Clinical Trials -- Who's Protecting Patients?

Nearly two years ago, three reporters for Bloomberg News exposed the lax government oversight of drug and device industry clinical trials, which enroll hundreds of thousands of patients every year to test new products. Their story concluded:

Every year, scores of people in the U.S. are injured and killed in clinical trials, while receiving little or no medical care. Unable to oversee human safety in most clinical trials in the U.S. by itself, the FDA has left much of the job to for-profit review boards.

Sadly, this crucial element of the story -- the privatization of the Institutional Review Board process that is the first line of defense for patients participating in clinical trials -- got left out of yesterday's front-page New York Times coverage of the Health and Human Service Department inspector general's report. Indeed, a close reading of the IG report shows that the investigators steered clear of discussing the conflict of interest inherent in turning over ethics and safety monitoring to private firms.

The report focused instead on the fact that the federal backstop for clinical trial safety and ethics is largely nonexistent. The FDA checked just one percent of clinical trial sites between 2001 and 2005 and almost never reviewed the performance of IRBs, which are primarily responsible for protecting the human subjects participating in the trials. Indeed, nearly three-quarters of few inspections it did conduct had nothing to do with protecting patients, but instead involved checking the validity of trial data. And in the few cases involving violations of patient rights that resulted in warning letters, the agency almost never conducted follow-up investigations to ensure compliance.

Remarkably, the FDA doesn't even know how many firms are in the IRB business, or whom they are. Among its recommendations, the report asked the FDA to register these firms. Deputy commissioner Janet Woodcock responded that the FDA and Office of Human Research Protection inside HHS had proposed an IRB registry in 2004, and were “working diligently” to complete it.

Meanwhile, an increasing number of industry clinical trials are moving offshore to India, China, and eastern Europe, where regulatory oversight is, if anything, even less stringent.

Cancer Society Runs a Great Ad

Given all the attention given the "General Betray Us?" ad run by Moveon.org, let's hope someone notices the great ad run by the American Cancer Society in this morning's national papers. Beneath a picture of a young child and a cigarette, with check boxes next to each, is the headline: "Mr. President, Choose Wisely."

The state Children's Health Insurance Plan bill taxes cigarette smokers to pay for adding four million kids to the rolls of those with health insurance. It's the best two-fer since Michael Jordan and Scottie Pippen. It not only insures kids, it saves lives (900,000, according to the ad) by encouraging adults to quit smoking and preventing youngsters from starting.

A few weeks ago, I blogged on the wisdom of separating out the Medicare changes contained in the House bill from the SCHIP/tobacco tax bill. Today's Washington Post reports on the Senate's passage yesterday of a clean SCHIP bill, and the heavy political price the Republicans will pay for standing with the President in his ideological fixation on defending market-based solutions to the health care mess.

Last night, I caught a few moments of the Republican presidential debate hosted by Tavis Smiley. Meant to address the concerns of the minority community, none of the leading Republican candidates showed up. Maybe they were with President Bush in his bunker, figuring out how to justify his planned veto (with their support) of SCHIP.

When Is Govt.-Financed Care NOT Socialized Medicine?

When President Bush uses it! So argues this delightful short essay in the New York Times by Philip Boffey, their health care issues editorialist. Do yourself a favor and read it.

YOYO Health Care

Jared Bernstein of the Economic Policy Institute coined a phrase to describe economic life in the U.S. that is increasingly marked by job insecurity, savings substituted for pensions and a tattered safety net: You're On Your Own (YOYO) economics. This morning's news coverage of the General Motors-United Auto Workers settlement describes how YOYO economics is taking over health care -- the last bastion of employer-provided social insurance.

The Wall Street Journal's trend story describes how large employers are increasingly shifting their retiree benefits from comprehensive Medicare supplemental plans to individual payouts. This mirrors the Republican approach to universal health care for all workers and their families. We make a flat payment to the individual, and YOYO, You're On Your Own to buy policies in the individual market.

But, as the story points out, there are a few problems with that market:

Shifting people to the individual market is problematic . . . at least under the current set-up. It is difficult for people to understand what they're buying, and those with existing illnesses have trouble finding any coverage.

Indeed, the word that most health care economists and wonks use to describe the individual insurance market is "dysfunctional."

Sen. Ron Wyden (D-OR) last year introduced a comprehensive health care reform legislation that repeals the implicit tax break for employer provided health insurance (it's currently not taxed as wages), encourages employers to give the money to their workers, and requires individuals to go out and buy their own insurance plans. But to deal with the dysfunctional individual insurance market, Wyden called for a national regulation scheme for health insurers that would establish community rating for pricing individual policies (it pools risk by mandating that all policies within a geographic area carry the same price for the same level of benefits) and flat-out prohibits insurers from discriminating against potential customers because of previous health conditions, age, or their health status (except for smokers).

The GM-UAW settlement shows that employers are not going to be reliable allies in the push for universal health care. They will opt for any solution that insulates them from rising costs. No one should be surprised. They are not social enterprises in the business of providing benefits. They are in business to make money. That goes for the insurance companies who sell health plans.

So the great debate next year is going to be between those who want to "solve" the health insurance crisis by turning that portion of our lives into another version of YOYO economics and those that would rather see health like the public schools: a universal system that guarantees a basic set of benefits for every person no matter what their age, economic or health status. That doesn't necessarily mean single-payer a la Medicare for all. But it will take an awful lot of regulation to make the insurance industry deliver that result. The Democratic plans that leave current insurance policies intact (and all of them do except for Dennis Kucinich, who is backing single-payer) all rely on such regulations.

A great way to highlight the debate would be to put the issue of national regulation of the insurance industry squarely on the table. Congresspersons who want to guarantee universal coverage while keeping insurance companies in the game should introduce the community rating/no discrimination law now. Make the Republicans and whoever wants to push individual mandates and policies prove that they're willing to do what it will take to remove the word "dysfunctional" from the phrase "dysfunctional individual insurance market."

That debate in Congress next year would be a perfect complement to the debate that will be taking place on the campaign trail.

Kucinich Votes No on S-CHIP

Rep. Dennis Kucinich, Democratic of Ohio who is running for president, voted against the state Children's Health Insurance Program (SCHIP) expressly because it didn't cover the uninsured children of legal immigrants. “I cannot support legislation which extends health coverage to some children while openly denying it to other children,” Kucinich said in a press release. “This legislation is woefully inadequate: and I will not support it. Legal immigrant children deserve the same quality health care as other children receive. It is Congress’ responsibility to address the main difficulties that prevent legal immigrant children from gaining access to health care. Today, we did exactly the opposite."

Kucinich noted that he had voted for the original House version of the bill, which did not exclude immigrant kids from coverage.

His was the only principled opposition to the bill among the seven Democrats who voted against it. The other six were conservative Democrats, largely from the South, who apparently are opposed to more government involvement in health care. Ironically, the only Hispanic legislators who voted against the bill were Republican Cuban-Americans from Florida, Lincoln and Mario Diaz-Balart (are these guys brothers?).

The Origins of Denying Benefits to Legal Immigrants

I had a brief conversation with a spokesperson for La Raza today, and she informed me that legal immigrants were denied coverage under state Children's Health Insurance Plans (SCHIP) from its very beginning in the mid-1990s. President Clinton agreed to the provision as a sop to the Republicans in Congress who opposed the original bill. Now that they're renewing the program (and hopefully expanding it to cover 10 million kids instead of the 6.6 million it now covers), Democrats in the House had hoped to remove that onerous provision and extend the benefit to the children of legal immigrants who otherwise meet the program criteria. The La Raza spokeswoman said that would be anywhere from 200,000 to 400,000 additional kids. Alas, no dice. The Senate-led compromise eliminated the provision.

I'm still for the bill. But this is an easy fix and would be the morally right thing to do. If you're an immigrant, you have a green card, you work hard and pay your taxes despite having an employer who doesn't provide health insurance, it only seems right that your kids should be able to take advantage of this program if your income is too low to buy your own health insurance. Alas, not in our America.

La Raza has withdrawn its support from the bill. And I suspect a number of liberal Hispanic legislators will oppose it. Those are votes the Democrats didn't have to lose.

CMS to Keep EPO Payment Limits?

