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Thread: Science Breaks Down When Cheaters Think They Won’t Be Caught and the story of tainted past of Imclone's CEO

  1. #1
    Senior Member bill j.'s Avatar
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    Science Breaks Down When Cheaters Think They Won’t Be Caught and the story of tainted past of Imclone's CEO

    Science Breaks Down
    When Cheaters Think
    They Won't Be Caught

    Wall Street Journal, Sept. 27

    As long as science is done by humans, there will be science fraud, for scientists are, no less than other mortals, tempted to cut corners, prettify results, look the other way when a colleague makes them look good and snatch at the gold ring of fame and fortune. But here's what I don't get: Why do the institutions that are meant to catch cheats (journals and the rules of scientific collaboration) keep failing us?

    This week, a panel of physicists concluded that Jan Hendrik SchOn of Lucent's Bell Labs had fabricated and falsified data, on molecular transistors, in several papers over four years. (Dr. SciOn says he stands by his results.) And this summer, scientists found that the 1999 "discovery" of a never-before-seen atom-element 118-at Lawrence Berkeley National Lab was based on falsified data. In both cases, collaborators were apparently duped. Although both involved physics, they were reminiscent of the infamous 1980s~biomedi-cal frauds.

    In the Schon case, investigators reached this shocking conclusioh: Except for the provision of materials, "all device fabrication, physical measurement and data processing...were carried out (with minor exceptions) by Hendrik Scion alone, with no participation by any co-author or other colleague. None of the most significant physical results was witnessed by any co-author."

    Have scientists no historical memory? In 1983, investigators found that more than 100 papers and abstracts on genes and heart disease by John Darsee, a rising star at Harvard Medical School, were based on made-up data. The real shock was that Dr. Darsee managed to con dozens of scientists into signing on as co-authors without being familiar with tie work. In 1985, cardiologist Hobert Slutsky of the University of San Diego was found to have falsified data. On 137 papers, he had roughly 90 co-authors, some of whom had no idea they'd been listed. Such scandals were supposed to end "gift" co-authorships. Apparently, the physicists collaborating with Dr. SciOn didn't remember that.

    Neither did the Berkeley physicists. "Some of these senior people are in their 70s or 80s," points out physicist Chris Quigg of Fermilab in Bata~fia, ill. "It looks like they didn't know how to run the program or do the analysis anymore, and were taken to the cleaner" by their young collaborator.

    Physicists used to think that they had some immunity to fraud. "In physics, the important experiments are on systems that are exquisitely simple and highly controlled, so when others try to replicate the results and can t you know something might be wrong," says Marc Kastner, head of the Massachusetts Institute of Technology's physics department. "But living systems are so unpredictable, it's difficult to conclude something's wrong just because you can't replicate a finding." Also, the culture of physics has traditionally leaned toward extreme self-criticism. "We see crazy things all the time and question them," Prof. Kastner says. Reviewers of the SchOn papers did just that, but journal editors overruled them.

    When you think about it, science fraud seems pointless. If the motivation is prestige, then cheating has to produce high-profile results. But those are scrutinized and subjected to replication, a sure way to be caught. If you cheat in some inconsequential way-and with some 30,000 journals publishing millions of papers a year, there's a lot of inconsequential research-you're unlikely to profit. Still, as Martin Blume, editor in chief of the American Physical Society, says, "You still get a publication or thesis out of it, and no one uncovers it."

    Unethical behavior will be always with us, but what's truly disturbing about the recent frauds is the role of journals. Physicists are fuming that Science and Nature were warned not to publish Dr. Scion's problematic papers in 2001. But the two are locked in such fierce competition for prestige and publicity that they may be cutting corners to get "hot" papers. "These were revolutionary findings," physicist Robert Austin of Princeton University says. "Science and Nature should have been very cautious. When journals fail-and they did here-the system breaks down." Editors at both say they published only after thorough review and in good faith.

    Everyone I spoke to says science has way more misconduct than comes to light. Richard Smith, editor of the British Medical Journal, calls'the 30 to 40 annual cases of scientific misconduct in Britain "the tip of the iceberg" and blames the misconduct on "lots of money sloshing around in biomedicine and the fact that you can get away with it for a long time."

    Why don't we hear about more science fraud? Maybe C.P. Snow had it right in his 1960 novel "The Affair." In it, a Cambridge University master says, "Scientific fraud is of course unthinkable; any unnecessary publicity about as near as unforgivable."

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    [This message was edited by Bill J. on Sep 29, 2002 at 11:14 PM.]

