Archive for March, 2010

The Yaz Lawsuit: Duty to Warn

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.

31

03 2010

Who’s Paying for Health Care?

by Joshua Goldman, MD/MBA 2010 | goldman@myhousecallmd.com

America spent 17.3% of its gross domestic product on health care in 2009 (1).  If you break that down on an individual level, we spend $7,129 per person each year on health care…more than any other country in the world (2).  With 17¢ of every dollar Americans spent keeping our country healthy, it’s no wonder the government is determined to reform the system.  Despite the overwhelming attention health care is getting in the media, we know very little about where that money comes from or how it makes its way into the system (and rightfully so…the way we pay for health care is insanely complex, to say the least).  This convoluted system is the unfortunate result of a series of programs that attempt to control spending layered on top of one another.  What follows is a systematic attempt to peel away those layers, helping you become an informed health care consumer and an incontrovertible debater when discussing “Health Care Reform.”

Who’s paying the bill?

The “bill payers” fall into three distinct buckets: individuals paying out-of-pocket, private insurance companies, and the government.  We can look at these payors in two different ways: 1) How much do they pay and 2) How many people do they pay for?

As you can see from the chart, the majority of individuals in America are insured by private insurance companies via their employers, followed second by the government.  These two sources of payment combined account for close to 80% of the funding for health care.  The “Out-of-Pocket” payers fall into the uninsured as they have chosen to carry the risk of medical expense independently.  When we look at the amount of money each of these groups spends on health care annually, the pie shifts dramatically.

The government currently pays for 46% of national health care expenditures.  How is that possible?  This will make much more sense when we examine each of the payors individually.

Understanding the Payors

Out-of-Pocket

A select portion of the population chooses to carry the risk of medical expenses themselves rather than buying into an insurance plan.  This group tends to be younger and healthier than insured patients and, as such, accesses medical care much less frequently.  Because this group has to pay for all incurred costs, they also tend to be much more discriminating in how they access the system.  The result is that patients (now more appropriately termed “consumers”) comparison shop for tests and elective procedures and wait longer before seeking medical attention.  The payment method for this group is simple: the doctors and hospitals charge set fees for their services and the patient pays that amount directly to the doctor/hospital.

Private Insurance

This is where the whole system gets a lot more complicated.  Private insurance is purchased either individually or is provided by employers (most people get it through their employer as we mentioned).  When it comes to private insurance, there are two main types: Fee-for-Service insurers and Managed Care insurers.  These two groups approach paying for care very differently.

Fee-for-Service:

This group makes it relatively simple (believe it or not).  The employer or individual buys a health plan from a private insurance company with a defined set of benefits.  This benefit package will also have what is called a deductible (an amount the patient/individual must pay for their health care services before their insurance pays anything).  Once the deductible amount is met, the health plan pays the fees for services provided throughout the health care system.  Often, they will pay a maximum fee for a service (say $100 for an x-ray).  The plan will require the individual to pay a copayment (a sharing of the cost between the health plan and the individual). A typical industry standard is an 80/20 split of the payment, so in the case of the $100 x-ray, the health plan would pay $80 and the patient would pay $20…remember those annoying medical bills stating your insurance did not cover all the charges?  This is where they come from.  Another downside of this model is that health care providers are both financially incentivized and legally bound to perform more tests and procedures as they are paid additional fees for each of these or are held legally accountable for not ordering the tests when things go wrong (called “CYA or “Cover You’re A**” medicine).  If ordering more tests provided you with more legal protection and more compensation, wouldn’t you order anything justifiable?  Can we say misalignment of incentives?

Managed Care:

Now it gets crazy.  Managed care insurers pay for care while also “managing” the care they pay for (very clever name, right).  Managed care is defined as “a set of techniques used by or on behalf of purchasers of health care benefits to manage health care costs by influencing patient care decision making through case-by-case assessments of the appropriateness of care prior to its provision” (2).  Yep, insurers make medical decisions on your behalf (sound as scary to you as it does to us?).  The original idea was driven by a desire by employers, insurance companies, and the public to control soaring health care costs.  Doesn’t seem to be working quite yet.  Managed care groups either provide medical care directly or contract with a select group of health care providers.  These insurers are further subdivided based on their own personal management styles.  You may be familiar with many of these sub-types as you’ve had to choose between then when selecting your insurance.

