Chapter 13
MEDICAL SCREENING & ELECTIVE PROCEDURES: WORTH THE RISK?
One of my professors in medical school once quipped that the major difference between doctors and the rest of humanity was doctors’ ability to order tests. In a classic case of “supply creates demand,” the number of tests that medicine is able to offer has increased exponentially in the past few decades. Not surprisingly, the public’s demand for medical testing has kept pace accordingly, and in many cases has even overtaken the current capabilities of medical technology. The result is an extreme push to develop new diagnostic and screening technologies. As these new technologies become available, doctors and hospitals begin using them even before data is accumulated to determine the risk-to-benefit ratio of the test in question.
Our overuse of medical screening and testing stems partly from massive public health and media campaigns. The notion that early detection saves lives has been promoted heavily by medical societies, public health officials, and celebrities. Millions of people get a warm and fuzzy feeling participating in walk-a-thons, earning money that will be spent on the promotion of medical screening. All of the publicity emphasizes the benefits of medical screening, but completely ignores the potential risks.
The result has been a mindset amongst the general public and health professionals alike that a given test will just give an answer, and that answer will be correct and make a difference in our lives. In this popular view, things are either yes or no, positive or negative. The public dutifully marches in to get their mammographies, Pap smears, PSAs, and colonoscopies. If the test comes out negative, we are reassured and vindicated. If the test comes out positive, we believe we have averted disaster by “nipping it in the bud.”
The reality can be quite different. In Chapter 4, we briefly walked through the statistics on Pap smears from an economic cost/benefit perspective, but in this chapter let me give some real-world examples on a more personal level.
COLONOSCOPY: A SUCCESSFUL CAMPAIGN
In 1998, Jay Monahan, the husband of popular NBC Today Show host Katie Couric, died tragically as a result of colon cancer. Mr. Monahan was only 42 years old. Having suffered through the arduous treatment protocol and premature death of her husband, Ms. Couric, understandably, sought to give meaning to her husband’s death by doing everything she could to make sure that others might avoid a similar fate.
Ms. Couric became a tireless worker and promoter of colorectal cancer awareness and screening. She co-founded the National Colorectal Cancer Research Alliance, a part of The Entertainment Industry Foundation. She also helped to establish The Jay Monahan Center for Gastrointestinal Health at New York City’s Cornell Medical Center. Ms. Couric’s biggest influence in the battle against the disease that took her husband is most likely to be her advocacy of screening colonoscopies. In March of 2000, she underwent an on-air colonos-copy on The Today Show in an effort to promote the importance of this screening test.
Three years later, authors from the University of Michigan School of Medicine published an article in the July 14, 2003 issue of The Archives of Internal Medicine confirming the effectiveness of Ms. Couric’s promotional efforts.1 They showed a 20 percent increase in colonoscopies after the March 2000 show and from Ms. Couric’s ongoing efforts. The effect was strongest amongst women. The authors coined the term “The Couric Effect,” and concluded that a celebrity spokesperson can have a substantial impact on public participation in preventive programs. (Note that the study made no comment on whether the increased screening was positive on net.)
When we consider increased participation in medical screening, we need to assess whether it actually reduces morbidity or mortality. We also need to consider the risks and side effects of testing. In doing so, we should keep in mind that the concept of number needed to treat (NNT) applies to testing in the same way that it applies to taking medication. The likelihood of a disease being present greatly affects the NNT. As we convince more people to undergo screening, we are more likely to include people who are at lower risk for disease. When this happens, the NNT to harm may actually become smaller than the NNT to benefit. Increased participation in screening may not always be a good thing. Stated differently, if more people who are less likely to have the disease participate, the benefits of screening will decrease, but the side effects (or complications) of the test go up. This is because the rate of side effects remains constant regardless of risk of disease, and with more people participating, the absolute number goes up.
Understand that I am not making a blanket statement that one should never undergo screening colonoscopy or that the guidelines for colonoscopy are incorrect. I am saying that we need to be careful when we push for broader and broader applications of a test. Too often, the public discussions of such matters make the assumption that medical screening has all benefits and no costs.
Currently, the guidelines for colonoscopy recommend that screening begin at age 50. This is probably reasonable, since about 90 percent of colon cancer occurs after the fifth decade of life. Simply being 50 or older is likely enough of a pre-test probability to swing the NNT numbers towards benefit over harm. This may be little consolation for Katie Couric whose husband died at 42, and it is understandable that she would feel those younger than 50 should get screened. (In fact, she was only 43 at the time of her on-air colonoscopy and had no other symptoms or risk factors that would put her at increased risk.)
AN ER DOCTOR REPORTS FROM THE FRONT LINES …
“As an emergency physician, I am in the unique position of actually being pulled into the loop when complications do occur with medical screening procedures. In the past 20 years, I have responded to four cardiac arrests in the colonoscopy suite (all four were successfully resuscitated). In the past year I have seen about four post-endoscopy GI bleeds. This typically occurs several days after polyp removal, when the eschar at the biopsy site sloughs and allows an underlying vessel to bleed. This results in significant blood loss that can potentially require ICU admission, blood transfusion, and emergent endoscopy to cauterize the bleeding site. Over the years I have also seen four bowel perforations, two splenic lacerations, and one liver laceration resulting from elective screening. These complications are indeed rare, and my observations are courtesy of the selection bias of being in the ER, but they are nonetheless real. When such complications occur in low-risk patients encouraged to undergo testing by public health campaigns, it highlights the dark side of the push to increase participation in low-risk populations.”
