go through the rule-out process before the right one is found. That is the same with stem cell research. We have to understand that there will be risks and there may be failures. But if one failure leads to one success, then in my opinion, it is worth it. If we believe that there are casualties of war and one person dying is better than 200,000, then why don’t we have that same mentality with healthcare and medicine? Can we put death caused by diseases in the same category as war? Aren’t we fighting a war against disease? If we are, then there are bound to be casualties of war, any war, whether it is a war against disease or terrorism, or to protect our freedoms.
Wednesday, February 18, 2009
Bayer: The Modern Hypothecary?
Today, some of the most popular branded drugs are nearing patent expirations, thus opening the doors to generic competition. In order to compete with generic companies, many big-name drug makers, such as Bayer Healthcare Pharmaceuticals, now rely heavily on direct-to-consumer advertising. An example is commercial advertisements for their product, Yaz.
In 2006, the FDA approved Yaz as a birth control pill that has a side benefit of treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz; that of improving moderate acne. However, Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, and its side effects include an increased risk of serious heart and other health problems.
Aimed primarily at women in their 20s, Yaz has been known for its slogan — “Beyond Birth Control” — which promotes it not only as pregnancy prevention, but as a lifestyle drug. This is where Bayer's problems started.
The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company’s ads ran afoul of federal laws against promoting the unapproved uses of a drug.
As part of an unusual crackdown on deceptive consumer drug advertising, the FDA and the attorneys general of 27 states have required Bayer to run new ads to correct previous Yaz marketing.
In addition, Bayer has agreed, for the next six years, to submit all Yaz ads for federal screening before they appear. Wait a minute…hold up; something sounds "bass ackwards" here.
The Food, Drugs and Cosmetics Act of 1938 gave the FDA greater authority to regulate the food and drug industry. Under this act, the FDA was granted the power to regulate the therapeutic claims drug manufacturers printed on their product labels.
Perhaps the most striking feature of the 1938 law was that the act introduced mandatory pre-market approval for new drugs; (I feel the problem beginning to emerge…wait for it….wait for it…) but authority over drug advertising, however, rested with the Federal Trade Commission (FTC). (And here is our problem!)
The FDA regulates the initiation of clinical trials, they accept safety and efficacy results of the trial, they approve a drug for marketing, and they even regulate safety of drugs post-marketing; but the FTC is the authority over drug advertisements?
If pre-market approval of new drugs by the FDA is required, then why aren't commercials also pre-approved by the FDA before airing? Isn't a commercial the same as a drug's package insert? And what does the FTC know about clinical trials, i.e., safety and efficacy anyway?
So, is Bayer unethical because they have been involved in deceptive advertising? Yes and no.
Yes, because while these commercials empower women to make their own decisions, it is also Bayer's responsibility to provide all of the information to consumers just as they would to the FDA. In the case of direct to consumer drug commercials, there is a fine line between creative marketing and responsible marketing. While Bayer may try to use different techniques to market their product, each commercial must be treated like a verbal package insert.
However, I also say "No" because Yaz is available by prescription only. While a commercial may suggest to a woman to speak with her physician concerning Yaz, it is also the physician's responsibility to know the benefits and risks and to prescribe drugs accordingly; not because a consumer viewed a commercial.
Either way, it appears that the Yaz controversy may raise new questions about whether the FDA oversight is sufficient. If deemed insufficient, then direct to consumer advertisement may become a thing of the past. With a staff of 52 people, the FDA division that oversees drug promotion cannot keep up with the tens of thousands of marketing and advertising items produced annually by drug manufacturers.
In 2006, the FDA approved Yaz as a birth control pill that has a side benefit of treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz; that of improving moderate acne. However, Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, and its side effects include an increased risk of serious heart and other health problems.
Aimed primarily at women in their 20s, Yaz has been known for its slogan — “Beyond Birth Control” — which promotes it not only as pregnancy prevention, but as a lifestyle drug. This is where Bayer's problems started.
The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company’s ads ran afoul of federal laws against promoting the unapproved uses of a drug.
As part of an unusual crackdown on deceptive consumer drug advertising, the FDA and the attorneys general of 27 states have required Bayer to run new ads to correct previous Yaz marketing.
In addition, Bayer has agreed, for the next six years, to submit all Yaz ads for federal screening before they appear. Wait a minute…hold up; something sounds "bass ackwards" here.
The Food, Drugs and Cosmetics Act of 1938 gave the FDA greater authority to regulate the food and drug industry. Under this act, the FDA was granted the power to regulate the therapeutic claims drug manufacturers printed on their product labels.
Perhaps the most striking feature of the 1938 law was that the act introduced mandatory pre-market approval for new drugs; (I feel the problem beginning to emerge…wait for it….wait for it…) but authority over drug advertising, however, rested with the Federal Trade Commission (FTC). (And here is our problem!)
The FDA regulates the initiation of clinical trials, they accept safety and efficacy results of the trial, they approve a drug for marketing, and they even regulate safety of drugs post-marketing; but the FTC is the authority over drug advertisements?
If pre-market approval of new drugs by the FDA is required, then why aren't commercials also pre-approved by the FDA before airing? Isn't a commercial the same as a drug's package insert? And what does the FTC know about clinical trials, i.e., safety and efficacy anyway?
So, is Bayer unethical because they have been involved in deceptive advertising? Yes and no.
Yes, because while these commercials empower women to make their own decisions, it is also Bayer's responsibility to provide all of the information to consumers just as they would to the FDA. In the case of direct to consumer drug commercials, there is a fine line between creative marketing and responsible marketing. While Bayer may try to use different techniques to market their product, each commercial must be treated like a verbal package insert.
However, I also say "No" because Yaz is available by prescription only. While a commercial may suggest to a woman to speak with her physician concerning Yaz, it is also the physician's responsibility to know the benefits and risks and to prescribe drugs accordingly; not because a consumer viewed a commercial.
Either way, it appears that the Yaz controversy may raise new questions about whether the FDA oversight is sufficient. If deemed insufficient, then direct to consumer advertisement may become a thing of the past. With a staff of 52 people, the FDA division that oversees drug promotion cannot keep up with the tens of thousands of marketing and advertising items produced annually by drug manufacturers.
Saturday, February 14, 2009
New UK Breeding Standards for Show Dogs
Artificial insemination is a common practice among dog breeders. In 2003, a female champion black standard poodle named Yes was conceived using 25-year-old frozen semen from another champion named Snapper, who died in 1990. It is highly unusual to use frozen semen that old and Yes’ extraordinary success as a product of artificial insemination using old semen is also highly unusual, according to Katie Thomas in Keeping Championship Bloodlines Alive (The New York Times, February 11, 2009). Another breeder recently used 20-year-old semen to produce a litter of Irish Wolfhounds. She and her partner were surprised at how different the litter bred from the “heirloom” semen looked in comparison to the Irish Wolfhounds of today.
The selective breeding of dogs to produce certain traits has been a common practice for several hundred years. Initially, this was done for practical purposes, such as hunting, herding, and retrieving. However, with the increasing popularity of dog shows, physical features and personality traits have been bred into and out of each dog species that may have nothing to do with a particular breed’s function and are simply a matter of fashion. Some of these traits may have been anomalies, abnormalities, or aberrations that would actually give the animal an evolutionary disadvantage in the wild. And some have caused health problems, especially in the case of inbreeding.
The benefits of artificial insemination, besides allowing the breeding of dogs from a long distance, include adding variety to the gene pool, which can become quite stagnant through inbreeding, and the ability to preserve and reintroduce old traits that may have been bred out of a particular breed, especially if the semen was produced before a particular health problem was introduced into the breed. This type of ”heirloom” semen may become quite valuable in light of a recent movement in the UK to address the ethics of breeding for fashion that may produce unhealthy traits in a dog breed.
New breeding standards have been introduced by The Kennel Club (UK) for 209 dog species, including the classic British bulldog, which, under the new requirements, will have a shrunken face, a sunken nose, longer legs, and a leaner body, much to the outrage of professional breeders and pedigree dog societies (Healthier New Bulldog Will Lose Its Churchillian Jowl; The New York Times, January 14, 2009). This change came after public outcry about breeding practices, following a BBC One documentary, Pedigree Dogs Exposed, which was aired last summer. Judges have been instructed to use new breed standards and inbreeding has been banned. However, many judges are also breeders and there is much opposition to the controversial changes.
Many bulldogs must undergo artificial insemination in order to conceive because mating is anatomically difficult. Most give birth by Caesarean section because the puppies’ large heads get stuck in the birth canal of the small-hipped female bulldog, making natural birthing difficult and dangerous. The bulldog has long been a symbol of strength but the traits that have been bred into it, such as the massive chest and pronounced underbite, actually make it physically weaker. Other breeds that will be affected by the new mandate include the Shar Pei, with its trademark skin folds that cause eye and skin problems, and the Pekingese, which has a flat face that causes breathing problems. These changes will, of course, take years as healthy traits are bred back in and unhealthy traits removed. (An example in the cat world would be the pushed in faces of Persian cats and the resultant blocked tear ducts that cause eye drainage problems.)
If the American Kennel Club (AKC) hasn’t been inspired by the decisive actions of its counterpart across the pond, I hope it is soon. I have always wondered why the Humane Society hasn’t done more about this issue. The thought of a female bulldog somehow being separated from her family and getting pregnant as a stray, only to die a painful death birthing her puppies because humans have designed her to be unfit for the most natural of physical functions is abhorrent to me, not to mention horrifying in its inherent cruelty. This should have been illegal right from the start. The attitude that an animal is a “product” to be engineered for human use, study, and convenience is one that I feel should have been obsolete by now. There are arguments pro and con regarding the use of animals for food, clothing, and research, and I don’t intend to discuss those any further. However, there is no excuse or rationalization that can justify or provide any validity to the manipulation of animal DNA for sheer vanity and human entertainment, as is evident in the breeding of show dogs.
