A note on Reagan

June 11, 2004
By

Had enough of the ill-informed, hagiographic coverage of President Ronald Reagan’s passing? The insipidness of the American press needs no further elucidation here. But I can’t let the moment pass without pointing out two of my own most vivid recollections of his presidency, issues that have received little notice this past week.

In the early 1980s, I was a reporter covering the South Side of Chicago and northwest Indiana. It was home to the U.S. steel industry’s largest concentration of factories and workers, an ethnic melange of Eastern European ethnics, blacks and Hispanics. Though integrated at work, the workers lived in segregated communities that were mirror images of each other. They owned small but comfortable homes, downed beers by the six-pack and believed their backbreaking labors had earned them a small but cherished place in the American mosaic.

But by early 1983, sky high interest rates enacted by Federal Reserve Board chairman Paul Volcker and an accelerated depreciation tax policy enacted by the incoming Reagan administration had encouraged companies to monetize their aging factories. Instead of spending the cash on modernizing the mills, they shut most of them down and invested elsewhere.

This deliberate dismantling of a huge swath of the U.S.’s aging industrial base drove unemployment in the region to 25 percent — a level not seen since the Great Depression. Layoff notices arrived not in batches of hundreds or thousands but in the tens of thousands. Over a two-year period, an urban landscape that had once been home to a great civilization became a barren wasteland.

You’d think that a president confronted by a human tragedy of such mammoth proportions would at least pay a visit to the area, express his concern for those whose jobs had been destroyed, shine the light of his fabled optimism on the nightmare that their lives had become. Fuhgeddaboudit. It never happened. Nor did his government ever come up with a single program beyond paltry trade adjustment assistance and superficial job training programs to ameliorate their plight.

The second great tragedy I witnessed during the Reagan years was the AIDS epidemic, a plague that was first identified in 1981 when five young homosexual men in Los Angeles came down with a rare form of skin cancer. By the mid-1980s, HIV/AIDS was killing tens of thousands of Americans per year. The obituary pages of the nation’s leading newspapers read like a dirge for the worlds of high fashion, literature and the arts, where many gay men had made their careers.

What was the Reagan administration’s first response to this crisis? In 1983, Presidential press spokesman Larry Speakes made a tasteless joke about “gay cruising” when a reporter dared ask about Reagan’s response to the epidemic. His government did not begin appropriating money to NIH to begin studying the disease until 1985. It took until 1987 — one year before leaving office — before the president made his first public utterance about AIDs.

If the test of a country is how it treats its least fortunate citizens, then the U.S. has gotten low marks throughout much of its history. But Ronald Reagan’s response to the two great domestic tragedies of his presidency set a new standard for callousness, one that we live with to this day.

Spitzer on drugs

June 4, 2004
By

New York Times readers with troubled kids must be very confused today. Yesterday, a front page story claimed that antidepressants worked wonders on children. Then, 24 hours later, the paper of record gave similar front page treatment to news that New York State Attorney General Eliot Spitzer had sued GlaxoSmithKline for failing to reveal clinical trial data showing its antidepressant didn’t work in kids.

Why the discordant messages? The first story reported the early results from a government-funded clinical trial showing that Prozac was better than talk therapy or a placebo. An objective source? Hardly. The trial was conducted by Dr. Graham Emslie, a Texas-based psychiatrist who is one of the nation’s leading advocates of medicating depressed children. Emslie’s corporate client list reads like a who’s who of the drug industry and includes Eli Lilly, maker of Prozac. Alas, the Times never told its readers this fact.

Though funded by NIH, Emslie’s was a curiously designed trial. It looked only at Prozac, the first serotonin reuptake inhibitor. Previous trials had already shown it to be the only SSRI that was effective in kids. For some reason, the government didn’t ask Emslie to compare it to other SSRIs.

Despite the missing comparisons, the Times story did nothing to differentiate Prozac from its many me-too SSRI rivals, which have entered the market in the years since Prozac’s spectacular debut. The headline suggested that all “antidepressants” were effective in children.

The Spitzer suit, coming only a day later, must have embarrassed the Times editors into giving it the same front page placement. Had they fact checked their headline the previous day, they would have learned that copycat SSRIs like Paxil and Zoloft have never been shown to be effective in children. In fact, tests submitted to the FDA for patent extensions revealed just the opposite: they were no better than placebo.

