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New York Times writer Dana Jennings, who's been publicly sharing his own story of prostate cancer, writes about a new book about someone else's prostate cancer story.

It's "Invasion of the Prostate Snatchers," by Ralph H. Blum and Dr. Mark Scholz.

Jennings writes:

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"(The book) is a provocative and frank look at the bewildering world of prostate cancer, from the current state of the multibillion-dollar industry to the range of available treatments.


About 200,000 cases of prostate cancer are diagnosed each year in the United States, and the authors say nearly all of them are overtreated. Most men, they persuasively argue, would be better served having their cancer managed as a chronic condition.

Why? Because most prostate cancers are lackadaisical -- the fourth-class mail of their kind. The authors say "active surveillance" is an effective initial treatment for most men.

They add that only about 1 in 7 men with newly diagnosed prostate cancer are at risk for a serious form of the disease. "Out of 50,000 radical prostatectomies performed every year in the United States alone," Dr. Scholz writes, "more than 40,000 are unnecessary. In other words, the vast majority of men with prostate cancer would have lived just as long without any operation at all. Most did not need to have their sexuality

Yet radical prostatectomy is still the treatment recommended most often, even though a recent study in The New England Journal of Medicine suggested that it extended the lives of just 1 patient in 48.

And surgery, of course, is most often recommended by surgeons and urologists -- who are also surgeons. Mr. Blum writes: "As one seasoned observer of the prostate cancer industry told me, 'Your prostate is worth what Ted Turner would call serious cash money.' " As for patients, their rational thinking has been short-circuited by the word "cancer." Scared, frantic and vulnerable -- relying on a doctor's insight -- they are ripe to being sold on surgery as their best option. Just get it out.

Every urologist I met with after my diagnosis recommended surgery, even though it was believed then that I had a low-risk Stage 1 cancer. The best advice came from my personal urologist, who declined to do my operation because it was beyond him: "Avoid the community hospital guys who do a volume business in prostates."

I did, but I'm still maimed. In my experience, doctors play down punishing side effects like incontinence, impotence and shrinking of the penis. Those are just words when you hear them, but beyond language when you go through them."

Read Jennings' full column. And you may want to pick up your own copy of "Invasion of the Prostate Snatchers." I'm getting mine.

This is a very important story.

"Unfortunately," as a Mayo Clinic physician says in the story, "this is something that isn't well understood, not just by the public - but by physicians who order the tests."

Special focus was placed on the nuclear technologies of breast-specific gamma imaging and positron emission mammography. The story says a single exam with one of these tests "exposes patients to a risk of radiation-induced cancer that is comparable to the risk from an entire lifetime of yearly mammograms starting at 40."

And the story goes on to discuss a concern that these tests will "become more widespread and casual...now being considered and even being used in some cases as screening tests, and this is not appropriate" - according to the Mayo physician quoted.

A well-intentioned ad campaign run by the American Cancer Society is too vague, and, therefore, may leave impressions that are imbalanced, incomplete and unsubstantiated - the kind of common tactic seen in many drug company ads.

That's my opinion based on my analysis of the ad and based on my reading of the text.


A Cancer Society news release states:

The American Cancer Society Cancer Action Network (ACS CAN) is launching a new print and online advertising campaign in congressional districts across the country this week, urging lawmakers to fully fund a lifesaving cancer prevention, early detection and diagnostic program that is celebrating 20 years of screening low income, uninsured, and medically underserved women for breast and cervical cancer. The ads also send the message that when it comes to increasing your odds of surviving cancer, access to evidence-based early detection tools is critical.


The ads reference the Centers for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which has a track record of reducing deaths from breast and cervical cancer. The program has provided more than 9 million screening exams to more than 3 million women and diagnosed more than 40,000 cases of breast cancer and more than 2,000 cases of cervical cancer since it launched in 1990. But with limited funding, the program is able to serve fewer than 1 in 5 eligible women.

The accomplishments of the CDC NBCCEDP are noteworthy. So this blog entry is no knock on that program.

It's a criticism of the ad.

We can't fight cancer if we can't see it AD.jpg
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There is no specific mention of the specific goals of the CDC NBCCEDP. The ad doesn't state what the news release states that this is promoting "20 years of screening low income, uninsured, and medically underserved women for breast and cervical cancer."

Instead, the ad promotes unspecified screening - all screening, one could infer. "We can't fight cancer if we can't see it....When it comes to cancer, screening is seeing...It's time to take the blindfolds off and stop cancer before it starts." Catchy phrases from an ad agency or from someone creative at the Cancer Society. But are we talking about prostate cancer screening? Lung cancer CT scan screening? Ovarian cancer screening? Show me where it does NOT say that. And show me where it DOES say this was about breast & pap smear screening for medically underserved women?

But this is a fund raising and political message: "current funding isn't enough...tell your members of Congress (to) increase funding..."

And when you're raising funds, a little vague fear-mongering can't hurt, right?

Wrong.

One other piece of copy from the ad demands scrutiny: "60% of cancer deaths could be prevented." The implication is that's all from screening because screening is the only prevention method mentioned in the ad. Nothing about stop smoking or other lifestyle changes. If the ad meant to imply that 60% of cancer deaths could be prevented just from screening, it should provide the evidence for that. If the ad did not mean to imply that, but was just misleadingly vague, then I call for the ACS to pull this ad. In either case, I think they have a problem.

That unsubstantiated 60% figure is especially ironic since the ACS news release includes this line: "Access to evidence-based prevention is just one component of the fight to defeat cancer." We needed a little more clear evidence here - evidence that would show that screening is just one part of prevention.

