Sunday, November 11, 2007

Memory Hole (8 November): Mostly about lawyers

Scientific Misconduct Blog Memory Hole: Events of November 8th

Definitions of the day

LAWFUL, adj. : Compatible with the will of a judge having jurisdiction.
LAWYER, n. : One skilled in circumvention of the law.
LITIGANT, n. : A person about to give up his skin for the hope of retaining his bones.
LITIGATION, n. : A machine which you go into as a pig and come out of as a sausage.
(The Devil's dictionary)

23 years ago today: Arthur Rudolph: US hides Nazi crimes

On 8 November 1984 it was reported that Arthur Rudolph imported from Nazi Germany to head the NASA Saturn Program (which led to the moon landing) was known to be an "Ardent Nazi" and a war criminal. He was operator of a slave camp. More importantly, the US knowingly provided cover for him. This is directly relevant to the more specific concerns on this blog - it concerns the role of government in a democracy.
"Papers Show Saturn Rocket Chief Was Called 'Ardent Nazi by U. S.": New York Times, 8 Nov 1984.

The law

14 years ago today: Inventing scientific findings is not fraud say lawyers

On 8 November 1993 the muddle of Scientific Misconduct "rules" reached the outer limits of farce
(Hilts, Philip J. "Science and Law Clash Over Fraud-Case Appeals," New York Times, 8 November 1993).

Procedures of science are designed to ensure the integrity of the scientific record, just as court procedures are designed to make sure that the legal game is played. This is an article about attempts to alter the procedures for deciding whether a scientist is operating within the rules of science. This was the midst of the Baltimore and Gallo "investigations". New rules were put in place by Bernadine Healy when director of the NIH to make lawyers the judge of appropriate science, radically altering the game in retrospect, and leading to these two cases being "lost" (at least legally).

"In the first case before the hearing board under the new rules, Rameshwar Sharma, a scientist at the Cleveland Clinic Foundation, was charged with making false statements in an application to the National Institutes of Health. He wrote that he had done a series of experiments and described the results, when in fact he had not done the work."

By any definition that would constitute research misconduct and a major offense against science, the public, and patients. This is not a game, and it is exactly how patients die.

In his defense, he said that he no intent to deceive but that his statements were 'anticipator writing' because he expected to do the work later. The hearing said this was not misconduct because the Office of Research Integrity could not prove the deliberately false statements were intended to be false. The need to prove intent is part of the new definition. Falsifying results does not constitute intent.

This is lawyers and the "big boys" of science saying that saying that science and honesty don't matter. The muddle began here.

Source: Hilts, Philip J. "Science and Law Clash Over Fraud-Case Appeals" New York Times, 8 Nov 1993


10 years ago today: UK "initiatives" to tackle scientific misconduct

The Journal Science published a bit of reality-free gobbledegook about a November 8th 1997 meeting concerning UK initiatives to "tackle scientific misconduct and fraudulent publication in a more systematic way". There is a disconnect between what folk say and what they fear to do.

Williams, Nigel. "Editors Seek Ways to Cope With Fraud" Science 278 (14 November 1997), p. 1221 [Full report].

Some quotes from the article:
  • A new committee, set up by the editors of nine prominent medical journals called last week for governments to tackle scientific misconduct and fraudulent publication in a more systematic way.
  • Cases are still exposed mostly by chance, and we worry about the scale of the problem
  • "Normal peer review can sometimes identify problems, but sorting through raw data to investigate them can be a miserable business".
  • These incidents were described without revealing names because of worries about libel laws [describing scientific deviations is libel]
  • The meeting backed calls by one of the legal experts on the committee, Ian Kennedy of University College London, for the development of a protocol for editors to help protect genuine whistle blowers.
  • COPE's efforts are being matched by other initiatives in Europe.
  • And at the most recent meeting of the European heads of research councils in Dublin last month, the problem of scientific misconduct was at the top of the agenda.
  • The council heads are looking in particular at Danish efforts that have culminated in a new national committee on scientific dishonesty. Unlike the U.S. Office of Research Integrity, which can investigate misconduct claims only when they involve government funds, the Danish committee can work across the scientific spectrum.
  • Editors can only go so far," says Kennedy. "Eventually you need an independent body to investigate claims fairly.
So what happened ten years later?:

UK research misconduct Hit-Squad announced (UK-PRI)

Self quotation: You should treat any offer of support from UK-PRI in the same way you would treat the offer of fellatio from a crocodile.

