House Call, MD

by Marissa Camilon, MD 2011 | camilon@myhousecallmd.com

Outbreak? What outbreak?

You may have seen the commercials and heard the rumors. It’s true. In California, we are in the middle of an “outbreak” of Whooping cough. On August 24, 2010 the California Department of Health reported a 7-fold increase in the number of cases of Whooping cough over the past year.  This puts California at the highest number of cases in the past 52 years. With that being said, this is a big deal for Californians and a potential “big deal” for the rest of the country.

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by Marissa Camilon, MD 2011 | camilon@myhousecallmd.com

What is infertility? When should you see a doctor?

In a world where one woman can become famous for having eight children and celebrities can have children at practically any age, some people lose sight of why this aspect of medicine even exists. Despite the media’s glamorization of the subject, infertility is not a condition taken lightly by the medical community. Infertility is a serious condition, just like diabetes, asthma or cancer, with proven medical treatments available. Many of us take the ability to become pregnant for granted; something we think happens with the blink of an eye. We have to remember that the chance of becoming pregnant is 20% per month of unprotected intercourse (not 100%). As physicians, we begin to investigate infertility after a couple tries a year of regular, unprotected intercourse that does not lead to a pregnancy. We pick one year as the cutoff because 85% of couples will conceive within that time frame. If you and your partner have been trying for that long, or even longer in some cases, it may be time to see a Reproductive Endocrinologist and Infertility specialist.

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by Georgina Lee, PharmD 2011 | lee@myhousecallmd.com

What do the movies “Pineapple Express,” “Cheech & Chong,” Bob Marley, and the TV series “Weed” all have in common?  The answer is marijuana, also known by its many aliases as Mary Jane, hemp, pot, dope, giggle weed and grass to name a few.  Its popularity dates back as far as the third millennium B.C.  It has been used for recreational, religious, spiritual and medicinal purposes (apparently it’s not just used by experimental college students!).  Marijuana, scientifically known as “Cannabis,” is made up of dried parts of the Cannabis sativa hemp plant including its flowers, stems, leaves and seeds.   The resinous part of the plant (the concentrated secretions the plant produces) is known as hashish or “hash,” which also contains psychoactive properties.  Most people recognize marijuana by its distinct smell when smoked which can be described as a simultaneously sweet and sour odor.  Typically, marijuana is smoked as a cigarette (aka “joint”), in a pipe or is humidified in a bong.  It is also smoked in “blunts,” which are cigars that have been emptied of tobacco and refilled with marijuana (immortalized by countless reggae songs).  Since the blunt retains the tobacco leaf used to wrap the cigar, this type of delivery combines marijuana’s active ingredients with nicotine and other harmful chemicals (a double whammy).  Additionally, people mix marijuana into foods such as the case with “magic brownies.” This form of consumption produces stronger effects than when smoked (it seems like the brownies would taste better too).  The use of Marijuana has long been a source of controversy and debate in regards to its role in the medical world and it’s easy to see why.  As medical marijuana dispensaries continue to spring up on street corners across America, the medical community must take a good hard look at the need for marijuana as part of its arsenal of medicinal therapies.

How does Marijuana affect the brain?

The main active chemical in marijuana is delta-9-tetrahydrocannabinol or THC for short.  THC acts upon cannabinoid receptors in various parts of the brain including the cerebellum.  The cerebellum is responsible for balance, posture and coordination of movement after receiving input from sensory systems and the motor cortex (the area in our brain that controls our voluntary movements).  THC also acts upon the hippocampus which contains many cannabinoid receptors and is involved with memory formation.  Some studies have suggested that marijuana affects memory by decreasing the activity of neurons in this area and, because the hippocampus is involved in new memory formation, someone under the influence of marijuana may have impaired short-term memory (“hmm…what happened last night?”).  However, most studies in humans suggest that if a person stops using marijuana, their memory abilities can recover.  Marijuana also affects sensory perception in the cerebral cortex, which can lead to an altered perception of incoming sensory information (such as finding a sock or your friend’s nose extremely funny).

How is Marijuana used medically?

