The Internet has transformed every aspect of health care. Online communities provide new forms of support for people with a thousand different medical conditions. Email has streamlined communication between stakeholders in the system. Electronic medical records and social networking sites hold a wealth of data that can be leveraged to study the effects of various treatments.

The most significant advance however, has been the ease with which people can access information about their health. As many as 74% of all people search for information about their symptoms and treatments online, and many of these information-empowered people now see physicians as guides to and interpreters of this information, a far cry from the era in which passive patients presented symptoms and relied on paternalistic physicians to act in their best interests.

But there are problems with the new paradigm, just as there were with the one it replaced. Online health information can be incomplete, biased, lacking for proper context or flat-out inaccurate. And not everyone, especially those without a medical background, can sort through these deficiencies in a way that assures they are properly informed.

A recent study by Alexander van Deursen and Jan van Dijk of the University of Twente has quantified these problems. The scientists used performance tests to assess health-related Internet search and other online skills in a representative sample of the people in the Netherlands.

Their tests focused on four types of skills:
Operational-These included basic internet skills like opening a health website, saving a PDF file and adding a website to a list of “favorites.”
Formal-These included navigating health-related menus and websites, and surfing a list of websites.
Finding Information-These included accessing specific information regarding medical conditions and answering specific questions like whether it is appropriate to begin a treatment after being infected with a particular germ.
Strategic-These included extracting information from different sources and making decisions based on the information. For example, “find out whether it is wise to give a 3-year-old boy Vitamin A and D.” (more…)

I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

Now, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked, from Parke-Davis’ point of view. Physician ‘investigators’ prescribed 38% more Neurontin as a result of their participation in the trial.

The drug company also leveraged the patient recruitment process to market Neurontin to ‘investigators,’ Ross’ group found. Company representatives asked ‘investigators’ to set-aside certain days on their schedule in which epilepsy patients comprised the bulk of the appointments, thereby permitting the reps to be present and promote Neurontin at the moment of truth. The reps even helped collect patient data for the trial.

The smoking gun though, was uncovered in the company’s marketing plans, which cited the trial itself, not its anticipated results, as central to the promotion of Neurontin. For example, a 1995 report listed STEPS as a deliverable under the strategy “Solidify Neurontin’s position with neurologists and select primary care physicians as the safe and easy add-on for refractory patients.” Another document stated that “the rapid growth of Neurontin depends on the ability to influence the large population of community neurologists that see the majority of nonrefractory seizure patients. The STEPS trial…was a strong start to this…” (more…)

Top Quotes of the Week: Federal Deficit Edition

“Come on, you and I, let’s lock arms and we’ll jump out of the boat together.” House Speaker John Boehner (R-Ohio), in May, urging President Obama to do a ‘big deal’ on the federal deficit.

“I want to get there, but it takes two to tango, and they’re not there yet.” Boehner, speaking about the Democrats last Sunday. Boehner then blew-up talks surrounding a $4 trillion ‘big deal’ he had been discussing with President Barack Obama.

“I’m prepared to take significant heat from my party to get something done. And I expect the other side should be willing to do the same thing.” Obama, responding to Boehner.

Inaction on the debt ceiling “would be catastrophic for the economy…no responsible leader would say the United States of America, for the first time in its history, should not pay its bills, meet its obligations.” Treasury Secretary Timothy Geithner.

“This is a misnomer that I believe that the President and the Treasury Secretary have been trying to pass off on the American people, and it’s this: if Congress fails to raise the debt ceiling by $2.5 trillion, somehow the United States will go into default and we will lose the full faith and credit of the United States. That is simply not true.” GOP presidential candidate Michele Bachmann.

“The astonishing feature of the federal fiscal position is that revenues are forecast to be a mere 14.4% of GDP in 2011, far below their postwar average of close to 18%. Individual income tax is forecast to be a mere 6.3% of GDP in 2011. This non-American cannot understand what the fuss is about: in 1988, at the end of Ronald Reagan’s term, receipts were 18.2% of GDP. Tax revenue has to rise substantially if the deficit is to close.” Martin Wolf, chief economics commentator at the Financial Times, London.

