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Meta-Analyses And A Capricious Drug Approval Process: The Actos And Avandia Stories

Both Germany and France have now suspended the marketing of Actos (pioglitazone) due to concerns of a link between Actos and bladder cancer. Though we have known about bladder cancer concerns for some time, these recent concerns about the bladder cancer link stem from a recent report analyzing the FDA’s Adverse Event Reporting System (AERS), which found that 93 cases of cancer were recorded between 2004 and 2009 in patients treated with antidiabetic drugs, of which 31 patients were treated with pioglitazone, representing a statistically significant increased risk of bladder cancer (ROR 4.30, 95% confidence interval, 2.82-6.52; P less than 0.0001).

Interestingly, the FDA announced that it was going to look into the link between Actos and bladder cancer only a few days before it made its final decision on what to do with Avandia (as if they didn’t know about the Actos cancer risk before the July 2010 advisory board).

Despite the many things you have heard about Avandia, back in July 2010, the FDA decided to severely restrict the use of Avandia for three reasons: Read more »

*This blog post was originally published at ACP Internist*

Another Petri Dish Study Touted By Media As Miracle Cure For Cancer

Maitake soup Tiny Urban Kitchen.jpgEarlier this week, I saw one of the best treatments of a misinterpreted story that has me thinking about how all news outlets should report in vitro laboratory studies.

Only thing is that it didn’t come from a news outlet.

It came a brainwashing site run by those medical socialist types – I am, of course, speaking of the UK National Health Service and their excellent patient education website, NHS Choices.

You may recall reading in the popular dead-tree or online press that investigators from New York Medical College in Valhalla published in British Journal of Urology International about maitake mushroom extract killing bladder cancer cells. The most widely cited reports came from the UK Daily Mail by Tamara Cohen entitled, “Mushroom ‘shrinks cancer tumours by 75 percent,’” and “Cancer Cure: Mushrooms Can Shrink Tumors,” by Jo Willey of the UKDaily Express. Read more »

*This blog post was originally published at Terra Sigillata - PostRank (PostRank: All)*

Bladder Cancer: What You Need To Know, Part 2

This is part 2 of an interview with urologist Mark Schoenberg. Please click here for part one of the interview.

Dr. Val: How is bladder cancer treated?

Dr. Schoenberg: Bladder cancer can be grouped into two categories: non-invasive disease and invasive disease. About 80-90% of the time the cancer is formed by the cells of the inner lining of the bladder, ureters, and kidneys and is non-invasive. This type of bladder cancer doesn’t spread or invade the bladder wall, so it doesn’t threaten the life of the patient, but it can recur.

Non-invasive cancers are usually removed surgically via a scope that is inserted into the bladder via the urethra, and then afterwards there are a variety of medicines that can be infused into the bladder. Those medicines are like a kind of weed killer for bladder cancer.

Unfortunately up to 20% of patients have invasive tumors at the time that they are diagnosed. Once the bladder cancer has spread outside the bladder wall, surgery is needed to remove the primary tumor and then IV chemotherapy and sometimes radiation therapy are needed to treat the life threatening, metastatic disease.

Dr. Val: Is there any way to screen for bladder cancer?

Dr. Schoenberg: Unfortunately at this time urine tests for bladder cancer are very expensive, and they don’t detect cancer reliably. However, many researchers (including myself) are currently on a hunt for specific bladder cancer markers that are inexpensive and reliable. Once we find such a marker or group of markers, it would make sense to begin screening — at the very least – high risk groups such as smokers or people with occupational exposures to chemicals.

Dr. Val: What are the most promising advancements in bladder cancer treatment? Is there new research in the pipeline that could improve its diagnosis or treatment?

Dr. Schoenberg: There are two different areas of research interest in bladder cancer. The diagnostics arena — finding cancer more efficiently, effectively, and less invasively – and the therapeutics arena — developing new tools, drugs, and agents to get rid of cancer cells.

On the diagnostic front, molecular diagnostic researchers are looking at abnormal cancer proteins and DNA that can be detected in urine samples. Because of this research, in the next 5-10 years it wouldn’t surprise me if we no longer had to rely on cystoscopes for the diagnosis of bladder cancer. Also we’d like to develop molecular and genetic profiles in order to risk-stratify people more successfully (i.e. figure out who is at greater risk for bladder cancer, and make sure they get tested).

On the treatment front, there are a number of companies developing targeted therapies for bladder cancer. It’s possible that these therapies will reduce the risk of progression and recurrence in people with bladder cancer.

Unfortunately, bladder cancer has only attracted a fraction of the research dollars that other cancers have in patients in the same demographic (like pancreatic cancer). In fact, NIH funding for bladder cancer research is pitifully small and shrinking, despite the fact that there are 600,000 Americans who have bladder cancer right now. Not only that, but bladder cancer is one of the most expensive cancers to treat – because it requires repeated cystoscopies, catheter-based infusions, repeat surgeries, and sometimes chemo and radiation. Bladder cancer treatment costs Americans about 1 billion dollars a year.

