Tuesday, June 28, 2005

Giant Corporations that can squash you like a bug need love, too

Watchdog Group Blasts FDA is the title of the article in Brandweek.com, a site devoted to advertising, branding, and leveraging (there's lots of leveraging happening in the Brandweek Universe). The 'watchdog group' in question is the 'Washington Legal Foundation', whose site can be found at wlf.org. The WLF believes the FDA is overstepping its bounds when it comes to policing drug advertising, and has written a letter to the FDA about just that, referring specifically to the letter the FDA sent to Eli Lilly about a Strattera TV ad (see previous entry for more details). They're not just stopping at writing this letter, either. They've started a new program to monitor the FDA's Division of Drug Marketing, Advertising, and Promotion, called, “DDMAC Watch.” Presumably this is like a neighborhood watch, only with lawyers.

After spending a little time at the WLF site, it seems a more accurate title for the story might be 'Lapdog Group rushes to Lilly's Aid'.

The first thing I notice about the site is the way they try to use the word 'Freedom' as much as possible. The WLF seems to have joined forces with the people who brought us 'Freedom Fries' in the war against 'Freedom'. That is to say, the war against allowing the word 'freedom' to retain any kind of meaning whatsoever. The WLF also drags 'Justice' into the fray, and has either copyrighted the phrase 'Advocate for Freedom and Justice', or maybe just the word Justice. It's not really clear.

A quick look at some of the cases the WLF has been involved in reveals a pattern you don't need to be John Nash (or, as P. Diddy refers to him: 'the Beautiful Mind guy') to detect:

Overturning the criminal conviction of Arthur Anderson, LLP for their part in the Enron debacle is considered a 'victory'.

They stand up for poor R.J. Reynolds.

If there's one thing the residents of Chicago need, it's more advertising, damnit!

Again with the poor tobacco companies.

They take a bold stand against punishing people that lie to their customers, and make money based on deceit.

They really don't like the idea of trying to keep the price of pharmaceuticals from getting out of hand.

Well, you get the idea. For people getting involved in FDA and health issues, they sure are cozy with tobacco companies.

Nobody knows what it's like, to be the bad man, to be the sad man, behind blue eyes.

Thursday, June 16, 2005

FDA to Eli Lilly: You better knock that shit off, that's some cheezy ass, fake bullshit

The FDA sent Eli Lilly a letter regarding a direct-to-consumer (DTC) advertisement for Strattera. The commercial features a person living in a video game (kind of like that Chappelle Show skit, I suppose), losing points for doing thing like forgetting to put the cover sheet on the TPS reports. PharmaLive has the text of the actual letter. It seems Strattera was actually approved for ADHD, and marketing it for ADD is inappropriate. This is actually not totally clear, and part of the letter more or less admits it's not entirely clear what exactly ADHD is, or who has it:

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Lilly is also taken to task for downplaying the risks associated with Strattera (potential liver damage, discussed here and elsewhere.

The bottom line:

DDMAC requests that Lilly immediately cease the dissemination of promotional materials for Strattera the same as or similar to those described above. Please submit a written response to this letter on or before June 28, 2005 describing your intent to comply with this request, listing all promotional materials for Levitra the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to me at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857, facsimile at (301) 594-6771.

It's not clear what Levitra (a drug for Erectile Dysfunction, made popular by former Senator Bob Dole, although Dole did commercials for Viagra) has to do with all this. This reminds me of a similar situation at work recently, where I was reviewing a statement of work, and all of a sudden there was a mention of a representative from Best Buy being involved in the project. We aren't Best Buy. The contractor is not Best Buy. Somebody cut-n-pasted without noticing this detail - whip out the Strattera, and take mine away because I actually read the thing.

Part of the FDA's problem seems to be the barrage of visual stimuli presented in the commercial. Some of us grew up on MTV and have seen Jerry Bruckheimer's movies, we can deal with it.

