Iran and Your Prostate

TO WHOM IT MAY CONCERN

Happy BIRTHDAY, Sweetness!

THINK THERE’S TOO MUCH MONEY IN POLITICS?

I do! Click here to help fix it.

CHENEY’S PLAN TO BOMB IRAN – CONFIRMED?

Click here. (The idea is, even Bush isn’t nuts enough to do this – so Cheney will get the Israelis to provoke an Iranian attack on American forces and then Bush will start bombing.)

GAY ARAB LINGUISTS IN THE MILITARY

Stephen Gilbert imagines this dialog: ‘Mr. President, the linguist says there is a terror attack planned for tomorrow.’ ‘I don’t care what he says – he’s gay.’

Because, having now fired 58 (fifty-eight!) gay Arab linguists, that’s essentially what the Republicans who back this nutty policy are saying. Here‘s the latest such story.

(And here‘s John McCain affirming his view that gays in the military are an intolerable risk.)

President Clinton has long since issued a letter lamenting how Don’t Ask/Don’t Tell went awry. All 21 of our 2004 and 2008 Democratic presidential primary contestants support lifting the ban. And last month, President Carter issued a letter of his own.

Even some Republicans have come around. ‘I believe it is critical that we review – and overturn – the ban on gay service members in the military,’ says Wyoming Senator Alan Simpson. ‘I voted for ‘don’t ask, don’t tell.’ But much has changed since 1993. We need every able-bodied, smart patriot to help us win this war.’

DNDN – PROSTATE CANCER – THE NEWS

ABC News last night had a piece on Provenge, a drug meant to treat prostate cancer, from a company called Dendreon (DNDN). DNDN was long around $4 a share before it jumped to $24 in a couple of days a few weeks ago . . . then dropped back to $6 in a day. Last night it closed at $8.20.

I don’t know whether or how the other networks may have covered it, but ABC was reporting on a demonstration in Washington by prostate cancer patients who wanted the FDA to approve the drug for sale. After all, the FDA advisory panel had voted 13-4 in its favor – it had extended life 4½ months on average in a small clinical trial (and as much as two to three years in a few cases) – yet the FDA had turned it down and the FDA brass would not comment.  By the end of the news report any decent human being was screaming at the FDA, through his or her TV set, “People are dying!  How can you call for another year’s clincal trials before approving this miracle drug?!”

Here are some things ABC did not report (full disclosure: because of these things, I am short the stock):

1. The head of the FDA is probably as eager as anybody to combat prostate cancer – he’s had it.  And he has spent much of his life fighting it . . . as head of the National Cancer Institute . . . as Executive Vice President and Chief Academic Officer of the University of Texas M.D. Anderson Cancer Center in Houston, leading a faculty of more than 1,000 cancer researchers and clinicians . . . as founding director of the Prostate Cancer Research Program . . . and on and on.

2. When the advisory panel vote was taken, the question was, “do the data [of the clinical trials] ESTABLISH EFFICACY.”  The first 4 panelists unanimously answered: “No.”  Seeing the handwriting on the wall, the chair of the panel changed the question.  The remaining 13 panelists were asked whether the data showed “SUBSTANTIAL EVIDENCE of efficacy.”  They answered yes, and the stock shot from $4 to $24.

3. I’m told by an expert who follows these things closely, the FDA can’t suddenly change the standards by which it approves drugs.  If they had stuck with the question that was supposed to be asked, the vote, far from 13-4 in favor, might well have been 17-0 against.  So my friend bet the FDA would not accept the recommendation of its advisory panel – and he was right.  The FDA said more trials would be needed (that would take two or three years at a cost likely well in excess of $100 million), and the stock dropped to $6.

4.  Here is the transcript of the FDA meeting.  You are a better man than I if you can make sense of it, but my Harvard-trained doctor pal (who would also very much like to see a cure for prostate cancer – who wouldn’t?) says:

Note the testimony that the product does not produce CD8 ‘cytotoxic’ T cells.  So how then does the drug work?  According to the company in the transcript, ‘we don’t know.’  MAGIC perhaps?

His point: the drug is supposed to use the body’s own immune system to attack the cancer – but for that you need T-cells . . . yet they admit it produces none.

Note that the overall survival of the Provenge-treated patients in the second trial was numerically less than the survival of the placebo-treated patients in the first trial.

Got that?  People using the drug survived less long than those using a placebo.

Dr. Maha Hussain pointed this out – she was chair in 2005 of the FDA’s committee on deciding the correct endpoints for trials of prostate cancer therapies.  She also happens to be chairwoman of the committee called ODAC that advises the drug division of the FDA on cancer products.

It’s heartbreaking that the drug hasn’t been proven to prolong life . . . may even shorten it based on the results comparing longevity of the second trial with placebo results of the first.

But for now, at least, my friend writes, “The FDA is consistent in applying its standards.  If the FDA were to approve Dendreon’s Provenge, then almost EVERY DRUG WOULD HAVE TO BE APPROVED” – because drugs aren’t taken to clinical trials without some encouraging evidence they might work – “and the US market would be flooded with useless placebos.  Not only is this against the law (the Kefauver act of 1962 states that drugs must be shown to be safe AND effective), it is very bad policy.”

(Because, presumably, since our health care system is already badly strapped even just paying for the drugs that have been proven to work, what if it had to cut back on those in order to pay for, also, loads of drugs that very possibly don’t?)

But even if you think Congress should change the law and not require proof it works before a drug can be approved (and if I were denied a cure I thought might help, I would think the same thing), look at it purely from a stock market perspective.

Far from the nearly $700 million at which the stock market currently values the company, my friend thinks it’s worth nothing.  All it has, he believes, is a drug that does not work.  (NTMD, at least, had a drug that did work.  It was just that there was no point paying six times what it would cost to buy its two generic components separately.)

The options on DNDN tell all.  People are paying $2.50 for the right to sell this $8.20 stock at $5 over the next year and a half.  Only to the extent it falls below $2.50 will they begin to see a profit.

Do not short the stock – how would you like to be sitting there short at $8 and see it run to $24 in a day if my friend is wrong (or right, but something sends it soaring for a while anyway)?

And probably do not buy the puts – so many people agree with my friend that they are very expensive, as in the example above.

But if you happen to own the stock, consider the parts of the story ABC didn’t tell, disheartening though they are to anyone hoping to prolong life even for a few months.  (Which is to say, all of us.)