Marijuana is currently used for the treatment of a number of medical complaints and conditions including nausea, vomiting, lack of appetite, spasms, glaucoma and pain.  In 1992, scientists discovered a naturally produced substance called anandamide that activates THC receptors and has many of the same physiological effects as THC.  The discovery of anandamide led to the discovery of additional cannabinoid molecules and receptors including 2-arachidonoglycerol, which helps to control pain.  Oral forms of THC such as Dronabinol (Marinol) are already available to treat chemotherapy-induced nausea and vomiting in addition to treating weight loss in patients who suffer from AIDS wasting syndrome.  However, some studies have shown that Marinol lacks several of the therapeutic compounds available in natural cannabis (aka Marijuana) that has 66 naturally occurring cannabinoids.  One of these is known as cannabidol (CBD), which is a non-psychoactive cannabinoid that has been clinically demonstrated to have analgesic, anti-spasmodic, anxiolytic, anti-psychotic, anti-nausea and anti-inflammatory properties.  Other researchers found that natural extracts of CBD, when administered with THC, significantly reduced pain and other symptoms in patients suffering from multiple sclerosis (an autoimmune disease that affects the brain and spinal cord).  CBD has also demonstrated neuro-protective properties against glutamate neurotoxicity (which occurs during a stroke), cerebral infarction (localized cell death in the brain) and ethanol-induced neurotoxicity.  Some clinical trials have shown CBD to have anti-tumoral properties (via the inhibition of the growth of glioma (brain tumor) cells and selectively induction apoptosis (programmed cell death) in malignant cells…pretty cool if you ask us).  The other cannabinoids found in Marijuana have demonstrated anticonvulsant, anti-inflammatory, anti-depressant, and antioxidant activity in addition to slowing disease progression in certain autoimmune and neurologic diseases including multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig’s disease) and Huntington’s disease.  Keep in mind, however, that some of these trials are in very early stages and more in depth research must take place to draw any concrete conclusions.

Wow this sounds like a great plant.  What’s the hold up?

According to the National Institute on Drug Abuse (NIDA), 25.8 million Americans aged 12 and older had abused Marijuana at least once a year.  The NIDA-funded 2008 Monitoring the Future Study showed that 10.9% of 8^th graders, 23.9% of 10^th graders, and 32.4% of 12^th graders had abused marijuana at least once a year prior to being surveyed.  That’s a lot of young people getting high!

Short-term side effects of Marijuana include cough, increased heart rate, dizziness, silliness (“the giggles”), sleepiness, hunger (better known as the “munchies”), confusion, memory impairment, bloodshot eyes and changes in eating and sleeping habits.  NIDA researchers rank peer pressure and curiosity as the leading reasons for this drug abuse.  They also note that users can become heavily dependent on “pot” as a way to cope with anxiety, anger, depression and boredom because of its relaxing properties.  In one study conducted in Memphis, Tennessee, researchers found that out of 150 reckless drivers, 33% tested positive for marijuana and 12% tested positive for both marijuana and cocaine.  That means 45% of “bad drivers” in Memphis are driving around under the influence of Marijuana!  Many anti-Marijuana ads and commercials have surfaced over the years as a result of these statistics in order to educate and prevent people from abusing the drug.  Long-term concerns about smoking Marijuana include dependency, increased risk of cough, bronchitis and emphysema (a progressive disease of the lung that causes shortness of breath) as well as increased risk of cancer of the head, neck and lungs due to the smoke inhalation (Google Image search “oral cancer” for some exquisite photos to scare your kids straight).  The moral of the story is that Marijuana, when used inappropriately or unnecessarily, can be a very dangerous drug.

