As academic institutions are getting into an orgy of incestuous relationships with industry, scientists find themselves testing drugs they have invented, sitting on committees approving the drugs and holding financial stakes in companies that stand to profit from them. Dr. Mae-Wan Ho reviews reports on how scientists in the growing 'academic-industrial complex' are endangering lives.
"All over the planet, especially in the majority world to which I belong, crimes are being carried out in the name of scientific and technological progress. Yet every few months conferences like this come together and do little more than discuss their fashionably abstract theories.." .
That sums up the rot in our academic institutions. For decades, the scientific establishment has been blithely hiding behind the façade of 'scientific objectivity' to declare "there is no evidence of harm", to allow corporations to poison people and our planet with impunity. It is now saying the same about genetically engineered crops and medicines. This time round, big money is eating away the soul of science itself.
Two years ago, teenager Jesse Gelsinger died in a gene therapy trial at the University of Pennsylvania. Government regulators cited the researchers for numerous safety violations. The scientist overseeing that trial and the medical centre had financial stake in the therapy tested. The public enquiry which followed concluded that gene therapy has been oversold by the scientists themselves .
But that was just the tip of the iceberg. Here's a litany of misconducts that recently came to light .
Doctors at the Fred Hutchinson Cancer Research Centre allowed a cancer experiment to go on for years, even though patients were dying at a higher rate than with standard therapy.
At least 20 patients died from causes directly attributable to the treatment. The Centre and some of its physicians had financial stake in the treatment.
A University of Pittsburgh scientist funded by several drug companies was accused in a lawsuit of manipulating a study of children's ear infections and contributing to the dangerous overuse of antibiotics.
The FDA reprimanded a Tufts University researcher for improperly treating a cancer patient with a gene therapy that may have caused his tumour to double in size. Both the scientist and a Boston medical centre held large stake in the company developing the treatment.
Society has long relied on publicly funded institutions and universities to research and develop drugs and therapies. But these traditionally independent institutions are teaming up with pharmaceutical and biotech companies and metamorphosing into a monstrous 'academic-industrial complex'.
Academic-industry partnership is not new. In the United States, it goes back to the 1862 federal legislation that created the land-grant universities . But the partnership developed at a greatly accelerated pace with the passage of the Bayh-Dole Act in 1980, which for the first time, allowed universities to patent the results of federally funded research . The Business-Higher Education Forum, a coalition of corporate and academic leaders, and similar groups lobbied to get universities joined up with the marketplace.
Since then, the US Congress has passed numerous other laws to cement university-industry ties, including generous tax breaks for corporations investing in academic research. From 1980 to 1998, industry funding for academic research expanded at an annual rate of 8.1% , reaching $1.9billion in 1997, nearly 8 times the level 20 years ago. Before Bayh-Dole, universities produced roughly 250 patents a year, many never commercialised. But in 1999, more than 120 US research universities filed a total of 7,612 patent applications. Licenses to industry generated $641 million for the universities - and about $40 billion in economic activity overall.
Another factor driving academic institutions into the maws of big business is the cut in public research budgets, which enables corporations to buy up departments and whole institutions for new ideas and prestigious labour at bargain prices.
Postdoctoral fellows earn as little as $15,000 a year working, at times, round the clock. Projects in a university lab typically costs about half what it would at a drug company. And the public has greater faith in research at universities than in private labs.
The Swiss drug giant Novartis is paying $24 million over six years to the University of Maryland's Psychiatric Research Center for access to its brain tissue bank and one of its labs. Novartis came at the invitation of Dr. William T. Carpenter Jr., Director of the Psychiatric Research Center. Carpenter was faced with budget constraints standing in the way of understanding schizophrenia, and approached the company's researchers at a scientific meeting several years ago.
The University of California at Berkeley, similarly, had suffered decades of financial cutbacks when Novartis agreed in 1998 to pay $25 million to be allowed to sift through the research of the department of plant and microbial biology, and license up to about one-third of the research results. Along with that, the company gains the right to sit on a committee deciding on the research of the department.
The company also pays $20 million a year for some research at the Scripps Research Institute in California and over the past decade has paid up to $100 million for research at the Harvard-affiliated Dana Farber Cancer Institute.
