Animal House

The Washington Post this morning gave front page coverage to the rotten medical care given animals at the National Zoo, which resulted in at least five needless deaths in the past several years. It's too bad the paper couldn't find room in its pages to cover a report issued yesterday that documented the systematic political abuse of federal government scientists who care about animals.

Public Employees for Environmental Responsibility and the Union of Concerned Scientists recently sent surveys to the 460 scientists who work at the National Oceanographic and Atmosphere Administration. More than half the 124 respondents (53 percent) were personally aware of situations where “commercial interests have inappropriately induced the reversal or withdrawal of scientific conclusions or decisions through political intervention.”

In addition, more than a third of respondents with direct responsibility for the nation's fisheries have “been directed, for non-scientific reasons, to refrain from making findings that are protective” of marine life with nearly a fourth reporting that they have been “directed to inappropriately exclude or alter technical information from a NOAA Fisheries scientific document.”

Last week, Sen. Larry E. Craig showed just how far some politicians will go to shut up government scientists bearing unwelcome news. The Idaho Republican inserted a rider in the energy bill that would close the Fish Passage Center, which since 1980 has been documenting the damage done to salmon and other fish populations by the Bonneville Power Administration's Columbia River dam system in the Pacific Northwest. The special interests behind Craig include local farmers (irrigation), shippers and industrial, commercial and residential users of the BPA's cheap power.

Michele DeHart, manager of the Center, was courageous enough to speak out about the attempt to silence her agency. "Maybe this is one of those deals where when you don't like the message, you kill the messenger," she told the Post.

The survey's results can be found here.

China Flexes Its Muscles

There’s an old saying in the oil industry: “The cheapest place to drill for oil is on Wall Street.”

China’s bid to take over Unocal has the policy world aflutter. Most commentary argues that China is becoming an economic and geopolitical juggernaut, the equivalent of 1980s Japan only this time with an army.

Leave it to Paul Krugman of the New York Times to point out the missing element in the press coverage. If ever there was a western company that could live easily under Chinese tutelage, it is Unocal. Its previous foray into Asian waters involved the alleged use of forced labor to build a pipeline through Myanmar (nee Burma).

But his column otherwise peddles the conventional wisdom, which argues that China poses a threat to America’s long-term security interests. I find such arguments unpersuasive. China is a rising economic power largely because of its access to the U.S. and other advanced industrial markets for low value-added goods like toys, clothes and small appliances. In the 1980s, Japan (and Germany) were devouring U.S. markets for automobiles, machine tools, steel and advanced electronics. Even today, which industries should the U.S. worry more about losing?

My own reading of Chinese history is that it has almost never sought to project military power beyond its borders, with the emphasis here on the word borders. Vietnam, Taiwan, North Korea, Tibet, Xinjiang – these are the areas that have the most to fear from China’s growing military might. The rest of Asia and large parts of the western world have more to gain from China’s greatest export – its people. The large overseas Chinese populations, including those in North America, will serve as a vast conduit for repatriating U.S. dollars into productive investments.

The Unocal bid reflects nothing more than China’s efforts to secure a hedge against the rising price of oil. China does not have large domestic reserves for its rapidly industrializing economy. Right now, not a single Chinese company benefits from the run-up in oil prices. It can hardly be a pleasant prospect to watch its dollar reserves earned from making toys and clothes getting recycled to the west in the form of dividends to ExxonMobil, Shell and Chevron.

In the 1980s, the Japanese challenge angered many Americans because the failure of U.S. corporations to successfully compete threatened their jobs. As oil moves inexorably toward $100 per barrel, I can’t believe that Americans will care one whit about the home country of the oil giants reaping the short-term rewards.

When The Kids Come Knocking, No One Answers

Today’s children face health threats that are far different from previous generations. Infectious disease has almost disappeared, but asthma rates have doubled. Learning disabilities are rising sharply with dyslexia, attention deficit disorder, autism and mental retardation now affecting somewhere between 5 and 10 percent of the four million children born each year. The prevalence of childhood obesity has tripled in recent years. And while it is a miracle of modern medicine that we can now cure a high proportion of childhood leukemia cases, it is sobering to realize that its incidence has risen by more than 60 percent in the past three decades.

Why is this happening? Is it something in the air? Is it chemicals in the water? Is it a diet laced with junk food and soda pop? Is it sedentary lifestyles? Is it the video games?

Over the past five years, a coalition of government agencies including the Centers for Disease Control, the National Institutes of Health and the Environmental Protection agency has prepared a study that will provide answers to many of these questions. The National Children’s Study – a 20-year, $2.7 billion plan to closely monitor 100,000 children from conception through their 21st birthdays – promises to be the government’s most audacious “big science” program since the $3 billion Human Genome Project.

In terms of scientific impact, its planners liken it to the classic Framingham heart study, which began in the late 1940s and taught scientists much of what they know today about the relationship between risk factors like smoking, high blood pressure and high cholesterol and heart disease. “We anticipate the NCS will yield equally enormous societal benefits,” said pediatrician Philip J. Landrigan, one of the intellectual architects of the study. “Six of the chronic diseases that the study plans to examine – obesity, injury, asthma, diabetes, schizophrenia, and autism – cost America $642 billion per year. If the NCS were to produce a reduction of only 1 percent in incidence of these diseases, the annual savings would amount to $6.4 billion, far more than the $2.7 billion price tag of the study.”