I applaud the UK Kennel Club for its immediate and decisive action on behalf of show dogs. It is easy to assume that these are pampered animals leading luxurious lives. We hear so much about the plight of mutts and stray dogs, but pedigree animals suffer from a unique brand of cruelty that affects their health and the integrity of their bloodlines. Dog breeding is big business and it is minimally regulated. There are many reputable dog breeders but puppy mills abound. I hope the United States follows in the footsteps of the United Kingdom and recognizes the need to protect the health of show dogs and all dogs that are bred for sale.
Blog 4
The selective breeding of dogs to produce certain traits has been a common practice for several hundred years. Initially, this was done for practical purposes, such as hunting, herding, and retrieving. However, with the increasing popularity of dog shows, physical features and personality traits have been bred into and out of each dog species that may have nothing to do with a particular breed’s function and are simply a matter of fashion. Some of these traits may have been anomalies, abnormalities, or aberrations that would actually give the animal an evolutionary disadvantage in the wild. And some have caused health problems, especially in the case of inbreeding.
The benefits of artificial insemination, besides allowing the breeding of dogs from a long distance, include adding variety to the gene pool, which can become quite stagnant through inbreeding, and the ability to preserve and reintroduce old traits that may have been bred out of a particular breed, especially if the semen was produced before a particular health problem was introduced into the breed. This type of ”heirloom” semen may become quite valuable in light of a recent movement in the UK to address the ethics of breeding for fashion that may produce unhealthy traits in a dog breed.
New breeding standards have been introduced by The Kennel Club (UK) for 209 dog species, including the classic British bulldog, which, under the new requirements, will have a shrunken face, a sunken nose, longer legs, and a leaner body, much to the outrage of professional breeders and pedigree dog societies (Healthier New Bulldog Will Lose Its Churchillian Jowl; The New York Times, January 14, 2009). This change came after public outcry about breeding practices, following a BBC One documentary, Pedigree Dogs Exposed, which was aired last summer. Judges have been instructed to use new breed standards and inbreeding has been banned. However, many judges are also breeders and there is much opposition to the controversial changes.
Many bulldogs must undergo artificial insemination in order to conceive because mating is anatomically difficult. Most give birth by Caesarean section because the puppies’ large heads get stuck in the birth canal of the small-hipped female bulldog, making natural birthing difficult and dangerous. The bulldog has long been a symbol of strength but the traits that have been bred into it, such as the massive chest and pronounced underbite, actually make it physically weaker. Other breeds that will be affected by the new mandate include the Shar Pei, with its trademark skin folds that cause eye and skin problems, and the Pekingese, which has a flat face that causes breathing problems. These changes will, of course, take years as healthy traits are bred back in and unhealthy traits removed. (An example in the cat world would be the pushed in faces of Persian cats and the resultant blocked tear ducts that cause eye drainage problems.)
If the American Kennel Club (AKC) hasn’t been inspired by the decisive actions of its counterpart across the pond, I hope it is soon. I have always wondered why the Humane Society hasn’t done more about this issue. The thought of a female bulldog somehow being separated from her family and getting pregnant as a stray, only to die a painful death birthing her puppies because humans have designed her to be unfit for the most natural of physical functions is abhorrent to me, not to mention horrifying in its inherent cruelty. This should have been illegal right from the start. The attitude that an animal is a “product” to be engineered for human use, study, and convenience is one that I feel should have been obsolete by now. There are arguments pro and con regarding the use of animals for food, clothing, and research, and I don’t intend to discuss those any further. However, there is no excuse or rationalization that can justify or provide any validity to the manipulation of animal DNA for sheer vanity and human entertainment, as is evident in the breeding of show dogs.
I applaud the UK Kennel Club for its immediate and decisive action on behalf of show dogs. It is easy to assume that these are pampered animals leading luxurious lives. We hear so much about the plight of mutts and stray dogs, but pedigree animals suffer from a unique brand of cruelty that affects their health and the integrity of their bloodlines. Dog breeding is big business and it is minimally regulated. There are many reputable dog breeders but puppy mills abound. I hope the United States follows in the footsteps of the United Kingdom and recognizes the need to protect the health of show dogs and all dogs that are bred for sale.
Blog 4
Friday, February 13, 2009
Prison Reform for Health Care's Sake?
Prison Reform for Health Care’s Sake?
Jails and prisons lie at the intersection of criminal justice policies that target already marginalized populations, health disparities, public health, and proven biomedical strategies. The explosive rates of incarceration since 1980 are direct consequences of criminal justice policies that adversely impact urban communities disproportionately affected by detrimental correlates of poverty – particularly poor health as a result of an influx of illicit drugs. Illicit drugs are a double-edged sword: on one end are the dealers and the other are users. In the eyes of the law both are criminals and, in some cases, subject to similar sentences. Therefore, a good portion of the national prison population consists of individuals incarcerated for non-violent offenses or, put another way, “crimes against themselves” (Russell Simmons, 200X).
Is it a wonder that jails and prisons are overcrowded?
In California, the problem is compounded by the fact that other states often transfer inmates to already overcrowded facilities. Should we / the tax-paying-population be concerned that a three-panel judge ordered the release of several thousand inmates (over the next few years) for health care reasons? Or should we be more concerned that the prison system has an expendable population of several thousand to begin with? If that is the case, is ‘health’ a disguise for a seething undercurrent of a much larger problem?
Physical and mental well-being (or health) start with a healthy environment which includes access to the very resources that secure health: employment and comprehensive education. Neither is abundant or is sparingly available in urban communities. But drugs are! And so are mixed messages that, on the one hand, proselytize the advantages of acquiring an education, for example, while simultaneously depleting financial resources that make educational success possible; or, shameless promotions of financial success through illicit drug sales while limiting the alternatives to starving or barely surviving through a less-than-minimum-wage salary.
If one is not mentally unstable from his environment before incarceration, most certainly the conditions within will destabilize him. With rehabilitation programs limited to constructing home-made weapons as cheap but as deadly as Walmart-sold guns, it should not be a surprise that these men and women return to their broken-environment in a worse mental and physical state than they were before incarceration – hence, the high recidivism rate. So it should not be a surprise that correctional facilities are overcrowded. And it is an insult to be shocked, let alone, outraged at the poor health of inmates since their health was poor to begin with.
The question, therefore, is not that corrections facilities are overcrowded but how did they get that way? More importantly, what is the plan to mitigate this problem from occurring again? Or, are we more comfortable with locking people away as a measure to correct problems we’re unwilling to confront and rectify?
Holly Tomlin
BW 706 – Blog 3
Jails and prisons lie at the intersection of criminal justice policies that target already marginalized populations, health disparities, public health, and proven biomedical strategies. The explosive rates of incarceration since 1980 are direct consequences of criminal justice policies that adversely impact urban communities disproportionately affected by detrimental correlates of poverty – particularly poor health as a result of an influx of illicit drugs. Illicit drugs are a double-edged sword: on one end are the dealers and the other are users. In the eyes of the law both are criminals and, in some cases, subject to similar sentences. Therefore, a good portion of the national prison population consists of individuals incarcerated for non-violent offenses or, put another way, “crimes against themselves” (Russell Simmons, 200X).
Is it a wonder that jails and prisons are overcrowded?
In California, the problem is compounded by the fact that other states often transfer inmates to already overcrowded facilities. Should we / the tax-paying-population be concerned that a three-panel judge ordered the release of several thousand inmates (over the next few years) for health care reasons? Or should we be more concerned that the prison system has an expendable population of several thousand to begin with? If that is the case, is ‘health’ a disguise for a seething undercurrent of a much larger problem?
Physical and mental well-being (or health) start with a healthy environment which includes access to the very resources that secure health: employment and comprehensive education. Neither is abundant or is sparingly available in urban communities. But drugs are! And so are mixed messages that, on the one hand, proselytize the advantages of acquiring an education, for example, while simultaneously depleting financial resources that make educational success possible; or, shameless promotions of financial success through illicit drug sales while limiting the alternatives to starving or barely surviving through a less-than-minimum-wage salary.
If one is not mentally unstable from his environment before incarceration, most certainly the conditions within will destabilize him. With rehabilitation programs limited to constructing home-made weapons as cheap but as deadly as Walmart-sold guns, it should not be a surprise that these men and women return to their broken-environment in a worse mental and physical state than they were before incarceration – hence, the high recidivism rate. So it should not be a surprise that correctional facilities are overcrowded. And it is an insult to be shocked, let alone, outraged at the poor health of inmates since their health was poor to begin with.
The question, therefore, is not that corrections facilities are overcrowded but how did they get that way? More importantly, what is the plan to mitigate this problem from occurring again? Or, are we more comfortable with locking people away as a measure to correct problems we’re unwilling to confront and rectify?
Holly Tomlin
BW 706 – Blog 3
Thursday, February 12, 2009
The Octuplets’ conception: was it unethical?
In an article on msnbc.com, the American Society for Reproductive Medicine questioned the actions of Dr. Michael Kamrava. The organization is investigating the procedure that Dr. Kamrava completed on Suleman. The organization has guidelines for the number of embryos that should be placed in a woman. However, if a doctor is found to have violated the guidelines, the organization cannot stop the doctor from practicing.