Earlier this summer I criticized a federal agency's vague screening promotion ads. I'll end this note in a fashion similar to the way I ended that note:

I know that the folks at the American Cancer Society (or their ad agency) had their hearts in the right place with this campaign. But their heads have to do a better job of learning how to communicate about screening. Or else they'll be guilty of the same disease-mongering techniques that are so prevalent in so many other messages in general circulation these days. The worried well are constantly whipped into a frenzy over the supposed weapons of mass destruction inside all of us. As a physician-colleague reminded me: "All screening tests cause harm; some may do good as well."

You'd never know it from the ACS ad. But then again, it's "only" a fundraising ad, right?

There may be just a few more important things to spend one's time on in the field of breast cancer.

But the Wall Street Journal reports on an ugly dispute, "Charity Brawl: Nonprofits Aren't So Generous When a Name's at Stake." Excerpts:

As the leading breast-cancer charity, Susan G. Komen For the Cure helped make "for the cure" a staple of the fund-raising vernacular. The slogan is so popular that dozens of groups have sought to trademark names incorporating the phrase. Among them are "Juggling for a Cure," "Bark for the Cure," and "Blondes for the Cure."


Komen sees this as imitation, and it's not flattered. Instead, it's launching a not-so-friendly legal battle against kite fliers, kayakers and dozens of other themed fund-raisers that it contends are poaching its name. And it's sternly warning charities against dabbling with pink, its signature hue.

"It is startling to us that Komen thinks they own pink," says Mary Ann Tighe, who tangled with the breast-cancer charity over the color for her "Kites for a Cure" lung-cancer fund-raiser. "We cannot allow ourselves to be bullied to no purpose."

Screen shot 2010-08-05 at 2.08.54 PM.png Read some of the online comments following the WSJ story to see rising skepticism - even cynicism - among posters about non-profits and their missions.

Breast cancer advocacy doesn't need this.

Breast cancer advocates should be trying to explain the tradeoffs involved in mammography screening, the tradeoffs involved in treatment decisions, the ramifications of health care reform legislation and involving themselves in many other pressing matters.

Otherwise all parties run the risk of hearing the public tell them all to go fly a kite.

Only so much to say about this story.

It's about Senator David Vitter of Louisana.

He says that an FDA advisory committee's vote to revoke the approval of Roche-Genentech's Avastin for treating breast cancer is "essentially government rationing." The WSJ reports:


New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.


"I shudder at the thought of a government panel assigning a value to a day of a person's life," Vitter said in a statement. "It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough." In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee's vote appeared to be based on cost effectiveness, not safety issues.

"I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy," he wrote.

This is the same Senator who, as the WSJ reminds us, "slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn't be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency's website."

Summary:


• Scientists find no overall survival benefit and considerable side effects.


• Senator says the drug has proven track record of effective treatment and calls rejection "sickening...rationing."

Questions:

• Who knows better?

• Whose advice to trust?

(There, I've blogged about it without injecting my own opinion. Just the facts and some pertinent questions. Talk amongst yourselves. I'm verklempt.)

What's known about the characteristics of men being treated aggressively for prostate cancer? Up to now, not much. A study published in the Archives of Internal Medicine describes "the first large-scale US population-based study to document the risk profiles and treatment patterns among men with PSA levels of 4.0 ng/mL or lower who were diagnosed as having prostate cancer." Between 2004 and 2006, about 14 percent of prostate cancer diagnoses fell into this category. Such men are considered less likely to have more worrisome, high-grade cancer and more than half were classified as having low risk cancer.

But despite the lower risk, treatment rates for these men were comparable to those of men with PSA scores between 4.0 and 20.0 ng/mL.

The researchers wrote:

"The finding that men in low-risk groups were treated intensively raises the concern of overtreatment, especially among older patients."

It's interesting to now have some idea of how many men get conservative treatment - about 25 percent - receiving neither radical prostatectomy nor radiation therapy as their primary treatment. There wasn't good data on the use of hormone therapy.

The researchers conclude:

Recently publicized results from the European Randomized Study of Screening for Prostate Cancer show that 1410 men would need to be screened and 48 additional cases of prostate cancer would need to be treated to prevent 1 death from prostate cancer. Given that US patients are in general diagnosed at earlier stages and are more likely to receive attempted curative therapy, the number needed to treat to save 1 patient is likely to be higher in the United States than in Europe.
...
Based on the recent update of the Scandinavian Prostate Cancer Group Study Number 4 trial, men 65 years or older treated with RP fared no better than men undergoing conservative management. Our results demonstrate that 66% of men aged between 65 and 74 years with low-risk disease and a PSA value of 4.0 ng/mL or lower received either radical prostatectomy or radiation therapy. These findings suggest that many contemporary men receiving treatment for localized prostate cancer are unlikely to benefit from the intervention. Furthermore, it has been documented that men who receive any treatment have increased risk of treatment-related adverse effects.Therefore, it is critical that patients be counseled about treatment-associated adverse effects and benefits when they are deciding about therapy.


The number of men with "abnormal" PSA levels would double to approximately 6 million if the threshold were decreased from 4.0 to 2.5 ng/mL. Estimates suggest that 32% of men with abnormal PSA levels would be diagnosed as having prostate cancer from their needle biopsy. Based on the results in the present study, 82.5% of these 1.9 million men would receive attempted curative treatments, while only 2.4% would have high-grade cancer. However, no evidence suggests that delaying biopsy until the PSA level reaches 4.0 ng/mL would result in an excessive number of potentially noncurable disease cases. Although abandoning an upper limit of normal for PSA level would allow physicians to detect more cancer, the benefits of diagnosing prostate cancer would likely be offset by treatment complications related to cancers that might never have caused harm.

Our study found that aggressive local therapy was provided to most patients diagnosed as having prostate cancer. These results underscore the fact that PSA level, the current biomarker, is not a sufficient basis for treatment decisions. Without the ability to distinguish indolent from aggressive cancers, lowering the biopsy threshold might increase the risk of overdiagnosis and overtreatment.


