A small biotechnology company announcing an exciting new treatment for Alzheimer's disease is now under fire for irregularities in its research results, as several studies related to its work have been withdrawn or challenged in scientific journals.
According to the New York Times, Austin, Texas-based Cassava Sciences announced last summer that its drug, simufilam, had improved cognitive ability in Alzheimer's patients in a small clinical trial, describing it as the first such progress in the treatment of the disease. Cassava later launched a larger test.
The studies began at a time when Alzheimer's is a "hot spot" in recent years for research companies and drug companies, with some drugs receiving FDA approval.
In this case, however, the citizen's report, filed by the law firm about the company, called on the FDA to force Cassava to stop the clinical trials amid allegations that the only academic associate in the craft lab produced data that was inconsistent with the results. from another laboratory.
Let's take the things from the beginning. With the publication of the first "good" findings, all attention was focused on this company.
Attention, stock launches and many billions
The potential of the drug has attracted a great deal of attention from investors, as Alzheimer's disease affects about six million Americans, a number that is expected to double by 2050. So everyone is looking for an effective treatment, which in addition to glory would bring many millions to the creator. Cassava shares jumped more than 1.500% at one point. The company was worth nearly $ 5 billion last summer.
However, many scientists were deeply skeptical of the company's claims, arguing that Cassava's studies were flawed, that its methods were opaque, and that its results were unlikely.
Tests without separate group with placebo
The families of some participants said during the trial that they saw improvements.
Critics, however, noted that the test that reported better memory due to simufilam did not have a placebo group, and argued that monitoring patients did not last long enough to confirm any improvements.
Some experts went further, accusing the company of manipulating its scientific results.
Mistakes, mistakes, mistakes…
In response to the allegations, in December The Journal of Neuroscience published a paper expressing concern about two brain studies by the company's lead partner, Hoau-Yan Wang, a professor at City University of New York. In addition, the magazine's editors also noted errors in the images that accompanied his latest study.
In March, the journal Neurobiology of Aging attached another paper of concern to another publication on Alzheimer's disease, authored by scientists who had worked with the company in its early stages.
The authors "did not find solid evidence of data manipulation with a view to falsifying the results", but went on to list a number of methodological errors. Both magazines have stated that they will wait for further action.
For his part, Dr. Wang did not respond to requests for comment. The university declined to confirm or deny that research was being conducted.
On March 30, another scientific journal, PLoS One, withdrew five works by Dr. Wang after five months of research, saying he had "serious concerns about the integrity and reliability of the results," according to a spokesman for the journal.
Two of the works, written by Dr. Burns, involved a brain protein that targets the Cassava drug.
For their part, the New York Times contacted nine distinguished experts to comment on the scientific background of the Cassava tests.
They all stated that they did not trust the company's methods, the results or even the hypothesis that governs the supposed effectiveness of the drug.
$ 20 million from. Taxable citizens
Dr. Roger Nichols, a neuroscientist at the University of California, San Francisco, said he was particularly outraged that Cassava's work was being funded by taxpayers. In total, the company has received more than $ 20 million from the National Institutes of Health.
"This medicine should not be given to patients. It should never be done. "Never," he said, adding that "the longer this lasts, the more I get angry."
What did the company answer after dozens of complaints
Remi Barbier, the company's founder and CEO, said many of Cassava's critics were rivals and that there were financial interests behind it. He said the allegations of data manipulation were false and noted that short sellers were trying to lower the company's share price.
"They have reached, and continue to reach, unrealistic extremes to stop our progress," Barbier wrote.
"Cassava Sciences' staining effort seems to be endless."
What does this drug- The criticism of a well-known Nobel Laureate
According to Cassava, simufilam restores the normal shape and function of a protein called filamin A, which is deformed in the brains of people with Alzheimer's disease, thus slowing dementia and improving cognition.
But Alzheimer's experts say they do not know of any independent studies that support this hypothesis or explain the results.
"The overall conclusions about Alzheimer's disease make no sense to me," said Dr. Thomas Sudhoff, a Nobel laureate and neuroscientist at Stanford.
Cassava's theories "do not belong to the prevailing trend of the industry and to me they seem improbable and fabricated," he said.
In her documents, Cassava stated that the theory is supported by strong evidence, but in reality, all the evidence appears to come from the same laboratory, said Dr. Lawrence Honig, Alzheimer's disease specialist in Columbia.
From rise to fall
Criticism and recall have tarnished Cassava's reputation. This month the company announced to investors that it had registered only 60 of the 1.750 participants needed for its new Alzheimer's disease test. On Monday, the company's stock traded at $ 25 per share, up from $ 135 last summer.
However, the complaints do not stop there.
In August, two scientists filed a complaint with the FDA through a lawyer citing "serious concerns about the quality and integrity" of Cassava's research.
Its share fell by about 30% after that.
However, both scientists were minority shareholders of Cassava and benefited from its downfall, which degraded the credibility of their report (s.s. citizen report). Both have since left those financial positions.
Concerns from the FDA
The FDA, in turn, rejected the request "solely on the grounds that your requests are not the appropriate subject of such a request," according to its statement.
The Hellenic Capital Market Commission is investigating allegations that the company manipulated the research results, the Wall Street Journal reported.
The National Institutes of Health is also conducting research, Mr Barbier acknowledged.
Finally, Dr. Vaux and other researchers lamented the limitations of peer review on error detection or manipulation, and stated that many scientific journals are reluctant to recall work for fear of being sued or damaging their own reputation.
"It is time for regulators to intervene, as it seems that the peer review process has reached as far as possible," said Dr Hu.
"If the tide has shifted to such an extent that science does not seem to exist, I do not see how clinical trials can proceed."
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