Babies put at risk, even killed, in ‘reputable’ studies over the years

The following is a news analysis.

Public health officials and other medical professionals have helped untold millions over the years. But the hard truth is that some have hurt many.

This was a difficult lesson I learned many times when I was assigned to investigate FDA, CDC, NIH and pharmaceutical industry scandals at CBS News.

One of the most heartbreaking early stories I investigated in 2000 was the death of a baby who was given an experimental heartburn drug called Propulsid as part of a study. His death had been ruled a mysterious SIDS (Sudden Infant Death Syndrome) death.

Little Gage Stevens’ parents didn’t know that the drug he took, Propulsid, had been linked to dozens of deaths, including at least one other baby, before Gage even got his first dose. Shortly after Gage died, Propulsid was pulled from the market — linked to more than 300 deaths.

Read the death certificate on Gage.

My investigation revealed that the study consent form falsely stated Propulsid, made by Johnson and Johnson, was “approved by the FDA” for children. In fact, the Food and Drug Administration had repeatedly rejected it for pediatric use.

After my report, the FDA cited Dr. Susan Orenstein, who led the study, for violating federal regulations and good clinical practices.

Read the FDA letter.

Among other problems, the FDA said Dr. Orenstein’s study had poor record-keeping, and that the consent form was coercive and didn’t clearly state the risks. And the FDA said Dr. Orenstein failed to report all serious adverse events, including another baby that showed “symptoms of severe intolerance — screaming spells, crying, pulling legs — after each dose.”

Read the faulty consent form.

Even worse, there is evidence suggesting Gage never even had the illness that supposedly qualified him for the study. Dr. Orenstein originally did a biopsy and told Gage’s parents it confirmed his esophagus was inflamed due to acid reflux. But I obtained those test results and told tell a different story. The biopsy was negative. There was “no evidence of…significant inflammation”.

Read the pathology report on Gage.

So why did Dr. Orenstein put Gage in her study? She wouldn’t say. But sources told me Dr. Orenstein was having trouble getting enough test subjects for her study. In fact, the four-year study had dragged out to seven years by the time Gage was enrolled.

As a result of my investigation in 2000, the coroner changed Gage’s cause of death from SIDS, to his participation in the Propulsid study at the respected Pittsburgh Children’s Hospital. Dr. Orenstein, continued to work at the Hospital after the revelations about the death and the false information on the consent forms.

Johnson & Johnson (Janssen Pharmaceutical) announced it would no longer market its drug. The FDA allowed a several months-long delay before Propulsid was actually removed from the market.

This type of conduct demonstrated by medical professionals is almost unbelievable. It’s one example of why we cannot blindly accept the word, at face value, of everyone working in the medical establishment.

I thought of Gage Stevens and his parents when I investigated a story years later about premature babies, primarily black children, put in an oxygen study that ended up killing some of them. There was likewise nearly unbelievable behavior on the part of reputable study scientists, hospitals, and institutions that led or took part the studies.

After the problems were exposed, the government not only defended the researchers, it moved to shut down the work of the ethics officer inside the National Institutes of Health who tried to flag the improper activities, and it commissioned published articles in journals attacking those who criticized the study.

Incredibly, instead of holding anyone accountable, the government began a campaign to loosen consent standards for studies under the argument that if parents were really told the whole truth about the risks of a study, they would never allow their children to take part. They argued society at large was suffering and that allowing parents of study subjects to be misled would be for the greater good, if not for the individual’s good.

These instances are still hard to believe. But they serve as important lessons about what our public health agencies and figures, and medical establishment experts have done and are capable of doing.

You can read more on the investigations at the links below.


Baby Oxygen Study:

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1 thought on “Babies put at risk, even killed, in ‘reputable’ studies over the years”

  1. Thank you for all your work Sharyl Attkisson. I follow you on social media. I have a google alert set for SIDS and your article has an interesting detail that struck me and is an area to explore. I have been researching SIDS for more than 5 years, and I have tried to understand what the mechanism is such that it occurs to infants who both have classic SIDS risk factors, and those who don’t, both vaccinated and unvaccinated, prone and supine. And one thing that nearly all these infants have in common is the trigger of a cholinergic pathway to death. The drug you are writing about, propulsid, which is also known as Cisapride, enhances the release of acetylcholine. During REM sleep, a person releases the most acetylcholine already. If an infant is taking a drug that increases the release of acetylcholine, it can result in a cholinergic toxicity during REM sleep, which could cause death in and of itself, that essentially looks like a SIDS death, either through excess acetylcholine, or inhibition of acetylcholinesterase. I have written about this, and it matches with nearly every case of SIDS. SSRI drugs also affect an infant’s cholinergic system.

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