Newark Star-Ledger journalist Ed Silverman over at the Pharmalot blog reports that a brokerage house has gotten its hands on a letter written by the Center for Medicare and Medicaid Services that signals its intent to reject pressure to return to paying for excessive EPO use in chemotherapy patients. The issue is being pushed by lobbyists for Amgen and J&J, which manufacture Aranesp and Procrit, respectively. The drugs raise red blood cell counts in cancer patients.

Background: Clinical trials released last year showed that the drug used to excess actually made tumors grow faster. After an FDA advisory committee last spring issued a strong warning against excessive use of the drugs, CMS scaled back its payment policy. Amgen and J&J immediately launched a massive lobbying blitz. The American Society of Clinical Oncology issued a statement supporting higher use of the drugs. They even got the full Senate to pass a resolution supporting the companies.

So, has that campaign officially come to naught? Reuters is also reporting that CMS is demanding more evidence from physician groups like ASCO to justify a change in policy. A quick search of the CMS website turned up nothing. Let's hope that the stock analyst (and Ed), who broke the story, have it right.

Throwing Legal Immigrants from the Train

According to this morning's CQ Today (subscription required), the National Council of La Raza, the nation’s largest Latino civil rights organization, dropped its support for the state Children's Health Insurance Program (SCHIP) bill on Friday. Apparently, a last minute addition to the bill forbade enrolling the children of legal immigrants in the program. “We’re going to urge all lawmakers to vote against the bill,” a spokesman for the group told the publication.

The Democrats are scrambling to come up with a veto-proof majority to pass the Senate version of SCHIP, which would expand the number of children covered to 10 million from 6 million, and make cigarette smokers pay for it. Some moderate Republicans want to support the bill, and are even willing to go against the president, but they are also under pressure from the anti-immigration forces that are playing an ever larger role inside the GOP.

This is Washington politics at its despicable worst, not to mention gross discrimination against foreigners who are here legally. The Democrats who okayed this provision to win a few more votes should be ashamed of themselves.

I will never forget while I was living in Japan when I needed to use their health care system on an emergency basis. No questions were asked and no fees were collected. I'll never forget what it was like to live in a civilized country.

Drug Marketing "Is Here to Stay"

The Senate passed the Food and Drug Administration reform bill last night without amendments, thus sending it on to President Bush, who is expected to sign it into law. In an interesting sidebar on the bill's failure to limit direct-to-consumer television advertising, this morning's Wall Street Journal (subscription required) concluded with this quote: "Many people thought this was a moment . . . when moratoriums and other restrictions on DTC would flourish," said Rich Buckley, vice president for federal affairs at AstraZeneca PLC (these are the people who bring you those "purple pill" and "new purple pill" ads). Instead, DTC "is here to stay."

Interest factoid from the story: "In the U.S., pharmaceuticals were the tenth biggest advertiser in 2006, spending $5.3 billion, or 3.5% of the total $149.6 billion U.S. ad market. Pharmaceuticals also registered the highest growth rate among the top 10 U.S. advertisers, growing 13.8% to $5.3 billion from $4.6 billion in 2006."

Conclusion: To paraphrase the old Chicago saw, when it comes to DTC, the FDA ain't ready for reform, especially when Big Media and Big Pharma team up to lobby Congress.

FDA Bill -- the Good, the Bad and the Ugly

The House passed Food and Drug Administration reform legislation yesterday; the Senate will do so today and send it to President Bush, where a quick signing is assured. Here's what I like in the bill:

* It requires registration of all clinical trials, and the public posting of the results of those clinical trials a year or so down the road (could go as high as 18 months later, if I read it properly). If the FDA writes good regs, and the National Institutes of Health constructs a good website, this will be a tremendous boon to researchers seeking safety clues in the data contained in scattered clinical trials, some of which is currently kept hidden from the public by the companies that sponsored the trials. Dr. Steven Nissen of the Cleveland Clinic, who played a central role in uncovering the dangers associated with Vioxx and Avandia, deserves much of the credit for ensuring this part of the legislation survived intact despite intense drug industry lobbying to remove it from the bill.

* The bill limits the practice of granting conflict-of-interest waivers to scientists and physicians who sit on the FDA's advisory committees, and will slightly reduce their number over the next five years. This is nowhere near the ban that consumer groups pushed for, but it's a start.

* There will be better post-marketing surveillance of drugs by both companies and the FDA, and the office of drug safety will get more money and people to do its job.

Here's what I don't like in the bill:

* The pharmaceutical industry removed a provision that would have taken three months off the additional patent exclusivity granted companies that conduct clinical trials on kids for their blockbuster drugs. For a $1 billion-a-year drug, this is like giving away $250 million in additional sales in exchange for running a trial that may cost $10 million. Even if you figure in the tens of millions of dollars that the drug industry poured into lobbying Congress this year, this one provision alone more than pays their lobbyists' fees.

* The bill does nothing to curb direct-to-consumer advertising, although it does give the FDA a bit more authority to pre-review the ads.

* The bill does almost nothing to subject medical devices like stents to the same scientific rigor that applies to drugs. This is clearly a missed opportunity, and a fit subject for ongoing hearings on Capitol Hill.

* The bill's bottom line is that the FDA will continue to depend on industry user fees for another five years. This is a structural conflict-of-interest that needs to end. You don't want the cop's salary to depend directly on the people who get the tickets.

And the ugly?

The drug industry tried to slip a provision into the bill that would eliminate consumers' right to sue in state courts when they are harmed by unsafe drugs that slip through the FDA safety net. Most product liability suits hinge on what lawyers call the duty to warn. The industry wanted a provision that said that: a) if the FDA failed to tell a company to put a warning on a drug's label; and b) the drug later turned out to be unsafe; and c) the safety concern had been known to the company and it had been communicated in some fashion to the FDA; then the company had met its obligation to warn consumers (by not warning them) and the lack of federal action preempted all state product liability laws.

Sound fair to you? Apply the above proposal to Merck, which spent years dickering with the FDA over the content of the warning label for Vioxx, and you get a picture of what was at stake. Consumers Union and the trial lawyers launched a last-minute lobbying blitz to keep the preemption language out of the bill, and they succeeded.

The Commentariat Weighs In on HillaryCareII

Ron Brownstein of the Los Angeles Times (he'll soon be joining David Bradley's National Journal/Atlantic Monthly empire) suggests (like me) that her carefully crafted centrist proposal can avoid overt hostility from the usual opponents of universal health care:

Although Clinton recognizes that "there will be features" insurance companies won't like, and that many Republicans will recoil from any expansion of government's role, she's optimistic the plan can attract a coalition that includes elements of both groups. "People are much readier for change than they were in 1993 and 1994," she said in an interview. "There is a greater appreciation of what is at stake."

Amid the hurricane of words responding to Clinton's proposal, two reactions suggest that her analysis isn't just wishful thinking. In 1994, John Breaux, a skilled deal-making Democratic senator from Louisiana, helped design a bipartisan Senate alternative to the Clinton plan, which he considered too partisan and rigid. Breaux, now a lobbyist, says her new proposal "is something that can find support in both parties."

The other intriguing response comes from Karen Ignagni, president of America's Health Insurance Plans, the industry trade association. She didn't like the rhetorical broadsides that Clinton gratuitously directed at the industry on Monday. But Ignagni praised Clinton's tax credit and said her insurance reforms might be acceptable to insurers as long as they are linked to a mandate on individuals to buy coverage. "It's a whole new game when you bring everyone into the system," Ignagni said.

Much of the Democratic healthcare debate is turning on which candidate will be toughest on insurance and drug companies. The better question is who is shrewd enough to reform those firms' practices without provoking them into a full-scale war that would also preempt the possibility of meaningful support from congressional Republicans.

Meanwhile, Steve Pearlstein of the Washington Post asks Sen. Clinton specifically and the Democrats generally to commit political suicide. He writes:

there are lots of trade-offs implicit in version 2.0 of the Clinton Health Plan, and it would be better for the cause of health reform, and for Clinton's candidacy, if she began to educate the public about them.

Everyone agrees that automated health records are a great idea and will save a ton of money. But someone (the government) has to set the standards and require that doctors, hospitals, and labs invest the upfront money for software and equipment.

And while everyone can rally around paying for performance, shouldn't someone point out that, in practice, that will mean some providers will be paid less while others may be forced out of business?

Mandating that everyone have basic and affordable insurance is the easy part. Less easy is acknowledging that an affordable policy may not cover everything you'd like.

