Wednesday, May 6, 2009

Gene testing?

As a society, we have evolved in many fields, before, we had no way of knowing who would have what disease and how we can avoid passing it onto our children. Now through gene testing becoming more common with the population, it’s revealing those hidden factors. They don’t have gene testing for a lot of diseases because there are too many genetic variations such as in chronic diseases (diabetes), that you can’t pinpoint one marker. Some of the gene testing is probabilities that you might or might not get it, meaning that some people have the strain, but it’s not active until some outside factor such as disease or other environmental factors influence it. Physicians use the few genetic tests that we have to target illnesses and prescribe the appropriate medications.

Most scientists question gene testing because there are too many genetic variations which we don’t have the medicine to treat it yet, even if found. Errors in testing can also have an impact on you. Gene testing is not regulated by the Food and Drug Administration. It is costly and it is not covered by insurance. Even if insurances are going to cover it, they’ll ask for the results of your genetic tests to keep on file. We are so big on privacy that we get angry if someone sees your medicine bottle, but you are going to let a bunch of people look at your genetic results, I don’t think so.

In this article, they mention that Medicare doesn’t pay for gene test. The Center for Medicare and Medicaid services believe that there isn’t enough evidence showing that these tests improve patient’s illness. Insurances can’t cover everything especially government provided insurances, so they have to be carefully in what they find applicable to cover. In this article, they wanted to give precise warfarin doses to each individual based on their genetic makeup. Warfarin, a blood thinner is hard to dose and any slight variations in it, will either cause blood clots or hemorrhages. We’re still far away from personalizing medicine with genetic testing such as to tailoring it to individuals and their needs. Maybe when we have more solid evidence and more participation in genetic testing, we can think about it being covered under an insurance plan.

Sunday, May 3, 2009

Pandemics and Politics - A Recipe for Pandemonium

The very nature of influenza virus makes prediction difficult. New strains of influenza for which populations are not immune in combination with increased global travel, urbanization, and overcrowding make pandemic conditions inevitable (see WHO Pandemic Preparedness strategy)(1). Also, seasonal epidemics heavily influence the impact of pandemics. Although the World Health Organization (WHO) and the Centers for Disease Control (CDC) have strategies for outbreak response (global outbreak/pandemic response) that includes communicating real and potential risks at the earlier phases;(2) unfortunately communications are filtered through sources with alternate agendas that do not account for the public’s short or long-term health.

The so-called swine flu provided the perfect mix of mystery and intrigue political mud slingers salivate over. From the first news reports the number of deaths was just as inflated as its origins. Turns out, swine flu doesn’t even come from swine – imagine that! Instead, swine flu is a strain of influenza virus - influenza A (H1N1) - isolated and reported to originate from a confined area in Mexico. Suddenly, suggestions of bioterroism and border closings ran through the media like California-wild fires through the canyons. Bioterroism from a flu virus? Border closings? Outbreaks do call for quarantine to complete epidemiologic investigations as well as treatment to avoid spread (when possible); however, no responsible medical authority made this declaration or even insinuated locking out an entire country as the option. So why did “the media” jump so quickly to this type of conclusion?

Politics. Throughout history disease has been used as an agent of power and politics (see Sheldon Watts for an excellent account on epidemics in history-3). Since a minority (about 20% according to a recent Washington Post poll) of disgruntled Americans (you can see a lot of them on Fox News) are beside themselves with anger about the last election and the perceived success of the First 100 Days, nearly any excuse for political posturing seems justified even in situations of extreme health. The paranoia that the news media has spread to elementary school children(4) who, yes, should be aware of ways to thwart human-to-human transmission but should not be afraid that they are going to die because someone sneezes on them. In fact, the precautions for this strain of flu are like precautions for any other strain of flu which should be taught outside of the confines of a pandemic alert.

Furthermore, what is not discussed nearly enough in the media is the link between very poor health and susceptibility to every day occurrences. The reality is, the American diet does not prepare American’s for epidemic catastrophes let alone pandemics. Furthermore, endemic flu continues to immobilize us as a nation because we have yet to confront the medical and social variants that propagate disease (see Holly Tomlin’s BW706 Final Project). This does not mean that pandemics or warnings should be ignored but the information should be communicated responsibly.

To panic people by combining basic fears of “terror” (thanks to the previous administration) with diseases that will become more commonplace with globalization is not only irresponsible but should be considered an act of treason; especially when the act is for political gain and not the public’s health.

Holly Tomlin
Blog 12

References
1. WHO. Pandemic Preparedness 2009. http://www.who.int/csr/disease/influenza/pandemic/en/index.html. Accessed 03 May 2009.
2. WHO. Global influenza programme: WHO pandemic descriptions and main actions. http://www.who.int/csr/disease/influenza/GIPA3AideMemoire.pdf. Accessed 03 May 2009.
3. Watts S. Epidemics and History: Disease, Power, and Imperialism. 1997
4. A personal account – my friend’s 8 year-old daughter called me with questions about the swine flu because of the stories she saw on the news and the information she received at school.

Saturday, May 2, 2009

Opulence and Insecurity and the outmoded 40-hour Work Week – A Personal Rant

How insecurity develops is a matter of psychology – quite frankly I don’t care where it comes from. What concerns me is the impact personal insecurities have on innovation, development, and progression. In a time when technology affords us the opportunity to exchange basic and complex information from seconds to minutes from one continent to the next as well as physically travel to those same regions within less than a day, for the life of me, I cannot understand why big businesses do not consider optimizing productivity potential beyond physical presence at a desk, behind a computer monitor, sipping gallons of coffee each day.

Part of the blessings (yes – I mean blessings) of technology is that it should free up people’s time to allow neurons and synapses to fire in different directions, expand brain capacity, and encourage creativity. Technology (laptops, iPhone®, Blackberries®, cars, buses, trains) should instill confidence in our capacities as human beings. Instead, people’s fear of technology has held the rest of us hostage to their insecurities and made us slaves (no disrespect) to an establishment that is afraid to embrace … dare I say it… yes – I will… embrace change. It’s like being an extra in your own reality t.v. show, a riddle wrapped in a Twinky®, Bizzaro to Superman – it doesn’t make sense!

Even more senseless are the salaries corporate fat cats make to keep the illusion going – particularly middle managers. They compound the insanity by celebrating mediocrity with big bonuses while utter stupidity is perversely excused and accepted. Do I really need to be chained to a desk listening to an earning’s call reiterating the same bleak economic forecasts of days before? Wouldn’t my time be better spent engaging in real scientific exchange that requires hours of research and contemplation that produces results? Perhaps such an exchange would add a little sunshine to the next forecasts…? But because I’m surrounded (quite literally) by the hypocrisy of an antiquated philosophy that impedes real work and progress (as well as an uncertain economy) I’m stuck between a rock and a hard place in a glass house built on quick sand.

Yet, I’m not giving up nor will I be fooled by misguided attempts to buy my personal ethic that craves intellectual challenge without being micromanaged.

Holly Tomlin
Blog 11

Beans (A Poem for Organ Donation)

Beans

Because they fail to work properly on their own

A catheter was inserted into her abdomen

For easy access to the machine she uses daily

To help her kidneys balance the minerals that flow

In and out of her blood stream

The process is intricately connected to her fluid and food-intake

As well as the money she makes

The support she has from friends and fam

That worries about the fragility visible in her face

As she recants tales of fighting her landlord

Who doesn’t care about her handicap placard

Or the government that sits on the hill counting kidney transplants,

Comparing them to dollars and cents

As if they were beans in a jar

For years she’s struggled with doctors

Trying to make sense of the disease they cannot fully explain

- It causes swelling, bone loss, brain damage, and severe joint pain

She was taken off the transplant list, put back on… then taken off again

No one understands the agony she’s in

Not even I – her sister-friend

Although weak from frustration, mineral imbalance, and poverty

She writes letters to congress, speaks at rallies, and talks to anyone willing to listen

To God she prays for a kidney that works

As hard as she does to make life meaningful and whole

Like two kidney beans in concert

It is for KH that I write

In hopes that others will get to know the miracle of organ donation

And know that life…your life amounts to more than a hill of beans…


Holly Tomlin

Blog 10

Friday, May 1, 2009

End of Life Health Care is Our Biggest Health Care Problem, both Financially and Morally

These are horrible questions, but these questions must be asked. I do not claim to know the answers, but I do know that what we are doing now does not make sense.

The truth is that an extremely disproportionate percentage of health care costs are incurred in the last year of a person’s life. Over ¼ of Medicare expenditures (27%) are made on patients in their last year. ( http://www.usatoday.com/money/industries/health/2006-10-18-end-of-life-costs_x.htm ) Roughly, $2000.00 to $3000.00 dollars are spent in a patient's last week of life.( http://archinte.ama-assn.org/cgi/content/short/169/5/480 ) As the baby boomers age, unpleasant choices are going to have to be made.

However, no one (understandably) wants to say, “Sorry, now that your best years are behind you and your utility to us has ended, you are more of a burden than you are worth, so if you wouldn’t mind too terribly, would you please die now?” “Broke your arm? Here is some morphine. These casts are getting expensive.”

