Latest Drugwonks' Blog
I think it is silly to pursue this approach. In the first place, making something prescription does nothing to limit abuse. Indeed, the sharing of prescribed medications is rampant. Secondly, there are other OTC medications that cause many more problems than cough medicines with DXM. That being the case, why not put every OTC that is abused back into prescription or behind the counter. Let's start with aspirin, Vivarin, Red Bull. Why not just ban everything that could possibly lead to adverse events or dependency.
Our poll shows that the first responders and the adults who interact with kids daily (teachers) have bigger issues. Before deciding to require the policing of another medication because it was in the news, the FDA should consider the perspective of those who already have responsibilities for keeping our kids safe. Instead of regulating in this instance the FDA could be educating about the safe and proper use of all medications.
By: Tevi Troy
President Barack Obama announced in his State of the Union address “a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”
Eight months later, Health and Human Services Secretary Kathleen Sebelius has come out with a report launching the initiative. It does not just call for additional spending, as most federal initiatives seem to do, but for a reconsideration of our life science development process, with a specific call for clearing up bottlenecks that hold up new countermeasures to combat a host of biological threats.
In trying to move the report from paper to policy, the administration may find that some of its most implacable opponents are its staunchest allies, while putative allies may cause the administration heartburn.
“The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers seeking to enter the MCM arena,” the report found. In other words, companies looking to create new lifesaving products find the product development process both intimidating and difficult.
To address this, according to the accompanying HHS press release, “HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”
There is little doubt that bureaucratic hiccups and “bottlenecks,” as the report calls them, make the development process for new medical products — including drugs, vaccines, biologics and devices — longer than it needs to be. It takes about 10 years and $1 billion to bring a new pharmaceutical product to market, making such an investment only available to large or well-funded entities. One longtime career staffer told me while I was HHS deputy secretary that he never understood why industry complained about the Food and Drug Administration until he began working on trying to develop and acquire new countermeasures through BARDA, the Biomedical Advanced Research and Development Authority, which manages Bioshield.
Two years ago, I produced an HHS report detailing strategies to approach bottlenecks in the life science development process, which I shared with the incoming administration.
It is noteworthy, however, that a Democratic administration is coming up with these findings, as criticizing pharmaceutical companies has become a staple Democratic attack. Both John Kerry in 2004 and Barack Obama in 2008 sent barbs their way, and congressional Democrats such as Henry Waxman have long been critical of the companies as well.
Many congressional Democrats, as well as other Pharma critics on the left, will not want to embrace Sebelius’ drive to clear up FDA bottlenecks — and they may be uncomfortable with the funding for the countermeasure enterprise as well.
The new administration initiative calls for $2 billion in funding as “Democrats on Capitol Hill have tried repeatedly to cut funding for the BioShield program to pay for other domestic priorities,” according to Congressional Quarterly’s Julian Pecquet. If the House succeeds in its efforts to cut $2 billion out of this area, the new initiative could be scuttled before it even gets off the ground.
It also is interesting that the report somehow fails to acknowledge the administration that made the greatest strides in encouraging the development of our current countermeasures.
The report notes that “the federal government began work over a decade ago, during the Clinton administration, to develop and stockpile medical countermeasures against biological threats.” Although the report acknowledges Bill Clinton by name, things that happened in the most recent decade are characterized by a sentence saying that “events after Sept. 11, 2001 led to an acceleration of those efforts.” These efforts included, as the report acknowledges, a new smallpox vaccine, the purchase of anthrax antibiotics and vaccine, and countermeasures against botulinum toxin.
Other important developments recognized by the report include the creation of Project Bioshield for development and procurement of countermeasures and the creation of the pandemic flu preparedness plan. Both were major achievements of the Bush administration, as were the creation of a new HHS office of preparedness and response, as well as BARDA itself.
The report’s inartful and passive “after Sept. 11” construction appears to be a kind of Soviet method for referring to actions undertaken by the Bush administration without actually mentioning George W. Bush’s name. The Obama administration may be loathe to acknowledge this, but in calling for clearer regulatory pathways and more funding for developing and acquiring medical countermeasures, it may be angering some key allies, as well as embracing an important part of the Bush legacy.
