Those Cloning Koreans

The South Koreans have not only leapt ahead of U.S. scientists in stem cell technology, they're pioneering in how to make that technology affordable.

New York Times reporter James Brooke chased down Dr. Woo Suk Hwang, the South Korean researcher who last week announced a major advance in mass producing stem cells for medical research. While the jury is still out on whether using stem cell colonies to regenerate exhausted or damaged tissues like brain cells or spinal cords will work, Dr. Hwang's advance will expedite experimentation.

Though the right-to-life crowd has limited federal involvement in this promising technology, states are beginning to invest big bucks. California's $3 billion has garnered the most publicity, but New Jersey also recently passed a stem cell initiative; the Massachusetts legislature will probably override its Republican governor's veto; New York is contemplating a major program as are a number of other states who don't want to be left off the next big biotech bonanza.

Using taxpayer money to fund medical research is nothing new, even at the state level. Before the creation of the National Cancer Institute in 1937 (the first National Institute of Health with many more to follow after World War II), state public health departments were major founts of medical innovation.

Now that states are getting back into the game big time, they should read today's story on the South Korean advance to its end. When asked about his financial interest in the breakthrough announced last week, Dr. Hwang called his work "holy, pure and genuine in trying to develop therapeutic technology to cure hard to treat diseases." He said patents on the invention would go to the South Korean government. "I want to be remembered in history as a pure scientist," he said. "I want this technology applied to the whole of mankind."

Had he been in the U.S., he would have patented it, started a biotechnology firm, sold the rights to the technology at the highest possible price, and demanded property rights to any subsequent inventions made with the use of his technology -- so-called "reach through" patents.

As they move to set up the rules for their programs, the states could learn a few things about protecting taxpayers (who finance all this research) from this wise South Korean scientist.

Industry Gags Academic Medicine

Public outrage over the dangers of using antidepressants in children and Merck's Vioxx was stoked by the fact that the drug companies suppressed the results of clinical trials signaling those problems. With the drug and biotechnology industries now sponsoring almost 70 percent of all clinical trials, these flagrant abuses raise the broader question: Has the industry takeover of clinical testing of new drugs systematically undermined traditional academic values like freedom to publish, freedom to share results and intellectual honesty?

Apparently it has. According to a new survey published in this week's New England Journal of Medicine (subscription required), fully half of all university medical center administrators allow industry sponsors to draft the initial manuscripts that describe the results of clinical trials conducted by their faculty.

And while 85 percent of administrators wouldn't approve contracts that allowed industry to revise the final manuscript or decide whether or not the results got published, 41 percent thought it was okay to prohibit sharing the data. Moreover, a large majority signed agreements pledging secrecy as long as six months after the trial was completed.

An accompanying perspective article, "Gag Clauses in Clinical-Trial Agreements," highlights the need for the Fair Access to Clinical Trials Act, which is sponsored by Senators Chuck Grassley (R-Iowa) and Christopher Dodd (D-Connecticut). The proposed law would ban clinical trial research contracts that limit or unreasonably delay the publication of clinical trial results or their discussion at scientific meetings.

Author Robert Steinbrook holds out little hope for medical schools voluntarily adopting stricter guidelines. Competition for industry support -- which is increasingly going overseas or to private contract research organizations -- will make it very difficult for them to enforce voluntary guidelines, he writes.

Stem Cell Secrecy

The California stem cell program is off to a rocky start. The board of the new California Institute for Regenerative Medicine (CIRM), which will spend $3 billion over the next ten years on research, is not interested in having the taxpayers look over their shoulders. Nor, it would appear, are they interested in complying with the state's conflict of interest laws.

According to a report in today's Los Angeles Times, the board yesterday unanimously voted to condemn a proposed constitutional amendment that would require that all its funding decisions be subject to the state's open meetings and conflict of interest laws. The architects of last fall's Proposition 71, which created CIRM, inserted language in the ballot initiative that not only exempted the new agency from public oversight, but required a constitutional amendment to change the exemption.

Needless to say, this didn't sit well with many politicians, including a number of liberal Democrats who are avid backers of stem cell research. Even though the CIRM board promised to conduct all its major meetings in public, the legislature is moving to put a constitutional amendment on California's November ballot that would guarantee that CIRM operate in public and comply with conflict of interest laws.

The CIRM board, led by Stanford Nobel laureate Paul Berg and CalTech president David Baltimore, read the amendment to mean that peer-review meetings that make research funding decisions would have to operate in public. No science agency, including the National Institutes of Health, does that now. "Peer review," Berg said, "can't happen in a public meeting."

Baltimore told the press after yesterday's meeting: "We needed to send a shot across the bow of the legislature."