The TV ad fails to clearly communicate the indication for Strattera because of competing visuals, graphics, and music that are presented at the same time as the information described above relating to the indication. As stated above, the images that are presented relating to the product’s indication are portrayed as seen through the screen of a videogame. The viewpoint of the screen changes periodically, from seeing the world through the eyes of the actor playing the main character, to seeing the character himself and back again. During the presentation of the various situations the character is engaged in, a box with the words “SCORE” (including a running tally of numbers) and “LEVEL 1” is shown in the upper right-hand corner of the screen and another box with superimposed text is shown in the middle of the right of the screen. The text scrolls and flashes. The text, graphics, and voice-over are also accompanied by eerie sound effects. All of this distracts from the viewer’s ability to process the visual information related to the product’s indication.

Ah, now if only somebody would get after Hollywood for using special effects and technology to distract people from their ability to discern if movies are crap.

Eli Lilly spokeshole Jennifer Bunselmeyer said the company has stopped the nationwide advertisement at the FDA's request, but the company didn't believe the ad was misleading, according to an article in The Kansas City Star.

And remember, cut-n-paste makes waste.

Friday, May 27, 2005

Drugging Kids Is Extremely Profitable

George W. Bush loves the word Freedom (the actual concept, maybe not so much). After September 11, he solemnly informed Americans that they (religious nuts from Saudi Arabia, mostly) 'hate us for our freedom'. When France opposed (along with most of the World) our ill-advised invasion of Iraq, 'French Fries' became 'Freedom Fries', and 'French Toast' became 'Freedom Toast'. Lately, he likes to remind us that 'Freedom Is On The March'.

Freedom was on the march April 29, 2002, when George W. Bush established the New Freedom Commission (NFC). What the Commission actually did was make recommendations about mental health care in the U.S. How it is distributed, and more importantly, how drug company execs can feed off the American taxpayer, much like their country club buddies at Halliburton do.

Evelyn Pringle writes about so-called two model programs for this future direction in mental health care, Teen Screen and TMAP (Texas Medication Algorithm Project), in an article for the Online Journal. In addition to being full of interesting information and background, the article mentions The Integrity in Science Database, which keeps track of which companies are funding which researchers. Thanks to that site, after seeing a Psychiatrist on CNN talking about a great the new drug from Pfizer is, you can go find out how much money they got from Pfizer last year.

Back to the programs, though. In case there is any doubt that the transfer of money from the Federal Budget to Pharma profits is the primary aim, consider:

The original TMAP list of drugs for adults included Risperdal, Zyprexa, Seroqual, Geodone, Depakote, Paxil, Zoloft, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, Buspar, Adderall and Prozac.

The decision to adopt TMAP brought with it the mandate to use the recommended drugs on all patients in the state system. A doctor cannot choose a generic drug until at least two, often three, drugs on the list have failed. And even then the doctor must set down his or her rationale in writing, and assume liability for deviating from the TMAP list.

It gets worse. Apparently when they decided to expand the program to children, too, some wise people (or, obstructionists, as they are sometimes called) suggested making sure the drugs being used for adults were appropriate for kids. You can probably guess what happened:

The panel soon decided a survey was unnecessary and said the same drugs being used on adults could be used on children. There were no studies or clinical trials whatsoever to support this consensus.

How could the drug companies pull this off? Because the members of the panel were on the take. For instance, one member of the panel was Graham Emslie, MD, professor and chairman of the Division of Child and Adolescent Psychiatry, University of Texas Medical Center.

The Integrity in Science Project tracks drug company money to researchers and lists Emslie as: "Consultant to GlaxoSmithKline, Forest, and Pfizer. Receives research support from Eli Lilly, Organon, RepliGen, and Wyeth-Ayerst. Member of the speaker's bureau for McNeil. ('Experience in the use of SSRIs and other antidepressants in children and teens')"

In light of recent concerns about the effect of Paxil (June of 2003, the FDA issued a warning that Paxil should not be prescribed to persons under 18) and other anti-depressants on children, this seems at best ill-advised. Also depressing is the extent to which drugs are used as chemical restraints by foster programs:

a reporter for the Columbus Dispatch in Ohio investigated the matter. He discovered that, in July 2004, 31 percent of children ages 6 to 18 in foster and group homes were on mental health medications. And 22 percent of the children in detention were on psychiatric drugs as of January 2005, with many on five or more. See the April 25, 2005 Columbus Dispatch.

