Amgen-Funded Docs A Majority

On NKF Panel Reviewing Amgen's Drug

In the wake of a recent study showing dialysis patients fared worse from using large amounts of Amgen's anti-anemia drug Epogen (see this GoozNews), the New York Times (registration required) reports today that the National Kidney Foundation will convene a meeting of its anemia management subcommittee to consider the new evidence. A report is expected in February.

As Alex Berenson's excellent story in the business section points out:

Some scientists complain that Amgen has until now had too much influence on the creation of the foundation’s guidelines. The most recent version of the anemia guidelines, released earlier this year, encourages more aggressive treatment than the Food and Drug Administration recommends.

“The guidelines are funded through the National Kidney Foundation by industry, by and large,” said Dr. Daniel Coyne, professor of medicine at Washington University in St. Louis. “They write guidelines that are opinion-based, by and large, and favor industry or would appear to favor industry.”

While Amgen sponsors the creation of the guidelines and donated $4 million to the foundation last year, both the foundation and the company say that the company does not control which doctors are chosen for the panel or influence their choice of treatment.

Fact: 10 of the 18 physicians currently listed on the anemia management subcommittee of the NKF that will consider the question have financial ties to Amgen, either in the form of research support or grants or through serving on its speakers committee.

Must Reading on the War in Iraq

Thomas Powers, our best chronicler of the nation's intelligence services, has a must-read op-ed in today's New York Times. Anyone who thinks that the peoples' voice on election day sealed the deal on U.S. withdrawal should read this piece.

Drug-Eluting Stents in the News

You're going to be hearing a lot about drug-eluting stents over the next week in the run-up to the Food and Drug Administration's advisory committee hearing weighing evidence about their safety. Here's a Reuthers report on the latest study from the Cleveland Clinic suggesting these tiny devices inserted in heart arteries to maintain adequate blood flow actually increase the risk of severe clots leading to heart attacks and strokes.

The report notes that it is widely rumored that the Cleveland Clinic's Steven Nissen, the president of the American College of Cardiology and a prominent drug safety critic who helped blow the whistle on Vioxx, has been named to the committee. Also on the panel, according to rumors: Eric Topol, who recently took a job at the Scripps Clinic in San Diego. Topol also worked at the Cleveland Clinic for many years and was part of the team with Nissen that wrote the 2001 paper warning about the risks from Vioxx, a warning the FDA and Merck ignored.

Next week's FDA hearing is shaping up as the most controversial this year. The agency has issued six waivers for conflicts of interest, an unusually high number for such a high profile meeting.

Best AIDS Drugs Still Unavailable to Global Poor

Even though Indian and Brazilian generic drugs for HIV/AIDS are finally flooding the developing the world (there's now more than a million people receiving treatments), Doctors Without Borders (Medicins Sans Frontieres) today launched a broadside against several drugmakers who have failed to make the latest and best versions of these crucial drugs available to poor people around the world.

Earlier this year, the World Health Organization endorsed a new heat-stable regimen for AIDS, which would be ideal for Third World countries. It's made by Abbott Laboratories. However, the company has not registered its product with a single less developed country and its list price in "second-tier" markets like Thailand is $2,200 a year. Despite protests from groups like MSF, a Washington meeting this week that brought together donor organizations like WHO, UNAIDS, and the World Bank did not take up the pricing issue.

"Donor money should not be squandered to pay for overpriced drugs. The priority is to make drug prices come down as much as possible,” said one MSF official. “International organizations, donors, and industry must overhaul their strategies to ensure that universal access to AIDS treatment for life becomes a reality – this means confronting companies and their patents.”

World Aids day is December 1.

Diabetes Assn. Still in Corporate Deals

This comes from the latest Integrity in Science Watch from the Center for Science in the Public Interest:

The American Diabetes Association continues to form million-dollar partnerships with food and pharmaceutical companies despite recent changes to their corporate fund-raising guidelines triggered by ethics concerns, the New York Times reported last Saturday. As part of a $1.5 million sponsorship deal with Cadbury-Schweppes, for instance, the ADA has allowed the confectioner to put its logo on "healthy" Cadbury products such as diet sodas, and has promoted the company as a sponsor at ADA events.

The pharmaceutical industry has contributed millions to ADA, including Bayer, Eli Lilly, and GlaxoSmithKline. Six of seven physicians sitting on an ADA panel that considered controversial drug treatments for the approximately 41 million people at elevated risk for Type 2 diabetes have received money from pharmaceuticals companies. Three of those reported direct compensation from GlaxoSmithKline, a company that recently finished clinical trials for a prediabetes drug and donated $1 million to ADA last year.

ADA's incoming president, Dr. John Buse of the University of North Carolina at Chapel Hill, told the Times that he does not believe that these relationships with industry influence the organization's policy. The Times failed to report that Buse has received financial support from Amylin Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Pfizer, Merck, and Novartis.

Two former top executives at drug and device companies have led the ADA in recent years. The ADA says the new guidelines will help them "refrain from associating with companies that have the potential to damage ADA's image because of the nature of the companies' products, services or reputation." The group has let some food company deals expire as a result of the new guidelines.

Germany Now on Big Pharma Hit List

Earlier this month, Bush administration officials showed up in London to badger the British health authorities into opening its market to the drug industry's predatory pricing policies. (See this earlier post.) Now, the British Medical Journal reports similar goings-on in Germany.

Last week in Cologne a member of an association for people with diabetes and representatives of the drug industry walked out of a hearing of the Institute for Quality and Economic Efficiency in Health Care in Cologne because they were not allowed to record the hearing, which was on the use of short acting insulin analogues. The institute has provoked anger among patients' groups and the drug industry by saying that no evidence has been shown that short acting insulin analogues had any advantage over human insulin.

After the walk-out drug firms accused the institute, which was founded in 2004, of insufficient transparency. The institute's director, Peter Sawicki, said that its rules did not allow participants to record hearings and that this had always been the case.

Tension between the drug industry and the institute has grown since the German government proposed expanding the institute's role, so that it will no longer consider only the clinical effectiveness of new drugs but also their cost effectiveness. The proposal is part of the government's package of reforms currently before parliament.

The institute's evidence based evaluations will become the basis for decisions by the federal joint committee of doctors, health insurance companies, and patients' representatives that decides which treatments will be reimbursed by the state health insurance companies. Under the new reforms this committee will include independent members as well as representatives of doctors and health insurance companies chosen by the health ministry.

"For the analysis of the cost effectiveness of treatments we will use internationally accepted methods, just as we do for looking at the scientific evidence," said Professor Sawicki.

The U.S. has no agency like this one in Germany (or the National Institute for Clinical Effeciveness in Great Britain) that compares drugs for relative efficacy and their relative cost-effectiveness (why take a pricey pill when the generic works just as well?). But calls for creating one are growing. Gail Wilensky, who ran Medicare in the Bush I administration, recently endorsed this reform in the usually conservative journal Health Affairs.