Alas, the NCS is about to fall victim to the Bush administration’s neglect. Over the past five years, the various agencies have cobbled together enough money to develop the comprehensive study plan (you can read all about the study here). It involves setting up dozens of centers in representative communities across the U.S. But monitoring the 100,000 families and their environmental exposures over two decades will take more than a thousand scientists, including epidemiologists, physicians, air and water specialists, sociologists and psychologists. In the ramp up years, the study needs about $200 million per year, gradually falling back to about $100 million after the program is underway.

The project’s start has already been delayed by more than a year. The administration again failed to include it in next year’s budget. At a Kaiser Family Foundation forum last week, NIH director Elias Zerhouni refused to reprogram other spending at his agency to pay for this vital research. “I don’t think it’s fair to take from Peter to pay Paul,” he said. The National Institute of Child Health and Development – the lead institute for the project – has little clout within the agency. The money will have to come by special appropriation.

Microbiologists and geneticists lobbied hard to make the human genome project a reality. But scientists who care about kids appear to have little sway in Washington. No one on Capitol Hill has stepped forward to champion the study even though it has been endorsed by over 30 major national organizations ranging from the March of Dimes to the American Academy of Pediatricians to the American Chemistry Council. Yes, even the chemical industry's chief lobbying arm is supporting this objective look at what may be poisoning the kids.

Last month, the coalition sent a letter to Rep. Ralph Regular (R-Ohio), who chairs the relevant appropriations subcommittee in the House. “We believe that it would be extremely shortsighted to put off this study,” the groups wrote. “Environmental influences are powerful determinants of health, especially in our children. Yet research into the impact of the environment on children’s health has lagged.” So far, nobody has answered the call. “When it didn’t get funding this year, there were real losses,” said Carol Stroebel, a lobbyist for the Children’s Environmental Health Network, one of the groups backing the study. “If it doesn’t get funding next year, the entire program will be in real trouble.”

Vaccines, Mercury Exposure and Autism

Over the past 14 years, the estimated incidence of autism in the U.S. rose from about one in every 2,500 children to one in 166 – a fifteenfold increase. This steep rise coincided with the sharp increase in the number of vaccines given children, most of which were preserved in thimerosal. Thimerosal contains mercury, a potent neurotoxin.

The case linking the autism epidemic to mercury-preserved childhood vaccines has become one of the most contentious issues in environmental medicine. It has pitted a small but vocal coalition of affected parents, environmental groups, epidemiologists, trial lawyers, and even some conservative Republicans against the entire U.S. scientific and pediatric establishment, starting with the Centers for Disease Control and Food and Drug Administration and extending to the drug industry and even some of its more vocal critics like Rep. Henry Waxman, the liberal Democratic of California.

The vaccine manufacturers began phasing out thimerosal in the late 1990s after the first alarm bells went off. But as late last year, the industry – with a helping hand from the Centers for Disease Control and the Food and Drug Administration – continued selling stockpiles to the developing world. The case linking vaccines to autism received a powerful boost yesterday from Robert Kennedy Jr. on Salon.com (it’s very long, and you’ll have to sit through a Microsoft commercial to read it online).

Kennedy, best known for his environmental activism, wrote that “I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine.”

I spent a few weeks earlier this year reviewing some of the evidence linking thimerosal to autism. I spoke with a number of leading environmental health epidemiologists, many of whom remain skeptical. How can one tease out early childhood exposures to mercury in vaccines from other exposures like power plant pollution, not to mention the swelling sea of neurotoxic chemicals that persist in the environment and cause similar disorders?

Indeed, some scientists argue that the rise in autism is an artifact of better diagnosis, not an actual increase in disease. But people who work in the schools and have been inundated with these children scoff at such assertions. But there is a way to tell. Because of the phase-out, most American children vaccinated in this decade have not received the same high levels of mercury as those vaccinated between 1989 and 2001. If there is a link, it should start showing up soon in sharply falling autism rates.

What’s needed now is an accurate, long-term epidemiological study of America’s children – one sufficiently large enough to gauge the incidence of diseases like autism that only affect a small percentage of the population. Fortunately, such a study has been in the works for five years and is ready to be launched. Unfortunately, the Bush administration is about to back out of its commitment to fund it.

I’ll write about the National Children’s Study – and why people should begin putting pressure on Congress and the National Institutes of Health to fund it – in my next posting.

Who Should Serve on Advisory Panels?

A Senate subcommittee next week will consider a bill that will prohibit scientists who work part-time for the drug industry from serving on Food and Drug Administration advisory committees. This legislation is important for rebuilding the public's faith in the deliberations of the agency since when it comes to approving new drugs or pulling unsafe ones from the market, the FDA usually follows the votes of its outside advisers.

Yet the FDA is opposing the bill. One issue raised by opponents is the availability of outside experts without conflicts of interest. They claim there are many medical subspecialties where virtually every physician who has an in-depth knowledge of the disease has at one time or another worked for the handful of companies developing potential therapeutics.