Of course, the above is absurd, but it begs the question: Where do we draw the line? To what degree do we care for the health of the elderly before we decide it is not worth it? Is it moral to ask that question at all? Is it a sliding scale? Starting at the age of 70, is a person entitled to less care with each passing year? Do we draw the line according to condition, as in a broken finger is treated but a stroke is not? Do we draw the line according to prognosis, as in once the doctor decides that a person will not last a year, the morphine drip is wheeled in? If you thought insurance companies were tough on claims before, what happens when this Pandora’s Box is opened? Once it is considered reasonable for insurance companies to deny claims for terminal patients, what happens when the patients do not die as quickly as predicted? What if the doctor was wrong and the patient has 10 years left?

Our success with medical technology is ironically a part of the problem. It sounds horrible to ask, but in some twisted way, are we a little too good at keeping people alive?

This issue makes me upset, because my parents are in their mid-to-late 60’s.

We can not fix this problem by rationing care and deciding who gets what. This is not an issue that politicians can fix or bureaucrats can manage. The only way this problem will be alleviated is if our opinions about death and our opinions about our life cycle change.

In the meantime, I guess it all needs to come back to what is best for the patient.

The Terms "Right to Die" and "Assisted Suicide" Won't Do

As I write this posting about end of life issues, I am well aware that I am not an expert on this topic. Thus, I am writing more in the spirit of asking questions rather than making statements. Even the statements that I make here will be along the lines of “thinking out loud.”

I consider life precious. It is a gift. We have been admitted into the club of human existence. Regardless of the quality or circumstances of one’s life, just being born makes one fortunate. I am not naive. Some lives turn out badly. However, to be given a shot at life makes a person one of the elite entities in the history of (as far as we know) the universe. While the following sayings are not valid when taken to extremes, there is an element of truth when people say “I never had a bad day in my life” and “I’m great just as long as I’m on the right side of the grass.”

I think that suicide by an otherwise healthy person is an unnatural act brought about by mental illness. However, if a person is physically (not mentally) suffering and that person’s best days are definitely chronologically behind him or her, then it is understandable why one may want to end their lives.

The term “assisted suicide” is one of those “b.s.” semantic terms used to place a spin on a philosophy, like “pro-life,” “pro-choice,” and the agenda-laden “anti-choice.” Besides, “assisted suicide” does not account for the terminal nature of the lives of those who choose to end things. I know I just criticized re-naming things for “spin” reasons, but I think in the context of end-of-life issues, it might be warranted. Euthanasia, while a legitimate term, has become such a loaded word that it seems no longer appropriate. Besides, we euthanize cats, dogs, and horses, and those animals do not choose to end their lives. Humans need their own term, one that reflects the choice one has made to end their own suffering on their own terms. I am not sure what term to suggest. I have some mind, but I will refrain from writing them here.

Though I never was passionate about the issue, I had always considered ‘assisted suicide” wrong. Dr Kevorkian seemed a little creepy to me, like he was a little too into it. He was turning what otherwise should have been the ultimate moment of dignity for a person into a circus.

My mind changed on the subject when I had surgery a few years ago to try to correct my sleep apnea. The surgery involved trying to open up my nasal passages. I then understood why suffering, terminally ill patients would want to end it all. My suffering was so great that if I did not know that I would get better, I would have wanted to die.

What is a better way? Have the person sign a do not resuscitate (DNR), no breathing assistance and no feeding tube letter then fill them with morphine to ease their last days?

Somehow, I think that might be the way to go. Unless I am mistaken, that is what we are doing now. Maybe we need to let more people know they have that option.

I do not know the answers here. I am just asking questions.

Another aspect of this issue is the cost of end-of life care. I will cover that in my next posting.

I am Beginning Consider "Comitting a Gaffe" Laudable

I applaud the Vice President’s candor recently with regard to the swine flu. He said that right now he would advise his family to avoid planes and trains and any tight spaces. I am sure the airline and rail industries were not happy, but they are not the Vice President’s first obligation. His first obligation is to protect the health and safety of Americans. Lest one think that we have completely entered a new era of openness and responsibility in Washington, the attempted corrective spin on the part of president Obama’s press secretary was beneath comical. Robert Gibbs’ attempt to make things “right” (i.e. politically correct) was so pathetic that it elicited laughter from the otherwise Obama-phile press corps. They were not laughing with him. They were laughing AT him. You can see the video here: http://www.realclearpolitics.com/video/2009/04/30/gibbs_on_what_biden_meant_to_say.html

This reinforces the issue I raised in an earlier post. Just how responsible should our government be when it comes to protecting the lives of our citizens? We cannot just shut down the society, especially at this point. Restricting trade and travel right now is not warranted. However, the population should know the risks and decide for itself. The key is the authorities providing accurate and complete information. Accurate and complete information should not be held back just to avoid a “panic” or to avoid dampening the economy. Staying out of airplanes or trains is not a panic. That is a conscious, measured decision that one makes based on what is best for that person and his or her family. Our government owes the common person honesty. We can decide for ourselves what risks we want to take with our own personal lives.

Hospitals are seeing up to a 50% increase in emergency room visits by people who are afraid they have swine flu. Is that not a good thing? Does increased overall vigilance make it more likely that we will be able to contain the problem and avoid a pandemic?

To smoke or not?

I don’t get it. They get so happy to tackle a smoking problem in this article. I wonder who they surveyed. They should come and survey the kids in the cities. Half of the kids quit because they want to and I don’t think it’s inaccessibility to smoking paraphernalia that is the cause of the decline. If you want to smoke, you’ll find away to get around it. I worked in a store and older kids just buy it for the younger kids. In the Pennsylvania smoking law, no where does it say that minors are restricted from smoking, just says that they can’t purchase it. You can get arrested for selling cigarettes to minors but police can’t arrest the minors who are smoking, if they catch them smoking. That’s a twisted way of putting things into perspective. It’s like saying something but doing something else which defeats the whole purpose.
I live by a busy road, with a high school on its side and police cars driving by left and right. All the stores are near there, and the high school, middle school, and elementary schools are near to each other. So when the school lets out all the “should be” role models for the younger kids are smoking and they give it to them as they pass by. You see smoking groups by each store. Then you see the police, just ignoring them. I think if you use reverse psychology, you have more of a chance to make kids stop smoking, by allowing them to purchase it legally. They’ll get tired of it once it becomes readily available. I mean, the whole thrill other than the addiction of smoking is because you are doing something against what society deems you can’t. So kids are at the age where they like breaking the rules. If there is no rule, they have nothing to break and it’s not fun anymore. Smoking will not be cool anymore. In certain areas, sometimes having no rules is more effective than having rules to follow. I mean who follows rules anyway, if we fully abide by them, we’ll all be at the bottom of the social ladder. It comes down to that whether to smoke or not, it’s their choice.

Restrict late term abortion: A law?

My opinions are neutral in the abortion area. I think no one should suffer whether it is the baby, the mother, the healthcare personnel, or the families. However, abortion is needed if carrying the baby to term will jeopardize the physical and mental health of the patient. If the family has no means to provide for the baby and putting the baby up for adoption, in most cases, not a good idea. The kid would suffer through the system as sad as that sounds. This doesn’t mean I condone reckless behavior beforehand of the caused problem. Sometimes, a person’s irresponsibility shouldn’t be the cause of death of a life. I mean having a baby should be a joyous occasion; a lot of abortions are proving that feeling wrong. All these anti-abortion people, it’s funny that the most statements I read are from the men, I mean what do they know and don’t tell me it’s that someone who was close to them had an abortion and that changed their life. If you had an abortion, I would think that would change anyone's life. I think they stay by the idea without knowing anything else. I get why they are against it, not killing a life, personal morals, and for religious reasons. However, are they willing to endanger one’s life to save another?
Nowadays people are jumping to sue everyone left and right, and passing this bill would have added more to that list. No wonder some of the best doctors avoid practicing certain areas, because they are inhibited in the care that they can give, by the same people that they cared for. I think if they passed the bill, it wouldn’t change things, everything runs its course. Restricting certain laws in late term abortions just so you could sue, I mean doesn’t that defeat the whole purpose about saving a life. Most of the time, it ends up that obtaining money is the true face of abortion. People are still going to do abortions. The person who has the money will do it silently and the person who doesn’t have the money will find other means. Restricting abortion will result in more people dying. I think being more open about sex, will help decline the rate of abortion. If you want to prevent abortion, put your energy in educating people on prevention, be more open about sex education and hopefully make them realize the value of life. Sometimes, the causes for abortion are ridiculous such as for career reasons.

Artificial insemination:Natural process or not?

