Addendum to Drug Survey: Hormonal Birth Control

A couple of weeks ago I posted an article on hormonal birth control. In this article I discussed some of the chemical components of the drug, the side effects, and some of the ethical issues. A friend of mine pointed out that I did not mention the Affordable Care Act (ACA), but many of my readers probably have the ACA and its regulations on birth control on their minds. In this post, we will discuss birth control with respect to the Affordable Care Act. The ACA was about 1000 pages. Blog posts are usually less than 1000 words. Space and patience (both my patience and the reader’s) does not permit me to go into detail on the specifics of the ACA.

 

One of the provisions in the ACA is that insurance providers cover “preventative services” for policy-holders at no cost at the time of the medical visit. For women, this mandates the availability of zero deductible (essentially free) contraception options. The Health Resources and Services Administration (HRSA) is the government agency that determines what constitutes “preventative services.” As of February 15, 2012, the following preventative services are covered by insurance providers: Well-woman visits, screening for gestational diabetes, human papillomavirus testing, counseling for sexually transmitted infections, counseling and screening for human immune-deficiency virus, contraceptive methods and counseling, breastfeeding support, supplies, and counseling, screening and counseling for interpersonal and domestic violence. Religious employers are excused from the contraceptive mandate for one year. The contraceptives include hormonal contraceptives (preventing pregnancy), sterilization methods, as well as abortifacients such as, Plan B, which serves to chemically abort a pregnancy soon after conception.

 

There are many ethical issues with this mandate. This disrupts state mandates that are already in place. This mandate does not respect an employer’s right to conscience. There are also issues with fiscal responsibility – who will pay for these “zero-deductible” preventative services?

 

One issue that concerns me is a federal mandate for insurance companies to cover optional medications or treatments that are typically given to otherwise healthy individuals. It is one thing to require treatment or medications that are life saving. It is reasonable to require coverage for pain management. It is a different matter to require coverage for something that actually impedes normal, healthy function. The argument is that this falls under preventative care, a category which is not terribly contentious. Most people today understand that things like going to the doctor, going to the dentist, exercising and eating right, and education can prevent disease and promote overall health. What constitutes preventive care, however, can easily become a debatable issue. By way of example, in many states, personal training sessions are not covered under preventative care, even though weight training has been shown to prevent the onset of debilitating diseases such as arthritis and osteoporosis, and can serve to manage other diseases such multiple sclerosis. This does not include the health benefits of exercise in general, such as preventing diabetes and heart disease. The ACA, as far as I know, does not mandate insurance companies to cover personal training sessions.

 

The ACA, however, mandates coverage for contraception, because, apparently, an unwanted pregnancy is a health issue deemed important enough to be included in a government mandate.  There is something circular about insurance companies being required to cover the prevention of a “condition” as well as the promotion of the same “condition” (i.e. wellness, OB/GYN visits, etc). The other items that fall under “preventative care” tend to be conditions that people do not (or should not) want, such as HPV or HIV, and can be prevented through education and behavioral changes. Pregnancy is wanted or not wanted depending a particular persons’ desires, health, or lifestyle. If we take this to its logical end, then how many other personal, optional decisions should insurance providers cover? Even if we grant that insurance providers should cover pregnancy prevention for health reasons, most people who use contraceptives are healthy individuals, and usually, it is because of their healthfulness that they require contraceptives.

 

I am NOT saying that contraceptives should never be covered by insurance. I am only arguing that it contraceptives seem to fall in an “optional” category for insurance providers, and should not be required by the federal government. I have maintained that drugs that are not used for curing disease should be held to a different standard when it comes to weighing the benefits and risks. We covered sleeping aids (Ambien), over-the-counter allergy medicines (Claritin D and Zyrtec), and sunless tanners (dihydroxy acetone). Hormonal contraceptives, while they can have some therapeutic benefits, are optional drugs that do not serve to cure a disease, and therefore should be held to a different standard when weighing benefits and risks. This is particularly true for hormonal contraceptives because there are non-hormonal and non-prescription options for birth control. In the same vein, contraceptives should be placed in a different category from those treatments that prevent disease.

*Information on the Affordable Care Act was taken from Dan McConchie’s presentation at the CBHD conference, which Cody reported on here.

Drug Survey: Hormonal Birth Control

I had several requests for a post on hormonal contraceptives. I did quite a bit of research on the actual medications in the past. I had the luxury of consulting several medical journals back when I was a chemistry grad student and had access to all the medical journals I could possibly want. Since then I have tried to keep up with the specifics on the individual medications, but I have to be a little more creative in obtaining information. This topic is quite extensive and rife with emotions, controversy, and confusion. I don’t believe a blog post would really do it justice, so I direct you The Pill (http://cbhd.org/content/the-pill), edited by Linda Bevington, MD and Russell DiSilvesto, PhD,  that is available for free from the Center for Bioethics and Human Dignity. I have not read all of the essays in the book, but I appreciate the introductory essay as well as CBHD’s perspective on bioethics issues. This is a great resource for answering questions and is fair with all the perspectives that are permissible from a Christian worldview.

Rather than reiterating what is in this book, I will try to work to my strengths and discuss the chemistry and physiology of this medication, as well as summarize the ethical positions that are presented in much more detail in The Pill.

Protestants hold many different positions on hormonal birth control, so for clarity, my position is that hormonal birth control can be ethically permissible if it is used cautiously, carefully, and correctly. Particular brands of hormonal birth control are ethically permissible as long as the aim and effect of the medication is to stop ovulation. Not everyone responds to hormonal birth control the same way, so I believe there should be much more doctor-patient interaction than there typically is, including additional tests and precautions to make sure that ovulation is NOT occurring while on the pill.