It was nice while it lasted, but the brief surge in optimism surrounding debt-reduction negotiations died Sunday, when Speaker of the House John Boehner announced that his party wouldn’t swallow President Obama’s proposed $800 billion tax increase as part of a package designed to save $4 trillion.

If nothing else, the collapse of the negotiations made it clear that Republicans don’t care about the deficit per se. What they care about is cutting federal spending and taxes, and they’ll do that even if it means partially dismantling popular entitlement programs in the process.

One would think the GOP would have gotten the message that this was a bad idea when a reliably Republican district in upstate New York elected Democrat Kathy Hochul to fill a vacant House seat in a special election last month. Hochul’s entire campaign revolved around preserving Medicare and denouncing a plan by Republican Paul Ryan to transform it into a voucher program, cutting benefits in the process.

In fact the draconian spending cuts envisioned by GOP deficit hawks would impact the health of American citizens far more profoundly than the Ryan plan envisions.

That’s because, as I argued here and here, public health isn’t a medical problem at all. It is a socioeconomic one, and cuts to many programs other than those proposed for our health entitlement programs will affect national well-being and health as a result.

Take Canada for example. That country provides universal, free access to health services for all citizens. If poor access to health care (a problem that would be exacerbated by GOP cuts to health entitlement programs) was the only factor driving poor health outcomes, then we shouldn’t see poor, or less educated people experiencing poor outcomes in Canada. But these differences do exist, in spades. In a recent study of 15,000 Canadian adults for example, participants in the lowest income group were nearly 3 times more likely to die of any cause than those in the highest income group. They were also more likely to have diabetes, high blood pressure, cancer, cataracts and many other conditions. The study revealed similar disparities when participants were stratified by educational level. (more…)

In the 12 years since our government acknowledged we had a problem with racial disparities in health care, we’ve made significant progress in reducing them.  Steep declines in the prevalence of cigarette smoking among African Americans have narrowed the gap in lung cancer death rates between them and whites, for example. Inner city kids have better food choices at school. The 3-decade rise in obesity rates, steepest among minorities, has leveled off.

Still, racial disparities persist across the widest possible range of health services and disease states in our country. The racial gap in colorectal cancer mortality has widened since the 1980s. Overall cancer death rates are 24% higher among African Americans. Sixteen percent of African American adults and 17% of Hispanic adults report their health to be fair or poor, whereas only 10% of white American adults say that. The number of African Americans and Hispanics who report having access to a primary care physician is 30-50% lower than white folks who have one.

How can EMRs Help?
Many studies that rely on EMRs for data collection or care coordination have shown them to have great potential as tools that can reduce racial disparities in health care. For example, a 2009 study showed that post-market surveillance using patient data stored in an EMR could have detected cardiovascular complications from the diabetes drug, Avandia much faster than traditional methods. That’s a plus because African Americans and Hispanics are disproportionately affected by diabetes. Another study showed that patient data from EMRs could identify patients at high risk for domestic abuse, which is more common in some minority populations. A third study showed that EMRs improved care coordination for patients with kidney failure, a condition that disproportionately affects African Americans.

Some of the Federal government’s Meaningful Use criteria may also reduce these disparities, once they fully take effect. The requirement that providers use clinical decision support tools embedded within EMRs holds promise in this regard. CDS tools whose development was underwritten by the Agency for Healthcare Research and Quality incorporate care management strategies designed specifically for minority populations, for example. In addition, Meaningful Use also requires providers to record patient demographic information in the EMR, and this development will likely increase the research value of the patient data contained in these systems.

