"We need a better test"... or do we?

A study, published online January 6 in the Journal of the National Cancer Institute, claims to show that screening men 55 years old or older for prostate cancer does not significantly decrease mortality from the disease.

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This study made headlines, in large part because it  runs contrary to conventional wisdom -- that cancer screening tests, by detecting the disease at an early stage, save lives.  A number of things struck me about this study and the way it was reported.

This is one of several relatively recent studies that has called into question the premise behind cancer screening tests.  Two years ago, I had a post about a revision of the US Preventive Services Task Force's position on Pap smears and mammograms.  In that post, I talked more about how screening tests might be applied to particular patient populations.  But cervical cancer and breast cancer are very different from prostate cancer.  Women rarely die WITH breast cancer... they die OF breast cancer.  In contrast, many men die WITH prostate cancer, but not because they had prostate cancer.  This is a key difference, and strongly influences thoughts about screening tests.  KevinMD did a great job addressing this issue, highlighting the idea that screening tests are not without their costs.

This episode also demonstrates that it is important to read the whole article, not just the headline.  (Reading the original research is best, but only if you know how to interpret it appropriately).  The Washington Post's headline, for example, reads, "Routine prostate cancer testing does not save lives."  Only if you read deep into the article does it become clear that one group of men was screened by the study doctors with PSA blood tests and digital rectal exams, while the other group of men were cared for by their regular doctors.  Of course, the regular doctors were allowed to do PSA tests and digital rectal exams, too.  But those data were not recorded, making it challenging to know how different the screening of the two groups really was.  This is important, because the "screened" group had a higher rate of cancer than the "unscreened" group, but no difference in the rate of death from prostate cancer.



How can that be?

The answer may come from pediatric oncology.  Neuroblastoma, the most common solid tumor (other than brain cancer) in children, can be detected by a simple urine test.  Since neuroblastoma primarily strikes kids less than 3 years old, a population of children who see their pediatricians quite frequently, it seems sensible to do a urine screening test for neuroblastoma as part of routine well child care.  In fact, that was the routine in Japan for many years.  In the beginning of this century, though, two large studies showed that screening for neuroblastoma increased the rate of diagnosis, but did not change the death rate.  On the basis of those two studies, Japan no longer screens children for neuroblastoma.

How can a screening program increase detection but not decrease the death rate, especially if there are effective treatments available?

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In the case of neuroblastoma, we believe the answer lies in the biology of the tumor.  Some tumors are very aggressive, grow rapidly, and kill a high proportion of patients, while others are more slow growing and can be cured pretty easily, often with surgery alone.  If screening detects more of the low grade tumors, but the high grade tumors end up being detected because they cause symptoms, then screening programs won't change the rate of detection of the aggressive tumors... the ones that cause most of the deaths. 

If this same biological principle applies to prostate cancer, the findings of the screening trial make sense.  Which brings me to my last point:  at the end of the article in the Post, Dr. Jonathan W. Simons was quoted as saying, "We need a better test than PSA."  That may be true, but it needs to be better not because it can detect prostate cancer even earlier, but because it can detect aggressive prostate cancer earlier.  Screening for that may change death rates.  Maybe we don't need a "better" test... we need a different test.

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My name is FDA, and I approve of this message

As the new year begins and election season accelerates, we will be hearing phrases like that more and more.  In the context of a political commercial, it is often pretty clear what is being approved and the basis for the approval.

But what about new drugs?  How does the FDA decide whether or not to approve a new cancer drug, and what exactly is being approved?  In the era of targeted therapies, which are incredibly expensive to develop, and therefore incredibly expensive for patients and their insurance companies, these are crucial questions.

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I think the case of bevacizumab (Avastin) is a perfect example.  Avastin was the first of a new class of drugs that treats cancer not by directly killing tumor cells, but instead by attacking the blood vessels that feed a growing tumor, essentially attempting to starve the tumor of oxygen and nutrients.  Avastin was approved by the FDA for the treatment of renal cell carcinoma (kidney cancer) based on its ability to prolong the life of patients with this disease.   Avastin was given a provisional FDA approval to treat metastatic breast cancer, based on its ability to delay progression of the tumor.  It was big news last month, however, when further studies failed to show an improvement in "overall survival" (meaning how long the patient lives from the time she begins treatment) in women with metastatic breast cancer, and the FDA withdrew its approval.