The law

8 years ago today: German Professor fakes 80 clinical studies - not a crime

On 8 November 1999 German investigators report that dozens of bogus scientific papers were published by a cancer research professor over 15 years.

The Professor was Friedhelm Herrmann, a leading cancer research specialist. The report states that "at least 80 of his published papers were faked", and "they developed an aversion to using genuine data."

The last sentence of the news report states: "Faking scientific research, however, is not a criminal offence under German law".

Source: German scientist 'faked cancer research', The Guardian, Nov 8, 1999

4 years ago today: Medical journal editors colluding with fraud

On 8 November 2003 there were some choice quotes from a BMJ article: Have editors got their priorities right? (BMJ 327:1113; 8 Nov 2003):

"Journal editors are much more frightened of being sued for libel by academics or drug companies than they are of publishing fraudulent research" Peter Wilmshurst claimed last week.

He said that every time that he submitted an article highlighting research fraud, every word was scrutinised by an army of libel lawyers and the article was frequently rejected.

"I have submitted many scientific articles for publication and many had implications for survival of patients, but no journal has ever asked me to prove that I got the results claimed. This might suggest that medical journal editors are more concerned with the reputations of academics and their institutions than the lives of patients.

"The simple truth is that editors are most concerned with money. Journals are never sued for publishing false results no matter how many patients died. In scientific research they can have the best of both worlds. They are absolved from blame if a study is wrong and gain an improved impact rating if the research is an important advance..."

"I would like to see whether the policies at journals changed if some were sued by patients harmed by implementation of treatments based on their publications."

"I believe that there should be random checks of raw data of work in progress and of submitted work. We know that the use of performance enhancing drugs is common in competitive sports because of enforced drug checks without warning at sporting events and between events. If we did not have these checks we might mistakenly conclude that doping was not common in sport."

"Failure to produce the raw data should be considered the equivalent of failing the inspection and should result in a ban on future research for a specified period and a review of previous research published.

"The code of silence that pervades the medical profession and the research establishment: There is still considerable reluctance to shop another doctor, no matter how dishonest".

2 years ago today: SSRI advertisements not exactly science-based

On 8 November 2005 PLoS medicine published as article titled: "Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature" (Lacasse JR, Leo J 2005 PLoS Med 2(12): e392).

Apparently direct to consumer advertisements for drugs are not exactly truthful. What a surprise. Next episode - the disconnect between the scientific literature and the underlying raw data. Hat tip HCR.

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Anonymous said...

HL Mencken memorably described a judge as "a law student who grades his own papers."

Anonymous said...

Current Depression Medications: Do The Benefits Outweigh the Harm?

Presently, for the treatment of depression and other what some claim are mental disorders, some of which are questionable, selective serotonin reuptake inhibitors are the drugs of choice by most prescribers. Such meds, meds that affect the mind, are called psychotropic medications. SSRIs also include a few meds in this class with the addition of a norepinephrine uptake inhibitor added to the SSRI, and these are referred to SNRI medications. Examples of SNRIs are Cymbalta and Effexor

Some Definitions:

Serotonin is a neurotransmitter thought to be associated with mood. The hypothesis was first suggested in the mid 1960s that this neurotransmitter may play a role in moods and emotions in humans. Yet to this day, the serotonin correlation with such behavioral and mental conditions is only theoretical. In fact, the psychiatrist’s bible, which is the DSM, states that the definite etiology of depression remains a mystery and is unknown. So a chemical imbalance in the brain is not proven to be the cause of mood disorders, it is only suspected with limited scientific evidence.
Norepinephrine is a stress hormone, which many believe help those who have such mood disorders as depression.

And depression is only one of those mood disorders, yet possibly the most devastating one. An accurate diagnosis of these mood conditions lack complete accuracy as they can only be defined conceptually, so the diagnosis is dependent on subjective criteria, such as questionnaires. There is no objective diagnostic testing for depression. Yet the diagnosis of depression in patients has increased quite a bit over the decades.