The reality of Sen. Clinton's plans are that she kicks most cost-saving measures off into the future. Press accounts suggest her plan would pour an additional $110 billion into health care to cover the uninsured. It would spell out the basic package that all plans must cover, including mental health parity and dental insurance. It is, in essence, an expansion of coverage for many if not most Americans. The cost savings in her plan that might come from electronic medical records reducing duplication and medical errors or limits on certain tests and procedures because they've been shown through research to be the same or less effective than less costly approaches are off in the future.

To begin educating Americans now about those limitations on "choice" would put a big fat bullseye on her or any candidates' back. Look at what the Wall Street Journal had to say on its editorial page this morning:

HillaryCare II is designed to cause minimal disruptions to current private insurance coverage in the short run, while dressing up the old agenda with slightly different mechanisms and rhetoric. Rather than fight small business, this time she is trying to seduce it with tax credits for small companies that provide insurance. Only later when costs rise will the credits shrink or other taxes rise. To court large manufacturers, like the auto and steel industries, she'll offer another, "temporary" tax credit to subsidize their health-care liabilities. Her plan, in short, is HillaryCare I in better clothes -- a transitional platform to shift people to the default option, which is government insurance.

As usual, the Journal's news columns get right what its editorial page misconstrues. Its headline reads: "Why Clinton Embraced Employer-Based Insurance; Candidate Discovers Workers and Bosses Attached to Status Quo." The story quotes Clinton: "We looked at every permutation of how you get to universal health care. There's great attachment to the employer-based system, even though it is eroding."

The Journal editorial fulminates at its conclusion that the only creativity in Clinton's plan is its political shrewdness. I definitely agree with that sentiment. It's going to take political shrewdness if we're ever going to get universal health insurance in this country. And I'm increasingly convinced, along with Clinton, that we're going to have to get that job done before we can turn to the more critical task of delivering better health care that is affordable.

Clinton's Plan Is Not the Slippery Slope to Single-Payer

Maggie Mahar, author of the excellent "Money Driven Medicine" who is now with the Century Foundation, has a posting over at TPM Cafe on Sen. Hillary Clinton's health care plan that suggests the Medicare-like default option in the proposal will put the government in head-to-head competition with the private sector, and that the public sector's efficiency and lack of profit motive will win the day.

She writes:

The Clinton plan emphasizes choices: Americans can a) keep the insurance they have now, b) buy a new plan from a for-profit insurer, c) pick a plan from the same menu of quality private insurance options that their Members of Congress receive through a new Health Choices Menu (FEHBP), OR d) choose a public plan option similar to Medicare.

This is the exciting news: under Clinton's plan Medicare would be competing with for-profit insurers.

Sorry Maggie. Where's the evidence that people will opt for the government plan? If the uninsured are adequately subsidized to go into insurance-company provided FEHBP-type plans, why would they opt for the default Medicare-like plan? It will probably be limited to the core benefits that every insurer will have to provide.

In theory, people would opt for the government plan if it was cheaper, which it no doubt will be. But the price mechanism only goes so far in health care. Medicare or the "plan similar to Medicare" that Sen. Clinton mentions won't market itself to patients. Physicians won't be whispering in their patients' ear: Psst, why don't you join the default plan? And while some employers may encourage their workers to choose one of the public alternatives (and go to the "pay" side of "pay or play in the plan), why wouldn't their employees choose Kaiser Permanente (one of the FEHBP alternatives) instead of an expanded Medicare, even if it costs a little more? Public sector programs, sad to say, have an image problem in this country.

I just don't see Clinton plan as a slippery slope to single-payer. Nor, it should be pointed out, does she. "We looked at every permutation of how you get to universal health care," she told the Wall Street Journal yesterday. "There's great attachment to the employer-based system, even though it is eroding."

By contrast, the plan offered by Yale political economist Jacob Hacker had just one insurer -- the government -- for the uninsured and for employers who wanted to buy their way out of employer-based coverage. That single government-run plan would provide the mano-a-mano competition that private insurers need.

Medicare consistently scores the highest satisfaction ratings among beneficiaries. There's no reason to think that a government-run plan for the uninsured wouldn't rack up similar high ratings, while providing lower cost and more efficient coverage.

That said, the liberal in me likes Sen. Clinton's plan a lot. Getting everyone insured in the end is about the politics of neutralizing the special interests who run this country, and run the health care system with a vengeance. Her plan has been carefully crafted to neutralize as many of those special interests as possible. A Hacker-type plan would bring back Harry and Loise.

I'm starting to buy her "I have the arrows in my back to prove it" argument that she's the one who can get the job done. Maggie, you and I will be be arguing about the quality of care and its inordinate cost until they lower us into our graves. Better we should be having those arguments with everyone insured.

Rove Rises to Lie Again

And you thought that you were rid of Karl Rove.

The architect of the most disastrous presidency in modern American history offered his analysis of Sen. Hillary Clinton's health care plan on the op-ed page of the Wall Street Journal this morning. It's just one more example of his Goebbels-like tendencies:

As the latest government-heavy plan announced by Hillary Clinton yesterday once again shows, the answers politicians offer on health care highlight the deep differences between liberals and conservatives. . . Liberals see the concerns of families as a failure of private insurance, and want the U.S. to move toward a government-run, single-payer model. This is a recipe for making problems worse. Socialized medicine inevitably leads to poor quality, inefficiency, rising taxes and rationing. The waiting lines and poor care that cause people from other countries to come here for treatment are not the answer.

Did you see a single line in her proposal -- not to mention the proposals of the other leading Democratic candidates -- that endorses a single-payer health care plan (not that some of us wouldn't want it to)? Highlights: tax credits for low-income individuals to buy private plans; tax credits for small businesses to provide private plans; relying primarily on private plans to cover the uninsured; and, yes, more government regulation, but only to make sure that, uh-huh, private plans don't engage in so-called adverse selection, where they refuse to cover people with pre-existing conditions or who are clearly marked for long-term ill-health (smokes or the obese, for instance).

I noted that the quotes from Mitt Romney and Rudy Giuliani also attacked her plan as "government-run."

With so many thoughtful conservatives engaged in the health care debate (Stuart Butler of the Heritage Foundation, for instance), why does precious space get allocated to the failed Mayberry Machiavelli?

Sen. Clinton Unveils Health Care Plan

You can read the details here.

Quickly:

A smorgasbord on the insurance side:

* Leave current insurance plans alone -- but allow people in them to opt out for the other altnernatives in the plan;

* Give people the choice of joining one of the private insurance plans that provide insurance to federal employees OR join a "Medicare-like" plan;

* Insist that all plans cover dental, mental health services and not be allowed to discriminate against people with pre-existing conditions or who are known health risks;

* Require individuals to buy insurance.

Big changes on the tax side:

* Begin taxing employer-provided "generous" health insurance plans if they go to families earning over $250,000 a year;

* Dun employers who don't provide health insurance to their employees;

* Offer a tax credit to low- and moderate-income people to help pay for their portion of health insurance; and

* Give small businesses a tax credit for offering health plans.

The Clinton campaign also says the increased taxes, less the new tax credits, will more than offset the increased costs of insuring 47 million uninsured Americans. How? By eliminating waste and unnecessary expenditures. Presumably, that's where cost-effectiveness research, subsidies for electronic medical records and better preventive medicine, addressed elsewhere in her plan, comes in.

My quick reaction? This is classic Clintonian politics. She's drawn from elements of every think tank proposal and all the other candidates' plans. She even opted for one element of President Bush's non-starter program. He began the year by calling for the end of the income tax exclusion for health care benefits, which Sen. Clinton would impose only on the well-off.

Her plan's name says it all. American Health Choices Plan is based on the most positively poll-tested concept in health care: freedom of choice.

While there is a lot to like in her approach, discussing it requires mastering a lot of concepts. And it leaves her opponents plenty of opportunities for attack. I'm sure we'll be hearing from the special interests who are clear losers under this approach: companies that don't provide insurance; well-off people with excellent health coverage; and the rich.

The biggest surprise? She didn't aim many barbs at the insurance industry, which helped sink her husband's plan with its Harry and Loise ads. Health insurers are given a major opportunity to insure the uninsured through an expanded FEHPP (Federal Employees Health Provider Plans). It will be interesting to see if that is enough to get them to call off the dogs on what has to be the bottom line of any universal plan: the end of adverse selection.

