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WASHINGTON (AP) -- Opposition to President Barack Obama's health care law jumped after he signed it - a warning to Democrats running for re-election this fall that his victory could become their liability.
A new Associated Press-GfK poll finds Americans oppose the health care remake 50 percent to 39 percent. Before a divided Congress finally passed the bill and Obama signed it at a jubilant White House ceremony last month, public opinion was about evenly split. Another 10 percent of Americans say they are neutral.
Disapproval for Obama's handling of health care also increased from 46 percent before the bill passed to 52 percent currently - a level not seen since last summer's angry town hall meetings.
Nonetheless, the bleak numbers may not represent a final judgment for the president and his Democratic allies in Congress. That's because only 28 percent of those polled said they understand the overhaul extremely or very well, and a big chunk of those remain neutral.
Democrats hope to change public opinion by calling attention to benefits available this year for seniors, families with children transitioning to work and people shut out of coverage because of medical problems.
"There are some things I like, because I think that there are some people who need health care," said Jim Fall, 73, a retired computer consultant from Wrightwood, Calif.
But "I don't like the idea of the government dictating what health care should be like," added Fall. "Nor do I like them taking money out of Medicare. They are going to create more waste and they are going to take away benefits."
Seniors - reliable voters in midterm congressional races - were far more likely to oppose the law. Forty-nine percent were strongly opposed, compared with 37 percent of those 64 and younger. Seniors' worries that Medicare cuts to insurers, hospitals and other providers will undermine their care are a formidable challenge for Democratic congressional candidates this fall.
Analysts said such wariness on a major piece of social legislation is unusual.
"The surprise of this poll is that you would expect people to be more supportive of the bill now that it's the law of the land - and that's not the case," said Robert Blendon, a Harvard public health professor who follows opinion trends on health care. "The election for the House is going to be competitive, and health care is clearly going to be an issue."
The nearly $1 trillion, 10-year health care remake would provide coverage to nearly all Americans while also attempting to improve quality and slow the ruinous pace of rising medical costs.
Nonpartisan congressional budget analysts say the law is fully paid for. Its mix of Medicare cuts and tax increases, falling mainly on upper-income earners, would actually reduce the federal deficit. And people covered by large employers may even see a dip in their premiums.
The public doesn't seem to be buying it.
Fifty-seven percent said they expect to pay more for their own health care, contrasted with 7 percent who expect to pay less. And 47 percent said they expect their own medical care to get worse, compared with 14 percent looking forward to an improvement.
"Based on the little information we know, somebody's going to have to pay for it, so it makes sense that taxes would go up," said Lang Fu, 48, an oil and gas engineer from Houston.
Politically, Americans are polarized. Democrats support the overhaul by 68 percent to 18 percent, while Republicans oppose it 85 percent to 9 percent. Whites oppose it by 57 percent to 32 percent, while minorities support it 61-27.
Political independents are roughly even, with 44 percent opposed and 40 percent in favor - within the poll's margin of error. Some may be swayed by appeals from Obama and the law's supporters.
Donna Christian of Kingsport, Tenn., is an independent leaning in favor of the law. A bad heart forced Christian, 45, to leave her job as a supervisor at a wireless phone company a few years ago. She and her 10-year-old daughter make do on a limited income, and have coverage through Medicaid.
"I think Americans are going to be better off in the long run even if they don't see that now," Christian said. "More will have coverage, and they'll be able to go to the hospital when they need to."
Ron Pollack, head of Families USA, a liberal advocacy group that supports the overhaul, said it will be "a real task" to turn public opinion around, but he's confident.
"When you dig deeper, individual provisions of the law have enormous support," he said. Pollack believes current polls reflect public disgust with a "very lengthy and messy process."
But Rep. Dave Camp, R-Mich., says Democrats already lost their chance to persuade the public.
"They have had 16 months to explain this bill," Camp said. "Good luck trying to explain it in the next six."
The AP-GfK Poll was conducted April 7-12, 2010, by GfK Roper Public Affairs and Media. It involved interviews with 1,001 adults nationwide on landline and cellular telephones. It had a margin of sampling error of plus or minus 4.3 percentage points.
PS/ The Associated Press is not owned by Fox News.
While narrower bioequivalence margins might be necessary for certain categories of generic drugs, FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee has determined that the specifications should not be tightened across the board for all generic drug approvals.
