Latest Drugwonks' Blog
Consider this new op-ed from today's Detroit News:
Moderate Democrats, Republicans quietly work on health care bill
PETER PITTS
Republican Congressman Bill Cassidy recently broke some news that could turn the health care debate on its head. During a radio interview, he revealed that Blue Dog Democrats have been quietly reaching out to Republicans to draft an alternative health reform bill.
This isn't surprising. After all, neither Republicans nor centrist Democrats nor the majority of Americans approve of the clumsy hodgepodge of big-government policies that make up Sen. Max Baucus' health care bill.
An alliance between Republicans and moderate Democrats could give Americans the reform package they're looking for -- one aimed at lowering costs while promoting competition and choice.
Polls show that public support for health care reform is at a new low. According to a Rasmussen poll from Sept. 28, 56 percent of Americans oppose the leading Democratic reform proposal.
They're not alone. Blue Dog Democrats -- a group of 52 moderate Democratic members of Congress -- have long been uneasy about health care reforms that give too much power to the federal government. In fact they were among the leading opponents of the government-run "public option." Although that idea seems to be off the table, there's still plenty in the Baucus legislation for these fiscally conservative Democrats to criticize.
The nonprofit health care cooperatives that the Baucus bill creates, for instance, would create many of the same problems as the public option. It's true that these co-ops wouldn't officially be part of the government, but they would benefit from federal financial backing (the Baucus bill provides $6 billion for the establishment of these co-ops) and an implied federal guarantee. Consequently, they would pose a serious threat to Americans' ability to purchase private coverage.
Since co-ops would be able to draw from a healthy supply of federal funds, they could push private insurers out of the market by offering artificially low rates. This would soon result in a health care sector with few alternatives to the federally chartered co-ops.
At the same time, the Senate bill -- which carries an $856 billion price tag -- also fails to sufficiently address the issue of cost. A recent Gallup poll showed that the No. 1 concern Americans have about health care is cost and affordability.
And a bipartisan alternative to Baucus' legislation has the potential to be the kind of practical, cost-lowering bill that American's want and America's healthcare system needs.
What would such a bill look like? It's hard to say, but one smart way to go about crafting a bipartisan bill would be to model it off existing successful health care policies -- namely, Medicare Part D.
By creating a system where private insurers could fairly compete to offer Medicare beneficiaries the best drug coverage, Part D has reduced the number of seniors without drug coverage by 17 percent, while still managing to cost about 30 percent less than originally estimated.
The program also enjoys a 92 percent satisfaction rating. This is largely because Part D provides seniors with a real choice over the kind of drug coverage they receive (the program offers over 1,800 plans).
This basic model could be used as the basis for a new bipartisan healthcare bill. Under such a program, the federal government would expand coverage to chronically uninsured -- those 8 million to 15 million Americans who can't afford private coverage but earn too much for government aid -- by creating a system of privately administered health insurance options. Customers would choose the plan most appropriate for them, and the federal government would help subsidize their premiums, depending on their need.
Such a program would keep costs down by rewarding insurance companies for providing the best coverage at the lowest price. It would also give Americans the freedom to choose from a wide array of different insurance plans.
The time is right for a real bipartisan reform to take shape.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.
Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.
Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.
Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.
Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.
Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.
Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.
The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.
More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.
Ad Age reports:
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
What about the other nine years?
That, it seems, is the purview of S.1776 and, according to the New York Times, “Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president’s promise.”
That promise again, “I will not sign a plan that adds one dime to our deficits — either now or in the future. Period.”
Well, it seems that many in Congress are looking at the “period” and seeing an ellipse.
The Times continues, “Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited.”
Unlike the problem of the uninsured? Unlike the problem of preexisting conditions? Unlike the problem of the donut hole? Unlike the problem of (FILL IN THE BLANK)?
Sounds like a total ellipse of the sum.
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Galen Institute Releases Poll Showing Overwhelming Opposition to the Individual Mandate and Other Key Components of Congressional Health Reform Proposals
Seventy-one Percent Are Concerned Their Health Insurance Will
Change if Congress Passes Health Reform Legislation
For more information, please contact:
Jeff Lungren, Communications Director
(703) 299-9207 or jeff@galen.org
ALEXANDRIA, VA. OCTOBER 19, 2009 – The Galen Institute today released new survey results showing overwhelming opposition to the individual mandate and other key components of health reform legislation Congress is considering.
“These findings illustrate strong opposition to fundamental aspects of the bills moving through Congress,” said Galen Institute President Grace-Marie Turner. “People don’t want to be forced to buy insurance they can’t afford or that might not fit their needs, yet the proposals would slap a tax on them if they don’t. And people overwhelmingly oppose reducing seniors’ health benefits or raising taxes on the working and middle class in order to expand coverage to some of the uninsured, yet many in Congress continue to push exactly that.”
“What the public does favor is a targeted approach to solving problems in our health sector, but not a complete Washington-style overhaul of one-sixth of our economy. Washington’s failure to listen is causing great apprehension and concern among the public,” added Turner.
The nationwide random survey of 510 adults was conducted October 8-11, 2009 and has a +/- 4.34 margin of error. International Communications Research (ICR), a non-partisan research firm based in Pennsylvania, conducted the survey.
More Than Seven in Ten Oppose the Individual Mandate
Seventy-one percent of those surveyed said they would oppose “a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year.” Only 21 percent said they would support the law. More than half (54 percent) of all respondents indicate a “strong” opposition to the individual mandate, including 58 percent of those 45-54 years of age and 58 percent of those 55 years and older.