Suleman’s first pregnancy was from that of in vitro fertilization where she gave birth to 6 children. I feel as though you can’t say that it was wrong for her to get in vitro a second time because she was a single mother with 6 other kids. However, I do believe that the guidelines that were created by the American Society for Reproductive Medicine should be followed. If doctors do not follow the guidelines of two to three embryos, then they should lose their license. If we left it up to doctor to decide what the correct number of embryos to implant were we would have doctors doing whatever they wanted.
In Suleman’s case, I believe that not only is the doctor to blame but Suleman herself. Instead of Suleman having a million children to make up for her “terrible childhood”, she should have gone to see a psychologist. Just as an ethical plastic surgeon would send a patient who has body dysmorphia to a psychologist, Dr. Kamrava should have sent Suleman to a psychologist. Now all of us are stuck supporting her kids because she had a “terrible childhood”. We all have bad things that happen to us during our life time. It’s LIFE; no one said it was easy.
Wednesday, February 11, 2009
Euthanasia - To Murder or Not to Murder, That is the Question
Okay, so get ready to not like me anymore, especially after you read this post. I have tried to avoid posting on subjects that rev my engine, except for last week that is, until now. When I read the article, “Italy Seeks Clarity on Euthanasia,” I just knew I had to respond.
So, basically, the article (http://news.bbc.co.uk/2/hi/europe/7881441.stm) reports that Italy’s politicians were in the process of creating a new right-to-die law, after the case of Eluana Englaro. Englaro was a 38-year-old patient who had been in a coma since 1992. Just as the Senate was preparing to pass a law to keep Englaro alive, the doctors pulled her feeding tubes and she died. Of course, this issue raised some serious concerns among the politicians and anti-euthanasia and rights-to-die activists.
“Prime Minister Silvio Berlusconi expressed similar sentiments. ‘Eluana did not die a natural death, she was killed,’ he said, blaming President Giorgio Napolitano for blocking his emergency decree that would have forced doctors to resume feeding her.”
However, the President reported that the prime minister had acted, “unconstitutionally by attempting to overrule the courts, which had judged that Ms. Englaro should be allowed to die, in accordance with her father’s wishes.”
My first issue with this entire case is when did it become the government’s place or right, let alone anyone else for that matter, to intervene in determining when someone else lives or dies? We have become so involved in the lives of others, whether it be celebrities or regular every day citizens, that we cross the lines between legalism and ethics. Is it right for us to force our beliefs on someone else’s life, when it interferes with their beliefs? When is it okay for the media and the rest of the world to play God with our lives?
I am, by the full meaning of the words, a Christ believer and Christ follower. So, my beliefs may often, as they always do, conflict with the morals or beliefs of most of the world. So, I do not fully understand how it becomes our right to become involved in determining who lives or dies. I’ve always been under the impression that this was inevitably God’s decision. No matter who wants to fight it, drag it into court, print it in the newspapers, pass a law against it, or whatever. My life’s beginning was not decided in the courts or the newspapers, and neither will my life’s ending.
This is the same issue as the Terri Schiavo case when the state of Florida had to become involved in deciding if Schiavo’s feeding tube would be removed because Schiavo’s parents disagreed with her husband’s right to have his wife disconnected from life support, even though the husband had a do not resuscitate order. Many people would argue that as long as the brain is still working, then you’re still alive, regardless of whether you have function of the rest of your body and organs. Then the question of quality of life comes into play. Is it really living, if there’s no quality of life? Should we be denied the right to quality of life?
This issue sparks a lot of controversy within the church and the government. It then becomes a religion versus ethics issue. Just like in Italy where the Roman Catholic Church became involved in Englaro’s case.
“The Roman Catholic Church, which was angered by the moves to withdraw Ms Englaro's life support, and prayed for God's "forgiveness" for those who "led her" to her death, agreed. ‘A just law is necessary for the good of our society and our civilisation,’ said Cardinal Angelo Bagnasco, head of the powerful Italian bishops' conference.”
On the religious aspect, some may even question if it’s biblical to even be hooked up to machines. Would not some fanatics say that God would not want us hooked up to life support at all, if He is our life support? Of course, I have my opinions on that matter, but I will not voice them here for fear that this post would be several pages long and spark numerous posts of controversy.
Is it really euthanasia if we are preserving quality of life? Is euthanasia just simply another word for murder?
The questions and the arguments are numerous, and have been argued for centuries. So, who’s right? In the end, we all have our strong opinions and views on this issue and no one will sway the other from their point of view. So, on this issue, I guess we just all have to agree to disagree, loudly.
So, basically, the article (http://news.bbc.co.uk/2/hi/europe/7881441.stm) reports that Italy’s politicians were in the process of creating a new right-to-die law, after the case of Eluana Englaro. Englaro was a 38-year-old patient who had been in a coma since 1992. Just as the Senate was preparing to pass a law to keep Englaro alive, the doctors pulled her feeding tubes and she died. Of course, this issue raised some serious concerns among the politicians and anti-euthanasia and rights-to-die activists.
“Prime Minister Silvio Berlusconi expressed similar sentiments. ‘Eluana did not die a natural death, she was killed,’ he said, blaming President Giorgio Napolitano for blocking his emergency decree that would have forced doctors to resume feeding her.”
However, the President reported that the prime minister had acted, “unconstitutionally by attempting to overrule the courts, which had judged that Ms. Englaro should be allowed to die, in accordance with her father’s wishes.”
My first issue with this entire case is when did it become the government’s place or right, let alone anyone else for that matter, to intervene in determining when someone else lives or dies? We have become so involved in the lives of others, whether it be celebrities or regular every day citizens, that we cross the lines between legalism and ethics. Is it right for us to force our beliefs on someone else’s life, when it interferes with their beliefs? When is it okay for the media and the rest of the world to play God with our lives?
I am, by the full meaning of the words, a Christ believer and Christ follower. So, my beliefs may often, as they always do, conflict with the morals or beliefs of most of the world. So, I do not fully understand how it becomes our right to become involved in determining who lives or dies. I’ve always been under the impression that this was inevitably God’s decision. No matter who wants to fight it, drag it into court, print it in the newspapers, pass a law against it, or whatever. My life’s beginning was not decided in the courts or the newspapers, and neither will my life’s ending.
This is the same issue as the Terri Schiavo case when the state of Florida had to become involved in deciding if Schiavo’s feeding tube would be removed because Schiavo’s parents disagreed with her husband’s right to have his wife disconnected from life support, even though the husband had a do not resuscitate order. Many people would argue that as long as the brain is still working, then you’re still alive, regardless of whether you have function of the rest of your body and organs. Then the question of quality of life comes into play. Is it really living, if there’s no quality of life? Should we be denied the right to quality of life?
This issue sparks a lot of controversy within the church and the government. It then becomes a religion versus ethics issue. Just like in Italy where the Roman Catholic Church became involved in Englaro’s case.
“The Roman Catholic Church, which was angered by the moves to withdraw Ms Englaro's life support, and prayed for God's "forgiveness" for those who "led her" to her death, agreed. ‘A just law is necessary for the good of our society and our civilisation,’ said Cardinal Angelo Bagnasco, head of the powerful Italian bishops' conference.”
On the religious aspect, some may even question if it’s biblical to even be hooked up to machines. Would not some fanatics say that God would not want us hooked up to life support at all, if He is our life support? Of course, I have my opinions on that matter, but I will not voice them here for fear that this post would be several pages long and spark numerous posts of controversy.
Is it really euthanasia if we are preserving quality of life? Is euthanasia just simply another word for murder?
The questions and the arguments are numerous, and have been argued for centuries. So, who’s right? In the end, we all have our strong opinions and views on this issue and no one will sway the other from their point of view. So, on this issue, I guess we just all have to agree to disagree, loudly.
Moral Distress
When Doctors and Nurses Can’t Do the Right Thing
Pauline W. Chen, M.D.
The New York Times
Doctor and Patient
February 6, 2009
The writer, a physician, describes her experiences of witnessing what an ethics consultant she knew called “moral distress.” The ethics consultant, also a medical doctor, stated that this was a growing concern at her hospital. Moral distress is the feeling of being trapped by competing demands from bureaucracy, family, and professional peers that forces doctors and nurses to compromise their commitment to what is best for patients.
Dr. Chen described a scenario that involved a very talented nurse who possessed tremendous perspicacity regarding clinical situations. She noticed over the years, however, that this nurse’s communication style devolved from sharp insight to vague non-commitment when communicating with doctors and supervisors. One situation in particular provoked the writer of the article to question the nurse about her change in attitude.
An intensive care unit (ICU) patient who appeared beyond help was taken into the operating room repeatedly over a period of a month. The patient’s abdomen was riddled with an unrelenting bacterial infection that was refractory to treatment. The nurse’s concern for the welfare of her patient as well as her questions regarding the futility of the surgeries were repeatedly ignored by the surgical team. She began to resort to sarcasm and, ultimately, resigned herself to silence whenever she was asked to take the patient in for yet another unsuccessful surgery.
The nurse shared her frustration over not being able to advocate for her patients. She was faced with the moral dilemma of choosing to do what was right for the patient or protecting herself from being criticized by doctors or warned by her superiors. This frustration is shared by many nurses. A recent study found that 15 percent of nurses leave their jobs because of moral distress. Doctors grapple with their own version of moral distress but not to the same extent as nurses.
