Another McNeil OTC drug recall: quality control issues not just for generic drugs

Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.
However.
On April 30, McNeil Consumer Products issued a voluntary recall of a litany of children’s cold products under the Tylenol, Motrin, Zyrtec and Benadryl brand names.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States [in Fort Washington, PA] and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

The complete product list can be found at the bottom of the press release (here) from which the above quote was derived.
McNeil noted that “some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”
However, an ABC News story on the recall provides an FDA report (PDF) indicating that some of the remedies contained as-yet unidentified gram-negative bacteria.
Your humble blogger was contacted for this story and quoted therein but I had not known at the time of the bacterial contamination. All reports suggest that these problems are unlikely to present any risks to infants and children, pending identification of the bacteria, but this cannot be good – especially since this is the third recall by the manufacturer in the last eight months.
ABC News quoted a statement released Tuesday from Johnson & Johnson, the parent company of McNeil Consumer Healthcare:

“The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,” the Johnson and Johnson statement read.

This recall is also yet another blow to the widely-held belief in the higher-quality of a brand name drug product over generic drugs, at least in the case of over-the-counter products:
“This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
What struck me was the report from the Associated Press and the FDA’s own Q&A site that until these products are back on the market, parents use alternative products with the same ingredients on the labels – i.e., generic versions of the McNeil products – rather than trying to calculate how much of an adult-strength product to use in an infant or child.
I wonder how many parents might switch to the generics, see the incredible price savings, and switch permanently to one of these products.
Commenters at several of the news site also note that there has been much ado about quality control issues at drug plants outside the US; that excuse can’t be invoked in this case.

Correction to James Ray Sedona sweat lodge post

Our post on drugs and documents found in the Sedona resort room occupied by self-help guru James Ray requires a correction and a clarification related to the Michigan doctor of osteopathy who, according to publicly-available records, prescribed some of the drugs as detailed in these publicly-available documents.
1. Correction: Dr. John Crisler was referred to as an “Internet physician from Michigan.” To be clear, he is a physician with an office in Lansing, Michigan, with an internet presence at allthingsmale.com. On his website, he lists an “Office Visit Fee – Office or Virtual” for $60.00 and “Anti-Aging Consultation” for $495.00. The patient information link on this page leads to a “Coming Soon” placeholder.
2. Clarification: According to his website, Dr. Crisler’s medical practice specializes in “testosterone replacement therapy,” or TRT, to treat hypogonadism. His frontpage prominently displays his talks and memberships in the “anti-aging” community. Some of the drugs employed in TRT are also used by bodybuilders but the apparent intention of TRT is to restore normal testosterone levels. In the case of Mr. Ray, the publicly-available document from the search warrant affidavit simply refers to the drugs as “treatment therapy.”
For reference, this was the paragraph from the original post:

Dr. Crisler operates the website, allthingsmale.com, and offers in-clinic and online consultations. The frontpage of his site argues strongly that he is in the business of anti-aging therapies as shown lecturing to the American Academy of Anti-Aging Medicine and offering subscriptions to Life Extension Magazine. Further exploration of his website reveals that he specializes further in assessment of low testosterone levels, or hypogonadism.

I welcome any and all feedback to clarify this post. I would, however, encourage first that one read the original post in its entirety.
Questions came to light after two posts went up on discussion forums at the All Things Male MuscleChatRoom.com and the anabolic steroids section of Meso-Rx Men’s Health Chat at mesomorphosis.com. We received 98 and 90 hits, respectively, from each of those sites (barely 5% of our last 4000 visits) and several commenters protested that TRT was being unfairly conflated with bodybuilding anabolic steroids.

It really pisses me off the way that he keeps referring to it as anti aging/bodybuilding, as thou it were some undercover way of getting steroids for bodybuilding enhancement.

d00d, do you not see the irony that you wrote this on a forum called “MuscleChatRoom?”
But I do stand corrected and will refer to this drug combination as testosterone replacement therapy. I suspect that as I age and face the inevitable decline of testosterone levels, I may become a candidate for such therapy.
My original post did make a lengthy point that, in medical terminology, testosterone is a steroid with anabolic activity but that the general public thinks of anabolic steroids as the semi-synthetic compounds sold on the black market. Testosterone, instead, is a naturally-occurring anabolic steroid that is available by prescription as a transdermal patch, gel, or injection.
The primary purpose of the post was to document the backstory on my ABC World News Sunday appearance last week where I was asked to comment on whether these agents had the potential for inducing in Mr. Ray behaviors that could have contributed to his actions observed at the sweat lodge tragedy in October. Last Sunday’s article celebrating the life of Kirby Brown, a victim from Los Cabos, describes these events. I noted that I am not a board-certified endocrinologist, or a physician for that matter, and that I could only comment on the effects that the drugs could have in a hypothetical person. Moreover, I was not privy to Mr. Ray’s behavior prior to being prescribed these drugs.
However, I’ll leave it to the reader to peruse the forum threads at MuscleChatRoom and Mesomorphosis to observe the personalities of other TRT users. Props to anyman for rising above the fray.

