[Update, March 2013: I originally wrote this post in December 2012. Three months later, the FDA announced it “is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.” Several news agencies ran with the news, including AP and Bloomberg, as did some pharma industry bloggers. The JAMA Internal Medicine medical journal ran a column urging more research into the link between the drugs and pancreatic cancer, an article with a concerning, but perhaps harmless, revision after it was published. We think the latest attention and research makes the case against these drugs even stronger, and we’re moving forward in our own litigation.]

Diabetes is a global epidemic, affecting over 25 million Americans and ten times that worldwide. That also makes it an economic opportunity: the diabetes control medication market is worth more than $40 billion in the United States alone. There are thirteen types of approved Type 2 Diabetes medications on the market today (comprising over two dozens drugs), with another seven therapies in various stages of research and development. There’s big money to be made, if you’re a pharmaceutical company — hence the recent advertising push for Januvia, Byetta, and Victoza (the one Paula Deen endorses), relatively new entries to the overcrowded diabetes control market.

I’ve discussed before on this blog how one of the biggest public health problems in America is the pharmaceutical industry’s reliance on the “blockbuster” drugs that exceed $1 billion in annual sales. The whole industry, from research, to clinical trials, to physician education, is oriented around creating and promoting drugs that will become household names — to the exclusion of other useful medicines and to the detriment of patient safety. A year ago, I wrote about why Merck still didn’t admit Propecia caused persistent erectile dysfunction more than eight years after competent research showed the problem. The reason is quite simple: Propecia / Proscar was routinely bringing in more than half a billion dollars a year for Merck, and they wanted to keep it going for as long as possible.

Which brings us to Januvia, a drug that stock market analysts call a “real success story” for Merck. The Type 2 Diabetes market is huge, and Januvia (marketed as “Janumet” when mixed with metformin) has captured 75% of the dipeptidyl peptidase 4 (DPP-4) inhibitor market — for $4.6 billion in revenue in 2011 and likely topping $5 billion this year. It’s not hard to see why Januvia and other DPP-4 drugs have been successful and their sales are growing. They’re a one-a-day pill, not a shot, they haven’t been shown to cause weight gain, and they have a lower incidence of the nausea, abdominal pain, and digestive problems that characterize most diabetes treatments.

But there’s a big problem brewing.
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Misdiagnosis is the most common type of medical malpractice case – roughly one-quarter of all claims – and the failure to diagnose cancer is the most common form of misdiagnosis that results in a malpractice claim. (For those interested in the statistics, the most commonly missed cancers are breast cancer, colorectal cancer, and prostate cancer.) I thus spend a lot of time thinking and talking about cancer as part of my legal practice, but over the past two weeks it has seemed like cancer has been a part of almost everything I’ve read and discussed.

Last week, I had to tell a woman that, though I thought her doctor was negligent in failing to diagnose her ovarian cancer, I couldn’t bring a lawsuit on her behalf. As will be explained below, there’s a big difference between malpractice in patient care and proving a malpractice claim in court.

First, a couple words about Steve Jobs. Now that the initial grieving has ended, the big question has been asked several times: would Jobs have lived longer if he hadn’t delayed surgery?

Most medical experts who have discussed his case in public believe the answer is “yes.” MedPageToday rounded up a number of surgical oncologists opining that Jobs should have undergone surgery immediately — a conclusion implicitly backed by a paper Jobs’ own surgeon published in 2006, and by a related follow-up paper earlier this year — for reasons explained in detail by a post on Quora by medical researcher Ramzi Amri:

The big confusion in the media is that Jobs had pancreatic cancer. Though his tumor might have originated in his pancreas, we’re not speaking of the dreaded pancreatic adenocarcinoma that has such a horrible prognosis and makes up for 95% of pancreatic tumors.

Jobs is cited to have said himself that he had an islet-cell tumor, which is a colloquially used, less accurate name for the other 5% of pancreatic tumors, so-called neuroendocrine tumors.

Neuroendocrine tumors are relatively mild forms of cancer. …

Neuroendocrine tumors caught in time can be treated just by surgically removing the tumor.

This is a relatively low-risk treatment that — especially compared to chemo and radiation — has negligible disadvantages. In many cases, a simple enucleation (just cutting out the tumor with a safe margin around it) is enough and leaves no residual side-effects.

In short, Jobs’ “pancreatic cancer” was initially a gastroenteropancreatic neuroendocrine tumor that, although it interfered with his hormone levels, could have been treated by simply removing it and performing a resection of any parts of the pancreas he lost. It wasn’t just a matter of buying him a couple months or years, the treatment would have changed his prognosis considerably, adding years to his life, potentially leading him to live an ordinary life span.

Cancer Remission MisconceptionsBut that’s the strange part about cancer. Until we or someone close to us has gone through cancer treatment, we tend to see it as the process memorably described by the beginning of xkcd’s comic, “Lanes,” part of which is posted on the right.

Consider this article from last week in the Dayton Daily News:

Glenda Christian’s license plates on her Chrysler Town & Country minivan say it all: She proudly wears pink as 19-year breast cancer survivor. …

Although the cancer is in remission, the 54-year-old Washington Twp. resident is adamant in sharing her story to help raise breast cancer awareness in people of all ages and stress the importance of early detection.

After spending 3½ years with her cancer misdiagnosed, Christian is admirably upbeat in recounting the details of her illness and, in particular, how faith guided her through the arduous process of treatment. …

She was diagnosed with stage 3B estrogen-receptor-negative breast cancer.

She had a left mastectomy in 1992 and then chemotherapy. Since she tested positive for BRAC1 – a gene mutation that increases a woman’s risk for breast and/or ovarian cancer – she also had an elective right mastectomy and a hysterectomy in 2008. …

From the beginning, the outlook was grim. Christian was given a two-year survival rate of 50 percent.

In addition to being a survivor of cancer, Glenda Christian is also a survivor of blatant medical malpractice. She first noticed symptoms more than two years before she was properly diagnosed. A mammogram was done and she was cleared. A year later, another mammogram and an ultrasound, and another all-clear. Two separate exams, two failures to diagnose. It wasn’t until she had “cottage cheese-like lumps encompassing more than half of her left breast” that a different doctor diagnosed her with breast cancer.

By the odds, she should have died a long time ago. Yet she’s still here, despite having spent two years with her cancer undiagnosed, while Steve Jobs went a mere nine months refusing treatment of his then-largely-benign tumor and it spread throughout his pancreas and duodenum, requiring he get the dreaded Whipple procedure before dying seven years later.

Their differing outcomes aren’t just due to the differences between breast cancer and pancreatic cancer (or neuroendocrine tumors), but rather to the arbitrary tragedy of cancer.
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