Editor’s note: The Disruptive Women in Health Care blog recently compiled an ebook exploring the issue of Comparative Effectiveness Research (CER) from a variety of viewpoints and perspective. We invite you to download the ebook or read the original posts.

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By Liz Scherer. Comparative effectiveness research (CER): it’s the buzzword of the new decade.  In fact, Congress recently passed legislation to provide more than $1B to support CER  in hopes of improving utilization of existing therapies while simultaneously holding down healthcare costs. The ultimate goal of CER goes even further and paints a rosy vision of patient-centered care and personalized medicine.

However, perhaps these goals are loftier than originally imagined.  Newly- published data appearing in this week’s JAMA show that the very research that is supposed to be forging the path for our nation’s health is filled with ills of its own.

An analysis of randomized and observational studies and meta-analyses published in six “high-impact” journals (i.e. NEJM, Lancet, JAMA, Annals of Internal Medicine, BMJ and Archives of Internal Medicine) demonstrated that there is a dearth of CER studies to guide policymaking or clinical decisions. Granted, this underscores the need to expand funding, preferably public funding to fill the gap. However, key findings also showed that only 32% of evaluable medication studies met the criteria for CER, efficacy outcomes were generally emphasized to a substantially greater extent than safety outcomes (only 19% of studies focused on safety), and that a critical element for promoting effective and efficient healthcare, i.e. cost-effective analyses, appeared in only 2% of the studies. Moreover, less than 50% of studies had active comparators and of these, less than a quarter used non-inferiority analyses, thereby obviating the ability to effectively evaluate and compare similar agents with different side effects profiles.

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According to the non-profit organization Vitamin Angels, one in three children across the globe are malnourished. Just think of how much that percentage has increased by the Haitian crisis Indeed, Vitamin Angels has already shipped one million childrens’ multivitamins to Haiti since the earthquake.

A viable and invaluable solution to malnourishment is to provide these children with essential nutrients both here at home and abroad.  According to research, one, high-dose Vitamin A capsule can reduce the risk of mortality among children under age five by 23%. Moreover, it can provide a sufficient dose to boost immunity for as long as six months, at a cost of only $.02 per capsule.

Multivitamins too, can help combat severe vitamin deficiencies and related diseases among the under five set, while also boosting cognitive and physical performance. In fact, according to a UNICEF Global progress report, almost 600,00 deaths from iron and zinc deficiencies could be prevented with proper supplementation coupled with food fortification. Another 18 million lives impaired by iodine deficiency could also be prevented.

These data are dire and the needs great. Supplements aren’t the only answer and better government coordination, food fortification, awareness and education are needed.

When most people think “global,” they don’t think “home.” But in order to be most effective globally, we also need to consider our own and our children’s wellness needs. I’ve been fortunate to become part of an Advisory Board for the Council for Responsible Nutrition Foundation’s Life Supplemented initiative.  Late December 2009, they launched America’s Wellness Campaign, which is a three-tiered program aimed at helping individuals here at home take charge and monitor their health through diet, exercise and supplements. By offering people an opportunity to gauge and monitor the areas in which they need improvement and in turn, providing research-based informational strategies, Life Supplemented aims to help improve the nation’s health.  But the effort extends beyond our borders as well; Life Supplemented has recently teamed up with Vitamin Angels to provide much needed funding for the programs by offering to donate one dollar for every individual who completes a Wellness Scorecard. Pretty simple; improve your own health and help improve others’ at the same time.

In 2009 alone, Vitamin Angels’ efforts reached approximately 11,000,000 infants and children in 40 countries  (including the United States) by providing them with  vital nutrients needed as a foundation for good health.  I’d like to think that we help them exceed this milestone in 2010 and perhaps even reach some of our own.

The following post by Liz Scherer, Principal of Digital Copy, LLC, is part of Disruptive Women’s “The Value of Health: Creating Economic Security in the Developing World” series.

Liz Scherer is a digital copywriter, health reporter, medical writer, marketing and social media consultant, blogger and women’s health advocate. With over 25 years experience in the healthcare arena, Liz has worked in the private and public sectors on behalf of web-based and traditional science publishers, public relations and advertising agencies and non-profits.