The drug industry is working hard to strangle this baby before it is born. Are efforts to discredit similar efforts abroad part of the campaign?

Upton Sinclair Speaks

Three alert readers sent me the reference to Upton Sinclair's original quote, which came from his memoir, "I, Candidate for Governor, and How I Got Licked," p. 109. University of California Press; New Ed edition (December 16, 1994). Hopefully, this photocopy of the page where the original quote appears will enlighten web readers for generations to come. The exact quote states: "It is difficult to get a man to understand something, when his salary depends on his not understanding it." . . .View image

CABG from NEJM on Thanksgiving

After a weekend of gluttony, you’ll be happy to know that the invasive cardiology industry (any field that records roughly $50 billion in sales each year deserves to be dubbed an industry) has undergone major changes in recent years. If you have severely blocked heart arteries, you are much less likely to get bypass surgery today (where they remove a section of vein, usually from the leg, and use it to replace one or more blocked arteries leading to the heart). According to the Agency for Healthcare Research and Quality, the number of coronary artery bypass graft surgeries (CABG) declined to 308,000 in 2004, down 28 percent from 1997.

Instead, less invasive options like balloon angioplasty or stent insertions have taken up the slack. These procedures, known as percutaneous coronary interventions (PCI) because they use catheters inserted through the arm or groin to prop open the blocked artery, rose 36 percent to 791,000 procedures between 1997 and 2004.

Except for the fact that the number of people needing any of these options is still growing (largely due to the failure of Americans to take preventive measures like improving their diet, getting regular exercise, reducing stress, and quitting smoking), this shift in medical practice is a good thing. PCI is not only less invasive, it costs less and appears to save more lives.

A recent cost-benefit analysis by a group of Veterans Administration researchers (where would we be without the VA to conduct these studies?) compared the use of both approaches in high-risk patients. They randomly assigned 454 patients and found that those given PCI cost 18 percent less over five years compared to those given CABG ($81,790 versus $100,522). Moreover, their survival rate was slightly higher – 75 percent versus 70 percent.

Given these results, you’d think CABG would be disappearing even faster. But physicians and hospitals, especially those that depend on the high fees and lengthier hospital stays of the more expensive procedure, resist change. As Upton Sinclair reportedly said (If anyone can find me the original reference rather than Al Gore’s use of it in his movie, “An Inconvenient Truth,” please send it along): "It is difficult for those to see whose paycheck depends on them not seeing."

I was motivated to explore the CABG patch by a disturbing exchange of letters that appeared in the New England Journal of Medicine last week.

They involved the recent Food and Drug Administration advisory committee meeting that concluded the use of the blood clotting drug aprotinin, which is made by Bayer and known commercially as Trasylol (see this previous GoozNews), is safe. To understand the implications of this exchange, however, I have to spend a few moments explaining why this drug is used, since giving a blood-clotting drug to a person with blocked arteries is, as they like to say in the medical literature, counterintuitive.

The drug’s purpose, according to Bayer’s presentation at the meeting, is to reduce the need for blood transfusions during CABG operations. It also can reduce the number of people who have to go in for a second operation because the first hasn’t properly healed. Moreover, a small percentage of patients have adverse reactions to foreign blood factors, so reducing the need for blood transfusions can avoid this side effect.

While that all sounds positive, there has never been any evidence showing that any of these benefits actually improve patient survival. No matter, the FDA approved Trasylol in 1993 with the warning to physicians to watch out for the kidney damage that had appeared in a small percentage of patients in the company’s clinical trials. There is also concerns about patient “hypersensitivity” to the drug itself. Despite these warnings, and the fact that there are cheaper alternatives available, Bayer by last year had carved out a small but growing $250 million niche for Trasylol, largely in the invasive cardiology market.

In February of this year, however, two studies appeared in the NEJM that showed that Trasylol recipients had higher levels of kidney failure than patients who took alternative drugs to promote healing. One of the studies, by Dennis Mangano of the non-profit Ischemia Research and Education Foundation in San Bruno, Cal., also found that patients on Trasylol suffered higher mortality from additional heart attacks and strokes. Based on those two studies, the FDA issued a new warning and called for the September advisory committee meeting to see if the new evidence merited pulling Trasylol from the market.

In the run-up to the meeting, FDA reviewers asked Mangano for his group’s data. The chairman of the committee, William R. Hiatt of the University of Colorado School of Medicine, offered a long explanation in the current NEJM as to why the agency, and any researcher for that matter, would need access to the underlying data.

Mangano’s study, he explained, had come to very different conclusions than the other independent study that had just been published. It also differed from the new data that Bayer had submitted to the agency for the meeting. Since the Mangano study was an “observational” study, which means the careful randomization controls of a clinical trial weren’t present, there might have been other factors – like the possibility that patients in observed by Mangano were sicker than patients in the original clinical trials –- that influenced his results.

The FDA needed to see if Mangano had made appropriate adjustment factors. “Unfortunately,” wrote Hiatt:

Mangano did not give the FDA or the committee full access to his data, which would have allowed the agency to perform an independent review and analysis to validate his group's findings. Although there are many legitimate concerns with regard to the sharing of data (for instance, confidentiality and the need for informed consent), the lack of independent review greatly limited the committee's ability to draw conclusions from the study.

But the exchange of letters suggest that may not be how events transpired. According to Mangano:

The FDA asked that we present our data to them. We agreed and sent a team of IREF scientists to the FDA. The FDA and Bayer then asked that we send them our database, because they each wanted to combine our data with Bayer's data and then perform a number of unspecified analyses. We agreed to the FDA proposal, making three requests: that patient privacy and legal trust be preserved, that the methods used to mix our patient data with the Bayer patient data be specified, and that in addition to their analyses, the FDA independently analyze our data, comment on each finding of our study published in the Journal, and make the results known to the public. In May (4 months before the Advisory Committee meeting), frustrated by the delay and concerned that our data would not be reviewed, I abandoned all three requests and informed the FDA that we would provide our database and any and all source data for its review. Hearing no response, after several weeks, I wrote to the FDA and again asked for a review of our data. However, the FDA refused, and we were told that a review was not necessary. As I publicly stated to the Advisory Committee on September 21, 2006, we stand by our offer to the FDA to provide for review any and all data regarding our publication without constraint or condition.

A review of the transcript of the meeting confirms Dr. Mangano’s offer.

However, FDA reviewers R. Dwaine Rieves and Karen D. Weiss in their letter did not acknowledged that Mangano offered to make his data available without restrictions.

Dr. Mangano imposed restrictions, including his physical presence at the FDA while the FDA representatives inspected and analyzed the data, and limitations on the nature of the analyses the agency could perform. Furthermore, he required the FDA to make a determination of the validity of the published findings and conclusions rather than assess the methods alone. Under these terms, the FDA could not perform a substantive, independent evaluation of his statistical methods.

