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Hamburg opposes separate safety reviews
FDA Commissioner Margaret Hamburg told BioCentury she opposes separating postmarket safety oversight from new drug reviews, a policy Rep. Rosa DeLauro (D-Conn.) and Sen. Chuck Grassley (R-Iowa) are promoting. DeLauro recently announced plans to attach a report instructing FDA to create an independent postmarket drug safety office to an appropriations bill.
"We need to strengthen the integration of safety and efficacy throughout the lifecycle of medical products," Hamburg said. "It would be a mistake to further separate and stovepipe safety and efficacy." Hamburg said she is considering organizational changes to better integrate safety and efficacy oversight. In addition, she said FDA needs to "strengthen safety science, and that's why I've asked the Institute of Medicine to do a report [on postmarket safety studies], and our Science Board will be undertaking a study about safety science at FDA"
Hamburg supports releasing complete response letters
Releasing information about negative decisions on drug applications could benefit drug developers and advance scientific progress, FDA Commissioner Margaret Hamburg said Tuesday at a conference on drug development. An FDA transparency working group's draft proposals include publicizing redacted versions of complete response and refuse to file letter.
"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," Hamburg said at the meeting, sponsored by Friends of Cancer Research, Ewing Marion Kauffman Foundation, Council for American Medical Innovation and others. Companies might oppose public release of information about rejection of their application, but "those same companies can recognize there are benefits if everyone opens up and does the same,” she said.
Hamburg told BioCentury that disclosures would describe the reasons for a rejection. They also "would obviously speak to the adequacy of data in certain instances, but more significantly, that certain approaches might not be effective or certain kinds of molecular entities have certain toxicities, and that could have relevance beyond a particular application." FDA would not release commercial confidential information "without industry's explicit permission," she said.
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Robert Butler MD died this week of leukemia at the age of 83, full of projects and brimming with new constructs for future research. I was a junior at SUNY Buffalo when I read "Why Survive? Being Old in America.” What I found striking about the book what Butler’s ability to deconstruct aging as a product of disease, not of getting old, which he argued was society’s convenient way of not investing time and money into understanding the biological processes that characterized “getting old.”
An excellent tribute to Dr. Butler can be found here: tinyurl.com/26ph5s9
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There has to be a solution short of a total ban, because with the CME industry a billion dollar business, there’s simply too much money at stake.
But one of the physician comments to Dr. Pho’s blog caught my eye:
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"It's private insurers who often are telling their clients that, "No, you can't get this recommended treatment that the doctor has made"; "No, you can't get this drug"; "No, you're not going to be able to stay in the hospital an extra day"; "No, you're not going to get this because we're concerned about costs."
HHS solution to the fact that Congress has underbudgeted money for temporary insurance coverage for people with pre-existing conditions in state run high risk pools:
Health law risks turning away sick
The Obama administration has not ruled out turning sick people away from an insurance program created by the new healthcare law to provide coverage for the uninsured.
Administration officials insist they can make changes to the program to ensure it lasts until 2014, and that it may not have to turn away sick people. Officials said the administration could also consider reducing benefits under the program, or redistributing funds between state pools. But they acknowledged turning some people away was also a possibility.“There’s a certain amount of money authorized in the statute, and we will do our best to make sure that that amount of money insures as many people as possible and does as much good as possible,” said Jay Angoff, director of the Office of Consumer Information and Insurance Oversight at the Department of Health and Human Services (HHS). “I think it’s premature to say [what happens] when it’s gone.”
Read more here
Sounds like rationing to me, at least according to the definition used by Sec. Sebelius: "We will not allow these companies to insure only the healthy and leave the sick to suffer."
instead, the government will make that happen.
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California is the front line in the war over patient-centric care and cost-based controls. And the present battle engagement is over Assembly Bill 1826 and “fail first/step therapy”
According to a report in the Sacramento Bee, insurance interests are lobbying state senators to reject the proposal.
“In letters, insurance associations and companies also contend that step therapy is a good idea because employees of health plans are often in a better position than patients' doctors to know the risks of drug interaction.”
Blue Shield of California also wrote, "step-therapy protocols also act as a check-and-balance to the cozy relationship that exists between many physicians and drug companies."
This from the industry that spiffs physicians with monetary incentives when they switch patients from innovator to generic medicines.
The group's letter says plans consult "expert opinion" and federal research, while many doctors lack a procedure to get "the latest information" about proper drug dosages.
All those in favor of disempowering physicians in favor of insurance companies signify by saying “Oy!”
The complete Sacramento Bee story can be found here.
LETTERS
July 1, 2010
Finger-Pointing Doesn't Provide Care
The financial disaster that will befall doctors and the corresponding lack of access to care that will befall seniors if Congress fails to address scheduled cuts in Medicare ("Doctors Chafe as Medicare Cuts Loom," U.S. News, June 16) isn't a new problem. In fact, the president was only able to claim that his health-reform plan didn't add "one dime to our deficit" by ignoring $371 billion in spending needed to fix Medicare reimbursement rates.
Congressional Democrats claimed that the cost of fixing the Medicare payment formula shouldn't count as part of their health-care reform package because it was a problem they inherited. But now isn't the time to assign blame. Now is the time to solve the problem, for which we all will have to pay.
Peter Pitts
President
Center for Medicine in the Public Interest
New York City
(Mr. Pitts is a former associate commissioner for the Food and Drug Administration.)
Biosensors added to underpants
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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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
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.
Read More & Comment...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.
"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.
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http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/06/28/the_myth_of_the_perfect_drug/
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FDA report reveals airline food could pose health threat:
http://www.usatoday.com/travel/flights/2010-06-28-1Aairlinefood28_ST_N.htm
Read More & Comment...As the saying goes, "A joy that's shared is a joy made double." And that may now be the case via more coordinated FDA and CMS actions.
A June 23 memorandum of understanding on data sharing (signed by FDA Commissioner Peggy Hamburg and CMS Acting Administrator Marilyn Tavenner), could serve as a first step toward parallel reviews by FDA and CMS. CDRH Health Director Jeff Shuren announced the pact at a June 24 public workshop on device innovation.
The memorandum "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions," commented Shuren.
As part of the new effort, the two agencies are "seriously exploring the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at FDA," for example, Shuren explained at the meeting. "Such an approach could reduce the time from FDA approval to CMS coverage and payment for some devices."
He also noted that the agencies may eventually consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to pay for a new technology "without additional evidence."
Shuren stressed, however, that only expanded information sharing has been agreed upon at this point. Parallel review is "not a done deal," he said
CMS' coverage-with-evidence-development policies, for instance, could help with FDA post-market data collection, he explained. FDA is already exploring use of Medicare claims data as a post-market surveillance tool as part of its Sentinel initiative.
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