Secondly, everyone who takes hormonal birth control or has a spouse that takes hormonal birth control should wrestle with this decision. Some people take hormonal birth control without any idea of how it works physiologically, or without every considering other options than hormonal, daily pills that are ingested.

Thirdly, there are certain people who, for other health reasons, should not be on hormonal birth control pills. For example, people who smoke should not take hormonal birth control pills. People who are prone to blood clots or have liver issues should not take combination hormonal birth control pills. People who have experienced adverse side effects or whose bodies cannot tolerate additional hormones should consider non-hormonal options.

It is important to monitor how hormonal birth control works (in you), that it is working properly (in you), and you are very careful to monitor your side effects. It is a medication that is given to an otherwise healthy person, so it should be held to a very high standard (See my initial Drug Survey post). It is my belief that no reproductive decision should be taken lightly, even the decision to not have children (for the time being or at all). Every Christian should wrestle with the relationship between sex and procreation and what is part of God’s design, what is a result of the Fall, and what is an artifact of our culture. The introduction to The Pill addresses the various Biblical interpretations pertinent to this matter.

Most hormonal birth control pills, shots, patches, or rings have some combination of the hormones estrogen and progesterone, or one of these ingredients. Brands such as Ortho-tri-cyclen, OrthoLo, Yasmin, and Seasonale are daily oral pills that contain a combination of an estrogen and progesterone.

Ortho-tri-cyclen has varying ratios of estrogen and progesterone depending on the week within the cycle. This may more closely mimic what occurs in the body. Yasmin and Yaz, another combination hormonal contraceptive, has come under scrutiny because of severe side effects in some people. Ortho Evera is a patch that is placed on the body. It delivers estrogen and progesterone to the body through the skin. It has come under scrutiny because it has been shown to cause a higher incidence of blood clots than oral contraceptives do. NuvaRing is a ring that is inserted intravaginally once per month. Progesterone and estrogen are administered through the ring and absorbed through the vaginal lining. Depo Provera is an injection administered once every three months. It and progesterone only “minipills” are progesterone-only; they do not contain estrogen. Progesterone only medications are often taken by women who are sensitive to estrogen or who are prone to blood clots.

While the first intention of these above mentioned hormonal contraceptives is to stop ovulation, they can also serve to thicken the mucous lining, making it difficult for sperm to reach the egg within the fallopian tube. They may make the womb environment hostile to implantation. If ovulation and subsequent fertilization does occur, the embryo may not implant properly. In this case, an abortifacient effect has occurred.

Progesterone only “minipills” and low dosage combination hormonal birth control pills have been shown to be more at risk for inconsistently stopping ovulation. The progesterone only “minipills” are more likely to create a harsher womb environment.

It is difficult to determine if hormonal contraceptives act as abortifacients. Many women have become pregnant and delivered healthy babies on the pill, calling into question whether the abortifacient effect is commonly the case, or the exception. Because hormones are “signals” in our bodies, many of the difficulties in studying the effects of the pill may be due to hormonal responses being much more patient-specific than was once thought.

Additionally, something that most people forget to account for in oral contraceptive studies is user error. Few women use the pill correctly 100% of the time, making it difficult to distinguish actual effects and effects from user error. The pill should be taken at the same time every day. While many women report taking the pill correctly, many doctors will tell you that patients often lie to their doctors, and based on my conversations with other women, very few women realize that the “same time” part of the instructions is just as important as the “every day” part of the instructions.

Lastly, because oral contraceptives are ingested, if a woman has any GI or digestive problems (such as vomiting, diarrhea, the flu), oral contraceptives may not work correctly.

All of the above mentioned hormonal birth control medications actually contain chemical derivatives of progesterone or estrogen. For example, the active ingredient in Depo-Provera is medroxyprogesterone acetate, which is a derivative of progesterone. Sometimes one form can have severe side effects in one person, but another form does not. The progesterone derivative that was originally used in Yasmin, for example, showed severe side effects in approximately 1/3 of users, while the progesterone derivative in other oral contraceptives did not see this large of a percentage of severe side effects.

Hormonal contraceptives have a sordid history. Originally intended for eugenic-based population control, scientists and doctors found that hormonal birth control (in daily pill form) was actually helpful in promoting fertility in some women (however, it could be related to infertility in other women). We have to be careful not to judge today’s use of birth control based on its historical origins, but we also shouldn’t ignore its history as that has certainly influenced our current cultural climate. People have been practicing various forms of family planning for centuries using barrier-type methods or natural family planning. While hormonal birth control may have come from eugenic origins, family planning did not necessarily come out of these motivations. We also need to be mindful that man is sinful and God is in the business of redemption. Some technologies, actions, or procedures may have been developed for nefarious reasons, but are used for good. Similarly, some technologies or procedures may have originally had good uses but have been hijacked for nefarious purposes. The story of Joseph’s brothers selling him into slavery is one example of God taking what man intended for evil and using it for good. The story of David and Bathsheba is another Biblical example of God redeeming a sinful situation. Using hormonal birth control can be unethical, depending on the intentions and circumstances of the user, as well as the type of hormonal birth control that is used and when it is taken. So-called morning after pills (or Plan B) have a similar chemical composition to hormonal birth control pills, but in much higher dosages. They are taken to abort a pregnancy, not to stop ovulation. In this sense, the intention and use of this drug is quite different and ethically problematic.

Hopefully this overview is helpful and informative. I recommend looking at the CBHD documents above for an in depth treatment of the subject.