The advisory committee heard Mangano’s presentation, but in the end decided against pulling the drug from the market. I did not attend the meeting. But reviewing the transcript over the weekend was eye-opening. The panelists without exception ripped into Mangano’s methods. Specifically, they accused him of failing to properly adjust his data for various confounding factors that complicate every observational study. Then, John Flack of Wayne State University, who needed a conflict-of-interest waiver to participate in the meeting because he earned somewhere between $10,000 and $50,000 a year for serving on the speakers’ bureau of a Bayer competitor, asked point blank if Mangano would share his data.

Are you prepared now to basically let the FDA scientists analyze the data and go from there, because otherwise, I have serious reservations about what you are putting through here.

“I did,” Mangano replied. “I would give it to them tomorrow.” He then went on to explain why he was initially reluctant to cooperate with the FDA. The first two calls he received after his study appeared in the prestigious journal were from Bayer and FDA, in that order. He insisted on prior knowledge of the methods the FDA would use in analyzing his data because, he told the meeting:

If you are going to do a meta-analysis of everything and put everything into a pot, what is the design of that study, what are your endpoints, what are your questions, because you could pull out anything you want.

No one on the committee asked the FDA analysts present how they planned to use the data. The Bayer presenters – about a half dozen consultants helped analyze the company’s data – were similarly handled with kid gloves. Every public presenter – there were just three – spoke in favor of the company’s presentation. A epidemiologist from Indianapolis whose non-profit works closely with Eli Lilly was especially harsh toward Mangano. This epidemiologist, Stan Young of the National Institute of Statistical Science, also attacked the editors of NEJM for allowing the allegedly poorly-controlled Mangano study into the journal. “Where were the adults,” he asked.

At the end of the day, the committee voted unanimously to leave the status quo unchanged for the drug. Wrote Hiatt: “Having reviewed all the data available, the committee decided that there was insufficient evidence to require an additional warning on aprotinin's labeling and agreed that the clinical data supported an acceptable safety and efficacy profile for aprotinin.”

I know I’ve gone at length about this matter, but subsequent events cast a harsh light on the the mindset of the committee and the FDA officials at that meeting. A day after the meeting’s conclusions appeared on the newswires, a whistleblower inside one of Bayer’s contract research organizations called the agency to report that Bayer had conducted its own observational study, but its results and its data had not been given to the committee. That study also showed an increased risk from the use of Trasylol. The FDA quickly issued a milquetoast release saying it was “actively evaluating” the new information.

What’s the lesson here? For public health and safety groups that are pushing for better post-market surveillance systems to identify safety problems and to come up with good cost-effectiveness and comparative effectiveness data, be forewarned. Epidemiological “observational” studies are easily attacked if you have a mindset to do so.

Mangano and his colleagues around the world spent a decade coming up with the database that led to the study published last February in the NEJM. They did it without government or industry funds. (The $45 million study was funded by the foundation, which gets its money from an endowment that, according to Mangano’s testimony at the meeting, was created from excess funds generated by industry-backed studies.) They sampled 5,000 patients and collected over 7,500 datapoints for each. “This has been an entirely consuming effort of my life for the last 15 years,” Mangano said.

You’d think the FDA would work closely with such a researcher, giving him the assurances he needed to insure that they could get their hands on his data and do their own analysis. But at the end of his labors, the agency ignored him. And an FDA advisory committee, which included one consumer representative who never opened his mouth except to vote with the majority, ripped him a new asshole.

Piecemeal Reform

The Wall Street Journal today has an interesting article suggesting it will be difficult for the Democrats to force Medicare to negotiate lower drug prices for senior citizens. Even if they get a bill past President Bush's veto pen, you can't force an agency to negotiate lower prices if it doesn't want to -- not unless you specify in the law that it must and how to do it! That's a formula for a not very successful negotiation, especially if the government officials on the public's side of the table are angling for a job within the drug industry once they leave office in two years.

Then there's the fact that most people receiving the benefit have been corralled into private sector drug plans, who have already cut deals with the big drug companies . . . or at least we hope they did. There's been precious little discussion in the press about the prices that Medicare is being forced to pay. As Ron Pollack of Families USA points out in the article, many of the "dual eligibles" (elderly Medicaid recipients who had drug coverage who had to switch to Medicare once Part D was established) found themselves paying higher drug co-pays because Medicaid by law must get the lowest available price in the market. Passing a similar "best price" law for Medicare is vehemently opposed by the drug industry because it would become the de facto price controls that the industry says will choke off innovation. (Wouldn't it be nice to test whether this "fear" actually come to pass if the U.S. did what every other advanced industrial country does: establish formularies and negotiate prices for drugs.)

Meanwhile, Rep. Pete Stark (D-CA) is pushing for the establishment of a government drug plan to compete directly with the private sector plans. He would let that plan establish formularies and negotiate lower prices, just as the Veterans Administration has done. This is similar in many ways to Stark's plan (authored by Jacob Hacker of Yale University) for insuring the uninsured. If employers don't currently provide health insurance, make them pay into Medicare and expand it to cover the uninsured. Then let the expanding government insurance program compete on price and quality with the employer-based insurance plans.

If the government is as cost-effective and efficient (because of lower administrative costs) as its boosters claim it is, most employers will eventually gravitate toward the "pay" side of this "pay or play" system for health insurance. In other words, they'll drop their own plans and simply begin paying a per capita tax into the government plan. Eventually, Medicare for All will become the U.S.'s default national insurance program.

I'm a devotee of single-payer. The question is what is the politically most acceptable way of achieving it. This incremental approach seems like a good way of moving the country toward the eventual solution with a minimum of short-run disruption. It's hard to write "Harry and Loise" ads when no one is forcing Harry and Loise to do anything -- accept have their employers pay a per capita tax into the government health insurance plan if they don't already provide insurance.

Ex-Pennsylvania State Pharmacist Indicted

He used his position to get consulting work with makers of antidepressant pills, the indictment handed up yesterday said. To read more, click here. The indictment is vindication for whistleblower Allen Jones, who lost his job inside the Pennsylvania inspector general's office when he tried to bring the wrongdoing to light. Background on his case can be found here.

Back Trouble

Here's a new study that speaks to me. The past few days, I've been suffering one of my periodic bouts of back pain, aggravated by shooting pains down my right leg. According to tomorrow's Journal of the American Medical Association, these are the classic symptoms of sciatica, where a bulging disk impinges on a nerve. But a new study that compared disk surgery to simply waiting for sciatica found that there was no difference in outcomes.

Guess I'll just wait for it to go away (I always do). I have no doubt that there are many cases where a chronic back ache may require surgery. But the data suggests that most people might as well wait. Less costly. Fewer complications. No difference in outcomes. Not a very hard choice, is it?

Stent Troubles

The Food and Drug Administration will hold hearings on Dec. 7-8 on drug-eluting stents, which recent studies show are harming more people than the regular stents they replaced. It's another example where the more expensive ($2,000) technology replaced a cheaper ($800) technology and wound up causing more harm than good.