  • Preferred Provider Organization (PPO) / Exclusive Provider Organization (EPO): This is the closet managed care gets to the Fee-for-Service model with many of the same characteristics as a Fee-for-Service plan like deductibles and copayments. PPO’s & EPO’s contract with a set list of providers (we’re all familiar with these lists) with whom they have negotiated set (read discounted) fees for care.  Yes, individual doctors have to charge less for their services if they want to see patients with these insurance plans.  An EPO has a smaller and more strictly regulated list of physicians than a PPO but are otherwise the same.  PPO’s control costs by requiring preauthorization for many services and second opinions for major procedures.  All of this aside, many consumers feel that they have the greatest amount of autonomy and flexibility with PPO’s.

  • Health Management Organization (HMO): HMO’s combine insurance with health care delivery.  This model will not have deductibles but will have copayments.  In an HMO, the organization hires doctors to provide care and either builds its own hospital or contracts for the services of a hospital within the community.  In this model the doctor works for the insurance provider directly (aka a Staff Model HMO).  Kaiser Permanente is an example of a very large HMO that we’ve heard mentioned frequently during the recent debates.  Since the company paying the bill is also providing the care, HMO’s heavily emphasize preventive medicine and primary care (enter the Kaiser “Thrive” campaign).  The healthier you are, the more money the HMO saves.  The HMO’s emphasis on keeping patients healthy is commendable as this is the only model to do so, however, with complex, lifelong, or advanced diseases, they are incentivized to provide the minimum amount of care necessary to reduce costs.  It is with these conditions that we hear the horror stories of insufficient care.  This being said, physicians in HMO settings continue to practice medicine as they feel is needed to best care for their patients despite the incentives to reduce costs inherent in the system (recall that physicians are often salaried in HMO’s and have no incentive to order more or less tests).

The Government


The U.S. Government pays for health care in a variety of ways depending on whom they are paying for.  The government, through a number of different programs, provides insurance to individuals over 65 years of age, people of any age with permanent kidney failure, certain disabled people under 65, the military, military veterans, federal employees, children of low-income families, and, most interestingly, prisoners. It also has the same characteristics as a Fee-for-Service plan, with deductibles and copayments.  As you would imagine, the majority of these populations are very expensive to cover medically.  While the government only insures 28% of the American population, they are paying for 46% of all care provided.  The populations covered by the government are amongst the sickest and most medically needy in America resulting in this discrepancy between number of individuals insured and cost of care.

The largest and most well-known government programs are Medicare and Medicaid.  Let’s take a look at these individually:

Medicare:

The Medicare program currently covers 42.5 million Americans.  To qualify for Medicare you must meet one of the following criteria:

  • Over 65 years of age

  • Permanent kidney failure

  • Meet certain disability requirements

So you meet the criteria…what do you get?   Medicare comes in 4 parts (Part A-D), some of which are free and some of which you have to pay for.  You’ve probably heard of the various parts over the years thanks to CNN (remember the commotion about the Part D drug benefits during the Bush administration?) but we’ll give you a quick refresher just in case.

  • Part A (Hospital Insurance): This part of Medicare is free and covers any inpatient and outpatient hospital care the patient may need (only for a set number of days, however, with the added bonus of copayments and deductibles…apparently there really is no such thing as a free lunch).

  • Part B (Medical Insurance): This part, which you must purchase, covers physicians’ services, and selected other health care services and supplies that are not covered by Part A.  What does it cost?  The Part B premium for 2009 ranged from $96.40 to $308.30 per month depending on your household income.

  • Part C (Managed Care): This part, called Medicare Advantage, is a private insurance plan that provides all of the coverage provided in Parts A and B and must cover medically necessary services.  Part C replaces Parts A & B.   All private insurers that want to provide Part C coverage must meet certain criteria set forth by the government.  Your care will also be managed much like the HMO plans previously discussed.

  • Part D (Prescription Drug Plans): Part D covers prescription drugs and costs $20 to $40 per month for those who chose to enroll.

Ok, now how does Medicare pay for everything?  Hospitals are paid predetermined amounts of money per admission or per outpatient procedure for services provided to Medicare patients.  These predetermined amounts are based upon over 470 diagnosis-related groups (DRGs) or Ambulatory Payment Classifications (APC’s) rather than the actual cost of the care rendered (interesting way to peg hospital reimbursement…especially when the Harvard economist who developed the DRG system openly disagrees with its use for this purpose).  The cherry on top of the irrational reimbursement system is that the amount of money assigned to each DRG is not the same for each hospital.  Totally logical (can you sense our sarcasm?).  The figure is based on a formula that takes into account the type of service, the type of hospital, and the location of the hospital.  This may sound logical but often times this system fails.

