The Public Advertisement of Genetic Cancer Testing

Myriad Genetics has received criticism and protest from oncologists and geneticists for its continuous advertisement of cancer gene testing to the public. The advertisement targets women aged 25 to 55 years with a family history of breast and ovarian cancer. The test, BRACAnalysis identifies mutations in genes, BRCA1 and BRCA2 when present in a sample. Patients with mutations deemed clinically significant have a 35 to 84 percent chance of developing breast cancer by age 70 and it is 10 to 50 percent likely they will develop ovarian cancer. This statistic is far higher than for women in general, in fact 1 in 400 women carry such a mutation. As of today 200,000 patients have taken the BRACAnalysis since it release in 1996. Three percent of the women who have taken this test were found to carry a mutation. This is only slightly higher than the 2 percent of the public a government agency says are good candidates for the gene testing. As a result, the company's marketing motives have come into question and are currently being investigated. In the midst, Myriad Genetics has release an advertisement campaign throughout New York City, encouraging women to inquire of the $3,120 assay.

 

http://www.nytimes.com/2007/09/11/business/media/11genetics.html?_r=2&oref=slogin&oref=slogin

Surcharge for Smoking?

As was discussed in my previous post, regarding SCHIP funding, the proposal was to draw monies from an increased Cigarette tax to help defray costs for the maintenance of SCHIP. Now, to clarify, I am no smoking enthusiast, nor is my wife, but as I mentioned in class, I am a fiend for personal liberties, as defined by the Constitution of the United States. What this is all circling around is a penalty for being a smoker, implemented by employers. Why? "Smokers cost more to insure" or "Smokers make other employees uncomfortable" and such. While it can be agreed in relative consensus that smoking is unhealthy, it is a choice that a person has made. In that light, and no other, is what protects tobacco, alcohol and other "questionable" material. As it is right now, there are certain establishments and towns that enforce certain ordinances and regulations regarding smoking patrons - either permitting it or denying it in that establishment. Or, alternatively, the smoker is only permitted to smoke in certain designated zones, like 20 feet from the doorway. However, artificially increasing the cost of health insurance, similar to how the Harrison legislation artificially increased the cost of marijuana, makes the coverage or activity essentially impossible. What is being circled around is the notion that those who use the said products are human too. While taxes are implemented by governments around the world on a plethora of items like gasoline, cigarettes and alcohol, it is not permissible for a business entity to assume that kind of power, and essentially tax their employee. That employee is harming themself, and nobody else; studies have not made a cogent argument describing how much second-hand smoke causes illness. That person who smokes may be the most intellegent person in the company, but due to some policy (which goes against the freedom of choice), that person is given a smaller salary, while a person who does not smoke, but is an idiot, is given a untaxed salary. The argument that a person can always pick a different employer is the same as the above, wherein if "the activity is too expensive, then do not do it" - it is making an artifical decision for the citizen. This is something expressly prohibited by the Constitution.

Waiving Vaccination: Personal Freedom versus Abuse of Parental Rights?

A CDC-sponsored study included 1,047 children children who have received their government mandated vaccinations underwent 42 neurological and psychological exam to test the theory that thimerosol, the mercury containing preservative in many vaccines, caused neurological or psychological problems in 7-10 year olds. Studies concluded that thimerosol is basically harmless. (Note that thimerosol and autism links are being evaluated in a separate ongoing study, and while thimerosol has been removed from vaccines, the rates of autism have not declined).

In the past several years, linking adverse events to vaccines has been all over the news and on the minds of many new parents. But most of these theories on adverse events to vaccines are unfounded.

The Institute for Health Freedom, National Vaccine Information Center, and Vaccine Information & Choice Network are among the many advocacy groups who promote education on vaccines, and ensuring the informed consent of parents on vaccines prior to their children receiving the vaccines. I have reviewed these sites and think they are a terrific resource for parents to find information on these vaccines, yet I can't figure out how a parent can decline vaccination. This is a subject where personal autonomy and the right to choice battles against the ethical obligation to protect your child from numerous deadly diseases. Have these parents gone too far in exerting their freedoms? I can't help but think this is an abuse of one's rights as Americans.

While I strongly believe in the one's right to autonomy and a parent's responsibilty to make the best possible decisions regarding their child's health, I can't understand why some parents opt out of having their child receive the readily available and CDC-recommended vaccines. In the School District of Philadelphia, there are 8 required vaccines that students must receive prior to beginning school, exemptions being granted for religious or medical reasons. It is safe to assume that the HPV vaccine will soon be mandated, and the meningitis vaccine is being highly debated as a mandatory vaccine for students entering college. I have 2 nieces in the public school system who did not receive any immunizations; it is not difficult to waive the vaccines and still be admitted into public schools. As a disclaimer, I must state that I do not have children. Right now I am speaking as an adult who received all the mandatory vaccines, and would have would have received Gardasil had it been available 12 years ago when I started college.

