Bush Downplays Health Reform

All the punditry (at least on domestic issues) before tonight's speech focused on health care reform. The president spent less than two minutes on the issue. I suspect his political handlers did some last minute polling and deep-sixed the more substantive paragraphs he planned to deliver.

After throwing rhetorical bones to small businesses and insurance portability (an issue that can be solved more easily with national insurance than with individual health care accounts), he attacked the trial lawyers and renewed his call for medical tort reform. Talk about catering to core constituencies. I doubt few Americans will even remember that health care was part of the speech.

On the other hand, the president make a big pitch for weaning the U.S. from foreign oil -- by 2025. He pledged to increase energy R&D budgets by 20 percent focusing on clean coal technology, renewables and nuclear power. He also pledged to step up U.S. investment in ethanol produced from wood stalks and switchgrass. Wood stalks and switchgrass! Now there's Clintonian wonkery at its best.

If a Democrat said this, I'd be applauding like crazy. So I'm intrigued by where Bush, with his ties to the oil industry, is going on this issue. The devil is in the details when it comes to energy. Let's see what's in his budget, which will be released next week.

Bush Declares War on Science

The most shocking element of President Bush's State of the Union speech tonight came when he called for a ban on human cloning in any form. This is a direct attack on the science establishment in the U.S., which sees embryonic stem cell cloning from a person's own cells (somatic cell nuclear transfer to use the technical term) as the key to maximizing the potential of stem cell research. It may not ever come to pass. But the president tonight said Americans shouldn't even try.

How many scientists, not to mention patient advocates, will buy into that argument?

The Union's Health Care State

If we’re lucky, President Bush’s state of the union address tonight will do for health care what last year’s speech did for Social Security.

Recall that a year ago, pundits bought his spinmeisters’ claims that the president’s election victory – “I earned capital in the campaign, political capital, and now I intend to spend it” – signaled a national endorsement of the Cato Institute wet dream: betting our guaranteed retirement system on a roll-the-dice strategy of individual accounts.

The president spent much of the year peddling this plan. And the American people – beset by disappearing corporate pensions, stagnant 401(k) accounts and personal savings hovering somewhere between minuscule and non-existent – heard what he said, digested its meaning, and rejected it wholesale. By year’s end, that idea of turning a guaranteed Social Security check into variable personal accounts had about as much value as Enron stock.

The president’s campaign did have one virtue, however. It began the process of educating another generation about the concept of social insurance, and why there are some things in life many people can’t prepare for on their own.

Since our presidential bubble boy doesn’t learn from his mistakes, tonight’s speech should tee-up health insurance as the next great battleground for educating Americans about those things that we must do together. I’m mildly optimistic that six months from now, after a sufficient number of Bush speeches extolling the virtues of individual health care savings accounts, Americans will finally begin listening to proposals for “Medicare for all,” which is the only solution to the national health care mess.

Medicare for all? What’s that, you ask? It’s the politically savvy way of calling for national health insurance. After all, Canada, England, France, Germany, Italy, Scandinavia, Holland, the Netherlands, Iceland, Japan, South Korea, Australia, New Zealand and just about any other country you’d care to name except Chile and China – now there’s great company – must know something. Their national plans spend anywhere from five to ten percentage points of GDP less than Americans on health care, and most of them live longer, too.

The first step will be educating Americans about what ails the current system, which has nothing to do with reckless consumers cut off from the financial pain of their choices opting for wasteful procedures and expensive tests. Individual health accounts would cure this non-problem by giving consumers the right to decide about first-dollar care – paid for by accounts filled with pre-tax dollars – while using the same tax-exempt accounts to buy catastrophic insurance plans for when they really get sick. Poor people who don’t pay taxes would get special tax credits to allow them to buy into the system.

Princeton University health care economist Uwe Reinhardt circulated a short gem of a paper over the weekend dissecting this nonsense. He starts by pointing out that this amounts to one more huge tax subsidy for the already well-off. Since most basic care and family plans cost about the same as long as your family is healthy, those in the highest tax brackets would get the biggest subsidies.

Meanwhile, the move toward individual accounts would be accompanied by wholesale dumping of existing employer plans – just as employers dumped their traditional pension plans in favor of 401(k)s. However, as families enter the insurance market, they’d find out that not everyone is equal. What insurance company willingly takes on the diabetics, the mentally challenged and cancer patients? The first question Reinhardt wants journalists to ask the president and his men is who will regulate this expanded market for individually purchased health insurance?

There’s good reason for Reinhardt is address his comments to journalists. There’s no shortage of health care experts in the scribbling profession who understand why individualized accounts won’t work. But, unfortunately, they don’t get to cover the main story when it’s the president making the pitch. That task falls to political reporters, most of whom, when it comes to economics, not to mention the convoluted field of health care economics, haven’t got a clue.

