Good Wine, Bad Research: Another Big Scientific Fraud Case

The New York Times reports today on another large case of scientific misconduct:

A charge of widespread scientific fraud, involving 26 articles published in 11 journals, was leveled by the University of Connecticut today against Dipak K. Das, one of its researchers, whose work reported health benefits in red wine.

Many of the articles reported positive effects from resveratrol, an ingredient of red wine thought to promote longevity in laboratory animals.

The charges, if verified, seem unlikely to affect the field of resveratrol research itself, because Dr. Das’s work was peripheral to its central principles, several of which are in contention. “Today I had to look up who he is. His papers are mostly in specialty journals,” said David Sinclair, a leading resveratrol expert at the Harvard Medical School.

The significance of the case seems more to reflect on the general system of apportioning research money. Researchers complain that federal grants are increasingly hard to get, even for high-quality research, yet money seemed to have flowed freely to Dr. Das, who was generating research of low visibility and apparently low quality. The University of Connecticut said Wednesday that it was returning two new grants to Dr. Das, worth a total of $890,000, to the federal government.

The agency that granted the funds was the National Heart, Lung and Blood Institute. Renate Myles, a spokeswoman, said in response that scientific misconduct “can go undetected for a length of time even under the most rigorous systems of research oversight and review.”

The investigation of Dr. Das’s work began in January 2009, two weeks after the university received an anonymous allegation about research irregularities in his laboratory. A special review board headed by Dr. Kent Morest of the University of Connecticut has now produced a 60,000-page report, which has been forwarded to the Office of Research Integrity, a federal agency that investigates fraud by researchers who receive government grants.

According to a 60-page summary of the report, Dr. Das’s published research articles were found to contain 145 instances of fabrication and falsification of data. Many involved cutting and pasting photographic images from a type of research record known as a western blot. Because western blots have often been subject to manipulations in the past, many journals require that the images not be altered in any way without an explicit description of the procedure.

Dr. Das did not answer his phone at the university or respond to e-mail.

60 Minutes Exposes "Stem Cell Fraud"

A chilling story here about how the desire for financial gain by could undermine the most important covenant between doctors and the publics.

Conflicts of Interest Allow Water Poisoning by Perchlorate

In 2002, wells were shut down in Bourne, Massachusetts, and homeowners were told not to drink from their taps until they were hooked up to the public water supply.

In 2005, Rialto, California, residents saw their water bills spike 65% as the local water company passed along the cost of a toxic cleanup.

And this past November, a state of emergency was declared as Barstow, California’s water supply was found to be contaminated.

The culprit in each case was perchlorate, a component of rocket fuel and fireworks. It’s been spreading via groundwater plumes for decades, leeching into water supplies in at least 26 states. It shows up in some capacity in nearly all states. Perchlorate is known to inhibit thyroid function, which can lead to a host of health problems, especially in babies.

So EPA chief Lisa Jackson recently announced a plan to start regulating perchlorate. Which is nice.

But why isn’t it regulated already? To answer that, we have to look at where perchlorate comes from. What do Bourne, Rialto and Barstow have in common?

Bourne partially sits on the Massachusetts Military Installation, an EPA Superfund site that has housed aircraft operations since the 1930s and has seen all manner of chemical and fuel spills. It has also been used as an old-munitions explosion site, the Cape Cod Times reported. Rialto is home to a 160-acre area first used during World War II to store ordnance-hauling rail cars, and over the years has been used by defense contractors and fireworks manufacturers. And the Barstow contamination was first discovered by the Marine Corps at its area Logistics Base.

The Feds say 90% of perchlorate is used in a defense/aerospace capacity and is most frequently found at Air Force, Army and Navy installations. In short, the massive cost of any cleanup that would result from federal regulation of perchlorate would fall largely on the Department of Defense and its contractors.

In early 2005, the National Resources Defense Council announced it had documents showing that there was an ongoing, willful attempt by certain government agencies to undermine efforts to address perchlorate pollution.