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There’s an elephant in the room: band-aids.

Poverty and its relationship to the provision of and access to healthcare is a global problem. This month, esteemed Disruptive Women in Healthcare bloggers and guest posters are writing on this critical issue with a unique look at the problems abroad. Yet, this has prompted me to look within, for if we can’t address our own problems, how can we possibly be successful at addressing problems outside our immediate borders?

It’s no secret that the divide in the U.S. comes down to socioeconomic status. And while our representatives in Washington continue to battle it out to devise a healthcare reform bill that, for all intents and purposes, may ultimately serve the power lobbies more than the public, a significant proportion of our population is being pummeled into submission with powerful drugs.

According to an article in the New York Times, children from poor families receive antipsychotic medications four times as often as those from wealthier families. What’s more, it appears that these children are likely to receive a prescription for less serious conditions than would commonly prompt a prescription for a wealthier child. The divide: Medicaid versus private insurance.
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The U.S. Preventive Services Task Force unleashed a tsunami this week with new breast cancer guidelines that are suspiciously timed to current efforts to rein in burgeoning healthcare costs. Indeed, the recommendations appear to be geared towards reducing overtreatment by eliminating what the Task Force considers unnecessary follow up screenings and tests. The recommendations even suggest the breast self-examination (BSE) should be discontinued.

In essence, what the Task Force concluded was that while screening reduces deaths from breast cancer, it does not save enough lives to justify associated costs.

To exacerbate the controversy, the American Cancer Society has publicly stated that it does not endorse Task Force recommendations and in a detailed analysis suggested that in the review of the evidence, the committee got caught up in semantics (i.e. risk versus benefit) and that at the very least, computer modeling may be flawed in terms of its ability to translate statistical data into real life.

Meanwhile, the New York Times reports that many doctors are ‘staying the course,’ and in between anger and disbelief, women across the nation are crowding the phone lines trying to discern what is true and what’s not.

Have we all gone mad?

Obviously, these new recommendations will be echoing in the halls of hearings that will determine the future role of mammography in government-run health programs, private insurance programs and the current healthcare reform initiative. Already, Congress is calling for Hearings. But more importantly, is the debacle is a prime example of what ails our healthcare system and reflective some of the more important changes that must take place if we are ever going to move forward in a way that benefits all the players. Truly, who’s really in the driver’s seat?

A study published in last month’s issue of Obstetrics and Gynecology suggests that post-traumatic stress disorder (PTSD) is quite common in pregnant women. In fact, among the 1,581 women evaluated, more than 80% reported experiencing trauma (i.e. domestic violence, previous history of a difficult abortion or miscarriage) that could trigger PTSD. Other risk factors included socioeconomic status and a history of mental health issues (i.e. depression, anxiety, family problems). PTSD also tended to be common among women attending publicly insured clinics.

In a recent post, I wrote that that pregnancy, a prior history of C-sections and a history of domestic violence are considered preexisting conditions by insurers in several states as well as in the District of Columbia. This implies that many women of childbearing age are currently denied coverage or forced to add expensive, unaffordable riders to obtain appropriate, and in some cases, minimal maternal health care. Coupled with these disturbing data that suggest that PTSD is probably more common among pregnant women than ever, and that the factors that trigger PTSD overlap with insurer’s preexisting red flags, demonstrate that change is a reproductive right.

The Healthcare Reform bill that passed the House includes a clause that prohibits insurers from using domestic violence as a preexisting condition. This is an important first step towards ameliorating PTSD in pregnant women. However, should it fail to pass the Senate, one has to wonder if additional financial burdens imposed by lack of access will only serve to increase risk?

Pregnant, traumatized, stressed and declined: four additional reasons why reproductive health reform is essential.

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Citation: Seng JS et al. Prevalence, trauma history and risk for posttraumatic stress disorder among nulliparous women in maternity care. Obstet Gynecol 2009; 114:839-847.

As politicians battle it out across party lines, there’s an important base of constituents that are taking a lot of the hits: women. In fact, “it’s becoming obvious that just having a female reproductive system is a pre-existing condition in the healthcare debate,” writes Wisconsin-based reporter Ellen Goodman.