Robert Bazell, NBC News' health care reporter, has an excellent explainer here.

EPA Names Exxon Scientist to Panel

and other outrages from Integrity in Science Watch, a Center for Science in the Public Interest newsletter:

The Environmental Protection Agency has placed ExxonMobil scientist Robert Schnatter and two industry consultants on the 16-member panel that will review the agency's risk assessment for ethylene oxide, despite protests from the Natural Resources Defense Council, the Center for Science in the Public Interest, and other health and environmental advocacy groups. EPA's draft risk assessment recommends reclassifying ethylene oxide to "carcinogenic to humans" from a "probable human carcinogen. "It also proposes tighter restrictions on the chemical, which is used to make antifreeze and polyester and is emitted in vehicle exhaust. The risk assessment review panel, whose deliberations could affect future air pollution and occupational safety and health regulations, meets Jan. 18-19, 2007.

In addition to Schnatter's employment in the oil industry, James Klaunig of the Indiana University School of Medicine and James Swenberg of the University of North Carolina at Chapel Hill have financial ties to companies or industry groups that have a stake in the outcome of the ethylene oxide reassessment. Klaunig has received research support from ethylene oxide manufacturer DowAgro and the American Chemistry Council, and Swenberg has received funding from the Chemical Manufacturers Association and the International Institute of Synthetic Rubber Producers.

USDA's Committee on Grain Skirts Law

Despite a 2004 Government Accountability Office study calling for reform, the Agriculture Department continues to ignore the Federal Advisory Committee Act (FACA) when staffing its outside advisory panels. The Grain Inspection Advisory Committee includes numerous industry stakeholders who vote on scientific and technical issues such as the best way to measure the nutrient content of grain. For instance, a scientist with ties to Monsanto, which manufactures a test for measuring the linolenic acid content in soybean oils, sits on the committee as an industry "representative" and earlier this year voted on the test's scientific validity. The representative designation allowed the USDA to skirt FACA's conflict-of-interest and bias rules. In a letter sent today to the Grain Inspection, Packers and Stockyards Administration (GIPSA), the Center for Science in the Public Interest called on USDA to establish an independent committee made up of scientists without ties to the regulated industry. CSPI also called on USDA to appoint a designated ethics officer to monitor the agency's compliance with FACA. GIPSA's Grain Inspection Service establishes standards for grain and related agricultural products.

Tougher CMS Policy on Clinical Trials Urged

The Center for Science in the Public Interest last week asked the Center for Medicare and Medicaid Services to strengthen its registration and conflict-of-interest disclosure requirements for clinical trials that are used to justify payment for the off-label use of anticancer drugs. Physicians and their patients can be reimbursed for a non-Food and Drug Administration approved use of a chemotherapy drug as long as a study suggesting the use is effective has appeared in a peer-reviewed journal that lacks publication bias and has a conflict-of-interest disclosure policy.

CMS currently lists 15 journals as acceptable outlets for those studies. It is considering adding eight more. But a CSPI Integrity in Science survey found that none of the eight proposed additions requires clinical trial registration prior to publication, which helps eliminate publication bias; and three of the eight do not automatically publish conflict-of-interest disclosure statements. Several of the 15 journals already in use by CMS have similar gaps in their policies. CSPI asked CMS to strengthen its guidelines by prohibiting payment for the off-label use of a drug if the prescription is based on a trial that had not been registered prior to enrolling patients. It also asked CMS to require all journals to publish conflict-of-interest disclosures if necessary, and require authors to declare the presence of such statements in the abstracts that are submitted to the National Library of Medicine's PubMed.

FDA Warns Against Using Guidelines Backed by National Kidney Foundation

The New England Journal of Medicine last week published a Johnson & Johnson-funded clinical trial showing that patients with failing kidneys who were given high doses of Amgen's anti-anemia drug Epogen suffered 34 percent more heart attacks and strokes than patients given lower doses nearer to the FDA-approved standard. A comment that appeared in the Lancet online pointed out that the higher dose achieved in the study was within guidelines recently issued by the National Kidney Foundation, which received 57 percent of its $19.7 million budget in 2005 from corporate and organizational partners, including $4.1 million from Amgen and $3.6 million from J&J. Amgen and J&J compete with variants of Epogen sold as Aranesp and Procrit, respectively, in the oncology market. The Food and Drug Administration late last week warned physicians not to exceed agency-approved prescribing levels for Epogen, Aranesp and Procrit.

Climate Skeptic Misleads Viewers About Funding

Global warming skeptic S. Fred Singer denied that he has received substantial funding from the oil industry, despite evidence of his long-standing ties to energy companies. In an interview during the Canadian documentary program "The Fifth Estate," Singer claimed he didn't remember whether the oil industry had given him money. "I don’t think so," he said. When reporter Bob McKeown pressed Singer further, relying on ExxonMobil documents showing the company gave $10,000 to Singer’s Science and Environmental Policy Project (SEPP) and $65,000 to a foundation located at the same address as Singer's office for a climate change conference featuring Singer, he admitted receiving a one-time donation of $10,000 that "came in over the transom." Singer gave similar answers during an interview on E&ETV's "OnPoint" interview program, which also aired last week. In a telephone interview with the Center for Science in the Public Interest, Singer said he only remembered receiving one check from ExxonMobil "10 or 12 years ago" for $10,000.

Yet, the Science and Environmental Policy Project, which Singer founded and leads, has received at least two $10,000 grants from ExxonMobil, in 1998 and 2000. In a 1993 sworn affidavit, Singer also admitted to receiving consulting fees from the Global Climate Coalition – a now defunct group of businesses including Exxon, Shell, Texaco and BP that opposed implementing mandatory greenhouse gas emission reductions -- and doing climate change research on behalf of oil companies. SEPP's website claims it does not solicit support from government or industry and that it receives contributions from charitable foundations and individuals. The project's most recent tax filings show the organization received $102,260 in contributions and $14,700 for lecture fees last year. (Singer has also served as a fellow or adviser for several organizations that receive funding from ExxonMobil, including the Advancement of Sound Science Coalition, American Council on Science and Health, Cato Institute, Frontiers of Freedom and Heritage Foundation.)

Polling the Netroots

The Daily Kos has an interesting set of surveys on its website this morning, asking its readers to weigh in on how well the Democratic Party leadership is doing as it positions itself to assume control of Congress. It has individual polls for Howard Dean, Nancy Pelosi, Charles Schumer, Harry Reid and Rahn Emanuel. Dean is the overwhelming favorite with the online crowd while only one person gets negative results. Can you guess who?

Answer: Rahm Emanuel.