CHBD’s Annual Conference

This past weekend I attended the Center for Bioethics and Human Dignity’s annual conference. This conference, as always, is challenging and enlightening with lectures by top-notch speakers from all over the globe. Needless to say, it was a jam-packed weekend, which means I did not get a chance to adequately research two more pharmaceuticals or over-the-counter drugs for this week. However, the topic of this year’s conference did address contraception. In two weeks, we will not only look at some of the drug facts related to hormonal contraception, but we will also look at some of the larger cultural issues that the speakers at this conference addressed.

Every year the CBHD conference covers an important and timely bioethics topic. Prior years included Healthcare and the Common Good, Beyond Therapy: Exploring Enhancement and Human Futures, and The Scandal of Bioethics: Reclaiming Christian Influence in Technology, Science, & Medicine, to name a few. This year’s topic was Reclaiming Dignity in a Culture of Commodification. This topic specifically dealt with our culture’s pressure to turn the woman’s body, whether it is her physical appearance or harvesting eggs for research purposes, into an object of financial worth rather than viewing the woman as an embodied and ensouled person with God-given dignity and intrinsic moral worth.

Commodification is a particularly global phenomenon. Several presentations discussed medical tourism and surrogacy, or “wombs for rent.” One way that couples have dealt with infertility is to hire a surrogate to carry a child for them. Sometimes the surrogate also provides genetic material; sometimes she is truly a “womb for rent” while other genetic material is inserted into her. This particular practice is often done overseas, and the women who typically agree to be surrogates do so for financial rather than altruistic reasons. This is a type of commodification because the woman is valued for a particular body part (her uterus) rather than as a whole person. Because of the financial component, these overseas arrangements are often exploiting the impoverished woman.

This just touches on some of the many interesting topics we covered. I also heard lectures on genetic testing and gene patenting, the abortion industry, and a great lecture on the Affordable Care Act, which fellow bioethics blogger, Cody Chambers, touched on here. Overall, this was another great conference that was both challenging and inspiring.

By the way, here are a couple of  resources from the Center for Bioethics and Human Dignity:

If you are interested in whether your denomination has a statement on particular bioethics issues: See Christianbiowiki.org.

If you would like to hear podcasts on bioethics topics that affect our everyday life: See Everydaybioethics.org.

Drug Survey Part 2: Allergy Medicines and Sleeping Pills

This week we will continue our drug survey by looking at over-the-counter allergy medicines and prescription sleeping pills. As noted in my first drug survey post, these posts are meant to be descriptive, not prescriptive. They are meant to help you ask your doctor the right questions, and let him know the right information. Adverse drug interactions can be an issue, particularly in the drugs that we are looking at today, but many patients don’t know what information can help a doctor determine if your symptoms are due to a drug interaction or not.

Both allergy medicines, such as Zyrtec-D and Claritin-D, and sleeping pills, such as Ambien, are medicines that control symptoms. They do not cure the underlying problem. In the case of allergies, there usually is not a cure. In the case of insomnia, there is usually an underlying cause that needs to be addressed, particularly if it is an indicator of another medical issue. Recall from Part 1 that when it comes to weighing out the risks and benefits of a particular medical treatment or medication, the standards are different when considering a drug that cures a potentially life-threatening disease versus a drug that manages pain or symptoms versus a drug that is taken by an otherwise healthy individual for lifestyle or cosmetic reasons. As a note, antihistamines, which are the primary ingredients in allergy medicines, do not cure the patient of the allergy, but in cases of a severe allergic reaction, controlling the symptoms can be a matter of life or death and should be prioritized accordingly.

Zyrtec-D, Clartin- D (antihistamines with pseudoephedrine)

Allergies occur when the immune system wrongly responds to a normally harmless substance, causing a range of symptoms from cold-like reactions, such as congestion, to an anaphylactic response. Zyrtec-D contains the antihistamine, cetirizine. Claritin-D contains loratadine. There are several other name-brand allergy medicines, but Claritin and Zyrtec tend to be widely used, particularly in their pseudoephedrine-containing forms. Both of these drugs also contain pseudoephedrine which is a decongestant.

Researchers have done some fairly extensive clinical trials with allergy medicines. Antihistamines have a few side effects including dry throat and drowsiness. Their function is to tell a particular part of the immune system to stop reacting. Histamines are part of the immune system and help the body fight foreign invaders. There are several histamines in the body. The Asthma and Allergy Foundation of America defines allergies as an overreaction by the immune system to substances that usually cause no reaction in most individuals. The antihistamine does not target the entire immune system or even all of the different types of histamines. It targets H1, which is the histamine associated with allergy symptoms such as bug bites and pollen-related reactions.

The pseudoephedrine portion of Claritin-D and Zyrtec-D, however, has quite a few side effects, and if taken in larger dosages can be addictive and habit-forming. See here for a complete list of side effects. The pseudoephedrine works to alleviate congestion by constricting blood vessels predominantly in the nasal passageway, although it may constrict other blood vessels in the head as well. Pseudoephedrine is a class of ephedrine drug, so it is a central nervous system stimulant, which carries some risks, including risk of abuse. In larger dosages it can cause a sense of euphoria, increased energy, anxiety, and alertness. Even if taken properly, pseudoephedrine can elevate blood pressure and can affect the heart.

Two issues are noteworthy with pseudoephedrine drugs: 1) There have not been sufficient clinical trials done on people over the age of sixty, 2) Dosage is important, so one must make sure not to accidentally take two cold medicines containing pseudoephedrine.

Overall, the ethical issues with allergy medicines stem from the potential abuse of pseudoephedrine more so than the histamine blocker. The risk of abuse is a known risk and measures, such as not having these drugs on the pharmacy shelves, and providing an ID to purchase them, are good ways to ensure someone is not stocking up on pseudoephedrine-based products. I do think people who have heart issues, are over 60, or on blood pressure medicine should keep in contact with their doctor before and while taking these drugs. Finally, pseudoephedrine is on the World Anti-Doping Agency’s list of banned substances. Athletes are not permitted to have more than 150 mg in their urine at the time of competition. Typical allergy medicines have 120 mg per capsule.

