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PHARMA: Everything you ever wanted to know about Vioxx but were too afraid to ask

So it may be that the doyen of American drug companies when I entered the business may be falling into a death spiral. Merck’s withdrawal of Vioxx from the market combined with its major statin Zocor going off patent in 2006 may relegate it to the second tier of international pharmas, falling well behind Pfizer, GSK and the new Aventis/Sanofi. The new Aventis/Sanofi combo has its anti-smoking anti-fat pill Acomplia coming out in a couple of years, which may end up being the biggest selling Rx product of all time.

Merck’s Vioxx had certainly had its problems. Today’s New York Times article details the very recent history of Vioxx. As THCB noted back in August, a Kaiser study suggested that there were instances of heart attack and stroke among Vioxx patients, though not for Pfizer’s Celebrex. Once Merck’s own clinical study (which was trying to extend the indication to stomach polyps) showed the same thing, the company in consult with the FDA and no doubt its legal staff and investment bankers decided to take the enormous step and bite the bullet.

Not since the withdrawal of Baycol has there been such as tizzy in big pharma land, and Vioxx was not a 5th in class drug like Baycol. However, the Cox-2’s are a interesting case where a drug that has a benefit for some patients was probably being used too widely anyway. The Cox-2s are no more effective at reducing pain but were introduced and marketed as being better for those 30-40% of NSAID and ibuprofen users who had stomach pain. Express Scripts has shown in its studies that many if not most of those using Cox-2s were not suffering that stomach pain in advance and should have been on a cheaper drug first. Another Expresss Scripts study showed that over half of older Cox-2 patients were taking aspirin anyway, which meant that they were still probably getting the pain relief and also stomach problems of aspirin, probably negating the value of the Cox-2 in the first place–if the Cox-2’s even worked for those stomach problems in the first place (and there’s some evidence that Celebrex doesn’t). As a PBM, Express Scripts of course wants its customers to take OTC ibuprofen and an OTC PPI for their associated stomach problems. And of course there are plenty of alternatives beyond the aspiring/PPI combination. Even the NY Times Editorial page weighs in on overuse of Cox-2s. All this of course will make the already delayed FDA approval of Merck’s delayed replacement for Vioxx, Arcoxia, and Prexige from Novartis, much trickier.

Longer term this is all very grim for Merck. Below (purloined from the Times and IMS) is a list of 2003’s top Rx sellers (by $$) in the US. Note that Merck has only Zocor, Fosamax and Vioxx on the list. (The list says that it has Nexium too, but of course that’s Astra-Zeneca’s).

  1. Lipitor, $6.8 billion, cholesterol,Pfizer Inc
  2. Zocor, $4.4 billion, cholesterol, Merck & Co.
  3. Prevacid, $4.0 billion, heartburn, TAP Pharmaceutical Products Inc.
  4. Procrit, $3.3 billion, anemia, Johnson & Johnson
  5. Zyprexa, $3.2 billion, mental illness, Eli Lilly & Co.
  6. Epogen, $3.1 billion, anemia, Amgen Inc
  7. Nexium, $3.1 billion, heartburn, Merck & Co.
  8. Zoloft, $2.9 billion, depression, Pfizer Inc.
  9. Celebrex, $2.6 billion, arthritis, Pfizer Inc.
  10. Neurontin, $2.4 billion, epilepsy, Pfizer Inc.
  11. Advair Diskus, $2.3 billion, asthma,GlaxoSmithKline PLC
  12. Plavix, $2.2 billion, blood clots,Bristol-Myers Squibb Co.
  13. Norvasc, $2.2 billion, high blood pressure, Pfizer Inc.
  14. Effexor XR, $2.1 billion, depression, Wyeth
  15. Pravachol, $2.0 billion, cholesterol, Bristol-Myers Squibb Co.
  16. Risperdal, $2.0 billion, mental illness, Johnson & Johnson
  17. Oxycontin, $1.9 billion, pain, Perdue Pharma
  18. Fosamax, $1.8 billion, osteoporosis, Merck & Co.
  19. Protonix, $1.8 billion, gastrointestinal reflux disease, Wyeth
  20. Vioxx, $1.8 billion, arthritis, Merck & Co.

