Comparative Comparisons

• 11.02.2009

Ah -- the vicissitudes of sausage making.

According to Andrew Dawson, staffer for the House Ways and Means Committee, “The final CER  product - whatever comes out of the Senate, whatever comes out of the House - they are different enough that where we end up in a conference report will be somewhere in the middle."

When Mr. Dawson refers to "CER," he means Comparative Effectiveness Research -- aka cost effectiveness, aka clinical effectiveness, aka healthcare technology assessment.  But it's important to recognize that these are not all synonyms. (For example, in the long ago and forgotten stimulus package, $1.1 billion was set aside for clinical effectiveness research.)

The Senate Health, Education, Labor and Pensions Committee's reform package would create a new center in the HHS Agency for Healthcare Research and Quality to oversee CER. The melded House health reform bill, unveiled Oct. 29 would also create a center within AHRQ, though supported by a combination of public and private funding and receiving advice from an independent stakeholder commission.

Another key pending issue is how research data generated by CER may be used. The House has previously added language stating explicitly that data "may not be used to deny or ration care." The Senate Finance Committee version lets CER data be used in Medicare coverage decisions, though only providing several criteria are met and a single CER study is not the only basis for a decision.

The Congressional Budget Office has scored the CER provisions of the revised House bill as lowering Medicare outlays by $100 million from 2010 through 2019, but increasing non-Medicare outlays by $1.2 billion during the same period.

How can CBO score CER studies – that (1) according to the revised House bill aren’t supposed to be used “to deny or ration care” and (2) don’t exist yet?  Hmm.

The Tweet Smell of Success

• 10.30.2009

The running joke about Part 15 hearings is that they're so named because there are generally only 15 interesting minutes.  Not so for the upcoming Part 15 hearing on social media.  Good topic.  Timely topic.  Sexy topic.

And the list of those testifying is also a guarantee of better-than-usual fare.  That list (subject to change) can be found here.

Pharmaceutical marketers and the FDA are in a tough spot when it comes to social media.  On the one hand, both recognize the importance of and opportunity in it.  It's where the people are.  It's where the action is.  On the other hand there are those pesky regulatory concerns.

To quote that well-known FDA pundit -- Buffalo Springfield -- "There's something happening here.  What it is ain't exactly clear."

And clarity (qua predictability) is the key to success for social media to become a powerful tool in advancing both marketing aims as well as the public health.  Not mutually exclusive goals -- and not necessarily in that order.

I'm just riled about Harry

• 10.30.2009

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.

Model health care reform on Medicare Part D

• 10.29.2009

Congress and the president need to craft new legislation that actually addresses the insurance needs of the American people and is based on the kind of post-partisan cooperation Obama promised in the campaign. A new insurance program modeled on Part D could unleash competitive forces that have already proven to drive down costs and expand coverage.

PETER J. PITTS is president of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.

Pandemic Planning: Learning From History

• 10.28.2009

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.

The Best Article on Healthcare Reform...

• 10.28.2009

Public plan mirage
By Robert J. Samuelson
Monday, October 26, 2009

In the health-care debate, the "public plan" is all things to all people. For supporters, it would discipline greedy private insurers and make health-care coverage affordable. For detractors, it's a way station on the path to a single-payer insurance system of government-run health care. In reality, the public plan, also known as the public option, is mostly an exercise in political avoidance: It pretends to control costs and improve access to quality care when it doesn't.

As originally conceived by Yale political scientist Jacob Hacker, the public plan would be a government-created, nonprofit insurance company providing Medicare-like coverage to the under-65 population. But unlike Medicare, benefits would be paid for mainly by premiums -- not taxes. Americans could buy coverage from the public plan or a private insurer.

Competition and choice would increase, say liberals. Facing the low-cost public plan, private insurers would hold down their own premiums, the argument goes. Health-care costs for everyone would moderate. Government subsidies to provide universal coverage would be cheaper. By some estimates, Medicare's administrative costs are only 3 percent of spending, compared with 13 percent or more for private insurers. A new public plan is widely presumed to enjoy an advantage in overhead.

Nonsense, retort critics. The public plan's low costs would be artificial. Its main advantage would be the congressionally mandated requirement that hospitals and doctors be reimbursed at rates at or near Medicare's. These are as much as 30 percent lower than rates paid by private insurers, says the health-care consulting firm Lewin Group. With such savings, the public plan could charge much lower premiums and attract lots of customers. But health costs wouldn't subside; hospitals and doctors would offset the public plan's artificially low reimbursements by raising fees to private insurers, as already occurs with Medicare. Premiums would increase because private insurers must cover costs to survive.

As for administrative expenses, any advantage for the public plan is exaggerated, say critics. Part of the gap between private insurers and Medicare is statistical illusion: Because Medicare recipients have higher average health expenses ($10,003 in 2007) than the under-65 population ($3,946), its administrative costs are a smaller share of total spending. The public plan, with younger members, wouldn't enjoy this advantage.

