Latest Drugwonks' Blog
A new poll sponsored by Medicare Today (an initiative of the Healthcare Leadership Council) shows that 90% of seniors are satisfied with Medicare Part D -- and approval has constantly risen since the plan came on line in 2006. "Nearly seven years later, 9 in 10 Medicare beneficiaries have prescription drug coverage," says the poll. "Satisfaction among those with Medicare Part D has grown 12 points from 78% to 90%. Most are very satisfied with their coverage and say their plan offers excellent value, reasonable costs, and convenience."
Seniors "feel peace of mind" with the prescription drug program, and regard it as "a safety net."
Among other poll findings show that without Part D: -- 84% report that out-of-pocket drug costs would be higher. -- 61% would be unable to fill all of their prescriptions. -- 53% would be more likely to cut back or stop taking medicine altogether.
Cooperation and partnership between the free market and Uncle Sam works.
Former US Senator Evan Bayh on the disastrous consequences of the looming medical device tax:
The Supreme Court decision in June upholding the Affordable Care Act leaves in place a tax on medical devices that threatens thousands of American jobs and our global competitiveness. It will also stifle critical medical innovation in the industry that gave us defibrillators, pacemakers, artificial joints, stents, chemotherapy delivery systems and almost every device we depend on to save lives.
The 2.3% tax will be charged to manufacturers on each sale and takes effect in January. Many U.S. device companies, in response, have already announced layoffs, canceled plans for domestic expansion and slashed research-and-development budgets. This month, Welch Allyn—a maker of stethoscopes and blood-pressure cuffs—announced that it will lay off 10% of its global workforce over the next three years, but all of the jobs being cut are in the U.S.
Given the fragile state of the U.S. economy, Congress must move quickly to redress the harm from this tax before it becomes irreversible.
The medical-device industry has been a great American success story. More than 400,000 U.S. workers are employed in this sector directly, and another two million, including those involved in supply and distribution, benefit indirectly. At a time when the economy struggles to produce good jobs, medical-device positions pay well. Average compensation is $58,188 annually compared with a national average of $41,673 annually for all employment, a 2010 Lewin Group report found.
Click here for the full WSJ piece.
From Medscape Medical News
Number of Uninsured Will Soar Under Romney Plan, Report Says
By Mark CraneOctober 2, 2012 — The number of individuals with out health insurance could soar to 72 million nationwide by 2022 under Mitt Romney's plan to repeal the Affordable Care Act (ACA), compared with 27 million uninsured if the law remains intact, according to a report released by The Commonwealth Fund, a liberal health policy advocacy group.
The report, "Health Care in the 2012 Presidential Election: How the Obama and Romney Plans Stack Up," is based on assumptions that Romney would replace the healthcare reform law with block grants to states for Medicaid, institute a premium support program for Medicare to provide beneficiaries with a specified sum of money to buy the plan they choose, and enact new tax incentives to encourage people to purchase insurance on the individual market.
Although some details of Romney's proposals have not been specified, economist Jonathan Gruber from the Massachusetts Institute of Technology, Cambridge, used a set of assumptions based on similar proposals advanced in the past. Specifically, to equalize tax treatment of health insurance, he assumed that premiums for individual market insurance can be deducted from income on an "above the line" basis, meaning a deduction available to all, not just those who itemize taxes.
Almost 18 million children younger than 19 years are estimated to be uninsured by 2022 under Romney's plan, compared with 6 million under President Barack Obama's plan to implement the law. Under Romney's plan, another 18 million middle-income Americans — with incomes between about $32,000 and $58,000 a year for a family of four — are estimated to be uninsured by 2022 (more than one third of this income group). By comparison, 3.3 million middle-income families are estimated to be uninsured under the ACA. Among families of four with incomes under $32,000 a year, 38.7 million people are estimated to be uninsured under Romney's plan and 17.2 million under the ACA.
