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Healthcare foes use fear, not reason

Sunday, August 16th, 2009

Healthcare foes use fear, not reason - link to original article

LEONARD PITTS 

Miami Herald - August 16, 2009

    ‘‘F ear is the most powerful enemy of reason. Both fear and reason are essential to human survival, but the relationship between them is unbalanced. Reason may sometimes dissipate fear, but fear frequently shuts down reason.’’ — from The Assault on Reason by Al Gore 

    ‘‘I’m afraid of Obama!’’ — woman at a Town Hall meeting on health care reform 

    I have no opinion on H.R. 3200. Mainly because I haven’t read it. 

    Pardon my presumption, but chances are beyond excellent that you haven’t, either. The PDF file of the bill, otherwise known as the America’s Affordable Health Choices Act of 2009, clocks in at 1,017 pages of often-dense legalese and jargon. I’d like to read it, but I’d also like to have a life, and the two are incompatible. 

    So excuse me, beg pardon, but it would be really valuable to hear an explanation of the bill by those who presumably have read it, followed by vigorous questioning. Instead, the circus has come to town. 

    I refer, of course, to the chaos that has erupted at townhall meetings as Democratic lawmakers try to sell the bill. The New York Times reports shouting matches, fistfights, threats, injuries and arrests. Georgia Congressman David Scott says he’s had death threats and a visit from vandals who painted a swastika outside his office. 

    If you wonder what the Nazis have to do with this, join the club. It’s an incoherent protest, and where there is incoherence, naturally, there is Sarah Palin. The former governor of Alaska weighed in on Facebook with a claim that Democrats were proposing a ‘‘downright evil’’ system in which the fate of the elderly and the disabled would be determined by ‘‘death panels.’’ 

    She said she was referring to Sec. 1233 of the bill, so I read it. It would allow your doctor to regularly consult with you on the need for a living will and advanced-care directives, i.e., decide ahead of time if you’d want to be kept alive in a persistent vegetative state. The provision may or may not be a good idea but it’s hardly ‘‘downright evil’’ and it bears no resemblance to the image Palin conjures: granny forced to justify her continued existence before a panel of men in black hoods. 

    Conservatives would have you believe this pandemonium is spontaneous. Truth is, it’s about as spontaneous as a shuttle launch. The Times account tells us a banner appeared on the web site of Fox News host Sean Hannity inviting people to ’’Become a part of the mob!’’ A group calling itself Tea Party Patriots advises its members to pack the hall and ‘‘yell out.’’ This is manufactured outrage. 

    And that’s fine. If people choose to become part of a synchronized protest, they have every right to. Nor is there anything wrong with dissent. As many of us pointed out when George W. Bush’s enablers sought to silence his critics, dissent is patriotic. 

    But shouting down those who disagree with you is not. Neither is threatening, shoving, hitting, painting swastikas or otherwise rendering reasoned debate impossible. That’s not love of country, it’s not dissent, it’s not even civilized. It’s boorish, oafish and crude, the rantings of people panicked beyond reason. 

    In other words, conservatives. OK, not all of them. But too many of them? Definitely. 

    By now, it has become reflex, this instinct of theirs to manipulate the debate and muddy the waters by stoking people’s primal fears, whether of gays, Muslims, Hispanics or now, healthcare reform. ‘‘I’m afraid of Obama!’’ screams a woman. And doesn’t that just say it all? Doesn’t that speak volumes about the intellectual bankruptcy and decayed moral authority of the political right? With apologies to Franklin Roosevelt, the only thing they have to sell is fear itself. 

    And no, that’s not patriotism. It is the cynical behavior of people who have little faith in their ability to win the debate. So they pick a fight and try to win that instead.

‘Un-American’ attacks can’t derail health care debate

Saturday, August 15th, 2009

‘Un-American’ attacks can’t derail health care debate - link to original article

By Nancy Pelosi and Steny Hoyer

 Americans have been waiting for nearly a century for quality, affordable health care.

Health coverage for all was on the national agenda as early as 1912, thanks to Teddy Roosevelt’s Bull Moose presidential run. Months after World War II came to an end in 1945, President Harry Truman called on Congress to guarantee all Americans the “right to adequate medical care and protection from the economic fears of sickness.” From President Lyndon Johnson to President Bill Clinton, to President Obama’s winning campaign on the promise of reform, there hasn’t been a more debated domestic issue than the promise of affordable health care for all.