  2. #2
    Senior Member bill j.'s Avatar
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    In Waksal's Past: Repeated Ousters

    At Four Prestigious Labs, ImClone Founder Faced Questions About Work

    A Powerful Gift of Persuasion

    By GEETA ANAND, WSJ, Sept 27,2002

    In the world of biotechnology, where sterling scientific credentials are critical to winning investor confidence, Samuel Waksal's bona fides seemed impeccable: a string of research positions at such prestigious institutions as Stanford and Tufts universities and the National Cancer Institute. His decade-long academic career lent credibility to ImClone Systems Inc., the biotechnology company he founded in 1985, and to the dozen other scientific ventures he says he has helped start since then.

    Missing from Dr. Waksal's official resume is that he was pushed out of each of those research institutions for what former supervisors and others say was misleading and, in one case, falsified scientific work. ImClone's board forced him out of the company in May because of directors' increasing anxiety about his truthfulness and legal problems, according to people close to the board.

    Once celebrated as a brilliant immunologist on the verge of launching a revolutionary cancer treatment, Dr. Waksal, 55 years old, stands accused by federal prosecutors of insider trading, his career seemingly in ruins. In December, when~ he learned regulators would soon turn away his company's cancer-drug application, he allegedly tipped off family members who owned ImClone stock and tried to sell his own shares. One of Dr. Waksal's high-profile friends, home-products executive Martha Stewart, is also under investigation for her sale of ImClone stock in December. Dr. Waksal faces additional charges of perjury, obstruction of justice and bank fraud.

    Dr. Waksal has pleaded not guilty and denied all of the allegations. His lawyers have portrayed him as "an accomplished scientist and researcher" who is the victim of circumstantial evidence. The lawyers are negotiating with prosecutors over a potential plea deal that would include a prison term of fewer than the seven to 10 years that the government initially threatened and leniency for his family.

    After repeated attempts were made to obtain comment from Dr. Waksal for this article, a spokesman said yesterday he was unavailable. ImClone's stock price has fallen to less than $9 a share from more than $75 in December, just before Dr. Waksal's world began to fall apart. And the trials of ImClone's cancer drug Erbitux-the object of intense hope by legions of cancer patients-are now in disarray.

    Dr. Waksal says in his resume that he has published more than 50 scientific papers over the years. But by many accounts, his rise in academia and industry stemmed from an unusual ability to talk conceptually about cutting-edge science and an uncanny power of persuasion.

    "Every 100 years, someone like him is born," says Robert Schwartz, a hematologist who supervised Dr. Waksal at Tufts University School of Medicine in the late 1970s and now is a deputy editor of the New England Journal of Medicine. "He's a very persuasive person who can convince you of anything," Dr. Schwartz adds. "Within five minutes, you're begging him to work for you."

    That Dr. Waksal was able to land a series of prestigious positions, despite his dubious record, illustrates a broader problem: Tainted scientists can move from job to job without bosses taking aggressive action to derail them. The fear is that a researcher tarred by a negative job review Will sue for defamation, says William Terry, former head of the immunology branch of the National Cancer Institute at the National Institutes of Health. He hired Dr. Waksal for a temporary research position in 1975 and later decided not to retain him. "Institutionally, we're under the gun to do no more than give [a prospective future employer] the most basic information. It sets up a situation where the bad eggs can move from one place to another with great facility."

    Born in Paris to parents who were Holocaust survivors, Dr. Waksal moved with his family in the early 1950s to Dayton, Ohio, where his father went into the scrap metal business. Young Sam excelled academically, married his high-school sweetheart and went to college and graduate school at Ohio State University.

    Even as a graduate student in .biology in the early 1970s, he caught the attention of top researchers. "We were all struck by the extremely bright graduate student," says Irv Weissman, a Stanford professor who met Waksal during a visit to the Ohio State lab where the younger man worked. In 1974, after a brief stint as a postdoctoral fellow at a scientific institute in Israel, Dr. Waksal landed a choice job at Stanford University, with Dr. Weissman's help.

    At Stanford, Dr. Waksal worked in the lab of Leonard Herzenberg, a prominent scientist who invented a widely used machine for analyzing and sorting blood cells. Dr. Herzenberg recalls his employee as "an absolute charmer" who at first struck him as having "a great scientific mind. Sam is absolutely brilliant."