Moreover, there are dozens of lawsuits across the country alleging the drugs have caused suicides and suicide idea formation in some youths who take them. Unpublished clinical trial data obtained in those lawsuits formed the basis of Spitzer’s suit.

Meanwhile, the Food and Drug Administration’s inquiry into the suicide side effects of SSRIs continues. Despite an internal review suggesting most of this class of drugs has no efficacy in kids (why would you accept any risk if there is no benefit?), the agency has refused to follow its British counterparts and ban their use in children. It awaits a comprehensive data review by Columbia University psychiatrists, which is due out this summer.

This scenario should sound familiar to anyone who remembers the government’s response to the Enron scandal. While the Securities and Exchange Commission dithered, the crusading A.G. from the Empire State rushed in to fill the void. Now we have a similar situation unfolding in drug regulation.

I applaud Spitzer. But in the end, state regulation is no solution. No state official, no matter how aggressive, has the scientists, the experience or the clout to effectively take on Big Pharma. Only the FDA can protect the American people from dangerous drugs. And when it comes to kids, they should err on the side of caution.

Liberal media?

May 28, 2004
By

Fairness and Accuracy in Media, which analyzes media content from a portside perspective, has just released a fascinating study on the evolution of NPR’s (Morning Edition, All Things Considered) content over the past decade. If you’re a regular listener, you don’t want to miss their analysis, which confirms the rightward drift at NPR that many regular listeners (like me) complain about.

Couple this study with yesterday’s mea culpa in the New York Times regarding its uncritical coverage in the months leading up to the war of the Bush administration’s and Ahmed Chalabi’s claims that Iraq had weapons of mass destruction, and you get a damning refutation of the notion that the media is dominated by liberals.

The zeitgeist of the culture, of course, is quite the opposite. Right wing talk show hosts, best-selling conservative authors and Republican politicians still regularly accuse the media of harboring a liberal bias. Their evidence is usually drawn from surveys of jounalists’ opinions at elite media institutions.

Opinions are one thing. Actions — what journalists actually do to earn their paychecks — are quite another. If you want an objective analysis of what the self-censoring liberal journalists at NPR put in your ear each day, turn your web browser to:

http://www.fair.org/extra/0405/npr-study.html
http://www.fair.org/extra/0405/npr-study.html

Abbott and AIDS

May 24, 2004
By

The National Institutes of Health is holding a hearing Tuesday on citizen demands that the government seize the patent of Abbott Laboratories’ AIDS drug ritonavir, whose initial version was discovered on a government grant. Here’s a few important facts to keep in mind while reading or listening to the news coverage.

First, between 1985, when President Ronald Reagan was forced to finally take the AIDS epidemic seriously, and 1996, when the triple cocktail for controlling the disease finally emerged, the U.S. government spent over $10 billion on AIDS research. Industry in that 11-year span spent less than $3 billion.

Second, all of the early drugs for fighting AIDS, which didn’t become effective until protease inhibitors were discovered, were largely developed by government scientists.

Third, the protease inhibitor class, which includes Abbott’s ritonavir, were developed in industry labs. But those private sector researchers collaborated with government researchers every step of the way.

Why is this ancient history still important? AIDS therapy in the advanced industrial world today is a $7 billion a year market. A few months ago, Abbott raised the price of its protease inhibitor fivefold in order to gain a larger share of that market. They could get away with it because virtually every AIDS doctor adds a bit of ritonavir to their prescribed regimen because of its unique properties — it inhibits the metabolism of the other drugs.

Abbott’s goal was to force new AIDS patients to take their combination pill, which has ritonavir built in, instead of combinations made by competitors. What Abbott’s marketers didn’t plan on was angry opposition from existing AIDS patients, who can’t easily switch from their existing drug cocktails without spawning drug-resistant forms of the disease. So the AIDS activist community, which in recent years had largely turned its attention to the problem of getting AIDS drugs to the developing world, once again went on the warpath.

Abbott has already mounted its counter offensive. “We’ve spent over $300 million developing ritonavir,” their spokesman are saying, “while the government spent only $3.7 million on this drug.”

