Medical Research FraudHelke Ferrie April 1, 2006
Plagued by Fraud, Corruption and Corporate Greed, Modern Medical ‘Research’ Struggles to Reassert Its Integrity – and Consumers Will Be the Winners In the End
“The Truth shall make you free.” – Gospel of St. John
“The Truth shall make you free – but first it hurts.” – Gloria Steinem
Nicolas Regush, well known for his investigative reporting on health issues for CBC radio and television, wrote the following observation shortly before his death in October of 2004:
“There is no way to be nice about this. There is no point in raising false hopes. There is no treatment or vaccine in sight. There is no miracle breakthrough on the horizon. Medicine, as we know it, is dying. It is entering a terminal phase. What began as an acute illness reached the chronic stage about a decade ago and progression towards death has been remarkably swift and well beyond anything one could have predicted. The disease is caused by conflict of interest, tainted research, greed for big bucks, pretentious doctors and scientists, lying, cheating, invasion by the morally bankrupt marketing automatons of the drug industry, derelict politicians and federal and state regulators — all seasoned with huge doses of self-importance and foul odour.”(Courtesy of Croft Woodruff’s e-mail service: firstname.lastname@example.org, July 23, 2003, originally from www.redflagsdaily.com)
Between December 2005 and March 2006, scandals have erupted in Norway, Korea, the U.S. and especially Canada that not only confirm Regush’s observations, but also raise hope for medicine’s rise from the ashes. The healthiest plants grow in the richest manure. Mainstream medicine is in an uproar, and it’s the most prestigious and most decent people who are doing the roaring. Consider the following four jaw-dropping events:
CANCER RESEARCH SCANDAL
Last Christmas, Camilla Stoltenberg spent Christmas Day catching up on the latest issues of the world’s oldest medical journal, Britain’s famous Lancet. To understand why that would be holiday reading, one needs to know that this woman happens to work for the Norwegian Institute of Public Health. An article in the October 2005 issue by world-renowned cancer researcher Jon Sudboe of Oslo University caught her attention. In it, he claimed the incidence of oral cancer is significantly reduced in patients regularly taking a simple pain killer (ie. acetaminophen, a.k.a. Tylenol, a common over-the-counter pain reliever known to be so toxic to the liver when taken long term, that in some cases liver transplants become necessary.) The patient base used for the research was a group of 908 people and, therefore, impressive.
Camilla Stoltenberg is a scientist, so she also read the super small print at the very end of the article where she found, to her amazement, that these 908 patients supposedly all came from Norway’s national database on cancer. Problem is – that database was not going to open until after Christmas, in January 2006, and therefore could not have been available to this researcher (Camilla happens to be in charge of it).
When she dug further, it turned out that 250 of those patients had the same birthday.
“He faked everything: names, diagnosis, gender, weight, age, drug use. There is no real data whatsoever, just figures he made up himself. Every patient in this paper is a fake,” said Stein Vaaler, director of the Oslo Radium Hospital and a colleague of Jon Sudboe’s. That hospital and Sweden’s Karolinska Institute (which coordinates the annual Nobel prizes) are now investigating Sudboe’s 38 other major studies published on similar topics since 1997. All of them are being reviewed because of their immense potential for harm to people. Cancer research is never just an academic exercise, because its results tend quickly to be put into action, especially if the author is as renowned as Sudboe was, and if the research is published in the Lancet. Getting corrections out to the world’s practising oncologists is of vital importance.
Camilla Stoltenberg also happens to be the sister of Norway’s prime minister. Now, my personal, highly irreverent and unsubstantiated guess, is that the prime minister did not have his political campaigns funded by Big Pharma, because within two weeks, by January 16, Norway’s parliament was already working on a national law that will, when likely passed this fall, make it the first country to criminalize medical fraud.
Until now, proven scientific fraud resulted in disgrace, being fired and unable to ever publish again. Now it’s going to be jail time. Norway’s minister of health takes the view that “there must be no doubt about the quality of our research.” If this approach to fraud is taken in the rest of Europe, as it easily might (given that Norway is part of the European Union), the quality of medical research will improve in ways that makes one’s head spin. (Source: The Guardian, Jan 16, and Nature, Jan. 19, 2006.)
