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Dr. Len's Cancer Blog

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Why Is New York Using Public Money To Support Unproven And Possibly Unethical Screening For Brain Tumors?

by Dr. Len March 04, 2011

Sometimes you see a story that is just too important to pass up--even if the comments I make here are going to get some New York politicians upset with me and possibly with the American Cancer Society.

 

But when you see something that defies logic and evidence, and involves millions of dollars that could be put to much better and more effective use, then I believe we have the responsibility to say something, even if it is at our peril.

 

The story is about New York City subsidizing "screening MRI brain scans" to detect brain cancer early as reported in yesterday's New York Times.  And my opinion and that of others is that at the least New York is wasting the taxpayers' money and at worst is promoting an unethical and experimental procedure to its citizens.

 

Here are the basics:

 

The City Council of New York has been subsidizing a truck loaded with an MRI machine that goes around the city from borough to borough offering MRI scans to detect brain cancer "early" and nominally save lives.

 

And here is the evidence:

 

There are no published studies that would support the value of these scans, much less evidence that they meaningfully reduce the risk of death from brain cancer. In short--absent a well-done research program (which I believe would fail anyway as noted below) the city is throwing millions of dollars down the drain--millions of dollars which if properly spent COULD save lives through the early detection of cancers.

 

And the sad part is that New York has--for other cancers, such as colorectal cancer--supported such effective screening programs for those with limited access to health care. This brain tumor scanning thing is simply not one of those programs, and political pronouncements are not going to change the scientific reality that this is completely unproven and illogical.

 

In fact, my colleague Otis Brawley MD who is the American Cancer Society's chief medial officer and an expert on the ethical issues surrounding clinical trials (think Tuskeegee, for example), thinks that such screening should be considered experimental and that those offering such screening need to inform the patients that it is experimental.  And if it is experimental, that opens up a whole set of other issues, such as whether it needs to be approved by an institutional review board for the protection of human subjects since it is an unproven medical procedure and whether people receiving these scans should sign an informed consent.

 

Lethal brain cancers are not common. The American Cancer Society estimates that in 2010 there were 22020 cases of brain and spinal cord (central nervous system) cancers diagnosed in the United States, and 13140 deaths. Not rare, but not common.

 

There are several qualifications needed to demonstrate that routine screening of people at average risk of will be effective in reducing the disability and death from a certain type of cancer. Remember, we are talking about screening literally millions of people who have no symptoms for a specific cancer, then demonstrating that when we do that screening we are able to prove--hopefully through effectively designed, randomized trials--that such screening meaningfully reduces deaths from that cancer, and that it does so at a "cost," in false positives, harms of unnecessary treatment, etc., that makes it "worth" that cost. We have evidence that colonoscopy and mammography save lives at a reasonable tradeoff in false positives and other problems (although there is obviously some dispute about which groups of women benefit most), and most recently we had an early report that CT lung scanning can indeed reduce deaths from lung cancer, but we await more data about false positives and such

 

But the same cannot be said of most other cancers. We do not yet have effective screening tools that reduce deaths for some cancers that are often fatal, such as pancreatic and ovarian cancer. Included in that group, as well, are brain cancers.

 

Having a screening test for brain cancers might be helpful if we had evidence that such a test could be done at reasonable cost, be offered to millions of people, enabled lifesaving treatment with minimal adverse effects and basically avoided disability and saved lives. There is no such evidence that screening for brain cancer works when these principles are applied. And, we must consider the harms of treatment, especially those who may have a lesion diagnosed that was not causing them difficulty, may never have caused them difficulty, and whose treatment could bring with it the risk of significant disability.

 

Just having a machine that can perform a function doesn't mean that using that machine will improve someone's health. We have spent decades digging ourselves into a huge hole created with just such thinking, and now we are paying the bill. Instead of paying bills, we should be paying attention to medical evidence of what works and doesn't work in medical practice. Evidence-based medicine is finally taking hold because physicians have finally discovered the folly of "what I think" vs. "what we know."

 

In fact, when I first heard a number of years ago about a doctor in the New York area who was offering MRIs to reduce deaths from the most aggressive forms of brain cancers, I was astonished. But it wasn't a major issue for me, other than to use the example in my talks since then to point out the difference between proven, effective cancer screening and a test where people want to believe it might work but have no proof, while spending untold amounts of money and putting patients at untold risk without proving there is real benefit.

 

And now the city of New York is spending precious resources on a van that apparently stands useless much of the time. And a Council leader castigates anyone who disagrees, citing mammography as an example of something that doctors "laughed at" years ago as justification for this fiasco.

