SANOFI’S REPLY TO ACCUSATIONS OF MEDDLING
On Dengue Vaccine Controversy
Plus Rebuttals from the Author
Facebook Page “Eastwind Journals” (no. 201)
By Bernie V. Lopez
Philippine Daily Inquirer Opinion Writer
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READ THE ORIGINAL ARTICLE ACCUSING SANOFI OF MEDDLING
If you have not read it yet, published as a Letter to the Inquirer Editor, Dec 10, 2016
SANOFI’S REPLY TO THE ACCUSATION OF MEDDLING
Plus Rebuttals from the Author (on portions in RED ALL CAPS)
Sent (to author thru Ms. Khristine Cabanayan’s email address) on behalf of Dr. Ruby Dizon, Sanofi Pasteur Medical Director
Dear Mr. Lopez,
Sanofi Pasteur wishes to clarify and correct the comments on the dengue vaccine’s safety and the process of obtaining its license in the Philippines mentioned in your Letter to the Editor which was published in Philippine Daily Inquirer on December 10, 2016.
Vaccines are developed through a process of rigorous scientific testing, clinical evidence of safety and efficacy that follow international good research and science practice and is highly regulated by national and international bodies including ethics committees and the global vaccine expert committees reporting to the WORLD HEALTH ORGANIZATION. In the case of the dengue vaccine this encompassed two decades of scientific innovation and collaboration, 25 clinical studies in 15 countries throughout Asia and Latin America involving more than 40,000 people. THE VACCINE HAS BEEN DOCUMENTED TO BE EFFECTIVE AT PROTECTING TWO-THIRDS OF INDIVIDUALS (66%) AGED NINE YEARS AND OLDER against dengue over the 25 month follow up phase of the efficacy studies. This clinical evidence on the dengue vaccine was published in the New England Journal of Medicine in July 2015 also reporting 1that the vaccine provides even greater protection against severe dengue (93%) and can prevent 80% of hospitalizations due to dengue in the study population 9 years and older over the 25 month follow-up period. As you may be aware, it is hospitalization and severe disease due to dengue that leads to the bulk of the human and economic burden of this disease in dengue-endemic countries like the Philippines.
Based on the PUBLISHED SCIENTIFIC AND MEDICAL EVIDENCE on this vaccine we want to assure the public that the dengue vaccine is safe and effective.
We also want to reiterate that SANOFI PASTEUR ALWAYS OBSERVES ALL LOCAL AND INTERNATIONAL LAW AND REGULATION WHEN SEEKING APPROVAL OF ITS VACCINES. Our company registers vaccines with governments all over the world and we have a highly regulated compliance process we follow which ensures we follow all local and international laws governing access to medicines.
DISCUSSIONS BETWEEN SANOFI AND THE PHILIPPINE GOVERNMENT HAVE BEEN ONGOING SINCE 2010 after promising results of the early studies on the dengue vaccine prompted meetings with FDA to share the potential breakthrough.
In 2014, after Sanofi presented the results of Phase III Clinical trials of the dengue vaccine in Asia (CYD 14), then DOH Secretary Ona called a press conference the following day to share this breakthrough in which he said, “These results are of great public health importance due to the high incidence of dengue and its disruptive effect on the health system. This vaccine should significantly contribute to achieving the Global Strategy for Dengue Prevention and Control Goals set by the WHO, which is 50% mortality reduction and 25% morbidity reduction by 2020.”
The initial dossier containing THE SCIENTIFIC, CLINICAL AND TEST DATA WAS SUBMITTED TO THE FDA IN JANUARY 2015. THE DECISION WAS NOT TAKEN UNTIL DECEMBER 2015 AFTER STUDY AND CONSIDERATION BY OFFICIALS. While the Philippines was the first country in Asia to license the vaccine and second in the world (to Mexico), THE NUMBER OF COUNTRIES WHICH HAVE APPROVED THE VACCINE HAS CONTINUED TO GROW. IT HAS NOW BEEN APPROVED IN 13 COUNTRIES - Mexico, Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Bolivia, Indonesia, Thailand, Singapore and Cambodia.
The vaccine is currently being used in public programs in two countries and in the private market in nine countries. In addition, the World Health Organization (WHO) published a position paper in July recommending the use of the vaccine as an integral part of comprehensive dengue prevention measure in areas where the disease is highly endemic following more than 2 year review of the documentation on the vaccine.
