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Tuesday, August 23, 2005

Powders of the Merchant

Like a bad doctor who has fallen down sick you are cast down, and cannot find what sort of drugs would cure your ailment.
Aeschylus (525–456 B.C.)

Sometimes, placing two news stories next to one another like puzzle pieces place them both in sharp relief. The Porcupine has no quick answer for this problem, as I come from a day when nostrums were mostly ineffectual. Genuinely curative drugs are a fairly new phenomenon in human history.

First, a story which first ran on the ‘American Morning’ on CNN on August 12, and several times again after that.

As part of a series on cancer drugs, Dr. Sanjay Gupta visited Dr. Eugenie Kleinerman at the Anderson Cancer Center at the University of Texas. Dr. Kleinerman is working with an experimental drug called ImmTher in a clinical trial for Ewing’s Sarcoma, a rare form of bone cancer which strikes primarily children. Dr. Kleinerman has had very good results with this trial, and children treated with the drug are in remission, and perhaps even cured. However, the drug will no longer be produced, and here are Dr. Kleinerman’s comments on that:
Basically, I was getting the message that our marketing people have done research and we're never going to be able to recoup our research and development costs. And it doesn't matter who we're going to help and who we're not going to help, the marketing people have made the decision that we're not putting any more resources in this.” Further:
Because sarcomas are a very rare tumor, and you have to understand that drug companies, pharmaceutical companies, have to report to their stockholders, and they're interested in their financials, and this will never be a money-maker.”
Dr. Kleinerman has about enough drugs on hand for six months, time enough to complete the current trial and help those children, and then that’s it.

Dr. Gupta of CNN then went on to say:

I think everybody feels the same way. It's really one of these things that sort of boggles the mind. Couple things. There is something called the Orphan Drug Act. This was actually from federal government to try and create drugs for diseases that affect less than 200,000 people in the United States. But what we found as we sort of explored this was the pharmaceutical companies, even with these federal incentives, don't always want to make these drugs. So maybe there needs to be improvements and amendments to the Orphan Drug Act. "

Greedy companies. Makes your blood boil. Here’s a little additional information that didn’t make it on to CNN.

ImmTher began its clinical trials for FDA approval in 1999, so they have been moving through the FDA process for about six years. The drug is made by DOR BioPharma, a division of a small pharmaceutical company called Endorex Corp. which does a lot of cancer research. This year, the 52 week high of its stock was 81 cents, and it now sells for 29 cents. Over the course of the year, it has lost over 40% of it overall value. Before you blame bloated bureaucracy, the company has 9 employees.

The Orphan Drug Act, designed to encourage companies to manufacture medication for obscure diseases, offers tax credits. The company doesn’t need credit to continue manufacture, it needs cash. Of all the 6 billion people in the United States, only about 100,000 have this rare sarcoma, and there are only 12,000 new cases diagnosed per year. So the likelihood of another larger company beginning production with no reward but the tax credit is slim. As Dr. Kleinerman says, this will never be a money maker. And money is needed by drug companies to pay court judgments like the one recently handed down against Merck Pharmaceutical about Vioxx.

This is the second piece of the puzzle. A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country. The jury deliberated for a grand total of 10½ hours over two days before returning the verdict in a 10-2 vote. The damage award to the man’s widow Carol Ernst is likely to be drastically cut to no more than $26.1 million because Texas law caps the punitive damages that made up the bulk of the total.

When Merck first learned of the problem with its drug through a blind placebo study, they recalled the drug and issued the following statement:

"We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president and chief
executive officer of Merck. “Although we believe it would have been possible to continue to market VIOXX with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”

Fat lot of good a voluntary recall has done them, of course. The legion of lawsuits is almost certain. In fact, to see if YOU have a case, just visit these web sites, and join in the plundering of Merck:

http://www.viox-heart-attack.com/ or http://www.vioxx-side-effects.com/

By what standard of reason would a jury award $253 million to the family of a man who died of the side effect of drugs which had already passed through the stringent FDA process? Do they understand that by doing so, they lengthen and make more expensive such clinical trials for drugs like ImmTher, and doom 12,000 children a year, by taking the $26 million they might have spent on rescuing such an Orphan Drug and giving it to one widow?

The drug companies can afford it, right? A little company like Endorex has tons of profit, don’t they? I wonder why we think it’s OK to punish drug companies for making a profit, but bemoan the fact that the salary cap prevents out team from getting the players they want.

ImmTher and Vioxx are two sides of a coin that we are loath to spend.



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12:46 PM  
Anonymous Nick G. said...

Thanks for writing about the ImmTher issue. I have Ewing's Sarcoma, and it is very frustrating that I can't get a hold of this drug that seems to work for people with Ewing's.

3:07 AM  

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