Are these parents going too far in making the decision to turn down vaccines for diseases that many children are still dying from in developing countries? I can only hope these parents are well-informed before they put their child at risk. The Gates Foundation focuses on providing these available vaccines in developing countries, and cite this World Health Organization fact on their web site: "The World Health Organization estimates that more than 2 million people die each year from diseases for which immunization is routinely recommended, including measles, diphtheria, pertussis, and tetanus. Half of them are children under the age of 5."

Postpartum screening and what to do if missed

Post partum depression/psychosis screening and punishment

Postpartum depression affects nearly 13% of mothers.1 There are two ethical concerns in the spectrum of postpartum depression. First, is there any way to implement screening to assist mothers who are experiencing postpartum depression? Second, in regard to those women who experience postpartum psychosis, a more severe form of postpartum depression, how should they be punished if they do not receive treatment and harm their newborn?

New Jersey has already implemented legal action to require doctors’ offices to screen each postpartum woman for postpartum depression. Screening can be as simple as a nurse asking mothers a few questions, such as the quality of their sleeping. If these questions and answers can be discussed during one of the several newborn’s medical check ups, there is no additional cost. While further treatment, should a mother fail screening, will not be feasible in such simple circumstances, assisting those women understand they need treatment and assist them in getting that treatment is certainly worth a nurse taking the time to ask a few additional questions as he or she takes the infant’s vitals at an already scheduled visit (of course, this does not provide the opportunity for screening in those who do not follow the recommended well baby visits schedule).

In the last few years, there have been several well publicized cases of women who harmed their children after suffering from a more severe form of postpartum depression, postpartum psychosis. The most well known is the Andrea Yates case, where she killed her 6 children. She was first found guilty, but her conviction was overturned by the perjury of a prosecutorial witness. She was sentence to time in a psychiatric facility after her second trial.

If Texas, the state where Andrea Yates lived, required postpartum screening, medical professionals probably would have recommended further treatment for her, and her 6 children might have been alive and well today (however, recommendation of treatment does not necessarily mean she will seek further treatment). A few simple questions might have saved the lives of those six kids. Since she did not seek treatment, her mental suffering was severe, and her reality was quite different from what was truly real. As much the blame for actual physical killing those children can only be placed on Ms. Yates, she honestly believed what she was doing was the best for her children – she was saving them from the monster in her head that she believed was real and was very much after her children. Because she did what she truly felt was in the best interest of her children, I don’t think I can classify her behavior as criminal. However, I do believe that she needs a great deal of treatment and should not be put in the same position again.

The catalyst to her disease was giving birth and the hormone fluctuation that follow. While a very careful family may be able to prevent her from harming another child should she again give birth (ie, not allowing her to be alone with the child, insisting upon psychiatric treatment after birth no matter her symptoms, etc..), perhaps sterilization is in order to ensure she is never put in a situation where she may cause harm to any child that she may have in the future. No matter what the preventative measure put in place for her reproductive future, she would only repeat the act if she gave birth and was not treated. Placing her in a jail cell will certainly not solve anything.
As screening could have saved those children, which is an obvious argument for implementing mandatory postpartum screening. As postpartum depression and postpartum psychosis are legitimate disease, if either disease is missed and disastrous results occur, the focus should be on treatment and prevention rather than punishment for something the perpetrator did not realize her or she was doing.


Maternal and Infant Health: Home. Pregnant-related Illness. Center for Disease Control and Prevention. Available at: http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/. Accessed September 30, 2007.

What if it’s not right vs. wrong, but right vs. right?

Last week, I attended a lecture at a conference given by Joseph Badaracco, a professor of ethics at Harvard Business School and the author of several books on business ethics. The main premise of his lecture was that the easy choice is between right and wrong, but the difficult choice is between right and right. He gave a brief overview of utilitarianism, deontology and basic human rights, personal character, and pragmatism, then outlined a choice called “The house of my dreams:”[1]

This choice was outlined as one of a manager maintaining confidentiality as required by a corporation just prior to a lay-off, and the duty to a co-worker who is about to undertake a large home loan and has asked pointblank if there is any reason the manager knows why the co-worker should not undertake this large loan at this time.

As outlined by Professor Badaracco, both choices are ‘the right thing to do.’ The manager had been told by officers in his corporation in confidence about the layoff that would likely affect his co-worker. The manager has a duty as an officer of this corporation to maintain this confidentiality. On the other hand, he had been asked by a co-worker directly if he knew of any reason why the co-worker should not undertake a financial risk right now. There is the duty to his friend and co-worker to tell the truth.

