A Drug Rep's Real Job

In the wake of an unprecedented wave of layoffs, drug representatives all over the country are suing their employers for unpaid overtime. The latest against Abbott Laboratories was filed yesterday in federal court in Chicago. Similar suits have been filed against Johnson & Johnson, Eli Lilly and Pfizer.

Sales people are exempt under federal labor laws. But in making their case, the former drug reps, who often work 60 to 70 hours a week, argue that's not really their job. “They actually don’t sell anything,” Los Angeles attorney Charles Joseph, who filed the suit on behalf of two former Abbott reps, said in a statement. “Rather, they are tasked to influence the prescribing behaviors of doctors.”

The Coming Age of Unwellness

The lead paragraphs in this article, which appeared yesterday on the Guardian (UK) website, was based on a Reuters report on the latest data on the uninsured from the Centers for Disease Control. It turns out Reuters confused two sets of data; the CDC actually shows a continued rise in the uninsured . . . from 41.1 million in 2005 to 43.6 million in 2006. The Census bureau previously reported the 46.6 million number for 2005, which has since been lowered to 44.8 million. The Census estimate for 2006 will be released in August. It is projected to also show a rise, meaning things are still getting worse. Anyway, the larger point of the story still holds: the U.S. health care crisis will be exacerbated in the coming decade by a rising number of young people in need of health care services because of rising obesity and asthma rates.

Pity poor Michael Moore. With Cannes-sensation “Sicko” set to open amid more press attention than an Angelina Jolie sighting, the federal government’s Centers for Disease Control and Prevention chose this week to release the latest data on the U.S. population without health insurance. It’s down to 43.6 million people in 2006 from 46.6 million the previous year.

Is this a government plot to deflect attention from the core message of his documentary: that America’s profit-driven health insurance system is immoral and needs to be replaced with a national health service along the lines of the western European, Canadian or (let’s admit it, this took chutzpah) Cuban models?

The CDC news isn’t as good as it seems.

Their latest tally of the ranks of the uninsured remains two million persons above 2001, the last time the business cycle peaked. Even on a percentage basis, the numbers are up with the latest survey showing more people – 14.8 percent or one in every seven persons – running the risk of personal bankruptcy and inadequate care because of no insurance than when President Bush took office. While it’s probably not the president’s fault that employers are bailing out of the U.S. job-based health insurance system, it is fair to blame him for a lost decade in dealing with this escalating crisis.

And despite this latest dip in the ranks of the uninsured, the crisis is only going to get worse in the coming decade. According to a new report out today, the health care system faces an unprecedented public health time bomb: the next generation of young people is going to need far more in the way of health care services than previous 20- and 30-something generations.

You’d think that with 77 million baby boomers moving toward retirement where taxpayer-financed Medicare picks up the health care tab, employers would get some breathing room. Younger workers generally require much less health care, which translates into lower insurance costs for those who employ them.

But the study in this week’s Journal of the American Medical Association documents a grim prognosis for the next generation of workers: they are going to be fatter, more asthmatic, and suffering from far more neurological disorders than any previous generation of American young people. And its young people who are most likely to go without health care coverage.

“We’re going to see increased health expenditures for people in their 20s,” said James Perrin, a professor of pediatrics at the Harvard Medical School and lead author of the report. “They’ll be coming to institutions for health care without any means of paying for it.”

How bad is it? About 18 percent of American children and adolescents are now considered obese, up from just five percent in the early 1970s when the baby boomers were entering the workforce. That translates into earlier onset of type 2 diabetes, hypertension and heart disease, chronic conditions that usually require ongoing, often lifelong medical interventions. With obesity already accounting for 10 percent of medical expenses, a doubling of adult rates will add $100 billion a year to health care costs, according to the study.

Childhood asthma persists into adulthood for about a quarter of all persons afflicted with the wheezing disorder. And today, about one in every 11 young persons has asthma, double the rate of the 1980s. Again, that translates into millions of young workers who will need immediate health care assistance as they enter the workforce, even as they lose work days and productivity because of their condition.

Ditto for neurological disorders like attention deficit and autism, which were virtually unheard of in the 1960s and 70s. Perrin and his fellow authors admit that some of the reported rise in these conditions may be associated with diagnostic creep. But whatever the cause, children who need treatments are much more likely to turn into adults who need treatment, and that translates into higher health care costs. “Employees with mental health conditions generate about three times the health care costs of other employees,” the authors noted.

Finally, blacks, Hispanics, Native Americans and low-income whites suffer far higher rates of obesity, asthma and attention deficit disorder compared to their better-off counterparts. These are precisely the groups in society most likely to be without health insurance.

The social factors behind these escalating childhood and adolescent epidemics are well-known: rising income inequality, poor diet, unrestricted television junk food advertising aimed at children and young adults, sedentary lifestyles, rising rates of pre-term and multiple births, environmental exposures – especially for poor, urban children. Universal health care does nothing to solve any of these problems.

We’ve already been told that if the social factors leading to these epidemics go unaddressed, the next generation of Americans may be the first in our history to lead shorter lives. What this latest study points out is that they’re also going to consume a lot more health care all along the way.

Sicko

About two-thirds of the way through "Sicko," Michael Moore takes us to France, where health care is free, doctors make housecalls, daycare is cheap, and vacations are long. A group of American ex-patriots, sitting around a cafe table, extol the wonders of their adopted, family-friendly environment. "Is there a reason the government wanted us to hate the French," Moore ponders. "It was enough to make me put away my Freedom Fries."

A few scenes later, we're back in the U.S. watching the largest hospital in Los Angeles dump an indigent, mentally confused patient on the doorstep of homeless shelter because she didn't have money or insurance. "Who are we," the filmmaker asks in his omniscient narrator's voice. "Is this what we've become? A country that dumps its citizens on the sidewalk because they can't pay their hospital bills?"

The national discussion provoked by the film will inevitably focus on the gross failures and inequities of the U.S. health insurance system, as it should. And like most people who know too much about that system, I could complain for hours about the inaccuracies, unfair comparisons, agit-prop stunts and questionable political judgments that went into the making of "Sicko." You'll read plenty such comments in the mainstream media when the reviewers get their hands on the film this weekend, and you may have a few of those thoughts yourself when you go see it.

But they pale by comparison to the larger point that Moore makes over and over again in this heartrending, brilliant and occasionally very funny film. Our patchwork private health insurance system is a tragedy for those whom it fails. But its failures are really just a metaphor for what a growing proportion of Americans recognize is wrong with this country.

