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Monday, February 13, 2012

Greed? Ego?

I am still aghast and angry over what I watched on CBS's "60 Minutes" last night.

Chemotherapy can be a tough road for people with cancer, often debilitating and even dangerous. Which is why five years ago, when Duke University announced that it had an advanced, experimental treatment that would match chemotherapy to a patient's own genetic makeup, it was hailed as the holy grail of cancer care. The scientist behind the discovery was Dr. Anil Potti, and soon Dr. Potti became the face of the future of cancer treatment at Duke, offering patients a better chance even with advanced disease. However, when other scientists set out to verify the results, they found many problems and errors. What our 60 Minutes investigation reveals is that Duke's so-called breakthrough treatment wasn't just a failure -- it may end up being one of the biggest medical research frauds ever...

Five years ago, Duke University announced it had found the holy grail of cancer research. They'd discovered how to match a patient's tumor to the best chemotherapy drug. It was a breakthrough because every person's DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke's innovation.

In 2010, we learned that the new method was a failure. But what isn't widely known, until tonight, is that the discovery wasn't just a failure, it may end up being one of the biggest medical research frauds ever - one that deceived dying patients, the best medical journals and a great university...


I first blogged about what looks to be the budding promise of pharmacogenomics back in November, in the mutual contexts of "Personalized Medicine" broadly and the Weeds' book "Medicine in Denial" in particular.
See also this interview with Leroy Hood.
Hood contends that digitizing medical records--the health-care industry's major push at the moment--is just one small part of the informatics overhaul the field needs to undergo. And pharmacogenomics--the practice of using an individual's genetic makeup to choose drugs --provides only a limited example of the potential power of personalized medicine.

This Duke thing could scarcely be more harmful. From the Duke University Chronicle:
The mentor of former Duke researcher Dr. Anil Potti has said that the discredited oncologist deliberately falsified data while at Duke.

Joseph Nevins, Barbara Levine professor of cancer genomics, told “60 Minutes” Sunday that it was “abundantly clear” that Potti had manipulated research data in order to support this theory that genomics could aid the treatment of tumors. This is the first time that Nevins, who collaborated and co-authored a number of research papers with Potti, has acknowledged that the errors found in Potti’s research data were intentional. The University’s investigation into the misconduct of Potti is ongoing.

“It simply couldn’t be random—it had to have been based on a desire to make something work,” he said. “I regret that if some of the issues were raised along the way, this could have been brought to a halt at an earlier time.”...
Lawrence and Lincoln Weed, again:
With the ongoing revolution in genomics and proteomics, the myriad resemblances and differences among individual human beings are becoming far more sharply defined at the molecular level. These advances are already making it possible to reconceive existing diagnostic entities, classifications and therapeutic understanding. But to fulfill their potential, these advances require more complete, organized, documented clinical observations in patient care, plus better linkages among these observations and existing knowledge. Were that to occur, there is reason to believe that we would learn how seemingly distinct disease conditions may actually be interrelated, how medical interventions that seem narrowly targeted at a specific gene or molecular pathway may actually disrupt multiple body systems, of how an individual’s phenotype may actually be more important than genotype for some diagnostic and therapeutic purposes, and how drugs and other powerful interventions sometimes may be more disruptive and less effective therapeutically than simple improvements in health behaviors. These possibilities are reinforced by evidence that common disease conditions appear linked to many rare genetic variants among individuals rather than to a few common variants across populations. [Medicine in Denial, pg 191]


Well, yes, assuming the rapid detection and elimination of both error propagation and outright fraud.
UPDATE

Well, turns out that this Anil Potti story has been around for a good while.

July 7, 2011, NY Times
How Bright Promise in Cancer Testing Fell Apart
By GINA KOLATA

When Juliet Jacobs found out she had lung cancer, she was terrified, but realized that her hope lay in getting the best treatment medicine could offer. So she got a second opinion, then a third. In February of 2010, she ended up at Duke University, where she entered a research study whose promise seemed stunning.

Doctors would assess her tumor cells, looking for gene patterns that would determine which drugs would best attack her particular cancer. She would not waste precious time with ineffective drugs or trial-and-error treatment. The Duke program — considered a breakthrough at the time — was the first fruit of the new genomics, a way of letting a cancer cell’s own genes reveal the cancer’s weaknesses.

