Twitter and information accuracy

I am going out on a limb: I do not wish to offend anyone, particularly those for whom I have a great deal of respect. However, this is potentially a moment where opinions need to be exchanged in the name of improved mutual understanding.

The other day I re-tweeted a tweet from someone whose Twitter activity I enjoy very much.  I like where his links take me, and I appreciate the intellectual and emotional honesty of his own writing. The message I re-tweeted was about Gardasil, Merck’s HPV vaccine marketed in the US. Diane Harper of the University of Missouri is a prominent researcher who was heavily involved in the Gardasil development program. Over the last several months she has cast serious doubt on both the cost-effectiveness and the risk-benefit profile of the vaccine. One of the facts she pointed out at the recent 4th International Public Conference on Vaccination in VA was that, though the drug is marketed to girls as young as 11 years old, the vaccine has never been formally evaluated in girls under the age of 16 years. Neither its safety nor efficacy, let alone effectiveness, is known in the younger population.

A link in the re-tweeted message took me to a newspaper article summarizing Dr. Harper’s objections to the wide-spread use of Gardasil in the US. As luck would have it, shortly following the first tweet, the author re-tweeted another message. This one directed one to a blog post by a British EBM celebrity railing against a deliberate fabrication of information by anti-vaccination ideologue reporters to cast doubt on GSK’s Cervarix in a story published in the British tabloid Sunday Express. In this blatantly sensationalist anti-vaccination article, the journalists were allegedly quoting Dr. Harper’s objections to Cervarix, objections that seemed identical to those she has voiced with regard to Gardasil. Being dubious of the veracity of such claims, the blogger diligently fact-checked with Dr. Harper directly, who promptly denied ever making any claims, or indeed having more than superficial familiarity with the data on Cervarix. In fact, the journal has removed the story from its web site. So, the blog recounted a necessary he-said she-said anatomy of distorting facts in service of the tabloid rag's sales. Perhaps in the UK these disreputable pseudo-news outlets have wider credibility than in the US. But I do not see that I need to get involved in further discrediting a source that would just as likely put news of alien abductions on its front page as the lies about a vaccine.

Since I have been following the Gardasil saga, I was interested in Diane Harper’s views of the data in the context of the epidemiology of both HPV infection and cervical cancer. Additionally, being a health services researcher, the cost-effectiveness questions also caught my eye. Not to mention the information about the age thresholds in the trials. For these reasons I re-tweeted the story. And while the debunking of the anti-Cervarix rhetoric was interesting, it did not add to my knowledge base, other than to trust all tabloids even less, if that is even possible. The blog post thus made the point that there is no evidence to date for any of the dire events that the reporters in their anti-vaccination zeal had made up. This does not excite me: as I keep pointing out, the absence of evidence does not mean that there is evidence of absence. The best we can say is that the vaccine proved safe enough in trials to be approved, and to date we have not seen any red flags. No new information here, other than confirmation of the lies, though, given the source, no big surprise. So, the post being simply more of voyeuristic than scientific interest to me, I chose not to re-tweet the second tweet. Particularly since this is a “controversy” I had not been following closely.

Shockingly, when I got back on Twitter a few hours later, I had a polite but insistent request from the author of the tweet to re-tweet his second, Cervarix, tweet. Now, because I respect this person, and because I am confident that, being an accomplished journalist, he was simply seeking balanced information, I complied without further ado. After all, this was harmless enough. However, I got to thinking about when it might be OK for a tweeter to insist that a particular tweet get re-tweeted. Journalists seek balance in reporting. Scientists seek balance when summarizing evidence. Both are averse to cherry picking. I am sure that my esteemed colleague felt that I was cherry picking the information to fit my point of view. In fact, I wish to assure him that I was cherry picking simply on the basis of what advanced my knowledge on the subject: a story about an important public meeting on vaccination vs. a recount of a tabloid inaccuracy. And even if my intentions had been nefarious, Twitter is neither a responsible journalism vehicle nor a peer-reviewed publication. The cynical view is that information chaos reigns, and while we should all strive for responsible diffusion of information, there is no contract to this effect. The less cynical way to look at it is that Twitter is an egalitarian vehicle, where individuals can make up their own minds as to what they deem important.

So based on this experience, let me respectfully suggest an alternative course of action around similar future situations, should they arise. Rather than emphatically asking to re-tweet a specific post, why not inquire why the person chose not to in the first place. And though it may be challenging to give a full explanation in 140 characters, it is worth a shot, as it is guaranteed to advance our mutual understanding and to build better relationships.

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AstraZeneca Settles

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times,

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,

AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here).  If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are.  Is it any wonder that we over-use and over-pay for these products?  Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment. 

(However, there may be hope.  Perhaps in the future there will be more effective deterrence.  A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)

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Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."
Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.
"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

• How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

• Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News
20 Years of Hospital Information Technology
by John Fries
(December 2005)


... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.
At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

• Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
• Who did/does the Site Executive report to?
• Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
• What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

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Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.

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The simple math of healthcare access

Look, here is the bottom line in broad strokes.

