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PHARMA: More smoking guns around Plan B’s no approval, by Blunter

If any further proof of the politicalization of the Plan B marketing is needed
(which there is none), this recent FDA Release on the oral hygiene product
should show what should have happened to Plan B, absent any conservative
religious agenda, if the FDA had any substantial concerns about women  under 16
years getting direct access to the product.  And it should underscore that FDA
need not create any new or novel marketing system for Plan B to approve its OTC
use.  Karl Rove makes a very poor  FDA Commissioner, de facto or de jure and
Crawford and Galson should have followed the existing law rather than cede their
responsbilities to a political  campaign.

 

The Food and Drug Administration (FDA) today approved a new prescription
treatment for gingivitis, a common gum disease that affects most adults at some
point in their lives. The Decapinol Oral Rinse treats gingivitis by
reducing the number of bacteria that attach to tooth surfaces and cause dental
plaque. Decapinol is approved for use in persons 12 years of age or
older when routine oral hygiene is not adequate to prevent gingivitis. Decapinol
is not recommended for use by pregnant women.

POLICY: What’s right about Krugman? What’s wrong about Don Johnson?

Krugman’s series on health care continues in the NY Times and no doubt Don Johnson (over at BusinessWord) will be fulminating over this too. Don got a little offended when I called his stance mean. Don is a sensible guy and understands health care well, even if we disagree on on policy and politics.  So what do I mean by "mean".  Let’s ignore the fact that Don thinks that moderate social democrats like Krugman and Uwe Rhienhardt are the hard left — any observer of real politics would be giggling at that one.  I mean have they seriously suggested nationalizing health care delivery? No. Let alone nationalizing steel, autos, oil, and even agriculture.  (Yup, Don, that’s what the "hard left" from Lenin to Bevin did.  By his standards FDR was a Bolshevik).  But let’s look at Don’s opinion:

"I guess it’s ‘mean" to advocate regulated free markets that:
1. Help us have the lowest unemployment levels and lowest income taxes.
2. Give people who take the time to become educated, find rewarding jobs and seek out health care providers they like the freedom to spend their money on health care, if they think that’s important.
3. Try to minimize the role of centralized governmental planners who’ve never successfully created a health care system that cares for everyone in the country and makes everyone happy.
4. Give everyone incentives to earn the money needed to buy the best health care they can afford.
5. Not force wage earners to pay for the health care of strangers who could buy their own insurance if the politicians weren’t so good at giving everyone else’s money away in exchange for votes of the unthinking left."

The problem with this rhetoric is threefold. First, even if one accepts that we have "regulated free markets" in the rest of the economy and all those commies in Europe, Canada and Japan don’t, no one can seriously maintain that health care is a regulated free market like, say, buying groceries. It fails all of Adam Smith’s sniff tests for being in a state of perfect competition, and any serious student of the subject only has to read another Princeton hard lefty Paul Starr to know that the combination of vigorously pursued professional hegemony and third-party payment has left us with a system run by providers of various types, mostly for their own benefit.  So health care isn’t a regulated free market and people aren’t in a position to "spend their money on health care, if they think that’s important" the way any rational economist would understand–even if the vast majority of people didn’t have third party payment to cover that spending — which they do.

Second, Mark Pauly, a health care economist who is in Don’s camp wrote a hysterical piece in Health Affairs a few years back suggesting the reason we were so inefficient in our health care spending and spent so much on it, was that we were so efficient in the rest of the economy —  and could therefore afford to act like drunken sailors when it came to health care. I never understood why just because we had (apparently) lots of money to spare because we are a rich and productive nation, we should spend it all on a very inefficient health care system rather than, say, on Frappuchinos, education for first graders, or invading foreign countries which don’t have anything to do with us. There is no rational connection between the overall economy and how we choose to allocate resources to health care.  How we allocate resources to health care, and how much we allocate, is largely a political question. It’s directly political (in the 50% that the government pays for) and indirectly political in how (in order of importance) the government treats the taxation of health benefits, how it controls the industry’s pricing and capital spending, how it encourages its citizens to allocate their resources, and how it allows lawyers to persuade doctors (and doctors to persuade doctors, and drug companies to persuade doctors) that more care rather than less care is better. What any of that has to do with overall productivity in the economy escapes me. Finally while it may be a nice idea that health care is a luxury good that consumers will buy on the margin in preference to other luxury goods, that is not how we’re buying it yet and won’t be for quite some time.

