Experimental drugs; Elders (Posted for Awad)

Posted for Awad Awad

An adequate approach for FDA to establish a successful pathway for terminal ill patients to have an access to experimental drugs

    FDA should establish a committee containing doctors, lawyers, religious representatives, and family members to assist terminal ill patient in process of forming his/ her decision to use the experimental drug. Each group of the professions in the committee should be able to help the patient know about his status and rights. For example, doctors will help the patient to form a clear view of the risks of using the experimental drug, and the damages that the drug may cause to the patient’s health and quality of life. Furthermore, the lawyers should assist the patient in his legal problems such as if he/ she dies after using the drug or goes into a comma, and the layer should protect what the patient desire if he / she goes into a comma or dies. Religious representatives of the patient’s faith if he has any and a family members have a similar role in aiding the patient emotionally, and also in the process of making important decisions such as after he/ she goes into a comma what they should do for him/ her. Libertarian and utilitarian are the two main ideologies, the FDA needs to ensure that patient can use to make his/her decisions. The patient should always have the important voice in the matter of his/ her life or death decisions, and the type of care he / she should receive. They also should choose if they want to trade off comfort for extension of life or vice versa. The committee goal is to assist the patient to make important decision and never to make them for the patient unless he/ she is unable to decide for himself/herself due to a disease, a disorder or an accident.    

Dependence and independence for Elders

As the book “Being Moral” describes characters in chapter three that each individual has 

a story where he/she favored a place that provided him/ her with a sense of independence and 

allowed them to obtain a life as close to their typical life. For elder patients, a nursing home, 

hospice should not represents to them a place of exile where they must denounce all of the 

activities and habits that bring them joy for the name safety. The society expects the elder to 

abide by rules that takes away their voices in what their life should be like. These creates a 

culture inside nursing home and hospice that ignores the elders’ demands and desires in the name 

of safety and longevity of the elders’ life than the quality of the time they spend inside a hospice 

An easy solution to this issue to start customizing the life an elder wishes to have. For 

example nursing should allow elders to customize their room and their food. Elders should be 

encouraged to explorer life rather than hide behind the wall of nursing home or hospice. They 

should be allow every month to leave nursing home and hospice to visit her family or go on 

picnic with her or mates at the nursing home or hospice. These are small changes to the culture 

of nursing home that would not cost a lot’ however, they will have appositive outcomes on the 

quality of life of the elders inside nursing homes.

SIDNEY FARBER VS. LEUKEMIA pt. III

SIDNEY FARBER VS. LEUKEMIA pt. III

In the last installment we saw what a breakthrough the use of aminopterin was in battling what was, at the time, a childhood illness with a one-hundred-percent mortality rate – ALL, or acute lymphoblastic leukemia.  This time we look at some of the statistics about the disease and the effect Farber’s treatment had on his patient’s odds of survival.

ALL accounts for twenty five percent of all cancer in people under the age of 15, and affects 1 in 50,000 people in the US.  As mentioned, when Farber first began administering aminopterin, the mortality rate was one hundred percent.  According to the Journal of Clinical Oncology, the survival rate had increased to about ten percent by the 1960s (read the article here: http://bit.ly/1ckrT0p).  This is important to note for two reasons.  First, while ten percent may not seem like much, it is a dramatic improvement over zero.  Imagine the difference between being told that your child had a zero percent chance of survival compared to being told her odds are one in ten.  It may only be a slim hope, but it is hope nonetheless, and the difference between no hope and slim hope cannot be overstated.  Second, it is important to note that aminopterin was not the end of the story – new and improved drugs would soon step in to replace it.  The breakthrough was in Farber showing the medical community that these types of treatments were indeed effective.  Up to this point, it was considered cruel, perhaps even inhumane, to inject these children with substances known to be poisonous.  “Let them die in peace” was the motto of the day.  But these children were not dying in peace – they suffered terribly before their inevitable end.  The extreme suffering of these children is what drove Farber to such a radical treatment, as he felt each loss deeply and personally.

As I said, Aminopterin was not the end of the story.  The same Journal of Clinical Oncology cited above states that, by 1985, the survival rate had increased to seventy seven percent.  By 2005 the survival rate had increased to over ninety percent, and that number has increased steadily up to the present.  It is important to note that these are five to ten year survival rates.  ALL is still a deadly disease that affects many children, and also affects adults, albeit at a much lower rate.  But Sydney Farber paved the way for the increased survival rates that we enjoy today by proving that chemotherapy was effective.  His legacy as the Father of Modern Chemotherapy is well deserved – may his memory be for a blessing.

