Clinical trials
I got this release from the Lupus Foundation of America yesterday and felt a bit of serendipity because I had spoken to an Oklahoma Medical Research Foundation lupus scientist-physician the other day about similar stuff.
The big picture: Potential cures for debilitating diseases are hindered because not enough people participate in clinical trials. I don’t know how widespread this is, but I’m fairly confident it’s common.
When people think of clinical trials, they (I include myself on this one) often think of last-ditch efforts to save cancer patients with some new wonder drug. While this certainly happens, clinical trials are more widespread than most people realize and go well beyond cancer. And they are needed for approval of new drugs.
In comes the lupus release, in which the foundation calls for greater participation in lupus drug trials.
The Food and Drug Administration has not approved a new lupus medicine in more than 40 years. Treatments instead are “borrowed,” to use the release’s term, from other disorders, definitely not the best way to deal with the autoimmune disorder that afflicts anywhere from hundreds of thousands to millions of Americans. This is common practice in medicine and sometimes is done “off the book” in which a treatment is given that hasn’t been approved for a particular use.
“Hope is on the horizon, however, as there are more than two dozen potential new lupus therapies in various stages of development and clinical evaluation,” according to the release. “Unfortunately, biotechnology and pharmaceutical companies are finding it increasingly difficult to identify enough eligible people with lupus at experienced clinical trial centers to participate in their studies. This shortage of well-informed patients could slow the momentum which has been building for lupus drug development.”
For more information, visit www.lupus.org. The LFA will conduct a live chat on its Website on Wednesday, September 12 at 2 p.m. to answer questions from individuals interested in lupus clinical trials. Kenneth A. Getz, a senior research fellow at the Tufts Center for the Study of Drug Development, will be the featured guest.
Heart procedure becomes more common
A less invasive procedure to open the heart’s clogged blood supply has exploded, the Agency for Healthcare Research and Quality reports.
Percutaneous coronary intervention — also known as angioplasty, balloon angioplasty and percutaneous transluminal angioplasty — is performed when a doctor inserts a balloon-tipped catheter from an artery in the groin to an artery in the heart. The doctor inflates the balloon, compressing the plaque that lines the artery, widening it to increase blood flow. Doctors also often implant a metal stent that keeps the artery open.
The goal is the have the patient’s artery “inflated” within 90 minutes of arriving at the hospital. This is called the “door-to-balloon time” and improves survival rates considerably.
PCI, the agency reports, “is now used nearly three times more often than the older and more invasive coronary artery bypass graft surgery.”
AHRQ found:
The number of angioplasties from 1993 to 2005 rose from slightly more than 400,000 a year to 800,000 a year.
Heart bypass surgeries rose from 344,000 to 426,000 a year between 1993 and 1997, and then declined to 278,000 a year by 2005.
Although hospital stays in 2005 for angioplasty are much shorter than they were in 1993 (on average 2.7 days instead of 4.6 days), hospital charges have increased by more than 50 percent during the period, rising from $31,300 to $48,000 (adjusted for inflation).
With 1.1 million hospital stays in 2005, coronary artery disease was the third most common reason for hospitalization after childbirth and pneumonia. It was the second leading reason for men, and the seventh for women.
Why should you care?
Because these procedures don’t require surgery and are part of a series of health care standards pushed by the Centers for Medicare and Medicaid and others. CMS ties extra reimbursement to submission of data for its reporting, so most hospitals, looking for extra reimbursement, comply. At some point this information likely will be mandated.
Either way, it’s a click away. Visit www.hospitalcompare.hhs.gov to see how your nearby hospital(s) rate. Take it with a grain of salt, because PCI isn’t for everyone, and meeting the 90-minute window is a work in progress, but it’s still a useful tool.
Jeff Raymond, Medical Writer
Organ donation misconceptions
Advocates have assembled to fight Hollywood portrayals of organ donation they say are inaccurate and end up discouraging the practice.