Whether looking at Canada's privately-run, provincially paid for health care systems, or England's National Health Service, or France's social democracy, or Cuba's impoverished egalitarianism, Moore finds the universal thread that makes their social systems more successful than ours. "They live in a world of we, not me," he says near the end of the film. "We'll never fix anything until we get that one thing right."

The film is filled with heartrending stories of people who couldn't afford or were denied care, usually by profit-maximizing insurance companies. And that is ultimately what keeps us glued to the screen. Indeed, the real people whose stories Moore tells triumph over the questionable settings in which he put some of them (I'm thinking here of the highly publicized stunt of taking ill and injured 9/11 rescue workers who can't afford needed medical treatments on boats to Guantanamo Bay to demand health care as good as the detainees ostensibly get).

But is individual misfortune enough to sway a political debate that will be dominated by people with their own well-financed megaphones and a compliant media willing to spread their distortions? Already Moore is being attacked for promoting socialized medicine, even though neither Canada nor France directly employ most of their physicians.

But that's the point with Moore's work. As with most of his films, Moore has succeeded in putting himself at the center of a major political debate. So what if there are enough mistakes to give the insurance industry, the drug companies, and their spokespersons plenty of ammunition. It's controversial! It's fun! And it's made Moore a rich man.

A few weeks ago, I watched Bill Mahar interview Moore on HBO. Moore said his only goal was to get people asking why we're the only industrialized country in the world that doesn't have universal health insurance coverage. Mahar enthused that he thought the political reaction to the film would push the movement for universal coverage "over the edge."

Even though I wholeheartedly agree with the film's overarching message, it's going to take a lot more than agit-prop to push this movement over the top.

High Court Unleashs Political Issue Ads

The Supreme Court this morning opened the floodgates for groups that run issue ads on the eve of elections. The 5-4 ruling stems from a 2004 case in Wisconsin where the local right-to-life group wanted to runs ads encouraging their senators (Democrat Russ Feingold was up for reelection) not to filibuster President Bush's judicial nominees. The McCain-Feingold campaign finance law prohibits ads in the two months before an election that surreptitiously attack candidates by highlighting their stands on issues, usually in a negative way.

This is very bad news for those of us who were hoping for an intelligent debate next year on health care reform. Candidates will be much less willing to go out on a limb with specific plans when they know every special interest group (can you say Big Pharma, Big Insurance, Big Doctors and Big Hospitals) can run unlimited attack ads in the months leading up to the election.

Cohn, LA Times on Moore

The New Republic's Jon Cohn reviews Michael Moore's "Sicko" here. Definitely worth reading, as are the dozens of comments, many from France that is a major point of comparison both in the film and the review. If nothing else, we're going to learn a lot about alternative health care delivery systems as the debate over health care insurance reform unfolds.

Meanwhile, a news story yesterday in the Los Angeles Times highlights the tension between the plans offered by leading Democratic Party presidential contenders and Moore's call for a single-payer national health insurance system. This story highlights another issue raised in the Cohn review: If Moore's film turns the debate over the failures of our own system into another endless argument over long lines in Canada or Cuba, we'll never get beyond the insurance debate to the really serious issue confronting America: the deteriorating condition of our children's health and the likelihood that for the first time in American history, the next generation may live shorter lives than the previous generation. A new study that comes out next week (still embargoed so I can't talk about it) will reveal some startling data along those lines.

FDA Reform Bill Goes to House Floor

The House Energy and Commerce Committee late today passed the Food and Drug Administration user fee reauthorization bill that slightly improves the ability of the agency to ensure new drugs are safe and well-monitored once on the market.

On the upside, the bill includes $225 million over the next five years for beefing up the agency's safety department. This was also included in the Senate-passed bill, and would enable the beleaguered safety department to conduct a lot more studies of problematic drugs once they've entered mass use.

The bill also includes a requirement to register all late stage clinical trials and their results. This is also in the Senate bill, and should help independent researchers and consumers -- not to mention the FDA's internal reviewers -- conduct many more meta-analyses of widely used drugs that may have safety problems.

While the bill gives the agency increased powers to levy fines for misleading ads, the Democratic-controlled House caved into the pharmaceutical and broadcast industry lobbies by refusing to give the agency the power to impose a three-year moratorium on direct-to-consumer ads.

On the conflict of interest front, the Republicans tried to repeal a clause that will limit the agency to appointing just one scientist with a conflict of interest onto any advisory committee. The FDA usually follows the advice of its outside advisory panels, but in recent years, nearly a quarter of all advisers (mostly academicians) have had ties to companies regulated by the agency.

Assuming the one-waiver-per-meeting clause stays intact through the full House vote, which is expected later this summer, expect a confrontation with the Senate in conference committee. The Senate bill has no limitation on the number of waivers the FDA can grant.

The bill also included an amendment offered by Bart Stupak (D-MI) that beefs up the adverse event reporting system and pushes the agency to require that companies complete clinical trials promised by companies at the time their new drugs get approved. About three-quarters of such promises never get fulfilled.

The bill also included a provision that all direct-to-consumer ads contain an 800 number where consumers can report adverse events.

All in all, it's a lot better than the Senate bill, and a lot better than the status quo. The action now shifts to the full House floor before it heads to conference. Look for a lot of behind the scenes lobbying by the pharmaceutical industry lobby to push the final outcome in the Senate's direction.

Health Skepticism Rewarded

Our congratulations to Dr. Peter Mansfield from down under and the Healthy Skepticism website. He won the Australian Medal of Honor yesterday for his ongoing work on behalf of medical consumers. He dedicated his award to all those who contribute to the site, which includes a number of readers of this blog. For those of you who are not familiar with the Healthy Skeptics' work, check it out!

FDA Crisis Confab?

Where's the Food and Drug Administration's top managers? With the House Energy and Commerce Committee on the eve of marking up FDA reform legislation, all the top officials at the agency -- including Andrew von Eschenbach, Janet Woodcock and Randall Lutter -- didn't show up for work yesterday. The rumor that swept through headquarters was that they'd been summoned to a "crisis management" meeting by Health and Human Services Secretary Mike Leavitt.

Listening to the EBM Gurus

I highly recommend the dialogue posted today on the Health Affairs blog. It features Sean Tunis, the former Center for Medicare and Medicaid Services official, and David Eddy, who is a prominent health care consultant, weighing in on evidence-based medicine (EBM).

There's not much disagreement between the two. They both believe that health care costs can be held in check by getting physicians to practice EBM. They both believe that EBM ultimately involves rationing.

