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Category Archives: Opinion/Editorial

Pfizer Strategy to Get You to Buy Lipitor not Generic Atrovastatin

November 3, 2011 Dr. Pullen

The patent on Lipitor expires this month, and inexpensive generic atorvastatin should be available within months. I cannot think of any good reason that generic atorvastatin prices should be higher than the prices of the other generic statins once true competition comes to the marketplace. Pfizer has in place a strategy to try to keep patients buying and physicians prescribing brand name Lipitor and maintaining their market share to some degree. Here is how they hope to retain sales as outlined in the Wall Street Journal in an article by Peter Loftus:

Discount Drug Coupons: In every state except Massachusetts the use of manufacturer coupons to reduce the copay for brand name drugs is legal. Federal insurance plans Medicare and Medicaid disallow these coupons, as their real effect is to negate the intent of the payer (the U.S. government and its taxpayers in the case of Medicare and Medicaid) to force the individual patient to pay a premium in the form of higher copayments in order to use higher price brand name drugs. The effect is to give incentive to patients to use cheaper generics, save money themselves and save money for the health care system. Discount drug coupons take the incentive away from the individual patient and end up raising the cost of health care. Pfizer hopes that physicians and patients will make use of these coupons and help them retain market share instead of using less expensive generic atorvastatin.
Making deals with the pharmacy benefits managers that insurance companies use to give rebates or market share incentive deals that in essence give larger profits to these companies if patients use Lipitor instead of generic atorvastatin. These pharmacy benefits managers have considerable power in the choices patients have and drugs they are dispensed.

If Pfizer is successful in their attempts to retain significant market share of the $11 billion in annual sales of Lipitor, the #1 grossing U.S. drug for the last several years we can be sure other pharmaceutical companies will follow suit as their drugs lose their patent. Don’t be fooled by drug discount coupons. They may save you dollars in select situations where an expensive drug is clearly the best alternative, but in my opinion are rarely good choices, and certainly not in the case where their sole purpose is to convince us to use a more expensive brand name of a drug where a generic alternative is available. Everyone wants to reign in the cost of medical care, and discount drug coupons are trying to circumvent incentives to lower the cost of health care.

I’d be in support of either the federal government or each of the states following the MA lead and make drug discount coupons illegal.

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Sequenom™ brings MaterniT21™ and a Whole New Set of Difficult Choices

October 22, 2011 Dr. Pullen

Coming to 20 major U.S. metropolitan areas this week will be a test called MaterniT21™ from Sequenom™. Over the past 25 years we’ve gone from alpha-fetoprotein testing, to adding 2, 3 and more recently 4 tests as “penta” screen to try to improve the estimation of a woman’s risk for having a trisomy-21, or Down’s syndrome pregnancy without actually obtaining fetal cells, but all they have really done is improve statistical prediction capability. Up to this point in order to tell if a woman is carrying a Down’s Syndrome baby required amniocentesis to obtain amniotic fluid at about 16-18 weeks gestation, or the arguably higher risk chorioamniotic villous sampling at 10-12 weeks gestation. Both of these tests ran low (estimated 1/350) but real risks of fetal injury and miscarriage. Now from a company named Sequenom™ comes a test on fetal cells obtained by a venous blood sample of the pregnant women’s blood as early as 10 weeks gestation that can do genetic screening for Down’s Syndrome without more invasive ways to obtain fetal cells. The initial study of 212 women showed a >99% accuracy rate. (1 false positive, 2 false negatives in 212 women tested).

This is both exciting and frightening. It raises huge questions including who if anyone should get this testing. Here is a list of some of the issues that come to my mind as we start the process of figuring out the role of this new technology:

