The massive increase in procedures over the past 20 years has added to the cost of providing care, to no one’s surprise. A study in the recent Radiology journal acknowledges this.

Part of the explosion in medical imaging over the past two decades may be attributable to overutilization, and steps need to be taken to cut back … Imaging services and their costs have grown at about twice the rate of other technologies in healthcare including lab procedures and pharmaceuticals…

Part of the problem fueling this growth has been the inclusion of many non-invasive standard imaging techniques as being procedure based — lumping the costs associated with uncomplicated, unenhanced CT imaging with, say, CT-guided renal biopsy — for example. Of course, bordering on the unethical side are the practices of self-referral within large imaging groups in many healthcare markets. | LINK

For the past six months insurance regulators in California have been working through negotiations with Anthem, a BC insurer whose initial premium rate hikes became a cause célèbre for healthcare consumers in that state and the Obama administration, alike. The previously proposed 39% increases created a firestorm in healthcare policy circles and provided Obama and HHS a temporary PR headache as a solution to lower premium increases was sought. The end result after scrutiny of state ledgers is a “smaller” increase —  of approx. 14 percent. | MP3 LINK

The initial impact of the new healthcare reform law won’t begin until late September/early October. But how much do Americans really know about the legislation’s benefits and changes? President Obama has embarked on some PR jaunts to remind the public of the virtues of reform, but is the White House’s awareness campaign really enough to get the word out that reform is actually imminent? Apparently not.

Many key parts of the new law, signed by President Obama in March, take effect in several stages beginning next month and continuing through 2015. Because it’s so complex, consumer advocates worry that people won’t take advantage of its benefits, so they have embarked on a nationwide education campaign. [..]

“People are still afraid that there are death panels . . . or that Medicare is going to go away,” says Cheryl Matheis of AARP, the nation’s largest seniors organization. “We have an obligation to get the information out there…”

It’s the new reality. Focus groups, polls, lobbies. To bad reform won’t cover the cost of these mechanisms of information dissemination. | LINK

Confirming what many, if not all providers in healthcare delivery already know, a study in the Annals of Int. Med. confirms the rampant favorability of results in pharma industry sponsored trials. In the meta analysis of over 500 trials, researchers found that industry-funded trials received positive outcomes approx. 80 percent of the time, compared to positive outcomes in just 50 percent of government-funded ones. Also, results of industry-funded studies were published within two years of study completion 32 percent of the time compared with 54 percent for government trials — suggesting not only certain bias in reporting in heavily invested outcomes, but also that government funding occurs sooner in trails when results may not seem as certain to produce a favorable outcome. The government’s registry of trials in development provides excellent information on study quality of over 90,000 investigations for those interested in getting at the true purpose of a proposed clinical trial. | LINK

The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those risks were not deemed strong enough to warrant removal. Twelve of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.

What is known now is that, according to the FDA, unless there is more long-term data on a link between Avandia’s use and cardiovascular death, there is nothing in terms of evidence currently convincing enough to warrant pulling the drug from the market. That’s the official statement by the agency, anyway.

As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?

An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.

GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data  to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.

Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.

GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it purposefully covered up that information. This, according to a report obtained by the NYT.

The reports … say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

GSK has always stuck to its guns in defending its assertions that statements like that are based upon faulty safety information gleaned from major trials casting the drug in a negative light — like the well-known RECORD trial, which found that the overall risk of cardiovascular death of Avandia was not statistically significant. That meta-analysis was commissioned by GSK at the request of the FDA.

This is just the latest revelation in a very public battle over a Pharma company’s credibility in the healthcare marketplace and the validity of new information from a Senate investigation into that company’s handling of the trial results. Implications on who controls subsequent drug safety and treatment data years after a drug’s initial availability and what it means for the welfare of the public taking the drug versus pharma profits from the sale of the drug should be weighing greatly on the FDA panel making the decision on the drug’s ultimate fate. | LINK

A spurned father and husband. A vindictive personality. A stalker’s mentality. A physician. These are all descriptors that would apply to a high-level University of Minnesota researcher whose private emotional meanderings are now the stuff of public scrutiny.

Locked out of his home and ignored by his loved ones, Schleiss, a prominent University of Minnesota researcher, took matters into his own hands. He used his position at the university to peek into the medical records of his wife and two teenage daughters a dozen times in 2008 and 2009, university and other records show.

Although the doctor was not formally disciplined (ie, at the very least reprimanded; worst — license revoked); his actions are the subject of a federal investigation into privacy laws regarding patients’ electronic health records. Is his position as the chief of pediatric infectious diseases enough to shield him unfairly from any sort of discipline that would most likely have been meted out to any other physician (or other healthcare worker) in a less prominent role? | LINK

It’s official. The FDA will convene this Tuesday (13) to discuss and come to a decision on the fate of GSK’s Avandia. I guess you could literally call this agent a wonder drug — as its continued availability in the Pharma marketplace in spite of hundreds of class action lawsuits, multiple studies stretching back to at least 2005 documenting a clear association with an increase in heart attack risk, and copious physician calls for its withdrawal — continues to amaze healthcare policy watchers.

