It was a phrase I would hear, and utter myself, many times over the next year. “The golden rule of prostate cancer is,” reads a maxim on the You Are Not Alone Now Web site devoted to supporting men with prostate cancer (yananow.org), “there are no rules.”
And so I had cancer. Not much of it, but cancer nevertheless. Something happens to you then. You’re a cancer victim, no matter what your level of victimhood. You have the Big C. You have, as Siddhartha Mukherjee’s best-selling book put it, the Emperor of All Maladies. I didn’t feel shock, outrage, or depression. I didn’t declare war on the cosmos. I didn’t mark down the date and only remember it now (September 16, 2011) because I had to go through my records as I researched this book. I knew I shouldn’t even complain about it. Young kids get leukemia. Young kids die of brain tumors.
But I had cancer. I was one of Those People.
It’s funny, but at the same time my wife and I turned to each other and said, “Let’s not tell the kids.” Because there’s no easy way to tell somebody you have cancer. It always sounds bad, even if it isn’t.
THE FIRST TIME I HAD AN MRI, about 20 years ago, I quite literally didn’t know what I was getting into. They laid me on a hard board, slid me into an airless tube, put on elevator music that would’ve offended a lobotomy casualty, and told me to lie as still as a mummy for 40 minutes.
“Excuse me,” I yelled about two minutes into the procedure, “but get me the hell outta here!”
They reluctantly pulled me out, no doubt calculating the minutes lost to the bottom line. I asked them to change the sound track to Van Morrison—I think they put on Van Cliburn, but it was an upgrade—took a couple of deep breaths and somehow endured the procedure in a cold sweat.
So needless to say I am not a fan of MRIs, never mind those accompanied by an anal probe. I have subsequently seen ads for MRIs that “eliminate the need for prostate anal probes.” Keep that in mind if an anal probe is in your future.
Once I was on the table, though, the anal probe wasn’t that bad. It was uncomfortable going in, but I grew accustomed to it. (Then again, one grows accustomed to acid reflux.) As for the MRI—what can I tell you? Come up with your own system for passing the time. My friend Bob Fink suggested playing an imaginary round of golf, shot by shot, to pass the time. I tried that, got to the fifth hole at the Architects Golf Club’s course in Phillipsburg, New Jersey, yanked my drive into the weeds, and mentally walked off the course. I decided to simply count. They had said 40 minutes, and it was over in 30.
By now it was early October, and the flood of stories about abstaining from PSAs had only intensified. My cancer would not have been found if my family physician hadn’t learned about my elevated number. Didn’t that matter? Weren’t people dying from this disease? Would I truly have been better off not knowing, which seems to go against every medical tenet, not to mention plain logic?
And, moreover, what was I going to do about it?
CHAPTER 5
... In which the author talks to a real person from the controversial USPSTF and wades into the murky waters of prostate cancer politics
THE NEW YORK TIMES, in my opinion the greatest newspaper there ever was and probably ever will be, had leapt with both feet, or whatever appendage the Old Gray Lady is standing on these days, into covering prostate cancer. As I pondered the fact that I had prostate cancer, hardly a day went by, it seemed, when there was not an article about the subject in the Paper of Record. And the relentless drumbeat came with a consistent admonition:
Do not get a PSA test.
What? My test and subsequent biopsy had already determined that I had cancer, albeit at a low volume, and now I’m supposed to accept that I shouldn’t have been tested in the first place?
Since I have spent my entire adult life in journalism, I am not inclined to buy into conspiracy theories about my business. It is my experience that we in the media are far too disorganized and internally argumentative to launch fusillades against specific targets. But while the Times’s stories on prostate cancer were based on reporting—i.e., they quoted medical sources and did not editorialize—it seemed to this interested prostate observer that they went overly heavy on the warnings against getting tested.
To be fair, the prostate wasn’t the Times’s only antitesting target. In the summer of 2012 Elisabeth Rosenthal, an environmental reporter and medical doctor, wrote an opinion piece suggesting that yearly physicals were a waste of time, too. So maybe there was a general Times jeremiad against standardized medical testing of all kinds.