Some women get pregnant and they abort due to various reasons. The women who want to have a child can’t but now through artificial insemination women can get pregnant. However, the negative side of this is that with artificial insemination, you never know how many babies you will conceive. This results in having too many babies that won’t survive or sometimes the women get reduction done, meaning they kill off the number of babies conceived. Reduction most of the time is done for health reasons, because with more babies, the women and the fetus have a higher chance of being in danger. Even if 9 fetuses are carried to term, the woman needs a caesarian to get the babies out which will lead to complications. The babies who are born are weak and need extra care, some of them might not survive. In both cases having artificial insemination causes you to choose to have abortion. There is also the factor that with artificial insemination you are choosing the characteristics of your baby, it’s not naturally conceived.
Religious groups and anti-abortionists have a field day with this. Just from one procedure, there are too many deaths, not to mention the unnatural process to pick what characterisitcs you want in your child. What if someone wants to create a superior race as many as they want?Hopefully in the future they find a way to select how many you can conceive at a time. People don’t like surprises when they have to take care of nine kids all at once. For the people who are against abortion, they’ll risk it and carry the babies to term, which might put a strain on them. As with the case of the octuplet’s mom, Suleman, the healthcare professionals also have a duty to care for the health of the patient. In this case, the doctors were at fault because they let her follow through with a dangerous pregnancy. They shouldn’t even have let her have IVF if she already had six other children. I thought they underwent psychological evaluation before choosing these fertility options. Personally, I wouldn’t resort to artificial insemination on the basis that it is not natural, no matter how modern the world gets, there are some things you shouldn’t do. There are plenty of kids, who are not wanted out there, help them before you help yourselves. However, as much as artificial insemination is against my beliefs, other people may have that much desire to create a child by any means. It’s their choice in the end, and whatever is comfortable for them.

Congress, the Food and Drug Administration (FDA), and Dietary Supplements

The dietary supplement industry (vitamins, herbs) has bought off Congress to keep the FDA from regulating products that in reality are sold as drugs.

The dietary supplement industry is huge in the United States. A 2002 FDA survey concluded that 75% of Americans used dietary supplements (vitamin or herbal) within the previous year. That survey also concluded that 14.5 of Americans (a different survey said 20%) used herbal (non-vitamin/non-mineral, NVNM) supplements within the previous year. About 6% of Americans used NVNM supplements every day. The most used NVNM supplements were Echinacea, ginkgo balboa, garlic pills, ginseng and saw palmetto.

Before Congress got involved in 1994, the FDA regulated dietary supplements under The Federal Pure Food and Drugs Act (1906) and The Federal Food, Drug, and Cosmetic Act (FD&C Act) (1938). Under these laws, supplements were treated as food, and the FDA emphasized truth in labeling and safety.

In 1958, the FD&C Act New Food Additive Amendments added supplements to the items under FDA control. With these laws, all new food additives needed prior approval.

Everything changed in 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA). The new law removed dietary supplements from food category and created a new, separate, and essentially unregulated “dietary supplement” category. The DSHEA defined dietary supplements as “a concentrate, metabolite, constituent, extract, or combination of vitamins, minerals, herbs (or other botanicals), or amino acids used to supplement the diet by increasing the total dietary intake.”

“Dietary Supplement” implies nutritional content though many have none.

The Dietary Supplement Health and Education Act of 1994 created a facade of regulation but essentially stripped the FDA of all authority in regulating the claims these products. The FDA lost its ability to insure that these products actually are what they say they are. An example of this “regulation facade” is the requirement that the supplement industry “evaluate” pill composition. However, the industry is not required to report that evaluation to the FDA. The FDA also cannot require submission of efficacy and safety information prior to the pill going on the market. New supplements do not require FDA approval. The FDA can act only after a dietary supplement has been on the market and there is a problem. The law mandated only voluntary adverse event reporting. Prescription drug companies are required to tell the FDA about any problems possibly related to their drugs, but the supplement companies were not required to do so. The law also stipulated that the supplements could not claim to “diagnose, cure, mitigate, treat, or prevent illness.” However, the supplements do just that, along with a disclaimer that says, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Supplement labels make claims on the front of the label while showing the disclaimer less prominently on the rear of the label. Even worse, the Federal Trade Commission (which regulates all drug advertising outside of the control of the FDA) does not require the disclaimer in dietary supplement advertising.

Do you remember Ephedra? Between 1993 and 1997, over 800 Ephedra adverse event reports were made by doctors. As a result, in 1997, the FDA proposed a ban on ephedra but could not get supporting evidence. The FDA was not allowed to demand adverse event information or product samples. In 2000, the FDA finally bowed to Congressional pressure and dropped the ban proposal. In 2002, the government ordered a safety study. In 2003, some states banned Ephedra. After a 2003 high-profile pro-athlete death (a pitcher for the Baltimore Orioles), Congress finally was forced to allow the FDA to ban Ephedra in 2004.

In 2006, there was growing pressure from the public to regulate the dietary supplement industry. Therefore, Congress passed another law that was designed to give the appearance of protecting the American people but in reality was designed to help the dietary supplement industry. It was “the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.” In this law, the supplement industry gave an inch and took a mile. The new law said companies must report serious adverse events (a government term loosely defined here as a health problem resulting in death or hospitalization) along with a copy of the product label. The supplement companies were also required to keep records of (but not report) all non-serious adverse events for six years. The new law also required product labels to include contact information.

All of this sounds good on the surface, but the supplement industries got a lot more than they gave up. Companies were still not required to provide any information to the FDA before selling a supplement. The adverse event reporting rules result in only about 1% of all adverse events being reported to the FDA. If there is a serious adverse event, the supplement company does not have to send a sample of the product along with the report. The law also (and this is the biggie) prohibited states from regulating supplements in any way whatsoever. The companies still did not have to prove that their products were good, but the FDA still (if it wanted to act) had to prove the supplements were bad AFTER something happened. In the first year of serious adverse event reporting, 608 serious adverse events were reported (368 required reports from supplement companies and 236 from private citizens and healthcare workers). Previously, before the reporting requirement, the supplement industry said they never received any adverse event complaints against any of their products.

Still, the FDA is doing what it can. In 2007, the FDA issued “Dietary Supplement Current Good Manufacturing Practices.” While prohibited from going any further by law, the guidance covered design and construction of physical plants, manufacturing operations, quality control procedures, testing materials, consumer complaints handling, and records maintenance. However, the FDA cannot enforce these practices, and nothing still need be submitted prior to a supplement going on the market.

Because the FDA is not allowed to require it, there is little clinical evidence that these supplements are effective or safe. Some clinical trials have been done on dietary supplements, but lack of standardization leaves results inconclusive at best and meaningless at worst. A given herb has varying potency depending on where and how it was grown (weather, altitude, soil quality, sunlight exposure, etc.) and prepared. The National Institutes of Health said, “Most of the studies we examined do not provide strong evidence for beneficial health-related effects of supplements taken singly, in pairs, or in combinations of three or more....However, several other studies also provide disturbing evidence of risk, such as increased lung cancer risk with β-carotene use among smokers.”

The problem of the FDA’s lack of authority over the supplement industry is made worse by the public’s perception that the supplement industry is subject to FDA authority. The vast majority of Americans believe that supplements are approved by the FDA and are thus effective and safe. Further, the conflicting claims and disclaimers on product labels result in people believing what they want to believe. Studies that show a lack of effectiveness do not cause a nationwide decrease in supplement use. Only well publicized incidents relating to safety result in decreased use.

For the future, the U.S. General Accounting Office recommends that supplement companies be required to 1) Register as dietary supplement companies, 2) provide all supplement names with labels and 3) report all adverse events related to dietary supplements. The General Accounting Office also recommends that the FDA “educate consumers that it does not analyze and approve dietary supplements and seek more authority over supplements sold in U.S.”

I do not expect it to happen anytime soon. Money talks.


References
Sadovsky R, Collins N, Tighe A, Brunton S, Safeer R. Patient use of dietary supplements: a clinician’s perspective. Current Medical Research and Opinion. Vol. 24, No. 4, 2008, 1209–1216

Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Congress. Available at: http://www.fda.gov/opacom/laws/dshea.html [accessed March 3, 2006]

U.S. Food and Drug Administration. Dietary Supplements Overview. http://www.cfsan.fda.gov/~DMS/supplmnt.html Accessed 4/21/09

Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding. The U.S. Government Accountability Office http://www.gao.gov/products/GAO-09-250 Accessed 4/21/09

Public Law 109–462—Dec. 22, 2006 http://www.fda.gov/cder/regulatory/public_law_109462.pdf Accessed 4/21/06

AJ Perez. (2008, September 23). Dietary supplements cause 600 'adverse events' :First data since reporting law. USA TODAY,p. D.7. Retrieved April 22, 2009, from National Newspaper Abstracts (3) database. (Document ID: 1560768251).

Katherine Wong. (2007). New Mandatory Reporting Requirements for Dietary Supplements and Nonprescription Drugs Solve Very Little. The Journal of Law, Medicine & Ethics, 35(2), 336-339. Retrieved April 22, 2009, from Research Library database. (Document ID: 1334834441).

Sarah Lueck and Anna Wilde Mathews. (2003, December 30). FDA Is Expected to Ban Ephedra, Citing Supplement's Health Risks. Wall Street Journal (Eastern Edition), p. A.1. Retrieved April 22, 2009, from ABI/INFORM Complete database. (Document ID: 517744241).