For the first time it appears that the handwringing on both sides of this hotly debated drug (Pharma/GSK vs. medical critics) appears to be taking on an overtly political tone, as even within the government agency itself, there is a deep devision over just how this entire case should be handled. The hoopla surrounding the removal of Vioxx and Bextra (anti-inflammatories with similarly documented cardiac risks) was never this contentious. Even U.S. senators have weighed in on the issue.^[1] What will the fate of this drug be? Tighter restrictions on its use, or complete removal from the pharma marketplace? Perhaps the answer says as much about the FDA as it does about GSK. | LINK

1. Sens. Baucus and Grassley published a report questioning the FDA’s rationale for keeping the drug available while GSK knew about the drug’s risks. [↩]

HIT alert: The HHS is proposing  new privacy guidelines designed to protect consumers’ (patients) health information when that health information is handled by third parties. The proposed rules come as part of the Health Information Technology for Economic and Clinical Health (HITECH) Act — enacted as part of the American Recovery and Reinvestment Act of 2009 under Obama. The ubiquitous HIPPA legislation signed into law in 1996 is essentially strengthened, and hopefully clarified, as finer points in patients’ health records in the past have been exploited and mismanaged under perverse interpretations of that law by third party entities — many of which are payers.

Among the expansion of HIPPA parameters expanded by these proposals by HHS:

• setting new limitations on the use and disclosure of protected health information for marketing and fundraising
• prohibiting the sale of protected health information without patient authorization
• expanding individuals’ rights to access their information and to restrict certain types of disclosures of protected health information to health plans

It only follows that if consumers have and expect access to their personal health information in whatever form desired, then they have to be encouraged to expect safety mechanisms are in place to protect the delivery of and accessibility to that information. These proposals are to go into effect later this year. | LINK to HHS’ privacy site | LINK to 60-day public comment site

Some headlines prior to the Independence Day holiday. Normal posting resumes here at Doctor Pundit on July 6. Have a happy and safe holiday weekend!

• Veterans Admin admits to the debacle surrounding dirty dental instruments placing hundreds of patients at risk of HIV transmission. [LINK]
• Minnesota nursing strike may be averted, but time will tell if threat to strike was more of a bluff. Hospitals and nurses pledged to work within the constraints of internal governance. [LINK]
• How’s healthcare reform going? Just fine, according to some. [LINK]
• How influential will states’ insurance commissions be when regulating insurers’ medical loss ratios in the age of reform?
  

  The medical-loss ratio measures how much of premiums insurers pay out for medical care versus administrative costs. The new law requires that insurers use at least 80% of the premiums from individuals and small businesses to pay for medical care and profit-taking, and 85% of premiums from larger employers. Health insurers are waiting for regulators to clarify how companies must account for the numbers—whether they can average the MLRs of their subsidiaries, for instance.

  [LINK]

• Study: Genes key to longevity. [LINK]

A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, heart failure, stroke or heart attack by almost 20 percent compared with its main competitor, Actos. Another trial noting heart-attack risks associated with Avandia found that one of every 52 patients using the drug had an almost 33 percent increased risk of getting one.

Not to be outdone, the pharma manufacturer of Avandia — Glaxo Smith Kline — is standing by the troubled drug, releasing a statement saying that randomized trials show it is, indeed, safe; the American Diabetes Association agrees, saying there is no increase in overall mortality from the drug — independent of its effect on one’s risk of cardiovascular complications. Physicians have gone on record as being, at the very least, circumspect on the safety data trumpeted by GSK — noting flaws^[1] every step of the way. | LINK

1. Physician-critics have said the overall rate of cardiovascular problems among patients in the trial was suspiciously low. Many Avandia patients took statins — 10 percent more than the non-Avandia users — and those cholesterol-fighters are known to cut heart attack risk. Also, they say, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results. [↩]

A study commissioned by the Commonwealth Fund confirms for some the dire straits quality healthcare delivery finds itself in today in the United States on the cusp of a reform effort. While, superficially, results like this are designed to provoke an immediate response (like from those on par with the Michael Moores of the world) — I find that the greatest asset findings like this can generate is creation of tough questions when one is forced to take a look at key quality indicators that reform will impact over the next decade.

On quality, the U.S. stood out “particularly with symptoms of more fragmented, poorly coordinated care,” Schoen said. In 2008, for instance, 14% of American adults with a chronic condition reported receiving the wrong medicine or the wrong drug dose in the past two years.

When compared to, say, Sweden or any other European country — an interesting stat. But getting out of the apples-and-oranges mentality allows us to see nuggets like this in a more sobering light. When placed in the context of Obama’s reform plight, it signals a call for urgency in healthcare delivery. | LINK