According to Ann B. Hamric PhD, RN, the lead author of a University of Virginia study of ICU nurses and physicians, moral distress may stem from a variety of situations, but it is, in large part, a product of the work environment. Doctors and nurses both suffer from feelings of a lack of autonomy and threatened integrity, fearfulness, and lack of respect. Doctors feel that lawyers and risk managers are dictating patient care over and above the physicians’ professional judgement. The United States has had a nursing shortage for years and a primary care shortage is pending. Dr. Hamric believes that the first step to dealing with moral distress is to recognize it as an issue and then to make a point of discussing it in the health care setting. If health care providers are unable to maintain their professional integrity and do what is right for their patients, the shortage will inevitably become a crisis.
I feel that respect, fairness, and autonomy are at the core of this issue. At the heart of nursing is the imperative to advocate for the patient. The nurse is the liaison between the physician, the social worker, the family, and the patient. No one is more intimately involved in the patient’s care than the nurse. This caregiving role distinguishes nursing from medicine and gives nurses a unique and valuable perspective. Patient hospital ratings are often directly proportional to the quality of nursing care received. Yet nursing professionals continue to feel undervalued and disrespected.
When healthcare providers work as a team of dedicated professionals rather than in the constraints of an outmoded hierarchy, everyone benefits. I was lucky enough to work with an amazing group of doctors and nurses (there were some bad apples, of course). I felt respected by the doctors, my colleagues supported me, my insights and recommendations were valued, and many of my patients appreciated the care I provided them. However, the manpower shortage confronted us on a daily basis. Mandated overtime was the norm. Burnout was common, resentment over not being able to give patients the full attention they deserved was an underlying theme, and safety was an overriding concern. Turnover was high as, week after week, my supervisor tried to balance the schedule, deal with upper management who had no clue about the realities of working on a hospital floor, and, somehow, appease the increasingly disgruntled troops. She too eventually left.
We were paid well and raises came often. But there was no life outside of work. We were required to work every other weekend. That meant working for two weeks at a time before getting two days off in a row. That, in addition to overtime. Days off had to be requested at least a month in advance and weren’t always granted. Sick days were offered but nurses who called out more than two days in a year were denied a raise. Some nurses did feel disrespected. On-call doctors were rude and imperious. The buck always stopped with the RN: Whatever the nurses aides didn’t get to or didn't feel like doing was dumped on the nurse; if social work wasn’t able to do something the nurse picked up the slack; doctors talked down to the nurses and some had the frightening reflex of blaming the nurse for their own mistakes. There were more patients than nurses to care for them.
Numerous studies, analyses, task forces and questionnaires later, nothing much has changed to improve the nursing shortage. The answers seem obvious to nurses but there seems to be a conspiracy of ignorance among the powers that be. The problem is systemic and one that is confronting professionals everywhere. Money is more important than people, timelines are more important than quality, the status quo is more important than teamwork, and upper management everywhere have their own agenda. There is no single solution to this problem but it doesn’t appear that any real efforts have been made to resolve it. If we were living in a different time, place, and culture, there would have been a revolution by now. But there seem to be too many competing interests for anyone to unify for a common goal and purpose. I don’t know the answer. I left nursing too for another job that has its own challenges with moral distress. That’s life in America I guess.
Pauline W. Chen, M.D.
The New York Times
Doctor and Patient
February 6, 2009
The writer, a physician, describes her experiences of witnessing what an ethics consultant she knew called “moral distress.” The ethics consultant, also a medical doctor, stated that this was a growing concern at her hospital. Moral distress is the feeling of being trapped by competing demands from bureaucracy, family, and professional peers that forces doctors and nurses to compromise their commitment to what is best for patients.
Dr. Chen described a scenario that involved a very talented nurse who possessed tremendous perspicacity regarding clinical situations. She noticed over the years, however, that this nurse’s communication style devolved from sharp insight to vague non-commitment when communicating with doctors and supervisors. One situation in particular provoked the writer of the article to question the nurse about her change in attitude.
An intensive care unit (ICU) patient who appeared beyond help was taken into the operating room repeatedly over a period of a month. The patient’s abdomen was riddled with an unrelenting bacterial infection that was refractory to treatment. The nurse’s concern for the welfare of her patient as well as her questions regarding the futility of the surgeries were repeatedly ignored by the surgical team. She began to resort to sarcasm and, ultimately, resigned herself to silence whenever she was asked to take the patient in for yet another unsuccessful surgery.
The nurse shared her frustration over not being able to advocate for her patients. She was faced with the moral dilemma of choosing to do what was right for the patient or protecting herself from being criticized by doctors or warned by her superiors. This frustration is shared by many nurses. A recent study found that 15 percent of nurses leave their jobs because of moral distress. Doctors grapple with their own version of moral distress but not to the same extent as nurses.
According to Ann B. Hamric PhD, RN, the lead author of a University of Virginia study of ICU nurses and physicians, moral distress may stem from a variety of situations, but it is, in large part, a product of the work environment. Doctors and nurses both suffer from feelings of a lack of autonomy and threatened integrity, fearfulness, and lack of respect. Doctors feel that lawyers and risk managers are dictating patient care over and above the physicians’ professional judgement. The United States has had a nursing shortage for years and a primary care shortage is pending. Dr. Hamric believes that the first step to dealing with moral distress is to recognize it as an issue and then to make a point of discussing it in the health care setting. If health care providers are unable to maintain their professional integrity and do what is right for their patients, the shortage will inevitably become a crisis.
I feel that respect, fairness, and autonomy are at the core of this issue. At the heart of nursing is the imperative to advocate for the patient. The nurse is the liaison between the physician, the social worker, the family, and the patient. No one is more intimately involved in the patient’s care than the nurse. This caregiving role distinguishes nursing from medicine and gives nurses a unique and valuable perspective. Patient hospital ratings are often directly proportional to the quality of nursing care received. Yet nursing professionals continue to feel undervalued and disrespected.
When healthcare providers work as a team of dedicated professionals rather than in the constraints of an outmoded hierarchy, everyone benefits. I was lucky enough to work with an amazing group of doctors and nurses (there were some bad apples, of course). I felt respected by the doctors, my colleagues supported me, my insights and recommendations were valued, and many of my patients appreciated the care I provided them. However, the manpower shortage confronted us on a daily basis. Mandated overtime was the norm. Burnout was common, resentment over not being able to give patients the full attention they deserved was an underlying theme, and safety was an overriding concern. Turnover was high as, week after week, my supervisor tried to balance the schedule, deal with upper management who had no clue about the realities of working on a hospital floor, and, somehow, appease the increasingly disgruntled troops. She too eventually left.
We were paid well and raises came often. But there was no life outside of work. We were required to work every other weekend. That meant working for two weeks at a time before getting two days off in a row. That, in addition to overtime. Days off had to be requested at least a month in advance and weren’t always granted. Sick days were offered but nurses who called out more than two days in a year were denied a raise. Some nurses did feel disrespected. On-call doctors were rude and imperious. The buck always stopped with the RN: Whatever the nurses aides didn’t get to or didn't feel like doing was dumped on the nurse; if social work wasn’t able to do something the nurse picked up the slack; doctors talked down to the nurses and some had the frightening reflex of blaming the nurse for their own mistakes. There were more patients than nurses to care for them.
Numerous studies, analyses, task forces and questionnaires later, nothing much has changed to improve the nursing shortage. The answers seem obvious to nurses but there seems to be a conspiracy of ignorance among the powers that be. The problem is systemic and one that is confronting professionals everywhere. Money is more important than people, timelines are more important than quality, the status quo is more important than teamwork, and upper management everywhere have their own agenda. There is no single solution to this problem but it doesn’t appear that any real efforts have been made to resolve it. If we were living in a different time, place, and culture, there would have been a revolution by now. But there seem to be too many competing interests for anyone to unify for a common goal and purpose. I don’t know the answer. I left nursing too for another job that has its own challenges with moral distress. That’s life in America I guess.
Salmonella...come and get your salmonella
Imagine, you go are going about your normal routine. You feed the dog. Then you feed the kids; they've been extra good today, so it's ice cream and brownies for desert. Sounds like a normal day, right?
Now imagine a food manufacturing plant with live roaches, mold and slimy residue on floors and equipment, and improper sanitation procedures. Disgusting, right?
Now you may be asking what your normal routine has to do with this food plant. In short, Peanut Corporation of America knowingly shipped products that had tested positive for salmonella. This product ended up in your dog's food and in your kids' ice cream and brownies. Now, they are among more than 500 illnesses and eight deaths caused by this contamination. You know that it's not your fault; you had no way to know. However, there must be someone to blame.
Federal officials have begun a criminal inquiry of Peanut Corporation of America after learning that it knowingly shipped products that had tested positive for salmonella. This bit of knowledge would leave you to believe that the plant is entirely to blame; however, it is not as straightforward as that.
The plant was subjected to regular visits and inspections by federal, state, and private inspectors; and most of these inspectors found the plant to be in tip-top shape. Now, food manufacturers and public health officials are trying to determine how so many inspectors missed what some have said were obvious problems at the plant.
Kellogg, one of the companies that recalled peanut products, received reports of third-party independent audits of Peanut Corporation of America. These audits were supposed to review the supplier’s food safety program, microbial test results, and internal audit results. Kellogg is now looking into whether the third-party auditor actually reviewed state inspection reports or the plant’s test results.
The salmonella outbreak at Peanut Corporation of America shows the illusion of independent audits. Auditors rely on tangible facts, but when it comes down to it, they are also relying on trust.