Cancer: The Emperor of All Maladies documentary: http://bit.ly/1EffZz7

Ethics of the Cosmetic Industry: When Patients Make the Wrong Decision and the Practitioner Lets Them

III. Rehabilitation of Self Image- Solutions to Decisions Made in Vainity
 In the last installment,  we left off with Bruce Jenner's potential transgendered surgery as the defining statement to his long history of cosmetic modification. In our youth abs beauty fixated society,  how a person looks is everything these days.  Cases wherein cosmetic surgery is medically needed to improve an individual's quality of life,  such as with skin graphing burn victims or the American coalition to give free plastic surgery to victims of the bombings of Hiroshima and Nagasaki after World War II, famously known as the Hiroshima Maidens. This group of 25 school girls were horrifically disfigured from the atomic bombs,  and in 1955 their journey was televised. 

Cosmetic surgery is not under attack here. It is one of the most innovative medical procedures we have been able to master in the modern age.  But as we all know,  with great power comes great responsibility.  The responsibility does not rest on the shoulders of the patients,  but on the surgeons and medical consultants to not preassure patients who may be disposed to psychological disorders or body image issues.  Rather than treating patients as a means to make a sell by feeding them whatever manipulative jargon is going to result with patient's strong and sure affirmative,  they need to instead provide the proper advice and information to let the patient know that if this is a quick fix to a deeper psychological trauma they'd are other avenues to explore prior to going under the knife.  With cosmetic surgery becoming such an integral component of our society,  the procedure is treated as recreational, which objectifies the human form to be treated as a new accessory to be updated with the fashion of the season.  

Rather than representing itself for the prestigious medical advancement it is, cosmetic surgery instead advertises itself as a confidence booster. This is detrimental to the patient in two ways.  Firstly,  it is trying to sell a perception where there are no means by which a true guarantee can be given or physical acquisition can be gained from "confidence" as a product. Secondly, the tactic of selling confidence perpetuates the insecurities of our culture. The article "A New Face: What Are the Psychological Risks?" in the Huffington Post by physiologist and author Dr. Vivian Diller Ph.d. examines the escalaction of cosmetic sugery in our culture:

You see, there are two important but separate issues at hand: the immediate emotional concerns faced by patients opting to surgically alter their physical appearance, and the farther-ranging cultural one about what this trend means in terms of ourdefinition of beauty, its impact on our self-image and on our society at large.

Now that we possess the capacity to change  every aspect of our nature from our environment to our bodies, we ha e made self-improvement limitless and have transformed survival of the fittest to take on a complately new meaning as we have introduced a slew of newly sought-after traits to our proverbial pallet. Take the competitive nature of Hollywood culture where survival really does depend on your loss when trying to be successful in either the film or movie industries.  If this is your world,  one obsessed with power and image,  your family's pedigree of a long history of tall men with strong broad shoulders is more likely to be overlooked in favor of what new feature you've added to your face or who you went to to have those few extra inches shaved off your knees to give you your willowy figure.  Do not mistake this for cynicism.  I am using extreme examples and rougher descriptions in order for us to understand just how much damage our obsession with self-image had done to the natural order of things, and Hollywood does almost makes too perfect a setting to see just how much damage we have wrought. 

Previously

The Rise and Fall of the Unnaturally Enhanced

I. Morality Salience

Many of us may go throughout our lives without ever letting the inevitability of our own mortality bring us down.  Maybe some of us look forward to it as the great test of the soul, or maybe you see it as some great experience where you can learn and grow.  Maybe it doesn't effect you and you are unencumbered. Then again, the essence of mortality could bring about about existential crisis,  where you find yourself asking "WHO AM I!" in the biggest way. 
Morality salience is when the self-awareness of mortality results in an anxious melancholy that begins to effect our personal/world view and wreak havoc on self-esteem.  It would be easy to say this principle is the cause to every power hungry, blindlessly greedy, treacherous effect in human history,  and in some cases you wound be right, but in our age of biomedical enhancement the anxiety has shifted to a more personal veiw. In our era,  should Napoleon Bonaparte be born again,  he needn't attempt to try to conquer the world to prove himself a "big" man. He could just do what the guy in this video did and have his legs broken and have telescopic rods implanted into them so that he may grow about one millimeter a day. No thousands of casualties and woes of revolutionary war need apply. Our history books taught us trying to conquer the world is messy and hardwork, and now that it's mostly done for us anyway with globalization it is so much safer to consult a plastic surgeon to fix yourself. 
But where does self-improvement become detrimental,  and how does "changing the self" come to effect the inner self in the end?