Increased Abortions and Earlier Abortions of Down’s Syndrome Pregnancies: One consequence of a more accurate test for Down ’s syndrome if it leads to more widespread testing or women for this condition is that more women will face the decision of abortion or not. Now women first face the question, “Would I abort my pregnancy if I knew I had Down’s syndrome, and if so am I willing to undergo a test that could cause miscarriage to get that information.” With the Sequenom™ MaterniT21™ test women will be able to get much more definitive information without a test that puts their fetus at risk from the test itself. This may lead to more women choosing to be tested. Putting aside the whole “pro-life vs. pro-choice” debate, the opportunity for earlier diagnosis will make technically easier and less physically traumatic abortions possible in women who have a Down’s Syndrome pregnancy.
Who should be Eligible for the Test?: Although the risk of Down ’s syndrome rises with increasing maternal age many Down’s Syndrome babies have young Moms. With a more accurate and less dangerous test available should all or more women be offered the test?
Who should pay for the testing?: This is a very complicated question. This test is not going to be inexpensive. On the Sequenom™ press release they suggest that the cost will approximate the cost of amniocentesis testing. They do not make it clear if this means the cost of the amniocentesis test itself, the cost of the genetic testing of the cells obtained, or both. If the test is done it will lead to higher costs for prenatal care as the test itself will significantly increase the overall cost of prenatal care. On the other hand the cost of having a Down ’s syndrome baby is not inconsequential. Down ’s syndrome children sometimes have major other congenital deformities, and the long term cost of education, support as adults, and associated family and societal costs are real and significant. A comprehensive cost-benefit analysis of this process will be interesting to see when it becomes available. These issues themselves will lead to ethical and moral choices.
Lower Incidence of Down’s Syndrome: If this tests becomes widely used, and if more women choose to abort pregnancies with Down’s Syndrome fetuses, the incidence of Down’s Syndrome could significantly decline. While many may consider this the desired outcome, some Down’s Syndrome supporters fear that this may lead to reduced support and reduced research into drugs and other techniques to help Down’s children.

I’m sure I’ve only touched the surface of the ethical, emotional, medical, moral and financial issues this new MaterniT21™ test from Sequenom™ and likely others to follow will bring. It seems a near certainty that with the ability to sample fetal cells from maternal blood other genetic tests like tests for cystic fibrosis, sickle cell disease, and many others will follow.

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What Vitamins Should I Take?

October 20, 2011 Dr. Pullen

I’ve been asked “What vitamins should I take?” by many patients over the years. I’ve usually answered that a store brand multiple vitamin is a good choice for most people, but recent evidence suggests that maybe the best answer to the question is that most people who have a reasonably healthy diet are best taking no vitamins at all. I know that answering the question, “What vitamin should I take?” with the answer that most vitamin supplements may cause more harm than good is not likely to be the answer patients want to hear, but as more evidence becomes available it is more clear that we just cannot get the healthy nutrients of a balanced diet in a pill, and that attempts to do so may actually be detrimental to our health.

In the nearly 30 years I’ve been practicing medicine there has been one miracle vitamin/mineral/supplement after another in vogue, and almost none of them have stood the test of time. The only way to get the full benefit of nutritious foods is to eat them. Bummer. It’s so much easier to just buy vitamins or supplements and eat junk. Sorry but that just doesn’t give the benefits of a nutritious diet.

In the last couple of weeks two new studies show that there may be more harm that good from taking several vitamins. A large study published in the Archives of Internal Medicine where 38,000 women were followed for 17 years showed slightly higher death rates in women taking multiple vitamins than in women not taking them. Specifically taking multiple vitamins, vitamin B6, iron, copper, zinc and magnesium were all associated with statistically significantly higher death rates. Only calcium seemed to be associated with slightly lower death rates in this study of older women.

An NIH study released recently showed that Vitamin E is associated with higher rates of prostate cancer. Over the years Vitamin C, Vitamin E, beta carotene, saw palmetto, multiple antioxidant regimens, and nearly every vitamin with a letter or number has been in fashion for reduction of one health condition or another. One by one they have almost all been shown to be useless or worse.

Who else remembers the theory that the whole trick to avoiding atherosclerosis was to ingest the right ratio of saturated to polyunsaturated oils. I remember a resident physician in Boston when I was a student who urged everyone to drink corn oil every day so that we could eat all the meat we want because our ratios of fat consumption would be in balance and that would make eating animal fat OK. Most of us laughed at him, but that theory had lots of followers 30 years ago. Beta carotene and vitamin E as antioxidants have been clearly shown to be more harmful than good.

