Era of Greed Explained in One Chart

My thanks to Larry Mishel and the Economic Policy Institute for sending this chart my way (the headline should read "Ratio of CEO Pay to Minimum Wage, 1965-2005").

Unchain the FTC!

As expected, not a single newspaper covered the Supreme Court's refusal to hear the Federal Trade Commission’s appeal of a lower court decision prohibiting the antitrust agency from going after Schering-Plough's sweetheart deal with a generic manufacturer. So don't expect to read about the fact that four senators introduced a bill yesterday that would prohibit deals that keep generic drugs off the market for an additional six months.

Fortunately, FDA Webview, an online subscription newsletter, covered the bill's introduction, whose sponsors included Sen. Charles Grassley (R-IA). According to Sen. Herb Kohl (D-WI), the chief sponsor, “These companies are playing fast and loose with antitrust law and padding their profits by forcing families and the federal government to pay far more than we should for prescription drugs.” Sen. Patrick Leahy (D-VT) pointed out that the Schering-Plough case may be the first time in history that the U.S. Solicitor General under any administration has opposed an FTC request for the Supreme Court to hear an antitrust case.

Drinking and Smoking

Public interest groups and Rep. Henry Waxman held a Food and Drug Administration anti-centennial press conference on Capitol Hill this morning. Friday marks the 100th anniversary of the passage of the Pure Food and Drug Act, a product of Upton Sinclair's muckraking expose of Chicago's meatpacking plants in The Jungle. The event was something of a disappointment -- not in the content of the presentations, which justifiably took the FDA to task for failing to protect the American public from unsafe drugs and food -- but in the turnout. Only a handful of reporters attended, and not a single one had a question after the presentations ended.

Rep. Waxman gave more details from his staff's excellent report documenting the collapse of enforcement activity at the agency over the past five years. Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, retold the long, sad story of how the Center for Food Safety and Nutrition has repeatedly failed to regulate food additives like transfats and salt, which literally kill tens of thousands of Americans each year because of their prevalence in the U.S. diet.

But the most eye-opening presentation came from Dr. Sidney Wolfe, the long-time director of Public Citizen's Health Research Group. Sid, as everyone who knows him calls him, has waged a 35-year campaign against unsafe drugs and dietary supplements. He's a one-man regulatory agency constantly on the prowl for violations of the nation's drug safety laws, which he promptly brings to the attention of the agency that is supposed to be doing that job.

So I shouldn't have been surprised when Sid showed up at this press conference with several outrageous anecdotes about regulatory failure. All in a week's work for him, I guess. Here's just one:

In December 2001, the FDA declared nicotine-containing gum, patches or drinks to be drugs in response to a petition from the National Center for Tobacco-Free Kids and former FDA Deputy Commissioner William Schultz. That means anyone who wants to sell them must get the agency's approval, unlike dietary supplements which are exempt from the safety and efficacy requirements of the nation's drug laws.

Could you imagine what might happen if nicotine-laced drinks could be sold as a dietary supplement? Sure, some people might buy them as a way to cut down on smoking. But if those drinks were sold over-the-counter (to kids perhaps?), they would hook the users on nicotine. That would be the first step on the road to taking up smoking, which is, after all, just another way to get one's nicotine fix.

Turns out that companies are out there peddling nicotine-laced drinks over the Internet, a clear violation of the nation's drug laws. Don't believe me? Click here. Four milligrams of "purified nicotine infused in pure grade water with a hint of lemon flavoring." Perfect for airports, restaurants, bars, movie theaters, sporting event, public buildings and at work -- all the places where smoking is now prohibited.

Is the company lying when it says the FDA has classified this drink as a dietary supplement, Wolfe asked. Or has the FDA reversed its 2001 ruling? Under "either scenario," Wolfe said, "the FDA is, again, extremely negligent in its responsibilities to enforce the laws and regulations. . . Where is the FDA?"

Under David Kessler's leadership in the 1990s, the FDA led a relentless battle against the tobacco industry and wracked up huge victories. Under this administration, companies peddling tobacco starter-sets get a wink and a nod.

Our Sleeping Watchdog

Rep. Henry Waxman released a report today documenting the precipitous decline in enforcement activity at the Food and Drug Administration over the past five years. One scary finding: central headquarters in Washington repeatedly ignored recommendations from the FDA's regional offices to crack down on companies that failed to follow good manufacturing practices when making drugs and devices. For a copy of the full report, go here.

Supreme Court Deals Blow to Drug Consumers

The Supreme Court this morning refused to hear a Federal Trade Commission antitrust suit challenging sweetheart deals between brand name drug manufacturers and their would-be generic competitors. The decision -- or more precisely the refusal to hear the case -- is a huge blow for consumers.

The Hatch-Waxman act gave industry additional patent protection if their drug applications are delayed at the Food and Drug Administration. But in exchange, the industry agreed to cooperate with generic manufacturers who want to begin producing the drug ahead of the patent expiration date. The idea was to get generics on the market literally on the day the patent expires.

The law also gave the first generic firm that seeks to market a brand name drug six months of "generic" exclusivity. That's why the first generic version of a drug coming off patent usually sells somewhere near the original brand name price. It's only after that six-month exclusivity period expires that other generic firms enter that market and the price falls to about half of the original brand name price.

What manufacturers have done in a disturbingly high number of cases is pay the generic first-mover to not market their drugs during that period of exclusivity. The deal in essence allows the brand name company to "buy" the incentive created in the law for generic firms to move quickly. Consumers (including insurance companies, Medicare, Medicaid, and the VA) pay the tab for this deal.

The FTC challenged this practice on antitrust grounds after Schering-Plough Corp., of Kenilworth, N.J., paid $60 million to Upsher-Smith Laboratories Inc. of Minneapolis to not market a generic alternative of Schering's high blood pressure potassium supplement K-Dur 20, which went off patent in 2001. But Schering-Plough appealed the agency's ruling. Two years ago the 11th U.S. Circuit Court of Appeals agreed that the dispute was in essence a patent law dispute, and therefore not subject to antitrust sanctions.

I am tempted to call this decision the last nail in the coffin for the nation's antitrust laws. But those laws died and were buried a long time ago. I suspect tomorrow's papers will note this Supreme Court sanction of a billion dollar consumer rip-off with brief items in the business section.

FDA Seeking Early Retirements

The Food and Drug Administration is looking for at least 80 people to take early retirement from the Commissioner's office, according to an internal memo obtained by GoozNews. The cuts are part of an agency-wide effort to cope with budget cutbacks imposed by the Bush administration. Similar early retirement offers have been made to long-time workers in the regulatory office and center for food safety, a source said.

These budget cuts and staff reductions come at a time when the agency is under increasing pressure to beef up its drug safety and clinical trial monitoring systems. Bipartisan legislation sponsored by Senators Kennedy and Enzi calling for such changes will be introduced later this summer.

Yet the Republican majority continues to hack away at the agency's budget, making the FDA ever more dependent on industry user fees. The agency is required to match every dollar spent by industry with one of its own, and all the funds must be spent on evaluating new drugs.

