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Pharma: Beatings to Continue Until Morale Improves?

For the last decade, as the biopharmaceutical industry has struggled — largely unsuccessfully — to live up to its anticipated potential, a litany of experts, analysts, participants, and commentators have offered up their diagnosis and treatment for pharma’s productivity problem.

The basic question they’re all trying to solve: how can it be that despite profound improvements in many aspects of drug discovery, actual productivity – measured by cost per new NME – seems to be declining?

That’s the problem that Jack Scannell (an industry analyst at Bernstein & Co.) and colleagues tackle in the latest issue of NRDD (here – abstract only), expanding upon a nice piece of work they did on this subject last year to now offer an even more comprehensive and thoughtful review of this important subject.  While painfully depressing, the article is worth reading, as it cogently summarizes many years worth of hand-wringing and angst.

Having spent much of the last decade wrestling with many of the same issues (his topics will be familiar to regular readers of this column), I was perhaps most struck by the rather dismal take-away: there isn’t a clear unifying explanation for the R&D productivity problem; perhaps if each company examined its internal failures rigorously, new insight might emerge, but meanwhile, essentially, beatings will continue until morale improves.

More specifically: the payor environment is likely to make reimbursement increasingly difficult; regulators will always have an easier time tightening screws than loosening them; each success raises the bar higher; and the only immediate solution is likely to be continued R&D cuts.

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What Is the Cause of Excess Costs in US Health Care? Take Two


We’ve discussed it before. Why are costs so much higher in US healthcare compared to other countries? The Washington Post has a pointless article which seems to answer with the tautology costs are high because healthcare in America costs more. How much more? Well, we spend nearly twice as much per capita as the next nearest country while failing to provide universal coverage.

In the WaPo article they make a big deal of the costs of individual procedures like MRI being over a thousand in the US compared to $280 in France, but this is a simplistic analysis, and I think it misses the point as most authors do when discussing this issue. The reason things costs more is because in order to subsidize the hidden costs of medical care, providers charge more for imaging and procedures. For instance, Atul Gawande, in his New Yorker piece “The Cost Conundrum” wonders why it is that costs are higher to treat the same conditions in rural areas and in a major academic centers like UCLA than at a highly specialized private hospitals like the Mayo Clinic? I think the reason is it’s not nearly as expensive to administer and provide care for a select group of insured midwesterners at the Mayo than it is to provide care to the underserved in the poor areas of inner-cities and in poor rural locations.

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Stop Lying to Your Doctor

George Washington never met an Oncologist. I know this because of the Cherry Tree story. If our first President had spoken to a cancer doc, then that honesty fable would have been different. Anyone can tell the truth about cutting down a tree. It takes real guts to say to an oncologist, “I cannot tell a lie, I have a problem.”

Doctors frighten all of us. No matter how warm and congenial they are, there is always the threat of what they may say. A few words from a physician can change your entire life. An oncologist may be the scariest of all. For this reason it can be very hard for any of us to tell our doctor the complete absolute truth.

It is easier to diminish or deny pain, then describe in detail and submit to tests. Emphasizing the balance in a diet has less risk than noting it is only 600 calories. Increasing fatigue can be blamed on stress, not progressive weakness. Everyone seems to have quit smoking, despite yellow stained nails. “Social” drinking sounds better than a daily six-pack. We carefully parcel out the information we tell our doctor. It is gut level denial and it does us no good.

Physicians understand the desire of patients to limit and control the conversation. They learn to recognize incomplete and evasive answers. They try to ask questions which produce accurate information. A compassionate doctor knows that his response to a patient’s words is as important as the question asked.

Even though it can be hard, it is in our best interests to supply good information to our caregivers. Doctors cannot make correct diagnoses or order proper treatment using erroneous data. Unneeded X-rays are frequently ordered to fill gaps in information, which the patient could have supplied.  Understanding it can be tough to disclose personal medical facts, here are several ideas that might make communication easier and more complete:

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Four Healthcare Trends Hospital Executives Cannot Ignore

Hospital leaders are busy trying to cope with the changes brought on by the Patient Protection and Affordable Care Act and the realization that the federal budget deficit translates into less money for all healthcare providers in the future. The seemingly inevitable transition from fee-for-service to global payments creates anxiety about how quickly the financial incentives will shift.

