The world was stunned when evidence of fraud surfaced last month in two major studies in prestigious medical journals on hydroxychloroquine (HCQ), a drug enthusiastically endorsed by President Trump as a cure for Covid-19.
The now-notorious studies claimed the drugs were not only worthless in treating the virus but actually heightened the risk of death.
The two research papers were published in May in the British-based Lancet, and the New England Journal of Medicine (NEJM), world-renowned publications that are considered the gold standard in medical research.
Questions have been raised as to why these publications, known to employ rigorous peer-review policies, missed numerous red flags that even a layman would have spotted.
“The studies were retracted after authors could not verify an enormous database of medical records” on which the studies rested,” the NY Times reported.
The retractions were made in astounding haste, just 11 days after the papers were published, in the wake of a flood of inquiries from medical experts troubled by errors and inconsistencies in the material.
Wholesale retractions, made so swiftly after publication, are unprecedented in the annals of trusted, authoritative medical journals with a reputation for meticulous peer-review, editing and cross-checking.
The study was allegedly based on data analysis of around 96,000 cases of people hospitalized with Covid-19 between Dec 20, 2019, and April 14, 2020, from 671 hospitals worldwide.
The database came from an analytics company called Surgisphere, run by Dr. Sapan Desai, a Chicago-based surgeon and businessman, who also co-authored the studies, the NYT article said. He claimed his firm had stored clinical data from thousands of patients in hundreds of hospitals all over the world.
Based on the data, called “deeply flawed” by the Guardian, the Lancet report concluded that neither hydroxychloroquine, nor its combination with azithromycin or any other drug, works as a cure for Covid-19.
In fact, the authors claimed, the use of these drugs increased heart problems in hospitalized Covid-19 patients, exposing them to a higher risk of mortality.
Both papers were published in May within a few weeks of each other and both had instant impact, making headlines around the world.
Responding to government and media pressure, without conducting its own investigation, the World Health Organization (WHO) suspended its global clinical trials of hydroxychloroquine just two days later. It urged other countries to do the same and sought to ban use of the “dangerous” drug.
Based on the (now discredited) NEJM article, doctors offered reassurance to Covid patients taking common blood pressure medications that they did not have to fear complications from these drugs.
House of Cards Begins to Collapse
The studies in the Lancet and NEJM were conducted under the guidance of Dr. Mandeep Mehra, a respected Harvard professor, and both depended on a huge international database of patient medical records from a tiny U.S. company called Surgisphere.
The medical community became suspicious of the findings cited by Lancet using this company’s data, as multiple health data experts said they had never heard of Surgisphere. It was inconceivable, they said, that people in the medical data industry would not have heard of the existence of such a giant international database.
That company’s huge database now appears to be almost certainly a scam. Critics note that Surgisphere has been unable to explain its data and methodology used in the retracted studies. The study omitted not only names of hospitals but even names of countries in which the partnering hospitals are situated, citing only the continents.
When contacted for verification by the Guardian, leading Australian hospitals all said they had no dealings with a company called Surgisphere.
Casting further doubt on the study’s veracity, several physicians wrote to the Lancet, pointing out that hospitals in Africa from which patient data was supposedly drawn are known to be unequipped with advanced cardiac-monitoring equipment necessary to compute data cited in the Lancet study.
When the Guardian conveyed a detailed list of concerns to Surgisphere CEO Dr. Sappan Desai about the database, the study findings and his medical background, Desai went on the defense.
“There continues to be a fundamental misunderstanding about what our system is and how it works,” he protested. “There is a clear bias toward attempting to discredit who we are and what we do. We do not agree with your premise and I am sad to see that what should have been a scientific discussion has been denigrated into this sort of discussion.”
What of the eminent Harvard Medical School doctor, Dr. Mehra, lead author of the two studies, who collaborated on the papers with Desai?
“It is now clear to me that in my hope to contribute to this research during a time of great need, I did not do enough to ensure that the data source was appropriate for this use,” Dr. Mehra, said in a statement to The New York Times. “For that, and for all the disruptions — both directly and indirectly — I am truly sorry.”
Dr. Mehra’s apology also appears on the official website of Boston’s Brigham Women’s Hospital where he practices.
Tip of the Iceberg?
Critics say Dr. Mehra’s mea culpa (“truly sorry”), aimed at papering over an emerging medical scandal, raises more questions than it answers, and may only be the tip of the iceberg.
Dr. James Todaro, a Michigan-based ophthalmologist who was the first to publicly expose the scandal on his website, “Medicine Uncensored,” calls attention to the many glaring red flags that jump out at anyone who takes a close look at the Lancet and NEJM studies.
