Clarification of off label prescribing and an update on Dr. Gleason

After the lively exchange triggered by my recent post on off label promotion of pharmaceuticals I thought this follow up might be useful. A commenter was concerned by my statement that off label prescribing was legitimate: “Yet, off label prescribing is, by definition, prescription to treat conditions for which there is NO EVIDENCE that such prescription works.” Thus the question is raised---does “evidence based” equate to “FDA approved”?

Not necessarily. I cited metformin for polycystic ovary syndrome, viagra cialis online pharmacy pharmacy for pulmonary hypertension, anticonvulsants and tricyclic antidepressants for neuropathic pain and caspofungin for invasive candidiasis as examples of evidence based treatments, all of which lack FDA approval for those uses. In other words, current examples of legitimate off label prescribing. Another example is the use of vasopressin in cardiac arrest---fully in accordance with ACLS protocols yet off label. And if memory serves, there are past examples in which evidence based prescribing preceded eventual FDA approval for particular indications. Thus, angiotensin converting enzymes were validated and used for heart failure at a time when they were only approved for hypertension.

The flip side is FDA approved (on label) prescribing which is not evidence based. Doxazosin, for example, (Cardura) is FDA approved as monotherapy for hypertension despite strong evidence from ALLHAT that such use is inappropriate. Old farts like me may remember phenformin (Ciba-Geigy’s DBI, the granddaddy of metformin) which remained on label and FDA approved for years despite clear evidence of harm. How many thousands of patients died of lactic acidosis before the FDA finally took action? So much for the FDA as the guardian of evidence based medicine!

That said, I’m sure there are widespread instances of off label prescribing that are non-evidence based and even harmful. One more point about inappropriate prescribing: off label prescribing is to be distinguished from on label prescribing which ignores warnings and contraindications in product labeling. I have blogged about this unfortunately widespread practice here and here.

On to Dr. Gleason. The commenter seems to have misperceived me as defending Dr. Gleason’s promotional activities and questioned my basis for stating that he did nothing clearly illegal. Having no legal expertise of my own, I merely cited experts quoted in the Times article who made that point. If this is a fuzzy area of the law subject to prosecutorial discretion, or zeal, it could be a dangerous precedent of concern to all who speak at CME events.

A discussion forum concerning Dr. Gleason has been set up here for those who wish to keep abreast or weigh in.

2008 Wayne County Dairy Day/Ag Day

The “30^th Annual Wayne County Dairy Day/Ag Day” is scheduled for Monday, February 18^th, from about 10:00 AM to 3:15 PM, at the Honesdale High School, Terrace Street, in Honesdale, PA.

This year’s event will feature the normal timely dairy industry-related information and new technology to area dairy farm families. In addition, different livestock, forestry agronomic, vegetable, general agriculture and agriculture information groups, associations and research and promotion groups have been invited to exhibit and participate and to inform people involved in the dairy and agriculture businesses in Wayne County and Pennsylvania.

Exhibitors and participants in this year’s “Dairy Day/Ag Day” will have an opportunity to present this important information through displays, exhibits, informal talks, demonstrations and one-on-one conversations.

This year’s “Dairy Day/Ag Day” will once again feature the popular “Ask the Experts!” forum where attendees can converse and gather information from participants in a one-on-one format!

Scheduled to participate in this part of “Dairy Day/Ag Day” are: “4-H Gets Your Motor Runnin’”, Kim C. Mikulak, Wayne County 4-H Program Coordinator, Wayne County Cooperative Extension, “Is Your Farm Earning Extra Income For You and Your Family?”, John Berry, Extension Educator/Ag Marketing, Lehigh County Cooperative Extension, Allentown, PA, “Use of Farm Manure In 2008 Wayne County Cropping Systems”, Dave Messersmith, Extension Educator – Agronomy, Wayne County Cooperative Extension, “Growing Berries In Northeastern Pennsylvania”, John Esslinger, Extension Educator/Agriculture-Commercial Horticulture, Lackawanna County Cooperative Extension, Scranton, Pa, “Solar, Wind and Biodiesel Energy Systems For Homes and Farms”, Rich Brinkman, Rich Brinkman’s Alternative Energy Supplies, Hamlin, PA, “Wells, Water Testing and West Nile Virus Program”, Pat Mohn, Wayne County Cooperative Extension and Wayne County West Nile Virus Program and “Addressing Effective Fiber Utilization In Dairy Cattle Rations”, Janet Deken Smith, Dairy Farm Consultant, Cargill Animal Nutrition.

