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  1. BitterSweet
    19367.jpg A SCIENTIST who faked research data at a Scottish-based drug development firm has become the first in Britain to be jailed for such an offence.

    Steven Eaton, 47, was working at the Edinburgh offices of US firm Aptuit in 2009 when he falsified test results on medicine the firm hoped would treat disease.

    He was jailed for three months at Edinburgh Sheriff Court.

    Eaton came up with the idea while employed by the firm, which was based at the Heriot-Watt University Science Park.

    He was hoping to generate funding that would allow the drug he was working on to be used on humans.

    Eaton concocted information about the medicine that would persuade Aptuit to let it be used on real-life patients.

    The court heard that if the scam had been successful, Eaton could have harmed the health of cancer patients who took the experimental drug.

    However, bosses at Aptuit became suspicious and reported him to watchdogs at the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA).

    Its investigators found Eaton had been selectively reporting research data since 2003.

    Eaton, of Cambridgeshire, was convicted last month under legislation called the 1999 Good Laboratory Practice Regulations.

    Sentence had been deferred so the court could obtain reports about Eaton's character.

    He is only the second person in the UK to be prosecuted under the law but is the first to be convicted of wrongdoing.

    Passing sentence, Sheriff Michael O'Grady QC said that under the terms of the legislation, a prison term of three months was the longest sentence that Eaton could be given.

    Sheriff O'Grady said: "I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly – you could have caused cancer patients unquestionable harm."

    At the earlier hearing, the court heard how Eaton had manipulated the results of experiments he carried out in his lab at the firm.

    His manipulation ensured an experiment was deemed successful when in fact it had failed.

    When bosses at his firm scrutinised his work, they noticed that it was fraudulent and were forced to stop work on the project Eaton was working on. The court heard that if Eaton's work had passed undetected, patients could have been given the drug and been exposed to an increased risk that the substance was unsafe.

    On Tuesday, defence solicitor advocate Jim Stephenson told the court that at the time of the offence, his client had been working in a stressful environment.

    Mr Stephenson said: "He was under a lot of pressure. He was working long hours. There were also issues in his personal life.

    "Mr Eaton did not benefit financially from this."

    Sentencing, Sheriff O'Grady said the case raised disturbing issues, adding: "Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable."

    Gerald Heddell, the MHRA's director of inspection, enforcement and standards, said he welcomed the conviction.

    "This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health," he said.

    Author: James Mulholland
    Source: HeraldScotland
    Date: April 18, 2013
    http://www.heraldscotland.com/news/...-for-falsifying-results-of-drug-test.20825663

Comments

  1. MadOne
    What an evil person ! 3 months in jail is far to lenient for him 3 years would be far more suitable.
  2. Boltzmann
    Whoa, whoa, whoa! While scientific dishonesty is absolutely unacceptable, the scientific community itself would already completely blacklist him and make him unemployable. That is sufficient punishment, IMO.

    At the same time, it's important to understand that the insane amount of hoops that must be navigated for the drug approval process is prohibitively rigorous, preventing many important and potentially useful drugs from making it to patients. One might see the desire to fast-forward the process being primarily from a desire to do good.

    "Prima non nocere" is the oath taken by doctors, not by scientists. Interesting when those who haven't taken the Hippocratic Oath start affecting health administration.
  3. Alien Sex Fiend
    sux to be him
  4. Gradient
    Falsifying data in academia is one thing, but falsifying data in industry is an entirely different creature. In academia - you're largely just ruining your own career, and wasting the valuable time and money of others.

    In industry, however, you can likely cause physical harm to other humans - which may indeed deserve legal intervention in my opinion. Consider a prosecutor falsifying evidence at a trial; the implications of such dishonesty do more than waste time and money.
  5. Boltzmann
    There was the big (recent) transcriptome-based Duke scandal where improper use of methods resulted in patients receiving the wrong medications. Institute of Medicine had to do a massive rehaul of accepted procedures. Those involved lost their careers, but only fining of the university and firing of the staff resulted. I don't see how this is any different.
  6. Gradient
    I'm not familiar with this event - but the difference appears to be intentionally falsifying data in the Scottish case above, compared to negligence in this Duke case. Ethically, these are two different actions.

    Additionally, Duke does not benefit in the same ways that a pharmaceutical company does from false supportive evidence - even if they've agreed to perform preclinical trials on behalf of a company. Sure, grants may be awarded - but it's not equivalent to a pharmaceutical company generating bogus evidence internally to support the translation of a drug from bench to bedside that they directly profit from.
  7. Boltzmann
    There was plenty of financial investment for those involved. Fraud in cancer care for falsifying data. That's not negligence. Notice this quote: "They and Duke stood to make a fortune."

