“The U.S. Food and Drug Administration is not involved in setting the price for the drugs it approves.”
- This was the sentence that sent a chill down my spine as I sipped my morning coffee and read an article from the Associated Press last week:(excerpt follows)
A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000. That’s because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved. But recently, KV Pharmaceutical … won government approval to exclusively sell the drug, known as Makena. Makena is a synthetic form of the hormone progesterone that first came on the market more than 50 years ago to treat other problems. The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get. None of them anticipated the dramatic price hike, though – especially since most of the cost for development and research was shouldered by others in the past. “The cost is justified to avoid the mental and physical disabilities that can come with very premature births,” said KV Pharmaceutical chief executive Gregory J. Divis Jr. “The cost of care for a preemie is estimated at $51,000 in the first year alone.” To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years. Some doctors said they were happy getting the cheaper version from compounding pharmacies, and Aetna’s Dr. Joanne Armstrong, the head of women’s health, said she was unaware of any quality concerns. Still, doctors will use the Ther-Rx brand, in part because of legal worries. Not that they have a choice: Last month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug [emphasis added].
Sometimes, the lines between fiction and reality are more than a little fuzzy. So it was both apropos and auspicious that I would be about halfway through The Trial, by Larry D. Thompson when the news broke about this latest injustice in the vicious cycle that is the modern health care system. Mr. Thompson will be introducing The Trial in an upcoming Meet-and-Greet at Barnes & Noble, and in researching the details for our Event Calendar, I was granted the opportunity to receive his latest novel in advance of release for review.
The story opens with a scene that is easily every parent’s worst nightmare, a doctor telling the main character, Luke, that his only daughter is rapidly deteriorating due to her failing liver. We cut quickly to a very different scene which, if played out on screen, could be performed silently with dark, forboding music, as nameless characters play out a murder made to look like a suicide, the purpose of which remains a mystery. If it sounds confusing, take heart; I admit I had to go back and re-read the first forty-odd pages when the time line for one story only progressed a few weeks but for the other flew through several years. But what to some may seem like an oversight in continuity, however, is in reality a genius form of storytelling.
Luke was a trial lawyer in Houston for many of his daughter Samantha’s first 15 years. But countless hours of trial preparation left little time for the single father to spend with his daughter, leaving her mostly to the care of her nanny. After collapsing in court from a perforated ulcer, then losing what was the biggest trial of his career, Luke decides it’s time to make some major changes; he leaves his practice and sells his home in Houston to move to them to his hometown of San Marcos. There he sets up a quiet, one-man office in his home in order have more time for his daughter. But throughout high school she drifts farther away, first fueled by her initial anger at leaving her friends behind, then as teenagers are wont to do, by managing to disagree with anything and everything with her father. Ultimately she chooses A&M for her college studies, but is quickly brought back home when Luke learns his once straight-A student is failing every course.
It’s at this point the two stories begin to converge in the time line. While so much has happened with Luke and Samantha, the inner workings of a major pharmaceutical company for that time period would have been dull at best. Mr. Thompson knows this and starts us at the present when we are introduced to Ceventa Pharmaceuticals, run by a Machiavellian CEO, who easily manipulates an equally greedy yet weak-willed supervisor at the FDA, causing the pure evil of his heartless pursuits to infect and corrupt the very safeguards that were established to protect the public from such complete disregard for human life.
Ceventa wants to release a new “wonder drug” – an antibiotic that could treat everything from pneumonia and bronchitis to sinusitis and tonsillitis. While the FDA’s review board has initial misgivings – after all, older, cheaper and most importantly, safer antibiotics that are already on the market are adequately handling these infections – a clinical trial is ordered to combat those uncertainties and get the drug fast-tracked for approval. It is this same trial that Luke’s daughter unwittingly joins only to have her liver begin failing almost immediately after completing it. And while Luke’s initial reaction to the news is to sue the doctor that enrolled her in the study for malpractice, it soon becomes apparent the root of the problem is far, far larger than one less-than-moral doctor’s actions. What starts as one man’s desperate attempt to save his daughter’s life – and hopefully those of countless other victims – literally explodes in all directions with bribes, cover-ups, shady government employees, courtroom drama, kidnapping, and murder. I won’t tell you how it ends, but I will tell you I read the last 186 (of 306!) pages in one sitting.
I greatly enjoyed The Trial; while at times I struggled with the dialogue (do people ever really address each other by name in nearly every sentence? Did Samantha have to say “Father” every time she spoke to him in order to emphasize she was still mad at him?) and with the narrative (there were times when the characters seemed momentarily dim-witted when recalling information I’d just read three pages back), as mentioned, it wasn’t enough to make me put the book down. Mr. Thompson’s experience in the courtroom as well as his obvious comfort level in the subject matter makes nearly every aspect of the story believable. In fact, it wasn’t until the verdict that reality came crashing back down. I won’t reveal the end, but suffice it to say the odds of the verdict being handed down in any present courtroom is slim to none. I am a die-hard fan of legal and political thrillers, and The Trial fit perfectly into that repertoire. I recommend readers of the same genres pick up a copy of The Trial; and keep an eye on Larry D. Thompson. This is his second novel, and he’s got another couple in the works.
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