Something Smells Fishy

I was rummaging through the medicine cupboard (outgrew a 'cabinet' long ago!) and a pack of Zicam nasal swabs fell down and hit me on the head.

 

Oops! thought I to meself. I forgot this was here. I need to throw it out.

But before I did, I decided to check on the current status. Has Zicam actually been recalled yet?  Because the last time I checked (which was some months ago), people were complaining that Zicam had caused them to lose their sense of smell, and the manufacturer of Zicam, Matrixx Initiatives, was pushing back pretty hard, saying it was perfectly safe and the hundreds of complainants were all making it up.

Around that time, I got quite engrossed with the unearthing all the herbal remedy scams I had found and I stopped following the Zicam stuff. I actually forgot about it until one fell on my head.

(Hello, Mr Newton)

So it turns out, I had stopped following the story right before the FDA stepped in. Sometimes the FDA, being big and lumbersome, is a bit slow to respond.  Anyhoo, the FDA set a letter to Matrixx, telling them to cease manufacture of three products, and on the same day, they issued a consumer warning about the same three Zicam products. The following is only an excerpt:

On June 16, 2009, the Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.

Intranasal products are administered through the nose.

What products are affected by this warning?
FDA's action affects Zicam’s three intranasal products that contain zinc. The three Zicam products claim to reduce the duration of the common cold and the severity of cold symptoms.

The products (listed with their size and product numbers) are

• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)...

...Why did FDA take action?
The agency has received more than 130 reports of anosmia—the loss of sense of smell—associated with use of these three Zicam products.

So yes, I should officially throw out that Zicam. And unlike my secret (and dwindling) stash of VIOXX, I actually will.

But I still had some questions about how Matrixx Initiatives have handled this whole incident and continue to handle it. They did not immediately recall the product when the complaints first started. Instead they waited until AFTER the FDA sent them a letter TELLING them to withdraw the product. And even then, they were protesting all the way!  See this story from US News, particularly their response to the writer's e-mail.

And on their website, in the Frequently Asked Questions page, there is this little gem (the question is "what research has Zicam done to show that its Cold Remedy nasal products do not cause loss of smell?")

The safety of Zicam Cold Remedy is substantiated with multiple studies:

(1)    An epidemiological study demonstrates that three of the most common conditions associated with anosmia are the common cold, sinusitis, and nasal injury.  This population study in 3.7 million patients demonstrated statistically significant associations between anosmia and numerous medical conditions and multiple classes of drugs.  These factors confound any attempt to attribute an association of anosmia with Zicam Cold Remedy zinc gluconate nasal gel.

(2)    Anatomic and behavioral data obtained in animal studies showed no detrimental effects on smell associated with single doses of Zicam intranasal zinc gluconate gel equivalent to between three and 6x the recommended dose for humans.  Even at doses up to 15x the recommended dose, little or no effect to detect odors was uncovered.

(3)    Human in vivo and cadaver studies using our dosage form and nasal pump delivery device confirmed that Zicam intranasal zinc gluconate gel does not reach the upper area of the nasal cavity where smell reception occurs.

(4)    Four peer-reviewed clinicals of intranasal zinc gluconate gel products showed no difference in olfactory function between the treated and placebo subsets.

...and another answer to an FAQ (in response to a "frequently" asked question about the "unpecedented" FDA action:

We believe it is unfair for any Federal agency to take the kind of precipitous action it took against the company in a situation like this.  Had it talked with us, we would have shared with this regulatory body the compelling data and information showing that Zicam Nasal Gel and Gel Swabs are not unsafe.

WHAT? 

As I brought it up already, let's look at the VIOXX recall in comparison to this one: Merck noted in their OWN data that there was a small chance that VIOXX caused heart problems, so it voluntarily recalled the product first, then told the FDA and everyone else. Even though this decision probably cost them billions of dollars, they did the right thing. I don't usually have much good to say about Big Pharma, but I have to hand it to Merck here. They realized there was a chance that  people were being hurt by the product, and they did the right thing. They put people and reputation before money. ..and yes, OK: They probably thought it might avert some lawsuits (It probably didn't. This is America, people).

Unfortunately, the FDA needs to rely on manufacturers to do the right thing. They have limited resources, so they can only audit every two years.  If a problem is noted right AFTER an FDA audit, there is two-year window before the FDA will find it (unless complaints direct from the public or medical community start flooding in). Therefore, the FDA needs to rely on the decency of the drug companies to report issues, because most people and doctors who find a problem with the drug will report it to the drug company first, and may not report it to anyone else. As I pointed out before, Many people -particularly consumers- don't know they can report directly to the FDA and many doctors won't bother -particularly as Zicam requires no prescription.