But the research at Duke turned out to be wrong. Its gene-based tests proved worthless, and the research behind them was discredited. Ms. Jacobs died a few months after treatment, and her husband and other patients’ relatives have retained lawyers.

The episode is a stark illustration of serious problems in a field in which the medical community has placed great hope: using patterns from large groups of genes or other molecules to improve the detection and treatment of cancer. Companies have been formed and products have been introduced that claim to use genetics in this way, but assertions have turned out to be unfounded. While researchers agree there is great promise in this science, it has yet to yield many reliable methods for diagnosing cancer or identifying the best treatment.

Instead, as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science...

The very next day, this weblog column appeared:
The Duke Cancer Scandal and Personalized Medicine

Here's a good overview from the New York Times of the Duke scandal. Basically, a team there spent several years publishing high-profile papers, and getting high-profile funding, and treating cancer patients based on their own tumor-profiling biomarker work. Which was shoddy, as it turns out, and useless, and wasted everyone's time, money, and (in some cases) the last weeks or months of people's lives. I think that about sums it up. It was Keith Baggerly at M. D. Anderson who really helped catch what was going on, and Retraction Watch has a good link to his presentation on the whole subject. The lead investigator in this sordid business, Anil Potti, ended up retracting four papers on the work and left Duke last fall (although he's since resurfaced at a cancer treatment center in South Carolina). That's an interesting hiring decision. Looking over the case (and such details of it as Potti lying about having a Rhodes Scholarship), I don't think I'd consider hiring him to mow my yard. Perhaps that statement will be something for his online reputation management outfit to deal with. But enough about Dr. Potti himself; I hope I never hear about him again. What this case illustrates are several very important problems with the whole field of personalized medicine, and with its public perception. First off, for some years now, everyone has been hearing about the stuff: the coming age of individual cancer treatment, biomarkers, zeroing in on the right drugs for the right patient, and so on. You'd almost get the impression that this age is already here. But it isn't, not yet. It's just barely, barely begun. By one estimate, no major new cancer biomarker has been approved for clinical use in 25 years...

Read the comments as well. Some good ones down there. e.g., comment #10, citing a CancerLetter.com article: "Donald Berry, chairman of the Department of Biostatistics and head of the Division of Quantitative Sciences at MD Anderson, said the Duke scandal [i.e. Potti] puts the entire field of genomics at risk."

More shortly. For now, see also www.DukeCheck.com. Some pretty scathing stuff.
___

OK, CAN I BRING THIS ALL BACK AROUND?

I'm just a lowly REC "Meaningful Use" support grunt. Indeed, when I started this blog, I took some rather acrimonious (albeit transient) early internal flack from a corporate higher-up for "exceeding your scope" -- in part for having had the temerity to directly email our CEO Marc Bennett with a link and some thoughts (having principally to do with ASQ Health Care Division's offer to assist the REC effort).

Whatever.

I was back out in the field this afternoon. Back to the pedestrian real world. Doc is irritated because his Q4 2011 Attestation numbers don't cut it (5 of 10 num/denom Core Set). This is our 4th or 5th visit to this practice.

How low does ONC/CMS have to set the bar? We gave you the workflow documentation. Follow it consistently.

Whatever.

So, tonight, apropos of HIT and the "Big Picture," I saw this:
Medicine’s Tech Future: the View from the Valley

A few quick impressions from last week’s FutureMed extravaganza put on by Singularity University at the Museum of Computer History, a stone’s throw from Google’s Mountain View headquarters...

...there’s a huge gap between the way many technologists envision medical problems and the way problems are actually experienced by physicians and patients...


...The worry more generally is that innovators are focused primarily on developing cool technologies, rather than solving actual problems; a century and a half ago, Oliver Wendell Holmes Sr. famously commented, “If the whole materia medica [available medications] as now used, could be sunk to the bottom of the sea, it would be better for mankind-and all the worse for the fishes.” It’s tempting to speculate that the same might apply today to the estimated 15,000 medical apps now available on iTunes...
Read the whole thing. Some funny stuff.

