Die gastronomischen Quereinsteiger Hilpert und Tiedje trafen auch die Entscheidung, das Resort trotz einer möglichen höheren Bewertung von der Dehoga mit vier statt fünf Sternen und dem Zusatz Superior einstufen zu lassen. Damit verstossen Pharmaunternehmen nicht gegen Paragraf 20 des freiwilligen Arzneimittelindustriekodexes, der eine Buchung in Fünf-Sterne-Betrieben untersagt, wenn sie Ärzte hier an die Brandenburgischen Seen einladen.

Dear Doctor:

You undoubtedly are aware of the sleep aid drug Rozerem marketed by Takeda. The company's sales representatives surely have paid you many visits extolling the so-called virtues of Rozerem. You may also have seen the big "Zero" logo at meetings and in print ads (if not, see "Rozerem Sleeper Cell at Pri-Med Conference").

But you may not have seen recent Rozerem DTC reminder TV ads that Takeda has run in violation of its pledge to abide by PhRMA's Guiding Principles for DTC Advertising, which specifically bans reminder ads on TV (see "Rozerem Reverts to Reminder TV Ads"). As you may know, reminder ads mention the drug name but do not mention the indication or side effects.

In addition to that questionable behavior, Takeda also received a Notice of Violation letter from the FDA that said some of these ads were aimed at children and were not reminder ads at all and should include side effect information (see "Back to School for Takeda, Rozerem, and Abe Lincoln!").

The worst offense, however, is Takeda's claim that no one in the company was involved in the "approval, release or broadcast of the advertisement in question" (see "Takeda Borrows Cephalon's Excuse for FDA Warning Letter").

I am sure that like most people, you find that excuse hard to believe and, if true, it must give you pause. That is, either Takeda is not trustworthy -- it lied -- or it is incompetent.

I am asking you, therefore, to refrain from writing prescriptions for Rozerem in protest. There are several other alternative drugs available for the treatment of your patients with insomnia.

The next time you see a Takeda sales representative, tell him or her that you are boycotting the product until you are assured that Takeda takes the necessary steps to (1) determine who in their company and/or ad agnecy was responsible for the violative DTC ads, and (2) terminates the employment of the responsible employee or cancels the contract of the responsible ad agency.

Only you have the power to make Takeda comply with FDA regulations, PhRMA DTC Guidelines, and minimal industry ethical standards. FDA and PhRMA appear to be ineffectual in this regard.

Sincerely,

John Mack

In letzter Zeit ist in Österreich auch ein zunehmender Einfluss der pharmazeutischen Industrie auf die Gesundheitsberichterstattung in den so genannten „Laienmedien“ (Monats-, Wochen-, Tageszeitungen, Fernsehsendungen) zu bemerken. Die Lobbyisten der Industrie verweisen selbst stolz darauf, welche Medien sie finanziell unterstützen und welche Möglichkeiten des „Agenda Settings“ sie dafür erhalten."

erstens hast du ein gutes budget zu deiner verfuegung. solange du es legal unter die leute bringst gibt es kein problem. keine schreibt dir eigentlich vor wie du es zu benutzen hast, ob veranstaltung oder ob du 10000 kulis davon kaufst ist normalerweise egal. das wichtigste dass alles seine ordnung hat, und was bedeutet das? die rechnungen/unterlagen muessen unanfechtbar sein. wer schon mal einen guten steuerberater hatte kann sich einige tipps holen wenn es um krative buchhaltung geht. und in der heutigen zeit wird man schnell kreativ. natuerlich gute kontakte sind das a und o.
wie vor einigen jahren einige mitarbeiter eines grossen englischen konzerns sollte man es nicht machen. teure geschenke einfach so mal abrechnen mit der firma, unter die restaurant rechnungen umsatzsteigerung schreiben (bewirtungsanlass).
Dann git es auch firmen eigene "projekte" die aendern sich mit der zeit und die wurden immer weniger aus bekannten gruenden.
hand aufs herz, alle sartane sind mehr oder weniger gleich, ob nun in der studie der eine 2 stunden langer wirkt oder 3mmhg mehr senkt mahct im altag keinen unterschied und kein arzt kann es in der praxis messen. da braucht man halt andere argumente um diese preparate zu platzieren.

Naive könnten dies jetzt für eine Win-win-Situation halten. Ich habe meine Fortbildungspunkte bekommen, durfte noch umsonst etwas essen, und die Pharmaindustrie konnte mich über ihre Blockbuster in spe informieren. Auf der Strecke jedoch blieb ganz sicher das, was mit der Fortbildungspflicht im DMP beabsichtigt war: eine wirtschaftliche und qualitätsgesicherte Arzneimitteltherapie. Und dies ist, fürchte ich, exemplarisch für das ganze Elend der Fortbildungspflicht. Man jagt die Kollegen in die Fortbildungen, wo sie mit offenen Armen von der Industrie begrüßt werden. Die Regelung, wonach es nur Fortbildungspunkte für Veranstaltungen gibt, die wirtschaftlich unabhängig sind, ist offensichtlich zahnlos. Nie liefen die Chappi-Veranstaltungen so gut wie heute, wo selbst solche Kollegen kommen müssen, die sich früher aus gutem Grund fernhielten.

Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question.

Breit bekannt wurde Pudel in seiner Eigenschaft als Geschäftsführer der WeCARE Gesellschaft für interdisziplinäres Gesundheitsmanagement mbH, die das Online-Schlankheitsprogramm Slimnet einführte, weswegen er vielfältiger Kritik ausgesetzt war. Einige Ernährungswissenschaftler bezweifeln die Wirksamkeit der von Pudel propagierten streng fettarmen Diätform, Verbraucherschützer kritisieren die Verknüpfung des Slimnet-Diätprogramms mit dem Verkauf kommerzieller Diätprodukte ("Delemi").

I was back in New York again. The American Airlines shuttle across the U.S. – another 3 mrems of radiation.

The Grand Hyatt hadn’t changed much. Same crowded sidewalk next to Grand Central Terminal. Same bustling lobby. Same set of four or five escalators up and over and up and over until you reach the ballroom level. As with every investor conference, it is filled with scurrying mice in tailored suits, all looking for the next greatest thing. And for days, every thirty minutes in six different tracks, companies endlessly pitch their golden prospects. Every damn one of them sounds like the next greatest thing, so the mice scurry some more, discuss amongst themselves and probe and prod CEOs with insightful questions until the mice are so confused, they just ask someone else what they should buy.

I’ve been to so many tech conferences, I could tell you where the bathroom and best cellular reception is in the leading hotels of the world. But this was a healthcare conference. I pulled some strings at Bear Stearns and wangled an invite. I figured it would be a great forum to get instantly up to speed on the healthcare industry. So I put on a suit, slogged to NY, sweated in 95 degree heat, and pretended to be interested in Phase 2 trials of monoclonal antibodies. What I learned was that healthcare investing was a bigger crap shoot then technology.

“What do you think of these guys?”

“Curagen?”

“Yeah.”

“Too early.”

“But they’re in Phase 2 on their cancer thing – PXD101 I think. I thought you like Phase 2?”

“I do, but it’s not theirs.”

“Sure it is.”

“Nope, they licensed it, not enough upside. No one is going to care.”

I was eavesdropping on two guys I recognized from the past. One guy used to run some tech money, I think I remember him getting blown out in 2000 for being long and wrong. But he’s obviously still in the business. I strained to read his name tag, without luck. The other guy was a classic popcorn hedgie. Always showing up where the action in, figuring out some angle and trading rapid fire looking for returns.

“For me, it’s just one thing.”

“Market size?”

“Nope, these are all billion dollar markets.”

“Management?”

“Nope, they’re all trying to hit fish with a baseball bat.”

“True. So what is it? Balance sheet? Partners? Their logo?”

“You just play the trials. I don’t give a shit what drug it is, it almost always works the same way.”

“Get out of here.”

“No, check it out. Preclinical is bullshit, you could get gum off the sidewalk to reduce tumor size in rats. So what? Even Phase 1 is a load. They are mostly bent around to get decent enough results so you can get to Phase 2. I’ve tried to time Phase 1 announcements, but no dice. You always wait until you are about a third of the way into Phase 2, then you buy the shit out the stock."

“C’mon.”
“It works. The first few press releases are almost guaranteed to be positive. Companies will do anything to get their stock up before the final results hit. Phase 3 is just so damn expensive, they want to sell stock or converts or something so they don’t have to give the damn drug away to big pharma.”

“OK.”

“Look, the stock almost always pops. I usually sell into it, unless the press release is blow-away efficacy numbers, then you can stick around. But not forever.”

“No?”

“Hell no, you almost always sell right before the Phase 2 trial is over. Everyone figures it’s gonna work, so the stock goes up until the day of the announcement. It almost always gets whacked when they announce the real results, people already know. The doctors have been trading the stock ahead of you and dump it on the news.”

“That’s it?”

“I sometimes do Phase 3, but that’s harder. Even if something works, the costs kill you. The stocks going
down.”

“But it pops on the news at the end of Phase 3.”

“Sometimes. Not always. You can get killed if the trial fails.”

“Can’t you play that?”

“Nah. I don’t like to gamble. Not even in Vegas.”

* * *

I spent several days walking the halls, popping into presentations, seeing if I could hear about some sea change in healthcare. Investors always hear about things first. Instead I heard about drugs that might or might not treat bone metastases, myelogenous leukemia, multiple myeloma, kidney inflammation, and on and on.

I didn’t hear about innovation – more like regimentation.

I don’t know how many times I heard the expression fully randomized, double blind, placebo trial. Every biotech and pharma company pitched some set of compounds in trials. They were rooting away, but had absolutely no idea if the damn thing really worked. Even big companies with billions in sales of some drug pitched their replacements when they went off patent. It seemed like a giant roulette table. If 17 black comes up, you win 35 to 1, else, zippo.

Even the popcorn hedgie didn’t like those odds, settling for smaller returns with a bet based on knowing how fast the wheel spins. Jeez.

Twenty-five to 35 percent of patients in nursing homes who are diagnosed with dementia received an antipsychotic drug such as Zyprexa last year, Hohenberg of Decision Resources said.