A Failure To Disclose

May 13, 2004
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For several years now, medical journals have insisted that authors who report on their scientific studies include financial conflicts of interest alongside the results. The reasoning behind the policy is based on science. Study after study has shown that clinical trials that are funded by drug companies are much more likely to show positive results than trials funded by government or independent sources.

Unfortunately, journalism has lagged far behind the medical journals in adopting enlightened policies on reporting the conflicts of interest of quoted sources. The Washington Post has a policy encouraging the reporting of such conflicts in their science stories, but it is often ignored by reporters. The New York Times, which routinely ignores obvious conflicts of interest in its reporting, is working on a policy. The medical hype that spices up the pages of Newsweek, Time and U.S. News almost never includes information about the financial self-interest of their quoted sources.
Another flagrant failure to report conflicts of interest was contained in yesterday’s Science Times. Reporter Anahad O’Connor reported on a possible method of identifying autoimmune diseases like rheumatoid arthristis long before they begin to wear down the body. She quoted two scientists from the University of Oklahoma medical school, R. Hal Scofield and John B. Harley, who recently published articles in the New England Journal of Medicine and Lancet touting the new biomarkers, which are called autoantibodies. They expressed the hope that autoantibodies will one day be used in tests for the early spotting of diseases.

By doing a little digging, I found out that the market for autoimmune testing is already $6.6 billion a year. Coming up with an early screening test would expand that market exponentially. By doing a little more digging, I found out that the two quoted scientists co-owned a host of patents on the earlier generation of biomarkers for identifying autoimmune diseases. One also served on the board of Ivax Diagnostics, the company that markets the tests. It’s likely they’ve filed for patents on autoantibodies.

They’re clearly using the pages of the Times to tout the next generation of tests without revealing their conflicts of interest.

If proven useful, would these tests be a good use of health care dollars? I’m skeptical. Does it make sense to screen millions of people to reassure them they haven’t yet started developing degenerative diseases like rheumatoid arthritis, when even if you do have raised levels of the biomarker, you may not get the disease and if you do get the disease, there isn’t much medicine can do about it?

The saddest part of this story is that the Lancet article that triggered the Times story ended in a lie. Scofield wrote that “I have no conflict of interest to declare.” No conflicts of interest information was included in the New England Journal of Medicine article last fall, either.

Excuse me. If owning patents on the first generation of biomarkers for a set of diseases and serving on the board of a company that markets it aren’t conflicts of interest, what are?

We’ve reached a point in the crass commercialization of medicine that academic entrepreneurs are flouting the rules of medical journal reporting and manipulating reporters to get into print what are essentially ads for their next private venture. Maybe those journal editors should take a second look at their science and their claims to its usefulness.

New Conflict-of-Interest Rules Could Jeopardize NIH Mission

May 7, 2004
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Last December, Pulitzer Prize-winning journalist David Willman of the Los Angeles Times wrote an eye-opening report on conflicts of interest at the National Institutes of Health. He revealed that in the decade since former director Harold Varmus liberalized consulting rules, a handful of senior scientists at the nation’s premier health research agency had pulled in hundreds of thousands of dollars in consulting fees from major pharmaceutical firms.

The scandal provoked outraged hearings on Capitol Hill and forced NIH director Elias Zerhouni to appoint a blue ribbon panel to come up with new conflict of interest guidelines for the agency. The panel, chaired by National Academies of Science president Bruce Alberts and Lockheed Martin chairman Norman Augustine, unveiled its proposals Thursday. Sad to report, the proposed guidelines are so lax that over the next few years they could radically transform the agency in ways that will jeopardize its primary mission of discovering the causes and cures for disease.
In defending the proposed rules, Zerhouni said he wanted NIH scientists to be just like their peers in academia, where the bulk of NIH funds get spent. Fearing a brain drain to either flush pharmaceutical firms or universities where lucrative outside consulting deals are commonplace, he said “we want to reinforce the idea of NIH as an academic endeavor.”

