Liberal media?

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

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

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.

A Failure To Disclose

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

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

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"

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

Can we afford the future cost of cancer care?

Lung cancer researchers came up with an important discovery this week that has important implications for our health care finance system.

It turns out that just one in ten lung cancer patients respond to AstraZeneca's drug Iressa because only one in ten have a mutation of the epidermal growth factor receptor (EGFR) gene, which gets expressed at rates far beyond normal and triggers abnormal cell growth. Iressa (the generic name is gefitinib) inhibits EGFR.

Of course, that's not what AstraZeneca wanted to hear. Thanks to the tobacco industry, air pollution and other factors, about 200,000 Americans get lung cancer every year. It's a huge market. The company adroitly exploited that patient population when seeking approval for the drug. It gave tens of thousands of dying patients the drug in a "compassionate use" program, thus building a huge constituency to lobby for its approval. We now know why a small percentage of them responded.

However, that limited response has been used to justify marketing the drug to all lung cancer patients. Unfortunately for AstraZeneca, knowing which ones will respond by administering a test to see which ones have the EGFR mutation will cut its potential market by 90 percent.

There are a number of lessons to be drawn from this story. First, most major

cancers are not single diseases. People either develop multiple genetic mutations in a single cancerous cell type or each person's cancer falls into tiny subset of the broader category that we call, say, lung, breast or colon cancer. Which subset a patient falls into will depend on which gene mutates. The result is that any single drug will help only a small fraction of the overall patient population with that type of cancer.

This doesn't bode well for the future cost of health care. Every cancer in effect becomes a rare disease. As scientists hone in on the cancers that may be inhibitable with targeted therapies like Gleevec or Iressa, each drug will only help a subset of the total patient population.

Identifying in advance which patients will respond to a drug by genetically testing their cancer cells will either sharply reduce the drug manufacturer's sales, or force them to increase their prices to astronomical levels to get the returns they'd hoped for when they embarked on developing the drug.

Can health care insurers, Medicare, Medicaid and private health care consumers support this kind of targeted therapy? Don't forget that these targeted therapies don't kill cancer, they control it. That means that as patients live longer, they require long-term, perhaps permanent treatment with wildly expensive drugs.

The simple answer is no. The nation will either ration through price, or allow health care spending to gobble up more and more of overall economic activity.

Here's where it is important to recall that most of the knowledge about these genetic mutations and identification of drug targets was generated by researchers funded by the government. Even though drug companies spend lots of money developing drugs to inhibit these targets, the drugs' eventual pricing is driven by the overall economics of the industry, not the cost of developing the drug.

And those economics are exceedingly depressing, especially as one looks out over the medium and long term. Drug companies are coming up with fewer and fewer blockbuster drugs to justify their huge expenditures on marketing, advertising and wasteful research on me-too drugs (not to mention a profit margin that is the envy of every other industrial enterprise). Trying to squeeze the cash flow needed to support those wasteful activities out of targeted therapies for cancer -- the nation's second leading killer -- will bankrupt the health care system.

Most of the leading chemotherapy agents -- the earlier generation of cancer drugs -- were developed in the public sector. The coming collision between the rapidly evolving science of cancer and the financial needs of the drug industry suggests we may have to return to that model if the American people are going to be able to afford treatments based on knowledge they've already paid for with their tax dollars.