Scientists at other institutions are uneasy of such close links to industry. Dr. E. Fuller Torrey, Director of the Stanley Foundation Research Programs in Rockville, says his group shares its collection of about 400 brains with researchers around the world. There's only one requirement: that all research be freely published. He is worried that deals like the one at the Psychiatric Center in Maryland is constricting research.
Many researchers collect consulting fees. The chief of psychiatry at Brown University medical school received more than $500,000 in fees from drug companies in 1998, much of it from the makers of antidepressants he praised in journals .
So many prominent academic researchers serve as paid industry consultants that the Food and Drug Administration, in need of expertise, has to allow them to sit on drug approval advisory committees. Sometimes, half the members of a panel will have a financial stake in the outcome, through ties to the drug manufacturer or a competitor.
Universities in the US still receive most of their money for research from the National Institutes of Health. But drug companies spend about $30 billion a year on drug research and development, and some of that goes to academic labs. Large drug companies spend up to one-fifth of their research dollars at universities; and small biotech companies may do half of their research on campus. At many universities, corporate grants are growing faster than federal support.
Johns Hopkins University has clung onto its independent status for the longest time. It passed up the chance to patent a DNA-testing method that was subsequently turned into a $100 million product by a Bethesda company, but not any more. Today, it is fast becoming one of the nation's most entrepreneurial universities.
Scientists at Johns Hopkins serve as paid consultants and scientific advisers to corporations. The university filed more patent applications in 1999 than all but two other major research centres. It helped launch 18 companies in recent years, and corporate-sponsored research at the medical school has nearly quadrupled in the past decade.
Johns Hopkins is taking a permissive attitude towards its scientists researching products on which they have financial stakes. For example, a senior scientist was allowed to test an experimental vaccine developed by a company he co-founded. Tiny Magnetic Resonance Imaging devices were tested on humans by scientists who invented the devices, developed by a company that the scientists and Johns Hopkins partly own.
Dr. Bart Chernow, then vice dean of research at the medical school, proposed a business partnership to Craig Venter of Celera, the private company that sequenced the human genome, back in 1998. He boasted that Johns Hopkins was "one of the biggest biotech companies in the world", and suggested that the school could supply Venter with blood and tissue samples from some of the 100,000 patients that Johns Hopkins scientists see each year.
"There is this supposed immorality in trying to patent genes and develop new medicines," Chernow said, shaking his head. But Johns Hopkins, he said, had finally recognised that industry was not its adversary but its greatest ally.
On 19 July 2001, the US government ordered a suspension of all clinical trials in Johns Hopkins following the death of a previously healthy 24 year old volunteer in an asthma experiment, for which the University accepted full responsibility. The shutdown lasted 3 days, but 2 200 research protocols will have to be reviewed by ethics board before they can recommence .
The unholy alliance of academia and industry is turning out some high profile science crimes and severely rattling public trust. The situation is so serious that British physicians are proposing the formation of a national panel to handle investigations of misconduct in biomedical research .
Researchers at the University of Alabama at Birmingham carried out tests on cancer patients with a drug they knew to be useless. But they had financial stakes in a company making the drug. The drug, BCX-34, was the first product developed by BioCryst, a biotech company co-founded in 1986 by Dr. Charles E. Bugg, a biochemist at the Birmingham school. Company officials traded 5 percent of BioCryst stock to the University Research Foundation in return for rights to university patents. Within a decade, the company was paying the university more than $500,000 a year for research. Faculty members moved freely between the university and industry.
BioCryst saw BCX-34 as a potential cure for a common skin disease, psoriasis, as well as a rare skin cancer. A dermatologist, Dr. W. Mitchell Sams Jr., a friend of Bugg was paid $2000 a month as consultant in two company-funded studies - one on 22 cancer patients at the Birmingham school, the other on 40 psoriasis sufferers.
As with many drug studies sponsored by the manufacturer, the company retained significant control. Sams provided the patients and oversaw the tests. But the company designed the study and analysed the results.
A lot hinged on BCX-34. BioCryst's losses had risen from $1.3 million in 1991 to almost $7 million in 1994. The drug was the closest thing the company had to a product. Because cutaneous T-cell lymphoma is rare, the FDA could waive expensive large-scale clinical trials if early studies produced striking positive results.
Dr. Harry W. Snyder Jr., a scientist who taught at Cornell University medical school before working in the biotech industry, joined BioCryst in 1993 and was given responsibility for the trial. His wife, Renee Peugeot, a nurse, was hired to assist Sams. Both husband and wife held shares in BioCryst and stood to gain from favourable trial results, but Bugg was unconcerned.
