MRI Use in the Detection of Prostate Cancer

As men live longer the likelihood of them developing prostate cancer increases. Some experts estimate that if we biopsied the prostate of every male 80 years old or older, we probably would find prostate cancer present in almost all of them.

The PSA test has been shown to be less valuable than previously thought when discovered because it does not distinguish between an elevated level due to normal prostatic enlargement, infection or the presence of cancer.  When it is elevated due to cancer it cannot predict which tumors are aggressive and require aggressive treatment and which tumors are non-aggressive or indolent and can just be watched.  For this reason, CMS or Medicare and the United States Preventive Task Force are opposed to PSA use as a screening test.

To deal with these issues, Robert K. Nam MD, MSc, chairperson of genitourinary oncology and professor of surgery at Sunnybrook-Health Sciences Centre in Toronto, Canada has published a small preliminary study in the Journal of Urology on the use of MRI (magnetic resonance imaging) to predict the presence of and the aggressive status of prostate cancer disease.

They recruited men who knew they would be undergoing a PSA test, a MRI of the prostate and a prostate biopsy. Their preliminary results show that the MRI was a better predictor of the presence of prostate cancer than the PSA.  It was also felt to identify how aggressive the disease was which influenced treatment options offered. It was additionally felt to be very accurate in identifying when no prostate cancer was present.

Small numbers of patients were entered in this pilot study. A larger randomized controlled study is now in the planning stages to further clarify these initial findings.  At the same time in our community some of the urologists are now ordering MRI scans to elucidate what is causing an elevated PSA in individuals who have a non-diagnostic digital rectal exam and an elevating PSA.

Generics and Therapeutic Substitution – Safety and Efficacy?

Excuse me for being a “doubting Thomas,” but when I saw articles in JAMA Internal Medicine and commentaries supporting use of generics instead of brand name drugs I asked myself “Where is the proof of equivalent results and safety?”.  Generic substitution implies that the original product is no longer patented and exclusive and another firm is now producing an identical chemical version which produces the same beneficial effects on the patient.  Therapeutic substitution means your pharmaceutical insurance company or pharmacy changes the drug you are prescribed to one in the same drug class. Think of drinking Coca Cola and having the supermarket substitute a comparable brand instead.

The reason for this is simply to spend less money. Many pharmaceutical insurance companies realize if they put an obstacle in your path of obtaining your medication you likely will pay for it independently saving them money.  The authors of the JAMA articles estimate between 2010 and 2012 therapeutic substitution would have saved $73 billion. The out-of-pocket savings to the patient would have amounted to $25 billion.

I’m for saving money and spending less with certain guidelines. However; I want to know that a generic medicine is produced in a factory inspected by the Food and Drug Administration (FDA) at least as frequently as the drugs produced in North American factories. I like to know where the drug was made including country of origin, city, location and the plant’s track record for health and safety. I also want to know the generic medication produces the same drug levels and positive effects as the brand name medication and is made with no more contaminants than the original branded product.

I need reassurance that my patient isn’t receiving a counterfeit product with stolen original labeling, which has been a scam fooling pharmacists and Customs agents for years.   I would additionally like to know that the generic product, or therapeutically substituted product, works as well as the original. We know for example that Levothyroxine generics and substitutions are problematic.  We additionally know that the beta blocker carvidilol (Coreg) has certain unique properties that other beta blockers do not provide making therapeutic substitution for less expensive medications in the beta blocker class problematic.

Once this information is available it should be distributed in package inserts, online and taught in pharmaceutical, nursing and medical school courses as well as CME courses for health care professionals.

There is an abnormally perverse concern that if a pharmaceutical representative takes a health care provider out for a meal and a drink while explaining their product, we will prescribe it even if it is more expensive or doesn’t work as well.  I doubt sincerely that most physicians would do that but do believe if the cost is comparable, or less, and the efficacy is as good, they might choose the product as a viable alternative.

Antibiotic Associated Colitis Increases Risk

At least a half dozen times per week patient’s call with symptoms of a viral upper respiratory tract infection or present to the office for a visit with symptoms and signs of a cold.  These illnesses are caused by small viral particles which do not respond to antibiotic treatment.   Your body’s defense system attacks these viral particles and over a period of hours to days defeats them.   Despite years of ongoing public health announcements and handouts by doctors and nurses and attempts at patient education you find yourself negotiating with strong willed patients who want a “Z Pack” or some other antibiotic which they do not need.  “I know my body,” they argue.  “My northern or previous physician knew to always give me an antibiotic, why won’t you?”

