- News Home
5 December 2013 11:26 am ,
Vol. 342 ,
Dyslexia, a learning disability that hinders reading, hasn't been associated with deficits in vision, hearing, or...
Exotic, elusive, and dangerous, snakes have fascinated humankind for millennia. They can be hard to find, yet their...
Researchers have sequenced and analyzed the first two snake genomes, which represent two evolutionary extremes. The...
Snake venoms are remarkably complex mixtures that can stun or kill prey within minutes. But more and more researchers...
At age 30, Dutch biologist Freek Vonk has built up a respectable career as a snake scientist. But in his home country,...
Since arriving on the island of Guam in the 1940s, the brown tree snake ( Boiga irregularis ) has extirpated native...
An animal rights group known as the Nonhuman Rights Project filed lawsuits in three New York courts this week in an...
Researchers have been hot on the trail of the elusive Denisovans, a type of ancient human known only by their DNA and...
- 5 December 2013 11:26 am , Vol. 342 , #6163
- About Us
Deja Vu: Second Probe Finds Problems With Hypertension Drug Trials
30 July 2013 3:45 pm
TOKYO—Claims made for the beneficial effects of a leading hypertension drug continue to unravel. A second medical school in Japan has found data manipulation and an undisclosed conflict of interest in a paper resulting from a large clinical trial of valsartan.
The main results of the study, known as the Jikei Heart Study, were published in The Lancet in April 2007. But "the scientific paper is fundamentally flawed, the lack of reliability cannot be denied," concludes an interim report (in Japanese) released today by an investigating committee of the Jikei University School of Medicine in Tokyo.
In a statement distributed at a press conference here, Seibu Mochizuki, the Jikei cardiologist who led the study and was the paper’s corresponding author, wrote "I take full responsibility." He also said that he has requested the paper's retraction.
Valsartan, marketed by Novartis, the Swiss pharmaceutical giant, was originally approved in Japan for the treatment of high blood pressure in 2000. In a postmarketing clinical trial, the Jikei Heart Study followed more than 3000 patients for 3 years with participants taking valsartan or an alternative hypertension drug. In their Lancet paper, the researchers claimed that patients taking valsartan not only saw improvements in their blood pressure, but also had reduced risk of stroke, heart failure, and other cardiovascular complications.
The Jikei investigating committee, however, found that a substantial amount of blood pressure data used for analysis did not match patient records, indicating deliberate manipulation. The report states that this manipulation was not done by anyone associated with Jikei, but occurred during data analysis.
The report also notes that an employee of Novartis Pharma, the Japanese subsidiary, was a member of the research team but his affiliation was not disclosed. The investigators concluded this was "a significant conflict of interest," according to the report.
The report states that "Mochizuki bears a heavy responsibility" as the study’s leader and primary paper author.
But it also notes that the Novartis Pharma employee, who is no longer with the company, was in charge of data analysis. According to the report, the employee met members of the committee and claimed to have had only minimal involvement with the data analysis and never saw the final paper. The committee concluded that the statements of the former Novartis employee “were, on the whole, not credible," the report states.
On 11 July, investigators at Kyoto Prefectural University of Medicine announced finding data manipulation in a similar clinical trial of the benefits of valsartan known as the Kyoto Heart Study. The paper reporting the main findings of the Kyoto Heart Study was retracted by the European Heart Journal in February. Three other medical schools are now investigating valsartan clinical trials.
At a 29 July press conference, Novartis Pharma President Yoshiyasu Ninomiya apologized for the trouble caused to patients, their families, the medical profession, and the public. The company also released a summary of a third-party investigation into the incident based on company records, e-mails, and interviews with key former and current employees. The report notes that one former Novartis employee was involved in five valsartan clinical trials and another former employee participated in at least one of those trials, activities that the company acknowledges were improper. But the investigators could not find any evidence that company employees manipulated data, though the report notes that investigators did not have access to computers owned by the former employees.
A health ministry official tells ScienceInsider that the ministry expects to finalize plans for its own investigation within the next 10 days. Novartis's Ninomiya promised full cooperation with any further investigations.