State Sen. Deborah Ortiz, a Democrat from Sacramento and a primary architect of the amendment, fired back that CIRM was deliberately misconstruing the amendment's intent. "We have made it very clear that we want to maintain the integrity of peer review, but at the same time assure the public that once a decision is made to fund one proposal, that they be required to justify how this particular proposal will benefit California."

Peer review may be a smokescreen. The CIRM board is larded with biotech industry patent lawyers and academic entrepreneurs. If their firms get research grants, it may run afoul of the state's conflict of interest laws. From their perspective, that's something better left in the dark.

Medical Journal Editors Issue No Registration-No Publication Rules

The world's leading medical journals today issued new rules for the public registration of clinical trials. The guidelines stripped away some trade secrets loopholes that companies have used in the past when registering clinical trials. But they left at least one major exception that ought to be reversed.

Last September, the editors of the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet and ten other leading journals declared that any trial started after July 1, 2005 must be registered in a publicly available database before the trial begins. If it wasn't registered, the editors said, the final results wouldn't get published no matter how significant the findings.

Why the crackdown? There have been a number of high profile incidents where companies hid critical clinical trial data from the public and regulators. The issue came to a head during last year's debate over anti-depressants and suicidality in children, which led New York Attorney General Eliot Spitzer to file suit against Pfizer for hiding data about Paxil.

Under the new rules (for a copy, click here), companies, academic institutions and the government will have to pre-register a trial's funding sources, the names of all the researchers, its ethical board seal of approval, as well as the details of the trial, from who will be enrolled to what will be measured. The joint editorial accompanying the guidelines pointed out that some trials registered recently in the government database have masked the drug's name or left out key points -- like what the researchers were hoping to find.

"The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every clnical trial whose principal aim is to shape medical decision-making," the editorial stated. "We will do what we can to help reach this goal."

Unfortunately, the guidelines gave industry a pass on registering first stage clinical trials -- where investigational new drugs are tested for safety. Te rules also gave a pass to some second-stage trials, where the drugs are tested for initial clinical effectiveness. Editors will judge publication of such trials on a case by case basis.

Why the exception? The editors bought into industry's defense for its secretive behavior in these early trials by suggesting that public notification "might slow the forces that drive innovation."

I can think of two reasons why this isn't so. First, good science requires collaboration and the sharing of information. If early stage trials that fail are made public, other scientists will learn what paths are not worth pursuing. Failed safety trials have a lot to teach other researchers about the possible pitfalls in a new drug class. Getting this information out early-on will save the collective biomedical research enterprise -- whether industry or government-funded -- time and money in the long run.

Moreover, while it is true that early public notification will tip a company's hand to other players in the field, is that something to be afraid of? If it spurs on competition, won't we get to those miracle cures even faster? Or are the editors suggesting that competition is bad for innovation? Only a monopolist thinks like that.

New Study Calculates the Economic Costs of Mercury Pollution

It was one of those small blips, duly noted and immediately forgotten by the mainstream press. Eleven states sued the Bush administration this week for failing to protect their citizens from the damage caused by mercury emitted from power plants.

The new mercury rules, enacted by the Environmental Protection Agency earlier this year, slowed the pace of mercury reduction (levels were steadily reduced during the Clinton years) and gave coal-burning power plants an additional decade to meet the health standards on mercury and other toxic emissions set in 1990. They also instituted a controversial trading scheme that would, in essence, shift pollution around without getting rid of it.

Environmentalists argue that this will leave many areas of the country with “hot spots,” a troubling prospect if one of the hot spots happens to be where your kids are growing up. About 70 percent of the mercury in the environment comes from coal-fired power plants, chloralkali production, waste incineration and other industrial activities. Once airborne, it travels long distances before landing in soil and water and entering the food chain. It reaches very high concentrations in predatory fish like swordfish and tuna. A potent neurotoxin (this was first learned in the 1950s when mercury-exposed Japanese mothers at Minimata had severely deformed and retarded children), mercury imposes its harshest penalties on developing fetuses and infants – the years before the blood-brain barrier is completely formed.

But instead of moving rapidly to control this known hazard, the utility industry has dragged its feet for years. Now, a new study from the Center for Children’s Health and the Environment at the Mt. Sinai School of Medicine in New York has calculated the price our society is paying for this short-term boost in utility company profitability.

According to Leonardo Trasande and colleagues, anywhere from 316,000 to 637,000 children have cord blood mercury levels above the levels associated with a loss in IQ. The authors calculated that this neurological damage costs society anywhere from $2.2 billion to $43.8 billion a year in lost economic activity, largely through lost productivity.