Avastin is in the news again today.  In today's issue of the New England Journal of Medicine there are two reports (links here and here) showing that Avastin prolongs Progression-free Survival (PFS; the time from beginning treatment until the tumor gets worse) but not Overall Survival (OS) in women with newly diagnosed ovarian cancer.  Based on these results, Genentech, the manufacturer of Avastin, declared that they will not seek approval from the FDA to treat women with ovarian cancer using Avastin, because they know approval will not be granted without an effect on OS.

Overall survival, an extension of life expectancy, is clearly the ideal for a cancer drug.  I certainly treat all of my patients with drugs that I expect will allow them to live longer (hopefully to cure, but even in patients who are not likely to be cured, I would like them to live longer).  But is that the only goal of cancer treatment?  Perhaps there is a benefit to an increase in PFS.  If I told you that your child was going to die in 10 months no matter what I did, but that there is a treatment that will keep his tumor from growing for 7 of those months, and that during those 7 months he would develop no new tumor-related symptoms, would you want him treated with it?  Probably that would depend on the side effects the drug causes, right?  If the drug was very toxic, you might decide that treatment isn't worth it, but if all that happened to your child was high blood pressure that was easily controlled by medication, you might say yes.

The primary result the FDA wants to see before approving a new cancer drug is an improvement in OS.  Although FDA guidelines do allow for approval based on an improvement in PFS, the degree of improvement required for PFS-based approval is much more strict than what is required for OS-based approval.  I believe that there may be cases where even a modest change in PFS would be a more appropriate standard.  Demonstrating a change in OS requires large studies enrolling many patients.  For rare diseases, studies like this may not be feasible.  In that circumstance, FDA approval based on a change in OS may be an unattainable standard, and PFS may be a reasonable alternative.

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Some may ask whether lowering the standard will change the entire drug approval process, because PFS is an easier standard to reach.  Concerns could be raised that no pharmaceutical company will ever try to reach the OS standard (which is more expensive and more time-consuming) if PFS is sufficient to be granted FDA approval, and thus we will never know which, if any, drugs prolong patient survival. 

These are valid concerns, but I believe they can be addressed.  Perhaps a two-tiered approval process, with a lower tier for drugs that affect PFS and a higher tier for drugs that affect OS, with financial incentives for reaching the OS standard, would be a solution.  I'm sure there are others.  But the status quo gives the impression that if a drug doesn't change total survival time, it has no benefit.  And I'm quite sure that's not true.

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Managing Pain

Pain.

Little scares a new oncology patient as much as the idea of pain.  Unfortunately, pain permeates my practice.  Often, pain is the initial symptom that leads to a new cancer diagnosis.  Cancer patients undergo frequent painful procedures -- biopsies, bone marrow aspirates, surgeries ... even a simple blood draw involves a small amount of pain.  Because of this, managing pain is something I have some experience doing.

So I was surprised when I read this article in The Washington Post this morning and discovered that "some [pain doctors] began decrying the increasingly widespread use of opioids and questioned whether the drugs worked."  Really?  There are pain doctors who question whether opiates (morphine, for example) work?

Over the years, I have seen a variety of pain management styles. From doctors who prescribe intramuscular injections of pain medications to small children recovering from surgery, through sophisticated regimens involving patient-controlled analgesia and the use of non-drug techniques designed to specifically combat different types of pain. Pain management skills vary widely, and careful use of appropriate therapies can make all the difference to a suffering child.

Unfortunately, because the drugs which are the mainstay of pain treatment, opiates, are highly addictive, their use is politicized.  The article in today's Washington Post, for example, was focused on a patient advocacy group, the American Pain Foundation, which gets the lion's share of its funding from the pharmaceutical industry.  Unfortunately, this creates the appearance of a conflict of interest when the group strongly advocates for the use of specific narcotic pain medications (such as OxyContin) to control chronic pain.  And the appearance of a conflict of interest, whether or not the conflict exists, is sufficient to cast doubt on everything the Foundation has to say, even when what they say is spot on.