Sebelius and other federal officials appeared at a press briefing to discuss issues involved in enrolling more children in the two health care programs following Sebelius's announcement in February of an initiative aimed at enrolling 5 million additional children within five years.
A report by the Urban Institute published Sept. 3 in the online journal Health Affairs found there were about 7.3 million uninsured children on an average day in 2008, of whom 4.7 million were eligible for Medicaid or CHIP but not enrolled.
Of the 4.7 million children, 3 million had family incomes below 133 percent of the federal poverty level, 1.2 million had family incomes of 133 percent to 200 percent of poverty, and 500,000 had incomes above 200 percent of poverty, said the report, "Who And Where Are The Children Yet To Enroll In Medicaid And The Children's Health Insurance Program?"
Medicaid and CHIP enrollment rates varied across states from 55 percent to 95 percent, and 10 states had participation rates close to or above 90 percent, the report said.
Thirty-nine percent of eligible uninsured children (1.8 million) lived in just three states-California, Texas, and Florida-while 61 percent (2.9 million) lived in 10 states, the report said.
Overall, the report estimated that the national rate of Medicaid and CHIP participation for children was 81.8 percent in 2008.
"This new data will help us to focus our efforts and our grant funding where they are most needed," Sebelius said. "We now have a much better sense of where most uninsured children live, and which communities may need more help."
Currently, health coverage is available to children in families with incomes up to about $45,000 per year in nearly every state, Sebelius said.
"Nothing is more important to our future than the health of our children," she said. "No child should have to skip a doctor's appointment or go without the medicine they need because their family can't pay."
"I'm challenging everyone, from my state and federal counterparts, to local governments and community-based organizations, to health centers and school districts, to faith-based groups and Indian tribes, to take this conversation about children's coverage to the next level-to find and enroll those 5 million kids," she added.
Connecting Kids to Coverage Challenge
Sebelius in February announced a new initiative aimed at enrolling children eligible for Medicaid and CHIP. She challenged advocates and policymakers to enroll those eligible for the programs but not enrolled and set forth ways that could be achieved.
The initiative, dubbed Connecting Kids to Coverage Challenge, dovetails with the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009.
The act gave states additional tools to help increase children's enrollment in Medicaid and CHIP. The tools included outreach and enrollment grants and bonus payments to states that adopt five of eight enrollment and retention strategies and states that experience Medicaid enrollment increases that exceed target growth rates, according to the Urban Institute report.
States also were given "Express Lane" options, which allow them to use administrative data from other programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children to facilitate enrollment, the report said.
The act also allowed states to use federal dollars to cover legal immigrant children who had been in the United States fewer than five years, and it provided states with additional federal funds to cover more children, the report said.
"By February 2010, one year after CHIPRA became law, a number of states had either expanded eligibility for coverage or introduced improvements to their enrollment and retention processes," the report said.
"By April 2010, the federal government had awarded $50 million in outreach grants, including $40 million to organizations in forty-two states and an additional $10 million for targeting Native American children," the report said.
"These policy changes are expected to change the composition of the population of children enrolled in public coverage and raise participation rates among children who are already eligible," it added.
CHIPRA and the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) provide $120 million for grants designed to promote enrollment and retention strategies that will increase the prevalence of health coverage, according to HHS.
17 Groups Signed On
Sebelius said 17 national organizations and a number of states have agreed to sign on to the "Connecting Kids" challenge. The organizations, ranging from the United Way to the American Academy of Pediatrics, represent a broad base of organizations who are working to enroll children in health insurance, HHS said.
The Urban Institute report said the recession and state budget problems could hamper state efforts to promote greater enrollment and retention among eligible children.
The new health care law will help boost coverage, but "it is not clear how much higher participation can be in the states that already have rates greater than 90 percent, given the dynamic nature of family circumstances and eligibility for public coverage," the report said.
"Without strong economic growth, states may be reluctant to seek aggressively to increase enrollment among eligible children in the near term, or even to maintain recent coverage improvements," the report stated. "The recently enacted extension of enhanced federal Medicaid matching rates through the first half of 2011 may encourage states to implement new policies or maintain existing policies aimed at increasing Medicaid/CHIP participation among children," it added.