Clinton, like most Democrats, is calling for a tough new federal regulatory scheme on insurers so they can't discriminate against people with pre-existing conditions or known health risks. Any plan that keeps the insurance industry in the game (i.e., anything other than a single-payer plan) must enact such a law. If the Democrats were smart, they'd start pushing for that single element now as a way to educate both the national press and the public about what is really at stake.

Hillary Care Cometh

Pay no attention to the details of Sen. Hillary Clinton's health care plan, which will be announced later today in Iowa. That's for wonks (like me). What really matters is the rhetoric, which reflects what her campaigns managers -- the best in the business -- want average Americans to hear.

Here's what I think she's going to say:

* I'm for a plan that provides health insurance for every American, but doesn't take away the coverage anyone has now.

* I'm for holding down costs through prevention, and I will create a separate trust fund to ensure that every American gets the preventive care they need.

* The employer-based insurance system is the American Way, and we should do nothing to undermine it. But too many employers don't provide their workers any coverage at all, and some only bare-bones plans. So we're going to require that every employer who doesn't provide coverage pay into a fund to cover the uninsured.

* Since privagte insurance will remain the backbone of the system, we have to make sure that insurance companies are unable to deny people coverage because of pre-existing conditions or their overall health status. We'll pass a law that forbids them from only insuring the healthiest people.

* We're going to help doctors and patients hold down costs by giving them solid information about what works best. Widely disseminated comparative effectiveness information will allow insurers and patients to know that they're not paying for overpriced and unnecessary care.

There's a few devils in the details of those bromides. Will the default plan for the uninsured be government-run or will it be provided by health insurance companies? This is the ideological bellwether of how she plans to pursue universal care. Will she appeal to the grass roots activists who support "Medicare for all"? Or will she try to triangulate away insurance industry opposition to universal coverage by turning the default plan for the uninsured over to the insurance industry?

In making employers "pay or play," will she make the "pay" high enough to cover all the uninsured, or will she call for additional taxes to support a universal system? Again, its a base vs. triangulation decision that will tell us lots about how the Democratic frontrunner plans to run the rest of her campaign.

I will have more to say tomorrow after the plan comes out, but allow me to recommend some essential reading for those following the health care reform debate. Paul Starr, a Princeton University professor, co-editor of The American Prospect magazine, and a close adviser to President-Elect and President Bill Clinton on health care, recounts Hillary's role in the 1993-94 health care reform fiasco in the cover story of the latest issue of the magazine. He effectively counters the conventional wisdom that the then First Lady was the architect of that failure. "Bill Clinton actually never gave up control of the policy-making process, and the work fell to a small team of advisors and analysts that (Ira) Magaziner directed," he writes.

Her gifts complemented Magaziner's. Besides her quick intelligence, she had the personal tact and ease in communicating with the public that would make her an ideal ambassador for the initiative, while he had organizational skills, command of detail, and imaginative boldness necessary for mastering an ambitious and complex reform. The overall direction of policy was not Hillary's choice.

That rings true. The current cover story in The Atlantic Magazine has a fawning profile of Bill Clinton's efforts to remake aid and charity efforts in the developing world. Architect of this plan? Ira Magaziner.

This revisionist history of Health Care Reform War I is not a flattering portrait. Hillary as spokesman and not architect? That isn't an image that that someone who claims she has the experience to lead free world wants to see.

But in fairness to her, that was then, and this is now. I know from personal contact that she has surrounded herself with some of the smartest minds in Washington on the issue of health care reform. There are going to be some extraordinarily far-sighted elements in her health care plan that deserve enthusiastic support no matter who becomes the Democratic standard bearer. Her emphasis on prevention and on financing comparative effectiveness research shows that she and her advisers -- more than any other group in the race -- have a firm grasp on what it will take to finally get health care costs under control.

But I doubt those far-sighted elements will get much coverage on tonight's evening news or in tomorrow's papers. The political reporters will want to know whether she is aiming her appeal to the special interests in health care -- the doctors, the hospitals, the drug companies, the insurance industry -- with a proposal carefully crafted to buy off their opposition -- a classic Clintonian triangulation gambit? Or will she appeal to the Democratic Party base by going after the insurance industry, drug companies and irresponsible employers with a populist plan to provide coverage for all?

Like I said. That was then. This is now. I'm betting on the latter.

Addendum to Greenspan's War-for-Oil Quote

Addendum to yesterday's posting: Today, the Associated Press carried a news story that prominently featured Alan Greenspan war-for-oil quote. I don't know if my mailing yesterday deserves credit for that (there are some AP folks on my email distribution list), but I'm glad it is gaining wider distribution. I heard it in a "top of the hour" radio newscast this morning while driving to see my mom at the nursing home.

Greenspan: "Iraq War Is Largely About Oil"

Former Federal Reserve Board chief Alan Greenspan's memoir hits the bookstores on Monday, and the weekend papers are filled with excerpts. The big story, all the accounts agree, is Greenspan's criticism of President George W. Bush and the Republican Congress' fiscal profligacy. He also gives high praise to the fiscal responsibility exhibited by President Bill Clinton, whose mind for details mirrors his own. "Republicans Deserved to Lose, Greenspan Writes" screamed one headline, referring to the 2006 Congressional elections.

But the Washington Post story by Bob Woodward contained the most damning revelation. Alas, it was buried five paragraphs from the end of a very long story.

Without elaborating, he writes, "I am saddened that it is politically inconvenient to acknowledge what everyone knows: the Iraq war is largely about oil."

Now there's a headline that deserved to be bannered across every front page in America: Greenspan: "Iraq War Is Largely About Oil." I wonder if his failure to elaborate includes a failure to discuss the fiscal implications of the war, since they will haunt this country for the next 50 years. Caring for tens of thousands of crippled veterans, the failure to invest in our own infrastructure, failing to even address, much less reduce our dependence on oil, scrapped social programs, a less generous retirement for millions of Americans without private savings -- the list of reasons why average Americans will take a step back and spit on the sidewalk when Bush's name gets mentioned a quarter century hence goes on and on.

Sadly, neither the Wall Street Journal nor New York Times accounts mentioned the telling paragraph.

Von Eschenbach Issues Veiled Threat of Layoffs

Food and Drug Administration commissioner Andrew von Eschenbach late this afternoon updated employees on the status of negotiations on the FDA reform bill, which contains reauthorization of the drug and device user fees that fund a substantial portion of the agency. Though failure to pass user fee reauthorization bills before the fiscal year runs out (October 1) has never resulted in layoffs in the past, the commissioner raised that specter in his email:

No one underestimates or fails to appreciate the disruption and demoralizing impact that even the threat of a RIF is having on you and your families. We all have our responsibilities and roles in seeing that this does not occur, and we at FDA will be fully responsive to Congress at every moment to help facilitate prompt passage of this essential legislation.

Von Eschenbach said next Friday represented the deadline for passing for bill.

White House Moves to Scuttle Key FDA Reform

The Bush Administration has notified Senate and House negotiators working on Food and Drug Administration reform legislation that it opposes posting of clinical trial results in a government database, an echo of the position taken by the Pharmaceutical and Research and Manufacturers Association that is reflected in the Senate version of the bill.

According to the industry newsletter Inside FDA (subscription required), the White House's "unofficial" position is that neither the FDA nor the National Institutes of Health will be able to "validate" the results before they are posted. Ignoring the fact that the NIH's Library of Medicine database links to scores of articles on a daily basis that have not been validated by peer review, the administration urged Congress to wait until NIH has completed a study of how to construct a valid database before passing any requirement for disclosing clinical trial results.

The White House also rebelled against giving consumers, patients or physicians demographic data, primary and secondary endpoint data, or the results of clinical trials for drugs that are not yet on the market. The Senate version of the Food and Drug Administration Revitalization Act (FDARA) requires that companies register trials, but not post their results. The House version requires posting of both results data and a summary that can be understood by the lay public.

White House opposition to this aspect of the FDA reform bill is in line with its general approach to open government, which is to say, it opposes it. But disclosure of clinical trial results data is crucial if independent researchers are going to be able to conduct meta-analyses of problematic drugs.

