Chamber of Horrors

All eyes are on Congressional races, but voters next week will also be casting ballots in hundreds of judges' races that they know almost nothing about. I voted absentee the other day (I'll be in Boston on election day at the annual American Public Health Association meeting), and my eyes glazed over as I stared at a ballot whose last page was filled with judgeship races that I had not seen, much less read, a single story about in the runup to the election.

If we did pay attention to judges' races, we'd quickly discover that the news isn't good. As Public Citizen pointed out in a press release today, the nation's business community has poured millions of dollars into these races to get a judiciary that is friendly to their anti-consumer and anti-worker agenda. But by going over the U.S. Chamber of Commerce's tax returns, Public Citizen discovered that the Chamber failed to report those taxable expenditures to the Internal Revenue Service.

The corporate gambit paid off in the short run. The nation's rightward drift over the past three decades has been fueled in part by a sympathetic judiciary willing to trample on our basic rights, ignore executive overreach, and undermine our economic security.

Abramoff, Ney, Cunningham ad nauseum are history. It's time to put corruption of the judiciary on the political agenda.

Integrity in Science Watch

The latest from the Integrity in Science project at the Center for Science in the Public Interest:

Industry-Backed Skeptics File Brief in Global Warming Lawsuit . . .

Eight global warming skeptics, many with well-established ties to the fossil-fuel industry, last week filed a Supreme Court amicus brief in support of the Environmental Protection Agency's 2003 decision against regulating carbon dioxide emissions under the Clean Air Act. The Competitive Enterprise Institute-sponsored brief argued that "it is simply impossible to conclude that the net effect of greenhouse gases is an endangerment of health and welfare." A coalition of 12 states and nonprofit organizations have filed a lawsuit challenging the EPA's decision. After the U.S. Appeals Court in Washington, D.C., last year sided with the federal government, the Supreme Court agreed to hear the plaintiffs' appeal. Oral arguments are scheduled for Nov. 29.

The climate-change skeptics who filed last week's brief include

· astrophysicist Sallie Baliunas, who has received funding from the American Petroleum Institute and serves as a senior scientist with the George C. Marshall Institute, which has received $630,000 from ExxonMobil since 1998;
· University of Delaware climatologist David Legates, who has written reports and served as an adjunct scholar for the National Center for Policy Analysis, an organization that has received funding from ExxonMobil, DaimlerChrysler Corp. and the El Paso Energy Foundation;
· Patrick Michaels, a senior fellow at the Cato Institute and a recipient of funding from the German Coal Mining Association, Edison Electric Institute, Cyprus Minerals Co., Western Fuels Association and Intermountain Rural Electric Association; and
· Joel Schwartz, a visiting fellow at the American Enterprise Institute, which has received more than $1.6 million from ExxonMobil since 1998.

Three of the four other signers of the brief have frequently contributed to publications of CEI, George C. Marshall Institute and other Exxon-funded organizations that downplay the risks from global warming.

Meanwhile, two senators asked ExxonMobil last week to stop funding global warming skeptics, ABC News reported. Sens. Olympia Snowe (R-Maine) and Jay Rockefeller (D-W.Va.) wrote ExxonMobil chairman and CEO Rex Tillerson with a request to "end any further financial assistance" to groups "whose public advocacy has contributed to the small but unfortunately effective climate change denial myth."

. . . While AP Fails to Disclose Climate Skeptics' Ties to Industry-Funded Think Tanks

The Associated Press ran a story that appeared in the Indianapolis Star and several other papers last week that cited global warming skeptic John Christy but failed to mention his long involvement with conservative think-tanks supported by money from the energy industry. In an article about the development of global warming "hot spots," AP cited Christy's belief that concerns about an increase in heat-wave related deaths due to climate change were without foundation. The widely used wire service identified Christy only as an atmosphere sciences professor at the University of Alabama at Huntsville, but did not note his frequent appearances and published work for the George C. Marshall Institute, Competitive Enterprise Institute and Independent Institute - conservative think tanks that receive funding from ExxonMobil and other energy companies.

Meanwhile, an AP story in the Washington Post earlier this month quoted global warming skeptic Patrick Michaels without noting his ties to the fossil-fuel industry. In a feature story showing how local communities are enacting their own versions of the Kyoto protocol, the AP allowed Michaels to dismiss the significance of those moves without reporting that, as a previous AP report noted last July, Michaels recently received "at least $150,000 in donations and pledges" from Colorado-based electric utilities, including the Intermountain Rural Electric Association.

Astroturf Patient Groups Exposed: Major Funding Comes from Rx Industry

Pharmaceutical companies provide a significant share of financial support for many of the patient groups that advocate for people with conditions requiring long-term treatment, an investigative report by the New Scientistfound. An investigation into a random sampling of 25 groups revealed that seven received 20 percent or more of their funding from drug and device companies. The Colorectal Cancer Coalition, founded in 2004, topped the list with 80 percent of its funding coming from the drug and device industry. The Restless Legs Syndrome (RLS) Foundation received a substantial amount of money from two major drug makers with products directly related to the syndrome: GlaxoSmithKline, which makes the RLS drug Requip, and Boehringer Ingelheim, whose RLS drug is pending approval, have collectively contributed more than $628,000 to the foundation, almost half of its total revenue.

FDA's Orphan Drugs Czar to Join Amgen

Marlene Haffner, the long-time head of the Food and Drug Administration's orphan products office, has retired from the agency after 35 years to take a job with Amgen, the nation's biggest biotech firm. Amgen was one of the first companies to take advantage of the seven years of market exclusivity granted under the Orphan Drug Act, which is given to firms that are first to market a drug for treating conditions with fewer than 200,000 patients. Amgen's Epogen, now taken by more than 300,000 Medicare-reimbursed dialysis patients, racked up $2.5 billion in sales last year. When she joins Amgen on Jan. 1, Haffner's new title will be Executive Director of Regulatory Affairs for Global Government Affairs. Three years ago, FDA whistleblower Robert F. Steeves accused Haffner of taking numerous wasteful and fraudulent overseas trips at government expense. In a suit filed in a Virginia federal district court, Steeves, now a private consultant, accused Haffner of making false charges and improperly suspending him from the agency after he made those allegations, which have never been investigated by FDA's top management, according to FDAWebview (subscription required). On the other hand, Abbey Meyers, president of the National Organization of Rare Diseases, praised Haffner's tenure at FDA, but expressed "surprise that she's going somewhere where they don't really focus on orphan drugs."

NAS: Conviction No Bar for Former FDA Head

Lester Crawford, the former head of the Food and Drug Administration who pleaded guilty two weeks ago to hiding conflicts of interest, has been named by the National Academy of Sciences to the new Army Science and Technology board that is charged with reviewing hygiene standards at a U.S. Army chemical disposal facility in Utah. Margaret Novack, the NAS official in charge of the committee, defended the choice by saying the board will be "looking at military chemical policy, which is a far cry from the type of things he was previously involved with."