Likewise, Medicare has low marketing costs because it's a monopoly. But a non-monopoly public plan would have to sell itself and would incur higher marketing costs. Private insurers' profits (included in administrative costs) also explain some of Medicare's cost advantage. But profits represent only 3 percent of the insurance industry's revenue. Moreover, accounting comparisons are misleading when they don't include the cost of Medicare's government-supplied investment capital. A public plan would also need investment capital. And suppose the public plan suffers losses. Congress would assuredly bail it out.
The promise of the public plan is a mirage. Its political brilliance is to use free-market rhetoric (more "choice" and "competition") to expand government power. But why would a plan tied to Medicare control health spending, when Medicare hasn't? From 1970 to 2007, Medicare spending per beneficiary rose 9.2 percent annually compared to the 10.4 percent of private insurers -- and the small difference partly reflects cost shifting. Congress periodically improves Medicare benefits, and there's a limit to how much squeezing reimbursement rates can check costs. Doctors and hospitals already complain that low payments limit services or discourage physicians from taking Medicare patients.

Even Hacker concedes that without reimbursement rates close to Medicare's, the public plan would founder. If it had to "negotiate rates directly with providers" -- do what private insurers do -- the public plan could have "a very hard time" making inroads, he writes. Hacker opposes such weakened versions of the public plan.

By contrast, a favored public plan would probably doom today's private insurance. Although some congressional proposals limit enrollment eligibility in the public plan, pressures to liberalize would be overwhelming. Why should only some under-65 Americans enjoy lower premiums? In one study that assumed widespread eligibility, the Lewin Group estimated that 103 million people -- half the number with private insurance -- would switch to the public plan. Private insurance might become a specialty product.

Many would say: Whoopee! Get rid of the sinister insurers. Bring on a single-payer system. But if that's the agenda, why not debate it directly? It's not insurers that cause high health costs; they're simply the middlemen. It's the fragmented delivery system and open-ended reimbursement. Would strict regulation of doctors, hospitals and patients under a single-payer system provide control? Or would genuine competition among health plans over price and quality work better?

That's the debate we need, but in truth, doctors, hospitals and patients don't want to be limited, whether by government or markets. Congress reflects public opinion. Fearing a real debate, we fake it.

Comparative Effectiveness Questioned By NIH Director

• 10.27.2009

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)

Meeting With Mitch

• 10.27.2009

I spent an hour talking about health care reform with Indiana Governor Mitch Daniels today.  Governor Daniels -- who won his second term as the Hoosier State's CEO in 2008 with over 60 percent of the vote even as Barack Obama was carring the state --  has taken an approach to providing health care coverage that is distinctly at odds with what is being proposed in Congress in three important ways:

1.  It is not an entitlement.
2.  It provides people with control over health care spending by funding health savings accounts
3.  It both encourages and rewards healthy behavior and preventive care. 

The program is modest in scope, limited now byt the fact that the federal government will allow Medicaid funds to be used only for less than ten percent of the chronically uninsured in the state.  Part of the spending (the money put inton health savings accounts) comes from an increasein the tobacco tax.  

But it is paired with the Daniels decision to add an HSA plan for all state employees and a program to encouage Hoosiers to improve their physicial condition through better diets, more exercise, etc. 

Preliminary data shows that the state is spending less on healthcare and premiums are rising more slowly. 

More important,  before reforming or thinking about reforming an entire system, Daniels focused on:

1.  the chronically uninsured who have the hardest time paying for coverage
2.  changing the way health care isi paid for by focusing on rewarding health and giving consumers choice

In Washington just the oppostie is true.  Healthcare reform is all encompassing and is an entitlement focusing on

1.  the people who already have coverage
2.  rewarding people for not getting insurance and postponing care
3.  restricting choice

Also,  Daniels has lowered the tax rate on biomedical innovation and created incentives for patent holders. 

In Washington, taxes on innovators are going up and patent protection on innovative products will be cut in half. 

It's a start

• 10.27.2009

In the heat of the healthcare reform debate, you might have missed the fact that President Obama signed an appropriations measure that provides the FDA (mostly CDER) with an additional $880.1 million in funding, of which at least $51.5 million will go to the generic drugs office -- a $10 million increase from fiscal 2009. CBER and related field activities will see a 12% budget increase to $305.2 million.

Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities.  Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB.  A bit of mission creep – but no complaints.

The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.

The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.

Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.

Critical Path funding.  Partnership activities.  Bioeqivalence.  That’s progress.

"Shaming" is good. Prison is better.

• 10.26.2009

China will launch a one-year crackdown on fake drug ads on the Internet and sales of fake drugs through postal services, according to an inter-ministerial conference on October 23. The campaign will be jointly launched by 13 ministries including the Ministry of Health, the Ministry of Industry and Information Technology and the State Food and Drug Administration (SFDA).

Health Minister Chen Zhu said Web sites, advertisement companies, postal services, medical institutions and commercial banks involved in such illegal businesses are the main targets of the crackdown.

Shao Mingli, director of the State Food and Drug Administration, said the SFDA's official Web sites will name and shame those sites advertising fake drugs to alert the public. Most recently, the administration exposed six drug producers whose advertisements contain content of over-promised efficacy and guarantee in the name of consumers.

Shaming is good -- prison terms would be even better.