Innovation in Biomedicine: Can Stem Cell Research Lead the Way to Affordability?

The following article appeared today in PLoS Medicine:

By Merrill Goozner

In November 2004, California voters approved a ten-year, $3 billion stem cell research program to pursue cures for diabetes, Parkinson disease, spinal cord injuries, and other chronic conditions. Campaign organizers also claimed the state would receive royalties from new therapies, economic development in the form of jobs and taxes, and access to cheaper medicines [1]. Once the initiative passed, its proponents sought to scale back unrealistic voter expectations about rapid advances in the field—recent revelations of scientific fraud involving a prominent stem cell scientist will undoubtedly have that effect.

Yet the goal that stem cell therapies resulting from the initiative will be made affordable for state residents remains in place. Toward that end, some California legislators are focusing on how the newly created California Institute for Regenerative Medicine (CIRM) should handle intellectual property (IP) generated by its grants. In August 2005, at CIRM's request, the state-funded California Council on Science and Technology (CCST) recommended that CIRM adopt with minor variations the federal Bayh–Dole system [2].

The 1980 Bayh–Dole Act gives research institutions the primary responsibility for maximizing the health- and economic-development benefits from government research funding. It encourages researchers or their institutions to patent inventions generated under government grants and transfer the technology to private firms. While the act gives the federal government the power to influence the affordability of the resulting technologies, it has never used this authority. The CCST report, embracing that stance, discouraged efforts to recoup revenue through high licensing fees and postponed a discussion of preferential pricing for state residents [3]. The report suggested such approaches would inevitably hinder the development of the public–private collaborations needed to bring new therapies to market.

While regional governments frequently fund biomedical research in Europe, California is the first state in the United States to embark on a large-scale program. The size of its commitment suggests that the state will be a major patron of stem cell research for years to come. This gives California a unique opportunity to create a climate that will not only be hospitable to innovation but also simultaneously deliver affordable medicine. The state government can do this by redefining how government, medical researchers, and the private sector interact. In doing so, it could serve as a model for reforming the US and global biomedical innovation systems.

Change is necessary for two reasons. First, under the current system, new technologies, no matter how marginally effective, come to market at the highest prices. These advancing medical technologies are a major cause of rapidly rising health-care spending throughout the industrial world. Second, biomedical innovation in the US, long considered the global leader, has slowed markedly in the past half decade. Despite escalating research spending in the public and private sectors, the number of new drugs and biologics recently approved by the US Food and Drug Administration (FDA) has fallen below previous eras (Figures 1 and 2). And those new therapies that have been approved tend to have less significance than medical advances of the past. While the popular press excitedly reports that breakthroughs in nanomedicine, targeted therapeutics, and genomic medicine are just around the corner, applications to launch clinical trials have fallen well below the levels of the early 1990s (Figure 3). Something beyond the usual culprit—higher failure rates—is at work [4].

Patent Thickets
The IP system may be contributing to the slowdown. The current innovation system encourages researchers to patent and commercialize discoveries that in an earlier era were considered basic science insights. This has led to an active market in the building blocks of further research, which can be anything from a genetic sequence or a cell receptor to the reagents needed to culture cells. This proliferation of basic science patents has raised the bar—what economists call transaction costs—for other researchers who want access to those research tools. While many researchers, especially in academia, find ways around patent restrictions, and many companies have no trouble executing license agreements, there are cases where “patent thickets” have discouraged other researchers from pursuing similar or subsequent lines of inquiry [5].

The stem cell field, which is still years away from its first approved therapy, has already experienced patent thicket problems. In May 2005, Nature drew attention to the case of Jeanne Loring, an embryologist at the Burnham Institute in La Jolla, California [6]. She claimed her startup firm collapsed when it couldn't get access to embryonic stem cells at a reasonable price from the Wisconsin Alumni Research Foundation, which owns James Thomson's seminal patents in embryonic stem cell research. The Wisconsin Alumni Research Foundation has granted several exclusive licenses to Geron, Inc., which funded his work [7].

A recent survey by the United Kingdom Stem Cell Initiative identified nearly 18,000 stem cell patents issued around the world since 1994, with two-thirds issued in the US [8]. The Washington-based law firm of Sterne Kessler Goldstein and Fox has warned clients that “any company or research institution that plans to develop stem cells for therapeutic purposes may face a number of blocking patents and applications that will require licenses, if available” [9]. The potential for patent licensing restrictions to slow the pace of research is impossible to quantify, but surely exists. How does one count the decisions of researchers who eschew a line of research because they don't want to bother securing the necessary licenses or material-transfer agreements? How does one count the decisions of researchers to avoid fields entirely because someone else has already locked up key inventions? How can one predict if cascading licensing fees will make downstream research prohibitively expensive?

Jumping into the Pool
CIRM and other stem cell funders can become catalysts for cutting through this patent thicket. They can require that all grant recipients agree to donate the exclusive license to any insights, materials, and technologies that they patent to a common patent pool supervised by a new, nonprofit organization set up for that purpose. A patent pool serves as a one-stop shop where investigators can obtain no-cost or low-cost licenses for subsequent research. Patent pools have been successfully used in other high-technology industries such as consumer electronics and software to facilitate the development of new technologies that either require common standards or rest on a common base of basic research. Several patent law firms and close observers of medical research have suggested that patent pools can work in biomedicine [9,10].

There is already some official interest in the patent pool approach, at least for early stage research. The CCST report to CIRM suggested mechanisms such as broad-use licenses could be used to facilitate the sharing of software, databases, and other research tools (see page 14 in [2]). The UK Stem Cell Initiative, a public–private partnership, included a call for a new UK Stem Cell Cooperative “to maximize the cross-fertilization between those involved in the subdisciplines of UK stem cell research” (see page 8 in [8]).

But the stem cell patent pool needs to reach beyond the early stages of research if it is going to maximize the chances of this targeted research campaign eventually producing therapeutic results. As researchers move further down the development trail, the pool can serve as a clearinghouse for all researchers in the public or private sector to gain permissions for pursuing the next stage of their research at minimal transaction costs, including time. Moreover, the pool authority can act as an agent for resolving challenges that will inevitably arise as the research progresses, including enforcing ethical standards. For instance, the pool authority in cooperation with the FDA can set common standards for cell line preparations as research moves toward the critical clinical trial phase. And the pool should have the scale to leverage the cooperation of existing patent holders whose IP predates formation of the pool or whose future research will be funded by other governments, nonprofits, or private firms.

The pool can also influence accessibility to the fruits of downstream research. As a condition for obtaining a pool license, any researcher would have to contribute any IP that results from using the pool license back into the pool. In the software world, this is known as open-source licensing, which was used successfully to develop the still-evolving Linux computer operating system and which is being pursued in agricultural biotechnology (R. Jefferson, personal communication; [11]).

There is one major stumbling block for the use of an open-source patent pool to facilitate stem cell research. Unlike software or even agriculture biotechnology—where the end products are relatively low cost, and the costs of development are relatively evenly distributed throughout the development process—biomedical research costs escalate once a therapeutically useful product reaches clinical trials. Applied research can take five to ten years from the start of human safety experiments. While the costs of pharmaceutical research are less than the drug industry claims, the investment required can run into the tens or even hundreds of millions of dollars. As a result, this developmental research has almost always been funded by the private sector [12]. (There are, of course, many exceptions to this rule: the early HIV/AIDS medications, many cancer drugs, some vaccines, and the development of several rare-disease therapies have been entirely funded by government agencies.) The private sector's price for taking these late-stage risks is exclusive rights to the technology. Its reward, if successful, is the right to charge whatever the health-care marketplace will bear.