For instance, Steve Nissen of the Cleveland Clinic, who uncovered the heart attack risks associated with the diabetes drug Avandia, used clinical trial results data that had been posted, ironically enough, by the drug's maker, GlaxoSmithKline, on its own website. As Nissen pointed out in his original article outlining the concerns, his analysis suffered because he did not have access to all the data from the Glaxo-funded trials.

Adopting the Senate version of the clinical trials registry will substantially weaken the final bill and make it much less useful to scientists and physicians concerned about patient safety. According to sources on Capitol Hill, this provision -- along with a measure that would limit conflicts of interest on FDA advisory committee to one per meeting -- are the major stumbling blocks as negotiators seek to hammer out the final details of the legislation before September 30.

What Works Best in Fighting Neglected Tropical Diseases

I don't know if Mark Hanna ate in the New York City restaurant where Mary Mallon (Typhoid Mary) cooked, but he is among the prominent American political figures (they include Abigail Adams and Stephen A. Douglas) who succumbed to typhoid fever. The disease is caused by the bacteria Salmonella enterica serovar typhi, which is spread through water or food contaminated with the fecal matter of infected persons. S. typhi causes a three-to-four week fever, which, if left untreated, is fatal ln up to a third of patients. School-age children are especially vulnerable.

The disease has largely been banished from the advanced industrial world through improved sanitation and prompt treatment with antibiotics. But occasional outbreaks still occur, often among people who have traveled in the developing world or live in precincts of the U.S. that approximate third world conditions. Last year, the Centers for Disease Control rushed to the Marshall Islands to help contain an outbreak of at least 22 confirmed cases.

Today, the disease remains common in the developing world's rural areas and urban slums, where typhoid strikes an estimated 16 million to 33 million people a year, and kills anywhere from 216,000 to 600,000. And, unlike the middle part of the last century when typhoid was licked in the U.S., most current strains of S. typhi have developed resistance to antibiotics, including powerful new ones like ciprofloxacin.

But, like most other drug-resistant diseases, this is one that can still be licked through effective public health measures. According to a timely wake-up call published in today's New England Journal of Medicine, there are vaccines that can provide immunity to typhoid fever. The vaccines could have an almost immediate impact because the most vulnerable population -- school-age kids -- are easily reached through public schools. And best of all, the vaccines are cheap -- about 50 cents a dose from the Indian generic companies that manufacture them.

But as with so many technology-driven solutions, the global public health community hasn't figured out a way to get children inoculated in the countries where it would matter most. In last week's NEJM, Peter Hotez and a host of colleagues associated with the Global Network for Neglected Tropical Diseases called for a comprehensive public health approach to treating and preventing the most common diseases that are ravaging the developing world.

What that would entail is equipping health care workers in developing countries with the tools needed to fight the health problems faced by the world's poorest citizens. This should include the proven generic drugs for fighting common infectious like hookworm or elephantiasis (the GNNTD identifies 13 diseases that need immediate attention in addition to the "big three," HIV/AIDS, tuberculosis and malaria). Though they don't mention it in their article, this piggy-back approach could also include proven vaccines like the one that is available for typhoid fever.

This is a very different approach from the current efforts of the Global Fund, the President's Malaria Initiative or bilateral aid organizations the the U.S's Agency for International Development. Their programs are aimed at specific diseases like HIV/AIDS, malaria or onchocerciasis (river blindness). Very often, this leads to different emissaries from various aid organizations concerned about different diseases knocking on the door of the same rural health clinic or government ministry. No doubt the one offering the most money and resources gets the most attention.

But is this what is best for achieving the greatest gains in public health in that area? The silo mentality fostered by the specialist approach to medicine is widely recognized as a major flaw in the U.S. health care delivery system. That failed model shouldn't be exported to the developing world.

SCHIP Not Eroding Private Health Coverage

My colleague Jared Bernstein at the Economic Policy Institute just posted this analysis of the "crowding out" issue, which I raised here a week ago and continues to be a hot topic in policy circles. Here's Jared's take:

The Bush Administration is engaged in a concerted effort to reduce states' ability to offer publicly provided health insurance coverage to children in families with incomes above 250% of poverty (about $50,000 for a family of four). These new restrictions are partly a reaction to certain states—like New York, New Jersey, California, and others—that planned to offer such insurance through SCHIP (State Child Health Insurance Program) to families with incomes up to 300-400% of the poverty threshold.

One of the Bush Administration's main rationales for the roadblocks it is erecting to keep states from expanding coverage is that the administration wants to prevent children from moving directly from private employer-based coverage (through an employed parent) into SCHIP. But how valid is that concern? Is the availability of SCHIP encouraging employers to drop families from private coverage?

The figure below, from a recently published study by the Urban Institute (UI), shows that this is not the case. Most SCHIP enrollees (72%) were not covered by private coverage six months before enrollment in the public program. Another 14% lost coverage within a six month period prior to SCHIP enrollment, due to a lost job, an employer dropping coverage, or change in family structure that led to the child's coverage being dropped (as in a divorce, separation, or death of covered spouse).

This leaves only 14% of SCHIP cases that substituted the public program for private coverage. But the Urban Institute's study points out that more than half of these cases (8%) cited an inability to afford private coverage as the reason for shifting over to SCHIP. That is, the cost of the family premium through their job was prohibitively high.

The results of the study pose a stiff challenge for those who want to restrict SCHIP access based on the concern that public coverage is crowding out private coverage. The fact is that cost pressures and the lack of a public mandate (a requirement that employers cover workers) are leading to the unraveling of the employer-provided system. We need public insurance to pick up the slack, both for children and their parents.

Meanwhile, the Alliance for Health Reform has published a briefing paper that lists a variety of sources for reporters wanting to write about the crowding out issue.

Amgen, J&J Dodge a Bullet

A Food and Drug Administration advisory panel voted 14-5 today against lowering the red blood cell target in patients on dialysis or suffering from chronic kidney disease. The vote was a small victory for Amgen and Johnson & Johnson, which make Epogen, Aranesp and Procrit, the various versions of the same biotech drug that raises hemoglobin or red blood cell counts.

Clinical trials completed last year showed that raising hemoglobin to near normal levels through more extensive use of the drugs increases the risk of heart attacks, congestive heart failure and early death in patients with kidney disease. Last March, the FDA slapped a black box warning on the drugs. The FDA had requested that the advisers approve setting a target hemoglobin range on the drugs' labels of 11 grams per deciliter of blood, halfway between the range of 10 to 12 g/dL generally considered safe.

Including that target range on the label would have probably led some renal physicians to begin using less of the drugs, since half of all patients on dialysis in 2005 had hemoglobins higher than 12 g/dL. Indeed, nearly 20 percent had hemoglobin levels over 13 g/dL, which, the latest trials showed, was clearly dangerous.

But when Amgen and more importantly the FDA reviews the transcript of the meeting, they may find that the advisers didn't totally cave in to the promiscuous use of these drugs. The primary evidence introduced at the meeting showed that chronic kidney disease patients with red blood cell counts averaging 12.6 grams per deciliter of blood suffered 50 percent more deaths than patients at 11.3 g/dL. In the final vote of the afternoon, the panel recommended by a 14-3 margin with 2 abstentions that the FDA write dosing instructions on the drugs' labels that will result in hemoglobin levels similar to the lower (and safer) arm of that trial.

So, the votes were, in a sense, contradictory. Don't target 11. But dose to 11.

It remains to be seen how the FDA deals with the results of this meeting. The agency is currently negotiating changes in the Epogen and Aranesp labels with Amgen, one of the most powerful lobbying forces in Washington. Last week, Amgen, in league with the American Society of Clinical Oncologists, got the full Senate to approve a resolution calling on the Center for Medicare and Medicaid Services to roll back its latest payment policy that would restrict the use of erythropoietin in cancer patients. The latest trials in that field showed tumors growing faster and patients dying sooner when red blood cell counts rise to near normal levels.

FDA reviewer Ellis Unger told the panel that based on available clinical trial data, there is no justification for going over hemoglobins of 10 g/dL for dialysis patients and 11.3 g/dL for chronic kidney disease (pre-dialysis) patients. But in the end, the agency asked only for a target of 11 g/dL for both groups and didn't even get that.

"We don't have any evidence to say that 12 is worse than 11, so let's go with 12," responded one panelist who voted against the lower target. "If you set it too low, you'll have a large proportion of people fall to a level that will diminish their quality of life," said another.