Health care, like the need to insure against unforeseen calamities like unemployment and disability, is a social good. You don’t know when you’re going to get sick. And once you get sick, you may stay that way for a long time. As Brookings economist Henry Aaron pointed out in Monday’s Los Angeles Times, people who spend over $4,000 a year for health care – i.e., the really sick – account for 80 percent of the nation’s $2 trillion health care tab. Is there any way individual health savings accounts can pay for that? Only social insurance can pick up the tab.

We’re approaching a teachable moment in health care. The business community is deeply split, with those paying the tab willing to take on those who collect it and profit from it.

There’s much more to be said on how to make a national health insurance plan affordable for the American people as a whole. But that discussion will come later, after it has assumed its proper place on the national agenda. Tonight, President Bush will kick off his misguided campaign for individual health care savings accounts. If the past is prologue, he will begin the process of teaching Americans that a single payer, national health insurance plan is the only way to go.

Our Polite FDA

First they waited until the bidding war was over, then they asked them to tea.

The Food and Drug Admininstration yesterday called a press conference to release a scathing letter attacking Boston Scientific's top management for failing to track and report deaths and injuries caused by faulty medical devices. Even though agency inspectors had been on Boston Scientific's case throughout the past year, the FDA leadership waited until just one day after the company won a $27 billion bidding war to buy rival Guidant Corp. before demanding a meeting with the company's top management.

The agency told the press the timing of the latest warning letter, dated Jan. 25, and its release the next day, had nothing to do with the buyout, which was announced the same day the letter went out.

What did Boston Scientific do wrong? In essence, they failed to analyze incoming complaints about deaths and illnesses caused by some its devices. More importantly, it failed to report them to the FDA. According to the letter, the devices included the widely used paclitaxel-eluding stent for cardiovascular disease.

Anyone interested in the details of the complaint can find it here. The most significant paragraphs came near the end where the FDA announced its penalties. The FDA said it would stop granting Boston Scientific new approvals or export licenses, which could hurt the company's business down the road.

What didn't it do? It did not slap immediate financial penalties on the company even though it could have seized inventory, obtained a court order forbidding further marketing of its products or assessed civil penalties "without further notice to you."

Instead, the FDA gave top management until Feb. 3 to prepare for another meeting with the FDA inspectors. Another day, another warning. The first warning letter to Boston Scientific with findings of "systematic failure" to analyze and report flaws in its devices went out last May. Follow-up inspections that resulted in additional warning letters took place in August and September.

In recent months, the Institute of Medicine (at the FDA's request) has been studying the FDA's inadequate system for tracking adverse events after it has approved a drug. If this latest window into the world of medical devices is any indication, the system for tracking manufacturing flaws is just as bad if not worse.

How To End the Ties That Bind

What? No tchotzkes?

A panel of prominent physicians has called for ending many practices that give the drug and medical device industries inordinate influence over the nation's 400 teaching hospitals and 125 academic medical centers.

In an article in today's Journal of the American Medical Association, a group associated with the George Soros-funded Institute on Medicine as a Profession at Columbia University (IOMP) proposed prohibiting drug companies from giving small gifts or paying for the meals, travel or continuing medical education of teaching docs. They also recommended ending the distribution of free drug samples in favor of giving vouchers to hospitals.

The group didn't stop there. They also called for hospital formulary committees to eliminate from their ranks any physicians with ties to drug manufacturers. Those committees play a key role in medical decision making by determining the best drugs to use in various medical situations.

While they didn't call for a ban on faculty participating in outside consulting or receiving speaking honoraria and industry research contracts, the IOMP group did say each contract should be tied to a specific deliverable (i.e., no "no strings attached" grants). "To better ensure independence, scientific integrity and full transparency, consulting agreements and unconditional grants should be posted on a publicly available Internet site, ideally at the academic institution," the group wrote.

The IOMP proposal, if voluntarily enacted by the nation's medical schools, would set a new standard for policing conflicts of interest and would go a long way to purging industry influence from academic life. But I see several problems with the proposal.

First, by focusing on the nation's academic medical centers, they ignore the fact that most of the drug and device industries' marketing practices are aimed at the nation's nearly one million practicing physicians, not the elite in the nation's medical schools. The last time I visited my doctor, drug paraphenalia -- the pens, pads, cups and calendars, not to mention free samples -- were everywhere. What about her?

It's true the teaching docs set the standard and provide the "thought leaders" in many medical specialties. But there is a large and growing continuing medical education industry (an adjunct of the advertising and public relations industries really) that is no longer beholden to the academy for its expertise. Their influence will only grow if this proposal is limited to academic medical centers.

Moreover, the practice of medicine is heavily influenced by clinical practice guidelines written by professional associations or patient advocacy groups like the American Society of Clinical Oncologists or the American Heart Association. This is where the rubber of industry influence meets the road of medical practice. Indeed, more and more insurance companies and even Medicare are moving toward rewarding physicians and hospitals for sticking to the guidelines as part of "pay for performance" schemes.

While many academicians sit on these guideline writing committees and most groups have strong conflict-of-interest disclosure requirements, industry exerts extraordinary influence over the guidelines either through direct funding of these groups or ongoing relationships with members of the guideline-writing committees. This proposal does nothing to liberate the writing of clinical practice guidelines from industry influence.