The answer is quite simple. They do not work to shorten the course, intensity or duration of your illness. They do in fact put you at risk of developing complications of antibiotic use. When your infection requires the use of antibiotics to restore health, it is worth taking these risks. When you do not need the medication it definitely is not. This was confirmed by an article and research presented by E Erik Dubberke, MD of Washington University School of Medicine in Saint Louis, Missouri commenting on Medicare Data about the death rate associated with antibiotic related colitis infections due to Clostridia Difficile.  Bacteria normally reside in our large intestine and promote health and digestion.  When we prescribe an antibiotic it kills off the healthy and beneficial bacteria as well as the infection related bacteria. This destruction of healthy bacteria creates an environment conducive to “opportunistic “bacteria normally suppressed by the normal flora to invade and take over your gut. The resulting fever, cramping, diarrhea with blood occurs as the intestine become inflamed with colitis. One of the common opportunistic pathogens is Clostridia Difficile.

Dr. Dubberke looked at Medicare data and compared 175,000 patients older than 65 years of age and diagnosed with Clostridia difficile infection and compared them to 1.45 million control patients. He found that those with clostridia difficile infection had a 44% increased risk of death. When comparing admissions to nursing homes for treatment there was an 89% increased risk due to antibiotic related colitis care.

Antibiotics are wonderful when appropriate. They will always carry a risk of a side effect, adverse reaction or complication which is a risk worth taking in the correct setting.  It is clearly not worth the risk when your doctor tells you that it will not work.

How Much of Yourself Can You Give to Others?

I have been practicing general internal medicine for over 35 years in the same community. I have many patients who started with me in 1979 and are now in their late eighties to early nineties.  Predictably and sadly they are failing.  Not a week goes by without one or two of them moving from general medical care to palliative care, very often with the involvement of Hospice for end of life care.   Medicare may now compensate for discussion of end of life issues but anyone practicing general internal medicine or family practice has been discussing end of life issues appropriately for years with no compensation. It just comes with the territory.

Most of us still practicing primary care thrive on being able to improve our patient’s quality of life and our major compensation can be hearing about their interactions and social engagements with family and friends.  It is an accomplishment to see you’re 90 year old with multisystem disease for years, dance at her great grandchild’s wedding.  No one who cares for patients longitudinally for years is that dispassionate that they do not give up a piece of their heart and soul each time they lose a patient or have one take a turn for the worse.   When I lose a patient, if time permits, I will attend the funeral or family grieving gathering during the mourning period.  Everyone gets a personal hand written letter. Completion of the circle of life and then moving on is part of the process.

I think physicians’ families take the brunt of this caring and I am sure mine does. As much as you want to have time and patience and sympathy and empathy for your loved ones, the work truly drains your tank and reserve. When you answer the questions of the elderly and their families over and over, often the same questions, it drains you.  Unfortunately, I believe my elderly failing mother is cheated the most by this process. Last weekend when making my weekly visit she was complaining again about the same things, asking the same questions that have repeatedly and compassionately been addressed by my brother and I. My wife interjected that I sounded angry and annoyed. I was. I told her that unfortunately all the compassion and understanding in me had been drained already today and I needed time to recharge.

I saw the widow of a patient who expired last month in his nineties. I had offered to make home visits and they were declined several times by the patient and his spouse. His last week of life he asked to receive Hospice care and they assumed his care.  I called the surviving spouse and wrote what I considered a personal letter of condolence.  His wife told me she was disappointed in me for not coming up to see him one last time. I apologized for not meeting their needs but wondered inwardly, how much can I give and still have something left for myself and my loved ones?

Changes Coming to Medicare Soon

CMS (Center for Medicare Services) is determined to eliminate fee for service medicine. Fee for service medicine is the system where patients see a physician or “provider” for a visit or service and the “physician or provider” bills the patient or Medicare for each service provided.  CMS argues that “providers” are seeing too much volume and providing too many services thus driving up the cost of health care and the percentage of the Gross National Product that healthcare consumes.  To contain costs they have come up with the public relations mantra of the “Triple Aim.”  The triple aim includes improving the global health of the US population while improving quality and reducing overall costs.  The true emphasis is on reducing overall costs!