Metabolife Praises FDA Withdraw of Proposed Ephedra Restrictions. (3 April). PR Newswire,1. Retrieved April 22, 2009, from ABI/INFORM Complete database. (Document ID: 52164278).
References

Timbo BB, Ross MP, McCarthy PV, Lin CT. Dietary supplements in a national survey: prevalence of use and reports of adverse events. J Am Diet Assoc 2006;106:1966-74

Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts. U.S. Food and Drug Administration. http://www.foodsafety.gov/~dms/dscgmps6.html Accessed 4/22/09

Report: FDA lacks authority over supplements – Without necessary resources, 'it's like the Wild West' USA TODAY (Arlington, VA) - Wednesday, March 4, 2009 Author: Elizabeth Weise: (c) USA TODAY

Bent S. Herbal Medicine in the United States: Review of Efficacy, Safety,
and Regulation J Gen Intern Med 23(6):854–9. 2008

Foote, J. Protecting Consumers in the Wake of the U.S. Dietary Supplement Health and Education Act. Journal of Allied Health , Spring 2007

Bent S, Ko R. Commonly Used Herbal Medicines in the United States: A Review
Am J Med. 2004 ;116:478–485.

NIH State-of-the-Science Conference Statement on Multivitamin/Mineral Supplements
and Chronic Disease Prevention. The National Institutes of Health. NIH Consensus and State-of-the-Science Statements Volume 23, Number 2. 2006

Tilburt J, Emanuel E. Does the Evidence Make a Difference in Consumer Behavior? Sales of Supplements Before and After Publication of Negative Research Results. J Gen Intern Med 23(9):1495–8 2008.


Plan A or B?

All this controversy surrounding two pills called Plan B, I wonder what happens to the rest of the population who have sex and don’t have access to Plan B. So now they made it readily available to women and men 17 years of age and over, so what, it is only going to be effective if you take it. It’s like other contraceptive methods; everything is there for you in plain sight, to protect yourself from an unwanted pregnancy but what’s the point if you are not going to utilize it. Teenagers severely lack the sexual education and most of them are not mature enough to make a decision or maybe they just don’t plain care. Parents are part of this too, encouraging kids too much by showing their lack of care in their kids’ activities and not restricting them in some cases. So far, kid’s decision making skills are poor.
We all went through that phase that we know everything and because the parents are providing for you, life is a breeze. It’s when the wind propelling that breeze cuts off, and you finally feel the weight known as reality. There has to be a better way to prevent teen pregnancies, and abortions. We just need to be more open about it and have to get through the barrier that the kids somehow can’t see through. The more you restrict the more challenging or wild it’s for teenagers. Kids think that having sex is the next step to adulthood, and when you’re hormones are running wild, it might be too addictive for some to control it. Also, why would you want to burden yourself with an extra person to care for when you can’t even take care of yourself?

Got milk?

I’ve been drinking milk all my life but never delved into what really goes into the process of store bought milk. If you are in most countries they don’t go through the whole food safety process that milks go through such as pasteurization and homogenized milk. They drink raw milk. I drank cow and goat milk before which didn’t go through any extra processes. The taste is different and according to experts, it contains better nutritional properties because you are not messing with its natural process. There is no injecting the cow with hormones, antibiotics, or putting them on a certain diet to increase the quality or the quantity of the milk produced. In this news story, they are trying to restrict raw milk from being in stores for health reasons. Some people got a bad case of raw milk that sent them to the hospital and now the agriculture police don’t want any in stores. I mean, any food handled without proper care is going to be poisonous to the body, doesn’t matter whether it passes through many safety processes or you just plain drink it straight from a cow.
It is the people’s choice whether they want to drink raw milk or not. You can get bacteria or diseases from anyone, don’t matter if they drink raw milk or not. Raw milk has more nutritional value than processed milk. It does have less of a shelf life. However, whether to consume it or not is up to the people. I mean not everyone can drive to a farm for fresh milk and if they are so worried, put a label on it to indicate a person’s right to drink the raw milk knowing that it might be hazardous to their health. They should be aware, I am assuming many people drink it based on having knowledge of what it is they are consuming. Restricting raw milk to certain places can hurt the people economically and take away their right to choose.

Mandating ultrasounds before abortion…

Abortion is a controversial topic for a lot of people. Some people see it as killing a living being. Others see it as a means to improve the health of the woman. As long as abortion is therapeutic meaning it is performed to save the life of a woman mentally or physically, for terminating pregnancies if the baby is going to be born with congenital disorders and who’s health is fatal or will lead to morbidity, and to prevent multiple births, if those births will be harmful to the woman and child.
Although many people yearly have abortions, more than a million according to the Alan Guttmacher Institute Statistics (AGI) in 2006-2007, it is their choice to make. Now, some states want to enforce viewing of ultrasounds before abortion even if the patient doesn’t want to see it. If they are comfortable with the abortion, there is no need to enforce ultrasound images on them when they don’t want to view it. Medical personnel can give them the choice to view ultrasounds to make sure they are making the right decision. However, it shouldn’t be mandatory. It would be uncomfortable for both the doctor and the patient. A person has the right to view or not view what they want. When they made the decision, they thought it through to prevent future complications. However, a life is a life, and anyone will preserve it even if it is against their better judgment. So if they view an ultrasound when they don’t want to see it, their judgment might be impaired due to wanting to keeps the life growing inside of them.
Instead of preventing abortions, they should educate people beforehand about the consequences of getting pregnant. Most of the reports from the Center for Disease prevention and control (CDC) indicate most of the abortions are done to girls less than fifteen years of age. There is something wrong with that number. Either people aren’t educating these kids or their parents just don’t care and it results in them getting an abortion. Instead of mandating ultrasounds for abortion after the cause, mandate educational approaches for prevention of the cause.

To live or let go?

Nowadays, we can’t even die peacefully without someone arguing over your life or death, mentally or physically. We all have a time to go, some sooner than others. Yes, you should die of natural causes, not by the help of something or someone else. In hospitals, you’re being kept alive by machines, so is it that you are on the brink of death, but something is keeping you here. Personally, I don’ think it is our decision to argue whether a person should live or die, especially a person who is immobile for 17 years. I don’t get why the government and other people related to this force this issue, maybe for political reasons. There are too many questions surrounding this, that I myself don’t even half an opinion. I mean other people who are alive and well are starving to death without any help from anyone. But the one who is dead mentally and physically are being force fed to live. I don’t see the logic in this. Yes, everyone should live, but let go, if someone who is related to them made a decision or themselves made a decision before their vegetative state to let them survive on their own without machines. It is much harder for the family than for the public to let go. It's not like they are making an irrational judgement. Each case is different and unique, what applies to one may not apply to the other. We don’t know how long someone might be in a coma. After a period of time, if you think to let go, let go. There are miracles out there of people waking up after spending years in a coma. That miracle might not be for everyone.

How tight is Airline Security in 2009?

Boca Raton, FL is home to Kenton Weaver, a 13 year old boy who suffers from autism. Kenton has always loved airplanes and dreams for one day becoming a pilot.

Kenton has been known to escape from home and attempt to travel to the airport. However, on a beautiful day in April Kenton finally made it to the airport. Only this time he was driving his father’s car. Kenton not only made it to the airport without putting a scratch on the car, he also flew all the way to San Jose, California with a couple of connecting flights. The worst part of this entire debacle is that Kenton never had an id only his report card that he used as his id.

According to Southwest Airlines, the boy “presented a valid ticket for travel and underwent security to board his flight”. In addition, the Transportation Security Administrations Web site states that under federal law, “only travelers 18 and older are required to show identification”. Southwest continued to state that minors are allowed to travel alone as long as an “Unaccompanied Minor” is completed. It was not confirmed whether or not this form was completed.

When you hear a story like this you wonder if people that work at airport really pay attention to what they are doing. If you were working for the airport, wouldn’t you find it a little strange that a 13 year old child is purchasing his own plane ticket, has no luggage and no one to fill out the “Unaccompanied Minor” form? It’s a little scary that airport staff does not use their instincts to realize when things don’t seem right. If a 13 year old boy fooled the system anyone with a good plan could fool the system.

Coloring Book Helps to Teach Kids About Tragedy

A coloring book with burnt out cars, buildings on fire and tornadoes does not sound like a coloring book that many parents would give to their children to color. However, this coloring book was posted on the Federal Emergency Management Agency’s web site.

The coloring book was posted on FEMA’s web site after the 9/11 attacks. The purpose of the coloring book was to help children cope with anxiety and fears that they may have had from their experiences of 9/11. However, the coloring book was removed from the website last week from FEMA’s web site.

The coloring book was created in Minnesota, by the Freeborn County Crisis Response Team. According to Rose Olmsted, a representative from the response team, “I’ve never received any criticism of the book until yesterday. “Everything we’ve heard in terms of feedback had been positive”.

This coloring book and others like it have been used for other disasters. In 2007, after the Minnesota bridge collapse a coloring book was used to help children. Australia also used a coloring book for their children after the wildfires.

Art therapy is often used to help children that have gone through traumatic events in their life. The therapy helps child to express their feelings that they often suppress after a scary experience such as 9/11.