Finally, their proposal would place restrictions on industry-funded clinical trials at academic medical centers. If I read the proposal correctly, they would eliminate individual grants to researchers for specific projects in favor of only allowing industry grants for general support of research. Presumably, this would leave the individual investigators free to design their own trials with their eyes set on determining what is best for the practice of medicine, not what is best for marketing a specific drug.

Over the past 30 years, the ratio of industry support for clinical trials has jumped from 30 percent of all research to nearly 70 percent. It accounts for a majority of the 15-20 percent of industry funds spent on research and development and a substantial fraction of the 25-30 percent of industry funds spent on marketing (these latter trials are sometimes called "seeding" trials; the industry lines up hundreds of doctors across the country to prescribe their latest drug even though it has already been approved by the Food and Drug Administration; it's a way of getting them to use the drug in their regular practice).

If this proposal is limited to academic medical centers, a large part of the clinical trial spending conducted there will simply gravitate to the private sector. The private contract research organizations like Parexel and Quintiles, which are already growing by leaps and bounds, will get another huge shot in the arm. More trials will simply move off-shore.

These reforms need to go much deeper. The IOMP should have included the parent organization of the journal where their article appeared -- the American Medical Association -- in their list of organizations that should adopt the reforms. They also should have included the Accreditation Council for Continuing Medical Education, the voluntary group that certifies which CME providers meet its standards for continuing medical education credits (which are required for maintaining physican licenses in virtually every state). And they should have spoken out about industry influence over patient advocacy groups like the American Cancer Society and the American Heart Association, which include many industry-affiliated physicians in prominent positions.

Finally, they should have expanded their horizon to include the federal government -- specifically, the Food and Drug Administration and the Centerfor Medicare and Medicaid Services. Conflicts of interest need to be ended on the outside advisory committees for the gatekeeping agencies that approve new drugs and devices and that determine what drugs and devices will be reimbursed.

After all, conflicts of interest are all about the money. So in looking for places to apply the new standards, they should remember Willie Sutton's maxim: go where the money is.

Washington Post Health Section: News or Advertorial?

You've seen them. They're among the cheesiest ads in print. On the left is faded (sometimes black-and-white) "before" photo of a frowning woman -- sometimes obese, sometimes wrinkled like a prune, sometimes both. On the right is the smiling "after" shot -- slim, smiling and smooth.

Even the people who buy the products being peddled must understand that the photos were deliberately chosen to show each condition (before and after) in its worst and best light, respectively. After all, it's just cheesy advertising.

But what was I to think this morning when the Washington Post Health section ran one of those cheesy before-and-after shots. Well, they're in business to make a profit, too. It's just advertising, right?

However, this before-and-after shot wasn't in a quarter-page ad at the bottom of page three of the section. It was on page one. It was at the top of the fold. And it wasn't an ad. It was an illustration for a news article.

How far has the Post sunk in this latest example of advertorial behavior on the part of American journalism? The photo on the left of a 54-year-old woman before her "thread lift" (an increasingly popular alternative to face lifts, the caption informs us) has her in a tight-lipped frown with deathly pale skin, unkempt hair, no make-up and bags under her eyes large enough for a weekend getaway. The picture was provided by Dr. Ricardo Rodriguez, the Baltimore physician who performed the procedure described in the first paragraph.

And how did Ms. 54-year-old look afterwards? The picture on the right, taken by a Post photographer, shows a smiling woman with attractively groomed hair, eyeliner and eyebrow setting off her gleaming blue eyes, and a smile so wide you could see seven -- count 'em -- seven top teeth.

How long will the look last? "May Take Some Time to Tell," the subhead informs us. Unbelievable. The hoariest cliche in journalism.

The only question for the Post in the wake of this mini-fiasco is not whether the editor should be fired, but whether the section has a journalistic reason for continuing.

Another Physician Kickback Scheme Exposed

Last week, I reported on a whistleblower lawsuit that described a scheme involving Genentech/Biogen payments to physicians to promote the off-label use of a pricey biotech drug. Today's New York Times has long report on another salesman-turned-whistleblower lawsuit, this time involving the medical device industry.

According to the suit, Medronic paid hundreds of thousands of dollars to back surgeons to promote the use of spinal implants, a particularly lucrative part of the $10 billion company's business. In addition to the huge payments, which may have totalled $50 million, all the usual accoutrements of medical marketing were involved: golf trips to fancy resorts; free snorkeling; and all-expense paid visits to strip clubs. Talk about bedside manner.

Despite the fact the government (Medicare, Medicaid) is the largest financial victim of what the suit referred to as a "bribery scheme," the Bush administration's Justice Department has refused to intervene in the case.

Whistleblower lawsuits brought under the Civil War-era False Claims Act allow plaintiffs to recover funds fraudulently obtained through federal contracts. The whistleblower usually gets about a third of the recovery, with the rest going to the federal treasury.