But prostate patter clearly predominated, and the warnings against testing were attributed, by and large, to the US Preventive Services Task Force (USPSTF). The first thing I would say about this group is that it has an overly complicated name. I memorized all of its adjectives and nouns, but I keep putting them in different places: The US Services Task Force on Prevention. The US Task Force on Preventive Services. The US Preventive Task Force Service. Plus, I think the longer “Preventative” sounds more natural than “Preventive,” though either, according to the dictionary, is acceptable as an adjective. However, “preventative” can also be a noun, as in “Crackers are a preventative for a hangover” (which has not been proven to my satisfaction).
But on one point the 16 volunteers making up the USPSTF made itself clear: Routine PSA testing is not a preventive for prostate cancer. In fact, the panel believes that it is quite the opposite.
I should make one point at the outset: The USPSTF is not the government “death panel” so colorfully described by Sarah Palin, she of the enlightened societal discourse. That is the Independent Payment Advisory Board (IPAB), which is charged with helping to reduce the rate of growth in Medicare spending, a purported bipartisan objective that has not turned out that way. But there’s no doubt that under President Obama’s Affordable Care Act, the USPSTF and the IPAB are at the very least first cousins.
The USPSTF is, according to its Web site, “an independent panel of non-Federal experts in prevention and evidence-based medicine and is composed of primary care providers (such as internists, pediatricians, family physicians, gynecologists/obstetricians, nurses, and health behavior specialists).” You will notice that “non-Federal” appears early; the organization wants to make it clear that it is not—technically—a federal agency.
USPSTF’s charge is to conduct “scientific evidence reviews of a broad range of clinical preventive health care services (such as screening, counseling, and preventive medications) and [develop] recommendations for primary care clinicians and health systems.”
So what does all that mean?
First, it is disingenuous of the organization to distance itself completely from Washington, DC. It is under contract to the Agency for Healthcare Research and Quality (AHRQ), which is part of the US Department of Health and Human Services—which the last time I checked was part of the federal government. The 16 USPSTF members, in fact, are appointed by the AHRQ’s director.
Second, it is correct that the panel is not an enforcement agency and can only make recommendations. It does so by assigning letter grades to various medical procedures. Those grades are A, B, C, and D, just like in school, and also I, which means the USPSTF has “insufficient evidence” to recommend for or against the procedure. The target audience for the USPSTF is not specialists, but rather family practitioners.
At its most altruistic, then, its goal is to establish best practices within all branches of medicine and to establish them at the “entry level” for patients seeking care—primary care physicians. The USPSTF’s official position is that it does not consider cost when analyzing the utility of preventive services. David Katz, MD, the director of the Yale-Griffin Prevention Research Center, wrote on Huffington Post on May 29, 2012, that the USPSTF “can certainly be trusted.” He continued, “A unique feature of this group is that while they do have skin in the game of evidence-based recommendations, they have no skin in the game of clinical care that ensues. In other words, members of the task f
orce don’t lose or win if we do, or don’t, screen for prostate cancer. They have no stake in the use of any particular test or technology.”
But it simply strains credulity that the panel does not consider cost, particularly in our current political and fiscal environment. “Best practices” doesn’t necessarily mean “cheapest,” but it’s not stretching the point to say that it means “best bang for the buck.”
“The object of the task force, ostensibly, is to save lives,” says Keith Van Arsdalen, my urologist, “but it’s really to save money. So if you want to save money, and you can do 3 PSAs as opposed to doing 30 PSAs, you’ll save a truckload.”
The USPSTF has been around for nearly three decades, but no one paid much attention to it until 2009, when it made headlines by taking on the efficacy of mammograms with the recommendation that women between the ages of 50 and 74 get a mammogram every other year, but women younger than 50 get mammograms only when individual circumstances warrant.