Over the next two years, Snyder and Peugeot falsified the records and made exaggerated claims about the efficacy of the drug.
More than a month before the BCX-34 studies ended in January 1995, Snyder wrote to colleagues, claiming that the drug was working, even though it was supposed to be a blind study and he had no legitimate way of knowing the results. In early January, Peugeot and Snyder bought BioCryst stock, adding to their shares and options. At one point, they owned BioCryst stock and options worth $600,000.
When Snyder's data were analysed at the end of the trial, BCX-34 seemed to have performed impressively. The company issued a news release in early February 1995, announcing that the drug had proven highly effective in treating psoriasis and, more important, the skin cancer.
About a week later, BioCryst told the FDA that the drug had reduced or eliminated the cancer in 59 percent of the patients. The company, it appeared, had found a cure for an incurable disease.
The company's stock shot up - from less than $6 a share at the beginning of February 1995 to nearly $13 some months later. One investor bought $5.5 million worth of newly issued BioCryst stock.
In June, Dr. William J. Cook, hired from the university as BioCryst's medical director and Snyder's boss, decided to write up the scientific paper. He asked Snyder for the key to the blind trials and got a computer printout. Cook calculated the results, and was dismayed to find they did not match those announced in February. He went to the trial co-ordinator for the original key, which was locked up safely, and repeated the calculations. The results were different again. In both the cancer and psoriasis trials, Snyder had made the results appear more favourable for the drug.
The company notified the FDA of the new results, but fell short of charging Snyder.
It took five more years and investigations by two federal agencies to bring Snyder and his wife to book. They were convicted last year of defrauding the U.S. Food and Drug Administration. Sams, one of the nation's top dermatologist, was banned from testing drugs for the FDA. Investors lost an estimated $34 million in the company. The National Institutes of Health accused the UAB of poor oversight and suspended enrolment of patients in 550 studies.
Across the Atlantic, things are no better, and possibly worse. Many fledgling companies in US test their new drugs in Germany to exploit loopholes to save time and cost .
Early in August, the German pharmaceutical giant Bayer was forced to withdraw its anti-cholesterol drug Baycol, with the admission that it might have killed 52 worldwide, with another 1 100 potentially crippled. Germany's health minister, Ulla Schmidt, accused Bayer of sitting on research documenting Baycol's lethal side-effects for nearly two months before the Berlin Government was informed. Bayer claimed it complied with EU rules when it reported the problems to the authorities in Britain where the drug was originally registered
Later in the same month, another case came to light in Germany over human experiments with a fraudulent "cancer vaccine". This vaccine came from a scientist in a prestigious university, who claimed to have discovered it, and was tested on more than 200 terminally ill patients at Gottingen University. It was an outright fake, and many of the first batch of human guinea pigs are already dead.
German scientist Alexander Kugler published a paper two years ago purporting to show that his fused cells had defeated kidney cancer. The crucial evidence was a photograph illustrating the miracle of vanishing cancer cells. There was no other proof, and no one else had duplicated his findings. Dr. Kugler received the prestigious Ernst-Wiethoff medical prize, and his group signed a deal with the German company Fresenius to manufacture and test the vaccine.
But Prof. Ulrich Zimmermann of Wurzburg, a leading authority in this field, had grave doubts from the start. He alerted his colleagues at Gottingen University of "accumulated errors" and "misinterpretations" in Kluger's paper. An investigation followed.
It turns out that the photographic 'evidence' came from the website of a US company, Molecular Probes. Nowhere in the world would this trial have taken place, Fresenius admits. But there is a loophole for "compassionate use". What was conducted was not a clinical trial but a 'healing experiment', claims Oliver Heick, a Fresenius spokesman. These experiments only have to be approved by local ethics committees.
Sams, the dermatologist in the UAB case, left the University and wrote an article for the Journal of the American Academy of Dermatology afterwards, in which he warned that "the very soul of medicine is corroding and eroding at an unprecedented pace." He lamented the medical profession's "convenient and sometimes excessively cozy relationship to ... industry."
"We let it happen. It happened slowly, by a sort of progressive creep," he wrote. "We succumbed to the siren songs of scientific advances, political power and, worst of all, financial success."
Article first published October 2001