Medicaid:

Medicaid is a jointly funded (funded by both federal and state governments) health insurance program for low-income families.  Eligibility rules vary from state to state and factors in age, pregnancy, disability, income and resources.  Poverty alone does not qualify an individual for Medicaid (there is currently no government-provided insurance for the American poor…despite the fact that almost all first world countries have such a system…enter the current health care debate) but is a significant factor in Medicaid eligibility.  Each state operates its own Medicaid program but must adhere to certain federal guidelines to receive matching federal funds (you may be familiar with California’s MediCal, Massachusetts’ MassHealth and Oregon’s Oregon Health Plan due to their recent media coverage). Medicaid payments currently assist nearly 60 percent of all nursing home residents and about 37 percent of all childbirths in the United States.

How are the bills paid?

We now understand who is paying the bill but we have yet to cover how those bills are paid.  There are two broad divisions of arrangements for paying for and delivering health care: fee-for-service care and prepaid care.

Fee-for-Service

As we mentioned briefly while discussing PPO’s, in a fee-for-service structure, consumers select a provider, receive care (a.k.a. “service”) from the provider, and incur expenses (a.k.a. “a fee”) for the care. Deductibles and copayments are also required as previously discussed.  Pretty simple.  The physician is then reimbursed for their services in part by the insurer (i.e. a private insurance company or the government) and in part by the patient, who is responsible for the balance unpaid by the insurer (the return of the unanticipated medical bill despite your overpriced insurance).  Again, the major downfall of the fee-for-service approach is that medical professionals are incentivized to provide services (and by this we mean any and all services they can legally request or must request to be protected legally), some of which may be nonessential, to increase their revenue and/or “C.Y.A.” (revenue that has steadily decreased as insurance companies continue to lower the amount they pay medical professionals for their services).

Fee Schedule

A fee schedule operates in the same way that Fee-for-Service does with one exception: instead of using the “usual, customary, and reasonable” amount to reimburse medical professionals, states set fees to be paid for specific procedures and services.  The reimbursement is very low ($.10-.15 on the dollar) and barely covers the actual direct cost of providing the care.  Physicians may chose to opt into the plan or not (starting to see why a doctor might not be so excited about this plan?).  Would you sign up to be paid 10 cents for every dollar you charged for your work?  Try the insurance reimbursement approach next time you go out to eat.  We’ll come bail you out of the Big House if things go awry.  What happens when the insurance system does this?  You get the Wal-Mart approach to medicine (high volume, low quality).  Not the kind of heath care we recommend.

Pre-Paid

Pre-paid health care?  Like a phone card?  Not exactly–but close.  The pre-paid system evolved out of the insurance company’s desire to share its risk ( a.k.a “pooled risk”) with health care providers.  Essentially, they wanted the doctors to have some skin in the game.  In the pre-paid system, insurers make arrangements with health care providers to provide agreed-upon covered health care services to a given population of consumers for a (usually discounted) set price—the per-person premium fee—over a particular time period.  What does that mean?  It means that Dr. Bob gets paid, say, $30 per month to take care of Joe the Plumber including his blood work and x-rays.  If Dr. Bob spends less than that caring for Joe, he makes money.  If Joe is sick every month and needs lots of tests and follow-up visits, Dr. Bob could lose money caring for Joe.  The set monthly fee paid to the doctor for taking care of a patient is set up on a per-member, per-month (PMPM) rate called a “capitated fee.” The provider receives the capitated fee per enrollee regardless of whether the enrollee uses health care services and regardless of the quality of services provided (not a good thing in our book).  Theoretically, providers should become more prudent and subsequently provide services in a more cost effective manner because they are bearing some of the risk.  Often times, however, less care is provided than is needed in hopes of saving money and increasing profits.   In addition, physicians are incentivized to cherry pick the youngest and healthiest patients because these patients typically require less care (i.e. they are cheaper to keep healthy).  We like that doctors are encouraged to keep patients healthy but we have to worry about the ways in which they are being encouraged to reduce costs (as little care as possible?).  Again, the incentive system falls short and encourages providers to act unethically.

The Take Home Message:

Health Care in the United States today is complex and messy at best.  The layers on top of layers of failed attempts to correct the system continue to encourage the wrong behavior in both patients (out of fear of medical bills) and providers (out of fear of bankruptcy).  We have yet to provide every American citizen with medical care (something that goes without saying in most 1st World countries…even Cuba has it!).  We spend more money on caring for our citizens than any country in the world yet we continue to lag behind in terms of national health outcomes.  We think it’s safe to say that we’re not getting the best bang for our buck.  The ultimate solution?  We wish we knew.  Only time will tell where the system goes from here.  Our goal: to help you better understand the system as it stands today in hopes of developing a more effective, efficient, and comprehensive system for the future. Are you with us?

