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By Elaine Schattner, MD, on February 8th, 2012
 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 works, and what it’s like to participate.
The site offers a menu of “basics” about clinical trials, addressing topics like:
What are clinical trials and why do people participate? What is clinical research? Who participates in clinical trials? What do I need to know if I am thinking about participating? What questions should I ask if offered a clinical trial? How am I protected? What happens after a clinical trial is completed? How does the outcome of clinical research make a difference?
There’s an imperfect glossary of terms, a selection of patients’ and investigators’ stories, information for kids in research, and other resources including a link to
See more NIH Sponsors New Website to Help Patients Understand Clinical Trials
By Elaine Schattner, MD, on December 1st, 2011
A recent post by Dr. Wes Fisher, a cardiologist-electrophysiologist and med-blogger in Illinois, caught my attention. It’s on HIPPA, the Health Insurance Portability and Accountability Act of 1996, and how patient privacy regulations might impede dissemination of new information and physicians’ education.
What he considers is a case report published in the Annals of Emergency Medicine. The authors describe a complicated cardiac procedure performed in a 42 year old woman who was brought to the emergency department of a hospital in Coon Rapids, Minnesota. The study is not HIPPA-compliant, Dr. Wes notes, and I agree.
The report exemplifies the “small cell problem,” an issue of privacy mentioned by some IRBs but (I found) hard to find published information on. Wes describes it succinctly:
Clinicians should be sensitive to the “small cell problem”: the existence of individuals with such unique or unusual diagnoses or illnesses, that it might be possible for others (or patients and families themselves) to
See more The Small Cell Problem, Case Reports and Valuing Patients’ Privacy
By Elaine Schattner, MD, on August 1st, 2011
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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 for physicians.
In 2010, NIH Director Francis Collins wrote: “As the nation’s biomedical research agency, the National Institutes of Health (NIH) must ensure that the research it funds on the behalf of US taxpayers is scientifically rigorous and free of bias.”
This sounds right to me, as it did to the folks at the health and safety arm of Public Citizen, according to the Nature report:
…a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. “They have pulled the rug out from under this,”
See more NIH to Drop Requirement for Websites Disclosing Researchers’ Ties to Industry
By Elaine Schattner, MD, on July 15th, 2011
The latest NEJM features a big story about a small trial, with only 39 patients in the end, on the potential for placebos to relieve patients’ experience of symptoms. This follows other recent reports on the subjective effectiveness of pseudo-pharmacology.
My point for today is that placebos are problematic in health care with few exceptions. First, in clinical trials, patients sometimes agree to take what might be a placebo so that researchers can measure effects of a drug, by comparison. A second instance is, possibly, when doctors treat children. Even then, I’m not sure it’s wise to “train” kids to take a pill and expect to feel better.
The relationship of an adult patient with a physician involves, or should involve, trust and mutual respect. A person cannot possibly give informed consent for a treatment he or she doesn’t know about. So if the doctor’s giving a placebo to the patient, and making the decision for the patient because it
See more The Trouble With Placebos
By Elaine Schattner, MD, on June 20th, 2011
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 shown. This point concerns the costs of doctors’ routinely ordering CTs, MRIs and other imaging exams, besides blood tests, for patients who’ve completed a course of cancer treatment and are thought to be in remission.
The NEJM authors consider that after a cancer diagnosis many patients, understandably, seek reassurance that any recurrence will be detected early, if it happens. Doctors, for their part, may not fully appreciate the lack of benefit of detecting a liver met when it’s 2 cm rather than, say, just 1 cm in size. What’s more, physicians may have a conflict of interest, if they earn ancillary income
See more Lowering Cancer Care Costs by Reducing Tests After Treatment
By Elaine Schattner, MD, on March 23rd, 2011
 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 trials to patients and physicians, and to generally increase transparency on study funding, design and availability of other trials evaluating the same condition or drug.
A mouthful of jargon, as you’ll find regarding pretty much any trial. But better that it’s public -
In recent years, some medical journals have required that clinical investigators seeking to publish study results register their trials, from the start, with the Clinical Trials database. Since 2007, when Congress passed the Food and Drug Administration Amendments Act of that year (US Public Law 110–85) researchers must register and report results for most
See more A Good Place to Find Information on Clinical Trials
By Elaine Schattner, MD, on March 6th, 2011
 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.
See more The Flip Side of Unrealistic Optimism
By Elaine Schattner, MD, on February 18th, 2011
 The FDA recently identified a link between breast implants and a rare form of lymphoma. From today’s report in the New York Times:
When talking to patients about a rare type of cancer linked to breast implants, plastic surgeons should call it “a condition” and avoid using the words cancer, tumor, disease or malignancy, the president of the American Society of Plastic Surgeons advised members during an online seminar on Feb. 3.
This is how doctors spoke to patients 50 and 100 years ago, and in some cultures still do, by not mentioning scary words – especially to women, and not calling a cancer what it is.
Cosmetic verbage?
Most cancers aren’t lethal* is one message for 2011: the “big C” turns out to be a spectrum of hundreds of diseases, each with distinct subtypes, and patients shouldn’t panic when they hear the word. Some are benign in behavior although technically malignant; others behave live chronic illnesses;
See more Stunning Comments on the Risk of Breast Implants, and Cancer
By Elaine Schattner, MD, on January 28th, 2011
I have to admit that when I first read about the FDA’s report tying rare cases of anaplastic large cell lymphoma to breast implants, my mind raced with a strange blend of excitement, intense interest and concern. My thoughts shifted from “wow, that’s really interesting” to “exactly what did the FDA find” to “should I be worried?“
So I’ve decided to write this morning’s post from my perspective as an oncologist
See more An Oncologist Considers Rare Lymphomas in Women With Breast Implants
By Elaine Schattner, MD, on January 25th, 2011
Today’s Times reports on our nation’s students’ poor science test results. The results are bleak: only 34% of fourth graders scored at a “proficient” level or higher; just 30% of eight graders scored at a proficient level or higher; 21% of twelfth graders scored at a proficient or higher level in science.
The mega-analysis, prepared by the National Center for Education Statistics, derives from 2009 testing of 156,500 fourth-graders and 151,100 eighth-graders, with state-by-state and nationwide metrics of those, and of 11,100 twelfth-graders. Student scores were ranked at one of three science knowledge levels for each peer group: advanced, proficient and basic, as defined by the Department of Education. Only a tiny fraction — as few as 1 or 2% of students — attained “advanced” scores on the science exams.
The complete report card analyzes the data by race, sex, urban vs. rural districts, private vs. public schools and other factors, and includes
See more Sad Stats for Science Knowledge in U.S. Schools
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