Dr. Val: Why isn’t bladder cancer receiving the research funding it deserves?

Dr. Schoenberg: Successful cancer groups have highly visible champions for the disease – like Lance Armstrong for testicular cancer, or Susan G. Koman for breast cancer. Research funding seems to be strongly influenced by highly visible people getting out there and making a ruckus. We need powerful spokespeople to help Diane Quale at the Bladder Cancer Association Network to get the word out.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

Bob Schieffer And Bladder Cancer: A Survivor’s Story

Bob Schieffer is broadcast journalism’s most experienced Washington reporter. He has covered Washington for CBS News for more than 30 years, and has been the anchor for Face The Nation (one of the longest-running news programs in the history of television) since 1991. I had the privilege of interviewing him about his bladder cancer at the CBS studios today. It is Bob’s sincere hope that his story will inspire others to seek medical help at the first sign of bladder cancer, and also gain comfort from knowing that they are not alone.

This is part two of our interview series. Click here for part one.

Dr. Val: Do you have any advice for patients facing bladder cancer?

Schieffer: Bladder cancer is a very insidious disease, you can have it for a long time without knowing that you have it. At the first sign of blood in the urine, you need to go to the doctor. I think men are often reluctant to go to the doctor, and their tendency may be to attribute blood in their urine to a muscle strain of some kind. But waiting is a dangerous proposition. When I think of my own situation, I realize that even waiting another week or two could have put me into a whole different risk category and I might not be where I am today.

Cancer research is such an evolving field – that if you can keep yourself alive today, there may be a cure tomorrow. That’s the good news about this. The bad news is that we spend about as much on cancer research in a year as we do on one day in Iraq. I don’t know anyone in the cancer community who doesn’t believe that if we invested enough money in it we’d find cures.

Dr. Val: Was it hard for you to speak publicly about your cancer?

Schieffer: Tony Snow and I became really good friends, and we both felt that we had an obligation to talk about our conditions in order to promote cancer awareness. Hamilton Jordan was also a good friend of mine, and he devoted his life to raising awareness. He survived 5 cancers though the 6th one got him. I was a very private person before all this started, and when Hamilton found out I had cancer he called me and said that I really needed to get out and talk about it because I have the opportunity to have an impact on so many people.

As it turned out, I went on Don Imus’ radio show one morning and talked about it, and soon afterwards Wolf Blitzer asked me to be on his show on CNN. I must have received 600 emails from people thanking me for talking about my situation – some were glad to know how to recognize potential bladder cancer, and others told me they no longer felt alone in their cancer experience because they knew that I was going through it too. At that point, I thought to myself that speaking out about my cancer might have been the most important thing I’ve done so far as a journalist. If one person goes to see their doctor when they first notice blood in their urine, then I may have had a part in saving a life.

Bladder cancer is a ”below the belt” disease and people are reluctant to talk about it. I think it’s really important to help people get past this barrier. It is nothing to be ashamed of, there’s nothing wrong with you as a person – it’s just that a certain percent of us are going to get bladder cancer.

Dr. Val: How do people get plugged in to the cancer community to get the help they need?

Schieffer: What I’ve noticed is that when you get cancer, you become acqainted with everyone else who has it. There’s a kind of natural networking that occurs when you participate in meetings and events. However, I’d encourage people affected by bladder cancer to go to the Bladder Cancer Advocacy Network. The founder, Diane Quale, left her job as an attorney to create the advocacy group after her husband was diagnosed with bladder cancer. She has raised hundreds of thousands of dollars for the cause, although sadly her husband lost his battle with bladder cancer a few weeks ago.

Hamilton Jordan told me this, “You have to take control of your disease. Nobody is going to be more interested in it than you. It’s your life, so you’re the one who has the most invested in this. Just Google ‘bladder cancer’ and learn as much as you can about it.”

When you go to a doctor, especially with cancer, it’s invaluable to get a second opinion. I got a second opinion from a wonderful physician at Johns Hopkins, Dr. Mark Schoenberg. And Dr. Schoenberg told me this: “A doctor is like a good craftsman. A good craftsman is always happy to show his work to other craftsmen. It’s the guy who isn’t really sure what he’s doing who doesn’t want to discuss his work with somebody else in the field.”

Dr. Val: What’s your bottom line about cancer?

Schieffer: Cancer is not something to be embarrassed about. It’s something that happens to us and needs to be dealt with. When the doctor tells you that you have cancer, it is not the death sentence that it once was. Cancer research is advancing every day and we’re finding new ways to fight the disease. There’s no need to say, “I have cancer – this is it” but rather, “I have cancer and what do I need to do about it?” And then you have to do it.

*Visit the bladder cancer center at Revolution Health*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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