Fired Scientist Accuses USGS of Blocking Study, Seeks Data

A scientist who claims he was fired by the U.S. Geological Survey after refusing to alter his findings on the effects of chemicals in the water supply has filed a federal lawsuit seeking access to his data and the right to talk to government colleagues who collaborated in the studies. Tim Gross' suit alleges that the USGS wrongfully fired him last January by claiming his ongoing affiliation with the University of Florida was a conflict of interest, even though USGS knew about his university ties when it first hired him in 1998. In an interview Gross said that he wants to publish the results of two government-funded studies: one conducted primarily while he was working solely for the University of Florida that found wastewater chemicals were affecting fish populations nationwide; and another USGS-sponsored study suggesting pollution in southern Nevada’s Lake Mead is having a greater effect on its fish than previously believed. However, the agency confiscated his data and forbade other USGS scientists from talking to him, which, Gross claims, makes it impossible for him to publish his interpretation of the data. The USGS, which has assigned a new team of researchers to the Lake Mead study, did not return phone calls seeking comment.

Internal Survey: Mixed Attitude Toward New NIH Ethics Rule

Almost 40 percent of 512 tenured and tenured-track research scientists at the National Institutes of Health said they are actively looking for other work or are considering doing so because of new conflict of interest rules, according to an Associated Press story in the Washington Post. However, just 18 percent of 3,336 NIH scientists surveyed stated that they are active looking for or would consider other employment. Nearly nine in 10 scientists reported they intend to work at NIH a year from now and the scientists reported a job satisfaction rate of 81 percent, one of the highest in government. There was no comparison to employee attitudes prior to the new rules. NIH strengthened its ethics rules last year after learning that some senior scientists had formed lucrative consulting agreements with biotechnology and drug companies without agency permission.

Odds and Ends

An open letter in Science Magazinethis week calls on Libya to release the five Bulgarian nurses and one Palestinian doctor who are facing execution after the government of Moammar Kadafi convicted them of intentionally infecting 400 Libyan children with HIV. The six health care workers, who've been in jail for nearly eight years, were tortured to extract confessions and then sentenced to death by a firing squad. The "Plea for Justice for Jailed Medical Workers" is being coordinated by AIDS research pioneer Robert C. Gallo at the University of Maryland, who can be reached at gallo@umbi.umd.edu . . . Senior Bush appointee Julie MacDonald, deputy assistant secretary of the interior for fish and wildlife and parks, has ignored staff recommendations that at least six times in determining whether animal and plant species should be protected under the Endangered Species Act, documents obtained by the Washington Post show . . . The Environmental Protection Agency has closed its Office of Prevention, Pollution and Toxic Substances Library in Washington, D.C., which provided research services to EPA scientists who review industry requests for the introduction of new chemicals into the market, according to documents released today by Public Employees for Environmental Responsibility.

Sachs' Unfashionable Rx for Third World Aid

Jeffrey Sachs drew nervous titters last week when he told a Washington meeting of neglected tropical disease researchers and advocates that a comprehensive campaign for combating malaria would cost “only” $3 billion a year, about three times more than what donor nations currently offer. Visibly taken aback by the audience reaction, Sachs tried to put the number in perspective. “I’m the last macro-economist in the world dealing with single-digit billions,” he said. “It’s nothing. It’s a rounding error.”

For this crowd, though, $3 billion seemed unimaginably huge. Neglected tropical disease (NTD) researchers deal with maladies like hookworm, trachoma, and elephantiasis, which in aggregate devastate nearly as many lives in the developing world as HIV/AIDS and more than malaria or TB. Even when they don’t kill, they stunt growth, impair intellectual development and permanently disable millions of people, dooming them and the villages that must support them to grinding poverty. Yet campaigns against these diseases over the years have been given short shrift by the global health community.

That may be about to change. Under the leadership of Peter Hotez of George Washington University, who is working to develop a vaccine for hookworm, non-profits that focus on 13 neglected tropical diseases recently banded together in the Global Network for Neglected Tropical Disease Control, which sponsored last week’s conference. They plan to press official aid agencies like the World Bank, U.S. AID and the World Health Organization to incorporate treatment for NTDs into the same outreach campaigns that are now spreading treatments for AIDS, malaria and TB around the globe. It’s a piggyback strategy that could have a rapid impact on reducing the incidence of these poverty-inducing illnesses.

While new drugs and vaccines are needed (once again the Bill and Melinda Gates Foundation has taken the lead on the technology front with its recent announcement of nearly $70 million in grants for NTD researchers), safe, effective and cheap drugs for treating more than half the 13 diseases already exist. Unfortunately, most never reach the people who need them.

For once, the global pharmaceutical industry hasn’t been a roadblock to wider deployment. Companies like Merck (Mectazin for onchocerciasis, which causes river blindness), Pfizer (Zithromax for trachoma), GlaxoSmithKline (albendazole for lymphatic filiarisis, which causes elephantiasis) and Bayer (praziquantel for schistomiasis, one form of intestinal worms) have generously made their products available at low or no cost to any non-profit agency or government that can successfully deploy them in the developing world. “The drug companies are the good guys in this story,” Hotez said.

So where’s the roadblock? The conference featured a number of non-profit partnerships that have succeeded in making inroads against these diseases in some countries. The African Program for Onchocerciasis Control (APOC), working with Merck to fight river blindness, appears to have done an especially effective job in the 16 countries where it operates. “It’s a ready-made network for distributing drugs for the other NTDs,” said Uche Amazigo, director of APOC. “If you want to distribute your ITN (insecticide-treated nets for malaria control), bring them to APOC. We know how to do it,” she declared.

However, overall distribution of newly available disease treatments, whether for HIV/AIDS, malaria or NTDs, has been poor across sub-Saharan Africa and the other developing countries. Rural health outposts in these countries simply are not set up for it. One conference attendee, a public health administrator from Uganda, complained that in his country all of these newly launched programs wind up on the desk of a single health outreach worker, who is often responsible for several geographically dispersed villages. “Who will support the health care systems in our countries,” he asked.

When several panelists suggested the non-profit partnerships could take the place of concerted government action, especially in areas plagued by civil strife or government corruption, Sachs, now sitting in the audience, leaped to his feet to give the conversation a dose of economic reality.

“These are countries that have per capita incomes of $200 to $500 a year,” he said. “That means there is, at best $45 per person a year for all government services, police, defense, water, education, health,” he said. “Health might be able to get $6 to $10 per year per capita at most, versus $3,000 per year in rich countries.” That countries somehow don’t have the will or are incapable of tackling these problems “is nonsense and a deep misunderstanding.”

He was especially dismissive of World Bank programs, which demand even the poorest countries repay their loans. He condemned social marketing schemes that operate on the premise that poor people will put more stock in remedies that they have to buy at subsidized (and theoretically affordable) rates. “I’ve seen people stand outside a clinic because they can’t afford the dollar for a donor-supported program,” he said. “Most of the people in these communities don’t earn money. User fees are an abomination in low-income countries.”

Sachs, who turns 52 this week, recently received a $50 million grant from George Soros to develop, through his Earth Institute at Columbia University, economic development initiatives to end poverty in selected rural African villages. It is in essence a pilot project for a massive ramp up in outside aid. Though he meets with ex-presidents and foreign leaders and is habitually mentioned as one of the 50 most influential people on the planet, he cuts a less than imposing figure in a conference setting. He travels with a backpack stuffed with notes and books, and his Powerpoint slides contained no fancy graphics.