    CBS Article

    February 12, 2012 7:03 PM
    Deception at Duke: Fraud in cancer care?

    Chemotherapy can be a tough road for people with cancer, often debilitating and even dangerous. Which is why five years ago, when Duke University announced that it had an advanced, experimental treatment that would match chemotherapy to a patient's own genetic makeup, it was hailed as the holy grail of cancer care. The scientist behind the discovery was Dr. Anil Potti, and soon Dr. Potti became the face of the future of cancer treatment at Duke, offering patients a better chance even with advanced disease. However, when other scientists set out to verify the results, they found many problems and errors. What our 60 Minutes investigation reveals is that Duke's so-called breakthrough treatment wasn't just a failure -- it may end up being one of the biggest medical research frauds ever.

    The following is a script of "Deception at Duke" which aired on Feb. 12, 2012. Scott Pelley is the correspondent. Kyra Darnton, producer.

    Five years ago, Duke University announced it had found the holy grail of cancer research. They'd discovered how to match a patient's tumor to the best chemotherapy drug. It was a breakthrough because every person's DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke's innovation.

    In 2010, we learned that the new method was a failure. But what isn't widely known, until tonight, is that the discovery wasn't just a failure, it may end up being one of the biggest medical research frauds ever - one that deceived dying patients, the best medical journals and a great university.

    [Dr. Anil Potti: Duke has made a commitment to fight this war against cancer at a much higher level.]

    Dr. Anil Potti, featured in this commercial for Duke University, had made a discovery that promised to change the face of medicine.

    [Potti: Genomics will revolutionize cancer therapy. It actually identifies a fingerprint that's unique to every individual patient.]

    Dr. Rob Califf: This is sort of like the holy grail of cancer.

    Dr. Rob Califf is Duke's vice chancellor of clinical research.

    Scott Pelley: Was the idea here that this would change the way we thought about treating cancer?

    Califf: Well, you've never seen such excitement at an institution, and it's understandable.

    It wasn't just Duke that was excited. A hundred and twelve patients signed up for the revolutionary therapy. Hope was fading for Juliet Jacobs when she learned about it. She had Stage IV lung cancer. And this would be her last chance.

    Walter Jacobs: She was my best friend, but that's kind of cliche. She's, she's somebody who after 49 and a half years, I was still madly in love with.

    She and her husband Walter were looking into experimental treatments. They had to choose carefully because there was only time for one.

    Scott Pelley: When you met Dr. Potti, what did you think?

    Jacobs: We felt that he was going to give us a chance. He was... He was very encouraging.

    For a patient with no time, Dr. Potti's research promised the right drug, right now.

    Pelley: Fair to say Potti was a rising star at Duke?

    Califf: Potti was one of our most important rising stars.

    A lot of people were pleased that it was Dr. Potti who made the discovery of a lifetime. Born in India, he was known as an earnest, modest, hardworking Rhodes scholar, who did research at the University of North Dakota before reaching Duke in 2003. He was a young man with a big idea, which he explained in an interview for Duke.

    [Potti: And that's the goal, is to...is to be able to tell a patient with cancer that I'm not just a cancer doctor, I'm here to treat your particular cancer.]

    Dr. Potti made the breakthrough in the renowned lab of Dr. Joseph Nevins. The Nevins Lab had built a reputation for important work. Dr. Nevins saw something in Dr. Potti and he chose the young researcher to mentor and support.

    Nevins: Very bright, very smart individual, very capable. He was a very close colleague to many, many people.

    Pelley: And to you.

    Nevins: And to me.

    When Dr. Potti decoded the genetic makeup of hundreds of tumors, the research created huge computer files of data. That data was the underlying proof in research papers under the names of Potti and Nevins that were a sensation in the top medical journals.

    Kevin Coombes: It was going to change medicine. It was gonna change how we treat patients.

    Doctors everywhere were eager to save lives with the new discovery. At MD Anderson Cancer Center in Houston, Kevin Coombes and Keith Baggerly began analyzing Dr. Potti's data to verify his results.

    Pelley: And as you dug into the data, what did you find?

    Keith Baggerly: We started some basic processing, and we noticed some things that were really odd that we just couldn't explain.

    Coombes and Baggerly are experts in the kind of data created in Dr. Potti's research. They emailed their questions to Duke and Dr. Potti admitted a few clerical errors, but he said that new work confirmed his results. Duke moved ahead. Drs. Nevins and Potti applied for patents and started a company to market the process. They and Duke stood to make a fortune. Patients enrolled in the clinical trial so that their tumors could be surgically biopsied to be matched with the best drug. But at MD Anderson, during months of analysis, Baggerly and Coombes kept finding errors that they thought were alarming.

