April 08, 2004
The $800 Million Trial
As a former member of the working press, I can speak from personal experience about the lack of critical thinking that accompanies most daily journalism. But today's Wall Street Journal front page story on Pfizer's new cholesterol drug was simply astonishing in its naivete.
The story claimed Pfizer will spend about $800 million on clinical trials to bring its next cholesterol blockbuster to market. The drug, called torcetrapib, raises "good" cholesterol.
Why will this trial cost so much? Deep in the story, the Journal dutifully repeats company claims that it will test 13,000 people for five years, with 3,000 of the patients getting ultrasound imaging tests to reveal what's going on inside their arteries. These tests "will eat up much of the $800 million."
In an email communication, Scott Hensley, one of the Journal writers, indicated some of these ultrasound tests will require cardiac catheterization, an expensive procedure. Okay, let's do the math. Ultrasounds cost about
$250. If each one of those 3,000 patients gets four ultrasound tests per year for the five years in the test, that comes to $5,000 per patient or $15 million. Let's double that cost to $30 million just to be conservative. Then let's throw in $10,000 per patient for cardiac catheterization. That's another $30 million. Let's round the whole testing portion up to $100 million just to be safe.
That leaves $700 million for drugs, doctor visits, record keeping, massaging the data, and whatever else accurate, authoritative clinical trial design requires. With 13,000 patients in the test, that comes to nearly $54,000 per patient.
Jamie Love of the Consumer Project on Technology has done considerable comparative research on the cost of clinical trials. This afternoon, via email, he offered these numbers for the average cost per patient in clinical trials:
* From a Tufts University study: $23,572 (this adjusts the costs for the time value of money)
* From a TB Alliance study: $644 to $22,000 (also time value adjusted)
* From a BMS Oncology study: $10,000
* An NIH Study: $6,202
* DataEdge survey for all Phase III trials (final FDA approval trials like the Pfizer study on cholesterol): $5,465
I suggest Pfizer simply turn the whole process over to the government. They'd save themselves and consumers a lot of money.
But I'll give Dr. Love the final word: "$800 million for a trial is absurd, but since these things are faithfully reported as if they are true, why should they stop making these claims?"