The use of narcotic pain medications is clearly expanding, and as a result, overdoses are an increasingly common cause of death in this country.  That doesn't mean these drugs should not be used.  They are highly effective at controlling acute, and even chronic, pain.  But like all medications, they need to be used appropriately, under medical supervision, prescribed by doctors who are experienced in their use, know how they work, know what kinds of pain they help, and know the risks and limitations of their use.

The diseases I treat cause pain.  One of the most common fears among cancer patients is the fear of dying in pain.  The treatments I use cause pain.  Some of the procedures we perform to monitor the progress of my patients cause pain.  Without highly effective drugs to treat pain, I could not do my job.  Rather than politicizing these drugs, we should be advocating for increased education about their proper use, about choosing the right drug for the right type of pain, and increasing research into the mechanisms of pain so that newer, more effective, safer drugs can be developed.

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Special Kids

All of the kids I take care of are special.  Is that cliche?  Maybe so, but it's true.  I truly have learned something from each and every one of them -- though not always what I thought I would learn.

Some kids stand out.

My first "real" patient, who was 13 at the time, and is now, at the advanced age of 27, joining the military.

The patient who got a transplant for her horrible leukemia... who was so sick going into her transplant that I said to her during her "consent conference"... "Well, if your kidneys fail during the transplant, at least your donor can give you one of his, too, and since your immune system will be his, you won't have to worry about rejection."  Not only did her kidneys not fail, but she is alive, well, in remission, and sometimes takes her hormones.

Marta also stands out.  Marta was a teen mother before I met her, though she was finishing her freshman year of college.  That, alone, impressed me.  But as I got to know Marta, first during her initial treatment, and then while we were unsuccessfully treating her relapse, I got to know a warm, caring, wonderful mother.  A young woman who faced adversity with grace, never complaining about her fate.  A young woman who made mature decisions, including continuing college through all of her treatment.  A young woman who accepted hospice care when she needed it, but continued to do what she could to extend the time she would have with her child.

From some kids, I learn about a disease.  From some kids, I learn compassion.  From some kids, I learn grace.  From Marta I learned how to face life, no matter what life has in store.

I'll miss her.

Another Kind of Tears

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Tears are a fact of life in my business.  Parents cry when I tell them their child has cancer.  Children cry when they undergo painful procedures.  We all cry when a child dies.

But sometimes the tears are tears of joy.

Jade came to my clinic for another opinion.  She has a benign tumor, but it's in a bad place.  As I have shared before, sometimes it isn't better to have a "benign" tumor.  In order to remove Jade's tumor, she would need disfiguring surgery.  She and her father were told there was no choice.


Thankfully, they were told wrong.

Even though Jade's tumor is benign, it can be treated with chemotherapy.  It's a small tumor, and it's not causing her any symptoms right now.  Even if we can't make it go away, if we can keep it from growing, she will be fine.

After discussing her options, I asked Jade and her father if they had any questions.  Her father started crying, and then Jade did, too.  They were so relieved to have non-surgical options!

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How nice to make someone cry tears of joy for a change.

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The Emperor's New Book

It may not be a new book anymore, and I actually read it a few months ago, but I would like to share my thoughts on Siddhartha Mukherjee’s The Emperor of All Maladies.  Dr. Mukherjee subtitled his book, “A Biography of Cancer.”  Much has been made in other reviews about the significance of this subtitle, and what it means to the approach he took to his topic – the history of cancer therapy.

I am fascinated by the history of medicine.  When I teach residents about current sarcoma therapy, I always teach them the history of how we got to where we are.  Dr. Mukherjee took this approach to its logical extreme, beginning with the first known record of the disease in ancient Egypt all the way to the present.

The main theme coursing its way through the book is the evolution of our therapies from radical to targeted.  Mukherjee starts with the 4^th century BC Persian Queen Atossa, who commanded her servant to cut her breast from her body, and traces the evolution of surgery up through Halsted’s radical mastectomies in the early part of the 20^th century and then to our current practice of lumpectomy, showing along the way how medicine is shaped by the personalities of those who set the standards of care.

Dr. Mukherjee gives chemotherapy a similar treatment, tracing the evolution of systemic therapies from the use of single chemotherapy drugs (beginning with nitrogen mustard-derivatives and anti-folates), through high dose chemotherapy with stem cell support, and back to the current vogue of molecularly targeted therapies.