Such would appear to be the case with acute decompensated heart failure, a fancy term for people whose heart-pumping ability has deteriorated to the point where they can't breath or walk. In 2001, Johnson & Johnson's Scios unit developed nesiritide (Natrecor), which is given in large doses intravenously when these dying patients showed up on hospitals' doorsteps. This new, pricey drug replaced massive doses of traditional blood vessel dilators or diuretics.

But this past February, an analysis of all the randomly-controlled trials of Natrecor (mostly done for the FDA) showed that more people died on Natrecor, which severely disrupts kidney function, than on the older therapies. As the article in the Journal of the American Medical Association politely put it, "despite being better than placebo, . . . nesiritide has not clearly been shown to be noninferior to diuretic and conventional vasodilator regimens."

For J&J, what was especially damaging about this news was how it immediately began impacting its business. It wasn't because the hospitals began switching back to the older drugs. Rather, Natrecor's lucrative off-label use began drying up. Hundreds of doctors had been encouraged to give the drug in out-patient settings to people whose hearts were failing but weren't yet on death's door. As today's New York Times pointed out, this procedure, for which a cheap, generic oral diuretic would have worked just as well, cost Medicare $600 per infusion -- not including the cost of the office visit.

So what did J&J do in response to the JAMA article? They asked Dr. Eugene Braunwald, one of the leading cardiologists at Harvard Medical School, to convene an outside advisory panel to review the evidence. Since this wasn't an official FDA advisory panel, there were no open meetings where the public could present evidence. There were no conflict of interest rules governing who could sit on the 9-member panel. Everyone was paid by J&J.

In a phone conversation with Dr. Braunwald today, he informed me that every person on the panel, including himself, had at one time or another had some relationship with the maker of Natrecor (including Scios before it was bought by J&J). Some of those relationships dated back a few years, but conflicts of interest on the panel were universal. "They told me to get the best people to get the best opinion. And to get the best opinion, you need people who have had some involvement," he said. "The final report was pretty tough on them."

Indeed it was. Braunwald and his eight colleagues warned against using the drug in an outpatient setting; asked J&J to immediately begin a clinical trial testing whether this FDA approved drug increases mortality or worsens kidney function; and suggested the company immediately begin a massive outreach campaign to doctors to educate them about problems with the drug.

Did one have to be an expert in this particular form of heart disease to arrive at these conclusions, as Dr. Braunwald and the FDA have suggested? It turns out the lead author of the original JAMA study also had financial ties to the European marketer of Natrecor. It seems that anyone who took a close look at this drug -- other than the FDA -- came to the same conclusion.

Indeed, anyone with the ability to evaluate statistics and who spent a few days reading the studies on this form of severe deterioration in heart function would have come to the same conclusion.

And that's the point: the FDA, or J&J in this instance, could have asked an unconflicted panel of physicians to evaluate the drug. Instead, they sought out physicians who were already on or recently had been on the company's payroll.

This time it worked out for consumers. But imagine what the public would have thought if Dr. Braunwald's panel had said there were no problems with Natrecor. That's why smart companies and the FDA should opt for advisory panels that are untainted by conflicts of interest. It's the only evidence the public can really trust.

NIH About to Backtrack?

National Institutes of Health director Elias Zerhouni today indicated he plans to scale back the agency's strict conflict of interest rules.

Zerhouni issued those rules last February in the wake of revelations that dozens of its top scientists had earned hundreds of thousands of dollars from drug and biotechnology companies while on the government payroll. The new rules prohibited agency scientists from accepting consulting deals, speaking gigs and stock grants from the private sector.

Zerhouni's comments came at an online forum sponsored by the Kaiser Family Foundation. When asked about the agency's commitment to the new rule by moderator Jackie Judd, Zerhouni said: "There are good reasons to have interactions with the private sector." Where would he now draw the line? "No promoting, marketing, or endorsing products or even giving advice without disclosing what those interests are."

Hmmm. That seems to be a disclosure standard, not a ban. If so, this would be a total cave in to the Assembly of Scientists, a group of NIH scientists opposed to the tough new rules. Zerhouni, responding to an audience question, gave no timetable for lifting the temporary ban. Zerhouni trotted out the standard reasons for lifting the ban -- that it is needed to recruit top scientists and that close collaboration is needed to translate scientific insight into medical cures.

But this explanation falls apart upon closer scrutiny. "Even under the current rules, we allow interaction with the private sector . . . transparently," he said. He was referring to the rules governing Cooperative Research and Development Agreements, which the agency signs with industry. But under those agreements, any reimbursements go to NIH, not the scientist involved. Moreover, no scientist can work on a CRADA where his own invention, assigned to NIH and licensed to a private firm, is involved. NIH scientists can earn up to $150,000 in royalties from inventions made on the government payroll.

When asked directly if he planned to reopen the doors to outside consulting or speaking gigs where the scientists get to pad their government salaries, Zerhouni dodged the question.

Heart Pains

The British Medical Journal last week reported that all the popular painkillers increase the risk of heart attack. But while the headlines emphasized that increased heart attack risk extended to ibuprofen, a close reading of the numbers showed that the "tummy friendly" Vioxx was worse.