But There is a Problem
Unfortunately, the National Ambulatory Medical Care Survey suggests that EMR adoption rates are lower among providers who serve minority populations. A study by Jha and colleagues confirmed these findings and also demonstrated that hospitals which served Hispanic and African American patients provided lower quality care. However, among the disproportionate-share hospitals that did use EMRs in Jha’s study, the quality gap disappeared. Jha’s group concluded that EMRs helped mitigate quality issues in hospitals where poor people and minorities received care. (more…)

In the last month, the Obama administration announced programs to reduce racial disparities and increase prevention in health care. Neither program was funded with actual money, so they are about political showmanship as much as any real desire to tackle the worthy causes. After all, who would oppose such programs? I half-expect the administration to follow-up these announcements with one focusing on moms and apple pie.

But have a closer look at what Iowa Democrat Tom Harkin said at the press conference introducing the latter initiative. “For every dollar we invest in prevention, we save $6. We need to provide an approach that makes it easier to be healthy and harder to be unhealthy.”

I haven’t found the report on which Harkin bases his assertion about the returns on health prevention efforts, but my sense is its more complicated than Harkin would have us believe. Some screening and prevention programs are not effective at all. Others are effective, but prohibitively expensive. Any national program to improve prevention needs to evaluate each potential component to assure it reflects Harkin’s focus on cost-effectiveness.

Many recently proposed screening programs do not meet this criterion, in fact. Let’s take a look at a few of them.

Screening for Prostate Cancer
Two months ago, scientists reported the results of a 20-year follow-up study of 1,500 Swedish men between the ages of 50-69. The study found that routine screening for prostate cancer did more harm than good. The screening program (which included digital rectal exams and prostate-specific antigen tests) enabled physicians to detect and treat nearly a third more cancers, but there were problems with overtreatment and treatment related side-effects. More importantly, prostate cancer death rates were the same in the screening group as they were in the control group. (more…)

In the 1993 film Groundhog Day, Bill Murray plays a TV weatherman who finds himself trapped in a do-loop, covering the numbingly boring display of Punxutawney Phil, over and over again.

Forgive those of us who follow news from the Department of Health and Human Services for feeling like Bill Murray in that movie.

Last month, HHS released an action plan to reduce racial disparities in health care. The plan called for new care models, more service delivery sites, a beefed-up health and human services workforce, and targeted efforts to reduce cardiovascular disease, childhood obesity and other scourges of minority populations.

Remarkably however, the plan came with no funding. Apparently, it was supposed to prompt agencies within HHS to assure that their own internal plans were aligned with the effort to reduce racial disparities. Worse yet, the plan involved only HHS itself. In effect, it assumed that a ‘medical model’ can solve racial disparities in health care. However as I argued here, these disparities aren’t about health, at all. They are about socioeconomic status, and HHS can’t fix that by itself.

Solving the problem of racial disparities in health care clearly requires input from many branches of government, including those involved with education, urban planning, transportation and more, in addition to HHS.

When it was all said and done, the HHS plan came off looking like a political stunt by the Obama administration. While the administration probably does want to fund a bona fide effort to reduce racial disparities, today’s incessant (and appropriate) focus on deficit reduction forced the administration to release a plan with no teeth. It isn’t going to make a dent in the problem.

“Oops!…I Did It Again.” Britney Spears

Now barely a month later, HHS has pulled the same stunt again! With considerable fanfare, it released something called a National Prevention Strategy. It too, is not funded.

To its credit, the National Prevention Strategy does involve multiple agencies. “If we want to achieve our goals and make a real change in the health of our nation, it can’t just be one department doing the work. If we’re going to serve healthier school lunches, we need to work with the departments of Agriculture and Education … If we want to create healthier homes, we need to work with the Department of Housing and Urban Development,” HHS Secretary Sebelius explained. (more…)

Spinal fusions jumped 1,500% among Medicare patients between 2002 and 2007. The explosion had nothing to do with changes in prevalence of the conditions for which the complex surgery is performed. It had everything to do with the release of Infuse, a bone growth stimulator that reduces the complexity of the procedure.

Infuse (pictured) is marketed by Medtronic. It was approved by the FDA in 2002, specifically for spinal fusions of the lumbar (lower) spine using a particular surgical technique: the frontal approach. Soon after the FDA green-light however, surgeons began using it for other kinds of lumbar fusions and cervical (neck) fusions as well. Peer-reviewed studies of these non-approved uses helped drive the explosion in spinal fusions. Now, remarkably, off-label use accounts for 85% of Infuse use. The biological garners nearly $900 million in annual revenues for Medtronic.