Hmm, this sounds like a tricky situation…

Essentially, legalizing medical Marijuana is a tug of war between parents, patients, medical professionals, pro- and anti-activist groups, city and state, state and federal, so on and so forth (you get the idea). Currently, the talk of the town surrounds Marijuana dispensaries and their growing locales around the nation.   Many anti-Marijuana activists want to shut down these dispensaries while owners and pro-Marijuana activists fight to keep them open.  A New York Times article stated in its June 24, 2005 editorial “When Medical Marijuana is Misused” that “Those who believe, as we do, that marijuana should be legally available for medical treatments have to be concerned about abuses in California’s pioneering medical marijuana program.  If the abuses cannot be curbed, a political backlash could undermine the ability of thousands of patients to get marijuana to treat the nausea of chemotherapy, loss of appetite that accompanies AIDS and other medical problems…Public officials would be wise to clean up their programs lest flagrant abuses by a few bad actors bring about destruction of a program that benefits many…”  In other words, Marijuana should be treated just like any other controlled substance in the medical world, meaning its abuse needs to be monitored through government regulations and its therapeutic benefits researched and developed for those who qualify after failing other therapies.  An example of such is Sativex, which was approved and launched in the UK on June 21, 2010 (only a few days ago!), making it the first cannabis-based (taken directly from the plant) prescription medication in the world (vs. Marinol, a synthetic version of a chemical in the plant).    It can be prescribed for the treatment of neuropathic pain and spasticity in patients with multiple sclerosis as well as pain relief in adult patients with advanced cancer who experience moderate to severe pain.  In October 2009, the Obama Administration Department of Justice announced an end to federal raids by the Drug Enforcement Administration of medical Marijuana dispensaries that are operating in “clear and unambiguous compliance with existing state laws.”  At the same time, the battle for legalizing medical Marijuana is far from over (get the popcorn ready).

What does the future hold for medical Marijuana?

The 2010 Congressional Research Service states that, “With strong opinions being expressed on all sides of this complex issue, the debate over medical marijuana does not appear to be approaching resolution.”  So does that mean you should run out and purchase a bong at the nearest dispensary?  Using our most sound medical judgment, we would recommend against it due to the potential risks and side effects of Marijuana contrasted with your “medical need” for treatment.  As more research is unveiled in the upcoming years, perhaps the role for medical Marijuana will be more defined.  The take home message: Seek professional medical advice before starting any new treatments!

Questions? E-mail the Author: lee@myhousecallmd.com

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References:

1. National Academy of Sciences, Institute of Medicine. 1999. Marijuana and Medicine: Assessing the Science Base. National Academy Press: Washington, DC. p. 25: Table 1.5: Cannabinoids Identified in Marijuana.

2. R. Mechoulam et al. 2003. Cannabidiol: an overview of some pharmacological aspects. Neuroscience Letters 346: 61-64; J. McPartland and E. Russo. 2002. Cannabis and cannabis extracts: greater than the sum of their parts. Journal of Cannabis Therapeutics 1: 103-132; A. Zuardi and F Guimaraes. Cannabidiol as an anxiolytic and antipsychotic. In: M. Mathre (Ed):Cannabis in medical practice: a legal, historical and pharmacological overview of therapeutic use of marijuana. McFarland Press: 1997: 133-141.

3. P. Consroe and S. Snider. Therapeutic Potential of Cannabinoids in Neurological Disorders. In: R. Mechoulam (Ed):Cannabinoids as Therapeutic Agents. CRC Press: 1986 21-51; E. Carlini and J. Cunha. 1981. Hypnotic and antiepileptic effects of cannabidiol. Journal of Clinical Pharmacology. 21: 417S-427S; J. Cunha et al. 1980. Chronic administration of cannabidiol to healthy volunteers and epileptic patients. Pharmacology 21: 175-185.

4. D. Wade et al. 2004. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Multiple Sclerosis 10: 339-340; D. Wade et al. 2003. A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Journal of Clinical Rehabilitation 17: 21-29.

5. A. Hampson et al. 1998. Cannabidiol and THC are neuroprotective antioxidants. Proceedings of the National Academy of Sciences 95: 8268-8273.

6. K. Mishima et al. 2005. Cannabidiol Prevents Cerebral Infarction. Stroke 36: 1077-1082.

7. C. Hamelink et al. 2005. Comparison of cannabidiol, antioxidants, and diuretics in reversing binge ethanol-induced neurotoxicity. Journal of Pharmacology and Experimental Therapeutics (electronically published May 5, 2005, ahead of printing).