So what’s a person to do? Here are my suggestions:

First and most important try to eat a healthy diet. Avoid fad diets, eat more fruits and vegetables, less meat, and exercise more. Don’t think you can rely on vitamins, mineral supplements, or gimmicks to substitute for healthy eating. See previous posts on Anti-inflammatory Foods, Foods High in Fiber , and Anti-aging Diet.
Be skeptical of whatever vitamin or supplement craze is in fashion at any given time.
Don’t think that more is better regarding vitamins. It has long been known that high doses of vitamins A, E and B6 can be toxic. There is little evidence to support high doses of any of the other vitamins either.
Keep in mind special conditions where supplementation with specific vitamins is important. Examples of these include many causes of malabsorption like gastric bypass surgery, some medication use, and celiac disease.
Understand that this is a long term issue. Eating well this month is good, but eating well for a lifetime is the key.
Avoid vitamin regimens that have been clearly shown to do more harm than good. These would include:
1. Beta-carotene supplements
2. Vitamin E supplements in most people
3. Iron supplements in men and post menopausal women
4. High dose supplements with nearly every vitamin. Currently Vitamin D is in vogue, and currently most of the data looks positive. Time will tell whether this works out or not.
5. I’d avoid even a multiple vitamin daily at this time if you eat a reasonably healthy diet and have no specific reasons to take the vitamin.

For other related articles check out:

Psyllium Husk

Dr Pullen Lives the Mediterranean Diet

Healthy Fruits – Healthy Vegetables

Use the subscribe section on the right sidebar to get e-mail notification of each new post, and follow @DoctorPullen on Twitter to see both DrPullen.com posts and other thoughts and information I find interesting.

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Keeping Perspective: A Key Role for the Family Physician

October 13, 2011 Dr. Pullen

I believe that one of the most important things I can offer to my patients is help in keeping perspective when making medical decisions. I have a fund of knowledge and experience that adds a layer of perspective to the patient’s own beliefs, situation and overall health scenario. Hopefully I can get enough of a feel for the patient’s own personal, psychological and interpersonal situation to add my own perspective to theirs to help advocate for them in keeping perspective on the issues they are facing.

By a physician’s balanced perspective I mean the ability to look at the whole clinical, personal and psychological situation in which a medical decision is being made and help their patient make choices that are aligned with both the medical facts and reality as well as the their own beliefs, values and desires. Often the emotional issues or prior anecdotal experiences of a patient can prevent them from keeping perspective in making important decisions. My role at times is to help them see the broader picture and make the best decisions.

Sometimes this is simple, but sometimes not simple at all. Let’s look at one simple and one complex example, and then summarize by looking at examples of times keeping perspective helps with making the best choices.

Simple: A 45 year old male with a blood pressure of 195/125 who has no symptoms but is a smoker, has a poor lipid profile and whose Dad had coronary bypass surgery at age 50 is reluctant to take blood pressure medication because he “just hates to take pills.” The physician has a simple task. Find out the real reasons for being reluctant to take medication, present the facts- this fellow has a >30% chance of a coronary event in the next 10 years, and find a way to convince him to use medications to control his blood pressure. In this case the evidence that treatment of this patient’s hypertension along with his cholesterol can reduce his risk of an event to 11% (if systolic BP goal of <130 and Total cholesterol goal of <180 are met, and if he can quit smoking to about 3%). Presenting this evidence to the patient, along with finding out the reasons for disliking taking medications is likely to persuade him to comply with therapy, and be hugely to his benefit.

Complicated: A 39 year old mother of two who is divorced but involved in a new relationship with a childless man is found to have an enlarged uterus on routine annual exam. Ultrasound shows a thickened endometrial lining at 1.7 cm, and endometrial biopsy shows endometrial hyperplasia with atypia. Her family physician refers her to a gynecologist for further evaluation, and she is presented with several options. She can have a laparoscopic assisted vaginal hysterectomy to remove the uterus and assure no progression to endometrial cancer. She can have a D&C, which will further assess the endometrial pathology and likely but not absolutely get rid of the atypical cells. She can take hormonal medications to get a “medical D&C” to bring on a heavy menses and try to rid her uterus of the hyperplastic lining. Keeping perspective of her wishes, future plans and feelings about the options is very important in helping this woman make the best decision for her individual situation.