On April 13, the panel voted that current bioequivalence standards are not sufficient for generic versions of "critical dose" drugs, drugs where there is a narrow therapeutic index and deviations can result in therapeutic failure or adverse drug reaction. But on April 14, the committee pulled back from FDA's proposal to revise the bioequivalence margins for all generics, rejecting that idea in a 12-2 vote.
FDA officials presenting at the meeting signaled strong agency support for the move.
Here are the four component parts:
1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
Subjective. Subjective. Subjective. Subjective.
Nothing new -- just more of the same old ambiguity. And more excuses to write warning letters that serve no purpose other than to satiate the hunger of those on the Hill who see volume of letters as equaling more robust oversight.
Really?
For a good overview of the issue and some top notch opinions, see this article from the RPM Report.
If you're wondering why "net impressions" has become "net neutrality" -- it's because the FDA doesn't do impressions.
(And don't call me Shirley.)
Former Senator (and almost HHS Secretary) Tom Daschle keynoted the opening of the 19th Annual Partnerships in Clinical Trials conference.
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Okay, once more with feeling – “generic” does not equal “identical.” That’s why the FDA wants to tighten the bioequivalence standards for generic drugs. Bravo!
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.
According to the agency, although that methodology is "statistically rigorous" and accepted as a valid way to establish bioequivalence in most of the world, "many consumers and health professionals do not understand these statistical methods and the approval standards based on confidence intervals … Many wrongly assume that the FDA places the standards ... on the mean or average of the study data rather than the confidence intervals."
"Since the public seems to have a basic understanding of averages, the proposal to be discussed is for an additional criterion to be placed on the geometric mean (average or point-estimate) of the data limiting it to 90-111 percent." The agency surveyed 12 years of generic approvals and found that only approximately 2 percent to 3 percent of approved generic drugs would not have passed with the additional criteria.
According to a report in the Pink Sheet, “There is regulatory precedent in the definition of narrow therapeutic ratio, where drugs that meet certain parameters of median lethal dose and median effective dose are required to have careful titration and patient monitoring. But that definition is not necessarily clinically practical, FDA states, because the relevant parameters are not always available during drug development. Thus, the agency is asking the advisory committee whether it should consider CD drugs to be a distinct class, and how it should be defined. The agency also wants to know whether if the current bioequivalence standards are appropriate for CD drugs.”
The agency has already set up specific requirements for one drug product, asking manufacturers of generic versions of Sanofi-Aventis's insomnia drug Ambien CR (zolpidem) to compare partial AUCs over clinically relevant time intervals. An appendix considers the role of partial AUC for generics of modified-release methylphenidate products as well.
Its good news that the FDA is taking a strong stance in favor of the public health – because there will be many who seek to undermine this important initiative.
In the words of John Stuart Mill,
“One person with a belief is equal to a force of 99 who have only interests.”
Biogen Idec is developing a test that can tell patients their odds of getting a deadly brain illness from Tysabri.
The screening tool could be marketed as early as 2011 if clinical trials involving 9,000 people show a low rate of false findings. The test is designed to detect the JC virus that causes progressive multifocal leukoencephalopathy, or PML, a brain-cell destroyer that can lead to disability and death. (Tysabri has been linked to 42 PML cases.)
If the test works, it is “absolutely a game changer,” said Patricia O’Looney, vice president of biomedical research at the National Multiple Sclerosis Society. With a false-negative rate of 2 percent, patients who are free of the virus would lower their risk of getting the brain disorder PML to 1 in 25,000 for the first three years of their Tysabri therapy.
And speaking of risk management, I’m chairing a panel on REMS today at the 19th Annual Partnerships in Clinical Trials conference.
A common question I get about REMS is – how is it different from what we used to call RiskMAPS? I see two main differences. The first, obviously and importantly, is that REMS has actual legislative language. And that’s an important detail – but it’s one-dimensional.
The second, more important and contentious difference is the environment into which REMS was birthed -- an environment in which there is growing realization that the 21st century FDA must add a third leg to its mission of safety and efficacy – and that third leg is safe use. The safe use of drugs. And the formulation, implementation and communication of plans – REMS plans -- that will assist physicians and patients achieve better outcomes through the strategies and tactics devised therein.
That being said, there are those in industry and in the broader healthcare policy arena who look at REMS and don’t see GEMS.
