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Tag: Pharma

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.

PHARMA: Why is Crawford’s FDA nomination stalled?

Good salacious stuff for a Friday.  Apparently the scuttlebut inside the FDA is that reason that the FDA acting commissioner Crawford’s nomination is being held up is because he’s favoring an FDA staffer. What this means, according to a much more frank article in FDA Webview is that he’s hoofing his secretary and taking her on lots of "business" trips.

FDA Webview has learned that the investigation into FDA commissioner-nominee Lester M. Crawford requested by Senate HELP Committee chairman Mike Enzi (R-WY) involves an anonymous allegation that Crawford has been having an affair with his special assistant, Susan Bond. A close confidant has denied any affair exists, however. According to well-placed sources, the investigation Enzi asked FDA’s Office of Internal Affairs (OIA) to conduct involves allegations of waste of government resources in unnecessary travel expense and irregular promotion of Bond to her present position. OIA, which has a long history of ineptness, secrecy and bullying, reports directly to Crawford, raising questions as to why Enzi turned to it instead of the HHS Office of the Inspector General, which has a much better record. Personnel issues, however, especially those involving improper use of government resources, are within OIA’s charter.

I’m of the opinion that what you do with your private parts in your private life is private, and that so long as you’re doing your job well who cares? But I suspect several of the Republican Senators on the confirmation committee don’t agree with me, and I suppose a government official shouldn’t play favorites (although of course they all do).  What with holding back on Plan B, it does appear that Mr Crawford’s "family values" planning is a little awry.

PHARMA: Patients are stil “complieant”

Patients don’t take their pills properly. Some estimates are that 30% of written scripts are never filled.  Now there’s a new Harris study out showing that 33% of patients are actively non-compliant. Of course if all these patients took all the pills that they were supposed to, then pharma costs would be much higher — Datamonitor is quoted as saying that’s $30 billion a year higher (or 15-ish percent).  And of course if they all took all their pills properly overall health costs would be much lower, right? Right? (Where is the echo from PhRMA when you need it?).  Still the cost impact of non-compliance is something to ponder.

PS "Complieant" was my add to the "just-off" definitions list run on THCB a few weeks back.

PHARMA: Squaring the circle on Pfizer’s job cuts

Over at the Pharma Marketing Blog and on the Pharma Marketing list-serv John Mack is confused about Pfizer’s real intentions.

Is Pfizer eliminating up to 11,000 sales rep jobs or isn’t it? A WSJ article states: "In another cost-cutting plan, Pfizer plans to streamline its U.S. force of 11,000 sales representatives." Then in the next paragraph it also says "Chief Executive Hank McKinnell didn’t give details on the job cuts, but did say few jobs would be lost in the company’s sales division." (Significant cuts in a force with) 11,000 jobs seems like more than a "few" so I am at a loss to understand what Hank actually said or meant.

John asked for the list’s take on this.  Remembering this article from THCB regular The Industry Veteran in which he suggested that Hank made about $50m a year (even though Forbes says it’s closer to $17m), I suggested that the solution to John’s quandary is simple: If Hank makes give or take $50m a year (as The Veteran believes), and a sales rep makes $100K, then it takes 500 sales reps to equal one CEO.  So if you fire 11,000 reps you’re really only cutting  22 "real" jobs. They’re never going to cut the whole workforce so any amount is less than 22 and that’s just a "few" in Hank’s terms.

(You are all welcome to do the real math if you want, but I’m no good at dividing by 17!!)

PHARMA: FDA orders Pfizer to withdraw Bextra

This just in at the Health Care Blog’s New York Desk … The U.S. Food and Drug Administration has ordered Pfizer to withdraw Bextra from the market and urged "the possible strongest warning" for it’s fellow Cox-2 inhibitor Celebrex.   See the AP story for details.UPDATE: Read the FDA press release here.

PHARMA: Where are the orphan cancer drugs? by The Industry Veteran

Greg Pawelski’s recent posting here about whether cancer care could improve has drawn several responses, many of which I’m trying to redirect back into the comments section.  One, however,  that deserves its own posting is from our old friend The Industry Veteran who wonders whether the current model of big pharma itself can sustain itself in the kind kind of designer-drug world Greg is proposing:

Greg Pawelski makes a good point in his post, specifically, that the economic
model under which Pharma companies develop oncology products may be inimical to
the individualized treatment approaches required for the disease(s).  I suspect
that the figurative lumber rooms of the Big Pharma companies are stacked with
discontinued oncology compounds that proved wonderfully effective and tolerable
for 5%-10% of the target candidates but, sadly, they were terribly toxic or no
better than placebo for the others.  In fact, I know that’s the case.  Not long
ago I completed a study for a client to find why the companies are so reluctant
to out-license these moribund compounds.  The overwhelming answer, the one that
dwarfs all the others, is ego of the fiduciary executives.  The executives feel
they would invite serious job trouble by out-licensing an abandoned compound to
a small startup that proceeds to make it a successful brand.
While
Pawelski deplores the one-size-fits-all requirement, that constitutes the
standard among Big Pharma for launching a product. 

Today the Big Pharmas will
curtail development of a product with projected, peak year, global sales of less
than $850 million.  Anything less will not sustain their high fixed costs or
permit the economies of scale on variable expenses that represents their
comparative advantage.  When BusinessWeek asked Pfizer’s CEO Hank
McKinnell if the era of the blockbuster (and the giant Pharmas created to
support such megaliths) has passed, he replied, “Anybody who says that doesn’t
understand our business.”  A small company, however, can derive a large return
on equity/sales/assets from a product that successfully treats 5%-10% of a
comparatively small, target population.  The CEO of such a company probably
won’t receive $50 million annual compensation the way Mr. McKinnell does, but
its stockholders and a reasonable number of patients can benefit when a Celgene
takes an abandoned and despised compound (thalidomide, developed as a
tranquilizer for pregnant women) and brings it to market as a major therapy for
multiple myeloma.