We believe it is healthy for such a historic effort to be subject to so much scrutiny and debate. The failure of past attempts is a reminder that health insurance reform is a defining moment in our nation’s history — it is well worth the time it takes to get it right. We are confident that we will get this right.

Already, three House committees have passed this critical legislation and over August, the two of us will work closely with those three committees to produce one strong piece of legislation that the House will approve in September.

In the meantime, as members of Congress spend time at home during August, they are talking with their constituents about reform. The dialogue between elected representatives and constituents is at the heart of our democracy and plays an integral role in assuring that the legislation we write reflects the genuine needs and concerns of the people we represent.

However, it is now evident that an ugly campaign is underway not merely to misrepresent the health insurance reform legislation, but to disrupt public meetings and prevent members of Congress and constituents from conducting a civil dialogue. These tactics have included hanging in effigy one Democratic member of Congress in Maryland and protesters holding a sign displaying a tombstone with the name of another congressman in Texas, where protesters also shouted “Just say no!” drowning out those who wanted to hold a substantive discussion.

Let the facts be heard

These disruptions are occurring because opponents are afraid not just of differing views — but of the facts themselves. Drowning out opposing views is simply un-American. Drowning out the facts is how we failed at this task for decades.

Health care is complex. It touches every American life. It drives our economy. People must be allowed to learn the facts.

The first fact is that health insurance reform will mean more patient choice. It will allow every American who likes his or her current plan to keep it. And it will free doctors and patients to make the health decisions that make the most sense, not the most profits for insurance companies.

Reform will mean stability and peace of mind for the middle class. Never again will medical bills drive Americans into bankruptcy; never again will Americans be in danger of losing coverage if they lose their jobs or if they become sick; never again will insurance companies be allowed to deny patients coverage because of pre-existing conditions.

Lower costs, better care

Reform will mean affordable coverage for all Americans. Our plan’s cost-lowering measures include a public health insurance option to bring competitive pressure to bear on rapidly consolidating private insurers, research on health outcomes to better inform the decisions of patients and doctors, and electronic medical records to help doctors save money by working together. For seniors, the plan closes the notorious Medicare Part D “doughnut hole” that denies drug coverage to those with between $2,700 and $6,100 per year in prescriptions.

Reform will also mean higher-quality care by promoting preventive care so health problems can be addressed before they become crises. This, too, will save money. We’ll be a much healthier country if all patients can receive regular checkups and tests, such as mammograms and diabetes exams, without paying a dime out-of-pocket.

This month, despite the disruptions, members of Congress will listen to their constituents back home and explain reform legislation. We are confident that our principles of affordable, quality health care will stand up to any and all critics.

Now — with Americans strongly supporting health insurance reform, with Congress reaching consensus on a plan, and with a president who ran and won on this specific promise of change — America is closer than ever to this century-deferred goal.

 

This fall, at long last, we must reach it.

 

Nancy Pelosi, D-Calif., is speaker of the House and

 

Steny Hoyer, D-Md., is House majority leader.

Current system not good enough

Thursday, August 13th, 2009

HEALTHCARE REFORM

Current system not good enough

Reform can have something for everyone

BY JOHN HALL

WWW.FCFEP.ORG

The Miami Herald - link to original article

August 13, 2009

As Floridians consider healthcare reform, here’s what they need to know: The current system is unsustainable. It costs too much, does not deliver results as good as those of other nations and suffers from great inefficiency. The proposals under consideration to improve the system build upon what we have, rather than move in radical directions or make fundamental changes in the way medical decisions are made.

• First, the cost issue. Compared with other developed countries, the United States devotes a substantially larger share of its economy to healthcare, and the expenditures continue to climb. That share was about 16 percent of the gross domestic product in 2006 — up from about 8 percent in 1975 — and it is projected to reach 20 percent in 2017 without reform. This is an inadvisable trend.

Annual health expenditures per person are projected to rise from about $8,300 in 2009 to about $13,000 in 2017. Federal outlays for Medicare and Medicaid are projected to grow from $720 billion in 2009 to about $1.4 trillion in 2019. Rising healthcare costs are one of the biggest causes of the large federal deficits forecast for coming decades.