    Baggerly: One of the things that was especially disturbing was that these types of errors happened again and again and again. That was far beyond anything that we'd seen.

    They suspected Dr. Potti had somehow reversed some of the data and that some of the patients could be getting, not the best drug for their tumor, but the worst.

    Coombes: Then you would be giving patients drugs that would definitely not benefit them. So there's clear, potential for harm there.

    Pelley: Exactly the opposite of what this was supposed to be.

    Baggerly: So-- yes. So we wrote them and we said, "This-- this-- this is a big problem."

    Baggerly and Coombes eventually concluded that Duke's holy grail was worthless. But Drs. Nevins and Potti disagreed.

    Pelley: I wonder why, at that point, you didn't say, as the director of the lab, "Look, stop. Too many questions. We have to get to the bottom of this." And put a team together to figure that out.

    Nevins: I didn't feel it ever got to that point. I felt that we had addressed the issues that had been raised.

    But that changed when researchers here at the National Cancer Institute said they too were having trouble with the data. Duke suspended the enrollment of patients and asked an outside review committee to analyze Dr. Potti's discovery. After three months, the review committee concluded that Dr. Potti was right.

    Baggerly: My immediate reaction was an expletive, which I will not repeat here.

    Coombes: We'd gone through the usual channels. We'd written letters to journals. We'd written the article. We'd succeeded in getting the trial suspended, and somebody investigated it. We'd done everything we could.

    Duke restarted the clinical trials. And that's when Juliet and Walter Jacobs sat down for their first meeting with Dr. Potti.

    [Walter Jacobs, audio recording: I'm recording this with your permission.

    Potti: Absolutely. That's a good thing 'cause you're gonna miss a lot.]

    The Jacobs were told, based on the research, that the chances of finding the right drug were approximately 80 percent. Walter Jacobs says no one mentioned that the clinical trial had been suspended because of so many questions.

    [Potti: I will help you. Trust me.]

    Many trusted because Dr. Potti's work had been vindicated. But there was just one more thing - discovered, not by a scientist, but by Paul Goldberg, the editor of a small independent newsletter called "The Cancer Letter." Goldberg got a tip from a confidential source: check Dr. Potti's Rhodes scholarship. It was right there on his applications for federal grants. Trouble was it wasn't true.

    Pelley: You asked him about it?

    Nevins: Certainly I asked him about it.

    Pelley: What did he say?

    Nevins: He said that while it wasn't the Rhodes scholar as we know the Rhodes scholar, it was a fellowship from Australia from a group of Rhodes scholars in Australia. So, a stretch of the truth.

    Pelley: Was that the moment when you realized?

    Nevins: Amazingly, I was still hanging on to the notion of "there must be a good explanation here." This was--

    Pelley: Why were you deluding yourself at that point in time? What is it that you want to believe?

    Nevins: I want to believe that somebody that I had trusted, that was a colleague for the last four, five years, someone that I viewed as a friend, was who I thought they were. And then you're faced with the reality of you've been deceived.

    Fearing that reality, Joseph Nevins, whose own reputation was at stake, reviewed the original data which had justified the clinical trials for 112 patients. Dr. Nevins discovered that when the underlying data disproved Dr. Potti's theory, the data were changed.

    Nevins: It became clear that there was no explanation other than there was a manipulation. A manipulation of the data, a manipulation of somebody's credentials and a manipulation of a lot of people's trust.

    Pelley: Manipulated data? These were not errors?

    Nevins: That's correct, it simply couldn't be random. It simply couldn't be inadvertent. It had to have been based on a desire to make something work.

    Pelley: Is it a close call? Or is it abundantly clear that the data were fabricated?

    Nevins: Abundantly clear.

    Pelley: When you switch the data, the theory is proved. If you put the data back the way it's supposed to be, the theory fails.

    Dr. Rob Califf: The theory's a dud if you put the data back to where-- the way it was supposed to be.

    Pelley: How could that switch happen?

    Dr. Rob Califf: If it happened by chance, it would be roughly equivalent to an asteroid hitting the earth.

    Duke University agreed to tell us this story as a cautionary tale for other institutions. Vice Chancellor Rob Califf is implementing new procedures for Duke and also overseeing the retraction of Dr. Potti's papers from the medical journals, one of the most significant retractions in medical history. He's examining how both a prestigious university and outside investigators missed all the warning signs.