8. H. Patsos et al. 2005. Cannabinoids and cancer: potential for colorectal cancer therapy. Biochemical Society Transactions. 33: 712-714; M. Guzman. 2003. Cannabinoids: potential anticancer agents. Nature Reviews Cancer 3: 745-755.

9. P. Massi et al. 2004. Antitumor effects of cannabidiol, a nonpsychoactive cannabinoid, on human glioma cell lines.Journal of Pharmacology and Experimental Therapeutics 308: 838-845; G. Carter et al. 2004. Medical marijuana: emerging applications for the management of neurologic disorders. Physical Medicine and Rehabilitation Clinics of North America 15: 943-954.

10. C. Turner et al. 1980. Constituents of Cannabis sativa L.: A review of the natural constituents. Journal of Natural Products 43: 169-304.

11. F. Evans. 1991. Cannabinoids; the separation of central from peripheral effects on a structural basis. Planta Medica 57: S60-S67.

12. P. Wirth et al. 1980. Anti-inflammatory properties of cannabichromene. Life Science 26: 1991-1995.

13. R. Deyo and R. Musty. A cannabichromene (CBC) extract alters behavioral despair on the mouse tail suspension test of depression. In: International Cannabinoid Research Society (Ed.) 2003 Symposium on the Cannabinoids. ICRS: 2003.

14. S. Baek et al. 1998. Antitumor activity of cannabigerol against human oral epitheloid carcinoma cells. Archives of Pharmacal Research 21: 353-356.

15. J. McPartland and E. Russo. 2002. Cannabis and cannabis extracts: greater than the sum of their parts. Journal of Cannabis Therapeutics.

16. Society for Neuroscience. “Marijuana-like compound may aid array of debilitating conditions ranging from Parkinson’s Disease to pain.” October 26, 2004. http://apu.sfn.org/content/AboutSFN1/NewsReleases/am2004_cannabinoids.html

17. G. Pryce et al. 2003. Cannabinoids inhibit neurodegeneration in models of multiple sclerosis. Brain. 126: 2191-2202.

18. C. Raman et al. 2004. Amyotrophic lateral sclerosis: delayed disease progression in mice by treatment with a cannabinoid. Amyotrophic Lateral Sclerosis & Other Motor Neuron Disorders 5: 33-39.

19. I. Lastres-Becker et al. 2003. Effects of cannabinoids in the rat model of Huntington’s disease generated by an intrastraital injection of malonate. Neuroreport 14: 813-816.

20. Marijuana Law Reform – NORML. Web. 25 June 2010. <http://norml.org/index.cfm>.

21. Medical Marijuana ProCon.org. Web. 25 June 2010. <http://medicalmarijuana.procon.org/>.

22. Eddy, Mark. “Medical Marijuana: Review and Analysis of Federal and State Policies.” Congressional Research Service. 2 Apr. 2010. Web. 25 June 2010.

23. “Medical Cannabis Dispensing Collectives and Local Regulation.” Americans for Safe Access(2006). Print.

24. Volkow, Nora D. “Research Report Series: Marijuana Abuse.” National Institute on Drug Abuse(2005). Print.

by G. John Mullen, DPT 2011 | mullen@myhousecallmd.com

The United States is the most obese nation in the world. Awesome…well done, America. 30.6% of Americans are believed to be obese, 6% higher than the next country, ironically, our Americanized neighbor… Mexico (3)! It is estimated 50% of Hispanics born since 2000 will become diabetic. Mississippi currently holds the crown as the fattest state in the fattest union and has been for the past 5 years, with obesity estimated at 32.5%3. Mississippi also holds the award for fattest children at 44.4% of 10-17 year olds (3). Five states have a current adult obesity percentage over 30%3. To top it off, obesity rates have more than tripled in the past 30 years! These obesity rates are out of control and are a huge weight on the United States budget. On the other end of the spectrum, Colorado is the thinnest state in the union with an obesity rate of 18.9% and is the only state with an obesity rate under 20% (3).  The take home message: America has a weight problem.

Where is all this weight coming from?