Goodman is referring to several issues that have recently come to light, such as tighter restrictions on abortion (a measure that was recently defeated in the Senate Finance Committee), or the debate over comprehensive maternal care. Indeed, the Kaiser Family Foundation reports that only 18 states have a requirement for such coverage, (the number falls to 14 when applied to individual insurance markets) while the numbers of plans without or adding expensive policy riders continues to rise.

However, it gets worse. If a woman purchases a policy after she becomes pregnant, the fetus is often considered a “pre-existing” condition, thereby excluding provision of care. The rationale? Pregnancy is “optional.” More appalling is the fact that many insurers consider having had a C-section an equally compelling reason to deny coverage, or to flag charts so that the ability to purchase a policy elsewhere becomes almost impossible.

Are our reproductive systems the only thing under attack? Unfortunately, the answer is no. The gender bias extends far beyond the aisle and into the realm of what is supposed to be a safe haven: the home. In the District of Columbia and eight other states (Idaho, Mississippi, North Carolina, North Dakota, Oklahoma, South Carolina, South Dakota, and Wyoming), having a history of domestic violence is also considered a pre-existing condition, and has been used as a factor when deciding whether or not to provide or extend coverage. Here, insurers have claimed that battered women are more prone to having medical or psychiatric issues that will raise costs. In these cases, these women are victimized not once, but twice: first by their abusers and then by insurers who are unwilling to take the risk.

So, what’s the answer? If you believe the argument of Arizona Senator Jon Kyl, who, speaking directly about maternity care stated that “I don’t need maternity care and so requiring that to be in my insurance policy is something that I don’t need and will make the policy more expensive,” then you are sitting on the wrong side of the aisle. This isn’t a reproductive issue; it’s a human one.

Do you ever wonder who the champion advocate for the patient is in the healthcare reform debate? More importantly, is the focus on consumer choice taking a front seat while the issue of how consumers will ultimately respond to those choices is being ignored?

Many people, myself included, believe that in aggregate, individuals are best equipped to advocate for themselves. In fact, this hypothesis forms the foundation for a key component of Health 2.0, in which the consumer takes more responsibility for managing his or her healthcare and by default, the delivery of that care becomes more fluid and cost-effective.

The rub, however, is that data suggest that most consumers of healthcare rarely if ever speak up.

A fascinating report published in the September issue of Milbank Quarterly shows that fewer than 40% of 5,000 patients surveyed complained to healthcare insurance plans when a problem arose, even when it cost them upwards of $1,000 in out of pocket expenses or if care (or lack thereof) led to a more serious health condition. What’s more, less than 15% of patients took steps to opt out of their current plans and search for a more palatable option.

What these results demonstrate is that current response to the coverage being delivered neither safeguards the patient or serves to highlight the most significant problems among current plans in the marketplace.

Clearly, two major components are missing in the current debate: unique, consumer-driven advocacy and optimized patient responsiveness. Without these, even the most attractive new options on the table may ultimately fail to lead to better overall quality of care.

“I’m mad as hell, and I’m not going to take it anymore.” Howard Beale, Network.

As the fight over healthcare reform continues to heat up in the Senate and House, the mob mentality has taken hold over America.

From town hall meetings, protests and OpEds and to blogs, Tweets and Facebook postings, ‘I’m mad as hell’ is permeating the interwebs, airways, and pages of our life. Even a newly formed U.S. “religious left” has wandered into the debate. Everyone, it seems, wants a piece “of me/you/him/them.”

So what is it exactly that is fanning the flames of passion? And why is so much misinformation being strewn across America?

Interestingly, fear mongering took hold shortly after 9-11 and didn’t let go in the 7 years that followed.

Fear mongering is once again taking hold and riling up the crowds. And the arguments aren’t intelligent ones. Socialism, Nazism, Constitutional Rights being destroyed, Obamacare, death panels…where does it stop? And does the mob mentality actually interfere with our free right of expression when those of us who attend the town halls can’t hear the information because of the accusations being thrown around the room.

Frankly, I believe that the only ones who can rein in the angry mobs are the mobs themselves – that individuals need to turn a deaf ear and begin to intelligently explore the options being laid out on the table.