That leaves fewer discretionary dollars for every other function at the FDA. The institutional capabilities lost through these early retirements will be very difficult to replace.

Childhood Cancer -- The Forgotten Ones

Many readers may have seen A Lion in the House, which ran on PBS stations the past few days. It's a poignant portrayal of how families deal with childhood cancer, the subject of my post on June 11. As reader Joana Ramos of Cancer Resources and Advocacy, a Seattle, WA-based group, notes, my column left out some very important realities about childhood cancer around the world. Here's what she had to say:

Adequate and appropriate R&D for new drugs to treat childhood cancer, accompanied by rational use of drugs, are only part of what needs to be done to combat this disease. Unfortunately, health and healthcare inequities in outcomes from childhood cancer continue to confound the perception that curing children with cancer is a success story. In low- and middle-income countries of the world, the survival and cure rates are almost the exact opposite as they are in the USA and other wealthy countries: about 80% of children diagnosed with cancer die, and in many countries, only some 10-20% receive any treatment at all, many times not even pain relief in their final days. (sources: International Confederation of Childhood Cancer Parent Organizations (ICCCPO) and International Society of Pediatric Oncology (SIOP).

Here in the USA, the same type of cancer outcome health disparities that exist among adults are reflected in the pediatric population also. Various studies have shown that survival and cure rates are significantly lower among children who are members of racial/ethnic minority and low-income groups, but that outcomes can be equalized when all have access to timely and appropriate care. With the ever rising numbers of uninsured and under insured children and families, and the bar on access to public benefits programs for immigrant children, appropriate access is still beyond the reach of many. From my colleagues in both ICCPO and SIOP, as well as the Association of Pediatric Oncology Social Workers, I am aware that it is not just in developing countries or the USA that all children do not have access to existing medicines needed for cancer treatment, but this is presently true also in Canada where access to prescription medicines is handled separately from coverage of care by HealthCanada, and each province sets it own formulary of covered drugs.

Combatting childhood cancer needs to be based not on just what is good for the pharmaceutical and medical supply companies, but on the needs of all affected children and adolescents. I agree that the whole area of medicines R&D, and the patent system -- which also grants Orphan Disease extensions for purported pediatric uses -- need to be urgently revised. Cancer advocacy organizations need to get on board too, as presently, besides very vital psychosocial supports and services to survivors, most of them focus primarily on raising awareness and funds for cancer research, not on improving access for all children. And even the most well-insured families whose children are diagnosed with cancer in the USA incur often tremendous uncovered expenses in the form of months or years of lost wages, costs of transportation, meals, and
double housing expenses, child care fees, follow-up care and myriads of prescription drugs, as well as the cost of many nonmedical supportive care needs of the patient, and much more. Those American children who do survive cancer often also find themselves among the ever-growing group of 18-35 year olds who are uninsured, and may end up never able to get insurance both despite and because of their lifelong need for specialty follow-up care.

Joana also corrects my statement that the Children’s Oncology Group (COG) is the only group conducting childhood cancer clinical trials and is run by the National Cancer Institute. In fact, COG is an independent entity, the research arm of the National Childhood Cancer Foundation. For more information about COG, see their CureSearch website. NCI has its own pediatric cancer research program, the Ped-Onc Branch, whose website is here.

Is Anyone Watching the Institutional Review Boards?

Before patients join a clinical trial, they must sign an “informed consent” agreement stating they’ve been told all the risks inherent in participating in that particular trial. Each year, hundreds of thousands of people join anyway. In some cases, they do it because they are desperate for the chance to try an experimental therapy on their disease. But mostly they’re motivated by altruism. Once asked, they’re more than happy to lend their bodies to the advancement of medical science.

On the other hand, the drug companies who sponsor a growing percentage of clinical trials may have other motives. As discussed here yesterday, some industry-funded trials are so-called seeding trials, where the company sponsoring the test is primarily interested in getting more doctors to prescribe their drug. Of course, that’s never the stated rationale for the study, since no institutional review board (each institution that takes part in a clinical trial must have an internal IRB that approves the study) is supposed to approve a trial whose only purpose is to sell more drugs.

So how do they slip by? One clue came from FDA deputy commissioner Janet Woodcock’s comments yesterday to the Drug Information Association, which is primarily made up of drug industry professionals. It’s the FDA’s job to monitor IRBs,

According to FDA Webview (subscription required), Woodcock revealed the agency does not have an internal database listing all IRBs. And although it published a proposed rule in 2004 requiring registration of IRBs, the agency is still reviewing public comments. She gave no timeline for its final publication. Moreover, she told the DIA, the agency has issued almost no standards for the field.

While the public thinks most clinical trials are run by university-based scientists subjected to strict oversight by their local IRBs, the field in recent years has been infiltrated by for-profit IRBs loosely affiliated with for-profit contract research organizations, which are playing a greater and greater role in industry-funded research. These organizations often turn to practicing physicians, who can earn extra cash by recruiting their patients for clinical trials.

Woodcock admitted the agency’s regional offices, who are responsible for overseeing this sprawling enterprise, do not have the capacity or the expertise to monitor this activity. It will be interesting to see if the FDA reform legislation that will be introduced in August by Senators Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) will beef up this crucial agency function.

Planting Seeds, Drug Industry Harvest

Do seeding trials cause doctors to prescribe more drugs from the company sponsoring the trial? Seeding trials, for those not familiar with the concept, are clinical trials on drugs that have already been approved by the FDA. Companies claim they are designed to show the drugs work for different indications, some of which is legitimate. But mostly it's a way to introduce doctors and their patients to me-too drugs entering a crowded field. How else can one explain a trial designed to show that a pain pill works not only on elbows, but on knees, too?

That’s why a new study out of Denmark appearing in today’s Journal of the American Medical Association offers some insight into this phenomenon. The authors compared the records of patients in post-marketing clinical trials for an asthma inhaler to patients in normal practice diagnosed with asthma. They found the prescription rate in both groups was almost exactly the same (about 70 percent), but that physicians in the trials increased their use of the sponsors’ drugs from 52.9 percent to 58.7 percent after two years while those in routine practice actually saw the use of those drugs decline slightly (52.8 percent to 51.9 percent).

This evidence suggests that when doctors sign their patients up to participate in a seeding trial, the drug companies get what they pay for. An excellent accompanying editorial (subscription required) by Bruce Psaty and Drummond Rennie reviews the voluminous literature on the drug industry’s influence over physician prescribing patterns, and concludes:

Practicing physicians and disinterested scientists need to recognize and acknowledge these forms of potential influence by the pharmaceutical industry. Agreeing to work as an investigator in industry-sponsored trials may represent a commitment to an effort that is more or less a scientific endeavor and, at the same time, a marketing initiative.

More importantly, the scientific rationale for launching thousands of small short-term trials remains unclear. The health of the public would be better served by the conduct of fewer small short-term studies and more well-designed large long-term trials. . . that fully address the health risks and benefits of pharmacological therapies used for chronic conditions.