Ambien (sleeping pills)

Ambien, or sleeping pills, is not nearly as straight-forward as allergy medicines. Antihistamines seem to target the particular histamine that causes symptoms and pseudoephedrine, while a risky drug, is highly regulated and generally targets the nasal passageway and sinuses. Sleeping pills, on the other hand, work on everyone whether you are having problems sleeping or not.  They do not target a specific issue in the body. They target the signals that tell your body to sleep. Sleeping pills only deal with an inability to sleep; they do nothing to address whatever is causing insomnia. The actual causes of insomnia, whether physical or psychological, must be addressed in order to cure insomnia. Therefore, sleeping pills are not a cure; they are for symptom control.  Additionally, sleeping pills have a number of side effects, some of which are more pronounced in some people than in others, and drug interactions are a major concern when using these drugs. High enough dosages of stronger prescription sleeping pills, combined with other drugs or alcohol can lead to unconsciousness, or even death.

Ambien’s generic name is zolpidem and is considered a sedative or hypnotic drug. Quick release pills help people fall asleep, and extended release pills (Ambien CR) help people stay asleep. Something that was emphasized in every report I read on sleeping pills was they are meant for temporary use only. Long term studies have not been done, although severe ‘withdrawl’ symptoms after taking Ambien for more than three weeks have been reported. Aside from the potential for addiction, probably the most dangerous side effect of Ambien (and Lunestra) is short-term memory loss or sleep-walking. It is difficult to know how common sleep walking and long-term memory loss occurs since information requires a spouse’s report or the person finding evidence of this occurring. For example, one woman found a half-eaten tub of butter on her kitchen counter, and realized that she had eaten it in her sleep. On rare occasions, police have pulled over people who were driving while sleeping after taking Ambien.

For a more complete list of side effects and risks, see the Mayo Clinic’s web site on sleeping pills and the NIH’s web site on zolpidem.

From an ethics standpoint, Ambien has several potential physical and psychological side effects, but is not necessarily a cure for the underlying cause, so the issue of weighing out the risks and benefits of a drug comes into play. One issue that raises a red flag for me is a drug that can cause short-term memory loss, possible sleep walking and sleep eating, and is also a highly regulated substance with exact indications of proper dosage. Overdoses can cause loss of consciousness and slowed heartbeat. This just doesn’t seem to be a very safe combination. It may be prudent for those taking Ambien to have some precautions in place, such as a spouse keeping the pills in a safe place.

The second issue that raises some red flags is that sleeplessness can often be overcome by changing certain lifestyle habits that are not conducive to sleeping. Furthermore, the Journal of Family Practice says that physicians report a similar success rate using cognitive behavior therapy as using prescription sleeping pills. This raises the “quick-fix-pill-for-everything” red flag. If we were honest with ourselves, many of us would rather take a quick-fix for the symptoms in a convenient pill form rather than change our habits or address the real cause of insomnia. For example, watching a bright screen before you go to bed can cause sleeplessness, yet how many people read with a back-lit laptop, ipad, e-reader or watch television in bed? Other causes of sleeplessness are drinking alcohol late at night, being overweight, eating dinner too late, not going to bed and getting up at the same time every day, not exercising (although exercising before going to bed can cause restlessness), and regularly getting eight hours of sleep.

The most common cause of insomnia is stress or anxiety. Sometimes it is caused by chronic pain or sleep apnea. If this is the case, then insomnia might be a blessing rather than a curse because it serves as a signal that you need to deal with some stress and anxiety or it is a signal that you need to be evaluated for apnea. I believe Americans are very productive people, but sometimes we get so caught up in our busy schedule and productivity while also balancing the tough trials of life that we rarely take time to deal with stress and anxiety. Sometimes just incorporating a little time for reading, reflection, exercise, prayer, or even just acknowledging that you are struggling with stress and anxiety can do wonders for insomnia issues.

Drug Survey Part 1: Dihydroxyacetone (Sunless Tanner)

Welcome to the first of a summer bioethics blog series on drugs. In each of my bi-weekly blog posts, we will take a look at some myths and facts about chemicals, drugs, or pharmaceuticals that are widely used in the United States. The goal is not to offer medical advice, but to 1) help people be better informed and practice discernment in regards to medical care, and 2) address the medicine-as-salvation perspective that our culture perpetuates in a very practical way. I invite medical health professionals to make any comments since my background is in chemistry.

Disclaimer: I am not a medical doctor; I am trained as a chemist and bioethicist so DO NOT use this information in lieu of seeing a doctor. Overall, these posts are meant to be descriptive, not prescriptive.

I believe it is important that we are cognizant of how the drugs we are taking work, what they are meant to do, and what they can potentially do, including side effects. With this information, we can ask our doctors the right questions about medical care, and give them proper personal information to avoid drug interactions. Here are some assumptions to consider:

  • EVERY drug has side effects; even the aspirin that you take for a headache has side effects. Furthermore, different people respond to different drugs and different dosages differently.
  • Oftentimes, we must make a decision by weighing the positive effects of a treatment with the potential risks. This means that there is necessarily a different standard when a drug is taken by a perfectly healthy person for cosmetic or lifestyle reasons and a drug that is take to cure a life-threatening disease.
  • These blog posts do not promote doctor-bashing, or medicine-is-evil tone. Doctors perform an important service, and my hope is that this helps you and your doctor with your health care. For example, our first topic is on sunless tanner. You may never think to tell you doctor that you used sunless tanner, but that might help him diagnose your symptoms.
  • These blog posts do not promote an anti-alternative medicine tone, either. My aim is to promote discernment. Most of these posts will cover over-the-counter or prescription drugs, but I may address supplements or herbal remedies if time permits.
  • The pharmaceutical industry has its problems (see my prior posts), and the FDA is not perfect, but compared to other countries, the U.S. has a good, regulated, standardized system. If a drug is FDA approved, I consider that a positive factor because we can assume that a drug has been through a certain level of testing and documentation.

