The studies, published in renowned scientific journals, produced astounding results and altered the course of research into the coronavirus pandemic.
One undercut President Trump’s claim that certain antimalarial drugs cure Covid-19, the illness caused by the virus, concluding that the medications in fact were dangerous to patients. The other found that some blood pressure drugs did not increase the risk of Covid-19 and might even be protective.
Both studies were led by a professor at Harvard, and both depended on a huge international database of patient medical records that few experts had ever heard of.
But on Thursday, the studies were retracted by the scientific journals in which they had appeared, The New England Journal of Medicine and The Lancet, because the authors could not verify the data on which the results depended.
The retractions may breathe new life into the antimalarial drugs hydroxychloroquine and chloroquine, relentlessly promoted by Mr. Trump as a remedy for Covid-19 despite a lack of evidence. On Wednesday, after the journals noted concerns about the studies, the World Health Organization announced that it would resume trials of the medications.
But the retractions also raise troubling questions about the state of scientific research as the pandemic spreads. Thousands of papers are being rushed to online sites and journals with little or no peer review, and critics fear long-held standards of even the most discerning journals are eroding as they face pressure to rapidly vet and disseminate new scientific reports.
“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. Mandeep Mehra, lead author of the two studies, said in a statement to The New York Times.
“For that, and for all the disruptions — both directly and indirectly — I am truly sorry.”
The paper about chloroquine and hydroxychloroquine appeared in late May in The Lancet. Though there had been other hints of side effects associated with the drugs, clinical trials were halted worldwide while alarmed investigators began safety reviews.
But questions arose almost immediately about irregularities in the data and the provenance of the data set used in the analysis as well as in Dr. Mehra’s earlier heart study, which had appeared in The New England Journal of Medicine.
The data came from a company called Surgisphere, which claims to have granular patient-level information shared by 1,200 hospitals and health facilities on six continents. The founder and chief executive, Dr. Sapan Desai, was listed as an author on both papers.
Dr. Mehra, who is the medical director of the Brigham and Women’s Hospital Heart and Vascular Center in Boston and has authored hundreds of publications, said in a statement that he became involved in the project because he felt a need to contribute to science during the pandemic.
Dr. Mehra said he was introduced to Dr. Desai through one of the co-authors, whom he did not identify, and was told about the existence of a mammoth private database of patient medical records compiled by Surgisphere. Dr. Mehra said he hoped the data could be used in rapid studies that improved outcomes of patients with Covid-19.
Dr. Desai furnished the statistics used in both the heart and hydroxychloroquine studies. Critics were quick to point out anomalies in both pieces of research, including implausible findings that should have been detected during the peer review process — like the registry’s apparent inclusion of a large number of Covid-19 cases very early on in the pandemic, even in Africa, where few hospitals have electronic health records.
Many researchers were astonished to find out that such a database could exist, or that the gathering and analysis of tens of thousands of medical records on multiple continents could have been carried out so quickly.
In an interview earlier this week, Dr. Desai vigorously defended the Surgisphere database, saying that he was “all for transparency” but was bound to secrecy by contractual agreements with the hundreds of hospitals that are his clients, and therefore could not show anyone the raw data from his registry.
“We did this because there was an opportunity to help,” Dr. Desai said. “We’re not making any money from this, we’re doing it at our own expense. This is why I went into medicine.”
Dr. Desai declined a request from The Times to be put in contact with a hospital or health care facility that provided its data to Surgisphere. He did not respond to inquiries after the retractions.
The controversy has brought close scrutiny to a small, little-known company, which Dr. Desai says has fewer than a dozen employees yet has amassed an enormous private registry containing detailed medical information from patients around the globe.
Dr. Desai has used the Surgisphere name in various ventures over the years, but until February, he worked as a vascular surgeon at Northwest Community Hospital in Arlington Heights, Ill.
He left the job because his wife was having a baby, and because business at Surgisphere was picking up, a spokeswoman said.
Frequently Asked Questions and Advice
Updated June 2, 2020
Will protests set off a second viral wave of coronavirus?
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
How do we start exercising again without hurting ourselves after months of lockdown?
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
My state is reopening. Is it safe to go out?
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
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.
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.
On its website, Surgisphere lists its office as the 31st floor of the iconic John Hancock building on Michigan Avenue in downtown Chicago — a co-working space that Dr. Desai confirmed is the company’s corporate office.
It is possible for a company to build an enormous database of patient medical records, said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale New Haven Hospital.
The ubiquity of “big data” can be tempting for researchers, he added, but they still must understand where the data came from, its authenticity and its quality.
It is not implausible that a large database could accrue records from a large number of hospitals without their knowing, he said — indeed, it is frequent. Hospital systems contract with vendors who then pass records along to other companies, including those compiling big data for health care marketing and research.
Nonetheless, Dr. Krumholz said, a database like the one promoted by Surgisphere should have raised some eyebrows.
“If this database is this good, why haven’t we been using it?” he said.