The Kaiser Family Foundation has developed a side-by-side, interactive comparison of the proposals being laid on the table. Do yourself a favor: visit the site, read through the proposals, and learn the truth. Then if you still feel angry, put down your dukes and express it intelligently and passionately, not angrily and ignorantly.

Education is power. Anger only serves to dilute it.

Several weeks ago, I wrote about the need for a new paradigm, one that integrates Eastern inductive and Western reductive methodology so that efficacy can truly be measured in alternative medicine trials. In that post, which was part of the DWIHC Comparative Effectiveness Research Series, I argued that Western researchers continue to try to squeeze a square peg into a round hole, and in doing so, ignore the subjective element that is an inherent part of the fabric that we call Eastern medicine.

This past week, I ran across a study in Menopause that not only supports this contention but also challenges us to more closely examine the limitations of current investigations into alternative therapies.

ACUFLASH (the Acupuncture on Hot Flashes among Menopausal Women Study) was a randomized, controlled, parallel study comparing the efficacy of weekly acupuncture plus self-care to self-care alone in 277 menopausal women experiencing, on average, 7 or more hot flashes daily. But here’s the rub: unlike previous trials, ACUFLASH actually estimated the effectiveness of acupuncture in practice, meaning that the study was specifically designed to mimic the basic tenets of Eastern philosophy and incorporate the subjective. Consequently, after agreeing upon expected diagnoses and recommended point selection, licensed Traditional Chinese Medicine acupuncturists were free to diagnose, select acupuncture points and individualize treatment for each study participant.

Not only did the mean frequency of hot flashes decline at least 50% in half of women receiving acupuncture plus self-care, but significant improvements were also noted in hot flash intensity and overall quality of life measures. More importantly, by incorporating a larger study group, and eliminating sham needles and “standardized” (compared to individualized) practice, the researchers were better able to preserve the overall quality of acupuncture and what it strives in achieve, while still remaining true to the tenets of evidence-based scientific methodological standards.

Is this study without flaws? Certainly not. Indeed, the investigators acknowledge that the study participants were not treatment naive, and point out that sham acupuncture, which may be necessary for a true comparative analysis, is hardly “physiologically inert.” Nevertheless, I remain hopeful that the study design and its positive results may open the alternative therapy door a bit wider and lend further credence to its role in treating disease.

“$2.5 Billion spent: no alternative medicine cures” screamed the headline two weeks ago. “You expect scientific thinking” one expert was quoted as saying, claiming that it’s become “politically correct to investigate nonsense.”

So what’s the real issue here? Better yet, is there a way to bridge the gap between Western and Eastern philosophies so that the constituent that matters most in this paradigm — the patient — wins?

I believe that when it comes to comparative effectiveness research (CER, i.e. the efficacy/superiority of one drug or modality compared to another), the heart of the West vs. East battle is two-fold and until we find ways to overcome philosophical barriers, never the twain shall meet.

First, we must examine the funding factor. Notably, most Western studies have been and continue to be privately funded and simply fade away with little fanfare if findings are negative or inconclusive. Conversely, a majority of studies that examine “unconventional” or alternative treatments have had the taxpayers footing the bill. Consequently, let’s ask what we can do to engage institutional and pharmaceutical interests so that the funding conundrum is more equitable?

Second, (and more importantly) are Western researchers attempting to fit a square peg into a round hole? Does ‘one size fits all’ work? Eastern research has long been based on an inductive method that relies on direct observation of the individual and his/her relationship to environmental insults. On the other hand, Western research is reductive (or deductive) with general observations evolving into a statistical design that leads to certain conclusions. Although there has been a movement within the Eastern research community to incorporate traditional Western methodologies (e.g. control groups, randomization) one must wonder if by doing so (and thereby eliminating the subjective element that has driven data collection for centuries) the modality under investigation becomes diluted in terms of quality of practice?

Rather than screaming ‘foul” and “nonsense,” shouldn’t we be encouraging innovation in scientific methodology and CER in ways that integrate Eastern inductive approaches into Western reductive strategies so that the researchers can truly measure efficacy? A new paradigm is a win-win for all.