Forestry Profs Seek to Snuff Out Enviro Research

Every once in a while something crosses my desk that just gets my blood boiling. It wasn't just that a couple of big time professors with ties to the wood products industry tried to stop Science magazine from publishing a study critical of industry forestry practices. It was the fact that the author was a 29-year-old graduate student whose research concluded that logging forests blackened by wildfires slowed their recovery.

Can you imagine what went through Daniel Donato's mind as his "colleagues" sought to quash his research? Publishing in Science is the highlight of many professors' lives. For Donato, getting published in the nation's most prestigious science journal as a young graduate student could make his career.

To their credit, the editors at Science resisted entreaties from Oregon State University professor John Session and professor emeritus Michael Newton to hold off publishing Donato's paper. Their research has suggested logging and replanting restores forests faster than the gradual process of natural restoration after fires. Are you surprised to learn that Newton's research has been supported by Weyerhauser and Sessions is a frequent speaker at industry conferences?

According to the Portland Oregonian, which had a complete rundown on the issue over the weekend, the two senior professors' work had "faced its own criticism for not undergoing as thorough of a review process as studies published in Science, for instance."

Reporter Michael Milstein followed up on Sunday with quotes from other OSU scientists expressing fear that the professors' actions would damage the
university's reputation. It turns out the College of Forestry at OSU is funded in part by logging taxes.

How Not To Fight Attacks on Science

Paul Nurse, the president of Rockefeller University, has a stimulating essay in the current issue of Cell, "U.S. Biomedical Research under Siege." Worried about the stagnating National Institutes of Health budget (the agency in constant dollars will decline this year for the first time since the 1970s), he sees the Intelligent Design movement and the religious right's opposition to stem cell research as feeding a national mood that if left unchecked will erode the nation's science infrastructure, especially in biomedicine.

What's notable about the essay is his willingness to attack the current leadership of NIH, which is quite unusual for a university president whose professors are very dependent on NIH funding. He blasts Elias Zerhouni, the agency's top official, for failing to take the lead in fighting Intelligent Design, which, Nurse points out, could never explain the emergence of resistance to antibiotics except by alleging that not only did God design us intelligent critters, but He/She is busy designing new microorganisms every day. In an inteview in Science, Zerhouni asked "Why do you think NIH should be visible in that debate?"

Nurse also takes National Cancer Institute (and Food and Drug Administration) director Andrew von Eschenbach to task for raising unrealistic expectations about curing cancer by 2015. "This cannot be justified even as a statement of aspiration because when we fail to deliver, as we surely will with such a claim, we will lose the confidence and trust of both the politicians and the public."

Readers of this blog are no strangers to that sentiment. But it's nice to see it repeated by a leader of a university that is a major pillar of the War on Cancer establishment.

The top of Nurse's essay is devoted to the woes that will befall NIH-dependent researchers as budgets contract. There's a lot to be said on that subject beyond what he offers. Though budgets have been tight the past three years, there were massive increases in health-related research in the past decade -- in both the public and private sectors. Yet medical innovation is in sharp decline.

There's a lot more to be said on that subject, but it will have to wait for another day. Have a great weekend.

Six Years of Study, And Then FDA Exempts Most Drugs from New Labeling Rules

The Food and Drug Administration trotted out its long-awaited new labeling rules today, and, as expected, did a major favor for drug companies facing liability lawsuits while exempting drugs older than five years from its requirements.

The purpose of the new labeling rule, the first major revision in 25 years of the package inserts given with all drug prescriptions, is to provide physicians and consumers with clear and concise information about the uses, side effects and potential dangers of FDA-approved medicines. FDA deputy director Janet Woodcock said the old package inserts containing scientific gobbledegook that most patients immediately throw in the garbage will soon be replaced with printed inserts whose information will be as easily read as the nutrition labels on food. The labels will also be posted on the web at a new website.

Sounds good. But the problem is that there was nothing in the new regulation that required drug companies with products over five years old from complying with the new rule. Since the drug industry's output of new drugs has been rather low of late, the vast majority of drugs in widespread use will not be covered by the new rule.

Moreover, one physician on a "stakeholders" conference call pointed out that many labels on older drugs -- he gave the example of HIV/AIDS drugs approved before the development of triple-cocktail therapy -- contain outdated information about the best uses of the drug, even if the label isn't technically incorrect. "If there is new information that causes the label to be false or misleading, then it should be revised," said Rachel Behrman, deputy director of the Office of Medical Policy at FDA. "But there is nothing in the rule requiring it."

Meanwhile, as the Wall Street Journal reported last Friday, the preamble of the rule contained a clause that said states cannot pass labeling rules that demand companies print more information than the FDA requires. Many product liability lawsuits against drug companies rest on the claim that the company failed to warn about hazards because they failed to comply with state labeling statutes.

One Washington law firm described the federal preemption language in the new rule as "not only an end-run around current law but also a broad extension of the Bush administration's effort to push for tort reform with respect to product liability. This initiative puts to rest any doubts that FDA decision-making has become politicized," said Ira Loss and Beth Steindecker, attorneys at Washington Analysis.

