The Citizen Oncologist

Several months ago we reported on the physics experiment from CERN that suggested that the Neutrino could travel faster than the speed of light.  It was observed at the time that no one, including those who did the experiment and reported the result, believed that the finding would stand up to further scientific scrutiny.  Light speed as the universe’s speed limit is such a fundamental principle of physics that it would require an extraordinary amount of evidence to contradict it.  It was much more likely that the result would be due to experimental error.

It turns out that this is exactly the case.  The original report stemmed from the results of an experiment at CERN named OPERA.  In a press release last week CERN reported that:

“The evidence is beginning to point towards the OPERA result being an artifact of the measurement,” said CERN Research Director Sergio Bertolucci, ”but it’s important to be rigorous, and the Gran Sasso experiments, BOREXINO, ICARUS, LVD and OPERA will be making new measurements with pulsed beams from CERN in May to give us the final verdict.”

The report was met with intellectual dispassion by Antonio Eriditato, a member of the OPERA team.  He has been quoted as saying “There results are in line with our recent findings about possible misfunctioning of some of the components of our experimental setup….This is the way science goes.  What matters is the global progress of scientific knowledge.”

CERN went on to note that “Whatever the result, the OPERA experiment has behaved with perfect scientific integrity in opening their measurement to broad scrutiny, and inviting independent measurements. This is how science works.”

We can’t help but wonder if this affair would have been managed and reported with the same degree of openness, professionalism, and equanimity if corporate interests had had a stake in the results.

Our post recent post on Provenge (Provenge Redux) has elicited a number of comments on the JNCI critique of the trials underlying the FDA approval of Provenge.   The tenor and the passion of these comments reveals the continuing difficulty we have in interpreting clinical trials, and is further evidence that the path of the diligent scientist is beset on all sides by unanticipated interests and motivations.

Rather than get into the tall grass and try to parse the validity of these comments, we shall continue to publish them and see how the conversation develops.

We would, however, suggest that we pause and consider just how much can be Continue reading →

Provenge, a form of active immunotherapy used to treat advanced prostate cancer, was approved by the FDA in April 2010, and in March 2011 CMS agreed that Medicare would cover the cost of the treatment.   The FDA approval was based in part on the results of the IMPACT trial, published in the New England Journal of Medicine on July 29, 2010. The scientific name for Provenge is sipuleucel-T, which will be used in the rest of this article.

The IMPACT trial demonstrated that sipuleucel-T prolonged survival in patients with advanced prostate cancer.  Continue reading →

Several studies on colonoscopies were published in this weeks New England Journal of Medicine, and are receiving prominent attention in the news.

One study, the National Polyp Study, examined the long term effect of polyp removal on overall colon cancer mortality.  A group of 2602 patients  had colonoscopy and polyp removal and were followed for a median of 15 years.  Over that time 12 died from colon cancer, compared to an expected 25 deaths in the historical control group, representing a 53% decrease in cancer deaths. Continue reading →

To understand what is really happening in oncology it helps to take two or three steps back and look at the big picture.  Too often we are caught up in the minutia of the latest clinical trials, trying to determine if the small differences in outcomes between treatment groups translate into differences that are meaningful for our patients.  Continue reading →

The recent assessment that Screening for prostate with the PSA blood test did not improve overall survival, recently reviewed in our article in the Fredericksburg Free Lance-Star, was based on 5 separate clinical studies.  One of the primary studies was the Prostate, Lung, Colorectal and Ovarian Screening Study (PLCO).  This was a United States Study that enrolled 76,665 men.   38,340 men were assigned to screening with PSA and digital rectal exam, while 38, 345 were assigned to usual care, which could include PSA testing if deemed indicated by the physician.   The original report was based on findings after 10 years, and showed that screening resulted in no difference in the number of deaths from prostate.  There have been a number of criticisms of the study, including the observation that 10 years might be to brief a period of follow up from which to draw conclusions.

An update to PLCO has now been published, in the Journal of the National Cancer Institute, presenting up to 13 years experience with the data.  Continue reading →

This week’s edition of the British Medical Journal includes a series of articles documenting a number of serious shortcomings in our system of clinical trials. Access to these articles is limited to subscribers, but the accompanying editorial is open to all and is available here.

The emphasis of this investigation is on the under-reporting of clinical trials, and the consequent absence of large amounts of data that most often alters the interpretation of previously reported trials.  The editorialists do not go into motivation for this under-reporting, but the usual suspects – professionals protecting their intellectual turf and downplaying potential disconfirmation of their work, corporate financial interests, and simple dis-interest is publishing a negative trial – are on the list. Continue reading →

Happy New Year from Fredericksburg Oncology and the Citizen Oncologist.  Throughout the year we shall continue to update you on meaningful developments in cancer medicine, and provide commentary on current trends in oncology research and health care delivery.  We welcome your comments on any of our posts, and encourage contributions on any relevant topics.