However, a L.A. based psychologist stated that “while she does see coloring as an effective coping mechanism for children who have experienced traumatic events, she warns against one tool being used too broadly”.

If your child experienced 9/11, as a parent you would have to decide what you felt was the best method of therapy for your child. I believe that art therapy can be extremely effective in children. However, I am not sure whether or not I would want my child coloring pictures of burning buildings or burnt out cars. All children are different and all children cope with traumatic events differently. Therefore, I agree that the coloring book should not be used to help treat all children. I feel as though the help of a professional art therapist would be the best solution to the problem.

Insurance Company Denies Claim After a Woman’s Husband is Murdered

Last year, Curtis McCraw was gunned down and murdered. The insurance company in which he has a $25,000 life insurance policy with is denying the claim which would be paid to his widow Stephanie McCraw.

Stephanie McCraw filed a suit against the Insurance Company stating the reason they denied the claim was because her husband had Hepatitis C. According to McCraw’s lawyer, “The policy is not specific as to whether there is a difference as to how you die. It does not event say you won’t get paid if you have a pre-existing condition”.

Curtis McCraw was gunned down last April outside of a housing project. The police declared his death a case of murder and was declared dead at the scene. Even though the police declared his death a murder the Insurance Company continues to fight the claim.

President, Michael Lowe of the company stated that “The law in Tennessee is clear that the cause of death is not relevant. What is relevant is whether the insured truthfully informed the company of his health at the time of his death”. The president continued to explain that under law the company has two years to contest the information that was provided to the company from the insured. If the company finds that the insured did not fully disclose his health history, the company has the right to rescind the policy.

At my previous job, I worked for The Hartford Insurance Company. The Hartford Insurance Company is a very ethical and trustworthy company whose best interest is their customers. Therefore, it blows my mind that a company would try and weasel there way out of this claim. It is clear that the man was gunned down and murdered. That was his cause of death not hepatitis. The actions of the insurance company could severely affect their reputation, especially in this type of economic climate. I would suggest that the insurance company pony up and pay the poor woman. If the company suspected that the customer was lying about his health, the company should have requested a blood test to be completed.

Thursday, April 30, 2009

Post Marketing Surveillance…No wonder doctors are skeptical to the point of confusion

For another class, I had to write a paper on the safety of statins (you’ll see why in the second paragraph). (But for now – a little background)…Statins are well established first-line drugs for the treatment of hypercholesterolaemia and dyslipidaemia implicated in the pathogenesis of coronary heart disease and atherosclerosis.1 Stains lower cholesterol levels by blocking the enzyme HMG CoA (don’t worry about the acronym for now) in the liver involved in the synthesis of cholesterol.2 There are five drugs (use to be 6 – again, second paragraph) in this drug class – each associated with certain toxicities (particularly myopathy) which may lead to a debilitating condition called rhabdomyolysis.3-5 One problem is, statin-induced myopathy is not well understood.1, 6-8 The other problem is, rhabdomyolysis is a rare muscle wasting disorder that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. If unchecked, this could lead to renal (kidney) damage. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The muscle groups involved most frequently are the calves and lower back; however, some patients report no symptoms of muscle injury. The FDA states “in rare cases” (this probably came from the product information or package insert – can’t remember what they are calling it these days – you know, the PI) the muscle injury is so severe that patients develop fatal organ damage, including renal failure.9

The controversy (here we go) over statin use stems from Bayer Pharmaceutical’s voluntary withdrawal of Baycol®/Lipobay® (cerivastatin) in August 2001.10 Bayer received numerous reports of side effects involving muscular weakness, particularly in patients treated concurrently with gemfibrozil. Subsequently the FDA reported 31 deaths associated with cerivastatin use; 12 were associated with concurrent use with gemfibrozil.9 (What happened?) In 1997 the FDA approved cerivastatin labeling for 0.2 – 0.3 mg/day; in 1998 0.4 mg/day; and in 2000 0.8 mg/day was approved without recommendations for a maximum dose.5, 11 However, reports indicate that many physicians prescribed cerivastatin at 0.8 mg/day instead of starting at the lower dose then titrating up.5 Furthermore according to an FDA report, the rate of fatal rhabdomyolosis associated with cerivastatin is up to 80 times as high as the rates for any other statin.5 Also, concomitant medications are pervasive in statin-patient populations with high-risk factors for cardiovascular mortality. Therefore, the risk of drug-drug interactions (DDI) is quite high.

What caught my attention was a report by Psaty et al (2004) who stated that internal company reports from Bayer, specifically case reports, suggested cerivastatin-gemfibrozil DDI data was available within 100 days of the 1998 drug launch; yet the company did not add contraindications about concomitant use to the product information until 18 months after launch.11 (Okay – they knew there was a potential problem but they waited for…what to report it)? According to a 2003 European news report, Bayer fought back (of course they did!) against “claims that it was aware of possible dangers long before the drug was voluntarily withdrawn…”12 Yet, Bayer paid out $125 million to 450 individuals who experienced “serious side effects” and was in negotiations with another 500 cases through 2005.10

Ultimately, who is responsible for post-marketing surveillance? Drug companies! Pharmaceutical companies are responsible for conducting their own post-marketing trials but this is usually more beneficial to the company than it is for the safety of patients. Post-marketing trials are usually conducted to expand the label: new indications, new patient populations (e.g., children), and voila patent extension. Physicians are also responsible to report adverse drug events to the FDA – however, this is voluntary. In collaboration with the FDA’s, CDER, division of pharmacoepidemiology, safety data is gathered and shared with the product firm and an agreement is reached with the firm to determine the next step. In essence, the responsibility to pull a drug lies with the company in question; the FDA may “support” the decision and in some cases engage in litigation when companies do not comply with specific FDA recommendations. Confusing?

How must doctors feel? One minute a drug is on the market and being marketed aggressively then the next its being recalled. One minute a drug is deemed safe and “well tolerated” by patients and the next it could be a lethal weapon. Let’s face it, drugs (I do mean drugs, plural) are a necessary part of life (so is food and yes, cosmetics, too for many of us). But who is ultimately accountable for ensuring, beyond a shadow of doubt, that what we put in and on our bodies will not cause harm (including death)? Surely, drug companies cannot be the sole bearers of responsibility – for reasons, shall we call it, conflict of interest…! Then the government needs to do its job and be allowed to do its job by expanding resources which means more money more money more money…! Less we forever ride the roller-coaster of post-marketing surveillance.

Holly Tomlin
Blog 9

References

1. Tiwari A, Bansal V, Chugh A, Mookhtiar K. Statins and myotoxicity: a therapeutic limitation. Expert Opin Drug Saf. 2006;5(5):651-666.
2. Evans M, Rees A. Effects of HMG-CoA reductase inhibitors on skeletal muscle: are all statins the same? Drug Saf. 2002;25(9):649-663.
3. Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114(25):2788-2797. Epub 2006 Dec 2711.
4. Moride Y, Hegele RA, Langer A, McPherson R, Miller DB, Rinfret S. Clinical and public health assessment of benefits and risks of statins in primary prevention of coronary events: resolved and unresolved issues. Can J Cardiol. 2008;24(4):293-300.
5. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med. 2002;346(7):539-540.
6. Smogorzewski M. The myopathy of statins. J Ren Nutr. 2005;15(1):87-93.
7. Jamal SM, Eisenberg MJ, Christopoulos S. Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme A reductase inhibitors. Am Heart J. 2004;147(6):956-965.
8. Strippoli G, Navaneethan S, Johnson D, et al. Effects of statins in patients with chronic kidney disease: meta-analysis and meta-regression of randomised controlled trials. BMJ. 2008;336:645-651.
9. FDA. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01095.html; 2001.
10. Bayer Withdraws Baycol/Lipobay. PR Newswire; 2001.
11. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. Jama. 2004;292(21):2622-2631. Epub 2004 Nov 2622.
12. Milmo S. Bayer Defends Itself on Baycol. Chemical Market Reporter. 2003;263(9).

Wednesday, April 29, 2009

Red Wine and Heart Disease: A Riddle Wrapped in an Association – Not Causation

In 1991, the widely popular CBS television news show, 60 Minutes, featured a story that attributed the lower risk of heart disease in France to drinking red wine. Since the original story aired, red wine sales skyrocketed1 along with the public’s consumption of the beverage and thirst for evidence about this proposed cardioprotective effect. Seemingly everyone attempted to “cash in” on the phenomenon, particularly red wine producers2 and nutrition “experts” who marketed the nutritional value in books like the New York Times Bestseller, French Women Don’t Get Fat by Mireille Guiliano (2004 hardcover; 2007 paperback). Earlier this year CBS followed-up on the 1991 story with additional information about the so-called French Paradox.3 The “French Paradox” refers to the low rate of cardiovascular mortality in France compared to the United States despite a high fat diet.4-6 The term “French Paradox” comes from the work of an Irish physician, Dr. Samuel Black (1891), interested in the observed differences in angina pectoris in Irish patients compared to the lack of discussion about coronary diseases in French patients.7 More than a century after Dr. Black’s query, evidence of biological mechanisms for cardioprotective effects continues to emerge – slowly; yet, the momentum has not died down in the popular media where the focus is primarily the medium of ethyl alcohol (ethanol) and red wine.

