A Second Look at the European Randomised Study Of
Screening For Prostate Cancer

Last week, The Lancet published 13-year follow-up results from the European Randomised study of Screening for Prostate Cancer (ERSPC), an international trial of PSA testing in seven countries (the Netherlands, Belgium, Sweden, Finland, Italy, Spain, and Switzerland). (Unfortunately, the complete study is behind a paywall.) The core finding reported was that after 13 years of follow-up, prostate cancer screening cuts deaths by about 20%. However, the investigators concluded that screening should be rejected pending “further quantification of harms,” with their elucidation “a prerequisite for the introduction of population-based screening.” Fair enough.

Even though the results were covered by more than 100 news outlets internationally, absent from the many reports were critical questions about the trial that speak to the trustworthiness of the findings. Study limitations were also given short shrift by the trial investigators and the editorialists.

In proceeding with this story, I learned first hand that even though outsiders reviewing the study pinpointed flaws, they placed near the top praise for the study’s conclusion, that screening be looked at skeptically, based on the knowledge base today.

Here, I take the liberty of sharing the pitfalls, believing that for patients to view screening without bias, honest communication, however complicated, is imperative.

What I learned about the trial sure startled me.

Just Two of Seven Countries Showed a Screening Benefit

Reviewing the trial for PatientPOV.org, Anthony Zietman MD, immediate Past President of the American Society for Radiation Oncology, and Professor of Radiation Oncology at Harvard Medical School, raised this question:

“An unexplained aspect of this multinational study is that the “benefits” of screening were seen in Holland and Sweden, but not in any of the other half dozen European nations contributing patients. Explain that if you can! I know I can’t.”

In an email, Peter Albertsen, MD, Professor of Surgery, University of Connecticut Health Center, Farmington, CT, explained it this way:

“Swedes have a very high incidence of prostate cancer –higher than the rest of Europe and equivalent to US African-Americans. Screening works better the higher the incidence of disease. The Holland study was barely statistically significant. Some have argued that the screen detected cases were treated more aggressively. The big question is Finland. They contributed the most patients, but screening made no difference. They took a population-based approach, rather than Holland that invited men to participate before enrolling them in the study. In all the other countries, the sample sizes were too small. Therefore there was insufficient statistical power.”

American Cancer Society Chief Medical Officer Otis Brawley, MD, amplified issues surrounding the findings in Finland. Like Albertsen, he pointed out that the Finnish component of the trial was negative. “It was the largest part of the trial and Finns have a high rate of prostate cancer as well.”

In addition to the pitfalls noticed above, Brawley said:

Sweden had an unusual non-straightforward randomization that biases toward a finding that screening works. The control group was never informed that they were in a clinical trial. They randomized census rolls. This means that men with metastatic disease at the time of randomization on the screen arm got to opt out, while men in the control arm did not.

Moreover, Brawley questioned whether those in the control arm had the same access to quality of care as the screened arm:

“The screened individuals were treated by experts running the study. The control group got whatever was in the community.”

Brawley considers some of the issues in the trial so troubling that he has called for independent external review of the trial.

Praise for Investigators Opposition to Screening

Opposition to population-based screening has grown in recent years and commentators in this story praised the study’s conclusion as well. In an email, Brawley wrote:

“I agree with that [the conclusion] and it’s consistent with a number of current recommendations, including the American Cancer Society and the US Preventive Services Task Force, which are against ROUTINE screening, but speak positively toward true informed decision-making. The benefits are possible, but are small if they exist, as several studies have shown.”

Albertsen added:

“This study and the recent SPG-4 [Scandinavian Prostate Group 4] results are actually quite consistent.  PSA testing does find some prostate cancers that are eventually fatal.  Radical prostatectomy does cure some prostate cancers that would have been fatal. But in the process of detecting these cancer, a large proportion will not progress, hence overtreatment occurs. In addition, when doctors find very aggressive cancers, they are especially lethal and treatment does not alter outcome. So screening works for some cancers, but not for others.  Now the problem is how to tell these two groups apart.”

Nonetheless, rejection of prostate cancer screening remains a bitter pill for many Americans to swallow. Some question whether they are trading a risk for death from cancer with harms that they think simply don’t compare.