Prior to attending this lecture, I assumed that the choice between right and wrong was the difficult one, but this lecture provided me with a new perspective and new questions. I’ve known many different managers and senior managers in my career, and I know some that would make the first choice (they have made a commitment to the organization and they will not compromise it), and I know a number who would choose the personal over the corporation (tell the co-worker about the lay-off or at least caution him not to take on the financial risk at this time). I even know which one I feel internally is ‘most right.’ But I hadn’t really considered that it actually is a choice between two competing ethical requirements.

I suspect many might recast this as a choice between right and wrong, with wrong being violating a company promise, or with wrong being a violation of a friendship. And the consequences of making one choice over another are great, in both directions. Potentially, you could be fired for letting out information of a layoff before the publication date. However, if you do not tell your friend when asked directly, then you are lying to your friend and run the risk of losing the friend forever, and having others know that you are a liar. How do you weigh this? There were duties to the company and the friend, there was the expectation of the basic human right of being told the truth, and even questions of what one's own character might require (what lines will I not cross and is there one here?).

This is related and is perhaps the same question as my post from last week, wondering if there were situations in which there was no ethical choice. I struggle with how these issues are decided by different people and how I might make these decisions, so I eagerly embrace tools that allow me to make better, more informed decisions, including the aforementioned lecture and the discussions and material we are covering in this class.

Posted by: Corey Jaseph, 09/28/2007

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[1] Badaracco JL Jr. Defining moments: When managers must choose between right and right. Harvard Business School Press, 1997.

Drug Industry Said to Exert Vast Power Over Research by Ghost-Managing Articles

An article from the Chronicle of Higher Ed:

September 27, 2007

Drug Industry Said to Exert Vast Power Over Research by Ghost-Managing Articles

Drug companies play a far bigger role than previously suspected in managing how academics publish articles in medical journals, charges Sergio Sismondo, an associate professor of philosophy and sociology at Queen’s University in Canada. In an essay this week in PLoS Medicine, published by the Public Library of Science, Mr. Sismondo says that “a substantial percentage of medical-journal articles (in addition to meeting presentations and other forms of publication …) are ghost-managed, allowing the pharmaceutical industry considerable influence on medical research.”

Mr. Sismondo bases his case on an examination of internal company documents revealed in a lawsuit and also on his research into so-called medical education and communication companies. Those businesses help pharmaceutical companies promote their products by preparing academic articles and then recruiting university scientists to put their names on the manuscripts, says Mr. Sismondo. “Ghost management of medical-journal publications is clearly a substantial business, employing thousands of marketers, writers, and managers,” he says.

It will take teamwork from journal editors, academic administrators, and scientists to solve the problem, he says. Editors could refuse to deal with third-party publication planners and insist that the listed authors specify the exact roles they played in preparing articles. Universities should not sign contracts that give the sponsors of research projects the authority to write or edit articles. And administrators should punish scientists who sign their names to articles written by others. Investigators, he says, should refuse to participate in projects where a company secretly writes the academic paper.

Scientists, he says, must be “more modest about how many articles they can publish, and more realistic about the amount of effort, legwork, and/or creativity it takes to publish an article.” —Richard Monastersky

Posted on Thursday September 27, 2007 | Permalink |

Is there always an ethical choice?

Many professional organizations have codes of ethics. [1]^,[2],[3] Professional medical writing societies, including many editor organizations (ICMJE and AMA, among others) have codes by which its writers and editors are expected to abide. Among the codes governed are conduct, publication, duplication, original authorship, and authorship qualifications. Most would agree that these codes are important in keeping scientific research open, honest, and rigorous.

However, non-professional considerations may come into play. Scientific and medical writers may have spouses, children and other dependents. And although whistleblowers are glorified in movies and fiction (“Erin Brockovich”, “Silkwood”), the reality is frequently less glamorous and more frightening. Although companies may pay lip service to their admiration of and support for employee whistleblowing, the messenger is frequently killed (more accurately, the offending employee marginalized, demoted, let go or fired).

In a case of scientific misconduct where a medical writer may be required to either hide something damning to a company or disclose it and be fired, is it possible that there is no correct answer, that there is no ethical answer? Making a stand to disclose a pharmaceutical company’s malfeasance or ‘spin’ may appear to be the ethical choice, especially as outlined in all the professional societies’ codes of ethics. But what if it results not only in losing one’s job, but losing the possibility of future jobs in that field, perhaps the only one for which a writing professional is truly qualified? What is the ethical obligation one has to feed, clothe and keep safe one’s family? Is it a lesser obligation? Ethics can be applicable to a person, to a small group, to a community, a state, a nation or an entire species. But how does one stratify the importance of each of these?