Eyes on the Prize
However, there is an alternative to the exclusive rights/high prices model used by conventional markets. A government body such as CIRM could establish a major prize for companies and institutions that collaborate to produce a successful stem cell therapy. The prize would have to be large enough to justify the substantial investment required to carry out the final stages of research. It would also have to be large enough to share with the upstream patent holders whose basic and applied research became part of the pool that led to the new therapy. One could imagine prizes in the billions of dollars based on considerations such as the prevalence and public health impact of the disease, the difficulty in developing its cure, and the capital investment required to achieve results. A prize system has been proposed at the federal level [13].

A prize system, coupled with an open-source patent pool, is entirely consistent with the existing IP system. Inventors and their institutions would retain the IP rights to their inventions. Any revenues generated from the prize could be shared with the inventor and reinvested in research and education. Though the rights to the invention would be turned over to the pool, the technology-transfer officials at an institution would still have an incentive (their share of the prize) to aggressively pursue its use by downstream scientists in the public or private sectors if they feel their invention is not being properly utilized.

Division of the prize could be based on mandatory arbitration among patent holders [14]. Or it could be based on the value of the research contracts that led to the underlying IP and were invested in clinical trials. Basing the prize on investment would weight its distribution toward the parties that conducted the final phases of research—usually private-sector firms—since the trials are generally the most expensive part of therapeutic development.

Governments can finance the prizes using tax-exempt bonds since a prize will only be awarded for success. At that point, the bonds can be repaid by a surcharge on each use of the new therapy as it rapidly diffuses through the health-care system. Once the prize has been awarded for a successfully developed stem cell therapy, the pool authority can grant licenses to one or more generic manufacturing firms, which can then compete to sell the therapy to health-care providers and the public on a cost-plus basis [15].

Wouldn't the surcharge to finance the prize, when added to the cost-plus production by generic manufacturers, add up to the same high prices for medicines generated by the current system? Not at all. This “shared prize model,” calibrated to the true cost of research and development, eliminates the 30%–40% of pharmaceutical industry revenue generated by wasteful marketing costs. The prize provides no rewards for industry research and development that goes to develop medicines that duplicate the action of medicines already on the market. Financing the prize with tax-exempt bonds ensures that the surcharge will be based on the lowest-cost capital available.

Conclusion
By combining a patent pool, an open-source model of IP development, and a shared prize system for developing stem cell therapies, the California state stem cell program can point the way to a new medical innovation system for the 21st century. This model could be used by all advanced industrial economies grappling with how to pay for the rising cost of the new medical technologies sought by their ill and aging populations.

References
[1] Baker L, Deal B (2004) Economic impact analysis: Proposition 71 California Stem Cell Research and Cures Initiative. New York: Analysis Group. Available: http://www.ag-inc.com/AnalysisGroup/uploadedFiles/News_and_Events/News/Proposition_71_report.pdf. Accessed 1 February 2006.
[2] California Council on Science and Technology [CCST] Intellectual Property Study Group (2005) Policy framework for intellectual property derived from stem cell research in California. Interim report to the California legislature, governor of the state of California and the California Institute for Regenerative Medicine Riverside (California): CCST. Available: http://www.ccst.us/ccst/pubs/IP/IP%20Interim%20Exec.pdf. Accessed 1 February 2006.
[3] US Food and Drug Administration [FDA] (2005) Original INDs received calendar years 1986–2004. Rockville (Maryland): FDA. Available: http://www.fda.gov/cder/rdmt/Cyindrec.htm. Accessed 1 February 2006.
[4] Heller MA, Eisenberg RS (1998) Can patents deter innovation? The anticommons in biomedical research. Science 698–701.
[5] Eisenberg R, (2001) Bargaining over the transfer of proprietary research tools: Is this market failing or emerging? In: Dreyfuss RC, editor. Expanding the boundaries of intellectual property: Innovation policy for the knowledge society Oxford University Press. pp 223–250.
[6] Wadman M (2005) Licensing fees slow advance of stem cells. Nature. E-pub 18 May 2005. Available: http://www.nature.com/news/2005/050516/pf/435272a_pf.html. Accessed 1 February 2006.
[7] Geron (5 November 1998) PNAS reports derivation of human pluripotent stem cells from cultured primordial germ cells. Menlo Park (California): Geron. Available: http://www.geron.com/pressview.asp?id=562. Accessed 1 February 2006.
[8] UK Stem Cell Initiative (2005) Report and recommendations. London: UK Department of Health. Available: http://www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf. Accessed 1 February 2006.
[9] Ebersole TJ, Edmond RW, Schwartzman RA (2005) Stem cells—Patent pools to the rescue? Washington (D. C.): Sterne Kessler Goldstein and Fox. Available: http://www.skgf.com/media/news/news.176.PDF. Accessed 1 February 2006.
[10] Kesselheim AS, Avorn J (2005) University-based science and biotechnology products: Defining the boundaries of intellectual property. JAMA 850–854.
[11] Pollack A (10 February 2005) Open-source practices for biotechnology. New York Times B: 1.
[12] Goozner M (2004) The $800 million pill: The truth behind the cost of new drugs. Berkeley: University of California Press. 296 p.
[13] US Congress (2005) Summary of the medical innovation prize fund, HR 417.109th Congress. 1st session (26 January 2005). Available: http://bernie.house.gov/documents/prescriptions/rd_read_the_bill.htm. Accessed 3 February 2006.
[14] Kesselheim A, Avorn J (2005) University-based science and biotechnology products: defining the boundaries of intellectual property. JAMA 293: 850–854.
[15] Barton JH, Emanuel EJ (2005) The patents-based pharmaceutical development process: Rationale, problems and potential reforms. JAMA 294: 2075–2082.

Merrill Goozner is Director of the Integrity in Science Project, Center for Science in the Public Interest, Washington, D. C., United States of America. E-mail: mgoozner@cspinet.org

Competing Interests: The author declares that he has no competing interests.

Published: February 28, 2006

DOI: 10.1371/journal.pmed.0030126

Copyright: © 2006 Merrill Goozner. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations: CCST, California Council on Science and Technology; CIRM, California Institute for Regenerative Medicine; FDA, US Food and Drug Administration; IP, intellectual property

Citation: Goozner M (2006) Innovation in Biomedicine: Can Stem Cell Research Lead the Way to Affordability? PLoS Med 3(5): e126

Funding: The author received no specific funding for this article.

From PLoS Medicine: Innovation in Biomedicine

Recommended reading by yours truly:

With every biotechnology, pharmaceutical, and medical device company, not to mention every university technology transfer office, trying to make a buck off medical research, is there any way to create new medical miracles without bankrupting the health care system? The May issue of the Public Library of Science: Medicine, released today on the web, contains a proposed solution: scientists who rely on government grants could be required to contribute their patents to an open-source pool sort of like the one that built the Linux computer operating system. Coupled with a prize system like the one proposed by Rep. Bernie Sanders (I-VT), this alternative medical innovation system could make future therapeutics affordable while preserving financial incentives for true innovation. California, which is embarking on a $3 billion stem cell research program, would be the perfect place to start.

Way Up North: My Own Private Clinic

The media has an endless fascination with stories out of Canada and Great Britain about long waits for basic health care services. Their national health care systems invariably get blamed. The stories generally revolve around anecdotes about elective surgery that many do not consider elective. The latest, in Sunday’s New York Times, revolves around a private Canadian clinic, operating outside the law, that replaces creaky knees and hips in seniors turned down by the national health care program.

The story suggests that in the wake of a recent Canadian court decision, its "slow motion" single-payer health care plan will inevitably be replaced by a two-tier system similar to our own that includes private insurance. Maybe so. But no one should mistake that for better health care. Let’s explore some issues the Times story left out.