There’s plenty more that has to be done if doctors and patients are going to get on the same page. A lot of work is underway to engage patients, share evidence-based data, and ratchet up understanding of the benefits, risks, and uncertainties.

These are complex issues and they don’t fit well into a simple slogan or headline. In writing posts like this, sharing what I hear patients saying about these issues, I hope to help bridge some of the gaps in understanding, further best care, and set in motion making informed choices.

NOTE: This post is the first of a series. There is a lot to discuss and I am interested in hearing from patients interested in these issues. I’ll try to get the next installment out before my summer vacation, but it may lapse until after Labor Day.

I invite you to comment below, tweet the link to the story, ask me about this on twitter @lauranewmanny, and by all means, like my Facebook page and discuss this there, and/or in comments below . I’d like to engage you all in further discussion.

U.S. Preventive Services Task Force Backs Routine HIV Testing

The U.S. Preventive Services Task Force formally published its recommendation for routine HIV testing for all individuals age 15 to 65 in the Annals of Internal Medicine this week. An editorial and patient materials are all available free to anyone with an Internet connection. Many people who work in HIV hoped that this would finally move HIV into mainstream medicine. With a U.S. Preventive Services Task Force Recommendation, patients don’t need to ask for the test, it would become a routine blood test like many others, stigma would be reduced, and insurance would likely cover it. The evidence backs it. However,  within 24 hours of the Task Force Recommendation going up online, the American Academy of Family Physicians questioned age 15 as the logical starting point, instead urging that testing begin at age 18. This is just some of the resistance that the medical community is putting forward now.

Several months ago, I spoke with Roger Chou, MD, MPH, associate professor of internal medicine at Oregon Health and Science University, Portland, Oregon, who headed the evidence review for the U.S. Preventive Services Task Force. “About 25% of people who have HIV are not aware of it,” Chou said. “They have no identifiable risk factors.”

Other reasons why data to back routine HIV testing are in, include that the screening test is highly accurate, we have direct evidence from randomized controlled trials that we can reduce the risk of transmission by 90%, and that you can’t trust what your patient says, or that patients don’t always think that they are at risk,” said Chou.

Disclosure a Huge Problem

“If we learned anything about the announcement earlier this week that Jason Collins is gay, it ought to be that you can’t just look at someone and put them into a risk category,” said Donna Futterman, MD, Director of the Adolescent AIDS Program, and Professor of Clinical Pediatrics, Children’s Hospital of Montefiore, Albert Einstein College of Medicine, Bronx, New York. “Most people who are gay won’t share that with providers that they are gay.” Notably, two days after Collins’ announcement, his former fiancé went on television to say that she had no clue that Collins was gay. This is not to imply anything about Collins’ HIV status whatsoever.

“People simply don’t volunteer that they are having unprotected male-to-male sex, taking IV drugs with dirty needles, and “we really can’t define what high-risk behavior is,” Chou explained. Therefore, targeted screening to so-called high-risk groups misses the boat.

“Step one of the HIV Treatment cascade – is finding and testing people with HIV,” Futterman told me. “It is the step that involves the non-HIV care system. We need to engage the primary care providers and system in routinely offering testing so as to find those with HIV who don’t know their status.”

Judy Levison, MD, associate professor of obstetrics and gynecology, Baylor College of Medicine, Houston, Texas, works with women with HIV who are pregnant. The USPSTF and many health authorities previously recommended HIV testing for all pregnant women. Levison sees enormous public health value in the medical community adding HIV testing to regular screening panels that patients have done when they see their primary care provider.

Although we all like to think we know the sexual patterns of people we are sleeping with, Levison says that she sees plenty of pregnant women who don’t fit the stereotype for HIV. These are women who have been in longlasting marriages, who get the surprise of their lives when they test positive for HIV. “Sometimes it is a married woman who has no idea her husband is having unprotected sex with men,” she said. “Or someone who slipped up once a long time ago with someone she thought she knew.” Levison remembered a patient quote in the book Mortal Secrets: Truth and Lies in the Age of AIDS, by Richard Klitzman and Ronald Bayer: “What was my crime? I loved someone.”