For example, the president of the third party auditor, Jim Munyon, said the company would not have received a superior rating if his auditors had seen the filth the federal government described. “It would mean that we didn’t see it on the day we were there,” he said of the rating. “What goes on the rest of the time, we don’t know.”
As consumers, we trust Kellogg when we buy and eat their products; Kellogg trusts their auditors; the auditors trust Peanut Corporation of America; and Peanut Corporation of America trusts its workers.
So who's to blame; the workers, Peanut Corporation of America, the auditors, or Kellogg? You can be sure that your kids aren't thinking about that as they are standing over a toilet vomiting. However, maybe each entity (the worker, the corporation, the auditor, and Kellogg) should take each step in their daily routines, from manufacture to marketing, with the visual of your kids in mind. Better yet, maybe they should take each step as if the product is specifically for themselves. Then, just maybe, we could feel comfortable relying on trust…oh yeah, and audits.
Now imagine a food manufacturing plant with live roaches, mold and slimy residue on floors and equipment, and improper sanitation procedures. Disgusting, right?
Now you may be asking what your normal routine has to do with this food plant. In short, Peanut Corporation of America knowingly shipped products that had tested positive for salmonella. This product ended up in your dog's food and in your kids' ice cream and brownies. Now, they are among more than 500 illnesses and eight deaths caused by this contamination. You know that it's not your fault; you had no way to know. However, there must be someone to blame.
Federal officials have begun a criminal inquiry of Peanut Corporation of America after learning that it knowingly shipped products that had tested positive for salmonella. This bit of knowledge would leave you to believe that the plant is entirely to blame; however, it is not as straightforward as that.
The plant was subjected to regular visits and inspections by federal, state, and private inspectors; and most of these inspectors found the plant to be in tip-top shape. Now, food manufacturers and public health officials are trying to determine how so many inspectors missed what some have said were obvious problems at the plant.
Kellogg, one of the companies that recalled peanut products, received reports of third-party independent audits of Peanut Corporation of America. These audits were supposed to review the supplier’s food safety program, microbial test results, and internal audit results. Kellogg is now looking into whether the third-party auditor actually reviewed state inspection reports or the plant’s test results.
The salmonella outbreak at Peanut Corporation of America shows the illusion of independent audits. Auditors rely on tangible facts, but when it comes down to it, they are also relying on trust.
For example, the president of the third party auditor, Jim Munyon, said the company would not have received a superior rating if his auditors had seen the filth the federal government described. “It would mean that we didn’t see it on the day we were there,” he said of the rating. “What goes on the rest of the time, we don’t know.”
As consumers, we trust Kellogg when we buy and eat their products; Kellogg trusts their auditors; the auditors trust Peanut Corporation of America; and Peanut Corporation of America trusts its workers.
So who's to blame; the workers, Peanut Corporation of America, the auditors, or Kellogg? You can be sure that your kids aren't thinking about that as they are standing over a toilet vomiting. However, maybe each entity (the worker, the corporation, the auditor, and Kellogg) should take each step in their daily routines, from manufacture to marketing, with the visual of your kids in mind. Better yet, maybe they should take each step as if the product is specifically for themselves. Then, just maybe, we could feel comfortable relying on trust…oh yeah, and audits.
Tuesday, February 10, 2009
Photojournalism and the public’s health: art or information?
My addiction to taking pictures started when my grandfather traded my cheap little camera for his better quality 35mm Kodak. Long before I considered myself a photographer, I just liked taking pictures. I’d annoy family and friends, intrude on mating animals, disrupt a dance, or make babies cry with curious clicking or a blinding flash. In the end, that shot of my 20-month old niece dumping milk over her baby brother’s head was worth my brother’s laughter and irritation.
I bring a camera everywhere I go. A few years ago I upgraded and bought a new one specifically for my move to
The first time I encountered resistance was on the street - cruising down the main boulevard a group of police officers with rifles sat on either side of a bench hoisted on the back of a standard
A fellow American colleague helped me put my intrigue into perspective. Just ask, he said; if not directly (since I didn’t initially speak the language), at least indirectly with gestures of the eyes not only visible through the camera’s looking glass. Permission – wow, what a novel concept? Unfortunately that wisdom fell on deaf ears when we attempted to empathize with the privacy of a young girl suffering from the debilitating physical symptoms of a deadly disease. At least, we tried to compromise, cover her eyes with a black bar for some measure of anonymity. The investigators and presenters did not see (no pun intended) that logic and, after that scientific health exchange, that young girl unknowingly became the poster-child of a disease that may have taken her life.
As a scientist and artist I am torn between the constant quest for knowledge and the desire to display that knowledge photographically. However, exploitation is rampant around the world. Especially when politically, economically, and socially-disenfranchised people are involved. Out of respect for them, I have to put my intellectual power and artistic ability aside and respect their right to privacy and to consent. The fear, understandably, is loss of the creative moment or lost opportunities for information sharing. Yet, there is a much appreciated richness when the spirit of collaboration is invoked and no one moment or person is taken for granted.
Holly Tomlin
BW 706 – Blog 2
Monday, February 9, 2009
Health Literacy - A Cry for Universal Health Care
Health care is now a business that rivals the industrial complex. Its major consumers are victims of lopsided capitalist principles that exploit weaknesses within our educational systems – mainly literacy. If literacy is at an all-time low in this country, health literacy must be virtually non-existent. But what does this mean? And more importantly, why should anyone care? These questions are made complicated by arguments that weave a moral blanket of hypocrisy which does not provide comfort – let alone security - to those most impacted by a poor health infrastructure. That is, too often we blame the sick for having sickness and the uneducated for not knowing when the real cause of either or both is mis-education combined with quests for power and, ultimately, control.
Literacy is not merely the act of reading and comprehending fragments of generic knowledge. It is a tool for understanding the constellation of knowledge that shapes our views of the world and defines our positions in it. Understanding who we are in terms of how our bodies work optimally is essential to securing a competitive advantage – particularly in a free-market economy. However, large swatches of the US population are disproportionately denied basic health needs such as potable water, adequate shelter, and access to basic health care - they do not have insurance or they have inadequate insurance which is poorly defined and, therefore, subject to intricate loopholes. The health literature is replete with epidemiologic data illustrating the link between access to basic health needs and illness while the health economic literature highlights the impact of sickness to the work force and societal growth. So wouldn’t it make sense to promote and support a healthy society if for no other reason than the well-being of our economy and securing a prosperous future? It does to me.
However, in order for this to happen we need to eliminate the barriers to access which includes class-based health insurance and, more importantly, advance a comprehensive education about the relationship of personal health to societal development. Yet, too often, we exert power by enacting laws on the basis of a sense of moral superiority; and we use oppressive means to control basic needs. This is best exemplified by the gross amounts of narcotics and pharmaceuticals that act to subdue harmless physiologic impulses and abolish the most basic human right – the right to health (as defined by the World Health Organization). Or, perhaps it is the intention of the powers-that-be to keep certain people ignorant and weak from poor health. What better way to control people than to continuously exploit their vulnerabilities while making them dependant on small acts of welfare disguised as generosity?
Holly Tomlin
BW 706 –Blog 1
Literacy is not merely the act of reading and comprehending fragments of generic knowledge. It is a tool for understanding the constellation of knowledge that shapes our views of the world and defines our positions in it. Understanding who we are in terms of how our bodies work optimally is essential to securing a competitive advantage – particularly in a free-market economy. However, large swatches of the US population are disproportionately denied basic health needs such as potable water, adequate shelter, and access to basic health care - they do not have insurance or they have inadequate insurance which is poorly defined and, therefore, subject to intricate loopholes. The health literature is replete with epidemiologic data illustrating the link between access to basic health needs and illness while the health economic literature highlights the impact of sickness to the work force and societal growth. So wouldn’t it make sense to promote and support a healthy society if for no other reason than the well-being of our economy and securing a prosperous future? It does to me.
However, in order for this to happen we need to eliminate the barriers to access which includes class-based health insurance and, more importantly, advance a comprehensive education about the relationship of personal health to societal development. Yet, too often, we exert power by enacting laws on the basis of a sense of moral superiority; and we use oppressive means to control basic needs. This is best exemplified by the gross amounts of narcotics and pharmaceuticals that act to subdue harmless physiologic impulses and abolish the most basic human right – the right to health (as defined by the World Health Organization). Or, perhaps it is the intention of the powers-that-be to keep certain people ignorant and weak from poor health. What better way to control people than to continuously exploit their vulnerabilities while making them dependant on small acts of welfare disguised as generosity?
Holly Tomlin
BW 706 –Blog 1
Thursday, February 5, 2009
The "Crazy Kid Lady" of California
We have all heard of “crazy cat ladies,” who collect unmanageable numbers of cats in one house only to have the cats themselves suffer. We now have the “Crazy Kid Lady” of California. There are parallels between the two, with the main and obvious difference being that there are children involved rather than animals. As is usually the case, these questions are much more complex than most people appreciate.
I used to think that parental rights were absolute, with the exceptions being sexual abuse, physical abuse, and refusal to allow low-risk yet life-saving medical treatment. I still largely believe that. The question of who is to determine the best way to raise a child is central to my reluctance to have the state have too much power in this regard. However, recent events in California and the movie “Gone Baby Gone” have made me moderate my tone somewhat. (While I do not base my beliefs on the plots of fictional movies, a good movie can show a different perspective on an issue. Anyway, it is a worthwhile movie, but it is not for the easily offended.)