Is it possible that sometimes there is no ethical choice, but only an array of unethical ones?

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[1] Zigmond MJ. Implementing ethics in the professions: Preparing guidelines on scientific communication for the Society for Neuroscience. Science and Engineering Ethics. Springer Netherlands, June 2003. Found at http://www.springerlink.com/content/2266871061636r40/. Accessed 23 Sep 2007.

[2] Code of Ethics for the Endocrine Society, 2001. Found at http://www.endo-society.org/ ethics/upload/ ee20018398.pdf. Accessed 23 Sep 2007.

[3] Regulatory Affairs Professionals Society Code of Ethics. Found at http://www.raps.org/s_raps/docs/ 4900/4869.pdf. Accessed 23 Sep 2007.

Bush and S-CHIP...

"Instead of expanding SCHIP beyond its original purpose, we should return it to its original focus, and that is helping poor children, those who are most in need.

And instead of encouraging people to drop private coverage in favor of government plans, we should work to make basic private health insurance affordable and accessible for all Americans."

This is President George Walker Bush's view on the SCHIP program and why he is refusing to allocate more money into this system. In case there are some that do not know what the CHIP system is, quite simply, it is insurance given to children of families that make too much income (which disqualifies the child for Medicaid), but cannot afford private coverage. In states like Pennsylvania, headed by Governor Ed Rendell, his particular implementation of CHIP does not disqualify any child, regardless of the family's income. In fact, it was he who provided the response to Bush's comment on the behalf of the Democrats.

What is most irritating and short-sighted of Bush's goal concerning SCHIP is that the original intention of the program was not just for "poor" children; rather, it is for children, period. What is demonstrated here is Bush's fingers clasping at the naive idea that some variant of socialized healthcare is evil. Has he no interest in the prosperity of the newer generations? As good as parents can be, not all can afford to pay for insurance, especially if the child was born with some morbidity. In that particular case, either the insurance companies would reject an application for the child to be covered, or raise the premium to a prohibitively costly point. Children are not exempted from these actions, nor are adults. Undeniably, this is why so many individuals in America are without insurance. Hell, for all I know, in the future I may not be able to secure coverage through my wife due to my pre-existing condition of Ulcerative Colitis. The point is, the children, regardless of monies had by the family, or conditions, should be able to blossom with no fear of their health failing them - or being able to be treated.

"My administration will continue working with Congress to pass a responsible SCHIP bill. In the meantime, Congress has an obligation to make sure health insurance for poor children does not lapse. If they fail to do so, more than a million children could lose health coverage. Health coverage for these children should not be held hostage while political ads are being made and new polls are being taken."

Coverage for children should be the mission of the government, plain and simple. By Bush's very own words, he has mutated it into a political competition between him and the Congress. When (or if) SCHIP expires, it will not be the fault of the Congress, but rather Bush, because he specifically vetoed a re-extension of SCHIP. The blood will be on his hands.

Source for Bush's speech:
http://hosted.ap.org/dynamic/stories/B/BUSH_TEXT?SITE=NCJAC&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2007-09-20-14-24-39

Do Seniors Deserve Doughnuts?

Officials of senior citizen centers around Putnam County, New York, recently decided to refuse donations of free sweets such as doughnuts and pies for their residents. The officials were cited in an Associated Press news article as being concerned that the county was setting a bad nutritional example by regularly providing the sweet treats to seniors. This change did not sit well with some the senior citizens, 7 of them picketed outside of one of the centers demanding for the ban to be lifted. One picketer stated that the ban was disrespectful and, “implied that seniors were gorging themselves on jelly doughnuts and were too senile to make the choice for themselves.”

Studies have shown that older people have high rates of cardiovascular disease and hypertension. And it is well known that, doughnuts and other desserts do not contribute to “good nutrition,” the fat found in such foods has been implicated in obesity, elevated cholesterol, and heart disease (Harvard School of Public Health: http://www.hsph.harvard.edu/nutritionsource/fats.html). Knowing this, what ethical responsibility lies with the leadership and dieticians of senior citizen centers, nursing homes, and assisted-living centers in providing not only nutritious food for their residents, but also providing “treats” for the older folks to enjoy? Do the senior citizen residents deserve their “just desserts,” as they live out their remaining years? Or do the centers need to adhere to nutrition standards to promote the well being of their residents?

While I understand that state and federal government supported centers would have a higher sense of responsibility to ensure their senior citizen residents partake in a healthy, nutritious diet, my grandparents, in their late-eighties, who are dairy farmers in California, still drink whole milk from the farm, have ice cream after dinner each night, and even though my grandmother has elevated cholesterol I would not coerce them to change their diets in any way. They have been happy and healthy throughout all of their years, and I can only hope that at that age, I am still strong and healthy enough to enjoy my ice cream too.