From a public relations standpoint, that proclamation did not quite rise to the level of advocating the clubbing of baby seals, but it came close. After making the breast cancer recommendation, the USPSTF also recommended that electrocardiograms, whether done at rest or during a stress test, not be performed on people who have no known risks or symptoms of heart disease, such as shortness of breath and chest pains. Heart disease is perhaps the overarching issue in health care, yet you heard zilch about that recommendation. The message: Nothing in our health care universe engenders the pink-ribboned passion of breast cancer.
After the mammography recommendation was made public, criticism came from everywhere—congresspeople, medical professionals, advocates, and, most fervently, survivors whose cancer had been detected by a routine mammogram. Months of public wrangling about mammograms ensued, during which the word “ta-tas” was elevated to holy writ. The embattled USPSTF tried to make the case that, while its message got bungled, its methodology was solid. It was essentially a “communication problem,” as it was put to me, which is what President Obama said was the primary reason for the negative reaction to the Affordable Care Act.
Clearly, one should not mess with the breast, and, after the outcry, the USPSTF walked back its recommendation. It now “recommends screening mammography, with or without clinical breast examination, every 1–2 years for women aged 40 and older.” It gave that procedure a B rating, which means there is “moderate certainty” that the net benefit is “moderate to substantial” for women. Can you imagine how many meetings it took to come up with that wording?
An A rating means that the USPSTF “recommends” that clinicians provide the service to eligible patients because its net benefit is “substantial.” Medicare is required to pay for a mammogram because it is a “recommended” procedure (and because Congress said it had to in a 1990 law). As for private insurers, it is reasonable to assume that they will continue to pay for most A- and B-rated tests, though making assumptions about what insurance companies will do is surely a fool’s game.
On C ratings, the USPSTF drops back to punt by saying that it “makes no recommendation for or against routine provision of the service” if the doctor feels it’s needed and the patient wants it. It’s equally safe to assume that many insurers will not pay for Cs.
Which brings us to the USPSTF’s current whipping boy—the PSA test. I’ll say this for the panel: It doesn’t shrink from controversy. Three years after the mammogram kerfuffle subsided, the organization doubled down by giving PSA screening a D. From a classroom perspective, the mammogram may not have been in the highest reading group, but it received a gold star or two along the way; the PSA test, by contrast, was ordered to stand in the corner and miss recess.
D ratings carry this declaration: “The USPSTF recommends against the service. There is moderate or high certainty that the service has no benefit or that the harms outweigh the benefits.” (Emphasis mine.)
However under the radar prostate cancer had been flying at the time, it now became a polestar.
Whatever one thinks of the panel, it is unquestionably an organization under perpetual siege, rather like the reservations staff at a trendy New York City restaurant. I called the USPSTF and was referred to Michael LeFevre, MD, one of the Chosen 16. He is a professor in the Department of Family and Community Medicine at the University of Missouri and the co–vice chair of the USPSTF.
Dr. LeFevre was honest enough to clarify the federal connection upfront. “We are not federal employees,” he said without my asking. “But when I fly to Washington for a conference, they feed me. And I get a $150 stipend for a two-day conference.”
I wondered, first of all, if the PSA denouncement had produced anything like the hubbub caused by the mammogram recommendation.
“The mammogram blowback was tremendous, very, very intense,” said Dr. LeFevre. “I would contrast the blowback for the PSA as much more muted. And the blowback came largely from two camps—urologists and prostate cancer survivors.”
One thing was certain right away—“blowback” was the chosen word for “criticism.” I’m not sure how to measure “muted.” My surgeon, Dr. Lee, heard that the blowback totaled 20,000 comments, “95 percent of them negative.” For the record, the official response from the American Urological Association (AUA) went like this: “[We are] outraged at the USPSTF’s failure to amend its recommendations on prostate cancer testing to more adequately reflect the benefits of the [PSA] test in the diagnosis of prostate cancer.”
The urologists were also offended that they were not represented (they still aren’t) on the panel, William Catalona, MD, director of the Clinical Prostate Cancer Program at Northwestern University and a towering figure in the urological world, told me in an interview. No specialist likes a nonspecialist telling him or her what to do, and “they were completely devoid of cancer study expertise.” Further, urologists resented the attention that was given to the panel. The AUA might have been an amateur athletic organization for all the general public knew, but the USPSTF was suddenly the darling of the New York Times.