"There are stark differences between what each candidate has proposed for our healthcare system, and this report shines a light on how Americans might be affected, based on their age, their income, and where they live," lead report author Sara Collins, vice president for affordable health insurance at The Commonwealth Fund, said during a news conference yesterday. "The report finds that repealing the Affordable Care Act would significantly increase the number of Americans without health insurance, limiting their ability to get the healthcare they need and exposing them to burdensome medical bills and debt."
Effect of Repeal?
What effect would repeal of the law have on physician practice? "The ACA has provisions to improve the kind of team practice envisioned by designers of the law, such as promoting medical homes and coordinating care," Stuart Guterman, another Commonwealth vice president, said during the press conference. "Accountable care organizations put primary care at the center of that model, allowing providers to be rewarded for cost savings. The ACA also raises Medicare and Medicaid fees for primary care physicians. If the law is repealed, a lot of those provisions would be eliminated. It's hard to see how to achieve the same goals relying only on market forces."
The report finds that young adults and baby boomers would also have better access to secure health insurance coverage under the ACA, with an estimated 7.2 million young adults aged 19 to 29 years remaining uninsured in 2022, compared with more than 18.6 million estimated to be uninsured under Romney's plan. Among older adults aged 50 to 64 years, 4.9 million are estimated to be uninsured in 2022 under the ACA, whereas nearly 11.8 million would be uninsured under Romney's plan.
Under Medicare, Romney's plan would eliminate the phasing out of the "doughnut hole" in the prescription drug benefit, beneficiaries' free annual wellness visit, and preventive care with no cost-sharing. Converting Medicare to a premium support program, as Romney has proposed, might raise beneficiaries' out-of-pocket costs if the premium allowances failed to keep pace with growth of healthcare costs. Without the reform law's provisions, the Medicare Hospital Insurance Trust Fund would be depleted by 2016, rather than 2024, as currently projected under the ACA, the report said.
In addition, according to a news release from The Commonwealth Fund, the law "imposes sweeping new rules on insurers to protect consumers. Some of these rules have already been implemented, including a ban on rescissions (insurers cancelling coverage when a beneficiary gets sick), bans on lifetime benefit limits, a phased-in ban on annual benefit limits, no longer allowing insurers to turn away children with preexisting conditions, and requiring insurers to cover preventive care without copayments from beneficiaries.... Romney's plan to repeal the ACA would rescind all of these protections. Romney has said that he would prevent discrimination against people with preexisting conditions who maintain continuous coverage."
False Assumptions?
Opponents of the ACA were quick to criticize the report, saying it uses false assumptions to bash Romney's plan by ignoring several of his proposals. They add that polls have consistently shown that most Americans favor repeal of the law.
"In a word, this 'study' is nonsense," Grace-Marie Turner, president of the Galen Institute, told Medscape Medical News. "Commonwealth made up a health plan they attributed to Gov. Romney in order to shed the worst possible light on an alternative to Obamacare. The result is nothing more than a political news release for the Obama campaign.
"The real effort here is to try to get the American people to forget how much they despise the law, which will cost at least $2.6 trillion and still leave 30 million people uninsured," she said. "Seniors are still exposed to the independent payment advisory board's ever deeper cuts to Medicare spending, compromising their access to care. The ACA did nothing to reform the out-of-control Medicaid program, which ill serves our most vulnerable citizens while threatening to bankrupt many states."
Robert Goldberg, vice president of the Center for Medicine in the Public Interest, agrees. "This report assumes a Romney proposal to turn Medicaid into block grants will lead states to limit coverage" and result in greater numbers of uninsured, he told Medscape Medical News. "That's because the vast majority of Americans would be forced into Medicaid under Obamacare. So Gruber is assuming the massive expansion in Medicaid is the only way to insure people.