While the above-described issues are certainly enough to monopolize any busy hospital executive’s time, there are other large-scale changes on the horizon that may impact hospital operations just as much. Leaders who ignore these trends will do so at their organization’s peril.

The important trends include: personalized medicine that concentrates on the individual not the population; the “quantified self” movement with constant remote physiologic monitoring; the smartphone health applications explosion, and the artificial intelligence, healthcare robot movement.

Personalized medicine: Advances in genomics and digital technology are making it possible to shift the focus of evidence-based medicine from the population to the individual patient. Today drug treatment and disease screening follow a one-size-fits-all approach that leads to overtreatment and unnecessary expense. Genetic testing allows us to individualize the treatment for the patients.

For example, about 20 percent of diabetic patients treated with metformin do not respond to the drug, a condition that can be identified by genotyping that is not routinely done today. Likewise, cancer screening by mammography after age 40 in women and colonoscopy after age 50 in men and women does not take into account the different genetic predispositions for breast cancer and colon cancer in individual patients. Two new books should be on every hospital executive’s reading list because they explore the implications for hospitals of personalized medicine: Eric Topol’s “The Creative Destruction of Medicine” and David Agus’ “The End of Illness.”

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Research Shows … the Obvious

A couple of studies out today from Health Affairs belabor the obvious.

First, the one less covered: Hospital Compare, the government website that for the last seven years has provided the public with detailed information about hospital performance, had no discernible impact on improving outcomes. It had no impact on how well the studied hospitals treated heart attacks and pneumonia, and only a modest improvement in outcomes for patients with heart failure. “The jury’s still out on Medicare’s effort to improve hospital quality of care by posting death rates and other metrics on a public website,” says lead author Andrew M. Ryan, an assistant professor of public health at the Weill Cornell Medical College in New York City.

Comment: Since when has disclosure ever affected behavior? Has it stopped physicians from taking money from the drug industry? Has detailed nutrition labels ended the obesity epidemic? Look at how well it is working in campaign finance reform. We have more information than ever about how our elections are being bought and sold. Disclosure is the reform that avoids reform. The real issue for hospitals is how well they do in improving their performance on checklists of quality indicators, and whether that improves outcomes (the QUEST demonstration project at CMS suggests it does). Disclosure of poor performance may be a goad to action (or not, as this current study suggests). But it is not a substitute for action.

The second, more widely reported study showed that doctors with electronic access to patients’ prior imaging studies wound up ordering more imaging tests than doctors without access to such electronic records. Absent other incentives, why would anyone expect otherwise? Imaging is one of the great generators of “false positives” in the medical system. See something on a scan, better get a biopsy or do an angioplasty. Or at least another scan. Double the number of eyes seeing that scan and you double the number of false positives. The depressing fact is that under the current fee-for-service payment system, everyone gets paid that second time around.

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How Much Will a Data Breach Cost You?

The going rate for a compromised medical record seems to be $1000 (well, at least that’s the asking price) as seen in papers filed in the eleven class action lawsuits against Sutter Health following the theft of a desktop computer last fall.  The computer contained unencrypted protected health information on about 4.24 million members.  The eleven class action suits are likely to be consolidated for ease of handling by the courts.

For an outfit whose most recently reported year-end financials show just under $900 million in income on just over $9 billion in revenue, a $4.24 billion claim certainly qualifies as a big deal.  The data breach claims against Sutter Health were filed last year following its self-reporting of the computer theft, and are in the news again due to the potential consolidation.

The company had reportedly begun to encrypt its data last year, starting with more vulnerable mobile devices, and moving on to desktop computers, but had not gotten to the desktop in question by the time of the breach.  It remains to be seen how these facts end up affecting the final damages awarded in this case.

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Wrong Rx for the FDA

The congressional legislators who oversee the Food and Drug Administration and control the nation’s coffers have shown again that they neither understand drug development nor the regulatory problems that plague it.

In February, Sen. Barbara A. Mikulski(D-Md.) unveiled a bipartisan bill intended to spur innovation in research and drug development for chronic, costly health conditions such as Alzheimer’s disease, cancer, diabetes and heart disease.

According to the press release, the bill will invest “in public-private partnerships to ensure scientists and researchers are able to develop new safe and effective drugs,” shrink product development timelines, increase the number of drugs in the development pipeline and expedite the FDA review process.

