September is National Childhood Cancer Awareness Month

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You would think that we wouldn’t need a month to make people aware of childhood cancer, but we do.

Most people don’t know a child who has cancer. I meet people all the time who don’t even realize children can get cancer.

Some facts about childhood cancer worth knowing: Cancer is the most common cause of illness-related death in children. Cancer is the second most common cause of death in children, after accidents. 12,500 children are diagnosed with cancer every year.

What is being done to combat the illness that kills more kids than any other? Well, the National Cancer Institute is supporting research to the tune of approximately $170 million per year.

That my sound like a lot, but it isn’t. An article in Forbes, written by the mother of a girl with osteosarcoma, discussed some of these issues. Funding for pediatric oncology clinical trials, which are so expensive that they can only be done with the support of NCI or a pharmaceutical company that hopes to uncover the next blockbuster drug, is at $26.4 million per year and has been dropping steadily since 2003. This decrease in funding has had a real impact. A number of trials being conducted by the Children’s Oncology Group have had to close, and others have been reduced in size or delayed.

These clinical trials are responsible for one more astounding fact about childhood cancer: approximately 3 of every 4 children diagnosed with cancer will be cured. For some types of childhood cancer, the improvements have been mind boggling – acute lymphoblastic leukemia (the most common type of cancer in children) has changed from a disease that killed almost everyone who contracted it within 3 months, to a disease that is cured 75% of the time.

How did this happen? Cooperation. Rather than competing with each other, pediatric cancer centers have banded together into a single group, the Children’s Oncology Group, which conducts nationwide clinical trials. According to this article in Newsweek, up to 80% of children with certain types of cancer are enrolled on clinical trials. The comparable figure for adults? About 1%.

And while $26.4 million to finance clinical trials may sound like a lot of money, NCI funding for AIDS research in 2006 was $254 million, and funding for breast cancer research was $584 million.

What can you do to help? One concrete step anyone in the US can take is to contact their representative in Congress and urge him or her to appropriate the funds for HR 1553, the Caroline Pryce Walker Conquer Childhood Cancer Act. Sponsored by Rep. Deborah Pryce, whose daughter died of neuroblastoma in 1999. Although signed into law by President Bush in July, the money, $30 million, still needs to be appropriated.

Another way to help is to join the MileStones Virtual Walk for 12,500, sponsored by CureSearch, the organization that supports the Children’s Oncology Group. Or you can support the Committee to Establish a Childhood Cancer Awarenes Stamp.

With your help, we can continue to make progress diagnosing and treating childhood cancer, and cure even more children.

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Standing Up to Cancer
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Today is World Cancer Day

Another Milestone

Our society puts a great deal of weight on anniversaries and especially on multiples of 10, and so it is in that spirit that I note that this is the 100th entry in my blog. Moments like this are supposed to prompt us to reflect on where we’ve been and where we are going to.

Where have I been? When I first started this blog, I had no idea what I was doing, no idea what to write, and no plan. I just started writing, and figured I’d follow whatever path presented itself. I’ve been pleasantly surprised at how things have turned out. I’ve enjoyed writing this blog – thank you all for reading and for your comments.

Where am I going? I’m going to keep following the same path. Writing about my patients, about new science, and about the health care system. It’s been a great ride, and I can’t wait to see where it goes from here!

Could Your Heart Medicine Cause Cancer?

There was a series of interesting articles in the last issue of the New England Journal of Medicine concerning a heart medicine called Vytorin. Perhaps you’ve seen the ads on TV. You know the ones… they show high cholesterol foods and a silly looking person dressed to look like the food to reinforce the idea that Vytorin has 2 medicines to address 2 ways your cholesterol could become elevated. In fact, Vytorin is a combination of Simvastatin, a drug that works by blocking your body’s ability to make cholesterol, and Ezetimibe, a drug that works by blocking your body’s ability to absorb cholesterol from the foods you eat.

In theory, this is a great idea. After all, cholesterol comes from 2 sources, why not create a drug that affects them both? This is exactly what Merck and Schering-Plough did in a joint venture using drugs that each company still had under patent.