With antiretroviral therapies proving that HIV can be treated just like many other chronic diseases, enabling people to have a full life, have healthy babies, and see them grow up, Levison sees enormous benefits with HIV testing expanding to adults and teens. “The successes of universal testing in pregnancy — and discovering many women not known to have risk factors do have HIV–is central to the recommendation to test all adults. Currently, those who do not know they have HIV are responsible for a large proportion of newly transmitted infections.”

Michael Saag, MD, Director of the Center for AIDS Research, University of Alabama Birmingham, amplifies this: “The bottom line:  Anyone who is sexually active, or has even thought about being sexually active should be tested for HIV at least once…and more often if they remain active, especially with multiple partners over time.” As for an age cut-off, he added: “I don’t know of a specific age cut-off that applies in either direction that would apply to everyone.  Therefore, I think age distinctions are a bit of a distraction.  This is about function and activity, not age.”

Medical Community Views HIV Differently

When we learn that large proportions of Americans have hypertension, diabetes, or high cholesterol, and don’t know it, what do we do? We view it as a missed opportunity, and mount large campaigns to get people tested, followed, and into care to bring their blood pressure down, and keep it down. Not so for HIV.

“It’s been a very difficult sell for providers,” Futterman told me. Providers resist thinking that their patients could possibly have HIV because they don’t obviously fit into the targeted risk groups and they don’t envisage much yield in their practice. What Futterman thinks is urgently needed is to add HIV testing to routine blood screening panels. But HIV testing is segregated, a “holdover from the early days when pre- and post-test counseling were in place.” Although there were good historical reasons for splintering it aside – patient protections and discrimination especially – that no longer justifies keeping it separate.

“Practice change won’t happen unless we work on physician buy-in, implementation, and evaluation,” said Futterman. What she would like to see is for the test to become streamlined, have HIV testing incorporated as a measure of quality for the Joint Commission on Accreditation of Health Care Organizations. “We need to get rid of the special laws related to consent,” she said. “If it is complicated to do it, it won’t be done.”






With Prostate-Specific Antigen (PSA) Screening Questioned, Why Not Hurl Out the Next Unproven Prostate Tests?

The headline in the New York Times story this morning, “New Prostate Cancer Tests Could Reduce False Alarms,” by Andrew Pollack, had me scratching my head. Had I missed something in the story of advances in prostate cancer screening and diagnosis? The search for finding something better than PSA tests to reduce false positives and unnecessary biopsies has been going on for time immemorial, or more accurately, maybe the last 15 years. Also, separating the lethal from the cancers that amount to no trouble at all has also been a key research question.

Had The Times been bamboozled into a story by industry copywriters and urologists, hoping to bring back attention to the prostate? Clearly, the US Preventive Services Task Force, the American Cancer Society, and other groups stomped on routine prostate screening. Plenty of thought leaders agreed it is not a good prostate cancer screening test.

It’s also not just screening of asymptomatic men that is at issue. What about the men diagnosed with prostate cancer? Can they be better stratified so that men with lethal cancers are separated from those that require no treatment?

The New York Times article waxes poetic about the “more than a dozen companies that have introduced tests or are planning to in the near future.” It moves on to the transformative potential of molecular markers and a high-stakes battle looming ahead between Genomic Health and Myriad Genetics.

Are readers supposed to be wowed? I think so.

My favorite line in the story was this one:

“Some experts say that even if the new tests are not perfect, they are better than what is available now.”

Was The Times in the dark about thought leaders who thought all this is premature, urologic oncologists included? Apparently. Will more men and their loved ones insist on these unproven tests? Most likely.

I don’t dispute that we need a good test that separates the bad cancers, but the test is not here yet. The data is thin.

Are Dense-Breast, Right-to-Know Laws Helpful?

Doctor reviews a digital mammogram of a dense breast and points to a potential cancer. Credit: National Cancer Institute.

In a victory for the dense-breast patient movement, Governor Jerry Brown (D-CA) signed legislation last week requiring that doctors who discover that women have dense breasts on mammography must inform women that:

  • dense breasts are a risk factor for breast cancer;
  • mammography sees cancer less well in dense breasts than in normal breasts; and
  • women may benefit from additional breast cancer screening.