So soon they’ll only have Fosamax on the list. Forbes has a hard hitting article suggesting that both the CEO Gilmartin’s days are numbered and that Merck itself will become a takeover target. For a company that was the leading pharma company in the world in the early to mid-1990s, that would be a mighty fall.

Of course, if this can happen in as big a market in Cox-2s, can it be long before there’s more analysis of the biggest market of all, the statins, to see if any share Baycol and now Vioxx’s fate? There are already (as reported by Medpundit) some dissident physicians questioning their value.

POLICY: Seniors continue to oppose new Medicare law. With UPDATE

By MATTHEW HOLT

Harvard’s Bob Blendon (a colleague of mine from my IFTF and Harris days), has new polling research out sponsored by the Kaiser Family Foundation showing that two thirds of seniors view the Medicare Modernization Act unfavorably. Here’s the end implication:

Nearly three in ten seniors and people with disabilities on Medicare say the passage of the new law will have an effect on their vote for president, and an even higher share– nearly four in ten–say it will have an effect on their vote for Congress in November. More people say that the law will make them more likely to vote for John Kerry and the Democrats than for President George W. Bush and the Republicans.

And here are some more details, which should ensure a huge amount of ads highlighting the shortcomings of the law from the Democrats filling the airwaves of Florida and Pennsylvania.

Nearly three in ten people on Medicare (28%) say that the passage of the Medicare law will have an effect on their vote for president. More than four in ten of those who say the new law will affect their vote (44%, or 12% of people on Medicare overall) say it will make them more likely to vote for John Kerry, while 18% of this group (5% of people on Medicare overall) say it will make them more likely to vote for George Bush.

Nearly four in ten (38%) say the passage of the law will have an effect on their vote for Congress. About half of those who say the law will affect their vote (53%, or 20% of people on Medicare overall) say it will make them more likely to vote for a Democrat, while 21% of this group (8% of people on Medicare overall) say it will make them more likely to vote for a Republican. When it comes to handling Medicare prescription drug benefits, people on Medicare are nearly evenly divided on whether they trust John Kerry (39%) or President Bush (34%) more, while about one in ten (11%) say they trust neither or trust both equally. Not surprisingly, Republicans (76%) are more likely to say they trust President Bush more on the issue, while Democrats (67%) are more likely to say they trust John Kerry.

UPDATE: This survey has sure gotten alot of press, which must make Drew Altman and the crowd at Kaiser FF happy. It has two articles in the NY Times, plus it was a lead on NPR last night and might even have made the network news (I don’t tend to watch those but judging from the DTC drug ads many seniors do!) This NY Times article points out the obvious–the elderly are a vulnerable Republican voting block. They vote proportionally more than any other group, and they tend to vote on health care. Last time around white seniors voted 52 to 47 for Bush partly because he promised drug coverage (as did Gore) but partly because they were the group most appalled by blowjobs in the Oval Office. Remember Bush promising to restore “Honor and Decency” to the White House? Well I guess if that only means no blowjobs in the Oval Office then that’s Mission Accomplished. But when seniors have got something serious to vote about like the Iraq war and drug reimportation — both of which the elderly oppose–then “Honor and Decency” may not be enough to keep them happy.

PHARMA: Even The New York Times has noticed that pharma has PR problems

In an article picking up on the Harris data TCHB shared with its stellar, avid readers (that’s you BTW) last week, the NY Times this morning places Pfizer’s decision to give cheap drugs to the uninsured next to the polling data about pharma’s unpopularity next to several examples of egregious price rises. They also quote extensively Roy Vagelos, scientist CEO of Merck in its 80s and 90s heyday, as basically saying that the industry has blown it.

It’s well worth reading the article because it shows that the mainstreaming of the anti-pharma opinion will have a political impact on the industry, and by extension on the election. (Need I remind you again that the two states with the oldest populations are Florida and Pennsylvania, both extremely close at the moment).

