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PHARMA: Big pharma gets aggressive over pricing

Two of my favorite contributors both have found me interesting stories about pharma company tactics today.  Jane Sarasohn Kahn sent me an article about the ongoing US-Australia talks on drug pricing.  Recall that the Aussies joined us in invading Iraq because they were promised in a nudge-nudge wink-wink way a free trade deal which would allow their agricultural products into the US market. However, fresh from victory in the Medicare drug coverage arena, the US pharmas a going after price "discounting" by governments abroad.  (For background info look at this latest edition of the Pfizer sponsored Health Politics which basically trots out Mark Pauly’s not entirely untrue line that Canadian drugs aren’t any cheaper than US drugs overall when you factor in that fact that they don’t use so many generics and don’t allow access to the some of the newest and most expensive drugs). As part of the Australian negotiations things are getting a little heated. The Australian (which is the pretty unsuccessful result of Murdoch’s attempt to create a highbrow national paper there) wrote that

    US drug lobbyists were peddling misinformation about Australia’s medicine subsidy scheme to secure a better deal under a free trade agreement, federal Health Minister Tony Abbott warned a delegation from Washington yesterday.

    During a meeting with a powerful US congressional delegation yesterday morning, Mr Abbott also said the Australian Government would not change the "basic architecture" of the $5.8 billion-a-year Pharmaceutical Benefits Scheme to secure a trade deal. But he left open the prospect of other concessions to multinational drug companies, saying he would be happy to talk with them about demands for greater transparency. After the talks with Acting Prime Minister John Anderson and eight influential Republican congressmen in Sydney yesterday, Mr Abbott accused drug lobbyists of waging a dishonest campaign against the scheme. "Misleading information is being peddled in Washington," he said in a statement. "The PBS is not a rationing system but a subsidy system. The PBS does not deny access to US drugs but treats them exactly the same as drugs made in Australia or elsewhere."

Now despite the party name (which harks back to the old European meaning of liberal not its American derviation) the Aussies have a very right wing government in power by all but US standards. (Randomly enough I’m a friend of Tony Abbot’s sister who’s political views are somewhat pinkish and despite the fact her brother is the rising star of the Aussie Liberal party and a likely future Prime Minister, she basically thinks he’s a right wing nut!) So if the Aussies feel that they can’t sacrifice their drug pricing system despite the huge carrot of free-trade in agriculture that the US is dangling, there’s no chance of the Europeans doing so.

Meanwhile, the Industry Veteran sends me this story about Abbot’s huge price increase in Novir, its protease inhibitor which is used as a component of many anti-viral HIV regimen. Basically Abbot has increased the price of a drug five-fold that is used in combination with its competitors anti-virals, but if you take Novir in a combo form with Abbot’s new protease inhibitor Kaletra, it’s now cheaper than taking it separately with the competitors’ drugs. The Seattle Times reports

    Abbott is pricing Norvir as though it is a "full component" in the drug cocktail, complained Shalit. "But it’s not being used for its activity against the virus — it’s used as a booster for the other drugs." While Abbott vigorously denies it, Shalit and others believe the Norvir price increase was aimed at Abbott’s competition. In essence, Shalit said, increasing Norvir’s price raises the cost of taking Abbott’s competitors’ drugs used in combination therapy. That could push patients toward Abbott’s newer drug, Kaletra, a combination drug with Norvir built in. With the Norvir price increase, Kaletra’s competition has become more expensive than Kaletra, approved by the Food and Drug Administration in 2000.

    In their letter to Abbott, the local doctors also expressed worry that the increased cost of Norvir would have a chilling effect on development of other drugs designed to work with its boosting power; at least one such drug is now being tested in Germany.

The Industry Veteran comments

    Here’s an ominous trend that I see as more pervasive than just the HIV area. Big Pharma will seek to extend patent protection and up-sell patients by exorbitantly raising the price of single-compound products, thereby coercing people onto fixed-dose combinations (one pill containing two or more compounds) that contain the unconscionably priced compound. Watch for this trend in (y)our favorite category: the statins.

In any event both these stories prove that big pharma, conscious of its potential problems with future drying pipelines, is going to fight hard to maintain its profits and protect its turf.  That’s to be expected and it is also part of their fiduciary duty which, lest we forget is not to Canadians, Australians or AIDS patients, but to their shareholders.  The question is will this type of behavior cross the line and cause sufficient resentment that politicians bring a backlash against them. That may yet happen in their incredibly unpopular opposition to Canadian imports.