Amgen, NKF and the Dialysis Killing Fields

Anyone who has ever attended a Food and Drug Administration advisory committee meeting knows about the incestuous relationshp between patient groups and drug companies. When a new drug is up for approval, the public comment period of the meeting is almost always dominated by patient-advocates offering their desperate stories suggesting how much they need this drug. In many cases, it's no doubt true, and it is hard not to feel empathy for these people. But I always wished that they had shown up there on their own, and did not disclose, as is required by the agency, that their plane fare and hotel bills were paid for by the company sponsoring the new product.

I'm reminded of that this afternoon after the Lancet published a commentary today on a newly published clinical trial showing high doses of Amgen's Epogen may be killing people on dialysis (see yesterday's GoozNews). It was written by Robert Steinbrook of Dartmouth Medical College. Here's a few selected sections:

There is no way to know with certainty why the hemoglobin concentrations in half the patients undergoing dialysis in the US are maintained at values higher than those specified by the FDA. One possible explanation is reimbursement methods and financial incentives that reward increased use of epoetin. Dialysis facilities can make more money from separately billed medications such as epoetin than from dialysis itself.

He then points out that the National Kidney Foundation recently amended its guidelines for dialysis care to increase the target hemoglobin level. Surprise, the higher level is the same as the target level in the study that showed a 34 percent increase in heart attacks and strokes over people kept at lower levels!

They (the NKF) have been questioned for their reliance on expert opinion and because of the close relations between the Foundation, the Kidney Disease Outcomes Quality Initiative (KDOQI) that formulates its recommendations, and the drug industry. In fiscal 2005, according to its annual report, the Foundation received $19.7 million -- 57 percent of its total support -- from various "corporate and organizational Partners." In calendar year 2005, it received $4.1 million from Amgen and $3.6 million from Ortho Biotech, a subsidiary of Johnson & Johnson, the current marketers of epoetin products in the US."

He ends with a plea for the National Institutes of Health or the Agency for Healthcare Research and Quality to write new guidelines. We don't need new guidelines. We need a Center for Medicare and Medicaid Services, which pays for dialysis, that will use the evidence that is already in the literature to crack down on excessive use of this drug.

Outgoing Ways and Means chairman Bill Thomas, who to his credit has been after CMS to change this policy, sent another letter to CMS yesterday demanding a change in policy. Pete Stark (D-CA), who has been fighting this battle for over a decade, will soon take the health subcommittee under Charlie Rangel's leadership.

The evidence is in. CMS reimbursement policy is killing people, all to benefit Amgen and its lobbyists. How long will it take the agency to respond?

The Trials of Amgen

Yes, Virginia, there can be too much of a good thing.

The New England Journal of Medicine on Thursday reports that dialysis patients given high doses of Amgen's best-selling drug Epogen (or Aranesp) wind up having more heart attacks and strokes than their counterparts on lower doses. Finally, after two decades of goofy Amgen "quality of life" studies, the arbiter of medical knowledge in the U.S. finally reports what everyone who paid close attention to what was going on in this field knew for years: Amgen was killing people by lobbying Medicare to overuse and overpay for its drug.

I have written this story so many times over the past few years that I barely have the energy tonight to recapitulate the details. Suffice it to say that people with failing kidneys need recombinant erythropoietin (Epogen, Aranesp, Procrit . . . it's all the same thing) to maintain their red blood cell count. The FDA in the late 1980s approved the drug for raising the level to about 85 percent of normal. Amgen, by funding studies showing higher red blood cell counts lead to "more energy," was able to convince Medicare (intense lobbying on Capitol Hill didn't hurt) that it should reimburse to near normal levels.

Now the results are in (actually, this has been reported for years in "lesser" journals): if people whose kidneys (which are basically a bundle of tiny blood vessels for filtering waste from blood) failed because they had untreated hypertension or poorly treated diabetes for long periods of their adult lives have their red blood cell count raised to normal levels, they have more heart attacks and strokes and die faster than people with slightly thinner blood. In other words, people with severe microvascular distress don't do too well with thicker blood. It took two decades to figure this out?

Now let's see how many years it takes for Medicare to dial back its reimbursement level to fit the evidence. On the one hand we have dead people and serving our corporate masters; on the other hand we have living people and saving the taxpayers money. How hard a decision is that?

Here's the public health math: The government spends over $2 billion a year for this drug. If even 25 percent of it is wasted (don't forget, correcting for the original anemia to a modest level makes sense), think of how many public health nurses that could hire in low income communities. I'll do the math for you. That's 8,000 jobs at $62,500 a year. Their job? Fan out across the country to identify and then teach people with untreated hypertension and poorly controlled diabetes how to control their conditions so that they don't wind up on dialysis.

Now that would be cost-effective medicine. Alas, it's called preventive health care and we don't do that in America.

One last point: I can't wait to see if Amgen attacks these studies because of their authors. Both studies were funded by Amgen's competitors: Johnson & Johnson's Orthobiotech division and Hoffmann-La Roche. They're mad because Amgen has been using Aranesp, a longer-acting version of Epogen, to horn in on their territory, which is the cancer market.

But that's another long, sad story. If you want details, read chapter one of my book, which is available for free on line at one of the on-line book retailers.

Bush Badgers Brits for Big Pharma

This is almost impossible to believe. U.S. trade zealots masquerading as health officials are in London this week to badger the British to adopt the U.S. drug industry model, according to The Guardian. The U.S. wants the British national health service to open its formularies to all drugs regardless of relative medical benefit vis-a-vis generics, allow direct-to-consumer advertising, and use insurance companies to deliver drug benefits.

In a visit with the newspaper's editors, U.S. deputy secretary of Health Alex Azar had this to say:

Allowing all new drugs to be used in the NHS would result in the companies fighting it out on price, which would drive the drug bill down.

Ever watch The Daily Show when Jon Stewart rubs his eyes in disbelief? That's what I'm doing right now after reading that one.

Before joining the administration, Azar was a partner at Wiley, Rein and Fielding, a K-Street law firm with numerous pharmaceutical industry clients.

Baiting the Trap for Liberals

The health insurance industry launched a pre-emptive strike onr insuring the uninsured yesterday. Their chief lobbying organization proposed expanding Medicaid, and giving tax breaks to people earning up to $60,000 a year to buy insurance. Here's the crucial paragraph from Robert Pear's New York Times story:

The industry did not say how its proposals would be paid for; did not recommend any budget cuts or tax increases; and did not say what, if anything, it would do to slow the growth of health costs.

Let me see if I have this right: The insurance industry would like to see the middle class and upper middle class continue to pay greater sums out of pocket as their employers shift the rising cost of premiums to their employees; raise taxes on those same people to expand Medicaid, which is half funded by the states and half by the federal government; increase the federal deficit by giving tax breaks to the near poor to buy inadequate health insurance; and do nothing to hold down overall health care costs, which is, supposedly, the health insurance industry's job.