When questioned by reporters, deputy director Scott Gottlieb, the Bush administration's second highest ranking political appointee at the agency, tried to downplay this gift to the drug companies. "This is just a rearticulation of a policy that the FDA has filed in various amicus briefs over two administrations," he said.

It's true that Big Pharma has exerted extraordinary control over the FDA legal counsel office in the past decade. One of former Vice President Al Gore's top advisers hailed from Genentech, a leading biotech firm.

However, this drug industry influence over legal affairs at the agency skyrocketed during the first Bush term when former industry lawyer Dan Troy assumed the top lawyer job at the agency. He is now back at his old firm representing industry clients.

The revised labeling rule was initially proposed in 2000 during the waning days of the Clinton administration. That version did not contain the preemption language.

New Scientist: Hwang Could Keep Patents

Korea's stem cell program may have lost its brightest star to fraud, but his intellectual property claims may live on. According to an investigative report just released by the New Scientist, Hwang Woo-Suk can still win patents on cloning human embryos for therapeutic purposes despite the fact the research behind those claims was made up.

Hwang and his Korean colleagues filed a patent claim with the World Intellectual Property Office that would cover more than 100 countries. It's unclear if anyone has filed in the U.S. But the Korean press has reported that University of Pittsburgh researcher Gerald Schatten, who co-authored the paper in Science where Hwang unveiled his invention, has claimed at least partial ownership of the Korean scientist's patent. The university, which has not commented on Schatten's patent claims, is investigating its star stem cell researcher.

Officials at the British patent house explained the rationale behind granting patents on technologies that haven't been proven. "“European patent examiners are not interested in whether something will work or not. The commercial world, which is where patents belong, will judge. As long as an invention is not clearly contrary to scientific laws – like time travel – research has no bearing on the grant of a patent,” Lawrence Smith-Higgens told the New Scientist.

Under international harmonization treaties, the same would be true at the U.S. Patent and Trademark Office.

What's Really Wrong With The New Medicare Drug Plan

IN ROLLING OUT ITS flawed Medicare drug benefit over the past two weeks, the Bush administration once again revealed how its incompetence and its philosophical contempt for government go hand in hand. Nearly a dozen states had to rush emergency assistance to low-income seniors threatened with being cut off from life-preserving medicines. Mark McClellan, the director of the Center for Medicare and Medicaid Services, mouthed platitudes about working day and night to get their switchover between plans right. Can “you’re a heck of a man, Mackie” be far behind?

But this short-term hiccup in drug program’s start-up is masking far deeper flaws in the bill that was rushed through Congress in late 2003. It did nothing to limit the drug industry’s ability to sell over-priced me-too drugs to unwary seniors or their insurers. And it actually forbade Medicare from negotiating prices, which every advanced industrial country in the world – not to mention the Veterans Administration, the Pentagon and large insurers do here.

The bottom line is that a program that could have provided real help for seniors at moderate cost to the taxpayers became a price support program that does almost nothing to rein in the industry’s worst marketing excesses.

The Senate Finance Committee highlighted one aspect of those excesses last week when Senators Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.) launched an investigation into the drug industry’s use of tax-deductible educational grants to promote off-label drug use. The committee sent off subpoenas to the industry’s 23 largest drug firms after exposing at least one case – Johnson & Johnson’s anti-acid Propulsid, which was withdrawn from the market in 2000 because it caused heart arrhythmias – where the firm’s marketing department used the grants to create a phony patient advocacy group and buy off influential physicians to push the drug on children.

The committee’s investigators shouldn’t stop there. Educational grants ($1.5 billion in 2004) make up a tiny fraction of the industry’s total marketing expenses, which are heavily focused on pushing the off-label use of drugs. To gain insight into the extent of those practices, the committee staffers might want to take a look at a whistle-blower lawsuit that was unsealed in a Maine courtroom last week.

The suit was filed by Paul McDermott, a former drug salesman for Genentech, Inc. While the focus of his complaint was Rituxan, an anti-cancer drug heavily promoted for use with rheumatoid arthritis patients by its co-sponsors, Genentech and Biogen-Idec, its explosive charges are an indictment of the drug industry’s entire system for reaching out to physicians to promote the off-label use of drugs. The suit called the system an illegal kickback scheme aimed at defrauding Medicare.

Here’s how it works. According to the complaint, Genentech and Biogen-Idec identified key opinion leaders among rheumatologists and signed them up as consultants. The drug reps then set up a series of “rheumatoid arthritis roundtable dinners” at fancy steak houses in many major cities (Morton’s and Ruth Chris got most of the business). The key opinion leaders were flown in and paid $2,000 to $2,500 to give presentations on the off-label use of the drug.

Don’t forget: It’s illegal for a drug company itself to promote the off-label use of a drug. But if a company outsider (the “consultant”) at a continuing medical education seminar or at a fancy dinner presents the information, then the company can pretend its hands are clean. In the words of the complaint, “materials promoting Rituxan for off-label treatment of rheumatoid arthritis are more fully accepted and integrated into physicians’ personal belief systems when they are presented as educational in nature in contrast to material that is clearly identified as promotional.”