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

References

1. Levey N. Soaring cost of healthcare sets a record. Los Angeles Times. Feb 4 2010.

2. McKenzie J, Pinger R, Kotecki J. An Introduction to Community Health, 6th Ed. Jones and Bartlett Publishers. 2008.

3. Bodenheimer TS, Grumbach K. Understanding Health Policy. 5th Ed.  Lange Medical Books/McGraw-Hill. 2002.

4. Kaiser Family Foundation. “EXPLAINING HEALTH CARE REFORM:  How Do Health Care Costs Vary By Region?” Brief #8030. December 2009.

24

03 2010

Pinch My What?: The Elusive “Pinched Nerve”

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

As a kid, my friends and I always got together to play tackle football.  None of us weighed over 100 pounds and, as such, we threw our bodies at one another like Adam Sandler in The Waterboy. We didn’t think twice about going head first into someone on the opposing team.  Little did we know, throwing our bodies around like this could potentially be extremely damaging.  This general disregard could have caused a plethora of injuries, the most common of which (caused by Goldberg-esque spear shots) being neck injuries.  Neck injuries are a serious concern in the NFL.  Millions of dollars are poured into research looking at the long-term effects of head injuries, specifically concussions.  This past week, Indianapolis Colts’ quarterback and Saturday Night Live star, Peyton Manning, underwent neck surgery to relieve symptoms of a pinched nerve that he has been suffering from for the past four years.  Despite the enormous media coverage his surgery received, the exact type of surgery he underwent was not disclosed…luckily we have a pretty good idea of what went down (one of the few perks of medical training).  This article will dive head first into the injury, from the anatomy of the nerves (called spinal nerves… ingenious!) to symptoms associated with a pinched nerve and the surgeries and physical therapy commonly used treat them.

Stat Fact: As of February 1st, 2010 more than 250 current and former athletes have volunteered to donate their brains to research the effects of repeated head trauma.

Spinal Nerve Anatomy

The cervical spine has seven bones called vertebrae.  Each vertebra contains a vertebral disc that acts as the “air bag” or cushion between adjacent vertebra.  Each of these vertebrae is associated with a spinal nerve root that exits the spine between the vertebrae.  Once the nerve exists, it travels a distinct path relaying sensation and providing motor control to specific regions of the body.  The nerves are the electrical system of the body.  One of their functions involves sending information to muscles causing activation and contraction.  The nerves in the cervical spine provide information to various areas of the neck and arms.  Pinched nerves are caused by a variety of anatomical adaptations to stress.  With the majority of pinched nerves, the gel-like disc between the vertebrae loses it’s elasticity and is compressed, decreasing the amount of space between vertebrae and subsequently causing compression of the nerve.  Another common cause of pinched nerves is from a bulged disc; in this pathology the gel-like center of the intervertebral disc bulges through the tough outer layer.  This bulging region then presses on the nerve root decreasing conductance of the nerves and causing excruciating pain.

Stat Fact: Vertebral discs begin to lose their size and absorption capacity by the third decade of life.

Signs and Symptoms

Pinched nerves present in a variety of ways, most of which involve pain and discomfort…not a good thing for any athlete, let alone a 10-time pro bowl quarterback.  Despite the fact that the “pinching” of the nerve occurs just outside the spinal cord, most signs and symptoms occur in the area that the nerve innervates (i.e. the region of the body to which the nerve supplies electrical connections).  As stated, most of the nerves in the cervical region of the spinal cord distribute sensation to the arms and neck.  Common symptoms of a pinched nerve include:

  • Numbness and decreased sensation in the area supplied by the nerve

  • Sharp or burning pain radiating over the region supplied by the nerve

  • Symptoms become more severe with coughing or sneezing

  • Muscle weakness or twitching in the affected area

  • Feeling that the area involved has “fallen asleep”

These symptoms can be felt on one or both sides of the body.  Medical doctors or physical therapist can confirm these symptoms with a variety of tests:

  • Reflexes: Reflexes are typically decreased in patients with a pinched nerve

  • Nerve Conduction Study: This involves the application of an electrode to the farthest point of a potentially compressed nerve followed by a mild electrical pulse (don’t worry…not Frankenstein style) to a point higher up the nerve.  The study is testing the speed with which that impulse is carried down the nerve.  Slowed conduction speeds can indicate that the nerve is being compressed at some point along the path.