The cause of obesity is relatively simple: weight gain occurs when caloric intake exceeds caloric expenditure. Despite the simplistic nature of obesity, weight maintenance and loss are thought of as difficult or impossible tasks. Roughly 25% of American adults report no leisure time activity and 60% report activity levels less than the value shown to reduce their risk of disease (5). No wonder we’re overweight! To add insult to injury, overweight individuals are more inclined to be inactive, with 33% of men and 41% of women reporting inactivity (5). At the same time, roughly 50% of women set a New Year’s resolution to lose weight2. We, as a society, acknowledge the problem and are committing to fixing it each January 1st but seem to fail over the course of the year.

What does it take to lose weight?

Federal guidelines suggest a minimum of 150 minutes a week of moderate-intensity exercise to obtain “substantial health benefits” (4). These health benefits are not associated with weight management, but rather with lowering rates of chronic disease. A recent publication in the Journal of American Medical Association followed 34,079 healthy US women from 1992-2007 studying their activity level and associated weight gains/losses. This study concluded that (amongst women consuming a “normal” diet) physical activity was associated with less weight gain (5 lbs) in women with a BMI lower than 25. The “activity level” was defined as 60 minutes of daily moderate-intensity activity for the duration of the study (4). However, only 45% of women in America are estimated to have a BMI of 25 or less. This study does a great job looking at activity level for weight management, but does not tell us about the volume of exercise necessary for weight loss.

Weight Loss vs. Weight Management

The Harvard study discussed above looked at women with an average age of 54.2 years with no medical complications (cardiovascular disease, cancer, etc.) (4). Women with a BMI of 25 were able to maintain their weight within 5 pounds of their weight at the beginning of the study if they exercised with moderate-intensity activity for 60 minutes a day throughout the study. Moderate-intensity exercise includes bicycling, callisthenics and fast walking (~3.0 MPH or 55-69% of maximal heart rate). However, these same protocols were not successful for weight management in females over a BMI of 25, which constitutes more than half of Americans! This research suggests that overweight or obese women need to change one of the two variables associated with weight management: decrease caloric consumption or increase caloric expenditure. The most important piece of a weight management program is consistency. As stated, many New Year’s resolutions include weight loss goals (fitness centers see an exponential membership increase during January), but the volume of people in the gym returns to normal within a month. The intent is correct but the execution falls short. There are many theories for this. We believe that lack of interest and enjoyment plays a huge role in the gym attrition rate between January and March. If someone does not like riding a stationary while bike watching CNN report another Earthquake in a third world country or another vandalism case by their neighborhood, then it is highly unlikely they will exercise consistently. If we don’t like it and we don’t have to do it, we don’t do it. It’s called human volition. The American view of exercise needs to shift dramatically from a chore to a hobby. The Harvard study used METS (metabolic equivalent) to assess activity level and determined a total of 14 MET hours per week or 3 MET hours a day was sufficient in weight management for women with a BMI of 25 or less. As stated, activities with a 3 MET or higher rating include biking, fast walking, etc. 3+ MET activities also includes various hobbies not typically viewed as exercise: canoeing/kayaking, dancing, ice/roller skating, hiking, gardening and racquetball to name a few (full list of activities with their MET ratings). If you perform these activities at a more rapid pace (really start cruising with that paddle!) these activities can reach the upper echelon of METS. The take home message: Make exercise fun. If you don’t, you’ll quit. If you do, you can potentially burn more calories than you would boring yourself to death on a stationary bike watching Larry King.

Weight loss is a tougher nut to crack and is often person-dependent. Common sense makes it sound as simple as increasing caloric expenditure, but exercising greater than one hour a day is unrealistic for many and leads to failed goals and the aforementioned NYE resolution abandonment. Often times, physical activity is not sufficient in weight loss due to the multivariable nature and complexity of the problem. Many of these issues are related to diet.