The truth is epidemiologic data demonstrates an association between heart disease, health and nutritional benefits, and alcohol and red wine consumption5, 6 but the association has been misinterpreted as causally related to heart disease. While biomedical research systematically explores the relationship between red wine and heart disease by exploring the biological pathways associated with cardiovascular risk factors (e.g., obesity, diabetes, blood pressure) as well as outcomes (e.g., heart attack or myocardial infarction, death), conclusive evidence for human benefit is lacking. Yet, a lack of evidence has not stopped the paucity of marketing campaigns postulating the benefits of red wine or the benefits of resveratrol (as a nutritional supplement or pharmacologic agent) for a healthy heart, anti-aging, or to combat cancer (all types of cancer).5, 8

Resveratrol is a polyphenol found on the skin of red grapes which protects the grape from bacteria and fungi. The compound is available in detectable quantities of red wine because skins of grapes are not fermented in the production process. In vitro data for resveratrol in human tissue and in vivo mice models of obesity, cardiovascular disease, and anti-aging effects is positive;9 however, its effects are the subject of ongoing clinical investigation in humans (see clinical trials.gov for a list of 10 active trials studying resveratrol). Numerous academic institutions and pharmaceutical companies such as Sitris, a Glaxo-Smith Kline (GSK) company, have jumped on the resveratrol-anti-aging/anti-cancer/anti-obesity/decreased-heart-disease-band wagon. As such, resveratrol has been isolated and marketed as a dietary constituent despite repeated warnings from the FDA to cease selling the product as a pharmacologic agent since there are no definitive results from clinical trials.8 In fact, there are warnings against purchasing resveratrol on many sites linked to Google.

Although alcohol has a well documented cardiovascular pathway, its pathway is independent of beverage type (i.e., wine, beer, or other alcoholic spirit).10, 11 The cardioprotective effects of alcohol includes increased high-density lipoprotein (HDL), antithrombotic effects, improved endolethial function, and decreased insulin resistance.5, 6, 10, 11 These effects, however, are confounded by individual characteristics such as gender, race, age, quantity, and type of alcohol (e.g., beer may be more beneficial for men while wine or a distilled spirit may be more beneficial for women).

Established risk factors for heart diseases include smoking, systemic hypertension, type II diabetes, blood lipids, atherogenic lesions, and thrombosis damage.6, 7 Both alcohol and red wine polyphenols antioxidant properties have antithrombotic and antiatherogenic action as well as significant impact on blood lipids (HDL and LDL); however, their association to other risk factors is confounded by intake and lifestyle variables. Alcohols’ positive impact on acute physiologic events (such as high blood pressure and heart rate) is a plausible explanation for the heightened interest in the association between alcohol, red wine, and heart disease. These findings excite nutrition proponents who fail to understand that red wine and alcohol independently impact heart disease risk factors; in fact, the non-alcohol related benefits (e.g., resveratrol) can be found in non-alcoholic beverages such as grape juice, other fruits and vegetables. Furthermore, the amount of property relates significantly to the benefit such that alcohol in large quantities has equally harmful consequences.


Fortunately, biomedical researchers, pharmaceutical companies, and legitimate organizations such as the American Heart Association are not marketing red wine or alcohol as beneficial mechanisms to decrease heart disease. In fact, it appears that only independently owned organizations such as Nutra-Smart.net by Stuart Adams or Bio-Medicine.org use evidence of an association between moderate alcohol consumption and acute cardioprotective benefit as explanations for the French Paradox while purporting causal relationships. Therefore, in light of the complex evidence for mechanisms of heart disease as well as the multiple pathways for alcohol and non-alcohol benefits people should be leery of the hypothesis that red wine decreases heart disease. Since alcohol consumption to the point of abuse represents a problem for a significant portion of American adults,12 it is not wise for popular news to continue promoting red wine consumption as a legitimate benefit for a healthy heart. Instead, promoting a low-fat diet with fruits and vegetables and exercise is a much more responsible message.

Holly Tomlin
Blog 8

References


1. McGraw A. Wine drinkers spark up sales. Central Penn Business Journal. 1995;11(5).
2. Dolan C. Marketing: Wineries and Government Clash over Ads that Toast Health Benefits of Drinking. The Wall Street Journal, 1992.
3. Fountain of Youth in Wine Rx. Jan 25, 2009, 2009.
4. Opie LH, Lecour S. The red wine hypothesis: from concepts to protective signalling molecules. Eur Heart J. 2007;28(14):1683-1693. Epub 2007 Jun 1687.
5. Saiko P, Szakmary A, Jaeger W, Szekeres T. Resveratrol and its analogs: defense against cancer, coronary disease and neurodegenerative maladies or just a fad? Mutat Res. 2008;658(1-2):68-94. Epub 2007 Aug 2017.
6. Saremi A, Arora R. The cardiovascular implications of alcohol and red wine. Am J Ther. 2008;15(3):265-277.
7. Klatsky AL. Alcohol, wine, and vascular diseases: an abundance of paradoxes. Am J Physiol Heart Circ Physiol. 2008;294(2):H582-583. Epub 2007 Dec 2014.
8. FDA. Warning Letter (09-ATL-01). In: Services DoHaH, ed; 2008.
9. Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006;5(6):493-506. Epub 2006 May 2026.
10. Pearson TA. Alcohol and heart disease. Circulation. 1996;94(11):3023-3025.
11. Sato M, Maulik N, Das DK. Cardioprotection with alcohol: role of both alcohol and polyphenolic antioxidants. Ann N Y Acad Sci. 2002;957:122-135.
12. CDC/NCHS, Survey NHI. Figure 31. Cigarette smoking and alcohol use among young adults 18-29 years of age, by sex: United States, 1997-2006. In: Health US, ed: CDC; 2008.

Monday, April 27, 2009

Health in the News is not the Health News

The media distorts the nature of our country’s challenges, especially those pertaining to our public health. One of those challenges is what the government calls “homicide by discharge of firearms.” While it is a more prevalent cause of death for certain demographic groups (I will use age as an example), firearms homicide is far from the predominant cause of death in society as a whole. When it comes to protecting the life and health of our citizens, several other health issues are much more important than firearms homicide. My intention here is not to defend guns as much as shed light on how the media emphases different public health issues disproportionately to the issues' true effects on society.

Here is the CDC’s list of the leading American causes of death for 2005 (all statistics in this article are from 2005):

Top Death Causes (Actual #) (% of Total)
All causes (2,448,017) (100.0)
Cardiovascular disease (856,030) (35.0)
Cancer (559,312) (22.8)
Cerebrovascular diseases (143,579) (5.9)
Chronic lower respiratory diseases (130,933) (5.3)
Diabetes mellitus (75,119) (3.1)
Alzheimer's disease (71,599) (2.9)
Non-transportation accidents (69,368) (2.8)
Influenza and pneumonia (63,001) (2.6)
Motor vehicle accidents (45,343) (1.9)
Kidney failure (42,868) (1.8)
Infection (34,136) (1.4)
Suicide (32,637) (1.3)
Chronic liver disease and cirrhosis (27,530) (1.1)
Hypertension / hypertensive renal disease (24,902) (1.0)
Parkinson's disease (19,544) (0.8)
Lung Tissue Inflammation (17,129) (0.7)
Human immunodeficiency virus (12,543) (0.5)
Homicide by discharge of firearms (12,352) (0.5)

Granted, the above data is for the entire population and is skewed toward natural causes and disease because of the inclusion of the elderly.

However, if we isolate the age group with the highest number of firearms homicide victims, firearms homicide is still far from the number one cause of death. Just as the general population numbers are skewed by the elderly against firearms homicide, the numbers for ages 15-24 are skewed in favor of firearms homicide (plus auto and other accidents) because of this group’s superior overall physical health and lack of world experience. In plain language, when people between the ages of 15 and 24 die, it is least likely from natural causes and most likely from their own stupidity.

Top Death Causes Ages 15-24 (Actual #) (% of Group)
All causes (34,234) (100)
Motor vehicle accidents (10,908) (31.9)
Homicide by discharge of firearms (4,499) (13.1)
Non-transportation accidents (4,465) (13.0)
Suicide (4,212) (12.3)
Cancer (1,717) (5.0)

This 15-24 age group is an extreme example. While the number of firearm homicides is unacceptably high for this age group, where is the outcry over the number of deaths from motor vehicle accidents? While a discussion about outlawing cars would be absurd, why is there not a similar (let alone a greater)media lust for traffic safety as there is for gun control? Why is it that motor vehicle accidents kill twice as many people as firearm homicide, yet the latter is hyped up in the news while the former is not?

To put it in perspective, let us look at an age group that 1) eliminates the very young and very old outliers and 2) has the firearm homicide death rate (4.6 per 100,000) closest to the firearm homicide death rate for the entire population (4.2 per 100,000). That age group is 35-44.