But the third issue is where I call Don mean. Politically we have a straight choice.  We know that the costs of the health care system fall disproportionately on the poor and the sick.  And we also know that access to health insurance coverage is lower among those groups. Suggesting that people could voluntarily buy health insurance but just aren’t doing so is in my opinion total BS, and appears to be backed up the the opinions of America’s employees who are desperate to maintain their health benefits from their employers. Further we know that those without health insurance struggle mightily with the costs of care, and many more of them are in trouble than their equivalents in other countries where their access to coverage is subsidized by those people paying those high taxes that Don obsesses about (something else that needs to be refuted in another post).

You may recall that in the last couple of years we’ve had the ability give big tax cuts to the rich, and to spend nearly $100bn a year invading Iraq. The money that went on either of those political initiatives would have easily covered expanding health insurance coverage for those at the bottom end of the social ladder. In general you’re either for this or you’re against it.  And I think that, knowing the consequences of not having insurance on the health and wealth of those without it, to take the "against" position is mean.

 

PHARMA: DTC advertising works; not exactly a revelation!

So I spent far too much of my life trying to figure out the exact impact that DTC drug ads would have on the exact consumer sub-demographic so that marketing could be refined, and consumer segments sliced and diced.  Turns out that was totally unnecessary.  All you have to do is to get the patient to say the name of the drug in front of the doctor and think that they might have an associated symptom and the doc is only to happy to get them out of the office with said script. 

And it’s good for a five-fold increase in prescriptions compared to patients who don’t ask for it by name. The hidden persuaders don’t need to be that hidden!

POLICY: Now they are saying that there are fewer uninsured?

As if this one couldn’t be seen coming a mile off.

When you have nothing to say about an issue, change the numbers. In the 1980s the Thatcher government in Britain reduced the number of unemployed at a stroke by changing the way they counted them. If you were not eligible to collect benefit because, say, your husband or wife earned too much, then — Hey Presto! — you weren’t unemployed any more, even if you’d been laid off and couldn’t find a new job. Now we hear that the Administration is saying that the CPS apparently overcounts the number of uninsured.
And this is from the clowns who brought us guarantees that WMDs were in Iraq and that the invasion of said nation would be paid for by the oil revenue, as our soldiers would be greeted with sweets and flowers. And we should trust them over decades of decent research by the census bureau why?

Oh, and Thatcher changed the counting to try to stop the unemployment number going over the political sensitive 3 million number.  But for all her efforts it went over that number under the new counting system within a few months anyway.  And anyone who doesn’t think we’ve got a crisis going on in uninsurance here either has never tried to buy health insurance in the individual market, or just doesn’t get out enough.

POLICY: Medicare to start real rationing

Just briefly today….

It looks like Medicare is just starting down a path that it inevitably will have to take.  Deciding when and how to say no.  The NY Times has an article about the very start of this trend.

(Fixed Link)

PHARMA: Overstepping the line. Who could have known?

It’s a tough life these days in the pharma business. Profits are down, sales force lay-offs are coming up, and the industry is restricted from using its favorite techniques to get doctors to write more scripts, while its reputation is in the gutter. Some people must be looking for a return to the halcyon days of the mid-late 1990s, when new blockbusters were rolling out of the pipeline (rather than off the patent), the public loved the industry, and anything went on the sales side. 

But wait. Apparently not absolutely anything went, or at least not according to the pesky US Attorney’s office in Boston.  They’ve apparently decided that offering a few important doctors an all expenses-paid trip to the south of France (where they’d supposedly have to show up at a conference, mind you) in return for writing a few scripts of a failing anti-AIDS drug, is apparently an indictable offence!

