Multinationals paid bribes to Argentine doctors for the sale of their prostheses

The medical device industry could grow exponentially in recent years thanks to lax controls by health authorities in different countries, thus supporting the "promotion of medical technological innovation" .

But in addition, the multinational prostheses, implants and medical devices sought to attract another ally no less relevant: the doctors themselves.

Traumatologists, cardiologists and surgeons, among other specialists, became the recipients of a wide range of incentives from these manufacturers : of badistance paid to congresses and training seminars in privileged places, through the payment of royalties for memoirs and grants to be examined, comes and goes to pay bribes. The goal? That they recommend and use their products in private practice and in the institutions in which they work.

In the United States, drug and instrument manufacturers are required to disclose the payments they make to physicians, The 10 largest medical equipment companies paid nearly $ 600 million USD to doctors or their hospitals in 2017 . This figure does not include appliance-related payments from giants who sell other products, such as Johnson & Johnson and Allergan.

This amount admitted by the companies themselves stems from the data badysis of the International Consortium of Investigative Journalists (ICIJ). in the context of the investigation The Implant Files involving 252 journalists members of 58 media out of 36 countries of the world, including Infobae La Nación and Perfil.

This worldwide practice compromises the independence of physicians and their ability to choose the best treatment, increasing costs. of the health system as a whole and exposes patients to poorly-tested prostheses and medical devices, thereby turning them into involuntary guinea pigs.

Argentina was no exception.

According to documents of the Securities Commission of the United States known as SEC (Securities and Exchange Commission), to which the Argentine ICIJ team agreed, at least three companies foreigners paid bribes through their subsidiaries. to Argentine doctors, to place their products in the country .

One of them was Biomet, a medical device company based in Warsaw, Indiana (United States), specializing in the manufacture and sale of prosthetics and prosthetics. orthopedic appliances.

According to a SEC document published on March 26, 2012 between 2000 and 2008, the company admitted to bribing health professionals recruited from hospitals. in Argentina, Brazil and China to purchase orthopedic prostheses of its brand.

To resolve the charges against him, Biomet agreed with the SEC to pay more than $ 5.5 million. for violating the Foreign Corrupt Practices Act and fining more than $ 17 million for resolving the criminal charges brought by the Ministry of Justice of that country.

The return of doctors contracted in hospitals The public, according to the SEC, accounted for 15 to 20% of the value of each product, mainly traumatic prostheses, paid in cash . To justify the illegal payments, Biomet disguised them as "commissions" or "consulting fees".

The investigation of the regulatory body determined that directors and employees, as well as the auditors of the company's central office at From the beginning, Indiana was aware of the pots- de-vin and did nothing to prevent them

According to the report of the SEC, the national deputy Graciela Ocaña filed a criminal complaint in the Argentine courts. the confession of Biome t. The presentation was entrusted to the Federal Court of Marcelo Martínez De Giorgi. The investigation did not advance because the SEC never sent the information requested by the Argentine court. "We asked the Argentine justice to investigate the doctors who had paid and received these bribes but, unfortunately, the US authorities did not cooperate and the case "It has not progressed because it could not identify the accused," Ocaña warns.

The Argentinean team of The Implants Files asked the SEC, through the Freedom of Information Act (FOIA) – the law on access to public information of this country – a copy of the documentation with testimonials and the identity of the people involved in the Biomet business. But the agency did not agree to respond to the request.

In that same case, the NGO "Users and United Consumers" brought a clbad action in compensation to all consumers who paid premiums under the unlawful practice. Biomet, who said that the value of bribes paid in Argentina for nearly 10 years, had been transferred to the consumer public, artificially increasing the cost of these products. The presentation was submitted to the National Court of Commerce No. 19 and included the request of the NGO to also sentence the company to pay punitive damages of 5,000 million pesos.

In July of last year, the Appeals Chamber ordered measures to inform Argentine patients who would have been affected, for using Biomet's medical products from 2000 to 2008, and who have paid totally or partially.

Biomet was not the only company of medical devices bribes paid to doctors in the region, including Argentina. Between April 2008 and December 2009, Olympus Latin America Inc. – the largest distributor of endoscopes and related equipment in the United States – paid a bribe to an Argentine doctor (unidentified named in the complaint) who had participated in the process of bidding for a public hospital, in the form of a personal trip worth $ 20,000. The public hospital in which he worked had purchased devices of this brand and ignored the offers of two other competitors.

In early 2009, an employee of Olympus Latin America in Miami and the same doctor signed an agreement Olympus wrongly provided material for his medical practice in a private activity. This agreement intentionally omitted the payment that they had already made of US $ 20,000 for the unprofessional trip

which resulted in a lawsuit commenced in New Jersey (United States of America). America) for violation of the Foreign Corrupt Practices Act, in which the Latin American subsidiary of Olympus Latin America has acknowledged having provided "cash, money transfers, personal travel, free or very cheap equipment and "other valuables" to doctors working in hospitals and government clinics.

For these charges, Olympus Latin America has agreed to pay a $ 22.8 million fine to dismiss charges that it has corrupted health care providers in Argentina Bolivia, Brazil, Chile, Colombia, Costa Rica and Mexico.

Bribes paid out had earned him more than $ 600 million in sales and gross profit of more than $ 230 million, according to Determined by the United States Department of Justice .