Epitaph for the Bush Health Care Plan

Every once in a while I run across a quote I just have to give wider circulation on the web. I'm reading up on people and organizations dealing with how to solve the health care mess. Donald Berwick runs a group out of Cambridge, Mass. called the Institute for Health Care Improvement, which is trying to improve the quality of care most Americans receive. In an interview with Health Affairs 18 months ago, here's what he had to say about the president's plan to move toward health savings accounts and make individual "consumers" more financially responsible for their own health care choices:

I do not believe that making the individual American patient more “cost-sensitive” has any rationale in science, ethics, or evidence. It will fail, and it will fail miserably. It will result in a shifting of care away from the people who need it the most. It is a displacement of responsibility for changing the system. You know, if CalPERS or Xerox or GE can’t change care through using its purchasing power, then I absolutely promise you that Mrs. Jones can’t. The idea that she will now be more sensitive because she pays an extra ten bucks out of pocket is, to me, nearly stupid.

Integrity in Science Watch -- June 19

Groups Protest EPA Choices for Evaluating Pesticide
The Environmental Protection Agency's candidates for reviewing a staff analysis of the carcinogenicity of a common sterilizing agent drew a sharp protest from 15 health and labor advocacy groups last week. The Natural Resources Defense Council, Service Employees International Union, and the Center for Science in the Public Interest among others asked EPA to remove three scientists who co-authored an industry-funded study on ethylene oxide (ETO) risks. The letter suggested they be replaced with independent health and occupational experts to balance the other industry consultants tentatively named to the committee. In 2004, Christopher Kirman and Michael Gargas from The Sapphire Group and Mary Jane Teta from Exponent conducted an industry-funded study recommending values for cancer risk about equal to those that were generated from the EPA's draft three years earlier, which those same authors helped write. The EPA is reviewing the carcinogenicity of ETO for its Integrated Risk Information System (IRIS) database, which numerous government agencies in the U.S. and around the world use to determine health risks.

Meanwhile, the EPA's Office of Pesticide Programs is conducting its own risk assessment of ETO in order to meet an August deadline for re-registering the chemical. Comments submitted last fall by producers and users of ETO slammed the OPP's draft risk assessment. The industry groups complained that the OPP's preliminary standard, 180 times stricter than the Occupational Safety and Health Administration's standard of 1 ppm for exposed workers, is impossible to achieve.

Time Runs Andrew Weil Advertorial
This week's Time Magazine includes a column by Dr. Andrew Weil touting the benefits of fish oil supplements. The column was sparked by a recent report in the Journal of the American Medical Association showing that fish oil supplements did not reduce the risk of serious abnormal heart rhythms. The article failed to disclose that Dr. Weil sells his own brand of fish oil supplements on his website.

Pfizer's NIH Researcher Gave Firm Tissue Samples
A top-ranked National Institutes of Health researcher who failed to comply with the agency's conflict-of-interest disclosure policy provided pharmaceutical giant Pfizer government-owned tissue samples. In a report released last week, House Energy and Commerce Department investigators concluded Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, failed to tell agency officials about his arrangement with Pfizer Inc. after sending the company thousands of NIH fluid samples he had worked on for Alzheimer's research. Sunderland received over $500,000 in consulting fees from Pfizer. The House investigators were tipped off by a former NIMH scientist who had worked with Sunderland and was unable to locate spinal fluid samples she had collected in the 1990s. Sunderland pleaded the fifth amendment when called by the committee last week. He had previously blamed his failure to disclose the conflict of interest on his office staff. The case has caused NIH to clarify its rules for managing tissue samples. "All transfers of human samples will require an appropriate agreement signed off by a senior official," said NIH spokesman John Burklow.

Texas Crony Sought White House Help to Weaken Rule
Four years after Texas oilman Ernest Angelo made a special appeal to hunting buddy Karl Rove, the EPA last week approved a weakened rule that aims to decrease groundwater contamination from oil drilling and construction sites, the Los Angeles Times reports. Angelo, a former mayor of Midland, told the White House's top domestic adviser that a more comprehensive groundwater rule from an early EPA draft would cause "our strongest supporters to openly express doubt as to the merit of electing Republicans when we wind up with this type of stupidity." Rove promised Angelo that the administration would consider the "economic, energy and small business impacts" of the rule. In 2005, the EPA draft was changed by the White House's Office of Management and Budget (and now finalized) to allow sediment from energy production sites to flow freely into streams and underground water. "We can't say that Karl Rove walked over to OMB and demanded these changes," said Sharon Buccino, director of the Natural Resources Defense Council's land program. "But it is clear that there was direction coming from the top of the White House."

Industry Asks OSHA to Limit Access to Documents
Industry groups have asked the Occupational Safety and Health Administration to deny a former high-ranking employee access to its data on OSHA inspectors' exposures to toxic beryllium, according to Inside OSHA. Adam Finkel, who resigned from the agency in January, wanted the documents for an academic research project. Industry officials claimed turning over the documents would disclose confidential commercial or trade secret information, threaten national security and initiate new lawsuits. Finkel, now a professor of environmental and occupational health at the University of Medicine and Dentistry of New Jersey, has filed a Freedom of Information Act suit against OSHA.

FDA Opposing Conflict-of-Interest Waiver Ban
Top FDA officials continue to speak out against an amendment to the agency's appropriations bill that would ban physicians with direct ties to drug and device manufacturers from sitting on FDA advisory panels. That amendment, sponsored by Rep. Maurice Hinchey (D-NY), passed the House last month and is now before the Senate. Center for Devices and Radiological Health director Daniel Schultz told a Medical Device Manufacturers Association meeting in Washington last week that the bill "could present major, major problems for the agency" by denying it needed expertise, according to the online publication FDA Webview. The Center for Science in the Public Interest, which backs the bill, says there are numerous experts without financial ties to regulated firms that could serve the agency equally well.

Odds and Ends
The House of Representatives Science Committee rejected an amendment to the National Oceanic and Atmospheric Administration appropriations bill that would prohibit NOAA supervisors from punishing employees who disseminate scientific research. . . The British Medical Journal is reporting that the International Obesity Task Force, which is closely affiliated with the World Health Organization and became part of the non-profit International Association for the Study of Obesity in 2002, draws two-thirds of its funding from Hoffman-La Roche, which makes the antiobesity drug orlistat (Xenical), and Abbott Laboratories, which makes sibutramine hydrocholoride (Reductil). . . The revolving door is swinging at the Food and Drug Administration as deputy commissioner Steve Niedelman departments the regulatory affairs office for a job at Quintiles, the clinical trials consultancy. . . The Energy Department's National Coal Council defends its lack of environmentalists by claiming none wanted to be associated with the coal industry officials who dominate the advisory panel. The Natural Resources Defense Council told Inside EPA it would likely accept an offer to join.

Genentech Moves to Block Cheap Blindness Drug

From today's Guardian (UK):

Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients.

But Genentech, the company that invented Avastin, does not want it used in this way. Instead it is applying to license a fragment of Avastin, called Lucentis, which is packaged in the tiny quantities suitable for eyes at a higher cost. Speculation in the US suggests it could cost £1,000 per dose instead of less than £10. The company says Lucentis is specifically designed for eyes, with modifications over Avastin, and has been through 10 years of testing to prove it is safe.

