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]

In the march toward his overall healthcare reform plan, President Obama has reversed a George W. Bush administration regulation that gave the feds the ability to trump state governments’ decisions concerning liability with medical devices. Device makers were essentially shielded from healthcare consumer lawsuits Bush generally deemed as “frivolous” in nature. Also, Big Pharma was helped by such actions since the FDA often did not follow regulatory guidelines in implementing new drug indications.

Obama in a two-page memo wrote that federal agencies and departments could claim state law is pre-empted by federal law only when there is a well-defined legal basis. The memo stated that state laws are important because they supplement federal regulations. “State and local governments have frequently protected health, safety and environment more aggressively than has the national government,” Obama wrote.

If efforts at stopping government pre-emption give the patient more of an incentive in trusting public delivery of healthcare, at the same time cutting massive bureaucratic waste from lack of government regulation in healthcare delivery, this effort of Obama’s is to be praised. On the contrary, concerns over a flurry of patient lawsuits from Republicans should be a nonissue since Obama acknowledges the rights of individual states in this case. | LINK

Another year, another survey list of sorts for Minnesota. This one, commissioned by a public watchdog group, finds the state near the bottom of said list, albeit for a thankfully different reason. For the second year in a row, the state which usually finds itself near the top of the nation’s healthiest lists, ranks dead last when it comes to the number (per 1000) of physicians disciplined within the past 12 months. There appears to be a correlation here: extremely healthy state = awesomely talented doctors. Well, at least the state’s medical board thinks so. 

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said Minnesota legislators should pressure the board to crack down on dangerous doctors. “In some cases, they need to be taken out of practice,” he said.

Sometimes, advocacy groups just need something to, well, advocate. | LINK

At the dusk of the first decade of the 21st century, a new FDA emerges — one that, shaped by the new Obama administration, will strive to ethically approve drugs and devices while considering every possible significant adverse risk to the general public. Call it a lesson learned from putting the politics of fast-tracking at the hands of major third parties, namely Pharma, ahead of patient and public safety.

This notion is all too cognizant in the minds of the FDA panel, which is struggling with the approval of a new anti-diabetic drug (similar in function to this agent) which shows even greater promise as an adjunct in the early stages of treatment of the disorder. The problem? During the early phases of the drug’s R&D, the incidence of a certain type of thyroid tumor began to show up in rats. Consequently, the FDA is “seeking additional clinical data” (since rats aren’t exactly people). It’s certainly a prudent move, especially in a weak healthcare economy overall, in which the process of new drug development is occurring at a snail’s pace — a rate at which a new approval’s faults would invite extreme immediate  and well deserved post-market scrutiny. | LINK

Two-thousand nine is being dubbed “the year of the generic”. Two senators are trying to keep it that way, citing the potential for Pharma (and its branded, patent-extending reformulations) to simply pay off the manufacturers of generics in an effort to halt their production. It is the aim of the Preserve Access to Affordable Generics Act to abolish the so-called “pay-to-delay” actions of drug manufacturers in which massive financial buyouts are given to generic drugmakers while they wait to market their product, guaranteeing patent extensions. But is this legislation really necessary? Not according to some critics who say that it is in the best  interest of Pharma to invest in next-generation research and development, as such buyouts targeted by the legislature in this case are “last-ditch” efforts by some manufacturers to stifle generic competition. | LINK

The Cochrane Collaboration, an international body which evaluates published medical trials, has interesting insights into the nature of the results of compilations of study data in trials done all over the world. A brand new Cochrane review upholds the clinical suspicions which physicians and healthcare lobbyists know only too well: that studies with positive results are more likely to see the light of publication, reach publication sooner, saturate the media easier, and influence healthcare policy more effortlessly.

So-called negative studies (those which conclude results which may refute established medical dogma or anecdotal belief) were seriously hampered by what the researchers/evaluators termed as “publication bias”. Many involved in shaping healthcare delivery policy in this country know how important a trial with a positive result is as it applies to high powered Washington lobbying; this issue will become much more important as the Obama administration has pledged “transparency” (a word it uses front and center on its official White House blog, describing it as one of its innate characteristics) with respect to all policy matters.

