Aletho News

FDA not fit for purpose – the Makena® fiasco

For years, the FDA allowed a drug to be injected into pregnant women that was neither safe, nor effective. Finally, it has been withdrawn.

BY MARYANNE DEMASI, PHD | MAY 15, 2023

Previously, I wrote about Makena, a synthetic hormone given to millions of pregnant woman, to prevent premature birth. It was highly controversial because there was no robust proof that it was safe or effective, despite having FDA-approval.

Last month, after many years of use, the FDA finally decided to withdraw Makena from the market.

Adam Urato, a maternal-foetal medicine specialist at MetroWest Medical Centre, Massachusetts welcomed the decision, but said it took the FDA far too long.

“I cannot believe we’ve been injecting this hormone into pregnant women for 20 years, all the leading medical organisations recommended it, the FDA approved it – and it took this long to finally acknowledge the drug did not work,” he said.

Urato opposed the use of Makena from the start. He testified before the FDA, he wrote in the media and in medical journals, and helped petition the FDA to withdraw the drug from the market.

Adam Urato, maternal-foetal medicine specialist, MetroWest Medical Centre, Massachusetts.

Preterm birth is a major issue in obstetrics. In the US, one in 10 babies are born prematurely, and accounts for most of the neonatal morbidity and mortality.

Physicians were desperate for a solution, and Makena seemed to hold promise.

It wasn’t cheap though. Makena was 5,200% more expensive than generic versions of the same medication.

Large amounts of public money in the Medicaid program and other health insurance dollars were used to pay for the weekly shots at a total cost of $30,000 per pregnancy.

How it began

The drug maker sought fast-track approval of Makena, citing a 2003 study that was so flawed, the FDA’s own statistical reviewer commented that the drug was not worth approving.

The FDA approved it anyway on the basis that the drugmaker conduct more in-depth research into the medication’s effectiveness.

Then, in 2019 a confirmatory trial found the drug did not work. And by this stage, there were documented harms including gestational diabetes, depression, blood clots and a non-statistical doubling in stillbirths.

But instead of pulling the drug off the market, the FDA allowed Makena to be licensed for another four years.

“It should’ve been pulled immediately,” said Urato. “There were substantial profits for the drug company even after a confirmatory trial found it did not work, so it’s no wonder it was dragging its feet.”

It begs the question…

How is it even possible that a drug, which was neither safe nor effective for pregnant women, was allowed to be on the market for so long?

Urato says it’s a direct symptom of the medical-industrial complex – an entanglement of big pharma, medical organisations, and regulatory agencies – that creates an underlying motive to bolster profits, over health.

“For two decades the drug brought in billions in profits, and that money was used to fund physicians, researchers, professional medical societies, and academic institutions,” said Urato.

This makes it exceedingly difficult, if not impossible, for patients to navigate the healthcare system and know who to trust.

“We need elected officials that are going to put the interests of patients and the public first, and not be tainted, or corrupted by industry. We need to separate our politics and our regulatory bodies from industry funding,” he added.

Lesson learned?

Urato feels vindicated for his work, but says it’s no time for a victory lap. Instead, the Makena fiasco should provide us with tangible lessons to safeguard us against such scientific transgressions in the future.

“We must ‘first do no harm’ and follow the precautionary principle,” insisted Urato.

“When you’re exposing developing babies to synthetic chemical compounds, you can’t just assume it’s safe, until harm is proven. You must assume that the chemicals are having chemical effects on the foetus, because that’s what chemicals do.”

The Diethylstilbestrol (DES) disaster should have been a reminder to all obstetricians about the harms of giving synthetic hormones to pregnant women without sufficient data. But once Makena was rolled out, Urato said, “it was like everyone forgot the past.”

“I counselled my patients on my concerns about exposing them and their babies to a synthetic hormone with unknown short and long-term effects, so I guess I could have been accused of peddling ‘misinformation’,” said Urato cognisant that he was going against medical consensus.

“But what is considered misinformation today, may be scientific fact tomorrow. I helped to prevent a generation of mums and babies in my community from being exposed to a useless drug. That’s why it’s so important that doctors have freedom of speech to express their views,” said Urato.

It’s estimated that hundreds of thousands of pregnant mothers and babies were exposed to the ineffective and risky synthetic hormone over the past 2 decades.

“Time and time again, drugs and devices are pulled off the market for safety issues. If the FDA approves a drug, it does not mean that it will be proven to be safe and effective over time. The FDA has lost the public’s trust,” Urato said.

May 17, 2023 - Posted by aletho | Corruption, Full Spectrum Dominance, Science and Pseudo-Science | FDA, United States