Diet is the number one contributor to weight loss. Here are a few simple tips for those trying to lose weight (be sure to stay tuned for more from our staff dietitian):

• Do not limit yourself to strict caloric restriction diets. The math is complicated and the stress at each meal is unnerving. This approach is hard to consistently maintain leading to failed goals and disappointment. Strict diets can decrease metabolism making the body more likely to gain weight once the diet is discontinued. Instead, monitor diet and decrease consumption of high caloric foods. For example, you can eat four bananas or one McDonald’s double cheeseburger…they have the same number of calories. We guarantee that eating four bananas will be just as filling as a double cheeseburger and the four bananas cost less and have more vitamins than the McDonald’s double cheeseburger.

• Monitor drink consumption. Energy drinks, frappuccinos, etc. contain high quantities of unfilling calories. Replace these high calorie, high cost options with….water! Simple and effective.

• Prepare your own food and eat foods that require some work. When was the last time you ate an uncooked carrot? It takes a while to consume and requires a lot of chewing. Increasing the amount of chewing can trick the mind regarding the amount of food being consumed, decreasing hunger.

These three tips are easy to perform and are, most importantly, cost efficient. Some additional factors affecting your ability to lose weight include:

• Sleep: Inadequate sleep impairs hormones (ghrelin and leptin) that regulate hunger and satisfaction following food consumption. One study found people who slept less than 8 hours a night had lower levels of leptin (controlling satisfication) and higher levels of ghrelin (controlling hunger) AND higher levels of body fat (1).

• Stress: Cortisol is a hormone produced in response to stress. Cortisol release causes insulin release resulting in increased hunger. The take home message: Relax! You can use multiple stress reduction techniques including deep breathing, meditation, visual imagery, and exercise. Take your pick.

We all know that weight management is an issue in America as obesity rates continue to rise. An undeniably effective approach to weight loss is exercise. The goals is a calorie expenditure > calorie intake. Remember that exercise should be a hobby and not a chore! Find activities you enjoy and stick with them. Set realistic goals that target three areas: appearance, health and consistency. If exercise alone does not achieve your weight goals, diet, sleep and stress can also be manipulated to make your weight goals a reality.

Questions? E-mail John: mullen@myhousecallmd.com

References:

1. Bouchez C. How Sleep Affects Your Weight. Webmd.com. 2007.

2. Losing Weight Is One Of The Most Popular New Year’s Resolutions. Medical News Today. 2005.

3. F as in Fat 2009 – Trust for America’s Health. Healthyamericans.org. 2009.

4. Lee I, Djoussé L, Sesso H, Wang L, Buring J. Physical activity and weight gain prevention. JAMA. Mar 2010;303(12):1173-1179.

5. Mokdad AH, Bowman BA, Ford ES, Vinicor F, Marks JS, Kaplan JP. The continuing epidemics of obesity and diabetes in the United States. JAMA JAM Aabbr. Journal of the American Medical Association 2001;256:1 195-1200.

by Tania Houspain, PharmD 2011 | houspian@myhousecallmd.com

You’re at the new happening lounge with your three closest model-looking girlfriends catching up on girl talk. Of course, in the tradition of female gossip, the subject turns to sex and then birth control.  One of your girlfriends starts gushing about her amazing new birth control that not only helped her avoid pregnancy but also decreased her PMS bloating and acne.  All your friends are in awe of this great new birth control and you all agree that you’re going to request it at your next doctor’s visit.  You buying all this?  While this may not be the most realistic dramatization, this is the scene painted by Bayer in advertisements for their birth control products, Yaz and Yasmin.  It’s this kind of casual, direct-to-consumer advertising that not only helped Yaz get on the list of the Top 200 Drugs sold in the US but also got Bayer in trouble with the FDA and, more recently, with the legal system.

Why is Bayer in trouble?

The class action lawsuit filed against Bayer claims that Yaz and Yasmin increase the likelihood of women forming blood clots more than other birth control pills. To make matters worse the lawsuit states that Bayer was aware of the increased risk with using these two birth control products but downplayed the risk with casual commercials that over exaggerated their uses.

Is it true?