But he was treated like a traveling rock star by the neglected tropical disease researchers and advocates, and not just because Bono wrote the introduction to his recent book, The End of Poverty. A decade ago, Sachs was widely vilified for advocating free market “shock therapy” to jumpstart the post-Communist economies of the eastern bloc (he rejects the shock therapy label). In some countries, at least, it worked. Now, in contemplating how to jumpstart economies in the poorest regions of the world, he’s come up with the opposite prescription: massive government aid.

But how massive is it, really? To spend $40 per capita for health in the developing world would cost $35 billion or one-tenth of one percent of GNP in the rich world, he says. “It’s easily affordable. Don’t beat up on poor countries that aren’t doing it because they can’t afford it.”

Sachs is one of the nation’s leading macro-economists and something of an intellectual bellwether. Should the political winds continue to shift, a U.S. establishment in desperate need of help on foreign affairs may once again look to him for a fresh approach in its dealings with the developing world.

Harold Ford's "Back Atcha" Ad

My Bartlett's informs me that it was Shakespeare in his play Henry IV who first wrote "I want there to be no peasant in my realm so poor that he will not have a chicken in his pot every Sunday." To win the white male vote, I suggest Democrat Harold Ford of Tennessee run a version of this ad to counter the desperate racist drivel emanating from the Republican National Committee.

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Still Smoking

Remember the 90s war on smoking? FDA commissioner David Kessler browbeat the tobacco companies about their marketing tactics. Big Tobacco chief executives found themselves before Congress, exposed as liars when they said their products weren't addictive.

The shame campaign, coupled with a massive legal assault by federal and state prosecutors, worked. Smoking dropped sharply. The filthy habit was banished from indoor spaces. And public health achieved what a half century's research into new cancer therapies could not -- it finally got the cancer death rate to begin dropping.

Well, guess what? The Bush administration has turned that "mission on the way to being accomplished" into a fiasco, too. A new report from the Centers for Disease Control shows that the percentage of Americans who smoked last year was no different from the year before -- the first time in a generation that this vital statistic did not decline. The arrested decline may be an artifact of this trend: adolescent smoking stopped declining in 2002.

But there's other factors at work. Cigarette prices aren't rising much these days, largely because taxes are holding steady. State programs for tobacco control and prevention fell 26.5 percent between 2002 and 2006. And, tobacco advertising rose from $6.7 billion in 1998 to $15.1 billion in 2003.

You'd think the president's Surgeon General would be up in arms over the resurgence of this public health menace. You know, what's his name?

The Permanent Bases Question

I highly recommend the latest issue of the American Prospect for its excellent investigative article by Spencer Ackerman exposing the U.S. military's plans -- or non-planned plans as it turns out -- to build permanent bases in Iraq.

In the 2004 presidential debate, Democratic candidate John Kerry pressed President Bush to disavow the notion the government had plans to build permanent bases. The president never responded directly, and the press never followed up. (I'm proud of the fact that I saw this as the major news event coming out of that debate, which no one in the press reported the next day.)

Ackerman interviewed former State Department aide Larry Diamond, who is a card-carrying member of the conservative Hoover Institution and a former Stanford colleague of Secretary of State Condoleezza Rice. She brought him into the administration as an adviser to the Coalition Provisional Authority in Baghdad, yet ignored his memos "implor(ing) the administration to renounce any long-term presence in Iraq."

In Ackerman's story, Diamond wondered:

It baffles me. Why is the White House press corps not confronting the president, saying, 'Mr. President, are we seeking permanent military bases in Iraq or not, and if not, why not take the issue off the table?' It's appalling. It's no less a scandal that the press has failed to pin the administration down on this, and the administration has failed to come clean to the American people as we bleed and die there."

Given that the permanent presence of foreign troops on Arab soil is one of the main issues goading terrorists into action, you'd think the press would demand that the administration provide an answer. You'd think Congress would hold hearings. You'd think the military brass would raise questions. But none has, and the military has simply stumbled along, building the permanent bases without, if we're to believe Ackerman's reporting, specific authorization from the White House or the Pentagon. They're still in what President Nixon's men used to call "plausible deniability" mode.

It has often been said that the genius of the American political system can be found in the system of checks and balances created by the nation's founders. Alas, when no one checks, there is no balance and the nation teeters perilously off course.

Health Care Costs On Their Minds

It barely registers as an election issue, but a new survey from the Employee Benefit Research Institute finds increasing dissatisfaction with the nation's health care system, primarily because of rising costs. "Six in 10 Americans rate the health care system as fair (28 percent) or poor (31 percent). The percentage of individuals rating the system as poor has doubled since the inception of the HCS in 1998 (15 percent)," the survey found.

One result especially intrigued me: When asked if they would trade in their employer-sponsored plan for tax-free cash and given the option of buying their own insurance, three-fourths of the respondents say no. So much for public interest in individual mandates or high-deductible plans. People want health insurance that makes them secure in the knowledge they'll be taken care of if they get sick. They don't want to become "consumers" in a wild west health care market.

The survey also found that more than a third of respondents said rising health care costs were eating into their ability to save for retirement, up from a quarter of respondents two years ago.

Health care and retirement. These issues aren't going away anytime soon. Perhaps in a few weeks we'll have a Congress ready to start considering long-term fixes for these problems.

Going After Amgen's Games

Journalists are once again discovering Amgen, the bad boy of biotech. Chris Rowland of the Boston Globe today reminds his readers that the government could save a half billion dollars a year by requiring dialysis patients to take Amgen's best-selling drug Epogen via injection rather than through intravenous drip.

Last week, Amgen signed a special deal with one of the largest dialysis chains to effectively freeze out a comparable drug produced by Roche. Will the Federal Trade Commission take notice? Maybe after November 7.

Statin Static and more . . .

From this week's Integrity in Science Watch from the Center for Science in the Public Interest:

Researchers have called into question the National Institute of Health guidelines that call for aggressive cholesterol lowering in people at high risk of heart attacks and strokes, or who have already suffered from these adverse events. Eight of the nine authors of the controversial 2004 guidelines had financial ties to manufacturers of statin drugs, which lower cholesterol. In a review published in the October 2006 Annals of Internal Medicine, University of Michigan researcher Rodney A. Hayward, who is associated with the Veterans Administration, and two colleagues said the "current clinical evidence does not support" the idea that aggressive statin therapy to achieve very low cholesterol levels for high-risk people "is beneficial or safe."

The New York Times called the Hayward review "provocative" and a challenge to "mainstream medical thinking and the consensus among most cardiologists." In countering his view with a quote from Sidney C. Smith Jr., a University of North Carolina professor and former president of the American Heart Association, the Times failed to note that Smith received "institutional research support" from Merck, a manufacturer of statin drugs, while he was helping to write the 2004 guidelines.

Stifled Cancer Research Finally Published

An independent researcher last week finally published his study showing elevated cancer rates among workers at IBM manufacturing facilities. The company had fought the study's publication for two years while supporting a researcher whose study, which appeared a year ago, showed no elevated risk, according to the Wall Street Journal. The independent study was conducted by Richard Clapp, a Boston University professor of environmental health, who was hired by lawyers in California who were representing a number of IBM workers who had gotten cancer. Using employee health records from 1969-2001, Clapp found an increased rate of cancer deaths in both men and women compared to either the national average or deaths at other IBM manufacturing plants.

