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Tag: Clinical Trials

When Opting Out Is Not an Option

Henrietta Lacks did not give researchers permission to take her cancer cells and study them. After she died in 1951, her family was not asked permission as her immortalized cells were used in countless laboratories. This month, the National Institutes of Health finally took a step in righting that wrong, announcing that the Lacks family would help decide who can access Henrietta’s DNA.

Today, getting a patient’s permission, often in writing, is standard in experimental medical research. Well, not always. Currently, there are at least nine ongoing studies involving 62 U.S. cities and towns with a combined population of more than 45 million that do not involve getting permission. They take place during emergencies, such as when ambulances arrive at an accident where patients are too injured to give permission.

For example, imagine this scenario based on a recent study sponsored by the University of Washington. You are involved in a car accident. Paramedics find you bleeding severely. They give you fluids to keep your blood pressure up, but they intentionally give you a bag of fluid that is smaller than the standard. Then they monitor your medical outcome and compare it with patients who received the larger amount of fluids. During the emergency, neither you nor your family know about the study.

Vital research

Research on medical emergencies is vital in determining how to care for people with life-threatening injuries because we often do not have proof that standard methods are the best. People involved should be told that is how their records are being used.

In 1996, the Department of Health and Human Services and the Food and Drug Administration passed regulations allowing research about emergency treatment to occur without permission. For a study to qualify, patients need to have a life-threatening conditioncurrent standards of care must be unproven or performing poorly, and obtaining permission must not be feasible (such as an unconscious patient or a patient whose condition does not allow time for informed consent).

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What If Doctors Had Instant Access to All Medical Research?

We are asking doctors to help us study what access to all medical research would mean for their practice. To study the value of such access, we are providing physicians who participate in this Stanford University Public Access Study with eleven (11) months of complete access to virtually all medical journals, as well as to an evidence-based clinical decision-support service.

Participating physicians will have free, one-click access to this vast body of research on their computer or tablet, whenever and wherever they are online. The study is intended to inform current discussions and legislation on the state of public and professional access to federally funded medical research.

Demands on Participant:  Participants must be a physician licensed to practice in the United States. Data will be collected on participants’ use of research, with selected participants asked to participate in a 30-minute confidential interview. As a control measure, participants are given an extra month of the evidence-based clinical decision-support service, either prior or following the eleven months of access to the research literature.

To learn more and/or to begin immediate participation (after providing informed consent) in the Public Access Study, follow this link: http://nihpublic.stanford.edu/.

The principal investigator of the Public Access Study is John Willinsky, Khosla Family Professor, Stanford University, Stanford CA; john.willinsky@stanford.edu.

Can Personalized Care Survive ObamaCare’s Assembly Line Medicine?

Previously, I wrote about some wondrous developments that are taking place in medical science. Implantable or attachable devices already exist — or soon will exist — that can monitor the conditions of diabetics, asthmatics, heart patients and patients with numerous other chronic conditions. These devices will allow patients and doctors to modify therapeutic regimes and tailor treatments to individual needs and responses. Genetic testing is reaching the point where patients can be directed to take certain drugs or avoid other drugs, based solely on the patient’s own genes.

Almost all HIV treatment these days involves therapy cocktails tailored for each individual patient. The FDA has approved a breast cancer drug only for women with a particular genetic makeup. Patients are being advised to steer clear of an ADHD drug and certain blood thinners if they have particular genetic variations.

We are entering the age of personalized medicine, where the therapy that’s best for you will be based on your physiology and genetic makeup — and may not be right for any other patient.

Yet standing in the way of this boundless potential is an Obama administration whose entire approach to health reform revolves around the idea that patients are not unique and that bureaucrats can develop standardized treatments that will apply to almost everybody with a given condition. When former White House health adviser Ezekiel Emanuel told CNN recently that “personalized medicine is a myth,” he was fully reflecting the worldview of the authors of health reform.

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Clinical Trials for Beginners

Have you ever wondered about what goes on behind the scenes—how new drugs are magically produced and brought forth? We’ll continue to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can make more informed decisions about whether they wish to participate in clinical trials or not.

Why care?

To develop a medicine, from the time of discovery of the chemical until it reaches your drug store, takes an average of 12-15 years and the participation of thousands of volunteers in the process of clinical trials (Fig 1).

Very few people participate in clinical trials—it is even less than 5% for patients with cancer—due to lack of awareness or knowledge about the process. We’ll go into detail about how drugs are developed in later posts.

An inadequate number of volunteers is one of the major bottlenecks in drug development, delaying the product’s release and usefulness to the public. Of course, many people may suffer or even die during this wait, if they have an illness that is not yet otherwise treatable. So if you want new medicines, learn about—and decide if you wish to participate in—the process. I have, as a volunteer subject, researcher, and advocate.Continue reading…

Calculating Risk

Thursday I traversed the frozen surface of the pond for perhaps the last time this season. The ice is thinning quickly. I had on my rubber boots and stayed what I felt to be a safe distance from shore: should I break through, the water would not be over my head. I got some fantastic photos and considered the little adventure a success. However, over dinner that evening when I mentioned that I’d been on the pond earlier, David and Peter were furious. Peter wouldn’t calm down until I promised I wouldn’t go out again.