"Absent increases in Medicaid/CHIP participation in the ten states that account for 61 percent of all eligible uninsured children, there would still be close to three million uninsured children nationally who are eligible for Medicaid/CHIP even if the remaining forty states were able to achieve participation rates close to 100 percent," the report said.
"Moreover, because California, Florida, and Texas together account for 1.8 million of the total eligible uninsured children, increasing participation in those three states will be critical to reaching the national goal," it added.
Support From Federal Government
In a commentary accompanying the report, Sebelius said the federal government "will provide support and technical assistance to build on efforts already under way in several states to streamline the enrollment process. We are also working with partners across the country to explore ways to expand the use of telephones, text messaging, and other technologies in outreach and enrollment."
Sebelius said the federal government also is working with states and community organizations to identify the most effective ways to reach out to families, and then enroll their children "where they live, learn, play, work, worship, and receive health care."
"We are striving to make enrollment assistance an ongoing and routine activity," she stated.
The Urban Institute study is available at http://content.healthaffairs.org/cgi/content/full/hlthaff.2010.0747v2
The commentary on the issue by Sebelius can be found at http://content.healthaffairs.org/cgi/content/full/hlthaff.2010.0852v1.
More information on Sebelius's "Connecting Kids to Coverage Challenge" program can be found at http://insurekidsnow.gov
According to a new study in Health Affairs, more than half of the 354 million doctor visits made each year for acute medical care, like for fevers, stomachaches and coughs, are not with a patient’s primary physician, and that more than a quarter take place in hospital emergency rooms.
The authors of the study pose a significant question about what we’re calling “healthcare reform” -- how can access to primary care be improved when an already stressed system with a dearth of primary care physicians takes on millions of new patients?
More than half of acute care visits made by patients without health insurance were to emergency rooms. That poses a heavy workload and financial burden on the system and means that basic care is provided in an expensive setting.
According to Dr. Stephen R. Pitts (no relation), the lead author and an associate professor of emergency medicine at Emory University, “More and more patients regard the emergency room as an acceptable or even proper place to go when they get sick.”
The study can be found here.
In theory, the new federal law is designed to enhance primary care by increasing reimbursement for practitioners, luring students into the field with incentives.
The real-world reality is, as we know, quite different. I recently went to my Upper West Side Jewish GP (just to give you an idea of the non-Tea Party demographic). She asked me, “So, how bad is it?” When I asked what she was referring to she said, “This new health care law – for me.” The concept that you can improve primary care by (1) restricting the independence a physician has to practice both the art and the science of medicine and (2) sending very mixed signals about the inevitability of a permanent “doc fix,” (3) increasing case loads, and (4) doing absolutely nothing about tort reform – certainly makes a dubious case for “luring students into the field,” let alone keeping those already in place in practice.
The authors issue a critical warning, “If history is any guide, things might not go as planned.”
And those who do not learn from history ...
And speaking of tort reform, another article in Health Affairs illuminates addresses the issue head on.
The paper by three Harvard professors and a colleague at the University of Melbourne in Australia estimates that the medical-liability system added $55.6 billion to the cost of American medicine in 2008, equal to 2.4 percent of total health spending.
More than 8 of every 10 of those dollars — $45.6 billion — was attributed to defensive medicine by physicians who order unnecessary tests and procedures to protect themselves from malpractice claims. Not decimal dust.
That study can be found here.
Attention must be paid. Whoever has the gavel for the 112th Congress has a lot of work to do.
Can consumers really understand what clinical trials have to say about comparative risk and benefit? And what are the rammifications?
The FDA is studying whether/how to add comparative and numeric information describing benefit and risk data to the brief summary in direct-to-consumer print advertising.
The agency is looking at various presentations of quantitative and qualitative information in a boxed format and determine how consumers perceive drug efficacy and risk as well as measure their understanding of the benefit and risk information.
FDA's summary of the study proposal notes that evidence indicates formatting can impact consumer comprehension of information, and using bullet points or section headings can make the information more readable.
"It is not known whether simply adding efficacy rate information to a consumer-friendly brief summary would be sufficient to enable consumers to understand a product's efficacy, or whether qualitative summations are necessary as well," the agency said in the Federal Register.