An excellent BBC report on the study put the risk in relative terms: For every 1,005 persons taking ibuprofen, the researchers found one additional heart attack (over the expected level). For every 695 persons taking Vioxx, there was one additional heart attack.

The worst drug among the painkillers was diclofenac (sold as Voltaren), which gave one additional person a heart attack for every 521 persons on the drug. The study didn't look at naproxen (sold as Aleve), but the earliest trials comparing it to Vioxx showed it had a significantly lower heart attack risk profile. Celebrex, the only major Cox-2 still on the market, was slightly better than ibuprofen (in terms of heart attack risk) but not as good as naproxen or plain old aspirin, which studies have shown to be cardio-protective.

The study didn't review ulcer risk from taking painkillers (the ostensible reason for taking Cox-2s over the generics like ibuprofen in the first place). But previous studies have indicated that the risk of getting ulcers from taking traditional painkillers is about the same as suffering a heart attack from taking those drugs.

Bottom line: Most of these drugs offer about the same pain relief. The increased risk of heart attack from taking any of these drugs is low. But some are safer than others and in the absence of any additional pain relief or even with a small reduction in an already small risk of ulcers (which is much easier to treat than a heart attack), it makes no sense for people to be taking the less safe ones like Vioxx.

The media could do the public a huge favor by sorting out the various risk profiles of these commonly prescribed and purchased medicines.

Merck's Singh Sings the Blues

NPR last night ran a revealing report about Merck’s efforts to silence potential critics of its blockbuster painkiller Vioxx. It introduced the story with this damning statistic: “At least 38,000 Americans are believed to have died from taking the pain pill.”

Relying on internal Merck documents turned up by trial lawyers representing the victims’ families, reporter Snighda Prakash revealed how marketing officials and a Merck senior scientist sought to silence one of their own consultants, who had become upset by signals from a clinical trial that Vioxx might be causing heart problems among its millions of users.

Who was that consultant? It was none other than Stanford researcher Gurkirpal Singh, who bears at least some responsibility for the fact that millions of Americans were taking Cox-2 inhibitors in the first place. The new class of pain relief medicines was designed to lessen the gastrointestinal side effects of generic pain pills like ibuprofen, naproxen and aspirin, the problem that was the focus of Singh’s own research. Instead, it wound up killing tens of thousands of Americans.

Prakash told an important story about the power that drug companies exercise over academic medicine, and for that reason alone the transcript is worth reading. But she stumbled badly in her portrayal of Singh as, in her words, an “independent scientific expert.”

Singh’s original study showed that traditional painkillers caused 16,500 deaths and 100,000 hospitalizations each year. The study was paid for by the drug companies that made Cox-2 inhibitors. After publication in a minor journal, the statistics were trumpeted in company press releases and appeared in mainstream media stories about the new “super-aspirins,” Pfizer’s Celebrex and Merck’s Vioxx, which were no more effective at halting pain than the older generation of drugs.

How did Singh arrive at his numbers? He got his death and injury ratios from a limited database made up of people suffering largely from serious rheumatoid arthritis, who take high doses of painkillers. Singh then extrapolated those numbers to the larger population – 17 million people – who popped painkillers for the more common (and less painful) osteo-arthritis. Dr. James Fries, Singh’s colleague at Stanford and also an arthritis specialist, recognized Singh’s estimates were way too high. No matter. Merck was willing to pay him tens of thousands of dollars a year to trumpet those numbers on the caviar-and-golf continuing medical education circuit.

When signals appeared in clinical trials that his sponsor’s drug might be causing heart problems, Singh, to his credit, began raising questions about the drug. But ever the industry sycophant, he went about it in his own way. The telling fact slipped past quickly in Prakash’s report, so it is worth highlighting:

“Singh's allegiance was shifting. He was now promoting Vioxx's rival, Celebrex. He was being paid by Pfizer, and he was telling his audiences that Merck had refused to answer his questions about Vioxx's safety.”

Mind you, this was about the time that the Cleveland Clinic’s Eric Topol and other physicians were looking through the same published trial on Vioxx that showed the heart attack risk. Letters of concern began appearing in medical journals. Topol prepared a paper for the Journal of the American Medical Association. But that wasn’t Singh’s way. He went to work for Merck’s competitor.

Singh’s science or ethics haven’t improved much over the years. A few months back, I called Singh after he once again repeated his “16,500 deaths” statistic for a story that appeared on the front page of the New York Times. He got back to me too late for my story (see GoozNews: The Press on Pain). But he stuck by his numbers. In fact, he sent me an abstract of his latest study, which hadn’t yet been peer reviewed or published.

It reads like a press release for Pfizer, the last remaining Cox-2 maker. Using a national sample drawn from community hospitals and extrapolating for the entire U.S. population, he estimated that total hospitalizations for gastrointestinal ulcers fell from 166,725 in 1988 to 139,597 in 2001. There were two periods of sharp declines over that 13-year period, according to his study, 11 percent in 1995 and 8 percent in 1999. He attributed the former to the 1995 National Institutes Health consensus conference recommending eradication of H. pylori, the bacteria that causes ulcers; and the latter to the introduction of Cox-2 inhibitors.