We regret any controversy which diverts attention away from the principal purpose of the vaccine and our program with the Philippine government – TO SAVE LIVES and reduce the social, medical and financial impact of this disease on the people of the Philippines. The approved dengue vaccine, which is endorsed for use in public immunization programs in highly endemic settings like the Philippines by the WHO, is being administered today in three regions of the PH and the program will be expanded to a fourth region as stated by the DOH in Congress. It is imperative that these school children who are receiving the vaccine and their families be reassured about the safety of the vaccine by BALANCED COVERAGE OF THIS TOPIC IN THE MEDIA and responsible, evidence-based statements by members of the Philippine medical community.
For the first time Dengue is now a vaccine-preventable disease. At Sanofi Pasteur, we believe in a world in which no one suffers or dies from a vaccine-preventable disease. We will continue to work collaboratively and transparently with the Philippines government and public health community to achieve this vision.
DR. RUBY DIZON, Medical Director, Sanofi Pasteur Philippines
REBUTTALS FROM THE AUTHOR TO DR. DIZON OF SANOFI
Dear Dr. Dizon,
You did not answer many questions I raised in the article. Those marked in RED ALL CAPS are quotes from your reply, followed by my response. Author Bernie V. Lopez
WORLD HEALTH ORGANIZATION.
Many articles in the Internet say that WHO is sometimes unfairly biased in favor of pharmaceutical multinationals, many of which give funds to WHO.
THE VACCINE HAS BEEN DOCUMENTED TO BE EFFECTIVE AT PROTECTING TWO-THIRDS OF INDIVIDUALS (66%) AGED NINE YEARS AND OLDER.
This percentage is not good enough. Some older malnourished kids may have weaker immunity systems against the vaccine’s bad effects than younger ones. Is there in fact a gray area where it is dangerous for children above 9 and safe for children below 9? Why 9? Is this absolute?
PUBLISHED SCIENTIFIC AND MEDICAL EVIDENCE.
Please post your evidence in the mass media, so we can question it. The New England Journal of Medicine featuring your tests is not mass media and hard to find.
SANOFI PASTEUR ALWAYS OBSERVES ALL LOCAL AND INTERNATIONAL LAW AND REGULATION WHEN SEEKING APPROVAL OF ITS VACCINES.
Did Sanofi, directly or indirectly, talk to Congressmen in the House Appropriations Committee, officials of the FDA and the DOH? Why did the DOH Secretary suddenly reverse her stand from against to in favour of Dengvaxia. Did Sanofi have a role in this?
DISCUSSIONS BETWEEN SANOFI AND THE PHILIPPINE GOVERNMENT HAVE BEEN ONGOING SINCE 2010.
Is it not highly irregular for Sanofi to be a direct supplier of Dengvaxia to the Department of Health, not passing through a distributor? Are there potential conflicts of interest or secret deals to be avoided?
THE SCIENTIFIC, CLINICAL AND TEST DATA WAS SUBMITTED TO THE FDA IN JANUARY 2015. THE DECISION WAS NOT TAKEN UNTIL DECEMBER 2015 AFTER STUDY AND CONSIDERATION BY OFFICIALS.
News articles accused the Philippine FDA of a quick midnight decision before the 2016 Philippine Presidential election, about a medicine whose safety is being questioned in Western countries. Did FDA approve Dengvaxia based on your clinical tests rather than theirs? Tests done by Sanofi are not independent, can be biased, and are inadmissible.
THE NUMBER OF COUNTRIES WHICH HAVE APPROVED THE VACCINE HAS CONTINUED TO GROW. IT HAS NOW BEEN APPROVED IN 13 COUNTRIES.
Except for Singapore, these are all Third World countries, which are prone to succumb to multinational pressures. Dengvaxia is so expensive, only governments can afford to buy them, because it is the only existing dengue vaccine worldwide? Even as a global monopoly, can you not lower your price to a reasonable amount for Third World countries as a humanitarian gesture? Even 50% of the price of 3,000 to 5,000 pesos per person ($75 to $100) is still too much. You are bleeding Third World governments for your windfalls.
TO SAVE LIVES.
Saving lives and raising alarm is not an excuse for monopolistic prices.
BALANCED COVERAGE OF THIS TOPIC IN THE MEDIA.
Your expensive PR campaign has come up with many pro-dengvaxia television interviews and articles. Your voice is louder than ours who protest. This is not ‘balanced coverage’.
Bernie V. Lopez, firstname.lastname@example.org
PRAYER FOR PEACE
Lord, teach us and our enemies
the virtue of forgiveness and good will
to break the vicious cycle
of hate and vengeance
inside all of us a battle rages
between good and evil
between love and hate
between satan and the Lord
a green plant sprouts from the arid sand
symbol of hope and life
a black hole is dug to defend against predators
symbol of despair and death
life has a mission before it is overwhelmed by death
E-book healing stories of Sr. Raquel, free download