The California law goes into effect on April 1, 2013. It follows four states (Connecticut, Texas, Virginia, and New York) with similar statutes. All have enjoyed solid bipartisan support. Rarely do naysayers or skeptics speak up.

Young women who are leading the charge often bring lawmakers the story of a young constituent, diagnosed with a very aggressive, lethal cancer that was not shown on film-screen mammography. The Are You Dense? patient advocacy group engages patients on Facebook, where women share their experiences with breast cancer, organize events, and lobby for legislation. Individual radiologists work with the advocacy groups, but many radiology groups and breast surgeons do not endorse these laws.

A Closer Look at Breast Cancer Data

Living in an age when information is viewed as an entitlement, knowledge, and power, many physicians find it hard to argue against a patient’s right to know. Can sharing information be a mistake? Some epidemiologists think so. Otis W. Brawley, MD, FACP, Chief Medical & Scientific Officer, American Cancer Society, says: “I really worry when we legislate things that no one understands. People can get harmed.” Numerous issues have to be worked out, according to Brawley. For one, he explains: “There is no standard way to define density.” Additionally, “even though studies suggest that density increases the risk of cancer, these cancers tend to be the less serious kind, but even that is open to question,” Brawley says. “We in medicine do not know what to do for women who have increased density.”

A study of more than 9,000 women in the Journal of the National Cancer Institute revealed that women with very dense breasts were no more likely to die than similar patients whose breasts were not as dense. “When tumors are found later in more dense breasts, they are no more aggressive or difficult to treat,” says Karla Kerlikowske, MD, study coauthor, and professor of medicine and epidemiologist at the University of California San Francisco. In fact, an increased risk of death was only found in women with the least dense breasts.

The trouble is what is known about dense breasts is murky. Asked whether he backs advising women that dense breasts are a risk factor for breast cancer, Anthony B. Miller, MD, Co-Chair of the Cancer Risk Management Initiative and a member of the Action Council, Canadian Partnership Against Cancer, and lead investigator of the Canadian National Breast Cancer Screening Study, says: “I would be very cautious. The trouble is people want certainty and chances are whatever we find, all we can do is explain.”

Women in their forties, who are most likely to have dense breasts (density declines with age) may want to seek out digital mammography. In studies comparing digital mammography to film-screen mammography in the same women, digital mammography has been shown to improve breast cancer detection in women with dense breasts. Findings from the Digital Mammographic Imaging Screening Study, showed better breast cancer detection with digital mammography. But digital mammography is not available in many areas.  Moreover, Miller explains: “We do not know if this will benefit women at all.  It is very probable that removal of the additional small lesions will simply increase anxiety and health costs, including the overdiagnosis of breast cancer, and have no impact upon mortality from breast cancer.”

Additional imaging studies sound attractive to people convinced that there is something clinically significant to find. But as I pointed out in my last post, many radiologists and breast physicians contend that there is no evidence that magnetic resonance imaging or any other imaging study aids breast cancer screening in women with dense breasts. Brawley notes: “These laws will certainly lead to more referral for MRI and ultrasound without clear evidence that women will benefit (lives will be saved.) It’s clear that radiologists will make more money offering more tests.” Miller adds: “A number of doctors are trying to capitalize on this and some of them should know a lot better.”

Many Advocates Question More Tests, Statutes

Even though the “Are You Dense?” campaign has been instrumental in getting legislation on the books across the county, other advocacy groups and patient advocates want research, enhanced patient literacy about risks and benefits of procedures. Many recall mistakes made that led women down the path of aggressive procedures. In that group is the radical Halsted mastectomy, used widely before systematic study, but once studied,  found no better than breast-conserving surgery for many cancers, and bone marrow transplants, also found to be ineffective, wearing, and costly.

Jody Schoger, a breast cancer social media activist at @jodyms who engages women weekly on twitter at #bcsm, had this to say on my blog about the onslaught of additional screening tests:

“What is needed is not another expensive modality… but concentrated focus for a biomarker to indicate the women who WILL benefit from additional screening. Because what’s happening now is an avalanche of screening, and its subsequent emotional and financial costs, that is often far out of proportion to both the relative and absolute risk for invasive cancer. I simply don’t think more “external” technology is the answer but one that evolves from the biology of cancer.”