What does this mean in layman's language? We can implant stents, defibrillators and do whole body imaging until the cows come home, and it will probably save lives. But many of those advanced technologies don't make economic sense. In terms of the cost per life saved, they are just not worth it. Therefore, it makes sense to ration the use of those services to those who would most likely benefit from them.

There's two missing elements from their discussion.

First, they ignore who created the evidence that goes into "evidence-based medicine." How much rationing is there going to be when the cost-benefit analyses are generated by industry-funded economists sifting through industry-funded clinical trials? Virtually every study I've seen in the literature (admittedly subject to publication bias; few analyses that say a technology simply isn't worth it make it into the literature for obvious reasons) says the new technology is worth every dime the health care system will be asked to pay for it. Only an objective arbiter of the evidence free from all ties to industry can generate information that will be trusted by either physicians or patients.

The second missing discussion was comparative effectiveness analysis. To her credit, Sen. Hillary Clinton, who spoke this morning to the Take Back America conference in Washington, has made setting up a center for studying the value of competing medical approaches a centerpiece of her health care program. She's also highlighted preventive care and better chronic care management (a fancy term for giving wholistic treatment to people with multiple conditions rather than having them see multiple specialists, each of whom makes high fees for treating each condition in isolation).

But, again, there is precious little in the literature outlining the cost-effectiveness of this kind of approach, even though most people intuitively understand that the health care system could probably save money in the long run if it deployed resources into prevention programs that help people live lives that don't lead to chronic illnesses with multiple conditions in the first place. Without a well-funded agency capable of conducting credible comparative effectiveness studies to inform policymaking, the public will never accept the rationing implicit in evidence-based medicine, or spend taxpayer monies on well-designed programs that have the best chance of preventing disease and improving the overall health of the American people.

We're Number 81!

eDrugSearch.com's HealthCare100.com ranks GoozNews number 81 among the world's top blogs on health and medicine. It's a fine site for finding all the health care comment you would ever want or need. For my money, the Cheerful Oncologist takes the prize for best-laugh-in-a-name blog.

Who's Number One? The musings of a London-based emergency medical technician, who writes daily about his ambulance runs. Fascinating reading at Random Acts of Reality.

My thanks to Jane Hiebert-White at the the Health Affairs Blog for pointing out the listing and the website!

House Caves to Pharma

The House Energy and Commerce subcommittee on health this morning dropped two controversial elements from the Food and Drug Administration reform bill. In the original bill, every new drug approved by the agency would be required to have a risk evaluation and mitigation strategy (REMS) for monitoring their use the first few years on the market. The drug industry succeeded in leaving those decisions to the FDA's discretion -- with all the susceptibilities to industry pressure that implies.

Also, a three-year-waiting period before direct-to-consumer advertising can begin was also dropped. Again, the bill simply gives the agency the power to impose such a temporary ban if it wants, something it has never done.

The House bill also contains a conflict of interest clause that will allow the FDA to continue appointing one scientist with ties to industry to each advisory panel. This is better than the Senate bill, and better than the proposed guidance by the FDA, which would grant unlimited waivers but allow conflicted scientists to participate in the meetings without a vote. But it's not a total ban on conflicts of interest, which would have sent a clear message that the FDA's days of cozying up to the drug industry are over.

While there are many improvements in the legislation that will be marked up by the full committee on Thursday -- especially the clinical trials results database -- this morning's actions represent a big win for Big Pharma.

Where Were the FDA's DTC Monitors?

The lead stories in the Sunday New York Times and Washington Post both focused on the Food and Drug Administration's inability to monitor imported drugs, especially from India and China. It's an important issue. Hundreds of people could get hurt or killed if a dangerous batch of drugs slip into the U.S., as recently happened in Panama. We need more inspectors, and the FDA should be given the money to hire them.

But is this threat from imports from China and India comparable to the threat posed by the illegal drug advertising that fills our airwaves, magazines and newspapers every day? I could not help but note the comments from Indian generic manufacturers that trade economics as much as safety were at the heart of these concerns.

John Dingell (D-MI), chairman of the House Energy and Commerce Committee and usually a vociferous trade hawk, doesn't think so. Last Friday, he sent a letter to Michael Leavitt, the head of the Health and Human Services department (the FDA's parent agency), demanding to know why the FDA never cracked down on ads for the anti-anemia drugs Procrit and Aranesp, which claim to make their users ready for chemotherapy because they make patients feel better.

The problem with that claim is that the FDA has never approved the drugs for that purpose. Every time oncologists used them to raise red blood cell counts above the FDA-approved level for correcting anemia (about 90 percent of normal), they were prescribing them "off label." You can't advertise a drug for other than its approved purpose -- at least I always thought that was the case. So weren't all those ads, ipso facto, illegal?

Hundreds of thousands of cancer patients were given these drugs off-label. Hundreds, perhaps thousands, died unnecessarily because of what we now know to be their dangerous side effects: when used to raise red blood cell counts to near normal levels, they raise the incidence of sudden death from heart attacks, strokes and other cardiovascular events.

Dingell is seeking all correspondence between the FDA and the companies regarding oversight of the ads. What if the agency responds that it has nothing to send to the inquiring House investigators? If you think the FDA is short-staffed for monitoring imports, do a head count over in the office that monitors DTC ads.

It will be interesting to see what the House Energy and Commerce committee does when it marks up the FDA reform bill, starting tomorrow. The drug industry and its allies in the broadcast and print media industries have been engaged in a full court press to avoid further restrictions on direct-to-consumer ads. They won in the Senate. Will they get away with it in the House, too?

Integrity in Science Watch -- June 18, 2007

Here's the latest Integrity in Science Watch from the Center for Science in the Public Interest:

Cell Phone Firms Exert Hidden Controls in NAS Deal

According to National Academy of Sciences regulations, no more than 49 percent of the money for any study conducted by the quasi-governmental agency can come from private industry. Yet a new NAS panel that will set the research agenda for measuring cell phone health risks (see last week’s Integrity in Science Watch) derives all of its funding from the Cellular Telephone Industry Association (CTIA), the industry trade group. The industry cash was funneled through a 1999 Cooperative Research and Development Agreement between the Food and Drug Administration and CTIA.

The agreement states that the FDA's Center for Devices and Radiological Health (CDRH) will recommend what research will be conducted under the agreement and review the results, but “the CTIA will administer research conducted by third parties.” “Both groups – CTIA and FDA – are engaged in research guidance. Both groups have an input into research goals and responsibilities," said Michelle Chenault, an associate director of the FDA’s CDRH. Responded NAS Executive Director E. William Colglazier: “Our contract is with FDA, and we consider the government to be the sole sponsor and funder of the study.”