Unfortunately, the EPA didn't take these costs into account when calculating the potential benefits of its new rule. In fact, it deliberately ignored its own study showing a much higher benefit from stricter controls. According to the Bush administration's EPA, your brain-damaged kids are your problem or the school system's problem, not the companies' problem.

This latest study on the health effects of mercury pollution was funded by the National Institute of Environmental Health Sciences, and Physicians for Social Responsibility and two environmentalist foundations. It can be found at http://ehp.niehs.nih.gov/members/2005/7743/7743.html.

"Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies"

Richard Smith, the long-time editor of the British Medical Journal, yesterday issued a scathing attack on the practices of the world's leading medical journals. Significantly, he posted it on PLoS (Public Library of Science), the open-access journal of medicine.

Smith says that drug industry advertising and reprint purchases, the mainstays of journal revenues and profits, are a far less corrupting influence than the studies that appear within the journals' pages themselves. Citing a number of studies that correlate the outcomes of randomized controlled clinical trials -- the gold standard of medical research -- to the self-interest of their funding source, he says "The evidence is strong that companies are getting the results they want, and this is especially worrisome because between two-thirds and three-quarters of the trials published in the major journals—Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine—are funded by the industry."

He goes over all the tricks that researchers can pull to make clinical trial results come out the way their sponsors would like. He calls for more public funding of drugs, especially for tests that compare new drugs to existing therapies (the major reform called for in my book). After lamenting the inability of peer review to catch the tricks, he concludes by saying that "instead of publishing trials, journals could concentrate on critically describing them."

That's a great idea. Moreover, this critic should be someone whose findings can be read by the lay public, a sort of Roger Ebert at each medical journal. If nothing else, it would liven up the prose.

To read the entire article, click through . . .

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies
Richard Smith

Richard Smith is Chief Executive of UnitedHealth Europe, London, United Kingdom. E-mail: richardswsmith@yahoo.co.uk

Competing Interests: RS was an editor for the BMJ for 25 years. For the last 13 of those years, he was the editor and chief executive of the BMJ Publishing Group, responsible for the profits of not only the BMJ but of the whole group, which published some 25 other journals. He stepped down in July 2004. He is now a member of the board of the Public Library of Science, a position for which he is not paid.

Copyright: © 2005 Richard Smith. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Citation: Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138

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“Journals have devolved into information laundering operations for the pharmaceutical industry”, wrote Richard Horton, editor of the Lancet, in March 2004 [1]. In the same year, Marcia Angell, former editor of the New England Journal of Medicine, lambasted the industry for becoming “primarily a marketing machine” and co-opting “every institution that might stand in its way” [2]. Medical journals were conspicuously absent from her list of co-opted institutions, but she and Horton are not the only editors who have become increasingly queasy about the power and influence of the industry. Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians [3], and the editors of PLoS Medicine have declared that they will not become “part of the cycle of dependency…between journals and the pharmaceutical industry” [4]. Something is clearly up.

The Problem: Less to Do with Advertising, More to Do with Sponsored Trials
The most conspicuous example of medical journals' dependence on the pharmaceutical industry is the substantial income from advertising, but this is, I suggest, the least corrupting form of dependence. The advertisements may often be misleading [5,6] and the profits worth millions, but the advertisements are there for all to see and criticise. Doctors may not be as uninfluenced by the advertisements as they would like to believe, but in every sphere, the public is used to discounting the claims of advertisers.

The much bigger problem lies with the original studies, particularly the clinical trials, published by journals. Far from discounting these, readers see randomised controlled trials as one of the highest forms of evidence. A large trial published in a major journal has the journal's stamp of approval (unlike the advertising), will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favourable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution. The doctors receiving the reprints may not read them, but they will be impressed by the name of the journal from which they come. The quality of the journal will bless the quality of the drug.

Fortunately from the point of view of the companies funding these trials—but unfortunately for the credibility of the journals who publish them—these trials rarely produce results that are unfavourable to the companies' products [7,8]. Paula Rochon and others examined in 1994 all the trials funded by manufacturers of nonsteroidal anti-inflammatory drugs for arthritis that they could find [7]. They found 56 trials, and not one of the published trials presented results that were unfavourable to the company that sponsored the trial. Every trial showed the company's drug to be as good as or better than the comparison treatment.

By 2003 it was possible to do a systematic review of 30 studies comparing the outcomes of studies funded by the pharmaceutical industry with those of studies funded from other sources [8]. Some 16 of the studies looked at clinical trials or meta-analyses, and 13 had outcomes favourable to the sponsoring companies. Overall, studies funded by a company were four times more likely to have results favourable to the company than studies funded from other sources. In the case of the five studies that looked at economic evaluations, the results were favourable to the sponsoring company in every case.