  • Electromyography: This test measures the electrical activity produced by a muscle.  This test is performed by placing a needle (which sounds scarier than it really is…think acupuncture needle not horse tranquilizer) into the muscle and record the electrical discharge made by the muscle during movement.

  • Magnetic Resonance Imaging: This technique uses a magnetic field and radio waves to produce an image of the affected area and look for a region of nerve compression.

These tests, as well as the patient’s symptoms, will provide the doctor (either a physical therapist or an MD) with a better idea of the severity of the injury and the ideal treatment course.  The more we know, the more we can help you…thus all the tests (they really aren’t as fun for as to perform as you think).

Stat Fact: 70% of cervical radiculopathies (a.k.a. the pain and loss of function caused by pinched nerve) occur at the 7th cervical vertebrae (indicated by the white arrow in the x-ray shown). This nerve innervates the triceps (We don’t play football anymore but we’re pretty sure the triceps are important…yes, our sources have just confirmed they are).

Treatment Options

Surgery

Most surgeries for a pinched nerve are part of the “otomy” family: foraminotomy, laminotomy, hip-hopotomy (OK, one of those is fake.  Any guesses?) The suffix “-otomy” is Latin for “partial removal” and “-ectomy” is total removal (for example, a cholecystectomy is the removal of the gall bladder). If I had to guess, I would say Mr. Manning had an “-otomy”, considering that the press releases proclaim it was minor surgery.  Nowadays, these types of surgeries are minimally invasive endoscopic surgeries (meaning that they are performed through small incisions with a video camera and tiny instruments). In Peyton Manning’s case, we do not know which form of surgery he received but it is most likely a foraminotomy or laminotomy:

  • Foraminotomy:  This outpatient surgical procedure is used to widen the foramen (the round opening that exists between the two vertebra) by removing small pieces of the vertebrae to relieve the pressure being placed on the nerve.

  • Laminotomy: This surgery can be performed in the outpatient setting as well and is used to clear space on the spinal cord.  This surgery relieves pressure placed on the nerve by removing part of the lamina of the vertebra (the portion of the vertebra seen in the picture above and below the intervertebral foramen) creating more space for the nerve to pass through.

Another typical surgery to relieve pressure is a discectomy.  A discetomy is performed when a bulging disc is the cause of the nerve compression.  The procedure involves the removal of the intervertebral disc that is putting pressure on the spinal nerves (you can see in the picture to the left that the inner gel-like part of the disc has ruptured through the tough outer ring of the disc and is now pressing on the nerve root…and a pinched nerve is born).  Total removal of an intervertebral disc increases the likelihood of degeneration since it takes away the cushion between the vertebrae at that level.  Newer minimally invasive procedures have been developed to decompress the bulging disc without removing the whole disc itself (easier to do AND you may be able to salvage your intervertebral disc).

Physical Therapy

In therapy, enhancing the strength of the muscles that hold the head upright is essential.  Most pinched nerves and bulging intervertebral discs are caused by poor posture for extended periods of time.  Hunched behind the center, the quarterback keeps their neck extended (to keep their eyes on the defense rather than the center’s robust butt) decreasing the space between the vertebrae.  Repeated bouts of poor posture may have lead to Manning’s pinched nerve…that or repeated bone-crushing blows from 300 pound linebackers moving at lightening fast speeds.  Our guess: The latter.  Since Manning was able to play with the injury for 4 years, it is likely that it was not an acute injury (enter the mental image of Manning being speared by Goldberg), but rather a progressive injury.  With these types of injuries, consistent neutral neck posture is mandatory (Good luck staring at the center’s booty, Peyton).  Increasing strength and flexibility will alleviate pain and prevent reoccurrence of the injury.  The goal of strengthening exercises is to increase strength in the front and back of the neck.  Recommended neck-strengthening exercises can be seen in our previous article, Pain in the Neck.

Conclusion:

Even though you’re not a 6’5”, 230 pound, 10-time Pro Bowl quarterback, you may still end up with the same neck problems if you do not address them now.  Proper posture, strength and flexibility of the neck and shoulders are key to preventing pinched nerves.  Keep this in mind next time you spend 8 hours sitting at a desk in front of a computer…nobody wants to end up as another Office Space neck pain statistic.  Help us help you.