The costs of healthcare have been rising exponentially, but people's incomes have not. Despite the biggest economic expansion over the last 50 years, and despite astronomic rise in our productivity, the real wages for the bottom 80% of all earners have not increased one iota since 1975! This means that, while the costs for all products and services have grown at the pace of inflation or more rapidly (as in the case of healthcare), our buying power has remained stagnant.

What is the result of this disparity? Well, one result was the implosion of the mortgage-backed derivatives market. Some economists posit that the productivity-wages gap allowed corporations to stockpile enormous wealth. This wealth, in turn, was translated by the Wall Street Wizards into the obscure mortgage-backed derivatives Ponzi scheme, where mortgage loans lent to people with no way to pay them back were being used as collateral for these assets. The math is simple: productivity was up, wages stagnant, consumerism rampant, cash abundant -- bingo! The nation lived beyond its means for over a decade, imaginary wealth made and lost in a blink of an eye.

What does any of this have to do with healthcare? The connection is pretty obvious to me: rapidly escalating costs in the face of stagnant wages and diminished capital. Without any changes in the trajectory of the healthcare costs even more people will be unable to afford health coverage. This simple arithmetic should not be so difficult to grasp. Closer to home, anyone who now says "Not my problem, I can still get 'everything' ", prepare for it to become your problem. Who will pay for "everything"? Without the needed cost containment, the faces of those left behind by our cruelly inequitable system will be getting more and more familiar.

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30 poems in 30 days

Check this out! Great fundraiser idea. If you want to sponsor me, please e-mail me at Healthcareetcblog@gmail.com.

Better late than never

Just heard about this fundraiser
To support literacy education.
Seemed like a good cause to get behind,
So here I am trying to rhyme.

I am not poetically inclined,
But do indulge me in this task.
Please do not judge these sorry lines,
Just go with the flow, and do not ask

For perfect rhymes -- they will not come.
I turn a phrase in mostly prose.
In fact I write about science,
And fear that poetry will expose

My inability to rhyme,
My inclination to be free
In how I say and what I find
To be of importance to me.

This verse is done for greater good.
So please won't you support this cause!
If you so choose, why then I would
Consider ending without pause.

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Public Option: the Democrats' albatross

I have purposely held off on putting in my 2 cents on the House healthcare bill passed last weekend -- there has been enough noise about it. As the dust is settling, I am thinking this is a good time to weigh in.

The big elephant in the room is whether or not Public Option included in this version of the bill will achieve the essential goals of improved access and quality, and curbed expenditures. As I understand it, the Public Option is meant to make coverage available to a larger swath of the US population than who is covered today. It does so by qualifying people, particularly those too poor to afford private insurance yet too well-off to qualify for government-sponsored programs, and small business owners. It claims to have a lower overhead due to reduced emphasis on profit and lower administrative costs. It is also meant to contain costs by its ability to negotiate reimbursements at the point of care, though the legislation does not allow the government to pool its negotiating muscle across all of its subsidized healthcare programs (Medicare, Medicaid, CHIP). Therefore, the Public Option reimbursements are mandated to be no lower than Medicare and no higher than the average private payments.

So, the way I read the legislation, the downward cost pressure is still at the interface of the patient and the provider/intervention. So, how is this any different from what is happening today? I would argue that the private sector insurers are probably pretty aggressive at holding the providers' feet to the fire already, and so far they have been unable to contain costs. Additionally, if we look at Medicare, its expenditures have also been sky-rocketing, despite a strong negotiating position at the provider level. So, why would an additional government-funded mechanism, that is different from and weaker from negotiating standpoint than Medicare, succeed at this Sisyphean task?

The bill does provide the Department of Health and Human Services with the ability to develop and pilot new coverage and reimbursement schemes. So, down the road it is possible that the Public Option will provide a laboratory for how best to fix our perversely aligned incentives to promote better health and not schemes to maximize income. Some estimates by the CBO indicate that the Public Option for various reasons will enroll only 6 million people. In addition, while all providers who now accept Medicare will have the opportunity to be on the Public Option provider panels, they can also opt out. Taking into account the impending 21% proposed cut in Medicare reimbursements and the relatively small number of patients predicted to take advantage of the Public Option, why would providers not opt out aggressively, the way many have opted out of Medicaid patients? And while some of the remaining 40 million uninsured will now be covered under Medicaid and CHIP, too many will still be left in the crevasse of no healthcare coverage to fend for themselves.  

So, the House bill's Public Option does not seem to me to be the answer. If it is to be administered in a straight-jacket of making sure that profits in the private sector can continue to climb and patient-consumers can still operate under the misapprehension of being entitled to every touted "advance", no matter how insignificant, Public Option is a recipe for failure. I am also not sure how much attention will be paid to the output of the nascent comparative effectiveness enterprise or what statutory or political backing there may be to follow through on these data. The bill does not go nearly far enough to ensure equity in the US. It has been diluted by pandering to its vocal opponents who, while counting and recounting what is in their own purses, are content to continue a system that has created a disposable class of citizens who cannot afford healthcare. Its passage may send a short-term political message to its opponents, but its long-term failure will be an albatross around the neck of the Democratic Party for decades to come. Not to mention the travesty of continuing to abandon millions of our friends and neighbors to the whims of the profiteering healthcare marketplace.    

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