Hang on a minute.  The "offence" was in 1996.  The indictment took 10 years. Isn’t this the same US Attorney’s office in Boston that couldn’t get a conviction in the TAP pharmaceuticals case, when basically everyone knew and the company all but admitted paying direct bribes to doctors to get them to prescribe Lupron? Do they really think that at the same time when Enron, Worldcom, Healthsouth and scamsters in dotcoms and Wall Street were putting together their schemes to defraud the world that a few regional sales directors, desperate to keep their jobs, should face hard time for offering out a few trips for a doc and his long-suffering wife or mistress to hit the beach? And how different is that from taking the doctor out to a dine and dash every week? How’s a poor pharma rep to know where the line is?

Coda: One of the docs that apparently wouldn’t take the bait was a Dr RL of Florida.  Over on DB’s MedRants one of the most fun commenters is a retired doc called RGL, otherwise known as Roaring Remy. Could Roaring Remy and the Dr. RL in the indictment be per chance related?  And if so, didn’t Remy want to go to the south of France?  Would he have preffered somewhere cooler?

PHARMA: Pay me more money or I’m moving my operations off-planet!

So poor impoverished Sir Tom McKillop, CEO of Astra-Zeneca, a man knighted for his services to British industry, is upset.  Now just because his main achievement in life is to replace one purple pill with another that is more or less identical but continues to be patent protected, doesn’t mean you shouldn’t hear him out.  Apparently those pesky Europeans are not paying enough for their drugs, and that has forced, forced, innocent European drug makers to move all their R&D operations out of Europe to the US. I’m frankly a little curious as to why this has happened,and why all research into pharmaceuticals in Europe has stopped — even if it’s true (which it probably isn’t). After all you can do the research for a product anywhere and sell it anywhere, and most research is done by teams in multiple countries anyway. Quite what the connection is between when a product is developed and where it’s sold is beyond me. McDonalds sells millions of cheeseburgers a year in Japan and China, but the hamburger was invented in the good old US of A (or Germany–take your pick).

But let’s give Sir Tom his due. He says that AZ sorta moved its research out of Europe to America because America pays the highest price for drugs.  This allegedly encourages innovation, although one might point out that plenty of innovation has come from companies developing products outside of the US aimed at the American market. Tom may himself have heard of Sony, Toyota or even Glaxo–all of whom have had a bit of success here with stuff invented and built there.

But no matter, here’s the next logical leap. If those pesky American politicians want to import drugs from Canada, just the way those pesky Brits and Germans did parallel imports from Spain and Greece, then gawdammit, we’re moving all our research shops to India and China! Well hang on a sec. Ignoring the fact that imports from Canada are less than $2bn of a $240bn US drug market, isn’t the innovation that makes research here so vibrant due to the high prices for drugs here?  And now the innovation is all going to move to China and India presumably because the price of drugs is going to be higher there, after ours here come crashing down to Canadian levels. Given average spending on drugs here is roughly $1,000 per head per year which is not a lot less than average GDP per capita there, someone better quickly tell the Chinese and Indian governments that they need to quickly increase the price of drugs in those countries to what is effectively the point that the entire national income is spent on pharmaceuticals!  That would please Sir Tom.

On the other hand, perhaps it’s not the price of drugs that would encourage Sir Tom to move his research shop to India or chin.  Perhaps it’s the price of PhD research slaves? On the other hand, after he’s moved his R&D to India and China, surely Jupiter or Mars will raise drug prices to tempt him there?

PHARMA/POLICY: Another Canadian import to cause trouble?

As you know I (along with a couple of other medical bloggers) have long been opposed to the War on drugs and the ridiculous ban on marijuana.  Marijuana has obvious medical uses, particularly as an anti-nausea and anti-neuralgia agent. Many other wonders are claimed for it as an anti-cancer agent, etc.  These may or may not be true but as clinical trials are not allowed we can’t tell for sure, and it doesn’t seem any less effective than many of the equally ineffective chemo regimens that are used in oncology–if a patient tells you that he’s alive because of marijuana, who are we to take it away from them? I of course think that marijuana should be legal, fully regulated (and taxed) like any other herbal supplement or alcohol. 