The Health Insurance Elephant in the Room

Does employer-based health insurance have a future? If not, what will replace it?

This is a fairly interesting way of presenting America’s health insurance crisis, which has left 45 million Americans uninsured and health care costs skyrocketing out of control. Paying doctors, hospitals, drug companies, device manufacturers, West African aides in our nursing homes and the like now gobbles 16 percent of the Gross Domestic Product, a full six percentage points greater than any other industrialized nation. Rising health care costs are contributing to the demise of some of our great industrial giants, yet we have health outcomes that rival Cuba and Ireland. Even the average Englishman – with his collapsing national health service, long waits for basic care, and bad teeth (it must be true, I read it in the New York Times) – outlives his American counterpart by a full year. Poor bugger.

In the face of this crisis, our Washington political leadership either a) ignores the issue (the Republican Party) or b) suggests incremental reforms like Sen. Hillary Clinton’s proposal to insure all kids. When a few states like Massachusetts and Oregon launch interesting experiments, the media cannot be bothered to spend more than a day on the story.

So I went out of my way this morning to attend a forum at the Brookings Institution, co-sponsored by the New America Foundation, that asked the two questions that led off this brief note. We often forget that the American system of providing working people with health insurance through their place of employment is rather unique, a product of employer efforts to attract and keep workers during World War II when the government imposed wage and price controls on the economy. But given what’s going on today – people changing jobs every couple of years; more and more contingent workers (I’m not laid off, I’m a consultant!); fewer and fewer small employers offering insurance; behemoths like Wal-Mart thumbing their nose at this basic social obligation – it would appear that this particular manifestation of American exceptionalism is headed for the scrapheap of history.

The New America Foundation would like to put itself at the head of a parade sending employer-based health care into oblivion. Len Nichols, director of its health policy program, positively kvelled at the support expressed this morning for NAF’s pet reform: requiring people to buy health insurance the same way states require people to get car insurance. The implication, of course, is that the tax break for employer-paid health care will be repealed, employers will stick the money they now spend on health care into worker paychecks, and empowered consumers will march off into the insurance marketplace to buy policies that fit their needs.

Strong support for this approach came from Todd McCracken, president of the National Small Business Association, few of whose members provide comprehensive health insurance in the first place and even when they do, usually require onerous co-pays and deductibles to help meet the pricetag of an insurance marketplace that routinely offers inordinately high prices to individuals and small groups. No one should really blame small businesses for screaming, “Let me out of here.”

Leave it to Brookings’ Henry Aaron, the aging don of health care economists (today was his 70th birthday, he informed the crowd, which means we were born on the same day), to add a dose of reality to the proceedings. Employer-based health care “works for most us,” he reminded the audience. It does so because “it pools risk – good risks and bad risks – as part of a single group.” Who will want to insure the 55-year-old with emphysema from a lifetime of smoking? Setting individuals loose in the marketplace, even with subsidies, will never work because the only way to provide health insurance at a reasonable cost is to “pool large numbers of people and charge people average costs. You have to pool somehow,” he said.

Andrew Stern of the Service Employees International Union gave the opening address and made the moral plea for a universal plan. But after listening to his poignant anecdotes about working moms who lost children because they couldn’t afford to pay a $900 hospital bill, Ron Brownstein, the veteran political reporter of the Los Angeles Times, poked his inquisitive finger in the obvious hole in Stern’s presentation. So what would you replace it with?

Stern said he didn’t care with one notable exception. You could expand the system that currently offers federal employees a choice of insurance plans; you could go with an individual mandate with subsidies; you could set a national standard, turn over all the money in Medicare and Medicaid to the states and let them figure it out, he said.

But Stern, whose union led the breakaway from the AFl-CIO last year and is considered a darling among sections of what the folks at the Nation call “the left,” folks at The American Prospect call “progressives,” and folks who belong to Hillary’s vast right-wing conspiracy call Liberals, definitively ruled one option off the table. On this signature issue, he came down squarely in the camp of the centrists. “Medicare for all” ain’t happening, he said. “We’re for choice of doctors and plans. There’s going to be multiple payers, not a single payer in America.”

For the record: All but two of the nearly 30 countries now considered part of the advanced industrial world have some form of national health insurance. All of them spend substantially less than the U.S. on health care. More than half have better health outcomes based on traditional measures like longevity.

Americans are craving, to use the words of Andy Stern, health care that is affordable, universally available, and of high quality. Amen brother. But there’s an elephant in the room when no one in the political firmament – left, right or center – is willing to even talk about how the rest of the world goes about achieving it.

Fake Drugs Plague Developing World

The development of artemisinin, a traditional Chinese medicine for treating malaria, represents one of the past quarter century's great triumphs in fighting infectious diseases of the developing world. A few years ago, the World Health Organization made a drug combination including artemisinin the first choice for treating malaria in most parts of the world.

However, the latest issue of PLoS (Public Library of Science) Medicine reports on the growth of a huge counterfeit industry selling bogus artemisinin pills in Southeast Asia. The fear now is that the proliferation of these "knock-offs," which are in fact not artemisinin at all, will soon spread to Africa and undermine nascent efforts to deploy this powerful drug.

Hillary's Sister Souljah Moment

The progressive movement held a massive pep rally at the Washington Hilton over the past two days. They gather every year around this time and it is testimony to the angry mood among at least part of the nation's electorate that all the leading candidates for the 2008 Democratic presidential nomination showed up. I went last year, and got to hear a few backbench Congressmen from Illinois, California and Ohio. Today, it was Hillary.

And what she had to say wasn't encouraging. On the war in Iraq, she offered the Democratic centrist view that we must "stay the course" in Iraq. No timeline for withdrawals. The centrist "wisdom" is to project toughness. We'll prosecute the war (is this really a war?) better than President Bush. She got booed for her efforts. I'm sure her handlers were pleased. What better way to cement your centrist credentials than to get booed at a leftist confab.

Sen. John Kerry, to his credit, finally saw the light and admitted he was wrong to vote for the war resolution because, as he put it, he was lied to by the administration. Him and 300 million others.

Iraq isn't Vietnam. The insurgency there is not broad-based or motivated by an ideology that can win widespread backing. But the two situations do have one thing in common. The U.S. has irretrievably lost the good will of any Iraqi who cares about his country.

I found a piece on NPR today enlightening. It recounted the various stories told by differing government officials over time about the permanent bases the military is building in Iraq. Sen. Clinton's embrace of a semi-permanent presence in Iraq is her effort to show the military that she is tough enough to be commander in chief. To my ears, that means that if she is elected, she will continue to prosecute the war, or whatever it is you want to call the steady drumbeat of drive-by bombings and shootings that are taking place in Iraq.

Vietnam? Got rid of Johnson and got Nixon. Iraq? Get rid of Bush and get . . . ?

What Next? Body Parts?

The headline over David Willman's December 2004 investigation in the Los Angeles Times read: "Dr. P. Trey Sunderland III: $508,050 from Pfizer, but 'No Outside Positions to Note.'" A story that began as a failure to disclose gross conflicts of interest has now morphed, allegedly, into a profiteering scheme using human tissue samples drawn from vulnerable seniors.