I suspect this dilemma will resolve itself as the
pharmaceutical industry evolves into what Oracle’s CEO, Larry Ellison, once
called the Hollywood approach to drug development.  I’ve written about this
before and don’t wish to repeat myself, but basically this involves the Big
Pharmas limiting themselves to acting as sources for development funding and
distribution, while independent producers (biotechs? specialty companies?) buy
the properties and develop them.  Movies today can successfully reach smaller,
more segmented audiences than the big Hollywood studios ever could during the
Mickey Rooney, Judy Garland days.  Unfortunately a lot of people will needlessly
die of cancer before Andy Hardy grows up and tells Louis B. Mayer to go screw
himself.  But hey, in a country that twice elects a wannabe redneck as
president, the market is sacrosanct and its pace of Darwinian change is all we
can expect.

PHARMA/QUALITY: Can Cancer Care Get Better? by Greg Pawelski

AP Biotechnology Writer, Paul Elias,  wrote an article this week that described how while the cost of cancer drugs have skyrocketed, the benefits are less apparent. It’s been more than 30 years since we declared a war on cancer and although there have been some real triumphs, and some great advances, the overall picture is not good. Tomorrow one of my closest friends is going into the local oncology center for the removal of what we all hope are some benign breast lumps. This post is dedicated to her, and to all those with cancer or at risk for cancer. Part of the issue is surely environmental, and we have much more to learn about what causes cancer and whether the toxins that we put into the planet are coming back to attack us.  Part of the issue, though, is how we approach cancer care.  THCB contributor Greg Pawelski has written before about the need for more chemosensitivity testing, and now writes on how we can use what we know to more effectively care for patients.


We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform well-designed, prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination. The problem is not with using the prospective, randomized trial as a research instrument. The problem comes from applying this time and resource-consuming instrument to address hypotheses of trivial importance (i.e. do most cancers prefer Pepsi or Coke?).

There are 60-80 different therapeutic drug regimens out there, any one or in combination can help cancer patients. The system is overloaded with drugs and underloaded with wisdom and expertise for using them. Government and academic clinical investigators have failed to support the individualization of chemotherapy through laboratory testing, in favor of attempts to identify "one size fits all treatments" through trial and error testing which has consumed tens of thousands of human lives. This entire effort has been a colossal failure and a colossal waste of human and financial resources.

One of the main problems in providing effective chemotherapy is the situation that every patient is unique. Tumors grow and spread in different ways and their response to treatment depends on these characteristics. The amount of chemotherapy that each patient can tolerate varies considerably from patient to patient. Therapeutic protocols currently in use are limited in their effectiveness because they are based on the results of clinical trials conducted on a general patient population, yet no two patients are alike. Chemosensitivity testing can help to improve the efficacy of cancer therapies on an individual patient basis.

Without the information provided by chemosensitivity testing, oncologists have the freedom to choose between multiple different drug regimens, all of which have approximately the same probability of working. Some of these regimens are highly profitable to oncologists. Other regimens are much less profitable. Pre-screen testing takes away a lot of this freedom to choose and narrows the selection to those drugs that have the highest probability to be successful but may have lower profitability for the oncologist. This cuts into the oncologist’s bottom line, though it benefits the patient.

The hallmark of the disease is heterogeneity, yet the powers that be insist on trying to homogenize it, rather than tailoring treatment to the individual nature of the disease. If we devoted 10% of the "one-size-fits-all" resources to developing and testing methods to individualize therapy, we’d have actually made some progress at lowering the costs of cancer drugs.

PHARMA: Two quickies

The guy who was mentioned in a THCB post a while back about writing a tell-all book about being a slacker Viagra salesman has found that his new employer, Eli Lilly, didn’t approve, and fired him. I assume he’ll do well in his new role as a consultant on the next Michael Moore movie.

Meanwhile, John Mack apparently has his sights set on a bigger challenge than turning around Merck, (chortle, chortle).

PHARMA/POLICY: The NY Times misses the point on medicinal marijuana

The New York Times has a very dumb article about medical marijuana called Medicinal Marijuana on Trial, which suggests that medical marijuana hasn’t been properly proved by clinical trials.

Well leaving aside that plenty of drugs have been approved by the FDA which have had less than full trials, there are three points not made in the article.

1st: Medical marijuana has been broadly favored by an Institute of Medicine report, and the Federal government has been sending it out for years to a very few patients.

2nd: There have been no major trials in the US, and precious few elsewhere, precisely because the DEA has stopped it for purely political reasons. So this article, which shows modest benefits from the few studies that have been done, but irrelevantly claims that this is outweighed by the impact on teenagers who smoke vast quantities of marijuana for no medical purpose. So we deny sick people medicine because of the actions of other people.  Well in that case, we shouldn’t allow Percocet for people coming out of surgery, because some people are heroin addicts.  Illogical rubbish and the NY Times should know better.

3rd: Most importantly, like Ginko, vitamins, fish oil and God knows how many other "cures", sick people take medical marijuana because they think it makes them feel better and healthier.  Making people feel better is the point of medical care. Rightly or wrongly people should be allowed to have what they believe to be medicine.  And despite some 75% of the country being in favor of allowing medical marijuana, it’s purely political grandstanding by extremist (and predominantly family values Christian) groups–being used as a front for the vast amount of money that the taxpayer has to pour into law enforcement–that has opposed sick people getting what they believe to be medicine.  Shameful.

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