Eve Harris @harriseve, a proponent of patient navigation and patient literacy, challenged Peter Ubel, MD, professor of business administration and medicine, at Duke University, on his view of the value of patient empowerment on the breast density issue. In a post on Forbes, replicated in Psychology Today, Ubel argued that in cases where the pros and cons of a patient’s alternatives are well known, for example, considering mastectomy or lumpectomy, patient empowerment play an important role. “But we are mistaken to turn to patient empowerment to solve dilemmas about how best to screen for cancer in women with dense breasts,” he writes.

Harris disagrees, making a compelling case for patient engagement:

“I think that we can agree that legislative interference with medical practice is not warranted when it cannot provide true consumer protection. But the context is the biggest culprit in this situation. American women’s fear of breast cancer is out of proportion with its incidence and its mortality rate. Truly empowering people—patients would mean improving health literacy and understanding of risk…”

But evidence and literacy take time, don’t make for snappy reading or headlines, and don’t shore up political points. Can we stop the train towards right-to-inform laws and make real headway in women’s health? Can we reallocate healthcare dollars towards effective treatments that serve patients and engage them in their care? You have to wonder.


Is the Bar High Enough for Screening
Breast Ultrasounds for Dense Breasts?

In a unanimous decision yesterday, FDA approved the first breast ultrasound imaging system for dense breast tissue “for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.” Patients should not interpret FDA’s approval of the somo-v Automated Breast Ultrasound System as an endorsement of the device as necessarily beneficial for this indication and this will be a thorny concept for many patients to appreciate.

If the approval did not take place in the setting of intense pressure to both inform women that they have dense breasts and lobbying to roll out all sorts of imaging studies quickly, no matter how well they have been studied, it would not be worth posting.

Dense breasts are worrisome to women, especially young women (in their 40s particularly) because they have proved a risk factor for developing breast cancer. Doing ultrasound on every woman with dense breasts, though, who has no symptoms, and a normal mammogram potentially encompasses as many as 40% of women undergoing screening mammography who also have dense breasts, according to the FDA’s press release. Dense breast tissue is most common in young women, specifically women in their forties, and breast density declines with age.

The limitations of mammography in seeing through dense breast tissue have been well known for decades and the search has been on for better imaging studies. Government appointed panels have reviewed the issue and mammography for women in their forties has been controversial. What’s new is the “Are You Dense?” patient movement and legislation to inform women that they have dense breasts.

Merits and Pitfalls of Device Approval

The approval of breast ultrasound hinges on a study of 200 women with dense breast evaluated retrospectively at 13 sites across the United States with mammography and ultrasound. The study showed a statistically significant increase in breast cancer detection when ultrasound was used with mammography.

Approval of a device of this nature (noninvasive, already approved in general, but not for this indication) does not require the company to demonstrate that use of the device reduces morbidity or mortality, or that health benefits outweigh risks.

Eitan Amir, MD, PhD, medical oncologist at Princess Margaret Hospital, Toronto, Canada, said: “It’s really not a policy decision. All this is, is notice that if you want to buy the technology, you can.”

That’s clearly an important point, but not one that patients in the US understand. Patients hear “FDA approval” and assume that means a technology most certainly is for them and a necessary add-on. This disconnect in the FDA medical device approval process and in what patients think it means warrants an overhaul or at the minimum, a clarification for the public.

Materials for FDA submission are available on the FDA website, including the study filed with FDA and a PowerPoint presentation, but lots of luck, finding them quickly. “In the submission by Sunnyvale CA uSystems to FDA, the company stated that screening reduces lymph node positive breast cancer,” noted Amir. “There are few data to support this comment.”

Is Cancer Detection A Sufficient Goal?

In the FDA study, more cancers were identified with ultrasound. However, one has to question whether breast cancer detection alone is meaningful in driving use of a technology. In the past year, prostate cancer detection through PSA screening has been attacked because several studies and epidemiologists have found that screening is a poor predictor of who will die from prostate cancer or be bothered by it during their lifetime. We seem to be picking up findings that don’t lead to much to worry about, according to some researchers. Could new imaging studies for breast cancer suffer the same limitation? It is possible.