Many have looked at the FDAAA language on REMS and see it as an ill-advised green light for the FDA to inject itself into the practice of medicine.
While I agree that REMS does indeed represent an expansion of the FDA's authority, I do not agree that it is either ill advised or an over-extension of the agency’s purview.
The concept of "safe use" as an integral part of the FDA's 21st century mission and REMS as one of many tactics to achieve better patient care are contentious and crucial. And it is that debate which brings us together today.
REMS must be viewed as a “win/win” situation for the agency (which can now move forward to approve drugs with higher risk profiles and have a more direct path for post-market surveillance), for sponsors (who can have their drugs approved with greater alacrity), for physicians (who will – at least in theory) have a more complete view of risks and benefits, and patients (who will have additional therapeutic options and will now – at least in certain circumstances – become a more complete part of the compliance/adherence proposition).
There’s much debate and discussion over where in the drug development process REMS should surface. Acknowledgement that this cannot be done in the absence of data – and confusion as to how to deal with early (even Phase II information) that might be REMS relevant. And “confusion” meaning both scientific uncertainty and internal confusion and discomfort.
There’s evident frustration about validated tools (the absence thereof). But this was at least somewhat assuaged by the timely release of the FDA’s draft guidance on “Format and Content of Proposed REMS Assessments, and Proposed REMS Modifications.” And it was a cool and refreshing draft indeed.
And there’s continued discussion as to whether or not companies should wait until the agency asks – or if sponsors should preemptively (you should excuse the expression) provide an outline of a potential REMS plan. This is important not just as an issue of timeliness (as opposed to having the agency introduce the topic in a complete response letter), but also of responsibility. If, as we all want to believe, the FDA must be both regulator of and colleague to industry, then what are the responsibilities of a sponsor relative to (among many other things) surfacing the REMS issue – and at what point in the process. Nobody said it was going to be easy.
CDER Director, Dr. Janet Woodcock said that, “Safety means doing the right things for patients. FDA must consider post-approval issues as part of a drug’s lifecycle.”
Janet understands that there’s a real difference between “headlines and help.” In other words, REMS and other safety mechanisms can be viewed as either “headlines” about “unsafe” drugs or in a more appropriate context of “safe use.” Janet opts for “safe use,” while others (in the media and elsewhere) seem more predisposed to the other.
According to Woodcock, “FDA does not control the health care system, so our improving the use of marketed drugs, to a great extent, is going to involve influence rather than control.”
“Influence rather than control” is a savvy and sophisticated concept -- one that many of our elected members of Congress could learn from, and one in which REMS plays an important role.
The FDA’s "Safe Use" initiative is the patient-facing sibling of the agency’s “Safety First” pharmacovigilance program. But it's more than that -- it's the FDA reasserting ownership of safety from those who would use it only as a mallet of fear. I will not mention names.
It's important to note that when the FDA announced the warfarin label change the agency (and Larry Lesko in particular) came under attack from critics who asserted that this was the FDA, inappropriately, telling doctors how to practice medicine.
Jane Axelrad, the associate director for policy at CDER, had to say about REMS, “These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use.”
Whether you say “appropriate” use or “safe” use – the principle is the same – making sure that the risk/benefit analysis of any given therapy is communicated in a lucid and (when required) strident manner.
Sometimes that requires a label change. Sometimes it requires a REMS plan, but it will always require the active participation and leadership of the FDA in partnership with the pharmaceutical industry, physicians, and yes – even patients.
Because no safe use program will succeed without the secret ingredient of patient responsibility.
But does it require additional agency authority. At a recent House Energy and Commerce Health Subcommittee hearing FDA’s Principal Deputy Commissioner Josh Sharfstein said that FDA could use more authority to bring negotiations over a drug's Risk Evaluation and Mitigation Strategy to a close. The agency can require a REMS, he commented, but not specify its contents.
Brand sponsors must implement such a plan, whereas FDA must pay for and operate a communication plan for generic drugs, he noted. Something to think about as we head into the PDUFA reauthorization debate.
Comparative Effectiveness Research and Alternative Medicine: Bring it On
"..Isn’t it at least possible that CER will focus on determining whether other commonly used therapies meet even that baseline standard?So rather than thinking of CER as a threat to big pharmaceutical brands, maybe there is an alternative vision for how it might work. Literally: as a tool to test the value of so-called “alternative” medicine."