The suit gave examples of physicians who refused to participate after learning they couldn’t change the slides or materials conveniently prepared by Genentech and Biogen sales reps.

The suit also alleged that Genentech marketers identified key journals where articles promoting the off-label use of Rituxan should appear, encouraged its consultants to write articles that would appear in those journals, and, in some cases, wrote the articles for the consultants. Not surprisingly, the off-label use of Rituxan for arthristis, which costs about $15,000 per treatment, has soared in recent years. Since most rheumatoid arthritis sufferers are seniors, Medicare picks up the tab.

McDermott was eventually fired after asking for a transfer. Genentech and Biogen are contesting the charges. Though the case was brought under the Civil War era False Claims Act, which returns two-thirds of any recovery to the government, the Bush administration’s Justice Department last week refused to intervene in the case.

Jerome Kassirer’s book, “On the Take,” documents how buying off key opinion leaders, using them at fancy dinners, seeding the medical literature with thinly disguised promotional studies, and creating a phony continuing medical education industry are now common practices in many medical specialties. The Genentech-Biogen Rituxan case provides a textbook example of how the system works.

Does it amount to an illegal kickback scheme? The Senate Finance Committee investigation should be expanded to include the full range of abusive marketing practices that are corrupting the medical profession. It may take new laws to rein them in.

Has Schatten Revealed All?

University of Pittsburgh stem cell researcher Gerald Schatten played a larger role in authoring the bogus Korean stem cell paper than previously revealed, according to the today's Pittsburgh Tribune-Review. Schatten helped Hwang Woo-Suk and his Korean colleagues respond to peer reviewers' questions about the 2004 paper that announced the initial breakthrough in human cloning. Schatten's name didn't appear on that paper.

But he co-authored and served "as an adviser to help analyze, interpret and write up the results for the 2005 Science paper," which announced a huge breakthrough in the technology's efficiency to worldwide acclaim. Schatten had previously said he served only as a conduit to getting the paper published in the prestigious journal, which is published by the American Association for the Advancement of Science.

Today I took another look at the latter paper as well as the brief communication that appeared in Nature last August announcing the cloning of Snuppy the Afghan hound (Schatten and Hwang were co-authors on that paper as well). I discovered something interesting: neither Schatten nor Hwang declared any financial conflicts of interest even though both scientists had applied for patents on related technologies.

Schatten's failure to disclose a U.S. patent application he filed in April 2003 appears to be a clear violation of Nature's policy. The patent is titled "Methods for producing transgenic animals." The Nature article is headlined "Dogs cloned from adult somatic cells." The Nature conflict of interest disclosure policy states that authors must disclose "patents or patent applications whose value may be affected by publication."

It's less clear whether Schatten's failure to disclose his patent applications in Science represented a violation of that journal's policy, which states the author should disclose "a planned, pending, or awarded patent on this (emphasis added) work." Schatten's other pending patent application involves "methods for correcting mitotic spindle defects associated with somatic cell nuclear transfer (SCNT) in animals" including humans. This might prove useful to SCNT some day, but it isn't SCNT itself. Under the Nature policy, this would have to have been disclosed.

Based on statements he made at press conferences last year and his patent applications on file at the World Intellectual Property Organization, Hwang clearly violated both journal's conflict of interest disclosure policies. The latest press reports out of Korea suggest Hwang may be under criminal investigation for the scientific fraud that went on in his lab.

Earlier this week, Science editor Donald Kennedy pledged to overhaul the journal's scientific review policies in the wake of the stem cell scandal. "We are doing a systematic review of the editorial history of both papers and our procedures for evaluating them, to search for ways in which we might improve those," he said in a prepared statement. "I have pointed out in the past that even unusually rigorous peer review of the kind we undertook in this case may fail to detect cases of well-constructed fraud."

Just as the tightest peer review can't catch deliberate fraud, a conflict of interest disclosure policy without teeth is no policy at all. Science should tighten its conflict-of-interest disclosure policy to require authors divulge all relevant conflicts, not just the ones directly related to the paper at hand. It should also publish them all alongside the paper. And it should put authors on notice that if they fail to disclose those conflicts -- as appears to have happened in this case -- it will result in their being banned from publishing within the journal's pages for, say, at least three years.

As we've seen in this case, a policy without meaningful sanctions for violators is no policy at all.

Pombo's Assault on Endangered Species

The Union of Concerned Scientists has put out an emergency alert to rally scientists to oppose a recently passed House bill that would gut the Endangered Species Act. There's a high likelihood that the Senate will pass some kind of measure, according to UCS. So as action shifts now to the Senate, they are hoping to put pressure on key Senators like Lincoln Chafee (R-R.I.) to stave off what could be the most significant environmental rollback of the Bush era.

House Bill 3824 was sponsored by Rep. Richard Pombo, a Republican from California who, according to a League of Conservation Voters official, "tops the list of history's most ruthless environmental bad boys." There isn't a part of the country that he doesn't want to drill, mine or develop, he said. (For a good backgrounder on Pombo, see today's Grist (an online Magazine), where an outstanding young journalist named Amanda Griscom Little plies her trade.