Another question is whether or not the detected cancers on ultrasound in the FDA study would have been identified shortly thereafter on a routine mammogram. It’s a question that is unclear from the FDA submission, according to Amir.

One of the problems that arises from excess screening is overdiagnosis, overtreatment, and high-cost, unaffordable care. An outcomes analysis of 9,232 women in the US Breast Cancer Surveillance Consortium led by Gretchen L. Gierach, PhD, MPH, at the National Institutes of Health MD, and published online in the August 21 Journal of the National Cancer Institute, revealed: “High mammographic breast density was not associated with risk of death from breast cancer or death from any cause after accounting for other patient and tumor characteristics.” –Gierach et al., 2012

Proposed Breast Cancer Screening Tests

Meanwhile, numerous imaging modalities have been proposed as an adjunct to mammography and as potential replacements for mammography. In 2002, proponents of positron emission tomography (PET) asked Medicare to approve pet scans for imaging dense breast tissue, especially in Asian women. The Medicare Coverage Advisory Commission heard testimony, but in the end, Medicare did not approve it for the dense-breast indication.

PET scans are far less popular today, while magnetic resonance imaging (AKA MR, MRI) and imaging have emerged as as adjuncts to mammography for women with certain risk factors. Like ultrasound, the outcomes data is not in the bag for screening with it.

In an interview with Monica Morrow, MD, Chief of Breast Surgery at Memorial Sloan-Kettering Cancer Center, New York, several months ago concerning the rise in legislation to inform women about dense breasts, which frequently leads to additional imaging studies, she said: “There is no good data that women with dense breasts benefit from additional MR screening.” She is not the only investigator to question potentially deleterious use of MR ahead of data collection and analysis. Many breast researchers have expressed fear that women will opt for double mastectomies, based on MR, that in the end, may have been absolutely unnecessary.

“There is one clear indication for MR screening,” stressed Morrow, explaining that women with BRCA mutations should be screened with MRI. “Outside of that group, there was no evidence that screening women with MR was beneficial.”

At just about every breast cancer meeting in the past two years, the benefits and harms of MR and other proposed screening modalities come up, and there is no consensus in the field.  It  should be noted, though, that plenty of breast physicians are skeptical about broad use of MR– not just generalists outside of the field. In other words, it is not breast and radiology specialists versus the US Preventive Services Task Force – a very important message for patients to understand.

One thing is clear: as these new technologies gain FDA approval, it will be a windfall for industry. If industry is successful and doctors are biased to promoting these tests, many may offer them on the estimated 40% of women with dense breasts who undergo routine mammograms, as well as other women evaluated as having a high lifetime risk.  The tests will be offered in a setting of unclear value and uncertain harms. Even though FDA has not approved breast MRI for screening dense breasts, breast MR is being used off label and it is far more costly than mammography.

When patients raise concerns about the unaffordability of medical care, they should be counseled about the uncertain benefit and potential harms of such a test. That may be a tall bill for most Americans to consider: it’s clear that the more is better philosophy is alive and well. Early detection of something, anything, even something dormant, going nowhere, is preferable to skipping a test, and risking who-knows-what, and that is something, most of us cannot imagine at the outset.


NEXT UP: The Dense Breast Lobby Pushes Legislation to Inform, Increase Access to Tests




What’s Next for Prostate Cancer Screening and Treatment?

Complex medical stories require time and energy to tell, talk about, and think about. When stories involve yanking a test or practice that is widely used, all hell breaks lose. That’s why I am grateful to appear today on Alaska Public Radio Station KSKA, Anchorage, Alaska, on an hourlong Line One program on Prostate Cancer Screening and Treatment today. Thank you, Dr. Thad Woodard, the Line One host.

At issue, the latest US Preventive Services Task Force conclusion on the benefits and harms of prostate cancer screening:

“Prostate-specific-antigen-based screening results in small or no reduction in prostate-cancer-specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary.”.

