Monthly Archives: May 2012
In January, I blogged about an open letter by Harlan Krumholz and Rodney Hayward to the panel that is currently engaged in writing new guidelines for cholesterol management. As discussed in my post, their letter challenges the committee to replace the current “treat to target” paradigm with a “tailored treatment” approach. This has been one of my more popular posts of all time, and people often find my blog by Googling “Krumholz Hayward open letter” and the like. It also has been discussed on CardioExchange. So I knew their paper had created a bit of a buzz in the cardiology community. Well, it appears that some in that community are not happy that someone is challenging the current paradigm. Dr. Krumholz reports on CardioExchange that he was approached by an influential person and asked to stop speaking out on the new approach he is advocating:
I had an experience the other week that reminded me that speaking your mind has its challenges. I was approached by someone with influence who asked me to cease my discussions on a particular topic. The reason was oblique – and I was told that people are viewing me negatively because my views are strong and wondering if there are conflicts of interest that are influencing me. In essence, I was told that people are whispering about me – though no names were given.
Now this topic was part of a scientific debate that has strong implications for guidelines and performance measures – and, well, patients. It is a situation where I am questioning conventional wisdom – and the long held beliefs by many individuals. I am trying to do so respectfully – and through the use of evidence – but still it is questioning dogma.
This conversation prompted me to write a message to my younger colleagues urging them to stand up for what they believe – and be willing to speak truth to power. I quote my friend Victor Montori, who eloquently advised a junior colleague about how to manage a concern about whether to express an opinion that was likely to be viewed negatively by her superiors. That person had been told to hold opinions tight until he had more grey hair. Victor starts by saying: ‘I have struggled with this issue for years. Turns out that this is a common struggle for those who find themselves unable to stay silent in the face of waste, error, low integrity, or abuse.’
The message Dr. Krumholz wrote is in the form of an editorial in Circulation: Cardiovascular Quality and Outcomes, entitled “A Note to My Younger Colleagues … Be Brave.” The editorial is open access, so I urge you to go read it in its entirety, but I’m going to quote this paragraph, which seems key:
If you take the path toward clarity, I guarantee that you will occasionally find people who will disparage you. They may seek to undermine you, find ways to marginalize you, and try to incriminate you. They may come from directions that surprise you. Powerful ideas often attract attacks that focus more on individuals than ideas. If you raise inconvenient truths or voice uncomfortable opinions, particularly if they threaten someone’s comfortable status quo, then you will discover much about the character of those with whom you disagree. But always take the high road, engage in dialogue about ideas and evidence, and be motivated by the opportunity to best serve patients and the public. You will not regret it.
Although I am not a physician, I certainly recognize and have experienced the issues Dr. Krumholz is describing in my own life. Speaking uncomfortable truths often isn’t considered nice and doesn’t win popularity contests, but it is necessary for progress to be made. So I will keep covering this controversy, and I invite you to read Dr. Krumholz’s editorial and then let me know your thoughts.
Addendum: Here are comments by Ben Goldacre on Dr. Krumholz’s editorial.
Via email from Adriane Fugh-Berman, selected abstracts for talks to be given at the third annual PharmedOut conference June14-15 at Georgetown University. Please see my previous post for more information.
Regulating Medical Devices: A Historical Perspective
Suzanne Junod, PhD, FDA
In drafting what would become the 1976 Medical Device Amendment, framers of the legislation sought to avoid some of the perceived shortcomings in the Kefauver Harris Drug Amendments which had been enacted after the thalidomide disaster in 1962. In particular, they wanted to minimize adverse effects on an industry characterized by change and innovation. At that time, however, there was no formal field of biomedical engineering while entrepreneurial zeal had begun to create indisputable regulatory issues. Two of FDA’s first device “hires,” in fact, were a pair of engineers from NASA who concluded after a week on the job that conditions in the biomedical industry at that time were “appalling” and that standard engineering practices including back up systems, redundancies, and performance standards were simply non-existent. Their insights, along with some early lessons learned “the hard way,” helped determine the unique ways in which FDA came to perceive its role in regulating medical devices, ways which differed markedly from those adopted for the regulation of new drugs.
Direct-to-consumer advertising of prescription drugs: educating the public to misuse medicines
Barbara Mintzes, PhD, Therapeutics Initiative, British Columbia
Direct-to-consumer advertising of prescription medicines (DTCA) is arguably the most intensive “educational” campaign the US public receives on health issues. On average, Americans spend over 100 times as long watching TV ads about medicines as seeing a doctor each year. These ads include powerful messages about how to recognize and treat everyday and serious health problems, thresholds for care, the role and value of medicines, and expected health effects. Because the aim is to sell a medicine, this “education of a special kind” consistently supports overuse of medicines. I will use examples of recent DTCA campaigns to illustrate the gulf between the scientific evidence on treatment effects, appropriate use, and advertising messages.
Cardiovascular Devices: The Role of Evidence in the FDA Approval Process
Rita Redberg, MD, Archives of Internal Medicine and UC San Francisco
There has been a rapid increase in complexity and use of medical devices, and many of them are cardiovascular. While some of these are life-saving, some are not, and even more have unknown clinical benefit. The current state of the quality of evidence prior to FDA approval of high-risk devices, with some examples and suggestions on how to improve this process so that patients could be more assured of benefits outweighing harms will be discussed.
Left To Our Own Devices: A Surgeon’s Perspective
Amy Friedman MD, SUNY Upstate Medical University
A practical overview of the extent to which the typical clinician comprehends the regulatory pathway for medical devices will be presented. The extent to which clinicians are (or are not) familiar with the specific level of scientific data review that the medical devices they use in patients have undergone prior to gaining FDA clearance for human use will be illustrated. Two specific examples of medical devices that have been associated with significant patient harm, but were not previously recognized to be of concern will be used to illustrate the context of unknown patient safety and risk in the clinical arena.