It is safe to say that this woman has issues. She went out of her way to have these babies (due to her health she could not have conceived without in-vitro fertilization) despite her financial and familial situation. She already has six children under 8 years old. She is a single mother (Do not try to tell me that is not a factor. It is.) She is unemployed. It is valid to criticize her.
People are also criticizing the doctor for going forward with this procedure. Much of this criticism is valid, including criticism of the number of embryos implanted. This doctor ignored well-established guidelines. Standard procedure for a woman her age is implanting two embryos. Multiple births carry increased risks for the children and parent involved. Another valid criticism is that the doctor should not have performed the fertilization at all given the woman’s situation. While doctors are only expected to know what the patient tells them (outside of medical records), this is the same doctor who preformed the fertilizations for all six of her previous children.
Most people agree that both the woman and doctor are wrong. Even then, there are many angles and questions related to this story that are not easy to pin down. For instance, in our rush to criticize the woman and the doctor, let us remember that we are not talking about a litter of puppies here. These eight children (and the preceding six) are human beings who are entitled to the same dignity and individuality that we afford anyone else. No one wants to grow up hearing that the only reason they exist was that their mom was nuts and her doctor was a bad man. While these circumstances are not optimum for these children, given the choice between being here and not being here, they would take the former. Also, let us not become too self-righteous over this woman giving life to 14 children for whom she can not properly care, as we often do not do what is right for the small children in our own lives. Further, roughly 1 million “fertilized eggs” yearly never even have the chance to become one of 14 children in a squalid house, which they undoubtedly would have preferred to their own fate. There is something upside-down about Americans' uproar over this creation of 14 lives, while there is relative ambivalence about the destruction of millions of lives. (Regardless of whether you think abortion regulations should be tightened or loosened, abortion is still a sad, unfortunate thing that ends a developing life. My views fall somewhere between the nuts on one side who think it is justifiable to shoot abortion doctors and the nuts on the other side who think that abortion is a right of passage along a woman's path toward self-actualization. However, this is another conversation entirely.)
Thus, while keeping an eye on the “crazy kid lady” and everyone else culpable in this debacle, let us also take more than the occasional glance in the mirror.
I used to think that parental rights were absolute, with the exceptions being sexual abuse, physical abuse, and refusal to allow low-risk yet life-saving medical treatment. I still largely believe that. The question of who is to determine the best way to raise a child is central to my reluctance to have the state have too much power in this regard. However, recent events in California and the movie “Gone Baby Gone” have made me moderate my tone somewhat. (While I do not base my beliefs on the plots of fictional movies, a good movie can show a different perspective on an issue. Anyway, it is a worthwhile movie, but it is not for the easily offended.)
It is safe to say that this woman has issues. She went out of her way to have these babies (due to her health she could not have conceived without in-vitro fertilization) despite her financial and familial situation. She already has six children under 8 years old. She is a single mother (Do not try to tell me that is not a factor. It is.) She is unemployed. It is valid to criticize her.
People are also criticizing the doctor for going forward with this procedure. Much of this criticism is valid, including criticism of the number of embryos implanted. This doctor ignored well-established guidelines. Standard procedure for a woman her age is implanting two embryos. Multiple births carry increased risks for the children and parent involved. Another valid criticism is that the doctor should not have performed the fertilization at all given the woman’s situation. While doctors are only expected to know what the patient tells them (outside of medical records), this is the same doctor who preformed the fertilizations for all six of her previous children.
Most people agree that both the woman and doctor are wrong. Even then, there are many angles and questions related to this story that are not easy to pin down. For instance, in our rush to criticize the woman and the doctor, let us remember that we are not talking about a litter of puppies here. These eight children (and the preceding six) are human beings who are entitled to the same dignity and individuality that we afford anyone else. No one wants to grow up hearing that the only reason they exist was that their mom was nuts and her doctor was a bad man. While these circumstances are not optimum for these children, given the choice between being here and not being here, they would take the former. Also, let us not become too self-righteous over this woman giving life to 14 children for whom she can not properly care, as we often do not do what is right for the small children in our own lives. Further, roughly 1 million “fertilized eggs” yearly never even have the chance to become one of 14 children in a squalid house, which they undoubtedly would have preferred to their own fate. There is something upside-down about Americans' uproar over this creation of 14 lives, while there is relative ambivalence about the destruction of millions of lives. (Regardless of whether you think abortion regulations should be tightened or loosened, abortion is still a sad, unfortunate thing that ends a developing life. My views fall somewhere between the nuts on one side who think it is justifiable to shoot abortion doctors and the nuts on the other side who think that abortion is a right of passage along a woman's path toward self-actualization. However, this is another conversation entirely.)
Thus, while keeping an eye on the “crazy kid lady” and everyone else culpable in this debacle, let us also take more than the occasional glance in the mirror.
$18 Billion in bonuses, I wish I worked on Wall Street
In an article from CNN.com Obama denounced the $18 billion in bonuses that employees on Wall Street received last year. He described the bonuses to be from “a culture of narrow self-interest and short-term gain at the expense of everything else”.
It is about time that someone stands up to the socially irresponsible executives and put them in their place. In order to help control the use of unethical bonuses, Obama has created a plan that would place limitations on how executives can be paid if they are making over $500,000 a year. If an executive is to make over $500,000 they must be paid the remainder in stock. In addition, the executive cannot sell off the stock until the company has paid back the government. Most importantly, the new rules are going to be implemented by the Treasury Department and therefore do not need be approved by congress.
Obama has also created rules that will allow shareholders of banks to have a larger say in the salaries that are given to the executives. Also, the new rules will make it easier to track money spent on things such as holiday parties and office renovations.
When many of us heard about the huge bailout that was going to save many crooked companies, we were upset that nothing was going to be done to the executives that were spending millions to renovate their offices and millions on their new private jet. It is wonderful to see that Obama is FORCING executives to take responsibility for their unethical actions and is creating rules that force these companies to conduct business, as they should in a responsible manner.
One can only hope that we learn from our mistakes. However, as we all know…history usually repeats it’s self.
It is about time that someone stands up to the socially irresponsible executives and put them in their place. In order to help control the use of unethical bonuses, Obama has created a plan that would place limitations on how executives can be paid if they are making over $500,000 a year. If an executive is to make over $500,000 they must be paid the remainder in stock. In addition, the executive cannot sell off the stock until the company has paid back the government. Most importantly, the new rules are going to be implemented by the Treasury Department and therefore do not need be approved by congress.
Obama has also created rules that will allow shareholders of banks to have a larger say in the salaries that are given to the executives. Also, the new rules will make it easier to track money spent on things such as holiday parties and office renovations.
When many of us heard about the huge bailout that was going to save many crooked companies, we were upset that nothing was going to be done to the executives that were spending millions to renovate their offices and millions on their new private jet. It is wonderful to see that Obama is FORCING executives to take responsibility for their unethical actions and is creating rules that force these companies to conduct business, as they should in a responsible manner.
One can only hope that we learn from our mistakes. However, as we all know…history usually repeats it’s self.
Wednesday, February 4, 2009
Doctors benefiting financially from pharmaceutical companies…Go Figure!
An article entitled “ Doctors: Under the drug industry’s influence?” explored the idea that doctors are being influenced by drug companies to promote specific drugs to their patients.
Not only do doctors receive free pens, meals and those hard to get concert tickets, some doctors have been known to accept monetary gifts. While attending college, I worked as a pharmaceutical technician. I can vouch for the “great” gifts that the pharmaceutical companies would leave for us. When pharmaceutical companies would visit our company, they almost always came bearing a wonderful lunch for us.
More recently the integrity of doctors and pharmaceutical companies were questioned when the Iowa Republican Sen. Charles Grassley and Dr. Joseph Biederman, a prominent Harvard University psychiatrist failed to disclose payments from drug companies.
Dr. Marcia Angell of Harvard Medical School in Boston expressed the importance of doctors keeping their distance from industry. She continued to state the doctor should pay for their own educational meetings and not attend lavish events that are thrown by industry.
The article continues to explain how doctors give patients free samples, thinking as though they are helping their patients. However, they are simply assisting in a very effective marking technique.
After reading that free samples are a marketing technique, I feel guilty for accepting free samples from my doctor. As I think about it now, typically when doctors give you free samples, they almost always give you a prescription to get the drug when you run out of samples. They are good.. really good.
Now with the economy in a downward spiral, hopefully pharmaceutical companies will learn that it is important to have corporate responsibility.
Not only do doctors receive free pens, meals and those hard to get concert tickets, some doctors have been known to accept monetary gifts. While attending college, I worked as a pharmaceutical technician. I can vouch for the “great” gifts that the pharmaceutical companies would leave for us. When pharmaceutical companies would visit our company, they almost always came bearing a wonderful lunch for us.
More recently the integrity of doctors and pharmaceutical companies were questioned when the Iowa Republican Sen. Charles Grassley and Dr. Joseph Biederman, a prominent Harvard University psychiatrist failed to disclose payments from drug companies.
Dr. Marcia Angell of Harvard Medical School in Boston expressed the importance of doctors keeping their distance from industry. She continued to state the doctor should pay for their own educational meetings and not attend lavish events that are thrown by industry.
The article continues to explain how doctors give patients free samples, thinking as though they are helping their patients. However, they are simply assisting in a very effective marking technique.
After reading that free samples are a marketing technique, I feel guilty for accepting free samples from my doctor. As I think about it now, typically when doctors give you free samples, they almost always give you a prescription to get the drug when you run out of samples. They are good.. really good.
Now with the economy in a downward spiral, hopefully pharmaceutical companies will learn that it is important to have corporate responsibility.
