A major focus of President Obama’s healthcare reform initiatives included over $1B in funding for comparative effectiveness research — a discipline designed to study the most efficacious, efficient, and low-cost methods for healthcare delivery. Perhaps the most basic scenario is defined by the study of two different pharmacological therapies for the same problem. A trial published in this week’s JAMA states, however, that relatively few studies were devoted to this research modality, a cornerstone of Obama’s pledge to research better ways to deliver healthcare more cheaply. Only a third of 328 studies published in six top medical journals from June 2008 through September 2009 met the definition of comparative effectiveness, according to the investigators.

Naturally pharma companies aren’t invested in such matters, with the majority of funding for CE trials paid for by public sources. Typical pharma-financed trials are usually designed to show positive results. Although the need for unbiased, pure research is high given Obama’s admirable concern for such resource deployments, the road to drug research using such models is a long one filled with roadblocks — as long as Pharma has a stake. Perhaps a better way to ensure greater adoption of this initiative is not only to earmark a steady stream of federal funds targeted at comparative effectiveness research, but also to compare newer treatments with longstanding existing modes of treatments (pharma or otherwise) whenever possible.

RELATED: House bill concerning CE [PDF] | Senate bill [PDF]

The questions and lingering concerns surrounding the overuse of antibiotics is an age-old and well-worn conundrum for physicians and patients. Even the latter group, well-informed as consumers of healthcare, can agree that most acute upper respiratory infections are most often the result of viral infestations which play themselves out in spite of antimicrobial treatment.The decision to (over)use them in standard medical practice is often the point of debate, as physicians weigh factors such as patient satisfaction and lingering medical and health policy issues surrounding resistance.

Last year, this blog reported on these issues as background for a program in which some retail pharmacy chains were giving away for free antibiotics to patients with prescriptions from their physicians as a way of helping with affordability in the wake of the debate on reform. The CDC offered a statement promoting the responsibilities providers, pharmacists, and patients should consider in taking part in such a program.

Smaller chain pharmacies are trying to compete with the big boys, and in trying to earn store-brand loyalty among their (un- and underinsured) consumers, they are throwing free antiobiotics their way. Last week, the CDC sent out letters those several chain pharmacies that offer no-cost prescription antibiotics to low-income consumers urging them to promote responsible use of antibiotics.

While the program was essentially successful in its efforts to bridge the gap between affordable, accessible healthcare and patient responsibility, no one was really prepared for the massive policy decisions that would have to be made as the June ‘09 H1N1 pandemic loomed — after its initial discovery just one month after this initial Doctor Pundit posting.

Any momentum gained by President Obama when the issue of exorbitant insurance premium hikes was the healthcare topic du jour last month seems to be all but forgotten as Insurance continues to conduct business as usual. In Mass., the Blues in that state face fighting caps on their rates as its governor, Duval Patrick, reviews requests for increases of anywhere from 8 to 32 percent.

In California, the apparent epicenter of the firestorm over rate hikes, insurance companies seem loathe to change as well, citing the “increasing costs of healthcare” as  a reason for those hikes. All of this movement by Insurance is forcing Obama to take his message to the public to get support for reform. He’ll begin his week by doing so today in Philadelphia.

Wise move? It’s perhaps his only move. With the GOP urging going back to the drawingboard, moderate Dems uneasy over the pricetag of reform ($1T), and House liberal Dems suspicious of Senate motives once the bill is passed; it appears that Obama is turning to the only group left to fully convince the utility of a healthcare overhaul — the American people. | LINK

It had all the trappings of a political football; a blue state’s extremely unpopular Republican governor — looking toward a possible presidential run a year after his term ends — used his partisan hardline to threaten veto of one of the most well-funded social programs for healthcare delivery to the state’s working impoverished, all the while setting the stage for a political attack on his character for all of the nation to see at the hands of the opposing party. The apparent newfound conciliatory stance taken by Minnesota governor and 2012 prez hopeful Tim Pawlenty concerning the threatened veto of GAMC headed this scenario at the pass, however, as the healthcare delivery safety net for thousands of the state’s working poor got a last-minute reprieve to continue being funded, albeit scaled back. Of course the negative PR surrounding a pending lawsuit by three beneficiaries of the program didn’t make eating crow any easier for the chief executive.

Though funding for the program was supposed to end on April Fools Day, the brokered change in funding commitment means that service providers will see less in reimbursements. Also,

[u]nder the agreement, hospitals will receive $71 million from the state’s general fund for the year starting July 1 and $131 million the following year. About 12 to 15 hospitals likely can start serving patients in the new program on June 1. For others not yet ready, $20 million will be set aside to pay for uncompensated care for six months.