Well – duh. No news there. All of this is pursuant to the media-friendly (but poorly designed) Dartmouth University study.
One thing that requires no additional study is, shall we politely say, the relative user-unfriendly nature of the current brief summary. The joke inside the FDA (if a joke it can be called) is that the brief summary is like the Holy Roman Empire – neither brief nor a summary.
Nor of tremendous utility.
According to the FDA’s 2002 study, 65 percent of doctors believed that the DTC ads their patients saw confused them about the relative risks and benefits of prescription drugs—and that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73 percent—an increase of seventeen percentage points. During that same three-year span, those saying they read “almost all” or “all” fell from 26 percent to 16 percent— these ten percentage points are not decimal dust by any stretch of the imagination.
In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.
For more on why the current long format brief summary doesn’t work see this article from Health Affairs.
As to the idea of a risk “window” – it’s already part of the FDA lexicon (see the January 2004 draft guidance on alternative presentations of the brief summary).
For more on that topic (as well as the variable nature of consumer comprehension and alternate solutions) see this paper from the Drug Information Journal.
First, a NEJM study about the risks of Meridia
The study reaffirmed that that patients with heart problems should not be prescribed Meridia," the New York Times (9/2, A25, Harris) reports, a "restriction already included in Meridia's label." But, the journal editors don't think the investigators went "far enough." Gregory D. Curfman, MD, NEJM's executive editor, added, "It wasn't that we disagreed with the interpretation of the authors," but "many patients...have cardiovascular disease and don't know it. How are you supposed to identify those patients who might be put at risk by putting them on drugs like sibutramine?"
And of course Steve Nissen has an informed judgment on the issue..
The other example of ignoring facts comes from the study of whether gene testing for response to warfarin improves outcomes in the NEJM. Two other studies suggested genetic testing was important for reducing bleeding associated with warfarin but not for new clot busting drugs.
“Results are presented only for patients of European or Latin American ancestry. Patients with other ancestries were excluded because of small numbers (99 patients in the next largest group) and concern about the potential for population stratification.”
“Only 18.0% of patients in the CURE population included in our study underwent PCI, and only 14.5% underwent PCI with placement of a stent, as compared with more than 70% in previous studies.”
So the study -- truly a one size fits all approach – excludes African Americans and people undergoing PCI
Further:
"Carriers had a more pronounced reduction in cardiovascular events with clopidogrel treatment as compared with placebo than did noncarriers (hazard ratio with clopidogrel among carriers, 0.55; 95% CI, 0.42 to 0.73; hazard ratio among noncarriers, 0.85; 95% CI, 0.68 to 1.05; P=0.02 for the interaction). A similar interaction was observed with respect to the second composite primary outcome (hazard ratio with clopidogrel among carriers, 0.66; 95% CI, 0.54 to 0.82; hazard ratio among noncarriers, 0.90; 95% CI, 0.76 to 1.06; P=0.03 for heterogeneity)."
Isn’t finding out who benefits more a good reason for testing? Eric Topol thinks so:
“Genomics expert Dr Eric Topol (Scripps Research Institute, La Jolla, CA) told heartwire: "Both TRITON and PLATO reinforce the CYP2C19 story . . . that loss-of-function variants lead to diminished clinical impact for clopidogrel. PLATO takes this a step further to now show that the gain-of-function allele *17 is associated with more bleeding."
http://www.theheart.org/article/1114619.do
The rush towards headline grabbing instant analysis undermines a more systematic analysis in the Meridia and genetic testing issues and ignores the fact that RCT’s have limitations.
As another editorial noted with respect to gene testing:
“Besides genetic profiles, the evaluation of the best management should also take into account the clinical determinants of platelet reactivity—from age and sex to body-mass index, diabetes, and inflammation—that modulate platelet function, while also considering the timing from the acute event, she adds. "Prospective studies evaluating different antiplatelet treatments tailored according to the individual characteristics of patients are urgently needed to identify therapeutic strategies that will provide the best benefit for the single patient in this high-risk clinical setting."
Too bad CER funding is not available for such research.
