All Trials | All Trials Registered. All Results Reported

Many thanks to Steve in the comments on the last post for alerting me to this movement:

It’s time all clinical trial results are reported.

Patients, researchers, pharmacists, doctors and regulators everywhere will benefit from publication of clinical trial results. Wherever you are in the world please sign the petition:

Thousands of clinical trials have not reported their results; some have not even been registered.

Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

All trials past and present should be registered, and the full methods and the results reported.

We call on governments, regulators and research bodies to implement measures to achieve this.

via All Trials | All Trials Registered. All Results Reported.

I signed the petition, and hope others will as well.

Realistically, this will require either a mindboggling scandal (even worse than the ones we know about) leading to group self-regulation, or more likely, intrusive and poorly thought out legislation.

I know what I’d bet on.

What the Tamiflu saga tells us about drug trials and big pharma | Business | The Guardian

Hint: Roche stinks, and the Cochrane Collaboration has done all of us a huge favor. Time to stop prescribing Tamiflu.

What the Tamiflu saga tells us about drug trials and big pharmaWe now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

via What the Tamiflu saga tells us about drug trials and big pharma | Business | The Guardian.

Navy Matters: A-10 Scrapping Justification Exposed

Please click through and read the whole thing. Something I hadn’t considered.

This is a Navy blog but I just can’t pass on the following Air Force item especially since it indirectly impacts Marine and Navy CAS.

DoD Buzz website quotes Air Force Gen. Mark Welsh as saying that scrapping the A-10 will save $4.2B over five years (1).  This apparently is the Air Force’s justification for letting the A-10 go.  Of course, the real justification is preserving the Air Force’s buy of F-35’s.  Be that as it may …

Let’s check that cost savings number out, shall we?

via Navy Matters: A-10 Scrapping Justification Exposed.

Stolen laptops lead to important HIPAA settlements

In case you wondered why your IT department isn’t reasonable about security, it’s because the penalties aren’t reasonable.

Stolen laptops lead to important HIPAA settlements

Two entities have paid the U.S. Department of Health and Human Services Office for Civil Rights (OCR) $1,975,220 collectively to resolve potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.  These major enforcement actions underscore the significant risk to the security of patient information posed by unencrypted laptop computers and other mobile devices.

via Stolen laptops lead to important HIPAA settlements.

1.7 Million dollar fine.

Bug can cause deadly failures when anesthesia device is connected to cell phones | Ars Technica

I can think of at least one reason phones are being plugged into USB’s…

Federal safety officials have issued an urgent warning about software defects in an anesthesia delivery system that can cause life-threatening failures at unexpected times, including when a cellphone or other device is plugged into one of its USB ports.The ARKON anesthesia delivery system is used in hospitals to deliver oxygen, anesthetic vapor, and nitrous oxide to patients during surgical procedures. It is manufactured by UK-based Spacelabs Healthcare Ltd., which issued a recall in March. A bug in Version 2.0 of the software running on the device is so serious that it could cause severe injury or death, the US Food and Drug Administration warned last week in what’s known as a Class I recall. In part, the FDA advisory read:

via Bug can cause deadly failures when anesthesia device is connected to cell phones | Ars Technica.

In my practice in the ER, there are two types of patients: those who travel with their phone chargers and plug them in, and those who don’t and whose phones are dying. The former will plug into any power port, the latter are the ones asking if anyone has a charger they can borrow.

So, your loved one is in the ICU on the vent, you’ve been calling and texting for what seems like forever, and you get to sit at the bedside. You’d never think twice about charging your phone off the nearest USB port; it’s never been a problem before, why would it be now?

Why that would shut down a ventilator is terrible planning on the part of the manufacturer, and it’ll get fixed. For you, though, don’t plug your pone into medical gear, as apparently some of it isn’t hardened against real life.

 

Top 5 Reasons Why ‘The Customer Is Always Right’ Is Wrong | Alexander Kjerulf

Top 5 Reasons Why ‘The Customer Is Always Right’ Is Wrong | Alexander Kjerulf.

Correct!

Medicare Payments to Providers in 2012 – WSJ.com

Medicare Payments to Providers in 2012
Newly released Medicare billing data show total payments to more than 880,000 medical providers in 2012, totaling $77 billion.
Search the database by provider name, specialty and location to see the types and number of procedures performed and the amounts paid to each provider by Medicare. Related article.

via Medicare Payments to Providers in 2012 – WSJ.com.

Use your new powers for Good.

Hilarious Tamiflu side-effect

Okay, it’s not hilarious, it’s funny that it’s included as a side effect of Tamiflu (treatment for influenza):

2013-11-26_16-53-35

I’m not a huge fan of Tamiflu (for the neuropsychiatric side effects), but I saw this last night on my pocket brain, and had to look today to see if it’s really listed.