First and foremost, all birth control pills with an estrogen component (refer to the article 28 Days a Month, 13 Months a Year… for the details of birth control) can increase the risk of blood clots forming. A clot is a clump of blood cells, tissue, and other parts of blood that stick together.  The problem with a clot is that once it starts to move through your arteries it may get stuck in narrower arteries and stop blood flow to the tissues beyond that point.  Imagine what would happen if blood supply were cut off from certain parts of your body due to a clot.  In case you don’t want to imagine the consequences, we’ve broken it down for you:

• Lungs (a clot here is called a Pulmonary Embolism):

  • Difficulty breathing

  • Coughing up blood

  • Sharp chest pain

  • Heart palpitations

• Heart (a clot here is called a Myocardial Infarction or heart attack)

  • Crushing chest pain (like an elephant standing on your chest)

  • Irregular heart beats

• Brain (a clot here is called a Cerebrovascular Accident or a stroke)

  • Inability to move or feel parts of your body

  • Inability to speak

  • Disorientation

• Leg (a clot here is called a Deep Vein Thrombus; an example is shown above)

  • Leg pain

  • Swelling of leg

  • Bulging veins in leg

  • Redness, inflammation, or discoloration of the skin of the leg

• Eyes (a clot here is called a Retinal Vein Occlusion)

  • Eye pain

  • Blindness in affected eye

In all of these tissues, if the clot isn’t taken care of right away the lack of blood and oxygen to the area can cause long-term damage and consequences. The take away: blood clots are a serious matter.  This risk of blood clots is why, when you ask for birth control, your doctor asks if you smoke (no, he doesn’t want to bum a smoke off of you), checks your age and takes a look at your medical history.  Women who smoke more than 15 cigarettes a day, who are over 35 and who have certain medical conditions are more likely to form blood clots. Using estrogen-containing birth control in these women is generally not recommended.

If all birth control pills cause blood clots (and this is a medically known fact), why is Bayer getting sued?

It seems as though Yaz and Yasmin may carry an extra risk of blood clots due to their second active ingredient, drosperinone.  Drosperinone comes from a family of compounds known as diuretics.  No, they don’t give you diarrhea but drugs in this class do make you pee more (they are often called “water pills”).  They’re usually given to people with high blood pressure causing them to pee out some extra water and decrease their blood volume and subsequently their blood pressure.  Drosperinone is a very mild diuretic and is given in very small doses in the birth control pill so you don’t lose that much body water.  The diuretic effect is thought to cause just enough water loss to decrease bloating-related symptoms.  Drosperinone also resembles certain hormones in your body so scientists believe that is may help curb the hormonal problems some women experience during their menstrual cycle (think irritability). Sounds great but here comes the catch: The problem with drosperinone is that it causes your body to hold on to more potassium that it usually would. Normally your body naturally maintains the ideal balance of electrolytes like potassium and sodium by either reabsorbing them in your kidneys or allowing you to pee them out (for a full breakdown of the kidney’s incredible electrolyte-regulating abilities, see the diagram below…are you as impressed with the kidney as we are?). Drosperinone has the potential to increases potassium levels to a dangerous level (referred to as hyperkalemia), which causes irregular heart rhythms.  It is medically proven that irregular heart rhythms increase the likelihood of forming blood clots.  The FDA knew about all of these side effects caused by Yaz and Yasmin before approving them and these potential risks are listed under the warnings section of the package inserts.

The Most Important Question: Did Bayer downplay the risks and over exaggerate the benefits of Yaz and Yasmin?

That question will have to be answered in a courtroom but some facts are available to us. In 2008 the FDA sent Bayer an eight page WARNING LETTER (bolded and all caps to emphasize the seriousness of the matter) telling the company that changes needed to be made to their commercials for Yaz and Yasmin.  The problems the FDA cited in regards to the commercials were the representation of the medications’ effects on PMS, acne, and the minimization of risks.

PMS Claims

In the letter, the FDA reminds Bayer that Yaz was never approved for treatment of PMS but for PMDD (Pre-Menstrual Dysphoric Disorder).  PMDD is a much more severe form of PMS that interrupts a woman’s ability to function in her normal life and needs to be diagnosed by a healthcare provider. Yaz and Yasmin were never evaluated for the treatment of PMS so any claims Bayer made about these medications helping with PMS are false.  During one commercial in particular, women can be seen pushing away giant floating words such as “irritability,” “bloating” and “fatigue.”  Obviously this is meant to imply that Yaz helps get rid of these symptoms.  Any woman watching that commercial will think “Yeah, I do feel that way when I’m PMS-ing.”  The commercials never take the time to explain that PMDD is a much more severe form of PMS and Yaz should not be taken for more mild symptoms.  Bayer’s boo-boo.