Allergan has agreed to pay $600 million to settle charges that it illegally promoted and sold Botox through 2005 for unapproved uses like treating headaches.
In addition to the monetary fine, Allergan has agreed to a five-year corporate integrity agreement requiring the company to publish information about its payments to doctors.
The agreement also requires Allergan to drop its First Amendment lawsuit against the F.D.A., in which it had claimed free speech protections when giving doctors information about unapproved uses of Botox.
Whether or not DDMAC dodged a bullet on this one is debatable -- but the core issue is clear -- if it's off label you can't promote it. And calling off-label promotion "physician education" is just way too cute.
A new poll shows that public support for healthcare reform dropped sharply in August.
The Kaiser Health Tracking Poll has support for the bill dropping 7 percentage points in August — down to 43 percent — while opposition rose 10 points to 45 percent.
Respondents listed healthcare as the third most important factor in deciding how they’ll vote this fall — behind the economy and “dissatisfaction with government.”
Forty-two percent of respondents said healthcare reform will play an “extremely important” role in their ballot-box decisions, on par with the 41 percent who said the same thing in June.
A series of insurance industry reforms, including a ban on lifetime or annual caps on insurance coverage and free preventive care on new insurance plans, have proved popular in polls, but the popularity of the overhaul on the whole hasn’t improved. Plus, opposition to other provisions — namely, the requirement that nearly all Americans buy insurance coverage — has increased. The so-called “individual mandate” was opposed by 70 percent of the Kaiser poll’s respondents.
First it is important to know what’s in JANUS and what is not:
“The JANUS warehouse was populated with sample synthesized human trial data related to two oncology studies. This data was furnished in standard STDM format and data load scripts were developed to import the data. A sample caCORE application was developed to demonstrate the analytical capabilities of such an application accessing the underlying JANUS repository. The application was modeled against SDTM domain views of the Janus warehouse instead of the warehouse schema itself to alleviate complexity and improve data access efficiency. The sample application was successful in that you could authenticate the users at signon using CSM authentication and then review the clinical trial data in the following ways:
- View patient enrollment by study
- View patient retention by study
- Efficacy reporting by study
- Safety reporting by study
Note the absence of genomic data.
· Conduct a review of a sample of FDA clinical trials performed to assess drugs, biologics and devices. This review shall include clinical trial data used in pre-market submissions for one class of drugs or devices.
· Evaluate comparator groups, populations studied, study designs, endpoints, statistical analysis methods, and trial conduct.
· Include an evaluation of the capability of each study to distinguish differences in effectiveness and safety among different populations, subpopulations and individuals.
· Provide formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons.
While a long term goal of analyzing JANUS data is identify robust data standards to capture and exchange clinical genomic data, that goal is not addressed or funded.
Most troubling is that the vendors interested in submitting bids lack any expertise in achieving this goa.l Many of them are superb and innovative providers of infrasture or developers of portals for delivering clinical data. But the only vendor that is in the business of analyzing data has significant conflicts of interest in my opinion. And that’s The Center for Medical Technology policy run by Sean Tunis. When Tunis left Medicare in 2005 and set up the Center, the Agency for Healthcare Quality and Research was his first client. Tunis also served on the Institute of Medicine panel that set the CER agenda for the Federal Coordinating Council on Comparative Effectiveness Research of which FDA is a part.
Moreover, Tunis has a distinct bias against using any new technology absent the kind of evidence he believes is important. Consider his self-serving white paper on how Designing More Informative Clinical Trials for Off-Label Uses of Oncology Drugs which has the goal of establishing CMT as the entity that will create standards and conduct studies using clinical data to compare a standard treatment to a newer use. Tunis wants payors to require such studies before reimbursement is made. And since CMT would be the standard setter, guess who would get all the CER business?
Tunis makes the same lame claim all CER advocates and contractors use:
“Despite the prevalence of off-label use of oncology drugs and related services, the health outcomes and value of expenditures on these products and services are not well
understood.”
“Off-label oncology CERs should be designed to be generalizable in that they include sociodemographic diverse patient populations as well as patients with common comorbidities that exist among cancer patients and/or are positively or negatively associated with the use of oncology 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.