 

It is quite different enrolling women in a controlled clinical trial (which is what happened in New York at the beginning of the mammography era in the 1960's) and having a city backed van going around town offering unproven medical studies to thousands of people who get duped with the help of their government into thinking the van is offering a proven medical service.

 

So what do we do?

 

What we don't do is assume defensive postures and continue blasting away at people who devote their lives to understanding the prevention and early detection of cancer. We don't continue to support unproven--and potentially dangerous--medical technologies with a government endorsement.

 

And if we want to do some good, we figure out how to redirect that money into more appropriate medical uses, such as screening for cancers where we know early detection really does work. In this case, screening MRIs to detect brain cancer "early" simply isn't one of those cancers.

 

So, I plea with New York to spend the money where it is needed for things that work, whether it is food, shelter, parks or proven cancer screening. Just don't waste money on something that doesn't stand a reasonable test of medical effectiveness. It simply doesn't make you look good--or responsible as stewards of the public purse or the public's safety.  And if someone is injured as a result of this unproven screening, it could prove very costly as well.

Comments

3/7/2011 2:17:09 PM #

Patrick J Kelly MD FACS

Dear Len

I read with interest your recent blog regarding the use of Brain MRI in the early detection of brain tumors which is based on a recent article in the New York Times. Like many articles in the press, some of the information is true but incomplete.

Please read a recently published peer-reviewed editorial that contains my own experience and follow-up data on gliomas. It explains the entire concept and the logic of brain tumor early detection and what we are doing with the Brain Tumor Foundation:

www.surgicalneurologyint.com/article.asp

I hope that you have time to read it. That paper has been out for over two months. Because this journal is open access, anyone – anywhere in the world is able to comment. Over 1100 neurosurgeons and neurologists have accessed that paper. There has not been a single negative comment! If all the experts really believed that the early detection concept for brain tumor was wrong and “unethical” where are they? I would love to debate them.

I also presented this material and described the Brain Tumor Foundation’s early detection program at the May 2010 meeting of the American Association of Neurological Surgeons in Philadelphia. More than 2000 colleagues heard that presentation. There was not a single dissenting comment! In fact I had many colleagues come up to me afterwards to congratulate me.  

As you will see in the Surgical Neurology International article, I have spent a career trying to cure primary brain tumors with the most advanced surgical methods available as well as state-of-the-art adjuvant therapy. The overwhelmingly common outcome is that the patient almost always dies of his or her disease - perhaps a little latter in the course than would be expected from the natural history without treatment, it’s true, but still dead nevertheless.

How quickly these tumors kill patients is a function of the malignancy of the tumor when first diagnosed. Malignant tumors kill patients faster than less malignant tumors. However, in my experience most symptomatic low grade (“benign”) gliomas almost always become the malignant glioma that kills the patient – in spite of whatever therapy they receive.

We are making the diagnosis of brain glioma far too late for any therapy to be curative. By the time the patient presents with his or her first symptom, the vast majority of these tumors have isolated tumor cells far a-field of the primary tumor mass. Treatment then is palliative, gives the patient a few months or years of survival before the patient usually dies of the disease. It is like making the diagnosis of breast cancer after the tumor has spread to regional nodes the lung, liver and beyond, a colon cancer to liver, lung or brain or diagnosing prostate cancer after it has spread to the pelvis and skeletal system.

That’s why we have early detection programs for breast, colon and prostate cancer. What’s wrong with an early detection program for brain tumors? Find them early when they are small and easier and safer to treat. Find and treat them before they turn into the malignant tumors that will eventually kill the patient.  And unlike breast, prostate or lung cancers that metastasize to other organ systems, brain tumors very rarely metastasize outside of the central nervous system. Theoretically if there is any cancer that is potentially curable, it’s a brain tumor! These usually don’t metastasize outside of the central nervous system! Why is this concept so difficult for some to understand?

Because it has not been shown??? How will we ever know if the concept of early detection is valid for brain tumors if we don’t try it?

As an academic neurosurgeon who has operated on about 7300 brain tumors over a 35-year career, I can tell you that it is much easier and safer to operate on a small brain tumor than a big one. In addition, surgery to remove a small early tumor can be far less invasive than surgery for a large and biologically advanced tumor. In fact, there are non-invasive methods such as stereotactic radiosurgery that can be used to effectively treat small early tumors.

However, in my experience once brain gliomas start producing symptoms, they are almost always incurable (with a few rate but notable exceptions – pilocytic astrocytoma, for example). I believe that we may have a better chance at curing them if we were to find them before they become symptomatic.
  