Source: http://news.yahoo.com/s/ap/20070923/ap_on_he_me/diet_doughnut_debate;_ylt=AoeRkDtJM5tWkRjV6gwO_jvVJRIF.

Doctor responsibility in delivery ba news

What responsibility does a physician have to educate a patient regarding a poor diagnosis/prognosis or need for a procedure, even if more tests are needed to confirm the diagnosis/prognosis or need for the procedure? The lack of patient education will only causes anxiety and answer-seeking from potentially dangerous sources. While this issue is not a major ethical issue, it is a question of doctor responsibility that affected me this week and is best explained by providing some personal details.

I have a congenital heart defect that was surgically repaired 21 years ago. I am still missing a pulmonary valve but have been very fortunate to not have any complications. However, last week, my cardiologist informed me that my right ventricle is enlarging due to blood from the pulmonary artery “falling” back into the ventricle. While this is not too much of a problem yet (I have no symptoms), as a precautionary measure, I need a pulmonary valve. To be certain this is the right course of action, my doctor wants an MRI done after this semester is over before discussing the surgery. I go to the top children’s hospital (adult congenital defects are still so new because most kids with congenital defects died before adulthood, so I am followed by a pediatric cardiologist) in the country so I am certain my doctor is correct and the MRI will not show anything contradictory to his current belief. Therefore, I expect to have surgery shortly after Christmas.

However, other than telling me that my other structural deformities prevent the valve from being inserted via catheter, my doctor failed to provide any additional information regarding the surgery. My last week has been filled with very anxious research and discussion, in which most cases, results only in more questions and concerns than answers and reassurance.

While I understand (and appreciate!) my doctor’s insistence on reviewing the MRI before taking such a drastic step as cutting my chest open, I still feel he had an obligation to provide a bit of education on the surgery to me now rather than waiting several weeks for the MRI and then discussing my options. Some questions, such as how this surgery and recovery will affect my other medical conditions, can only be answered by a doctor. While I feel I am smart enough to look at reliable research, many others are not and do not have reliable resources, such as friends and colleagues who are physicians. I cannot imagine having to go through the next few weeks without having the ability to answer basic questions as some patients may be required to do. If a physician has to deliver some bad news, he or she should provide some basic information regarding that condition or procedure so that the patient can have some understanding and not suffer the anxiety of not knowing and not understanding.

Help Pay for Vioxx?

The HPV vaccination Gardasil protects against 4 strains of HPV, 2 of those responsible for 70% of cervical cancer cases. This vaccine is administered to females between the ages of 9 to 26, is recommended by the CDC, and is said to be almost 100% effective. So what's all the fuss about?

The cost of the full dose is $360, and many naysayers suggest that Gardasil is Merck's way to cover the costs of Vioxx lawsuits, considering Merck's aggressive lobbying in DC for the government to mandate the vaccine for schoolgirls. Merck also donated to Women in Government, a group of female legislators--a Maryland senator introduced a bill to mandate Gardasil after learning of the vaccine from Women in Government. In reaction to the suggestions that Merck is 1) only looking to line their pockets with the lobbying, and 2)encouraging promiscuity with the vaccine, Merck announced in February that they would cease the lobbying for the federal mandate.

Merck's intention at the Capitol is suspicious (can't Gardasil's abilities speak for itself-it is a cancer vaccine!), and provides another black eye to Big Pharma, viewed as money-grubbing greed machine. Note that Merck estimates $2.8 billion to $3.2 billion in revenue from Gardasil sales this year. Texas has already mandated the vaccine, and many other states are considering this action as well. Merck: patience is a virtue, the big pay day from Gardasil will no doubt arrive! Don't use our government as a marketing tool.

The Vatican Answers the Church on Moral and Ethical Dilemmas Surrounding the Terri Schiavo Case

After 2 years of deliberation, the Vatican answered the question posed by the American bishops on behalf of the American Catholic Church. The question,

"When nutrition and hydration are being supplied by artificial means to a patient in a 'permanent vegetative state,' may they be discontinued when competent physicians judge with moral certainty that the patient will never recover consciousness?"

The answer was simply "no." The Vatican further stipulated that " a patient in a 'permanent vegetative state' is a person with fundamental human dignity and must, therefore, receive ordinary and proportionate care which includes, in principle, the administration of water and food even by artificial means."

The Vatican clearly expresses a deontological perspective. According to the Vatican's answer human dignity encompasses being provided—or forced—nourishment to keep his or her body alive, irrespective of a patient's expressed wishes regarding a permanently vegetative state, or factoring his or her personal sense of human dignity.