Anyone who has suffered from the constant pain of crippled joints might have a second opinion about a determination that their operation can wait six to nine months. But how did the Canadian health authorities make that decision? It inevitably hinges on an evaluation of the health benefits of the operation, its cost, the number of people who might take advantage of the service if it were made freely available on demand, and the cost constraints on the entire health care delivery system, of which this is just one part.

How did they determine the benefits? While many joint replacement surgeries are needed, some are not. Some even make things worse for the recipients. Unfortunately, very little is known about who is most likely to benefit from these surgical procedures.

In the U.S., a December 2003 study by the Agency for Health Research and Quality found that Medicare in 2001 paid over $3.2 billion for joint replacements in nearly 200,000 seniors, two-thirds of whom were women and one-third of whom were obese. Despite these 200,000 operations every year, the AHRQ researchers could find virtually nothing in the medical literature that documented the results of these operations other than improved mobility for the group as a whole and greater benefits from those suffering from rheumatoid arthritis.

Did it improve outcomes for the obese? Did the severity of arthritis matter? How long did it take before another operation was required? “The current state of empirical work does not provide a strong basis for making clinical recommendations,” the report concluded. “As pressures mount for more discrimination in identifying subjects for elective surgery, better information will be needed.”

Unfortunately, better information is not easily obtainable. Compared to drug makers, device manufacturers have to meet much lower standards at the Food and Drug Administration before getting approval to sell new devices like artificial hips. Placebo-controlled trials are almost impossible since who would voluntarily sign on for an operation that might turn out to be a sham? Of course, extensive post-operative monitoring of the millions of people who have had these operations would tell researchers a lot. But the FDA rarely requires post-marketing studies and rarely enforces its mandate when it requires them. Moreover, what device manufacturer would voluntarily conduct such a study once it has already gained FDA approval? From its perspective, the study could only hurt sales.

Meanwhile, the cumulative cost of these popular operations are heading higher as more and more members of our graying and increasingly obese society opt to undergo the procedures. The result: public systems (the average age of patients in the AHRQ survey was 70, making Medicare the principal payer) will come under increasing financial stress without tools to discriminate among those who want the operation.

Governments could, of course, fund studies to show who really benefits the most from such operations. But manufacturers have been very adept at dissuading the authorities from conducting such studies. The Medicare Modernization Act’s budget for outcomes research was deliberately kept minuscule by a Republican Congress beholden to drug and device industry lobbyists.

While I don’t know the details, I am guessing that Canada decided, in the absence of research, to adopt a waiting period to sort out who really needed the operation. It’s probably the only choice they could make in the absence of good information.

But the result, in the wake of a recent court decision opening Canada's provincial health care systems to competition, will be the worst of both worlds. Patients who have money or insurance will get their operations whether they need them or not. Meanwhile people who really need them but don’t have money or insurance will have to wait.

Rationing by price may be a good business decision for the knee and hip joint manufacturers and the osteopaths who install them. But it is lousy health care.

Integrity in Science Watch -- 2/24/06

Conflicted Scientists May Play Key Role at Upcoming FDA Advisory Panel
Half the scientific experts chosen for the Food and Drug Administration's March 6th Anti-Infective Drugs Advisory Committee have financial ties to Cubist Pharmaceuticals, whose new antibiotic is up for approval, or its competitors. Steven Ebert sits on Cubist’s speakers bureau, while Jeffrey Borer, John Bradley, and James Omel sit on speaker’s bureaus, own stock or consult for a direct competitor of Cubist. A fifth waiver was granted to Jan Patterson, whose spouse sits on the speaker's bureau and consults for a firm that competes with Cubist. The FDA routinely grants financial conflict of interest waivers by claiming it cannot find experts without such ties. It also does not reveal the names of scientists’ corporate clients.

Yale Sets Tougher Rules for Big Pharma on Campus
Yale University has issued new guidelines for faculty and medical students that will place strict limits on future dealings with the pharmaceutical industry. The limits include a ban on free meals, drug samples and other gifts from the industry. The university also pledged stricter management of faculty conflicts of interest. “One medical school has attempted to meet the challenge of maintaining professionalism, integrity and public service" in working with pharmaceutical companies, a university statement said.

Top Scientists Decry Washington's Muzzling of Science
At a session organized by the Union of Concerned Scientists at the annual meeting of the American Association for the Advancement of Science, hundreds of top scientists heard David Baltimore, Noble-prize winning scientist and President of the California Institute of Technology, attack the Bush administration for its "suppression of scientific freedom" by an increasingly powerful executive branch. Susan Wood, the former FDA director of women's health who resigned in protest over the FDA's handling of Plan B (emergency contraception), blamed Congress for establishing an environment that neglects science in policy-making.

UK Scientist Deprived Data; Questions Pharmaceutical, University Interface
How much control do corporate benefactors exert over their university-based research? Sheffield University professor Aubrey Blumsohn’s run-in with Proctor & Gamble suggests far too much. Blumsohn was denied access to data compiled for a 2002 study of Actonel, P&G’s osteoporosis drug, in which he took part. The company also published abstracts and drafts under Blumshon’s name without his consent. "I asked repeatedly for the data, they refused," Blumsohn said in a stopover in Washington this week. He and others question whether companies that contribute financially to research should "be allowed to help write the results for publication or insert their own interpretation of those results."

Weinberg Group Helps Industry Side-Step Regulation
Environmental Science and Technology revealed this week that the Weinberg Group sought to represent DuPont in its battle against stricter standards on PFOA, a chemical used to manufacture Teflon. The company’s pitch, contained in an EPA filing, said the Weinberg group is expert at "successfully [guiding] clients through...challenges posed by those whose agenda is to grossly over regulate, extract settlements from, or otherwise damage the chemical manufacturing industry."

Canadian Medical Association Fires Top Editors
The Canadian Medical Association has dismissed editors John Hoey and Anne Marie Todkill from its journal after a December article described the experiences of Canadian women who were asked personal questions, including sexual history, by pharmacists before being allowed to purchase the morning-after pill. The Canadian Pharmacist Association had complained. Jerome Kassirer, a member of the Canadian Medical Association Journal editorial board, called the action "reprehensible."

BLM Biologists Forced to Monitor Drilling, Not Wildlife
The Washington Post reports that Bureau of Land Management biologists now spend most of their time processing oil drilling permits and not protecting wildlife. "I spent less than one percent of my time in the field,” said Steve Belina, a former BLM biologist. A BLM study three years ago found one-third the bureau’s wildlife management money was spent on other things. "No matter how large the benefits are from this development, it does not justify turning a blind eye to the environment," said Wyoming Gov. Dave Freudenthal (D), whose state has had areas experience since a six-fold increase in drilling in recent years.

BLM Reinstates Funding to Contested OSM Logging Study
Update: Under pressure from federal officials and the scientific community, the Bureau of Land Management restored money for a graduate student's study showing the negative effects of logging burned forest. Rep. Jay Inslee, (D-WA), among others, questioned whether the Bureau had "stopped the funding because the study findings ran against the Bush administration's position on logging."

Who You Gonna Call?

Does your company manufacture or use a chemical that may be poisoning people and the environment? Do you need to seed the scientific literature with studies questioning those scientists who raise such questions?

Who you gonna call?

After some investigative digging, Environmental Science and Technology reporter Paul Thacker came up with the answer: The Weinberg Group.

For more on this consulting group that mixes science and public relations to whitewash chemicals, click here.

Roadblocks on the Medical Information Superhighway

Among the four major medical journals, the British Medical Journal is my favorite. It has the most extensive news coverage of the fight against the infectious diseases that are ravaging the developing world, a subject in which I take a keen interest. And it consistently prints iconoclastic studies that take on the medical establishment.