In the former situation with family doctor trying to convince the patient to treat their hypertension is straight forward. Hopefully the physician can help the patient in keeping perspective of the whole picture and will lead the patient to comply and take the drugs to reduce their risk of serious long and short term cardiovascular problems. In the latter case the physician will hopefully discuss the needs of the woman involved and help her in keeping perspective of both the medical facts and risks as well as her feelings and needs in making her choice. Does she want further children? How does she feel about a hysterectomy? Is she willing to submit to long term careful follow up of the condition if she chooses a less aggressive therapy? Keeping perspective involves figuring out the needs of the patient involved.

Examples of when keeping perspective in mind rises to the top of the physician roles include:

prostate cancer treatment, especially in the older man
treatment of moderately elevated LDL cholesterol
whether to take estrogen for moderately severe hot flashes and night sweats around the time of menopause
whether to use oral contraceptives, an IUD, or barrier contraception at various times of your life
whether to take Accutane for moderately severe acne
whether to start insulin for poorly controlled type 2 diabetes

The list could take up pages, as it really comes up to some degree with every physician visit. Sometimes the issues are so simple as to be obvious to both the patient and the physician, and go almost without overt comment. Other times as the physician we can help by labeling our role as helping the patient at keeping perspective, and assisting in their decision making by adding our perspective while trying to understand theirs.

You may also enj0y reading:

Which Arguement Shoots Down Your Excuse for Not Getting a Flu Shot or

USPSTF: Losing its Independence?

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Moral Responsibility to Get Your Flu Shot

October 10, 2011 Dr. Pullen

Moral Responsibility to Get Your Flu Shot

I Got Mine

This topic comes to mind again this year as we have plenty of influenza vaccine, on time this year and ready for distribution. A prior version of this post was posted in 2010. I have strong enough feelings on the subject to repost an updated version. If anything good came of the Swine Flu epidemic on 2009 it was that more Americans get immunized not than ever before.

This year as every previous year Dr. Pullen was first in line at our office for my influenza vaccination. I take seriously the mantra primum non nocere, first do no harm. It’s hard to imagine doing more harm than seeing a patient with influenza on Monday, and on Wednesday, the day before I get sick, sneezing and passing the influenza germ to one of my vulnerable older patients, or a pregnant woman, or a young baby who then dies from influenza. This scenario is just inexcusable given that I could have avoided harming the patient if I had received the recommended and easily available influenza vaccination. It would be immoral and irresponsible to put my patients at that type of risk unnecessarily. I encourage, coax, tease, and everything short of intimidate my employees and fellow physicians to get their influenza vaccination also. School teachers, emergency workers, and others in close contact with the public should similarly feel morally compelled to get influenza vaccination. It is our moral responsibility.

I also got a Tdap vaccination last year also, even though was several years until I was due a tetanus shot. See Dr. Pullen Gets His Tetanus Booster Shot Years Early! My thinking was the same, try to avoid a pertussis infection, and not put my patients at risk.

It’s a small step from discussing health care workers and influenza and pertussis vaccination, to talking about parents and childhood vaccinations. The parent who chooses not to vaccinate their children against measles and pertussis puts not only their own child, but other children in the community and the school who may be at particular risk for complications from these infections in danger. These children at high risk may catch these infections from these unimmunized children. As a parent I’d feel terrible if my child died or became brain injured from measles, but I’d also feel horrible if my child passed Pertussis or measles on to a child with leukemia, or HIV because I chose to not immunize my child. I appreciate that this is a free society, and we can make our own personal choices about health care including immunizations. It’s not illegal to decline recommended immunizations, but in many cases it is irresponsible and not living up to our community moral responsibility. Parents who choose not to immunize their children and take advantage of the herd immunity of the majority of children whose parents responsibly immunize their kids are just ignorantly selfish. They think they are protecting their children from risks of immunizations, though a great mass of evidence refutes this point of view. In fact they are putting both their own child, and other children who lack immunity through no choice of their own or their parents at risk.

I’m anticipating a rash of angry comments calling me a mouthpiece of the brainwashed physicians of organized medicine. Don’t believe them.

See these references on the safety of childhood immunizations.

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism (there is none).

Data Fail to Support Thimerosal-Autism Link

The end of the autism/vaccine debate?