The evidence is strong that companies are getting the results they want, and this is especially worrisome because between two-thirds and three-quarters of the trials published in the major journals—Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine—are funded by the industry [9]. For the BMJ, it's only one-third—partly, perhaps, because the journal has less influence than the others in North America, which is responsible for half of all the revenue of drug companies, and partly because the journal publishes more cluster-randomised trials (which are usually not drug trials) [9].

Why Do Pharmaceutical Companies Get the Results They Want?
Why are pharmaceutical companies getting the results they want? Why are the peer-review systems of journals not noticing what seem to be biased results? The systematic review of 2003 looked at the technical quality of the studies funded by the industry and found that it was as good—and often better—than that of studies funded by others [8]. This is not surprising as the companies have huge resources and are very familiar with conducting trials to the highest standards.

The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the “right” questions—and there are many ways to do this [10]. Some of the methods for achieving favourable results are listed in the Sidebar, but there are many ways to hugely increase the chance of producing favourable results, and there are many hired guns who will think up new ways and stay one jump ahead of peer reviewers.

Then, various publishing strategies are available to ensure maximum exposure of positive results. Companies have resorted to trying to suppress negative studies [11,12], but this is a crude strategy—and one that should rarely be necessary if the company is asking the “right” questions. A much better strategy is to publish positive results more than once, often in supplements to journals, which are highly profitable to the publishers and shown to be of dubious quality [13,14]. Companies will usually conduct multicentre trials, and there is huge scope for publishing different results from different centres at different times in different journals. It's also possible to combine the results from different centres in multiple combinations.

These strategies have been exposed in the cases of risperidone [15] and odansetron [16], but it's a huge amount of work to discover how many trials are truly independent and how many are simply the same results being published more than once. And usually it's impossible to tell from the published studies: it's necessary to go back to the authors and get data on individual patients.

Peer Review Doesn't Solve the Problem
Journal editors are becoming increasingly aware of how they are being manipulated and are fighting back [17,18], but I must confess that it took me almost a quarter of a century editing for the BMJ to wake up to what was happening. Editors work by considering the studies submitted to them. They ask the authors to send them any related studies, but editors have no other mechanism to know what other unpublished studies exist. It's hard even to know about related studies that are published, and it may be impossible to tell that studies are describing results from some of the same patients. Editors may thus be peer reviewing one piece of a gigantic and clever marketing jigsaw—and the piece they have is likely to be of high technical quality. It will probably pass peer review, a process that research has anyway shown to be an ineffective lottery prone to bias and abuse [19].

Furthermore, the editors are likely to favour randomised trials. Many journals publish few such trials and would like to publish more: they are, as I've said, a superior form of evidence. The trials are also likely to be clinically interesting. Other reasons for publishing are less worthy. Publishers know that pharmaceutical companies will often purchase thousands of dollars' worth of reprints, and the profit margin on reprints is likely to be 70%. Editors, too, know that publishing such studies is highly profitable, and editors are increasingly responsible for the budgets of their journals and for producing a profit for the owners. Many owners—including academic societies—depend on profits from their journals. An editor may thus face a frighteningly stark conflict of interest: publish a trial that will bring US$100 000 of profit or meet the end-of-year budget by firing an editor.

Journals Should Critique Trials, Not Publish Them
How might we prevent journals from being an extension of the marketing arm of pharmaceutical companies in publishing trials that favour their products? Editors can review protocols, insist on trials being registered, demand that the role of sponsors be made transparent, and decline to publish trials unless researchers control the decision to publish [17,18]. I doubt, however, that these steps will make much difference. Something more fundamental is needed.

Firstly, we need more public funding of trials, particularly of large head-to-head trials of all the treatments available for treating a condition. Secondly, journals should perhaps stop publishing trials. Instead, the protocols and results should be made available on regulated Web sites. Only such a radical step, I think, will stop journals from being beholden to companies. Instead of publishing trials, journals could concentrate on critically describing them.

NIEHS Gets Its New Director

Duke University's Dr. David Schwartz will join the National Institute for Environmental Health Sciences after all. A month ago, you may recall, Schwartz balked at taking the top job because of the National Institutes of Health's new conflict of interest rules, which forbid ownership in stocks of companies that may be affected by one's work.

NIEHS, based in North Carolina, is the agency that evaluates chemicals for their carcinogenicity and toxicity, among its other tasks. Virtually every company that manufactures anything is affected by its studies.

Did Schwartz get a special dispensation from the new rules? Has NIH gotten the nod from higher ups at the Health and Human Services department that it can repeal its most onerous restrictions -- the one that forbids stock ownership?