I am aware that many groups are working on “genetic testing” as a possible way to detect early brain tumors (among other cancers). Nonetheless, we don’t have these methods available now.

But we do have MRI. An MRI can find very small tumors as well as other conditions that might be good for a person to know about – like aneurysms, various types of malformations and degenerative diseases that have not yet become symptomatic. But we’re talking about brain tumors here. What’s wrong with using MRI for early detection of brain tumors?

There are a number of details regarding selection and follow-up that may be too complicated to discuss here. However, if there are any readers, NIH employees or spokespeople from any other “Foundation” interested in brain tumors, who would like to discuss the merits and logic of early detection with me in an open forum, I would be happy to do so.

The key question is: should City money have been used to fund such a public health project?  Your readers should be aware that an NIH study that detailed the findings1000 MRI brain scans in normal volunteers was published in the July 1999 issue of the Journal of the American Medical Association. Among 165 abnormalities found in these “normal” volunteers were 3 early gliomas.  Well, 3 gliomas in 1000 individuals in a general healthy population may not seem like very many. But let’s multiply that number (3 in 1000) by the population of New York’ s five boroughs as per the 2009 census data.  These would indicate that there are 7700 undiagnosed brain tumors in Brooklyn, 6920 in Queens, 4191 in the Bronx, 1475 in Staten Island and 4887 in Manhattan. All together, 58,624 citizens theoretically harbor undiagnosed and potentially lethal gliomas in the city of New York! We know how many will become symptomatic in a single year (about 1500 in New York City’s greater metropolitan area). We do not know how many will become symptomatic in a lifetime.

How many of these supposed 58,624 New Yorkers will show growth and need treatment? Probably only a small percentage. The rest will require follow-up studies. We are not proposing to treat every abnormality we find – that would be like doing a coronary by-pass operation on everyone with high cholesterol and hypertension! Only persons having a glioma that meets certain criteria would be offered treatment. The rest would be followed with repeat MRI’s. If any of these show growth of the lesion, treatment would be advised.

In addition, it may be far less expensive to treat small low-grade gliomas by non-invasive radiosurgery or minimally-invasive image guided surgery than it would be to treat malignant, lethal tumors that require one or more extensive surgeries, radiation therapy and various types of chemotherapy for a total overall cost of between $450,000 - $1,000,000. The benefit of all this expense at present is to provide that patient with another 12 months or so of sometimes poor quality survival. Finding tumors earlier, when they will require less expensive treatment may ultimately be less costly for the city and society in general and may save lives.

Patrick J Kelly, MD FACS
Joseph P Ransohoff Professor and Chairman (Retired)
NYU School of Medicine

President and Founder
Brain Tumor Foundation
New York, NY


Patrick J Kelly MD FACS

3/7/2011 3:26:04 PM #

Len Lichtenfeld

Dr. Kelly, thank you for your post and providing your perspective on this issue.

Len Lichtenfeld

Len Lichtenfeld

3/7/2011 6:58:36 PM #

Patrick J Kelly MD FACS

Len, Thanks for at least acknowledging the post. If you read my perspective did it change your mind on this subject? If not, let's debate the issues on this forum.

You are a medical oncologist and I am a neurosurgeon who has seen a couple of thousand of my glioma patients with gliomas die in my 35 years in neurosurgery in spite of the best treatment available. In fact, Len, I have had a distinguished career in academic neurosurgery and am considered an authority on gliomas. But no one has ever before accused me of being unethical.

In my retirement,  am simply trying to shift the balance of inevitability in the patient's favor and, perhaps by early detection, possibly help cure some of these that would die otherwise. What's wrong with that? I'm certainly not making any money on this. In fact, I have supported this effort out of my own pocket because I believe in it.

If we can't use early detection until it's "proven", how are we ever going to prove its efficacy?

Patrick J Kelly MD FACS

Patrick J Kelly MD FACS

3/9/2011 1:53:53 AM #

Gregory D. Pawelski

Over at Gary Schwitzer's HealthNewsReview Blog, he posted about The New York Times article on this. He also pointed out that The Cancer Letter - which he feels is written by serious journalists that think about evidence, harms along with benefits, and costs - once reported on this mobile MRI: "The question is what is the best use of resources to deal with the brain tumor population? The incidence of brain tumors in a population per year is in the range of 6 to 10 per 100,000 population. So what you would have to do is perform MR scans on 100,000 people to find somewhere between 6 and 10 brain tumors, and of those 6 to 10, about half of those lesions would be benign. It wouldn’t seem to be a reasonable expenditure of resources.”