I pulled out my trusty calculator. The total decline over the period was 16.3 percent. Singh’s numbers were mathematically impossible. Moreover, a decline of 12,000 hospitalizations a year – perhaps saving the health care system $250 million annually – pales beside the $5 billion a year spent on Cox-2s.

Merck’s efforts to silence academic critics of its blockbuster drug, as documented in Prakash’s report, is unconscionable. But it’s hard to defend someone’s academic freedom when it’s already been sold to the drug industry.

House Votes Biz-Backed Scientists Off FDA Advisory Panels

The House of Representatives voted this afternoon to prohibit outside doctors and scientists who work for drug companies from sitting on Food and Drug Administration panels that pass judgment on those same companies' products.

The vote on a rider to the FDA appropriations bill was 218-210, with dozens of Republicans joining the an overwhelming Democratic party vote in favor of the measure, which was sponsored by Rep. Maurice Hinchey (D-NY). The measure now moves to the Senate where Illinois Democrat Richard Durbin is planning a similar maneuver.

The vote punctuates six months of intensive research, education and lobbying work by the Center for Science in the Public Interest's Integrity in Science project, which I direct. The issue gained national attention in February when the New York Times, relying on CSPI research, reported that 10 of 32 scientists sitting on the FDA advisory panel evaluating Cox-2 painkillers had ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in the class would have received a thumbs down vote from the panel.

The conflict of interest issue reared its head again in April when an FDA advisory panel evaluating the safety of silicone gel breast implants included a physician who had previously completed a video for the manufacturer touting the safety of the product. A broad coalition of consumer and women's health groups protested his presence on that panel.

Speaking on the House floor, Hinchey quoted at length from the recent Lancet editorial that took issue with the FDA's defense of hiring part-time advisers who simultaneously worked for companies with new product applications before the agency. The idea that the FDA can't find highly qualified, unconflicted scientists among the thousands of persons who teach at America's 125 medical schools or abroad "is simply ridiculous," Hinchey said.

The Democrats who spoke in favor of the measure included Bart Stupak (D-Mich.), whose son committed suicide while on Accutane, the acne drug, and Rep. Marion Berry (D-Ark.), the only certified pharmacist in Congress.

The Republican leadership, meanwhile, perhaps feeling the heat from its own ethics and conflict of interest scandals, couldn't round up anyone besides the floor leader to speak against the rider.

It's still a long way before the measure becomes law, and even then it would only be for the coming year. But Wednesday's vote represents a good start in rebuilding the public's faith in the agency, which has been badly shaken by the past year's safety scandals.

However, eliminating scientists with conflicts of interest from FDA advisory panels is only the first step in the larger project of reforming the FDA. Legislation in the Senate (Grassley-Dodd) and House (Hinchey) would give the agency's safety department more power to veto drug applications, pull drugs off the market and order new clinical trials. Until those bills pass, the American people will continue to wonder if their medicines are truly safe and effective.

Whistleblowing v. Leaking

There’s a big difference between blowing the whistle and being a leaker. Whistleblowers take responsibility for their actions and suffer the career consequences, as today’s news amply points out.

The White House war on global warming science suffered another damaging blow today thanks to Rick S. Piltz, a former high official in the government’s Climate Change Science Program. He resigned in March after a former petroleum industry lobbyist now working for the Bush administration watered down his office’s reports on the need for near-term action to halt global warming.

Piltz could have remained in the shadows and leaked his information to the press. But instead he went to the Government Accountability Project, which provides legal assistance to government employees who want to go public with knowledge about government wrongdoing. In today’s New York Times story documenting his allegations, Piltz not only attached his name to the allegations that Philip Cooney, a non-scientist who previously lobbied for the American Petroleum Institute, added equivocating language to a 2002 global warming report, but he provided the documents that proved the allegations.

The movement to improve the Food and Drug Administration’s safety record is also benefiting from the actions of a courageous whisteblower. David Graham, who testified before Congress late last year on the problems with Vioxx and a number of other potentially unsafe drugs, is still working at the agency. In today’s Washington Post, Graham attacks the independence of the FDA’s new Drug Safety Oversight Board, claiming it contains too many officials with ties to the agency’s new drug approval arm – an institutional conflict of interest. He and Sen. Chuck Grassley, chief sponsor of the bill that would make the safety arm of the agency independent, sent a letter to the FDA protesting the oversight board’s make-up.

The FDA asked Graham to serve on the new oversight board, but he turned down the offer. According to the article, he feared it would limit his ability to criticize the agency.

Like Piltz, Graham was assisted by the Government Accountability Project. While GAP often counsels would-be whistleblowers not to go public because legal protections for public employees have been all but eliminated by the courts, in these cases the stories were so compelling and the individuals involved so intent on getting their stories known that they ignored that legal advice in favor of serving the public interest.

If legal protections are ignored in the public sector, they are virtually non-existent in the private sector, as the sad tale of Pfizer vice president Peter Rost in today’s New York Times shows. Rost appeared on 60 Minutes last Sunday to repeat his claims that the drug industry consistently overcharges for its products, games public sector agencies like Medicare, Medicaid and the IRS, and has essentially lied about the safety problems of imported drugs.