An IBM spokesperson said that Clapp's analysis misused the data and conflicted with their own 2005 study  which showed "lower overall mortality and cancer incidence rates than the general population." The IBM study was led by Elizabeth Delzell, an epidemiology professor at the University of Alabama, Birmingham (see Integrity in Science database), who has conducted studies for numerous large firms and trade groups including Phillips 66, Ford Motor Company and Shell Oil.

Cancer Groups Withdraw from Campaign Funded Solely by Drug Firm

The representatives of two European anti-cancer advocacy groups have pulled out from a major initiative funded entirely by one of the world's largest makers of anti-cancer drugs.  Adamos Adamou, a Member of the European Parliament (MEP) who withdrew from the Cancer United board after attending one meeting, wrote a letter with two to other MEPs to the chair of the board, citing their concern "about the transparency of the...initiative."  The chairman of the European Cancer Patients Coalition also asked to be removed from the board after she was listed as a member without her consent.  Roche, a leading manufacturer of breast and lung cancer drugs, launched the Cancer United initiative last week in Brussels to bring together "all parties concerned with the care of all cancer patients...in Europe."  

Meanwhile, top oncologists have criticized the Roche-funded study on which the initiative is based, which was conducted by the Karolinska Institute in Stockholm. That study linked patient survival to the amount governments spend on cancer drugs. Due to this initiative, "governments will no doubt be pressed to fund a big increase in expenditure on cancer drugs - on the entirely spurious grounds that such an increase has been proven to increase national survival rates," said Michel Coleman from the London School of Hygiene and Tropical Medicine.

Business Week: "Disclosure Is A Lousy Solution"

Citing research from the Carnegie Mellon University business school, the latest issue of Business Week Online says disclosure may actually exacerbate the problem of conflicts of interest in medicine. The January 2005 study in the Journal of Legal Studies said participants in a mock situation who disclosed conflicts exaggerated the advice they gave, "possibly because they felt the disclosures gave them moral license to lie." The sidebar was contained in a feature story about Columbia University heart specialist Martin B. Leon, who has numerous ties to manufacturers of surgical devices. Leon chairs the well-attended Transcatheter Cardiovascular Therapeutics (TCT) conference, which is meeting in Washington this week. The conference frequently features devices made by companies Leon either owns or with which Leon has financial ties. "In 2005 no fewer than 345, or 44%, of the more than 750 doctors and researchers who made presentations at TCT had received compensation from companies, some of whose products they evaluated at the conference," the story noted. This year the conference invited medical ethicists to give a half-hour presentation on conflict-of-interest issues to go along with the 704 hours of presentations.

Blunt's Bluster

Wall Street Journal: "House Majority Whip Roy Blunt, a Missouri Republican, yesterday sent an email to the media suggesting House Democrats would "plot to establish a Department of Peace, raise your taxes and minimize penalties for crack dealers."

I like the Peace Department idea.

Where Are The Dixie Chicks?

I had the opportunity two nights ago to see a sneak preview of Barbara Koppel's new film, "Shut Up and Sing," which documents the fall and anticipated rise of the country singing group The Dixie Chicks. Here's a prediction: Koppel, and her co-filmmaker Cecilia Peck, will win the academy award for best documentary film next year and the Dixie Chicks, once the best-selling female group in American pop culture history, are about to discover a whole new audience.

This is by far Koppel's best cinematic work. The narrative cuts between the December 2002 off-hand comment by lead singer Natalie Maines about not being proud that President Bush was from Texas (it took place at a London concert just a few hours after a million people marched against the looming war in Iraq) and their present travails in Los Angeles trying to rebuild their careers. The film uses classic cinema verite techniques that include everything from touching family scenes to the fevered meetings between the Chicks and their public relations consultants who tried to stem the vicious assaults that extended all the way to the White House.

I'm not a country music fan, and I can honestly say that before seeing the movie, I couldn't identify a Dixie Chicks song if I heard it on the radio. But the film introduces their new album, "Taking the Long Way," and its heartfelt songs, many of them drawn from their recent experiences. I guarantee it will send you running to the CD store. If you like Bonnie Raitt, here's the next generation.

I didn't intend to write about the movie except I saw an interesting post last night on Donkey Rising. It cites a poll of southern voters that showed 57% of southerners now believe the U.S. "should have stayed out of Iraq." Moreover, 56 percent of southerners, compared to 59 percent in the nation as a whole, believe the U.S. should begin withdrawing its troops. In other words, country has gone mainstream.

The media gave extensive coverage to the campaign against the Dixie Chicks, which was orchestrated by extreme right wing groups who organized call-in campaigns to pressure country radio stations to stop playing their records (don't forget, this was the best selling band in country music history). What they never covered was the deep well of support their stance had, not just in liberal free-speech precincts where you'd expect it, but among the thousands of so-called rednecks who continued to fill arenas in the immediate wake of the London incident.

The Chicks are not political people. The movie shows us three young women who somehow found the courage in the face of this massive and unjustified political assault to stick by their convictions, convictions that they only discovered by coming under fire. If you're like me and paid little attention to this extraordinary story as it unfolded, see "Shut Up and Sing," which will be opening around the country later this month. You'll become a fan of these three young women, too.

Can Left, Right Unite on User Fees?

While drug safety dominates the news, the big battle brewing over at the Food and Drug Administration is next year's reauthorization of the Prescription Drug User Fee Act, which accounts for nearly half the funds that flow into the agency. Consumer groups oppose user fees because it makes the agency beholden to the very firms it regulates for staff salaries.

The answer, of course, is get Congress to properly fund the agency. If the mission of the FDA is to protect the health and safety of the American people, then the American people -- all of them -- should fund the agency, not predominantly the drug and device manufacturers.

That's a bit of background for today's news, which came in an interesting letter to the editor in the Wall Street Journal, (subscription required). Henry Miller, an associate at the ultra-conservative Hoover Institution and a former FDA employee, complains that industry fees are unfair! Here's what he had to say:

These kinds of user fees are, after all, nothing more than a discriminatory tax on a single industrial sector. You could at least have raised the possibility of appropriated funds substituting for user fees when Congress takes up the reauthorization of PDUFA next year.

This could make for some interesting coalition building next year.

New Study Challenges NIH on Cholesterol

Independent researchers sponsored by the Veterans Administration have called into question the National Institute of Health’s 2004 update of the national cholesterol guidelines. I wrote about this issue extensively during 2004 after the guidelines came out
(click here, for instance), in part because I was part of a group of over 30 physicians and researchers demanding that NIH create an independent panel to re-review the evidence. Eight of the nine authors of the 2004 guidelines had financial ties to statin manufacturers.

To quickly recap, those guidelines called for aggressive use of statin drugs, which lower cholesterol, in people who are at risk of having a heart attack or stroke. For people who had already suffered an attack, the guidelines called for getting the "bad" cholesterol as low as 70. That would take a lot of statins.

We were, of course, ignored. But in a review published in this October’s Annals of Internal Medicine, University of Michigan researcher Rodney A. Hayward and two colleagues, who reported no ties to industry, said the “current clinical evidence does not support” the idea that aggressive statin therapy to achieve very low cholesterol levels in people at risk of heart attacks and strokes “is beneficial or safe.”