However, the Times lumps several reasons together as to why pharma is so profitable in the US:

    The pharmaceutical industry earns nearly two-thirds of its profits in the United States since drug prices in the rest of the industrialized world are largely government controlled. Those profits rely almost entirely on laws that protect the industry from cheap imports, delay home-grown knockoffs, give away government medical discoveries, allow steep tax breaks for research expenditures and forbid government officials from demanding discounts while requiring them to buy certain drugs.

It is not the case that each of these "privileges" has equal weighting for the industry. The fact is that allowing personal imports would not have that big an impact on the overall market. Allowing Medicare to bargain as aggressively as say the VA (or worse, the Spanish or Australian governments) would bring what are called "price controls" by Americans talking about the EU or "discounts" by PBMs to a large section of the market.

That would certainly have a big impact on the industry’s margins. But the pharma industry can take note that, under a similar environment of strict price controls from Medicare and Medicaid, its colleagues on the inpatient, outpatient and ambulatory care side have seen their share of the overall economy grow dramatically in the past 40 years. So, if forced to, pharma companies could manage the potential change in their environment. As a potentially relevant example which also works under monopsony purchasing, the defense industry seems to struggle by OK.

Not that the industry would want to go there, and it will continue to do what it can to fight what is increasingly looking like a rearguard action. Of course in a rearguard action a strategic retreat can often work wonders. I stick by my guns and think that big pharma, looking out strictly for its own self-interest, should cave on the Canadian imports but try to continue to muddy the waters on discounts and price controls. After all 15 years of allegedly aggressive discount seeking by the PBMs hasn’t exactly reminded observers of the way Wal-mart treats its suppliers!

TECHNOLOGY: The state of play at America’s leading health systems

More musings from the Healthtech meeting. Given that this is a somewhat private meeting, and I’m an invited guest, I’m not going to name names, but suffice it to say that the health systems here include many of the largest (predominantly non-profit) regional hospital systems in the US.

So from my non-scientific surveillance, where are they and what are the challenges they are facing? In general the last few years have been about automating their laboratory, pharmacy and PACS (radiology) systems. At least in some hospitals, this has led to reducing costs in testing , and getting results back much faster (in 6 minutes in one case). This of course promotes quicker decisions which filters into lower ALOS and increases ROI. The rest of the effort in the last few years has been about creating the wired and wireless infrastructure that’s needed to support the next stage of their plans–in fact wireless is a major focus.

The new challenge is CPOE and bedside medication records. Now they are starting at varying rates to move to clinical documentation at the bedside and also at the nurses station. CPOE (i.e. getting the physician ordering, particularly medication ordering, in the loop) is the major push many of the systems are working on now. This somewhat tracks with various studies showing that CPOE use is pretty low (of course it’s existed at some hospitals such as Brigham & Womens and Intermountain for several years).

Some of these systems are creating big time process improvements (so long as the medical team is bought into the decision process). But by no means do the medical staff appear to be so compliant in all cases–in one case there was no improvement in several basic process measures. So putting the system in is only part of the battle, and the medical culture still seems to be the biggest hurdle.

One big system (which has introduced a lot of new technologies) is very rigorous about incubating a test-lab learning environment before any new technology is moved into different facilities. This is part of an extremely detailed planning process, which needs exceedingly high levels of buy-in from clinical and operational staff, and rigorous assessment at all levels of every roll out. In other words there’s no organic growth of IT use, its all carefully designed. Nor are new or innovative, but untried, technologies allowed into the system. Instead the IT group makes sure that any devices or applications they introduce does not distract them from their total focus with keeping the network up for Five Nines reliability (99.999% up time). So their priority is keeping the mission critical network up. Their system hasn’t gone done unscheduled in 2 years. Some time ago Paul Saffo at IFTF said that eventually computer downtime (like phone downtime) would start killing people. Plenty of these hospital CIOs seem to believe it. So as IT becomes more integral to other parts of the hospital (ie. lab/pharmacy first, nursing next, then physicians) many hospital systems are looking for incredibly (and justifiably) high levels of network/application uptime and reliability.

And don’t mistake that putting this all in is anything other than damn hard work. The words Six Sigma and Process Improvement were heard alot. All in all they are probably not having as much fun as we technology futurists have looking at all the new toys. But in terms of creating the environment for process-driven hospital-based care, at least some of the leading systems in America are making progress.

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