Having created this drug, the pharmaceutical companies had to get the approval of the FDA to market it. Otherwise, they could not have aired those memorable ads. To earn FDA approval, a drug company has to provide data from a clinical trial showing the drug’s effectiveness. Vytorin was approved based on its ability to lower blood levels of LDL, the "bad cholesterol" that is associated with heart attacks and strokes. After FDA approval, the company launched another study called the ENHANCE study. This study was designed to show an effect on atherosclerosis ("hardening of the arteries"). It lasted just 2 years and enrolled 720 patients with a genetic disorder (familial hypercholesterolemia) that causes high cholesterol levels and heart attacks and strokes at a very young age. The study showed that Vytorin lowers cholesterol levels in these patients, but it did not detect a decrease in heart attacks or strokes.

Importantly, the study did not show that Vytorin was any better than Simvastatin alone.

There have been 2 drug company-sponsored trials since then: the SEAS trial (SEAS stands for Simvastatin and Ezetimibe in Aortic Stenosis) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) trial. Both studies were designed to test whether Vytorin reduces the risk of heart attacks and strokes better than Simvastatin alone. The results of the SEAS trial were released this week (The IMPROVE-IT trial is still ongoing). In a disappointment for the drug companies, Vytorin did not decrease the risk of progression of aortic stenosis (a narrowing of the valve leading from the heart into the aorta, the major artery that drains the heart) or on cardiovascular events in general.

Surprisingly, the patients taking Vytorin had an increased risk of cancer compared with patients taking a placebo.

What’s going on here? Does this new heart medicine not only not work, but also cause cancer?

The answer is probably not that simple.

When the data from all 3 trials are combined, there is no increase in the incidence of cancer in patients who take Vytorin. However, there was an increased risk of dying from cancer.

How could this happen?

Well, one possibility is that this is just a coincidence. The studies were not designed to detect a risk of getting or dying from cancer. So maybe it was a statistical fluke.

But it could be real. An editorial in the New England Journal accompanying the articles warns about this possibility. Ezetimibe inhibits the absorption of plant sterols from the diet, not just cholesterol. Epidemiologic studies have linked diets high in plant sterols to a lower incidence of cancer. Laboratory animals (mice and rats) fed a diet high in plant sterols show modest resistance to chemical carcinogens and to tumors grown from injected human cancer cells. Plant sterols have a number of inhibitory effects on human cancer cells grown in the lab. These findings could provide the basis for a plausible biological explanation for the results in the SEAS study.

I wrote this piece for two main reasons: one reason is that I think this case (and the fiasco surrounding Vioxx) is an important reminder not to be so eager to take a new drug just because it’s new and has a cute ad. FDA approval is no guarantee that a drug is safe, and some relatively rare but certainly very significant side effects only become noticed during what is called post-marketing surveillance. The other reason is as a teaser for my upcoming, first ever book review: Reasonable Rx: Solving the Drug Price Crisis, by Finkelstein and Temin.

Stay tuned.

Related Posts:
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I can buy it over the counter, doesn’t that mean it’s safe?

This topic was also covered extensively by one of my friends in another blog. Read her posts here and here.

A Concerning CT

“So you’re perfect?”

“Yep.”

“Unfortunately, you’re CT isn’t perfect.”

Today in clinic, I had to tell a family that there is a new nodule in their child’s lung.

After the family left, the fellow who follows this patient with me asked, “How do you decide how to break news like that to them?” An excellent question. I’m not sure I have the answer.

When I was a younger oncologist, I would never have just come out and said, “Your scan has something bad on it.” I’d have worked up to it, emphasizing how well the patient is doing (assuming that’s true), and ultimately would try to use a more gentle euphemism when first breaking the news. I’d also ensure that by the end of the discussion we had moved beyond euphemisms and were speaking frankly about what the scan showed, but initially it somehow used to feel easier to start out softly.

More recently, I’ve found myself just coming right out and saying it. Bluntly.

I don’t know which is the better approach. I think that once one of my patients has a scan, the parents can’t think of much else other than what it shows. I think that approaching a bad result softly, with euphemisms, just delays the inevitable, and doesn’t really change the impact of the bad news. I wonder if it even makes it worse somehow, because as I’m saying something other than what the scan showed, I may be drawing out the anxiety and making things worse.

Of course, I’ve been blessed not to have ever been the parent of a child with cancer. How would I want the doctor to break news like this to me? I’m just not sure.