This falsely assumes that what is going on at the nation’s medical schools and universities is worth emulating. Since passage of the Bayh-Dole Act in 1980, universities’ biomedical departments have become hotbeds of entrepreneurialism. Any professor with a patentable idea is encouraged to partner with a firm (or create his or her own) to bring the technology to market.

The problem with this gold rush mentality is that it has created an environment where any slight medical insight, not to mention genes, proteins, and biomarkers, have become grist for the patent mill. Researchers who once might have dreamt of saving lives or winning Nobel prizes now dream of privatizing their basic science insights and using them to lure venture capital funding. If you can sell your story on Wall Street, who cares if you’re peddling a speculative theory, or something that even if proven to work would add little or nothing to physicians’ armamentarium for fighting disease?

NIH is supposed to be different. If the agency that spends $30 billion a year in taxpayer funds in the name of curing disease doesn’t uphold the public health mission, who will?

The proposed guidelines could jeopardize that mission in both overt and subtle ways. The advisory panel would allow NIH scientists to earn up to 50 percent of their base salary (which can range up to $200,000 a year) in outside consulting income. It also would allow them to privately patent inventions from this outside work as long as it is “not related” to their primary NIH job.

Imagine this scenario. A few years from now, an Alzheimer’s disease expert at NIH is getting $20,000 a year from several large pharmaceutical firms for helping them develop drugs to combat the dread disease. One day, he gets a call from a researcher at a non-profit institute who thinks he has a new and better approach. This researcher has no money to offer, but he’d like the NIH scientist’s help in reviewing his slides, and perhaps come down to give a lecture to his team.

Will the NIH scientist go? If he goes, will he be able to share all the knowledge he gleaned at the private firms? And once he’s there, will he be willing to admit that, holy cow, this team really does have a better approach and he ought to be working on this (for no extra money) instead of on that private company’s approach where he can continue pulling in $20,000 a year?

Allowing NIH scientists to take on consulting gigs and other lucrative corporate engagements will inevitably cloud their vision. It could wind up making their expertise available only to the highest bidders.

That would be a disaster for public health research in this country. The fact is that what goes on in the market and where the best science is getting done do not coincide.

NIH sits at the epicenter of the U.S. biomedical research system. In its investigations into the causes and cures for disease, it is the one agency that must dispassionately pursue the most promising research paths, no matter where they emanate from and no matter where they lead. It shouldn’t allow its scientists to be distracted by the false signals sent by the promise of private gain.

San Diego Union-Tribune: Another positive review

May 5, 2004
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Click here to find out why one business reporter says The $800 Million Pill “offers an eye-opening tour of the labyrinth that is drug discovery at a crucial time, for consumers traumatized by the wallop they receive with every trip to the pharmacy counter.

“Goozner takes his readers into government and private industry labs and offers insights into the decisions made in corporate boardrooms. His heroes are the researchers who toil at the bench, sometimes for decades, driven more by the prospect of scientific breakthrough than the monetary reward of commercializing their discovery.”

Philly Inquirer: "An Enlightening Examination"

May 3, 2004
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The $800 Million Pill convinced a Philadelphia Inquirer scribe. For his review this past weekend, click here.

Throwing Away the Rules

May 2, 2004
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In its zeal to kowtow to business, the Bush administration is dismantling a century of regulations that protect middle class consumers from financial fraud and health hazards.

By Merrill Goozner

CORPORATE AMERICA’S IDEOLOGICAL ASSAULT ON government regulation has undermined middle America’s understanding of why these rules exist in the first place. It is true that some regulations have lived past their prime, protecting monopolies and stifling innovation. But the free-market ideologues of our era were not content to adjust those regulations to accommodate new economic realities. Instead, they preferred wholesale deregulation. The results are predictable.

The most spectacular market disaster of recent times — the accounting and stock-analyst frauds that robbed large swaths of the middle class of its retirement savings and misallocated trillions of dollars of investment capital — was a direct result of the deregulation of financial markets that began under Ronald Reagan and intensified during the Bill Clinton years. If you weaken the Securities and Exchange Commission (SEC) and limit investors’ right to sue accountants and corporate managers for fraud, you get Arthur Andersen and Enron, Bernie Ebbers and WorldCom, Dennis Kozlowski and Tyco. If you repeal the Depression-era Glass-Steagall Act, you get a financial world where stock analysts publicly tout the products of investment banks while whispering to holders of big shares that it’s time to sell.