What they won’t say is that they wouldn’t even pay to have their own scientist work on the initial stages of the drug’s development until the government ponied up the cash. Nor will they admit that it was only at the urging of independent researchers that they moved to testing their drug in combination with others already approved by the Food and Drug Administration. Nor will they admit that most of that $300 million was spent AFTER ritonavir was approved by the FDA. It was spent on so-called seeding trials that are designed to familiarize doctors with the drug, that is to say, trials that are really part of marketing even though it is called R&D.

A lot of Tuesday’s discussion will revolve around legal interpretations of the government’s technology transfer laws. Industry proponents (which includes most of the NIH bureaucracy) will argue that the “government rights” clause does not pertain to unreasonable pricing of government inventions.

My own reading of the late 1970s debate leading up to passage of the tech transfer laws says the issue was never really discussed in those terms. Government advisers like Admiral Hyman Rickover worried more about subsidizing big business. His close relationship with military contractors over the years had taught him that price gouging was inevitable when the government granted exclusive licenses for inventions discovered on the taxpayer nickel. In those days, it was the $600 toilet seat. Today, it’s the $10-a-day AIDS drug.

There’s no doubt that Abbott will escape Tuesday’s hearing unscathed. The drug industry rarely loses when money is at stake and Washington is the battleground.

But they may wind up losing the war. Generic AIDS medications are finally on their way to the developing world. Even the Bush administration couldn’t stand up to the pressure mounted by the World Health Organization, UNAIDS and global non-governmental groups.

One of the industry’s main arguments against allowing countries like India to make generics for Africa was their fear that these drugs would inevitably leak into the advanced industrial world through the so-called gray market, thus undercutting domestic prices.

If the industry responds to the arrival of Third World generics with price gouging a la Abbott, their fears will become reality. And when it does, they’ll have no one to blame but themselves.

Pricing AIDS drugs

May 18, 2004
By

Yesterday’s announcement that the Bush administration is finally willing to provide generic AIDS medications to the developing world is welcome news. Previously, the administration’s Third World AIDS czar, former Eli Lilly executive Randall Tobias, had pushed for U.S. aid to buy patented drugs at near-market prices.

Before we break out the champagne to congratulate the administration (and heave a sigh of relief that our taxpayer dollars will go a bit farther), a few salient facts are in order. Between 1985 and 1996 when the AIDS triple cocktail emerged from research labs, the U.S. government poured more than $10 billion into AIDS research. European governments and Japan spent billions more. Industry spending, meanwhile, totaled less than $3 billion, well under a quarter of the total.

So it should come as no surprise that every one of the first AIDS drugs, most of which are still on the market, emerged from those early government efforts. Even several members of the first generation of protease inhibitors, the drugs that made the triple cocktail work, began their lives on government grants or relied on government-funded clinical trials to pass Food and Drug Administration muster.

I don’t bring up these facts merely to harrumph over the Bush administration’s reversal. Access to affordable medicines is a problem here, just as it is in Zimbabwe and South Africa. AIDS therapy in the advanced industrial world is now estimated to be a $7 billion a year market, much of which is picked up by Medicaid and other government assistance programs. The drug industry invested significant sums in developing the first and subsequent generations of AIDS drugs, to be sure. But they have been and continue to be well reimbursed for their efforts.

The question now is this: If the developing world can have affordable AIDS drugs, why not here? A few months ago, Illinois-based Abbott Laboratories quadrupled the price on its protease inhibitor, Norvir, which was approved in 1996 and is the direct descendant of a drug invented on a government grant.

Why the massive price increase? Norvir (the generic name is ritonavir) has some peculiar properties. It makes all the other AIDS drugs stay in the blood stream longer. So many physicians prescribe it in small doses to go along with the triple cocktail. As an old-time ward heeler from the city that gave birth to Abbott once put it, “I saws my opportunity, and I took it.”

The price increase drew howls of outrage from the AIDS activist community. One group sued. The Consumer Project on Technology, a Nader spin-off, petitioned the National Institutes of Health to exercise a “government rights” clause that is attached to every invention made with government funds. If CPT had its way, the government would seize the ritonavir patent and give it to a generic manufacturer.

On May 25th, NIH will hold a hearing on that petition. Don’t expect much action from the government. But it should provide an entertaining glimpse into industry thinking. We’ll keep you posted.

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