Here's a Reuters summary of the article.


WebMD's is here.

Katie Hobson on the WSJ Health Blog offered good perspective.

Excellent story by New York Times on DCIS

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I've spoken and written about the imbalance in the news coverage about the U.S. Preventive Service Task Force's new guidelines on mammography last November.

If stories and communications are going to use anecdotes, then for every anecdote about a woman who claims her life was saved by a mammogram in her 40s (something that can't be proven), there should be a countering anecdote with a woman who had a mammogram in her 40s and got a diagnosis of DCIS or ductal carcinoma in situ.

Well the New York Times nailed that story this week, under the headline, "Prone to Error: Earliest Steps to Find Cancer."

I'll only offer the link and will post only this one excerpt:

"Diagnosing D.C.I.S. "is a 30-year history of confusion, differences of opinion and under- and overtreatment."

Everyone should read this story in its entirety.

It covers what was missing too often in the discussion about mammography screening last November. There are tradeoffs of harms and benefits. There is a need for fully informed shared decision-making in the face of this diagnosis. This story makes that clear. Much of our public discussion has not.

Overseas overstatement of "breast cancer breakthrough"

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We don't always comment on medical research news from overseas. But when we know it might impact US news coverage and news consumers - as when the New York Times drooled over a French artificial heart last week or when the New York Daily News would lead you to believe a cancer cure is right down the pike - then we write about it.

New case in point: A story in The Herald of Scotland headlined, "Breast Cancer Breakthrough." Excerpt:

"The researchers at Edinburgh University have established that a specific gene plays a key role in causing the spread of an aggressive form of the disease. Dr Elad Katz, who led the study, said that in test-tube experiments they had already managed to halt the spread of tumour cells by targeting drugs at the gene."

OK, it's clear that it's very early interesting research. The story goes on with a researcher's quote:

"We are at an early stage, but there is now a real possibility there could be a new treatment for women with HER2 positive breast cancer."

Hmm. That's letting him get away with a bit of leap. Yes, there's that possibility. There's also the huge possibility that there would NOT be a new treatment. But let's go on.

"Drugs that can potentially kill ¬cancer cells that rely on C35 are already in development. They do this by disabling a protein associated with the gene, which stops it from working.
Katz explained: "The real potential here is not to replace Herceptin, but the fact we can improve on it."

Semantics is important. It's not a FACT that they can improve on Herceptin until they, in fact, have done so. Back to the story:

"Professor David Harrison, director of the Breakthrough Breast Cancer Research Unit, said: "It is exciting to know there is a drug out there which could potentially stop this ¬process happening and save the lives of women with breast cancer.
"We now need to do more work in the lab to prove this ¬concept before we can start patient trials." "

Well, there isn't a drug "out there" yet. But thanks for the reminder that human trials have not yet begun. Perhaps a bit early to tell a general audience that there's been a breakthrough.

I know that many people just dismiss the New York Daily News, but you can't dismiss the number of readers it has and the potential impact its stories may have on them - especially an unconscionable piece like one published today, headlined, "Shot that stops many deadly forms of cancer may be ready in 5 years."

Continuing a bad trend of just republishing things from the London Daily Mail without adding any new reporting or vetting, the Daily News reports:

"A tumor-busting, life-saving injection may be ready for prime time in about five years.


The vaccine, effective against deadly cancers in areas of the body like the breast, bowel and cervix, is being tested on some patients, according to the Daily Mail.
...
The shot shrinks the tumors and stops them from spreading.
...
The vaccine, now being tested on 60 bladder cancer patients, has been used on animals with "extremely good" results, according to the Daily Mail."

No details on evidence so far, except that there were supposedly "extremely good" results in animals.

No perspective from an independent expert.

Apparently no concern for the harm that might be done to anxious cancer patients and their families.

Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, blogs about the question, "Can You Really Measure The Quality Of Cancer Care?"

Dr. Len concludes:

"...emphasizing that just because someone says one place is better than another, or one doctor is better than another it is important to keep in mind what information stands behind those statements, and how much transparency there is in the methods and the meaning of what they say. If "quality" it is based on lower costs alone, then that frequently is a non-starter since spending more or less money is not necessarily associated with "quality outcomes."


Ultimately-in my personal opinion--it is spending money appropriately and wisely that is the key to success in cancer treatment. How we measure that accurately and consistently continues to be a significant problem. The good news-as mentioned above-is many of us are aware of that and are trying to do something about it.

We can't let perfection be the enemy of the good, but as I have maintained for years, it would be terrific if the medical profession stood up and took charge of this issue, offered transparency into what they do and how they do it, and accept that we have a responsibility to our patients to hold ourselves accountable in some reasonable way to offer the assurances the care we provide our patients meets some fundamental measure of quality care. I believe our patients are entitled to no less. We need to measure and demonstrate our commitment to our mission and our patients' expectations. Just saying we give quality medical care does not make it so.

In the meantime, we will have to settle for whatever quality measures someone offers-even if they aren't necessarily the quality measures that really define the quality of care we offer or receive. A little transparency into the process would go a long way in providing insight into the accuracy of the data and the assumptions that are made based on that data.

Just saying you measure quality cancer care does not necessarily make it so."

He's reacting to one of my blog posts from last week that was based on a commentary by former US Senator David Durenberger that was based on a story by Jeremy Olson of the St. Paul Pioneer Press.

Nice communication chain of events; let's keep the discussion going.

On the Forbes blog this week:

"Dendreon shares are down today on the heels of news that the Centers for Medicare and Medicaid Services (CMS) will undergo a lengthy review of whether or not Provenge "is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act" and should be reimbursed by Medicare.