According to a story out today, the House Energy and Commerce Committee unveiled a 26-page report accusing Sunderland of essentially selling Pfizer 3,000 NIH samples of human spinal fluid and plasma taken from patients with Alzheimer's disease. His price tag, according to press accounts? $285,000.

Sunderland's lawyer released a statement saying his client, who is still employed at NIH, "acted legally and ethically . . . There is no connection between his receiving funds from Pfizer and Pfizer's access to any tissue samples."

Integrity in Science Watch -- 6/12/06

Each week, the Integrity in Science project at the Center for Science in the Public Interest publishes Integrity in Science Watch. Here's the latest:

EPA May Pick Chem Industry Consultants to Review Ethylene Oxide Update

The Environmental Protection Agency has proposed naming three scientists with current or former ties to ethylene oxide manufacturers to peer review the final draft of a health assessment for the chemical. The International Agency for Research on Cancer considers ethylene oxide (ETO) a known carcinogen. Environmental and labor groups are preparing a challenge to the committee's make-up, which must be filed by Thursday.

Ethylene oxide is used to manufacture ethylene glycol and for sterilization of medical equipment, spices and other agricultural products. In the mid-1980s, the Occupational Safety and Health Administration adopted a stringent one-part-per-million standard on workplace exposures based on a California analysis showing ETO slightly increases leukemia among exposed workers. Last fall, a preliminary draft of the new health assessment drew heated protests from industry groups because it might lead to significantly lower thresholds for regulating the chemical. The EPA has not yet released the final draft.

In late May the agency published a list of 31 proposed nominees to a Scientific Advisory Board panel that will review the final draft when it is published. The list included three consulting toxicologists who published a 2004 paper in Risk Analysis concluding that exposures many times higher than the OSHA standard "are not likely to pose an appreciable risk of leukemia in human populations." That paper contained no conflict-of-interest disclosure. However, the three industry consultants, Christopher Kirman and Michael Gargas of the Sapphire Group and Mary Jane Teta of Exponent Inc., either are currently serving on or previously served on the American Chemistry Council's Ethylene Oxide Industry Council, according to the EPA website and a 2001 email communication received by the Natural Resources Defense Council. The editor-in-chief of Risk Analysis recently joined Exponent.

The chemical industry is pushing for a new cancer risk assessment in time for the EPA's August deadline for re-registering the chemical as a pesticide. An assessment based on industry-funded science and peer-reviewed by the industry consultants who conducted that science could lead to weaker pesticide regulations and OSHA standards. Protests over the make-up of the panel should be addressed to Sue Shallal at shallal.suhair@epa.gov.

Tobacco Scientist Moves On to Particulate Matter

A new industry-funded study downplaying the risks of particulate matter (PM) was authored by a researcher who previously published studies downplaying the risks of second-hand smoke, documents available at the Legacy Tobacco Documents Library at the University of California at Los Angeles show. The Electrical Power Research Institute hired James E. Enstrom of the University of California at Los Angeles to analyze 30 years of air pollution data. His recently published analysis, which showed PM had no effect on mortality after the initial ten years of the study, is now being used by industry trade groups in their letters to the EPA arguing against a tighter PM standard. Enstrom's study, published in Inhalation Technology, was subsequently questioned in the same journal by Bert Brunekreef, a highly-regarded professor of environmental health at Utrecht University in the Netherlands.

In 1997 Enstrom asked Philip Morris scientific affairs director Richard Carchman for $150,000 to study the link between environmental tobacco smoke and mortality rates. "A substantial research commitment on your part is necessary in order for me to effectively compete against the large mountain of epidemiologic data and opinions that already exist regarding the health effects of ETS and active smoking," he wrote. In 2003, Enstrom's study, "Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians, 1960-98," concluded that it is "premature to conclude that environmental tobacco smoke causes death from coronary heart disease and lung cancer." The study appeared in the British Medical Journal, after being rejected by the Journal of American Medical Association. Enstrom recently founded the Scientific Integrity Institute, which offers "epidemiologic research services . . . designed to investigate weak and/or controversial epidemiologic relationships with the highest level of scientific integrity." The example posted on the site is his 2003 tobacco study.

Top Allergy Journal Will Publish Contributors' Conflicts of Interest

The nation's leading allergy journal now requires authors to publish their ties to industry whenever their articles appear in that journal. The Journal of Allergy and Clinical Immunology, the official scientific journal of the American Academy of Allergy, Asthma and Immunology, recently adopted new guidelines requiring authors to disclose consultant arrangements, stock or other equity ownership, patent licensing arrangements, and expert witness testimony. Editor-in-Chief Donald Y.M. Leung initiated the policy change after the Center for Science in the Public Interest uncovered the journal's failure to report that a review on the health risk of mold exposure had been authored by two key defense witnesses in mold liability lawsuits. (See Integrity in Science Watch, 3/31 and 4/24)

Bisphenol A: Who Did the Research Matters

Industry-funded research on a common chemical used in making plastics found no significant health effects in low-dose animal experiments while comparable government-funded studies found significant effects, a new article in Environmental Research says. University of Missouri biology professor Fred vom Saal's review of 109 government studies concluded bisphenol A (BPA) affected the hormones of lab animals, with forty showing the effects occurred at exposure levels below the Environmental Protection Agency's currently acceptable dose (the so-called reference dose). Meanwhile, all 11 studies on BPA funded by industry found no significant effects. Vom Saal concluded that the industry-funded studies were part of a campaign by the chemical industry to have the EPA and the Food and Drug Administration ignore the conclusion of the [National Toxicology Program] Low-Dose Peer Review panel that found there is credible evidence the chemical has negative health effects at low-dose exposures.

Good News for Coffee Drinking Boozers (like me)

Finally, somebody has offered scientific support for my lifestyle.

Actually, I don't drink all that much (isn't that what we all say?). Still, I was heartened to read this evening in the latest Annals of Internal Medicine that people who drink lots of coffee and are prone to cirrhosis of the liver because of heavy drinking are much less likely to come down with the disease than people who choose tea and other methods of keeping hangovers at bay.

According to researchers Arthur Klatsky and colleagues at Kaiser Permanente Medical Program in Oakland, California, heavy drinkers who drink four or more cups of coffee a day (how did they know?) have just 20 percent of the risk of developing liver cirrhosis compared to people who do not drink coffee. The same was true for people who are not heavy drinkers but develop liver cirrhosis, a rarer phenomenon. However, the results in the latter case were not statistically significant. Still, "these data support the hypothesis that there is an ingredient in coffee that protects against cirrhosis, especially alcoholic cirrhosis," the researchers concluded.

Of course, as part of my campaign to always report absolute risk as well as relative risk, this good news is leavened by the fact that just a shade under 200 of the 125,000 people interviewed for the study developed cirrhosis of the liver due to alcoholism. So while a reduction of 80 percent sounds good, the odds for most people of contracting the disease are fairly low - especially if they are moderate drinkers.