Even after these events led to the most significant re-regulatory legislation in decades, the Sarbanes-Oxley Act of 2002, the SEC failed to uncover the mutual-fund scandal in which fund managers systematically robbed 85 million ordinary customers in order to please their corporate clients. If it weren’t for Eliot Spitzer, the crusading attorney general in New York, the public still wouldn’t know about the fraud.

Men and women of moderate income who are trying to clamber up the economic ladder are frequently victimized by a Wall Street-financed predatory lending industry that caters to car and home buyers with poor credit ratings. Neighborhood-based payday lenders prey on lower-middle-class people who live from paycheck to paycheck. Yet the Bush administration’s response — issued earlier this year through the Treasury Department’s Office of the Comptroller of the Currency — is to seek rules preempting aggressive state regulators who have taken the lead in policing the industry. “This [is a] blatant attempt to shield banks from legitimate state law enforcement,” says Connecticut Attorney General Richard Blumenthal.

While the deregulatory movement has been a bipartisan affair greased by campaign contributions, the assault of the Bush administration has taken it to a new level. Indeed, the headlines about the market failure may even suggest a way to challenge the prevailing orthodoxy in this election year.

Consider the meatpacking industry. Upton Sinclair’s The Jungle led to an age of regulation a hundred years ago. Yet today’s protectors of the nation’s food supply, officials in the Agriculture Department, failed to prevent the first case of mad-cow disease from entering the United States. Within weeks of the incident, scientists on the inside admitted that the agency had ignored warnings that a spot inspection system was flawed — and was an accident waiting to happen. Even today, Ann Veneman, the former meat-industry lobbyist who heads the agency, continues to drag her feet on implementing universal testing on animals heading for slaughter.

Meanwhile, officials with the Food and Drug Administration (FDA) have ignored a decade of mounting evidence of the dangers of over-the-counter stimulants. They only overcame industry pressure when a major-league ballplayer died last year after using ephedra. Meanwhile, the agency has pursued policies that could appear on a Big Pharma wish list: working to prevent senior citizens from importing cheaper Canadian drugs, opposing price controls or even price negotiation by Medicare, moving slowly on warning consumers about potentially dangerous drugs, and doing nothing to regulate the vacuous and confusing drug ads aimed directly at consumers.

At the Justice Department, Federal Trade Commission, and Federal Communications Commission (FCC), their watchdogs sit around as cable rates go up, telephone competition is stifled, and the ownership of media is concentrated. In fact, FCC Chairman Michael Powell has even relaxed rules concerning cross-ownership and media concentration — despite widespread opposition to media conglomeration.

On the energy front, the effort by Vice President Dick Cheney to bend policy and regulations in an effort to promote an industry wish list — renewed nuclear power, coal, oil drilling in pristine regions — was too much even for Republicans. Unfortunately, the media’s focus on that effort has meant not enough attention is being paid to the fleecing of the energy-buying public, a move that has been tacitly condoned by the Federal Energy Regulatory Commission (FERC).

The effects of energy deregulation are widespread and can be seen in a series of price gougings by oligarchies. And in recent months, we’ve experienced the California electricity crisis, skyrocketing natural-gas rates, and the current gasoline-price spike. In every sector where deregulation has been tried, energy pricing became unhinged from supply and demand, not more responsive to market forces as promised by its proponents. Instead of regulators policing prices, we have producers colluding with one another in an effort to withhold supply and drive up prices. Yet the political appointees to FERC won’t admit that energy deregulation is a failure.

Don’t forget the environment. Not only does the Bush administration work hard to meet the demands of corporations, it also uses Orwellian doublespeak to gull the public. Polls show overwhelming support among the middle class for policies to protect the environment and move America toward a clean-energy future. So the Bush administration’s plan to log in national forests far from fire zones is called the Healthy Forests Initiative. Eliminating pollution controls on power plants becomes the Clear Skies Initiative. Defiling Alaska becomes Energy Independence.