Pombo's bill, according to a National Wildlife Federation analysis, would remove protection for habitats that species need for survival and recovery. It also would undermine the scientific underpinnings of the act, according to UCS, by allowing political appointees rather than scientists to decide what is the best science available. The implications for other science-based laws -- think clean air, clean water, safe food, safe drugs, etc. etc. -- is truly frightening.

UCS is asking environmental scientists to sign a protest letter that it plans to distribute to all Senators in early February. Interested readers can learn more about how to stop this pernicious legislation here.

Stem Cell Patent Dispute Heats Up

The Korean stem cell research scandal isn’t over yet.

University of Pittsburgh stem cell researcher Gerald Schatten, who co-authored the fraudulent Korean stem cell paper withdrawn last week from Science magazine, filed for a U.S. patent on the technology in mid-2004 without crediting his Korean collaborators, according to a press report out of Pittsburgh over the weekend. Moreover, disgraced Korean stem cell researcher Hwang Woo-Suk did the same thing a few months later, filing for an international patent without mentioning his U.S. co-author.

This latest turn of events in the still unfolding drama suggests Schatten may have had motives beyond ethical concerns when he blew the whistle on how Hwang procured eggs for his embryonic stem cell experiments. Schatten publicly broke with Hwang in mid-November after claiming he’d just learned that Hwang coerced female lab associates to provide eggs. A month later, Hwang’s government-funded science empire collapsed when it was revealed he doctored his results.

But as the press scrambled to cover the emerging scandal, the influential JoongAng Daily in both its Korean and English language editions reported that Schatten had quietly met in San Francisco with Hwang and his lawyer more than a month before the highly-publicized break. At that meeting, which coincided with a California Institute for Regenerative Medicine scientific meeting that Schatten attended, the U.S. researcher demanded a 50 percent share of the Korean patent, which Hwang rejected, according to the report. No U.S. paper has followed up on the story.

Ownership disputes over key stem cell patents have been simmering since the field emerged in the late 1990s. The University of Wisconsin, whose researcher James Thomson used Geron Corp. funding to isolate the first embryonic stem cell lines, charges $100,000 to commercial concerns and $5,000 to academics for access to those lines. It also granted Geron exclusive rights to pursue therapies in the most promising fields. Last May, San Diego-based stem cell researcher Jeanne Loring told Nature magazine her start-up firm collapsed because it couldn’t get access to the Wisconsin patents at reasonable rates.

That was about the time that Hwang announced his alleged breakthrough, which would allow production of individualized embryonic stem cells using far fewer eggs than previous technologies. The state-supported scientist claimed the technology belonged to the Korean government, but at the same time said it would be made readily available to researchers worldwide. “I want to be remembered in history as a pure scientist,” he told the New York Times. “I want this technology applied to the whole of mankind.”

He stuck to his guns after his fraud was exposed. During his December 23rd resignation press conference, Hwang insisted that though the current experiment was tainted, he was still the inventor of the method for generating genetically matched embryonic stem cells, which is likely to become a core technology for an entire industry should stem cells prove therapeutically useful. “Technology for patient-specific embryonic stem cells belongs to South Korea,” he said. “And you will find out that this is true.”

The method involved is known as somatic cell nuclear transfer, a polite way of saying human cloning. Under SCNT, lab workers take a person’s DNA, insert it in donated eggs denuded of their own DNA, and grow the cloned human cells long enough to generate stem cells that genetically match the original DNA donor. The technology will be key to developing personalized cell lines – which should reduce tissue rejection rates – and could be incorporated into a wide range of diagnostic tests.

The Schatten U.S. patent application was filed April 9, 2004, about six months before the two scientists published their first paper together (the May Science paper was their second). It describes a method of cloning humans and using the resulting stem cells in treating “cardiovascular disease, neurological disease, reproductive disorder, cancer, eye disease, endocrine disorder, pulmonary disease, metabolic disorder, autoimmune disorder, and aging.”

Though the patent application contains a “government rights” clause because Schatten’s funding came from the National Institutes of Health, there was no assignee listed on the application. Government-funded research patents are typically assigned to the university or institution where the researcher works. Numerous patent applications in the Patent and Trademark Office’s database list assignees, even though the patent hasn’t yet been granted.

The University of Pittsburgh, which has its own investigation underway, has so far refused to answer questions about the Schatten patent application.

How Now Mad Cow

When does a corporation want more regulation? Apparently when its ox is being improperly gored.

McDonald's Corp. this week complained to the Food and Drug Administration that the government wasn't taking strong enough measures to keep contaminated meat from entering the food supply. Their concern, of course, is mad cow disease. The nation's biggest burger chain fears that people will flee its restaurants in droves if new cases of bovine spongiform encephalopathy (BSE or mad cow disease) show up in the U.S.