Another recent example of industry attaching strings when it underwrites government research involves the Environmental Protection Agency, which has launched the first nationwide study of air quality effects from large-scale animal feeding operations. The study is being financed by livestock producers. The study will measure levels of particulate matter, hydrogen sulfide, volatile organic compounds and ammonia emitted from livestock facilities, which will allow the EPA to determine if they comply with the Clean Air Act. One provision of the agreement exempts feedlots from prosecution for Clean Air Act violations during the study period.

Owl Scientists Cry Foul over Habitat Protection Revamp

Endangered-species experts in the academic community have accused former industry lobbyists now in key positions at the Agriculture and Interior departments of misrepresenting their work in order to override agency scientists and weaken a proposed spotted owl habitat protection plan, which is now open for public comment. The so-called “Washington Oversight Committee,” which includes undersecretary of Agriculture Mark Rey, a former timber industry lobbyist, and deputy secretary of the Interior Lynn Scarlett, the former chief executive of the Reason Foundation, which receives substantial funding from the American Forest and Paper Association, cited several recent studies in quashing the original plan offered by the Fish and Wildlife Service (FWS), which proposed stronger protections for old growth forests.

“The authors of the studies specifically cautioned against using the results to guide forest management actions for spotted owls," said Dominick Dellasala, a scientist involved in drafting the original FWS plan. The studies showed that spotted owls appeared to be thriving in parts of their range outside old growth forests. The former lobbyists seized on that finding to craft a proposal that gives local Forest Service and Bureau of Land Management (BLM) officials greater leeway to determine which owl-dwelling forest lands need protection.

Meanwhile, the tide appears to be turning against government appointees who manipulate science. A federal judge in Idaho has struck down new cattle industry grazing regulations because the BLM ignored agency scientists. The BLM’s rules, proposed by the livestock industry and issued in 2005, loosened restrictions on grazing on 160 million acres of public lands throughout the western U.S. Judge B. Lynn Winmill said the rules violated federal environmental laws and failed to heed warnings from government scientists that the changes could have “significant and long-term adverse effects on wildlife resources and biological diversity in general.” In a similar vein, federal district Judge John C. Coughenour in Washington has thrown out a policy that weakened Endangered Species Act protections for wild salmon by equating hatchery fish with wild fish.

Conflict of Interest Charges Roil Cochrane Collaboration

Officials at the voluntary Cochrane Collaboration have launched an investigation into charges that the author of a controversial guideline challenging the routine use of anticoagulants to treat blood clots that peer reviewers substantially changed his conclusions. David Cundiff, a Los Angeles-based physician and lead author of the guideline, in an article that appeared on Medscape last week, also claimed that four of the seven peer reviewers had conflicts of interest. The review is posted on the Cochrane website and backs continued use of the drugs. In his Medscape commentary, Cundiff claimed there is no evidence supporting the use of warfarin, heparin, and other anticoagulants, which has been standard medical practice for lung and leg blood clots since the 1940s. He also says that epidemiological evidence suggests they cause internal bleeding that leads to unnecessary deaths.

The Cochrane Collaboration, founded in 1993 to promote evidence-based medicine, now has a strict policy forbidding conflicts of interest for its authors, editors, and peer reviewers. But at the time the review was commissioned, the voluntary organization had no policy, according to Gerald Fowkes, a professor of epidemiology at the University of Edinborough and head of the group that approved the guideline. An independent check by the Center for Science in the Public Interest confirmed that at least three of the peer reviewers – Martin H. Prins of the Netherlands, David Bergqvist and William Hiatt the University of Colorado – have recent ties to drug makers. Though Cundiff has no ties to industry, he reported to Cochrane’s editors that his research interest in anticoagulants resulted from a malpractice case involving a patient’s death after he failed to prescribe anticoagulants. The case eventually resulted in his losing his medical license.

Polluters Cite Oil Industry-Funded Scientist to Cloud Ozone Picture

Permissible levels of smog-producing ozone should be lowered, an Environmental Protection Agency science panel unanimously agreed in March. But in a series of closed door meetings this month at the White House’s Office of Management and Budget, the first of which excluded the EPA, industry lobbyists claimed the science is still in doubt. According to Inside EPA, the lobbyists cited the work of William Adams, a retired professor of exercise science at the University of California-Davis, who claims the EPA proposal to lower the permissible ozone level misinterpreted his findings that lung capacity improves at the lower levels. Adams’ research was supported in part by an unrestricted grant from the American Petroleum Institute. A final standard will be issued next year.

Cheers and Jeers

• Cheer: To psychiatrist Daniel Carlat, who, in an op-ed in the New York Times, called for revoking the accreditation of continuing medical education courses sponsored by commercial interests. Over half of all CME courses are now paid for by the drug industry.
• Jeer: To psychiatrist Daniel Carlat, who failed to disclose in his op-ed that he could personally benefit from the change. His newsletter, the $109-per-year Carlat Psychiatry Report, offers “up to 12 hours per year of Category One CME credit” for passing the CME post-test contained in each monthly issue. The newsletter takes no money from the pharmaceutical industry.

Biogenerics Advancing

The Washington Post editorializes this morning in favor of a biogenerics bill that will make easier for consumers to buy discounted versions of the priciest drugs now on the market once their patents expire. That's good news. The Post editorial page is an important bellwether of the inside the Beltway consensus, and the fact it addressed the topic now suggests some key compromises may have been reached on the bill moving through the Senate Health Committee.

Biologic drugs like erythropoietin or human growth hormone are genetically engineered versions of complex proteins, and the processes needed to produce them with guaranteed purity and consistency is equally complex. But it isn't beyond the capacity of any well-trained biochemistry team working in labs equipped with the latest fermenters, filtering and fractionating columns, which are readily available on the commercial market. As deputy FDA commissioner Janet Woodcock recently testified, the FDA routinely monitors biologics production lines for good manufacturing practices and to ensure that what goes into every vial is the same. There's no reason why it couldn't apply the same standards to a generic manufacturer.

The crucial question is whether the law will require generic firms to conduct a full range of clinical trials for its first production batches of follow-on biogenerics, rather than just a limited trial to ensure that the generic manufacturers' cell lines produce the same biological effect once injected into humans. If the law requires a full efficacy trial, it will restrict the number of companies willing to make the investment, and make the price of the follow-on drug more like the innovator's price, not the 40-50 percent discount typical of generics. In other words, biogenerics will be more like me-too drugs than true generics.