    Pelley: How could they have found nothing wrong, nothing suspicious about the work at that point?

    Califf: They were analyzing a data set that had been prepared by Dr. Potti. So, the data set they got was one that produced the same results that had been seen in our own analyses.

    Pelley: You know there are people watching this interview who are thinking to themselves, "Look, they stood to be wealthy. The university stood to make a lot of money. No one wanted to believe that this research was corrupt." To what extent was that the reason that the warning signs were overlooked?

    Califf: In my view, it was not the money that was the primary driver, it was this great opportunity to help people that was driving people to say, you know, we've got to make this work because it looks so good.

    Pelley: The patients were told that there was an 80 percent chance that precisely the right drug for their tumor would be found. That wasn't true. Do you bear any responsibility for that?

    Nevins: I regret that some of the issues that were raised along the way I didn't recognize earlier, and that this could have been brought to a halt at an earlier time.

    Juliet Jacobs died three months after she entered the clinical trial. Walter Jacobs and eight others have filed suit. In his answer to the Jacobs lawsuit, Dr. Potti says he was "not aware that false or 'improper' information had been included in the research." Duke has apologized for the trials. And even though the patients hoped that they were getting an innovation that could save their lives, Duke says no one was really harmed because all of them received the standard of care in chemotherapy.

    Jacobs: They did not advertise this as a standard of care program, they advertised this as an advanced clinical trial with great results. For what happened to my wife, I have to blame Potti and anyone else associated with him who knowingly promoted a false counterfeit clinical trial exploiting human beings.

    Dr. Potti resigned from Duke. He faces an investigation into research misconduct. He told us, in an email, that it would be inappropriate for him to comment. He wrote, "My primary concern at all times is and will be the care of patients and seeking new ways to treat cancer." These days, he's working as a cancer doctor in South Carolina. And if you look online, you will see that he is celebrated for "his significant contribution to the arena of lung cancer research." The websites were created with the help of an online reputation consultant, perhaps to put the best face on the available data.

    © 2012 CBS Interactive Inc. All Rights Reserved.
  8. Gradient
    Boltzmann - it's fine that there's precedent of scientists falsifying evidence and having their careers ruined without jail time. However, there's precedent for a scientist sentenced to prison in the past for falsifying data as well. See the USA V. Eric T. Poehlman - sentenced to about a year in prison for grant fraud.

    I don't intend to take this discussion in a tit-for-tat direction, however. Our discussion doesn't speak to whether or not penalties should be more severe, now that the line between society and academia is quite a bit more blurred relative to old relationships between the two entities - which is the origin of science as a self-policing discipline.

    100, even 50 years ago, research that was conducted was largely insulated from the public until some deliverable was generated. Funding dynamics were an entirely different creature - and so the incentives to falsify evidence were rather different, and not quite as lucrative. However, now that funding comes from two main sources - the public-funded government and private for-profit entities - the landscape of falsifying evidence is changed in a fundamental way.

    Regardless of the outcome of this Duke case that you've presented, I don't like the fact that the most common outcome of committing the single most immoral crime a researcher can commit is the loss of job prospects and obliteration of academic reputation & career. Yes, science is a largely self-policing discipline - but I would argue that this is an unsustainable structure as funding continues to transition more towards private sector entities. It lends to the growing public distrust in science that we all, as scientists, suffer tremendously from - particularly in times of austerity.

    Perhaps the implications of research in biology are somewhat different than those in disciplines like materials science & physics (though I doubt it), in that experimental data yielded can more directly & immediately influence public health - but I don't think that science, as a discipline, operates sufficiently differently relative to other disciplines that present more concrete consequences for misconduct to warrant a unique penalty structure.

    Maybe I'm being overly harsh, but I don't think that someone who's proven beyond a shadow of a doubt that they are not fit to participate in, or even teach, science - as, at least in biology, ethics and science go hand-in-hand - should be able to sustain rights equivalent to individuals who've not obtained comparable levels of education. In other words: being forced to change careers without serving prison time may not be a severe enough disincentive when amoral individuals perform a sort of risk-benefit analysis of falsifying data.

    In my mind, it's essentially a white-collar crime - so, while it may seem to not be so significant, I think severe legal ramifications may be justified in the most severe cases.
  9. Boltzmann
    Very well-argued, Gradient. It seems to me that a scientist's ego and soul is usually in their work, and to be removed (might it even be exorcism?) from that is a terrifying idea indeed.

    That being said, I think you are right. It's hard to think in other frames of mind - and you do a wonderful job explaining how incorrect some academic attitudes and opinions are. As if being a scientist put one above the law....
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