Todaro noted that Surgisphere’s house of cards began to collapse after it surfaced that the company’s handful of employees, just four to be exact, were supposedly keeping afloat a gigantic global cross-continental operation partnering with over a thousand hospitals, in half a dozen languages.
Such an operation would require online security and multilingual experts to monitor and convert sensitive electronic data in real time. It would necessitate the creation of sophisticated custom-made software, and seasoned electronic engineering teams.
Among the four employees listed on the firm’s website—two of whom came aboard only in the past three months—are a sci-fi writer and a female model/party planner. The only one with a medical or science degree is the CEO, Dr. Sapan Desai.
“A company that came out of thin air conducts the most sweeping, influential global study in this pandemic in a matter of a few weeks,” with virtually no personnel? How did this not raise enormous red flags at a prestigious medical journal like the Lancet, asks Todaro.
One question prompts another. Why was a once-respected medical journal prepared to run a study from so dubious a source, having apparently submitted it to such feeble scrutiny?
And what are the consequences for those who perpetrated what seems to be major scientific fraud with life-threatening consequences, in the midst of the worst global health crisis of the last century?
Conspiracy theorists are having a heyday with the bizarre coincidence that rolled out another study by New England Medical Journal (NEJM) the very same day as the Lancet report. But while the Lancet report took down hydroxychloroquine as dangerous and deadly, the NEJM article pumped up a new drug, remdesivir, as the answer to Covid-19.
This study, entitled “Remdesivir for the Treatment of Covid-19,” was sponsored by the National Institute of Health (NIH) and National Institute of Allergies and Infectious Diseases (NIAID), headed by Dr. Anthony Fauci who has held this position since the Reagan administration.
The preliminary results, disclosed at the White House by Fauci, found that the drug accelerated the recovery of hospitalized patients but had only a marginal benefit in the rate of death. Nonetheless, Fauci’s remarks boosted speculation that the FDA would seek emergency authorization that would permit doctors to prescribe the drug.
That is in fact what happened.
On June 29, based on the findings of the NIAID Report published in the New England Journal of Medicine, the Department of Health announced on behalf of the Trump Administration an agreement to secure large supplies of remdesivir from Gilead Sciences Inc. for the treatment of Covid-19 in America’s private hospitals and clinics. The drug is expected to be priced at about $1000 per pill.
In another coincidence of timing, it turns out that remdesivir studies were carried out by Brigham and Women’s Hospital (BWH), where Dr. Mehra of the bogus Lancet report practices.
While Mehra was not directly involved in the Gilead study, he nonetheless had contacts with Gilead Sciences Inc., as reported by the popular online French paper, France Soir, on May 23, 2020.
In a follow-up article after the Lancet retraction on June 5, France Soir noted that Mehra “participated in a conference sponsored by Gilead in early April 2020 as part of the Covid-19 debate.”
The article went on to remark that in the interview with Mehra, the doctor’s “often evasive answers [regarding whether he had a conflict of interest] did not produce confidence, instead fueling doubt about the integrity of his study and its results.”
Excerpts from an Interview With the Author of The Lancet Study
Excerpts of an interview of Harvard’s Professor Mehra (who authored the now-disgraced Lancet study) with France Soir, published immediately following the study’s release, follow below.
Dr. Mandeep Mehra: In our study [referring to the Lancet study], it is obvious that the lack of benefit and the risk of toxicity observed for hydroxychloroquine are fairly reliable.
France Soir: Do you have the data for Remdesivir?
Mehra: Yes, we have the data, but the number of patients is too small for us to be able to conclude in one way or another.
France Soir: As you know, in France, there is a pros and cons battle over hydroxychloroquine which has turned into a public health issue, even involving the financial lobbying of pharmaceutical companies. The question is, why not measure the effect of one drug against the other to put an end to all speculation?
Mehra: Because there is no rational basis for testing remdesivir versus hydroxychloroquine. Remdesivir has shown it poses no risk of mortality and causes reduction in recovery time. For hydroxychloroquine, the opposite is true: it has never been shown any advantage inasmuch as most studies are small or inconclusive. In addition, our study shows that there are harmful effects.
France Soir: You said that there is no basis for testing or comparing remdesivir with hydroxychloroquine. Do you think you have done everything possible to conclude with certainty that hydroxychloroquine is dangerous?