—Co-author Doug McGuff
Another thing to consider with regard to screening is whether early detection actually decreases the mortality from disease. Some polyps have pre-cancerous or cancerous cells in them, and the presumption is that removal is curative and prevents a colon cancer that would have gone undetected. Polyps that are left alone can undergo adenomatous change where they form cancerous cells, and cancerous polyps can grow into full-blown colon cancer. It would only seem logical to seek these out and remove them. However, the March 5, 2008 issue of CA-A Cancer Journal for Clinicians (the Journal of the American Cancer Society) notes that “[t]here are no prospective randomized controlled trials of screening colonoscopy for the reduction or incidence of colorectal cancer.” Gina Kolata, science writer for The New York Times, noted in a 2006 article: “The patients in all studies had at least one adenoma detected on colonoscopy but did not have cancer. They developed cancer in the next few years, however, at the same rate as would be expected in the general population without screening.”2
Another troubling fact is that the American Cancer Society in 2007 noted that the annual incidence of colorectal cancer has risen by 30,000 cases annually, a 22 percent increase since 1999.3 On the face of it, this suggests the possibility that the Couric Effect might be negative: the incidence of colorectal cancer has increased precisely during the period when screening increased. We must remember that when we discuss the incidence of a disease, that is a figure that should be constant and unchanged by testing; the benefits of screening are supposed to allow us to catch an existing disease early and improve mortality, not to change our assessment of what fraction of the population has the disease. The increase in cancer rates amidst increased screening suggests one of two things: first, that increased testing is overcalling the diagnosis or discovering lesions that were previously clinically insignificant and did not progress to disease. (For instance, if doctors started giving pregnancy tests to millions of men annually, it’s possible we would measure a slight uptick in the rate of pregnancy nationwide—due to false positives.) The second possibility is that the screening procedure itself may be doing something to increase the incidence of the disease.4 The first possibility is the much more likely one, namely, that the public campaigns urging people to be screened for colorectal cancer have resulted in a higher proportion of false positives among test recipients, since people in lower-risk populations are receiving the screening than would have occurred in the absence of the public campaigns.
I personally believe that the removal of a polyp is likely indicated and is most likely beneficial when it is found to have cancerous or pre-cancerous cells. But I also believe that screening should be done only in those with an elevated pre-test probability of disease (age greater than 50, strong family history, history of rectal bleeding, positive fecal occult blood screening, or another positive screening test). When you cast too wide of a net, the real and theoretical risks of screening are more likely to manifest.
Thus when we consider undergoing screening colonoscopy, we must not only consider the potential benefits (real and imagined); we must also consider the real and imagined downsides. The real downsides include the possibility of bowel perforation, acute bleeding after polyp removal, delayed bleeding after polyp removal, infection, sepsis, or complications related to the bowel prep. A recent study investigated the frequency of these complications and reported the following:
Of the 16,318 eligible colonoscopies (96% performed by board-certified gastroenterologists), the incidence of serious complications was 5/1000 procedures. The 82 cases of serious complications that occurred involved 15 perforations, 6 cases of postpolypectomy syndrome, 53 cases of bleeding requiring hospitalization (15 requiring surgery or transfusion), 38 cases of bleeding requiring inpatient observation, 6 cases of diverticulitis, and 2 unusual complications (1 snare caught in a large polyp requiring surgery and 1 case of diabetic ketoacidosis associated with the colon preparation). There were 10 deaths within 30 days of the procedure, but only 1 of these was directly related to colonoscopy (a patient with congestive heart failure and sepsis after a transfusion for postpolypectomy-related bleeding).5
Finally, although it is not likely a major contributor, we have to consider at least the theoretical possibility that the sharp rise in detected cases coinciding with more widespread screening is due to a perverse effect of the “safety first” approach itself: specifically, that polypectomy may directly cause disease. There are many types of cancer capable of spreading by a mechanism called “seeding.” Cancers can erode through local tissue barriers or into blood vessels, resulting in metastasis (spread to other body sites). Recent research seems to indicate that tumors can also undergo “self-seeding,” where a tumor grows or spreads by a process of local chemical signaling that causes tumor cells to re-infiltrate primary tumors or surrounding local tissue. A recent journal article noted that breast cancer, colon cancer, and melanoma have this self-seeding capability.6 Melanoma lesions are commonly excised with a wide margin to prevent seeding. If colon cancer has similar capabilities, I worry about the possibility that “nipping colon cancer in the bud” may actually result in scattering cancer cells to the four winds.
As we can see from this review, there are genuine risks of colonos-copy, meaning that the decision to be screened is more complicated than the public awareness campaigns would have you believe. This is especially true for someone who has successfully incorporated healthy primal laws. One of the major factors raising your risk for colorectal cancer is your lifestyle. If you are a smoker, drink alcohol to excess, are obese, have a poor diet that includes lots of inflammatory mediators, and are deficient in nutrients and antioxidants, then your risk goes up. If you eliminate these risks factors over a period of time and eat a primal diet that is anti-inflammatory and full of antioxidants, then your risk of disease diminishes. That means you are becoming part of a category that should be more reluctant to undergo testing, because the benefits of the screening (i.e., early detection of existing disease leading to early treatment and better outcome) go down, while the costs are the same.
What we can now understand is that is a widespread general recommendation should actually be a complex decision involving risk-benefit analysis. This is not a decision that you should be expected to make on your own. Hence why we spent an entire chapter on physician selection. A personal physician who knows you well and has a sense of your own risk/benefit orientation can help you determine when you might personally have enough of a pre-test probability to indicate a need for screening colonoscopy. You and your doctor might consider other testing, such as fecal occult blood testing or fecal DNA testing, as a threshold that must be crossed to trigger colonoscopy. Only by considering all the risks, the benefits, your pre-test probability of disease, and your own personality and preferences can you make the best decision about colonoscopy.
MAMMOGRAPHY: HOW TO SCARE THE HELL OUT OF YOURSELF
Every once in a while, I will have a distraught woman check into the ER after having completed a mammogram. When a woman is told that she has a positive mammogram, she naturally assumes she has a very high likelihood of having breast cancer. Typically her first action will be to call her husband or significant other in tears. Visions of mastectomy, loss of her femininity, and baldness from chemotherapy rush through her mind. Then she considers that even after all the disfiguring treatment, within a few years she may still be dead, leaving her husband a widower and her children motherless. As these thoughts race through her and her loved one’s heads, there arises the small hope that it is just a false positive. Perhaps it is all just a scare and life can return to normal. Typically, the patient will then call the office of the family doctor, OB/GYN, or surgeon that ordered the test. If she is lucky enough to get hold of the doctor, the results will not have been sent to them yet and they will not know what to say. Typically, an appointment will be set for days or weeks away to review the results and decide the next step. These will be among the longest days of a woman’s life, filled with ruminations of suffering and death. Sleep will be near impossible, and when it occurs, it is haunted with fitful dreams. Some women cannot face this prospect and will come to the ER in hopes of expediting the process. Sometimes we are able to help; sometimes we are ineffective. Most of what I have to offer is a discussion of the actual possibility that her positive mammogram indicates cancer. We will go over that later.