The Post editorial gets this crucial question right. It said:

"The FDA should be given greater latitude to design approval requirements on a case-by-case basis, which almost certainly would include clinical trials of various sizes. This is a flexible approach that would ensure speedy approval when possible and that could adjust to changing science."

The science will only make it easier over time to make and approve follow-on biologics. Requiring full-fledged efficacy trials for every biogeneric would put the FDA in a straightjacket tailored by the biggest players in the biotechnology industry, Amgen, Genentech and Genzyme, whose only goal is to protect their patent monopolies.

Higher Spending, Not Better Health

Not only doesn't higher health care spending result in better health, it sometimes makes things worse.

A new study in Pennsylvania evaluating state hospitals that perform heart bypass surgery found those charging $100,000 for the operation had no better death rates than hospitals that charged one-fifth as much, according to today's New York Times.

Meanwhile, a New England Journal of Medicine perspective warns oncologists against overprescribing erythropoietin-stimulating agents. Recent studies have shown that trying to normalize red blood cell counts using Amgen's Aranesp or J&J's Procrit may actually make some cancers worse, and leads to strokes and blood clots. The FDA in March issued a black box warning on the drugs, and cautioned physicians against raising red blood cell counts above 90 percent of normal.

Given the massive advertising behind the drugs and the huge profits that doctors earn from administering them in their offices, "medical oncologists should begin using these agents in a compassionate but disciplined fashion, placing patient benefit above all other considerations," Emory University hematologist Fadlo R. Khuri wrote.

Lutterly Lacking

There are two crucial Food and Drug Administration reforms that the House must insist upon as it reauthorizes of the Prescription Drug User Fee Act: First is giving the FDA the power to impose a two-year moratorium on direct-to-consumer advertising for newly approved drugs; the second is the right to insist that the company complete a post-approval clinical trial within a specified period of time or the drug gets withdrawn from the market.

This became clear to me as I listened to the various members of the health subcommittee of the House Energy and Commerce Committee attempt to elicit meaningful responses from Randall Lutter, the deputy commissioner who had been sent up to the Hill to testify. Lutter is a former fellow at the American Enterprise Institute, and has now taken over the reins of the FDA’s regulatory affairs office. He’s well versed in the many proposed guidances that have come pouring out of the FDA in recent months, including one involving conflicts of interest on FDA advisory committees.

Which, of course, is the other major provision that has to be inserted in to the House bill – a complete ban on appointing scientists with ties to industry, not the “one waiver per meeting” policy included in the current version of the bill. The committee also needs to insert a “look back” period for determining conflicts of interest that is at least three years long. There’s nothing on this question in the current bill, and it represents a huge loophole that will render any reform the House passes on this issue moot.

Lutter was woefully underprepared for the meeting. The most entertaining back-and-forth involved Rep. Diane DeGette (D-CO), who at a previous subcommittee meeting had asked the FDA for some data involving medical devices. They were supposed to have responded in writing within a few weeks of the hearing – a typical response at Congressional hearings when the witness can’t immediately put his hands on the information being requested. A month ago, DeGette wrote a follow-up letter asking "where's the data?" When she brought that letter to Lutter’s attention today, he admitted that he hadn’t read it because he hadn’t seen it. It was a graphic portrayal of an administration that is either totally incompetent or contemptuous of the Democrats who now control Congress. Maybe both.

The various Congress-folk took turns trying to pin Lutter down on the different elements of the reform package, which includes establishing risk management plans for new drugs, sending all new drugs to advisory committees, a mandatory clinical trial registry, including results, and smorgasbord of add-ons that run from extending extra patent term to companies that conduct pediatric clinical trials to establishing a new institute within the FDA (named, oddly, Reagan-Udall) that would develop new science to help the agency do its job of protecting the public from unsafe and ineffective drugs and medical devices.

In the Senate, a coalition of broadcast, print advertising and drug industry lobbyists – you know what you call that in Washington? Powerful – succeeded in stripping from the bill language that would have given the FDA the power to limit direct-to-consumer advertising during the first several years the drug is on the market. This is crucial when there are signals in the data at the time of approval that a drug may have harmful side effects. Those signals can only be tested by an appropriately designed clinical trial, and until the results are in, the drug should diffuse slowly, like in the old days before DTC was allowed.

The argument made by the lobbyist coalition that a lawfully imposed moratorium would violate commercial freedom of speech suggests the public’s interest in protecting the public from needless exposure to a potentially life-threatening events (heart attack and stroke in the cases of Vioxx and Avandia) is outweighed by the First Amendment. I was a reporter for 20 years. I don’t think so. Oliver Wendell Holmes understood that freedom of speech isn't absolute – the famous yelling fire in a crowded theater illustration. It seems to me that protecting public health is one of those situations where the rights of commercial speech do not hold sway.

The FDA also needs a new weapon to ensure the trials get done during this moratorium period. That's where the threat of losing the drug’s tentative approval comes in. Companies have failed to start or complete hundreds of trials that were ordered by the FDA. These post-marketing trials are supposed to test whether the hints of harm in the pre-approval trials was real or just a statistical fluke. If it is real and the risk outweighs the benefits of the drug (Vioxx was just another pain pill; and Avandia, the latest drug in the dock, is just another blood sugar lowering drug), then the drug can be withdrawn before too much harm had been done. And what if the signal turns out negative? Then it can begin marketing the drug to a mass audience, if that is part of the corporate strategy.

There’s a number of other pressing issues that should be included in the bill during the mark-up session, which takes place Thursday. For instance, scientists at the agency should be protected if they go public with safety concerns, and they should be given the right to publish and speak independently. Rep. Jan Schakowsky asked Lutter about the recent case involving the scientist who tried to issue a warning about Avandia a year ago, but was told by her higher-ups at the agency to sit down and shut up. Schakowsky also mentioned the case of David Ross, who recently departed for the Veterans Administration after blowing the whistle on Ketek, an antibiotic with dangerous side effects.

“We take these concerns very seriously,” Lutter said. “I am unfamiliar with their cases.” There was a lot he was unfamiliar with Tuesday.

Meanwhile, the Republicans pressed an opening handed to them by whoever stuck an anti-preemption clause into the bill. This would not allow companies to use, as a defense in drug safety suits, the excuse that they complied with all the FDA regulations. (The failure to warn is the essence of many if not all product liability cases.)