 

Dihydroxyacetone (a.k.a. sunless tanner)

 

Based on my unofficial survey, most people are interested in knowing more about pharmaceuticals (or chemicals or alternative medicines) that are used for cosmetic, lifestyle, or symptom relief. For whatever reason, drugs used for curing disease seemed to not concern people as much as these “optional” drugs. However, any drug choices and treatment choices require discernment; just ask anyone who has had to weigh out the risks and benefits of various cancer treatments. The most popular drugs requests were Ambien, Zyrtec, and hormonal birth control. Since summer is in full swing, today’s drug is dihydroxyacetone, or the active ingredient in sunless tanning lotions and sprays. In two weeks, I will cover allergy medicines containing pseudoephedrine (e.g. Zyrtec and Claritin-D) and sleeping aids (e.g. Ambien).

By accident, chemists discovered that dihydroxyacetone (DHA, not to be confused with Docosahexaenoic acid, a common omega-3 supplement also abbreviated DHA) will turn skin a brownish color. By the 1960s, sunless tanning lotions were on the shelves, although they did not sell very well because the formulation had not been perfected, leaving people a bit more orange instead of brown. Modern formulations usually have a more brown-ish, “natural-looking” color, although coloration still depends on the user’s skin tone.

DHA is a ketone that reacts with the amino acids on the surface of your skin. The FDA reports that DHA does not penetrate past the skin’s outer layer. However, studies that were recently reported on ABC News indicate that a small percentage of DHA may penetrate below the first layer of skin. If DHA penetrates below the first epidermal layer, then it may go into the blood stream. Scientists are unsure of the effects of DHA in the blood stream, and while the very small amount that may enter the blood stream doesn’t pose a problem with a single use, the concern is for people who use the product on a regular basis.

The FDA has approved dihydroxyacetone for topical use only, but has not approved it as a spray because of the lack of data and testing. The FDA says contact with eyes and mucous membranes, including nose and mouth, should be avoided. The ABC report indicates that DHA may pose a risk to DNA and to lungs if inhaled or if it enters the blood stream, but these reports are still speculative. Spray tanning, particularly the kind where you stand in a booth, usually involves a high pressure spray that blasts the person all over his or her body. Very few salons offer the appropriate eye protection, nose plugs, or mouth covers, and few have regulations on whether you wear a swimsuit or not inside the tanning booth. Additionally, the FDA does not regulate spray tanning salons, which do not have to report the ingredients in their sprays. Any over-the-counter lotion must report all ingredients, so if someone has a reaction to one of the ingredients, he or she can bring the lotion to the doctor, but cannot say what is in the salon’s proprietary formulation.

As a final note, the FDA has received some reports from people who have had adverse effects from sunless tanners. As stated from their web site:

FDA has received reports from consumers stating that they have experienced adverse events associated with sunless tanning, including rashes and, primarily in the case of spray tanning booths, coughing, dizziness, and fainting. It is uncertain what, if any, ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events, whether an individual’s allergic reaction might have played a part, or whether factors unrelated to the sunless tanning products may have been involved, such as pre-existing medical conditions.

See this FDA web site for good information on sunless tanners and bronzers.

As with most of these drugs or chemicals, I am not in a position to give a medical recommendation. If a drug or a chemical poses an ethical dilemma or is ethically problematic, then, as is appropriate for a bioethics blog, I will address that here and welcome comments.  The immediate ethical issue I see here is the lack of data regarding the effects of DHA as a spray tanning solution. According to reports, many tanning salons are not knowledgeable on their products and some have given consumers inaccurate information. Furthermore, sunless tanner is a cosmetic product, which is important to consider when weighing risks and benefits.  With cosmetic products it is important to honestly assess your personal motivations as to why you are using them, and to understand that the cosmetic industry is a  lucrative business that seeks to profit from people’s personal insecurities. This isn’t to say using sunless tanners or getting a spray tan (or wearing make-up, or dying your hair, or using many other over-the counter cosmetic products) is bad, but it is certainly important, both for yourself and as an example to other young men and women, to carefully walk that line with integrity and discernment.

What is the state of biomedical research?

This week, a couple of articles caught my eye. One discusses how drug development companies may need to come up with a better method for doing pharmaceutical research. The other discusses guidelines for greater transparency in clinical trials. Last week, I reported on the prevalence of bias in the scientific literature. All of these articles seem to point towards the need for changes in how research is conducted and researchers are held accountable.

The first article from the BBC addresses some fundamental problems with the old model of drug discovery:

This so-called blockbuster method – which commits large sums of money to finding a drug that promises to treat a huge proportion of the population, and generate swathes of cash to cover other experimental losses – can no longer sustain the industry.

Drug discovery is expensive and inefficient. Furthermore, the promise of genetically tailor-made drugs has proven to be much more difficult than originally thought, and much less lucrative. Many researchers believe that the market is going towards tailor-made drugs, but they also believe the current model is not conducive to developing drugs that will not have a mass market. According to this article, one of the problems with the current model is researchers do not publish negative results; therefore competing companies will often re-do experiments that will not work. As a result, some scientists call for greater collaboration and free access to data.