I have great admiration for Ron Pollack at Families USA, whose organization is a tireless champion for people without health insurance. But his warm welcome of the insurance industry's opening gambit on NPR last night and in today's Times should not be echoed by other, more sober voices in the progressive community. Pitting the middle class against the poor and uninsured is not a winning solution. It's bad economics and, more importantly, bad politics.

It's not even good for health care. The coming battle over health insurance reform most also include a frontal assault on the weaknesses of our health care system, which ignores preventive care and public health and wastes its resources on expensive technologies that add little if anything to the nation's overall wellbeing. Getting rid of waste -- insurance company waste and medical system waste -- is the key to achieving affordable, quality health care for all without bankrupting us all.

Medicare May Reward Drug Trials That Skip Registration

Medicare may add over a half dozen medical journals to the list of publications that determine reimbursement for the off-label use of anti-cancer drugs. None of the proposed journals requires registration of clinical trials prior to publication, and several don't guarantee that they will publish conflict-of-interest disclosures, according to a Center for Science in the Public Interest survey.

Since 1994, Medicare has paid for non-Food and Drug Administration-approved uses of anti-cancer drugs, but only after studies published in an acceptable peer-reviewed journal report that the protocols prolong patients' lives, significantly reduce tumor size or reduce symptoms related to the tumor. The Center for Medicare and Medicaid Services (CMS) currently lists 15 acceptable journals. The American Society for Clinical Oncology (ASCO), which represents over 20,000 oncologists, last May petitioned the agency to add eight more journals to the list, most of them highly specialized.

The CMS notice seeking comment says the agency will only put journals on the list if they use rigorous peer-review, lack publication bias, and require full and timely public disclosure of potential conflicts of interest of authors, reviewers and editors. Registration of clinical trials helps eliminate publication bias by allowing reviewers to compare the results submitted to the journal to the trial's original protocols. Legislation requiring universal, mandatory registration of clinical trials including trial results, which has been introduced in Congress, would enable Medicare and other insurers to compare published trials to any unpublished trial results before they authorize payment for those protocols.

A CSPI review of author guidelines in the eight journals under consideration found that not one currently requires clinical trial registration as a condition of publishing the trial's conclusions. And while all but one required authors to privately disclose potential conflicts of interest, three left it up to the editors' discretion whether those disclosures would be published.

An e-mail survey sent to editors of the eight journals on Nov. 2 asked if they would amend their guidelines to meet both criteria. It generated just one response. "We do not currently require registration of clinical trials prior to publication," said David Gershenson of the University of Texas M.D. Anderson Cancer Center and editor of Gynecologic Oncology. "However, we have no objection to requiring this in the future."

Many of the original 15 journals on the CMS list already adhere to the International Committee of Medical Journal Editors' "Uniform Requirements," which require conflict-of-interest disclosure and clinical trial registration. There were several notable exceptions, however.

"At this time, CANCER does not require the authors to register their clinical trials," responded Angela Cochran, managing editor of the American Cancer Society's journal. "However, the editorial board will be discussing this topic in the near future."

When queried about their failure to require clinical trial registration, the editors of the Journal of Clinical Oncology, which is published by ASCO, immediately updated its author guidelines to include the requirement. However, it will only apply to trials that began enrolling patients after Nov. 1, 2006, according to a spokeswoman.

We're Number 30!

The United Nations just released its human development report, with the latest (2004) statistics on life expectancy. Here's the top 30 countries:

1 Japan 82.2
2 Hong Kong 81.8
3 Iceland 80.9
4 Switzerland 80.7
5 Australia 80.5
6 Sweden 80.3
7 Canada 80.2
8 Italy 80.2
9 Israel 80
10 Spain 79.7
11 Norway 79.6
12 France 79.6
13 New Zealand 79.3
14 Austria 79.2
15 Belgium 79.1
16 Germany 78.9
17 Singapore 78.9
18 Finland 78.7
19 Cyprus 78.7
20 Luxembourg 78.6
21 Malta 78.6
22 Netherlands 78.5
23 United Kingdom 78.5
24 Greece 78.3
25 Costa Rica 78.3
26 United Arab Emirates 78.3
27 Chile 78.1
28 Ireland 77.9
29 Cuba 77.6
30 United States 77.5

Yup, we just fell behind Cuba. Ye gads. Our correspondent from the University of Washington who emailed this in added this comment:

When I went to medical school in 1970, the US was about 12th, when I went to public health school in 1992, we were about 20th, and last year, 29th, the year before that 27th. I have no idea how much farther we will descend. It just means that we all die much younger than we should.

Want to feel even worse? In the CIA tables, where they include small countries such as Andorra and Monaco, we're number 48!

Rhetoric v. Reality on Health Care

When it comes to health care, rhetoric and reality live in separate universes. Many members of the incoming Democratic majority attacked the drug and health insurance industries in their winning campaigns. But if they try to make that rhetoric their policy, they will quickly discover that curbing those industries’ power – necessary as it may be – is only a start on dealing with the problems of our health care system.

Rising health care costs are not just an artifact of high drug prices and insurance company overhead. Drugs account for just 12-15 cents of the health care dollar. And even if we were to go to a single-payer system and eliminate the administrative waste and profits of the insurance sector entirely, we’d still be facing skyrocketing health care costs.

Medicare costs, just like insurance company premiums, are rising at 9 to 10 percent a year. Eliminating insurance company waste would present a one-time savings only. It may be enough to get the uninsured into the system, but it’s not a long-term solution to what ails health care.

Why are overall health care costs rising so rapidly? There are two main reasons: one on the demand side, and one on the supply side.

On the demand side, America is aging, like most advanced industrial societies. Older people consume more health care resources. Moreover, people who get sick today are likely to need expensive, long-term care for chronic conditions. In the 1980s, overweight, out-of-shape smokers dropped dead from heart attacks. From a health care cost point of view, that wasn’t very expensive. Today, we treat them for their diabetes, pulmonary and cardiovascular conditions. They live longer. But everyone pays.

On the supply side, what we're paying for is increasingly costly interventions of dubious value. Everyone in the system -- the drug, device and diagnostic test makers, in concert with physicians and hospitals that earn piece-work rates for deploying their wares -- has an interest in claiming "advancing technology" leads to better care. No one has an interest in objectively measuring patient outcomes.

As a result, total health care costs have gone up 70 percent since 1995, with health care accounting for 16 percent of our economic output in 2004. It would be one thing if we were getting real bang for that buck, but we’re not. We have worse health care outcomes at higher cost than any other advanced industrial nation on earth. According to the Organization of Economic Cooperation and Development, our nearest competitor in health care spending is Switzerland, which is more than four percentage points behind the U.S. Life expectancy? We’re 22nd out of 30 nations.

Not all economists view this as a problem. Those who worship at the altar of free markets and rational choice theory say rising health care costs are a mere artifact of consumer preferences in a wealthy society. In their view, as our collective income rises and the cost other goods falls (think about the real prices of airline tickets, food, cars and computers compared to what they were two decades ago), consumers are expressing their preference to use their surplus income to buy admittedly pricey health care goods. As long as we’re getting value for money in terms of health care outcomes – a point recently argued by Harvard health care economist David Cutler in the New England Journal of Medicine -- why worry?