The key is in acute care — often the first and only mode by which this underserved patient population will continue to receive care. With a decrease in monies to provide it — even with a grace period of sorts for charity care — the level of participation of acute hospitals is emblematic of both ongoing problems with funding (providing care) and simply surviving as they continue to operate in a program whose demand will only increase until reform is achieved on the national stage. | LINK

Physicians — especially those of the primary care type — are spared the potential problems that come with cuts in Medicare payments. At least for another month. President Obama has delayed the anticipated 21% cut in reimbursements while Congress has to take the matter up yet again.

Sen. Jim Bunning (R-KY) created a legislative frenzy last week when he placed a procedural hold on the bill that would have extended health care benefits to the unemployed for an additional length of time. That measure would have also allowed taxpayer subsidies to be used for premiums. Bunning relinquished his standoff yesterday, allowing this extension on cuts in payments to be avoided for another 30 days.

Polling, as a result, shows just how far cuts in Medicare payments to providers and provider organizations will go in threatening care delivery to a huge segment of the chronic care patient population — the same demographic responsible for the heaviest utilization of pharma, primary care, and acute care. Approximately two-thirds of primary care physicians polled by Medscape said they would cease to care for Medicare beneficiaries as a result of the cut.

An extension only holds off the inevitable, and although Senate Democrats are looking for ways to delay cuts further, there has to be a day of reckoning. That could come October 1, if senate legislators work to pass another bill [PDF] and try to reverse the SGR formula [PDF], which is responsible to establishing pay cut schedules in Medicare provider reimbursements.

With reform, the current band-aid strategy the Obama administration is using continues on its sloppy course.

Pfizer’s current research on a potential blockbuster anti-Alzheimer drug is currently back to drawing-board status. According to the pharma company

[T]he drug, called Dimebon, had shown virtually no effect after six months in treating the cognitive decline or behavioral problems associated with Alzheimer’s when compared with a placebo.

Apparently, Wall Street has been watching the results of this Phase I study; the verdict is still out on whether Pfizer will continue to fund the research for this agent — designed to work better and longer at inhibiting some of the most distressing symptoms related to the disease. | LINK

Does the higher cost of providing care actually mean better care? In more fiscally flush times, the knee-jerk among patients and providers would probably be a nod toward the affirmative. Today, in the wake of a reform fight which has placed front and center the once-mundane issue of healthcare delivery previously reserved for ivory tower wonkish types; this issue is as bread-and-butter essential to the American public as, say, enormous property tax increases.

Researchers, studying over 3000 hospitals over a two year period (2004-2006), put this question to the test when they compared Medicare beneficiaries who were treated for pneumonia and heart failure. Those treated for the latter condition at “lower-cost” hospitals fared better^[1] chronically with this diagnosis than those treated for the former — essentially calling into question the hypothesis that low-cost hospitals discharge patients earlier but have higher readmission rates (for certain diagnoses) and greater subsequent inpatient care costs. The implications of this trial — no major differences in outcomes between hospitals with longer patient stays and shorter ones — could be far-reaching when setting policy on Medicare reimbursements for acute patient care. | LINK (Study abstract only)

1. using 30-day mortality rates, readmission and six-month costs of inpatient care among two of the most common Medicare-covered inpatient diagnoses [↩]

House Speaker Pelosi says she is confident that healthcare reform will pass. This, apparently, is the major mode of thought coming from the Democrats as a result of the flurry of activity and speculation filling the Sunday morning talkfests yesterday. Relying on the sheer numbers of votes in her party, the pronouncement comes a few days ahead of President Obama’s announcement later this week of how he’ll proceed on reform.

Votes are one thing, but how those votes will be cast is quite another — and in the Beltway, perception is everything. The GOP is ready to counter any move by the Dems with criticism they hope to ride all the way to November. If it’s getting the bill through reconciliation (to avoid a filibuster)^[1] or starting over from “scratch” — the GOP’s version of a legislative “gotcha” directed toward Obama — the Democrats seem to be playing a risky game with the nation closely divided on the reform bill as it stands today.

Spring break in Congress occurs on 3/26. Will things be wrapped up by them? Will the long road to reform end with votes to secure a bill, any bill? Or will it come down to reconciliation as the line in the sand: for the Dems, it means passing a bill to expand Medicaid, require employer-sponsored coverage, and require people to have coverage; for the GOP, it means fighting against reconciliation and turning Obama’s push for reform into a protracted referendum on the balance of power in Congress come November. | LINK

1. The House would pass the health bill approved in December by the Senate, and both chambers would approve changes, separately. [↩]

President Obama’s healthcare summit has come and gone. The mere fact that this meeting took place in front of cameras was reason enough to discount any potential for real bipartisanship to occur. The upshot? The Republicans stand firm on their ground to rally against any Obama proposal as the party brands itself on this issue ahead of a potentially gratifying November midterm.