Most analysts believe that Medicare will ultimately agree to pay for Provenge, because it's FDA-approved, and it was shown to extend survival by 4 months in clinical trials."

Meantime the UK's Telegraph reports:


Kidney cancer patients denied drug that can extend their lives


Kidney cancer patients will not be allowed a new drug that could extend their lives by up to three months because it is too expensive, the NHS drug rationing body has said.

Four months added survival for one drug - and questions are raised about why the U.S. is even reviewing the drug.

Three months added survival for another drug - and the British National Institute for health and Clinical Excellence says the drug does not offer enough benefit to patients to justify the cost.

I wish we'd see more comparisons like this in American journalism. Both headlines - both stories - were right out there for anyone to see this week. The irony was unavoidable.

CBS' Dr. Jennifer Ashton started with the numbers: Pancreatic cancer kills three-quarters of the people diagnosed with it within a year, and 95 percent within five years. But then she stopped. In discussing a clinical trial at Johns Hopkins that is testing a new immune therapy, she gave absolutely no data on what's been seen so far: nothing on how many people tested, for how long, with what results, with what side effects. Nothing. Just gee whiz. And one positive personal anecdote, for which viewers are given no basis to know if it's a representative story of what's been seen so far or not.

Pancreatic cancer is an awful disease. But if this is going to be the standard for what gets reported - and how - viewers are not going to learn very much about the true progress and pitfalls of research.


The New York Times had an important story that "highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. ...Those with the most to lose are the hundreds of thousands of people who receive an orthopedic device each year."

The Wall Street Journal Health Blog wrote that "The FDA is proposing new rules on consumer prescription drug ads aimed at making the information about side effects more understandable. (Off the top of our heads, we'd just suggest they slooooooowwww down when discussing all the rare, but often-horrific sounding side effects of a given medication.)... The comment period ends Monday (June 28)."

Blogger Brian Reid offered one more important followup about news coverage of the big American Society of Clinical Oncology meeting earlier this month. In so doing, he referenced George Carlin's 7 words, as I've been known to do. Excerpt:

"But during the meeting, the national media -- the New York Times, the Wall Street Journal, USA Today, the broadcast networks and the Associated Press -- wrote on only seven studies, a tiny snippet of what was presented. These seven stories, in turn, were pulled from the small number of studies promoted by the ASCO communications department with press briefings."

And, if you missed it, the New York Times reported that the University of Michigan did what its Big 10 counterpart Minnesota couldn't:

"In the latest effort to break up the often cozy relationship between doctors and the medical industry, the University of Michigan Medical School has become the first to decide that it will no longer take any money from drug and device makers to pay for coursework doctors need to renew their medical licenses."

A committee (on which I served) recommended to the Minnesota med school that it eliminate corporate funding of CME within 5 years, but that recommendation was rejected by the administration. Score one big one for the Wolverines over the gutless Gophers on this one.

Headlines every day in the New York Daily News are luring men in as part of a mass prostate cancer screening campaign which the American Cancer Society not only does not endorse - its chief medical officer recommends against. Yet the paper brags that it is beginning its second decade of this non-evidence-based campaign. Sample headlines:


• Doctors urge New York men to take advantage of free, city-wide PSA testing


• What you don't know can kill you. Get a FREE prostate cancer test. It can save your life

• Bring dad in for FREE prostate cancer test across the city on Father's Day

and

• Don't skip the PSA test! My prostate cancer is treatable because simple test caught it early (written by a Daily News staffer).

Meantime, as I wrote one year ago when the Daily News promoted this campaign:

Either the paper doesn't realize or doesn't care that:


* The American Cancer Society does not support routine testing for prostate cancer at this time and specifically recommends AGAINST such mass screenings.

* The US Preventive Services Task Force and the American Academy of Family Physicians state that "Current evidence is insufficient to assess the balance of benefits and harms of screening for prostate cancer in men younger than age 75 years."

* No major group - except urologists - recommends starting screening as early as this newspaper does - starting at age 40. And that urology group's thinking is the source of major controversy.

That's a huge public responsibility for a newspaper to take on - especially when it conflicts with medical evidence.

Before being screened, what did the newspaper inform men about the tradeoff of harms and benefits? On the American Cancer Society website, its president, Dr. Otis Brawley says:

"There are some proven harms associated with screening. Screening, for example, leads to unnecessary treatment in some men who are diagnosed with localized disease.


It is difficult to comprehend, but there are prostate cancers that are confined to the prostate and never destined to metastasize (spread to other parts of the body). Screening diagnoses a large number of men who would never be bothered by the disease. In one clinical trial, more than 12% of average risk men were diagnosed through screening over 7 years. This group of men is estimated to have a lifetime risk of death of less than 4%. This study suggests that 2 out every 3 men in this study did not need to be diagnosed nor treated. While this study suggests that the proportion of men in the overall population who are diagnosed with cancers that do not need therapy is as high as 67% of men with localized disease, others estimate it to be as low as 30%. We have very poor ways of predicting who needs treatment because their prostate cancer might kill them, and who does not need therapy because their tumor is of no threat to them."

It's not just a simple blood test, as it is so often promoted. That's why Dr. Brawley says:
"Many health care provider organizations and many well-meaning community groups encourage prostate cancer screening and offer mass screening at health fairs and other activities. The American Cancer Society is concerned that so many do not understand that the benefits of screening are still undetermined. The ACS recommends against such mass screening activities because one cannot be assured that the patient has the opportunity to hear a balanced explanation of screening in an environment in which he can feel comfortable to ask questions and make an informed decision."

