NOTES FROM THE UNDERGROUND; PWA Health Group - April, 1996

This rant was written and sent to community activists and organizations around the country on March 14.

We met on 3/13/96 with activists and Merck & Co.’s merry marketeers, so that they could lay out for us their so-called plan to distribute, sell, and continue to study Crixivan, our newest friendly protease inhibitor. Well, they were more than willing to admit that their plan was probably unfair, totally complicated, and barely not fodder for a fabulous anti-trust lawsuit. But Merck pleaded for mercy (which some activists who attended this mini-meeting were more than willing to give), because they had to devise this so quickly, and they were being rushed, pushed by the FDA to get Crixivan into the market-I’d rush too if I could make $131,000,000 in a year like the Merckies. So, Crixivan was approved by the FDA, probably within minutes of our sorry backsides walking out the door of Merck’s visitors compound in Blue Bell, PA. The only really good news is that Merck’s base price is way cheaper than Norvir or Invirase-$4,380 per year ($12 per day). BUT they cut a sweetheart deal with Stadtlanders, so the retail price sucks. (see pricing).

CRIXIVAN WILL NOT BE SOLD IN DRUG STORES!!!

It will be distributed only through Stadtlanders, a mail order pharmacy service, at least until October. This will happen ON A FIRST COME, FIRST SERVE BASIS. There is no priority for patients with low CD4, or high viral load. The Merckies claim, and this really burns us, that they ‘can’t play God’, and that any type of patient priority would be too complicated to be economically feasible. As if they are not already playing God by making people jump through flaming hoops for an expensive, gel-capped powder they hope might save their lives. Also, it was too late to change the plan (DUH!!! -the meeting for ‘community’ input finished one minute before they were legally able to implement the stupid plan!!). The Merckies asked that we tell them if we hear of problems (AS IF!!! Stadtlanders doesn’t accept Medicaid in 28 states, usually charges more than most drug stores, -ugghhh. Surprise, surprise, the stories are rolling in. Last week one Crixivan customer waiting for drug, was bugged for his credit card by none other than Gregg Perelman, Pres. of Stadtlanders - doesn’t he have better things to do? And if they’re so broke, shouldn’t someone else be distributing Crixivan?)

The patient assistance program is trademarked SUPPORT , hilariously. Merck refused to tell us what the income limit is, so we can’t tell you whether to apply or not. But trust them, Merck PR-types said, it will be generous. Of course we have no way to know-the info’s all proprietary, you see. NOTE:you can apply for patient assistance even if your HMO, ADAP, or Medicaid has not decided yet to cover Crixivan. The Merckies claim that they’re working with the VA (the US’s largest health care provider to PWAs) and prison systems, but gave no detail-so we’ll just have to see how much drug gets up the river in the next 4 weeks.

WHY SUCH A PAIN?

Merck tells us that their (money-clutching) hands are tied. First, they don’t have enough Crixivan to supply it to everyone, and they need to ensure that everyone has a steady supply to avoid speeding up HIV resistance. OK, That’s serious enough. The rumor in certain circles is that Merck conservatively estimates it has enough Crixivan to continually supply 30,000 patients until their new factory is finished next Fall, when there will be enough Crixivan to feed it to the pigeons and fertilize your garden with it. Protease inhibitors, a totally new class of drug, were developed and approved by the FDA faster than any drugs in the past. Because of this, we have literally NO information about how long Crixivan works, how it works with other drugs, how long it takes HIV to become resistant to it, why and which people respond very well or not at all, and what the long term side effects of taking Crixivan are. Merck stated that they will compile ‘long term’ safety data in a small number of people for 3-5 years, but would only commit to the first year. This data will be from patients who enrolled in phase II trials (#s 4,6,10,18,19,20,21,35) and one phase III trial (#39), for a total of ‘around’ 800 patients. They will continue to receive Crixivan for free and get their labs, blood counts, and viral RNA counted through Merck. ¡Horrores! Merck won’t give these patients their own viral load counts on a regular basis as they are taken. Why? Could it be that Merck doesn’t want people to stop Crixivan when they find out they have developed resistance? So much for the standard of care.