Pediatric Cancer Research Needs Reform

Here's a column I contributed to Bay Area Oncology News, a West Coast publication whose latest issue just arrived in physicians' offices:

Combating childhood cancer is one of oncology’s greatest success stories. While cancer in children remains, thank goodness, rare, it still strikes about 14,000 kids a year and kills about 3,000, making it the second leading cause of childhood mortality after suicide.

But the field has made tremendous strides in recent years. While some tumors of the central nervous system remain stubbornly resistant to treatment, many forms of childhood cancer like acute lymphoblastic leukemia are approaching an 80 percent cure rate. That disease’s cure rate was near zero in the 1950s.

What accounts for this progress? Every form of childhood cancer is, by definition, a rare disease. Therefore, it usually receives less than adequate attention from the pharmaceutical industry. Clinicians who want to investigate potential treatments usually turn to the National Cancer Institute’s Children’s Oncology Group (COG), which knits the nation’s 200 children’s hospitals into an effective network for carrying out clinical trials.

The COG has had remarkable success over the years in encouraging community oncologists to enroll their underage cancer patients in clinical trials. Fully 94 percent of the children diagnosed with cancer in the U.S. are treated at institutions affiliated with COG, and more than 60 percent enroll in trials.

But much remains to be done. At a meeting last fall of the pediatric subcommittee of the Food and Drug Administration’s Oncology Drugs Advisory Committee, officials laid out the dimensions of the problem. There are the 169 generic cancer drugs on the market that, although they are still in widespread use in adults, have no pediatric labeling and no pediatric dosing information because they were never tested in kids. And since they’re off patent, no drug company has a stake in testing them, even with the incentives created in the 2002 Best Pharmaceuticals for Children Act (BPCA)

That bill grants six months of additional exclusivity if a company tests its drug in children. While that’s great for drugs that have been on the market for a while and are still on patent, it does nothing for generics.

New cancer drugs coming to market are another matter entirely. Since 2003, they’ve come under the Pediatric Research Equity Act, which requires drug companies to conduct pediatric tests for every new drug brought to the FDA as long as there is a potential use in the underage population. “But most of the blockbuster cancer drugs are for diseases that don’t exist in children – cancers of the breast, colon and lung,” said Gregory Reaman, chairman of the pediatric subcommittee and of COG. “The existing incentives are not enough.”

Indeed, the existing incentives can be abused. Earlier this year, the FDA sent out a press release marking the 100th drug that had been given six months additional patent life under BPCA. One of the seven cancer drugs on the list was fludarabine, which had been approved in 1991 for chronic lymphocytic leukemia, a cancer that does not strike anyone under 30.

How did that happen? In 2003, fludarabine was approaching the end of its patent life. So Berlex, its maker, conducted a trial in 62 children, according to FDA documents, thus meeting the requirements of the law. When the company got its six-month extension, the FDA felt compelled to note that the data was insufficient “to establish efficacy in any childhood malignancy.”

Officials at COG are hoping the National Cancer Institute will step up its efforts in testing off-patent cancer drugs in kids. At last October’s meeting, the agency promised to develop a priority of list of 15 to 20 drugs and invite proposals from pediatric oncologist specialists around the country. Dosing trials are already underway on vincristine, dactinomycin, and methotrexate. Other generics high on COG’s wish list include cisplatin, etoposide, and cyclophosphamide.

The focus on older drugs defies conventional wisdom, but conforms to the lessons learned over the years at COG. Earlier this year, the British Medical Journal published a survey of 126 randomized, controlled clinical trials carried out over the past 45 years by COG. The reviewers, led by Dr. Benjamin Djulbegovic of the University of South Florida, found that a new treatment or regimen in the trials was just as likely to be inferior to standard treatment as superior to standard treatment.

While the authors were primarily concerned with shoring up the ethics of putting children into randomized clinical trials (if you knew a new drug or regimen was going to be better, it would be unethical to put someone on the standard regimen), it concomitantly proved that new isn’t always better. Indeed, the reviewers found that “industry sponsored trials are associated with increased likelihood of outcomes favoring sponsors, most likely due to selective reporting of favorable outcomes and violation of the uncertainty principle in the design of the trials.”

This meta-analysis of childhood cancer testing is a powerful argument in favor of increasing the amount of government funding for objective clinical trials. Conversely, the early experience of the Best Pharmaceuticals for Children Act calls into question the wisdom of incentives like patent extensions, at least when it comes to cancer drugs.

Industrial Policy for Big Pharma

I am one of many guest bloggers on Steve Clemons' The Washington Note this week. Steve's a long-time acquaintance and colleague who now is vice president at the New America Foundation. Here's my offering for tomorrow:

I first met Steve Clemons in Japan in the early 1990s when industrial policy was the subject du jour for up-and-coming policy wonks like him and sympathetic journalists like myself. How can we resuscitate America’s manufacturing base to compete against the Japanese threat, we wondered.

Times change. These days, most Democrats wouldn’t be caught dead uttering the “IP” word while this morning I attended a session in Washington sponsored by the free-market Manhattan Institute that was promoting a government-led industrial policy to replenish the pharmaceutical industry’s new product pipeline, which has slowed to a trickle in recent years. Robert Goldberg, the vice president of the Manhattan Institute’s Center for Medical Progress, even referred to his proposal as a “Sematech consortium” for the drug industry.

It gets better. The confab’s keynote speaker was Andrew von Eschenbach, the Texas cancer surgeon and Bush family friend who recently decamped from the National Cancer Institute to run the Food and Drug Administration. One of the panelists was Janet Woodcock, now the chief of operations at FDA after running its Center for Drug Evaluation and Research, which makes her the highest ranking career bureaucrat at the agency. Quite a coup for the free marketers at the Manhattan Institute: Top Bush administration officials showing up to back industrial policy.

What’s up? Despite the billions poured into pharmaceutical industry and government-funded biomedical research in recent years, new product approvals at the FDA dropped to 20 new drugs last year, down from 34 the year before and about half the level of the mid-1990s. Genomics, proteomics, metaboleomics – we know more about how the body works than ever before and we still don’t know how to cure our most intractable medical problems: incurable cancers (most of them); dementia in its multiple forms; neurological disorders like Parkinson’s and Lou Gehrig’s disease; many forms of heart disease.

Moreover, the drug industry blockbuster economic model is clearly dying. To maintain the profits to which they’ve become accustomed, they need to sell their drugs to tens of millions of people. By definition that means a one-size-fits-all approach, often promoted by direct-to-consumer advertising and the thinly disguised bribery known as physician detailing. That approach winds up subjecting millions of people to inappropriate care. If you want to see where that road ends up, track Merck’s stock over the past three years.

The scientists on the cutting edge of drug discovery, whether at government regulatory agencies, in universities or at drug and biotech company labs, understand better than anyone that the old model no longer works. Two years ago, Woodcock authored a report calling for creation of a “critical path” initiative to identify technologies that can help translate the wealth of basic science knowledge generated over the past several decades (the Human Genome Project, the microbiology knowledge generated by the War on Cancer, and more recently the War on Bioterror) into therapeutic products that might actually help someone who is sick.