    But after a series of strange events, Dr. Herzenberg and his scientist wife, Lee, concluded that the young researcher had misled them. Soon after arriving, Dr. Waksal boasted that for research purposes he had obtained a supply of difficult-to-produce antibodies, which are proteins that fight foreign matter in the body. Dr. Waksal said he got the antibodies from the lab of another well-known scientist, Edward Boyse of the Sloan-Kettering Institute, in New York.

    Dr. Herzenberg says he asked Dr. Waksal to share the material with another young researcher who had produced promising results in an experiment using other antibodies. Using Dr. Waksal's antibodies, the other researcher couldn't repro
    duce his earlier results, Dr. Herzenberg recalls. Then, a lab technician reported finding the remainder of the Waksal antibodies spilled in a refrigerator, making it impossible to test them further.

    "I became suspicious," Dr. Herzenberg says. He questioned Dr. Waksal about the origin of the antibodies. "He said they'd been sent to his home at Ohio State and [added], 'I've got the brown wrapper to prove it.' I said, 'Show me the wrapper,' "Dr. Herzenberg recounts. Dr. Waksal couldn't produce the wrapper, Dr. Herzenberg says.

    Dr. Herzenberg says he called Dr. Boyse, who told him he had not provided any antibodies to Dr. Waksal. Dr. Boyse and his wife, Judith Bard, say their records show that their lab did ship Dr. Waksal a batch of antibodies, but four years later, in 1978, after he had left Stanford.

    Convinced Dr. Waksal had made up the entire story, Dr. Herzenberg says he asked the younger man to leave his lab later in 1974. Some time later, Lee Herzenberg recalls, Dr. Waksal called and apologized to her. "He called to say he really didn't mean anything bad by anything he'd done, and he wanted to be friends. He said the story about the wrapper was not true," Lee Herzenberg says. She adds that Dr. Waksal told her he was seeking psychiatric help and had changed.

    Dr. Waksal made arrangements to move to the National Cancer Institute near Washington. Dr. Herzenberg says he warned Dr. Terry of the NCI about the strange experience with the antibodies. But Dr. Herzenberg says he learned that Dr. Waksal denied there had been any problem at Stanford, and Dr. Terry went ahead with the hiring.

    Dr. Terry says he doesn't recall such a conversation with Dr. Herzenberg and suggests that the Stanford scientist may have spoken to someone else at the NCI. Dr. Terry says he can't remember whom he talked to about Dr. Waksal before hiring him, but he says he probably went to scientists at Ohio State who knew the applicant from his student days.

    'Extremely Bright'

    Dr. Terry remembers Dr. Waksal as "extremely bright, articulate, and personable, with a breadth of knowledge on immunology literature." But after Dr. Waksal had held a temporary research post at the NCI for about three years, Dr. Terry says he decided against offering the younger man a permanent job, effectively forcing him to leave. The reason was a disturbing pattern in Dr. Waksal's research. Dr. Waksal was involved in a large number of projects with other scientists, recalls Dr. Terry. "When the critical time carne to deliver his part of the collaboration, there would be a catastrophe of some sort-a tissue culture would become contaminated or the mice would develop an infection and have to be killed," Dr. Terry says.

    In 1977, Dr. Waksal moved to Tufts to work for Dr. Schwartz, the hematologist, whom he had met at a conference. Dr. Terry says he relayed general negative impressions of Dr. Waksal to Dr. Schwartz, even though under the NCI's policy, he was supposed to affirm only that Dr. Waksal had worked there and state the years of his employment. "The fact that I was not prepared to keep him on was known by Bob Schwartz," Dr. Terry says.

    Dr. Schwartz says he doesn't remember such a conversation with Dr. Terry. Dr. Schwartz says that in hiring Dr. Waksal, he relied principally on strong recommendations from two senior scientists who had supervised the younger man during his research in Israel.

    Dr. Schwartz recalls that Dr. Waksal had an almost hypnotic effect on him and that he was eager to have him work in his lab. But Dr. Schwartz says he grew suspicious of Dr. Waksal in the late 1970s, after bumping into Wallace Rowe, a virologist who had worked at the National Cancer Institute at the time Dr. Waksal was employed there. "He told me, 'Watch out for Waksal,' " Dr. Schwartz recalls.

    The warning, he adds, was like "cold water in my face." Suddenly he began to see a pattern to Dr. Waksal's behavior. "He would tell people the results of experiments [he] never carried out," Dr. Schwartz says. In one case, Dr. Schwartz remembers Dr. Waksal saying he had bred a particular type of mouse for use in experiments. After waiting for a long-period to see the mice, Dr. Schwartz says, he finally sent a technician to the breeding room to find them. The technician never found them, and Dr. Schwartz says he concluded "that such a mouse never existed."