If you’re in this long term follow-up program, you can’t take any other protease inhibitors, and new experimental drugs (non-FDA approved, study drugs) will be reviewed on a case by case basis by Merckian wizards. The other 2200 people in Merckian programs, including those in their limited expanded access program (a.k.a. restricted marketing access program), will be "rolled into commercial access" (as though buying prescription drugs at the drug store is a whole new access program.)

YAY, PRICE!! BOO, DISTRIBUTION!!

This distribution looks like it will be complicated, complicated, complicated, which sucks. The supply issue could have been worked out in many, easier ways, if Merck and the small group of community people who were involved in the entire development process, had acted a little earlier than two weeks before the drug was bottled up and sent out to PWAs. The people who will bear the brunt of this ugly situation are the many PWAs who need this drug the most right now: people who have outlived other antivirals, have lower T cells or high viral loads. They may not receive this drug for months and months, if ever. The vast majority of PWAs have no experience using mail order pharmacies, and if the paper trail extends too far, many doctors will be less willing to prescribe the drug-disgusting, but true. People who want Crixivan now and are unable to get it should be angry at Merck for devising this labyrinth of hooey, and should be angry at their activist community reps for not calling them on it sooner.

(Since this was written Merck has decided to provide Crixivan directly to the VA system, Federal Prison system, as well as Kaiser and some smaller HMOs. Merck has also promised enough drug for 15,000 PWAs, in France, by September, even though they confirmed on April 1, that they have Crixivan for only 30,000 PWAs worldwide, until their factory opens. Community Prescription Service and MediExpress will assist people with the paper work from Stadtlanders for access to Crixivan.)

In his Welcome-To-Stadtlanders letter, Gregg Perelman, President of Stadtlanders, writes: "We know there can be numerous obstacles for individuals who are living with challenging health conditions. When winds blow softly or the storms rage violently, we hope that the foundation of patient support we create at Stadtlanders can help to keep our customers grounded in a safe place."

Safe for whom? STADTLANDERS... Friend of the Community and PRICE GOUGER!!

For the FDA approved Crixivan dose of 2,400 mg/day, Merck charges Stadtlanders: $12/day or $4,380/year

Stadtlanders charges you: $16.50/day or $6,022/year

THAT’S AN OUTRAGEOUS 37.5% MARKUP!

Stadtlanders reps claim that their price is only 10% above the average wholesale price ("AWP"). BUT THERE IS NO WHOLESALE PRICE. Stadtlanders is buying Crixivan directly from Merck. No wholesaler is involved. And, of course, no competition either.

Merck estimates that they can supply 30,000 people until next fall. If so, Stadtlanders’ gross profit in six months will hypothetically be: 24.3 million dollars! Stadtlanders whines that they have had to hire 420 new employees! And that it’s really just their usual, higher than average markup! Ahh, the joys of monopoly distribution. Remember that they don’t have a monopoly on anything else, vitamins or 3TC or Fosarnet. Get Crixivan at Stadtlanders and everything else anywhere else, preferably a place that really supports PWAs.

Hopefully, by the time you read this Stadtlanders will have done the right thing and lowered their price. But meanwhile, TAKE ACTION! Call and/or fax Stadtlanders, the "friend of the community." Rainbow flags are not enough!

Copyright © 1996 - NOTES FROM THE UNDERGROUND - The PWA Health Group Newsletter. All rights reserved. No part of this publication may be copied or reproduced in any form or by any means without the written permission from the PWA Health Group. NOTE: The PWA Health Group is no longer in existence, as per notification in 2003. An organization called Visionary Health Concepts has succeded them. VHConcepts is a HIV/Hepatitis+ owned and operated health education company specializing in providing free HIV & Hepatitis treatment programs For more information please contact Email: edu@vhconcepts.com. .