Tune in next time for: Who Is This Monster in the Mirror, and What Have You Done With My New Lips?

Extraneous Metamorphism Does Little to Mend Internal Strife

II.  Who Is This Monster in the Mirror, and What Have You Done With My New Lips?

The prestige of cosmetic surgery began to rise during the late 1960s and early 1970s and medical advancement grew and the emergence of the "self-esteem" generation begins to take hold, of which there is a full emanation come the 1980s- or the era of "Me. From the first breast augmentation in 1895 to the first plastic surgery instruction by french surgeon Dr. Hippolyte Morestin during the first World War, the desire for humanity to physically alter their appearance is not as unique a trait of our post-modern, transgression generation as we would of thought. After Dr. Hippolyte Morestin's efforts, cosmetic surgery steadily grew until it became fully integrated into medical institutions by 1959, but it climbed to pragmatic heights after the invention of the Silicon breast implant in 1962. 
However,  what at first glance seems like a simple easy solution to self-improvement, a study done in 2009 yields evidence to support the claim by many that cosmetic surgery does little to fix the preexisting psychological conditions driving many individuals to go under the knife.  It goes without saying that a quick decision to change a reflection in a mirror is going to do little to the real problems that dwell just beneath the surface. Yes, there are many success stories of plastic surgery,  but it is when we let our patients make life-altering decisions with an unhealthy mind the ethical sanctity of the medical profession hangs in the balance.  

Early cosmetic surgery advertisement from 1890s

In the 2009 article "The Effects of Cosmetic Surgery on Body Image,  Self-Esteem, and Psychological Problems" published by T. von Soest, I.L. Kvalem, H.E. Roald, and K.C. Skolleborg, they conduct an experiment via a questionnaire from 155 female patients six months after their cosmetic sugery. Results yielded an improvement of body image but no change was apparent in relation to the psychological conditions the patients had preoperation. "Postoperative measures of appearance satisfaction, self-esteem, and psychological problems did not differ from values derived from the comparison sample," (von Soest etc al. 2009). Because the patients sought out cosmetic surgery in order to fix whatever it was about themselves they considered to be a problem, once they realize the problem is still there,  they aremore likelyto repeat process to search for a new solution. This is how cosmetic surgery addiction has found itself among a hord of new age self-inflections that really takes the "finding that next fix" component to an entirely different level. 

We find ourselves in a generation that can examine the long term results cosmetic surgery has on its patients, both the good and bad,  healthy and unhealthy alike. A recent example would be the extreme long-term physical (and hypothetically as a result from this-psychological) transformation of celebrity Bruce Jenner. 

After his face became a staple of the Wheaties box and he was thrown into the realm of reality television stardom from his marriage to Kris Kardashian,  Bruce Jenner has struggled to keep his body image culturally relevant for nearly the last two decades. There has been recent tabloid buzz of Jenner's long-term battle with depression and body image and how he has made the recent decision to undergo transgendered cosmetic surgery. In a recent article by false gender transformation activist and author Walt Heyer, he relates his own story to that of Jenner's by stating,  "Bruce’s desire to be a woman could be the result of the adult onset of a disorder in his psyche triggered by traumatic events," and that after he underwent gender transformation, Heyer was diagnosed with dissociative disorder- "The underlying disorder was appropriately treated, my desire to change genders faded away like a mist in the bright light of day. One of the hardest things was to admit to myself, my family, and my friends that the whole surgical change had been unnecessary."  Hopefully Bruce Jenner is making a decision that will alow him to live with "herself", but this is why certain psychological disorders need to be addressed and treated prior to operation when the very permanent results take effect. Cosmetic surgeons and spokespersons should make treatment and information regarding psychological conditions regarding personality, body image, and self-esteem avaliable to prospective clients. This way individuals are aware that the very painful process of cosmetic transformation not only permanently affects the physical self, but the psychological self as well. 