• Second, the result. The facts are that despite having the most costly healthcare system in the world, the United States fails to achieve better health outcomes than many other countries. When compared to Australia, Canada, Germany, New Zealand and the United Kingdom, the United States ranks last in quality of care, access to care, efficiency, equity and healthy lives — but ranks first in expenditures per person.

In addition, 46 million Americans are uninsured, and the number is estimated to rise to 54 million in 2019. Millions more have limited access to healthcare. As a consequence, hospitals provided more than $35 billion in uncompensated care last year, some of which is offset under Medicare and Medicaid and some with cost shifting to patients covered by private insurance. People without insurance often postpone healthcare that could prevent future more serious problems that end up being treated in highly expensive emergency care settings.

• Third, the inefficiencies. Serious concerns exist about the efficiency of the current healthcare system. It doesn’t give incentives to doctors, hospitals and other providers to control costs. Rather, the payment systems and threat of malpractice suits lead to increased use of healthcare services and providers that may not be necessary or effective.

These problems cannot be solved without reforming our current system to expand health insurance coverage and establish better cost controls. The administration’s goal for health reform is to provide affordable, high-quality coverage for all Americans while also slowing the growth of healthcare costs is on target.

• Fourth, the changes under consideration. Healthcare reform is not about “socialized medicine,” rationing and euthanasia as some would like to make it to frighten you and maintain the status quo. Instead, the bills being considered by Congress:

Preserve the employer-based healthcare system. For those who will buy coverage for themselves, a range of private plans will be available to choose from, as well as a “public plan.” This is not socialized medicine.

Preserve the relationship between doctors and patients to make choices about healthcare options. This is not rationing.

Will not allow the government to make life or death decisions for anyone regardless of age. Those decisions will continue to be made by the patient, doctor and the patient’s family. No reform bill will put government in charge of making life or death decisions for people.

Our healthcare system is stifling economic growth, hurting businesses and resulting in huge costs for government. If we fail to act, premiums will climb higher, benefits will erode further, the number of uninsured will increase and the deficit will grow. With reform we can provide quality healthcare that costs less.

As members of Congress return to Florida during their August recess, it is important that Floridians learn more about the reform bills, give their views about those bills — and of the cost of not passing reform.

John Hall is executive director of the nonprofit Florida Center for Fiscal and Economic Policy in Tallahassee.

Health Care Realities

Monday, August 10th, 2009

A case for Obama’s health-care proposal

By PAUL KRUGMAN

The New York Times - link to original article

July 31, 2009

At a recent town hall meeting, a man stood up and told Representative Bob Inglis to “keep your government hands off my Medicare.” The congressman, a Republican from South Carolina, tried to explain that Medicare is already a government program — but the voter, Mr. Inglis said, “wasn’t having any of it.”

It’s a funny story — but it illustrates the extent to which health reform must climb a wall of misinformation. It’s not just that many Americans don’t understand what President Obama is proposing; many people don’t understand the way American health care works right now. They don’t understand, in particular, that getting the government involved in health care wouldn’t be a radical step: the government is already deeply involved, even in private insurance.

And that government involvement is the only reason our system works at all.

The key thing you need to know about health care is that it depends crucially on insurance. You don’t know when or whether you’ll need treatment — but if you do, treatment can be extremely expensive, well beyond what most people can pay out of pocket. Triple coronary bypasses, not routine doctor’s visits, are where the real money is, so insurance is essential.

Yet private markets for health insurance, left to their own devices, work very badly: insurers deny as many claims as possible, and they also try to avoid covering people who are likely to need care. Horror stories are legion: the insurance company that refused to pay for urgently needed cancer surgery because of questions about the patient’s acne treatment; the healthy young woman denied coverage because she briefly saw a psychologist after breaking up with her boyfriend.

And in their efforts to avoid “medical losses,” the industry term for paying medical bills, insurers spend much of the money taken in through premiums not on medical treatment, but on “underwriting” — screening out people likely to make insurance claims. In the individual insurance market, where people buy insurance directly rather than getting it through their employers, so much money goes into underwriting and other expenses that only around 70 cents of each premium dollar actually goes to care.