There’s More to the Story
Unfortunately, newer studies of spinal fusion have found it to be no more effective for common back pain than physical therapy. Use rates of Infuse have not responded to this growing literature.

Beyond this, the off-label use studies mentioned above were sponsored by Medtronic and led by scientists that received tens of millions of dollars’ worth of royalty payments and consulting fees from Medtronic. It has recently been alleged that these scientists knew about certain complications caused by Infuse, and either failed to disclose them or de-emphasized them in their write-ups.

The complications include some that are potentially fatal– neck swelling severe enough to compromise breathing, and possibly an increased cancer risk, for example. They also include sterility in men, a complication Medtronic and surgeons with financial ties to Medtronic appear to have been aware of—but did not report–since 2002. (more…)

Some of the greatest discoveries in the history of modern medicine came from scientists who noted spatial and temporal relationships between events that had not been previously recognized, and deduced from their observations that the events were causally linked.

In 1854 for example, John Snow observed that high cholera death rates in 2 districts of Soho were linked by a common water supplier. Snow created maps (pictured) to display the link and eventually traced the outbreak to one of the supplier’s water pumps. He convinced the supplier to remove the pump handle and treat the water with chlorine, and that promptly ended the epidemic. Snow’s work was canonized as a founding event in the science of epidemiology.

Then in 1928, Alexander Fleming–already renowned as a brilliant scientist with an untidy laboratory–accidentally spilled a beaker filled with a fungus (genus, Penicillium) onto a petri dish containing the staphylococcus bacteria, just before he left on vacation.

Upon returning, Fleming noticed that staph colonies close to the spill had died. Fleming subsequently showed that the fungus produced a substance which killed staph and many other bacteria. He named the substance Penicillin. The discovery revolutionized the treatment of bacterial infections and spawned the entire pharmaceutical industry in the process.
 
Last month, Finnish scientists used similar spatiotemporal analyses to explore the purported link between mobile phone use and brain cancer. Unfortunately, their results were not nearly as clear-cut as those of Snow and Fleming.

Here’s the Story
Mobile phones produce radio-frequency electromagnetic fields. To date, no study has proven that the radiation is tumorigenic, but doubt persists because it has proven difficult to quantify the amount radiation exposure in various areas of the brain, and the long latency period before cancer first develops and becomes clinically manifest. (more…)

The Affordable Care Act is the most important piece of federal health care legislation since the Social Security Act created Medicare in 1965. It assures that 32 million Americans will gain access to health insurance for the first time. But who will care for these people?

The flood of newly insured people will create a surge in demand for physician services. By 2015—one year after the major provisions of the ACA take effect—the US will have 63,000 fewer physicians than it needs to meet this demand, according to the Association of American Medical Colleges.

The shortfall will hurt everyone, but its impact will be devastating for medically underserved populations where finding a doctor is already difficult. This includes nearly 20% of the US population.

Unfortunately, the ACA doesn’t include a manpower plan that sufficiently accommodates the surge. The most optimistic projections suggest it will add 500 or so physicians per year to the workforce during the next decade, and even that modest growth has recently come under attack by House Republicans.

Two weeks ago, the GOP-controlled House voted 234 to 185 to eliminate $230 million in mandatory ACA funding for the creation of a new teaching model for residents in primary care. The model is based around “teaching health centers,” which would be placed in medically underserved areas and mirror the practice environment residents will enter upon completion of their training.

The GOP isn’t against the new training model, but objects to the automatic, mandatory payouts associated with it. They propose that funding for the manpower initiative should be subjected to votes each year during Congress’ annual appropriations process. “It’s time to move these programs back to the discretion of this Congress,” Marsha Blackburn (R-Tenn.) explained, referring to it as one of many  “slush funds” provided by a debt-ridden federal government. (more…)