Reading the novel as a oncologist who treats children, I was, of course, thrilled with the center stage given to pediatric oncology, especially the focus on childhood acute lymphoblastic leukemia as the first example of the successful use of chemotherapy to cure cancer.  Given the importance cooperative groups have played in the development and dissemination of cancer therapies over the past 40 years, I was a bit disappointed at how little attention was paid to the role of these organizations in advancing cancer treatment.  Reading this book, you would get the impression that most important clinical trials were run by small groups of physicians at their own hospitals.  The staggering successes seen in pediatric oncology over the past 30 years have come about almost entirely as a result of pediatric oncologists working together across the country to perform the kind of trials that would otherwise be impossible.

My other problem with the book is a common problem among medical oncologists – a marginalization of the successes of pediatric oncology.  In his effort to support the thesis that radical treatments (radical surgery, high dose chemotherapy…) are of little value, and that the future of cancer treatment is molecularly targeted therapies, Mukherjee substantially downplays diseases where high dose chemotherapy has been shown to make a difference.  Randomized trials have demonstrated superior survival for children with neuroblastoma if they have high dose chemotherapy with stem cell support compared with standard chemotherapy.  Neuroblastoma is the most common solid tumor of childhood, so this is not an insignificant finding.  High dose chemotherapy clearly improves the survival of both children and adults with relapsed leukemia.  Sure these diseases are not as common as breast cancer, but they serve as stark examples of how in some cases, the radical treatments Mukherjee deplores clearly improve survival.

Certainly childhood cancer is biologically distinct from the common adult tumors (breast, prostate, lung, colon), and what works for kids may not work for adults.  But the paradigm pioneered by pediatric oncology – the cooperative group – is responsible for some of what Mukherjee proposes are the most important advances in adult cancer (such as the National Surgical Adjuvant Breast and Bowel Project).  As I have said before, I think the medical oncology world has a lot to learn from the advances made in treating and curing cancer in children, and I wish that high profile works like this one did more to emphasize that point.

Nevertheless, I really enjoyed this book.  It makes the history of medicine an easy read, and its focus on the personalities of some of the giants in our field was truly fascinating.  If you have even a passing interest in oncology (and if you’re reading my blog, you must), you’ll enjoy this book.

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Why Study Rare Diseases?

The times they are a-changin’!  When I began my career as a scientist, NIH funded 25% of the applications they received.   That number is now down to less than 10%, and if there really are radical cuts in the discretionary federal budget, that number could fall even further.  Many of my colleagues (including myself) are concerned that this would lead to an emphasis on funding projects directly related to common problems (heart disease, breast cancer, emphysema) at the expense of less common diseases (like childhood cancer).

An article published on my birthday by Science:  Translational Medicine demonstrates the danger in cutting off funding for rare disorders.

In this study, Dr. Jaime Guevara-Aguirre and his colleagues published the results of their 22 year study of an isolated population of individuals living in a remote village in Ecuador.  The 99 subjects all have Growth Hormone Receptor Deficiency, or Laron Syndrome.  This is not a public health menace, even in Ecuador.  This article states that there are only 250 known people with Laron Syndrome worldwide.

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So why study such a rare disorder?  Well, interestingly, people with Laron Syndrome don’t get cancer (they also don’t get diabetes, but this is a blog about cancer, so we’ll focus on that).  This interesting observation raises a really obvious question:  Why not?

At first blush, there could be a very simplistic answer:  IGF-1 makes your body grow.  For you to grow from the size of an infant to the size of an adult, your cells have to divide many, many times.  Each time a cell divides, it risks developing a mutation, and the accumulation of mutations leads to cancer.  If you don’t grow any larger than a 7-year old, there are fewer cell divisions.  Fewer cell divisions means fewer mutations.

But if that were the answer, people with Laron Syndrome would have a lower than average rate of cancer.  That is not what was observed, however.  What was observed was an almost complete lack of cancer.  This must tell us something profound about how cancer develops.