And, until this year, it was entirely free on the web. That made it distinct from the other big-time journals (the New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association), which charge hefty fees to view individual articles of interest if you weren’t a subscriber. But, alas, BMJ’s open access policy went the way of the dodo bird this January, leaving medical consumers locked out of all the major journals. Accessing some of BMJ’s original research articles and all of its news section now require a subscription to the journal.

It’s testimony to the poverty of the public policy debate in this country that no one in the mainstream media has yet raised this issue – access to cutting edge medical information – in response to the Bush administration’s push for “consumer-driven health care” through individual health savings accounts. How are consumers to choose wisely when and where to get health care if they are cut off from key sources of information? It’s like sending car buyers to the used-car lot while denying them access to the Kelley Blue Book.

I’m a skeptic when it comes to consumer-driven medicine anyway. Buying health care isn’t like buying a house or car or even legal services. The vast majority of expenditures occur in emergencies or when the patient, i.e., the consumer, is under the duress of ill-health. If I find myself in that situation, I want a doctor who can quickly guide me to the most effective care and give me carefully thought-out options that hopefully are not based on some drug industry-funded study published in a second-tier medical journal and dropped off in his or her office the day before yesterday by a drug industry salesman (these reprints are a major source of medical journal publishing revenue, by the way).

Though I’m not a doctor, my research and writing over the past five years has probably made me one of the better-educated medical consumers in the country – I venture to say at least in the top five percent. But if I were to get deathly ill, I wouldn’t trust myself for a minute to have figured out all the options for speeding my own recovery. Even in routine care, I need professional help to sort out the issues.

For instance, I had a colonoscopy three years ago and got a clean bill of health. I’m in my mid-50s. Do I need another one? Do I want to make that determination based on the size of my health savings account or some uninformed speculation evaluating my need to save that cash for a rainy day versus preventive medicine?

Of course, I could go to the internet for advice. But if I search “colonoscopy frequency” on Google, I find a similar set of unspecific advisories on for-profit and non-profit websites: have one every 3-5 years but more often if you’re at risk or if there is a family history of colon cancer; get one every ten years if you’re over 65. My brother had polyps removed after his last colonoscopy. Is that a family history? I’m lost already. And how about evaluating risk? What exactly are the risk factors? My diet? My weight? My propensity for flatulence, diarrhea or constipation? Hmmm. If I have to make this decision on my own, this is going to take some time. And what am I to think about this article from the National Cancer Institute (the third listing) that reports on a study showing that doctors over-prescribe colonoscopies?

Before I trusted the internet to help me make this decision, I would prefer to read a solid review of all the most recent studies printed in a well-respected, peer-reviewed journal like the BMJ. But the change in policy doesn’t allow me that option anymore.

But in true BMJ fashion, the latest issue contains a survey of BMJ authors on their response to closing off free access. Sara Schroter, a senior researcher at the journal, reported that 75 percent of 211 authors surveyed considered it “very important” or “important” that articles be freely available to the public when considering where they would publish their studies. A majority said it would make them “slightly” less likely to submit articles to BMJ because of the change, while 14 percent said it would make them “much less likely” to publish there.

As I suggested at the top, physicians and researchers who publish in BMJ tend to be a more progressive bunch than the profession as a whole. But this strong endorsement of open-source publishing is heartening news. It suggests broad support within the ranks of medical researchers for opening up the medical literature to the consuming public along the lines of the Public Library of Science, the Moore Foundation-funded open-access journal launched a few years ago.

Here’s hoping the ill-conceived push for health savings accounts furthers the cause of open access to medical information – and nothing else.

Integrity in Science Watch -- Week of Feb. 17

Scientist, Harvard Center Snub Full Disclosure

The New York Times revealed this week that a recent $500,000 Harvard Center for Risk Analysis study downplaying the risks of mercury-laden fish did not disclose that the Tuna Foundation, an arm of the tuna fishing industry, was its primary funder. The original study cited the National Food Processors Association Research Foundation and the Fisheries Scholarship Fund, which are broadbased industry trade groups, as its only funding sources. When asked about the oversight, primary author Joshua T. Cohen said he wasn't trying to hide the tuna industry's role in the study. "It never occurred to me anyone would think National Food Processors Association was less industry than Bumble Bee tuna," he said. The study appeared in the November issue of the American Journal of Preventive Medicine.

Graeme Pearson: The Australian James Hansen

The Commonwealth Scientific and Industrial Research Organization (CSIRO), a national research outfit created by the Australian government, is under fire after being accused of "gagging" their climate change experts.  Dr. Graeme Pearson, one of twelve senior climate change scientists who have left CSIRO over the last few years, claims he was "encouraged to resign after he spoke out on global warming."  Pearson feels that prominent researchers are pressured to fall in line with federal ideology; Pearson's relationship with CSIRO became further strained when he joined an environmental lobbying group advocating for alternative procedures to reduce greenhouse gases.

FDA Overrules Staff, OKs Unproven Device

A Senate Finance Committee report released Thursday questioned the integrity of FDA's approval process after it endorsed an implantable electric shock device for severe depression without scientific evidence demonstrating its safety and effectiveness. More than 20 FDA staff evaluated clinical trials for Cyberonics' Vagus Nerve Stimulation (VNS) Therapy System for treatment-resistant depression (TRD) and found no benefit over placebo. Yet FDA's Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health, overruled the staff report and approved the device. The report also castigated the agency for failing to inform the public and physicians about "scientific dissent" within the agency over the VNS system's approval.  

What Pill Can a Profession Take for This?

With the nation focused on the $2 billion spent annually to influence politicians, how about the $20 billion spent each year to influence the nation's 700,000 physicians and buy off their professional organizations? Former New England Journal of Medicine editor Jerome Kassirer, writing in the Boston Globe, reveals that next June's Toronto meeting of the American Psychiatric Association will feature no fewer than 46 symposia sponsored by drug companies that make antidepressants and other psychiatric drugs. These symposia are "special events, usually lectures by leaders in the field, sponsored by drug and device companies and typically held before the official program or in the evening following the day's usual program. Nice snacks and drinks are often served and sometimes dinner also," Kassirer wrote. The Senate Finance Committee is investigating the role of drug industry "educational" grants in influencing physician prescribing patterns.

Worker Safety Expert Wins Prestigious AAAS Award

I reprint here in its entirety the American Association for the Advancement of Science press release announcing that George Washington University professor David Michaels has won this year's Scientific Freedom and Responsibility award. For more than three decades, David has been a tireless fighter for justice for workers injured on the job. While in the Clinton administration, he won compensation for defense workers exposed to radiation and beryllium.

He and his group, the Project on Scientific Knowledge and Public Policy, have been an inspiration for me, and a great help to my work at the Integrity in Science project at the Center for Science in the Public Interest. I'm really happy for him and his family. Mazel Tov David!

AAAS Honors Scientist for Commitment to Justice and Integrity

ST. LOUIS — David Michaels is this year’s recipient of the prestigious AAAS Award for Scientific Freedom and Responsibility. He is recognized for his commitment to obtaining justice for workers who became ill after working in nuclear weapons programs and for advocating scientific integrity in public policy-making.

David Michaels is research professor and associate chair in the Department of Environmental and Occupational Health at George Washington University’s School of Public Health and Health Services, and directs the department’s doctoral program. He has extensive experience in research, regulatory and public policy, and program administration, and focuses much of his work on the health of the disadvantaged and the use and misuse of science, especially in the courts and the regulatory arena. He has taught epidemiology and biostatistics at several medical schools, and conducted epidemiologic studies on typographers, commercial pressmen, construction workers, bus drivers, and paper workers, as well as on tuberculosis, sexually transmitted disease, drug abuse, mental health, homelessness and HIV.