His reward inside Pfizer has been near total isolation. Though he’s still on the payroll at $600,000 per year, the marketing executive’s employees have been taken away and he has no authority. Pfizer even locked him out of its corporate email system for a brief time this week until the New York Times reporter called to inquire about the move. “I guess everybody’s waiting for me to get fired,” he said.

The article speculates that the only thing keeping him on the payroll is a federal investigation into the marketing of a Pfizer drug that Rost used to manage.

These whistleblowers’ actions stand in stark contrast to the methods of anonymous leakers. In this week’s New Yorker, legendary investigative journalist Seymour Hersh recounts his own experiences with anonymous sources during the Watergate years. It wasn’t just Mark Felt, the 91-year-old former number two man at the Federal Bureau of Investigation who came out last week as Deep Throat. The Nixon White House couldn’t control the unraveling cover-up “because of the wealth of information, including documents, that reporters got from sources within the Administration. Many reporters also had sources on the various congressional investigating committees and in the Justice Department and other agencies,” he wrote. “Anonymous sources were essential to the Watergate story.”

They talked because they were “outraged by the sheer bulk and gravity of the corrupt activities they witnessed in the White House . . . some feared that the government might fall, and some talked to reporters about their concern that the President, facing impeachment, might try to hold on to his office by defying the Constitution.”

These anonymous sources, most of whom dealt with national security secrets, had their “worst fears confirmed by the revelation” that Nixon was taping their conversations. Presumably, this dictated their need to stay anonymous.

Scientists concerned about the fate of the planet and the safety of common medicines somehow found the courage to put their careers at risk to unmask administrative wrongdoing by high government officials. But when the fate of the Republic was at stake, top government officials – who had been entrusted with the nation’s highest secrets – felt the need to stay anonymous to bring serious malfeasance to the public's attention. The system may have worked during Watergate, but I still say it set a bad precedent.

We're Not All Mad -- Just Half of Us

Perhaps your eyes glazed over like mine at the story in today's New York Times that suggested half of all Americans will suffer from mental illness during their lifetimes. You had to read far down into the story to learn that this "government survey" was partially funded by the pharmaceutical industry, which is tireless in its efforts to put the entire nation on psychotropic drugs.

One is tempted to respond that with George Bush as president, of course half of us are permanently depressed. But I tip my hat to Vera Sharav of the Alliance for Human Research Protection for posting this quote from Dr. Paul McHugh, former chairman of psychiatry at Johns Hopkins University and a member of the President's bioethics commission:

"Fifty percent of Americans mentally impaired - are you kidding me? The problem is that the diagnostic manual we are using in psychiatry is like a field guide and it just keeps expanding and expanding. Pretty soon we'll have a syndrome for short, fat Irish guys with a Boston accent, and I'll be mentally ill."

Score One for the Party of Lincoln

Let's give a small cheer this morning for the Party of Lincoln. Not the modern-day GOP, mind you. I'm referring to the Civil War-time Republican Party which passed the False Claims Act to prosecute manufacturers who were undermining the war effort by providing Union soldiers with shoddy blankets, shoes and muskets.

The Wall Street Journal reports this morning that state and federal prosecutors have over 150 pending cases, most of them brought under the False Claims Act, against drug manufacturers for allegedly ripping off Medicaid and Medicare programs. The common thread to all the cases is differential pricing: charging the government (read taxpayers) significantly higher prices than they charge customers who are smart enough to negotiate with the drug companies. The law requires that government programs get the best available price.

These cases expose the inanity of our disfunctional health care payment system. They also raise an early warning flag about the Medicare drug benefit, which goes into effect next year. The government has earmarked $720 billion over the next ten years to pay for seniors' drugs. Unless the government negotiates decent prices and aggressively monitors the marketplace to ensure it is getting the best available deal, this "subsidy" for seniors will be transformed via the magic of a dysfunctional market into a price support program for already overpriced medicines. CMS (the Center for Medicare and Medicaid Services), meet the Agriculture Department.

Last week, there was news reports about a broad coalition of Washington lobby groups, ranging from the liberal Families U.S.A. to major corporate lobbying groups like the Business Roundtable, getting together to push for incremental changes to deal with America's rapidly deteriorating health insurance system. Today's report should serve as a reminder to those groups that the window for slapping bandaids on this problem is closed. When it comes to a public good like health care, only a single payer system can, to use the jargon of the economists, efficiently allocate resources.

Hedge Fund Docs

With hedge funds much in the news, I'm surprised that one article from last week's Journal of the American Medical Association got zero attention from the press. Eric J. Topol of the Cleveland Clinic and David Blumenthal of Harvard revealed that 1 in 10 physicians in the U.S. have formal consulting relationships with some segment of the investment industry. A decade ago, these ties were virtually non-existent.

Topol was clearly motivated to write the article by his recent experience in this regard. Last fall, shortly after Merck withdrew Vioxx from the market, the Wall Street Journal revealed that Topol had been consulting with a hedge fund that had bet heavily against Merck's stock prior to the withdrawal. Topol was one of the most articulate and outspoken critics of Vioxx. After his relationship was exposed, Topol ended all his industry ties -- not just to the financial industry, but to the drug and biotech industries as well.