The “Wayne County Dairy Promotion Committee” will be at the “Dairy Day/Ag Day”. The “2007-2008 Wayne County Dairy Princess, Alternate Dairy Princess, Dairy Maids and Dairy Ambassadors” will have their promotional materials and educational displays available for all attendees to observe and enjoy.

Also, some health testing and screenings for farm workers and families, will be offered by the Wayne County Office – Pennsylvania Department of Health, Wayne Memorial online pharmacy viagra and Wayne Memorial Hospital Health Services, and the Northeast Regional Cancer Institute.

The popular milk, cheese, ice cream and specialty meats bars will be set-up near the exhibit area courtesy of area dairy producers, dairies, ice cream manufacturers, meat processors and the “Dairy Day/Ag Day” exhibitors, participants and supporters.

Door prizes, supported by the “2008 Wayne County Dairy Day/Ag Day” Planning Committee and exhibitors, participants and supporters, will be awarded throughout the day.

A buffet lunch, prepared by “The Red Schoolhouse” staff, will also be served to all dairy and agriculture farm families courtesy of the “2008 Wayne County Dairy Day/Ag Day” exhibitors, participants and supporters.

For additional information about the “2008 Wayne County Dairy Day/Ag Day,” please contact Ed Pruss at the Wayne County Cooperative Extension by dialing 570 253-5970, extension 4110, by fax at: 570 253-9478 or via email at: edp4@psu.edu.

For inquiries about participating in the “2008 Wayne County Dairy/Ag Day” as an exhibitor, a participant or as a supporter, please contact Ed Pruss at the Wayne County Cooperative Extension at the above listed telephone, fax or email information.

Click here for a printable 2008 Wayne County Dairy/Ag Day brochure.

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I think I've killed the sex life of two people I've never met.

Sometime in the last two or three months, the girl in the apartment below us got a boyfriend. A boyfriend who comes over every night and apparently pounds her like a jackhammer on speed until 4:15 AM. This is not an exaggeration -- every night. From about 2 AM to 4 AM. I know, because I hear every second of it.

It sounds like she is sticking her head out the window, shrieking wild sex yodels into the night. Possibly through a megaphone. Nothing could drown out the monkey sex... not earplugs, not fans, not pillows, not the fantasies running through my head of me busting through their door, snatching the megaphone out of her hand and beating both of them over the head with it.

To make matters worse, Mr. and Ms. Humpy McFeckface prefer to get it on weeknights, not weekends. I think they don't have jobs. Or maybe they work in a bar. A bar where the specialty is the oyster-choco-viagra cocktail with a twist of tiger penis, and employees get all-you-can-drink.

This past Sunday night they were carrying on louder and longer than ever, and I actually hollered out the window, "FECKING WRAP IT UP ALREADY!!" right about 3:57 AM. But they didn't hear me. I was no match for the megaphone. I wanted to claw my ears off.

So the next day, I composed a very polite, very direct letter and had Mikey go affix it to their door. He almost drew a big, red "A" on the door, too, but we couldn't find the markers. For your reading pleasure:

Apartment #4,

There is an issue that's become enough of a problem that I must bring it to your attention. I don't know if you realize it, but your sex is very loud. I've tried everything I can think of to sleep through the screaming – using earplugs, pillow-over-the-head, trying to drown it out with the fan – but the screams are just too loud; nothing seems to work. For those of us with regular jobs, it's especially rough to miss that precious sleep between 2 and 4 AM on a work night, when you know you have to get up and try to function in just a few hours. We've all gotta share this tiny, noisy planet, and when we help each other out, our kindness comes back to us. Maybe you could try and tone down the volume of the screaming in the wee hours? Re-schedule your romps for a more decent hour? Or at least shut your window? Think of the great karma you will earn yourselves!

Thanks SO much for considering this problem, and happy (hopefully quieter) humping!

We dropped off the note Monday evening, while Mikey was doing laundry. Since the laundry room is right across from Apartment 4, he got to peek and see if the letter had been picked up every time he checked on the laundry. Finally, on the last load, the letter was gone. Mike and I stared at each other wide-eyed, partly giddy, partly frightened. He said, "You've seen the dude, right? Do you think I could take him if he comes knocking on our door all pissed off?" I assured him that surely this dough-y, aging frat boy would be no match.

Well, it's been three nights and not a PEEP from the downstairs sex fiends. Part of me is worried that we embarrassed the poor girl so badly, she's too afraid to even have polite, quiet sex now. Or maybe loud sex was the only thing they truly had in common, and we've given them no choice but to break up. Or maybe they started keeping HIS neighbors up for a change. Whatever it is, now I feel like sending them a fruit basket, or yelling out the window through a megaphone "THANK YOU FOR GIVING ME MY SLEEP BACK!!!"