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President Trump’s Idea to Limit the FDA Could Have Disastrous Results

GettyImages_50674351_helixBefore a televised audience, President Donald Trump told assembled pharmaceutical executives that drug prices needed to come down. Sounds good so far, right?

But in the next breath, he offered the public’s well-being as a trade-off. He said he plans to streamline the regulations that pharmaceutical companies complain leave them hamstrung. You know, those pesky regulations imposed by the FDA that cause delays in getting drugs to the marketplace?

According to Trump, there are some drug companies that “employ more people to deal with those regulations than they have doing actual work for the company.” As the Huffington post put it, “I only have two words to say: Remember thalidomide?”

The only nonbarbiturate sedative on the market from 1957 to 1962, thalidomide was a wildly popular sleep aid. Unaware of the risk for birth defects because of inadequate pre-market testing, pregnant women started taking it to treat morning sickness.

By the early 1960s, 20,000 babies were born with missing or shortened limbs because their pregnant mothers took the drug. Thalidomide was also blamed for more than 90,000 miscarriages.

The thalidomide tragedy was the catalyst for the rigorous drug approval and monitoring systems in place at the FDA today ― the very ones that Trump wants to sidestep to speed up the drug-to-market process. All of which makes remembering the story of thalidomide crucial.

It Was As Common As Aspirin

Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based on the maker’s safety claims. The company, Chemie Grünenthal, advertised it as “completely safe” for everyone, including mother and child, “even during pregnancy.” Its developers boasted that they “could not find a dose high enough to kill a rat.” Within three years, thalidomide was being sold in 46 countries, with sales nearly matching those of aspirin, Northwestern University’s Helix magazine reported.

But thalidomide was far from safe. An estimated 20,000 babies were born with severe physical disabilities, including flipper-like arms and legs. Heartbroken families were sometimes forced to institutionalize their newborns. Add to that another 90,000 miscarriages linked to the drug.

Then links surfaced that the thalidomide research originated in Nazi concentration camps from doctors who worked there.

Credit Goes To One Researcher

The thalidomide scandal did not reach the United States, something that is largely credited to Dr. Frances Oldham Kelsey, a young pharmacologist at the FDA who in reviewing the drug for approval became alarmed by the lack of rigorous scientific research supporting the drug’s safety claims.

Once she examined the research carefully, the case for thalidomide quickly unraveled. She kept asking the company for more data, delaying approval. In late November 1961, long-ignored evidence became public in Germany linking thalidomide to birth defects. Grünenthal, which in a court case years later blamed causes like nuclear fallout or botched home abortions for the children’s deformities, did not apologize to the victims and their families for more than 50 years.

Because of Kelsey’s perseverance, the drug never received FDA approval and in 1962, it was banned worldwide. But something else happened too. It ushered in a new era for the FDA, which finally forced major regulatory oversight on the pharmaceutical industry, much of which is still in place today. Now, drug approval can take between eight and 12 years, involving animal testing and tightly regulated human clinical trials.

For that, we can thank the thalidomide crisis. It behooves Trump not to ignore it.

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