AN ER DOCTOR REPORTS FROM THE FRONT LINES …
“One of the best surgeons I have ever known had a policy of only ordering mammograms on a specific day of the week and holding a batch of open appointments at his office on that day. The purpose of this was so that he could be able to see any woman who had a positive mammogram immediately. If there were a positive mammogram, he would set a same-day appointment for the patient and perform an immediate needle aspiration (or biopsy) so the woman would not be left hanging. Most times, the needle aspiration reveals fluid that is typical of a benign cyst and the woman can be immediately reassured. If things are less clear, the results of fine needle aspirate can also return fairly quickly and are most often negative. If things are inconclusive, the surgeon can perform an excision biopsy or lumpectomy, which is also negative the majority of times. This surgeon recognized that the biggest risk associated with a positive mammogram is the morbidity of worry and dread. If you have selected your doctor appropriately, and you decide to undergo screening mammography, I highly recommend that you make similar arrangements with your doctor. Many hospitals now have Breast Centers that are set up to function in exactly this way.”
—Co-author Doug McGuff
The reason that a positive mammogram instills such fear is that the general public and even many physicians misinterpret the statistics of screening mammography. Our natural misinterpretation of statistics has been amplified by the politicization of breast cancer, as well as by the numerous pink ribbon walk-a-thons and awareness campaigns. Even NFL players spend an entire month of their season playing in pink shoes. Certainly if something is so important and commands such attention, then the screening that is being pushed by these “awareness” campaigns must be reliable—right? In truth, it depends on context and a proper understanding of statistics.
I remember my favorite surgeon telling me that if you perform mammography on a woman with known breast cancer, the mammogram will detect the cancerous lesion about 95 percent of the time. This statistic is what launched mammography as a potentially reliable screening test in the first place, because the rate of false negatives is low. Most people, including many physicians, assume that if this statistic is true, then its converse is also true—but no, this is not really the case. In other words: if a woman with known breast cancer undergoes mammography, her tumor will be visualized some 95 percent of the time; but that does not mean that a woman with a positive mammogram will have a 95 percent chance of having cancer. The actual figure is closer to 9 percent.7 Thus we see that a mammogram is not very likely to miss it if you actually have breast cancer, but at the same time a mammogram very often reports false positives, warning of cancer even when you are fine. I should also point out that even though the 9 percent figure is a much more reassuring number, it still does not quell the anxiety for a woman receiving a positive mammogram, because there is still the very real possibility that she has cancer. After all, if an individual is part of the 9 percent, it is 100 percent for her.
A 2013 article in the Annals of Family Medicine quantified the negative impact of “false positive” results, as well as its duration long after the women had been notified that the initial “positive” result had been a mistake.8 Specifically, the researchers recruited 454 women who had received a “positive” result (both true and false) on a mammogram during the course of a year, and for each such woman recruited an additional two others from the same clinic who had been screened the same day but who initially received a “negative” result on the mammo-gram. Because some of the women who had initially received a “positive” result were later given the good news with a follow-up “negative” result, the researchers could use surveys administered to the three different groups to assess the psychosocial impact on a woman of believing (incorrectly) that she might have breast cancer. The researchers followed the three groups of women for a full three years after the final diagnosis. They concluded:
False-positive screening mammography causes long-term psychosocial harm. In a period of 3 years after being declared free of cancer suspicion, women with false positives consistently reported greater negative psychosocial consequences compared with women with normal findings. The first half-year after final diagnosis, women with false positives reported changes just as great in existential values and inner calmness as women with breast cancer.
In other words, these researchers found that not only were women objectively harmed (psychologically) by the experience of receiving a “false positive” result on a mammogram, but that this harm was empirically detectable a full three years after the erroneous diagnosis had been corrected. Furthermore, on two of the indicators examined, the women who had received the false positive were just as rattled as women who really had breast cancer, for a full six months after the two groups of women received their final diagnoses. Acco rding to this study, then, frequent administering of mammograms carries quite serious and lasting costs; the harm of a “false positive” result is not mere angst until a follow-up exam reverses the initial (and erroneous) finding.
With such a negative impact of false positives, there must be a very positive impact of early detection if we are to justify the practice of frequent mammograms. We would hope that the harm of false positives is offset by the lives saved through the early detection of true positives. The best place to answer such questions is to search the database of The Cochrane Collaboration. This is highly regarded as a good source of unbiased information on many medical and scientific topics. They have produced over 5,000 Cochrane Reviews, which involve scouring the literature for the best studies to answer a given question. They are meticulous about addressing potential areas of bias and confounding data.
Their summary on mammography (along with many other summaries) can be found at their website (www.cochrane.dk). Their original summary published in 2008 reads:
It may be reasonable to attend for breast cancer screening with mammography, but it may also be reasonable not to attend, as screening has both benefits and harms.
If 2000 women are screened regularly for 10 years, one will benefit from the screening as she will avoid dying from breast cancer.
At the same time, 10 healthy women will, as a consequence, become cancer patients and will be treated unnecessarily. These women will have either a part of their breast or the whole breast removed, and they will often receive radiotherapy, and sometimes chemotherapy.
Furthermore, about 200 healthy women will experience a false alarm. The psychological strain until one knows whether or not it was cancer, and even afterwards, can be severe.9
Not exactly a strong endorsement of the value of mammography screening, is it? This goes completely against the grain of public sentiment, which has largely been framed by advocacy groups, the government, and the media. The message women have had pounded into their heads is that it’s their responsibility to get frequent mammogram screenings, and that there are no downsides to this except the hassle involved. But as we have explained, this popular message is simply wrong. There are quite real harms from mammogram screening, which must be balanced against the potential benefits.