Meanwhile, the White House and the Democrats will say that every effort is being made to “forge ahead” amid the apparent obstructionist natures of the GOP. The problem for both parties is that the American public is becoming tired of what it sees as a spectacle. According to a CNN poll [PDF], 86 percent felt that government is broken, with 14 percent saying it isn’t. Of that 86 percent, 81 percent say the government can be fixed, with 5 percent saying it’s beyond repair.

Whatever the ultimate effect this televised meeting had on patients, lawmakers, physicians, insurance companies, and other interested parties; one thing’s for certain: closed-door meetings are the only way anything can get done. Political theater for the world to see accomplishes nothing but shallow grandiosity on the bumpy road to an ultimate reform bill. | LINK

RELATED: The GOP’s proposals. | LINK

A safety review of GSK’s Avandia, under fire and intense scrutiny for its role in the possible development of cardiac adverse effects is nearing completion. In spite of the continued negative press, the pharma company has issued a thirty page rebuttal [PDF] of the Senate Finance Committee’s report alleging those safety issues.

The pharma company faces an uphill battle. In the wake of 24-hour, always on news cycles which seemingly filter only stories of negative sensationalism, it should be taking its damage control cues from Toyota these days.

Among the report’s most “glaring omissions” is its lack of discussion about the final results of the ADOPT, DREAM, or RECORD trials, the company said in a release. It said data from these three trials were reviewed by an FDA advisory committee in 2007 that voted overwhelmingly to keep rosiglitazone on the market.

Perhaps, but the issue now is that GSK chose to keep this information from the meta analysis of these trials from prescribers and patients, according to the Cleveland clinic physician responsible for bringing this data to the forefront. | LINK

Ready…set…yawn? With all of the fanfare surrounding this morning’s healthcare reform summit in Washington, you’d think that its organizers were pulling double duty with producing the upcoming Oscars. We’ve heard the eleventh hour rhetoric from all sides — the potential for bipartisanship at this late stage in the game and how “wonderful” it is to get this forum televised so that the American people can finally acknowledge the transparency President Obama and the White House have always wanted to characterize since he came into power.

But with all of the pomp, circumstance, and…hyperbole surrounding this morning’s summit, it seems the prevailing thought is more of a, well, an afterthought. Although Barack Obama has trumpeted the bipartisan get-together as having the potential to hammer out a last minute deal that will please everyone everywhere, the public seems to have already made up its mind about the state of reform today — and the court of public opinion shows collective ennui over the multiple set-ups for multiple letdowns. Reform fatigue has finally set in.

When the ultimate news item from today’s marathon session will more than likely echo the fact that nothing can be agreed upon of any substance, the public whom Obama so much wanted to convince that reform was within reach has already packed up and moved on. According to one private Medicare exchange’s polling, approximately 1700 of them have already done so. Mr. President, let the latest installment of this drama begin.

What could possibly be worse for patients as the current state of reform (tune in tomorrow) is more uncertain than ever? According to a JAMA study [PDF], the fact that more physicians are cutting hours — not just primary care docs, but most physician demos across most specialties. Reasons are myriad, but the one essential kernel remains: the increasing layer of oversight (administrative and managed care constraints) has slowly but steadily gained a prominent foothold into how much time a physician can actually devote to seeing patients. According to one family physician

“It added five or six years onto my practice life – and I love what I do,” [Virginia family physician] Dr. Ellington said. “I couldn’t have continued to do what I was doing. I couldn’t do it physically, emotionally and financially. It had become overwhelming.”

And it will only get worse — at the very least for the primary care physician who is already burdened with heavier admin and paperwork hassles, lower pay, increasing patient loads, and lower Medicare reimbursement schedules. | LINK

Pennsylvania and Hawaii are the only two states in the country that do not have a mechanism in place for the regulation of premium rates set forth by insurers as it applies to their small businesses — a demographic courted heavily by both Republicans and Democrats as players in the final direction of pivotal health reform. The Pandora’s Box cast wide open by the recent Anthem BC scandal is adding a new critical layer of scrutiny not only to Barack Obama’s reform trajectory, but also to the ways in which Insurance market fluctuations influence the overall cost of healthcare delivery and access.

Implications for the these two states are obvious, as government regulatory oversight could go a long way in keeping the relationship between small business and the insurance they purchase an open, transparent, and freely accessible system for consumers of healthcare (patients), giving states’ insurance commissioners added muscle. Alternatively, control of regulatory processes by the federal government could add just another layer of bureaucracy (read: increased administrative healthcare costs to the taxpayer and shifting rising costs to other entities — like Pharma) to an already overburdened HHS Dept. Over the next few days, the unfolding issue of federal gov’t Insurance regulation over state’s private insurance markets will become a hot-button one, adding some eleventh-hour drama to the health reform debate. | LINK