Truly, there is justice in this world. Just as the Dengvaxia scandal involving the irregular disbursement of P3.6 billion in public funds to buy this experimental anti-dengue drug for the test immunization of 830,000 unknowing victims was fading from public scrutiny, its proponent, Sanofi, the giant French pharmaceutical company, was ordered by the US Securities and Exchange Commission to pay $25 million for engaging in bribery and related unprofessional practices in Kazakhstan and other Middle East countries.
As it turned out, the experience of the countries involved in the New York case was eerily similar to what happened with the Aquino administration’s purchase of Dengvaxia in record time a few days before the end of the 2015 fiscal year was done, in much the same way as with the pharmaceutical firm’s introduction of this anti-dengue drug in the country.
In the case of Kazakhstan, for example, Sanofi injected a new set of products in that country’s menu of both prescription and non-prescription drugs using a kickback system to win public contracts and increased prescriptions of its products. Of course, the main proponent of the Dengvaxia deal, then Health secretary Janet Garin, wants the public to believe that a similar arrangement was never, as in not at all, in place in the case of Dengvaxia. This even as Pnoy, through his most trusted Cabinet secretaries, then Executive Secretary Jojo Ochoa and his law school buddy Budget secretary Butch Abad, scrambled to have the purchase done in haste. Documents show that the deal was approved immediately after the last meeting of Pnoy with Sanofi officials in Paris. He had earlier met senior Sanofi officials in Beijing.
It appears that Pnoy and his team were truly convinced of the efficacy of this wonder drug even as the WHO and even the firm itself issued a number of caveats before it could be used for mass immunization.
Those caveats were cavalierly ignored as Pnoy insisted that this was surely the needed cure for a dengue-epidemic-in-the-making which may involve two million, mainly poor, Filipinos. Nice touch. All in good faith. Well, if these guys can make the public believe this narrative, then they deserve the commendation of a grateful nation. But let’s see if they can get the families of the 830,000 children (and some adults) to kiss and applaud them if they start a campaign to advise them not to worry about the possible ill effects of the drug as earlier indicated in the WHO bulletins and as published in the prestigious New England Journal of Medicine. But before they proceed with such an operation, they should probably publish a list of the children they injected with this drug. This will be better so that the public can assist them in monitoring the real situation.
Here’s what the SEC said in its ruling against Sanofi as reported by the dailies:
“French pharmaceutical giant Sanofi will pay more than $25 million to settle US charges over bribery committed in Kazakhstan and the Middle East, US authorities announced Tuesday.
The US Securities and Exchange Commission said Sanofi employed a kickback system in Kazakhstan to win public contracts and increase prescriptions of its products.
In the Middle East, the company employed “pay-to-prescribe” schemes to induce healthcare providers to increase their prescriptions of Sanofi products, the agency said.
“Bribery in connection with pharmaceutical sales remains as a significant problem despite numerous prior enforcement actions,” said Charles Cain a SEC enforcement official who leads the unit on the Foreign Corrupt Practices Act.
“While bribery risk can impact any industry, this matter illustrates that more work needs to be done to address the particular risks posed in the pharmaceutical industry,” Cain said.
The probe covered Sanofi and its affiliates in Kazakhstan, Jordan, Lebanon, Bahrein, Kuwait, Qatar, Yemen, Oman and the United Arab Emirates for activities between 2006 and 2015.
Sanofi did not admit or deny any wrongdoing.
This was not the first and will probably not be the last adverse ruling against Sanofi as it battles for market share with other pharmaceutical giants worldwide. Early on, in 2013, Sanofi was investigated by Chinese authorities also on charges of bribery. Reports had it that a whistleblower, who asked to remain anonymous, told authorities that Sanofi paid a total of CN¥1.69 million ($274,000) at 79 hospitals to 503 doctors in Hangzhou, Gangzhou, Shanghai and Beijing. These bribes allegedly occurred in 2007 and were passed off as research grants. A year later, in 2014, the company had to pay a whooping $40 million in fines after it was found guilty of payoffs to medical centers and doctors coursed through “consultants.”
According to Xinhua, China’s official news agency, the municipal health bureau of Beijing will coordinate with its equivalents in the other cities to investigate the matter. Xinhua added that determining at what point a research grant becomes an example of corruption will be key to the case.
A Sanofi affiliate, Sanofi Aventis, was also charged with using bogus data in seeking the licensing of an anti-biotic drug for pneumonia, bronchitis and other chronic pulmonary diseases which was eventually processed and approved by the US FDA even as the company’s licensing team for the product were indicted and jailed. Even as the drug, Telithromycin, got into the market, it was monitored to have caused the death of four patients for liver failure. It was also pinpointed as the cause of 33 cases of acute liver failure and 53 cases of hepatotoxic damage. Just like in the case of Dengvaxia, the FDA’s Office of Surveillance and Epidemiology later on found that this antibiotic was 350 percent to 1000 percent more likely to inflict “serious adverse events.”
That strongly worded ruling should put Secretary Francisco Duque III and the Department of Health on the spot and back in the public eye. This time, not only to give an update on the measures which are already in place to assist those who have been injected with the drug under the agency’s rapid immunization plan two years ago to cope with their trauma. Duque and company should also be asked to explain why up to now the government has not thrown the book at Sanofi and its enablers, in and out of the DoH, despite all the unearthed irregularities and unanswered questions regarding the purchase, usage and post usage of Dengvaxia. Of course, the most critical issue is: Whatever happened to the 830,000 people, mostly children, immunized with Dengvaxia? What has the DoH done to ensure that they do not suffer the fate of those who have fallen along the way?