Top Death Causes Ages 35-44 (Actual #) (% of Group)
All causes (84,785) (100)
Cardiovascular disease (15,852) (18.7)
Cancer (14,566) (17.2)
Non-transportation accidents (9,624) (11.3)
Motor vehicle accidents (6,748) (8.0)
Suicide (6,550) (7.7)
Human immunodeficiency virus (4,363) (5.2)
Chronic liver disease and cirrhosis (2,688) (3.2)
Diabetes mellitus (2,045) (2.4)
Homicide by discharge of firearms (2,010) (2.4)

Going by the statistics for this demographic group, if the primary motivation of the media was the welfare of Americans, then there would be over three times as many stories in the national news about traffic safety as there were about firearm homicide. There would also be three times as many stories about suicide as there were about firearm homicide. One would think there might be at least twice as many (let alone eight times as many) stories about cardiovascular disease as there were about firearm homicide.

It is pretty safe to say that is not the case.

It would seem that the media is less motivated by the health, safety, and well-being of the American people than it is motivated by a hatred of guns.

Here is one last point, to emphasize that I am not defending gun violence but attacking what the media chooses to emphasize. During the darkest days of the Iraq war, the media howled incessantly about our soldiers dying in Iraq, while a much worse slaughter was happening here at home. In 2005, 673 Americans were killed in action in Iraq, while 18,124 Americans (27 times that number) were firearms homicide victims here at home. Relying on the media, one would not have realized that.

The lesson here is, when it comes to health news (and all news in general), view the stories that the media chooses and thus emphasizes with a great deal of skepticism.


Sources
Kung HC, Hoyert DL, Xu JQ, Murphy SL. Deaths: Final data for 2005. National vital statistics reports; vol 56 no 10. Hyattsville, MD: National Center for Health Statistics. 2008. http://www.cdc.gov/nchs/data/nvsr/nvsr56/nvsr56_10.pdf Accessed 4/25/09

United States Department of Defense. Global War on Terrorism - Operation Iraqi Freedom
By Month http://siadapp.dmdc.osd.mil/personnel/CASUALTY/oif-total-by-month.pdf Accessed 4/26/09

Sunday, April 26, 2009

Homeland Security? For Swine Flu?

I watched the press conference today in which the Homeland Security Secretary, Janet Napolitano, was coordinating the United States’ Swine Flu efforts.

From its inception, the Department of Homeland Security has been chargrd with taking the lead in a pandemic (which we do not yet have). I need convincing that this is the best policy.

Not only does a DHS Secretary lack the medical qualifications and expertise to lead the planning for this possible crisis, but this takes her attention away from the whole reason her position exists—protecting the United States from terrorism. The message is that we are not offering the most appropriate response in one area of concern while taking our eye off the ball in another area of concern.

She has been put in charge over the Cabinet Secretary (or actually Acting Secretary—that this position is still not officially filled three months into the administration points to another problem) whose assumed area of expertise is in the current area of concern—public health. The DHS Secretary was placed in charge over the Department of Health and Human Services (HHS) Acting Secretary Charles E. Johnson and the various agencies under his direction, including the Centers for Disease Control.

The Department of Homeland Security was created specifically to guard against terrorism on U.S. soil. Being the DHS Secretary requires one’s area of expertise to be protecting the U.S. against terrorism. If her area of expertise is in health rather than terrorism, then why is DHS Secretary in charge of health policy? One can argue that a possible pandemic IS a matter of domestic security, but that is wrong, especially at this juncture. The Department of Homeland Security should only become involved only if a pandemic had caused a breakdown of society with the resulting chaos placing the country’s infrastructure and citizens at greater risk of terrorism. We are not even near that situation, but even then, the DHS Secretary would not have the lead but be one of many considerations. Instead, a Department Secretary whose supposed area of expertise is not even in the area of current concern is in charge of Secretaries who are better qualified to handle the situation than she is.

Saturday, April 25, 2009

Swine Flu and the Right Thing to Do?

The outbreak of swine flu in Mexico (which has spread to the U.S.) raises some difficult questions.

As of this writing early Saturday evening (4/25/09), news outlets were reporting that 20 to 80 are dead in Mexico with over 1000 infected, and 0 dead in the U.S. with roughly 15 infected (California, Texas, Kansas and New York). The Mexican president has declared an emergency, giving himself broad powers to impose quarantines and cancel events. The Mexico City government has closed school indefinitely and canceled other activities involving gatherings. This strain of swine flu does not kill only the very young or very old. An unnamed Mexican government source claimed most of the dead there are between 25 and 45 years old.

I am not an expert in the spread of disease, so I do not know if it is too late for travel and trade restrictions, should conditions in Mexico deteriorate to the point where they may be needed. When should health-related travel restrictions be placed between countries, essentially placing a country under quarantine? A pre-mature travel ban could spark cries of racism or xenophobia. If a travel ban should be necessary, will authorities wait longer than they otherwise would out of racial or diplomatic sensitivity? Feelings and pride are irrelevant when lives are at stake.

There are other questions. What are the rights of private citizens to move around and conduct commerce vs. society’s right to be protected from the spread of disease? How far should worldwide swine flu conditions have to deteriorate before the World Health Organization (WHO) declares a pandemic? A pandemic declaration by the WHO asks for voluntary worldwide trade and travel restrictions. With the world economy already in shambles, there will doubtless be pressure to postpone a pandemic declaration as long as possible. Some countries would comply, while others would not. What actions should be taken against countries that are not complying and are thought to be endangering other populations?

If we are fortunate, we will not have to learn the answers to these questions.


Sources
http://in.reuters.com/article/oilRpt/idINN2443181920090424
http://www.bloomberg.com/apps/news?pid=20601087&sid=aEsNownABJ6Q&refer=worldwide
http://www.alertnet.org/thenews/newsdesk/N24449988.htm
http://www.breitbart.com/article.php?id=D97PNI383&show_article=1

A Non-Religious Case against Abortion

I have concluded that abortion is wrong, but my reasons are not based on religion. Don’t get me wrong. Unlike the specious Bill Maher, I am not anti-religion. However, “the Bible says so” is not an acceptable basis from which to argue a point. While I am religious, my conclusions about abortion are based on humanistic and (yes) secular considerations.

First off, life begins at conception. Once the egg is fertilized, a chain of events is unleashed that, outside of malformation, medical problems, homicide or accidental death, invariably result in a fully formed adult human.

From conception through their mid-teens, human beings are in a constant state of physical development, gaining physiological capabilities and self-sufficiency. Not being fully physically developed is not an acceptable rationale for discounting one’s humanity. Does a pre-pubescent inability to reproduce make a child any less human? Does a baby’s inability to walk or speak make her any less human? Does not having teeth make an infant any less human? Does an infant’s inability to feed or defend himself make him any less human? Does having a soft skull make an infant any less human?

Of course, it does not.

By that rationale, not breathing air but getting nutrients from an umbilical cord does not make a baby any less human. Not having fully formed eyes does not make her any less human. Not having a fully developed brain does not make him any less human. Thus, development at any stage, including nascent development, does not make a person less human.

Human beings are physically dependent on their parents (especially, and increasingly so in modern times, their mothers) for nutrition and protection to varying degrees from conception through their mid-teens. A ten-year old depends on her parents for protection (no one is inclined to go to extremes to protect a child as is that child’s biological parents) and the means to acquire food. A five year old depends on his parents for protection and nutrition (lacking the means and knowledge to acquire proper food, both today and in prehistoric times). A six month old is dependent on her parents for protection and nutrition (mother’s milk or formula). In the same way, a person in utero is dependent on her mother for nutrition and protection from conception to birth.

It is intellectually inconsistent that society charges parents with the responsibility of providing nutrition and protection to their post-utero children but not in utero.

Many people mistakenly think that a child in the beginning is not human but a mere glob of cells. Let us look at in utero child development.

In a previous blog, I wrote about how genetic testing of fertilized eggs is now used to pick traits in children such as eye color, skin pigmentation, hair color, sex and more. If those traits are already determined in a fertilized egg, it is difficult to argue that the egg, zygote, fetus, or whatever one wants to call it, is non-human. While not yet manifested at this age, the child’s traits, including eye color, hair color, sex and even (to a large extent) personality are set. He or she is more than mere nondescript cells.

For some reason, pregnancy is officially calculated as starting on the first day of the woman’s last period, though conception generally takes place two weeks after that. Thus, most discussions of child development are misleading, since people are left with the impression that the child is two weeks older then he or she really is. In reality, the child initially develops and manifests widely known human characteristics much more quickly than people are led to believe. Therefore, I am going to describe child development in terms of “weeks after conception” instead of the common (and in my opinion, misleading) “gestational weeks.”

The first week begins with conception, and the child instantly starts to grow new cells as she travels down the fallopian tubes and lands in the lining of the uterus.

In the second week after conception, the child continues to grow new cells that divide into different groups, laying the initial groundwork for different areas of the body.

In the third week after conception, the child’s heart, spine and brain begin to form, though he is only 1/25 of an inch long. (This is about the time generally when a woman is missing her period and suspecting an unplanned pregnancy.)

In the fourth week after conception, while she is not more than of an inch long, the child’s heart starts to beat, pushing her own blood around her own circulatory system.