Today's New York Times reported on the Hayward review, and I thank them for that. But reporter Roni Rabin countered Hayward’s review with a quote from Sidney C. Smith Jr., a University of North Carolina professor and former president of the American Heart Association. In giving Smith’s credentials, the Times failed to note that Smith received “institutional research support” from Merck, a manufacturer of statin drugs, while he was contributing to the guidelines.

Of course, the point isn't to go nana-nana-boo-boo over who's getting money from whom. As this latest review points out, NIH wrote guidelines for which their is no clinical evidence proving there will be a benefit. It also points out that there is no clinical evidence proving that people can safely take the level of statin drugs needed to reach very low levels of cholesterol.

That's worrisome. NIH needs to retract the guidelines, and immediately sponsor a clinical trial that tests both propositions: Does reducing cholesterol levels down to very low levels improve outcomes for people at risk of heart disease? And can the level of statin drugs needed to get there be taken safely?

You'd think a taxpayer-supported institution would demand answers to those questions before endorsing guidelines written by researchers with extensive ties to the companies that sell cholesterol-lowering drugs.

Crawford Charged with Lying to FDA

Former Food and Drug Administration administrator Lester Crawford, who for a time was the Bush administration's pick to permanently lead the agency, was charged today with lying about stock he held in firms regulated by the agency. Here's the relevant paragraph from the Bloomberg account:

Crawford, who was acting or deputy FDA commissioner for more than three years, also served as chairman of the FDA's Obesity Working Group in 2003 and 2004 while owning shares of Sysco, a distributor of snack foods, and Pepsico Inc., the world's No. 2 soft drink maker, according to court papers. The panel was formed to study the link between weight and health in the U.S.

You couldn't make this stuff up.

Two Buck Chuck, Too?

And now for some good news from the Reuters Newswire:

Red wine might work to protect the brain from damage after a stroke and drinking a couple of glasses a day might provide that protection ahead of time, U.S. researchers reported on Sunday.

In an effort to better understand how red wine works, the scientists from Johns Hopkins University fed mice a moderate dose of a compound found in red grape skins and seeds before inducing stroke-like damage.

They discovered that the animals suffered less brain damage than similarly damaged mice who were not treated with the compound, which is called resveratrol.

And for those who don't get the "two buck chuck" reference, it refers to the $2-a-bottle wine produced by the Charles Shaw winery in California a few years ago. One lady I heard on Air America Radio today said it was now going for $3 a bottle in her neighborhood.

The Political High Season

The consensus is hardening that the Democrats will sweep the November election, winning at least the House and possibly the Senate. I still have my doubts, driven in part by a front page story in today's New York Times that pointed out that the Democrats Have Intensity, But G.O.P. Has Machine. I vividly recall how shocked many liberals were in November 2004 when President Bush posted a two million vote margin of victory, largely because of the overwhelmingly Republican ex-urban vote. Are we in for another rude surprise?

Turnout is the key to every election. Recall that the U.S. has one of the lowest voter participation rates among industrialized nations, and non-presidential election year turnouts are lower than years divisible by four. Moreover, it is largely poor and lower-middle class people who don't vote.

Those who do tend to be brought to the polls by issues or political machines. As today's article points out, the Republicans still have more resources to pour into turnout operations. The pro-Democrat Moveon.org operation is targeting the already convinced. The AFL-CIO and other unions can only target their own members, who already turn out at a higher rate and more reliably Democrat than their non-union colleagues. During the Democratic primary here in Maryland, I got hit up three times on election day to make sure I voted. I have zero confidence that the Democratic Party under Howard Dean's leadership has built a solid turnout operation, or that it is aimed at the precincts that really need it.

But there's still the issues, right? So what issues might motivate traditionally Democratic lower-middle class voters to come to the polls this year? The failure of Congress to enact a higher minimum wage, there's one. How about the 46 million people without health insurance. Or the growing insecurity of aging working class boomers who are staring at a retirement without savings or pensions. Heard anything about any of these issues lately? I saw more issues in one movie trailer for the remake of "All the King's Men" that I've seen in the endless stream of political ads on my television this fall.

Sure, lower middle class folks are like the rest of America in their concern that the war in Iraq is going badly and realize they've been lied to by Bush and his coterie. (The best article on that subject today was in the Washington Post by Rep. John Murtha, the Pennsylvania Democrat and 37-year Marine veteran who has become the conscience of the nation on this war.) But is disaffection from a failed foreign policy enough to bring people who don't usually vote to the polls?

Let's hope so.

Yours Truly Featured on Renal Docs' Website

Check it out.

Forbes Has Amgen in Its Cross-Hairs

Forbes Magazine just published a scathing critique of Amgen's lobbying crusade, which has won it ever-higher reimbursements for its dialysis drug, Epogen, even while it was harming patients. Hats off to reporter Kerry Dolan, and not just because she quotes me. She had the story pretty much knocked by the time she got around to calling.

More Data Withholding at FDA

Public Citizen's Sidney M. Wolfe has turned up another case where a company withheld key data from the Food and Drug Administration. Last week, it was Bayer and Trasylol. This week, it involves the controversial silicone gel breast implant manufactured by Mentor Corp. To read Dr. Wolfe's letter to the FDA, and the letter from an internal whistleblower at Mentor, click here. Given the drumbeat of criticism from women's groups about the hazards associated with these devices over the years, how could the FDA have ignored this whistleblower scientist's letter?

Reform FDA's Advisory Committees, Too

The Institute of Medicine report calling for reform of the Food and Drug Administration got a strong boost today from the New England Journal of Medicine. The journal's editors called on Congress to take prompt action to enact the more far-reaching elements of the report.

There is "a crisis of confidence" at the agency," they wrote, and the growing problems with drug safety are "a mounting public health crisis. . . The critical issues of financing, transparency, and independence must be addressed."

Unfortunately, the editorial makes no mention of the issue that the Center for Science in the Public Interest (where I work) helped bring to the fore: the FDA's overreliance on outside advisers with financial ties to the drug industry. The IOM report called for a "substantial majority" of those advisers to have no ties to firms the agency regulates.

Could it be that the NEJM editors disagree? If so, they would find strong support from the American Enterprise Institute, whose leading drug scholar, John Calfee, today published a ringing defense of the FDA's current practices.

Feel free to read it for yourself. But before you do, allow me to point out the arguments that Dr. Calfee ignores.

First, he argues that the "best and brightest" among the nation's academic physicians work for the drug industry. If the FDA cut them out of the advisory process, it would deny the public the best help. Hogwash. The nation's 125 medical schools, the National Institutes of Health and leading health delivery systems like Kaiser Permanente and the Mayo Clinic are filled with experts who are equally qualified as those academicians and scientists who advise industry. Given the chance, these scientists would gladly serve the public by evaluating the safety and efficacy of new drugs that come before the FDA.

Indeed, many committees have few advisers with conflicts of interest. Is the FDA and defenders of the status quo arguing that these people are somehow unqualified or less qualified? If not, surely there are more where they came from.