The Vatican is wrong to ignore people's wishes. We go through life exercising free will. As American's we're given this right as it follows with the right to exercise independent free will. Today's Americans may choose to die with varying measures of dignity. The Church would argue that the right is not ours; that God gives us life and therefore is the only one who may remove it justly.

The long-awaited decision handed down by the Vatican is little more than an extension to its already established beliefs. Particularly, the belief of the Church that suicide is a sin. However, no one has yet to be charged in this country. The necessity of the separation of church and state is especially evident in these issues.

http://thelede.blogs.nytimes.com/tag/vatican/2007/09/14/

The Inevitable Discussion Surrounding Marijuana

May as well get the controversial issues brought forth...

What is the controversy surrounding the medicinal uses of marijuana, and how does this compare to how other countries are handling the "issue"? It is an odd set of statutes that the United States has, wherein legislation at the state level (e.g. California) can be at direct odds with the federal statutes. In addition to the question of whether state sovereignty is a real concept, it raises the larger question of defining a substance as harmful.

Alcohol, for example, is mostly handled by the state governments, with only certain instances where the federal government is involved (think ATF). However, alcohol is a harmful substance - we know this, and there are hundreds of thousands of pieces of literature to support this claim. From causing fatty liver to encephalopathy, among numerous other conditions (and drug interactions), ethanol consumption, in excess, can, and does really kill. There is a LD50 associated with ethanol.

When discussing marijuana, the picture is different. As intoxicated on marijuana as some individuals have been, there have been no fatalities associated with its use. We do understand the biochemistry and pharmacology of the cannabinoids, and specifically, the system in the brain that facilitates its activity, the endocannabinoid system. As it implies, there is receptors and ligands that mimic the pharmacology of marijuana, and are crucial for certain physiology. There is no found LD50.

The question that is before us is how the statues came to be the way they are. Very simply, there are lawmakers making the decisions left best to scientists. Early on in the twenties, the Harrison Narcotic tax made banning of very many drugs - heroin, marijuana, etc. - prohibitively expensive. What is more, part of the ideology surrounding marijuana usage came from xenophobia of Mexican culture, who had been smoking marijuana for a very long time. The story that the United States government has used since has been that now marijuana is a "gateway" drug, wherein more "hard" drugs will be used after exposure to marijuana.

Despite the papers and research that has been published regarding the safety and therapeutic potential of marijuana, it is still a schedule-1 narcotic, prohibited from being used in any medical context. All that is permitted by the United States is an extract from marijuana - a single alkaloid of hundreds if not thousands - called Marinol (dronabinol). It has found scrutiny in the medical profession due to its unpredictable pharmacokinetics and half-life in the body. Marijuana that is smoked does not cause the same problems and is more effective in treating certain conditions than the orally ingested Marinol.

Canada has gotten wise to the situation and has allowed the entry of Sativex, an oral spray, of marijuana extracts. Without doubt, the country knows the value in palliating the very serious conditions that cancer patients and HIV infected individuals who have progressed into AIDS face. The condition is not too dissimilar in the European Union, and notoriously, the Netherlands.

Without baiting you all too much, consider this: a country that decriminalizes a certain substance may see a brief spike in usage, but after that initial enamor wears off, humans recognize when it is appropriate to use said substance, and when not. Rampant underage drinking is not as much a problem in Canada and the United Kingdom as it is here in the United States. Why? There is no social stigma associated with it, and there is no need to creep around, in secrecy, for fear of getting caught by law enforcement. Another kibble to nibble on: consider the right for humans to ingest what they wish. If I really wanted to, the gasoline in the garage could be a great compliment to my filet mignon before me at dinner time. However, I choose not to ingest it, and moreover, law enforcement would not be able to stop me from doing so. I will supply a link for a movie on Google Videos regarding the etiology of marijuana fear and obsession by the United States later on this week.

Epogen prescribed for treatment of patients or profit?

A recent article in the New York Times discussed a Federal investigation of the potential unethical behavior by a large dialysis company, DaVita. DaVita is one of the largest dialysis companies in the United States, and along with its main competitor, Fresenius Medical Care, controls about two-thirds of the dialysis business. DaVita treats about 106,000 of the estimated 350,000 Americans currently receiving dialysis. DaVita is under investigation for the substantial revenue it makes by administering the drug, Epogen, to treat anemia in patients receiving dialysis at their centers. Medicare and private insurance companies reimburse more to DaVita than the company actually spends on purchasing the drug from its manufacturer, Amgen. Epogen accounts for 25% of DaVita’s revenue and up to 40% of its earnings.