"Romney's plan gives millions of Americans tax credits to buy insurance, allows states to use Medicaid to target those in greatest need and combine federal dollars with their own revenues to allow people to choose and keep coverage even if they lose or change jobs," Goldberg said. "Gruber doesn't measure the impact of the 'real' Romney proposals. Hence, he ignores that they will stop the diversion of $716 billion from the soon-to-be-bankrupt Medicare program to pay for Obamacare."
"I'm shocked, shocked to find that gambling is going on in here”
-- Captain Renault
Dozens of weight loss and immune system supplements on the market are illegally labeled and lack the recommended scientific evidence to back up their purported health claims, government investigators warn in a new review of the $20 billion supplement industry." The report, which is "being released Wednesday" by HHS' Office of Inspector General, found that "20 percent of the 127 weight loss and immune-boosting supplements investigators purchased online and in retail stores across the country carried labels that made illegal claims to cure or treat disease." Notably, Federal regulations do not require the FDA to "review supplement companies' scientific evidence for most of their products' purported health benefits before they hit the market"; and the OIG "found that in numerous cases, when companies did submit evidence to back up their health claims, it fell far short of government recommendations."
The liberal Commonwealth Fund is at it again, releasing today a new study, “Health Care in the 2012 Presidential Election: How the Obama and Romney Plans Stack Up.” But the “study” is, in a word, nonsense.
The crucial sentence in the publication is this one: “Because Romney has not yet fleshed out the details of [his health reform] proposals, a set of assumptions was made.” That is a significant understatement.
The work regurgitates a similar “study” by the liberal FamiliesUSA last week, which devised its own assumptions about what a Romney plan would look like.
Read the full piece here.
Avik Roy took apart the Families USA study here.
President Obama and Congress should have checked with the country’s physicians before passing a law that relies on our efforts to handle health insurance expansion to more than 30 million more people.
A new on-line survey by the non-profit The Physicians Foundation, one of the largest doctors surveys ever performed, confirms that over two thirds of physicians are pessimistic about the future of medicine, over 84 percent feel that our profession is in decline, and a majority would not recommend it as a career for their children. (The survey was sent to over 600,000 doctors and over 14,000 responded).
If you ask my three children you will find that neither my wife or I (also a physician) are recommending a medical career to them despite the fact that we still manage to find ways to enjoy what we do.
Read the full piece here.
Dear CDER Staff:
On September 6, 2012, CDER Center Director Janet Woodcock informed you that she would be proposing important organizational changes within the Center to sharpen the Center’s focus and strengthen resources around pharmaceutical quality.
As part of these organizational changes, we will also be proposing that the Drug Shortages Staff (DSS) be moved from the Office of New Drugs and be elevated to the Office of the Center Director under the leadership of Deputy Director for Regulatory Programs, Dr. Doug Throckmorton.
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. In this new law, Congress provided FDA with new authorities to combat shortages of drug products in the United States and imposed new requirements on manufacturers regarding early notification to FDA of issues that could lead to a potential shortage or disruption in supply of a product.
Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. They have reached crisis proportions for many healthcare systems and are creating personal crises for many patients. Fortunately, the Agency has been able to prevent a significant number of drug shortages. In 2011, FDA helped prevent 195 drug shortages; as of August 2012, FDA prevented close to 100 shortages.
FDA places tremendous value on the Center’s efforts to curb drug shortages. In addition, with the new authorities brought by FDASIA, we look forward to an ever-increasing focus on this crucial program.
The proposed elevated placement for DSS -- with its greater visibility and prominence within the Center -- reflects how important the work of the DSS is to ensuring that patients in need have critical and life-saving drugs available to them. Undoubtedly, this work is paramount to the Center’s mission to guarantee that safe, effective, and high-quality drugs are available to the American public.
Doug Throckmorton
Deputy Director for Regulatory Programs, Office of the Center Director
John Jenkins
Director, Office of New Drugs
Each year, physicians in America conduct over 1.2 billion patient visits, treating illnesses ranging from the minor to the life-threatening.