The BBC article is the positive side. Another article by the American Medical Association addresses the negative side of biomedical research. In this article the AMA calls for greater transparency in clinical trial research to avoid the growing number of discrepancies in reporting data:

There is good reason for suspicion of industry-funded research, say experts who point to examples such as Merck’s selective reporting of cardiovascular data related to Vioxx (rofecoxib), which the company withdrew from the market in 2004 due to the increased heart attack risk linked to the anti-inflammatory drug.

These are important, and I think, good steps towards accountability in research. Now, I want to take a step back and address the broader issue in these reports of bias, transparency, and methodology in research.

In some ways, the most surprising thing about these reports is that they are surprising. It is as if we are just learning that scientists are human too, with all of the baggage that comes with human nature. Scientists are passionate about their subject. They want to succeed. Sometimes they are willing to lie, cheat or steal to succeed. Sometimes, with best of intentions, they see what they want to see in the data or their “randomization” is not really very random. The tone of many of these reports suggests that the “humanness” of science is a surprising new finding.

I can attest that there is no special cleansing ritual in graduate school that somehow removes the sin of human emotion and bias from you. We do not have a class on stoicism and there is not some drug they give us when we receive our first lab coat and glasses that makes us into a docile, honest, objective observer of the world. Admittedly, many of us do get big egos, but that comes with time.

So considering that science is done by human beings, why hasn’t there been more accountability? Perhaps what is surprising is not that scientists are human but that the scientific method is not impenetrable. Our humanness affects it too. Perhaps on a deeper level, we are coming to grips with the fact that our conduit for objective truth is not so objective after all.

Progress and Research

Publish or perish. This is the mantra for the academic research world. At its best, this pressure to publish forces researchers to set goals, carefully select their research topics, and push scientists to not sit on their results. However, the dark side of the publish-or-perish world is when researchers publish results with hand-picked data that may or may not be reproducible. Furthermore, journals do not prefer to publish negative results. In operations science, part of the investigation is testing one’s hypothesis, and sometimes that hypothesis is wrong. This is a valid result, but it does not sell in the publishing world.

An op-ed in Nature, “Beware of the creeping cracks of bias” by Daniel Sarewitz, addresses the staggering number of research results that have turned up unconfirmed or in error due to investigator bias. Furthermore, many of these cases of unconfirmed results are in the biomedical industry. In the 1990s, additional standards, including disclosure of conflicts of interests and stricter reporting requirements, were established to off-set the biases found in pharmaceutical research. However, as Sarewitz reports and many other articles have confirmed, biases are still “trending towards pervasive over-selection and over-reporting of false positives.”

Sarewitz contends that the underlying reason for this trend towards bias is our culture’s priority on the idea of progress:

The belief is that progress in science means the continual production of positive findings. All involved benefit from positive results, and from the appearance of progress. Scientists are rewarded both intellectually and professionally, science administrators are empowered and the public desire for a better world is answered. The lack of incentives to report negative results, replicate experiments or recognize inconsistencies, ambiguities and uncertainties is widely appreciated — but the necessary cultural change is incredibly difficult to achieve.

I believe Sarewitz makes a good point. Culturally, we live in a postmodern world, a world that saw the results of scientific ingenuity in World War II. Optimism in science as a truly objective form of knowledge and conduit for human endeavor turned to cynicism, at least in the philosophy, literature, and humanities departments. Scientists, who tend to be a little slower on the cultural uptake, continued on the high of modernity as we welcomed ourselves to the space and computer age.

Even with waning optimism in certain aspects of the scientific endeavor, there is still a priority on progress. Technological progress is now about making man healthier and stronger and optimism in science has turned towards optimism in medicine. The idea is that we must always be progressing, although, as G.K. Chesterton points out, as a culture, we do not always know what we are progressing towards. Progress implies a direction, but without a common moral foundation, we disagree as to what we are progressing towards, leaving our priority to progress for progress’ sake:

For progress by its very name indicates a direction; and the moment we are in the least doubtful about the direction, we become in the same degree doubtful about the progress. Never perhaps since the beginning of the world has there been an age that had less right to use the word ‘progress’ than we…But it is precisely about the direction that we disagree…It is not merely true that the age which has settled least what is progress is this ‘progressive’ age. It is, moreover, true that the people who have settled least what is progress are the most ‘progressive’ people in it.  (Chesterton, Heretics, 1905)

False positives in clinical research settings are a problem for very practical reasons, and we should strive to decrease false positives and seek more reliable studies. However, the prevalence of false positives in all areas of science is symptomatic of a much larger problem. Rather than addressing the end (goal) of science, which would require moral claims, we talk about progress for progress’ sake and consider it good that we are progressing even if that progress sends us right over a cliff.

Ethics of Sport

Recently, the New Orleans Saints were dinged with a heavy penalty for “bounty hunting.” Bounty hunting in football is when players, in this case the defensive line, are offered cash incentives to knock out a particular player on the opposing team. The Saints’ defensive coach offered two different rewards, one if the player has to be taken off the field and another, larger incentive, if the player is knocked out. When a key player is injured, the tides can quickly turn in favor of the other team.  Additionally, injury can jolt the flow of the game. Some teams will agree that one of their own players is going to take a hard hit so that an injury will occur, stopping the game, and stopping the opposing team’s momentum.

 

In researching the death of twelve-time pro-bowl player and twenty-year NFL veteran, Junior Seau, I found quite a few references to Chronic Traumatic Encephalopathy (CTE). Thus far, Seau’s death has been deemed a suicide due to a gunshot wound to the chest. The family is still deciding whether to allow an autopsy of his brain which would is the only way to determine if he suffered from depression caused by CTE. As of now, and despite what some media reports may say, the reasons for Seau’s suicide are unknown.