Recently, the evidence against mammography as a screening intervention has gotten even stronger. In 2013 the Cochrane group updated their summary with the following:
We believe that the time has come to re-assess whether universal mammography screening should be recommended for any age group. Declining rates of breast cancer mortality are mainly due to improved treatments and breast cancer awareness, and therefore we are uncertain as to the benefits of screening today. Overdiagnosis has human costs and increases mastectomies and deaths. The chance that a woman will benefit from attending screening is small at best, and— if based on the randomised trials—ten times smaller than the risk that she may experience serious harm in terms of overdiagnosis. Women, clinicians and policy makers should consider the trade-offs carefully when they decide whether or not to attend or support screening programmes.10
It seems clear that default screening mammography for all women is not the way to go, but what is an individual woman to do? Two things will help you decide on the correct answer for yourself. The first is to go through the process of selecting a good physician who understands your personality and health history. The second is to return to our notion of NNT. In order for the NNT to benefit to predominate over the chance for harm, there must be significant risk factors for the disease for which you are testing. Clearly, mammography applied as a general screening test across the general population does not meet this standard. However, a given individual may have enough risk factors to tip the scales in favor of screening. Such risk factors include prior confirmed breast cancer or a history of breast cancer or ovarian cancer in primary family members (a mother or sister), especially if the cancer occurred at a young age. Such a history might trigger genetic screening that can uncover the presence of the BRCA1 or BRCA2 mutations, which increase risk for this disease.11
Even then, we must consider that, with the improved treatment protocols, there may not be a demonstrable benefit to earlier diagnosis. In other words, if you don’t have mammography and the cancer is not discovered until it is larger and obvious, the cure rate may be no different.12 In this case the only benefit of mammography may be additional years of anxiety and worry.
One of the mainstays of a primal mindset is not to follow general recommendations intended for the population at large. You must always consider any screening or treatment in light of the number needed to treat and your own risk for disease. Sometimes you can reach these conclusions on your own; at other times, you may need to consult with your physician. What you should never do, however, is jump on a bandwagon because of media or celebrity endorsement.
ONE FOR THE MEN: PSA TESTING
Women are not the only ones who have the opportunity to scare themselves with false positive screening tests; men get their chance as well. Prostate cancer screening via the PSA (prostate specific antigen) has also been promoted as an early detection tool. Like our other screening tests, it falls down when we cast too wide of a net. What was hoped to be a means of early detection to help avoid progression and spread of prostate cancer actually had no influence on long-term survival. Further, false positives and the diagnosis of what would most likely be small and/or slow-growing tumors resulted in many men being treated unnecessarily. We found out only after the fact that many men suffered the risk of radiation and or chemotherapy, as well as incontinence and impotence, for no corresponding benefit.
To cut right to the chase, the Cochrane summary for prostate cancer screening (including digital rectal exam and prostatic ultrasonography) was as follows:
Prostate cancer screening did not significantly decrease prostate cancer-specific mortality in a combined meta-analysis of five RCTs. Only one study (ERSPC) reported a 21% significant reduction of prostate cancer-specific mortality in a pre-specified subgroup of men aged 55 to 69 years. Pooled data currently demonstrates no significant reduction in prostate cancer-specific and overall mortality. Harms associated with PSA-based screening and subsequent diagnostic evaluations are frequent, and moderate in severity. Overdiagnosis and overtreatment are common and are associated with treatment-related harms. Men should be informed of this and the demonstrated adverse effects when they are deciding whether or not to undertake screening for prostate cancer. Any reduction in prostate cancer-specific mortality may take up to 10 years to accrue; therefore, men who have a life expectancy less than 10 to 15 years should be informed that screening for prostate cancer is unlikely to be beneficial. No studies examined the independent role of screening by DRE.13
Even the American Urological Association has backed off from routine screening, but still recommends that men from ages 55 to 69 consider screening, noting that the risks and benefits require shared decision making. They stated in a 2013 guideline:
For men ages 55 to 69 years, the decision to undergo PSA screening involves weighing the benefits of preventing prostate cancer in 1 man for every 1,000 men screened over a decade against the known potential harms associated with screening and treatment.14
My own addendum would also include the loss of the downstream revenue generated by these harms caused by screening and treatment.
One of the best sources for getting to the bottom of most questions of efficacy in the medical field is the website www.thennt.com. They review the strongest literature and boil it down to a summary that shows the benefits in percentages and the harms in percentages. Reviewing their evaluations of many of the treatments I use on a daily basis makes me wonder what the hell I am even doing in medicine, as much of what is considered standard of care is not supported by the evidence. I strongly suggest visiting this site when you are considering any medical treatment.
With regard to PSA testing, www.thennt.com details the benefits as follows: 100 percent saw no benefit; 0 percent were helped by preventing death from any cause; 0 percent were helped by preventing death from prostate cancer. With regard to harms, 20 percent were harmed by undergoing a prostate biopsy for a false-positive test.
IF YOU GET TOO CLOSE TO THE PROM QUEEN YOU WILL SEE HER WARTS
I can draw on my experience in emergency medicine to give a perfect example of the problems with indiscriminate screening: the widespread use of CT scanning in trauma. In the past, we always screened for pneumothorax—an air collection in the chest cavity from a punctured lung—with a plain chest x-ray. When a pneumothorax was seen, we evacuated it by placing a plastic chest tube about the size of your index finger or thumb between the ribs, into the space between the lung and chest wall. With the advent of CT scans, we started to identify very small pneumothoracies that were previously not visible on chest x-ray.
As a result of the increased sensitivity of this test, we started to turn up a lot more tiny pneumothoracies that we didn’t know what to do with. Knowing that they were there, it was hard to do nothing, especially with the medico-legal consequences should anything go bad. This was especially true for any patient entering the OR who was going to be on a ventilator with positive pressure ventilation, as this could theoretically expand a small pneumothorax into a large tension pneumothorax that might cause cardiac arrest. The consequence was that for almost a decade, large numbers of trauma patients needlessly underwent a painful invasive procedure with a high complication rate.
As we accumulated more cases of pneumothoracies diagnosed on CT that were not visible on plain chest x-ray, we did start to wonder, “Where were all the bad outcomes before the advent of CT scanning?” Eventually, through both retrospective and randomized trials, we came to realize that such tiny pneumothoracies could be watched expectantly and required no intervention.