It is, that’s off the Tamiflu full-download of the medication information (Link on the official Tamiflu page).

So you know, when patients are in studies, basically everything that happens while the subject is taking the medication has to be reported to the FDA, which is how all that oddness gets enshrined as less than 1% side effects. I do find it a little amusing that ‘pyrexia’ (fever) is listed as a side effect, since influenza classically has a fever, and the peritonsillar abscess diagnosis quite possibly indicates the patient didn’t have the flu, they had an undiagnosed condition subsequently diagnosed.

Tamiflu is a Genentech product, FYI.

Why the Zero Defect mentality will never work

At least, not in real life:

The idea that “failure is not an option” is a fantasy version of how non-engineers should motivate engineers. That sentiment was invented by a screenwriter, riffing on an after-the-fact observation about Apollo 13; no one said it at the time. If you ever say it, wash your mouth out with soap. If anyone ever says it to you, run. Even NASA’s vaunted moonshot, so often referred to as the best of government innovation, tested with dozens of unmanned missions first, several of which failed outright.

Failure is always an option. Engineers work as hard as they do because they understand the risk of failure. And for anything it might have meant in its screenplay version, here that sentiment means the opposite; the unnamed executives were saying “Addressing the possibility of failure is not an option.”

via » Healthcare.gov and the Gulf Between Planning and Reality Clay Shirky.

Healthcare has this idiocy. It’s a disconnect between the doers, who will tell you what’s possible, and the managers, who either don’t know or don’t remember.

Leaders, by the way, would know the difference.  Need more of those.

Grading a Physician’s Value — The Misapplication of Performance Measurement — NEJM

NEJM realized the PQRS Emperor has no clothes.

Perhaps the only health policy issue on which Republicans and Democrats agree is the need to move from volume-based to value-based payment for health care providers. Rather than paying for activity, the aspirational goal is to pay for outcomes that take into account quality and costs. In keeping with this notion of paying for value rather than volume, the Affordable Care Act ACA created the “value-based payment modifier,” or “value modifier,” a pay-for-performance approach for physicians who actively participate in Medicare. By 2017, physicians will be rewarded or penalized on the basis of the relative calculated value of the care they provide to Medicare beneficiaries.

Although we agree that value-based payment is appropriate as a concept, the practical reality is that the Centers for Medicare and Medicaid Services CMS, despite heroic efforts, cannot accurately measure any physician’s overall value, now or in the foreseeable future. Instead of helping to establish a central role for performance measurement in holding providers more accountable for the care they provide and in informing quality- and safety-improvement projects, this policy overreach could undermine the quest for higher-value health care. Yet the medical profession has been remarkably quiet as this flawed approach proceeds.

via Grading a Physician’s Value — The Misapplication of Performance Measurement — NEJM.

How many tens of thousands of hours are spent jumping through hoops like these that turn out to be more meaningless (or worse) ‘government work’?

Spin in the cancelled-policy articles

All the articles about cancelled Individual Insurance plans have some variation of this spin in them:

For some who have received the letters, the new plans being offered are more expensive, but for others — especially those who qualify for a federal subsidy to bring down the cost of the premium — their insurance bill will go down.

via Canceled health insurance plans add to angst of change | Local News | The Seattle Times.

Emphasis added.

Here’s the thing: people (like me) in the Individual market don’t have IBM or Exxon sitting across the table from an insurance company, dealing from a position of some strength. We’re individuals. We’re independent Contractors (me), self employed and scraping by, or doing well. We looked at our options, bought plans we could afford, and realized there are tradeoffs from a cost/benefits standpoint. Not a lot of people in that group bought a soup-to-nuts expensive plan (some did, most don’t).

The emphasized thing above is pure spin on the part of the writers. I have no doubt they’ve been told this over and over, but I have yet to see one article about someone in the Indy market that got a ‘better’ plan that dropped in price. There will be a few, but most if not all will see their costs go up.

Just so you see it for what it is.

AAPS Sues to Stop the Unlawful Revisions to ObamaCare

A constitutional argument. From docs:

The Association of American Physicians & Surgeons (AAPS) has filed a lawsuit today in federal court to halt the unlawful revisions to ObamaCare (the Patient Protection and Affordable Care Act).

The separation of powers required by the Constitution prohibits the executive branch—the Obama Administration—from rewriting laws passed by Congress. Yet that is what Obama has done by changing key parts of ObamaCare in order to implement it.

The AAPS lawsuit, which was filed today in the Eastern District of Wisconsin, asks the Court to enjoin the Obama Administration from imposing its “individual mandate” while delaying the “employer mandate.” The law that was passed by Congress in 2010 requires that the employer mandate go into effect at the same time as the individual mandate: Jan 1, 2014.