Tune in next time for: Rehabilitation of Self Image- Solutions to Decisions Made in Vainity

Sources:

The Effects Of Cosmetic Surgery- T. von Soest (etc al.) 2009

History of Plastic Surgery- American Society of Plastic Surgeons

Bruce Jenner- In Transition or Psychological Crisis?- Walt Heyer

Advertising & The Physician-Patient Relationship: Part III

Part III: Policy & Ethics

I have described the tobacco companies of the mid-twentieth century and modern pharmaceutical companies as almost predatory in their tactics. I should take a moment to clarify my attitude toward Big Pharma as a whole.

In class, we have discussed at some length the harm that can result from extensive distrust of allopathic medicine by groups such as anti-vaxxers. I think these anxieties are depicted poignantly in Alexander Beydeman’s “Homeopathy watching the horrors of Allopathy” (1857). Supernatural forces on the right represent Homeopathy, while doctors at work embody Allopathy on the left. Notice the gold bars behind the doctors as they pour medicine from an oversized bottle and amputate a patient’s lower leg. This is an image with which many people holding suspicions about direct-to-consumer pharmaceutical advertising would likely identify.

By no means am I promoting a paranoid attitude toward pharmaceutical advertising. I don’t think this is an “us vs. them” issue or that Big Pharma’s end game is to profit at the expense of public health. I do think main goal of these companies is to profit, but not explicitly at the expense of public health.

That being said, I think it is important to evaluate such advertising with a critical eye.

Policy

The Federal Food, Drug, and Cosmetic Act grants the Food & Drug Administration (FDA) authority to oversee advertising of prescription (but not over-the-counter) pharmaceuticals. FDA is not at all involved in the process of creating ads and does not prohibit the advertising of any drug, including drugs with serious risks and the potential to become addictive. There are certain requirements for drug ads that make efficacy claims. These ads must demonstrate one or more FDA-approved uses for the drug, the generic name of the drug, and the risks of using the drug. There are also certain requirements for the way the ad content is presented visually. For example, risk information must be presented in a similar way as the potential benefits of the drug (similar font size and style).

However, drug companies are not required to submit ads for approval before launching them, which means they are freely accessible to the public even if they are in violation of the law. Violations may include excluding or understating risks associated with the medication, suggesting that the drug is appropriate for a condition it has not been approved to treat, and misrepresenting data from studies. I suspect the latter violation is the most difficult to correct because only a very small population of people are qualified to detect it, including researchers and physicians who are intimately familiar with the drug and the research characterizing it.

FDA states that the typical action in response to an illegal ad is sending a warning letter to the company explaining the violation and requesting that the ad be withdrawn. If the company does not comply, legal action may be taken. The most extreme outcome is seizing the drug from the company and filing criminal charges.

Meanwhile, New Zealand is the only other country in the world that allows direct-to-consumer advertising of prescription drugs.

Ethics

A study published in 2013 found that over 50% of the most-emphasized pharmaceutical claims were “potentially misleading” and that 10% were false altogether (although this includes only 2% of ads for prescription medications). Reporter Chris Lo writes that this “level of doublespeak might be par for the course in the advertising sector, but from a clinical standpoint it's truly worrying.”

It seems clear that direct-to-consumer pharmaceutical advertising significantly impacts the relationship between doctors and patients. A potential benefit could be that patients are encouraged to be more active participants in their care by asking questions and becoming informed, and therefore empowered, regarding treatment options. As of May 2011, however, medications that used public advertising were prescribed at nine times the rate of medications that didn’t employ public advertising.

According to the World Health Organization, there exists "an inherent conflict of interest between the legitimate business goals of [drug] manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way".

I have concluded that there is legitimate cause for concern about modern pharmaceutical advertising. Unacceptable ads from both the past (tobacco, psychotropic medications) and present involving rampant misrepresentation of prescription drugs demonstrate the need to re-evaluate the way pharmaceutical advertising in the U.S is supervised.

Sources:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm071964.htm#input

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htm

http://www.pharmaceutical-technology.com/features/feature-big-pharma-ethics-of-tv-advertising/

http://abcnews.go.com/Business/Wellness/pharmaceutical-ads-good-bad-consumers/story?id=9925198