The article states that dialysis clinics lose money on the fee paid by Medicare and other insurers for dialysis treatment, however the companies recoup these losses by the reimbursement for Epogen and other drugs. In addition, Amgen offers discounts on Epogen for dialysis companies based on how much is used per year and how much that use increases per year. Therefore, it is feasible that to increase their revenue, DaVita would treat more patients with Epogen to receive a bigger discount from the manufacturer. Some studies of Epogen have shown that if the drug is used too aggressively and the RBC count is raised too high, it may cause cardiovascular adverse events or death. United States Renal Data System data show that more than 60% of DaVita patients have RBC levels that are considered “risky” due to elevation.

Currently, Congress and Medicare are moving to cease the separate payments for dialysis treatment and drugs for dialysis companies by bundling the payment together that would cover all aspects of dialysis treatment and drugs. While this would eliminate the financial incentive to overuse Epogen, the dialysis companies, such as DaVita may begin to reduce the drugs given to patients to save money which would potentially leave patients with not receiving the care or drugs they require. In addition, if the dialysis centers are not using as much of the drug, the drug manufacturers will not provide as big of a discount – therefore, patient care may decline as a result of dialysis companies cutting corners in other areas of dialysis treatment.

Link to NYT article: http://www.nytimes.com/2007/09/16/business/16dial.html

Ban on Morphine in Certain African Countries

Early last week, Donald McNeil wrote in the New York Times about the ban on prescribing morphine for extreme suffering in some countries of Africa, raising questions on the ethics of this ban. The World Health Organization advocates the use of the opioid morphine in pain relief of HIV and cancer, yet many countries in Africa, striken with HIV and certain cancers, deny the availability of this accessible and effective drug. McNeil's article sites examples of suffering such as a woman with breast cancer where the cancer had spread to her lymph nodes and ribs; a 2-year-old with third degree burns down the front of his body; an 7-year-old with sickle cell anemia; and an 8-month-old with meningitis. Morphine would put all 4 of these patients in some comfort that they are no longer familiar with. Usually, the unavailability of drugs in Africa is attributed to the high costs; that is not the case with morphine. The author states a hospital in Uganda makes its own and the price of a 3-week supply is less than a loath of bread. Instead, morphine is unavailable in certain countries because of ban on morphine. Some of these governments only allow doctors to administer morphine, one such country being Sierra Leone, where the doctor to patient ratio is 1 in 54,000. Patients in need rarely get one on one time with a doctor. In other African countries, morphine is allowed by their governments, yet pharmacies will not stock it in fear of potential consequences.

People suffering in intense pain, near death, should be allowed some comforts in their final days. The author writes that the benefits administering morphine to those in severe pain far outweigh the risks, and I agree. There should at least be an attempt in these countries to provide relief for the suffering citizens, and closely monitor the distribution of the drug and be aware of any sort of corruption/crime issues that may arise. I can understand the fears some of these governments and the pharmacies have due to corruption, crime, and addiction; however, these governments watch people suffer in such severe pain when there is an easy and affordable remedy to allow some comfort in one's last days. That seems like the true crime to me.

Mandatory HIV testing of pregnant women

Twenty-six year ago, HIV was thought to be a homosexual and drug user disease. However, the disease is no longer confined as originally thought. HIV is now transmitted more through heterosexual sexual contact than homosexual relationships and drug use. Unfortunately, the only way to eliminate this growing epidemic is prevention. The best place to start prevention is to start with a population that is not infected by any specific behavior on their part – infants who contact HIV through their mother at the time of birth.

The first case of pediatric AIDS was found in the United States 2 years after HIV itself was discovered. In 1992, transmission cases from mother to infant in the time of birth peaked at 25% for known HIV positive women.1 They will grow up waiting to die, essentially. While chances of these infants living to reach adulthood and spreading the disease through sexual intercourse are limited, their care also puts a severe strain on our healthcare system.

By ensuring that the mother has proper HIV treatment throughout her pregnancy, we can decrease that 25% transmission rate to 1-2%.1 Twenty-three to 24% percent of infants otherwise condemned to be born with HIV will have the opportunity to live a healthy life. However, ensuring that all HIV positive pregnant women receive proper treatment is a multifaceted ethical and legal. However, several government agencies already have recommendations and polices that make this legal precedence foreseeable. The CDC has been recommending voluntary testing since 1995, and the Institute of Medicine has been doing so since 1998. 1 Congress already provides funding for prevention of transmission during birth in states with the highest birth transmission rates.1 The CDC has also contacted obstetricians to show their support of universal testing during prenatal care. 1 In 2006, the CDC also published more recommendations on specific trimester screenings based on the woman’s risk for HIV.