The article is highly recommended. It ends on a hopeful note, in Bush's brother's state, Florida:

But it's not going so well in Florida. Anti-child-drugging advocate Ken Kramer has led the fight to prevent TeenScreen from getting into schools in several counties in Florida. In Pinellas Country he urged parents to send e-mails to the school board and voice their objections to the program. The board received more than 700 e-mails.

Kramer won the battle in two large counties. According to the Jan 26, Tampa Tribune, Pinellas County School Board members refused to subject students to suicide screenings, quashing any hope of introducing a controversial mental health plan in two of Florida's largest school districts.

To protect its students from issues of privacy and wrongful labeling, the Pinellas County School Board voted 6–1 to bar TeenScreen's suicide questionnaire program, the PR Web reported on Jan 30.

Sunday, May 22, 2005

The Trend is Not My Friend

When I started up this blog, it seemed there was a big pharmaceutical industry backed full-on Adult ADD craze going on, but things done changed, as the Notorious B.I.G. said. Although the Superfriends of Diversity at Eli Lilly posted decent earnings numbers, Strattera sales were off a bit (15%) due to the liver damage concerns. AdderallXR got banned in Canada. People all over the country, yes, the same people who bought Milli Vanilli albums, started to wonder if maybe this adult ADD thing was just a load of crap to move some pills.

I even notice my Google Alerts on Strattera and Adult ADD come with much lower frequency than as recently as a month ago, and a lot of them are sportswriters making lame jokes about somebody's attention span, anyway.

So sorry, ADD sufferers, you're not in the spotlight now. Maybe Sepsis sufferers will get some love.

Anyhow, all is not lost, because Shire Pharmaceuticals has this happening program called the Adderall Achievers. It's reminiscent of the Coffee Achievers of the 80's. At that time, Jay Leno was an up and coming, even edgy young comic (really!) and his joke was: 'they have rock stars in these Coffee Achiever commercials. For these people, coffee is a sedative!' (in the 80's, people thought that was funny).

So now how it works is, you get really bored at meetings at work, or when you're hearing a neighbor drone on about the comparative advantages of lawn mowers, and you tell your doctor this is happening. Your Doctor then tells you 'it sounds like you have Adult ADD, you should try some of this AdderallXR stuff'.

At this point you ask the doctor about an article you read about Adderall getting banned and people dying and stuff in Canada, and he kind of snorts and explains how that's just politically motivated, it's something for Canada and the US to sort out, and it was only a few people who died anyway. You are given a card with a phone number on it. You call the number to activate the card. You also get a refridgerator magnet with a rectangular hole in it (you need to find a picture of yourself kicking ass, taking names, figuring out who moved the cheese, or some gung-ho shit like that, and put it in the rectangle, and put it on your fridge). You take the card to the pharmacy and hand it to the guy there, and he asks for ID, and then, bang, you have 30 free AdderallXR pills. Side effects include 'emotional lability'. What is that? Well, according to this website for people taking care of stroke victims, it's a sudden change of emotion, or an emotional response out of proportion to the stimulus. Emotional lability also affects people with MS, Menopause, or Lou Gehrig's (also known as Stephen Hawking's) Disease.

Anyhow, apparently college students love the Adderall for studying.

For more unbiased info from bloggers and internet forums about Adderall Achievers, see:

A Shout Out To My Pepys

I forgot to mention the really funny part about this drug. It's called Adderall, and the package with the magic card on it noted that I was joining the ADDERALL ACHIEVERS!! Which of course reminded me of the Coffee Achievers ads from the 80s.

But the best part was that the box contained not only an infotational booklet about being an Adderall Achiever and how this drug was going to fix my life, but an Adderall Achievers FRIDGE MAGNET! The doctor didn't believe me at first about this. "They put a what in there?"

So, even if this stuff doesn't do jack for me I still get a fridge magnet. If things go well, it'll go next to the Zeppelin Bread one. If poorly, it goes in the section of the fridge full of failed dot com fridge magnets.

Also the Amen Clinic discussion group

Dawg answers, "Americans are more tightly wound, explosive, unfriendly, stand offish, as a rule..Now the Aussie's are more laid back, very deep thinkers, warm and friendly almost Tigger Like..." "So we figured about 7 years ago, that we'd send you folks "Down Under" a sizable shipment of Adderall-30mg Tabs...So off they went to the far side of the Planet...

