A passel of smarts from the pen of Kim Strassel:

Regarding Harry

The public option diverts attention from the legislation's real faults.

By KIMBERLEY A. STRASSEL

You couldn't swing a cat this week without hitting a discussion of the public option. Somewhere, in some Capitol office, Senate Majority Leader Harry Reid is grinning.

Two weeks ago, the subject of a government-run insurance plan was a sore point with the Nevadan. He didn't have the votes for it, his base was bitter, and he didn't want to talk about it. This week, a transformed Mr. Reid devoted an entire news conference to it. Americans support the public option! His caucus supports a public option! He supports a public option! The public option is in! No problem!

In the real world, this kind of behavioral shift lands you in a psych ward. In Washington, the press just marked it down to forces bigger than Harry. The majority leader had been pushed into a public option by his liberal members, we were told. Chuck Schumer was scarier than Ben Nelson. The Huffington Post was even scarier than Chuck Schumer. Poor Mr. Reid, clucked observers, had been backed into a corner.

Maybe. Then again, maybe he is majority leader for a reason. Maybe Mr. Reid didn't just wander out of the Nevada desert. Maybe he has a plan. Maybe, just maybe, he sees a big upside in turning the public option into the centerpiece of the health-care debate. After all, what does he have to lose?

Up for re-election next year, Mr. Reid is facing Nevada polls that suggest he's lost most voters outside his base. His base too, was slipping, with Moveon.org making him a punching bag for not embracing the public option. With this week's announcement, he is once again the hero of the left, and has that baboon off his back.

Who knows? It might even work. Mr. Reid included the fig leaf of an "opt-out" for states that don't want the public option. It's a ruse, but it might provide cover for votes. If not, he's got room to maneuver. There's the "opt-in" alternative, which even some Republicans claim to like. There's the fall-back "trigger," which re-earns him Olympia Snowe.

And if it doesn't fly, well, is that so bad? Mr. Reid can still say he gave it the varsity try. He'll get it to the floor and let those swing-state Democrats amend the public option away. Not his fault! What he also knows, even if the press doesn't, is that for all the big talk of his liberal members, they are the more likely to give way. Even without a public option, this bill is a big step toward a single-payer system. And it isn't as if any of them risk losing their seats by voting "only" for a $1 trillion health expansion.

Better yet, by turning the public option into the big, bad bogeyman, he makes it more likely he'll snag those swing-state votes in the end. Nebraska's Mr. Nelson, Arkansas's Blanche Lincoln, Indiana's Evan Bayh—they can all claim victory for stripping the bill of a national insurance plan, then feel comfortable voting for all the tax hikes and Medicare cuts that remain.

Speaking of tax hikes, premium jumps and Medicare cuts, notice how nobody is today talking about them? Mr. Reid surely has. The public option might be controversial in D.C., but the majority leader knows most of the country doesn't understand it, or assumes it doesn't apply to them. Most Americans already have health care that they like, and polls show their real fear is that this experiment will leave them paying more for less. This, not the public option, is ObamaCare's exposed jugular.

The insurers get this, which is why (as they now try to bottle the genie they helped loose) they are issuing reports on how "reform" will double or triple premium prices. It is why America's Health Insurance Plans, the lobby group, has run ads in swing states warning about huge cuts to Medicare Advantage. Some of the grass roots get it, too, which is why Americans for Tax Reform is now live on TV in Nebraska noting Sen. Nelson has signed its taxpayer pledge and that he'd violate it by voting for the bill's nearly $500 billion in tax increases.

If Mr. Reid had pulled the plug on the public option, these highly unpopular policy issues would be front and center. As it is, the public-option sideshow is sucking up all the air, and will continue to. It even overshadowed liberal divisions, such as union pushback on Cadillac-plans taxes. Maybe, just maybe, Mr. Reid likes it that way.

Granted, this is the cynic's view of Democrats' health-care strategy. Mr. Reid did, after all, goof last week, failing to round up the votes to pass his party's proposed "fix" to Medicare reimbursement rates. Maybe he doesn't know which way is up. Maybe he is taking a flier.

Then again, anyone who has watched this debate has earned the right to cynicism. Democrats are determined to get a health bill, and Mr. Reid is no rube. His opponents—those trying to save the country from this wreck of a bill—would be wise not to forget it.