Calfee also argues that few if any votes are swayed by the ballots cast by conflicted advisory committee members. He points to the Public Citizen study in the Journal of the American Medical Association that turned up that unremarkable statistic. An FDA re-analysis of those numbers showed that most conflicted scientists actually work for competitors of the firm with a drug application before the agency. Since most advisers with conflicts of interest vote to approve new drugs, they are, in fact, voting against their supposed self-interest.

Alas, Calfee fails to address the central point, which I'm sure he is aware of because he heard me present it at a conference last week at Hofstra University. The core problem with larding advisory committees with conflicted members is not that there is some crude quid-pro-quo behind their votes.

Their presence creates an ideological imbalance. Scientists and clinicians who serve industry are biased toward approving drugs, whether it is their sponsor's drug or a competitor's drug. They do not cast a cold eye on the underlying data. They do not hunt for signals in the data that hint at a safety problem down the road when millions of people -- not the few hundred or thousand in a clinical trial -- are taking the drug. By continually drawing from the same crowd of scientists with long-standing ties to industry, the FDA fails to balance its committees with scientists who have these critical skills and perspectives.

No one argues that ending conflicts of interest on FDA advisory committees is a panacea for what ails the agency. But the presence of so many scientists with financial ties to the firms the agency is supposed to regulate casts a pall over the entire process. When it comes to the agency charged with overseeing the health and safety of the American people's food and drug supply, appearances matter.

If the new Congress takes FDA reform seriously, ending conflicts of interests on the FDA's advisory committees will rank high on its agenda. The other reforms in the IOM report are, quite frankly, more important. They will give the FDA the tools it needs to do a better job. But ending conflicts of interest will send a clear signal to the public that a new day has dawned at the agency. That's a signal worth sending.

Who Do You Trust?

No, it's not a game show, but the latest study from the British Medical Journal comparing industry-funded studies to more independent analyses conducted by the Cochrane Collaborative, an international consortium devoted to writing evidence-based clinical practice guidelines.

The meta-analyses reviewed in the study compared new drugs for a disease to an existing drug. Given that industry rarely funds comparative trials or comparative analyses, it's not surprising that the three Nordic scientists, two of whom were associated with the Cochrane Collaborative, found only eight industry-funded meta-analyses for their review. Seven of those studies "recommended the experimental drug without reservations." When the researchers looked at the seven Cochrane reviews for the same drugs, none of the newer drugs in the studies proved superior.

"Industry supported reviews of drugs should be read with caution as they were less transparent, had few reservations about methodological limitations of the included trials, and had more favorable conclusions than the corresponding Cochrane reviews," the study concluded.

Stark Challenges WSJ on Medicare

Should the Democrats take back control of Congress, Rep. Pete Stark (D-Cal.) will be in line to run the influential health subcommittee of the House Ways and Means Committee. That's good news for anyone concerned about accountability and cost-effectiveness in the nation's health care system. Here's a letter he wrote to the Wall Street Journal today. It provides solid talking points for anyone combating the arguments of those who believe that competition among insurers will succeed in holding down health care costs.

Privatizing Drives Up Cost Of Administering Medicare

Your Oct. 4 editorial "Markets and Medicare" implies that the private sector is more efficient than Medicare. Medicare trustees suggest the opposite, finding that administrative costs for the new prescription drug program's private drug plans average 12% -- six times Medicare's historic 2% ratio.

You also claim that "competition" is responsible for a decline in the drug program's cost. But these reductions are primarily a result of a trend of lower drug spending that is unrelated to Medicare.

And you allege that the Veterans Administration limits drug access. But the VA covers 16,000 prescription drugs on its formulary, and ensures access to other drugs when necessary. VA patient satisfaction is high and the VA negotiates price discounts far below those in Medicare's private plans.

On one point you are correct: I am unhappy with the GOP agenda to privatize Medicare. Why? At the behest of Republicans, the government now pays Medicare-sponsored HMOs and other private plans 11% more than would be spent in the traditional fee-for-service program. If the private sector is so efficient, why do we have to pay it more to do the job?

Rep. Pete Stark (D., Calif.)
Ranking Member
Ways and Means Subcommittee on Health
Washington

MEDLINE Mulls Outing Corporate-Backed Studies

The National Library of Medicine will consider a major revamp of its indexing policies in the wake of revelations that industry-sponsored supplements without full conflict-of-interest disclosures are slipping into MEDLINE, the government-funded database for health studies. The issue arose last week when Integrity in Science Watch revealed a recent supplement in the Journal of the American College of Nutrition was sponsored by the International Life Science Institute's Salt Committee, which is made up of major food corporations. Articles in the supplement did not list the corporate ties of their authors.

MEDLINE's existing policy states any supplement sponsored by "private, for-profit" organizations must contain disclosures before it is indexed. ILSI, though largely funded by industry, is a non-profit organization, thus allowing it to slip through the loophole. "We will review our policy and strongly consider changes that would require author disclosure for any supplement funded by an outside source in the future," NLM head indexer James Marcetich said. "It may not be practical in a large scale production operation like MEDLINE to investigate whether a sponsor represents non-profit, for-profit, or non-profit but funded by for-profit interests -- so it may be best to require disclosure for all outside sources."

For more from this week's Integrity in Science Watch, click on.

Harvard Prof Told FDA About Bayer's Hidden Study

It was Alexander Walker, a professor at Harvard University's School of Public Health, who first reported Bayer's failure to tell the Food and Drug Administration that an ongoing study showed serious safety concerns with its best-selling blood clotting drug, Trasylol, Bloomberg News reports. Walker was conducting the study for a private firm hired by Bayer. An FDA advisory committee met on September 21 to review evidence from two small trials that Trasylol, which is used to control bleeding during heart surgery, caused kidney failure, heart attacks and strokes. But the committee never heard about Walker's much larger, 67,000-patient study, which was first revealed to the FDA on September 29. Bayer conceded its failure to release the data in time for the advisory committee meeting was a mistake. Several advisory committee members told Bloomberg that the additional information would have convinced the committee to recommend that the FDA issue a stronger safety warning.

Scientists Protest as EPA Delays Dry Cleaning Rule

Environmental Protection Agency scientists are protesting demands by a senior political appointee at the agency for further tests on perchloroethylene, or perc, a widely used dry cleaning solvent, InsideEPA reports. The new in-house tests were requested by Office of Research and Development head George Gray, who previously ran the Harvard Center for Risk Assessment. He wants the tests completed before the assessment moves on to the National Academy of Sciences for review.

The NAS study itself is a product of industry delaying tactics. In June, the American Chemistry Council and Halogenated Solvents Industry Alliance met with the Office of Management and Budget to protest the pending perc regulation. The EPA subsequently threw the entire issue to the NAS for an independent review. At issue is the use of threshold levels for determining toxicity, with industry claiming that low levels of exposure do not cause harmful effects. EPA scientists say there is no scientific justification for using this theory in regulatory proceedings. "George Gray uses uncertainty to delay decision-making," said Judy Schreiber, with the Attorney General's Office of New York, who works with affected citizens who live above dry cleaning facilities in apartment buildings, "Its time the EPA sits down and makes a decision."