When 47 million people are uninsured and health insurance premiums are rising four times faster than wages, there’s plenty to worry about. The health care system is like a 1970s-era Cadillac – overpriced, inefficient, and filled with unnecessary features. If health care were a tradable good, you’d see our market flooded with alternative health care systems. But it’s not. And the result is that any business facing international competition is at a structural disadvantage because of what it has to pay for health care. Indeed, total health care costs are about to exceed total profits for U.S. business.

One option, of course, is to give up competing and become a nation that does little more than take care of our sick, old and infirm (this is a variant of the philosophy, first articulated by an official in the Reagan administration, “Computer chips, potato chips, what’s the difference?”) As companies facing international competition go down the tubes, our health care system can expand to fill the gap.

One of the best-kept secrets of this decade’s economic expansion is that the bulk of new jobs were created in health care fields. Between 2001 and 2005, the nation added a total of 1.6 million jobs. But nearly two-thirds of those new jobs were in health-related fields. While General Motors and Ford were announcing tens of thousands of layoffs, hospitals added 400,000 jobs. Worried about decimated newsrooms? There may be a job for you in a physician’s office, a sector that added over 250,000 jobs. Did your call center job go to India? Not to worry. Nursing homes added 200,000 jobs caring for our sick, elderly parents.

With the aging baby boomers entering their high health care cost years, the nation is either going to bring economic and health-related discipline to this out-of-control sector, or it will give in to it, which will decimate the rest of the economy. Even John Rother, the top health care lobbyist for AARP, the 20-million strong senior citizen group, recognizes that. “It’s ultimately about costs,” he told a post-election forum last week.

When Democrats get back to Washington this week, they will put Medicare drug price negotiations (the Bush-backed 2003 plan prohibited it) at the top of their agenda. It’s a start. But it’s not yet a plan.

"There Is A Strong Populist Tinge To This Class"

Today's New York Times captures the spirit that animated many swing voters who went to the polls on Tuesday. Economic populism is back in fashion.

On Thursday, I attended a forum where I was able to watch a series of campaign commercials ran by candidates who ousted Republican incumbents in closely contested districts. Over and over, the newly elected Democrats pledged to do something about health care by curbing the power of the drug and insurance companies.

In stressing the centrist credentials of many winners, the media has ignored this aspect of the electoral earthquake. Just 44 percent of the electorate heard about health care during the election, according to Democratic pollster Celinda Lake. But that shouldn't be surprising. In most of the country, House races were not contested, no ads ran, and the press, both national and local, ignored health care as an issue.

But in swing districts, 62 percent of voters heard about health care because the Democratic candidates made it a major point in all of their ads. "It was a powerful issue," Lake said.

These incoming freshmen may have a major say in how the health care debate shapes up over the coming years.

The Adaptability of Parasites

The virulent strain of the malaria parasite has grown resistant to chloroquine, the most common drug used to combat the disease. So several million mostly African children die every year even though many of their desperate parents buy them medicine that they think is going to work.

The economics of the situation are perverse. Chloroquine costs 10 cents a day, something poor people can afford. Drugs that work like artemisinin (the fast-acting, fast-clearing drug is used in combination with older drugs to avoid its falling victim to resistance) costs $2.50 a day. If you made $2 a day or less like most people in Africa, which would you choose?

Today's New England Journal of Medicine contains a report from Malawi showing that if chloroquine is discontinued for a decade or so, the malaria parasite evolves to the point where it once again become susceptible to the drug's action. It turns out that the genetic mutation that confers resistance makes the parasite somewhat weaker overall. Without the selective pressure of the drug, the susceptible strain resumes its dominance in the overall population.

So should chloroquine be reintroduced in those countries that are following the World Health Organization's advice and switching to artemisinin-based combination therapy for treating malaria? Absolutely not, says Nicholas White of Mahidol University in Bangkok, who is probably the world's leading malariologist. In an accompanying perspective article, White points out that "if chloroquine were reintroduced alone, resistant parasites would probably return rapidly, imported in people from neighboring areas." He holds out hope that chloroquine can once again become a useful drug, but not until it is stopped everywhere for a long period of time. "It needs to leave before it can come back."

Meanwhile, the World Bank and other multi-lateral aid organizations are dragging their feet in implementing the 2004 Institute of Medicine report that called for setting up a global fund to purchase 500 million doses of ACT a year for use in the developing world (it would cost about $1.5 billion a year). This central authority could then distribute it through the same channels that currently distribute chloroquine -- and at the same price.

That way, the desperate mothers of the two million children who die each year could not only afford to buy their children medicine, but they would be assured that the medicine they give them works.

State House Politics

Don't overlook the importance of the gubernatorial races. The Democrats won 20 of 36 races and now hold the executive branch in a majority of statehouses.

The television pundits are talking about gridlock. But over the next few years, I think we will begin to see a lot of state experimentation on issues like energy independence, health care and campaign finance reform. States are our laboratories of democracy. The next round of change won't be coming out of Washington, but in states with strong governors and progressive-minded legislatures.

I was especially pleased to see Republican Ken Blackwell go down in flames in Ohio. I've followed the evolution of his opportunistic career (he began as a liberal) closely for three decades (I lived in Cincinnati during the 1970s), and it is fitting that it ends ignominiously. Conversely, Baltimore mayor Martin O'Malley's narrow win in Maryland (my current home state) over Republican incumbent Robert Ehrlich signals a repudiation of the desperate racist tactics employed by Republican admen. Voters didn't buy the pictures that showed rundown buildings with a voiceover saying this was what O'Malley had planned for the rest of the state. What garbage.

Arnold Scharzenegger won big in California. But he tacked left throughout the campaign after hitting rock bottom in the polls last year. The left coast, don't forget, passed a single payer health insurance bill a few months ago, which the Governator vetoed. Our biggest state isn't afraid of experimentation. It's a perfect testing ground for a national solution to our health care mess.

Arnold, you can't become president (sorry, weren't born here). Make a legacy for yourself. If not single-payer (like your native Austria), what?

Speaker Pelosi Speaks

"The campaign is over. The Democrats are ready to lead."

We'll see. If I were writing President George W. Bush's lines for his morning press conference, I'd invite Speaker-designee Nancy Pelosi to the White House to listen to her "new directions" for Iraq.

This is not a Democratic problem. It's an American problem. As Barack Obama just said, "most of all, this is about a change in Iraq." But nothing was articulated during the campaign. We're going to learn fairly soon if somebody has a good idea about what to do next about this horrible conundrum the Bushites got us into.

Today's Election Day

Vote!

