Sunday, July 18, 2010

Total Recall: When it's back, will you buy it?

The series of recalls of particular lots of liquid Infant and Children’s Tylenol, culminating in the final “whatever you have—chuck it” advisory of April 30, 2010, has crossed my mind a lot lately.

But, it was only two days ago, when I was speaking to a woman at McNeil Consumer Healthcare, the division of Johnson and Johnson that makes the recalled products, that I had to confront a question head on.

“Would you like to leave your email?”

I’d just been told they’d send me a check for $21, more than this stay-at-home mom earns in a month—because I’d given the NDC numbers of the few bottles of the stuff I still had stashed in a travel bag.

“Why do you want my email?” I asked.

“So we can let you know when the products are back on the shelf.”

Did Johnson and Johnson, which, to its credit, emerged from the cyanide episode of the 1980’s respected for how it handled the recall, think I was now pacing the drugstore aisles, anxious to get my brand name fix?

Sometime around the B. cepacia bacteria recall of September 2009 (found in the raw material but, according to the FDA, not the finished product) and the tiny metal particles and wrong amount of active ingredients recall of late April, I began buying the generic version of pediatric Tylenol and Motrin. It’s less expensive, and so far, the companies that make them have not been referred to the FDA crime division.

Why, exactly, am I supposed to switch back?

I do have a peculiar soft-spot for that red box with the photo of a mother and child. My pediatrician’s office handed it out as freely as lollipops and stickers. It’s what I’ve reached for in the darkness when a soft whimper signaled a fever brewing in one of the girls’ bedrooms. I associate that red box—and yes, even the name TYLENOL, with the end of discomfort: a fever subdued, a toothache calmed, and a baby, at long last, back to sleep.

And, Johnson and Johnson is a local company. The headquarters in New Brunswick is twenty- five miles from my house, the McNeil plant in Fort Washington, Pennsylvania, less than forty. My friends work, or have worked there, and, as much as I am happy the FDA is stepping up to the plate, I’m saddened to see a business with this much connection to my own area stumble.

Besides the concern for the health of those who took the medications, I am disappointed that a company that gives people jobs and supports a community has failed. It’s not so much about looking out for the little guy, or the schadenfreude of seeing a giant tumble, it’s about wanting to believe in some sort of dignified competency. For the same reasons people love the feel-good story of Captain Sully Sullenberger, perhaps we get angry when sloppy quality control leads to avoidable failures.

In trying to make sense of this issue, I’ve read several articles online, and I always look at the comment section afterward. Adults who finished off entire boxes of the now recalled Tylenol Arthritis Pain, found to contain 2,4,6-tribromoanisole (TBA), write of being riddled with the classic symptoms of stomach pain, vomiting and diarrhea. Pregnant women, taking recalled products, thought their symptoms were morning sickness. Once, I found a post from a man who works at the plant in Fort Washington, the one voluntarily shut down by J&J, and as announced July 15—about to see 300 of the 400 employees let go. He wrote of the fact that the men and women who work there are parents and grandparents, too.

So, I don't want to be glib about this subject or climb too high on my lunchboxes without wondering what it’s all about.

First, how dangerous has this been for our health?

In every McNeil press release, and by the FDA’s own account, the chance of adverse health effects has been stated as remote. According to a May 26 article in The New York Daily News, the FDA, “does not consider the 775 reported adverse events a ‘spike’ " and the seven deaths reported since April 30 are still under investigation. As I learned with the post on the vaccine Gardasil, it’s hard for someone like me, in the nonmedical community, to put this particular type of information in context.

For the recall of adult medication, the prime culprit has been reported to be 2,4,6-tribromoanisole (TBA). I have never seen this substance mentioned on the press releases describing the recall of liquid  pediatric medicine. Yes, for Children’s Tylenol Meltaways (bubble gum flavored) see recall of July 8, 2010, but not for the liquid pediatric OTC’s. I’d love for CEO Bill Weldon to clarify this issue for me, and maybe when he’s done doing interviews for Fortune, he’ll find time for Lunch Box Mom.

In the meantime, what is TBA and how did it become such a headline maker?

McNeil describes their discovery of TBA in a letter sent to the FDA on February 5, 2010. The once CONFIDENTIAL letter, which is now posted on the FDA website, is in response to the January 8, 2010 Warning letter, and  January 15, 2010 “483” the FDA issued after inspecting a McNeil plant in Puerto Rico.  A 483 sounds a lot like a progress report or failing report card; it means the FDA found a plant to be not complying with, or actually violating good manufacturing practices.