Book Is Rallying Resistance to the Antivaccine Crusade

Also see the great video at the top of the Musical Docs page Immunize: The Vaccine Anthem.

PSA Controversy Continues

October 5, 2011 Dr. Pullen

The controversy over PSA testing is tough. Nobody wants to hear that although prostate cancer is the second leading cause of cancer death in men behind lung cancer that there is no good reason to believe that PSA testing leads to either longer or better lives. It is a tough dilemma. Death from prostate cancer is not good. Men sometimes die after long, painful illness with metastatic bone cancer and a wasting painful death. Everyone including me wants to believe that early diagnosis must be good. Unfortunately the evidence just does not lead you to that conclusion. You may have enjoyed my last post on Prostate Cancer Screening, “Don’t Do Something: Just Stand There” and in todays New York Times is a very thourough historical and analytical article outlining the controversy of PSA screening. It is full of emotional quotes by advocates and skeptics. Also is a link to Dr. Kenny Lin’s latest article on the subject also. These make a good read for anyone considering PSA screening.

Can Cancer Ever Be Ignored? by Shannon Brownlee and Jeannie Lenzer

I especially like the article’s visual. It raises the seldom stated but often considered axiom that every good primary physician knows: If you don’t want to know the answer, don’t ask the question.

Dr. Kenny Lin, a key player in the PSA debate as the ex-USPSTF point investigator on the PSA screening dilema who resigned in protest of political pressure to withhold new recommendations to make PSA screening a grade D (as in don’t do it) for PSA screening in healthy males that was based on the best available evidence but was politically unacceptable writes another excellent discussion of the topic:

The Meeting that Wasn’t Revisited by Kenny Lin MD.

Stay tuned for the latest on this controversy. Subscribe to DrPullen.com to not miss a post. You can choose to subscribe to all posts, or just by category. Just enter your e-mail address in the subscribe area at the right.

NOTE THAT SINCE THIS WAS POSTED THE USPSTF HAS POSTED A PROPOSED UPDATE TO THEIR RECOMMENDATIONS FOR PSA TESTING FOR MED AS A “D” RECOMMENDATION, i.e. RECOMMENDING AGAINST USE OF PSA AS A PROSTATE CANCER SCREENING TOOL.

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When No Immediate Treatment is The Best Option for Prostate Cancer

October 3, 2011 Dr. Pullen

“Don’t Just Do Something, Stand There!” When No Immediate Treatment is The Best Option for Prostate Cancer

by Patrick Maguire, MD

As we near the end of Prostate Cancer Awareness Month this September, hopefully many of us have learned a thing or two that we didn’t know about the disease in August. Just last week, a major study of predictors of sexual function after prostate cancer treatment was published in the prestigious Journal of the American Medical Association (JAMA). I found some important info in the paper and recommend it highly to men who are considering their options for treatment. The link for the full document is: http://jama.ama-assn.org/content/306/11/1205.full.pdf. An in-depth discussion of the topic can be found at on my blog The Cancer MD. As opposed to various treatment choices, one option for men after a prostate cancer diagnosis that we don’t hear too much about in theU.S. is active surveillance.

Many terms have been used to describe what is now most often called active surveillance. These include: watchful waiting, close observation, and expectant management, among others. Given the right circumstances, the option of avoiding prostate cancer treatment altogether is often best. Which men are candidates for watchful waiting after their diagnosis?

To be sure, prostate cancer is a spectrum of disease that can range from indolent to extremely aggressive. Men with low-risk prostate cancer may be good candidates for no immediate treatment. These cancers can’t be felt or are only felt in part of one side (lobe) of the prostate, produce a low level of prostate specific antigen (PSA) in the blood, and appear not too aggressive under the microscope (Gleason score of <7). Among this group, younger, healthier men are usually the best served by treatment.

Men with low-risk disease who are either older or in poor overall condition should strongly consider expectant management. In general, it takes more than a decade for early prostate cancer to spread to other sites in the body (metastasize) and ultimately kill a man. Therefore, men who have a life expectancy less than 10-15 years should think long and hard about the option of no treatment. In medical school, we docs agree to abide by the Hippocratic Oath, a major principal of which is “primum non nocere” (do no harm). We don’t want to put a man at risk for possible side effects of treatment, unless we have reason to believe that the treatment has a good chance to improve survival or quality of life.