Latisse®: Tell me more about my eyes

Lookie what came in to my e-mail box overnight after yesterday’s post about the hypotrichosis treatment, Latisse® brand of bimatoprost.
Latisse E-card 515px.jpg
Hmm…I have a few ideas who might have sent this (no profanity, so it wasn’t Comrade PhysioProf). And very interesting that this comes just a week before FDA holds an opening hearing entitled, “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. For your information, here’s the PDF schedule courtesy of colleague John Mack – Pharma Marketing Blog and @pharmaguy. John is currently running a survey in his masthead to solicit reader input as to what topics might interest them most – John is scheduled to speak early on the first day.
Just an aside: does the fact the hearing is being held at the National Transportation Safety Board Conference Center in DC mean it’s going to be a trainwreck? (sorry, couldn’t resist)

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Doping Grandpa?: Performance Enhancing Drugs for the Senior Set

I’m not a competitive athlete but there are just some drugs I *must* take because of my asthma. I expect that as I continue to age, I will have to take more drugs.
But what if I were an elite master’s track & field athlete? John Leland takes on this topic in yesterday’s New York Times:

Mr. Levine, who is 95 and has had operations on both knees, in June set the American record in the 400-meter dash for men ages 95 to 99, only to see it broken at the U.S.A. Masters Outdoor Track & Field Championships a few weeks later. “Nothing counts unless you’re first,” he said.
Mr. Levine belongs to a generation of track and field athletes who are breaking records for speed, distance and endurance at ages once considered too old for competition. In a sport tarnished by doping scandals, the older athletes raise anew the question of what constitutes a natural body for people who are at an age when drugs are a part of life.
“Who’s 75 years old and not taking medications?” asked Gary Snyder, national chairman of U.S.A. Track & Field’s masters committee, which will oversee more than 100 competitions this year for athletes over age 30.
Most drugs like Mr. Levine’s are not banned for competitors, but some common treatments for asthma, menopause and inflammation contain steroids that can disqualify athletes if they do not get written medical exemptions.

Yes, there is a 95-99 age group at the master’s track and field competitions. My only question is why there is a cap at 99? Does that mean there is also a 100+ age group? I’ll be happy to just be breathing at 95, much less run 400 meters.
In any case, Leland describes cases where questions have arisen regarding use of required drugs and disqualifications despite competitor claims of necessity.
As Ms Rosalyn Katz, a 67-year-old hammer thrower from Queens, was quoted:
“I don’t think anyone taking asthma medication is going to throw or run any better,” Ms. Katz said. “I think they’re doing it because they can’t breathe.”

Derek Lowe gets all Mooney and Kirshenbaum about the pharmaceutical industry

lowe pharmagossip.jpgYes, this is my second post on Derek Lowe of my last three.
No, I am not his publicist.
But Derek has another nice post on how drug company scientists could do a better job on educating the public on the drug discovery process:

I do a lot of talking around here about how the general public doesn’t really have a good idea of what goes on inside a drug company. But a conversation with a colleague has put me to thinking that this might be largely our own fault.

One of Dr. Lowe’s talents is the ability to put a lot of ideas into very concise posts. So take two minutes to read about the 90% problem.
h/t and Lowe-bama courtesy of Jack at Pharmagossip

Derek Lowe (In The Pipeline) on ghostwriting and a real drug industry project meeting

I know that we have been very fortunate to attract a few new readers over the last year or so. For those, and as a reminder to others, I wanted to focus on some of my major blog influences. One of these is Derek Lowe, an early science blogger who is perhaps the only pharmaceutical company chemist who writes under his own name. Dr Lowe writes the blog, In The Pipeline.
Dr Lowe gives invaluable insights into the industry about companies large, small, and tiny, and provides on of the few places where scientists entering the job market can truly get a glimpse of what it’s like to work for a drug company. (Here is his archive category on academia vs. industry.).
At the end of last week, he put forth back-to-back posts that reveal insights on the industry, including a fair criticism of one high-profile industry practice, ghostwriting.