In its response, McNeil says they hired an external forensic laboratory, and eventually traced the troublesome TBA from certain bottles to wood pallets, “and then, more specifically, to wood used to build the pallets that was sourced from (blacked out) and treated with 2,4,6-tribromophenol (TBP). From literature, we know TBP can lead to the formation of TBA under certain environmental and handling conditions..” and this led to the recall on January 15, 2010.

Why did McNeil need to explain this?

In the FDA’s January 483, they chastised the company for taking too long to investigate complaints of musty odor and subsequent gastrointestinal upsets. It said McNeil had been receiving a “heightened number” of complaints in 2008 but did not conduct a formal investigation. In September 2008, the FDA says McNeil concluded, “based on macroscopic and microscopic examination the odor does not originate from the presence of microorganisms in the product or container closure. Your (McNeil’s) quality unit failed to conduct additional testing to evaluate the possibility of chemical contamination or other change or deterioration in the distributed drug product. No field alert was generated in 2008 for the distributed drug product.”

Ok—back to the issue.

TBP is used to treat wood, and in certain environments it is turned into TBA by microbes. As intimidating as these words sound, there is another realm in which they sound less related to beakers and more to wine glasses. You’re heard of wine taint?

I called a specialist out in the wine country to help put this in layman’s terms. Essentially, some substances are treated with 2,4,6-TBP (2,4,6-tribromophenol); it can preserve wood, be a fire-retardant, or a fungicide. When TBP comes into contact with the very fungi it is designed to kill, the fungi can do something to it called biomethylation, which means, in an effort to defend themselves, they turn 2,4,6-TBP (toxic to them) into 2,4,6 TBA (2,4,6-tribromoanisole) which is non-toxic to them. But, very, very stinky to us.

And, this is what McNeil is referring to when they said that after great investigation, and many months, they determined what was causing the problem.

Interestingly, the wine industry has been dealing and combating this problem for a long time, and the ubiquitous presence of chlorine (a precursor to TBA) has only made it worse. And, it’s pretty easy to find well written articles online, written by experts, detailing the precautions a winery must take to keep this devastating problem at bay. (Including inspections and testing for TBA, sanitizing to eliminate the fungi that can cause TBA and certification from third party vendors that their materials are TBA free.)

The expert I spoke with said the wine, coffee and shellfish industries have been alert to this potential for a while. Should McNeil have been wiser? Not necessarily, if they’d never encountered this problem in the industry before, he said. All I could find out about that was a New York Times article from twenty five years ago (to the day--July 18, 1985) which refers to a recall of, “Tylenol Children’s Elixir...” which “may be contaminated with a mold and yeast combination.”

Similar? I don’t know. Given the fact that this came shortly after the cyanide tampering, I image mold and yeast were met with sighs of relief.

Back to the questions about safety. In the wine industry, the presence of TBA, wine taint, is said to be one of quality, not health. Perhaps that is because the problem is evident immediately upon opening a bottle or nearly sipping a glass. Compare that to the issue of TBA in the bottle of adult medication, such as Tylenol Arthritis Pain. In some situations, it was reported that the bottles, more than the contents, contained the foulest odor. People often consumed entire bottles—or more—over the course of time, only to develop unexplained gastrointestinal problems.

Focusing on the pediatric medication, if you want to drive yourself crazy, you can read all the press releases on the McNeil website.

Which brings me to the curious case of Burkholderia cepacia.

B. cepacia is a gram negative, antibiotic-resistant bacteria that is said to not pose much threat to those with healthy immune systems, but can cause pneumonia in people with Cystic Fibrosis.

I say curious, because if you take a look at the transcript of the May 4, 2010 media briefing conducted by the FDA about the historic recall on April 30, 2010 of all unexpired children’s liquid OTC medication produced by McNeil at the Fort Washington plant, you will read about the discussion of contamination of raw material by of a gram-negative substance.

A reporter from a highly respected newspaper asks the Associate Commissioner of Regulatory Affairs, Mike Chappell, “ Can you just give us some sense of what, you know, gram negative organism. What would that be? Would that be the bacteria or the black particles or can you just please clarify that a little bit for us?”

The associate commissioner does not disclose the name of the bacteria, but said, “Right. And there are certain microbiological tests that determine that you have a certain category of organism. It does mean a microorganism. There are many gram negative organisms.”