Even more to the point of the newspaper's promotion and advertising of this mass screening, Brawley wrote in an editorial in the Journal of the National Cancer Institute:

"I heard a radio commercial that brings perspective to the issue. A local celebrity was promoting prostate cancer awareness. He said, "Prostate cancer is 100% curable when caught early." He encouraged all men to get screened and announced that a van was touring the area offering screening in supermarket parking lots. This was a community service project sponsored by the radio station, the supermarket chain, and a radiation oncology practice.


A commercial like this plays to our fears and prejudices. ...

Prostate cancer screening has resulted in substantial overdiagnosis and in unnecessary treatment. It may have saved relatively few lives. ... The benefits of prostate cancer screening are still open to question. This means that informed or shared decision making should be done using the data now available before screening is performed. Some of the confusion of prostate cancer screening can be avoided if we all clearly label what we know, as what we know; what we do not know, as what we do not know; and what we believe, as what we believe. Of course, one must not confuse what is believed with what is known to do this."


A German physician wrote me about this - so, while CNN may have an international reach, it's not always with an adoring audience.

The physician was reacting to the weekend "Paging Dr. Gupta" program, which Dr. Gupta referred to once as "SG, MD." The first thing that struck me was his introduction, in which he said:

"I'm your doctor. I'm also your coach."

Later in the program he said,

"Think of this as your appointment. No waiting. No insurance necessary."

I find this very troubling. He's not my doctor. He's not my coach. When I watch a "news" program, it's not my medical appointment. It's supposed to be news. Not medical advice.

But that's not what the German physician wrote to me about, so I kept watching. (The segment in question appears about 5:30 deep, and after the :30 commercial you must watch to get there.)

Gupta reacted to a viewer's message on Twitter in which the tweep asked, "Does anyone know a "miracle" treatment for ovarian cancer?"

Gupta's answer began cautiously with a note about the word "miracle," but he then transitioned into a description of a study described at the American Society of Clinical Oncology meeting last week about treatment of advanced ovarian cancer. Gupta said the results showed that adding the drug Avastin to standard chemotherapy "can slow the spread of this cancer pretty dramatically." He also said that, "Cancer experts believe these results could change how doctors treat women with advanced ovarian cancer."

Dramatically?

Cancer experts believe this could change practice? Which cancer experts?

Not Dr. Len Lichtenfeld, who's just across town from Gupta at the American Cancer Society, and who wrote about that same study, "Is It Right To Hype Ovarian Cancer Study?":

"What appeared to be a very positive study in an abstract may not have been so positive after all.

Patients, families and their physicians are now under the impression that a new advance has been made in this deadly disease, when that may not be the case. The positive press releases and news conferences were not balanced. Most of the media ignored the expert who raised legitimate concerns and cautions. But that information was only available to those who waited for the study to be presented and were in the audience at the time.

Hopes have been falsely raised, when some caution is needed and appropriate."

Lichtenfeld also pointed out the careful and cautious comments from a Canadian oncologist Dr. Elizabeth Eisenhauer:

"Given the cost issues, the side effect issues, and the unanswerable question as to why bevacizumab appeared to be beneficial as part of a maintenance program but not as a primary treatment, Dr. Eisenhauer concluded that more work needs to be done before this regimen can be considered as a standard treatment option for women with advanced ovarian cancer."

Lichtenfeld himself concluded:

"...many experts and treating oncologists are going to be scratching their heads wondering what to do and whether or not to believe the results of the abstract, if they even know about the concerns such as those raised by Dr. Eisenhauer. More importantly, patients, families and friends are going to be wondering how a study that received such a positive response in the press could possibly not be the hope they had been waiting for, and had learned about through the media reports."

Perhaps the news wasn't as dramatic as Gupta announced, nor does it sound like cancer experts are poised to change their treatment immediately based on this abstract presented at a meeting. And it wasn't just Lichtenfeld and Eisenhauer. I've already blogged about a Forbes piece that reported:

"Memorial Sloan-Kettering colon cancer specialist Leonard Saltz says that ...new drugs like Avastin and Erbitux "have added very modest benefits. They increase survival a few months, but they increase the cost of care tremendously."
...
...researchers revealed that ovarian cancer patients who got Roche's Avastin in addition to standard chemo lived 14 months before their tumors progressed, vs. 10 months for those who got standard therapy.

But to get this modest improvement, patients had to remain on the Avastin drug for 15 months, adding to the potential expense, hassle and side effects. So far, there is no statistically significant survival difference between the two groups; because most patients are alive it may be too early to measure this. "We may never know" whether it extends survival, admits lead researcher Robert Burger of the Fox Chase Cancer Center."

This is balance. This is perspective. This is analysis. Not what we got from a TV MD-journalist telling you he's your doctor and your coach.

Addendum: See science writer Paul Raeburn's analysis on this same topic on the Knight Science Journalism Tracker.

Another in the excellent Associated Press "overtreatment" series. Excerpt:

"Americans get the most medical radiation in the world, even more than folks in other rich countries. The U.S. accounts for half of the most advanced procedures that use radiation, and the average American's dose has grown sixfold over the last couple of decades.


Too much radiation raises the risk of cancer. That risk is growing because people in everyday situations are getting imaging tests far too often. Like the New Hampshire teen who was about to get a CT scan to check for kidney stones until a radiologist, Dr. Steven Birnbaum, discovered he'd already had 14 of these powerful X-rays for previous episodes. Adding up the total dose, "I was horrified" at the cancer risk it posed, Birnbaum said."

Dr. Len Lichtenfeld of the American Cancer Society joins his colleague, Dr. Otis Brawley, in writing about his concerns about news coverage of the big American Society of Clinical Oncology meeting. Lichtenfeld cites a specific example, and drills down in more detail:
lichtenfeld_len.gif

"Most of the media hypes the study which demonstrated improvement in treatment of advanced ovarian cancer with a targeted therapy drug and ignore the concerns. What appeared to be a very positive study in an abstract may not have been so positive after all.