Still, most Americans do have health insurance, and are reasonably satisfied with it. How is that possible, when insurance markets work so badly? The answer is government intervention.

Most obviously, the government directly provides insurance via Medicare and other programs. Before Medicare was established, more than 40 percent of elderly Americans lacked any kind of health insurance. Today, Medicare — which is, by the way, one of those “single payer” systems conservatives love to demonize — covers everyone 65 and older. And surveys show that Medicare recipients are much more satisfied with their coverage than Americans with private insurance.

Still, most Americans under 65 do have some form of private insurance. The vast majority, however, don’t buy it directly: they get it through their employers. There’s a big tax advantage to doing it that way, since employer contributions to health care aren’t considered taxable income. But to get that tax advantage employers have to follow a number of rules; roughly speaking, they can’t discriminate based on pre-existing medical conditions or restrict benefits to highly paid employees.

And it’s thanks to these rules that employment-based insurance more or less works, at least in the sense that horror stories are a lot less common than they are in the individual insurance market.

So here’s the bottom line: if you currently have decent health insurance, thank the government. It’s true that if you’re young and healthy, with nothing in your medical history that could possibly have raised red flags with corporate accountants, you might have been able to get insurance without government intervention. But time and chance happen to us all, and the only reason you have a reasonable prospect of still having insurance coverage when you need it is the large role the government already plays.

Which brings us to the current debate over reform.

Right-wing opponents of reform would have you believe that President Obama is a wild-eyed socialist, attacking the free market. But unregulated markets don’t work for health care — never have, never will. To the extent we have a working health care system at all right now it’s only because the government covers the elderly, while a combination of regulation and tax subsidies makes it possible for many, but not all, nonelderly Americans to get decent private coverage.

Now Mr. Obama basically proposes using additional regulation and subsidies to make decent insurance available to all of us. That’s not radical; it’s as American as, well, Medicare.

Costs of Medicare/Medicaid Have Outpaced Other Health Costs by 1/3 Since 1970

Sunday, August 9th, 2009

The Weekly Standard - Blog - link to original post

Posted by Jeffrey H. Anderson on July 29, 2009 

Ezra Klein has posted a blog criticizing the claim (made by Bill Kristol on the Daily Show Monday night) that the costs of government-run health care have greatly outpaced other health costs. But Klein is mistaken.

Advocates of ObamaCare like to rely on studies comparing the cost-increases of government-run care with the cost-increases of private insurance. But such studies completely ignore private out-of-pocket costs. They ignore the fact that out-of-pocket costs have gone from being 62 percent of the private market in 1970 to just 26 percent today — and that private insurance correspondingly covers almost twice as much care today as it did back then (74 percent compared to just 38 percent). They completely ignore a profound shift in the private market and draw conclusions as if that shift had never occurred. It’s a lot like looking at LP and CD sales, but ignoring MP3s, and concluding that Americans are no longer as fond of music.

If you look at all of private care, and don’t just cherry-pick a select part of it, the picture is quite clear. As my study for the Pacific Research Institute shows, since 1970, the costs of Medicare and Medicaid have each risen one-third more, per patient, than the combined costs of all other health care in America — the vast majority of which is purchased privately. Medicaid’s costs have risen 35 percent more, and Medicare’s 34 percent more, per patient, than the combined costs of all other health care nationwide.

The costs of the two flagship government-run health-care programs have also outpaced all other nationwide health costs since 1980, 1990, and, in Medicare’s case, 2000. (Medicaid’s costs haven’t risen much since 2000, as billions of dollars have been shifted from Medicaid to SCHIP.)

Moreover, my study is quite generous to Medicare and Medicaid in a variety of ways. It counts the Medicare prescription-drug benefit among the costs of private care rather than among the costs of Medicare, it doesn’t adjust for the cost-shifting from Medicaid to SCHIP, and it counts all care that is purchased privately by Medicare and Medicaid beneficiaries (including Medigap insurance and Medicare copayments) among the costs of private care without counting those who receive it among the recipients of private care. (Because Medicare’s and Medicaid’s enrollments have increased disproportionately over time, this magnifies private care’s per-patient cost-increases.)