In the fifth week after conception, the mouth and digestive system are beginning to develop. Arms, legs and hands are starting to form. The baby is roughly 1/8 of an inch long.

In the sixth week after conception, the baby is about 1/3 inch long, and the eyes and nostrils are developing. Fingers, toes, and genitalia are beginning to develop. (Roughly, 62% of abortions are performed by this time (8 weeks gestation)).[1]

In the seventh week after conception, fingers and toes are taking shape, and the baby is at least ½ inch long.

In the eighth week after conception, the internal organs (including testes or ovaries) are all formed and the baby is about 1 inch long.

In the ninth week after conception, the baby is 2 inches long, and his skeleton is developing.

In the tenth week after conception, the genitalia are identifiable and sex is distinguishable.

In the eleventh week after conception, the baby is 3 inches long and has fingernails and toenails. (Roughly, 88% of abortions are performed by this time (13 weeks gestation)).[1]

There are many social and economic reasons why women feel compelled to abort their children. However, whatever motive one has for aborting a child, one cannot claim that abortion does not kill a human being. It does. An aborted baby is more than a discarded glob of random, unorganized cells. "It" is a dead human being.


References

[1] Abortion Surveillance — United States, 2005. Centers for Disease Control and Prevention. November 28, 2008 / Vol. 57 / No. SS-13. http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5713a1.htm Accessed 4/24/09

Fetal development: What happens during the first trimester? Mayo Clinic. http://www.mayoclinic.com/health/prenatal-care/PR00112/METHOD=print Accessed 4/24/09

Pregnancy calendar. Nemours. http://www.nemours.org/e-service/kidshealth.html?p4if_ps=102 Accessed 4/24/09

Thursday, April 23, 2009

¿Tu hablo inglés?

What did you say? ¿Cómo? Many hospitals, emergency rooms, clinics, and healthcare personnel must deal with language barriers every day. With the numbers of immigrants in the United States increasing rapidly, the need for translators also increases dramatically. But, it seems that the lack of translators is not the problem, as is the doctors’ attitude towards using translators. In the article, “Lost in Translation,” physicians admit to not using translation services because it takes too much of their time, which can be used for more time with more patients. They admit to having a negative attitude toward employing translators when visiting patients in the hospital, even surgical patients. Dr. Pauline Chen, author of the article, when meeting with a Spanish-speaking patient after performing kidney transplant surgery, admits, “Pressed for time and acutely aware that a couple dozen more patients were always waiting, I never called an interpreter to Armando’s room during my daily rounds after his operation. Although interpreters were available at all times, it would take time, I thought, for one to arrive, and then the translation itself could slow things down.”

The article reports that there has been numerous research studies conducted on the use of translators and the effect of language barriers in healthcare. “…according to a new study published in The Journal of General Internal Medicine, doctors’ assumptions about communication — what they deem important in a conversation — may also have a role.” Dr. Chen says that although she would use translators to speak with patients about lab results, potential complications, or medication regime, she did not use them for “more routine checks.” She admits to “getting by” by feebly stumbling “through three, maybe four, words of Spanish.” In the recent study published by the Journal of General Internal Medicine, Dr. Alicia Fernandez and her research team at the University of California, San Francisco, studied language barriers at two hospitals with “excellent translator services.” Her study found that “While the doctors acknowledged that they were underutilizing professional interpreters, many made the decision not to call an interpreter consciously, weighing the perceived value of patient information against their own time constraints. Moreover, despite their personal misgivings, the doctors often felt that this kind of shortcut was acceptable and well within the norms of their professional environment.”

It seems clear from the results of the study that many physicians are bothered by the need for translators and see them as irrelevant and a waste of time. But what does this say about their attitude toward the patient? Does not their attitude toward using translators emote an attitude of resentment toward non-English-speaking patients? Do they not value their quality of life the same as those of English-speaking patients? Is it not the creed of physicians to “first do no harm,” regardless of race, creed, or in this case, language? Dr. Fernandez even admits about herself that she if “‘rounding late at night, (I) might just decide not to use an interpreter.” Through conducting this study, Dr. Fernandez realized that not employing the use of translators “‘…has become an acceptable shortcut in care. But the truth is that the patient deserves to speak to the doctor as well.’” She admits that this negative attitude towards using translators is not reflective of their feelings toward translators, their patients, or even their time pressures, but “yet “how we (as doctors) think about communication with our patients.”

According to the study, 43 percent of people in California do not speak English in their homes. So, the use of translators in a medical setting is critical to their ability to communicate with almost half of the California population. Too, not only does the doctors’ lack of translator use cause a problem, but the study also cites costs of translator services as a cause. Acknowledging this issue, Dr. Fernandez reports that “…many doctors simply do not have access to basic interpreter services…(however) California recently passed an unprecedented law mandating that health and dental plans supply interpreters and translated material to H.M.O. and P.P.O. patients.” Although this law may be a positive step towards increasing the number of translators in a medical setting, the article reports that “…still leaves a growing segment of the population – more than 20 million people in the United States – with inadequate care.”

If we are to improve quality of care for all United States residents, congress must acknowledge the growing need for quality healthcare for every one, even those non-English-speaking people. But where in the long line of problems with healthcare does the need for translators fall? With all the issues with healthcare today, including the millions of people without healthcare insurance, rapidly increasing nursing shortages, and the FDA coming under fire for controversial drug approvals, where does the effect of language barriers on quality of life fit in? What gets first priority? Not to knock language barrier problems or FDA drugs, but as one without healthcare insurance, I hope it is first in line. But that’s just my selfishness showing. Forgive me, I am working on it.

Monday, April 20, 2009

Poor Justice for the Innocent

Living a Life Sentence

Kelly Cobiella

CBS Sunday Morning

April 19, 2009

 

Anything can happen to anyone at anytime and good things do not always happen to good people. One of the worst nightmares that can happen in a person’s life is to be falsely imprisoned and, even worse, executed. But this recurring nightmare has been experienced by thousands of people through the years. Some spend the remainder of their lives in prison, never returning to the life they once knew. Thanks to the breakthrough of DNA evidence, many have been fortunate to be exonerated of rape and murder charges after years and even decades behind bars. Others are freed as a result of determined sleuth work on the part of supporters or loved ones, people recanting original testimonies, suppressed evidence being revealed, or the surfacing of new evidence. Whatever the circumstances of their release, all of the newly freed face the same challenges of reintegrating into society.

 

After the initial elation of finally achieving the dream of freedom, reality is a real slap in the face for the newly exonerated. While decades passed, society moved on, technology advanced, and life slipped away. Homes were lost, careers destroyed, families broken up, insurance coverage stripped away, and children grew up. Release brings a new beginning for the wrongfully accused, with a prison record on their resumes. Many were imprisoned based on little or no evidence. In some cases, evidence was suppressed by police or prosecutors, physical evidence planted by police, other evidence manufactured by forensic scientists, and lying witnesses knowingly placed on the stand by prosecutors, all for the purpose of getting a conviction, whether to advance a career or for political or other reasons.

 

Beverly Monroe was 55, with a successful career as a chemist, when she was convicted of murdering her companion, Roger de la Burde, in 1992, even though police thought it was a likely suicide. There was no other evidence against Beverly but the prosecutor withheld this crucial information during her trial. Beverly’s daughter, Kate, was just starting her career as a lawyer and she quit her job to devote the next six years to freeing her mother, which she was able to do in 1999 based on the suppressed evidence. Beverly is now 62 and trying to piece her life together. Although potential employers have been sympathetic to her story, her prison record remains, and she has only been able to find a job as an administrative assistant with no benefits, a stark contrast to the success she had enjoyed before her conviction.

 

Following her mother’s release from prison, Kate Monroe moved to Utah to work as executive director of the Rocky Mountain Innocence Project, which has worked to pass a compensation law to aid the wrongfully convicted upon their release from prison. The law, which was passed in 2008, awards about $35,000 for each year of false imprisonment up to 15 years, and expunges the person’s criminal record. Only 25 states have such a program. Virginia, where Beverly Monroe lives, is not one of them. Another group called the Innocence Project has helped free 235 people with DNA evidence; 17 of them were on death row. The Innocence Project also works to reform the criminal justice system in order to prevent recurrences of such stories, many of which are far worse than Beverly Monroe's.

 

It’s true that mistakes can happen. But it’s hard to imagine the sheer powerlessness and devastating bitterness one must feel at the hands of someone who deliberately steals your life from you for personal gain. We never hear the names of the prosecutors or police officers who tamper with evidence or suppress information. There must be a law that is protecting them. We need laws that provide accountability for such misconduct. Or maybe we have them but the victims simply don’t have the fight left in them or the resources to engage in another battle. Or maybe they’re just grateful to be free. It seems that there is a conspiracy of silence regarding this issue. It is fair that victims of the justice system should be compensated and their records expunged in the case of wrongful incarceration. State governments should all adopt laws similar to the one passed in Utah and I further propose that resources should be allocated to psychological counseling and job counseling, as well as job placement and other services to ease the transition from prison to society. It wouldn’t give back the lost years but it would help to make the remaining ones better.