The huge drive to immunize the masses against threat of H1N1 in the 2009/10 influenza season (which the WHO has officially declared concluded) has created more than a watershed moment in 21st century public health response to a potential biological catastrophe, it has also touched off a political debate that’s just getting started. And it all has to do with authoritarian mandate of the vaccine for healthcare workers.

Contrary to popular thought, many healthcare workers do not receive the vaccine; in fact, approximately 40 percent of said workers actively refused [PDF link] the vaccine last year — during infection’s peak. This notion does not sit well with a couple of policy organizations — one academic and one medical. Both groups say mandatory influenza vaccine should be a condition of employment. The groups stress increased availability of the vaccine, a steadier supply of healthy workers to administer care in times of a crisis, and an overall decrease in the incidence of influenza-related deaths in already compromised inpatients with other medical problems.

Already, the state of New York is hard at work in developing regulatory actions for its public healthcare workers. | LINK

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

The application of the philosophy that is at the core of medicine: first do no harm — is a little at play in an article in the NYT. The rise of so-called concierge practices in the wake of healthcare reform has touched off a debate of sorts on the ethics of delivering such care. That is, you essentially pay for what you get — nothing more, nothing less. Perhaps its the myriad names by which its central workings are known that give it some ethical cover: membership medicine, concierge health care, cash only practice, direct care, boutique medicine. These terms convey one basic fact — the patient pays an annual fee (with other possible charges). In exchange for the retainer, doctors provide enhanced care.

[I]t’s hard not to wonder whether it is possible to practice in a way that reconciles concierge medicine with all the ethical concerns. One group of doctors in Boston believes it is possible. [...] But unlike other boutique practices, the retainer fee of $1,800 per year that these patients pay does not go directly to the doctors’ coffers. Instead, it is used to support the traditional general medical practice, the teaching of medical students and trainees and free care to impoverished patients.

Thinking of the delivery of this type of “specialized” primary care in which fees go to the process of delivery itself before direct provider revenue is another way some primary care practices hope to regain some lost footing in practices on the brink of dissolution or acquisition under the brave new world of reform. For some of these practices, for now, arrangements seem to be paying off — ethically, if not fiscally. | LINK

I have always viewed as circumspect the interest of certain medical specialty societies which take stands that could be viewed by some as political. The need for these groups to make some sort of societal statement applied to medical corollary without the acknowledgement of the majority of its members implies ever so slightly of a kind of elitism better served by organizations more overtly deemed “political”.

Consider the statement by the APA on the recent effects of the oil spill on the incidence of mental illness diagnoses and subsequent insurance claims for treatment.

Mental illnesses brought on by difficult situations surrounding the BP oil spill may be less visible than other injuries, but they are real. An entire way of life has been destroyed, and this is causing anxiety, depression, [PTSD], substance use disorders, thoughts of suicide and other problems,” said APA President Carol A Bernstein, M.D.

The position –  the result of a response to BP’s chief claims administrator essentially denying payment equity with physical ailments payable with the government’s escrow relief funds — sounds more like a pitch to the feds and Big Insurance for more action guaranteeing accessible mental health care under reform. Since the biggest oil fiasco in this country’s history won’t be fading in importance anytime soon, the drive is on for greater awareness of the need for improved access to mental healthcare services.

While there is nothing wrong in actively lobbying the federal government for goals like this — the timing of this announcement, the association with a prominent DC-area mental health lobby, and the strong interest in this particular tragedy (as opposed to other numerous, less newsworthy ones) — should remind healthcare providers of the blurred line between political activism and healthcare advocacy.

I know Facebook exists, but I am not part of its ever-growing half-a-billion member network. But a pharma company apparently is. Novartis — maker of such patented mainstays as Lotrel and hot seller Diovan — was sent a notice by the FDA in which the government agency accused the drugmaker of violating Facebook terms in relation to their misleading potential consumers over a leukemia drug.

Once the drug info is viewed on the popular social network, users can spread the word about all of its benefits, but about none of its risks. In the ad for the drug, claims were made that it outperforms other anti-leukemia drugs on the market; those claims have not been proven. | PDF LINK

In addition to re-evaluating its pharmacotherapeutic review process against the backdrop of reform, the FDA is proposing changes to its medical device review process. Essentially, it’s focusing on the scheme in which medical device makers have to prove their product is similar to one already in the marketplace before launching it commercially. This proposal may be in response to critics of the present process, which bypasses clinical trial rigor — potentially releasing an unsafe device to public. Other points the FDA is considering:

• Making the approval process smoother for so-called medical devices brand-new to the market (novel), as those would not be similar to a product currently on the market but are still relatively low-risk.
• Issuing guidelines on when a device on the market shouldn’t be used as the basis for approval of a new device; so that approvals cannot be based on an unsafe product.
• Issuing alerts/bulletins to medical device makers to better communicate changes in preapproval expectations.

LINK

In a reform environment in which appearances are everything, providers could be looking to the AMA for some help. Some physician groups/health systems, the AMA says, could be unfairly targeted by insurers’ quality ratings to steer patients toward systems they deem more “efficient”, creating a somewhat dubious practice reputation for those health systems cited as “inefficient”. Insurance companies counter that, in this age of reform, the delivery and coverage marketplace will have to adapt to measures, they say, are being mandated by the Obama administration as necessary mechanisms of reform and quality.

The AMA is particularly worried about individual physicians being rated by insurers. The doctors’ group says physicians who are deemed expensive may be looking after sicker patients, or the claims data may simply be inaccurate.

A very simplistic view by the AMA, as the 21st century patient and healthcare consumer is able to make informed decisions on provider networks based upon resources unavailable to them just a few years ago. Patient advocacy groups, disease advocacy organizations, support groups, and … even insurance companies themselves are sources of care informatics designed to “steer” patients to where they should be seeking care based upon the best available data matching their unique chronic care needs. Healthcare quality doesn’t just appear out of nowhere; it must be earned. Patients cannot benefit from it without physicians who are capable of providing it.| 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

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. [↩]

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]

What is known about the H1N1 epidemic that plagued the world in 2009 was its influence in global approach to this infection — for good or bad — and the costs to nations which chose to meet its threat head on. What wasn’t known at the time (but may be increasingly apparent if many European countries have their say) is that the trajectory of the influenza strain’s influence as a major media event may have been manufactured, by, of all entities, Pharma and its association with the World Health Organization. The concerns are outlined in an 18-page report criticizing costs deemed by many nations as unnecessary, as were “amplified” fears at the hands of the organization in galvanizing support for guidelines influenced by Pharma makers of the H1N1 vaccine.

Calling the WHO and its response to the H1N1 epidemic “exaggerated” and “lacking credibility”, many European nations are quite vexed that, among other things, guidelines issued by the WHO in response to what it termed as an epidemic came from consultants who received much in the way of fees from two leading Pharma manufacturers of the vaccine that would prevent the virus’s spread: Roche and GSK. The WHO has opened up its own international investigations into the matter — one of which involves the Institute Of Medicine on these shores.

The WHO asserts no potential for conflict of interest within its ranks, as this appears to be the central question in this entire matter. | LINK