“The U.S. Constitution requires a strict separation of powers between the three branches of government, such that the executive branch cannot change laws passed by Congress,” AAPS’s lawsuit explains. By imposing the individual mandate in 2014 without the protection of the employer mandate, the Obama Administration has changed the legislation passed by Congress.

via AAPS Sues to Stop the Unlawful Revisions to ObamaCare.

Bizarre congress is super-cool with the executive branch picking and choosing the laws to bother enforcing.

Obamacare Is the Worst-Case Scenario | National Review Online

I’m not usually up this early. Ate a lot of carbs last evening, paying the price all night. And today. Probably tomorrow, from the course of events.

 

Enough about me. This is a nice summary of thoughts on Obamacare:

…What do we have to look forward to? Obamacare in effect outlaws traditional insurance and substitutes in its place a mandatory system of prepaid health care administered by the kind and gentle souls who run insurance companies, which is in fact in many ways similar to the mandatory health-savings accounts in Singapore — minus the property rights, wealth building, heritability, efficiency, and consumer choice. Likewise, Obamacare is in some ways similar to the Swiss system, but without the downward price pressure associated with high out-of-pocket expenses, and, as we have seen in recent weeks, also minus the competence and efficiency. As they say in Switzerland: Ich be chrank.

And it is worth remembering that under Obamacare there will still be millions of Americans with no health-insurance coverage, while many (and possibly most) of those added to the coverage rolls will simply be given Medicaid cards,…

via Obamacare Is the Worst-Case Scenario | National Review Online.

Speechless, I am.

Obama’s Broken Promise of Better Government Through Technology – Businessweek

The top part of the article is typical Klein (intent is all that mattered, not execution, which he only allows to one party), but his writing about government in general and government IT in particular is interesting:

The saga of healthcare.gov has been a symphony of government inefficiency. The effort, directly overseen by the IT department of the Centers for Medicare and Medicaid Services, involved no fewer than 55 contractors. The process was thick with lawyers and political interference. In violation of current best practices in the software world, the code was kept almost entirely secret; other engineers weren’t able to point out its flaws, and it wasn’t tested rigorously enough. The Obama administration has been assailed for not calling in Silicon Valley’s top minds to collaborate, but that misses the fundamental problem: The best coders in the Valley would’ve never agreed to work under such deadening, unpleasant conditions.

There are people in Washington who share Bracken’s views, but their struggle against bureaucratic inertia can seem Sisyphean. “Government becomes really afraid of failure, which is a bit ironic, as this ends up leading to failure,” says Clay Johnson, a technologist who was one of the White House’s presidential innovation fellows. “But that fear of failure leads them to only want to work with known quantities, and known quantities mean contractors who’ve done this work in the past. That puts them with a group of entrenched vendors who haven’t really had to compete in the world of technology.”

That fear of failure has been institutionalized in the way the federal government awards contracts. The complex, arcane process favors those companies that devote resources to mastering it and repels the Silicon Valley startups the government desperately needs. “I realized I could figure out how to develop these very complex, very new software programs, or I could figure out how to contract with the government,” says Trotter, who worked on health IT projects with the Veterans Administration. “And so I chose to do the thing that was innovative.”

via Obama’s Broken Promise of Better Government Through Technology – Businessweek.

The front end of the website will eventually get fixed, then the back end. Then we’re going to wait for the employer mandate to hit. All this market disruption was just the self-insured, a very small piece of the health insurance pie.

 

Peter Schiff Blasts “The Website Is Fixable, Obamacare Isn’t!” | Zero Hedge

Wait, wait, this was supposed to bend the cost curve Down…

It is also ironic that high-deductible, catastrophic plans are precisely what young people should be buying in the first place. They are inexpensive because they provide coverage for unlikely, but expensive, events. Routine care is best paid for out-of-pocket by value conscious consumers. But Obamacare outlaws these plans, in favor of what amounts to prepaid medical treatment that shifts the cost of services to taxpayers. In such a system, patients have no incentive to contain costs. Since the biggest factor driving health care costs higher in the first place has been the over use of insurance that results from government-provided tax incentives, and the lack of cost accountability that results from a third-party payer system, Obamacare will bend the cost curve even higher. The fact that Obamacare does nothing to rein in costs while providing an open-ended insurance subsidy may be good news for hospitals and insurance companies, but it’s bad news for taxpayers, on whom this increased burden will ultimately fall.

via Peter Schiff Blasts “The Website Is Fixable, Obamacare Isn’t!” | Zero Hedge.

Lack of skin in the game.