Not surprisingly, the administration and its oil-industry patrons are alarmed by the growing public awareness that environmental and national-security issues are converging. Even the Pentagon has begun planning for worst-case scenarios, such as a coastal deluge caused at least in part by global warming. In last year’s State of the Union address, the president spoke about a clean-fuel technology 20 to 50 years down the road. Meanwhile, he ignores things that could be done immediately to reduce greenhouse gases and diminish our dependence on Middle Eastern oil, such as raising the fuel-efficiency standard, eliminating the SUV — is-a-small-truck loophole, and providing tax credits for buying and producing hybrid vehicles.

When it can’t bend the rules, the administration has sought to manipulate and degrade science in an effort to achieve dubious goals. The Union of Concerned Scientists has rounded up 60 scientists, including 20 Nobel Prize winners who served on advisory panels that date back as far back as the Eisenhower administration, to sign a public letter of protest. “I don’t recall it ever being so blatant,” Princeton University professor Val Fitch, who served under Richard Nixon and won the 1980 Nobel Prize for physics, told a news service. “It’s just time after time after time, the facts have been distorted.”

By manipulating science, the administration is catering to its political base of religious fundamentalists and corporate clients. For the religious right, the administration placed anti-abortion and anti-contraception opponents on an FDA advisory panel evaluating the scientific merits of an over-the-counter morning-after pill. Even after the committee gave the product a 23-to-4 nod, the FDA extended its review for 90 days to investigate potential adolescent use that might bolster opponents’ charges that the pill promotes promiscuity.

Then, in February, the administration pushed out three prominent biologists who had opposed a restrictive stem-cell research policy on a bioethics panel headed by Leon Kass. In response, an array of scientists has attacked the panel for undercutting U.S. efforts in this medical arena.

The administration also pulled out of the Kyoto Protocol on global warming, citing industry-funded studies that claim scientific understanding of the phenomenon is “incomplete.” A National Academies of Science review has debunked the charge and affirmed a scientific record on global warming that has been embraced by scientists worldwide.

Amid mounting concern that obesity will soon become the leading cause of death in the United States, Health and Human Services (HHS) Secretary Tommy Thompson has lectured the American people about their waistlines and told them to go on a diet. Behind the scenes, though, HHS officials have responded to concerns about sugars, beverages, processed foods, and restaurants by casting doubt on the link between obesity and addictions to soft drinks and fast food. When the World Health Organization issued a report embracing these linkages, for example, HHS officials sent a 28-page memo to Geneva attacking the report.

That’s not all. An Agriculture Department official’s warning about the meat-inspection system was ignored. A Center for Medicare and Medicaid Services official with realistic cost estimates for the prescription-drug bill was threatened with dismissal. And EPA enforcement chiefs resigned after the agency abandoned its suits against major polluters. Their protests are a warning to every professional whose career intersects with the government regulatory process: Expertise counts for nothing when arrayed against political and economic clout.

Regulation in the public interest once protected the middle class from short-term economic reversals. The cost-benefit crowd overstates the costs and understates the benefits in costs saved. Mark Cooper, the director of research at the Consumer Federation of America, which has done yeoman-like work on many of these issues, has compiled estimates: $ 90 billion from natural-gas price gouging, $ 40 billion in gasoline prices, $ 30 billion in cable rates.

The few crumbs of the Bush tax cut that went to middle-class households have been eaten up by the unregulated rip-offs that take place every month when folks pay their gas, electric, telephone, and cable-TV bills (not to mention health-insurance costs). That may not be a tax increase per se, but it drains the financial resources of average consumers and helps explain why in this profit-rich but jobless recovery, most middle-class Americans feel like they are losing ground.

MERRILL GOOZNER, author of The $ 800 Million Pill: The Truth Behind the Cost of New Drugs, directs the Integrity in Science project at the Center for Science in the Public Interest.From The American Prospect

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