I have always considered fear the enemy; something to conquer and overcome and I’ve had a lot of practice. Being risk adverse and scrappy has been an asset now that I have lung cancer.  As a participant in a phase I clinical trial, there is the potential for unforeseen and possibly life threatening side effects of treatment itself. Before you are given your first dose of an experimental drug, you must read through and sign consent forms which acknowledge this risk. It is something most healthy persons would never do. When you have a terminal illness, it is similar to coming to the edge of a ravine with a tiger on your trail. Between you and safety is a rickety bridge that may or may not support your weight. However, even chancy passage is an easy decision when the alternative is certain death.

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Drug Data Shouldn’t Be Secret

In the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu ― data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission ― were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin.

After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica. Independent verification of the data seemed imminent. But more than two years later, and despite repeated requests, we have yet to receive even a single full trial report. Instead, the manufacturer released portions of the reports, most likely a very small percentage of the total pages. (One of us, Tom Jefferson, has been retained as an expert witness in a lawsuit relating to some of these issues.)

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Eric Topol: Too Clever by Three-Quarters

Eric Topol was once a lowly (well not that lowly) cardiology professor at the University of Michigan, but he’s now without question the leading renaissance man in health care technology. Virtually every week sees him on some big stage disgnosing his own heart murmur with an iPhone app or showing off how his sleep brain waves and his genome interact or don’t.

His new book, The Creative Destruction of Medicine is a tour de force romp through basically every type of cool new medical technology. He covers the Cloud/Web/Wireless/Sensor phenomenon from both a social, transactional and diagnostic  point of view–leaning heavily on his connection to the West Wireless Health Institute which he helped persuade Gary & Mary West to fund. He’s the creator of a new medical school program at Scripps focusing on the genomics and proteomics revolution, and the book covers in great detail the evolution of the human genome project and its impact on disease discovery (coming eventually) and matching patients to the right drug (available more or less now). Finally he was of course the head of Cardiology at the Cleveland Clinic where he not only was heavily involved in the testing of tPA (the drug that built Genetech) but also in unveiling the problems with Vioxx not limited to the drug itself but also concerning Merck’s behavior at the time. (Remember Dodgeball?)

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Human Farming & the Limits of Medical Research

A Museum of Modern Art exhibit by Michael Burton once proposed that human beings themselves would be the soil for a “future farm:”

Future Farm predicts that the emerging pharmaceutical research in harvesting adult stem cells from fat tissues and its convergence with future nanotechnologies, will bring with it scenarios that reconsider the body as income. We live in a world where industries exist to offer financial rewards for those willing to sell a kidney or produce hair to beautify others. Industries have grown to facilitate transplant tourism as a result of the success of contemporary surgery. And scientific and technological advances continue to bring new possibilities for the practice of farming the body.

This may seem like an overly dramatic or even science-fictionalized description of desperation due to poverty and larger economic trends. But the global economic race to the bottom has now so influenced medical research that Burton’s dark vision is coming closer to realization.

A recent article by Bartlett & Steele and a book by Carl Elliott describe the rise of “contract research organizations” that organize the initial phases of drug trials. Bartlett and Steele choose a provocative metaphor to describe the trend:

To have an effective regulatory system you need a clear chain of command—you need to know who is responsible to whom, all the way up and down the line. There is no effective chain of command in modern American drug testing. Around the time that drugmakers began shifting clinical trials abroad, in the 1990s, they also began to contract out all phases of development and testing, putting them in the hands of for-profit companies.

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Can Health 2.0 Fix Clinical Trials?

Saturday’s New York Times portends more trouble for big Pharma. The headline is wrapped up in an examination of foreign corrupt practices, but the bigger issue is that clinical trials have hidden serious adverse events. The recent allegations that GSK hid data about heart attacks from an Avandia trial conducted abroad highlight the reality that over the last 20 years or so it’s been very hard to recruit patients for clinical trials in the US. It’s expensive to find patients, and the numbers of patients available near centers has not proved enough. The answer has been to go to places with lots of people and lower costs, like India.

One obvious consequence is that few of the significant advantages of Internet connectivity and patient community which have been developing in recent years have been adopted as part of these pre- or post market trials. Several online communities–notably PatientsLikeMe–have been running their own studies but they have typically been observational studies and haven’t had much acceptance from Pharma or regulators.

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The Evidentiary Basis for a Clinically Meaningful Benefit

We entered the 21st century awash in “evidence” and determined to anchor the practice of medicine on the evidentiary basis for benefit. There is the sense of triumph; in one generation we had displaced the dominance of theory, conviction and hubris at the bedside. The task now is to make certain that evidence serves no agenda other than the best interests of the patient.

Evidence-based medicine is the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients”. [1,2]

But, what does “judicious” mean? What does “current best” mean? If the evidence is tenuous, should it hold sway because it is currently the best we have? Or should we consider the result “negative” pending a more robust demonstration of benefit? Ambiguity is intolerable when defining evidence because of the propensity of people to decide to do something rather than nothing. [3] Can we and our patients make “informed” medical decisions on thin evidentiary ice? How thin? Does tenuous evidence mean that no one is benefited or that the occasional individual may be benefited or that many may be benefited but only a very little bit?Continue reading…

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