However because of its obsession with promoting arrests, prisons and the black market, the US government has been blind to all the news on medical marijuana as it’s just too inconvenient to note that a supposedly evil drug with no medical value is actually therapeutically useful. Well now the Canadians have gone further than allowing patients to use their own marijuana, they’ve actually approved a medicine that is liquid marijuana. I’ll let the MPP take it from here, but suffice to say if the drug warriors cared a fig for reason, they’d be tying themselves in logical knots over this one.

The Canadian government has just delivered a body blow to the U.S. government’s irrational prohibition against the medical use of marijuana. Today, Canada approved the prescription sale of a natural marijuana extract — for all practical purposes, liquid marijuana — to treat pain and other symptoms caused by multiple sclerosis.

In short, the Canadian government has just certified that virtually everything our own government has been telling us about marijuana is wrong. Sativex, produced by GW Pharmaceuticals in Britain, is literally liquid marijuana. It is nothing like Marinol, the synthetic THC pill old in the U.S. and sometimes falsely touted as an adequate substitute for marijuana. Rather, Sativex is a whole-plant extract, containing the wide variety of naturally occurring compounds called cannabinoids that are unique to marijuana. It also contains trace elements of other compounds in the plant, which scientists believecontribute to its therapeutic value.

Sativex is to marijuana as a cup of coffee is to coffee beans. If Sativex is safe and effective, marijuana is safe and effective. And Sativex is safe and effective. Studies have shown significant effect against pain and other symptoms caused by multiple sclerosis and other debilitating conditions, and over 600 patient-years of research have established a remarkable record of safety.

Sativex should certainly be approved in the U.S., but the process may take years — if it is allowed to happen at all, given our federal government’s reflexive hostility to the medical use of marijuana. And more importantly, now that we know beyond doubt that marijuana is a safe, effective medicine, how long will our government continue to arrest patients who use it?

Visit http://www.mpp.org/sativex.html to learn more about the issues associated with Sativex. Please visit http://www.mpp.org/donate2088 to give MPP the money we need to continue lobbying to end our government’s war on medical marijuana users.

POLICY: Unrealistic, unfair mercatilism in health care.

I like Don Johnson’s blog Businessword but sadly when you really push him, as I’ve done in his comments over the last couple of years, he either won’t answer or his answers reveal a political philosophy that is downright mean. So in his criticism of Krugman’s analysis on his blog and in comments at THCB here, Don essentially says that if you’re poor or sick in America, well that’s just tough titties. And, as a by product, it’s OK for the insurance market to screw over those who really need individual insurance because, well, because it’s a "market". Same way it’s OK for Enron to defraud the California rate payer, or same way it’s OK for Healthsouth to defraud its shareholders. After all they’re operating in "markets" too.  But Don misses the wider point. Because of the way the US system is set up  — because we’re a richer country than any in Europe, and because the majority of people can afford to pay way too much for our health care —  we systematically overpay for things that no rational market would value. That does not help our economy, it hurts it as most health care spending is non-productive to the overall economy.

The other point that pro-unrestrained booty capitalists in health care, or those Krugman was criticizing, go on about is the huge waiting lists in Canada and the UK.  Well as I mentioned in the UK the wealthy can trade up with their own money while the less well-off get a decent standard of care. Meanwhile single payer advocate Don McCanne found this just excellent chart from Stats  Canada which shows that median waiting times for non-emergency surgeries in Canada  are just over 4 weeks! I’m more than prepared to wait 4 weeks for non-emergency surgery if it means that poor people wont be crushed by their medical bills and can get access to basic health care. (For far more details on this see my "Oh Canada" piece).  And anyone who doesn’t think that’s a fair equation is just mean in my viewpoint. Not to mention that such a system would cost me as a tax payer and a premium payer less money! Money I could spend on other, more productive things, like Frappuchinos.

POLICY: Ezra Klein on Health Care in France

Ezra Klein is a nauseatingly over-achieving student at UCLA who, at an age when I was trying to pick sufficient 10p pieces out of the gutter to buy myself a half of ale at the college bar (and usually end up back in the gutter), has a successful blog and is on the way to becoming a writing star of the liberal ilk. Ezra’s blog goes all over the map in a fascinating way.  This week he’s featuring a whole series on health care systems in other countries.  Dangerous work, Ezra — that’s where I started.  The first one is about Health Care in France and it’s really good.

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