I’m not up on the intricacies of this issue, but I do know this: in more than a year of talking about, writing about, and lobbying for FDA reform, this never came up. Why now? If this has something to do with undoing the handiwork of Dan Troy, the drug industry corporate lawyer who ran the FDA’s legal counsel office early in the Bush administration, then those issues ought to be fully discussed. Something that has far-reaching implications shouldn’t be snuck into a bill at the last minute, which appears to have happened in this case.

Consumer-Directed Plans Go Bust

Consumers are confused, satisfaction is low, and enrollment in consumer-directed health plans is stagnating, according to this morning's Wall Street Journal (subscription required). Under such plans, individuals or families buy high-deductible hospital insurance coverage at low rates while pocketing the savings into a "health savings account" that they can spend on first-dollar routine health care expenditures. Couple it with an individual mandate to buy insurance, and you've essentially got the Republican plan for universal health care coverage. The story reports that many consumers are voting with their choices -- after a year in the plan, one gladly jumped back into his employer's traditional health insurance program.

FDA Reform On Tap This Week

Reform of the Food and Drug Administration moves front and center this week as the House Energy and Commerce Committee takes up legislation approved by the Senate last month. Hearings will be held Tuesday morning in the health subcommittee, with a mark-up hearing slated for Thursday.

I want to spend a few moments this morning talking about one aspect of the bill that pertains to my work at the Center for Science in the Public Interest, where I head the Integrity in Science project. The proposed House bill includes language that would limit FDA advisory committees to just one scientist with a conflict of interest per meeting. Currently, nearly a quarter of all scientists appointed by the FDA to advisory panels have ties to companies with a stake in the outcome of the committees' deliberations, whether the sponsors of the drug or device, or their competitors.

This one-waiver language, taken from a failed effort to sway the Senate, does not go far enough.

There is one overriding reason for eliminating all conflicted scientists from these panels. It will send a clear message that Congress wants a culture change at the agency.

Since passage of the Prescription Drug User Fee Act in 1992 and comparable legislation for drug devices a few years later, the FDA's resources, increasingly dependent on industry fees, have been targeted towards expediting the approval of new drug and device applications. The result has been a mindset at the agency that downgrades concerns about safety.

The advisory committee system, which brings in outside physicians and scientists to review the clinical trial data about new drug and device applications, has been similarly transformed. Most committees, whose advice the FDA usually follows, are filled with physicians whose primary professional interest is in having more options for their patients. Many have close personal and financial relationships with the industry. They don't bring a green eyeshade mentality to the advisory committee proceedings, they bring a green light mentality.

Will filling these committees with scientists who bring a more critical perspective slow down the pace of innovation? Any company that has a true breakthrough product, one that will cure a disease or slow its advance where none existed before, or ameliorate its symptoms, need not fear an objective review. Even if there are safety risks like the heart attacks recently associated with the diabetes drug Avandia, the new drug will gain approval because the clear benefits of taking the drug outweigh the occasional risks.

On the other hand, new drugs for conditions where there are already many options on the market -- like Avandia -- may have a harder time getting through. After all, if there is no additional benefit from this new drug, but it poses a greater risk than other, proven medicines already on the market, the benefit-to-risk ratio is greatly reduced, and a truly independent committee may decide against approving it. After all, the magic of mass marketing, where a new drug can seize an overwhelming share of a large market like the one for diabetes drugs even though there are cheaper, proven alternatives available, means millions of people will wind up taking this new drug. And if there is even a slightly elevated risk, that could translate into tens of thousands of unnecessary incidents like heart attacks or strokes. The FDA was set up to protect the public from such unnecessary risks.

Objections may be raised that in some fields -- rare diseases, for instance, or certain pediatric conditions -- there are very few true experts and nearly everyone who is anyone has ties to industry. But there's nothing in a total ban on conflicts of interest that would prohibit the FDA from hiring these experts to make presentations to an advisory committee and answer any questions those chosen to serve may have.

These conflicted experts, however, wouldn't be allowed to participate in the discussions at the end of the meeting leading up to the final vote, which would give them a chance to sway the proceedings. Nor would they be allowed to vote.

The claim that everyone does it, another frequent objection to banning conflicted scientists from these committees, is a slander on the thousands of academic physicians and scientists who do not take money from industry, preferring instead to stay on the National Institutes of Health grant treadmill or to get their research funding from foundations or their own institutions. By voting for a total ban, the House will send a clear message to the FDA leadership that it's time for a culture change at the agency, and it can find independent scientists if it just spends a little time looking for them.

Avandia's New Label

The New York Times this morning ran an account of yesterday's House hearing that may confuse some readers. The labeling change on Avandia revealed yesterday by Food and Drug Administration officials warns about the long-known side effects of this class of diabetes drugs (Avandia and Actos): they cause weight gain and water retention, which can lead to congestive heart failure.

This is very different from the risk of sudden heart attacks and strokes associated with Avandia use, which was the subject of the New England Journal of Medicine meta-analysis by Steven Nissen and will go before an FDA advisory committee meeting on July 30th. The agency still hasn't decided where it stands on that issue.

Avandia Hearing Bust

There wasn't much new at today's House Government Reform Committee hearing on the heart attack risk associated with GlaxoSmithKline's diabetes drug, Avandia. Dr. John Buse, the incoming head of the American Diabetes Association, revealed another effort by company officials to shut him up -- this time in 1999 -- when he began raising questions about heart attack risk. It took him another two years to take those charges to the Food and Drug Administration, which did nothing.

If anything, the forum gave Republican critics a chance to launch personal attacks on Steve Nissen of the Cleveland Clinic and the New England Journal of Medicine, where last month a meta-analysis exposing those higher risks finally came to light.

The attacks began last week with Scott Gottlieb's op-ed in the Wall Street Journal attacking NEJM for politicizing the issue, and continued today with a guilt-by-association attack on Nissen's alleged conflicts of interest in the Washington Times by Peter Pitts and Robert Goldberg, who call their inappropriately named organization the Center for Medicine in the Public Interest.

The trumped up charges aired today included allegations that Nissen sought to politicize the issue by going straight to Capitol Hill without bringing his information first to the FDA. As Nissen responded at the hearing, the FDA by law is not allowed to share the clinical trial data that the company had given the agency. This is something he would know first hand since he serves on numerous FDA advisory committees.

Nissen had also tried to get source data from Glaxo for the clinical trials that had been posted on its website. When those talks went nowhere, Nissen said today, he went to Rep. Henry Waxman's committee for help, a logical place since he was already talking to Waxman about FDA reform issues.