It turns out that Growth Hormone Receptor Deficiency results in low circulating levels of insulin-like growth factor-1 (IGF-1; also called somatomedin C because it mediates the effects of growth hormone, or somatotrophin).  IGF-1 has been in the news a lot recently because its receptor appears to be important for the growth and survival of a wide variety of tumors, making it a darling of drug developers.   The fact that people with Laron Syndrome don’t get cancer suggests that IGF-1 signaling through its receptor probably plays a role in cancer development, not just the survival of cancer cells once the tumor develops.  More importantly, this must be a general property of cancers, because it’s not the case that people with Laron Syndrome are protected from just one or a few types of cancer.  They don’t develop cancer at all.

This sort of insight could never have come about from a focused study of a particular tumor type, nor could it have been derived from studying cells in a lab.  Only because someone was interested in the biology of a rare disorder was this discovery made.  I can only hope that the people in charge of the federal government’s medical research budget consider this when deciding how much research we can afford, and whether to focus on the common disorders, or whether we can let scientists study what is interesting… because we never know where the next important discovery will come from.

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David's First Book Review: The Immortal Life of Henrietta Lacks

I've discovered reading again.  Or maybe what I've done is made a conscious decision to set aside time to read.  Some books I've recently read have nothing to do with cancer, like Cloud Atlas.  Then there's The Immortal Life of Henrietta Lacks.

Rebecca Skloot did a marvelous job telling the story of Henrietta Lacks, a woman from Baltimore whose cervical cancer cells became the very first immortalized cell line.  I think this book is a "must read" for anyone engaged in cancer research, if for no other reason than it reminds us that every cell line we work with was once a tumor growing in an individual... a person who had a family and friends, a person who suffered and probably died of cancer.  Each of these people has a story, and knowing that story can inspire us to work harder to find better treatments with fewer side effects.

But aside from the human interest angle, the book is an interesting study in the evolution of medical ethics.  When Mrs. Lacks was treated, in 1951, there was nothing "unethical" about taking some of the cells that were removed from her during the course of her treatment and trying to grow them in the lab.  She did not give informed consent for her cells to be cultured, but the very concept was not a part of medical research at the time.

Times have changed.  Just last week I was getting informed consent from a woman one of whose children was going to donate bone marrow to another.  Our cancer center has a "leukemia bank," a freezer full of bone marrow removed from patients with leukemia, frozen away for future research.  As I explained to her, it can be hard to tell what is abnormal about the leukemia cells if we don't have normal cells to compare them to.  So we ask each normal bone marrow donor to allow us to freeze a teaspoon or so of marrow for comparison studies.  In order to do this, we have to get approval from an Institutional Review Board and the donor (or the donor's guardian, in the case of a minor) has to sign a statement asserting that he or she consents to having this normal marrow stored away.

And that is just to STORE the marrow.  If we want to use the marrow for research, we have to get approval from the Institutional Review Board for the research project and use the marrow anonymously.  If we need clinical information about the marrow donor (or the leukemia donor), we need to either track that person down and get informed consent for the specific experiment or we have to convince the Institutional Review Board that doing so would be an undue burden (if, for example, the patient has subsequently died or has left no contact information or the study will involved hundreds of samples and the data will be used anonymously).

None of these safeguards were in place in the 1950's.

Another fascinating question raised by Ms. Skloot is the question of intellectual property and a patient's rights to his or her own tumor.  Ms. Skloot contrasts Mrs. Lacks, whose family received nothing in exchange for her cells (although, to be fair, neither Johns Hopkins nor Dr. Gey, the man who cultured her cells, received any money for her cells, either.... they were distributed freely to any interested lab anywhere in the world), with Ted Slavin and John Moore.  Mr. Slavin was a man with hemophilia who sold his serum because it had extremely high levels of antibody against Hepatitis B and then supplied serum to Baruch Blumberg, a virologist who discovered the link between Hepatitis B and liver cancer and created the first vaccine against Hepatitis B.  Mr. Moore's spleen was removed as treatment for Hairy Cell Leukemia, and his physician grew a cell line from the spleen, which he then patented and licensed to biotechnology companies to "commercially develop."  In each of these cases, something of value was taken from a patient, sometimes with their knowledge and consent, sometimes not.  In each case, the material contributed to the development of the nascent biotechnology industry, eventually being used to generate profit.