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

16

03 2010

Vaginas: An Abbreviated Owner’s Manual

by Sarah Gilman-Short, MD 2010 | sarah@myhousecallmd.com

Almost every woman has, at one time, experienced that “Ummm… something’s not quite right down there…” sensation. Today we’ll be discussing three cases of vaginas gone wrong – Bacterial Vaginosis, Candida Vulvovaginitis, and Trichomoniasis. Not the sexiest part of womanhood, but often an unavoidable aspect of it. All three have simple treatments and sound much more sinister than they actually are.

Firstly, let’s just say that, contrary to what some people (even some male doctors) believe, not all vaginal discharge is abnormal. Happy, well-adjusted vaginas can regularly release a small amount of milky, whitish, or clear fluid daily.  This fluid is made up of sloughed off cells from the vaginal lining (vaginal cells slough off just like your other skin cells). The color and consistency of the fluid can change with your menstrual cycle. Yes, it’s true – the vagina is a self-cleaning organ. And even though it may be slightly unpleasant to think about, normal vaginas are full of bacteria (just like many other places in the body…your nose, for instance, is packed full of bacteria). Every woman’s “vaginal flora,” as we medical folk call it, is made up of a personalized balance of different species of bacteria, kind of like how every forest has a slightly different mix of foliage. Most vaginas are in a peaceful symbiosis with Lactobacillus acidophilus and Staphylococcus epidermidis.

Things go wrong when this delicate vaginal balance is disrupted. Here are some ways this could happen:

  • Douching: We thought that people stopped doing this in the seventies, but it turns out that it is still popular in some social circles. A word from the wise: Don’t do it! It’s never a good idea – you are flooding your personal space with a bunch of annoying, irritating chemicals that will make your vagina unhappy and make it easier for that delicate balance to be disrupted. Also, if you have a STI, (and you might not even know it if you do) douching can push the evil bacteria into your uterus and fallopian tubes in an ugly, infectious tidal wave, making the problem much, much worse. The best way to clean down there is with some gentle soap and water on the outside. Also falling into the “no no” category would be other irritants such as hygiene sprays, bubble baths, and perfumed detergents. Your vagina does not have to smell like flowers!

  • Antibiotics: Remember the idyllic forest analogy? Taking antibiotics can kill the healthy bacteria your vagina likes and needs, making room for other bacteria or yeast that your vagina hates. But of course, this isn’t a reason for not taking antibiotics if you really need them. An imbalanced vagina is easier to treat than Scarlet Fever.

  • Contraception: Oral contraceptive pills, IUD’s, condoms, and spermicide (especially nonoxynol-9) have been associated with increased yeast infections. Once again, this is not a good reason to stop using contraception – yeast infections, though annoying, are much less annoying than unwanted babies and incurable STD’s.

  • Health conditions: Diabetes, pregnancy, or infections can mess with your vaginal flora.

  • Sluttiness: Just kidding, we don’t judge – but having unprotected sex can put you at high risk for a lot of bad things, including Trichomoniasis.

  • Who knows? Women can get BV or yeast infections out of nowhere, for no identifiable reason whatsoever.  It sucks, but there’s a lot that we doctors just don’t know.

Bacterial Vaginosis (BV)

BV is a very common cause of vaginal annoyance – a third of women who visit their doctor complaining of a vaginal issue end up being diagnosed with BV. Although almost half of women with BV have no symptoms at all, most complain of a fishy-smelling discharge that can be yellow, creamy white, green, or gray (have we ruined your appetite yet?  Our sincere apologies). They can also have some minor itching. No one knows the exact cause of BV, but we know that somehow there is an overgrowth of new, annoying bacteria in the vagina, usually Gardnerella vaginalis, Mobiluncus, or Mycoplasma hominis (the can be seen in the picture to the right…the little dark spots mixed in with the large healthy cells are the unwanted intruders). BV can be more likely to rear its ugly head when a woman has been involved with a new sexual partner, and studies have shown a concordance of BV between lesbian partners; however, there is no clear evidence that it is sexually transmitted.

Candida Vulvovaginitis (a fancy term for a yeast infection)

Candida is a yeast – yes, similar to the yeast that makes your bread and beer delicious – that is present on many people’s skin, but can make vaginas exceptionally angry. This is the type of yeast that many women self-treat with over-the-counter creams but it is, in fact, less common than BV, accounting for about a quarter of the women who come to the doctor with vaginal symptoms. Women with yeast infections often have a thick, curd-like white discharge that kind of smells, well, yeasty. Unlike BV, yeast infections can make your vagina and vulva notably painful, itchy, and red. As we said before, many women will try over-the-counter creams but, if for some reason the symptoms persist or come back, it is important to see a doctor and make sure there isn’t something more serious going on. Studies have shown that most women aren’t very good at diagnosing yeast infections on their own so don’t hesitate to go in for a check-up if you’re unsure.