The scientists brought together by the Manhattan Institute sketched out some of the more intriguing ideas on this critical path. Can we use genetic markers identified in people who suffer the relatively rare side effects of drugs to create diagnostic tests that will enable physicians to pre-screen people before prescribing widely used medicines like statins (to lower cholesterol) or painkillers? When a new cancer drug like Iressa works in only 5 or 10 percent of the patients who have lung cancer, can we generate a test that will identify which patients will actually benefit from the drug by identifying the mutations that are specific to their tumor? You've probably heard the phrase “personalized medicine.” It will take some critical thinking about how we test and approve drugs to get there.

To get the ball rolling, the government has created the Critical Path Institute under the leadership of University of Arizona pharmacologist Ray Woosley, who had been touted as a potential FDA chief if Al Gore had won the 2000 election. In the Institute's first effort at reducing drug industry development costs, it has lined up 12 major pharmaceutical companies in a consortium that will share data on pre-clinical toxicology testing – the kind of information that previously was never shared because it might help competitors by identifying failed pathways you’ve already trod. “We’re essentially like Sematech,” said Jeffrey Cossman, the chief scientific officer at the Institute.

The Institute's efforts are nascent. The FDA has been systematically underfunded by a succession of administrations and now relies on industry user fees for nearly half of its budget. Therefore, it doesn’t have much money to devote to the critical path. But it was clear from today’s meeting that the highest levels of the agency are committed to the process. Industrial policy for Big Pharma will have bi-partisan support no matter who wins the next election.

The old industrial policy wonk in me is intrigued by this effort. But I see some real problems down the road. More rapid drug approvals and regulatory approval of tests based on genetic markers will hinge on accepting surrogate markers of drug efficacy (rather than tried-and-true clinical trials) and elegant theories of genetic causation that may or may not be true.

Let me give just one an example. Today’s imaging technology can show the sugar uptake of fast-growing cancer cells. Successful cancer drugs dramatically slow sugar uptake. So, in theory, if one sees that in an image test, it is a sign they are not growing so quickly anymore. One way to bring drugs to market more quickly is to use that imaging technology to show the drug candidate has slowed the uptake, and base the approval on it.

But does that mean the person with cancer who takes that drug will actually have their tumor shrink? Does it mean it will add years to their lives? Or months? Or will it turn out to be just one more false hope in the long war on cancer?

The answers to those questions can only be determined by controlled clinical trials, which have been the gold standard at the agency for nearly half a century. I heard a lot of talk about the rapid advances in basic science today, but I didn’t hear the phrase “clinical trial” mentioned once. If the “critical path” turns out to be a subterfuge for getting around the FDA’s current requirement that hard, clinical evidence of efficacy is needed before a new drug gets approved, the agency’s leadership, the companies, the institutes and think tanks that have signed onto this agenda will run into a justifiable consumer (and payer) revolt. It is inevitable that some of these elegant scientific theories will turn out to be false premises.

The Insurance Industry Take on Global Warming

Last week, I wondered aloud why the insurance industry was financing some prominent global warming skeptics. Environmental Science & Technology reporter Paul Thacker wrote me today pointing out that the industry has a long-standing interest in global warming studies, and over the years has supported research by a range of scholars. He also alerted me to a fascinating interview he conducted with Evan Mills, a staff scientist at the U.S. Department of Energy’s Lawrence Berkeley National Laboratory, who closely monitors the insurance industry's response to global warming. One interesting factoid: weather related insurance losses in 2005 approached $80 billion, four times the losses of 9/11.

Here's Evans on why they're so concerned:

Insurers are better equipped to understand and evaluate the science than most other industries, and they have no particular vested interest in propping up polluting industries. To the contrary, pollution liability is one of the emerging (often insured) risks that keep them up at night. They are also more vulnerable to the impacts; they can’t afford to overlook or be wrong about the science. Insurers who have looked at the climate-change issue closely see more burdensome economic costs from inaction than from prudent action, and, in fact, they are developing business opportunities associated with climate-change mitigation and adaptation solutions. They are also quick to recognize that investments in reducing greenhouse-gas emissions can be highly cost-effective in terms of reduced energy expenditures.

Will Single-Payer Solve Our Health Care Woes?

I just returned from a forum at the Center for American Progress where an all-star cast of Times columnist Paul Krugman, CAP senior fellow Gene Sperling, Times reporter Louis Uchitelle and Economic Policy Institute economist Jared Bernstein weighed in on the growing inequality in the U.S. economy. Other than Uchitelle, who didn’t address the topic, all seemed to agree that health care is going to be one of the, if not the, major domestic issue of this election and for years to come.

Krugman and Bernstein held up the left flank admirably, calling for a single-payer system to replace our truncated insurance-based system that provides worse health outcomes at twice the price. Not a very good advertisement for free-market approaches to providing this social good. “We have a society now in which people face a lot of gratuitous risk,” Krugman said. “The aggregate cost of health care is well known. Why make individuals absorb that risk?”

Sperling, who was a key figure in the President Clinton’s 1993-94 health care fiasco, seems to have retained that administration’s fervent embrace of small bore reforms that won't solve really big problems. While he admitted corporate America's growing demand to get out of its current health care obligations could well be the trigger for another massive reform effort, the best he could come up with was a program for “health care between jobs” for those who get downsized, outsourced, laid off and otherwise cast aside by our ever changing and globalizing economy.

I was disappointed by all the presentations on this vital topic. I’m a big backer of “single-payer,” “Medicare for all,” or whatever you want to call nationalized health care. After all, why shouldn’t we join the rest of the industrialized world? But it’s not the ultimate answer to our health care problems. It will deal with the uninsured. It will eliminate the 15 to 20 percent of health care costs absorbed by duplicative administrative waste. But that’s a one-time saving. Then we’re right back to health care spending rising at two to three times the rate of inflation.

Until we deal with why Americans are sicker than our counterparts in Europe and eliminate the waste in much of the new technology that is driving health care costs skyward, we’ll never get our health care costs under control.

Integrity in Science Watch -- June 5

Pesticide Industry Influenced EPA's Policy Allowing Testing on Children
The Bush administration approved the new chemical testing rules that would allow children to be exposed to pesticides after agrochemical industry lobbyists met with government officials in a closed session, according to notes from the meeting obtained by Public Employees for Environmental Responsibility (PEER). Crop Life America and Bayer Crop Life Science representatives met with Office of Management and Budget and Environmental Protection Agency officials in August of 2005, one month before the EPA announced its new policy on human testing. The current policy, which went into effect this January, states that "all third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA is banned." The meeting notes from August show former top EPA official and current chemical company lobbyist, James Aidala, wrote, "Some workers may legally be children..." referring to pesticide dosing which would be unintentional, and therefore acceptable under the administration's policy. The EPA rules "also allow chemical testing on children if it is not a pesticide, or if it is a pesticide being tested for reasons other than registration," said Jeff Ruch, PEER Executive Director.