Patients, families and their physicians are now under the impression that a new advance has been made in this deadly disease, when that may not be the case. The positive press releases and news conferences were not balanced. Most of the media ignored the expert who raised legitimate concerns and cautions. But that information was only available to those who waited for the study to be presented and were in the audience at the time.

Hopes have been falsely raised, when some caution is needed and appropriate.
...
More importantly, patients, families and friends are going to be wondering how a study that received such a positive response in the press could possibly not be the hope they had been waiting for, and had learned about through the media reports.

Sometimes, it all comes down to getting the right understanding of what a research study really says and how that relates to its true impact. And sometimes it's the story behind the story that you don't see addressed in enthusiastic media reports, as is the case with this particular trial.

My sense of this particular trial is "stay tuned." There is surely going to be more discussion of this study in the months and years ahead.

And always remember that hope sells. Tempered hope doesn't. Failure of hope rarely gets reported. That would be (unfortunately) too brutally honest.

Sometimes, it is as simple as that."

It is so important that these ACS officials are speaking up and writing about these issues. For many years, you would not have heard such comments from anyone at the ACS. But Brawley and Lichtenfeld are seeing things through the same prism that we see things through every day in our review of health news coverage - some excellent, but far too many unacceptably naive, fawning, cheerleading "churnalism" that may do more harm than good.

That's what news organizations need to grasp: there can be harm caused by superficial reporting - as both Brawley and Lichtenfeld adroitly point out.

Dr. Otis Brawley, chief medical officer of the American Cancer Society, in a column headlined, "Bad medical writing hurts public health," reflects on this week's news coverage from the American Society of Clinical Oncology.

He says such major medical meetings "have more and more become venues for drug companies and medical device manufacturers to tell physicians about their drugs and medical hardware. Today, much of the presented research is sponsored by industry, and these medical meetings are increasingly an opportunity for companies to make a name for themselves by promoting their products."

More from Brawley:

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"Successful promotion of positive findings through meeting abstracts and press releases can double or triple a small company's share price. But observers note a troubling trend. It is a shame that the desire to pump up a stock price often leads to over-promotion and exaggeration of paltry scientific findings.
...
Reporters must understand that the motivation of every scientific report must be questioned as part of routine due diligence. The caveats from each report must also be clearly detailed in each story. From where I sit, all too often, that is not happening.

This combination of scientists and businessmen enthusiastically promoting products or themselves with sales pitches, and inexperienced reporters struggling to make sense of their claims, has led to some unfortunate articles.

I was motivated to write this after reading articles in reputable newspapers in the United States and Europe that a cure for breast cancer was on the horizon and a blood test was coming to market that could detect lung cancer early and save lives.

Truth be told, a lab cured breast cancer in six mice. But translating these findings to humans is difficult, and experience has taught us that it likely will never happen. Some of these articles also failed to say that this is a very early piece of scientific progress at best -- and may not even be progress.

As for the blood tests, I have read reports of some that are somewhat effective in finding lung cancer. But the articles failed to point out that any test will require years of more development to determine whether it's useful. They also failed to report that the study showed that the test was no more accurate than X-rays, which are not recommended by any major medical organization.

Unfortunately, by the time measured voices put these stories into perspective, the media have moved on to a new story. The end result of all this is very harmful. The nonscientific public gets misled, and some of those folks who have an interest in a specific disease get their hopes up, only to be disappointed."

This was an opinion column on CNN.com. It's interesting to note a couple of comments left by readers:


• "Anyone else find it ironic that the example this man uses of bad medical writing (cancer cures found in mice) can be found on CNN?"


• "Very very very good article. Unfortunately CNN is plagued with poor medical reporters who misrepresent published articles and fail to explain the full extent of the findings, methodology, and limitations."

How much cancer treatment progress, and at what cost?

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On the NPR Health Blog, Scott Hensley reflects on news out of this week's American Society of Clinical Oncology meeting. Excerpts:

"The American Society of Clinical Oncology confab is the place to present the latest research on cancer treatments. But if you're hoping for breakthroughs, this doesn't look like the best year to attend.
...
But cancer keeps turning out to be more complex, as researchers tease apart the genetic characteristics that distinguish one variety from another. The differences make it hard to come with drugs that will help lots of people.


"Cancer is like cable television," Dr. George Sledge, a breast cancer specialist and ASCO president, told the Wall Street Journal. "Thirty years ago you had three channels. Now you have 500." "

He links to another good piece by Forbes' Robert Langreth on disappointments outweighing victories. Excerpts:

"The paucity of successful trials raises serious questions about whether big drug companies, in their efforts to replenish their empty pipelines, may be rushing too fast to push their targeted cancer drugs into large-scale trials before they understand the biology enough. It suggests that the success rate for novel cancer drugs remains dismal despite the big advances in basic science.
...
Memorial Sloan-Kettering colon cancer specialist Leonard Saltz says that despite all the hype and excitement about pricey new cancer drugs, in fact, by far the most important colon cancer drug remains a 50-year-old chemotherapy drug called 5-FU. No one has been able to find a better drug to replace it. "It is humbling and embarrassing," he admits. New drugs like Avastin and Erbitux "have added very modest benefits. They increase survival a few months, but they increase the cost of care tremendously."


In some cases, researchers don't know whether tremendously expensive new drugs keep people alive longer. In one of the big studies presented Sunday at the meeting, researchers revealed that ovarian cancer patients who got Roche's Avastin in addition to standard chemo lived 14 months before their tumors progressed, vs. 10 months for those who got standard therapy.