Well no sooner than we did that, there's 'ol Prime Minister John Howard making this frantic call to Sh*** Labs...
"Oh Mr. Bigwig, you must stop anymore Adderall from reaching our Shores..."

"Why is that Mr. Prime Minister, we had a deal right?" asks Sweaty Greedy CEO of Sh*** Guy....

"No Mr. Fatcat! You don't understand! It seems to effect us Australians differently!" says PM Guy...

"What do you mean? That can't be!" moans Sh*** Dude as he lights another cigar with a $1000 bill...

"Well Mr. Milk the Little Guy, you know how you Americans are All Adderall Achievers right?" says PM Guy...

"Yes!" Satans/Sh*** Side Kick says

"Well this group of Misfits, Outcasts and Losers got ahold of the entire shipment of Adderall 30-mg Tabs and they took off with it...Mr. Rip Off these were the wimpiest, most unintelligent, no talent group Australia has ever produced...I actually think they came from New Zealand, but I have no Proof.." hurridly say worried PM JH

"For godsake what's your point, I'm busy, I'm negotiating a deal now to raise the price of Adderall 30-mg Tabs
in the inner cities, I need new Gold Faucet Handles, who are they? what do they look like? what do they want?" a now impatient Mr. Steal from the Poor and Give to the Rich Guy from Sh*** Labs says...

"Well I have a few names, Uh, let's see they are Mel Gibson, Nicole Kidman, Paul Hogan, Russell Crowe and they appear to be Led by Steve Irwin...You better do something that Irwin fellow snatched up 20 30-mg Adderall Tabs and took them all at once...Oh, it's bad sir, it's bad...What do you suggest?"

"Well Mr. Howard I doubt that we'll ever hear from Mel, Nicole, Paul and Russell again, and the leader was, oh yeah Steve Irwin...Never Mind we'll replace the Adderall, with Adderall XR 30-mg...And don't worry it's not very effective anyway, all Americans know that..I made sure of that..Har-Har-Har!!!"

Sunday, April 03, 2005

From the Desk of Shucks Olajowan

On Eli Lilly's site for Strattera, www.adultadd.com, there's a form you can fill out and they'll send you more info. I filled out the form around the time I started this blog as 'Shucks Olajowan', and only this weekend did I get the information (I really hope they're a bit quicker with the info on anti-depressants). They must be swamped, or else they were busy revising the material to add the warnings about liver damage.

Anyhow, the material is similar to what they have on the website. There's a one page letter starting with a warm 'Dear Shucks Olajowan' (aw, shucks). There's a photo of a serious looking middle aged woman model probably meant to be a medical professional, or else just a caring relative or co-worker, above the phrase 'Every journey begins with a single step'. The implication is, get on Strattera now, before the journey of your life turns into one of those meandering, dotted-lines tracing Billy's trip to the store to get smokes for Dad that Bil Keane does for the 'Family Circle' comics.

There's also a 3-color cardboard version of the 'Adult Self-Report Scale'-VI.I (ASRS-VI.I) Screener'. It's just like the website, only you can use pencil or pen instead of your mouse.

Finally, there's a black and white page of 'INFORMATION FOR PATIENTS OR THEIR PARENTS OR CAREGIVERS'. The font on this page is small, and the writing is blurry, but we've all heard 'constipation, dry mouth, nausea, decreased appetite, dizziness, problems sleeping, sexual side effects, problems urinating, menstrual cramps' before anyway.

Thanks Eli Lilly, Shucks is glad to know you're there.

By the way, I recall when a company I worked for launched a new website, let's call it 'irrational-exuberance.com', the marketing people had the foresight to register domains like 'irrational-exuberancesucks.com', and 'igotyourirrational-exuberancerighthere.com', as a pre-emptive strike against people who would use such domains against them.

Apparently Lilly marketing didn't consider the possibility, b/c if you go to www.adult-add.com, guess what, it's a site slamming pharmaceutical marketing shams. The writing is kind of weak. On the continuum of medical writing ranging from How to Good-Bye Depression: If You Constrict Anus 100 Times Everyday. Malarkey? or Effective Way? to the Journal of The American Medical Association, it's probably further from the JAMA than we like to see, but their hearts appear to be in the right place, and I really appreciated the links and images from drug ads. The links include the eerie Methylin for Kids site. OMFG, the kid on the landing page for the site has to be about three years old.

