When Pharma Use the Defence of the FDA

Fascinating exchange of views on Twitter between myself and a market analyst for Canadian pharmaceutical company, Duchesnay Inc.

Earlier in the day I had wrote about celebrity Kim Kardashian and her promotion of Duchesnay's morning sickness medication, Diclegis.

Diclegis is a combination of pyridoxine and doxylamine. Pyridoxine/doxylamine was first marketed in the U.S. in 1956, back then it was branded as Bendectin (Debendox in the UK). It was developed in the mid-1950s by the Wm. S. Merrell Company of Cincinnati, Ohio and, just like Diclegis, was aimed to help with nausea and vomiting during pregnancy.

Controversy surround the drug and lawsuits were filed against the makers claiming birth defects. One such case was JEFFREY BLUM, a minor by his parents and natural guardians, JOAN and FRED BLUM, and JOAN and FRED BLUM, in their own right VS. MERRELL DOW PHARMACEUTICALS, INC.

It was a case, as you will see further on down this post, that Duchesnay's market analyst, Danny Martel, used as a form of defence to support his opinion that I, apparently, needed to "Educate myself".

In Blum vs Merrell Dow we saw three decisions. Merrell Dow and, it appears, Danny Martel, feel confident enough to raise the issue of the third decision.

Here's what happened. This is straight from the court document, which can be found here.

Jeffrey Blum was born with clubfeet, which would require eleven surgical procedures in thirteen years, James Newberne, Merrell Dow Vice President for drug safety, was addressing the Maternal Advisory Committee of the Food and Drug Administration. He testified unequivocally that Bendectin was safe for maternal use during pregnancy. He under-represented the incidence of clubfeet found in animal studies. He overstated the number of animals studied. He failed to disclose that an inadequate number of animals had been tested, or that test animals had died due to improper care. He did not disclose that dosing accidents had killed test animals. He did not reveal that the tests were scientifically inadequate due to insufficient dosing levels. He did not tell the FDA that he was not proud of Merrell Dow's testing procedures. He did not reveal that Merrell Dow "chose" what information to report to the FDA, or that relevant testing on Bendectin was hidden by being reported to the FDA. Fifteen years later, at this trial, a jury of twelve citizens learned the rest of the story.

After nine weeks of testimony in 1986, a jury found that the drug Bendectin, taken by Joan Blum to control morning sickness in pregnancy, was a legal cause of Jeffrey Blum's clubfeet. That jury awarded one million dollars in compensatory and one million dollars in punitive damages.

Sadly, for the Blum family, Merrell Dow appealed the decision and 7 years later, in 1993, the Supreme Court reversed that verdict.

It was a point of law that they used in their favour. In the original trial (1986) one juror of the twelve became ill and the Judge proceeded with 11 jurors. Merrell Dow successfully argued in 1993 that they were denied their "constitutional right"

The whole case was sent for a retrial and, in 1994, the outcome (again) was in favour of the Blum family. This from the court document...

After seven weeks of evidence, twelve jurors rendered a constitutionally valid, unanimous verdict awarding Joan and Fred Blum two hundred thousand dollars for medical expenses. They also rendered a constitutionally valid unanimous verdict of four million dollars as compensation for the pain and the disfigurement and the emotional affliction Jeffrey Blum endured during his twelve  years of life prior to trial, as well as for all the injury he will suffer for the remainder of his life. The jury also awarded fifteen million dollars in punitive damages. Following this verdict, damages for delay pursuant to Rule 238 were awarded in the amount of four million, nine hundred eighteen, one hundred forty seven dollars ($ 4,918,147.00).

So, let's put this into some sort of context. Two trials, both ruling in favour of the Blum family, both awarding damages. What did Merrell Dow do next?

Well, this is where it gets all legal.

Merrell Dow sought a Judgment Notwithstanding the Verdict; or, in the alternative, a new trial.

I had to do some research on this as I wasn't quite sure what it meant.

In layman's terms it means they are saying, in US football terms, that the jury’s decision is not rational, outside the 10-yard lines, so the judge needs to weigh in and bring it back in line.  Normally, there is some issue of law that the jury disregarded and the party unhappy with the verdict frames their motion for judgment notwithstanding the verdict around that issue of law.

There were lots of points of law raised and, sadly, the outcome was not favourable for the Blum family. The verdict was reversed with instructions to the trial court to enter that judgment in favor of Merrell Dow.

At this point, I think I should mention the severity of clubfeet, or at the very least show a picture of what clubfeet looks like.

Here's an image of a relatively newborn child with clubfeet.

The plaintiff in the above case, Jeffrey Blum, required eleven surgical procedures in thirteen years.

Now, moving on to the Twitter correspondence with  Duchesnay's market analyst, Danny Martel.

Martel had decided to join in on a thread of discussion regarding Kim Kardashian's promotion of Diclegis. I do like to debate with pharmaceutical employees, even market analysts. You'll note Martel's insistence that I should "educate" myself.

Bizarrely, Martel entered into debate then removed all of his comments. Fortunately, for me at least, I saved the comments.

One thing that I find rather irksome of pharmaceutical companies is their inability to give straight answers. Martel, as you will see, was kind of evasive when I pushed him for an answer (personal answer) on whether or not he could confirm, for the record, that Diclegis cannot cause birth defects. This is where we see pharmaceutical companies and medicine regulators form 'as one'.

Here's the conversation.

Click to enlarge

It appeared that Martel could not, or just would not, commit himself to giving me a personal answer (for the record)

I flicked him a message after I learned he had removed the thread. Sadly, he never replied.

My issue here is, and has always been about informed consent. Just how much information did Duchesnay give to Kim Kardashian. Did Kardashian ask the same question that I did, if not, why not?

FDA approved Diclegis (Duchesnay Inc.) carries the same compounds as Bendectin, a drug that was voluntary removed from the market thirty years ago.

Thalidomide 

As the story of the thalidomide debacle unfolded, the FDA decided to look through its files to see if they had any adverse reactions reported that bore any resemblance to those of the thalidomide side effects. They found four that bore a striking similarity.

• Infant born 1/15/61 Missing left thumb and right thumb. Club foot and heart disorders.
• Infant born 12/22/60. Absence of left arm, some metarsus varus of the left leg, left side of face flattened, both hands missing index fingers, bilateral club foot.
• Infant born 5/10/62 Nasal bone with no )airway. Fibulars missing from both legs, no knee caps or ankle bones, red mark on forehead between eyes.
• Infant died 4/10/62 Atresia of extremities, imperforate anus

All four reports came via mothers who had taken Bendectin during their pregnancies.


I think it only fair that someone as uneducated as I should offer balance.



Bob Fiddaman.


Back story

Kim Kardashian on the Pharma Payroll

Related

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?