 

Unfortunately, though, CTE is a possibility. CTE is a degenerative brain condition whose cause is unknown. Scientists suspect that it is due to receiving multiple concussions. Concussions, themselves, are difficult to determine. There are many definitions of a concussion, and there are many types of concussions. With such an unclear definition, they can be difficult to diagnose. The one common factor with people who have had a concussion is difficulties paying attention or mentally tracking.  CTE can only be diagnosed after death, but there are some similarities in symptoms among those who have been found to have CTE: depression, erratic behavior, forgetfulness, memory loss and other signs of dementia. After death, the brain with CTE generally has an abnormally high number of tau proteins. Actually, some reports I’ve read said that the number of tau proteins are extremely high and that upon opening the skull, the brain looks like “mush.” One case was that of a 45 year-old former football player, whose brain, neurologists said, looked like that of a 90-year-old with advanced Alzheimer’s.*

 

Scientists have found example after example of former football players with CTE, and have found cases in former boxers and hockey players. Not all players seem to exhibit signs and not all brains that have been analyzed have tested positive for CTE. However, there are a large number of former athletes who have been found to have CTE. The story of the youngest, a 21-year-old football player from the University of Pittsburg, Owen Thomas, can be found here.

A lengthy investigatory report on the founder of CTE can be found here (note: some of the quotes contain mild language).

 

As more of this research has come to light, the NFL commission has made some efforts to change rules to protect players. For example, players cannot jump off of the ground, head first, and tackle another player in the head. Also there are now stricter rules for when a player is allowed to return to play after suffering a concussion. However, these rules have sparked debate about whether this dilutes the game, and whether it may eventually completely change the game.

 

I bring this up because I think it poses interesting questions about the ethics of sport. To get a couple of caveats out of the way, first, I love watching sports. I am from Dallas, so sports are part of our culture, and I enjoy participating in that culture. When I say “audience” I am including myself. Secondly, this is not a question about whether sports are okay. Generally, sports are great for teaching teamwork, healthy competitiveness, and overall fitness. I can think of many examples where sports have helped people with confidence, helped people with disabilities, and have been a healthy outlet for those who have gone through trauma or loss.  The question is about the professional sports industry and the relationship between the athlete, the audience, and the business. Athletes are treated as commodities, items that are worth millions of dollars (for a few years, anyway) and are shuffled around and negotiated for as if they were a prized cow. It is a billion-dollar industry where audiences enjoy paying the ticket prices to see athletes who are bigger, better, faster, and stronger do things on a huge scale. The suits love it because they make a substantial amount of money, and the athletes get to bask in the glory and the limelight while bringing home a sizable paycheck playing the sport that (hopefully) they love to play. It is a complex industry that demands everything from players who are more than willing to voluntarily give it while we clap, cheer and maybe vicariously enjoy the thrill of winning.

 

In the sports industry, theoretically, everyone is engaging in it voluntarily, and if you don’t like it, you don’t have to participate.  Yes, it treats people like commodities, yes, athletes are brutal to their bodies, and yes, it’s all voluntary. But just because it is voluntary, that doesn’t mean that there should not be standards, precautions, and considerations in place. There should still be an ethics of sport. The New Orleans Saints were punished for bounty hunting. Of course, the players did not have to participate in the sense that the D-line didn’t have to try to knock a player out. They could just get him down, call it a tackle, and the play is done. The problem was incentivizing. Similarly, the industry (and that includes us audience members) incentivize extremes. We want to see bigger, stronger, and faster, but we get mad when an athlete tests positive for steroids. We want to see the fierce competitiveness and sheer physical prowess in football, boxing, or hockey, but we call for tighter regulations when we see the heavy toll it takes on the retired athlete’s body. Unfortunately, safety doesn’t sell. Breaking records sell. Winning sells, and for many sports, it is the possibility of injury, danger, or risk is a selling point.

 

*The accumulation of tau protein tangles in the brain is associated with Alzheimer’s disease (See www.alz.org), but is also associated with other neurological issues.

 

Note (05/25/12) ABC posted an article on brain injuries in football players.

FMRI and Normal

Recently I was researching functional magnetic resonance imaging, both for a post on this blog and an article that I am writing for The Best Schools blog. I wanted to look at where fMRI has been used in the clinical setting, and was looking through Functional MRI: Basic Principles and Clinical Applications (2006), which was a very helpful book on the subject. Chapter eight was on “Applications of fMRI to Psychiatry.” In several places the chapter kept referring to testing a person with a particular mental disorder compared to a “normal” patient, but the chapter provided neither a quantitatively nor qualitatively definition of normal. I am not sure if I am missing a technical definition here, or if the definition is assumed.

Brain scanning technologies, such as fMRI, are qualitative measurements. This means your readings are meaningless unless you compare them to something else, preferably a baseline from the same patient. For example, the chapter on “FMRI and Clinical Pain” mentions that fMRI is a good tool for measuring acute pain, but is not as helpful for measuring chronic pain. With acute pain, one can take a baseline reading of the patient while not feeling pain. Then by inducing pain, usually through touching the site of acute pain and an image of the brain can be taken showing what parts of the brain became more active when the pain occurred. In this way, doctors might be able to classify the pain or develop a treatment to reduce the pain. Chronic pain is different because doctors cannot take an adequate baseline (no pain) to then study the neurological response to inducing the pain.

The chapter on psychiatry, however, compares patients with autism spectrum disorder, or attention deficit disorder, or schizophrenia, or manic depression or obsessive compulsive disorder with brain scans of normal patients. Since this technique relies on a baseline for meaningful information, the lack of clarity on what is meant by “normal” makes it difficult to interpret.