With all the bad news (or rather reporting and opining about the bad news) regarding vaccine "shortages" it is important to put into perspective how far we have come and how well we are prepared for a highly unpredictable and relatively lethal form of flu. Contrary to the uninformed claims of people like Shannon Brownlee who insist that vaccines will not reduce mortality by 50 percent in high risk populations (only look at averages is misleading and deliberately so Shannon), the vaccine for swine flu delivered to people who need it most, (kids, pregnant women and immune compromised people) will be life saving. And we have a plan that -- like any plan -- will change on contact but will do what it is supposed to do because it has learned from past pandemic response efforts.

The following testimony delivered by Paul Offit in 2006 about how an outbreak of Asian flu was prevented in 1957 provides a perspective on how well we are doing today. Now if only CDC would tell the anti-vaccine and thimerasol scaremongers to go shove it!

www.fas.org/irp/congress/2006_hr/biodefense.html

PHILADELPHIA
Dr. Offit. Good morning, Senator. My name is Paul Offit. I am Chief of Infectious Diseases at Children's Hospital in Philadelphia and a former member of the Advisory Committee on Immunization Practices to the CDC.

I would like to talk briefly today about an event that occurred 50 years ago in 1957, the only time in our history that we have made influenza vaccine in advance of a pandemic, because I think there are several lessons that can be learned from that event. On April 17, 1957, Maurice Hilleman, a scientist working at the Walter Reed Army Medical Research Institute, read an article in the New York Times titled ``Hong Kong Battling Influenza Epidemic.'' The article stated that 250,000 people, 10 percent of the entire population of Hong Kong, had suddenly come down with the flu.

Hilleman found that this outbreak signaled--feared that this outbreak signaled the start of the next pandemic. So the next day he sent a telex to the Army's 406th Medical General Laboratory in Zama, Japan, asking them to send him specimens from people infected with the virus. The first specimens arrived 1 month later on May 17, 1957.

For 5 days and nights, Hilleman worked to determine whether the influenza virus circulating in Hong Kong could be a pandemic strain. He tested sera from members of the American military and adults in the general population, but could not find anyone whose immune systems had seen this virus before. Hilleman then sent the virus for testing to the United States Public Health Service, the Commission on Influenza of the Armed Forces Epidemiological Board, and the World Health Organization. They found that only a handful of people in the United States and the Netherlands had antibodies to the virus. Because few people in the world had antibodies to stop it, the influenza virus circulating in Hong Kong in 1957 could spread from one country to the next unchecked.

Hilleman then sent the virus, now called Asian flu, to six American-based companies. He figured that if he were to have any chance of saving lives companies would have to make and distribute tens of millions of doses in only 4 months. Hilleman sped up the process by ignoring the Division of Biologic Standards, the Federal agency responsible for regulating vaccines.

He also asked vaccine makers to advise chicken producers not to kill their roosters, even though it was late in the hatching season. He knew that production of tens of millions of doses of vaccine would require at least 200,000 eggs a day.

As predicted, in September 1957 Asian flu entered the United States from both coasts. The first laboratory-proven cases occurred aboard naval vessels in Newport, Rhode Island, and San Diego, California. The first outbreak was triggered by a San Diego girl who carried the virus to an international church conference in Grinnell, Iowa. The second occurred in Valley Forge, Pennsylvania.

Companies made the first lots of Asian influenza vaccine in June 1957 and vaccination began in July. By late fall, 40 million doses were distributed in the United States. Within a few months, influenza infected 20 million Americans. 70,000 died from the disease. Worldwide, the pandemic killed at least 4 million people.

The Surgeon General of the United States, Leonard Burney, later said, quote: ``Many millions of persons we can be certain did not contact Asian flu because of the protection of the vaccine.'' For his efforts, Maurice Hilleman won the Distinguished Service Medal from the American military.

Several features of this outbreak and our response to it are instructive. First, Hilleman had to rely on reading an article in a newspaper to know what was happening in Southeast Asia and he had to wait 1 month before he received samples of the virus. Today the international community of scientists, clinicians, and public health officials, armed with sophisticated virological techniques, are much better at surveillance of outbreaks and characterization of possible pandemic strains.

Second, Hilleman called on six U.S.-based influenza vaccine makers. Today no U.S.-based companies make the inactivated vaccine. Sanofi Pasteur has a manufacturing facility in Swiftwater, Pennsylvania, but is not a U.S.-based company.

Third, Hilleman had to rely on eggs to produce vaccines. Recognizing that egg production is unreliable, the President's pandemic flu plan has effectively encouraged vaccine makers to gear up facilities to grow influenza virus in mammalian rather than avian cells. For example, GlaxoSmithKline recently purchased a manufacturing facility in Marietta, Pennsylvania, and MedImmune, the makers of a live attenuated influenza vaccine, will manufacture vaccine in mammalian cells in Maryland. Given that the influenza vaccine is generic and inexpensive, it is unlikely that vaccine makers would have done this without financial encouragement.

