Wake Up, Joe
Let’s say you’re a drug company executive. That’s right – you’ve got piles of money that would make Donald Trump blush like a smitten schoolgirl.
Now let’s say you devote millions to the development of a drug that starts to get a reputation for safety problems even before it’s submitted to the FDA for approval.
And let’s say that further down the line the FDA discovers instances of fraud in a major safety study of your drug. In fact, you turn on NPR one morning to hear that the doctor who enrolled the largest number of study subjects was sent to prison for fabricating false data about the study!
That would seem to be plenty enough to doom a new drug right there. But the bad news isn’t over yet. Let’s say on another morning you open up the New York Times to read this: An FDA report concludes that when representatives of your company became aware of safety problems they didn’t inform the FDA, but the agency later discovered that little indiscretion on its own.
With all these revelations flying, you’ve got to figure your drug will never see the light of day, correct?
Well not exactly.
As an e-Alert reader, you actually do have something in common with a drug company executive: Unlike the Average Joe who still believes the FDA rigorously protects consumers from unsafe medications, you have a good idea how this outrageous story will play out.
Who could have predicted?
The drug company is Sanofi-Aventis and the drug is telithromycin, better known by its brand name: Ketek.
Ketek is an antibiotic that treats bacterial infections associated with sinusitis, bronchitis and pneumonia. After the safety concerns and outright fraud described above, was it approved by the FDA? Of course it was! And now – two years after approval – some ugly chickens have come home to roost.
Here’s the latest box score for Ketek adverse effects, according to a 6/29/06 Reuters report:
The FDA has received 12 reports of acute liver failure linked to Ketek. Four of those patients died. One patient required a liver transplant
So, of course, the FDA response was swift and the drug was immediately taken off the market. I mean, getting rid of a sinus infection isn’t worth risking acute liver failure, right? It’s not like this is the cure for cancer, after all.
Well, that’s the response the Average Joe might expect. Actually, the FDA simply announced that Sanofi-Aventis decided to add a new warning to the drug’s information flyer.
Don’t you feel safer already?
Loss of consciousness
Last week, the antibiotics hit the fan.
Sanofi-Aventis execs and FDA officials may have thought this scandal was going to quietly go away, but a 7/18 New York Times report exposed a heated Ketek debate going on behind the scenes at the FDA.
The Times states that liver failure has occurred in 14 patients, and 23 others experienced serious liver injury. The Times also notes that Ketek may cause blurred vision and loss of consciousness. So it’s no surprise really that SOMEONE at the FDA is up in arms about this drug.
That someone is Dr. David Graham, associate science director of the FDA’s Office of Drug Safety. As I’ve noted in previous e-Alerts, Dr. Graham’s opinions have frequently run contrary to official positions of the agency, and the Ketek problem is a perfect example.
The Times piece quotes from e-mails written by Dr. Graham: “We don’t really know if the drug work sand we’re flying blind as far as safety goes.” He also notes that FDA adverse drug reaction data on Ketek suggests that the drug is “uniquely more toxic” than most other drugs.
Yikes! Not just toxic, and not just more toxic, but UNIQUELY more toxic! That’s got to be a new low in characterizing a drug.
So why is Ketek even on the market? Dr. Graham: “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned.”
After reading that, if there’s an Average Joe out there who still believes the FDA is a guardian of safety, he can at least take a tiny shred of comfort in this news: The Times reports that when an FDA safety official called on Sanofi-Aventis to stop testing Ketek on children with ear infections, the company announced a “pause” in pediatric clinical trials.
A pause! Obviously they’re going all out to insure (the appearance of) safety.
“US Cites 12 Liver Damage Reports in Ketek Patients” Reuters, 6/29/06, reuters.com
“Approval of Antibiotic Worried Safety Officials” Gardiner Harris, The New York Times, 7/18/06, nytimes.com
“Questions Surround Safety of FDA-Approved Drug” Morning Edition, National Public Radio, 7/19/06, npr.org