So, if you or your loved one has been diagnosed with prostate cancer that’s found very early, ask your urologist or radiation oncologist whether active surveillance or watchful waiting is a reasonable option. Sometimes, though it may feel strange, you might have to tell him or her, “Doc, don’t just do something. Stand there!?

Dr. Maguire regularly posts on TheCancerMD.com and is the author of a book that I have enjoyed reading that helps laypersons understand the language, facts and treatment options for the most common cancers. When Cancer Hits Home: Cancer Treatment and Prevention Options for Breast, Colon, Lung, Prostate & Other Common Types.

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Medicare Wellness Exam: A Family Physician’s Nine Month Perspective

September 29, 2011 Dr. Pullen

With the implementation of the Affordable Care Act now since Jan 1, 2011 for the first time Medicare authorizes a wellness exam for our elderly patients. I have been doing a large number of these exams and have a few thoughts on the experience so far. A good description of the encounter is like a sprint to cover the mandated components of the Medicare Wellness Exam and get these documented so there is a little time left to meet the patient’s expectations of a physical exam.

At the crux of these comments is that the required elements of this wellness exam bear little resemblance to what most patients would consider a physical exam. CMS intentionally made up brand new CPT codes for these exams so that they are not considered the same service as a preventative care “physical exam” code for an adult patient. Those cynics among us suspect that the primary reason for this was financial. Medicare did not want to use the age adjusted RVU payment multiplier for this newly authorized service. In order to justify a mush lower payment amount they simply defined a new service as a Medicare Wellness Exam. The RVU for a preventative service code is considerably higher than the code for a routine office visit, so Medicare conveniently chose to reimburse the Medicare Wellness Exam at the level of a routine office visit, not as at physical exam level. That when combined with the fact that Medicare uses a compensation scale per RVU that is considerably lower than all commercial insurers make doing a Medicare wellness exam for an elderly patient pay considerably less than a typical office visit for younger insured patient with modestly complex medical problems.

Given that a family physician who wants to stay in business cannot spend twice the time of a regular office visit on a Medicare Wellness Exam that pays considerably less, the required elements of the Medicare Wellness Exam visit consume much of the time a reasonable physician can allot for the visit.

Making this all the more complicated for patients is that Medicare patients in my practice for years have become used to not being able to have a wellness visit, and so I have tried to provide these services broken into pieces at the time of disease management visits. This rather sudden change has left patients wondering what I’m doing spending my time at a wellness exam discussing things that may seem silly to them, or may not be what they perceive as having much to do with wellness. Most patients coming in for a wellness exam reasonably expect this to include a medical history, a medical exam and addressing preventative services due as well as at least documenting and formulating a plan for future evaluation of any concerns they bring up at the visit. This seems reasonable, except that the Medicare proscribed wellness exam has to include an assessment of:

Patient fall risk
Depression screening
Addressing their end of live decision status
Ability to accomplish a variety of needed daily tasks like managing money, shopping, housework, and transportation needs, and other activities of daily living.
Vision assessment
Hearing assessment
Assessment of immunization status
Assessment of other USPSTF category A & B preventative services due, including colon cancer screening, breast cancer screening, prostate cancer screening discussion, and diabetes screening.

The healthy, active and otherwise well 67 year old may think many of these queries re irrelevant, and they may in fact be irrelevant. Some may even feel insulted that I’m asking about their risk of falling and managing their household when they want to talk about their risks of heart disease, diabetes, stroke and cancer. The frail, near blind and near death 96 year old living with family may have difficulty with so many of these issues that to adequately cover even some of them would require more time than can be allotted to the entire exam. Many of these patients may feel this visit should include a much more comprehensive hands-on physical exam than is realistic in the visit given the mandated topics to cover and the time reasonably expected for the level of compensation allowed.

Still other patients will expect their chronic health conditions, or various other complaints to be addressed at this visit. Their shoulder hurts, their ankles swell, they have some constipation, and their back aches in bed at night. It is difficult to tell the patient that this visit is only for the mandated Medicare Wellness Exam issues and not to address their multiple chronic health problems. Yet other patients really don’t want a Medicare Wellness Exam at all, rather they want a problem focused visit but want to have the visit billed as a Medicare Wellness Exam because it is paid by Medicare without copayment or deductible payments by the patient.