At first the Methylin for Kids site looked like some kind of Onion-inspired joke, but after digging around some more, it appears to be for real. Unless Walgreens and others were conned into believing some practical joke about a Methylin recall because some lots of the chewable tablets contained up to three times the active ingredient, that is.

The one thing I still find curious is that Alliant Pharmaceuticals' websites were designed by Artic (sic) Designs, Inc, a company whose other web design clients include numerous churches and some company that sells pit bulls, and a Brownie Troop. Not that there's anything wrong with that. I suppose since Alliant is not a deep pocket big pharma, they couldn't rent a stable of $300/hour EDS folks.

Thursday, March 17, 2005

Ty Pennington's got your back

The 'Accent'(?) section of The Palm Beach Post featured this article today: The Chaos of The Distracted Mind. Much of the info is material we've seen before, as yet another reporter has decided to write about the Adult ADHD craze. There were some items I hadn't encountered, though:

First off, I didn't know Ty Pennington (Extreme Makeover: Home Edition) had spoken out publicly about his ADHD. Nor, for that matter, was I aware of the show: Extreme Makeover: Home Edition.


"ADD/ADHD is a popular diagnosis (since) the 1990s because it serves as a neat way to explain away the complexities of turn-of-the-millennium life in America," commented author Thomas Armstrong. "Ritalin use is up 500 percent over the past six years, yet it does not cure the problem."

Opponents also point out that 80 percent of the world's ADHD medications are sold in the United States.

In a public letter to then-Attorney General Janet Reno, pediatric neurologist Fred A. Baughman wrote: "The single, biggest health-care fraud in U.S. history is the representation of attention deficit (hyperactivity) disorder to be an actual disease, and the drugging of millions of entirely normal American children."

Finally, food for thought for those of you holding off on filling those prescriptions:

"Some researchers estimate that 90 percent of the U.S. prison population has ADD," says W. Gardner Morgan, Palm Beach Gardens psychologist, author and ADHD coach.

"Just ask the police department, prosecuting attorneys and parole officers," confirms Judge Cynthia Cox of St. Lucie County. "Judges, especially in family court, see ADD offenders before them all the time."

I imagine being in jail would make most individuals pretty bored and irritable.

Here's further info on the study finding chromosome abnormalities in children taking Ritalin, from the Kansas City Star: Small study links Ritalin, cancer risk.

Wednesday, March 16, 2005

Happy Birthday Eliot! also Pharma Execs: "We're doing great!"

Sue Pelletier has a very fine blog called Capsules, focusing on pharma and medical meeting news. In a recent post she relays the story of a very good prank played on Express Scripts, a company being sued by NY Attorney General Eliot Spitzer for $100 million for inflating the costs of generic drugs.

Stories like this renew your faith in your fellow man (well, for me they do).

On the opposite end of the continuum, there's this article from Ethical Corporation: US pharmaceutical industry ethics rated higher by executives than public.

A survey late last year by Rating Research among senior executives across the pharmaceutical industry found that 65% of executives interviewed "agreed" or "strongly agreed" that leading figures at major drug companies "adhere to ethical business practices".

But in a nationwide poll conducted by Opinion Research in early February only 44% of the 1,000 US citizens surveyed said they trusted senior leadership of major pharmaceutical makers to "engage in ethical business practices".

'Soo-prize, soo-prize, soo-prize!', as Gomer Pyle would say.

But wait, there's more:

Another public opinion survey was carried out in February by the Kaiser Family Foundation. It found that although 90% of adults said pharmaceutical companies made an important contribution by developing new drugs, half had an overall unfavourable view of the industry.

And 70% of participants in the Kaiser survey said the pharmaceutical industry put profits ahead of people.

There were some results sure to be excerpted for the in-house FDA mass emails and newsletters, though:

The study also found, however, that despite the recent controversy surrounding Cox-2 inhibitors like Vioxx, 80% of adults surveyed still felt confident about the safety of prescription medications sold in the US. 77% said they were confident in the Food and Drug Administration's ability to ensure drug safety.