Acne

The FDA also sternly warned Bayer about claims regarding acne.  In one commercial the narrator says, “It can also help keep your skin clear” and the camera zooms in on the faces of women with clear skin.  Creepy, but it gets the message across.  The FDA never approved Yaz to “help keep your skin clear.” It was approved only for moderate acne vulgaris.  It was also never shown to produce completely clear skin like the commercial would have us believe.  The study data showed that it helped decrease the number of pimples when compared to doing nothing.  That being said, zooming in on faces with beautiful glowing skin may be a tad misleading compared to what the actual data shows.

Minimization of Risks

We’re all familiar with drug commercials with the voice over guy telling us all the possible side effects and risks, rapid-fire style, at the end.  So why is Bayer in trouble with the FDA when it seems everyone does that?  Well, in addition to skimming over the serious complications that can result from using this drug, the commercials seem to also try to distract the viewer’s attention away from the serious statements being made.  While the voice over guy is talking, music is playing and women are leaping around on screen (possibly overwhelmed with the joy that comes with using Yaz?). The FDA felt that this was way too distracting and did not convey the seriousness of the possible side effects.  The FDA felt that Bayer did not take their duty to warn consumers seriously, focusing solely on selling their product.

In response to the WARNING LETTER, Bayer changed their commercials and clarified the points the FDA had requested.  The commercials emphasized that Yaz only helps with PMDD and not PMS.  The edited version explained that Yaz and Yasmin don’t completely get rid of acne but can help decrease pimples. There is also more emphasis placed on the possible risks. See the new version of the commercial below.

It’s great that they complied with the FDA’s demands but this may be a case of too little too late.  The commercials were running for a significant amount of time before the FDA requested changes.  In the meantime, women saw these commercials and went to their doctors’ offices requesting Yaz and Yasmin for birth control.  Some of these women should not have been on Yaz and Yasmin due to the increased risk of blood clots but Bayer did not properly informed them of the increased risk that these drugs carried (although we would hope their doctors would discuss such issues).  Now many women who developed a blood clot while on Yaz are coming forward stating that they had no risk of forming blood clots before starting Yaz and were unaware that the medicine could cause clots.  Trouble in River City.

Who will win the lawsuit?

Three words: Settle, settle, settle.  In the past, when drug companies are sued for issues like this they try to settle.  They’ve spent millions of dollars developing and marketing their drug and lawsuits create bad press and bad karma for them and their drug.  In addition, the lawyers handling the lawsuit on behalf of the patients have every motivation to settle since they’re working on a contingency basis (meaning they don’t get paid unless they win or settle).  The physicians who prescribed Yaz or Yasmin for patients who didn’t necessarily qualify to be taking the medication (PMS and mild acne) are also being sued by some of their patients.  The outcome in those cases is a little harder to predict due to the case-by-case nature of the suit.

The Moral of the Story

Do NOT walk away from this article thinking that you should not take birth control or that new medications cannot be trusted.  The moral of the story is to ask questions and be informed. Drug companies are multi-million dollar corporations focused on increasing their bottom line.  While the FDA does everything it can to try to protect you, oversights like this do happen. That’s why, as the patient and as a consumer, you need to be informed (and by informed we mean information beyond direct-to-consumer commercials).  Commercials for drugs are just like commercials for anything else.  They are intended to sell you a product regardless of whether or not you need it.  Trust your health professionals and ask plenty of questions.  One more time for the people in the back of the room: Ask questions.

Questions?  E-mail Tania: houspian@myhousecallmd.com (It’s never too early start practicing for your next visit)

References:

Bayer Warning Letter.  Abrams, Thomas. Department of Health and Human Services. Oct 3, 2008.

Yaz Package Insert. Bayer Health Care. April 2007.