But to get this modest improvement, patients had to remain on the Avastin drug for 15 months, adding to the potential expense, hassle and side effects. So far, there is no statistically significant survival difference between the two groups; because most patients are alive it may be too early to measure this. "We may never know" whether it extends survival, admits lead researcher Robert Burger of the Fox Chase Cancer Center."

And, according to the New York Times, Avastin's cost - around $72,000 to slow the growth of ovarian tumors by about four months - raises questions:

"Many would not consider this cost effective for the gain seen," said Dr Elizabeth A. Eisenhauer of Canada's National Cancer Institute, in the Times.

Over the next few days, news readers/viewers/listeners will be bombarded with news from the big American Society of Clinical Oncology conference in Chicago. But how does some of this stuff become news? Read an excellent post by an excellent reporter, Ron Winslow of the Wall Street Journal, to see some of the crazy, ugly sausage-making that goes on in the manipulation of the media.

In the example Winslow raises, as is often the case, what may be packaged as news isn't really new.

There has been so much hype of proton beam therapy - especially for prostate cancer - much of it dismissing any discussion of lack of evidence and soaring costs. Given that backdrop, it was refreshing to see a Sanjay Gupta piece on CBS last night that exercised some restraint in reporting on proton beam therapy for pediatric brain tumors.

Strong points:

• CBS had one sound bite with an independent expert stressing the need for evidence, especially given the approach's high cost.
• The high cost was emphasized three times in the piece - $100,000 per treatment.
• It was emphasized that it may take a decade to have sufficient evidence.

Weaker points:

• Gupta showed off the technology's "gantry, cyclotron and snout" but this was just high-tech gobbledygook that wasn't necessary. Rather, he could have mentioned the $125-225 million investment medical centers must make in such technology.
• Too much emphasis and time on the little girl's "cuteness." Is it less of a story if she weren't "cute"?

Nonetheless, I somehow feel the hand of CBS producers in the restraint and context in this piece, especially when Katie Couric followed up by asking Gupta, "As exciting as this is, it's very new and very expensive, right?"




Here we go again.

The big annual conference of the American Society of Clinical Oncology meeting is still weeks away. But last week ASCO held a news briefing in which it selected six out of more than 4,000 abstracts posted online in advance of the meeting.

6 out of 40,000.

Predictably, journalists started reporting on those posted abstracts and especially on the ones highlighted in the briefing, even though:

• they haven't been peer reviewed

• it's difficult to get informed second opinions from other experts when the full data haven't been presented, much less published
• the abstract may reflect unfiltered optimism for an unvetted claim.

One ASCO headline was entitled, "Promising New Ovarian Cancer Screening Strategy" building on the CA-125 blood test.

The Houston Chronicle (whose story was reviewed by us) at least injected one note of caution from the American Cancer Society's Dr. Len Lichtenfeld, who said, "More research and refining needs to be done before it should be implemented. I can remember when doctors all rushed to adopt the Prostate Specific Antigen test, and we still don't know how to use it."

And on his own blog, Dr. Len wrote:

"Before we get too excited, let's take a step back and realize that we still have a long way to go before we have an effective screening test for the early detection of ovarian cancer in women at average risk. More studies need to be done, and in fact the authors of the current report stress that they plan to move forward with those studies, including examining other tumor markers to see if they help improve the results of the current program.


We have a tendency in this country to hear news about "new science" and believe that it provides all of the answers. We tend to discount the limitations of our science and knowledge, especially when it comes to making a devastating cancer curable. Such has been the case with prostate cancer over the past 20+ years, where it has taken us that long to find out that the PSA test--although it may prevent deaths from prostate cancer--may not be as perfect as we once thought.

Let's not make the same mistake with ovarian cancer. Is there reason to be encouraged? Absolutely. But there is still a long road to travel before we validate the concept that CA-125 is in fact the answer to our prayers for the early detection of this devastating disease."

That didn't stop Bloomberg news from posting a story under this headline: "Blood Test for Early Ovarian Cancer May Be Recommended for All."

And there was a lot of other hyperbole in other stories by other news organizations.

Once again, some journalists seem to fall in love with screening stories - evidence be damned.

US Senator David Vitter (R-LA) wrote to HHS Secretary Kathleen Sebelius last week requesting that she have the Agency for Healthcare Research and Quality remove from its website last Fall's breast cancer screening recommendations from the US Preventive Services Task Force. Vitter writes:

"The recommendations were ill-conceived from the start - developed via a process without transparency, without input from those with experience and expertise in the field, and without due regard for the thousands of lives that could be impacted by the recommendation. They represent a step backward in our fight against a horrible disease and the taxpayers' dollar must not be spent in further promotion of them."

He could not be more wrong.

Vitter is a politician, not an evidence-based medical researcher, but he should know that the USPSTF process is perhaps the most transparent of any organization that publishes recommendations or guidelines. In fact, on the very website Vitter wants taken down, are html and pdf files of the complete recommendation, a supporting article, an evidence update article, an evidence synthesis and a clinical summary.

Government should be so transparent. USPSTF is widely praised for how completely it documents how it arrives at the recommendations it makes.

Strike one, Senator.

He says the recommendations were made "without input from those with experience and expertise in the field." Has he checked the qualifications of the USPSTF members? Is he making the ridiculous claim that only an oncologist or a radiologist can judge evidence?

Strike two, Senator.

He claims that the recommendations were made "without due regard for the thousands of lives that could be impacted by the recommendation." Is that why the punch line of the published recommendations reads: "The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms."? Where is the lack of regard for the individual in that statement?

Strike three, Senator.

As he heads back to the dugout to dream up more rhetoric, he may want to stop over at the meeting of the National Breast Cancer Coalition which meets in DC this weekend. That smart bunch of evidence-based breast cancer advocates doesn't agree with him at all. On their website they state:

NBCC continues to conclude that there is no statistically significant evidence that screening women age 40-49 years reduces mortality, and no strong evidence that it does so in women over 50 years.