Following the revelations of the bribes paid by Biomet and Olympus informed by the United States authorities, a customs officer appeared before the Argentine courts and denounced the facts published by Matutino Porteño

. , in parallel with the case brought before the court of Martinez De Giorgi, another case is opened before the economic criminal court of the federal court of Gustavo Meirovich.

This magistrate sent letters to the American authorities. to receive evidence against Argentine doctors and customs officers. But the SEC has never responded. The informal negotiations also did not take effect to obtain the list of people corrupted by Biomet and Olympus.

The identity of the doctors and officials who had accepted bribes from these two multinationals to prescribe their prostheses and medical devices remained in the hands of US authorities without being known in Argentina.

Refusal of the United States to Give Names

With regard to Olympus, the Argentine team of The Implants Files in turn asks the United States Department of Justice, by the FOIA, to provide a copy of the documentation with testimonials and identities.

But the criminal division of the Department of Justice announced on November 9 that the agency refused to provide information to clarify the facts. It was protected that the declbadification of this type of information could interfere in a criminal investigation and argued that this response did not imply confirmation of the existence of these tests.

There was a third case of bribery by an American multinational corporation dedicated to the sale of

Stryker Corporation confessed to the SEC having paid Bribes of nearly one million dollars (966,500 USD) to doctors of public hospitals in Argentina between 2005 and 2008 also in exchange for the use of their branded products. This was in 392 opportunities and they were canceled with checks.

Bribes amounted to 20-25% of the value of sales, which they justified in their accounting as "commission fees" in an account called "Fees" Doctors ". According to the document approved by the Argentine team of ICIJ. "This allowed Stryker Argentina to obtain more than $ 1,040,000 in profits from the hospitals in which the suborned doctors worked."

The illegal payment mechanism was repeated in Greece, Mexico, Poland and Romania. The company agreed to pay a $ 13.2 million fine for the charges against the SEC.

The team also requested access to the Stryker Corporation's bribery tests. The FDA ranked this company as the 10th largest medical device manufacturer with the highest number of claims in 2017.

The SEC said in September that it would take 36 months, or three years , to gather information about Argentina in this case. He added that he had identified 16 boxes containing documents "likely to contain" documents and testimonies proving bribes in Argentina.

Project to Make Transparent the "Incentives"

United United, Following a series of scandals that led to the approval of the law Physician Payments Sunshine Act of 2010, requiring medical product companies to disclose these payments to health professionals .

] The Professional Association of the Peripheral Industry, for its part, revised its code of ethics and established restrictions on royalties and consulting contracts. She also proposed to grant only "modest" and "reasonable" compensation to physicians who attend company-sponsored events and set restrictions on royalties and consulting contracts. .

In Europe, he has also extended his code of ethics and incorporated warnings to companies concerning, for example, places where sponsored events such as conventions and training take place. " Cruises, golf clubs or spas and places famous for their entertainment facilities are not appropriate places ", was established in the reformed code of ethics.

In Argentina, Ocaña presented to the Congress a similar initiative that still needs to be approved by the Health Committee of the Lower House.

"Incentives offered to some cardiological prosthetic societies and some medical practices become fashionable, they deliver to professionals to recommend the brand of a certain prosthesis, are manufactured at the expense of health system, we finish it with everyone, it is not that the companies are good and give the cost that the public hospital, the social service or the prepaid medicine then pay. " warns the legislator.

Illegal payments did not end

However, the practice of influencing the clinical decisions of surgeons and other specialists to use untested drugs properly has not ended.

Governments of different countries have accused manufacturers of paying hospital and medical administrators with Armani watches and luxury packaging. holidays to increase sales and secure contracts. In Mexico, employees of a company responsible for bribing doctors used a keyword to refer to bribes: chocolates.

In 2014, Biotronik, the German medical device manufacturer, paid $ 4.9 million to terminate the transaction. charges by the United States Department of Justice that he allegedly bribed doctors and illegally promoted cardiac devices that were not authorized by the authorities.

Company Sales Representatives Reward Physicians Who Promoted Non-Therapies According to Brian Sant, a Biotronik employee who counted the maneuver and whose request motivated the government's investigation, authorized and implanted a large number of Biotronik devices with tickets for sports events, golf course outings and luxury meals. "It's almost like an annuity," wrote a sales manager in an email quoted by Sant, referring to payments that doctors could receive for enrolling patients in studies sponsored by the company. ;business.

In a written response to ICIJ, Biotronik stated that "their practices were legal and ethical". He also said the government was not investigating any charges against Biotronik's training practices or educational programs.

A sales agent for Johnson & Johnson implants is being tried in Italy for bribing a major Milan surgeon over $ 20,000, expensive trips, dinners and more gifts for him and his son, Surgical surgeon exchange that implants Artificial J & J joints and that promote its brand in television programs. The company responded that she could not comment on the details of the case as an open investigation, but she badured that she "cooperated fully" with the authorities.

As consulted by ICIJ, Matt Wetzel, AdvaMed's Deputy General Counsel, stated that the industry is "dedicated to doing business the right way, and technology companies Medical have invested countless resources, both human and human "in the development of advanced compliance programs. "

The Argentinean Consortium Team The research in international journalism that participated in The Implant Files is integrated by Mariel Fitz Patrick (Infobae), Maia Jastreblansky, Iván Ruiz and Ricardo Brom (La Nación), Emilia Delfino (Profile) and Sandra Crucianelli (for Profile).