Several decades ago, less than 1 percent of the U.S. population were thought to have depression. Today, it is believed that about 15 percent of the population have depression at some time in their lives. Why this great increase in the growth of this condition remains unknown and is subject to speculation. What is known is that the psychiatry specialty is the one specialty most paid to by certain pharmaceutical companies for support of their psychotropic meds, as this industry clearly desires market growth of these products, as this objective is part of their nature. Regardless, SSRIs and SRNIs are the preferred treatment methods if depression or other mood disorders that may be suspected by a doctor.
Over 30 million scripts of these types of meds are written annually, and the franchise is around 20 billion dollars a year, with some of the meds costing over 3 dollars per tablet. There are about ten different SSRI/SRNI meds available, many of which are now generic, yet essentially, they appear to be similar in regards to their efficacy and adverse events. The newest one, a SNRI called Pristiq, was approved in 2008, and is being promoted for treatment for menopause. The first one of these SSRI meds was Prozac, which was available in 1988, and the drug was greatly praised for its ability to transform the lives of those who consumed this medication in the years that followed. Some termed Prozac, ‘the happy pill’. In addition, as the years went by and more drugs in this class became available, Prozac was the one of preference for many doctors for children.

Furthermore, these meds have received additional indications besides depression for some really questionable conditions, such as social phobia and premenstrual syndrome. With the latter, I find it hard to believe that a natural female experience can be considered a treatable disease. Social phobia is a personality trait, in my opinion, which has been called shyness, which probably should not be labeled a treatable disease as well. There are other indications for certain behavioral manifestations as well with the different SSRIs or SRNIs. So the market continues to grow with these meds. Yet, it is believed that these meds are effective in only about half of those who take them. The makers of such meds create such conditions besides depression for additional utilization of these types of medications, and are active and have been active in forming symbiotic relationships with related groups, such as providing financial support for screenings for the indicated conditions of their meds- screening of children and adolescents in particular, I understand.

More concerning, however, is the adverse effects associated with these types of meds, which include suicidal thoughts and actions, violence, including acts of homicide, and aggression, among others. While most are approved for use in adults only, prescribing these meds to children and adolescents has drawn the most attention. The reasons for this attention are the off-label use of these meds in this population, yet what may be most shocking is the fact that some of the makers of these meds did not release clinical study information about the risks of suicide as well as the other adverse events related to such populations, including the decreased efficacy of SSRIs in general, which is believed to be less than 10 percent more effective than a placebo. Paxil caught the attention of the government regarding this issue some time ago for hiding such important information, for example, some time ago.
And there are very serious questions about the use of SSRIs in children and adolescents regarding the effects of these meds on them. For example, do the SSRIs correct or create brain states considered not within normal limits? Are adolescents depressed, or just experiencing what was once considered normal teenage angst? Do SSRIs have an effect on the brain development and their identity? Do adolescents in particular become dangerous or bizarre due to SSRIs interfering with the myelination occurring in their still developing brains? No one seems to know the correct answer to such questions, yet the danger associated with the use of SSRIs does in fact exist. It is observed in some who take such meds, but not all who take these meds.

Finally, if SSRIs are discontinued, withdrawals are brutal, and may be a catalyst for suicide in itself, as not only are these meds habit forming, but discontinuing these meds leaves the brain in a state of neurochemical instability, as the neurons are recalibrating upon discontinuation of the SSRI. This occurs to some degree with any psychotropic med, yet the withdrawals can reach a state of danger for the victim in some classes of meds such as SSRIs.
SSRIs and SRNIs have been claimed by doctors and patients to be extremely beneficial for the patient’s well -being regarding the patient’s mental issues where these types of meds are used, yet the risk factors associated with this class of medications may outweigh any perceived benefit for the patient taking such a drug.

Considering the lack of efficacy that has been demonstrated objectively, along with the deadly adverse events with these meds only recently brought to the attention of others, other treatment options should probably be considered, but that is up to the discretion of the prescriber.

“I use to care, but now I take a pill for that.” --- Author unknown

Dan Abshear