The conceptual common denominator to keep in mind when considering screening is the idea of prior probability. The more sensitive you make a test for a disease, the more important it is not to apply it as a population-wide screening test. The “better” a test is, the more important it is only to apply to people who have an elevated risk of the disease in question.
GENETIC TESTING: A SCREENING TEST FOR A SCREENING TEST?
Our discussion of prior probability begs the question, “Is there anything that can be done to determine my prior probability other than the presence of symptoms or a strong family history?” There exists technology to screen for genetic mutations or variations that increase risk for certain diseases. Some of these are diseases for which screening tools exist, like the examples discussed in this chapter.
Currently, the biggest supplier of genetic testing technology is the company 23andMe. The name refers to the 23 gene pairs that we all possess. Your genes are analyzed using a saliva or cheek swab sample. Your DNA goes through a process where it is broken up into pieces and mixed with known DNA base pairs that bind to known gene variations. These are labeled with a fluorescent tag that identifies “SNiPs,” known as single nucleotide peptides, which are basically segments of DNA that correspond to certain gene variants.
Much of what is identified is just information that is cute or interesting. Things such as your ability to make asparagus pee, or your capacity to taste bitter, or the geographic region from which your ancestors came. However, more ominous things are also reported. These include your risk for Alzheimer’s disease, type II diabetes, and colon cancer, and especially the presence of the BRCA1 and BRCA2 genes that define a markedly increased risk for breast and ovarian cancer. The presence of this gene variant (along with a strong family history) is what led Angelina Jolie to undergo a prophylactic mastectomy.
The following are my general thoughts on how you should go about forming your own decision when it comes to genetic testing:
If you are trying to collect information to get around the issue of low prior probability, you still need to remember that you are gathering this information through … a process of screening. So unless you have symptoms or a family history that makes you want to go looking, then all the problems of false positives still exist. Further, genes do not just operate on a yes/no basis. Environmental conditions probably contribute 70 to 80 percent towards whether a gene will express disease or not. Thus, the detection of a disease-prone genotype does not necessarily help you quantify a family history that you already know you have.
Before you dive in and take the test, you really need to consider how you might react to results that you do not want or like. You might fancy yourself as the type of person who doesn’t care or who can shrug off ominous findings. But perhaps things will be different when you see unexpected results. The psychic toll of such knowledge is legitimate, and can cause your mind to generate real physical symptoms that can ultimately put you on the road to increased medical testing. False signals of greater prior probability raise the odds of false positives or incidental findings that, again, set into motion psychosomatic symptoms that can only be quelled by testing that comes back negative. In the process, there is risk for iatrogenic injury, more false positives, infection, and radiation exposure that greatly outweigh the risk for any real disease.
Will the results of a genetic test alter your behavior? For example, suppose you undergo genetic screening and find yourself at risk for type II diabetes and Alzheimer’s dementia. What should you do? It turns out the answer is to follow primal principles that ensure proper dietary, exercise, and environmental signaling. If you are already diligently following the primal lifestyle, then your new knowledge will not change what you are doing whatsoever. So, if testing does not change what you should be doing, why do it in the first place?
WEIGHING THE PROS AND CONS OF ELECTIVE PROCEDURES
We have established that how you behave during hospitalization is of critical importance. Your mindset and demeanor can have a profound influence on the degree of risk that you will encounter while in the hospital. When you undergo (or consider undergoing) an elective procedure, your mindset and demeanor are even more critical.
When you are in the hospital, you are more likely to be at greater risk because you are sick or injured, and most likely did not arrive there by your own volition. While it is generally true that you will have to be in better condition to undergo an elective procedure, the more critical issue is that you don’t necessarily have to be there. You are there of your own choosing. The risks may or may not be as great as a hospitalization, but the decision to take the risks is entirely one of free will. Thus, if any of those risks come to fruition, then the damage that occurs will seem much more bitter, because they will then seem totally unnecessary. For this reason, your orientation and approach to elective procedures is of extreme importance.
In this section we will provide general guidelines for deciding whether to undergo an elective procedure or not. You will be taught how to gather information on the risks and benefits of a given elective procedure, as well as how to seek out alternative treatments. Should you decide to undergo treatment, we will discuss how to locate the most qualified professional to perform the procedure and how to find the best price.
There are two general categories of elective procedures. First, there are those procedures that are elective in terms of their timing and location, but are otherwise mandatory. Elective in the medical world means “not emergent.” In other words, the surgery or procedure does not have to be done immediately, but instead, can be put off until a later date. The second category consists of those procedures that fit the lay definition of “elective.” Not only is their timing optional, but whether to do them at all is also an option. (If we apply the strictest of definitions, nearly all procedures fall into this second category.)
Some examples of procedures that are of the first category (optional timing but must be done) are the elective repair of a torn ACL knee ligament in a professional athlete or laborer who depends on knee stability in high force situations. Another example might be a professional baseball pitcher who has a torn labrum in his shoulder. Or perhaps an anesthesiologist with a compressed C7 nerve who has lost pinch strength and can no longer perform an intubation procedure.
The exact same procedures listed here may fall into the second category under different context. If the ACL injury or torn labrum is in an office worker, or even in an athlete who does not place severe stresses on the joints in question, it is truly optional to undergo corrective surgery. I once trained a professional BMX racer who competed several seasons with bilateral torn ACLs.
In most cases, almost all elective medical procedures are in this second category. Even conditions that produce a lot of pain or impairment will heal themselves if given enough time. This includes conditions that many doctors will tell you will not self-correct. For example, I know of an ER doctor who suffered an L5 disc herniation that produced such severe nerve compression that he developed atrophy of the muscles, foot drop, and partial paralysis. He refused to undergo surgery or even take a Tylenol. He suffered through the pain and drug his leg around on ER shifts over 18 months, when suddenly one day all of his symptoms resolved. Within a few weeks his muscle mass and function returned to normal and he has been symptom-free since. What seems like a matter of necessity is really a matter of our unwillingness to endure the pain and suffering for the period of time it takes Mother Nature to heal the injury.
