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posted on 11 December 2015

Why Did Thalidomide's Makers Ignore Warnings About Their Drug?

from The Conversation

-- this post authored by Garry Gray, University of Victoria

In the 1950s, German company Chemie Grünenthal developed a "wonder drug" sleeping pill that it marketed around the world as safe for everyone, including expectant mothers. This mild sedative was also found to mitigate the effects of morning sickness, resulting in increased use by the population that turned out to be most vulnerable to its risks.

Shortly after the drug came on the market, reports of infant deaths and startling birth malformations were made worldwide. Grünenthal rigorously denied thalidomide's association with these adverse effects for a long time.

It took until 1962 for the pill to be banned in most countries and decades of extensive legal battles ensued. More than half a century later, the thalidomide crisis is continuing to shed insights on pharmaceutical ethics, scientific integrity and professional wrongdoing.

Scientists are people too

Fifty-six years after the first known victim of thalidomide was born to a Grünenthal employee, the company's chief executive officer Harold Stock issued an apology, which did little to appease victims.

Stock said Grünenthal researchers had conducted all possible tests on thalidomide based on latest science. This is directly contradicted by the work of Dr Frances Kelsey, who in 1960, despite pressure from supervisors at the Food and Drug Administration (FDA), refused thalidomide's application for sale in the United States.

She noted important gaps in the data used to support the claim that thalidomide was safe for pregnant women. Kelsey's training in pharmacology helped her notice the lack of evidence. So if Kelsey saw the obvious shortfalls in thalidomide's safety profile, then what did Grünenthal scientists know, or ought to have known?

Francis Kelsey was a hero for refusing thalidomide's application. Reuters pictures

Conventional wisdom suggests that scientists do science; that they are specially trained professionals who conduct research in a way that systematically explores the unknown, minimises bias, and reaches beyond assumptions using latest information and technology.

Whether they work in universities or pharmaceutical companies, scientists are supposed to be governed by scientific principles before anything else. Kelsey demonstrated this principle when she resisted pressure from above. But given her heroine status, this may be the exception and not the norm.

For pragmatic scientists who depend on their employment or research funding, these principles could be compromising. Relaxing them can be rationalised as normal or acceptable, with hidden biases taking root and impacting how they conduct research and subsequent results.

Subtle decisions (often perfectly legal) can distort medical research and corrupt scientific knowledge. With most of us believing we are "good people", it follows that scientists may resist acknowledging their subtle shifts in approach and there are always reasons to explain it away.

Grünenthal's alleged "omit then deny" strategy fits this perfectly.

By not conducting the tests Kelsey inquired about, Grünenthal could free itself from evidence that would limit its market for the drug. By claiming it was not normal practice to test for the effects of medications on developing fetuses, Grünenthal could argue against any obligation to conduct these tests.

Indeed, the claim that these tests were uncommon formed one of the pillars upholding Grünenthal's denial of responsibility.

Corporate culture and Nazi war crimes

Some have speculated that Grünenthal's culture was tainted because several World War II Nazi war criminals - including Otto Ambros, a scientist found guilty of mass murder at the Nuremberg trials - had been employed there.

But how much should we rely on this "bad apple" narrative when trying to make sense of the thalidomide crisis?

Grünenthal employee Otto Ambros was found guilty of mass murder at the Nuremberg trials. By US Army photographers/Wikimedia Commons, CC BY

The reality is that many pharmaceutical companies have and continue to be fined, charged, and accused of unethical behaviour related to production and marketing of their drugs.

The scientists who conduct research on these drugs and become tied up in unethical practices are less often like Nazi war criminals, and more often like us. They take pride in their work and have no intention to harm others. But they face pressures that lead to compromises with implications they may choose not to consider.

Complicating matters is the unique set of risks faced by scientists who speak up for public safety against the wishes of their funders or superiors. In doing so, they risk their reputations, employment and future funding opportunities.

German paediatrician Dr Widukund Lenz was allegedly threatened with legal action by Grünenthal after he suggested a possible link between thalidomide, while it was still being sold, and birth deformities.

Allegations have also been made that Grünenthal attempted to corrupt science by blocking medical publications. In one case, they were allegedly successful at convincing a medical journal to purposely delay publication of an article by neurologist Dr Horst Frenkel that demonstrated thalidomide's negative side effects. Again, the drug was still being sold at this time.

Attempting to corrupt the scientific process is not something unique to this particular pharmaceutical company. In fact, attacks on scientists and attempts to distort science are a growing concern.

The story of Canadian scientist Nancy Olivieri especially highlights the tremendous personal costs scientists face speaking up for public safety. The drug company partially funding Olivieri's research (that planned to market the drug after trials) threatened her with legal action if she followed through on her ethical obligation to inform patients and the scientific community the drug she was testing on them was potentially toxic and could be ineffective.

But, like Kelsey, Olivieri went ahead despite "severe consequences". She received the 2009 AAAS Award for Scientific Freedom and Responsibility for her

"... determination that patient safety and research integrity come before institutional and commercial interests".

What now?

More than half a century after the thalidomide crisis, we are still haunted by the opportunity for compromised science.

Just this year, doctors raised red flags on another popular drug for morning sickness (called Diclectin in Canada and Diclegis in the United States) that is being prescribed in as many as 50% of live births in some countries.

Concerned experts claim the published results on Diclectin overstate its benefits, understate its risks, and ignore safer (and cheaper) vitamin alternatives.

Research integrity and the institutional structures that support scientific research are key to understanding and eliminating scientific compromises. Without this understanding, we can't truly progress beyond the "Grünenthal science" that underscored the thalidomide tragedy.

Stay tuned for other instalments in the thalidomide series this week.

The ConversationGarry Gray, Assistant Professor, Sociology, University of Victoria

This article was originally published on The Conversation. Read the original article.

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