Good for them. Organ donation rates are pitifully low. I proudly have the box checked on my driver’s license and, while I am uncomfortable thinking about the possibility of my organs being taken from my body after death, I can’t imagine a better gift to give someone.
That’s the clincher: the organ donation multiplier allows one person to save or improve several others’ lives. Listen to the stories of organ donors’ families and receipients’ families — they’re heartbreaking.
“About 20 million Americans tuned in for an October 2005 episode of ABC’s medical drama ‘Grey’s Anatomy’ in which a woman is prematurely declared brain dead. When an intern discovers she is still responsive to stimuli, a literal tug-of-war over the patient breaks out, and the transplant team chides the hospital staff for its resistance.
“Such inaccurate and negative portrayals of organ donation and transplantation are surprisingly common on TV and feed the public’s fears about the process, according to new research,” an American Medical Association story reported.
“Now, a coalition of dozens of organ procurement and transplant organizations, Donate Life Hollywood, is urging TV producers and writers to think twice before taking creative license in telling stories that could indirectly hurt the more than 96,000 patients waiting for organ transplants,” the AMA reported.
The campaign “targets a ‘top 10′ list of inaccurate storylines that recur frequently on TV,” such as the idea that Americans are killed for their organs.
“Other common lapses include misrepresenting brain death and how organs are allocated,” the AMA reported.
The goal, the AMA reported, is to meet with entertainment executives to explain the importance of accurately portraying organ donation and to offer expertise.
Now, the industry may say successful (as opposed to contested) organ donation can’t provide the inherent dramatic tension needed for TV (although few shows ever really capture this, but I’m a TV cynic). My response, as I’ve seen firsthand, is to suggest spending a night at a trauma center.
Scene I
A family, inconsolable at the loss of their teenage son/daughter, is approached by a social worker, a compassionate, tough person who already has spoken to grieving, scared relatives of several accident and disease victims today. The social worker — who has one of the hospital’s tougher jobs — or an organ donation liaison — someone — asks if the family would consider organ donation. The family agrees.
The body is quickly prepped and the person’s organs removed and shipped on dry ice to a nearby hospital. A person who has been on a waiting list for months receives the person’s liver. He or she is ecstatic, having been given a reprieve on dying. He or she will be on a cocktail of immune system-repressing medications until death, but at least death is less likely to be around the corner.
Scene II
The victim’s family agrees to meet the person who received the donated organs. They, and the deceased, will forever be heroes the person whose life was saved.
Sounds like real drama to me. But what do I know. I’m a writer, not a TV producer.
And, while we’re on the subject, WRITE A LIVING WILL. Just do it. Specify your preferences on life-prolonging care. It will save your family potential heartache.
Jeff Raymond, Medical Writer
Opting out
I spoke to Steve Anderson, a research fellow with the Oklahoma Council of Public Affairs, today about Census data released this morning that showed an increase in Oklahoma’s poverty rate.
Part of the American Community Survey, which, to my understanding, replaced the Census ”long form” so many Americans loathed, the “poverty report,” as one Tulsa advocacy group called it, is an annual assessment of cities and states’ income. A related report included statistics on health insurance.
Anyway, if you read Wednesday’s paper, or check the Web, you’ll get all this.
What interested me most about the conversation with Anderson, a certified public accountant with a wide knowledge of state government, was his assertion that the rate of uninsured Oklahomans may not be as accurate as is normally portrayed — either numerically or qualitatively.
Anderson said the Census didn’t count American Indians who receive tribal health care. Nor did it reflect those who choose not to have health insurance — the young and fearless, for example. Or those who just aren’t responsible.
I haven’t been able to research his tribal health care claims, and if I have run across statistics on people shunning health plans they can afford, I have long since lost them. However, the bigger picture is more important: Are we making a public-policy crisis out of a problem? If so, to what end?
I’m not weighing in one way or the other. I just think it’s wise to consider things we repeat and take as truth sometimes have shaky foundations. The more we repeat them, the more ingrained they become.
