April 26, 2018, 7:39 pm
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Dengue expert reveals Sanofi’s lapses

A LEADING US expert on dengue research yesterday said he was very surprised the Philippine government proceeded with the mass immunization program using Dengvaxia to combat dengue among children aged nine years and up.

Appearing during the resumption of the hearing by the Senate blue ribbon and health committees, Dr. Scott Halstead of the Uniformed Services University of the Health Sciences in Bethesda, Maryland said he earlier warned that blood tests should have been done before the vaccine was given.

“I made a suggestion that before the Dengvaxia was given to everybody, there should be a blood test. Everybody said “hahaha’ that is impossible and that nobody has done that before. But I am sorry, that’s not “hahaha” that’s possible,” Halstead said.

“I was quite upset that this mass immunization was going forward,” he added, prompting Gordon to reply “I agree with you, Doctor.”

Halstead said he had a dialogue with Sanofi Pasteur, makers of Dengvaxia, for several years that its vaccine is safe for seropositives or those who had previous infection of dengue.

He said a blood test would have separated the children who had previous dengue infection from the seronegatives or those who have yet to contract dengue.

Gordon said giving the Dengvaxia without first testing whether the individual who is going to be vaccinated is seronegative or seropositive is a fault of the government, the implementor of the mass immunization program.

“Sanofi was able to bring the vaccine but our government is apparently in a hurry maybe because of the election, maybe because of some reason,” he said.

Gordon said it is the right of the parents to know the effects and possible consequences if they allow their children to be vaccinated.

“Even if Sanofi had the best intention but many died because they were not given the right information…Government should have ensured Sanofi’s responsibility before giving mass immunization,” he added.

Halstead said he is sure that Sanofi doesn’t want to cause harm to anybody but added he nearly “fell off his chair” when the pharmaceutical giant recommended that the vaccine be only given to those aged 9 and older after a three-year review in 2015.

He said this prompted him to write a paper on this matter.

“When the three-year review of Sanofi was published, I read two-to-five year-old children were hospitalized at a higher rate than the control group. If I’d been here, you would have seen me. I fell off my chair.”

Sanofi’s allegation that nine years was a safe year because there are some intrinsic difference between nine-year-olds and younger, simply did not fit the biology of the human species, he added.

Halstead said there is a safe vaccine against dengue but it is not yet available in the Philippines.

Dr. Antonio Dans of the National Academy of Science and Technology claimed that Sanofi knew of the risks of Dengvaxia but buried in its studies the evidence of the risk on seronegative individuals.

He said Sanofi should have informed the public about the risks before endorsing to the government the dengue vaccine.

Her said they even tried to communicate their findings.

“The findings suggest that the vaccine could be harmful in seronegative children or those who have not yet contracted dengue of whatever age -- not just more than 9 [years old], not just more than 5,” he explained.

But Sanofi’s regional representative Thomas Triomphe told the inquiry that they only found out about the potential risk to seronegative individuals in November last year, prompting them to issue an advisory.

During the hearing, Gordon also said then President Aquino apparently rushed the procurement of P3.5 billion worth of Dengvaxia after he met with Sanofi executives in France.

He said even if then Health Secretary Janette Garin was the “captain” Aquino as president was the commander-in-chief.

“Somebody has to be responsible. Folks, who pushed the button? Who said gawin na natin ‘to? Damn the torpedoes, full speed ahead?” Gordon asked Ubial, with the latter saying it should be Garin since she was then the DOH chief.

“When you see the President of the Philippines meeting Sanofi executives in a foreign country, are you surprised that the timeline will be so fast? Secretary Garin could be the captain, but the commander-in-chief of the captain is the one that gives the signals, especially kung lalabas yung pera na ₱3.5 billion to buy the medicine,” he said.

“The people who pushed the button, the president, the budget secretary, the health secretary and all those who disregarded conditions and protocols, even violating procurement provisions,” he added.

Aquino in previous testimony in the Senate denied the implementation of the mass anti-dengue vaccination program was rushed.

Gordon also told the parents who attended the inquiry that he would be filing a bill that will allow the children affected by the Dengvaxia mess to use the P1.2 billion refunded by Sanofi for unused vaccines for their treatment.

Health Secretary Francisco Duque III said his office has asked for authorization from the Department of Budget and Management to use the funds for the affected families.

Gordon said Tuesday’s hearing - the 7th on the issue - would be the last. He assured the public the committee will issue a “hard-hitting report” on its findings.

In his opening statement, he said the report was already 90 percent completed but new information could be included. 

Gordon later told reporters that “criminal proceedings will definitely” be filed against those involved in the Dengvaxia mess.

He said the charges could range from dereliction of duty to negligence through bad faith, violation of the government procurement reform act to reckless imprudence and even murder.

He said the respondents could include Aquino.

Duque said the Department of Health (DOH) is preparing to address the stress and other emotional and psychological concerns of Dengvaxia recipients and their parents.

Duque visited the Dengvaxia fast lane of the Quezon City General Hospital yesterday.

He said training for health personnel that will provide psychosocial services is already underway.

“That is quite in order and our Health Emergency Management Bureau is on top of the situation. They are doing training by deploying psycho-social experts to do the training,” he said.

He also said the DOH is in talks with the Department of Social Welfare and Development (DSWD) and the Philippine Red Cross (PRC) for possible collaboration. – With Gerard Naval
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