    Dr. Waksal, he adds, "had an extra gift of creating an illusion."

    Henry Wortis, a Tufts immunology professor, says he talked often with Dr. Waksal, and he, too, was bowled over by his "imagination, creativity and far-ranging knowledge." But much like Dr. Schwartz, Dr. Wortis began to have questions about Dr. Waksal's research. He seemed to have "difficulties in getting the experiments he participated in done in a timely fashion," Dr. Wortis says. In one collaboration, Dr. Waksal was supposed to produce some cell lines for experiments, but he never provided them, Dr. Wortis says.

    In 1981, Dr. Waksal's brother, Harlan, then a medical resident at Tufts, was arrested and charged with possessing cocaine with intent to distribute. Harlan Waksal, now 49, and chief executive of ImClone, was convicted of cocaine possession the next year in federal court in Miami. But an appeals court threw out the verdict after finding he had been illegally searched.

    Around the time of the arrest, Dr. Schwartz says, the chairman of the department of medicine at Tufts-New England Medical Center, Sheldon Wolff, complained to him that Sam Waksal, who is not a medical doctor, had covered for his brother by seeing patients at the center. Dr. Wolff has since died. Harlan Waksal declined to comment.

    "All of these problems put together made me decide [Sam] Waksal had to go," Dr. Schwartz says. He recalls telling Sam Waksal, "I want you out." Sam Waksal has said in the past that he visited one of his brother's patients but did so only to chat with her.

    In 1982, Dr. Waksal landed at Mount Sinai School of Medicine in New York. He was hired to run an immunology lab by Jerome Kleinerman, the chairman of the pathology department. Dr. Kleinerman has since died. Dr. Schwartz of Tufts says that he didn't warn anyone at Mount Sinai about Dr. Waksal because no one called to ask his opinion. Later, after problems developed at the~ New York school, Dr. Schwartz recalls that "the man who hired and fired him [at Mount Sinai] called to complain. I said, 'Sir, you never asked for a recommendation.'

    At Mount Sinai, Alexandra Bona, a scientist who worked for Dr. Waksal as an assistant professor, says he was friendly and charming. They had lunch twice. "He was young, tall, well dressed," she says. He had good taste, and his office was fashionably decorated, which was unusual at the school, she says.

    But one day in 1985, the Waksal lab imploded, she recalls. Returning from lunch, Dr. Bona found "everyone crying and Sam was out of his mind." He and a few technicians had been asked to leave immediately, she says. The circumstances of his departure were kept secret from her, she says, and she never learned for certain what had happened.

    Mount Sinai says it can only confirm that Dr. Waksal worked in the pathology department in the early 1980s. His file is legally sealed under a confidentiality agreement he reached with Mount Sinai. But a person familiar with the situation says Mount Sinai asked Dr. Waksal to leave because of evidence he had falsified data.

    Dr. Bona'~ husband, Constantin Bona, an immunologist and professor at Mount Sinai, says that before the ouster, he had identified a problem with a paper Dr. Waksal had submitted for publication in a scientific journal. Constantin Bona says Sherman Kupfer, then Mount Sinai's senior vice president of research, had asked him and others to review the paper. "I looked at the results. There were discrepancies," Constantin Bona says. "The results in the end were not the same as the lab books."

    Serious Breach

    Dr. Kupfer confirms that Mount Sinai viewed the discrepancies in the Waksal paper as a serious breach. "Is it lying? Not necessarily. But no scientist will accept it as significant proof of a hypothesis," he says. "It's viewed as misconduct and is dealt with severely."

    Dr. Waksal has said in the past that he had some disputes with people at Mount Sinai but denied he was forced out.

    The year that he left Mount Sinai, 1985, Dr. Waksal founded ImClone to develop new vaccines, among other things. His brother, Harlan, soon joined him as second-in-command at the company. They set up shop in an office building in Manhattan's SoHo district, buying a long-term lease from a bankrupt shoe manufacturer.

    The company, which went public in 1991, struggled until Dr. Waksal met John Mendelsohn, then the chairman of medicine at Memorial Sloan-Kettering Cancer Center. Dr. Mendelsohn, who is now president of M.D. Anderson Cancer Center in Houston, had discovered a potential cancer drug and was searching for a company to bring it to market. Where others were skeptical, he says, Dr. Waksal instantly recognized the potential. "Sam said, 'I want that molecule,' "Dr. Mendelsohn, now on ImClone's board, recalls.