SHOULD YOU HAVE THE PROCEDURE AT ALL?
The most important question to first answer is: should you have the elective procedure in the first place? In the setting of this book, it is not practical for me to discuss every possible procedure that one might face. Instead, let us lay out some general guidelines for deciding whether to undergo a procedure or to let nature take its course.
REVISIT THE NNT
One of the first places I suggest you start is to visit the website www.thennt.com. The concept of number needed to treat (NNT) has come up repeatedly throughout this book; this website looks at the scientific literature, dissects the raw data on clinical issues, and then expresses the results in a NNT format. When you visit the website, don’t just look for the clinical issue or procedure that concerns you. Instead, peruse the entire website (especially the blog) to get a flavor of how uncertain and often completely backwards the standard practices are for medicine in general. Another pattern to notice is that the conclusions of many medical studies—even in renowned journals— are actually inconsistent with the raw data within the study. The vast majority of medical practitioners and institutions accept these conclusions at face value, and this is generally what will be recommended to you when you speak to physicians. Yet the raw data in even the most definitive studies may actually point in the opposite direction. I suggest that you use this website to investigate the procedure or therapy that you are considering, along with similar therapies. Each analysis is summarized and represented by a traffic signal type system. A green light means benefits exceed harm, a yellow light means benefit is uncertain, a red light means there is no benefit, and the black triangle/exclamation point means that harms exceed benefits.
Many times, a visit to this website, along with reading some of the literature itself, will be enough to make the decision for you. If the issue is still uncertain, you can proceed to the next step and consult with a physician.
ASK AN EXPERT
If your question is not answered by visiting www.thennt.com or searching the literature, then it is time to pose the question to an expert. You cannot, however, just schedule an appointment with a local specialist, especially if this is the same person that may be doing your procedure. Most doctors are very objective and honest, but the bias that occurs when you ask a barber if you need a haircut is very hard to overcome. This is especially true because such bias is usually of a subconscious nature. Even if the physician is a close personal friend, this bias cannot be escaped.
I generally recommend asking your local specialist, “Who are the most renowned practitioners in the field?” Another route is to ask who is the chairman of the department or the director of the residency where they trained. Once you find these names, perform some Internet searches, or look at a listing of their publications on PubMed. Soon this will lead to discussion articles that will help reveal who the thought leaders are in the field that pertains to the procedure you are considering.
Once you have decided on a leading authority, attempt to schedule an appointment at their clinic for consultation. If you have decent health care coverage, you will find these appointments easier to acquire than you think. Even better, pay out of pocket, and offer to pay the full cost of the appointment ahead of time. Offer to give your credit card information over the phone to schedule the appointment. You will be surprised how much this can expedite your appointment or move you up in the queue. As to the content of the consultation, just let them know your clinical situation and that you are seeking counsel on whether or not an elective procedure would be recommended. Offer to send all of your pertinent medical records and studies ahead of time. At the very least, assure them that you will bring all of these records with you. The best option is to do both.
Here is the catch that you do not want to discuss until the day of your appointment. You are there just to get their expert opinion on whether or not to undergo a procedure. If the procedure in question is recommended, you will not be having it done at their institution. Most academic physicians are salaried and thus do not have a financial interest in the decision to have the procedure or not. However, they are usually at the helm of a residency or fellowship and are always actively seeking cases for their residents and fellows. By stating your intention to have the procedure done elsewhere, you diminish the risk of any bias, conscious or unconscious. Also, your consulting physician will also feel great relief knowing that he will not have to wrestle with the conflict associated with trying to draw in new cases.
There is one major precaution to this approach, and that is the overwhelming desire you may develop for this world expert to be the one to perform your procedure. If and when such a desire develops, I generally advise not to succumb to it. There are a couple of reasons for this. First, becoming a department chairman, director, or otherwise famous physician requires much more in the way of charisma and political cunning than any sort of clinical or technical excellence. Second, someone who has risen to this level is usually not very clinically active, and in any event the bulk of your actual procedure may be done by a fellow or residents in training.
Another tip for your meeting with your renowned expert is to try to speak with his or her colleagues, and especially the residents. Commonly, an upper level resident will be present during your evaluation and discussion. Watch the demeanor and expressions of the consultant. Sometimes, a department chair will have gained so much power and influence that they may have “gone off the reservation” without any real resistance. Such is the dark side of tenure. If this is the case, it will be evident in the body language of the resident. You may even get a tell-tale head shaking directed at you or an eye rolling. Often, you may be left alone in the room with the attending resident. Take the opportunity to ask if they are in agreement, or if this is an unorthodox view. The resident may self-deprecate and try to bow out, but you should insist on their input. In most cases, if something is amiss, they will be dying to tip you off. If everything lines up, you can feel confident that the advice you have received is good. If it does not, you can most likely rely on the opposite advice, but can seek confirmation elsewhere if you feel the need. In either case, the information obtained will be very worthwhile and the trip will have been worth the time and effort.
BRING IT HOME
Once you have had your meeting with the most renowned expert you could find, bring the information and records back home with you. Your next step is to contact your family doctor (the one you have picked by the criteria previously discussed). You can either set an appointment or request a phone conversation. Simply request a referral to your doctor’s preferred specialist for the procedure you are considering. This referral is especially important if your expert has recommended in favor of performing the procedure.
Ideally, your family doctor will have a strong referral relationship with the specialist, which should result in an expedited appointment. When you have this appointment, tell the specialist that you want his or her opinion on the situation. Let the specialist know you have visited a renowned expert in the field, but do not name that expert or what was recommended to you. Also, inform the specialist that you intend to pay in full for the appointment, but will not commit to having the procedure done by him or her. Ideally, and most commonly, the specialist will reach a conclusion that is the same or very similar to your renowned expert. Gather up all of the recommendations, pay for the appointment by cash or credit card, and state that you will be in touch.