It is simply not realistic to try to complete the mandated Medicare wellness exam points, do a history and physical exam in the traditional sense, and have time to even listen to other complaints. To try to listen to and also address these complaints is even less likely.

I think Medicare is way off base in setting rigid and rigorous expectations for a wellness exam. Allowing the patient and the physician to set an agenda that meets the patient’s needs and expectations would have been a much wiser approach. The concept of giving patients the opportunity to see their physician once annually to address their personal preventative care issues without making a laundry list of mandated issues to include in the visit could have been great. As it is now the visit becomes a race to cover the mandated topics while trying to include at least some of the reasons the patient wants to be seen. This is one more example of the Medicare rule-makers just trying too hard standardize care and mandate excellence, with the unintended consequences of forcing every American over age 65 and on Medicare to be subjected to essentially the same one-size-fits-all Medicare Wellness Exam.

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What is Hospice: A Hospice Volunteer Point of View

September 26, 2011 Dr. Pullen

by Christina Lufkin, Hospice Volunteer and Author.

What is Hospice?

Hospice is not a death sentence. It is an opportunity to live life to the fullest until you die.

I have been a Hospice volunteer since 1994. It is my passion. To be of service to others during such an important and intense time of life is an honor. The more I give, I am repaid tenfold. In order to qualify for Hospice a patient must be diagnosed with a terminal illness that if it were to progress at the normal rate, would only have six months to live. To be eligible a patient can’t be involved in treatment to try cure the illness. Their doctor must write a referral for the patient to be evaluated for Hospice care.

Once enrolled, if the patient lives to the six month timeframe they can be evaluated and reinstated in the program. Hospice provides many services that assist both the patient and the family. I have had many conversations with family members and friends of terminally ill patients who were anxious because of unresolved issues with the patient or because they just felt they needed to share something and had not done so. I always encourage them to make time to talk about the issues. It will be too late once the patient has passed. If left unresolved these situations can lead to the survivor feeling regret, sadness, guilt or frustration. Grief is natural but adding the pressure of not talking openly before someone dies can make the grieving process much harder.

Many patients have talked with me about the importance of relationships in their life. They have never expressed regret about wishing they had more money, possessions or fame. It is so important to most people to know that they don’t have any unfinished business, which allows them to pass peacefully. Once a patient has been diagnosed with a terminal illness, Hospice is the best way to have their wishes met. The Hospice team; Nurse, CNA, Chaplain, Social Worker, Medical Director, Volunteer Coordinator and Volunteers work together to accomplish the patients desires. This team effort helps address the patient’s complete needs; physical comfort, emotional and spiritual support. Treating the entire patient is very important. Then, after the patient passes the family has a great support system and grief counseling, and support groups available anytime there is a need. I have had many heart-to-heart talks with patients in addition to fun and silly times together. After every assignment I take time to reflect on the experience. I have always learned something from each patient. The patients and families have always thanked me and said how much my service and the Hospice services in general made a positive difference.

I encourage anyone interested in Hospice or in volunteering to call your local Hospice organization. If you have questions please contact me at christinalufkin1@yahoo.com. Christina is also available for interviews or guest speaking engagements. Christina Lufkin, Author “Live with Purpose:Die with Dignity” www.christinalufkin.weebly.com

Comments by Dr. Pullen: Over the years I have had nothing but positive experiences with hospice. When my Mom passed last spring Hospice was involved and they definitely made for a better experience all around. See my post, Saying Goodbye. Hospice has several major advantages from a flexibility and financial standpoint also for terminal patients. The Medicare reimbursement for Hospice is on a per-diem basis, and the Hospice team has a great deal of flexibility in choosing services to provide to patients, many of which would not be eligible for regular Medicare coverage.

You may also enjoy How We Fail and End of Life Care.