So, this is directly to Matrixx Initiatives about their whining: The FDA took this action because they had no choice. You were not only ignoring the complaints, you were trying to dispute them. The FDA had to step in to protect people (and children -there was a children's version on that list!) because you refused to.

And now you have the nerve to whine about it? 

Grow up!

But I'm not finished. Here is another little gem from Zicam's FAQ page. This in response to a question about consumer complaints being withheld from the FDA:

Matrixx has always cooperated fully with the FDA, willingly shared all information requested by the FDA, and fully complied with its understanding of the FDA’s regulations. Any reports to the contrary are simply not true. As required by FDA regulations, Matrixx has always maintained detailed records of all consumer complaints and followed up with them. In the past four years the FDA has conducted two audits of the company, most recently in May 2009. During each audit, Matrixx made available to the FDA all adverse event complaints received by the company, along with complaint trends. These included all consumer complaints alleging loss or diminishment of the sense of smell.

Let's read between the lines here, and remove some of the spin.

...and fully complied with its understanding of the FDA’s regulations

Translation: we didn't KNOW we had to report adverse reactions to the FDA (yeah, right)

As required by FDA regulations, Matrixx has always maintained detailed records of all consumer complaints and followed up with them.

...but not actually SHARED them with anyone, like other consumers or the FDA.

In the past four years the FDA has conducted two audits of the company, most recently in May 2009. During each audit, Matrixx made available to the FDA all adverse event complaints received by the company

OK that makes sense, the FDA audits biannually. The timing is very interesting here, don't you think? The FDA audits them in May '09, then issues the warning in June '09.  Why?  Because Matrixx didn't report the adverse complaints voluntarily, that's why. Instead, they waited for the FDA to go in there and find them.

Let's just imagine the scene:

FDA Guy:  "hey, Mr. Matrixx Executive, What's in this folder tucked in here at the back of the drawer?"

Matrixx Executive (breezily):  "Oh that's nothing.  Just some positive consumer feedback.  ...er.  Have you any plans for the weekend?"

FDA G.: "Well let's take a look." (starts to remove the folder and open it)

M. E.:  "No!" (starts to move towards the FDA guy, hand outstretched to take the folder, thinks better of it, stops and clasps hands awkwardly) ...it ...it's nothing really..."  (sees the FDA guys face) Oh. You mean THAT folder?  The red one? That's the complaints folder. I was just about to show it to you..."

FDA guy: (scanning the contents) "Some of these are pretty serious. Loss of smell? How come I have no record of these?"

M.E. "but we followed up with all of the customers. We're not supposed to tell you about this stuff, are we?   I thought that.. I mean, well... (claps hands, smiles, attempts lightheartedness; -fails) ...you know about it now!

...Hang on a tick. I need the bathroom..."

(Matrixx executive rushes from the room, looking ill. However, he heads towards the CEO's office, in the opposite direction of the bathroom)

(I should write for (bad) TV. My friend AM always said it.)

And so the FDA action was taken.

One might wonder why Matrixx were so reluctant to report this adverse data and recall the products. Well the answer is very easy: Money. Have a look at their stock price. 

June 15th: $19:24
June 16th: $05.78.

Note that the volume spiked hugely too, in what was obviously an enormous selloff.

If I take into account that MTXX now have about 9.46 million shares out there,  we can estimate that the company was devalued by approximately $127 million dollars in one day in the US alone. (there are at least two other listings on other exchanges, but I didn't check them. I am pretty confident the Matrixx stock price didn't rise anywhere in June).

That's $127,000,000.00.  Just in the US.

Ouch.

So unlike Merck, Matrixx put money before people or reputation.  But you know, I bet if they had done the right thing, they would have lost less money. In fact, as a former Wall Streeter, I can almost guarantee it.  believe it or not, the market does actually take notice of things like corporate responsibility.

Speaking of corporate responsibility: I noticed when researching the stock price stuff that there was a change in principal officer. Great!  I thought They are cleaning house. But no. Instead they are promoting the guy who was acting helmsman at the time of the FDA action, to official helmsman.

Nice.

I have now decided not only to throw out the nasal swabs. But I will also throw out the (not-recalled)  Zicam tablets I got for the kids, too.

I'd rather deal with a cold than use their product

P.S. I had to laugh: When spellchecking this piece, the spellchecker, which did not recognise "Zicam" as a word, kept suggesting "Scam" as the alternative! 

P.P.S. Matrixx have until Sept 15th to respond to a class-action lawsuit (the first?) Let's watch the stock price then, shall we? 

Just for a laugh...

Comments

[Diane J Standiford]

Yes, even spell checker knows the truth!