Wow. As if that is the primary purpose of the $600 million a year the Agency for Healthcare Research and Quality will be receiving.
The In Vivo folks note: "Sebelius diplomatically avoided taking a stand on the value of alternative medicine, and stressed that private plans—not the feds—will decide what to cover."
I have a suggestion for In Vivo: Less sucking up to Sebelius and more reporting. Here is what the legislation actually has the feds deciding and using CER in making these decisions on behalf of consumers, doctors and private plans:
1. Development of a national health quality strategic plan that will be used for improving Federal payment policy with an emphasis on " quality and efficiency" (as in payments to health exchanges)
2. Establishment of annual benchmarks for each relevant agency to achieve national priorities. (see number 1)
3. Establishment of a " process for regular reporting by the agencies to the Secretary on the implementation of the strategic plan.
4. Strategies to align public and private payers with regard to quality and patient safety efforts.
5. Incorporating quality improvement and measurement (using CER) in the strategic plan for health information technology required by the American Recovery and Reinvestment Act
Just to make it clear (and maybe the In Vivo folks might want to break away from their fawning to check this out), the legislation requires: ‘quality
measure’ means a standard for measuring the performance and improvement of population health or of health plans, providers of services, and other clinicians in the delivery of health care services.
Then too, the legislation requires" A group health plan and a health insurance issuer offering group or individual health insurance coverage shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for— ‘‘(1) evidence-based items or services that have in effect a rating of ‘A’ or ‘B’ in the current recommendations of the United States Preventive Services Task Force; ‘‘(2) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved; and ‘‘(3) with respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration. "
How is this evidence developed? Through the application of comparative effectiveness research within the context of development of the quality strategic plan.
But of course " private plans—not the feds—will decide what to cover."
Which is why CER is required to be used to determine the the effect of new technologies on " national expenditures associated with a health care treatment, strategy, or health conditions....priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section. "
But of course " private plans—not the feds—will decide what to cover."
In Vivo makes fun of those who worry about CER being used for rationing when it is obvious to them that all the CER dough will be allocated comparing flu shots to massages from chiropractors or aromatherapy. Of course it will. So we should ignore the fact that the legislation gives AHRQ significant authority in setting CER and quality agenda, control over dissemination of CER findings and preference in conducting and controlling CER research, especially as it pertains to coverage decisions for health plans, Medicaid and the Independent Medicare Advisory Board. And we should ignorestatutory language stating:
The Secretary may only use evidence and findings from research conducted under section 1181 to make a determination regarding coverage under title XVIII if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.
Paragraph (1) shall not be construed as preventing the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under title XVIII based upon a comparison of the difference in the effectiveness of alternative treatments in extending an individual’s life due to the individual’s age, disability, or terminal illness.
‘‘(d)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability.
‘‘(2)(A) Paragraph (1) shall not be construed to— ‘‘(i) limit the application of differential copayments under title XVIII based on factors such as cost or type of service; or ‘‘(ii) prevent the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under such title based upon a comparison of the difference in the effectiveness of alternative health care treatments in extending an individual’s life due to that individual’s age, disability, or terminal illness.
Which if you flip it around means you can use CER to steer people to what you think is best using copays and limit coverage of new technologies if you think treatment A raises fewer questions about "safety" (and risk of death) than treatment B which is newer.
And in the final analysis, has anyone asked what the additional cost and time will mean to patients in terms of life expectancy, morbidity, cost of care?
The soundbite about AHRQ and CER is that it’s “non-political.” That remains to be seen. Previous examples of Uncle Sam as CRO (CATIE, ALLHAT) speak otherwise.
Consider this – NICE (the National Institute for Health and Clinical Excellence) is suspending publication of all decisions until after the U.K. general elections on May 6th. According to the Pink Sheet, “The decision reflects just how controversial the organization is in the U.K., where it has become a lightening rod for political debate.”
Something to think about.
According to a study in the May issue of Pediatrics, many Spanish-speaking people in the United States receive prescription instructions from the pharmacy so poorly translated that the medications are potentially hazardous to their health. (The errors occur largely because of deficiencies in computer programs that most pharmacies rely on to translate medication information from English to Spanish.)
This is an important issue that should be immediately addressed by the FDA as part of the agency’s Safe Use initiative.
This is a real health disparity that can and must be fixed inmediatamente.
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.