Well, that led me here:


Serious Adults throwing down. Which led me here:
Opinion: Thinking Outside the Genome
By extending its reach beyond science, the field of omics will change the way we live our lives.
By Stephen Friend | October 1, 2011


...The democratization of medicine
As omics data and models accumulate, they will put pressure on existing guilds of experts. And as the information needed to diagnose diseases and track cures begins to be generated by “knowledge experts” who are not necessarily physicians, we should expect an activation of citizens empowered to help build better models of diseases. Patients in disease-advocacy organizations, such as the Love/Avon Army of Women or PatientsLikeMe, who have already been organized to track their symptoms and who can self-enroll in clinical trials, will recognize that they can move much further beyond the passive role of being “the sick.” In the near future, organized and active patients will start providing their own genetic samples for omics-based trials to determine whether they will respond to particular therapies. They will surely want to follow studies that they have enabled—and possibly even self-fund parts of future studies. And these involved patients will want to be educated about interpreting the outcomes of such trials. This establishment of a partnership between scientists, citizens, and physicians will be comparable to the democratization of publishing when the guild of editors and publishers partnered with the masses to launch Wikipedia. Individuals will realize that by using omics information, they can become the builders of the disease models needed for defining new medicines and deciding who should get which therapy. Patients will become copilots, jointly navigating the way to new therapies.
Which, of course, leads me

Stephen Friend: "...involved patients will want to be educated about interpreting the outcomes of such trials. This establishment of a partnership between scientists, citizens, and physicians will be comparable to the democratization of publishing..."
A noble sentiment, to be sure. Resonant with those set forth in the Weeds' "Medicine in Denial."

More shortly, starting with the whole "democratization" thing...
___

FEB 15th DIVERSIONARY UPDATE

Thought-provoking author/blogger I've just run across (Duke U, no less):

Impressive man. Click the image above.

OTHER ERRATA...


Tonight I'm continuing to traverse an inch-thick binder I assembled comprising a number of the PPACA Supreme Court challenge amicus briefs. Interesting reading, the partisan polar interpretations of the same set of facts.

The 4 overlapping principal areas of contention:
  • Commerce Clause legislative authority, pro and con;
  • "Severability" (i.e., if they strike the "Minimum Coverage" provision, does PPACA necessarily fall in toto? But, if they only strike the "Mandate" are we then left with a problematic zombie statute?);
  • Unfunded Medicaid imposition on the states;
  • "Ripeness" re the Anti-Injunction Act (can you proscribe that which has yet to occur?).
The Cato et al Brief is particularly poignant, and could pretty much fit on a bumper sticker. The AHIP/BCBSA Brief makes no bones about it; they want recissions, pre-existing condition exclusions, individual risk rating, and free-rein on MLR should the Mandate fall -- i.e., wind the clock back to 2008.

We'll know before long.

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SOME LAUGHS FROM SBM

Like I've said, I routinely hang at "ScienceBasedMedicine.org," where the comments can be as good as the posts. to wit:
“I’ve bitched out a few “nurses” for keeping me waiting, and I’ve walked out of doctors offices because clearly they weren’t interested in being on time for appointments OR communicating their problems.”

Dude, you need to get a grip on yourself. If you want your physician’s appointment to start on time, book the first appointment in the morning. I do. I confronted my very good internist about chronically late appointments and he explained that during the course of his day some patients require longer visits than expected and that there are interruptions from a thousand sources that drag on his time. He was understanding, apologetic, and suggested the early morning or immediately-after-lunch bookings. It also gave me a bit of appreciation for the difficulties faced in his practice. His advice on booking appointments has served me very well.

You also seem to ignore the financial realities of running a practice. Rent has to be paid; nurses, clerks and aides have to be paid; charges disputed by insurers have to be resolved; all those neat diagnostic tools have to be paid for. Physicians in private practice are both medics and business owners. They have only one commodity: their time (and it isn’t just the time they spend with you, it is the time they invested developing the skills to treat you). They necessarily maximize the return on their time.

There is a difference between quality of care and petty inconveniences to you. Yes, hospitals run on schedules. Without some organization there would be chaos and that would not accrue to anyone’s benefit.

A patient-centered approach to medicine does not suggest being met at the door with a flute of champagne and whisked tout suite to a physician who has waited patiently for your arrival.

More to come...

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