Investment funds benefit in obvious ways from discussions with their consultant-docs. Company stocks can gyrate wildly based on the outcomes of clinical trials. Getting insight into how a trial is going can give the savvy investor the kind of inside information needed to anticipate those swings.

This is illegal insider trading, and us small investors can only hope that the Securities and Exchange Commission enforcement division takes careful note of the Topol/Blumenthal article. The authors quoted from one investment industry physician source at a company called Leerink Swann, "Clever clients can read a lot in a doctor's silences and pauses" and "on occasion some doctors slip up."

Given the shocking extent of these ties, the prescription for change in the article was far too pallid. The authors called for full disclosure of financial ties to investment funds and more careful monitoring by academic institutions when the consulting physicians teach at medical schools. "The relationships between physicians and the investment industry have clearly become pervasive, although not necessarly perverse," they conclude.

I wonder if the people who volunteer to participate in clinical trials, once apprised of their physicians' ties to hedge funds, would feel the same way.

Garment Weighs In

Once again I find myself in the weird position of agreeing with Republican warhorses on the Deep Throat issue. In today's Wall Street Journal, Leonard Garment, Nixon's lawyer, points out that while the press focused on the revelations leaked by FBI director wannabe Mark Felt, Judge John Sirica was threatening James McCord with a long sentence, which led directly to his "spilling the beans" to a federal grand jury. "In this drama, which led directly to the exposure of the Watergate cover-up, Deep Throat was a marginal player," Garment said.

But then he made this very important comment:

If Deep Throat was not critical to the unraveling of Watergate, then what was his importance? Perhaps it was to foster in American politics the idea that the central feature of our government is the secret knowledge held by those at the center of power, and that only through the bravery of whistleblowers like Deep Throat can the polity gain the keys to the secrets and the ability to reassert democratic control. This idea has had consequences since Watergate, many of them problematic.

I agree. It was the progressive movement of the early 20th century that fought long and hard to win the right for professional civil servants to carry out their jobs free from political pressure or the threat of losing their jobs if they didn't toe a preconceived line. This was especially critical at the nation moved toward greater regulation of business, which in those days when organized labor barely existed and non-profit pressure groups were non-existant largely controlled all three branches of government (shades of today!).

When those professionals -- including law enforcement professionals -- don't have the courage, ethics or integrity to stand up in public for what they know to be right because of fear of political retaliation, the foundations of our democracy are demonstrably weaker. The very fact that we have a whistleblower protection law speaks volumes about the post-Watergate environment. The fact that today it has become a useless tool speaks volumes about life in modern America.

Wall Street Journal Gets It Right -- Sort Of

I find myself in strange company on the Mark Felt issue. I almost never agree with the Wall Street Journal editorial page, but its lead editorial this morning raises the right questions regarding Mark Felt's options in 1972. The paper requires a paid subscription to visit online, so I reprint the relevant text here:

Perhaps Mr. Felt believed that going to the press was his only recourse. But as a senior government official, he had other alternatives -- confronting Richard Nixon himself, or resigning in protest and then taking his story to Capitol Hill. It's fascinating to consider what might have happened had Mr. Felt helped to crack the cover-up before the election of 1972, when voters could have had a say rather than have to endure a painful impeachment two years later. We will certainly be interested in hearing Mr. Felt explain why he acted as he did.

The press got Watergate right as a story about Nixon's cover-up. But even Messrs. Woodward and Bernstein, who covered the story virtually alone for months, didn't expose most of the abuses. Those became known only after the other institutions of government -- the courts and Congress -- began to do their work. Judge John Sirica's decision to give harsh sentences to the Watergate burglars proved to be the first break in unraveling the cover-up. Later Congressional hearings turned up word of the secret White House tapes, which ultimately proved to be Nixon's undoing.

The Journal still can't get over its anti-Clinton fetish. They are wrong to compare Nixon's transgressions to President Clinton. Whatever happened in Whitewater, the un-scandal that the Journal editorial page harped on for years, those events took place years before Clinton took office and its parameters were well known to voters BEFORE he got elected.

But this editorial recalls an important lesson from the Watergate affair that resonates more than ever today. Our constitutional democracy rests on a separation of powers where it is critical that each branch of government do its job. Where is Congress today in investigating the Bush administration's mishandling of the war in Iraq? The Valerie Plame affair? The executive branch's flouting of the nation's environmental laws?

The Woodward-Felt Connection Pre-Dated Watergate

What should a whistleblower do: Leak or go public?

Put yourself in Mark Felt’s shoes in the late summer of 1972. The results of the FBI investigation into the Watergate break-in show clear White House involvement. Your boss, a Nixon appointee you resent, is under pressure to deep-six the investigation. You should:

A) Demand that you and your boss go down to the White House and confront the President with information that his re-election campaign was involved in the crime.
B) Resign in protest over the failure of the FBI to pursue all leads in an ongoing investigation.
C) Call a reporter and offer to meet him in a garage in suburban Washington.