Despite all of these advantages, on a per-patient basis, for every $3 that all other U.S. health-care costs have increased since 1970, Medicare’s and Medicaid’s costs have each risen more than $4. Klein and Co. can only claim otherwise by completely ignoring a major chunk of the private market.

Klein also criticizes Kristol for his exchange with Daily Show host Jon Stewart over military health care. My wife is a young officer in the military. My dad was a career officer. Military health care is not first-class. It’s more or less what you would get if you were to mate first-class health care with the DMV.

At my wife’s current base, I’ve gone to the doctor twice. Neither time did I get to see an actual doctor. The first time, I saw a major, the second time a lieutenant — both nurse-practitioners.

As I waited for my first appointment, I saw my wife’s friend Loren in the waiting area. We were both going to ask about getting an antihistamine for our allergies. The person she saw adamantly refused to give her anything that she couldn’t have purchased over-the-counter. I walked out with 9 different bottles of pills or inhalers of various sorts. My guy believed in aggressive medicine. When I asked whether the onslaught of medicines he proposed was really necessary, he looked at me, paused for a split second, and then replied (with complete seriousness) that while “some docs” like to take a more incremental approach, we’d tried that approach in Vietnam, and “we lost the damn war!” (One couldn’t make this up.)

In this one example, we see both sides of government-run health care: waste and rationing. Because no one has to pay for care directly, there’s no incentive to pursue good value. I thought that what my non-doc planned to prescribe sounded like a ridiculous waste, and I had no intention of poisoning my system with most of it. But I figured that the only way I was going to know which of the medications I should actually take was to keep my mouth shut, take my bounty home, and do some online research. However, because something has to be done to keep costs down, rationing inevitably follows — as Loren learned. So you end up with a mix of care that you wouldn’t pay for yourself, and care that you cannot get even if you would have been willing to pay for it yourself.

One last anecdote about the military’s first-class-meets-DMV-style medicine that the rest of the country will get soon enough, should ObamaCare pass. Three years ago, my wife (not then my wife) had salmonella poisoning. She went to the military clinic, and the nurse-practitioner ran inadequate tests and gave her a useless antibiotic to tide her over. When her tests were inconclusive, she returned for a second visit days later for more tests. In response to her complaint of severe dehydration, and of having lost more than one-seventh of her body weight, the technician asked if she had been given an IV, but did not offer one after my future wife replied that she had not. After ten days of prolonged suffering with severe food poisoning, she finally received the diagnosis and treatment she needed, while never once seeing an actual doctor.

In short, government-run health care is the ticket to higher costs, less choice, and worse care.

Lax scrutiny allowed Medicare fraud to flourish in Miami-Dade

Saturday, March 14th, 2009

Miami Herald - link

Posted on Mon, Mar. 09, 2009

BY JAY WEAVER

In January 2007, Medicare shut down the businesses of 18 medical equipment suppliers in Miami-Dade County after investigators told the federal agency that the companies were shams.

But when Medicare heard their appeals, the operators were quickly reinstated — only to be indicted later that year for submitting more than $10 million in phony claims to the very agency that had let them back in business, court records show.

Medicare wound up paying those suppliers at least $5 million. Despite mostly successful prosecutions, much of that ill-gotten money was never recovered.

”Healthcare fraud in Miami is viral, and these perpetrators replicate it,” said Kirk Ogrosky, deputy chief of healthcare fraud at the Justice Department.

Last fall, the U.S. Department of Health and Human Services’ Office of Inspector General cited the 18 medical equipment suppliers in a critical report concluding that Medicare’s appeals system was flawed because it lacked strict rules of evidence. Medicare officials don’t disagree.

”It’s always troubling when you have 18 reinstated like that,” acknowledged Kimberly Brandt, Medicare’s anti-fraud director. “They may have gotten back in, but they didn’t get back in for a very long time. That doesn’t mean we couldn’t have been more vigilant.”

But nearly six months later, Medicare officials told The Miami Herald they have yet to establish new guidelines that would thwart fraudulent medical equipment operators from regaining billing privileges, as recommended by the inspector general. Brandt said the change in presidential administrations has caused delays.

The Miami Herald, in a public records request, obtained the names of the 18 Miami-Dade medical equipment operators who had filed bogus Medicare bills for respirators, artificial limbs and other healthcare supplies over several years.

