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PHARMA/QUALITY/PHYSICIANS: Rational sense on opioid use for cancer sufferers, with reference to Kinsey and rationalism.

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A very important THCB reader — one that I have to be nice to if I want to feature in the will, and you might guess that I’m a couple of wickets down already — has forwarded me this BMJ article on opioid use for cancer patients.

Last night I saw the movie Kinsey, which told the story of how Kinsey’s research on human sexuality in the 1940s and 1950s created great advancement in human understanding, and helped remove the weight of hundreds of years of damaging religious bigotry — yup into the 1930s married couples were taught that any non-missionary position sex (including using the mouth or the fingers) was wrong and unnatural. There’s a harrowing scene were his father eventually tells him that he was fitted with a strap to prevent masturbation. I thought of this in the context of opioids, because apart from certain lunatics on the Christian right, rational people agree that the behaviors imposed by society on sexual "deviants" — homosexuality was a jailable offense as recently as the 1950s –were both morally wrong and harmful to individuals and society as a whole. We needed science (and I know there’s a lot of criticism of Kinsey, M&J and Hite’s methods, but they approached the issue from a scientific not a moralistic perspective) to show us the truth in a rational dispassionate way.

The war on pain doctors and patients is being fought by a similar band of lunatic puritans as attacked (and still attack) Kinsey.  Only these moralistic jihadists have the full force of the Justice Department behind them and are clearly bending every commonsense understanding of justice and ethics to imprison and destroy anyone who holds a different, more humane view.

Of course the main problem here is that the puritan jihadists have equated opioid use for pain as some kind of great moral failing. Well the scientific view is succinctly and excellently put by a leading British physician:

Concerns about morphine: Morphine has long been feared by the general public and the medical profession. Underlying this fear is the mistaken belief that the potential for misuse of opioids is linked with their use as analgesics. Unfortunately, concerns about addiction, respiratory depression, and excessive sedation cause healthcare professionals to avoid using opioids or to use them in suboptimal doses. Clinical experience has shown that these fears are largely unfounded and that addiction is not likely if morphine is used to manage pain responsive to opioids in doses titrated to the degree of pain. Withdrawal symptoms indicate physical dependence and should not be confused with psychological dependence (addiction).

It’s mainstream educated work like this that needs to be broadcast widely, and all physicians and other scientists need to continue to trumpet this loudly. Don’t forget that the puritan jihadists want to take us back to their equivalent of Sharia law, and the real fight among civilizations is not between Christians and Muslims, it’s between the rationalists and the zealots. And if you think I’m overstating it let me  use this quote from the Guardian of a smattering of leading anti-Kinsey campaigners (yup, they really exist)

The religious right still fear and despise Kinsey and all his works. Check out some of the (apparently coordinated) responses to the new movie. "Kinsey’s proper place is with Nazi doctor Josef Mengele," says Robert Knight of Concerned Women for America, inadvertently showing us what he thinks of the Holocaust. Robert Peters of Morality in Media: "That’s part of Kinsey’s legacy: Aids, abortion, the high divorce rate, pornography." Focus on the Family’s film critic (they have a film critic?), Tom Neven, calls the movie "rank propaganda for the sexual revolution and the homosexual agenda". And Judith Reisman, who has waged a decades-long war against Kinsey’s memory, refers to "a legacy of massive venereal disease, broken hearts and broken souls".

And is it a Jihad?  Well the lunatics certainly think so:

A recent newsletter of the abstinence-education group Why know? compared the publication of “The Kinsey Report,” in 1948, to the attacks of September 11th, and labeled Kinseyism “fifty years of cultural terrorism.”

PHARMA: Senator Grassley, I presume? by Mr JiB

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IN CALIFORNIA things are starting to heat up in advance of the November special election. Proposition 78, the drug-industry backed ballot measure targeting high prescription drug costs, picked up a key endorsement this week. On Monday, Governor Arnold Schwarzenegger gave his blessing to the proposal.  The politically powerful American Association of Retired People (AARP) formally announced its support on Wednesday, said it is siding with Proposition 79.  