Women need honest information regarding the value of all medical interventions. Public health resources need to be used with certainty to improve the public's health. The reality is that screening has not been effective. While the incidence of ductal carcinoma in situ and localized invasive breast cancer increased substantially as a result of screening programs, the incidence of regional or distant stage disease declined only slightly. There may be several reasons for this, but primarily it is because screening increases the detection of non-threatening cancers, while missing the most aggressive cancers.

NBCC continues to affirm the position we have taken for over a decade. Women should make a personal decision about whether to undergo screening mammography after weighing the risks and benefits.

But maybe Senator Vitter thinks these women don't know anything about breast cancer, either.

Liz Szabo fits several important reminders into her story about the FDA's approval of Provenge for prostate cancer. For example:

• Benefits: the vaccine helped men with advanced prostate cancer live four months longer than men given placebo shots.

• Harms: one in four Provenge patients had a serious side effect, with 3.5% suffering a stroke, compared to 2.6% of those on placebo.

• Uncertainties: "doctors still have many questions about the vaccine"

• Cost: "A February analysis by J.P. Morgan estimates that Provenge could cost closer to $70,000 to $100,000 ... That could put the drug out of reach even for patients with insurance, as some plans require patients to pay 20% of their medication costs."

There is no question this is a significant advance in introducing a new method of targeted cancer therapy, but some of the stories we've seen are caught up in hyperbolic language like "breakthrough" and "landmark. " More stories should emphasize the life-extending benefit of four months at a time when Szabo reminds us:

'A growing number of health economists and patient advocates have expressed concern about the skyrocketing cost of cancer drugs. Many health plans are raising out-of-pocket costs to help cover these expenses, research shows."


Good story in a collaboration between Kaiser Health News and the Washington Post.


Overdiagnosis in cancer & role of shared decision-making

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Gil Welch and Bill Black of Dartmouth address cancer overdiagnosis in a new review article in the Journal of the National Cancer Institute. Excerpt from the abstract:

"We estimated the magnitude of overdiagnosis from randomized trials: about 25% of mammographically detected breast cancers, 50% of chest x-ray and/or sputum-detected lung cancers, and 60% of prostate-specific antigen-detected prostate cancers. We also review data from observational studies and population-based cancer statistics suggesting overdiagnosis in computed tomography-detected lung cancer, neuroblastoma, thyroid cancer, melanoma, and kidney cancer. To address the problem, patients must be adequately informed of the nature and the magnitude of the trade-off involved with early cancer detection."

In any talk I give to journalists, I encourage them to look into the proliferation of proton beam facilities for cancer therapy. Few have done so with any zeal.

The New York Times did a good job.

The Columbus Dispatch did not.

Journalist Merrill Goozner gives ample food for thought in an article in the Journal of the National Cancer Institute, "The Proton Beam Debate: Are Facilities Outstripping the Evidence?" (subscription required for full access). Excerpt:

"A recent report from the Agency for Healthcare Research and Quality (AHRQ) found no evidence to support claims that cancer patients undergoing pricey proton beam radiation therapy (PRT) achieve better outcomes or experience fewer side effects than patients receiving traditional photon radiation.


In the report's wake, proton therapy practitioners are pushing for the first trial comparing the two approaches for prostate cancer, which is the fastest growing use of PRT. The hope for PRT is that it will cause less collateral damage to surrounding nerves and tissue than intensity-modulated radiation therapy (IMRT), the most advanced form of traditional photon radiation.

"It hasn't proven itself to be superior," said Anthony L. Zietman, M.D., professor of radiation oncology at Harvard Medical School in Boston, whose affiliated Massachusetts General Hospital runs one of seven operating proton beam cancer treatment centers in the U.S. "We've applied for a comparative-effectiveness grant to do a head-to-head trial with IMRT with the same radiation dose," he said. The primary endpoint is quality of life.

Even if funded, it will be years before the results of such a trial are known. With dozens of facilities already built or in development worldwide, use of the technology and the controversy surrounding it are bound to grow. In the U.S., where at least three new $100 million-plus proton beam facilities are either under construction or in the planning stage, the costly treatment could dramatically increase Medicare spending on prostate cancer care alone."


We just don't see many stories that profile someone who declines aggressive treatment for prostate cancer and chooses watchful waiting - or active surveillance - instead.

But that's what Judith Graham of the Chicago Tribune delivered yesterday, explaining that:

"...for the first time it's being endorsed for large numbers of men by a major medical organization: the National Comprehensive Cancer Network, an alliance of 21 leading cancer centers across the U.S.


In new guidelines, NCCN recommends active surveillance for men deemed to have "very low risk" prostate cancer and a life expectancy of less than 20 years. Also, the organization recommends the strategy if a man's prostate cancer is considered "low risk" and his life expectancy is less than 10 years."


There's been surprisingly little coverage of an analysis by the Nordic Cochrane group in this week's BMJ that concludes:

"We were unable to find an effect of the Danish screening programme on breast cancer mortality. The reductions in breast cancer mortality we observed in screening regions were similar or less than those in non-screened areas and in age groups too young to benefit from screening, and are more likely explained by changes in risk factors and improved treatment than by screening mammography."

Of the stories I could find, Andre Picard of The Globe and Mail had one of the better reports, including a quote from one of the researchers:

"We have to start asking unpleasant questions about mammography screening."

Kaiser takes blood stool test kit campaign to YouTube

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Dr. T.R. Levin, a gastroenterologist at Kaiser Permanente Medical Center in Walnut, Creek, California, has a YouTube video on Kaiser's widespread use of blood stool test kits for colon cancer screening. Click here to see the video.


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