Among the offenders: Celso Gonzalez, Iliana Evora Hernandez, Oscar R. Martinez and Rafael Turro, all of Miami-Dade.

By the time federal prosecutors charged the four in September 2007, their two companies — Medwell Equipments Corp. in Doral and R&E Medical Equipment in Miami — had filed almost $2 million in false claims. Medicare had paid them more than $550,000.

The four, who pleaded guilty, fleeced Medicare by stealing physicians’ identification numbers to order supplies that were either medically unnecessary or not provided to patients, court records show.

The providers also acquired fake invoices to support their phony claims for reimbursements and paid kickbacks to patients to use their Medicare numbers for fraudulent billing.

In South Florida, their story is not uncommon.

FRAUD EXPOSED

Last year, The Miami Herald exposed numerous examples of Medicare fraud in a series of stories on the medical equipment industry, HIV infusion clinics and home healthcare agencies — spotlighting not only criminals who scam the system, but also the agency’s lax policy of paying bills without verifying them.

The problem is so widespread in South Florida — at least $2.5 billion in bogus billings a year, experts say — that the region is recognized as the nation’s Medicare fraud capital.

Medicare is a federal health insurance program for the elderly and disabled.

Last week, President Barack Obama, in an address to Congress, said rooting out Medicare fraud will be a priority as lawmakers seek to reform the beleaguered healthcare system.

An example of Medicare’s failings was highlighted in the inspector general’s report released in October. The report said Medicare allowed more than 220 South Florida medical equipment businesses — mostly in Miami-Dade — that had been shut down in January 2007 to reopen after appeals.

Medicare hearing officers restored the firms’ billing privileges even though they had no offices or employees during site visits by Health and Human Services inspectors in late 2006.

HHS Inspector General Daniel R. Levinson said Medicare’s appeals process was flawed because it did not set standards of proof establishing that businesses were real and actually operating.

Some medical equipment operators submitted photographs and licenses while others offered leases and utility bills. Still others offered sworn statements saying their businesses were open on the date of the original site visits.

Ultimately, most of the reinstated companies had their Medicare billing privileges revoked again, later in 2007, after a government contractor sent inspectors to their businesses and found little to no activity.

”Our findings suggest that a more critical review of the types of evidence submitted by suppliers is warranted to ensure that fraudulent suppliers are not reinstated,” Levinson wrote.

In a letter, Medicare’s former acting administrator, Kerry Weems, agreed with him, saying the agency ‘’should consider establishing guidelines” for evidence during appeals.

But Medicare has yet to inform the inspector general of any new standards, according to Don White, a spokesman for Levinson’s office.

Medicare’s flawed appeals system allowed sisters Maria Hernandez and Maivi Rodriguez and their mother, Marta Jimenez, to reopen soon after their operations were shut down in January 2007. They continued to run two Miami-Dade companies, Action Best Medical Supplies and Esmar Medical Equipment, until they were indicted four months later.

The family members, along with a Miami dermatologist, Dr. Ana Caos, were found guilty last May of conspiring to defraud Medicare and filing $620,000 in false claims for aerosol medications.

The physician received $100 kickbacks for each prescription, records show.

At trial, prosecutors showed that the family members also used the same roster of Medicare patients to bill millions of dollars to the government program for unnecessary home healthcare services.

CRIME PATTERN

”If you look at the bios of these perpetrators, what you’ll see is the fraud comes in waves,” said Ogrosky, the Justice Department prosecutor.

Another offender who allegedly scammed Medicare: Idalmes Sansegundo, owner of a Hialeah business, A&K Medical.

In early 2007, Medicare also allowed Sansegundo to reopen her shuttered medical equipment business, which continued to operate until the FBI caught up with her about nine months later.

Sansegundo was charged with filing $4.2 million in false claims with Medicare. The agency paid her company about $1.5 million.

But prosecutors immediately hit a snag in the case. After Sansegundo was granted a bond in Miami federal court, she fled.

The FBI is trying to track down the fugitive, who had lived with her mother in Miami-Dade.

The Truth About Medical Innovation

Saturday, March 14th, 2009

Wall Street Journal - link

Whatever one thinks of the ethics of using human embryos in medical research, the rhetoric around President Barack Obama’s decision to expand federal funding for embryonic stem-cell science reveals a widespread misconception of how medical products are created.