What sounds like a seachange in practice merits some further analysis:

Did you know that PSA screening, defined as testing asymptomatic men with a PSA test, was adopted in the United States widely, and before it was tested in clinical trials? Screening recommendations for and against prostate cancer screening vary widely around the world.

From the late 1980s, PSA testing emerged and was presented as a wonderful new biomarker that could save men from dying of prostate cancer.

Soon, we saw a rising incidence of prostate cancer, detected by PSA. These men lived longer ostensibly with PSA-detected prostate cancer…but was it really clinically significant prostate cancer that would interfere with a  man’s life, kill him, or do we know enough?

Radical prostatectomies, minimally invasive prostatectomies (nerve-sparing, robotic) proliferated, as did similar trends in radiation therapy.

Eventually, news came out that maybe the treatments are worse than the disease. Quality of life outcomes pointed to impotence, urinary incontinence, and bowel problems.  The question also emerged  as to whether men’s lives were really extended.

Curiously, prostate cancer screening has not been embraced in many countries outside of the United States simply because the yield, number of lives saved is not viewed as compelling and the harms are substantial (overdiagnosis, overtreatment, impotence, urinary incontinence, bowel problems). Countries more committed to clinical trials did not recommend for prostate cancer screening.

In 2001, the UK, the ProtecT trial set out to evaluate the effectiveness of treatment for clinically localized prostate cancer, randomizing men to three treatments: active monitoring, radical prostatectomy, and radical radiotherapy.  This kind of trial could never have happened in the US, where treatment is embraced so strongly that it would be seen as unethical to randomize men to active monitoring (not watchful waiting, but much better- hence active). Interestingly, though, when ProtecT started, the investigators had trouble enrolling men because many men feared being randomized to one of the treatment arms and actually preferred active monitoring. Now that’s really different from what happens in the US.

Plenty of cultures wince at the thought of aggressive treatment for anything, be it cancer or other conditions. Readers might be interested in taking a look at the late Lynn Payer’s book, Medicine and CulturePayer’s work was eye-opening and might give patients confidence in trusting their point of view on how they want to work with physicians.

There is plenty of backstory to the way prostate cancer screening and treatment evolved in the United States. I hope to delve more into on the show tonight.

My own biases are closer to where the US Preventive Services Task Force is on screening.  But I’d like to hear from patients and men who have looked at the data.  I don’t think it is a black-and-white issue. Hoping you’ll tune in to hear me in less than an hour on Alaska Public Radio’s Line One. It will be streaming on your computer. (link is above). As always, I welcome your comments below.





Confused About What Health Reform Has to Offer:
Sept. 23rd Marks One Year with New Patient Protections

Obama signs the Patient Protection and Accountability Act, 2010

You may not love every single bit of health reform coming down the pike, but make no mistake about it: new patient protections that went into effect one year ago had their one-year anniversary Sept. 23. I think health reform, as enacted by the Patient Protection and Accountability Care Act (AKA “PPACA”), is a milestone for patients.

PPACA has a universal mandate, meaning that every American must have health insurance. If you’ve followed this issue, challenges to the law have been filed, but it is too early to tell how things will end.

I like the concept of a universal mandate and coverage because it brings us closer to everyone sharing the risk and financial cost of health care for all. Sure, I’d rather see something like single payer, but politically, I doubt that would fly at this moment. I admit that I am biased in favor of health reform and I did plenty of writing for a living that clarified health reform. So continue reading with that in mind.
PPACA Measures Enacted  Sept. 23, 2010

New patient protections that went into effect on Friday are good news. In comparison with where we were before, or where the right could move this issue, the public should applaud these changes. Consider these changes that went into effect on Friday:
1.    Insurers can no longer impose caps on essential benefits like hospital stays.
2.    Health plans cannot drop you when you get sick.
3.    Recommended preventive care, such as screening mammograms, colonoscopies, and vaccinations no longer require copays, coinsurance, or deductibles in all new insurance plans.
4.    Your health plan is more restricted in enforcing annual spending caps, but they will be completely eliminated by 2014.
5.    Individuals with Medicare Part D coverage get a $250 rebate, and 50% of the doughnut hole will be eliminated in 2011. By 2020, the doughnut hole will be eliminated.
6.    Prior authorization for emergency care and denial of out-of-network emergency care has been eliminated.
7.    Women can go directly to their ob/gyns without referrals.
8.    Lifetime limits on most policies are eliminated.
9.    An appeals process at health plans must be in place.