Informed Consent…We Dun' Need No Stinkin' Informed Consent
Hundreds of African American men were murdered, children were fed poisoned Quaker Oats, and honorable soldiers were exposed to toxins. Were these the acts of multiple serial killers? I guess it all depends on how you look at it.
Studies involving human subjects/patients have been a topic of controversy for many years. Government reactions, such as The Declaration of Helsinki, are meant to put controversies to rest; however, recent accusations within an article published in the New York Times are yet another example of weaknesses in controlling human studies.
Apparently, in the late 1980s, the Boston's child-welfare agency developed a policy to allow foster children to enroll in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Sounds harmless right? They had acted in good faith and in the interests of the children. However, you must remember; it all depends on how you look at it.
Liam Scheff, a freelance journalist in Boston, charged that the children were put in trials without their parents’ knowledge and were given medications known to cause death. He said that the drugs in question had Food and Drug Administration warnings on them and that they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses".
As a result, in 2005 the city commissioned the Vera Institute of Justice, an independent nonprofit group, to investigate the claims.
The Vera Institute of Justice found no evidence that any children died as a result of the trials or that the foster children were selected because of their race. Sounds like Liam can put his money where his mouth is, right? We're not done yet.
On the flipside, it was also found that the child-welfare agency had not always followed its own protocols and kept poor records. Sixty-four children participated in 30 medication trials that were not reviewed by a special medical advisory panel.
Moreover, the informed consent forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases. In some cases handwritten consents were found instead of the official consent forms. No big deal, right?
Wrong! The problem with this case is the issue of enforcement. It's all well and good that we have guidelines and policies set in place, but if researchers do not follow these guidelines, then what use are they? Without informed consent, there is no way to know if the parents/legal guardians knew the details of the study or if they even agreed to the child's inclusion.
The unethical events within this story may not have the same magnitude and lasting effects as the Tuskegee Syphilis Study; however, isn't this story an ethical consideration that must be viewed with same the amount of gravity?
I guess it's all depends on how you look at it…
Studies involving human subjects/patients have been a topic of controversy for many years. Government reactions, such as The Declaration of Helsinki, are meant to put controversies to rest; however, recent accusations within an article published in the New York Times are yet another example of weaknesses in controlling human studies.
Apparently, in the late 1980s, the Boston's child-welfare agency developed a policy to allow foster children to enroll in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Sounds harmless right? They had acted in good faith and in the interests of the children. However, you must remember; it all depends on how you look at it.
Liam Scheff, a freelance journalist in Boston, charged that the children were put in trials without their parents’ knowledge and were given medications known to cause death. He said that the drugs in question had Food and Drug Administration warnings on them and that they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses".
As a result, in 2005 the city commissioned the Vera Institute of Justice, an independent nonprofit group, to investigate the claims.
The Vera Institute of Justice found no evidence that any children died as a result of the trials or that the foster children were selected because of their race. Sounds like Liam can put his money where his mouth is, right? We're not done yet.
On the flipside, it was also found that the child-welfare agency had not always followed its own protocols and kept poor records. Sixty-four children participated in 30 medication trials that were not reviewed by a special medical advisory panel.
Moreover, the informed consent forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases. In some cases handwritten consents were found instead of the official consent forms. No big deal, right?
Wrong! The problem with this case is the issue of enforcement. It's all well and good that we have guidelines and policies set in place, but if researchers do not follow these guidelines, then what use are they? Without informed consent, there is no way to know if the parents/legal guardians knew the details of the study or if they even agreed to the child's inclusion.
The unethical events within this story may not have the same magnitude and lasting effects as the Tuskegee Syphilis Study; however, isn't this story an ethical consideration that must be viewed with same the amount of gravity?
I guess it's all depends on how you look at it…
Prepared Statement to the Senate Foreign Relations Committee from Al Gore
Former Vice President and Nobel Peace Prize winner Al Gore went before the Senate Foreign Relations Committee on January 28 to advocate President Obama’s spending plan for addressing the issue of global warming and to reiterate the importance of reducing carbon dioxide emissions and other pollutants implicated in the climate change crisis. His prepared statement was posted in The New York Times by John M. Broder in Gore Restates Climate Case in Senate.
Mr. Gore stated that the plan’s focus on four key areas—energy efficiency, renewables, a unified national energy smart grid, and movement toward cleaner cars¬—will result in a four-fold benefit of creating new jobs and hastening economic recovery while strengthening national security and addressing the effects of climate change.
The speech describes a triple crisis of climate change, a worsening economic situation, and the endangered state of our national security that is linked by a dangerous over-dependence on carbon-based fuels that shackles our society into a cycle of borrowing money from China to pay for oil from the Persian gulf so that we may burn it to pollute the planet, all at the whim of OPEC and its fluctuating oil prices. While we continue participating in this destructive cycle we are moving toward irreversible tipping points that will undermine the habitability of our planet and civilization as we know it.
Just as our ecological, economic, and security threats are entwined in a seeming Gordian knot, the solution to the crisis appears clear-cut to Mr. Gore: the acceptance of President Obama’s Recovery package in its entirety, as a bold first step. Mr. Gore challenged the belief that Americans must choose between the environment and our way of life and between moral duty and economic well-being. He believes that the Obama Plan is an effective strategy to address all three crises and the path to restoring our place as an economic and moral world leader, independent of ties that compromise our way of life. According to Mr. Gore, it is essential that the United States quickly expands its capacity to generate clean electricity so that we can move forward effectively in the plan.
The second step to solving these crises would be the institution of a cap-and-trade system for CO2 emissions that would also serve to restore our country’s credibility. As the Copenhagen treaty talks draw near, this action would place us on a more balanced footing with other countries and many states that have already instituted such a system, and allow us to take a leadership role in creating a fair, effective, and balanced structure for restoring the global environment. Mr. Gore outlined what he felt would be key elements to a successful agreement in Copenhagen, which included targets, timetables, solutions, and the need for accountability.
While the United States has remained inactive on the global climate scene, developing countries have assumed increasing leadership roles in calling for action in the world arena and taken bold initiatives in their own regions. Heads of state and even some corporate leaders have become involved in this movement. The American public is also becoming more aware and engaged in the scientific evidence for global warming. Mr. Gore stressed that this is a bipartisan issue that requires immediate and unprecedented action based on new scientific evidence and pointed to successes within the Reagan and Bush administrations that have helped pave the way to Copenhagen.
Making the change from a mentality of conquest to a philosophy of conservation has been a difficult challenge for Americans as a group. We have a love affair with our automobiles—they are an intrinsic part of our culture and our mythology. But it is time for us to move into the 21st century. While other countries have forged ahead with innovative green technologies, we have clung to old standards buttressed by the greed of large corporations like “The Big Three” who have systematically and deliberately extinguished the fires of green technologies such as the electric car and solar power. We have become obsolete, out of touch, as countries like Germany surpass even their own goals for attaining solar and wind energy, and some of us continue the shrill chant of “drill, drill, drill.”
I remember a television commercial from my childhood: a traditional Native American man standing by the roadside as cars drove by dumping litter at his feet, a single tear rolling down his sad face. How that commercial broke my heart each time! The Native American philosophy was to always consider how the actions of one generation would affect the lives of future generations. Modern Americans have became so short-sighted that we couldn’t even conceive of the possibility that our enemies would have the patience, foresight, and dedication to wait a decade or even a generation to strike at us. Out innocence and our arrogance took a big hit on 9/11.
Winston Churchill said, “Americans can always be counted on to do the right thing…after they have exhausted all other possibilities.” I believe that we have arrived at that point. Americans are resilient and innovative. We need to dig deep into our collective consciousness and dredge up some of that trademark American optimism that always gets us to the other side. This is a terrible time in our history. But it is also an opportunity for American ingenuity to shine once more and bring us back to a leadership role in the world.
Mr. Gore stated that the plan’s focus on four key areas—energy efficiency, renewables, a unified national energy smart grid, and movement toward cleaner cars¬—will result in a four-fold benefit of creating new jobs and hastening economic recovery while strengthening national security and addressing the effects of climate change.
The speech describes a triple crisis of climate change, a worsening economic situation, and the endangered state of our national security that is linked by a dangerous over-dependence on carbon-based fuels that shackles our society into a cycle of borrowing money from China to pay for oil from the Persian gulf so that we may burn it to pollute the planet, all at the whim of OPEC and its fluctuating oil prices. While we continue participating in this destructive cycle we are moving toward irreversible tipping points that will undermine the habitability of our planet and civilization as we know it.
Just as our ecological, economic, and security threats are entwined in a seeming Gordian knot, the solution to the crisis appears clear-cut to Mr. Gore: the acceptance of President Obama’s Recovery package in its entirety, as a bold first step. Mr. Gore challenged the belief that Americans must choose between the environment and our way of life and between moral duty and economic well-being. He believes that the Obama Plan is an effective strategy to address all three crises and the path to restoring our place as an economic and moral world leader, independent of ties that compromise our way of life. According to Mr. Gore, it is essential that the United States quickly expands its capacity to generate clean electricity so that we can move forward effectively in the plan.
The second step to solving these crises would be the institution of a cap-and-trade system for CO2 emissions that would also serve to restore our country’s credibility. As the Copenhagen treaty talks draw near, this action would place us on a more balanced footing with other countries and many states that have already instituted such a system, and allow us to take a leadership role in creating a fair, effective, and balanced structure for restoring the global environment. Mr. Gore outlined what he felt would be key elements to a successful agreement in Copenhagen, which included targets, timetables, solutions, and the need for accountability.