However, there is currently plenty in the development pipeline. The federal government is boosting funding for research and development on Alzheimer’s disease; the Department of Health and Human Services alone will allot more than $500 million to it in fiscal year 2013. Moreover, drug companies spend more than $65 billion annually on R&D.

For example, there are now nearly 100 drugs in development for Alzheimer’s disease, dementias and other cognitive disorders, and almost 900 medicines being tested for cancer.

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Autofill Gone Wild

I appreciate getting notes from specialists. Really. It’s great to be kept in the loop with patients’ care, especially when other doctors are using EMRs that directly fax me notes the same day as the visit. Sometimes, though, things can get a little out of control.

I’ve ranted before about offices that use templated EMRs to generate documentation of things they never actually did. Today I received the following letter:

Reason for the appointment:
1. Abdominal pain
2. Post colonoscopy with biopsy

History of present illness:
1. Abdominal pain: he failed to show up for this appointment

Current medications:
[med]
[med]
[med]

Past medical history:
[problem]
[problem]
[problem]
EGD 2008 negative, EGD 2011 negative, colonoscopy 2005 normal
2010 Chest CT with 3 mm lung nodule, low risk

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The Power Couple: Common in Medicine, Rare in Business??

tweet not long ago from Andrew Rosenthal of Harvard Business School (HBS) and  MassiveHealth announced that at a recent conference presented by the HBS Women’s Student Association, it was reported that 80% of women at the top (in business, I presume) have husbands who don’t work.

Whoa.

As high as that number is, I believe it – and I’m sure the reverse is true as well.

What fascinates me is the apparent contrast with medicine, where so many of the women and men at the top seem to have spouses who not only continue to work, but often are physicians as well.

For example, Boston.com recently presented an interesting spread on power couples in the Boston medical scene.  This feature – including such notables as HMS Dean Jeffrey Flier and his wife, endocrinologist  Terry Maratos-Flier; oncologist and New Yorker writer Jerome Groopman and his wife (and occasional co-author), endocrinologist Pamela Hartzband; and Barbara Bierer, SVP of research at the Brigham, and her husband, neuroscientist and former Harvard Provost Steven Hyman — only scratched the surface, and could easily have included many more examples.

I follow this area with particular interest, as my parents are both physicians, my wife is a physician, and many of our colleagues from training have married other physicians as well; generally, both partners continue to work and climb their career ladders together.

Dual career couples were also a prominent feature of my training. I learned immunology from the late Charlie Janeway, whose wife, Kim Bottomly, is also a distinguished immunologist, and currently President of Wellesley; one of my favorite preceptors in medical school was the late Nina Braunwald, a cardiac surgeon whose husband is the legendary academic cardiologist Eugene Braunwald; I learned about fetal ultrasonography from one of the field’s leading lights, Beryl Benacerraf, whose husband, Peter Libby, is chief of cardiology at the Brigham.Continue reading…

The Bottom Line

It’s cool. So cool, that President Obama used one. So cool, it’s been on the cover of Newsweek. It’s been in multiple television commercials, radio advertisements, highway billboards, and was even coined one of the top 14 medical breakthroughs of 2011 by Boston Magazine, a city teeming with medical innovation. Yet surgeons and health economists are unable to explain the fascinating rise of robotic-assisted surgery.

Currently, a single company manufactures and distributes the robot, a line of surgical equipment used to conduct robotic-assisted surgery. The robotic system consists of a surgeon’s console with 3-dimensional high definition vision and a patient-side cart featuring robotic arms with proprietary wristed instruments. The system translates the surgeon’s natural hand movements on instrument controls into corresponding movements of instruments inside the patient, giving the surgeon control, range of motion, and depth of vision similar to open surgery.

The sole manufacturer hopes to establish the robot as the standard for surgical procedures by encouraging surgeons and hospitals to adapt the technique while marketing aggressively to patients about the benefits of robotic surgery. As of June 2011, the manufacturer had installed 1,933 robotic systems. They estimate that 278,000 robotic-assisted surgical procedures were performed in 2010, up 35% from 2009, and aims to achieve one million annual procedures in the United States over the next few years (Invester Report 2011). To achieve this goal, the manufacturer strategically markets to smaller hospitals and surgeons who may not be skilled at conventional laparoscopy to give them an edge for attracting patients.

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