“Dr. Michaels’ advocacy on behalf of sick workers and his responsible efforts to draw public attention to threats to the integrity of scientific decision-making in government exemplify the exercise of responsibility by scientists envisioned by the Board when it established this award,” said AAAS Science and Policy Director Albert H. Teich.

From 1998 to 2001, Michaels served as Assistant Secretary for Environment, Safety and Health at the U.S. Department of Energy, where he championed a decades-long struggle by workers who had been employed in the manufacture or testing of nuclear weapons. They were seeking compensation for chronic and often fatal illnesses that may have been caused by exposure to materials used in the U.S. weapons program. The now-aging workers were required to litigate their claims on a case-by-case basis, a process that could take years to reach a resolution. Although they were experiencing life-threatening occupational illnesses at a higher-than-expected rate, the government insisted on keeping secret the very information that could have helped prove the validity of their claims.

Seeking justice for these individuals, Michaels took on powerful interests in his own agency and in the U.S. Department of Defense to uncover previously secret records documenting exposure to radiation and beryllium at work sites, as well as more than two dozen scientific studies demonstrating the high risk of cancer deaths among these workers. His efforts led him to be cited as the architect of a historic initiative, the Energy Employees Occupational Illness Compensation Act of 2000, which guaranteed that workers be compensated for illnesses likely caused by occupational exposure. The knowledge that Michaels gleaned from the long-secret documents led him to successfully fight for stricter limits on exposure to beryllium, once again overcoming objections from the Department of Defense and industry.

The AAAS selection panel noted that the efforts cited above were typical of Michaels’ work earlier in his career. At that time, his concerns for disadvantaged groups of people often ignored by researchers in the health sciences was exemplified by his service as founder and director of the Epidemiology Unit of the Montefiore-Rikers Island Health Service, the first unit of its kind in a prison. In that role, he conducted studies on tuberculosis, sexually transmitted diseases, drug abuse, mental health, homelessness and HIV/AIDS in an incarcerated population.

The panel also cited Michaels’ devotion and contributions to the integrity of science in public policy-making. He is chair of the Planning Committee of the Project on Scientific Knowledge and Public Policy, a group of scientists focused on how science is used and misused in government decision-making and legal proceedings.

Among the issues that he has been instrumental in putting before the scientific community and the public at large is the composition of federal scientific advisory committees. While acknowledging that these committees are intended to reflect a variety of views and areas of expertise, Michaels warned of attempts to “stack” the committees to ensure that unwanted advice would not be rendered.

Michaels was also visible in the debate over a proposed executive branch policy that was designed to give the Office of Management and Budget more oversight and control over regulatory decisions based on scientific or technical data. He, along with others, objected to the initial proposal on the grounds that it could harm scientific research.

Another aspect of scientific integrity to which Michaels has directed his energies is what he terms “manufacturing uncertainty.” He contends that both industry and the government undermine science that points to the need for additional regulation by overstating the uncertainty that accompanies all science. By emphasizing the uncertainty and ignoring scientific consensus, those opposed to new or stricter regulations are strengthened in their public positions.

The annual Scientific Freedom and Responsibility Award was established in 1980 and is approved by the AAAS Board of Directors. The recipient receives $5,000 and a commemorative plaque. It is presented annually by AAAS to honor individual scientists and engineers or organizations for exemplary actions that help foster scientific freedom and responsibility. The award recognizes outstanding efforts to protect the public’s health, safety or welfare; to focus public attention on potential impacts of science and technology; to establish new precedents in carrying out social responsibilities; or to defend the professional freedom of scientists and engineers.

The American Association for the Advancement of Science (AAAS) is the world’s largest general scientific society; it serves 262 affiliated societies and academies of science, reaching 10 million individuals. It also publishes the journal Science, which has the largest paid circulation of any peer-reviewed general science journal in the world and an estimated total readership of 1 million.

The awards will be presented 18 February at the 2006 AAAS Annual Meeting in St. Louis, Mo.

Science Editorial Attacks Bush Gag Rules for Scientists

Science editor Donald Kennedy, who once served as FDA commissioner, has lashed out at the Bush administration's crude attempts to silence scientists. A hard-hitting editorial lambasted them for attempting to silence global warming proponents at the National Oceanographic and Atmopshere Administration and the National Aeronautics and Space Administration. It concludes:

"These two incidents are part of a troublesome pattern to which the Bush administration has become addicted: Ignore evidence if it doesn’t favor the preferred policy outcome. Above all, don’t let the public get an idea that scientists inside government disagree with the party line. The new gag rules
support the new Bush mantra, an interesting inversion of Secretary of Defense Donald Rumsfield’s view on war: “You don’t make policy with the science you have. You make policy with the science you WANT.”

Health Care Hits a Gusher

Page A17 of this morning's Wall Street Journal (subscription required) has an interesting chart headlined "Oil Hits a Gusher." It shows that fourth quarter profits for U.S.-based oil companies rose a stunning 66.4 percent over a year ago, and accounted for nearly two-thirds of the entire $20 billion increase for all corporations.

The chart was buried in a story about China's increasingly voracious appetite for oil, which is predicted to continue to push up oil prices. Coupled with today's front page story in the New York Times revealing that the oil and gas industry will reap an additional $7 billion in windfall profits courtesy of the taxpayers, it's enough to give one a headache.

But what also caught my eye was the other really long bar in the Journal chart. Health care corporations increased their profits in the same quarter by 68.5 percent -- two full percentage points more than Big Oil! And that accounted for another 30 percent of the increase in total corporate profits in the fourth quarter.

In other words, Big Oil and Big Health got it all (utilities accounted for most of the rest). Whose profits fell? Telecommunications, Basic Materials, Consumer Goods and Industrials . . . you know, the things people want, but might postpone when their gasoline, heating and health care bills rise exponentially.

So what accounts for this rapid increase in health care profits? Perhaps Big Health will take a page from Big Oil's playbook and blame it on the Chinese.

Schatten's Tangled Web

Administrators at the University of Pittsburgh don’t need lessons from the spinmeisters in the White House when it comes to releasing bad news. First, do it late on Friday so it will appear in the Saturday papers, the least read paper of the week. Then, spin it in the best possible light while burying the most significant findings.

The news in question is the university’s special investigative panel finding that stem cell researcher Gerald Schatten played a key role in writing disgraced South Korean researcher Hwang Woo-Suk’s fraudulent embryonic stem cell paper; that he lobbied Science magazine to publish the paper; that he took cash and research support for his efforts; that he sought an annual retainer for future collaborations; and, in an element of the UPitt report that I haven’t seen reported elsewhere, that Schatten relied on Hwang’s alleged discoveries for his own patent application, while not crediting – if that’s the proper word when the whole thing is a sham – Hwang.

According to the university report released on Friday, the panel of six senior investigators – several of whom “had participated with Dr. Schatten in research projects and in funded grants” – did not find Schatten’s behavior rose to the level of scientific fraud.

They could only reach that conclusion by taking a pretty narrow view of what constitutes fraud. Like many leading researchers in the stem cell field, Schatten is in a scramble for funds to support his lab because of the Bush administration’s limits on embryonic stem cell research, which is one of the more promising areas of this still exploratory field. But that doesn’t explain why he took $40,000 in honoraria from the South Korean scientist, including a $10,000 fee passed to Schatten during a joint press conference announcing their cloning breakthrough.

Nor does it explain his failure to credit Hwang’s work when he filed for his own patent on an aspect of the technology in late 2004 after, according to the report, being in almost daily telephone and email contact and meeting almost once a month throughout the year. Schatten’s patent application “presents claims that likely could not be fulfilled by inventions developed at Magee (the foundation that supported his work with Hwang) alone, but might plausibly be supported by technologies reportedly developed by Dr. Hwang’s group between the filings of provisional and actual patents.”