BIOTECH RESEARCH FRAUD
Simultaneously, starting last December, and fully hitting the fan also this January, is another fraud scandal which, in financial terms, is the biggest in science to date. It involves another world famous medical scientist, the Korean geneticist Woo Suk Hwang. He cloned a dog, an Afghan Hound called Snuppy, which made him famous as did the (in)famous sheep Dolly cloned by Scottish scientists. This success allowed Hwang to lead a big, international project: the cloning of human stem cells.
In December it was announced that his claimed success was a “complete and deliberate fake.” Apparently, he also bullied fellow female researchers into donating eggs for this project, and that ethics breach is now also under investigation. The Korean government had funded this effort to the tune of $30 million (USD), and a dozen big-name U.S. scientists backed it with research, prestige, and a few more million dollars.
The biotech companies that stood to gain by this research, had it been real, are still reeling from the impact of this fraud case on the value of their stock. They are now especially worried about Korean government policy. Korea had doubled its spending on biomedical research since 2001, largely due to Hwang’s influence, and now is likely to divert resources to rival research areas. Meanwhile, the many scientists, who had their names added to Hwang’s publication of faked results, are busy trying to clear their names. No fraud in scientific history has cost so much money and damaged so many reputations on three continents. This also means the hope that human cloned embryos could be used in a patient-matched method very soon, to replace damaged tissues and treat genetically anchored diseases, is pretty much on the back burner for now. (Nature, January 5, 12, 16 and 19, 2006.)
BABY FORMULA FRAUD
While Sudboe and Hwang defrauded their governments and raised false hopes for millions of potential patients, two-time Nobel nominee Dr. Ranjit Kumar Chandra of Canada’s Memorial University in Dalhousie, Newfoundland, managed to perpetrate a hoax on three sectors at once — and for a long time as well. First, his false reports on the non-allergenic effects of leading baby formulas deceived consumers who were feeding their babies these products for more than two decades. Second, he accepted a pile of money from several drug companies to fund his illusory research and then literally ran off with it to Switzerland. Third, more recently he produced fraudulent research which misled nutritional medicine with an absurd multi-vitamin study. The scandalous story was expertly produced by CBC television and aired in late January under the title “The Secret Life of Dr. Chandra.”
More specifically, food and pharmaceutical companies in the 1980s were competing for control of the formula market. Nestlé had a product called Good Start, and Ross Pharmaceuticals makes Isomil and Similac. Both wanted to provide research evidence that would show that their product was less likely to cause allergies in babies. Dr. Chandra took money from both and produced completely fictitious studies based on no data at all. He even produced a five-year follow-up study based on no follow-up whatsoever. Memorial University officials put their heads in the sand and did nothing, even though Chandra’s chief research assistant, Marylin Harvey, had blown the whistle on her boss and the British Medical Journal formally requested the university to commence fraud investigations. The BMJ had refused to publish Dr. Chandra’s studies when he would not submit the raw data for verification.
His recent multivitamin scam finally brought everything to a head because it was so weird that it caught the attention of the New York Times. Fraud investigations finally began and resulted in Dr. Chandra skipping off to Switzerland. In this study, Dr. Chandra claimed that by merely taking a daily multivitamin (conveniently his own product) after the age of 65, one would be protected against dementia. His study showed dramatic improvement in memory function in some 96 seniors from St. John’s, Newfoundland. These people supposedly went from being seriously demented to being completely normal within one year. However, Dr. Chandra had messed around with the complicated scoring system required for measurements of memory performance: closer analysis showed that the patients were perfectly healthy at the start of the study. Dr. Chandra’s entire body of work since 1992 is now suspect.
What motivated these fraudulent scientists, each of whom was deservedly famous for his work before he went off the deep end?
The Korean disaster has the feel of corporate pressure to perform. How that pressure has now almost ruined basic research worldwide is described in a fabulous new book by investigative journalist Jennifer Washburn, University Inc., entitled The Corporate Corruption of Higher Education (Basic Books 2005). She shows how universities “increasingly refer to students as consumers and to education and research as products . . . they now spend more on lobbying in Washington than defense contractors do.” Chapter 5 describes how health research is now largely controlled by corporate interests, such as the biotech industry.