More Than Two-Thirds Oppose Reducing Seniors’ Health Benefits to Pay for Covering the Uninsured
More than two-thirds (68 percent) oppose reducing “some health insurance benefits for senior citizens in order to expand health insurance for some people who are uninsured,” while 28 percent support the idea. Opposition is spread across political party lines as 86 percent of Republicans, 66 percent of Independents, and 59 percent of Democrats oppose this idea.
Opposition to Raising Taxes on the Working and Middle Class to Cover the Uninsured
Fifty-eight percent disagree, most of them “strongly” (44 percent), with the following statement: “I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans.” Only 39 percent support the position.
Seventy-one Percent Are Concerned Current Health Insurance Will Change if Congress Passes Health Reform
Seventy-one percent said they were concerned that their current health insurance would change if Congress passes health reform legislation. One-quarter (25 percent) said they were not concerned. Groups with the highest level of concern include: people 55 years and older (84 percent), those aged 45-54 (80 percent), Republicans (82 percent), and Independents (78 percent). Almost half (47 percent) of all respondents indicate they are “very concerned.” Sixty-two percent of people aged 55 years and older are “very concerned,” along with 61 percent of Republicans, 63 percent of those in the South, and 54 percent of Independents.
Support for a Targeted Approach to Addressing Health Care
Forty-nine percent support, “A targeted approach that addresses a few problems at a time.” Forty-one percent support, “A comprehensive approach that makes significant changes to our current health care system.”
_________________________________
Here are Details of the Survey’s Results
Question: Let's say that Congress passed a new law saying that everyone either would have to obtain private or public health insurance approved by the government or pay a tax of $750 or more every year. Would you support or oppose this law?
STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 8%
SOMEWHAT OPPOSE 17%
STRONGLY OPPOSE 54%
DON’T KNOW/REFUSED 8%
Question: Which of the following approaches to health care reform do you favor?
A comprehensive approach that
makes significant changes to our 41%
current health care system?
A targeted approach that
addresses a few problems at a time? 49%
NEITHER 4%
DON’T KNOW 5%
Question: Do you agree or disagree with the following statement? "I would support an increase in taxes on the working and middle class if it would help provide health insurance to more Americans."
STRONGLY AGREE 18%
SOMEWHAT AGREE 20%
SOMEWHAT DISAGREE 14%
STRONGLY DISAGREE 44%
DON’T KNOW/REFUSED 4%
Question: How concerned are you that your current health insurance will change if Congress passes health reform legislation? Are you ...?
VERY CONCERNED 47%
SOMEWHAT CONCERNED 24%
NOT VERY CONCERNED 9%
NOT CONCERNED AT ALL 17%
NOT APPLICABLE/ I 3%
CURRENTLY DO NOT HAVE
HEALTH INSURANCE
DON’T KNOW 1%
Question: Let's say Congress proposed a bill that would reduce some health insurance benefits for senior citizens in order to provide health insurance for some people who are uninsured. Would you support or oppose this bill?
STRONGLY SUPPORT 13%
SOMEWHAT SUPPORT 15%
SOMEWHAT OPPOSE 20%
STRONGLY OPPOSE 48%
DON’T KNOW 4%
###
On September 29th, the New York Times reported:
Former Drug Executive Convicted of Wire Fraud
In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.
(Full story here: http://www.nytimes.com/2009/09/30/business/30drug.html)
There are rules that need to be followed and there are consequences for those who play fast and loose with them.
Except, it seems, if you are the rule-maker.
Here’s an FDA announcement that appeared Friday (October 16th):
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.
(Full FDA release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm)
Wonderful public health news and certainly worth promoting. And kudos to the FDA for using a regulatory action to discuss an important public health issue.
The interesting issue is how the release ends:
“Gardasil product information: www.fda.gov/cber/products/gardasil.htm”
That link doesn’t bring you directly to the package insert, but rather to a page where you can access the package insert.
Would a pharmaceutical company be permitted to forward such an FDA announcement along to others without more detailed risk information? What about posting the FDA announcement to a commercial website? What about handing it out to physicians?
In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock (then, as now, CDER Director) came in to my office and she was not smiling. She waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"
I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.
What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.
So, this isn’t about FDA needing to add more risk information – their release speaks in plain English to the general population. Well done. The question is, shouldn’t pharmaceutical companies be allowed to do the same? Isn’t a clear message in the best interests of the public health? What’s required is a more titrated approach to communications that -- like DTC TV guidance -- provides a clear pathway for achieving compliance while respecting the inherent space/time limitations of any given medium.
John M. Taylor, III will occupy a new position at FDA, Counselor to the Commissioner, where he will oversee the agency's crisis response functions as well as advise on a range of policy and regulatory matters. An attorney, Mr. Taylor served previously with FDA as a staff lawyer, an advisor to previous Commissioners, and as Associate Commissioner for Regulatory Affairs. He most recently has been Executive Vice President, Health, at the Biotechnology Industry Organization, after serving as a Divisional Vice President for Federal Governmental Affairs at Abbott Laboratories.
I served with John and he is a stand-up guy. Great hire.
Now the other news:
Peter G. Lurie, MD, MPH, will serve in the agency's Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy. Dr. Lurie has most recently been Deputy Director of Public Citizen's Health Research Group in Washington, DC and is an adjunct faculty member at Johns Hopkins Bloomberg School of Public Health and the George Washington University School of Public Health and Life Sciences.
I’ve debated Peter. Smart guy. Highly political guy. Public Citizen’s well-known position on “medical product availability” is that most products are “too dangerous.” What’s next? Sid Wolfe as FDA’s Philosopher-in-Residence?
Josh Sharfstein -- similarly.
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.