A Patent Worth This Much Is Worth Disclosing

This story comes from the latest Integrity in Science Watch, which I edit:

It was the science story of the week. Cartoonists had a field day. A compound in red wine called resveratrol keeps fattened mice healthy, and they live longer, too. Now that was something that the researchers could grab onto and rush, not into print, but first to the patent house. As stories in the New York Times, Wall Street Journal, and Washington Post pointed out, Harvard researcher David Sinclair has developed chemical derivatives of resveratrol and started a company called Sirtris Pharmaceuticals to commercialize their use for glucose control in diabetics. Sinclair applied for a patent on the resveratrol-like substances in May of this year. However, the subsequent science article by Sinclair and colleagues, which didn't appear in Nature until last week (and triggered the media onslaught), did not reveal that fact, nor his relationship to Sirtris.

Nature also ran a cheeky essay entitled "Grapes versus gluttony" that was co-authored by University of Washington scientist Matt Kaeberlein. For the record, neither Nature nor New York Times reporter Nicholas Wade, who quoted Kaeberlein to throw some cold water on the idea that resveratrol itself is the best way to get the desired results, revealed that Kaeberlein has applied for a patent on his own version of a resveratrol-like substance. The other major player in the news accounts was Leonard Guarente of the Massachusetts Institute of Technology, who discovered the gene that produces the protein that triggers the desired responses in yeast. Only the Wall Street Journal reported that he is a co-founder of Elixir Pharmaceuticals, "a biotech company that competes with Sirtris." Guarante has several patents on the gene and its use. His latest patent application filed last year is entitled simply, "Method of Extending Life Span." None of the pending patents, all of which are products of government-funded research, were revealed in the news accounts.

Meanwhile, the Journal of Medical Ethics, last week published a study by the advocacy group GeneWatch UK that analyzed Nature's patent disclosures in a sampling of articles published over a six-month period last year. Two-thirds of the articles did not disclose that their authors had either outstanding patents or connections to the biotech industry. The study called for journals to impose sanctions on authors who fail to disclose conflicts of interest and suggested "universities and institutes establish a public register of scientists' interests."

Our Weird Political Culture

Are these really, as Frank Rich claims in today's New York Times, "the most perilous times in our history"? Let's review the weekend headlines on the eve of the election.

Discounting all the horserace stories (take your pick: Democrats to win anywhere from 15 to 40 seats in the House, 3 to 5 in the Senate), what do we have? Republican Congressman Bob Ney resigns in Ohio; Saddam Hussein faces death by hanging in Baghdad; and Ted Haggard, the former head of the National Association of Evangelicals, tells his 12,000-member flock that yes, it's true, he's guilty of buying drugs and consorting with male prostitutes. Hardly the stuff of momentous times.

Meanwhile, the Times felt the need to apologize for endorsing all Democrats. "It is frightening to contemplate the new excesses he (Bush) could concoct if he woke up next Wednesday and found his party had maintained its hold on the House and Senate." Yet I didn't read a word in the paper of record about the joint editorial running in a series of military papers this weekend that demanded that Secretary of Defense Rumsfeld resign. The military establishment is deserting the president. His freedom to wreak havoc is over, no matter who is declared "winner" of the mid-terms by the sycophantic press.

The only front page stories that mattered continued the steady drumbeat of bad news out of Iraq, with a heavy focus on what it is doing to the troops. A Times story focused on how the military lied to a family whose son was killed by a fellow soldier, and the Washington Post reported that the National Guard can expect more call-ups and extended stays abroad in the months ahead.

Meanwhile, the leftwing blogosphere is proving it's a not ready-for-prime-time player by preparing the "they cheated, they lied" defense in case the Democrats don't win a major victory. Robo-calling with aggravating messages, ostensibly from Democratic candidates; handing out phony leaflets for judicial candidates, claiming they're Democats when they're in fact Republicans; we'll be hearing about all manner of Republican perfidies after the polls close on Tuesday, especially if things go badly for the Ds.

I care deeply that Karl Rove has dragged the practice of American politics into the gutter. Yet somehow I don't feel compelled to add my voice to the cacophony.

The latest polls show a late Republican surge (completely expected, given their financial advantages and monopolization of the airwaves). The most likely outcome of this election is that not much will change, even if one or both Houses change hands. The war in Iraq is the source of most of our woes. The overreaching of the Bush administration in pursuing that disastrous policy may make these feel like the most perilous of times. But this campaign has basically proven that there is no longer public support for those policies.

No matter what happens on Tuesday, we're going to see a distinct if minor shift in the key of government that will put the realists once again in command of U.S. foreign policy. The centrists will also be in charge of domestic politics. Imagine a Senate that owes its Democratic majority, should it occur, to Joe Lieberman, Harold Ford and Jim Webb.

The domestic issues that this blog cares about -- health care, retirement security, social inequality, the relative deprivation of the bottom half of the workforce -- will go nowhere in the next Congress, no matter which party is in charge. I hope the right wing is repudiated. But the task that moves front and center for me the minute the votes are counted is making those issues, and not electing Democrats, the centerpiece of our politics. It's time for America to come home.

Throwing Our Youngest Citizens to the Wolves

Robert Pear of The New York Times reports this morning that the Bush administration has quietly begun requiring birth certificates for U.S.-born babies of illegal immigrants before they are eligible for Medicaid.

I defy anyone to read that story and not be shocked by its heartlessness. In these childrens' crucial first months of life, their illegal immigrant parents are being told they have to GO TO A GOVERNMENT OFFICE to get A CERTIFICATE before the newborns can be seen by a doctor.

Yeah, right. I can see the stampede now.

Another stunner was this factoid: over one-third of the four million children born in the U.S. each year are delivered by mothers who rely on Medicaid for their health care.

How Good Is Your Primary Care Physician?

Everytime I hear or read that the U.S. health care system is the best in the world, I wonder why we wind up so low on so many basic indicators like longevity and infant mortality. A study out today that focuses on primary care -- that first interface with the health care system -- helps explain why.

A Commonwealth Fund survey published in Health Affairs asked 6,000 primary care physicians in the U.S., U.K., Germany, Australia, New Zealand, Canada and the Netherlands about their practices. I am especially sensitive to this topic because my wife and I, both approaching 60, are desperately seeking a decent doc to replace the ones assigned us by our HMO.

Here's what the study found:

Primary care doctors in the U.S. are less likely . . . to be able to offer patients access to care outside regular office hours or to have systems that alert doctors to potentially harmful drug interactions. U.S. primary care physicians are also less likely to receive financial incentives for improving patient care.

Yup. Sounds like our experience. Here's another disturbing finding from the study: "Only about a quarter of primary care doctors in the U.S. (28%) and Canada (23%) use electronic medical records, compared with a large majority of primary care doctors in the Netherlands, (98%), New Zealand (92%), the U.K. (89%) and Australia (79%)."

Exactly. I know what my blood pressure and cholesterol levels are today; but I have no idea what they were five years ago. And neither does my doctor.

And we're the high-tech society?