If there was any one person behind this attempt, it was Ray DuBois, according to the nonprofit Public Education Center’s DC Bureau. As Deputy Under Secretary of Defense for Installations and Environment during much of President George W. Bush’s first term, DuBois constantly questioned EPA strategies that might impact the military’s.

Though it had never mandated maximum perchlorate levels in drinking water, the EPA for years had been issuing provisional reference doses – maximum levels of exposure safe for the average person. In 1992, that reference dose was 4 parts per billion. In 1995, it was updated to between 4 and 18 ppb. In 2002, EPA planned to drastically lower it to 1 ppb. But before it could, DuBois undercut the EPA by asking a National Academy of Sciences panel to conduct its own study, DC Bureau says. The panel’s makeup was decided with input from a number of interested parties. The panel’s result: an updated reference dose of 24.5 ppb.

Two members of that NAS panel, Dr. Richard Bull and Dr. Charles Capen, were shown to have conflicts of interest, both previously having done work for defense contractor behemoth Lockheed Martin, according to California Sen. Barbara Boxer.

The EPA re-examined the NAS conclusion and eventually lowered its reference dose to the current 15 ppb, but, in 2008, the EPA declared it would not regulate perchlorate, because it wasn’t a public health concern.

Despite defense contractors’ continued lobbying of the White House to block any EPA move on perchlorate regulations, as illustrated by a 2009 Greenwire story in the New York Times, the EPA has now reversed course. But government agencies with interests beyond public health continue to have a say. Indeed, the EPA, in its Feb. 2 announcement of its intention to regulate perchlorate, said the process will include receiving input from “key stakeholders.”

This sort of “stakeholder input” can be dangerous, the Government Accountability Office reports, because it may delay the implementation of regulations needed to protect public health. In perchlorate’s case, it’s already been a near 20-year process. But it’s these very delays that the Defense Department and its contractors appear to be banking on.

As DuBois told DC Bureau, “The Defense Department is huge. It has a lot of money. It has enormous power in terms of what the Congress is willing to appropriate to it. If you’re in EPA you can rhetorically say, ‘My god, all we get are the crumbs and DOD gets the wedding cake.’”

Controversial Autism Research Is Deemed "An Elaborate Fraud"

After twelve years of controversy and heated debate, the General Medical Council (U.K.) has retracted an article which linked autism and colitis to the common MMR vaccine. The study, originally published by Andrew Wakefield in 1998, sparked wide-spread panic, and not only in the United Kingdom. Many attribute the last decade’s historic lows in immunization rates to the fear perpetuated by Wakefield’s findings.

Because of its controversial implications, the study (found here) was subject to scrutiny upon its publication. As Fiona Godlie of the British Medical Journal summarized in a recent article condemning Wakefield: “critics quickly pointed out that the paper [Wakefield's] was a small case series with no controls, linked three common conditions, and relied on parental recall and beliefs." Evidence suggests that he also purposely misrepresented children’s medical records (here). The facts seem to speak for themselves, none louder than the fact that Wakefield and his co-authors only chose twelve subjects on which to focus their research. Even to a layman, this is clearly an insufficient population to use as the basis of such a bold claim.

There is no shortage of people who openly dismiss Wakefield and his research. Of his twelve co-authors, ten disassociated themselves with the study offically in 2004. Even the American Academy of Pediatrics weighed in, stating “numerous studies have refuted Andrew Wakefield’s theory that MMR vaccine is linked to bowel disorders and autism. Every aspect of Dr. Wakefield’s theory has been disproven.”

The outcry against Wakefield’s methods re-energized allegations of fraud in 2004 when British journalist Brian Deer began an independent investigation of Wakefield’s research. Deer revisited the standing allegations and also publicized Wakefield’s patents, revealing that the surgeon and medical researcher (by the way, Wakefield's medical background is mainly gastroenterology) planned and filed a patent for a safer measles vaccine during the months before he made his study public. This move may not appear dubious under different circumstances—but considering Wakefield’s research methodology falls short of “rigorous,” the financial incentives seem to be stronger motivation than the research: according to Deer, the patented vaccine is exactly what Wakefield proposed as a safer alternative to the traditional MMR vaccine his research deemed unsafe.