Trichomoniasis

Trichomoniasis is caused by a little protozoan with a tail (named Trichomonas) that swims around in seminal or vaginal fluid, causing mischief. Trichomonas, although cute, is without a doubt an STI, and can be easily prevented by wearing condoms with every sexual encounter. Trichomonas can live on objects like sex toys and towels and can also be found in urine. Women with Trichomoniasis usually have a significant amount of thin, discolored, foamy discharge, as well as a strange odor and itching. When the infection gets really bad, it can cause fever and lower abdominal pain (but these can be symptoms of other serious infections as well). Trichomonas also likes company – a third of women who have it will have another STI at the same time.

Your Take Home Message

Vaginas can be rather finicky and complicated. Happy, healthy vaginas have their own natural balance of bacteria and anything that disrupts that delicate balance can cause itching, discharge, or odor. If you think that your vagina’s balance is off, it’s a good idea to see a doctor. With a quick swab of your vagina (you don’t usually need a speculum for this) and examination via microscope or laboratory, he or she can diagnose the problem and treat it accordingly. All three conditions can be cured quite easily so there’s no reason to try and fight it off alone. We’re here for you… might as well let us help!

Questions?  E-mail Sarah: sarah@myhousecallmd.com

12

03 2010

The Power of Touch: Snuggling = Better Performance?

by Kelly Erickson, MD 2010 | erickson@myhousecallmd.com

We, at House Call, MD, are big fans of the “snuggle.”  There are few people on this planet who will not benefit in some way from a hug, massage or simple back rub.  A recent New York Times article suggests that we may be on to something (1).  While outright snuggling may create interesting and awkward scenes in the workplace, recent studies are showing that positive interactions involving touch may increase in human performance.

Before we dive into the details of the research on this topic and the science behind them, let’s start with some simple logic: If touch makes us “feel better” and “feeling better” makes us work harder, then it follows that positive or cooperative touch can improve performance.  Seems fairly reasonable to us.  Now on to the science behind the theory.

First, we must show that touching someone is a means of communicating—right?   Some of the most compelling studies regarding the role of touch in communicating emotion are currently being performed at UC Berkeley.  The most recent study sought to show that a wide array of emotions could be conveyed between two complete strangers using only touch.  What is interesting to us is how they conducted their study…

Imagine you are a freshman in college taking a Psychology course and, as part of your grade, you are required to participate in a study currently taking place on campus.  As part of the study you are taken to a small room and blindfolded (and yes, this does sound like the opening scene of a cheesy horror film, but stick with us).  After a minute, an individual enters the room, slaps your wrist, and walks out.  You are then given a list of emotions and asked to identify the emotion the other person was trying to convey to you.  You circle your answer (What would you answer, by the way?), re-blindfold yourself and wait for the next assault.  An individual walks in for the second time, hugs you, and leaves.  You are given the same list of emotions to choose from…etc.

The experiment showed that touch, independent of words, sounds or facial expressions, functions as a distinct means of communicating emotion.  The emotions that were successfully communicated in this study include: anger, fear, disgust, love, gratitude, sympathy, happiness and sadness.  Pretty impressive, right?

You may still be thinking “OK, so how is snuggling supposed to make me perform better?”  This is where the fun comes in.  Michael Kraus of UC Berkeley conducted a study examining the role of “tactile communication” (a.k.a. touching) and its effects on the performance of NBA players (2).  The study hypothesized that players who touched fellow teammates more often throughout a game would be more successful on the court.  They believed that the same would be true for entire teams as well (i.e. the more high-fives and butt pats, the better the team would play).  They watched each individual player in the NBA for an early season game and tallied the number of times the player touched a teammate. “These celebratory touches included fist bumps, high fives, chest bumps, leaping shoulder bumps, chest punches, head slaps, head grabs, low fives, high tens, full hugs, half hugs, and team huddles.”  Can you imagine a bunch of scientists sitting around a television tallying “chest bumps”?  Welcome to the wacky world of UC Berkeley.  After assigning each player a score based on the number of touches throughout the game, the researchers quantified each player’s performance throughout the season in terms of points scored, rebounds gained, successful passes completed, and a number of other parameters that make a player valuable.  The researchers found that the more a player touched his teammates in that early season game, the more successful the player was that season. Teams that had the highest number of positive touches between players were also the most successful teams in the NBA!

