Journal Fraudulently Retracts Séralini GMO Paper

In a shocking betrayal of any semblance of scientific legitimacy, the pseudo science publishing group, Elsevier, has retracted the seminal Séralini study that clearly documents severe toxicity of Roundup (glyphosate). It’s worse than their publication of 6 faked journals. Can there be a more craven act on the part of a journal publisher?

by the Institute of Science in Society
Original Title: Retracting Séralini Study Violates Science and Ethics

Giles-Eric Séralini, a professor of molecular biology at Caen University, led a toxicological study on GM maize and Roundup herbicide involving 200 rats over a period of two years; it found an alarming increase in early death, large tumours including cancers, and diseases of the liver and kidney. The study, published in 2012 by the journal Food and Chemical Toxicology (FCT) [1], was by no means the first, nor the only one to show adverse health impacts from GM feed or Roundup herbicide (see [2] GM Cancer Warning Can No Longer Be Ignored, SiS 56; and ISIS report [3] Ban GMOs Now for a comprehensive review on the health and environmental hazards of GMOs). It was the latest warning – perhaps the most dramatic – and the most in-depth long-term toxicological study ever done. Significantly, many of the most damaging effects came after 90 days, the officially mandated period of feeding trials for regulatory approval of GMOs.

What followed was a concerted worldwide campaign to discredit the findings, including the appointment of ex-Monsanto scientist Richard Goodman to the newly created post of associate editor for biotechnology at FCT [4]. Soon after Goodman’s appointment, a study by researchers in Brazil also finding potentially harmful effects from GMOs was withdrawn from FCT, but reappeared almost immediately in another journal.

On 27 November 2013, FCT editor Wallace Hayes wrote to Séralini’s team requesting them to retract their paper published just over a year ago on grounds that it was “inconclusive”, not because there was fraud or errors [5]. In fact, the paper was published after peer review by 5 referees – the usual number being 2 or 3 – and the criticisms post-publication answered in full by the team, and appeared in the same journal [6].

The substantive criticisms boil down to two: the Sprague-Dawley strain of laboratory rats used is inappropriate, as it is prone to cancer, and the number of animals for testing cancer is too small. In fact, the study was explicitly aimed not at cancer but at toxicity, for which Sprague-Dawley is the strain most commonly used; and the number of animals, 10 in each group, was in accordance with the OECD guidelines.

The reason the OECD protocol specifies larger groups for cancer testing than for toxicity is that cancer is less common and takes longer to become apparent and is therefore more likely to be missed, i.e. the aim is to avoid a false negative. The fact that excess tumours and cancer was detected even in 10 animals is arguably all the more significant, and may be due to the strong carcinogenic potential of the agents tested (see [7] Excess Cancers and Deaths with GM Feed: the Stats Stand Up, SiS 56). Even though the study was not designed to test for cancer, it would have been totally irresponsible for Séralini and his group not to report what they had found. Equally it is important for the article to remain in the public record for its implications on public health.

As Séralini’s team pointed out, the retraction of their paper is a violation of the international ethical norms as prescribed by COPE (Committee on Publication Ethics) accepted by FCT, as it had been most thoroughly reviewed, and by the clear admission of the FCT editor, absolutely no fraud or error was perpetrated [5]. In contrast, a study published by Monsanto in the same journal in 2004 does contain errors if not outright fraud, basically because the effect of GMOs was not compared with matched isogenic non-GMO controls, while the feed for controls was most likely contaminated with GMOs. That paper should be considered for retraction, but the issue was never even raised.

A day later, a press release was put out by a PR company entitled, “Elsevier announces article retraction from journal Food and Chemical Toxicology” [8], making it clear that the decision came from the highest level, the publishing giant that describes itself as “a global company employing more than 7,000 people in 24 countries,” and “partner with a global community of 7,000 journal editors” [9].

Elsevier is already notorious for having published 6 fake journals sponsored by unnamed pharmaceutical companies made to look like peer reviewed medical journals [10]. It is also the target of a still current boycott initiated by eminent mathematician, Sir Tim Gowers FRS, as a protest by academics against the business practices of Elsevier, especially the high prices it charges for journals and books [11]. So far, 13 974 people from all subjects have signed and pledged they will not publish, referee, or do editorial work with Elsevier [12].

Séralini’s team is standing firm against the retraction, and would resort to legal measures against the journal to protect their rights [5].

The journal and its publisher are operating a double standard in retracting a paper reporting adverse health impacts for which no fraud or error was found, as opposed to one claiming no health impacts where serious error at least is involved. This is not just a blatant violation of publishing ethics, it means conspiring to remove from the public record results that could be of great importance for public health. Furthermore, it is an abuse of science and amounts to corporate terrorism on independent science and scientists. It strikes at the very heart of science and democracy, and the aspiration of scientists to work for the public good.