The press release is cryptic. NIH director Elias Zerhouni said, "I am pleased that we have been able to conclude his recruitment and address his concerns regarding the interim rules on stock divestitures."

Said Schwartz: "My concerns about the conflict of interest rules have been heard and are being seriously considered and addressed. I will work with Dr. Zerhouni and others at the NIH to ensure the careful handling of real conflicts of interests among our employees, while treating all of our employees reasonably and fairly."

Hopefully the morning press will shed more light on this situation. I know what I would have asked if I had been on the story.

Saving for Retirement When You Have Nothing to Save

The New York Times lead editorial this morning highlights a new study from the Retirement Security Project, whose luminaries include former Treasury Secretary Robert Rubin. Researchers collaborated with H&R Block in a controlled experiment to see how much of a tax refund a typical H&R Block client would put in an individual retirement account if given matching funds.

The results were disheartening. Only 17 percent of the group given the highest amount -- a 50 percent match -- put money in IRAs with their refunds and matching funds. That's better than the three percent in the "no match" group and 10 percent in the "20 percent match" group. But the bottom line is that more than four out of every five low- and moderate-income persons will not save for retirement, even when given a fairly generous match from either their employer or the government.

That just a small fraction participated in the program isn't surprising. Most people in the bottom half of the income distribution live from paycheck to paycheck. Most carry large credit card balances. Most of the medically uninsured fall into this group. And as Elizabeth Warren of Harvard University has pointed out, medical emergencies among the uninsured are a primary cause of the rising tide of bankruptcy in the U.S.

So when tax time rolls around and these steadily employed get an extra paycheck, they don't have the luxury of saving for retirement. They pay those bills that are mounting at an 18 percent annual rate on their credit cards. Or they pay off that hospital bill. From a financial planning standpoint, it's the absolutely right thing to do.

Unfortunately, neither the the Times editorial nor the authors of the original study pointed out these negative findings. They preferred to look on the bright side -- that some low- and moderate-income people will save in private retirement accounts if given matching grants.

The point is well taken. The government has a responsibility to target some of its generous incentives for retirement savings to our poorer citizens. Right now, the value of the tax breaks for IRA contributions is lower for the poor because they're in lower tax brackets. Moreover, the cost of such a program -- even with universal participation -- would be just a fraction of what President Bush handed out in tax cuts for the wealthy.

For over 40 percent of Americans, though, the only retirement program they have -- or are likely to have -- is Social Security. Encouraging these folks to save in retirement accounts outside the government program (liberal opponents of Social Security privatization call them "add-on accounts") is a great idea. But the lesson of this latest study is that unless the add-on accounts are mandatory with a very generous match, most low- and moderate-income folks will not sign on. They just have too many other demands on their money.

If Bioshield II was written without industry input, where did this come from?

Last week, Charles Ludlam of Sen. Joseph Lieberman's staff claimed that industry played no role in writing Bioshield II, which was introduced in the Senate last month. Under the bill, any new drug developed to fight a potential bioterror pathogen earns its developer an extension on any expiring patent.

If pharmaceutical and biotechnology companies played no role in writing the bill, how does one explain the specificity found in this provision, which was buried deep within the bowels of the bill:

"Not later than 180 days after the date of enactment of this Act,
the Director of the Centers for Disease Control and Prevention,
in consultation with the Assistant Secretary for Medical Readiness
and Response of the Department of Homeland Security and the Director
of the National Institute for Allergy and Infectious Disease of the National
Institutes of Health, shall submit a report to Congress that describes
alternatives to traditional vaccines and anti-viral therapeutics for viral
diseases, including negative immunomodulation compounds that partially
suppress a macrophage-dependent innate immune response of an
individual to viral pathogens, in order to decrease morbidity and mortality
from an excessive immune response."

Here's one possible explanation. One week after Lieberman, along with Orrin Hatch (R-UT) and Sam Brownback (R-KS) introduced the bill, GenoMed Inc. of St. Louis, a struggling start-up biotech firm, issued a press release applauding the measure.

"This language exactly describes GenoMed's patent-pending method to gently suppress the innate immune response in order to treat most viral diseases in the general population," Dr. Moskowitz, GenoMed's CEO and Chief Medical Officer, gushed. "If it's passed, the 'wild-card' patent feature of BioShield II could create a very interesting business opportunity for GenoMed. We may be in the position of having a number of 'wild-card' patents, perhaps one for each of the listed diseases in the bill which we could treat. A drug company interested in extending the patent life of any of its own blockbuster drugs might think about acquiring GenoMed just for the 'wild-card' patents we might own."