That latter comment was odd, given that the review of the quality of life studies by Ann Marie Trentacosti of the FDA Office of New Drugs had concluded that the trials submitted by Amgen to the agency were poorly constructed and never established that the drugs actually improve patients' overall well-being. Of course, there is anecdotal evidence, some of it offered by patient advocates at the meeting. Dialysis or pre-dialysis patients in relatively good health who have red blood cell counts near the top of the allowable range no doubt have more energy and feel better than their counterparts with severe co-morbidities like poorly treated diabetes, hypertension and heart disease.

But Amgen and Johnson & Johnson, which markets erythropoietin as Procrit for the cancer, HIV/AIDS and pre-dialysis markets, have never conducted well-designed clinical trials to prove that. Nor have they conducted trials that prove that patients whose hemoglobin has been raised to, say, 12 g/dL, the target sought by Amgen and J&J, fare better than people at 11 or 10 g/dL.

"It is unconscionable that we've gotten to this point in time and still do not know the answers to these questions," fumed Judith Kramer, a researcher from Duke University who voted in favor of lowering the target range. "It is ultimately the responsibility of the sponsor to do those studies and they did not."

Representatives from the Renal Physicians Association, the National Kidney Foundation and both major dialysis chains showed up to argue against the lower target. Their representatives repeatedly raised the specter of a return to the bad old days of routine blood transfusions if the FDA lowered the target range to 11 g/dL.

Left unsaid was the fact that the number of patients in the higher hemoglobin arms of the clinical trials under review had nearly as many blood transfusions as patients randomized to the lower levels of 10 or 11 g/dL. Moreover, no one on the committee or from the FDA pointed out that the current target range of 11-12 g/dL pushes an estimated 20 percent of dialysis patients into the danger zone of greater than 13 g/dL, where there is a sharp increase in the annual death rate.

If I were on the panel, I would have asked the renal docs who showed up to argue Amgen's position this question: What do you think your patients would want, a lower risk of dying or a lower risk of a blood transfusion?

All in all, it was a curious meeting.

For more coverage, you can read the New York Times report and the Wall Street Journal report.

Endgame in the Pursuit of Normal

A Food and Drug Administration advisory committee this morning will consider the safety of the anti-anemia biotech wonderdrugs, Epogen, Procrit and Aranesp, which are made and marketed by Amgen and Johnson & Johnson. One question they have been asked to consider is whether there is any basis for targeting a specific red blood cell count to make patients in dialysis or approaching dialysis because of chronic kidney failure feel better. For over a decade, both companies have been attempting to prove that near normal hemoglobin levels (which requires using more drugs) gives dialysis, chronic kidney disease and chemotherapy patients more energy and improves their quality of life.

The answer, according to the FDA reviewers' presentation, posted on the agency website last Friday, is a flat-out no. Despite Amgen's 242-page submission, the agency concluded "overall, FDA has received no randomized, controlled clinical data establishing treatment benefits associated with the attainment of specific hemoglobin levels."

The language in parts of the review amounts to nothing less than a severe rebuke of Amgen's and J&J's research capacities. In describing the three clinical trials the companies submitted in pursuit of a targeted hemoglobin levels to achieve a better "quality of life" for dialysis patients, the agency said:

* Patients were not enrolled based upon a prespecified degree of anemia symptoms;

* All studies were not powered to detect changes in . . . "quality of life";

* None of the symptom efficacy claims instruments (i.e., patient surveys) were developed or validated to measure anemia symptoms in the target population; instead, post-hoc selection of specific items and subscales from various instruments were utilized to support symptom claims.

Here's what went on in one study. "Sometimes several questionnaires had to be provided with reminders that completing and returning each questionnaire promptly and on schedule was very important to the study. There were
still many questionnaires returned late or not returned at all," the reviewers noted. Of the 152 patients enrolled in that study, the researchers came up with information for just 77 patients (51%).

What did Amgen tell the FDA when they turned that study in, "The dog ate my homework"? There are 470,000 people on dialysis in this country and an estimated 8 million people with chronic kidney disease, who might end up there. They deserve better.

The other major focus of today's meeting will be the dangers that patients face when hemoglobin levels go too high. Amgen and J&J have been promoting "near normal" hemoglobin for years, claiming it would improve survival. Yet both studies that have tested that proposition in kidney disease patients -- one published in 1998; the other published last year, both funded by the companies -- came to the opposite conclusion. Hemoglobin levels above 13 grams per deciliter caused more heart attacks, strokes and premature death, not less.

Here's some data that won't be presented at the meeting. A study completed in 2003 (also funded by Amgen) that compared dialysis outcomes around the world found that the crude one-year mortality rates were 6.6 percent in Japan, 15.6 percent in Europe, and 21.7 percent in the US. Even after adjusting for age, gender, race, and 25 comorbid conditions, U.S. dialysis patients died at a rate that was more than 3 1/2 times greater than the Japanese and 33 percent higher than Europeans.

Another study published just last year (also supported by a grant from Amgen) found that Japanese dialysis patients had the lowest hemoglobin levels with a mean level of 10.1 g/dL -- about the level at which the U.S. begins dosing (or should we say overdosing) patients. The Europeans and U.S., meanwhile, had mean hemoglobin levels of 11.4, and 11.7 g/dl, respectively. The researchers said the difference could only partially be explained by the 30 percent higher burden of severe comorbidities of patients in the U.S.

One thing the advisory committee will hear is that when the mean hits 11 g/dL or higher, about 40 percent of patients are actually over 12 g/dL, which the FDA label now says you shouldn't go beyond. And about half of those are over 13 g/dL, the clinically proven danger point. Dennis Cotter of the Medical Technology Patterns and Practice Institute will also present data that shows that the sickest patients are the ones that get the highest doses of the EPO, and they are the ones that are most likely to suffer heart attacks and strokes.

The committee will have to wrestle with how to write a label that warns doctors against overdosing these non-responders, even if their hemoglobin levels are well below 11 or 12 g/dL. The sad thing is that neither Amgen and J&J, despite earning billions of dollars every year from selling these drugs, has ever conducted a clinical trial that will help the FDA or its advisers answer that question.

This Morning's In-Box . . .

Stories that caught my eye this morning:

Bush Administration Makes Seniors Pay Their Bills, But Not Insurance Companies

Today's New York Times buries another workmanlike gem by Robert Pear, who runs rings around most other reporters simply by following the bureaucracy. A Government Accountability Office study shows that the Center for Medicare and Medicaid Services (CMS) is failing to audit payments to insurance companies for Medicare Advantage plans, the private insurance component of the Medicare program. The result is tens of millions of dollars going into insurance companies pockets instead into rebates and/or additional services for seniors, which is the only basis for the claim that these plans are superior to traditional fee-for-service medicine. Halfway through the story, Pear does his own burying. Medicare, he reports, is going after 135,000 seniors that the agency forgot to dun for their prescription drug coverage. The acting administrator, Karry Weems, tells the paper: “I am intently focused on this matter and will make it a priority to correct the errors and minimize them in the future.”

Cervical Cancer Vaccine Duo Get Their Due

Largely overlooked in the controversies surrounding the cervical cancer vaccine marketed by Merck -- Should it be marketed to young teen-age girls? Why does it cost $400 for a series of shots? -- is the fact that two National Institutes of Health scientists discovered the vaccine. Today's Washington Post business section reports that dynamic duo -- Douglas R. Lowy and John T. Schiller -- are up for an award. This discovery follows the usual pattern: the truly inventive steps in drug discovery are often done by public sector scientists and only after decades of research. Private sector firms then license those technologies and spend the large amounts of money needed to bring the new drugs or vaccines through clinical trials.

Didn't Anybody Agree With Brooks on Single-Payer?

The Times' conservative in-house columnist David Brooks last Friday dismissed single-payer health care as unacceptable to most Americans. Today, the paper ran six letters not only attacking his column, but making quite cogent arguments defending universal systems and in favor of expanding Medicare to cover the uninsured population in the U.S. The paper didn't print a single letter agreeing with the column. Bias, or an accurate reflection of the response? Perhaps the ombudsman could enlighten us next weekend.