The University of Pittsburgh report did not address the fact that Schatten in two published papers, one in Science and one in Nature, made no mention of his patent filings. Those non-disclosures clearly violated both journals’ conflict of interest policies.

There is growing concern about the negative consequences of excessive entrepreneurialism at the nation’s premier research institutions. Former Harvard University president Derek Bok’s in "Universities in the Marketplace" and Jennifer Washburn in "University, Inc." document the problems caused when profit-maximizing professors fence off the intellectual commons in a mad dash to patent and commercialize basic science insights. Chief among them: it corrodes the collaborative spirit that is far more important than market motives to furthering science.

The emerging stem cell field is clearly threatened by this commercialization fever. Scientists are years, if not decades, away from making stem cell research useful to patients. The subject of the Hwang-Schatten paper, now exposed as fraudulent, involved the basic step of growing cloned embryonic stem cells in bulk, which will be a key building block of this technology when somebody actually gets around to doing it.

But it is just the first step on the long road to a therapy. Scientists must still learn how to differentiate those cells into the different types that might be useful – pancreatic cells, nerve cells, heart cells or brain cells. Then they must figure out how to successfully transplant them. And then they will have to figure out how to make them in a manner that passes muster at the Food and Drug Administration, that is, in a way that is not only safe, but effective.

Schatten’s self-serving scramble for a patent on a building block of further research (his application didn’t even list his employer, the University of Pittsburgh, as an assignee, suggesting this “star” researcher snagged a pretty sweet deal when he was recruited a few years ago) simply adds to the growing patent thicket that is entangling the stem cell field.

Patent thickets, for those not familiar with the lingo, describe situations where there are so many cross-cutting and competing patent claims that it makes it almost impossible for subsequent researchers to negotiate licenses to conduct the next phase of research. In essence, too many patents taken out too soon in an emerging science produce a classic anti-commons effect.

That may not be fraud. But it’s antithetical to good science. And it sure is anti-social.

Integrity in Science Watch

EPA Ignores Science Panel's Advice on Soot

The Environmental Protection Agency's Clean Air Scientific Advisory Committee blasted EPA Administrator Stephen Johnson’s proposed rule on fine particulate matter, which ignored CASAC's recommendations for tougher rules. A letter signed by panel chair Rogene Henderson of the Lovelace Respiratory Research Institute in Albuquerque and Frank Speizer of Harvard University pointed out that "tens of thousands of lives could be saved each year" if the agency followed CASAC’s advice. Nine Senators led by Ranking Member of the Senate Environment and Public Works Committee, Jim Jeffords, wrote Johnson demanding he base his decision solely on scientific evidence.
 
New York Times Fails To Disclose Researcher's Ties to Antidepressant Makers

A new study published this week in The New England Journal of Medicine showed an increased incidence of lung disease in children born from pregnant women taking antidepressants like Paxil, Prozac, Celexa and Zoloft. While the New York Times report quoted a Food and Drug Administration official calling the results "very worrisome," it countered with study co-author Christine Chambers of the University of California at San Diego, who downplayed the risks. "We don't know for certain that the drugs actually caused persistent pulmonary hypertension, and that if they did, the risk is still low, about one in a hundred," she said. The Times failed to report that Chambers and her co-authors have numerous ties to pharmaceutical firms, including Barr Laboratories, Par Pharmaceutical, Teva Pharmaceuticals, Sandoz, and GlaxoSmithKline, all of which make at least one of the drugs in the test.

BLM Pulls Grad Student's Grant; Rep. Inslee Calls for Investigation

The Bureau of Land Management pulled funding from an Oregon State University graduate student whose study showed salvage logging slows renewal of forests swept by fire. After the BLM claimed Daniel Donato failed to follow the agency's grant rules, Rep. Jay Inslee (D-WA) immediately called for an investigation into BLM's actions, according to the Seattle Post-Intelligencer. Andy Stahl, head of the Forest Service Employees for Environmental Ethics, charged BLM with attempting to suppress science that contradicts White House policies favoring salvage logging. "It sends a chilling message to all researchers. If you don't get the right answer, you don't get the money," Stahl said. Last week, OSU professor John Sessions, who has close ties to the logging industry, called on Science to retract Donato’s paper, which the magazine has refused to do.

Revolving Door: Former FDA Chief Joins Medical Industry Lobbying Firm

Former FDA commissioner Lester Crawford, who resigned last September amid financial conflict of interest allegations, has joined the pharmaceutical lobbying firm, Policy Directions Inc.  The firms clients include the Pharmaceutical Research and Manufacturers Assn., Merck, Altria, Amgen, Genzyme, Baxter and the American College of Neuropsychopharmacology among others, according to the Center for Public Integrity. The Health and Human Services Department Inspector General Daniel Levinson is investigating the circumstances behind Crawford’s sudden resignation two months after receiving Senate confirmation for the agency's top job.

Minnesota Agency Pays Whistleblower to Leave

Minnesota Pollution Control Agency former employee Fardin Oliaei accepted $325,000 to drop her charges against MPCA and resigned from the agency, according to the Minneapolis Star Tribune.  However, Oliaei still claims her research on perfluorochemicals, previously made by 3M Co., was stifled by her superiors, including MPCA Commissioner Sheryl Corrigan.  The chemicals, which are contained in Teflon cookware and other everyday items, persist in the environment and accumulate in human blood.

Cleveland Clinic Patients To Learn More About Physician Ties to Business

The Cleveland Clinic board voted to toughen its conflict of interest disclosure rules in the wake of Wall Street Journal (subscription required) revelations about financial ties between chief executive Delos Cosgrove and AtriCure, a Cincinnati-based heart device manufacturer. Cosgrove failed to inform patients the clinic's venture capital arm, which he partially owned, owned stock in AtriCure, whose experimental devices were being tested on those patients. A spokeswoman said the new rules will include board members, a majority of whom have ties to companies that do business with the Cleveland Clinic. Separately, heart specialist Eric Topol, a frequent critic of physician ties to industry, resigned from the Clinic to join nearby Case Western Reserve University.

24-Year-Old College Dropout Resigns Post At NASA

George C. Deutsch, White House-appointed public affairs officer for NASA, resigned this week after weblogs revealed he lied about having graduated from college. The New York Times on Jan. 29 revealed Deutsch blocked reporters from interviewing a leading climate researcher at NASA, claiming his job was "to make the President look good." This imbroglio is just the latest instance of White House attempts to suppress science with which it disagrees, and drew widespread editorial condemnation across the country.

GM's Woes Bode Ill for All Americans

It’s pretty easy to blame General Motors for its declining fortunes in the global car market. When gas prices were low, they took the easy path to profits by churning out gas-guzzling SUVs, which escaped the fuel efficiency standards by masquerading as light trucks. They ignored hybrid technology and instead focused their technologists on pie-in-the-sky hydrogen vehicles, which are decades (if ever) away.

But yesterday’s decision to slash pensions and health care benefits for GM’s retirees and salaried workers, following similar cuts for unionized workers, bodes ill for all Americans. The employer-based system that the public has relied on to provide these benefits since World War II is collapsing.

In recent months, bellwether companies like GM, IBM and Verizon have joined the thousands of U.S. corporations, whether headquartered in Silicon Valley or Bentonville, Ark., which no longer provide guaranteed pensions and health care for their employees. Instead, they are turning to a system that provides individual retirement accounts in the form of 401(k)s and capped health care insurance plans supplemented with individual health savings accounts.

In the world that has been slowing arriving over the past two-and-a-half decades, it is every man/woman for him/herself. And if conservatives can get their way on school vouchers, they’ll extend the new social insecurity into childhood.

There is something deeply American about this urge to go it alone. Huck Finn striking out for the frontier, and all that. But it is radically at odds with how the rest of the world is dealing with globalization.