“They are so cocky and so convinced that they’re correct,” says Dr. Walsh, “that nothing would change their mind.” Adds Dr. Lee, who is not much given to sarcasm, “The guys from this panel are basically on tour.”
Such complaints, however, are not specific to urology; the Chosen 16 are experts in biostatistics and research, not individual medical disciplines. “It would simply be impossible to have specialists for 50 different specialties,” says Dr. LeFevre. “We are experts in prevention, evidence-based medicine. We make no apologies for that.”
Dr. LeFevre says that urologists were consulted in the early stages of the panel’s investigation. “We started by formulating a research plan,” says Dr. LeFevre. “We said to ourselves, ‘What questions do we need to be answered?’ and we laid out those questions. ‘Are these the right questions? Are these the right studies to look at? Is this a fair review? Did we miss studies? Did we misinterpret anything?’ What we do is evidence-based procedure.”
Again, there is disagreement about how much consultation went on. They didn’t talk to either Dr. Walsh or Dr. Catalona, the men say, which is roughly like icing out Jonas Salk on a polio issue—Dr. Walsh is arguably the most important person in the history of prostate cancer treatment, and Dr. Catalona is the man most responsible for using PSA to screen for prostate cancer. There is absolutely no doubt that both doctors would’ve argued against scrapping the PSA test. But shouldn’t the USPSTF have at least asked for their input, if only to defuse criticism that it hadn’t?
In formulating its recommendations against PSA testing, the USPSTF studied the results of two major trials: the US PLCO (Prostate, Lung, Colorectal, and Ovarian) Cancer Screening Trial and the ERSPC (European Randomized Study of Screening for Prostate Cancer). According to the panel, the US trial “did not demonstrate any prostate cancer mortality reduction” and the European trial “found a reduction in prostate cancer deaths of approximately 1 death per 1,000 me
n screened in a subgroup of men aged 55 to 69 years.”
Dr. Walsh, Dr. Catalona, and scores of others say that the USPSTF misinterpreted the data.
“I’m sure they’re good people,” says Dr. Walsh, “but the problem is they don’t know anything about prostate cancer. They relied on 10-year survival, but there is now a very good study from Scandinavia that is a 30-year follow-up. At 9 years, yes, the risk of death from prostate cancer is negligible, but at 15 years and beyond it’s three times higher. It’s really pathetic what they’ve done.”
Understand that this is heavy-duty, graduate-level statistical stuff, much of it beyond the scope of this book. But if you’re the kind of person who likes to climb into bed with a book on, say, binomial coefficients in Pascal’s triangle, feel free to have at it. Links to the studies are furnished in the Sources and Resources section of this book, and other summations and arguments for and against the conclusions about both trials are readily available on the Internet.
The key thing to remember is that the USPSTF’s interpretation was that PSA screening not only did not save lives across the population, but also caused harm. According to the panel, that harm could come from:
• Serious infection from the prostate biopsy
• Serious risks posed by the intervention, whether surgical or radiological
• Permanent side effects in the form of erectile dysfunction and urinary incontinence in the event of unnecessary treatment
Without exactly smothering the panel with wet kisses, the American Cancer Society, or at least the most influential member of it, Otis Brawley, MD, is clearly on the side of the USPSTF. The society’s chief medical officer and a professor at Emory University, Dr. Brawley wrote a 2012 book called How We Do Harm: A Doctor Breaks Ranks about Being Sick in America (coauthored with Paul Goldberg, a longtime muckraker in the cancer world) that is primarily about the perils of overtreatment. But when Dr. Brawley is presented as antiscreening, he demurs and says, rather, that he advocates telling men the whole prostate story instead of just ordering up a PSA test. “It’s a shame when a man is screened for prostate cancer and not told that his cigarette smoking is more likely to kill him than prostate cancer,” Dr. Brawley told the magazine Atlanta in February 2012.
The Prostate Monologues Page 4