Scientists Resign from Unbalanced EPA Advisory Panel on Toxins

Three members of a federal science advisory panel on pollution prevention resigned last week, citing excessive industry influence over the board's agenda. Richard Denison, senior scientist for Environmental Defense, Joseph Guth, executive director of the California League for Environmental Enforcement Now, and Joel Tickner, assistant professor at the University of Massachusetts, resigned October 2 from the Environmental Protection Agency's National Pollution Prevention & Toxics Advisory Committee, which is charged with reviewing the agency's assessment and management of chemicals under the Toxic Substances Control Act. The three scientists said the seven industry representatives on the 15-member panel have limited its agenda to "narrow, short-term issues" that do not warrant the time or expense to EPA. The panel includes representatives from Dow, Procter & Gamble, the American Chemistry Council, and the American Petroleum Institute.

The FDA and Drug Safety

The Archives of Internal Medicine contained an article today that called for far-reaching reforms at the Food and Drug Administration. Several of its authors are people with whom I've worked over the years. I do not have a subscription to the Archives, but someone kindly sent me a pre-embargo copy (it is now released). After reading it, I thought its contents were, from start to finish, a significant contribution to the current public debate over the state of the U.S. drug safety system. The editors should have made this article open to the public. Even though this is often done with significant articles in other medical journals, the editors of the Archives chose not to in this case. So, as a public service, I am republishing it here in its entirety.

The Republicans' Penis Woes

This Foley thing prompted some thoughts this morning, after a week of non-stop coverage in the press:

A month ago, this election was shaping up as a referendum on the Bush administration's war in Iraq and a Congress beholden to special interests that ignores every pressing domestic concern. Now? The press is obsessed with a meaningless sex scandal, and is suggesting Republican losses will be due to a decline in evangelical turnout (see today's New York Times and yesterday's Washington Post).

Unless the public and the press return to the real issues in this election, the Bush administration will have a perfect foil for browbeating the newly elected Democratic Congress (should that occur) into continuing its unpopular war policies. And the so-called "values" of the religious right will once again have been given far more political credence than they deserve.

NIH To Fund Study on Macular Degeneration Treatments

After months of dithering, the National Eye Institute finally announced it will sponsor a head-to-head trial between two Genentech treatments for macular degeneration, an affliction of old age that robs the eyesight of an estimated 155,000 Americans a year. Even though both antibodies cut off blood vessel formation in the same way, one costs nearly $2,000 a shot and the other about $50. It looks like the articles that appeared yesterday in the New England Journal of Medicine forced NIH to do the right thing. NIH should be funding dozens of such comparative effectiveness trials.

A Test For Older Eyes

I’m participating in a conference this week at Hofstra University on Long island that brought together a small group of experts from industry, academia and the government to discuss conflicts of interest in medicine and how it affects government regulation of the drug industry.

Last night, Rep. Maurice Hinchey (D-NY) spoke about his Food and Drug Administration reform bill (HB 2090) that would create an independent safety department within FDA (separating it from the new drug approval arm); put industry user fees in the treasury to insulate the agency from the subtle pressure that comes from having industry pay your salary; and ban conflicts of interest on Food and Drug Administration advisory committees, among its excellent, far-reaching provisions.

A major discussion point at several points during the sessions was the failure of the FDA to insist that industry carry out post-approval trials, which are required when there is some question about the long-term safety of a new drug prior to entering large-scale use. In addition, a number of physicians in the audience complained about the paucity of information that compares newer drugs to what’s already on the market so physicians can make the best and least costly prescribing decisions for their patients.

Borrowing a proposal made five years ago by Princeton University economist Uwe Reinhardt, I asked Hinchey if he would support a small levy on prescriptions to fund such trials, perhaps through a new institute at the National Institutes of Health.

A 1 percent surcharge would raise over $2 billion a year and go a long way toward covering the cost of the most pressing of these comparative effectiveness trials (a large scale trial on a widely used class of medicines can cost $100 million or more). While that sounds like a lot, it’s just 7 percent of what NIH spends every year.

A perfect example of the need for such trials was reported this morning in the New England Journal of Medicine. A new trial comparing Genentech’s new drug for macular degeneration (a condition that gradually robs the eyesight from about 155,000 senior citizens a year) to an older laser procedure showed the drug, ranibizumab or Lucentis, was vastly superior. Unfortunately, Genentech is charging $1,950 per shot for this biotech drug (it’s a monoclonal antibody that inhibits the formation of new blood vessels that cloud the eye). Even under the new Medicare drug plan, seniors will have to pay about $400 a month out of pocket for this treatment.

Ophthalmologists have discovered an interesting alternative to this new product. It’s one of Genentech’s old products. Avastin, which is also an anti-angiogenesis drug used for colon cancer, appears to work just as well. And while Avastin costs $4,400 per treatment as a cancer therapy, the vials used for chemo contain nearly 100 times the volume needed to treat macular degeneration. By using Avastin off-label, rather than Genentech’s newer drug, doctors can charge their patients just $17 to $50 a shot.

So far, the use of Avastin has spread through case reports in the medical literature and word of mouth (and some good reporting by Andrew Pollack of the New York Times). No one has conducted a controlled clinical trial proving that this blood vessel formation inhibitor works. No one has compard Avastin to Lucentis.

The company certainly isn’t interested in conducting such a trial. Here’s what Hal Barron, the Genentech’s chief medical officer, told the NEJM: "We have a huge database suggesting that Lucentis is very effective and very safe, so we are just not sure of the value of taking something that is not formulated for the eye and subjecting patients to a randomized trial when there is, in our opinion, a very low likelihood of its being superior.”

Writer Robert Steinbrook concluded:

Since late 2005, the National Eye Institute has been considering a proposal for a prospective multicenter trial that would compare ranibizumab directly with bevacizumab. Although the institute has signed off on the need for a trial, as of mid-September it was still considering the research design and how to pay for the study, which would probably cost tens of millions of dollars. If the study is to go forward, the federal government will probably have to buy both drugs from Genentech. And the investigators will probably have to submit to the FDA an investigational new drug application for intravitreal bevacizumab. Such a comparison might not ultimately affect the difference in price between the drugs, but it is certainly the only way to determine which drug is better for patients.

Last night, I asked Hinchey if he would support a small tax on prescription drugs to support such trials. Stupid me. I used the T-word (tax). Hinchey bristled and said he thought drug prices were high enough.

Even if this hadn’t come up during election season, I suspect even the most liberal members of the House and Senate will shy away new taxes for worthy trials, given the precarious state of the nation’s finances. Should the Democrats win back the House and Senate (which is a growing possibility because of the Foley scandal), those pushing for worthwhile programs – like comparative effectiveness testing for new and existing drugs – will need to eliminate some other programs.

To this morning, I’m officially changing my position, which I articulated in the last chapter of my book. I am no longer for a small tax on prescription drugs to fund comparative effectiveness trials. I think the NIH should eliminate some wasteful programs. Perhaps a good place to start would be the $2 billion NIH spends on researching cures for obscure potential bioterror agents since there is no evidence that anyone anywhere in the world (except the U.S. government) is doing research on these agents.

The Triumph of Marketing Over Science

The Washington Post reports that the newest generation of atypical anti-psychotic drugs is no better than older drugs, which have been around since the 1950s and had moderate success in treating schizophrenia. This isn't exactly news. The Lancet reported the same thing back in 2003.