Then again there is the other question that Jane posed in her post here a month or two back. She wrote

    Pharmas are looking to biotech for new formulations, but they’re also looking to smaller pharmas too for licensing deals. This will be important over the next few years. Obviously, biotech will be important in the longer term, but the juries are still out on so many very expensive drugs. We will be hitting the wall on who is going to pay for those expensive bio drugs, and I anticipate that will be a big area of contention. It’s not clear really who will be willing to pay for innovation.

Jane’s follow up goes to the heart of the "how much will who pay, and be able to pay?" question.

    In today’s news, I see that the small pharma Trimeris based in NC which produces the $20K/year drug, Fuzeon, for HIV/AIDS, is now laying off and looking like it could close shop…for a few weeks, literally, a few payers last year said they’d be willing to pay for such an expensive HIV drug. However, as I recently told one of my clients who is big in HIV, that’s one disease state where that high cost just won’t get rationalized….now an expensive prostate cancer drug used by rich old white (mostly) men, sure…but even $20K a year for that wouldn’t be chronically taken virtually ‘forever.’ Some discussions are afoot about whether we have "enough" innovation for now.

QUALIITY: Says here that Doctors read the news!

Over at DB’s Medical Rants Robert has responded  to my gentle chiding and has written a nice piece regarding what’s wrong (in his view) with Wampum’s piece on malpractice.  (Note that he got up at 4 am to write it too! Who’d be an intensive internist?)

He’s also alerted me (and you) to a very interesting report about how doctors changed their behavior after the results of the two big trials on HRT and Alpha Blockers in the last couple of years. (Reuters release here but both full articles are unusually available for free from JAMA via my earlier links). The findings suggest that doctors do indeed respond in their prescribing habits to the latest evidence, particularly if the results of the trial are blared all over the press. This just makes the whole conversation over evidence based medicine more and more confusing.  How come doctors change practice on a dime over the HRT study but take years and years to apply some of the best practices elsewhere . . . . . I think Robert’s deliberately trying to make my future article about this harder to write!

PHARMA: GSK says to contest $5.2 billion U.S. tax claim

Just in case you thought you had tax troubles, the IRS thinks that GlaxoSmithKline owes it $5.2 billion. GSK has about $2bn in reserves to pay this, but obviously will be in tax court for a few years whittling this number down.  Given the way the stock market works the relative certainty of this upper limit may end up being a positive thing for GSK, and I doubt that rest of us will be passing the collection hat for them any time soon!

QUALITY: IOM meeting focuses on asthma, other key areas while Berwick puts it to the sword

The IOM just held a two day meeting to follow up on the 2001 report on Crossing the Chasm, which focused on the quality of chronic care management. This meeting focused on how to make real improvements in the areas of Asthma, Depression, Diabetes, Heart Failure and Pain Control. (I presume that no one from the DEA was there to discuss how locking up doctors improves pain control). Don Berwick was there and gave what sounds a pretty raucous speech about how we’re wasting our money in the health system.  If you haven’t read his speech called Escape Fire, then take a few minutes and do so.

QUALITY: More on malpractice

Stephen Schoenbaum and Randall Bobjerg, from the Commonwealth Fund and the Urban Institute respectively, probably just got themselves crossed off the AMA’s Christmas card list by publishing  this article in the Annals of Internal Medicine.  They suggest that doctors are paying too much attention to malpractice and not enough to actually improving patient safety.  In case you missed the point, Schoenbaum, an ex-Exec at Harvard Community Health Plan, one of the "good guys" HMOs is quoted in this interview as saying "All the discussion is about how do we minimize the impact of the suits rather than how do we minimize the number of suits". He also points out that certain groups of physicians, notably anesthesiologists,  have improved their patient safety activities over time leading to the question of why other specialists have not.

I’m going to waffle as to whether greater efforts by specialists to improve patient safety would be immediately effective, given my fuzzy position on whether evidence based medicine is easily-attainable in the real world (see yesterday’s post on appendectomy failure rates).  But it is fair to say that if some of the energy physicians spend on malpractice reform was redirected towards patient safety issues, we’d all be better off.