To reach their goals, CMS is changing the way it pays for health care and services. By 2019, less than three years from now, CMS hopes to pay one flat fee per beneficiary to large health care organizations ( think HMOs) thus fixing their costs. That large organization will then be responsible for providing total care to a local population.   Hospitals and large health care systems have been purchasing physician practices and employing the doctors in organizations known as Accountable Care Organizations (ACO’s). These health systems believe that by employing the doctors they will control their ordering and spending habits and reduce costs to the overall system. They hope to drive an aging private community physician population into early retirement or at least to stop coming to the hospitals to care for their own patients. They still want these patients to come to their hospital for care but want their employed physicians to provide the care.

If you look around the community you will notice that the major hematologic and oncology groups are now owned by Boca Raton Regional Hospital, as is the major surgical group, several cardiology groups and a host of internists and family practitioners.  The hospital has additionally partnered with its contracted emergency room physicians to open numerous walk in clinics in young population centers to capture that business. At the same time that our local regional hospital is purchasing practices and discouraging local private physicians from continuing to practice, they have introduced a residency training program in internal medicine and surgery. By the fall of 2017 we can expect 100 internal medicine physicians and up to 45 surgical physicians fresh out of medical school and beginning their training, to be serving as a cheap physician labor force for Boca Regional Hospital.  The hope is that ultimately, the Charles Schmidt College of Medicine at FAU will attract and develop a clinical faculty worthy of a university and academic medical center that will enhance medical care in our area but until then we will always wonder, as anesthesia puts us to sleep, who actually is performing our surgical procedures?   Additionally one wonders if you become ill with a serious illness, will you be permitted and covered to see the best physician at the best institution for your problem or will you be required to stay in a narrow network of local providers contracted with the local health entity?

If physicians choose not to join a large health system organization as an employee they will be required to be part of a merit based payment system.  Government administrators, employers and private insurers are certain they can define and quantitate “quality care.”  It is unclear whether there is any meaningful evidence of what “quality care” really is.   Quality care will include parameters like patient satisfaction ( if you are not given an antibiotic for your viral illness or a narcotic pain medicine for your injury appropriately based on the illness or injury will the provider be given a low patient satisfaction grade?), did you counsel an obese patient to lose weight?  Did you counsel a tobacco smoker to stop?  Did you intervene to control a patient’s blood pressure?  All the data entry will require the physician to spend time in front of the computer screen checking more boxes and less time in face-to-face patient care.  Computers will need to communicate with each other from the office to the hospital to the lab etc. but it is unclear who will pay for this? At the end of each year the doctors will be required to send all their patient care data electronically to CMS for review.

Many physicians will choose to just leave or “opt out” of the Medicare system. They will contract privately with patients and be able to order tests and studies at approved institutions but they will not be reimbursed by Medicare for their services nor will the patient be reimbursed by Medicare for the cost of those doctors’ visits and services.  In most areas of the country where the population is not overwhelmingly composed of senior citizens 65 years of age or older, doctors have stopped seeing Medicare patients for just this reason. This may become the norm rather than the exception in South Florida as well.

For the moment my concierge practice is not changing anything. We continue to participate in all the CMS quality programs such as Meaningful Use and PQRS , vaccine registry and Eforcse (a controlled substance prescribing data base) despite the cost and time involved just to leave our future options open. I remain committed to giving my patients longer quality visits and following them where possible into the hospital when they need hospital services. As patients and citizens it is urgent that you become familiar with what CMS and the Federal Government are doing with your taxes and health care options and hold them accountable to your wishes!  If you have questions about this give me a call or set up a special time to discuss this face-to face.

Medicare Will Not Pay For Bone Marrow or Umbilical Cord Blood Transplants

Treatment of blood disorders, leukemia and lymphomas today includes the use of life saving transplants of bone marrow from genetically similar donors and use of newborn childrens’ umbilical cord blood containing stem cells.  The National Marrow Donor Program (NMDP), Be the Match, is the organization which operates the national match registry and has worked for the last 30 years to find 13.6 million adult bone marrow volunteer donors and 225,000 units of fetal cord blood for use. The NDMPs relationship with similar organizations across the globe creates a pool of 24.5 million potential marrow donors and 609,000 units of cord blood.