It would not be until a day after this briefing that the FDA would confirm to CNNMONEY that the name of this bacteria was B. Cepacia. According to the CNNMONEY story about the FDA’s findings, “ the bacteria was found on some drums used by McNeil’s vendors to transport raw materials (inactive ingredients)” and some drums at the Fort Washington plant were contaminated with B. cepacia.

However, the FDA has stated that none of the finished products tested positive for the bacteria.

If only the national press corps shopped at Sam’s Club.

I received a robo call from Sam’s club in September of 2009, informing me that the Infant’s Tylenol I purchased may be part of a recall. It was a recall of particular lots, and when I went to the McNeil website, I read about Burkholderia Cepacia.

Look at the September 2009 McNeil press release on this subject today, and you’ll find this instead of the bacteria’s name: “....the company is implementing this recall because during this period, an unused portion of one inactive ingredient did not meet all quality standards”

You can find plenty of secondary sources from that time period that spell it out in black and white, and there is a September 18, 2009 letter from McNeil to healthcare professions that explicitly explains the situation.

But, it seemed as if the entire B. Cepacia situation was entirely forgotten about and rediscovered in May of 2010. Considering the bacteria is said to have not been found in the finished product, this entire subject might seem moot. If I were the parent of a child with Cystic Fibrosis, who had not heard about the September recall, or assumed that if my lot number were not mentioned, I was ok, I think I’d feel differently when I heard that every liquid pediatric product of McNeil had been recalled in late April, out of an abundance of caution, in part, because of this very issue.

Put in context, the Fort Washington plant was closed by McNeil in early May, preceded by this:

A March 29 recall on the wholesale level of certain lots of Infants’ Tylenol, Infant’s Motrin, and Children’s ZYRTEC professional samples because of a labeling issue which might cause expiration date to become illegible; March 29 recall of certain lots of Children’s Tylenol and ZYRTEC because some areas of the bottle plastic are thinner than required; and the historic recall on April 30 on all lots of not yet expired Children’s and Infant’s Tylenol, Motrin, Zyrtec, and Benadryl. (Reportedly 70% of the market and the FDA says, 135 million bottles, although that number has been disputed.)

This because:

“Some of the products included in the recall may contain a higher concentration of active ingredients than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”

In testimony before the House Committee on Oversight and Government Reform, the FDA’s principal deputy commissioner said no “final products that were released for sale had high concentrations of the active ingredient acetaminophen,” according to an article on CNN Money.

As for B. cepacia, at the media briefing on May 4 that I mentioned earlier, an FDA official explained this about the yet-to-be named bacteria, “... just to sum it up. So in this case McNeil purchased lots of excipients meaning line (of) an inactive ingredient from a vendor. Those vendor lots tested positive for the bacteria but McNeil’s finished product did not.”

In terms of the metal particles, identified in one story as nickel and chromium? We’ve been told they will pass through without any consequence.

As for the status of things now, McNeil recently submitted, “...what it called its comprehensive action plan on quality improvement for the Fort Washington plant to the FDA”, according to an article last week on CNNMONEY.

Meanwhile, the House Committee on Oversight and Government Reform, which held hearings in late May, and was supposed to hold a second round in mid-June has postponed them to another date.

That, of course, has given the FDA time enough to issue yet another 483, this time to a plant in Lancaster, Pennsylvania, run by Johnson & Johnson-Merck Consumer Pharmaceuticals, which makes Over the Counter versions of Merck’s prescription drugs.

So, when I get that email telling me it’s ok to buy and use Children’s Tylenol (by this point we’ll have outgrown the Infant bottle), what will I do?

The funny thing about all of this is that I finally took a look under the flap of the bottle to read what was actually supposed to be in this stuff.

High Fructose Corn Syrup.

But, then again, after Nickel and Chromium, that doesn’t sound so bad.

But that statement, like so many others cited in this post, doesn't exactly answer the question.

Got 2 seconds? Take the 2 second survey asking how you feel about what you might do when the recalled products are back on the shelf. I created this survey on survey monkey to try to get a sense of how other parents are feeling: Click Here for survey. Thank you!


Tim Morrissey said...

This is the kind of reporting we used to get from the "mainstream media". You are a one-woman "Washington Post"!

Anonymous said...

This is the most readable, clear description and compilation of events I've read. You definitely got the reporting & writing gene.