The $800 Million Pill Goes "Coast to Coast"

George Noory's "Coast to Coast" will be featuring yours truly late Wednesday night, or should I say early, early Thursday morning (2-5 a.m. on the East Coast). While the hour is ungodly, the reach is fantastic. The 500-plus stations that carry the syndicated talk show include WABC (770 AM) in New York, WMAL (630 AM) in Washington, WLS (890 AM) in Chicago where it comes on an hour earlier, and KFI (630 AM) in L.A. where my segment of the show starts at 11 p.m. Wednesday night. If you can't sleep, tune in!

Bioshaft

During World War II, the British researchers who discovered penicillin needed U.S. help to mass produce the miracle drug. FDR's aides assigned the task to researchers at a federal lab in Peoria, Illinois. Once the government scientists developed a mass fermentation technique, they turned the technology over to five firms, which rushed penicillin into production at generic prices as a war time emergency measure.

Times change. The U.S. is once again at war -- this time against an unseen, non-state global enemy who may or may not be developing bioterror weapons. There are several ways the government could respond to this amorphous threat. It could beef up the nation's public health infrastructure and response system. Or it could try to develop a therapeutic response -- tests, vaccines, drugs -- for every imaginable threat.

The Bush administration and Congress have opted for the latter. They give lip service to public health, of course. They ladeled out large grants to first responders like police and fire departments, which have stockpiled high tech gear like moon suits and decontamination tents. But these funds have been offset by cuts at the state level in personnel who would actually combat a bioterror attack.

David Ozonoff, a professor of public health at Boston University, told a Center for American Progress forum yesterday that three-and-a-half years after the anthrax attacks in New York and Washington, the nation's public health infrastructure is in shambles. Local clinics, health departments and emergency response units are short-handed, underfunded and ill-prepared for a disaster. Why? The routine tasks of these programs -- giving influenza vaccines, running substance abuse or maternal and child programs -- are being sharply cut back by cash-strapped states.

Meanwhile, the government is aggressively pursuing anti-bioterror agent research. The National Institute for Allergies and Infectious Disease is doling out more than $2 billion a year to study potential anti-bioterror agents. Last year, in a piece of legislation called Bioshield, the feds set aside $5 billion to purchase any products that come out of this research.

But apparently that wasn't enough. Sen. Joseph Lieberman (D-Conn.) is proposing a new round of incentives to encourage the pharmaceutical industry to take up the cause of developing drugs and vaccines for anthrax, botulism and tuliremia (deer tick fever), diseases which absent any bioterror attack affect fewer than a dozen people in the U.S. every year.

Lieberman's bill ignores the lessons of history. Cost-plus contracts have worked in the past for drug research. They work at the Pentagon, whose gear may be overpriced but no one would claim lack technological sophistication. Indeed, biotechnology companies are lining up for government grants under Bioshield.

But Lieberman, whose state is home to a number of major pharmaceutical facilities, wants to grant drug firms a patent extension on a best-selling drug for every new drug that fights a potential bioterror agent. In other words, drug firms would not only get to sell the new drug to the government stockpile at a profit, but they would get to levy a tax on the American people through higher prices on their old drugs.

Supporters of this so-called "Bioshield II" legislation claim patent extension bribery is the only way to get the drug industry involved in the war against bioterror. Imagine a politician making this claim during WWII. "They just won't make penicillin for the boys over in Europe unless we pay them five times the cost of making the drug!"

At yesterday's hearing, Lieberman's top aide for bioterror issues, Charles Ludlam, claimed he wrote the legislation without consulting anyone from the drug industry. "Industry will not participate if we go down the government road," he said.

If I were working for PhRMA (the industry trade group), I'd call Lieberman's office and ask them to stop slandering the industry's patriotism.

One Award I Wouldn't Want

Steven J. Milloy, publisher of JunkScience.com, uses his corporate-funded perch to attack scientists whose work offends tobacco companies, polluters, junk food peddlers and other corporate miscreants. He is an adjunct scholar at the Cato Institute and a featured voice on FoxNews.com. And now, much to the chagrin of the American Association for the Advancement of Science, he was a judge of their annual science journalism awards.

The AAAS, publisher of Science magazine and the pinnacle of the nation’s science establishment, apparently chose Milloy by pulling his name from a media guide. Yet even after learning of his Cato connections, the organization posted his quotes praising one of the winners on its website, according to Environmental Science & Technology (EST) magazine. When the EST reporter inquired why the prestigious science group had embraced the well-known corporate flack, who on a daily basis trashes things most of its members hold dear, the AAAS pulled down the quote.

Some other juicy tidbits in the EST article: Milloy in the late 1990s took money from ExxonMobil to debunk global warming and used it to dabble in Exxon’s stock (he lost money apparently). This year, he set up a booth at the National Association of Broadcasters trade show in Las Vegas to tout his latest for-profit venture – a consulting company that advises manufacturers about the “dangers looming in mandates by the EU and others which prohibit lead and other substances in products.”