FDA Questions Quality of Life Benefits of Epogen

The Wall Street Journal in its weekend edition gave a brief synopsis of the Food and Drug Administration's presentation for Tuesday's advisory committee meeting that will evaluate the safety of Epogen when given in high doses to dialysis patients. According to the paper, the quality-of-life studies that have been used to justify higher hemoglobin levels in patients, which have now been shown to cause increased heart attacks and strokes, "were limited and might not meet current regulatory standards." The story included a small error. Medicare does not begin cutting off payments for Epogen until hemoglobin levels reach 13 grams per deciliter, not the 10 g/dL mentioned in the paper.

Another Portal for Direct-to-Physician Advertising?

Reed-Elsevier, the largest academic and scientific publisher in the world, announces plans to make its oncology journals free to physicians on line in exchange for subjecting themselves to online advertising, most of which will undoubtedly come from the drug companies whose products are being reported on in the journals. Newspapers aren't the only print information outlets whose economic model is threatened by the internet. But is this the right answer?

PAYGO and SCHIP

Welcome to the wonderful world of wacky Washington acronyms. PAYGO and SCHIP aren’t characters from a new fall sit-com featuring two college buddies who come to the nation’s capital to intern for House Speaker Nancy Pelosi. They’re the odd-couple that will star in a drama over the next few weeks about getting health insurance for ten million American children.

Last fall, the Democrats pledged to reinstitute the balanced budget rules of the Clinton years. Under the so-called PAYGO or pay-as-you-go rules, which the Republican-controlled Congress repealed in 2002, any new program enacted by Congress must be paid for with tax increases and/or spending cuts.

Since most middle-class Americans live within their budgets, PAYGO has lots of political appeal. For them, it’s just common sense, something that’s been in short supply during this administration. President Bush in his first six years turned a 10-year projected budget surplus of $5.6 trillion into a $3 trillion deficit, largely through tax cuts for the wealthy (about two-thirds of his “spending”) and the wars in Iraq and Afghanistan, one of which was unnecessary.

Though they’ve gotten little credit for it, this is one area where the Democrats have kept their promise. A compilation of budget projections from the non-partisan Congressional Budget Office shows that $129 billion in new spending over the next five years in the House-passed farm, energy, education and health bills (including the expansion of the States’ Children’s Health Insurance Plans or SCHIP) will be more than offset by $101.7 billion in spending cuts and $32 billion in new taxes.

In the SCHIP bill, only a quarter of the new revenue comes from new taxes and all of that comes from an expanded cigarette levy. That’s doubly beneficial, since it not only helps uninsured kids, but it reduces the nation’s long-term health care costs by reducing cigarette consumption. Indeed, if we look at the two line items, it’s almost a perfect match. Insuring six million more kids will cost $47.8 billion over the next five years, while a 61-cents-a-pack increase on cigarettes (making the federal levy $1 a pack) will raise $35 billion. Bump it up another 20 cents a pack and it’s a wash.

But the SCHIP bill isn’t just about kids, and this is where the House leadership stumbled in applying the PAYGO rules.

The House bill became a catch-all for a number of adjustments to the Medicare program, each of which has important policy implications. (That’s why they nicknamed their bill CHAMP for Children’s Health and Medicare Protection Act instead of SCHIP.) But instead of having a debate about those policies and a discussion about the tradeoffs, it all became a jumble.

For instance, although it has received almost no attention in the press, the CHAMP/SCHIP bill contains an additional $20 billion over the next five years for increased Medicare payments to physicians – the result of intense lobbying by the American Medical Association and other physician groups. It is designed to make up for cuts that otherwise would go into effect under formulas passed in 2003 as part of the prescription drug benefit.

There’s more in the bill that deserves applause (and a few items that deserve criticism – like the incentive program to give more drugs than necessary to dialysis patients that I wrote about last week). There’s $12 billion over the next five years to help low-income Medicare beneficiaries; there’s $2 billion for increased mental health benefits; and there’s even a billion dollars to eliminate co-pays for colorectal cancer screenings – a prevention measure that could extend lives.

How does all of this get paid for in the bill? The Democrats repealed the Medicare Advantage program, which gives insurance companies a 12 percent premium over normal Medicare rates to enroll seniors in health maintenance organizations. That saves $50 billion over the next five years.

There are very good policy arguments in favor of eliminating the subsidy for Medicare HMOs. While the insurance companies claim they’re providing extra services for seniors who enroll and serving rural communities, the reality is that the Medicare HMOs are cherry-picking the healthiest seniors from the regular program. Only a handful of those enrolled in HMOs come from underserved rural communities. Even the AARP favors its repeal.

Moreover, the program allows the insurance industry to begin the process of carving up Medicare, which is the long-term goal of the free market zealots in the Republican Party. They abhor all successful government programs, especially one that delivers health care services more efficiently and with greater satisfaction than the private marketplace.

But by wrapping the Medicare Advantage rollback into the SCHIP bill, those policy discussions are getting lost in the debate over insuring kids. It allows the insurance industry (a letter last weekend from Karen Ignani, president of the insurance industry trade group America’s Health Insurance Plans, to the Washington Post is a good example) to claim the Democrats are pitting “children against seniors.”

The proponents of repeal can just as easily claim (and a separate bill could have been structured to say) that the real tradeoff was between insurance companies and doctors. To whom would you rather give the money?

The PAYGO rules gave the Democrats a strong platform for debating these tradeoffs. Do we want enhanced benefits for a few healthier seniors or a better program for all seniors? Do we want to insure more kids at smokers’ expense?

But by jumbling everything together, they provided the insurance lobby with an opening to pit kids against seniors. That’s too bad. It would have been fun to watch the doctors fight the insurance companies for their raise.

That Controversial SSRI Study

I finally got my hands on a copy of the study in the American Journal of Psychiatry that claimed that a recent increase in youth suicides can be tied to psychiatrists dialing back on their use of anti-depressants in the wake of a Food and Drug Administration warning in 2004 that the drugs may actually increase suicide idea formation in youths. The Centers for Disease Control in a separate report confirmed the trend, if not the conclusion.

What struck me in looking at the data was how small the change was (14 percent doesn't seem small, but look at the raw numbers). The rate went from 2.83 per 100,000 or 1,737 suicides in a population of 61.45 million youths 19 and under in 2003 to 3.23 per 100,000 or 1,985 suicides in a population of 61.47 million youths in 2004, according to the study. The CDC data covered young people up to age 24 and showed a smaller increase in 2004, going from 6.78 to 7.32 per 100,000 youths, an 8 percent uptick. The CDC did note that this was the largest percentage increase since at least 1990 when the CDC began tracking the data.

However, looking at either set of numbers, the 2004 rate remained in the relatively low range that it has been in since the late 1990s. Youth suicide rates began falling in 1988 when, some argue, illegal drug use among youths began declining and legal drug use (various forms of speed for ADHD and serotonin reuptake inhibitors or SSRIs for depression) began its long-term upswing.

Critics of anti-depressants say the real danger period when using these drugs comes when kids start taking them and when they stop taking them. As one put it today: Taking these drugs is like riding the space shuttle; the riskiest part of the journey is going up and coming down. That theory suggests that one year blip in response to a downturn in prescriptions may have been related to drug withdrawals.

In any case, a one year change in a curve's direction doesn't a trend make. The danger signal from anti-depressants in kids that were highlighted by Food and Drug Administration reviewers in 2004 came from controlled clinical trials. This study's broad conclusion, "If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect," is based on a crude correlation based on a small one-year shift in broad population data.

The study's chief author was Robert D. Gibbons, a professor of psychiatry at the University of Illinois. His conflict-of-interest disclosure at the end of the study (not revealed in the Washington Post article) reported that he also provides expert testimony in product liability trials for Wyeth Pharmaceuticals, which makes Effexor, an antidepressant in the SSRI class.

It takes a lot for the FDA to ignore clinical trial results in favor of population-based studies like this one. FDA psychiatry drug chief Thomas Laughren was properly circumspect in today's Post: "FDA is obviously concerned about possible negative impacts of labeling changes but also feels a strong obligation to alert prescribers and patients to possible risks associated with the use of antidepressants." He added, "We will continue to monitor antidepressant use and suicide rates, and will take appropriate regulatory actions as new data become available."

Today's Health Care In-Box . . .

Where I read the papers so you don't have to (but include links so you can if you want):

Health Insurance Reform in Holland

The health insurance revamp in Holland, which last year transformed its state-run health care system into one that is based on insurance companies selling individual plans, gets an intriguing review in this morning's Wall Street Journal. Key component: Insurance companies must take all comers, and are prohibited from discriminating against anyone with pre-existing conditions or easily foreseeable health care problems.