Just as many have cried out that healthcare policy was over politicized and favored Pharma and Big Insurance in the Bush administration, time will tell if Barack Obama is pressured by those same critics to renounce policies which have their genesis in findings like those provided by Cochrane. | LINK

Has the need for attention and online social contacts been co-opted by Pharma? According to a study done by a national healthcare research company, physicians who participate in trade online social networks are writing 24 more prescriptions per week than physicians who are not engaged in such a way. While it is probably a little premature to equate online social networking with tech savvy (a comparison many marketers are apparently just dying to make), this form of information sharing takes the term “curbside consult” and runs with it. Portals such as Sermo (the largest and most entrenched) and Medscape are providing the means for dissemination of timely information; however, it was only a matter of time before it would be exploited by Pharma — in a good way, of course…. | LINK

Minneapolis-based UnitedHealth, which also happens to be the largest healthcare insurer in the state of New York, has settled out of court to pay $50 million to establish a new database that will be used to determine rates for patients who choose physicians outside of the insurance giant’s network. An investigation begun by NY Atty. General Andrew Cuomo concluded a UnitedHealth subsidiary known as Ingenix Inc. was rigged to limit payments to doctors and, therefore, forced consumers to pay more. Cuomo also alleged that there was a conflict of interest because UnitedHealth owns the database.

Typically, patients usually pay 20% of their medical visits to out-of-network physicians. The overall base amount (which also includes the 80% the insurer pays) is determined by a complex method which uses data obtained from that patient database to determine the insurer’s charges to the patient and payments to the provider. Factors such as geographical data and age demographics also play a part. Patients are not supposed to be shortchanged because of this alleged “oversight” by UnitedHealth, says Cuomo. | LINK

The Food & Drug Administration is a scientific government organ, right? A group of scientists is making sure President Obama does not forget it.

In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration. ”The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

LINK

• Medicare alters benefit formula for 2020 pharma plans.
• Physicians puzzled as to Apple CEO’s health.
• Did you know there was a plan in place to epidemiologically eradicate the measles virus by next year? Apparently, there are some speed bumps in the road.

The global plan to eradicate measles by 2010 is unlikely to come about say epidemiology experts because of high rates of infection in some parts of Europe where many children go unvaccinated.

• Blue Cross of California plans to reinstate coverage for patients it had dropped in response to investigations by the LA Times.
• An speaking of California, many healthcare workers are not screened adequately for criminal pasts.

With the clock ticking ever so quickly toward Jan. 1, asthma sufferers will no doubt try to make a run for the border to get refill scripts on their inhalers. Because, effective that date, metered dosed inhalers must go green:

“It’s possible people may skimp on their medicine because of the cost,” said Dr. Bradley A. Becker, co-director of the Asthma Center for Children at Cardinal Glennon Children’s Medical Center in St. Louis. “Clearly that would not be a good strategy because you might end up in the emergency room.”

Many doctors have been prescribing the new inhalers for several months, helping their patients transition to the devices, which use the more environmentally friendly propellant hydrofluoralkane (HFA) and deliver the quick-relief drug albuterol.

Some physicians and pharmacists, however, say they wouldn’t be surprised to see patients rush to snag up the old inhalers, which utilize harmful chlorofluorocarbon as a propellant. The last day for the old inhalers to be sold is Wednesday.

Seems a little late for environmental concerns, don’t you think?

These days, professionals in healthcare have learned to accept the certain fate of pharmaceutical reps and their decreasing stranglehold on the provider targets on whom they prey to essentially hock the respective pharma company’s wares.  Now-ubiquitous state statutes require pharma companies to report financial ties to physicians and their representative healthcare organizations, creating the environment Pharma finds itself in today — a culture of advertising restriction and full physician-client disclosure of association.  

One state that was originally at the vanguard of legislating and, and in many cases, restricting the amount of gifts which providers or their organizations could obtain at the hands of pharma marketing is Minnesota. Now, a MN state senator wants to craft his version of a federal bill aimed at broadening the reach of this type of full disclosure, and the objects of his legislation are the medical device companies and the physicians to and for whom they market and commission randomized trials. | LINK