What is the reform that Nissen is pushing? Complete transparency of clinical trial data, from the earliest pre-approval trials to all trials conducted after a drug hits the market. The Avandia case is just the latest in a long line of examples (Vioxx, anti-depressants in children) showing why this change is badly needed.

As for the ad hominem attacks, Pitts and Goldberg said Nissen had his own conflicts of interest because his boss at the Cleveland Clinic, an interventionist cardiologist who has been raked across the coals for his inappropriate investments in companies whose devices he's testing, is also a limited partner in a firm that Nissen is doing drug studies for. They also claimed Nissen has a conflict of interest because one company he consulted for donated the money he would have otherwise earned to the American College of Cardiology, which Nissen later headed, for employee gym memberships.

This would be a serious charge if it were for Nissen's gym membership. And, frankly, I have never felt comfortable with the "I give it all to charity" dodge. It's especially dicey if you're naming the charity. Memo to Nissen: Give it all up, or at the least, let the donor name the charity.

But, that said, even I, whose day job involves policing conflicts of interest, would never accuse flacks like Pitts and Goldberg of being on the take if they decide to give all the money they receive from Big Pharma (I'm just guessing here) to charity.

You see, I have to guess. When Nissen writes an article for NEJM or another journal, he discloses the names of the companies from which he received money before donating it to charity. Here's the disclosure from his article on Avandia:

Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.

On the other hand, I noticed that the Washington Times piece had no conflict of interest disclosure. What about it guys? Do you want to let my readers know who funds the so-called Center for Medicine in the Public Interest?

Avandia Hearing Today

Rep. Henry Waxman's Government Reform Committee will highlight flaws in the Food and Drug Administation's ability and willingness to uncover flaws in best-selling drugs like GlaxoSmithKline's Avandia, a glucose-control agent for diabetics and pre-diabetics. Commissioner Andrew von Eschenbach's comments will undoubtedly be the focus of attention. But I will also be interested in hearing what John Buse, the next head of the American Diabetes Association, has to say. This group, which, like most patient advocacy groups, has substantial ties to the drug industry, has been noticeably silent as the furor over Avandia unfolded.

Glaxo-funded scientists weighed in this morning in the New England Journal of Medicine with an interim report on their ongoing study of the cardiovascular risks associated with the drug, which is known generically as rosiglitazone. In an accompanying editorial, David Nathan of Harvard, who, interestingly enough, has also taken speaking fees from Glaxo, had this to say about the study, which is known as the RECORD trial:

The RECORD trial was directed at determining whether the "promising" impact of thiazolidinediones on insulin sensitivity and cardiovascular risk factors would translate into an improvement in cardiovascular clinical outcomes. In addition, the investigators wanted to "address concerns over cardiac failure; confirm that the better outcomes associated with improved glucose control . . . are applicable to this group of drugs; and allay concerns based on LDL [low-density lipoprotein] cholesterol concentrations." . . . In my opinion, several of these goals seem to reflect a company-oriented posture regarding rosiglitazone, rather than a neutral scientific inquiry.

Another argument for moving to a system where all trials, whether industry or government funded, are run through an agency that could put the proposed protocols out for scientific review prior to beginning the trial (see my post here). The answers you get depend on the questions you ask.

Carson Bashing and the Ill-Informed DDT Campaign

As I've written several times in this space, the New York Times has become the chief outlet for an ill-informed and unscientific campaign to boost DDT use to combat malaria. Today's entry comes from John Tierney, a conservative columnist who even includes a link to corporate defender Steve Milloy's "junkscience.com" website alongside his diatribe.

His hook is the 100th anniversary of Rachel Carson's birth, which has set off a mostly negative set of responses in the national press. Whether or not Carson overestimated the damage done by DDT, the cudgel with which writers like Tierney beat her and her latter-day disciplies are the dying children of Africa. As he put it:

The human costs have been horrific in the poor countries where malaria returned after DDT spraying was abandoned. Malariologists have made a little headway recently in restoring this weapon against the disease, but they’ve had to fight against Ms. Carson’s disciples who still divide the world into good and bad chemicals, with DDT in their fearsome “dirty dozen.” Ms. Carson didn’t urge an outright ban on DDT, but she tried to downplay its effectiveness against malaria and refused to acknowledge what it had accomplished.

His chief witness? One I.L. Baldwin, who wrote a review of Carson's book, "Silent Spring," in Science Magazine. Unless you paid very close attention to the attribution, you might have missed the fact that Baldwin at the time was an agriculturalist from Wisconsin. How would he know what was happening on the ground in Africa, Asia and Latin America, where the World Health Organization's campaign to eradicate malaria was taking place? That campaign was largely based on the faulty proposition that widespread mosquito control, such as had taken place in agricultural areas of the U.S., could eliminate malaria in the rest of the world as it had in the southern U.S.

Tierney's article is laced with references to Carson's unscientific methods. It's a funny charge for one journalist to level against another. She was, after all, a New Yorker writer. Her mission was to excite interest and concern. And the fact that we know her name today suggests she did a pretty good job.

But defending Carson is not my mission. The real question is why the New York Times continues to open its pages to diatribes by people who obviously have axes to grind, and who make statements that can be refuted by spending just fifteen minutes in online databases that contain scientific abstracts. The facts are that the pro-DDT campaign spearheaded by writers like Tina Rosenberg, John Tierney, and corporate flack Steven Milloy has only limited application in the real world, and even a brief tour of the scientific literature would corroborate that point.

For instance, here's what I culled from recent papers on the specific points he raise -- that the malaria eradication campaign in the 1960s failed because of growing first world environmentalist concern about DDT:

“Perhaps the most important (reason for the eradication campaign's failure) was the rapid development of immunity to DDT and later to other insecticides. . . . But politicians and other decision-makers were dazzled by the power of DDT.”

-- Arthur Brown, WHO representative in Southeast Asia from 1955-1962, writing in 2002 in the Journal of the Royal Society of Medicine.

Are there better methods that ought to be getting the emphasis?

“The historically most effective campaign against African vectors . . . relied overwhelmingly upon larval control. . . These affordable approaches were neglected after the advent of dichlorodiphenyl trichloroethane (DDT) and global malaria-control policy shifted toward domestic adulticide methods.”

-- Gerry Killeen of the Swiss Tropical Institute writing in Lancet Infectious Diseases in 2002.

While it may be effective in some settings, are there any downsides to spraying homes with DDT?

“In high transmission settings, indoor residual spraying (IRS) must be implemented indefinitely and at high quality to achieve control. As current infrastructure limitations and unpredictable funding make this unlikely, each country must carefully consider the role of IRS. There remains a need to support ongoing insecticide-treated net scale-up. Insecticide choice is hampered by the lack of economic costing data.”