According to the study, the Boston Celtics and the Los Angeles Lakers were at the top of the list of the touchiest teams, while the Sacramento Kings and Charlotte Bobcats were the least touchy teams in the league (1).  And the league’s most touchy-feely player?  Kevin Garnett of the Celtics (see photo of picture-worthy hug at left).  While the study showed a correlation between touching and performance, they did not prove that touching causes improved performance.

This observation has been studied in other settings as well.  Tiffany Field, one of the more prolific touch researchers, studied women with prenatal depression.  In the study, they compared participants whose partners gave them a regular massage to a control group in which the subjects got didily-squat (isn’t that sad?).  Guess what they found? Yep, those receiving regular rub-downs reported both a decrease in pain as well as improved relationships with their partners (3).  The same group of researchers studied autistic children and showed that touch therapy (which consisted of 15 minutes of physical contact two times per week for four weeks) was associated with less touch aversion, off-task behavior and stereotypic behavior and improved attention, behavior regulation, social behavior and initiating behavior (4).  Put simply, autistic kids were able to more easily control their behavior (this is one of the biggest challenges of the disease).

What is the science behind these observations?

Lets look at two hormones the body produces in relation to touch: oxytocin and cortisol.

Oxytocin

Oxytocin is the ultimate snuggle hormone.  It is best known for its action in pregnant women and is particularly responsible for milk “let-down” (a.k.a. allowing the milk made in the mammary glands of the breast to move to a “holding chamber” so that when the baby sucks on the nipple, milk is actually released).  Interestingly enough, the very act of suckling causes an increase in release of oxytocin by the pituitary gland (we have no political position regarding that statement.  Use this newfound knowledge at your own risk).  It is a self-perpetuating cycle to make sure babies get the food they need!  In terms of pregnancy, oxytocin also prepares the cervix for the birthing process (“Pitocin”, as oxytocin is called in this setting, is used as a topical gel to move things along and get the baby out faster).

Oxytocin is not only found in pregnant women…no need to feel left out, gentlemen.  Both men and women release oxytocin in relation to touch.  Studies have even found an increase in its release with warm contact on the skin.   Increases in oxytocin levels have been correlated with an increase in trusting behavior and decrease in fear.  It has also shown to be associated with generosity, empathy and even sexual arousal.   All of these emotions contribute to the formation of a bond between individuals.

Cortisol

On the opposite end of the spectrum, cortisol is commonly referred to as the “stress hormone.”  It raises blood pressure, spikes your blood sugar and suppresses the immune system among other things.   The body naturally increases its levels of this hormone in times of stress and anxiety (Remember “fight or flight” from high school biology?  This is a related chemical reaction).  Interestingly, one of the actions of oxytocin is the inhibition of cortisol.  One would think that a peak in cortisol levels in situations like an NBA game would help with performance.   The research, however, shows that it may actually be beneficial to have some level of suppression of cortisol in this scenario.

Therefore, when an NBA player high-fives his fellow teammate, he is triggering a biochemical signal in his teammate’s mind and body that says, “You can trust me.”  Perhaps it is this sense of security that allows players to push themselves physically and out-perform their rivals.  So next time you are on the spot, whether it be before shooting the game-winning free throw or as you sit down to take that final exam, giving the person next to you a motivating high-five will make a lot more sense.  It may be the “secret-weapon” you have been looking for.

Questions? E-mail Kelly: erickson@myhousecallmd.com

References:

1. Carey, B. Evidence That Little Touches Do Mean So Much.  The New York Times.  February 22, 2010.

2. Kraus, M, Huang, C,  and Keltner, D. Running Head: Touch, Cooperation and Performance.

3. Field T, Figueiredo B, Hernandez-Reif M, Diego M, Deeds O, Ascencio A.  Massage therapy reduces pain in pregnant women, alleviates prenatal depression in both parents and improves their relationships. J Bodyw Mov Ther. 2008 Apr;12(2):146-50. Epub 2007 Oct 2.

4. Field, T., Lasko, D., Mundy, P., Henteleff, T., Kabat, S., Talpins, S., Dowling, M. Brief Report: Autistic Children’s Attentiveness and Responsivity Improve After Touch Therapy. Journal of Autism and Developmental Disorders.   Volume 27(3), June 1997, pp 333-338

10

03 2010

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