That is why a group of scientists have drafted an open letter requesting a reversal of the retraction and a fulsome public apology to the authors. Until this is done, we will boycott Elsevier, decline to purchase Elsevier products, submit papers for publication, review papers or do editorial work for Elsevier [13] Open Letter on Retraction & Pledge to Boycott Elsevier. The letter is open for signing by both scientists and non-scientists. Please sign on and forward as widely as possible.

Sources

1. Séralini G-E, Clair E, Mesnage R, Gress S, Defarge N, Malatesta M, Hennequin D, de Vendômois J-S. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology published online September 2012. http://dx.doi.org/10.1016/j.fct.2012.08.005

2. Saunders PT and Ho MW. GM cancer warning can no longer be ignored. Science in Society 56, 2-4, 2012.

3. Ho MW and Sirinathsinghji E. Ban GMOs Now, ISIS, 2013, http://www.i-sis.org.uk/Ban_GMOs_Now_-_Special_ISIS_Report.php

4. “Journal retraction of Seralini study is illicit, unscientific, and unethical”. Claire Robinson, GMWatch, 27 November 2013,

5. “FCT requests the retraction of Prof Seralini’study”, Frédérique Baudouin, CRIIGEN, 29 November 2013,

6. Séralini G-E, Clair E, Mesnage R, Gress S, Defarge N, Malatesta M, Hennequin D, de Vendômois J-S. Answers to critics: why there is a long term toxicity due to NK603 Roundup-tolerant genetically modi?ed maize and to a Roundup herbicide. Food and Chem. Tox. 2013, 53, 461-8.

7. Saunders PT. Excess cancers and death, the stats stand up. Science in Society 56, 4-5, 2013.

8. Elsevier announces article retraction from journal Food and Chemical Toxicology”, PRNewswire, 28 November 2013,

9. At a glance. Elsevier, accessed 2 December 2013, http://www.elsevier.com/about/at-a-glance

10. “Elsevier published 6 fake journals”, Bob Grant, TheScientist, 7 May 2009,

11. “Elsevier boycott gathers pace”, John Whitfield, Nature news, 9 February 2012,

12. The cost of knowledge, 13970 researchers taking a stand, accessed 2 December 2013, http://thecostofknowledge.com/

13. Open letter on retraction & pledge to boycott Elsevier. Science in Society 61 (to appear).

Tagged , , , , , , , , , , , , , , , ,

Why New Antidepressant Brintellix May Be a Killer

Brintellix is being marketed with implications that it’s the best antidepressent yet and that it’s exceptionally safe. What is this based on? Close examination shows the usual smoke and mirrors, and an even closer look points out disturbing indications of potentially devastating and deadly effects—with no indication that it’s better than existing SSRIs, which are known killers.

by Heidi Stevenson

One of the most devastating classes of drugs ever developed is antidepressant SSRIs, selective serotonin receptor inhibitors. Not only can they destroy your own life, but they can also turn you into a murderer. Now, the FDA has approved Brintellix, which may prove to be the worst of them all.

In a press release by pharmaceutical company Lundbeck, the developer of Brintellix[1], it’s admitted that the cause of depression is unknown. Nonetheless, they cavalierly play with brain chemistry about which they know very little. Making this particular drug potentially even worse than any other SSRI is that it doesn’t limit itself to one or two pathways in the brain. It manipulates a total of 6 receptors!

Although Takeda Pharmaceuticals and Lundbeck, the US distributors, are expecting Brintellix to become a blockbuster drug, the hyped studies that appear to demonstrate both efficacy and safety are far from the full story. In fact, some studies have shown no benefit over placebo whatsoever.[2] It’s apparent from their approval announcement that the FDA did not take studies with negative results into account. They referred to only 6 studies, which the agency states, “demonstrated that Brintellix is effective in treating depression”.[3]

SSRIs

SSRIs do not work as claimed. They interfere with normal brain functioning. They don’t stop depression. Instead, they stop the ability to feel emotions. They result in emotional flatness. Some people may find that beneficial, something of a time-out. But it never resolves the problems that lead to depression, and even interferes with resolution. How can anyone resolve a problem when a drug interferes with their ability to even know that it’s there?

All SSRIs do the same thing. They prevent serotonin, also called 5-HT, from being reabsorbed, as their name, selective “serotonin reuptake inhibitors”, indicates. That hasn’t turned out well. These drugs are now known to cause previously nonsuicidal people to take their own lives without warning. They have also made many people violent and are associated with almost all school shootings.

There is little reason to believe that Brintellix will be more effective than other SSRI antidepressants. In fact, the more SSRIs manage to shut down serotonin production, the more harm they do. The brain works to counter the effect. As Dr. Peter Brennan notes, it can result in permanent brain damage.[4]

In fact, the Los Angeles Time reported that Dr. Michael Thase, a Brintellix development consultant, stated:

It is different enough from the welter of SSRIs currently available that it’s not simply a ‘me too’ drug.[5]

That’s likely true, but does that make it better?

