Engineers at UC San Diego are testing new ways to build biosensors into the elastic bands on underpants to monitor key biomarkers on health. One day the super underpants could be used to check everything from the level of alcohol in your system to the level of stress you're operating under. Story
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Biosensors added to underpants
Now set the teeth and stretch the nostril wide.
A separate safety office?
Hold hard the breath and bend up every spirit.
Report language in a House appropriations bill for FDA outlines the creation of an independent office within the agency to evaluate a drug's post-market safety profile.
Straining upon the start. The game's afoot.
According to Representative Rosa DeLauro (D, CT), who chairs the House Appropriations subcommittee, this new FDA office would (per the Pink Sheet) “avoid the potential for bias that arises when FDA staff who approve a drug are the same people who make decisions when a marketed drug's safety is called into question.”
This is a bad idea for many reasons, let me mention two:
(1) How can you determine a drug’s “safety” without also understanding its real world concomitant benefit?
(2) The more-than-implied accusation that FDA staff that worked on a drug’s ultimate approval cannot be trusted to view safety issues without “bias” is entirely untrue and highly insulting. Who can be trusted? FDA's own "Bard of Safety" -- David Graham? Shame. Shame. Shame.
Representative DeLauro did not provide specific language on a separate safety office during the subcommittee markup, but noted that she developed it with assistance from Senator Charles Grassley (R, IA), and Representative Maurice Hinchey (D, NY). Mr. Hinchey introduced H.R. 4816, the FDA Improvement Act of 2010, which would establish within FDA an independent Center for Post-Market Drug, Device and Biologics Safety and Effectiveness.
Once more unto the breach, dear friends, once more.
On the DDMAC front, the report calls for $3 million more for Abrams & Associates to review DTC materials and an additional $2 million for professional communications.
Depending on where you sit, that’s either too much or too little.
But when the blast of war blows in our ears,
Then imitate the action of the tiger
Check out CMPI's interview Charles Djou
Watch Grover Norquist on Health Care Reform
Bravo.
Medicare and Medicaid patients with a chronic condition will be able to review all their medications in one-on-one sessions with pharmacists under a bill introduced Tuesday by Sen. Kay Hagan (D-N.C.). The Medication Therapy Management (MTM) Expanded Benefits Act would also reimburse pharmacists to follow up and educate patients about their medication regimen.
"This bill will allow seniors with one chronic condition, such as diabetes or heart disease, to bring all of their medications to the pharmacy and ensure they are following doctor's orders," Hagan said in a statement. "If more seniors properly follow their medication regimens, we can save lives and Medicare dollars."
Currently 12.9 percent of seniors in the Medicare prescription drug program — all of whom have multiple chronic illnesses — are eligible to participate in MTM programs. Hagan's bill would allow seniors with only one chronic illness to participate in the program at pharmacies, hospitals and other entities that distribute pharmaceutical drugs and provide MTM services.
Wither comparative effectiveness?
"We are now right on the cusp of an era where we can get all the data we want," but getting the research methods and analytics right "is going to be quite critical," said Carolyn Clancy, director of the Agency for Healthcare Research and Quality.
But data, as the saying goes, is like a bikini – what it shows you is interesting, but what it conceals is essential.
Clancy believes (and appropriately so) that data could help, say, a newly diagnosed cancer patient who wants to know, "What happens to people like me if I choose this path, that path or another path?"
They don’t call it the Critical Path for nothing.
Clancy: "Increasingly we're seeing in legislation the opportunity to inform policy with science, but the details really matter in getting it right."
Indeed. And those details need to lead us towards the “four rights” – the right medicine in the right dose at the right time for the right patient.
And that’s not comparative effectiveness – that’s clinical effectiveness.
Canada’s solution to ever-longer hospital queues: “Technowait” -- a program that allows patients to register at the front desk, then through a phone line, check in periodically to determine when the doctor is “really” ready to see them.
You can stop reading the JAMA article about the dire risks of Avandia when you come to this seemingly innocuous line:
"Several unplanned, post hoc analyses were performed to evaluate the failure of some Cox proportional hazards models to meet the proportional hazards assumption. These unplanned analyses included those restricted to patients who entered the study before or after publication of a widely publicized meta-analysis of rosiglitazone randomized trials on May 21, 2007,1 and partitioning of follow-up time into intervals of 0 through 2 months, more than 2 through 4 months, and more than 4 months."
Read the full JAMA article here.
Translation:
"Several unplanned, post hoc analyses were performed to evaluate the failure of some Cox proportional hazards models to meet the proportional hazards assumption. These unplanned analyses included those restricted to patients who entered the study before or after publication of a widely publicized meta-analysis of rosiglitazone randomized trials on May 21, 2007,1 and partitioning of follow-up time into intervals of 0 through 2 months, more than 2 through 4 months, and more than 4 months."
Read the full JAMA article here.
Translation:
"Post-hoc analysis, in the context of design and analysis of experiments, refers to looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely something will be found. More subtly, each time a pattern in the data is considered, a statistical test is effectively performed. This greatly inflates the total number of statistical tests and necessitates the use of multiple testing procedures to compensate. However, this is difficult to do precisely and in fact most results of post-hoc analyses are reported as they are with unadjusted p-values. These p-values must be interpreted in light of the fact that they are a small and selected subset of a potentially large group of p-values. Results of post-hoc analysis should be explicitly labeled as such in reports and publications to avoid misleading readers.
In practice, post-hoc analysis is usually concerned with finding patterns in subgroups of the sample."
In other words, Graham, et. al. tortured the data to get it to say what it wanted. And even then it found a slightly elevated risk for those on Avandia over a year period, a difference so slight that it could be easily explained by, say, severity of illness or blood sugar levels, neither of which Graham and company cared to measure.
What they did do was, after discovering no difference in risk, a post hoc subgroup analysis to find risk. That's cheating by their own admission since in the entire group they studied their were only 15,000 people on Avandia compared to 100,000 or so on Actos. But they still subdivided the two groups into two smaller groups (2-4 months on each drug and 4-6 months) and finally found what they claimed were "significant differences" in hazard ratios but only in composite scores.. And even then it was a difference of 20 percent or so. Not really statistically significant. Hey, why not test in between trips to the bathroom? It would be more fitting giving the quality of the research.
I can't believe JAMA published this nonsense with an accompanying editorial warning against use of Avandia instead of an editorial tearing about the questionable data mining.
My guess is the FDA will see right through the charade.
An excellent piece in The Boston Globe by VC Chris Westphal about the hyperventilation about drug safety absent a science-based discussion of benefits...
http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/06/28/the_myth_of_the_perfect_drug/
http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/06/28/the_myth_of_the_perfect_drug/
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