The easiest example to cite is Japan, whose Toyota Motors yesterday declared a huge increase in profits and will soon become the largest car company in the world. In Japan, the government pension program (the equivalent of Social Security) picks up a far larger share of retirement income and Toyota workers enjoy the benefits of a national health insurance program.

Today’s Wall Street Journal front page story on the collapse of pension programs in the U.S. carried some useful comparisons. “Employer pension plans are far less significant in continental Europe, and health-care costs are lower in nearly every other country. . . Health-care systems in some countries, such as the United Kingdom and Canada, are financed through general tax revenue. In Germany and several other European countries, all employers and employees pay for health care through a payroll tax. The per-person health-care tab is smaller, and the systems provide universal coverage,” the business paper of record reported.

But here, employers and the Republican-led government are opting for a system that embraces individual risk sold to the public as individual choice. You get to choose what health care coverage you want or need. You get to manage your own retirement investments. Woe unto you should you bet on a dot.com, or a GM. And if you decided to skip going to the doctor for a pain in your side in order to save your health savings account for a rainy day, too bad. That cancer is too far gone to treat.

This emerging social system will create winners and losers, something that America has been very good at over the years. Some people will do well and others will do without. The number of people without health insurance will continue to rise. The number of people in poverty in their old age also will rise, a reversal of a 50-year trend.

In the early 1980s, somebody applied the tag “me generation” to the Baby Boomers. The leading edge of that generation is turning 60 this year. The two men it has sent to the White House so far – Presidents Clinton and Bush II – have been the architects of this anarchic social system, or at least allowed its imposition by corporate America unchanged and unmitigated.

Unless a new political force emerges soon to counter its ill-effects, our children will inherit a brave new world, one marred by social inequality, social insecurity and a void where concern for the common good should be.

Diagnosis: Is WaPo Health Section Bipolar?

Last week, I took the Washington Post health section to task for running a top-of-the-fold story about cosmetic surgery that featured photographs no different from a cheesy ad. This week, the section features an excellent top-of-the-fold piece about health charities like the American Diabetics Assn. that are in bed with the drug industry. I'd like to think they were feeling guilty about last week's story, or heard so much criticism that they had to respond. But today's article was written by a freelancer funded by the Fund for Investigative Journalism, so it must have been in the works for quite a while. Maybe the section is bipolar.

But I wouldn't take drugs for the condition if I were one of the editors. I'd simply elimate the flubs. (They can always call me up if they want talk therapy at no cost.) As for this week's excellent story by freelancer Tinker Ready, you can find it here. Let's hope it's not a manic episode but the establishment of a new normalcy.

AIDS Drugs and the End of the Plague

A few years ago, I engaged in an online back-and-forth with Andrew Sullivan, a conservative writer and blogger, about the cost of drugs and pharmaceutical innovation. My view, of course, is that they are not related. He took the opposite point of view. We even appeared on a panel together sponsored by the New Republic.

It would be easy to say he was in the back pocket of the drug industry, but if you knew his background, you would realize that isn't the case. Andrew is HIV positive and penned a famous article in the New York Times magazine shortly after the protease inhibitors became FDA approved in the winter of 1995-96 that was headlined, "When Plagues End." The point of the article was that the arrival of PIs allowed triple cocktail therapy (now called HAART for highly active anti-retroviral therapy) to save lives, thousands of lives. The anecdotes in his article were about young men who literally got up off their death beds as their immune systems recovered.

The triple cocktail didn't cure AIDS. But it did and does enable infected people to keep the virus in check. And that is life saving.

The reason why I am bringing all this up is that the morning papers bring news about an NIH-funded trial showing that stopping HAART intermittently carries a small but distinctly higher risk of mortality. This is a grave disappointment to AIDS patients who suffer terrible side effects from the drugs, not just the complicated and never-ending regimens, but disfiguring lipidystrophy where the body's fats get redistributed in all the wrong places. No wonder people want off the drugs.

Moreover, I have received several emails in recent days and had lunch with a physician who articulated a theory that appears to be coming back around: that AIDS drugs have nothing to do with controlling this disease, that the HIV (human immunodeficiency virus) doesn't cause AIDS, and perhaps lifestyle factors are the reason for immunosuppression.

Well, it's all hogwash. I suppose the drug companies have no one to blame but themselves for the steady reappearance of these theories. They charge ridiculously high prices for drugs that were largely the result of government research and public sector investment (read chapters four through six in my book for the entire story). People who get angry about that fact can become irrational.

Why do I say irrational? Well, to answer one writer, I decided to go back into the data about AIDS deaths. As you look at this chart below, think about this timeline. The protease inhibitors went into clinical trials in 1992-93. They went into their third stage (final) proof of efficacy trials in 1994. Deaths from the epidemic were at a peak in those years and climbing skyward. People were clamoring for the new drugs. And as soon as they got them, the death rates began to decline. By the time they were approved in late 1995/early 1996, huge numbers of people who might have been dying at that point were in "compassionate use" programs set up by the drug companies to provide the still experimental drugs in combination with other approved drugs. It was saving their lives.

If you don't believe it, here are the numbers, drawn straight from the Centers for Disease Control mortality statistics website:

AIDS Public Information Data Set
YEAR Number
Before 1982 154
1982 . . . 584
1983 . . . 1,940
1984 . . . 4,250
1985 . . . 7,954
1986 . . . 12,558
1987 . . . 20,624
1988 . . . 29,582
1989 . . . 32,072
1990 . . . 38,972
1991 . . . 40,358
1992 . . . 41,177
1993 . . . 76,428
1994 . . . 50,436
1995 . . . 37,633
1996 . . . 25,862
1997 . . . 17,273
1998 . . . 11,599
1999 . . . 8,549
2000 . . . 2,926

Is Access to Health Care a Right?

This post appeared over the weekend OnTheCommons.

There is ample reason to worry about the 45 million Americans who don’t have health insurance. The uninsured postpone dealing with health problems until they are serious, when they are the most difficult and most expensive to treat. The uninsured often seek care in emergency room settings, which is the most expensive way of providing health care.

Everyone pays when people don’t have health insurance. In the narrowest sense, everyone pays because treating the uninsured that way shifts the costs to the insured, thus driving up everyone else’s costs. But everyone also pays in broad, social ways. People without health insurance tend to be sicker and less productive citizens, which reduces society’s overall economic well-being. And to the extent that children grow up without access to vaccinations, treatments for minor infections and routine monitoring of their development, the cost of the uninsured is passed along to future generations.

I don’t know anyone from either side of America’s ideological divide who would argue that the nation wouldn’t be better off – physically, economically, and spiritually – if everyone had health insurance that provided access to the health care they need. There is a consensus that the universal provision of health care, like education, employment and housing, is wholly beneficial.

Indeed, it is their universality – or at least our desire that they be made universal – that makes health care, employment, housing and education as much a part of our social commons as our desire to preserve clean air, fresh water and a sustainable natural environment.

Yet unlike housing or employment, there has never been a law proclaiming universal health care as a goal or a court decision claiming it as a right. During the Carter administration, the nation declared it federal policy to promote full employment. This commitment has been largely ignored during the tenures of the last two Federal Reserve Board chairmen, Paul Volker and Alan Greenspan. But it exists, and any close reading of the semi-annual presentations Fed chairmen make to Congress (the Humphrey-Hawkins Full Employment Act requires those presentations) shows they honor that commitment by discussing inflation and economic growth in terms of generating full employment. (An aside: In the wake of Friday’s announcement that unemployment had fallen to a four-year low of 4.7 percent – remember the 3.9 percent unemployment rate at the end of the Clinton years? -- it will be interesting to see how “straight-shooter” Ben Bernanke handles the jobs question when he testifies before Congress on February 15th.)