While the United States has remained inactive on the global climate scene, developing countries have assumed increasing leadership roles in calling for action in the world arena and taken bold initiatives in their own regions. Heads of state and even some corporate leaders have become involved in this movement. The American public is also becoming more aware and engaged in the scientific evidence for global warming. Mr. Gore stressed that this is a bipartisan issue that requires immediate and unprecedented action based on new scientific evidence and pointed to successes within the Reagan and Bush administrations that have helped pave the way to Copenhagen.
Making the change from a mentality of conquest to a philosophy of conservation has been a difficult challenge for Americans as a group. We have a love affair with our automobiles—they are an intrinsic part of our culture and our mythology. But it is time for us to move into the 21st century. While other countries have forged ahead with innovative green technologies, we have clung to old standards buttressed by the greed of large corporations like “The Big Three” who have systematically and deliberately extinguished the fires of green technologies such as the electric car and solar power. We have become obsolete, out of touch, as countries like Germany surpass even their own goals for attaining solar and wind energy, and some of us continue the shrill chant of “drill, drill, drill.”
I remember a television commercial from my childhood: a traditional Native American man standing by the roadside as cars drove by dumping litter at his feet, a single tear rolling down his sad face. How that commercial broke my heart each time! The Native American philosophy was to always consider how the actions of one generation would affect the lives of future generations. Modern Americans have became so short-sighted that we couldn’t even conceive of the possibility that our enemies would have the patience, foresight, and dedication to wait a decade or even a generation to strike at us. Out innocence and our arrogance took a big hit on 9/11.
Winston Churchill said, “Americans can always be counted on to do the right thing…after they have exhausted all other possibilities.” I believe that we have arrived at that point. Americans are resilient and innovative. We need to dig deep into our collective consciousness and dredge up some of that trademark American optimism that always gets us to the other side. This is a terrible time in our history. But it is also an opportunity for American ingenuity to shine once more and bring us back to a leadership role in the world.
OMG! The Baby Lady Again
Okay, I know this story has been run into the mud. There have been thousands of blogs, articles, and news stories about this lady and her eight babies, plus the six she already has at home. But coming from a big family myself (there were 12 of us), I felt compelled to reply to this crazy, unbelievable story. So, here it goes.
The ethical issues surrounding this story is overwhelming. First, you have the fertility clinic and doctor who knowingly implanted eight embryos into a woman who has filed bankruptcy, has no income, and has been living with her parents, whom have accumulated much debt and become bankrupt themselves trying to take care of the mother and her other six children, while she attends college. Then you have the mother, who has tremendous amount of problems (financially and mentally, as noted by her mother), decide to pursue multiple births. Not to mention, the physical damage the mother has inflicted upon her body. Now, this same woman is asking for $2 million to tell her story on national television.
While the media has caused a stir of panic over this supposedly overwhelming story of "medical triumph," as articulated in a MSNBC article, every day more facts about the birth mother come to the forefront that now makes us question our initial reaction of elation and support.
As Dr. Summer Johnson notes in her article, "Update: And Baby H Makes 8...No, 14":
"As the story over the California octuplets born this week has unraveled, the ethical issues surrounding their birth have expanded beyond those of just the health and welfare of the mother and 8 tiny little fetuses but to questions of social justice and the choice of the mother to have 8 more children, period."
Hailing from a big family myself, I know the difficulties of raising and caring for a numerous amount of children. I often wonder how my father and mother kept their insanity, let alone the clothes on their backs. I'm extremely proud to say that because of my father's pride, dedication, and committment to being the sole provider for his family, we never needed governmental assistance and we never went hungry, cold, or deprived of anything and everything we wanted. So, for the birth mother to assume these tremendous responsbilities without the financial and emotional support she needs (which she'll need plenty of), how will she take care of these 14 children? According to AOL News,
"Fox News crunched the numbers and announced that it will cost Suleman - and us! -- $35 million to raise these kids. And even fellow MOM (mom of multiples) Kate Gosselin of the TLC reality show "Jon & Kate Plus 8" has jumped in to criticize: "Personally, I would never have set out to even have a seventh child - especially if I was a single parent."" (http://news.aol.com/article/whats-the-octuplets-anger-really-about/328057#Comments)
Should the State of California's Department of Child Services step in to access this mother's living situation, as well as her mental state, before allowing her to go home with these babies? I mean, isn't it the duty of the State to ensure these children will be well cared for mentally, socially, and financially? What measures will the State take to investigate the fertility clinic who implanted the eight embryos, knowing the mother's situation?
And, now, knowing that the grandmother suggested mental healthcare for the mother who she believed unstable and obssessed with having children, should we even allow this mother to take these babies home from the hospital?:
"She always blamed me for having only her," Angela Suleman told the Web site. "...She was always upset that I didn't have more." Angela Suleman also told Us that Nadya first talked about having a large family when she was a teenager. "I have been supportive, but you know, now that I am thinking back, she wanted children so much that it was almost not normal as far as I am concerned," Suleman said, adding that she once consulted a mental health professional about the issue." (http://news.aol.com/article/octuplets-grandmother/328911)
Please forgive me if I am rambling, but after reading that the mother now wants to be paid to tell her story and give advice on being a mother, I could not contain myself any longer. According to Fox News,
"The mother of octuplets born in California last week is seeking $2 million from media interviews and commercial endorsements to help pay the costs of raising the children, the Times of London reported. Nadya Suleman, 33, plans a career as a television childcare expert...Although still confined to a Los Angeles hospital bed, Suleman reportedly intends to talk to two influential television hosts this week — media mogul Oprah Winfrey and Diane Sawyer.
Her family has told agents she needs cash from media deals." (http://www.foxnews.com/story/0,2933,486645,00.html)
So, now the mother is seeking fame from her medical miracle. I think I speak for everyone who pays taxes and will have to pay even more come April 15, please make sure this lady can have no more babies!
The ethical issues surrounding this story is overwhelming. First, you have the fertility clinic and doctor who knowingly implanted eight embryos into a woman who has filed bankruptcy, has no income, and has been living with her parents, whom have accumulated much debt and become bankrupt themselves trying to take care of the mother and her other six children, while she attends college. Then you have the mother, who has tremendous amount of problems (financially and mentally, as noted by her mother), decide to pursue multiple births. Not to mention, the physical damage the mother has inflicted upon her body. Now, this same woman is asking for $2 million to tell her story on national television.
While the media has caused a stir of panic over this supposedly overwhelming story of "medical triumph," as articulated in a MSNBC article, every day more facts about the birth mother come to the forefront that now makes us question our initial reaction of elation and support.
As Dr. Summer Johnson notes in her article, "Update: And Baby H Makes 8...No, 14":
"As the story over the California octuplets born this week has unraveled, the ethical issues surrounding their birth have expanded beyond those of just the health and welfare of the mother and 8 tiny little fetuses but to questions of social justice and the choice of the mother to have 8 more children, period."
Hailing from a big family myself, I know the difficulties of raising and caring for a numerous amount of children. I often wonder how my father and mother kept their insanity, let alone the clothes on their backs. I'm extremely proud to say that because of my father's pride, dedication, and committment to being the sole provider for his family, we never needed governmental assistance and we never went hungry, cold, or deprived of anything and everything we wanted. So, for the birth mother to assume these tremendous responsbilities without the financial and emotional support she needs (which she'll need plenty of), how will she take care of these 14 children? According to AOL News,
"Fox News crunched the numbers and announced that it will cost Suleman - and us! -- $35 million to raise these kids. And even fellow MOM (mom of multiples) Kate Gosselin of the TLC reality show "Jon & Kate Plus 8" has jumped in to criticize: "Personally, I would never have set out to even have a seventh child - especially if I was a single parent."" (http://news.aol.com/article/whats-the-octuplets-anger-really-about/328057#Comments)
Should the State of California's Department of Child Services step in to access this mother's living situation, as well as her mental state, before allowing her to go home with these babies? I mean, isn't it the duty of the State to ensure these children will be well cared for mentally, socially, and financially? What measures will the State take to investigate the fertility clinic who implanted the eight embryos, knowing the mother's situation?
And, now, knowing that the grandmother suggested mental healthcare for the mother who she believed unstable and obssessed with having children, should we even allow this mother to take these babies home from the hospital?:
"She always blamed me for having only her," Angela Suleman told the Web site. "...She was always upset that I didn't have more." Angela Suleman also told Us that Nadya first talked about having a large family when she was a teenager. "I have been supportive, but you know, now that I am thinking back, she wanted children so much that it was almost not normal as far as I am concerned," Suleman said, adding that she once consulted a mental health professional about the issue." (http://news.aol.com/article/octuplets-grandmother/328911)
Please forgive me if I am rambling, but after reading that the mother now wants to be paid to tell her story and give advice on being a mother, I could not contain myself any longer. According to Fox News,
"The mother of octuplets born in California last week is seeking $2 million from media interviews and commercial endorsements to help pay the costs of raising the children, the Times of London reported. Nadya Suleman, 33, plans a career as a television childcare expert...Although still confined to a Los Angeles hospital bed, Suleman reportedly intends to talk to two influential television hosts this week — media mogul Oprah Winfrey and Diane Sawyer.
Her family has told agents she needs cash from media deals." (http://www.foxnews.com/story/0,2933,486645,00.html)
So, now the mother is seeking fame from her medical miracle. I think I speak for everyone who pays taxes and will have to pay even more come April 15, please make sure this lady can have no more babies!
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