Proposition 79, the alternative backed by Health Access California, key consumer groups and major unions, is seen as taking a tougher line on costs. It is also intensely disliked by drug companies, who see it as likely to encourage similar attempts to pass tougher laws in other states.  Recent tracking polls show support among Californians for the two measures about even. That is a bit of a surprise for those who were predicting the campaign would essentially be a formality, given the lobbying power and resources of the pharmaceutical industry.

HealthVote.org has been tracking ad spending, as it did during last year’s election. Huge amounts of money have been spent already. But the real action is likely to come over the last six weeks of the campaign.  According to the group’s release today:

Prop. 78 supporters aired 11,485 ads in California’s five largest media markets (Los Angeles, San Francisco, San Diego, Sacramento and Fresno) through September 25 at an estimated cost of $13.4 million. Proponents of Prop. 79 launched their ad campaign on September 29.

When the Prop. 79 spot is posted, I’ll link to it, so you can take a look. But for now, you can go take a look at the spots the campaign for Prop.78  is running here.UPDATE: Lisa Girion has a piece on the topic in today’s LAT. The paper’s take:

Californians like the idea of a statewide drug-discount program for the poor: A recent Field Poll found Proposition 78 leading by a healthy margin. But that support sagged when respondents learned that the nation’s big drug makers were behind the initiative.  And therein lies the problem for supporters of the measure: Its biggest backer is also its biggest liability. 

— Mr JiB

PHARMA/POLICY/POLITICS: Well at least he gets to put “former FDA Commissioner” on his resume!

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So just like that after a contentious time getting confirmed, FDA Commissioner Lester Crawford resigns, after only formally being in the job for less than three months (although effectively having basically run the agency for three years). I wonder what further skeletons have crawled out of his closet?

Get ready for more confirmation fatigue as the Administration searches for someone else ready to screw their reputation by placing politics (and deeply unpleasant, mean spirited politics at that) before science.

PHARMA: How to make a fortune in health care

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The Industry Veteran is right. Don’t bother with expensive degrees or clever busines planning. Just get close to an organization (preferably in it) that can’t keep its hand out of the cookie jar, and nail them by letting the Feds know. It works for PBMs, and even better for drug companies — to the tune of $26m for this go-round, with Glaxo as the fall guy. Frankly this one looks pretty dumb. Didn’t Glaxo note exacty the same thing was pulled on TAP not so long ago?

Meanwhile in this list of the top 20 Fraud settlements of all time, health care companies get to star in 16 of the top 20! And that’s before Part D comes into effect!

PHARMA/PHYSICIANS: Trying to stop the biting of the feeding hand

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So there’s a bunch of rabble-rouser docs who are actually trying to enforce the often mouthed concept that doctors shouldn’t take freebies from pharma companies. They’re called No Free Lunch

And of course, given the actual views of mainstream doctors who believe that life was better when the pharma companies had no restrictions on the graft they could send their way, they are being banned by specialty societies from doing things like handing out the specialty societies own guidelines on gift-receiving to its members, and of course from buying a booth at the oh-so-well incorruptible AAFP’s convention. Jim Edwards at Brandweek has more. But let’s not be too surprised.

PHARMA/INDUSTRY: Hurricane Katrina Direct Relief!

I was contacted late last night by Grace Davis who is one of "two moms" who is running a blog helping support relief for Katrina victims. The other mom is Victoria Powell, a doctors wife, who is visiting health clinics (and all types of other places offering help) in Mississippi to see what they need and getting them supplies. It’s a practical and innovative way of cutting through the bureaucracy, and it may be getting to some of the places that are otherwise being missed.