In spite of the evidence against him—which has been verified by numerous medical bodies and experts—Wakefield continues to wage a rather loud and public crusade against his purported persecutors. He has recently published a book (Callous Disregard - Autism and Vaccines: The Truth Behind a Tragedy) and continues to appear on many programs in an attempt to vindicate himself.

People who make their living selling and manufacturing traditional vaccines aren’t the only ones with reason to raise concerns about Wakefield’s study; unfortunately, the real victims of such a scandal could be those with autism. If Wakefield’s research is falsified, insufficient, or misrepresentative, that isn’t—as Wakefield seems to suggest—irrefutable proof that there exists no link between the MMR vaccine and autism; it simply means that one researcher failed to execute research properly. However, Wakefield’s approach to his ‘adversaries,’ i.e. the vilification of (just one example) Brian Deer, the BMC, and those who are trying to ensure that a controversial study is sound, does not feel like a satisfactory replacement for solid research.

Perpetuating under-researched links between common afflictions and victimizing yourself when censured by the medical community only delegitimizes possible real links between the MMR vaccine and autism. It belittles the integrity of everyone involved. More importantly, it detracts focus from where it should be: discovering the underlying causes of autism. Wakefield’s handling of the matter certainly does not seem to take into account the importance of discovering the truth. In this particular case, those that deserve this respect, perhaps even more so than the medical community, are people with autism and their families.

Wakefield’s defense.  

Hauser's Case Becomes More Convoluted

The controversy surrounding Harvard professor Marc Hauser has become more convoluted as Hauser’s defenders speak up, publicly invoking the researcher’s “unimpeachable scientific integrity.” Hauser himself remains silent on the issue—since he is legally bound to keep details of the investigation undisclosed, he can't mount a full-fledged attempt to clear his name.

According to a recent article in The New York Times, Hauser’s most outspoken non-Harvard accuser, Gerry Altmann, has recently backpedaled slightly in his accusations. Altmann—who had previously accused Hauser of fabricating data—now concedes that “laboratory error” could be responsible for the indiscretion that is reportedly the most egregious charge of misconduct leveled against Hauser, a 2002 article published by Hauser and a colleague that deals with rhesus monkeys and their cognitive ability to process language. Altmann says that his confidence in making the claims was bolstered by Harvard’s initial indictment of Hauser; he is now stressing the importance of “due process” in the proceedings against the Harvard professor. 

The specifics of these types of cases are intricate, especially for laymen. Basically, Hauser has been accused of knowingly influencing his students’ lab findings so that their results supported his conclusions. The case in question is a ground-breaking study on rhesus monkey cognition; research assistants in Hauser’s lab maintain that they received very different results than Hauser in certain tests that wouldn’t have supported the professor’s claims. However, some are referring to this as a "technical difference of opinion." David Wade of the Times summarizes the essential difficulty: “The e-mails leaked to The Chronicle of Higher Education were portrayed as an instance of Dr. Hauser pressuring his students to reach conclusions they thought unjustified. But they could also have involved a technical difference of opinion about how to score rhesus monkey behavior, a matter in which Dr. Hauser is trained and the two students were not.”

Hauser’s case is pertinent to many of today’s conflicts in the world of scientific misconduct. Where does scientific expertise take precedence in this case, and who is the final authority when it comes to highly specialized and esoteric branches of science? 

Tom Bartlett of The Chronicle of Education raises a good question about Hauser’s allegedly “untrained” students: “Besides, if they weren’t trained, then why would Hauser let them score experiments in the first place?” Did Hauser think that his expertise allowed him to exercise final judgment in his lab, even if it meant overriding his students’ and fellow researchers’ opinions?

The jury is still out, as it were—but if Hauser is found culpable of misconduct, let’s hope that his motivations get chalked up to an abuse of power rather than his "expertise" lest he give "expertise" a bad reputation.