It turns out that Mark Felt was a mentor to Bob Woodward prior to Watergate (Woodward’s first person account in today’s Post reveals how they met in a White House waiting room while Woodward was still in the armed forces). So the path Felt took (C) was greased by the personal connection that existed between the older man and the young, ambitious journalist.

A lot of GoozNews readers wrote yesterday to complain about my quoting Charles Colson, the Nixon hatchet man turned prison evangelist who said Felt should have chosen course A or B. Forgive me for sleeping with the devil. Will it help if I quote the Jesuit Father Robert Drinan, who was overhead on the radio yesterday wondering why Felt didn’t come to the House Judiciary Committee. Rep. Drinan, a liberal Democrat from Massachusetts, was the first Congressman to call for Nixon’s impeachment.

Let me be clear. I didn’t mean to say that journalists shouldn’t talk to people who don’t want to be quoted. How else would journalists get tips? What I was decrying was the use of anonymous sources as the primary source of information for a story where the tipster demands anonymity as the price of the information.

Based on today’s account, Woodward appears to have relied on this technique (and his relationship with Felt) from the outset of his career. A few months before Watergate, Woodward was on the Wallace assassination attempt story. His page one lead, based on a Felt leak: “High federal officials who have reviewed investigative reports on the Wallace shooting said yesterday that there is no evidence whatsoever to indicate that Bremer was a hired killer.” This would become the model for the classic Washington insider story. A high government official wants something known. He leaks it to the press. And by doing so, he avoids personal responsibility if it turns out wrong.

Felt is being hailed as a hero. His defenders say without courageous whistleblowers like him, we’d never learn what is going on in government. But there’s a big difference between going public or resigning to protest when one objects to mistaken policies in government – as a few courageous officials have done in this administration – and talking behind the scenes to the press. The former are true whistleblowers and should be considered heroes. The latter are tipsters, and, in my view, shouldn’t be used as primary sources for stories.

In the wake of Watergate, the nation passed a whistleblower protection law so more government officials like Felt could act on their information without entirely ruining their careers. Like so many laws in this country, it is being violated with impugnity by this administration (see GoozNews, Jan . 9, 2005).

To all the reporters who insist on quoting their anonymous sources to report on national security issues in “this town,” here's a suggestion. Write about that.

W. Mark Felt's Bad Example

Deep Throat did deep damage to daily journalism.

I worked in the composing room of a minor metropolitan daily during the Watergate/end of the Vietnam War years and entered the reporting ranks shortly thereafter. Modern-day journalism was forged in that era. Every young reporter wanted to be like Woodward and Bernstein (or was it Redford and Hoffman?). News accounts reflected a healthy distrust of government authority. Applications to journalism schools swelled.

By the early 1980s, a telling phrase began appearing routinely in the stories of those reporters who wanted to be part of this new elite. "Sources said." "A source close to the investigation said." "Knowledgeable participants said."

Felt's coming out party coincides with a full-fledged government assault on this routine practice. Two journalists -- Time Magazine's Matthew Cooper and the New York Times' Judith Miller -- face jail time for refusing to divulge the names of their sources in the Valerie Plame affair. They were not guilty of outing that CIA agent. That honor belongs to Robert Novak and still unnamed administration officials upset by her husband's unmasking the Bush administration's false claim that Middle Eastern terrorists were trying to obtain Nigerian plutonium. Rather, they were simply trying to report the story behind the story.

And therein lies the trap that all the Mark Felt's of the world set for journalists who would go along with their demands for anonymity. The leaker has tremendous power over the journalist. When they refuse to attach their names to their information, the news consumer cannot judge the veracity of the source. The news consumer cannot consider the speaker's motive. And the journalistic competition gets caught up in chasing the same piece of information, thereby abjuring more useful tasks like analysis or moving the story forward. These were Cooper and Miller's real sins -- not the trumped up charges made against them by government prosecutors who still haven't arrested Robert Novak or the White House leakers.

Like most reporters (and ex-reporters), I had my own experiences with leakers and "on background" or "off the record" government briefings. I can't count the number of times an experienced newsmaker said to me at the outset of a crucial interview, "But you can't use my name with this." The less experienced news manipulator would often tack on something similar at the end of an hour-long conversation. "You're not going to put my name in the paper, are you?"

This was especially pernicious in the world of business journalism where I spent most of my formative years. Business people have axes to grind, especially against their competitors. They want to manipulate government agencies and officials. It's a lot easier to get that local property tax abatement if you leak to the local press that your firm is considering moving to North Carolina.

Mark Felt taught them to do that. I can't sit here this morning and say I never said yes to those requests for anonymity. I wanted to be a player, too. And now as I look back on 20 years of using the phrase "sources said," I can't think of a single instance when my readers and the general public wouldn't have been better off if I just made it clear at the outset of the interview that when you're talking to a reporter, you're talking in public.

Charles Colson, President Nixon's former special counsel and now an evangelical Christian, made that important point in this morning's New York Times. Felt, he said, "could have held a press conference and announced what he had done and he would have been a hero." And he would have struck a telling blow for the constitutional separation of powers that undergirds our democracy and is very much in jeopardy today. Felt's damaging legacy lives on.