Clean Technology on the March

General Motors and Ford are in deep trouble. Their bonds were relegated to junk status Friday. Sales of their big-profit SUVs are plummeting while environmentally-conscious consumers are increasingly turning to higher mileage cars produced – you guessed it – in Japan.

Things have gotten so bad that GM chief executive Rick Wagoner will soon travel to Toyota’s headquarters to “collaborate” on hybrid technology. As a practical matter, this means borrowing technology from the Japanese. A grateful quarter million Americans who still depend on GM and Ford for jobs will be glad to hear the Toyota CEO has agreed the Americans need “breathing room.”

I’m curious why the hard pressed U.S. car makers didn’t rip a page from the drug manufacturers’ playbook. If they had, they would double the price of their cars and run full page ads in the nation’s newspapers claiming that without high prices, Americans will never see the 70-miles-per-gallon vehicles that might put a dent in the greenhouse gas emissions that are contributing to global warming.

Smart companies see which way the wind is blowing. General Electric this morning ran a four-page supplement in the New York Times touting its wind technology. GE is one of the world’s largest builders of wind turbines for electricity production.

The company hopes to double its “clean technology” sales to $20 billion by 2010. The company plans to reduce its energy emissions by 1 percent over the next seven years and has committed itself to complying with a global cap on greenhouse gases – the Kyoto protocol that the Bush administration refuses to sign.

It’s becoming increasingly clear that the recent drift of U.S. political events is wildly out of whack with the rest of the world. Major corporations are realigning their own futures to coexist with our shrinking world.

This is a harbinger of political shifts to come. No matter how much one wishes this country were more democratic, the sad fact is that change only occurs in the U.S. when a substantial portion of the business community signs onto those changes. The day is rapidly approaching when responsible business leaders will recognize that a White House beholden to the most troglodyte elements of their class – the oil conglomerates – is too great a liability to carry on the books.

When that day comes, it will be amazing how quickly the “power” of that small fraction of the body politic known as the religious right will fade – first from the media and then from our consciousness.

Correction

I misquoted Merck vice president Dennis Erb in the story I sent out late last night. He actually said "accurate and balanced," not "fair and balanced." It was after the third or fourth time that he used the phrase that it began sounding like the Fox News mantra to me.

Sorry about that.

"Fair and Balanced"

Today's House Government Reform commitee hearing on the pained painkiller Vioxx proved a nostalgic reminder of the good that can come from Congressional oversight, which has largely been absent under Republican rule.

Though the committee is chaired by Rep. Tom Davis (I goofed this morning when I said it was Joe Barton, the Texas Republican who chairs Energy and Commerce), today's show belonged to Rep. Henry Waxman, the California Democrat who has been bird-dogging the drug industry for more than two decades.

On the eve of the hearing, Waxman's staff released a devastating report on Merck's marketing practices. Using the committee's subpoena powers, Waxman culled 20,000 pages of internal documents that showed how the company trained its detailers (the office-to-office drug salesmen) to deflect any questions about the heart attack risks associated with Merck's blockbuster drug.

If doctors asked about the 2000 study that showed an uptick in heart attacks among Vioxx users compared to naproxen, the detailers were instructed to say, "I cannot discuss the study with you." One training manual encouraged them to tell doctors that Vioxx could be 8 to 11 times safer than other anti-inflammatory drugs.

Pressed over and over by Waxman about the company's responsibility to properly inform physicians about all the benefits and risks associated with the drug, the Merck official in the dock claimed the detailers' presentations were "fair and balanced." Shades of Fox News!

Merck sales reps' fair and balanced presentations convinced more than 2 million patients to take the drug with more than 100 million prescriptions filled in the U.S. FDA safety officer-turned-whistleblower David Graham has estimated anywhere from 88,000 to 140,0000 Americans suffered Vioxx-related heart attacks, strokes, and other serious medical complications.

The majority party gets to name the most witnesses, so I wasn't surprised to see Jack Calfee of the American Enterprise Institute at the witness table. Calfee, whose work at the corporate/conservative think tank is supported by the drug industry, used his time to argue that direct-to-consumer ads played no role in the rapid expansion of Vioxx sales.

His presentation dovetailed nicely with Merck vice president Dennis Erb's claims. Erb suggested a couple of articles in the New England Journal of Medicine and Journal of the American Medical Association and company presentations at scientific meetings about the possible risks met the company's responsibility to physicians. He also said the drug reps' presentations in doctors' offices were limited to what was on the label. He was reminded by several Congressmen that Merck had fought a two-year, successful battle with the FDA to avoid putting the heart attack risk warning on its label.