DISCUSS WITH YOUR LOVED ONES
Assuming that the recommendations seem in agreement and solid, the next step is to discuss it with the other stakeholders in your life: your loved ones. Ideally, they will have already been along for the ride. Even so, a good heart to heart can help solidify your decision. If you are at odds about the decision to undergo a procedure, I strongly advise not to proceed until the conflict has been fully resolved. If you are married or otherwise in a committed relationship, and your spouse or partner strongly opposes, then I would yield. Most times this person is seeing something that you are refusing to see or are incapable of seeing. If you do not wish to yield, then keep working on the debate until it is amicably settled. Once settled, spend a few days or weeks letting it sink into your consciousness. Sleep on it. Let your gut and the content of your dreams deliver any data that is still needed. Once everything falls into alignment, then and only then make your final decision.
PICKING YOUR SPECIALIST
The remainder of this discussion is predicated on the assumption that you have decided to go ahead with your elective procedure. There are many considerations with regard to selecting a specialist and an institution for your procedure. The reputation and experience of the specialist and the institution where the procedure will take place, insurance and preferred provider status, comfort and ease of travel, cost, and post-procedural care are but a few of the considerations that need to be made.
EXPERIENCE AND REPUTATION
The importance of experience can vary somewhat based on the elective procedure in question. Procedures that are “bread and butter” for a given specialty or that involve automated technology are less dependent on the absolute number of cases involved, and because they are routine, almost any specialist will have exceeded the minimum number of cases to be proficient. Cholecystectomy (gallbladder removal), appendectomy, Lasik, and cataract surgery fall into this category.
Procedures that are less commonly performed, are technically complex, and are at the mercy of the specialist’s technique are more dependent on experience. Also, procedures that are new or cutting edge make it more challenging to accrue enough cases to be truly facile and experienced. Total hip replacements are a good example of the former. New endovascular procedures or keyhole surgeries are examples of the latter.
For the more bread-and-butter procedures, you would like to see the high double digits performed per year (ideally, in the hundreds) and thousands of the procedure done to date. For the newer or more unusual procedures, you would like to see at least a dozen a year with total procedures in the hundreds. Also, you would like to know that the training for the procedure in question exceeded a weekend course. Instead, ideal is some evidence of supervised advanced training (even if obtained outside official or credentialed channels), or perhaps a mini-fellowship. You should not be shy about asking for this sort of information.
With regard to reputation, a simple Google search of the physician’s name will turn up a variety of consumer rating organizations. Don’t expect anything like Angie’s List where you get detailed descriptions from satisfied customers. Instead, be on the lookout for any bad reports or evidence of bad outcomes or losing privileges. The best source for reputation is any friend that you might have in the medical field, or who works at the hospital where you may be getting your procedure. If you can find out who certain physicians or nurses are going to for the procedure in question, that is worth its weight in gold. Even if your connection is not “high in the food chain,” they can still provide useful reconnaissance. Hospitals are like small towns: everyone knows what’s what. The janitorial staff could very likely tell you who is best and who to stay away from.
Keep in mind that as you collect this data, you may not be looking just for a particular person who is best. Sometimes you will be looking for who does a particular procedure the best. The best overall surgeon may not be the one who does the best gallbladder removal. One surgeon may be best for gallbladders, and another may be preferred for lumpectomies. In the vast majority of cases, there will not be an issue of having to root out a bad player. Usually, the issue is just finding who is best for your particular procedure.
INFECTION RATES
While you are deciding on a physician, check into the infection rates of the facility in which your physician will be operating. The national average for surgical infection rates is around 2 to 2.5 percent. Ideally, you want to be cared for in a facility that has an infection rate of 1 percent or less. This is not based on any scientific studies or data; rather, it is only my personal opinion. I just do not think any elective procedure is worth more than a 1 in 100 chance of post-operative infection. A higher infection rate does not necessarily reflect poorly on the institution. In fact, quite the opposite may be true, since taking on a higher volume of tougher cases will naturally drive the infection rate higher. The tricky part is to find a physician with a caseload that supports the right amount of experience, practicing in an institution with a lower infection rate. Many times this can be achieved by engaging that physician in an outpatient surgery center. While it may not be the fault of the institution with a higher infection rate, it is not your fault either. Also, the higher infection rate is an indirect indicator that the infections are more likely to be from multi-drug resistant organisms. In an elective procedure, such a complication would be truly tragic.
PRICING
If you are still in an employer-sponsored, third-party payment insurance program, then pricing will be less of a concern for you. You will just need to be aware of any deductibles and co-pays you may have. You will also need to get “prior approval” for your procedure. Make sure that you obtain your prior approval from your insurance company in writing. Do not rely on the doctor’s office staff to secure this for you and do not proceed simply on their say-so that your procedure has been approved by the insurance company. You do not want to be stuck with the full bill—which will run into the tens of thousands, commonly—when you find out that your procedure did not receive proper authorization. This is why you should obtain prior authorization from the insurance company in writing.
If you have taken my earlier advice and purchased true insurance with a high deductible, or if your insurance company would not approve to pay for your elective procedure, the price of your procedure will become very important to you. If insurance is not picking up the bill after a deductible, you will probably find it very difficult to fund your elective procedure.
In order for pricing to work, third-party payment needs to be removed from the equation. Fortunately, there are surgery centers that accept only cash payment. This removes the entire overhead of government and third-party payment systems and allows prices to come down to true market levels. The flagship example of this model is the Surgery Center of Oklahoma (www.surgerycenterok.com) located in Oklahoma City. They have devised an all-inclusive pricing system that gives a single price for all components of your procedure (surgery, anesthesia, facility fees, and any others). There are a handful of similar facilities scattered throughout the country. If insurance and pricing are a problem, traveling to a facility like this is probably the ideal solution. In general, I have found that it is the very best doctors who resent the current system the most. As a result, centers like the Surgery Center of Oklahoma tend to attract some of the best practitioners available. However, as we will discuss later, there are downsides to traveling away from home for an elective procedure.