I would love to hear my readers' thoughts on the ethics of these situations.  After all, it seems wrong for someone to profit from cells taken from my body, but the cells are not inherently valuable... it's how they are used that is valuable.  Without intellectual input from a scientist, they are just cells.  But does this mean that, as the California Supreme Court ruled, I don't have any right to profits generated from tissues removed from my body?

One final note:  Ms. Skloot speaks eloquently about how Mrs. Lacks was treated by Johns Hopkins (and subsequently seemingly forgotten).  Just recently, the Johns Hopkins Urban Health Institute announced the Henrietta Lacks Award for Community-University Collaboration, a prize of $15,000 to a community entity that collaborates with Hopkins to work to improve the health and well-being of the residents of the City of Baltimore.

Thanks to Ms. Skloot, Van Smith, and Mike Rogers (all of whom have written about her), Henrietta Lacks will achieve some level of immortality beyond the HeLa cell.

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What is Life?

Life is hard to define.  Perhaps former Supreme Court Justice Potter Stewart summed it up best (though he was referring to hard-core pornography, not living organisms) when he said, "I shall not today attempt further to define [it]... and perhaps I could never succeed in intelligibly doing so. But I know it when I see it."  

Erwin Schrodinger gave a series of lectures in 1943 that were published under the title "What is Life?" 

NASA has an Astrobiology group that is charged with searching for evidence that there is life on other planets.  Key to that mission is understanding what life is.  How else would they know what to look for?

Up until today, living organisms were thought to require four elements:  oxygen, carbon, hydrogen, nitrogen, sulfur, and phosphorus.  A paper published today by the NASA Astrobiology group has challenged that belief.  NASA scientists discovered a bacterium that can live without phosphorus, using arsenic instead.

The bacterium, designated GFAJ-1, can build the molecules of life, including DNA, proteins, and the energy molecule ATP, with either phosphorus or arsenic.  This is very handy, considering the organism was found in a lake with an extraordinarily high concentration of arsenic in its water.

Up until this discovery, life forms were the stuff of science fiction novels.  I've read novels about silicon-based life forms, based on the idea that silicon, being just below carbon on the periodic table, could take the place of carbon in the building blocks of life.  This is actually the basis for how GFAJ-1 uses arsenic.  Arsenic is just below phosphorus on the periodic table of the elements.  So the bacterium just substitutes arsenic for phosphorus.

This finding has important implications for the search for life away from earth.  Clearly phosphorus is not a requirement for life.  Perhaps neither is carbon.  Maybe not even oxygen is needed.  Life can take many forms, so finding it is going to require knowing it when we see it.

Question to ponder:  if ATP is the main energy molecule in a cell, and the P stands for phosphate, does GFAJ-1 have ATA instead?

You're Kidding, Right?

(Another of David's rants about insurance companies)

I've written many times about the absurdities I've encountered dealing with insurance companies.  I've had another experience that I'd like to share.

The patient came into clinic for chemotherapy.  The PA examined him and heard an irregular heartbeat.  Neither of us know the patient well, so we looked through his chart to see if anyone has ever noticed an irregular heartbeat before.  No one had.  We ordered an EKG, and it showed an abnormal rhythm.  The patient has had several EKGs in the past, and this rhythm was a new finding.  One possible explanation for the new abnormal rhythm would be if the patient's central line had moved a bit and was irritating the right ventricle of his heart.  The best way to figure out if that could be happening is to get a chest x-ray to see where the catheter tip is.

We ordered a chest x-ray, only to learn that the patient's insurance company doesn't cover radiology procedures at Johns Hopkins.  Since an abnormal heart rhythm can cause sudden death, diagnosing a cause is an emergency, so we called the insurance company for "permission" to order the x-ray.

You may think this is a "no brainer."  After all, a chest x-ray is cheap, and we could discover the cause of the patient's abnormal heart rhythm and fix it relatively easily.  The insurance company, however, needed to authorize the x-ray.  So I was told the nurse would review the case and get back to us.


Once again, I find my judgment about a case under review by someone with a financial stake in the decision.  In this case, a nurse, sitting in an office in another state, not able to see my patient, was going to decide if my decision to order a chest x-ray was justified.

No.  I'm not kidding.

But if you ask, insurance companies don't make medical decisions, they make coverage decisions.

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