Democrats used their one witness slot to counter the industry and AEI nonsense. Michael Wilkes, the associate dean at the University of California-Davis Medical School, pointed out that most doctors "don't have the time" to read the medical literature. "Someone coming in with tickets to a sporting event or a dinner sends a far more powerful message. . . When patients come in and ask for a specific drug (after seeing an ad), they're more likely to get it," he said.

In one encouraging sign, even some Republican moderates on the committee blasted the company's actions and called for a tougher FDA. Gil Gutknecht (R-Minn.) waved a new FDA flyer warning consumers not to buy "dangerous" drugs from Canada. "The FDA is putting out information on the safety of drugs imported from Canada, but none on the Cox-2s," he said.

Yet the FDA reform legislation introduced in the Senate and House this past week was barely mentioned. Those bills would give the FDA more powers to regulate the industry. The House bill would forbid scientists who work for drug companies from serving on FDA advisory committees that consider their employers' new drug applications.

The question now is whether Democrats and moderate Republicans can band together to at least get the bills a hearing. If chairman Davis' tone at today's hearing was any indication of where the leadership is at (Rep. Barton's Energy and Commerce committee would probably hold it in the House), I wouldn't bet on it.

House Government Reform Committee to Meet on FDA

The House Government Reform committee meets this morning to discuss reform of the Food and Drug Administration. Merck's actions on Vioxx will be front and center.

We'll be looking to see if chairman Joe Barton (R-Texas) will defend the status quo on the FDA's structure. Last week, Senators Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) introduced legislation that would separate the agency's safety department from its drug approval department and give the safety officials more powers to pull drugs from the market and order new clinical trials. Yesterday Rep. Maurice Hinchey (D-N.Y.) introduced a more sweeping reform bill in the House. It would cut the ties between industry user fees and the agency's funding (the fees would go into the Treasury) and forbid scientists with conflicts of interest from serving on FDA advisory panels.

If Barton through his questioning shows he is sympathetic to reform, then FDA legislaton stands a fighting chance this year.

It will also be interesting to see how the the committee handles the conflict of interest issue. The American Enterprise Institute's Jack Calfee plans to defend the "benefits" of Cox-2 inhibitors like Vioxx, which rest on a specious drug-industry funded study that claims 16,500 people die each year from ulcers caused by painkillers. Hopefully, some Congressmen will force Calfee to point out that not only is his work funded by the drug industry, but so was the study he will be quoting.

More bad math on Social Security

The Sunday business section of the New York Times contained an "economic view" whose math was so transparently inaccurate that it's a wonder the copyeditors didn't pull the plug on the piece. The paper even included a graphic illustrating the economic nonsense.

The author was Ann Bernasak, whose byline I'm not familiar with and who otherwise was unidentified. She wanted to highlight the risk of the government borrowing to privatize Social Security -- something I also oppose. But it does no one any good when specious arguments are used to advance a worthy cause.

The article, "The Outer Limits of National Debt," argued that the "sound limit" for a nation is 150 percent of gross domestic product. She arrived at this benchmark by looking at Great Britain right after World War II, a questionable choice since it marked the departure point for the British empire from the global stage.

No matter. The real problem was in her calculations of current U.S. debt for her comparison to our current $12 trillion GDP. She first added up debt held by the "public," (read Chinese, Japanese and all other holders of U.S. T-bills) and debt held by the Social Security and other government trust funds. That came to $6.6 trillion -- well below the $18 trillion that would mark 150 percent of current GDP.

But then she added in $4 trillion in unfunded Social Security obligations over the next 75 years and $30 trillion in unfunded Medicare obligations over the same time period. She added this to the $6.6 trillion and concluded this $40.6 trillion was "well over the prudent limit of $18 trillion."

Wait a minute. This wasn't an apples to apples comparison. What will the size of the U.S. economy be in 75 years? It won't be $12 trillion. If it grows at only 3 percent per year (slightly less than its historic average), the U.S. economy will be at least three times its current size or about $36 trillion in 75 years. That doesn't make the projected shortfalls less of a problem, but it certainly makes them seem more manageable.

This is just a minor point on the overall Social Security debate. But as Dean Baker of the Center for Economic Policy Research has pointed out, all projections about the 75-year-future of Social Security -- whether you're talking about the projected returns from privatized accounts invested in the stock market or the magnitude of the unfunded liability of Social Security -- must take into account the size of the economy in those out years.

Politicians like the President who are hell bent on destroying Social Security routinely distort the economics of the nation's retirement system. One would hope for better from the Times' business pages.