You may not have to leave home in order to benefit from the Surgery Center of Oklahoma’s price structure. The incredible thing about competition is that its effects can be felt far and wide. At their website, the Surgery Center of Oklahoma lists its price structure. Patients are already having success printing off their price list and bringing it to their local surgery center or hospital. Present the quoted price for the procedure you wish to have and let them know that you would love to have your procedure done at their facility, but will travel to Oklahoma if they cannot match their price. Allow them a little extra in their pricing to account for the expense that would be incurred traveling to Oklahoma. Let them know that you want a single price and that you will pay in full at the time of the procedure. Even though the entity you are dealing with may still take Medicare, Medicaid, and commercial insurance, they will likely jump at the chance for immediate cash without all of the expense and hassle of filing with a third-party payer. They will quickly realize that their net profit is likely to be higher than what they obtain through the current system. If you cannot strike such a deal, I highly recommend that you plan a trip to Oklahoma.
Speaking of travel, another option for free market medical procedures is international medical tourism. This is not something with which I have personal experience, but I refer interested readers to start with Timothy Ferriss’ book The Four Hour Body, which has a chapter on medical tourism entitled, “How To Pay For A Beach Vacation With One Hospital Visit.”
POST-OPERATIVE COMPLICATIONS
One thing to always remember is that things may not go as planned. You may develop an infection, your wound may open up, or you may develop pneumonia or a deep vein thrombosis. You need to discuss ahead of time with your physician what will happen in the event that you have a complication and how that will be paid for. This is especially true if you are going the cash route. Most cash practices will eat the cost for complications. Third-party insured patients will rack up a bill, with substantial co-pays potentially heading your way.
If you are having your procedure done locally, find out from your doctor how you will be handled if you develop an after-hours complication. You should have a written agreement if your doctor will meet you at his office or ER if you have problems. If your doctor has arrangements with an on-call partner or uses the ER for post-operative complications, this needs to be discussed ahead of time. This is perfectly acceptable, provided the coverage is pre-arranged. No one expects a surgeon or doctor to work 24/7/365, but he does need to have appropriate arrangements during after hours. If your doctor utilizes the emergency department to help manage his post-operative care, this is also acceptable. You may, however, want to contact the emergency department director to make certain that it is common practice for them to evaluate your doctor’s post-operative complications. Usually, there is a collegial and cooperative process in place. Not uncommonly, however, some doctors just instruct their patients with post-operative complications to go to the ER without any prior agreement or communication with the ER physician. They abuse EMTALA to have their after-hours patients cared for, and then if they need to be admitted, the problem gets passed to the on-call surgeon (who they may not have a prior agreement with), or worse yet, the hospitalist service. You do not want to be the “hot potato” in one of these dumping scenarios, so make certain you have this ironed out ahead of time.
If you are traveling to have your procedure done, the issue of post-operative complications is even more critical. As an emergency physician I can tell you that one of my most hated scenarios is the patient who had surgery done at the Mayo Clinic or Duke or another mecca and who shows up with a post-operative complication. I perform my workup and contact the surgeon at the mecca, only to be told to admit them to the local surgeon. This is totally unacceptable, and no surgeon wants to be stuck with another surgeon’s post-op complication. Usually, I arrange an aeromedical transport back to the surgeon of record. You do not want to go through this.
One option, although very hard to arrange, is for the physician performing your procedure to contact one of your local specialists to establish an agreement to see you for any complications. The compensation would have to be arranged between all three parties ahead of time to make this work. Many times, professional courtesy alone will allow this plan to be successful.
More ideally, you should arrange to stay in the area after your procedure for a period of time that equals or exceeds the time period where complications would be expected to occur. That way, if anything untoward happens, you can be seen by the physician responsible for your care. It may be a little less convenient, and cost a little more, but the peace of mind will be well worth it.
I will offer one final precaution about traveling to have a medical procedure. That involves the risk of travel itself, especially as it relates to your procedure. Undergoing surgery or an invasive procedure is an inflammatory process that activates many inflammatory mediators affecting healing and blood clotting. As such, you are at greater risk for developing blood clots. Post-operative deep vein thrombosis (clots in the deep veins of the legs) is not uncommon, and the risk is greatly amplified by prolonged sitting or immobilization. The type of sitting that occurs in air travel and car travel in particular increases the risk of deep vein thrombosis, so much so that the term “coach class syndrome” has been used to describe DVTs obtained during airline travel. These blood clots can break free and become lodged in the lung, known as a pulmonary embolism or PE. A PE can trigger severe respiratory distress, low blood oxygen, and even cardiac arrest. Changes in cabin pressure and oxygen levels can prove dangerous for patients who have undergone any vascular procedure or who have any history of lung disease or a pulmonary procedure. If you have abdominal surgery, it may take time for your intestines to become fully mobile. Any gas trapped may expand at low cabin pressure, causing severe discomfort or even obstruction or perforation. Remember, even if traveling by auto, you need to consider risks. If you had blepharoplasty (eyelid surgery), consider the consequences of a face full of air bag. With a healing incision, or a leg full of pins and wires, consider the effects of even a minor traffic accident. Travel is probably one of the greatest risks associated with having a procedure done away from home. Be sure to discuss with your physician these risks and any provisions that should be made to mitigate them.
FINAL WORDS ON ELECTIVE PROCEDURES
The decision to undergo an elective procedure is one of the most important decisions you will ever make. The likelihood of anything going wrong is truly small, but the consequences are significant, and will be amplified after the fact by the knowledge that you chose to do this thing. So the first step in considering an elective procedure is to really think about whether you want to have it done. Consider that the problem may self-correct given enough time, and your urge to do something may be born out of impatience. If the issue is cosmetic, consider that it may be a much bigger issue for you than it is for anyone looking at you from the outside. What you deem undesirable may actually be an attractive, defining feature for you.
Do your research. Find out the chances of your problem self-correcting. If the decision is not clear, seek out the best consultant in the field and solicit his or her opinion in a circumstance where the consultant does not stand to materially or financially benefit. Once you have that opinion, confirm it with the expert’s colleagues and trainees, as well as with your local expert.
If everything lines up and you decide to go ahead with the procedure, investigate where you wish to have it done and with whom. Check out the statistics and reputation of the physician and the facilities available. Finally, negotiate the price. Consider private pay centers or medical tourism. Even if you do not end up traveling, you may be able to use their price structure to negotiate a better deal at home. Finally, make certain that you have made appropriate arrangements for any post-procedural complications. Elective procedures are just that: elective. Ensure that you have them on your own terms.