There are people who need these vital products and cannot find a match but, fortunately, that number is declining. The real problem in men and women 65 years of age or older is that outdated Medicare reimbursement policies do not pay for these products and services and the cost is too expensive for many to bear themselves. The Centers for Medicare & Medicaid Services (CMS) has created barriers to Medicare age recipients being covered for these products resulting in financial uncertainty for the patient. The actual cost is beyond the means of most working individuals to bear.

While private insurers cover more than 70 diseases and conditions, Medicare covers less than a dozen.  The US Department of Health and Human Services calculated that almost 20,000 people in the U.S. could benefit from life-saving marrow or cord blood transplant each year but do not receive them because CMS policy does not cover them.   Where Medicare covers the conditions, the rate of reimbursement is often insufficient to cover the costs.  As Baby Boomers become eligible for Medicare the problem will intensify.

Dr Fred LeMaistre, M.D., director of the Sarah Cannon Blood Cancer Network authored an editorial and appeal to the physician community to lobby for better coverage of marrow and cord blood transplants as a life saving measure.

I for one was stunned to realize just how poor the coverage has remained for these services and find it disgraceful that Sarah Palin’s predicted death panels have now materialized in the form of accepted lifesaving technology not being covered after age 65.  If you are as surprised as I am write to your Congressional representatives and demand appropriate reimbursement for bone marrow and cord blood transplants to save lives!

Does Tdap Protect You From Whooping Cough?

Within the past few years an epidemic of whooping cough swept through and injured youngsters in California and Arizona. There were tragic childhood mortalities in the frail not yet vaccinated pediatric population. The researchers from the Center for Disease Control and National Institute of Health swooped in and concluded that adults, primarily grandparents, were transmitting the disease to their newly arrived and not yet immunized grandchildren. They reasoned that the adults’ immunity from their childhood vaccinations with DPT had worn off and they were unknowingly transmitting it to the youngsters after a mild adult upper respiratory tract infection with bronchitis.  We were told that in adults, Bordetella pertussis produced bronchitis indistinguishable from a viral bronchitis. This was just the type of illness health care leaders were telling physicians not to prescribe an antibiotic for in their international campaign for the prevention of antibiotic resistance developing.  Little did they know at first that in adults, the bronchitis is a mild illness but in children it is aggressive and is often lethal.  They were not originally aware that long after our adult mild bronchitis resolved we could still transmit the bordetella pertussis to our grandchildren.

Their solution was to re-immunize adults with a pertussis booster in combination with your next tetanus shot. The combination was called Tdap.  A national information campaign was undertaken to get primary care physicians to spread the word to their adult patients.  The question is does it really work? In a recently published study led by Dr. Nicola P. Klein of the Kaiser Permanente Vaccine Study Center in Northern California which appeared in the Journal Pediatrics, it seems that the vaccine is only effective for a short time in the very healthy and robust 11 and 12 year children.  Their study showed that Tdap protected young adolescents 69% of the time in the first year, 57% in the second year, 25% in the third year and only 9% in the fourth year.  The vaccine was given during an epidemic in California in whooping cough in the hopes of averting a greater infection rate.

 

The failure of the vaccine to provide long term benefits in adolescents and teenagers will lead to different immunization strategies. Tdap is already a milder form of a former vaccine, scaled down to prevent some of the rare side effects seen when it was administered.  A possible return to that previous vaccine or whole cell preparation may be needed. Another proposal calls for vaccinating pregnant women hoping that their maternal antibodies will pass to the fetus and provide long term protection.

The real question with no answer is what about the millions of adults who received Tdap with immune systems far less robust and protective than adolescents?  Are they immune and for how long?  No one knows because the research has not been done or published yet.  Still the CDC and the NIH and the American College of Physicians call for adult immunization with Tdap.  The Kaiser Permanente Study will surely establish the need for an adult efficacy investigation. Until then we will give the Tdap while we wait for answers. It does raise the question of whether our approach to adult bronchitis should include an antibiotic that treats Bordetella pertussis until a quick test is developed to distinguish it from run of the mill viral pneumonias.