Many of the same political leaders who are the strongest champions for federally funded research seek to impose myriad restrictions, regulations, and economic controls on the private companies that translate public science into practical medical innovations. As a result, while Mr. Obama’s stem-cell decision only affects federal funding, and while more funding will mean more research, it’s far from certain that this will hasten the realization of new medical products.

The achievements of the National Institutes of Health (NIH) are monumental. But its efforts only translate into practical benefits for patients if its scientific research can be turned into new medicines, something that’s not part of the agency’s mandate. By its own recent count, the NIH cites only 84 examples over the last 60 years where the agency — or academic institutions it supports — discovered, let alone developed, a new drug or biologic.

Making new medicines is the work of a robust private life-science industry. In the case of stem cells, there are more than 150 private companies trying to turn stem cells into new treatments. But almost all of the companies pursuing this sort of chancy science are small biotechnology companies — the kind that rely on private venture capital in order to fund their high-risk and expensive endeavors.

That capital may well start shifting to other enterprises as the Obama administration unveils policies that diminish the incentives to invest in new medical products. There’s precedent for the availability of this sort of capital to turn on a proverbial dime. Shortly after President Bill Clinton unveiled his proposal for nationalizing the health-insurance market in the 1990s (with similar limits on access to medical care as in the Obama plan), biotech venture capital fell by more than a third in a single year, and the value of biotech stocks fell 40%. It took three years for the “Biocentury” stock index to recover. Not surprisingly, many companies went out of business.

Mr. Obama is giving those sources of capital plenty of reasons for new anxiety. Along with championing more funding for stem cells, he’s issued a budget that advocates importation of drugs from countries with price controls (as a way to introduce those price restrictions into the U.S. market). He plans to give a Medicare agency that’s short on clinical expertise the power to pay only for medical products that it “judges” to be the “least costly alternative” for treating a particular condition. He’s also creating a new federal agency to make decisions about the comparative value of different medical products, with new biotech drugs at the top of the list.

These are just a few policies that have already spooked investors, leading to a significant drop in the share prices of many public health-care companies since Mr. Obama unveiled his budget proposals last month.

Even if private companies succeed in translating stem-cell science into new drug therapies, they still need to navigate the Food and Drug Administration (FDA), which has been coaxed by Congress in recent years to raise its regulatory hurdles to new products. The FDA has responded with aplomb, contemplating for stem-cell products some of its most stringent requirements, save perhaps those in place for gene therapies.

Sadly, such restrictions have all but shut down that entire category of research and development. At one scientific meeting that the FDA held to develop regulatory guidelines for embryonic stem cells, the agency suggested that the appropriate period for following people enrolled in clinical trials is “for the life of the patient” — a costly, if not unfeasible mandate.

The one biotech company in the U.S. with a clinical-stage, embryonic stem-cell product, Geron Inc., was kept at a standstill in “clinical hold” for eight months before the FDA allowed it to begin testing its therapy for spinal-cord injury. A trial with just 10 patients is now underway. The company submitted a record 22,500-page application just to ask for permission to start the small trial. Even then, it’s only allowed to enroll about one patient per month in the study.

The FDA has reasonable worries, one of which is that the very properties that may allow stem cells to turn into mature human tissues could also enable them to turn into certain kinds of tumors. But regardless, the agency lacks a systematic way of evaluating these products. It’s another example of how enthusiasm for public science funding, and stem cells in particular, has outpaced practical truths.

Mr. Obama lionizes federally funded research as paths to “cures,” while his only policies aimed at the biotech industry are confined to strategies for cost control. Life-science investors are comfortable taking scientific risk, but what they can’t calculate is the increasing political risk emanating from Washington. We could lose a generation of progress fast as private capital flows to less dicey endeavors.

Things for the biotech sector have gotten so bad that one senator is rumored to be shopping to the Treasury Department a TARP-like bailout for the biotechnology sector. But public funding doesn’t efficiently discriminate winners from losers when it comes to drug programs. Political lobbying will trump science when it comes to investment decisions, a fact borne out by the shortcomings of the government’s BioShield program, which was established in 2004 to protect against biological weapons and other threats.