Mehra: Exactly. Understand, what we are saying is that once you have been infected to the point of having to be hospitalized with a severe viral load, the use of hydroxychloroquine is not effective. The damage from the virus is already there and the situation is beyond repair. With this treatment [HCQ] it can generate more complications.
HCQ Must Be Administered Early
One major problem with the clinical trials described in the Lancet study is the complete blurring of an essential point: all patients in the clinical trials were already in the ‘inflammatory’ stage of the illness, when hydroxychloroquine is not expected to be effective.
The Lancet’s report failed to address this vital issue, and Dr. Mehra continued to ignore it in his comments to France Soir. It is a key piece of information that Dr. Zev Zelenko, a renowned expert on Covid-19 featured in a Yated interview last week, has tried for months to disseminate: you must treat the patient early, within five days of the virus’ onset. Only then will anti-viral medications be effective.
Anecdotal evidence from several countries overwhelmingly point to the efficacy of the 3-drug regimen– hydroxychloroquine coupled with azithromycin and zinc—in curing the majority of Covid-19 cases without hospitalization, when administered early in the disease process.
Comparing the benefits of hydroxychloroquine with those of remdesivir in clinical trials carried out only on hospitalized patients in the inflammatory stage, is to miss the point entirely.
Another glaring oversight in the study published in the Lancet is its failure to cover the use of zinc in the protocol. As Dr. Zelenko and others advocating his regimen have stressed: “Zinc is the bullet; hydroxychloroquine is the gun.”
Could the Prayed-For Cure Be Right Before Us?
Following the discrediting of the Lancet research, WHO did a u-turn and the HCQ clinical trials have been resumed. A confused public was reminded that hydroxychloroquine was approved as a safe anti-malaria drug by the FDA and has been in use for over 15 years. It was used in the SARS-1 outbreak in 2002 with the endorsement of the CDC.
Nonetheless, it feels surreal to confront evidence that the prayed-for cure for Covid-19 already exists—simple, safe and ready for instant use by doctors around the world.
This admittedly would pose a huge problem for the drug industry; not that a cure has been found, but that it costs next to nothing, and therefore has zero profit potential.
Estimates are that remdesivir will rake in a $1.6 billion dollar bonanza for Gilead Sciences Inc., its investors, hospitals and clinicians. But there is no fortune to be made from expensive drugs if the disease can be cured in its early stages with cheap ones.
The added dimension of a presidential election, and the overpowering need to discredit and undercut President Trump at any cost—even at the price of human life—is no doubt part of the destructive dynamics at play in the HCQ/Remdesivir drug wars, say experts.
That may well underlie the refusal of elected officials to end lockdown policies whose devastating effects can be blamed on the president, while these officials claim to be “following the science.”
With the lessons of the Lancet affair underscoring how easily science can be manipulated, perhaps grass roots America will muster the political will to force its elected officials to face down the vested interests still trashing a simple cure, available months ago before so many lives were lost.
The Lancet—A Fallen Idol
Despite its pride in its 200-year old heritage and its prestige as leading medical journal, the Lancet has been compelled before to retract material in its pages found to be fraudulent.
In 1998, the Lancet published what was then considered to be a landmark study by discredited physician Andrew Wakefield, that falsely claimed to prove a link between the measles/mumps/rubella vaccine and autism. That article helped establish and legitimize the anti-vaxxing movement which continues to this day.
Twelve years after its publication, the Lancet retracted the article after conceding that “several elements” of the study were “incorrect” and “contrary to the findings of an earlier investigation.”
One can’t help but picture all those parents who, thanks to the scare tactics in the Lancet article, were too frightened to have their children vaccinated. What of those unvaccinated children who either contracted, or have been at risk of contracting diseases that could cripple and cause lifelong health issues?
The study had gathered so much attention that until today, it continues to ignite strong anti-vaccination sentiment, despite overwhelming scientific evidence that vaccines do not cause autism.
In another unverified claim, the Lancet in 2006 reported that the death toll among Iraqis due to the US-led invasion had reached 650,000. According to Wikipedia, that number vastly exceeded the figures suggested by the U.S. and British governments, the Iraqi Health Ministry and the United Nations.
In 2014, the Lancet made headlines again when it published an ‘open letter for the people of Gaza’ in its correspondence section, accusing Israel of a “massacre” in Gaza. The letter was a mouthpiece for the libels and propaganda of pro-Hamas spokesmen, another moment of shame for a journal increasingly tainted by partisan politics.
With the fresh humiliation of the retracted HCQ studies surpassing that of its previous lapses, the Lancet’s once vaunted image as a leader in scientific truth and accuracy will not easily be resurrected.