Gregory D. Pawelski

3/9/2011 5:17:13 AM #

Patrick J Kelly MD FACS

Gregory - Your incidence numbers are correct but you are totally missing the point. Your numbers refer to patients who become symptomatic and are diagnosed. And, excluding meningiomas, acoustic neurinomas and pituitary lesions,  the vast majority of these (gliomas) are incurable once diagnosed. And low grade "benign" gliomas become the high grade gliomas that kill the patient.

The goal of the Brain Tumor Foundation's MRI early detection program is to find these tumors earlier when they are still small and before they become malignant. From a number of reports in the world's literature (there are about 14 of them) of imaging studies done on healthy asymptomatic individuals, the prevalence of gliomas is about 3 per 1000 population (at least 40 times the reported incidence). The population of the US - according to  2010 US Census data - is 308,745,538. Three cases in a thousand works out to about 926,234 Americans walking around with undiagnosed brain tumors (gliomas). We know the number that will become symptomatic in a single year (19,600). What we do not know is how many will become symptomatic in a lifetime and would benefit from earlier intervention.

Seventy years of neurosurgery has shown that once these gliomas are diagnosed they are almost always incurable with a contemporary treatment cost from diagnosis to death of about $500,000 to $1,000,000 per case for another 12 months of survival beyond the natural history of the disease once they become malignant. And there is no known treatment that will stop a low grade glioma from becoming a lethal high grade glioma(except in those few cases where the tumors are found early,  small and completely removed). The overall goal of this project is to define a population at risk, follow those affected and recommend early treatment for those with tumors greater than 2 cm in diameter and/or show growth on follow-up imaging.

Is this worth the expenditure of public resources? Certainly a public health program that, say, teaches people taking their drinking water downstream to not have their latrines upstream would be a reasonable expenditure of resources. But the USA is not a 3rd world country. We spend over $1billion per year on Viagra and Cialis, several billions on cosmetic surgical procedures and trillions of dollars each year treating incurable diseases with expensive and marginally effectual therapies. To me arguments based on a "reasonable expediture of resources" ring very hollow and are beside the point.

Patrick J Kelly MD FACS

Patrick J Kelly MD FACS

3/9/2011 4:38:24 PM #

Len Lichtenfeld

Greg, thanks for your comments (as always).

Dr. Kelly, you have stated your thoughts.  I believe others will be able to assess what you have said.  As a rule, I do not get involved with discussions on this website, and prefer to have readers provide their commentary.

Len Lichtenfeld

Len Lichtenfeld

3/25/2011 12:52:39 PM #

GastonHernandez

I have been a  Brain Tumor patient for 13 years and I am extremely  interested in these topics. Your last answer to Gregory seems to suggest that Dr. kelly do not get involved here anymore. Please! I do need to listen to Dr. Kelly's answers to whatever the comments or questions are. After all, we are discussing here the topic of early detection, precisely proposed and started by Dr. Kelly. There is just no one as qualified as him to answer those comments.

Thanks

Prof. Gaston Hernandez  
Brain Tumor patient

GastonHernandez

3/25/2011 1:04:18 PM #

Len Lichtenfeld

Professor, so every one is clear: Dr. Kelly is welcome to post his thoughts on the blog.   No one has restricted him in any way.

Len Lichtenfeld

4/10/2011 6:57:02 PM #

Patrick J Kelly MD FACS

Dear Professor Hernandez

I will be happy to answer any question you wish to ask. Like you I am perplexed by the hostility the American Cancer Society has shown to the concept of early detection of brain tumors when they support the early detection of tumors elsewhere in the body.

So "Dr Len" here are my thoughts: You have gone so far as to say that the early detection by MRI is "unethical" and even "dangerous". But who do you think knows more about brain tumors? A medical "reporter" and a part-time general oncologist or a neurosurgeon who has operated on and followed over 7300 brain tumors over a 36 year career? If you want to get some background on the American Cancer Society I suggest that you read: www.preventcancer.com/.../wealthiest_links.htm. The title of this piece is: "American Cancer Society:   The World's Wealthiest "Nonprofit" Institution" . And where do you think some of  that wealth is coming from? Big Pharma! And "Dr Len" has the gall to call me "unethical" for simply wanting to diagnose these tumors earlier when we may have a better chance of curing them than we do now.

So these are my thoughts, Dr Len. But I'm just getting warmed up!

PJ Kelly

Patrick J Kelly MD FACS

4/13/2013 3:37:41 PM #

investment property

Great job here.  I really enjoyed what you had to say.  Keep going because you definitely bring a new voice to this subject.  Not many people would say what youve said and still make it interesting.  Well, at least Im interested.  Cant wait to see more of this from you.

investment property

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About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.

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