Scientists Question Validity of Major Hydroxychloroquine Study

More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded the use of chloroquine and hydroxychloroquine to treat people with Covid-19 did not help and may have increased the risk of abnormal heart rhythms and death.

In an open letter addressed to The Lancet’s editor Richard Horton and the paper’s authors, the scientists asked the journal to provide details about the provenance of the data and called for the study to be independently validated by the World Health Organization or another institution.

Use of the malaria drugs chloroquine and hydroxychloroquine to prevent and treat Covid-19 has been a focus of intense public attention. President Trump has touted the promise of hydroxychloroquine, despite the absence of gold-standard evidence from randomized clinical trials to prove its effectiveness, and has recently said he was taking the drug himself in hopes of preventing coronavirus infection.

The scientists’ challenges to The Lancet paper come at a time of increasing debate about the risks of the rush to publish new medical findings about Covid-19, the disease caused by the coronavirus. The paper, published May 22, included data on tens of thousands of patients hospitalized through April 14, meaning that the authors analyzed the trove of data, wrote the paper and went through the journal’s critical review of its findings in less than six weeks.

The experts who wrote The Lancet also criticized the study’s methodology and the authors’ refusal to disclose information on the hospitals that contributed patient data, or even to name the countries where they were located.

The company that owns the database is Surgisphere, a firm in Chicago that claims to have access to patient medical records from around the world.

“Data from Africa indicate that nearly 25 percent of all Covid-19 cases and 40 percent of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording,” the scientists wrote. “Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”

A spokeswoman for The Lancet, Emily Head, said in an email that the journal had received numerous inquiries about the paper, and had referred the questions to the authors. “We will provide further updates as necessary,” she said.

Dr. Sapan S. Desai, the owner of Surgisphere and one of the paper’s authors, said the database that was used is an aggregation of the anonymous electronic health records of hospitals that are Surgisphere’s customers.

Contractual agreements with the hospitals bar the sharing of patient level data, Dr. Desai added, though it is available to qualified scientists for research purposes.

Latest Updates: Coronavirus Outbreak in the U.S.

As the C.D.C. recommends workplace changes, millions of the unemployed have more immediate concerns. Scientists are questioning the validity of an influential hydroxychloroquine study. Stocks dropped as tensions worsened between the U.S. and China. See more updates Updated 6m ago More live coverage: Global Markets New York

“Our strong privacy standards are a major reason that hospitals trust Surgisphere, and we have been able to collect data from over 1,200 institutions across 46 countries,” the statement said.

He said the company is certified by the International Organization for Standardization and audited by an external third-party auditor, which he identified as DQS, in Schaumburg, Ill.

“Every aspect of our data acquisition, warehousing and reporting is audited as part of those very strict certifications,” Dr. Desai said in an email, adding that mandatory audits take place at least four times a year.

Scientists who wrote and signed the letter criticizing the study included clinicians, researchers, statisticians and ethicists from academic medical centers, including Harvard’s T.H. Chan School of Public Health, the University of Pennsylvania, Vanderbilt University and Duke University.

The Coronavirus Outbreak

Frequently Asked Questions and Advice

Updated May 28, 2020

What’s the risk of catching coronavirus from a surface?

Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

What are the symptoms of coronavirus?

Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

How can I protect myself while flying?

If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

How many people have lost their jobs due to coronavirus in the U.S.?

More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.

Is ‘Covid toe’ a symptom of the disease?

There is an uptick in people reporting symptoms of chilblains, which are painful red or purple lesions that typically appear in the winter on fingers or toes. The lesions are emerging as yet another symptom of infection with the new coronavirus. Chilblains are caused by inflammation in small blood vessels in reaction to cold or damp conditions, but they are usually common in the coldest winter months. Federal health officials do not include toe lesions in the list of coronavirus symptoms, but some dermatologists are pushing for a change, saying so-called Covid toe should be sufficient grounds for testing.

Can I go to the park?

Yes, but make sure you keep six feet of distance between you and people who don’t live in your home. Even if you just hang out in a park, rather than go for a jog or a walk, getting some fresh air, and hopefully sunshine, is a good idea.

How do I take my temperature?

Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.

Should I wear a mask?

The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

What should I do if I feel sick?

If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

How do I get tested?

If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.

How can I help?

Charity Navigator, which evaluates charities using a numbers-based system, has a running list of nonprofits working in communities affected by the outbreak. You can give blood through the American Red Cross, and World Central Kitchen has stepped in to distribute meals in major cities.

“In the interests of transparency, we also ask The Lancet to make openly available the peer-review comments” that led to this manuscript’s acceptance for publication, they wrote.

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

Allen Cheng, a professor of infectious diseases at Monash University in Melbourne, Australia, who signed the letter, said in an email that the individual hospitals included in the database should be identified.

“Ideally, the database should be made public, but if that isn’t possible, it should at least be independently reviewed and an audit performed,” he said.

The paper’s authors said they had analyzed data gathered from 671 hospitals on six continents that shared granular medical information about nearly 15,000 patients who had received the drugs and 81,000 who did not, while shielding their identities.

Surgisphere’s data was also the basis of a study of coronavirus patients published in the New England Journal of Medicine earlier this month by some of the same authors, including Harvard’s Dr. Mandeep R. Mehra, as well as for two versions of an article on the use of an antimicrobial drug to treat Covid-19 that were not published in an established medical journal.

Though other observational studies had already reported possible harms associated with the malaria drugs and the Food and Drug Administration had issued a safety warning about their use, the World Health Organization suspended clinical trials of the drugs after The Lancet paper was published.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.