The U.S. has found two cases of mad cow disease, one in 2003 in Washington state and one in Texas. Unlike the Washington case, which was found in a cow imported from Canada, the Texas case involved a native born cow who probably ingested the bug that causes BSE in its food, which may have contained the remains of stricken cows.

Responding largely to pressure from importers of U.S. beef, the FDA announced a new program to test cows for BSE two months ago. Leading farm state senators and public interest groups immediately attacked the measures as woefully inadequate.

Critics say much higher testing levels than those proposed by the FDA are needed to reassure Japan and other trading partners. "I've said time and time again, there is little risk of BSE in U.S. beef, but it is obvious that we have not yet convinced key trading partners of that," Iowa Sen. Tom Harkin, senior Democrat on the Senate Agriculture Committee, told the Associated Press last November. Harkin wants the Agriculture Department to perform at least 20,000 more tests on healthy cows. That would still leave the vast majority of the U.S. beef supply untested.

Public interest critics are pushing the FDA to ban entirely the use of dead cattle, restaurant wastes and any tissues that contain nerve tissues, eyes or intestines in animal feed. Without specifying specific measures, McDonald's agreed that the agency should adopt measures that will reduce the risk of BSE-tainted beef to "nearly zero."

Had to Search to Find It

Only USA Today among the four big papers I read daily carried a bylined story about the new studies showing statins are ineffective against cancer. The New York Times, Washington Post and Wall Street Journal carried briefs based on an Associated Press story.

Never Mind

"Statin drugs may lower the risk of colon cancer," shouted headlines in most major newspapers last May. That same month at least three studies unveiled at the annual meeting of the American Society of Clinical Oncology suggested taking cholesterol-lowering statins, which are primarily aimed at curbing heart disease, might also reduce the incidence of breast, prostate and lung cancers.

It will be interesting to see how much play the bad news gets. In the latest edition of the Journal of the American Medical Association, scientists at the University of Connecticut report a pooled analysis of 26 clinical trials involving over 86,000 people taking statins. Their conclusion? "We found that no type of cancer was affected by statin use and no subtype of statin affected the risk of cancer."

Hmmm. I wonder who funded the earlier studies. The UConn docs reported no ties to drug manufacturers.

My Top Ten Predictions for 2006

What does 2006 hold in store? Why do journalists and journalist-wannabes engage in this timless exercise in post-New Year frivolity?

Because they can. So here’s my top 10 predictions for what to expect in the year ahead:

1. The Justice Department will vigorously pursue the Bush administration’s investigation into who leaked information about its domestic wiretap program to New York Times reporter James Risen. Risen will go to jail to protect his sources, where he will have plenty of time to celebrate his book’s rise to number one status on the best-seller list.

2. The economy, already signaling a recession in the waning days of 2005 (housing slowdown; inverted yield curve), will slow dramatically by mid-year with at least one quarter where Gross Domestic Product declines from the previous quarter.

3. The mainstream press will relegate the economic story to the business section where free market apologists will engage in a largely meaningless debate about whether it is a recession or just the “pause that refreshes.” Meanwhile, millions of Americans will endure real economic hardship.

4. The Bush administration’s next tax cut for the rich will be dead on arrival as Republican fiscal conservatives finally bail on the president. Unfortunately, alternative minimum tax reform, which will hit millions of upper middle class families, also goes nowhere. Bad timing. Paul Krugman and E.J. Dionne will be lonely voices pointing out that tax cuts for the working poor and middle class are precisely what’s needed to counteract the downturn.

5. Health care affordability will emerge as the number two domestic issue (after the economy) in the 2006 Congressional elections, driven in large part by employers desperately seeking a way to cut costs as their profits evaporate in the face of a slowdown.

6. Democratic centrists led by Rep. Rahm Emanuel of Illinois will seize control of the Democratic Party after a handful of liberal Congressional candidates who challenged war-hawk Democrats in primaries are easily defeated. The low-intensity war in Iraq grinds on with no end in sight.

7. Emanuel, touted as the next Speaker of the House, will banish talk of “Medicare for all” (a single-payer system) to solve the health care crisis. Instead, he champions a managed competition plan to prove once and for all that Hillary-care had it right and make Sen. Clinton the undisputed frontrunner for the 2008 Democratic nomination.

8. The Democratic Party will win back the Senate by a narrow 50-49-1 margin by picking up Republican seats in Pennsylvania, Ohio, Montana, and, in a shocker, Arizona. Sen. Lincoln Chafee will win in Rhode Island but switch parties.

9. Acting Food and Drug Administration Commissioner and Bush family friend Andrew von Eschenbach, a cancer surgeon who also runs the National Cancer Institute, will resign after exhibiting a woeful ignorance about specific cancer chemotherapy agents during a Congressional hearing where he is asked to explain his belief that the pain and suffering of cancer will be ended by 2015.

10. In December, the House of Representatives will hold a special session to consider impeaching President Bush after a bloc of Republicans joins a united Democratic Party in calling for a halt to the administration’s illegal torture and domestic wiretap programs.

You see, in some things at least, I’m an optimist. Happy New Year!