Dangers of Neglecting Safety in Vaccine and Drug Trials
Lessons from Some Tragic Episodes

Bharat Dogra

Recently in the Philippines there were a series of indictments, public protests and legal actions when as many as around 600 children were reported to have died after the administration of dengvexia vaccine which was supposed to protect them from dengue. An investigation was announced by the Public Attorney’s Office and the controversial vaccine was banned in the Philippines.

There have been several other recent examples of grave harm being caused by neglect of safety aspects in the hurried introduction or trials of vaccines and drugs in developing countries. Similar public outrage led by local doctors was earlier caused in Kenya as hidden infertility agents were found to have been placed in vaccines meant for entirely different purposes. In a paper titled ‘HCG found in WHO Tetanus Vaccine in Kenya raises concern in Developing World’ John Oller of University of Lousiana and three co-authors wrote, “Published research shows that by 1976 WHO researchers had conjugated tetanus taxoid (TT) with human chorionic gonadotropia  (HCG) producing ‘birth-control’ vaccine . Conjugating TT with HCG causes pregnancy hormones to be attacked by the immune system. Expected results are abortions in females already pregnant and/or infertility in recipients not yet impregnated. Repeated inoculations prolong infertility.” The authors then described how several Kenyan doctors had exposed and opposed this, using several lab tests to collect evidence.

Depo-Provera, a dangerous injectable progesterone contraceptive was widely spread by strong campaigns for use in Africa and also elsewhere for use particularly by poor women of color. In the course of these efforts serious side effects were often ignored, including blood-clots in arms, legs, lungs and eyes, stroke, higher risk of HIV and breast cancer and much else. Why should a contraceptive with so many hazards be used at all and why was its use concentrated on poor and black women, critics asked in anger. Finally, it led to a large number of drug recalls and legal cases.

The phase 3 trials of an experimental malaria vaccine in Africa led to reports of deaths of nearly 150 children and very adverse side effects (including seizures and febrile convulsions) for many more. Again, introduction of Manafricavac vaccine to preventing meningitis in sub-Saharan Africa led to at least 40 children out of 500 developing paralysis. Local newspapers screamed that African were being used as guinea pigs. A report from a village Gouro in Chad said that following the large-scale attack of paralysis suffering children had been removed to a bigger hospital and ministers and officials visited the village to hush up matters.

Explaining the reasons behind the proliferation of various vaccine trials in developing countries, a widely-discussed research paper published in the Annual Survey of International Law 2017 by Sharmeen Ahmed ( titled Human Rights Violations in Health Care Provisions and the Effectiveness of Current Measures) says, “ The cost of new drug development in the US is about $5.8 billion. Ninety per cent of the cost of new drug development is incurred in Phase 3 clinical trials required by the Food and Drug Administration (FDA) in the USA and similar agencies in Europe. In Phase 3 clinical trials tests are administered to human subjects to monitor side-effects and confirm treatment. As a result of the regulating requirements to conduct costly clinical trials in the US and Europe, the relocation of these trials to developing countries with emerging markets where regulatory regimes are laxer, and less costly (takes place).”

It is clear from this that to cut costs more trials may be shifted to developing countries and so it is very important to increase vigilance and improve and strictly implement regulations relating to safety issues in such trials.

The author is a freelance journalist who has been involved with several social movements.

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May 26 2020

Bharat Dogra

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