The president’s “American Recovery and Reinvestment Act” increases NIH funding by $10.4 billion (on top of its current $29 billion budget). But federal funding isn’t a substitute — politically or in practical terms — for support of a vibrant private biotechnology industry. Rather, rich federal funding of basic science has been complementary to an exceptional private life-science sector. These two ingredients — public support for basic science and private medical enterprise — underpin one of our great industrial achievements.

Unveiling his stem-cell policy, Mr. Obama remarked that “Medical miracles do not happen simply by accident.” They also, however, don’t happen through federal funding alone. They require a thriving private-sector research enterprise. Pouring federal funds into basic research while at the same time blocking the path for its translation into human therapies is no way to advance medical innovation.

Dr. Gottlieb is a resident fellow at the American Enterprise Institute and a former deputy commissioner at the Food and Drug Administration. He works for a firm that invests in health-care companies.

Orszag’s Health Warning

Monday, December 29th, 2008

Dec 29, 2008

Link to original article published in The Wall Street Journal

Obama’s budget chief delivers a reality check on costs.

Democrats are gearing up for a new run at health care next year, which is another way of saying that it’s an arms race to promise the most while disguising the costs. So when the expensive realities of “universal” coverage somehow intrude, taxpayers can’t afford to let those moments disappear down the Beltway memory hole.

The most recent such moment comes courtesy of Peter Orszag, the former head of the Congressional Budget Office. CBO is the shop responsible for estimating how much legislation will cost the government, and recently it released two important reports on health-care financing that should hit Democrats like a cinderblock, assuming they read them. The executive summary for busy politicians is that liberal health reforms will be extremely costly, while measures intended to “save” money won’t even come close to the promises. None of this will come as a revelation anywhere besides Capitol Hill.

Even so, this skepticism is notable because Mr. Orszag has since left CBO to become Barack Obama’s budget director. Mr. Orszag’s useful work on the unchecked growth of U.S. health spending, especially entitlements, ought to put the cost issue at the center of the 2009 debate. CBO expects government outlays on Medicare and Medicaid to rise as a share of the economy to 6% from 4.2% in a decade — to $1.4 trillion, or nearly 30% of the entire federal budget — and eventually ruin federal solvency. If costs grow on pace, U.S. medical spending will rise to 25% of GDP in 2025 from 17% today.

The liberal solution to this looming catastrophe is to add even more obligations. The insurance program for children that Democrats plan to expand in January will cost an extra $80 billion over the next 10 years. Preventing automatic cuts in the reimbursement fees that doctors receive for treating Medicare patients — as Congress does every few years — runs to $556 billion.

Those are nothing compared to the centerpiece of the universal health-care agenda — a “public option” to provide government insurance for Americans of all ages and incomes. In one scenario, CBO finds that allowing the nonpoor to buy into Medicaid would have net costs of $7.8 billion over the next decade. If that sounds like pocket change, keep in mind that Democrats want to make both the public option and private insurance less expensive for beneficiaries by transferring the extra costs onto the government. Just one subsidy plan CBO examined would run to $65.5 billion by 2019. Having the government assume responsibility for high-cost claims would hit $752 billion.

CBO rolls through 115 of these reform options — and it quickly becomes evident why even Democrats concede that their new health programs will cost $150 billion or even $200 billion per year. The real numbers will be higher. Keep in mind, too, that these are new recurring obligations, not one-time spending like (presumably) the financial bailout. They’re politically unrepealable programs that will remain for decades.

Democrats, including Mr. Obama, suggest that covering everyone under a government plan will reduce costs through efficiency. Not according to CBO. It notes that there are “difficult trade-offs between the objectives of expanding insurance coverage and controlling both federal and total costs for health care.” CBO also finds that programs designed to trim costs, such as health information technology or comparative effectiveness research, will produce only modest savings.

Mr. Orszag is a centrist liberal, and he supports reforms intended to squeeze waste out of the health markets. But to his credit at CBO he didn’t ignore the data. Many Democrats (and a few Republicans) are glad that he’s departing and are searching for a CBO replacement who will “score” their bills more favorably. The best outcome would be if Mr. Orszag manages to introduce some health-care sobriety to the Obama White House.

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