With A Survey of America’s Physicians, the Physicians Foundation has endeavored to provide a “state of the union” of the medical profession. What are physicians thinking about in the year 2012: about the practice of medicine, about their career plans, and about the current state of the healthcare system?
The survey was sent to over 630,000 physicians – or over 80 percent of physicians in active patient. One thing is clear -- it is a challenging and uncertain time to be a doctor.
The results of the survey reflect uncertainty and should be taken in the context of current events.
Key findings include:
* Over three quarters of physicians – 77.4 percent – are somewhat pessimistic or very pessimistic about the future of the medical profession.
* Over 84 percent of physicians agree that the medical profession is in decline.
* The majority of physicians – 57.9 percent -- would not recommend medicine as a career to their children or other young people.
* Over one third of physicians would not choose medicine if they had their careers to do over.
* Over 52 percent of physicians have limited the access Medicare patients have to their practices or are planning to do so.
* Over 26 percent of physicians have closed their practices to Medicaid patients.
* Over 62 percent of physicians said Accountable Care Organizations (ACOs) are either unlikely to increase healthcare quality and decrease costs or that that any quality/cost gains will not be worth the effort.
* Over 59 percent of physicians indicate passage of the Patient Protection and Affordable Care Act (i.e., “health reform”) has made them less positive about the future of healthcare in America.
What’s wrong with this picture?
The complete study can be found here.
A companion’s words of persuasion are effective.
-- Homer
Diagnostic test quality may not be something that pharmaceutical and biotechnology companies have had a lot of experience dealing with, but shortfalls in a diagnostic development program can undercut efforts to streamline clinical trials for personalized medicines.
The Pink Sheet reports that the need for a high-quality diagnostic test development program was a key message delivered by a representative from FDA’s devices center at a September 14th conference on drug/diagnostic co-development.
The conference, sponsored by the Friends of Cancer Research and Alexandria Real Estate Equities Inc., served as a discussion forum for a multi-stakeholder draft proposal aimed at enabling late-stage clinical development of drugs with companion diagnostics by quickly identifying a patient subset most likely to benefit from treatment while minimizing exposure of patients least likely to benefit.
FDA officials were generally receptive to the draft ideas put forward. However, they highlighted the threshold need for a well-characterized, high-quality diagnostic that can accurately distinguish between those patients well-suited for treatment and those unlikely to derive any benefit.
The draft conference paper presented at the meeting was developed with the goal of guiding design of Phase III trials to evaluate a drug and companion diagnostic in situations where prior studies do not provide a clear definition of the diagnostically selected population and sufficient evidence to restrict development.
The draft is intended to fill some of the stakeholder-identified gaps in FDA’s July 2011 draft guidance on vitro companion diagnostic devices. In that 12-page guidance, FDA explained how it defines a companion diagnostic and its expectations for simultaneous development and approval of a drug with the accompanying test.
However, the guidance left many in the drug and device industries wanting more details, such as the regulatory ramifications for drug/diagnostic combinations that are not developed and reviewed in parallel fashion and how laboratory-developed tests fit into the agency’s paradigm for companion diagnostics.
“Patients have to be protected by appropriately balancing the strength of the diagnostic hypothesis with the need for thorough data generation and evaluation,” the draft paper states. “We believe the appropriateness of including marker-negative patients primarily depends on the strength of the science in support of the diagnostic hypothesis (including but not limited to mechanism of action, pre‐clinical efficacy and, if known, class effect), the potential for risk to patients, and clinical data available to date,” the draft paper states.
FDA Office of Hematology and Oncology Products Director Richard Pazdur highlighted several basic principles that FDA considers when evaluating the use of biomarkers in applications submitted to the agency.
The first among these is that the companion diagnostic must be essential for use of the drug, Pazdur said. “It’s not like we’d like to have it or it might be nice to have it or we might in the future need it. It should be essential for the use of the drug when it is licensed.”
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.
