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Risky business

In the multiple probes on the dengue vaccine mess, those whetting the knives appear to be interested mostly in sticking the blades into officials of the Aquino administration.

This effort can gain traction only if willful negligence in promoting public safety can be established on the part of those who were responsible for administering the Dengvaxia vaccine to over 700,000 children.

Or else someone might prove that stories proliferating on social media, about overpricing in the P3.5-billion vaccine procurement, are not fake news.

Whether there was overpricing or negligence, the one directly accountable will be the former secretary of health, Janette Garin. How high up command responsibility should go will depend on the current political winds in Congress, Malacañang and the Department of Justice.

Officials have said the probe coverage will include former president Noynoy Aquino. There’s talk that the probe might cover possible fund-raising by Aquino’s Liberal Party through the vaccine procurement.

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Besides pinning blame and determining the culpability of former government officials, any probe will surely also tackle the liability of Dengvaxia manufacturer Sanofi Pasteur. Even without a congressional probe, however, the company is expected to face legal woes, perhaps not only in the Philippines.

Sanofi Pasteur is the vaccine-producing arm of multinational giant Sanofi-Aventis Group, reputedly the world’s third largest pharmaceutical company after Pfizer and GlaxoSmithKline. Sanofi Pasteur produces vaccines for yellow fever, tuberculosis, bladder cancer, polio, meningococcal, Japanese encephalitis, typhoid fever, influenza, tetanus, diphtheria, pertussis and rabies. So when Sanofi-Pasteur announced the development of the world’s first anti-dengue vaccine, there was enough confidence in the company for 18 countries to approve the procurement of Dengvaxia.

Developing a drug is a tortuous, expensive process that can take an average of 10 years, from research to final approval for commercial release into the global market. And even then, there is no guarantee against unexpected side effects or results in the longer term.

In the case of Dengvaxia, the unexpected turned up rather early. It is to the credit of Sanofi Pasteur that it announced its findings to the world.

The announcement would not protect the company from individual and class action suits that are likely to be filed in connection with Dengvaxia. But it might moderate the amount of damage settlement in case the company is found liable.

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At least the Dengvaxia victims will have a company to sue.

I understand the important role played by pharmaceutical companies in making people live longer and healthier. I also understand their need to protect the products of their painstaking research and development from those who ignore global patents and intellectual property rights.

Still, anyone who has suffered the adverse effects of a drug will want redress. Especially if the effects leave permanent scars or cause disability or death.

When I was a toddler I was bitten by a flea from our pet dog. My father, who worked for what was then called the United Drug Co., applied sulfanilamide on the wound.

The antibacterial sulfanilamide, patented in 1909 and first prepared by an Austrian chemist, proved highly effective for reducing wound infection among Allied soldiers during World War II. German bacteriologist Gerhard Domagk won the Nobel Prize in Physiology or Medicine for his work in the development of sulfanilamide as the first commercially available antibiotic.

In 1937, however, elixir sulfanilamide, produced with toxic diethylene glycol and sold without clinical testing by S.E. Massengill Co. in Bristol, Tennessee, killed over 100 people. The scandal led to the enactment of the Food, Drug and Cosmetic Act in the United States.

Modern antibiotics eventually replaced sulfanilamide. Today it is still used, but mainly for vaginal yeast infection, and the drug comes with numerous warnings against allergic reactions and other side effects.

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There must have been no such warnings when my father applied the drug on my tiny fleabite, hoping for quick healing with no lasting mark on my baby skin.

Instead my entire body including my mouth and throat erupted into pus-filled blisters. My mother told me I had difficulty eating and I nearly died. Every day during my month-long confinement in the hospital, she carefully peeled off dead skin from drying blisters while I wailed in pain.

Each blister left a discolored patch of skin, like burn marks, some of which took over two decades to vanish. Some of the marks are with me forever.

Doctors told my parents that it was a severe allergic reaction to sulfanilamide, and warned that I should avoid all sulfa drugs for the rest of my life.

Did I have a unique reaction to sulfanilamide? Was it just my body, or was it the drug?

I had no way of knowing. My misfortune was choked up to the will of the heavens; my parents were happy enough that I survived.

Sometimes I wondered if anyone else went through the same hell, which would indicate that the reaction to the drug was not unique and its manufacturer could then be held responsible.

S. E. Massengill, however, is no more. I’m also not sure about the statute of limitations for damage claims in my case. Founded in 1898 by a graduate of medicine, Samuel Evans Massengill, the family-owned firm was acquired by Britain’s Beecham Group in 1971. A merger created SmithKline Beecham in 1989, which also merged in 2000 with Glaxo Wellcome to become GlaxoSmithKline.

Big Pharma has had its share of flak, scandals and disasters. These are inevitable in developing drugs, but these do not exempt the companies from liability. It’s basically trial and error, a risk taken by both pharmaceutical firms and the people who take drugs in hopes of being cured.

All these issues will be considered in the face of the Dengvaxia mess. There are no easy answers.

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