    The drug, Erbitux, became ImClone's leading prospect. Top researchers in the country began experimenting with it and reported encouraging results. Many cancer patients began to pin their hopes on Erbitux being approved for general use.

    By all external appearances, Dr. Waksal had made it big. He counted among his friends and business partners Ms. Stewart and financier Carl Icahn, both of whom invested in ImClone. He became chairman of the New York Council for the Humanities and hosted monthly soirees in his swank Soho loft, where guests were invited to discuss current issues of intellectual interest. Attendees included actress Lorraine Bracco and Stephen Gould, the scientist and author, who has since died. Mick Jagger once performed at a Waksal party.

    While living a lavish lifestyle, Dr. Waksal was borrowing heavily from his companies. In the early 1990s, he borrowed about $300,000 from ImClone, which had just gone public but had no products and little revenue. He paid back the money.

    Two years later, when ImClone was almost insolvent, he borrowed $225,000 from another small company he helped start, Merlin Pharmaceutical Corp. He served as chief executive of Merlin. In 1996, after Merlin had merged with another biotech firm, Somatix Therapy Corp., he still owed the combined company about $200,000, according to Somatix filings with the Securities and Exchange Commission. Dr. Waksal served on Somatix's board. The next year, another firm, Cell Genesys Inc., took over Somatix. Dr. Waksal's loan doesn't appear on any Cell Genesys filings with the SEC. Cell Genesys declined to say whether he repaid the loan.

    Later in the 1990s, encouraging Erbitux test results attracted keen investor interest. In his crowning business achievement, Dr. Waksal persuaded drug giant Bristol-Myers Squibb Co. to invest $2 billion in ImClone in September 2001. In return, Bristol-Myers received some rights to market Erbitux.

    While he was negotiating with Bristol-Myers in the summer of 2001, Dr. Waksal borrowed $18 million from ImClone, with which he bought more of the company's stock and increased the worth of his ImClone stake to more than $200 million. As a result of the unconventional deal with Bristol-Myers, he was able to sell ImClone stock worth $57 million last fall. It couldn't be determined what profit he enjoyed on the sale.

    When the Food and Drug Administration took the unusual step of refusing last December even to review Erbitux, the agency cited significant problems with the design and execution of ImClone's pivotal trial of the drug. A Bristol-Myers scientist told a House subcommittee in June that its review of ImClone's data last year indicated there was some missing evidence on 11 of the 27 patients for whom ImClone had reported positive outcomes. Bristol-Myers
    and ImClone are still working to get Erbitux approved.

    In January, securities regulators began reviewing trading in ImClone shares in the days before the FDA decision was announced in late December. Investigators looked into trades by Waksal family members and certain friends, including Ms. Stewart. Brokers declined to process Dr. Waksal's trades, so he wasn't able to sell before the FDA announcement, according to prosecutors. His family members sold stock valued at a total of about $10 million. Ms. Stewart sold stock valued at about $230,000. All concerned have denied they did anything improper.

    In a March 4 meeting, lawyers for ImClone's outside directors discussed with them an allegation that Dr. Waksal had signed the corporation counsel's signature on a Bank of America Corp. document in connection with a personal loan, according to people close to the board. Later that month, the lawyers told the outside directors that Dr. Waksal had refused to testify before the SEC, contrary to his promise to cooperate fully with all investigations, the people close to the board say. The outside directors decided to ask him to resign, according to the people close to the board.

    In the following days, Dr. Waksal persuaded the board-the Waksal brothers, plus the 10 outside directors-to let him keep his job by promising he would now testify before the SEC, according to the people close to the board. But two months later, on May 21, after learning that the SEC staff had recommended filing a civil fraud lawsuit against Dr. Waksal, the ImClone board pushed him out.

    The board agreed to give him a $7 million compensation package on his way out the door. But ImClone has since sued Dr. Waksal in state court in New York to get the money back. In the suit, the board accuses him of making "deliberately false and misleading statements to the company," indicating he was cooperating with federal investigators. Instead, the suit says, he was destroying documents and computer records, which he has denied.

    On the morning of June 12, Dr. Waksal was awakened by federal agents who, fearing he might flee, blocked the potential escape routes from his apartment. Once inside his loft, the agents arrested him. In August, a federal grand jury indicted Dr. Waksal on the charges of insider-trading, perjury, obstruction of justice and bank fraud.

  3. #3
    Bill, what a sad story.

  4. #4
    Senior Member bill j.'s Avatar
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    Yes, what is really sad is perhaps this cancer drug has some merit and could someday save people. However, its development has been set by years.

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