So will this scientific insight be bad news for Johnson & Johnson, whose blockbuster anti-schizophrenia drug Risperdal racked up $3.6 billion in sales last year, making the biggest selling anti-psychotic on the market?

Not likely. Last week, the Wall Street Journal reported that the company is on the cusp of receiving Food and Drug Administration approval to market a new drug for this troubling condition. Is it a major breakthrough? I’m sure psychiatrists will be told it is by the small army of detailers that will be visiting their offices in the coming months. But don’t believe a word of the hype. As Scott Hensley reported last Friday (subscription required, or I'd give you the link), paliperidone is nothing more than the metabolite of Risperdal. What used to be done in the patient’s stomach will now be done in the company’s lab.

And for this, they will get an additional five years to market this line of antipsychotics, which are no better than generics that have been around for two generations.

We’ve seen all this before. Sometimes the companies subtract out the inactive portion of an older molecule (AstraZeneca did that and came up with Nexium to replace Prilosec). Sometimes the companies add a chemical tail to the drug to make it stay in the body longer (Amgen did that and came up with Aranesp to replace Epogen).

Then they make great claims that the new drug is somehow better. But it rarely is. J&J didn’t even try to make that point. It’s clinical trial for paliperidone tested it in 1,600 patients against a placebo – not Risperdal, the drug it was meant to replace. The one physician Hensley found who defended the “new” drug was, no surprise here, a paid consultant to J&J.

Still, stock analysts are predicting sales of $2.5 billion annually for paliperidone by 2010. That would be $2.5 billion for a drug that works no better than generics available for a tenth the cost (if they work at all, and there's plenty of people out there who argue they don't and have side effects that far outweigh the alleged benefits).

Is it any wonder that we have the highest health care costs in the world?

Integrity in Science Watch -- Oct. 2

Nutrition Journal Failed to Disclose Editor's and Authors' Ties to Salt Industry

The Journal of the American College of Nutrition's June supplement on sodium intake and human health failed to reveal that its editor and several authors had long-standing ties to the food industry. Then, in violation of the National Library of Medicine's rules, the editors allowed MEDLINE to index the supplement.

Guest editor Alexander G. Logan, a physician at Mt. Sinai Hospital in New York, is a consultant to the salt industry and scientific advisor to the International Life Sciences Institute's North American Technical Committee on Sodium, which sponsored the supplement. The committee's members include Frito Lay, Heinz Co., Kraft Foods, Inc., and Proctor & Gamble. The editors at JACN allowed ILSI to select Logan to edit the articles, which did not undergo the journal's peer review process.

Supplement authors included Suzanne Oparil, a paid consultant to the Salt Institute, and former editor of an American Journal of Clinical Nutrition supplement that included papers from a salt conference that was also sponsored by ILSI. A second author, Michael H. Alderman, is an unpaid consultant to the Salt Institute. His article concluded, "the available data provides no support for any universal recommendation of a particular level of dietary sodium." Robert P. Heaney, a paid consultant to the dairy industry, reviewed calcium and salt effects on bone density. None of those ties were revealed in the articles.

ILSI did not inform JACN's editors about Logan's ties to the salt industry, according to editor-in-chief John Cunningham, who sent a formal inquiry to Logan and ILSI after the Integrity in Science Project at the Center for Science in the Public Interest and other groups inquired about the lapses in the journal's normal conflict-of-interest disclosure rules. Cunningham also said he will investigate the authors' undisclosed conflicts of interest. In a letter to JACN, CSPI demanded that the next issue contain a formal apology to readers, full conflict-of-interest disclosure information for all authors and a prominent notice that the supplement did not undergo peer review. In a separate letter to the National Library of Medicine, CSPI requested that the abstracts be withdrawn from MEDLINE since the journal failed to follow NLM policy. The agency recently ruled that privately-sponsored journal supplements must contain conflict-of-interest disclosures for all authors and editors before they can be indexed in the government-funded database.

Risk Analysis To Carry Conflict-of-Interest Disclosures

The Society of Risk Analysis has agreed to start printing conflict-of-interest disclosures in articles published in its journal Risk Analysis. The new policy, announced in its fall newsletter, also prohibits officers and appointees of the Society from using their positions for financial gain or to give their industrial clients preferential treatment. The change in policy comes after documents unearthed from the Legacy Tobacco Documents Library at the University of California, San Francisco revealed that Risk Analysis' editor-in-chief, Elizabeth Anderson, who currently works as an industry consultant for Exponent Inc., offered to use her editorship to expedite publication of her own tobacco-industry funded study downplaying the risk of phosphine, which is used in rodenticides.

Affected companies, fearing tighter Environmental Protection Agency regulations, had formed the Phosphine Coalition to fund her study. "A scholarly paper prepared for publication and then submitted to the EPA as a pre-publication paper can be just as effective as a published paper," she noted in a memo to her new clients. "Since I am currently Editor-in-Chief of the international journal Risk Analysis, perhaps the peer review process could be expedited if we decide that it is the journal of choice." Risk Analysis eventually published the paper in October 2004. That paper did not disclose that two of her co-authors were employees of R.J. Reynolds Tobacco Co.

Coincidentally, in August of 2004, the Center for Science in the Public Interest asked the editors of Risk Analysis to adopt a conflict-of-interest disclosure policy. Managing editor Richard Reiss, who now is also employed as an industry consultant by Exponent, replied in an email that "Risk Analysis employs a double-blind review process to ensure that all papers are evaluated on their scientific merits alone. That is principally how we manage conflicts of interest."

Feds Restrict Report Showing Global Warming Increases Hurricane Strength

A federal agency blocked an internal National Oceanic and Atmospheric Administration report that concludes hurricanes are intensifying due to climate change, the journal Nature reported last week. The seven-member panel was created after NOAA scientists complained their views were being stifled. While NOAA and Department of Commerce officials deny suppressing this latest global warming report, lead author Ants Leetmaa was reported as saying he received an email in mid-May from an official telling him that the report would not be released because it was too technical.

EPA Clean Air Panel "Disappointed" with Administrator's Decision on Soot

The scientific advisory panel for the Environmental Protection Agency is up in arms after agency administrator Steven Johnson ignored the 22-member panel's near unanimous advice to strengthen regulations on soot. One published report last week quoted Johnson saying he had received advice from private sources, which caused him to override the recommendations of the official advisory committee. Rogene Henderson, chair of the Clean Air Scientific Advisory Committee, said that she is worried that their current report on ozone, due in October, will be rejected in the same manner. "The scientific advice he heard in private trumped the scientific advice he heard in public," she said. "[EPA] is paying for CASAC, and then just disregards" its advice.

Scientists Form Group to Back Pro-Science Candidates

A group of prominent scientists last week launched Scientists and Engineers for America to back politicians who support a scientists' bill of rights. They want to eliminate political manipulation from federal policymaking that is supposed to be based on science, and are demanding that the government never intentionally publish false information, as has happened on reproductive rights and global warming issues. The group leaders include John H. Gibbons and Neal Lane, former science advisers to the Clinton administration, Nobel laureates Peter Agre and Alfred Gilman, and Federation of American Scientists' president Henry Kelly.