This morning they are putting out a call for supplies for health clinics that are running low on medication. If you are from a pharma company or a wholesaler or have some other way of getting them medical supplies, please go over the Hurricane Katrina Direct Relief! blog and see what you can do to help, or please pass it along to whomever in your organization is coordinating your efforts to help.  Many thanks.

PHARMA: Blogging impact on pharma

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I will be speaking at a conference on Blogging and Pharma later this year.  More details here and there’ll be more about it on THCB soon. Meanwhile, do you think that this is the kind of story that pharma companies should be concerned about?  It never mentions the word lawsuit, but if SSRIs cause birth defects, how long before the Vioxx lawyers get ahold of this one and run with it?

It may be a while before we can be all grown up about our pills.

PHARMA/POLICY/POLITICS: FDA Official Quits Over Delay on Plan B, with UPDATE

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The FDA official in charge of women’s health quits over the delay on Plan B‘s approval. Well it’s good to see that some of the staffers left at FDA have some spine, because it’s clear that, whatever the lies being told by the Administration, this is all about cow-towing to the loonies on the Christian right rather than the science of the situation.

There are a couple of telling shots in the story. Crawford swore up and down that this was his decision and that it was a science-based one.  Not so. 

Susan F. Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, said she was leaving her position after five years because Commissioner Lester M. Crawford’s announcement Friday amounted to unwarranted interference in agency decision-making. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.

Of course there were strenuous denials from all concerned, but what was she told?

Wood also said other FDA officials who are typically involved in important matters were kept in the dark about the contraceptive, called Plan B, until Crawford announced his decision, which she believed was made at higher levels in the administration. Wood said that when she asked a colleague in the commissioner’s office when the decision would be made, the answer was, "We’re still awaiting a decision from above; it hasn’t come down yet."

So you could argue that this was not Crawford doing what he thought the loonies wanted him to do, but instead he was actually taking instructions from Leavitt or Rove or whomever.  On this issue  they can send a sop to their "social conservative" friends. After all it’s only a small pharma company they’re pissing off here, not a big one, Just as well Lipitor doesn’t impact birth control, eh?

Meanwhile, there’s just a delicious piece of doublespeak from Leavitt that really outdoes some of the stuff we’ve had to put with from Rumsfeld over the years:

Many supporters of the Plan B application — including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) — accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford’s ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.

Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn’t always yes and no. Sometimes it requires additional thought.

So now when you’re asked by your wife, boss, teacher, whomever why you haven’t done something you were supposed to have done (you know, "taken action") you can tell them that you were thinking about it and that is exactly the same thing! Not only that — it’s now official policy in what passes for the circus we call a government.

UPDATE: Bob Steeves points me to this quote from the spokesman for Mike Enzi (a Senator with an "R" after his name), showing that he didn’t get the Talking Points on this one and looks a little pissed:

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, is considering whether to hold hearings on the FDA’s handling of Plan B, said spokesman Craig Orfield. Enzi had expected "a firm decision" from the FDA, not further delays, Orfield said.

BLOGS/PHARMA: John Mack on “ethical pharmaceutical marketing”

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John Mack attributes one of my contributors words to me.  So first some remedial education.  When I say that this is The Industry Veteran’s views on XYZ, and here are The Veteran’s words, and I introduce that in an indented paragraph,  I mean that a guy calling himself The Industry Veteran wrote it and he is NOT me.  If an article appears here without such a paragraph you can assume that I wrote it. Sorry to be pedantic, but my desire to have differing view-points up here why this is called The Health Care Blog and not Matthew Holt shoots his mouth off about health care. It’s the same theory as the New York Times having  Paul Krugman and David Brooks both writing op-eds. I have enough opinions of my own without wishing to have other people’s attributed to me–even if I agree! And just to prove it I’ll have another article from Eric Novack up here very soon..

Meanwhile, what John has to say about the Veteran’s words is pretty interesting.  He notes that the tone set by pharma comes from the top, and I think that the Veteran would agree.

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