Now, I am not saying that the author of this chapter is a eugenicist, nor am I saying that the field of psychiatry is bunk. Furthermore, I am not saying these issues do not having a neurological component to them.  I, actually, am concerned with scientific method here: Are researchers able to obtain meaningful data from these scans when the baseline is 1) a different person from the patient (similar to chronic pain), and 2) is seemingly subjective?

To the authors’ credit, they do point out that as of now “the clinical utility of fMRI to patients has thus far been limited, as no findings have been shown to be diagnostically specific for any psychiatric illness or treatment. Although many hospitals and research facilities complete MRI on psychiatric patients, this information cannot, as yet, be used reliably to generate a psychiatric diagnosis; however scans often are used to rule out the presence of a neurological illness” (185). They seem to be careful not to overstate their case. This is careful science, which is good, but the issue is what is meant by the comparison to normal.

(By the way, neuroscience is an active field. If new research has come out about diagnosing psychiatric disorders, please let us know in the comments section.)

I do not want to make the mistake of quote hunting especially because the chapter is very thorough, but I did want to give a sampling of what I mean by comparing to a “normal” subject. Some of the findings are reasonable, but with others, it seems like the only conclusion that can be drawn is this person’s brain is responding differently from this other person.

Autism spectrum disorder (ASD):

Functional MRI research on autism, although limited, has illustrated that individuals diagnosed with autistic disorder demonstrate an alternate method of facial processing when compared to normal healthy control subjects… In contrast to control subjects, when autistic individuals were asked to respond with a button press to determine the emotion of a facial photograph, they again showed no activation in the left amygdalahippocampal region and left cerebellum. (186)

The patients were people who were diagnosed with ASD and are compared with “normal healthy control subjects” that I am assuming are normal and healthy because they not diagnosed with ASD or any other disorder that would qualify as a mental disorder. This was not stated, specifically, though.

Schizophrenia

Because of the severity of schizophrenia, much fMRI research has been devoted to it. One study that did seem helpful was looking at a patient with schizophrenia before medication treatments, and then after a course of treatment. In this case, the baseline is the patient, himself, so a comparison can be made. Even so, the drug was assumed to be working because the patient’s fMRI looked more similar to the control subjects.

“Mood Disorders”

Depression and bipolar disorder studies are limited because of difficulties with diagnosis. However, studies that have been done have been conducted compared to “nonpsychiatric populations.” This apparently means people that do not meet the criteria for depression, bipolar disorder, or any other psychological disorder.

Certainly there are people who are affected by any of these psychological disorders, and surely many of these disorders have a neurological component. However, I am uncertain how helpful an analytical technique that relies on comparative studies, particularly comparisons to an accepted, yet undefined “normal,” really is for understanding a disorder.

Part 3: Can I Know What’s on Your Mind?

In this third installment concerning military technology, we are going to look at functional magnetic resonance imaging (fMRI). Magnetic resonance imaging is one of the most popular diagnostic tools because it is non-invasive and safe. MRI can be used to determine if a bone is broken or if a tumor is present because it detects differences in tissue density. Various forms of MRI, such as functional MRI or real-time MRI are used to investigate specific parts of the body or specific activities. Functional magnetic resonance imaging analyzes brain activity. The military is interested in using fMRI as a more accurate lie detector than the typical polygraph.

Polygraph tests usually measure changes in physiology that are thought to be associated with lying. For example, it is assumed that a person’s heart rate, breathing rate, and sweat production will likely increase if the person is lying. The lie detector will measure when these factors change compared to a baseline. However, polygraph tests are controversial because they can result in false-positives or can be faked so that the person’s physiology does not appreciably change when he is lying. Therefore a more accurate lie detector is needed. Since fMRI provides information on what part of the brain is active, the theory is that it would serve as a more accurate lie detector.

But does fMRI really show us what someone is thinking? When a particular area of the brain becomes active, it consumes more oxygen. The body responds by sending oxygenated blood to the part of the brain that is actively consuming oxygen. FMRI measures this blood flow. This is the observed phenomenon. The assumption is that this correlates to a particular thought pattern. Furthermore, many of these assumptions are based on the idea that there are regions of the brain where certain functions take place (such as the memory part of the brain, or the decision-making part of the brain), which is also a controversial. Scientists who use fMRI for lie detection assume that a lie is neurologically more complicated than the truth, so if someone is telling a lie, his fMRI scan will show a more complicated pattern.

Importantly, while fMRI may be advertised as being more precise or definitive, it is still a qualitative measurement, just like the polygraph. As National Academy of Science magazine, In Focus, suggests, “But brain scans encounter the same problem as polygraphs: no physiological indicator, or neural activity pattern, exists that has a one-to-one correspondence with mental state.” Furthermore, because of how fMRI acquires a signal, there is approximately a 6-second delay between the brain signal and the image display, meaning that the actual part of the brain that becomes active in response to a stimulus is still only an estimate.  Researchers have been working on improvements in the time lag. For example, they have looked at heart activity using “real-time MRI.” However, neurological activity is very fast, and blood flow is relatively slower, so there may be a fundamental issue with relating blood flow with certain neurological activity.

Tennison and Moreno discuss in their article on military technology the ethics of using brain scanning technology for lie detection. They focus on whether brain scans would violate the guarantee against self-incrimination, and whether they would constitute an inappropriate search and seizure. I would say that the bigger ethical question is amount of legal weight we should place on a technology that is qualitative and subjective. Should brain scans be considered definitive proof that a person is lying? Technology helps us in many ways. DNA data has exonerated and incarcerated many individuals who might have been given the wrong sentence. But we should be careful how much we can trust the technology. Yes, the fMRI can show us brain activity, but it does not show us a man’s thoughts.