Fourth, Hilleman completely ignored the Division of Biologic Standards, the Federal agency responsible for regulating vaccines. At the time vaccine regulation was in its infancy, regulated by a small division within the National Institutes of Health. Today vaccines are regulated by the Food and Drug Administration and they do an excellent job. Vaccine regulation I think has helped to make vaccines arguably the safest and best-tested products that we put into our bodies. But the process is slow and if we are to make vaccine quickly the regulatory process would have to be streamlined significantly.

Fifth, Hilleman was a committee of one. He took responsibility for shepherding each step of the process. It would be impossible for him to do that today, but it would certainly be of value for one central agency to be held accountable for making sure that vaccine was made, tested, and distributed quickly and efficiently.

Sixth, Hilleman never considered liability protection for vaccine makers. In 1957 pharmaceutical companies were not held liable if they were not negligent in the production or design of their product. Ironically, the birth of liability without negligence for pharmaceutical companies began with a jury verdict against a vaccine maker, Cutter Laboratories, only a few months later. However, it is clear that vaccine makers would not make a pandemic flu vaccine today without substantial protection from frivolous litigation.

Thanks for giving me an opportunity to speak before this committee.

I wonder if Dr. Collins is laying down a (bio) marker...
www.reuters.com/article/idUSTRE59P4UD20091026
Risks to personalized medicine seen in U.S. reform

By Julie Steenhuysen

CHICAGO (Reuters) - The federal government's push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual's genetic makeup, the chief of the National Institutes of Health said on Monday.

"There is a potential collision here," Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.

Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.

"That's going to get lost in the wash by considering everybody equivalent, which we know they are not," said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.

"The antidote to that is pretty straightforward," said Collins, saying that studies need to include genetic information that allows researchers to find such responses.
Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.

"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins told the meeting, which was broadcast on the Internet.

COST-CUTTING POTENTIAL

There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health's Oncotype DX, a genetic test that can predict the recurrence of breast cancer.

"This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information," Collins said.

He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.

"In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test," Collins said.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why -- why certain patients benefit while others do not.

The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers -- such as specific proteins or genes -- that improve the odds that a new, high-cost biotechnology drug will work.

She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug's application, lending more scientific certainty about why a new drug works.

"Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed," she said.

(Editing by Eric Walsh)

When it comes to healthcare reform, bipartisanship begins with "D."

Consider this new op-ed from today's Detroit News:


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.

Ad Age reports:

 U.S. Senator Al Franken (D-Minn.), along with co-sponsors Sens. Sherrod Brown (D-Ohio) and Sheldon Whitehouse (D-R.I.), have introduced legislation (S. 1763) to disallow the federal tax deduction for all advertising and marketing expenses for prescription drugs. There are rumblings that the senators would like to have the proposal added to the health-care reform legislation, and the possibility exists that they may offer it as an amendment when the proposed bill is considered by the full Senate.

Former Food and Drug Administration associate commissioner Peter Pitts, now the president of the Center for Medicine in the Public Interest, said the proposed legislation to cut the ad tax deductibility endangers more than just the health-care reform bill.

"What this endangers is the public health, as every survey -- including those done by the FDA -- show that DTC advertising, beyond helping to sell product, actually increases the health literacy of the American health consumer," he said. "Such a move is actually an anti-health reform amendment and is nothing more than grandstanding by a long-time opponent of the pharmaceutical industry [Mr. Brown] and a 'Saturday Night Live' alum [Mr. Franken]. Painting pharmaceutical marketing as an 'enemy' of health reform is like saying automotive advertising is the enemy of emissions control."

The full Ad Age article can be found here:

 http://adage.com/article?article_id=139826

Finally, a poll that asks Americans specific questions about the actual details of the proposal squirming through Congress....

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%
###

 

Ann Witt, health counsel extraordinaire to Representative Henry Waxman(and who previously served as acting director of DDMAC and advisor to the Commissioner), is returning to the FDA to serve in the agency’s Office of Policy, Planning and Budget.  

Does this mean Ms. Witt will fill Jeff Shuren’s shoes?  (Jeff is currently serving as the Acting Director at CDRH.) That would give Ann the platform to address some of her favorite issues such as off-label communications, advisory committee operations, and the medical device review process.  It’s also interesting to note that Ms. Witt was a key player in Dr. Kessler’s (failed) attempt to claim regulatory authority over tobacco.