-- A group of Uganda specialists writing in a soon-to-be-published article in Transactions of the Royal Society of Tropical Medicine and Hygiene.

Their argument, based on experience on the ground: Give individuals their own bednets, rather than ask governments to go door-to-door spraying every home twice a year.

When will the New York Times send a reporter to Africa to report some facts about mosquito resistance to DDT and other insecticides? When will the paper explore cultural barriers to widespread use of indoor residual spraying (which in large parts of Africa, means someone from the government showing up on your doorstep with a spray gun, not a tommy gun, and saying, "Hi, I'm from the government and I'm here to help.")

And when will they report what might be more effective malaria control policies in the face of those realities? Continuing to rely on people holed up in right wing think tanks grinding axes is shamefully bad journalism.

How to End Drug Marketing Trials

The Sunday edition of the New York Times carries a well-executed investigation of the drug industry's use of suspect physicians for marketing and testing new drugs. By cross-referencing Minnesota's database of drug company payments to doctors -- it's required under a new law -- with medical discipline records, the Times identified over 100 physicians who had received substantial payments from drug companies after receiving disciplinary actions.

The lead anecdote involved the former head of the Minnesota Psychiatric Society who, after having his license temporarily revoked for wilfully disregarding the welfare of his patients, including several who committed suicide, resumed his career earning tens of thousands of dollars from at least a dozen drug companies for either testing or promoting their new drugs.

Responding to the reporters' query, the Food and Drug Administration's Janet Woodcock vowed to examine the agency's oversight of clinical trials. As usual, an agency that doesn't have the resources to do its job responsibly is promising to do better. Next up: Hope the furor goes away.

I can't help but point out that nothing in any of the FDA reform bills now moving through Congress touches on the question of clinical trial oversight. And, as the article suggests, the drug industry appears uninterested in policing itself.

The Times didn't make it clear in its story, but these trials usually involve getting doctors to sign up patients to test aready approved drugs in situations that are slight wrinkles from the approved indication. Does the serotonin reuptake inhibitor (SSRI) that has already been tested in people with obsessive compulsive disorder also work in people with depression? The real goal of this type of trial is to get physicians prescribing the drug, not to prove it works in a different set of patients.

When the doctors involved get thousands of dollars for each patient they enroll in the trials, they are much more likely to prescribe it off label for that and other indications. That's why they are called seeding trials -- a phrase that unfortunately didn't make it into the story. I've always wondered about the ethicical bearings of the institutional review boards that approve such trials. But that's another story.

So what is to be done? The better FDA reform bills in the House (not the Senate version, which passed 93-1 last month and is backed by PhRMA, the industry trade group) would make the results of all clinical trials public. If it passes, enterprising reporters and researchers will have a field day pointing out the scientific nonsense behind many of these trials. But as we've seen over and over again, this is an industry that takes its anti-shame pills.

Perhaps the time has come to start talking about judging the science behind all clinical trials, whether pre- or post-approval. One way to do that is to put the process of conducting all clinical trials in the public domain.

Companies would still be allowed, indeed, encouraged to sponsor trials. But they would submit their proposed protocols to a public agency, which would then put it out for peer review to determine its scientific validity. Once a protocol was approved, the agency would then advertise for investigators to conduct the trials, just as the National Institutes of Health now does through its clinical trial networks for testing HIV/AIDS and cancer drugs. The system would be paid for by industry user fees -- just like industry user fees now pay for the FDA reviewers who evaluate the results of trials submitted to get experimental drugs approved.

The Times story quotes an outraged David Rothman, head of the Institute on Medicine as a Profession at Columbia University. “Clinical trial investigators must be culled from only the finest physicians in the country,” he said, “since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage.”

These seeding trials are not the frontiers of medicine. They're marketing schemes, greased by lucrative payments to the doctors who enroll their patients. Moral outrage won't get industry to stop. Nor does the FDA have the resources to police them.

User fee-financed public funding won't get rid of all the specious trials. But applying outside scientific oversight in the form of peer review and competitive bidding ought to cut down on the worst abuses.

Global Warming Investment Opportunity

Apparently rising concern about global warming -- embraced finally yesterday by President Bush, even if in half-hearted fashion -- is good news for the electric utility industry. The Dow Jones Utilities Average, which tracks the stock prices of leading electricity and natural gas companies, is up nearly 15 percent on the year, double the increase of the S&P 500 average, which hit another record high yesterday.

You'd think the prospect of increased emissions regulations would dampen interest in the stocks that used to be considered investments for cautious grandmas. And nothing I learned yesterday by attending a forum at the Center for American Progress on the prospects for carbon capture and storage systems for electric power plants would have changed that outlook. Indeed, if anything, you'd think the prospects of having to make billions of dollars of investment to build Integrated Gasification Combined Cycle plants that allow carbon capture, and billions more to drill deep wells for underground storage, would send investors fleeing the sector like the plague.

One possibility is that investors are taking the typical short-term view. Energy prices are rising and caps on prices that accompanied ill-conceived deregulatory schemes in the late 1990s are coming off. My own bills here in Maryland are up 50 percent from a year ago, and today, June 1, are scheduled to take another leaps upwards. Who cares about global warming regulations that are still years -- if ever -- in the future.

But there's another possibility. Perhaps investors understand that global warming is a great investment opportunity. If regulatory certainty is guaranteed (i.e., if utilities know that carbon emission rules put in place today won't be repealed tomorrow or ten years from now), then electricity generating plants that meet those rules are going to be a pretty safe place to put your money.

David Hawkins, the former EPA official who now heads the air office of the Natural Resources Defense Counsel, was sanguine about impact tough new carbon rules would have on prices. If spread across all utility payers, it would generate just a 2 percent increase in prices, he claimed.

But I think he underestimates the impact that the interplay of deregulated markets -- a legacy of the Clinton years -- and tougher carbon rules -- one probable legacy of the next administration, whether its Democratic or Republican -- will have on individual consumers, especially those that are poor or in the bottom half of the middle class.

Who should pay for the global warming fix? Unless progressives come up with something better than "don't worry it will only be 2 percent" for the people whose bills are going through the roof, those folks may warm to politicians who claim that we don't really have to worry about rising temperatures. The scientific debate may be over. But the political debate has only just begun.

If the head of NASA can say we really don't have to worry about it, then there will be no shortage of politicians willing to say the same thing, especially when the choice for their constituents is between keeping the lights turned on or dealing with a problem whose impact is far down the road.