Dr. Gerald M. Sacks settles drug company bribery allegations with DOJ — ProPublica

ByDonald L. Leech

Aug 1, 2022

A dozen years ago, a Santa Monica, California pain doctor named Gerald M. Sacks became one of the pharmaceutical industry’s highest-paid speakers – anointed to extol the virtues of a variety of medications, although several pain medicine experts have said they’ve never heard of him.

His haul by the pharmaceutical company had gone largely under the radar until 2010, when ProPublica began digging into what companies were paying doctors to lecture and consult on their pills. That’s when we consolidated payments from seven companies, most of which had been forced by government agreements to make them public, into a database we called Dollars for Docs.

Sacks turned out to be a big winner, and we wrote how his resume explained why. It was even the subject of an op-ed we wrote in the Los Angeles Times about how patients are often unaware of their doctors’ relationships with pharmaceutical companies.

Nevertheless, the companies continued to pay large sums to Sacks. From 2015 to 2021, he received more than $2 million from businesses to speak and consult on their behalf, including travel and meal expenses, according to federal data.

But last month — 12 years after we first wrote about him — Sacks’ puzzling role as one of the drugmakers’ chosen pain doctors took a different turn: Federal prosecutors allege he was paid to prescribe.

Sacks has agreed to pay more than $270,000 to resolve US Justice Department allegations that he took bribes from drug companies Purdue Pharma and DepoMed to prescribe their products. Purdue is the maker of OxyContin and pleaded guilty in 2020 to, among other things, conspiring to bribe doctors. The anti-bribery law prohibits doctors from prescribing drugs in exchange for talk or consultation payments from drug manufacturers.

From 2015 to 2018, Purdue paid Sacks more than $70,000 for his interventions and advice. DepoMed, which changed its name to Asserti Therapeutics in 2018, paid him more than $285,000 for lectures and consultations from 2015 to 2018, according to the federal government’s Open Payments database. Neither Assertio nor its predecessor, DepoMed, have been accused by the government of wrongdoing.

Sacks writes a few thousand prescriptions a year, including refills, to federal Medicare patients. Among the tally from years gone by were hundreds of prescriptions for drugs for which the government accused him of taking bribes.

Sacks denied wrongdoing in the settlement and did not return phone calls seeking comment. Neither Purdue Pharma nor Assertio returned emails seeking comment.

“Physicians are prohibited from accepting bribes intended to influence their decision-making,” Assistant Deputy Attorney General Michael D. Granston said in a press release. “Compliance with this prohibition is particularly crucial with regard to dangerous drugs such as opioids.”

The allegations against Sacks relate to his prescribing the drugs Butrans, Hysingla and OxyContin, made by Purdue, to patients on Medicare between December 2010 and October 2021. They also cite his prescribing the drugs Gralise, Lazanda and Nucynta, made by DepoMed, to beneficiaries from Medicare in 2016.

Experts say the evidence is now overwhelming that there is a strong association between drug company payments and doctor prescribing. This link is worrying, they say, because doctors should prescribe drugs only based on what’s best for the patient, not because they’re getting money from the company that makes a drug. Some prescription drugs may be more expensive or have greater side effects than cheaper or generic alternatives.

Today, the federal government collects payment information from all drug and device manufacturers in its Open Payments Database. The researchers say such payments show that patients and regulators need to be on their guard.

In a research article published last month in the Journal of Health Politics, Policy and Law, the authors note that there is not just one study that has found a troubling link between drug company money and what doctors prescribe. “Every published, peer-reviewed study that has assessed the association between payments and prescribing using a causal inference framework has found evidence that receiving payments from industry increases the prescribing of doctors,” they wrote. They call on various parties, including doctors, the pharmaceutical industry and regulators, to take action to reduce these conflicts.

Dr. Aaron Mitchell, one of the authors and an oncologist at Memorial Sloan Kettering Cancer Center, said the ever-growing list of research findings overturns the presumption that payments to doctors, especially small ones like meals, do not influence doctors’ prescriptions.

“The legal interpretation of a bribe has long been that industry payments and other transfers of value to physicians are acceptable as long as they do not influence prescribing,” he said. . “We now have overwhelming data that such payments influence prescribing. In light of this, we must seriously re-examine the status quo. »

Mitchell suggested that regulators, like the U.S. Department of Health and Human Services’ Office of Inspector General, revise their guidelines for industry payments and “make it clear to everyone that these are going to do subject to increased scrutiny and increased risk of prosecution than they have in the past.

The OIG’s Office of Guidance said in a statement that it “has long expressed concern about the practice of pharmaceutical manufacturers providing anything of value to physicians in a position to make or influence referrals.” to manufacturers’ products. The bureau issued a special fraud alert in 2020 that addressed the risks of speaker program payments to physicians and other practitioners by pharmaceutical and medical device companies.

“OIG has continued and will continue to pursue abusive financial relationships between pharmaceutical manufacturers and physicians,” the statement said.

In 2021, the most recent year for which there is publicly available data on payments to doctors, drug companies paid Sacks more than $84,000.