INDUSTRY: Malpractice at Wampum, with UPDATE

An interesting little storm is brewing over at Wampum about malpractice and its role in the latest Tort reform issue. There’s a lot of lefty and righty rhetoric in the comments, and I stuck my 2 cents in about the lack of attention to the defensive medicine issue–which is the only really meaningful and substantial part of the whole debate.  Of course, legislation doesn’t always get passed in this country because of keen insights into meaningful or substantial issues.  However, you should read the whole thing in order to see where the political arguments lie (pun intended).

While you’re there the Koufax awards are a great source for intros into some of the best political blogging on the left side of the American spectrum. (I’m a Brit so I have to use that qualifier!)

UPDATE: DB’s Medical Rants has a quick comment on Wampum’s piece, but the most intelligent pieces are in his comments.

QUALITY: Appendix surgery, too often needless but inevitably so?

I am determined to get back to the conversation on evidence based medicine that I was having with Robert Cantor over at Medical Rants before the holidays. Sadly I’m too gummed up with other work to finish the thoughtful response his last reply to me deserves–although I have subsequently interviewed Michael Millenson, the bete noir of the EBM-deniers (if that’s a term!), who’s last piece The Silence took a pretty hard line with the IOM for not being as aggressive as it should be on the topic.  More to come on that later.

But I remind you that I started this by discussing why evidence-based medicine was so hard to achieve in real world  practice.  This balanced article from the Boston Globe shows that big city hospitals which do lots of procedures on kids do better on reducing the false positive rate for pediatric appendectomies than lower volume hospitals. It seems that it’s pretty hard to get the mistake rate of the big city med centers (still up at around 4.8%) at the local hospital where they don’t see so many and have twice the error rate. The key point in the Pediatrics abstract that’s not in the write up for the lay reader is that two thirds of these pediatric appendectomies are done at the lower volume hospitals, and therefore have the worse results. Yet how many parents want to drive an extra hour or so to a distant hospital when their child is in pain? Does the "centers of excellence" concept make sense for this relatively trivial level of surgery? Is an 8% error level acceptable when the cost is more likely to be financial than medical?  It’s still a tough subject. 

I shall vent later mostly about information use, and this study provides useful information on how we should be tackling this type of procedure.  But it’s a bigger system change to move this type of surgery than to get all the transplants, say,  to high-volume physicians.

PHARMA: Drug stocks low risk in the new year?

The AP reported on New Year’s Eve that the rough consensus of analysts is that 2004 will be a reasonable but not great year for the pharma stocks. Those stocks have of course underperformed the S&P over the last year but actually haven’t done too badly over the last 2 years compared to the S&P after their plunge 18 months ago. One potential major problem has been dodged, with a Medicare bill that’s as friendly to the pharmas as possible.  The longer term problem is the paucity of the pipelines, so I’d look for more deals in the biotech sector like the one Pfizer did with Esperion Therapeutics. But of course some time after 2006 when the Medicare coverage comes in, the likelihood of more governenment interference is a risk in the much longer term.

In the shorter term the most interesting stock remains Astra-Zeneca. Since its beautiful technical double bottom in February and March last year A-Z has rallied over 65%.  THCB has reported at length about the potential problems with both Crestor and its struggles with Lipitor. This past weekend the influential finance magazine Barrons essentially came out  warning that A-Z’s rally was overdone, but if you’d shorted A-Z a few months ago when this discussion started, you would be under water. Is it any different now?

HAPPY NEW YEAR

Welcome to 2004 at THCB.  I hope to do a revamp to the site in the next few weeks, but I don’t think you’ll see too much change to the way things are run. I don’t think I’ll be adding comments, but please keep those emails coming and please feel free to write pieces that fit into the spirit of THCB. I’ll keep posting them if they’re suitable, whether or not I agree with them. Also please let me know if there are other topics you’d like to see covered in the future.

And in the spirit of New Year Renewal for some years now I’ve written an end of year letter suggesting some charities and issues that I’m supporting. It has nothing to do with health care, but if you’ve got some time I’d be delighted if you took a look and supported some of the charities and causes I feature.

HAPPY NEW YEAR

Thanks for reading THCB in 2003. I’m off to see if my knee will hold up to a little gentle snowboarding.  See you next week and happy 2004.

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