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Michael Jackson: Cherilyn Lee, Diprivan® (propofol), and Myers’ Cocktail

Judging from the press inquiries I’ve had since 5 am EDT today, expect today’s focus in the Michael Jackson case to be on the anesthetic drug, propofol (Diprivan®).
Last evening, California nutritionist and registered nurse Ms Cherilyn Lee gave an interview to Campbell Brown on CNN (and this AP exclusive report) describing Michael Jackson’s repeated requests of her for the intravenous sedative drug for his insomnia. She wisely rejected his requests, instead providing him with a vitamin and mineral “energy” injection called Myers’ cocktail.
However, four days before Jackson’s death she reported a frantic phone call from a Jackson staffer to her that led her to believe he had somehow procured the drug or something like it:

While in Florida on June 21, Lee was contacted by a member of Jackson’s staff.
“He called and was very frantic and said, `Michael needs to see you right away.’ I said, ‘What’s wrong?’ And I could hear Michael in the background …, ‘One side of my body is hot, it’s hot, and one side of my body is cold. It’s very cold,'” Lee said.
“I said, `Tell him he needs to go the hospital. I don’t know what’s going on, but he needs to go to the hospital … right away.”
“At that point, I knew that somebody had given him something that hit the central nervous system,” she said, adding, “He was in trouble Sunday and he was crying out.”
[. . .]
“I don’t know what happened there. The only thing I can say is he was adamant about this drug [Diprivan],” Lee said.

In the photo of Ms Lee that accompanies the AP report and the video interview now at ABC News, she looks terrifically distraught and was obviously very concerned about Mr Jackson. My thoughts go out to her as I suspect she is second-guessing what she might have done differently to help him.
What is Diprivan (propofol) and how is it normally used safely?

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Pediatric cancer patient checks in at age 55; beneficiary of Dr Charlotte Tan’s actinomycin D work

gary grenell.jpgI love it when new readers stumble upon old posts.
Such was the case when I received the following delightful comment from Seattle-based psychologist, Dr Gary Grenell, on my April 2008 post about the passing of Dr Charlotte Tan, a pediatric cancer chemotherapy pioneer:

I was probably in one of her earliest actionmycin-D trial groups for Wilms tumor in 1957. Now at age 55, 52 years later, still going strong!

Most of you scientific youngsters today probably only know of actinomycin D as a laboratory tool for inhibiting RNA synthesis. But here in the following repost, learn about the bacteria-to-bench-to-bedside application of actinomycin D:


This post appeared originally on 4 April 2008.
Childhood cancer chemotherapy pioneer, Dr Charlotte Tan, dies at 84
http://scienceblogs.com/terrasig/2008/04/childhood_cancer_chemotherapy.php
Charlotte%20Tan.jpgActinomycin D was the first antitumor antibiotic isolated from Streptomyces parvallus cultures by the lab of 1952 Nobel laureate, Dr Selman Waksman, at Rutgers University. However, it took a young Chinese physician and the confidence in her by a future US Surgeon General for this natural product drug to positively impact the lives of children with cancer.

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Pharm Girl, not mine

88864-witherspoon_reese_2_341x182.jpgI just learned last week from Insider/Jack Friday at Pharmagossip that Reese Witherspoon will be starring in (and producing) a movie entitled, “Pharm Girl.” (btw, if you are interested in the pharma industry and don’t follow Pharmagossip, you must do so.)

Reese Witherspoon is going into Big Pharma
Universal Pictures is developing “Pharm Girl,” an aspirational comedy centering on one woman’s odyssey through the drug industry.
“Bad Santa” screenwriters Glenn Ficarra and John Requa are writing the screenplay and in talks to direct. Witherspoon is producing via her Type A banner and will play the lead role.
The project concerns a woman who gets a job at a pharmaceutical powerhouse and begins to see the underbelly of the industry as she rises through the company’s ranks.

Regular readers know that my lovely and brilliant wife goes here by PharmGirl MD. (This is sometimes confusing because people sometimes think that PharmGirl is my daughter, hence why I add the “MD” – it’s also confusing because I call myself Pharmboy and not Pharmman. For the record, our daughter is PharmKid.)
So, I am grateful that Witherspoon has decided to name her movie after my wife. We will be more than happy to accept a cut of the revenues and royalties.

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Allergan will be doing just fine with Latisse™

Even at this incredibly slow time of the year for blog traffic, we hit about 250% of our average readership yesterday with search engines finding our post on Allergan’s new eyelash enhancing cosmeceutical, Latisse.
Lots of folks wanting to know where to buy Latisse – Allergan stock anyone?
(Aside: Among my other search term hits yesterday was: “‘junior faculty’ hate my job.” It hit an older post on whether junior faculty should invest time in writing review articles. I suggest that the reader start adding feeds to many of our commenters who with whom they may be able to commiserate.)