If you live in a city with homeless people roaming the streets or have seen some of the sprawling trailer park slums outside some of our Sunbelt metropolises (and not just the ones filled with New Orleans evacuees), you might wonder about America’s commitment to adequate housing. But it’s there in law: the 1949 Housing Act. While that law was responsible for many of the nation’s most poorly designed public housing projects, it opened by declaring that it is U.S. policy to promote decent housing for all its citizens.

Education has never been a federal obligation. But every state constitution – I believe it is universal but someone can correct me if I’m wrong on this one – includes a clause making it the duty of the state to provide an equal and adequate education for all its citizens. These clauses, in place for over a century, have been the basis for numerous public school financing lawsuits where the plaintiffs in property-poor school districts demand equal opportunities compared to those in property-rich districts.

But health care? A year ago, Rep. Pete Stark (D-CA) and Rep. Jesse Jackson, Jr. (D-IL) proposed amending the U.S. Constitution to guarantee health care as a right for every American. It drew just 27 co-sponsors and no attention. But as Stark said in introducing the bill, which he explained as promoting a “common interest”: “Until we can guarantee that all people have the right to equal, high-quality health care through the Constitution, the interests of the people will continue to play second fiddle to the corporate bottom-line.”

I was really hoping President Bush would tout his plan for individual health savings accounts (HSAs) during his State of the Union address last week. Last year’s failed campaign to privatize Social Security did a pretty good job educating Americans about the nature of social insurance and how there are some things in life that we must do together as a society – like providing for a secure income in old age and not leaving that up to the whims of the market.

A loud campaign promoting HSAs would have provided a similar teachable moment for health care. As the public learned more about individualized health care insurance and how that would make the current health care crisis worse, they would be well-primed for embracing the only reasonable alternative: a national health care system that provides universal access to adequate health care.

Alas, President Bush ran away from his own advisers’ HSA proposals. I suspect it didn’t poll well. By week’s end, he was donning wonk robes to tout high technology and science education.

But the health care financing crisis hasn’t gone away. And as the Baby Boomers age, it will only grow worse. The national discussion about how to provide this common good is once again heading to the top of the nation’s domestic agenda.

Integrity Watch

The Center for Science in the Public Interest’s Integrity in Science Project this week launched a new service – Integrity Watch -- documenting the uses and abuses of science. Since I think readers of this blog will be interested in items posted in this weekly mailing, I've decided to cross-post them here.

WHO Excludes ILSI from Panels on Global Food and Water Supplies

The World Health Organization’s executive board voted last Friday to exclude the Washington-based International Life Sciences Institute from WHO committees that set global standards for food and water supplies. The Natural Resources Defense Council, Environmental Working Group, United Steelworkers of America and 15 other health, environmental and union groups complained to WHO last December that ILSI "has a demonstrated history of putting the interests of its exclusively corporate membership ahead of science and health concerns.” Click here to read more.l

Lung Association Teams with Rx Firm for New DTC Advertising Mag

The online newsletter FDA WebReview reports that the German drug company Altana AG and the American Lung Association have teamed up to produce Lung magazine, which will be distributed through doctor offices and to association affiliates. The magazine will carry direct-to-consumer advertising aimed at people with asthma, chronic obstructive pulmonary disease (COPD) and other lung conditions. An Altana-Aventis partnership is currently seeking Food and Drug Administration approval for Alvesco, an asthma drug.

IOM President Claims No Conflicts of Interest in Its Reports

At a presentation on Capitol Hill last week, Dr. Harvey V. Fineberg, president of the Institute of Medicine at the National Academies of Science, claimed NAS science panels issue authoritative reports because they avoid conflicts of interest. He failed to note that Harvard scientist David C. Bellinger, sitting on an IOM committee reviewing mercury risks in seafood, recently completed a study on the subject for the fishing industry.

OSU Professor Attacks Science over Grad Student’s Findings

Oregon State University professor John Sessions, who has close ties to the forest products industry, is continuing his campaign to quash graduate student Daniel Donato's report in Science magazine that showed logging after wildfires slows regrowth. Sessions claims the magazine’s peer review fell short. According to the Portland Oregonian, Science editor Donald Kennedy rejected his petition because “Sessions is aligned with the timber industry” and “Sessions' work is influenced by political views.”

Fish and Wildlife Official Promoted After Manipulating Conservation Data

Jay Slack, former FWS Field Supervisor in Southeast Florida, has been promoted to a top job in the Mountain-Prairie Region. The promotion comes after top FSW officials confirmed Slack ordered employees to deliberately alter scientific data on the endangered Florida panther to make way for development projects. Government biologist Andrew Eller in Kentucky almost lost his job after filing a whistleblower complaint about the deception.

The Necessary and the Insufficient

This month, I'm been invited to be the guest blogger at www.onthecommons.org. So I'll be double-posting in the hopes that many of you will take a look at this project of the Tomales Bay Institute, which describes itself as "a group of outside-the-box thinkers seeking to expand the scope of the possible in American politics and policy." I like the sound of that and I hope you do, too. For now, here's my first post. Future posts will start here with links to the www.onthecommons.org website. Have a peak and enjoy!

It’s going to take a lot more than pouring money into research to protect public goods like the global environment. Once President Bush turned to domestic issues in last night’s State of the Union address (most of the talk was devoted to justifying the ongoing deceit and demagoguery that has marked his administration’s incompetent response to global terrorism), he sounded downright Clintonesque. The cornerstone of his new proposals was a major “American Competitiveness Initiative,” which would double research funding for physical sciences over the next ten years (remember how Clinton doubled the National Institutes of Health’s budget over five years?). Our oil-man-in-chief promised major investments in clean coal, nuclear energy and ethanol. Did I actually hear the president say “switch grass” last night?

But as the New York Times pointed out in a hard hitting editorial this morning, we’re way beyond the research phase when it comes to weaning this country from reliance on foreign oil (which requires weaning ourselves from reliance on oil, period). Ice caps are melting, islands are sinking below the waves, unprecedented droughts are ravaging parts of Africa and the Amazon, and New Orleans is gone. And the President? His eyes are firmly fixed on 2025. Where was the call for raising the fleet fuel efficiency standard to, say, 40 miles per gallon in 2009 (having reported on the Midwestern auto industry for many years, I recognize that a three-year breathing space for retooling is necessary), 50 mpg in 2011 and 70 mpg and 2013?

Research clean coal? This administration has done everything in its power to avoid forcing electric power plants to curb their emissions by installing technologies that already exist. Career enforcement officials like Eric Schaeffer, now at the Center on Environmental Integrity, fled the government because they couldn’t do their jobs.

And how about renewable energy and fuels? This country spends somewhere in the neighborhood of $40 billion to subsidize farmers to grow sugar for soda pop, corn for animal feed and other commodities. Pay farmers to grow switch grass for ethanol and they will come. This isn’t a research question, it’s a priorities question.

The national government has always played a key role in creating the public goods that set the stage for the next phase of the U.S. economy. It sometimes comes in the form of big infrastructure projects like the Erie Canal, the Tennessee Valley Authority and the Interstate Highway System. It sometimes comes in the form of prudent regulation. We have transparent financial markets because of the Securities and Exchange Commission. We have a housing market because of the post-World War II FHA loan program. We have a cleaner and safer environment today because of the 1970s era Environmental Protection Agency and the Occupational Safety and Health Administration.

There is no greater challenge facing America today than becoming a responsible member of planet earth. That means deploying the vast public resources of our government to the task of creating the next generation public good – an energy and transportation system compatible with substantially lower carbon emissions. This research President found time to issue a call for banning embryonic cloning (a direct slap in the face to the stem cell research community), but never once mentioned global warming. That’s all historians will need to know about the content of the 2006 State of the Union address.