10. Dependents can remain on the parents’coverage until age 26.

My discussion of the law is far from comprehensive. There is plenty more.

It’s easy to feel blue when we hear potential nominees for President sit silently while a mob suggests an uninsured 31-year-old man die.

So I am taking a moment to pause so that we can remind ourselves what new patient protections health reform offers. If you have more to add, please put them up in comments and tweet them. Here’s a nice graphic of what becomes effective, when. Bookmark it, show it to skeptics. Challenges to health reform are often scary.

Writing About Alzheimer’s and Dementia Gets Complicated

Now that I have spent three days listening to expert neurologists, demographers, caregivers, and policy people talk about Alzheimer’s, I come away from the meeting with a sense that the story is complicated, and that I hope it is not reduced to talking points and sound bites. I didn’t feel that it was at the meeting, but I can see how reporting could go awry, and not really help readers or society out.

I don’t want to cover Alzheimer’s disease pursuing the “awareness” route, namely pressing how many millions of Americans have the disease, and how unabated, with the graying of America, these numbers will rise astronomically. There is no cure for Alzheimer’s disease. Existing drugs are not all that beneficial, and when they help alleviate symptoms, it seems to be for a very brief window, in a subset of patients, that nobody has convinced me you can predict. Are we at square one? Should we grab at any way to mobilize the troops for the disease?

There’s more negative news: clinical trials for years have been negative and clinical trial enrollment is poor. Can it be improved? Should I promote enrollment in clinical trials? What might a patient gain from participating in a clinical trial? What about informed consent? How do patients with Alzheimer’s disease give informed consent?

Is using amyloid as a biomarker something that should be abandoned because reductions in amyloid have not shown improvements in the disease? What is the state of the science?

What about labeling patients with mild cognitive impairment or Alzheimer’s? Is mild cognitive impairment an entity that is meaningful, or should it be discarded? Some speakers at the Alzheimer’s disease forum were skeptical about the classification, which is not used in many parts of the world. Will mini-screens being in primary care offices become popular because experts and advocacy groups say that they will reduce stigma and work effectively? Under what conditions, could Alzheimer’s disease be overdiagnosed? Remember, older people are on many medicines, they can have electrolyte problems, hearing problems, and other conditions that could impact on diagnosis.

What kinds of protections are in place for people? There is a big push by pharma and the Alzheimer’s Association to be certain to record an Alzheimer’s disease diagnosis in a medical record. That may seem relatively innocuous for old, retired people, but could some people lose jobs, lose health and long term care benefits, be barred from housing? What is the upside to getting a higher count of Alzheimer’s patients? Do the benefits outweigh the risks?

I also think that battles over Medicare need to be discussed with the possibility that many more Americans are likely to be afflicted with Alzheimer’s. Where will they get care? How do Americans want it to look? Will Alzheimer’s patients be warehoused? Can community programs manage people with end-stage Alzheimer’s?

Should innovative non-drug approaches in the arts be funded more widely? How can we reduce stigma about Alzheimer’s disease? I’d like to know a lot more about what is happening today to people with advanced Alzheimer’s disease. Can they find placements? Where? What are equitable ways to fund Alzheimer’s and dementia care?

Long Term Care

How should the country support long-term care? Should children be taught, as they are in lower school, in some parts of Japan, about caregiving, dementia, and Alzheimer’s? What about minorities, lesbian, gay, bisexual, and transgender people with Alzheimer’s? What about aging single people, who are all over America, and growing around the world? What services are available for them? How will we plan for them?

Alzheimer’s disease issues do not exist in a vacuum.

People should be aware of all of these issues, as people think through a national plan for Alzheimer’s disease and think through federal and state policy. I am intrigued that some countries have national plans for Alzheimer’s and I hope to write about them. Perhaps they will be instructive for the US. Far more patient stories need to be told to understand the complexities.