Radiation From Medical Imaging: A Hidden Epidemic
Rebecca Smith-Bindman, MD, UC San Francisco
Many clinicians are unaware of the amount of radiation delivered from CT scans and other medical imaging techniques and extant data regarding increased risk of cancer from radiation exposure. This presentation will cover the long-term risks of radiation from medical imaging, legislative and quality improvement efforts around CT imaging, and present a framework for reducing inappropriate imaging.
The Failure of the DePuy ASR Hip Prosthesis: Implications for device safety initiatives
John Restaino, DPM, JD, MPH, University of South Carolina School of Pharmacy
The use of metal-on-metal bearings in total hip replacements has seen a sharp decline after a decade-long increase in their use, due to the recall of DePuy’s ASR prosthesis and the growing realization that metal-on-metal prostheses are associated not only with a high failure rates but also elevated systemic cobalt and chromium levels. In the U.S., the ASR XL total hip replacement passed through the FDA’s 510(k) clearance process via the “substantial equivalence” route wherein companies need only to show that their product is similar to a ‘predicate’ device already on the market. In 2007 the Australian National Joint Replacement Registry reported that the ASR required revisions at a rate five times the expected rate at two years. Following years of denial by DePuy that ASR implants were failing, ASR hip prostheses were recalled from the U.S. market on August 24, 2010.
The Supreme Court Strikes Back: IMS v. Sorrell – a Constitutional Right to Track Prescription Data?
Sean Flynn, JD, American University Washington College of Law
The Supreme Court ruled in IMS v. Sorrell that Vermont’s law restricting the use of prescription data to target pharmaceutical detailing to doctors violated the First Amendment of the Constitution. How broad is the right recognized? What room is left for states to control commercial access to confidential medical data for marketing purposes?
Julie Taitsman MD JD, Health and Human Services Ofﬁce of the Inspector General
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) provides oversight for the Medicare and Medicaid programs. This presentation will offer an overview of OIG efforts, via audits, evaluations, inspections, and enforcement actions, to combat unnecessary or harmful medical care.
Exploiting Homeless Mentally Ill Patients in Drug Safety Trials
Carl Elliott, MD, PhD, University of Minnesota Center for Bioethics, author of White Coat, Black Hat
For years pharmaceutical companies have paid marginalized populations to test the safety of new drugs. In recent years, however, specialized psychiatric trial sites have begun recruiting mentally patients from homeless shelters, boarding houses and recovery facilities. These subjects are often paid to test the safety of new drugs in Phase I trials, raising new ethical questions about exploitation of vulnerable populations.
PharmedOut, a Georgetown University Medical Center-based pharmaceutical marketing research project, hosts its third annual conference focusing on the misinformation and patient harm that can occur from pharmaceutical and medical device marketing.
- Rita Redberg M.D., M.Sc., Archives of Internal Medicine Editor-in-Chief; professor of medicine, University of California, San Francisco
- Carl Elliott M.D. Ph.D., author, White Coat, Black Hat; professor, University of Minnesota’s Center for Bioethics
- Kay Dickersin Ph.D., director, Center for Clinical Trials, Johns Hopkins Center for Global Health
- Julie Taitsman M.D., J.D., chief medical officer, Office of the Inspector General, U.S. Department of Health and Human Services
- Sharon Treat J.D., executive director, National Legislative Association on Prescription Drug Prices
- Joel Lexchin M.D., professor, York University
- Donald Light Ph.D., professor, University of Medicine and Dentistry of New Jersey
For more information and to register, visit the PharmedOut conference page.
WHEN: Thursday, June 14 and Friday, June 15, 2012, 8:00 a.m. to 5:30 p.m. ET.
Thursday morning: Marketing of antipsychotic medications and other drugs
Thursday afternoon: Potential health risks of CT scans and other medical devices
Friday morning: Legislative and regulatory updates and solutions
Friday afternoon: Informing and protecting patients: The role of industry, media, and payers
WHERE: Lohrfink Auditorium in the Hariri Building, Georgetown University, 37th and O Streets, N.W., Washington, D.C., 20057.
In the May 2012 issue of The Scientist, Data Diving: What lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review. Discusses the problem of missing data and how it affects the reliability of systematic reviews.
On the Scientific American website, a guest post by cardiologist and researcher Jalees Rehman, Open Science and Access to Medical Research. Rehman discusses the special challenges of sharing clinical research, including the need to maintain patient confidentiality and the need for independent institutions to interpret the data in an unbiased manner so that vulnerable patients are not misled or given false hope.
In the November 21, 2011 issue of the Medical Journal of Australia, Time to mandate data release and independent audits for all clinical trials, by Ian Haines and George Gabor Miklos. Here are the last two paragraphs:
Medical journals and their editors have a choice — to be viewed as “an extension of the marketing arm of pharmaceutical companies,” or to be beacons of transparent data processes that inform clinicians, improve patient treatment, and provide high standards on which governments, health care providers and patients can have confidence.
Medical journals should demonstrate strong leadership by mandating open access to detailed clinical trial protocols and de-identified raw study data. They should insist on independent audits of data, concomitant publication of an “accompanying abstract,” and lodgement of the data in independent databases; these three actions should be a precondition for publication. (citations omitted)
Finally, in Science Translational Medicine, Learning from Hackers: Open-Source Clinical Trials, by Adam Dunn, Richard Day, Kenneth Mandl and Enrico Coiera. Behind a paywall, but here’s a news article in Australian Life Scientist and a post on Dunn’s blog.