EPO Fails in ICU Trial

A Johnson & Johnson-funded study that administered EPO (Procrit) in emergency room and intensive care unit settings to reduce blood transfusions failed. Not only did it fail to reduce the need for blood transfusions, but patients in the Procrit arm of the trial suffered 40 percent more heart attacks -- another sign that overuse of EPO raises cardiovascular risk. While there was a non-statistically significant reduction in mortality in the Procrit arm of the trial, an accompanying editorial in the New England Journal of Medicine warns doctors not to prescribe the drug for critically ill patients. J&J tells the Wall Street Journal that it is cancelling plans to seek Food and Drug Administration approval for emergency room and ICU use of the drug.

NEJM Bashes Bush on Kids Insurance

The nation's leading medical journal also weighs in this morning with a hard-hitting editorial slamming the president's opposition to the expansion of the children's health insurance program. Noting that organizations as diverse as the American Medical Association, the Pharmaceutical Research and Manufacturers Association, the AARP and the Children's Defense Fund have endorsed the bill, the NEJM intones: "If the president is sincere in his commitment to leave no child behind, he must begin by leaving no child uncovered."

The editorial accompanies an overview of "The Battle over SCHIP", written by John K. Iglehart, the former editor of Health Affairs who is now a national correspondent for NEJM. While the article mentions that physicians will get their scheduled fee-cuts restored in the bill, it skates over the fact that the increase in physician payments costs almost as much as what the legislation spends on kids' health insurance.

FDA Fails to Follow Through on IOM Report

The NEJM also contains a thorough review of the Food and Drug Administration's response to the Institute of Medicine's 2006 report on drug safety, which faulted the agency for emphasizing getting new drugs approved over protecting the public from unsafe drugs. While good as far as it went, the review made no mention of the FDA reform legislation attached to the Prescription Drug User Fee Act reauthorization now before Congress. An independent review of how well those reforms will succeed at correcting the problems identified in the IOM report is sorely needed. Sheila Weiss Smith's review (she's a long-time ad hoc member of FDA advisory panels and consulted with the IOM on its report) suggests the legislation has severe shortcomings, especially its failure to establish an independent safety department within the agency.

Study Shows Teen Suicides Rise After Anti-Depressant Warnings

The Washington Post carries a front page story on a new study showing an increase in teenage suicides the year after the FDA warned that use of anti-depressants increases the risk of suicide in youths. Prescriptions for the drugs declined sharply after the warning. David Healy is the only critic quoted in the story. He suggests an increase in atypical anti-psychotic drug use among the young may be responsible for the increase -- not a decline in the use of anti-depressants. No one in the story addresses the issue of talk therapy and its declining use in America because insurance companies won't pay for it. Many studies show this is a critical element in any program to decrease teen suicide. And then there's gun control. Far more boys than girls succeed at killing themselves because they're much more likely to use guns, while girls tend to use easily obtainable household poisons, which are much less effective. Eighty percent of teenage male suicide attempts succeed; 60 percent of teenage female suicide attempts fail.

No Health Insurance? Leading Economist Blames the Government

Jonathan Gruber of the Massachusetts Institute of Technology is considered one of the nation's bright young health care economists. The former Clinton administration official was a key architect of the Massachusetts universal health insurance plan, which relies on a mandate for individuals to go out and buy health care insurance if their employers don't provide it.

This bias in favor of individual insurance markets comes through in his latest paper, which can be found on the National Bureau of Economic Research website. It reflects the mainstream economics profession view that public programs like state Children's Health Insurance Plans (S-chip) "crowd out" private insurers. According to Gruber, for every 10 people who enroll in a public program, about six lose private insurance.

His data? Between 1984 and 2004, the number of non-elderly enrolled in public programs rose from 13.7 percent to 17.8 percent of the population, while the number of non-elderly without private insurance fell to 62.4 percent from 70.1 percent. Through "robust estimates of crowd-out," he concludes 60 percent of the switching was voluntary.

I am reluctant to pay $5 to download the study since I'm not very good at interpreting those calculus formulas that economists use. But this study defies common sense. Is he including all those people who work for the Wal-Marts of this nation who provide health insurance that's so skimpy that their employees would rather go on Medicaid? (Wal-Mart's family plan has as $3,000 deductible plus numerous co-pays once you've gotten past the six-month waiting period to get into the plan).

And how about the people who work for employers who provide nothing at all? Every survey that has been done among people who don't have insurance shows they simply can't afford the individual insurance market. Here's what a Commonwealth Fund survey conducted in 2005 found:

An overwhelming majority—89%—of working-age adults who sought coverage in the individual market during the past three years ended up never buying a plan. A majority (58%) found it very difficult or impossible to find affordable coverage. One-fifth (21%) of those who sought to buy coverage were turned down, were charged a higher price because of a pre-existing condition, or had a health problem excluded from coverage.

"More workers and their families are losing employer-sponsored health insurance," said Commonwealth Fund Assistant Vice President Sara Collins, lead author of the report. "Most of the increase in the number of uninsured Americans—now upwards of 46.6 million—was due to a decline in workplace coverage. Although the individual market is a last resort for those shut out of employer-sponsored coverage, it is by no means a safe or secure haven for everyone."

Crowding out? Seems more like locked out to me.

(It turns out that even Gruber is backing away from some of the implications of his study. See this letter to House Energy and Commerce chairman John Dingell, where he says his study shouldn't be applied to states' Children's Health Insurance Plans or SCHIP.)

So, Which Is It?

You had to read VERY carefully to know what is being reported at a European cardiologist meeting about the controversy surrounding drug-eluting stents. From the New York Times:

Studies Say Newer Stents for Arteries Show Promise

Makers of stents and many cardiologists who implant them said yesterday that reports at this year’s major meeting of European cardiologists bolstered their confidence in the safety of the newer drug-coated versions of the devices, which are used to prop open coronary arteries.

From the Wall Street Journal:

Drug-Coated Stents Are Questioned

VIENNA -- Patients given drug-coated stents after an acute heart attack are nearly five times as likely to die six months to two years later as those with bare metal forms of the arterial scaffolding, new research showed.

The difference? The Times was looking at a study that looked at the routine placement of drug-eluting stents in people with angina and minor blockages; the Journal looked a study of drug-eluting stents put in people who had suffered a heart attack.

How Risky Is Tobacco?

Tobacco is the number one preventable public health problem in this country. The number of people who die from using tobacco is greater than the number who die from most of the other things that we worry about: It's greater than the number of people who die from adverse reactions to drugs, from alcohol, from fires, from environmental contaminants. It's greater than all of those put together.

-- William B. Schultz, former FDA attorney now in private practice, in an interview with the Boston Globe.

In Defense of Comparative Effectiveness Trials

The following letter ran in today's Wall Street Journal:

I was surprised by the anti-capitalist undercurrent of Scott Gottlieb's attack on comparative effectiveness clinical trials -- "The War on (Expensive) Drugs," editorial page, Aug. 30. When I took Economics 101, it was axiomatic that efficient markets required consumers to pursue their own economic interests -- like choosing less expensive drugs if they provide the same or better therapeutic benefits as more expensive options.

Unfortunately, today's pharmaceutical marketplace operates inefficiently because it doesn't provide consumers or prescribing physicians the information needed for medically or economically rational decision-making. The comparative effective trials authorized in the children's health insurance bill would help eliminate this information gap.

Dr. Gottlieb brackets his defense of marketplace inefficiency by complaining about secrecy and the selective interpretation of government-funded clinical trials. That's as inexcusable as when companies do it. That's why consumer groups have been pushing for full transparency of all clinical trials -- from their initial registration to the posting of their final results. Dr. Gottlieb's case would have been stronger had he endorsed that aspect of the FDA reform legislation now moving through Congress.

Merrill Goozner
Director
Integrity in Science Project Center for Science in the Public Interest
Washington

Generic EPO Competition Arrives in Europe

More bad news for Amgen and J&J yesterday when the European Union's health authorities approved a generic version of erythropoietin made by Novartis.

If folks up on Capitol Hill are looking for ways to raise money to pay for the children's health insurance bill, they should consider passing a generic biologics bill and allow sale of that drug here.