Dr. Chandra appears to have been motivated simply by money which he took from anybody willing to pay. Reportedly, he told Nestlé, “Well, you didn’t really pay me enough money to do [the study] correctly.” Personal and corporate greed both have the same effect: the generation of lies. The editor of Scientific American observes in the March issue, that “the increasing cases of fraud in immunology, breast cancer, brain aneurysms, and genetics will probably rise . . . because of the growing financial ties between university researchers and corporations [and] the jockeying for leadership among nations in high-stakes areas such as stem cells; some scientists may feel more pressure to deliver results quickly — even if they have to make them up.”
In the January 12, 2006 issue of Nature, its editor discusses these current as well as past fraud cases and observes, “This will surely leave people asking: if this single cell in the body of science was so malignant, how fares the rest?” That brings us to perhaps the biggest scandal of all, which, however, paradoxically offers hope for medicine’s rebirth.
FAMOUS EDITOR FIRED
On February 20 the Canadian Medical Association’s holding company, in charge of the CMA’s medical journal, fired its editor-in-chief Dr. John Hoey. He appears to have been fired because he supported the medical use of marijuana, criticized Quebec for downsizing its hospital emergency departments, which has resulted in deaths, and for taking on the Canadian Pharmacists Association over the antediluvian behaviour of some of their members with regard to the “morning-after pill”: the Association did not censure pharmacists who would not fill a request for these Plan B pills without asking extremely personal questions about the women’s sexual behaviour — in violation of current privacy laws. Finally, Dr. Hoey also criticized our new federal Minister of Health, Tony Clement, calling him “two-tiered Tony” for his endorsement of privatizing medicine.
In each of these four instances Dr. Hoey was asked to withdraw or substantially change his editorials — an absolute no-no in journal publishing which requires a solid fire-wall between owners and editors. Shockingly, the CMA itself totally wimped out, and instead of supporting editorial independence essential to medical integrity, did nothing. So to their great credit, most of the CMA’s editorial board resigned, as did most of the journal’s staff, as did the next two appointees expected to fill their places. It is anybody’s guess when the next issue of the 95-year old Canadian Medical Association Journal will appear.
The CMAJ is internationally recognized as one of the five leading medical journals in the world, and deservedly so ever since Dr. Hoey became its editor 10 years ago. The other four are the British Medical Journal, the New England Journal of Medicine, Lancet and the Journal of the American Medical Association. Dr. Hoey made the CMAJ the first medical journal freely available on-line, opened the CMAJ to research in nutritional and environmental medicine, relentlessly called Big Pharma and medical researchers’ conflicts of interest to account, and set new international standards and rules in 2004 for research integrity as the president of the Vancouver group (the international association of medical journal editors). Dr. Hoey is a living embodiment of the conscience of medicine. (Treat yourself to Dr. Hoey’s fiery editorials over the past six years, free on-line at www.cmaj.ca)
To the surprise of the forces in corporate medicine undoubtedly happy to see Dr. Hoey go, the editors of the other four leading journals roared and closed ranks in support of him. Dr. Cathrine DeAngelis, editor-in-chief of the Journal of the American Medical Association went through a similar confrontation on editorial independence with Big Pharma and government forces six years ago — and she won, with the result that JAMA has finally become worth reading. On the issue of the firing of Dr. John Hoey, she observed, “If they (the CMA) think they’re going to get any editor worth anything or any editor that anybody would respect, they’re kidding! And if they think anybody in their right mind would send any decent paper there, they’re wrong. They destroyed their journal.” (www.cnews.canoe.ca, March 1, 2006; see also New England Journal of Medicine editorial, March 30, and google The Globe and Mail and CBC for the whole story.)
Retired chief Canadian Supreme Court justice, Antonia Larmer, has been appointed to head a panel charged with sorting out this mess. Whether Dr. Hoey will again lead the CMAJ is unclear, but leading medical editors will not bend. This is finally the beginning of open war declared by the leaders of medicine against corruption. When this controversy is finally resolved, we will all be a lot healthier for it.
J. P. Kassierer, On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health, Oxford University Press, 2005 (Dr. Kassierer was, until recently, the editor of the New England Journal of Medicine; he is a leader in the current battle for research truth and editorial freedom)