There are several ethical and legal factors in the plan to make HIV testing mandatory. Is the fetus’ right to life (though I believe the government feels a fetus does not have a right to life as abortion is still legal, but a fetus will become an infant who does have a right to life) more important than the mother’s right to privacy? Because testing is not voluntary for this specific population, is it right to require physicians to report cases of HIV found only thought prenatal testing to the Public Health Department? Although Congress has already distributed funds for some states, from where will the funds for testing for the rest of the states come? If we do require treatment through pregnancy, is it just for the mother (though it would benefit her also, doesn’t she still have the right to refuse medical treatment?), and how would we enforce her complicance in taking her medication, especially given the strict regiment needed for proper treatment? From where will funds for all the medications come? Would those women who have medical insurance through their employer be required to use their insurance to pay for these medications, which would essentially inform their employer of their HIV status? If the infant does contact HIV through birth, does the child have a right for his or her guardian to know his or her HIV status so he or she can start treatment immediately so the virus can be stymied rather than wait until the virus spreads?

Although there are several very important factors to be considered, the bottom line is that by mandating HIV testing and treatment in pregnant women, we can almost eliminate the spread of HIV in this specific transmission method, and stopping the spread is the only cure we have available. By preventing these infants from contracting HIV, we also prevent the opportunity for them to spread HIV. My personal belief is that the life of these infants who otherwise would have HIV is worth the privacy infringement of the mother, provided that her privacy in other settings can be maintained.

Reference

1. Glenn Folwer M, Lampe MA, Jamieson DJ, Kourtis AP, Rogers MF. Reducing the risk of mother-of-child human immunodeficiency virus transmission: past successes, current progress and challenges, and future directions. Am J Obstet Gynecol 2007; 197; S3-S9.

Elective cosmetic surgery

I have been pondering what is probably a non-issue ethically, but one that has niggled at the back of my mind and my consciousness for a while. A year or two back, I watched a Discovery channel special on people who have lots of plastic surgery performed. The person I remember particularly was one who they called the “Barbie woman.” She had had numerous operations, looking younger and younger and more like the Barbie doll.

Her money is hers, to do with what she wants. But what about the doctor(s) who are performing these surgeries? Do they just take the money and do what the patient wants, operation after operation? Does this satisfy the Hippocratic oath? In the Barbie woman’s case, perhaps so. She appears happy with the results and in fact has made a career and a skin care line out of it. But some women (and men) have worse results.[1]

What about the doctors? I don’t see where they are following any of the ethical theories, utilitarianism, deontology, any of these. They are performing for pay, and appear tp be paying no attention to the concepts of beneficence, non-malificence, utilitarianism or justice. Perhaps they are serving autonomy. However, were I them, I might have a twinge of consciousness at continuing to perform operations for some people, for what most would consider diminishing returns (Michael Jackson’s nose, Jocelyn Wildenstein’s face). Are these doctors just making money? Are they performing an important service? I don’t think the case is clear.

Is this a non-issue? Are doctors who perform elective plastic surgery in exactly the same ethical place as emergency room physicians or surgeons? Do they feel they are doing the same type of good? In some cases, I believe they are, but I don’t believe all cases are clear. How do they reconcile with themselves some of the things they are asked to do? Do they fall back on the ethical principals we are learning about?

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[1] http://www.hec.ohio-state.edu/bitf/PlasticSurgery.htm

About medical publishing and advertising

[Cross-posted from blog.bioethics.net]

The web delivered a bit of a serendipitous dialectic today on the subject of how medical journals pay the bills. This morning, the New York Times published a story about the launch of OncologySTAT, Reed Elsevier's new ad-supported portal for cancer research. The publisher's plan basically goes like this:

1. Aggregate cancer research
2. Get doctors to register to use the site by providing free access
3. Tell pharmaceutical advertisers about all the doctors gathered in one place
4. Profit

NYT reports that Elsevier's medical journals are making money, but revenue is flat. The company hopes this new model will generate higher profits and provide a workable strategy in the future as everything heads online.

If that's the thesis, here's the antithesis (of sorts). This afternoon Slate published a piece by Kent Sepkowitz that criticizes medical journals for... their cozy relationship with pharmaceutical advertisers. Sepkowitz argues that if journal authors must submit to conflict of interest disclosure, so too should journals. His solution? Each journal issue should include stats about current advertisers and how much coin they've dropped for display ads, special sections and reprints.

So, is there a synthesis to be found here?

-Greg Dahlmann

hey everyone!

Skype is taking a heck of a long time to dload on my comp, but I will be online for class asap. The readings were really cool, the origins of medical ethics and such

Welcome BW 706 students!

Welcome to my students at USIP! We'll be blogging here until ANGEL allows us all access!