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Oracea vs. Generic Doxycycline for Rosacea

September 20, 2011 Dr. Pullen

I continue to be amazed at the crazy pricing of old drugs with new formulations, and Oracea at over $420./ month is a great example. Doxycycline first came to market 1967 and has been a commonly used antibiotic for my whole career in medicine, especially since it has been available as an inexpensive generic for years now. In recent years we have learned that the use of doxycycline for some conditions, especially periodontal disease, acne vulgaris and acne rosacea may be primarily effective for its anti-inflammatory effects rather than its antimicrobial effects. Doxycycline seems to have anti-inflammatory effects at doses below doses needed to have antimicrobial efficacy. Periostat, a 20 mg dose of doxycycline has been used as a twice daily dose for years by dentists and periodontists to reduce pocket cavity in periodontal disease, seeming to function as a collagenase inhibitor and give slightly improved results over routine aggressive dental care alone. Even better news is that generic doxycycline 20 mg is now available as an FDA approved generic alternative.

Oral antibiotic therapy, topical antibiotic therapy and combination of oral and topical antibiotic therapy has long been used in the treatment of rosacea. Rosacea is a very common and disconcerting facial skin condition. It is estimated to affect up to 16% of women and 6% of men in its milder form, and 1-3% or people in the more severe pustular type. Tetracycline antibiotics in particular have been popular in treatment of rosacea, and the inconvenience of use of tetracycline which needs to be taken on an empty stomach makes doxycycline more popular. The typical antimicrobial dose of doxycycline is 100 mg twice daily, but for rosacea lower doses seem as effective. Enter Oracea, a once daily 40 mg doxycycline dose, packaged as 30 mg of immediate release doxycycline combined with 10 mg that is released slowly to the intestinal tract to give longer low serum level concentrations of doxycycline. The manufacturers claim that this formulation keeps the serum levels of doxycycline below the concentrations needed for antibacterial effects during all or almost all of the day, and can thereby avoid the common doxycycline side effects of yeast infections as well as the induction of antimicrobial resistance. This sounds great, until you read find that the retail price of Oracea is $426.25 / 30 pills at Costco pharmacy vs. $60.51 / 100 pills of doxycyclie hyclate 20 mg, and $10.83 for 100 pills of doxycyline 50 mg. This means that in return for making 10 mg of the once daily dose of doxycycline sustained release Galderma labs marks up the price 11.7x the price of generic twice daily doxycycline, and 65x the price of taking 1/4 of a 50 mg doxycycline tablet. (not incidentally the cost of doxycycline 100 mg tabs is also $10.83/ 100 pills at Costco, the lowest price Costco gives on bottles of 100 pills of prescription). You might assume that it was tremendously expensive for the makers of Oracea to do vast studies of Oracea to prove its efficacy. Not likely as in the only placebo controlled studies I could find the total number of participants was 537 followed over 12 weeks. In these studies Oracea was in fact found to be more effective that placebo, with about a 50% reduction in the “active lesion” counts noted. Still in the first line of the study publication in the American Academy of Pediatrics the Background assumption was, “Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea.” I can find no study comparing 20 mg twice daily or 25 mg twice daily of generic doxycycline with Oracea.

I’ve seen the graphs shown by the Galderma reps showing a lower percentage of a 24 hour period where their product remains below the antimicrobial serum levels, while once daily doxycycline 50 mg rises into the antimicrobial range for part of the day. They jump to the conclusion that this will lead to more yeast infections and more antimicrobial resistance. I could not find any evidence proof of this being the case. Oracea claims an incidence of yeast infection of less than 1%, but has not compared the incidence of yeast infections with Oracea to generic doxycycline 20 mg twice daily. Dentists suggest that the incidence in their patients at this dose is quite low too. They also show not data to support their claim of lower antimicrobial resistance than alternative low dose doxycycline regimens.

Until Oracea has been shown in head-to-head studies to outperform low dose doxycycline immediate release once or twice daily, or has at least shows significantly lower incidence of doxycycline side effects than low dose immedicate release doxycycline I’ll just save my patients the expense of this ridiculously expensive reformulation of an old, well known and effective drug. Don’t fall for the Drug Discount Coupons theory that if it doesn’t cost the patient out-of-pocket dollars it is inexpensive. It’s still a real cost and one we can steer clear of at this point in time. It is estimated that oracea will bring in over $260 million in sales in 2011. That is a quarter of a billion dollars we can avoid in holding health care costs in line.

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