That many Americans are uninsured is undeniable. That they cost a lot of time, money, efficiency and are less healthy than those with insurance is also, in my opinion, undeniable. What is debatable are the scope of the problem and its solution.
On an unrelated note, if you have ever had trouble managing your cholesterol but tried to make a real effort to do better nonetheless, I’d like to talk to you. Please e-mail me by clicking on my name or call me at (405) 475-3364.
Some hope for health care costs?
I don’t want to announce victory in the earliest stages of a long fight, but I’m encouraged by the steps taken so far to deal with the uninsured in Oklahoma.
Baby steps, to be sure, but steps nonetheless.
The Oklahoma Department of Insurance is soliciting input from around the state about health care priorities and needs to present to a task force that may draft a core benefits plan for residents.
I know, I know … reports, task forces, blue ribbon committees … shuffle paper here, shuffle paper there, talk a lot and change little — at least that’s how I often perceive them.
Under the clever name of Oklahoma CHAT (Choosing Healthplans All Together), Insurance Commissioner Kim Holland plans to collect information from 31 communities across the state using the CHAT computer simulation.
“The CHAT program will assess how people prioritize what health benefits are important to them when the resources are insufficient to purchase every type of coverage,” according to a news release.
I imagine the research has already been done to some extent, but the way this appears to be designed looks genuine to me.
Now, maybe I’m uncritically giving up my skepticism. After all, solving the problem of the social and economic toll of the state’s 600,000 uninsured won’t happen over night. But, I figure, from where else than a state with a glaring, vexing problem will an innovative solution arise?
OK, Massachusetts notwithstanding.
They have beaten us to common-sense health insurance reform, but I consider the South more of a peer group.
I guess I’ve concluded that philosophical differences should not keep us from doing something; that what we do doesn’t have to break the bank and may even save money, again, philosophical differences aside; and that some sort of mandatory enrollment in some sort of plan, while it goes against my libertarian sympathies, will be needed.
Just like with 401K plans, people, even those of adequate means, won’t choose to participate in sufficient numbers for society at large to gain unless at least nudged that way, if not pushed.
At this point, I know the reform movement is more of a Doolittle Raid than an Iwo Jima, but acknowledging something must be done, even if we can’t agree on what, is a step in the right direction. And the sponsors of Holland’s project are an impressive bunch that includes Integris Health, the OU College of Public Health, the Oklahoma Hospital Association, the Oklahoma State Department of Health and The State Chamber of Oklahoma.
Strange bedfellows? Maybe. Or maybe not. It depends how you look it at.
The press conference is Tuesday at 10:30 a.m. in the Governor’s Blue Room at the Capitol.
In March, a group called Health Alliance for the Uninsured bemoaned the number of uninsured who turn to emergency rooms because free clinics were full. Or just turned to emergency rooms for basic care, which is costly in time and money and is hugely wasteful in terms of hospital utilization.
“Our 16 free clinics are overwhelmed and do not have the resources they need,” Dr. Murali Krishna, chairman of the alliance and president of Integris Mental Health, said at the time. “That leaves the uninsured with no choice but to go to the emergency room for routine medical care.”
A study presented then showed 53 percent of emergency room visits in Oklahoma County were for nonemergency symptoms.
Among clinics’ problems are getting specialists to volunteer, finding free- or low-cost drugs and locating radiology services.
Because of its location, St. Anthony Hospital deals with a number of poor, transient patients. As such, it has received assistance to put together a system to find these people a “medical home” so that they visit a general practitioner for routine care rather than the emergency room. For a patient with an HMO policy, this is a given. For the uninsured, it’s innovative, at least for Oklahoma.
I haven’t followed up on the project for some time, but it has intrigued me from the start. Will it work? I aim to find out.
As always, please e-mail me or comment on this blog. If you agree, disagree or think I’ve gone off the deep end, let me know one way or the other.