House Protects Public's Right to Know about Pollutants
The House of Representatives overwhelmingly voted in mid-May to maintain annual public disclosure of industries' toxic emissions data after massive public protests against an administration plan to reduce the reporting requirement. The amendment, introduced by Reps. Frank Pallone (D-NJ) and Hilda Solis (D-CA), prohibits the Environmental Protection Agency from spending money to make the Toxics Release Inventory (TRI) a biannual report or increase by tenfold the minimum levels requiring reporting. The EPA received more than 100,000 public comments and the House received a letter signed by nearly 200 environmental and health organizations protesting the proposed changes. "Lawmakers have sent a clear message to the EPA that they and their constituents value the public's right to know about toxic pollution," said Sean Moulton, director of federal information policy for OMB Watch. The EPA appropriations bill amendment now moves to the Senate.

Mum's the Word for Northwest Salmon Scientists
National Oceanic and Atmospheric Administration scientists working on West Coast salmon issues were told to route all media questions to headquarters in Washington, D.C. after a Washington Post article last month quoted scientists' positive reaction to recent decisions on salmon that ran counter to previous Bush administration policy. One decision, written by experts from NOAA and the Interior Department, said that hydroelectric dams on the Klamath, a river running from Oregon into California, "should either be removed or be rebuilt in a way that allows salmon passage." In the past, the Bush administration has asserted Western river dams must never be altered because they are part of the "environmental baseline." The gag order designated three political appointees in Washington to speak to the press about salmon issues.

Lieberman Questions Balance on National Coal Council
Senator Joe Lieberman (D-CT) is demanding the Inspector General of the Department of Energy investigate the National Coal Council's compliance with the Federal Advisory Committee Act, which requires that panels be "fairly balanced in terms of points of view represented." The Council, which recently advised Secretary of Energy Samuel Bodman to double coal consumption by 2025, is made up of almost all industry-related members and only one member from an environmental group, according to Lieberman's letter. A recent Council report failed to address clean coal technologies or costs. It also ignored Bodman's request for "a comprehensive evaluation of environmentally protective technologies such as low-impact coal mining," Lieberman said. Connecticut, where Sen. Lieberman faces a tough primary fight this August in his quest for a fourth term, is among those northeastern states most heavily impacted by acid rain caused by Midwestern power plant emissions

Environmental Journal Retracts Fraudulent Study on Chromium
The Journal of Occupational and Environmental Medicine will retract a 1997 article on chromium written under the names of two Chinese scientists after a Wall Street Journal investigation revealed that the article was actually drafted and edited by consultants for a major chromium polluter. Chemrisk, founded and directed by Dennis Paustenbach (see http://www.IntegrityinScience.org/), purchased in 1995 JianDong Zhang's original data on the link between chromium-6 in drinking water and cancer in Chinese villages. Chemrisk, which had been hired by Pacific Gas and Electric, the California utility company being sued for chromium contamination, then reworked the data to show that Zhang, who objected to the publication, had reversed his conclusion on the chromium-cancer link The JOEM retraction, signed by editor Dr. Paul Brandt-Rauf, states that the article did not comply with the journal's policy because "financial and intellectual input to the paper by outside parties was not disclosed." Since its publication, the fake article has influenced regulatory decisions on chromium, including being used by a scientific panel for a 2001 report which forced California health officials to revise a recommendation for how much chromium-6 should be allowed in drinking water.

Odds and Ends:
Two of the U.S. Appeals Court judges who ruled against allowing the Environmental Protection Agency to regulate carbon dioxide emissions failed to disclose on their financial statements that they attended an all-expenses-paid, six-day conference on the topic financed by the corporate-funded Foundation for Research on Economics and the Environment, Eric Schaeffer, director of the Environmental Integrity Project wrote Sunday in the Washington Post. . . The National Governors Association is offering states grants to promote healthy lifestyles, according to a request for applications available from its Center for Best Practices. About 14 states will get up to $100,000 to create "action plans" to improve health and wellness for constituents through worksites and in community-based programs. Corporate contributors to the new program include Altria (formerly Philip Morris; $250,000), General Mills ($100,000), PepsiCo ($100,000), and Anheuser-Busch ($75,000).

Price Competition in Cancer Drugs?

The American Society of Clinical Oncology meeting underway in Atlanta is generating lots of excitement about the next generation of targeted cancer therapies. It’s the most interesting development in cancer therapeutics since the arrival of drugs like Gleevec for one form of leukemia and Herceptin for breast cancer, which were the first targeted drugs.

While David Hamilton in Saturday's Wall Street Journal (subscription required) raised the specter these new drugs will lead to price competition, the real use for these new options will either be in combination with the older drugs or on their own after first line chemotherapy has failed.

Cancers are, by definition, the rapid proliferation of mutant cells. Simple population genetics inside the body dictates that when cancer cells are subjected to a change in the external environment – for instance, the presence of a chemotherapy drug – the mutant cells that survive and thrive become the dominant strain. Patients then need a different drug to keep the cancer at bay. That's why most chemotherapy agents when tested in controlled clinical trials extend life by a few months, and are almost never a cure.

So this new generation of cancer drugs are not like the “me too” drugs that populate the blood pressure, anti-cholesterol, or antiacid classes of medicines. They are badly needed follow-on options for desperately ill patients who, if they’re willing to put up with the side effects, deserve a chance at a few more months of life.

That’s also why the analysts quoted in Hamilton’s article who raised the specter of price competition are raising false hopes for the people or insurers who will pay for these drugs. As Andrew Pollack suggested in his story in the New York Times, many of these drugs will be used in combination with older medicines, so even if their prices come down slightly, the total bill for patients will be higher.

In any case, I doubt there will be significant price competition. It certainly won’t be at the same level as generics, which often come to market at half the price of a brand name drug going off patent. A study a few years ago by the drug-industry funded Tufts Center for Drug Development suggested new patented entries coming to market in a class previously dominated by a single patented drug led to significant price competition. But if you looked closely at the data in the study, most drugs actually came in within 10 percent of the price of the innovator’s product. When you’re talking $100,000 per year, which is the price of many of the new targeted cancer therapies, that’s no break at all.

The drug industry should be congratulated for coming up with these new options for cancer patients. But as cancer moves closer to becoming a manageable disease using a succession of drugs that extend life for six months or a year and each commands a $10,000 a month fee, one has to wonder how the health care system will be able to afford it.

Cancer therapeutics may well be the wedge for developing mechanisms for divorcing the way we fund innovation from the way we fund health care.

Rx for Physicians Debated in AMA Ethics Journal

The American Medical Association Journal of Ethics devoted its entire June issue to ways of managing drug company influence over physician prescribing practices. Articles like the "Hidden costs of free samples" and "The gift-giving influence" speak for themselves. But the debate that caught my eye began with an op-ed by Adriane Fugh-Berman and Sharon Batt calling for an end to allowing Big Pharma to financially support physicians' continuing medical education, which is a government-mandated requirement in most states. Murray Kopelow, the executive director of the Accreditation Council for Continuing Medical Education, offered a lame defense for its existing policy, which relies on conflict-of-interest disclosure and not allowing companies to design and control the content of courses. To ACCME, whose governing board includes the American Medical Association and the American Hospital Association, it's okay if every doc in the front of the room is on Big Pharma's payroll as long as they tell you that fact. I suggest you read both articles at the above link and decide for yourself who gets the better of the argument.