Brintellix May Be Even Worse

Inexplicable violence, turned both inward and outward, is the result of SSRIs causing a single change to brain function. Brintellix will cause several changes! These changes involve the handling of glutamate, which is a critical amino acid that’s required for brain function and cellular metabolism. Glutamate is necessary—at proper levels, in the right places, and at the right times—for learning, remembering, thinking, and emotions. It’s also involved in energy production throughout the body.

Glutamate excites neural function. Too much glutamate can burn nerves out and too little keeps them from functioning properly. Not only does Brintellix manipulate 5-HT (serotonin), like all other SSRIs, it also manipulates glutamate in several neural receptors:

  • 5-HT1A: Agonist
  • 5-HT1B: Partial Agonist
  • 5-HT3: Antagonist
  • 5-HT1D: Antagonist
  • 5-HT7: Antagonist

Note: An agonist triggers a response from a cell. An antagonist does the opposite. It blocks a cell’s response.

Does anyone really know what the effects of this manipulation of neural transmission will be?

No. Here is what the manufacturer’s press release announcing Brintellix’s approval says about it:

The contribution of each of these activities to Brintellix’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.

Let’s look at that again:

No one knows what relationship exists between any of these neural receptors and Brintellix’s effect.

No one knows what these manipulations of the brain will do to the body, intelligence, emotional state, sexuality, criminality, empathy, or anything else.

Nearly all the effects of Brintellix are unknown.

How Much Harm?

Like so many drugs, Brintellix is being rolled out as safe. Like others, that safety is based on a very slim thread: short term studies, which evade the risks. The existing studies produced by Lundbeck are short term, and many adverse effects take time to be seen. They’re also based on a small number of subjects. Most severe adverse effects don’t show up in such studies.

At this point, the list of adverse effects is both brief and appears to be fairly minor. Medscape[6] reports the following adverse effects, followed by the percentage who suffered it:

  • Nausea: 21-32%
  • Diarrhea: 7-10%
  • Dizziness: 6-9%
  • Dry mouth: 6-8%
  • Constipation: 3-6%
  • Vomiting: 3-6%
  • Flatulence: 1-3%
  • Pruritus: 1-3%
  • Abnormal Dreams: Less than 1-3%

These adverse effects are not as innocent as they first appear. Notice that as many as a third of the subjects suffered from nausea, and other gastrointestinal effects were not unusual. This is a red flag that there may be a dangerous adverse effect on the digestive tract that doesn’t show up quickly—not something to take lightly.

Dizziness and abnormal dreams are indicative of very serious harmful neurological effects. Pruritus is a neurologically-induced extreme urge to scratch an itch. This symptom is also indicative of neurological damage. Even at this early stage, the adverse effects point to the potential of severe and dangerous, potentially deadly, reactions.

The history of all other SSRIs, which interfere with only one specific function, has been dismal. Is there any reason to expect Brintellix to be different? The studies certainly aren’t more extensive than they’ve been with other SSRIs, so the reality is that, as usual, the people whose doctors prescribe it will be the guinea pigs.

If your doctor tries to prescribe Brintellix, perhaps the correct response should be, “Oink!”

Even Big Pharma’s faithful lapdog called the FDA has acknowledged some risk. They’re requiring a boxed warning that people younger than 24 years are at risk of developing suicidal thoughts. This, of course, is meaningless. All SSRIs carry that warning, and it certainly doesn’t seem to have reduced prescription levels!

SSRI = Killer

As the FDA admits, all SSRI drugs are known to be killers, and worse than most drugs, they can result in the deaths of people who don’t even take them! They are implicated in virtually all the school shootings. That’s a lot of carnage.

Brintellix is an SSRI. Is there any reason to believe that it will produce less harm than other SSRIs? In fact, there is every reason to suspect the opposite.

By its developer’s own admission, no one knows what effects are produced by 5 of the 6 functions Brintellix was designed to cause. But we do know that the 6th function, serotonin/5-HT reuptake inhibition, is a killer. All of the other 5 functions interfere with normal brain activity—and the manufacturer admits that no one knows what those effects will be!

What more do you need to know?

Sources:

  1. Takeda and Lundbeck announce FDA approval of Brintellix™ (vortioxetine) for treatment of adults with major depressive disorder. Lundbeck’s Brintellix press release.
  2. Antidepressant – vortioxetine. Manufacturer’s Chemist’s review of Brintellix.
  3. FDA approves new drug to treat major depressive disorder. FDA’s Brintellix approval announcement.
  4. Psychiatric drug-induced Chronic Brain Impairment (CBI): Implications for longterm treatment with psychiatric medication; International Journal of Risk and Safety in Medicine; DOI 10.3233/JRS-2011-0542.
  5. FDA approves a new antidepressant: Brintellix; Los Angeles Times.
  6. Vortioxetine Adverse Effects; Medscape Reference.
  7. Vortioxetine (Lu AA21004) hydrobromide.
  8. Glutamate.
  9. Glutamate benefit and side effects, risk and danger.
  10. Vortioxetine: A New Antidepressant Choice in the United States

Tagged , , , , , , , , , , , , , , , , , , , , , , ,