As for 10 months of PFS, that’s valuable. Imagine that you’re 55 years old and living with metastatic breast cancer. A drug that is likely to delay, by most of 2 years, your tumor’s expansion into the lungs …A concern I have is that this study wasn’t blinded,
Published trials can be flawed. Even if they’re well-analyzed, the findings can be hard to interpret when it comes to a single patient’s course and well-being. What’s a dying man to do?
Topol’s comfortable writing about the intersection of science and medicine as few physicians are….One theme that emerges through the book is the capacity for technology – by “knowing” and processing so much real-time information about each person’s condition – to inform more effective, individualized treatments.
This week the NIH launched a new website, NIH Clinical Research Trials and You. In a Feb 6 press release, NIH Director Dr. Francis S. Collins said “The ability to recruit the necessary number of volunteers is vital to carrying out clinical research.” The idea behind the website is to help patients understand how clinical research […]
Last week’s NEJM delivered an intriguing, imperfect article on a new approach to treating hepatitis C (HCV). The paper’s careful title, Preliminary Study of Two Antiviral Agents for Hepatitis C Genotype 1, seems right. The analysis, with 17 authors listed, traces the response of 21 people with hepatitis C (HCV) who got two new anti-viral agents, with or […]
Last week I came upon a new term in the cancer literature: the Disease Control Rate. The DCR refers to the total proportion of patients who demonstrate a response to treatment. In oncology terms: The DCR is the sum of complete responses (CR) + partial responses (PR) + stable disease (SD). Another way of explaining […]
Tomorrow the American Society of Clinical Oncology* will host its 9th annual GI Cancers Symposium. Bloomberg and the LA Times have already reported findings of a paper, still in abstract form, to be presented on Saturday. The drug of interest is regorafenib, a pill that loosely inhibits quite a few kinases – enzymes critical in […]
Today’s breaking breast cancer news is on Avastin. The FDA has just announced, formally, that it will rescind approval for the drug’s use in people with metastatic breast cancer. Commissioner Dr. Margaret Hamburg writes this her statement: I know I speak on behalf of the many physicians that have been involved with this issue here […]
Something I learned at the MBCN conference is that the Patient Protection and Affordable Care Act of 2010 (PPACA, a.k.a. HCR), will require that private insurance companies cover the routine costs of medical care for patients participating in approved clinical trials. Medicare does so already, said Dr. Tatiana Prowell, an oncologist on the Johns Hopkins […]
Today’s word comes from Nature News that the NIH is dropping a proposed requirement for universities to disclose researchers’ financial ties to industry on websites. This is a loss for patients, who may not be aware of their doctors’ relationships with pharmaceutical companies and others who fund clinical trials, fellowships, conference junkets and other perks […]
This is the second in a series of posts on Bending the Cost Curve in Cancer Care. We should consider the proposal, published in the NEJM, gradually over the course of this summer, starting with “suggested changes in oncologists’ behavior,” #1: 1. Target surveillance testing or imaging to situations in which a benefit has been […]
The Times alerted me, this evening: Lowering bad cholesterol levels reduces heart attack risks, and researchers have long hoped that raising good cholesterol would help, too. Surprising results from a large government study announced on Thursday suggest that this hope may be misplaced…. Common wisdom has been that such patients should take a statin drug […]
The author learned a new word this weekend while attending the annual meeting of the Association of Health Care Journalists in Philadelphia. In a richly-informative session on ethics of clinical trials, one of the speakers, Dr. Jason Karlawish – a bioethicist, geriatrician and Alzheimer’s researcher at the University of Pennsylvania, taught me a new term: […]
If you’re thinking of participating in a clinical trial for cancer or any other medical condition, a good place to find out about the research is ClinicalTrials.gov. The site, sponsored by the NIH, NLM and FDA, is one outcome of the FDA Modernization Act (FDAMA) of 1997. The database aims to provide information on clinical […]
Last week, Pauline Chen wrote on medical ethics and clinical trials. She reflects on her training at a cancer research hospital, where some cancer patients go with unrealistic optimism.
Like Dr. Chen, I spent part of my training at a famous cancer center where I worked as a resident and fellow on rotations. And yes, some patients were unreasonably optimistic and some – perhaps even most, it seemed – didn’t fully “get” the purpose of their trial, which in Phase I studies were not designed to help them. This is a real dilemma for treating oncologists.
This morning’s news feed delivered some seemingly excellent news for some people with melanoma. At least until now, this form of skin cancer has been considered incurable when metastatic. In the last year, we heard details about the ups and downs of ongoing clinical trials of new drugs to treat the disease. The Times reports […]
Today the NY Times printed the third part of Amy Harmon’s excellent feature on the ups and downs and promise of some clinical trials for cancer. The focus is on a new drug, PLX4032, some people with melanoma who chose to try this experimental agent, and the oncologists who prescribed it to them.
What I like about this story is that, besides offering some insight on the drug itself, it balances the patients’ and doctors’ perspectives; it explains why some people might elect to take a new medication in an early-stage clinical trial and why some physicians push for these protocols because they think it’s best for their patients.
And it provides a window into the world of academic medicine, where doctors’ collaborate among themselves and sometimes with corporations.
Here’s some of what I learned: