The King Is Dead, Long Live The King

There was one piece of news that probably didn’t make many of your feeds this morning that is very important in my industry: today is the day the patent on Lipitor expires.

I’m sure most of you are saying, “Huh?” or “So what?” or perhaps “Maybe now my prescription will cost less…”, but I look at it as the end of an era of one of the most important drugs in the last 20 years. First synthesized in the mid-1980s, it was approved by the FDA in at the end of 1996 (how’s that for a product development cycle?). Lipitor (like other statins) inhibits HMG-CoA reductase, which catalyzes the rate-limiting step in cholesterol synthesis in your liver. Turns out, that’s a good thing.

So much of a good thing that the promise of Lipitor sales has prompted three mega-pharmaceutical mergers, the most recent being Pfizer’s acquisition of Warner-Lambert about 10 years ago. And for good reason. During its patent life, Lipitor sold about $130 billion worth of product. That’s a lot of pills. I suppose it’s also a lot of pizza and cheeseburgers.

Lipitor

With the onrush of new generics (look for atorvastatin), certainly its place as the best-selling pharmaceutical in the world will be displaced despite what I’m sure will be a huge effort by Pfizer to keep the number scrips up. And while that’s probably good for the consumer, from a product standpoint it’s sort of a shame, because Lipitor rocks.

In this business, there’s an inside joke that a medicine only needs to be two things: effective and safe. Lipitor is both.  The drug not only decreases cholesterol and lipid concentrations, but more importantly in long term trials has been shown to decrease the number and severity of cardiovascular events (heart attacks and strokes), while maintaining an excellent safety profile. In fact, an 11-year study published in The Lancet this week showed that treatment with statins had cardioprotective properties for five years after people stopped taking it. Better yet – there were no red flags in terms of long-term safety.

As someone that’s worked in the drug industry for close to 20 years and has heard all the bad news, billion-dollar failures, and toxicity stories, it’s important to remind myself that sometimes we get it right. And in case like Lipitor, sometimes we get it really right. Maybe it takes an insider– someone who has seen the sausage getting made — to appreciate it, but Lipitor is to pharmaceuticals what a Beethoven symphony is to classical music, or the Chrysler Building is to architecture. It’s not perfect – nothing is – but it’s about as good as you’re likely find.

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29 thoughts on “The King Is Dead, Long Live The King

  1. I had no idea Lipitor was the best selling drug in the world! I guess I shouldn’t be surprised with our (increasingly) greasy diets. Looking over patient’s medications, I do frequently see Lipitor on their lists. Interesting post!

    • Lipitor’s been the best-selling drug in the world for several years. My guess is that it will be passed by Plavix this coming year as generics eat into the Lipitor market.

  2. Lipitor (Atorvastatin) is one of the largest selling drugs in India as well. And it has saved more lives than any drug in recent history.
    Yes, long live the king !

  3. “I suppose it’s also a lot of pizza and cheeseburgers.” True. Very true.
    Well said, Steve. Lipitor is an excellent example of how something can be done right. The fact that this particular drug exists provides hope that other drugs will be created to tackle other diseases, etc. Meanwhile, having the generic door open will enable many others to access this ‘wonder drug’.

    • LD — it’s interesting that there is a huge shift in the drug industry going on right now. For the last couple of decades, all the companies have focused on trying to get the next “blockbuster” like Lipitor. Now, with a tougher regulatory marketplace, they’re focusing more on niche indications (all the big ones are taken, in effect).

  4. I find I have mixed feelings watching Lipitor’s patent expire, since it spurred Pfizer to its merger-mania, which I think has harmed that company and has certainly caused a lot of turmoil for a lot of my friends. And it helped fuel the blockbuster-hunting business model that I think has harmed our industry as a whole.

    But you are right, it is a pretty amazing drug.

  5. Some of my current colleagues are ex-Pfizer and have some interesting stories to tell about Lipitor development. Apparently it very nearly didn’t get developed and without a few lucky breaks it might not have made it to market. As much as we need the science to work, it helps to be lucky too!

    • J — yes, I remember talking to WW about it not too long ago, and he mentioned that they almost canned it because there was little enthusiasm for a drug that was going to be “the 3rd or 4th statin”. And here it ends up being the best of the bunch. Something for FDA reviewers to remember.

  6. Papa and Rosey (The Duchess’ best friend) were both on Lipitor for some years before they doctors realized it was adversely affecting them. I think it’s not so common that it happens but odd that 2 people so close to me had it! This was definitely a life-saver for many who simply couldn’t (wouldn’t) switch to a vegan lifestyle. I should make a lot better choices, having an auto-immune disorder and I don’t, so I’m not casting stones!

    • There are some side-effects in parts of the population — but the good thing is that they’re easy to spot and so they’re easy to avoid. One of the worries in taking a drug chronically is that something will crop up a long way down the road (5, 10, 15+ years) like cancer or dementia or something that can’t be spotted by the patient or physician until it’s way too late. After 15 years in the marketplace, still no signs of that for the statins, which is great.

    • Take so long? I hate to tell you Budd, but 11 years is down right SPEEDY for the time for drug approvals from the time of discovery. And it’s only getting longer and more expensive. The most recent estimates that the average time is approaching 13 years and $800,000,000 for development. And that’s before the company ever gets to sell a single pill.

      The next time someone complains about the high cost of drugs, remind them of that.

  7. If only track records like these could be had on psychiatric drugs…

    I have a very jaded view on Big Pharma. Some meds I was prescribed messed me up terribly.

    • Psychiatric drugs are almost a dartboard of trying something and seeing if it works and moving on if/when it doesn’t. The animal models are not particularly predictive and the mechanisms are hard to disentangle. I’m glad I’ve never worked in that area — endocrinology, anti-infective and even oncology are much easier to target in my opinion.

  8. I’m very distrustful of the pharmaceutical industry, if only because I know how much public money goes into their research and how we get gouged with insane prices when we paid already to have the drugs produced. I suppose I should credit Lipitor with saving my father’s life, however: he had his first heart attack when he was 68, and an angioplasty when he was 70. The latter didn’t help that much, unfortunately, and for a while I was convinced my father would be dead before he reached 80—his own father had died of a massive stroke in his 60s, and his older brother of a heart attack, also when he was in his 60s. Then Lipitor came out, and his doctor put him on it right away. Suddenly his cardio problems disappeared. It was like a miracle of sorts, and Dad is still here at 89. Of course, he now has other problems, dementia being among them. If only there was a drug to help the brain live as long as the body.

    • No one seems to mind that Apple can pile up billions upon billions in profit selling gadgets that people are convinced that they need and has a valuation that dwarfs any pharma, but if a drug company makes a big profit, they’re extorting people or threatening to let them die. There’s a post in there somewhere, but it’s going to take more thought and data.

      Last decade, the Fed revised its rules about what sort of companies can apply for grants and it’s gotten very restrictive. If you’re public, or majority owned by financial institutions or venture groups, gov’t funds are off limits.

      One reason drug prices are so expensive is what I referred to in Budd’s comment. The average time to develop a drug is over 12 years and is approaching almost a billion dollars. And that doesn’t guarantee you’ll get final FDA approval or that it will sell in the marketplace once it does. I’ve seen a handful of drugs die that way — and that’s a billion dollars that the company has to eat each time. Poof.

      • Steve, nobody needs an iPhone (as I’ve told my children a number of times), but many people require certain medications to stay alive, such as the “cocktail” of drugs AIDS patients now take. If you’re lucky, your health insurance company will cover your prescription, but in some cases, like antidepressants, many will not. When I was taking Prozac back in its heyday, I was paying $124 a month, because my HMO refused to pay for “mental health services.” I was a single mother with three children back then, and the cost was hard to absorb into the monthly family budget. Before I began taking the drug, however, I had to force myself out of bed to get my children to school, and I used to spend whole days just crying—no particular reason, because that’s what depression does to one. It’s a cruel, unreasoning disease (though the HMO didn’t see it that way), and I know of several people who “lost the battle with depression,” which has become a euphemism in obituaries for having committed suicide.

        I’ll grant that health insurance companies who refuse to cover drugs that could radically improve the lives of many are largely at fault for this situation; and I’m not against an innovator enjoying the profits of her or his hard work. But it makes little sense why a person in Canada was paying half of what I paid for Prozac in the U.S. The way medical care is provided to people in this country is deeply flawed. To go back to your analogy of Apple vs. pharmaceutical companies, it’s a lot easier to buy a rebuilt iPhone than it is to buy many medications, generic or otherwise.

        • HG — you’ve hit on the conversation that I think everyone in the drug discovery and development has with themselves and their colleagues — or at least they should be having: what is the moral-ethical requirement for the production of medicines?

          If it costs a billion dollars just to get to the marketplace, how much is “too” much profit to make, since as corporations the company is primarily responsible to their shareholders and not to society. Medicine is a commodity and product, like any other — though it’s hard to think of that way when you or someone you love is sick. For example, Steve Jobs lived much much longer with pancreatic cancer than almost anyone — why? Because he paid (likely millions by the end) for the best treatments available. If you or someone you know has cancer like that should society foot that bill? I don’t think so, but what is the right balance?

          I don’t think there’s an easy answer, but it’s one we talk about all the time.

    • GOM — it will be interesting to see how Pfizer approaches trying to get people to stay on Lipitor. My guess is we’ll see a big price drop plus marketing campaigns that try to convince that “the original” is better than the generics. And they might be right — formulations matter in drugs and can change their effectiveness, even though the active ingredients are identical.

      • My wife takes a prescription that had a generic available, but BOTH her doctor and the pharmacist advised her (and convinced our insurance company) that they were not the same and only the “real” drug was what she should be taking. Now, many years later, a generic has been developed that she can take.

        Commenting on what you said before – I think it’s ridiculous that it takes that amount of time and money to “okay” a drug, especially when it’s readily available (and has been for quite some time in some cases) in other countries. This really causes me to wonder when the FDA does approve a drug that later has to be recalled.

        Also agree to your comment regarding profits vs. development cost and why “big pharma” is held to a different standard than tech companies. Sad that being successful has become a bad thing in this country.

      • Steve, you are right that for some medications the formulation can impact the drug’s effectiveness (primarily by altering its absorption rate). Generics manufacturers still have to show that they are able to manufacture the drug product and the active ingredient in a way that meets regulatory requirements for quality and stability. In addition they have to show equivalent pharmacokinetics, meaning the generic version of the drug gets into the body in the same way and at the same rate as the branded version. All this costs money for the generic company, but it costs far less than all the safety and efficacy work done by company holding the patent, and at far less risk than the original development.

  9. I had never really thought of lipitor as particularly safer than any other drug, Possibly because I have treated several people for the liver problems that it can cause. BUT, I have never considered how many people are actually taking it…and the amount of problems seen. My own physican would not place me on it, and preferred Welchol, as she was concerned about myalgias. She may have been over cautious. I like what Welchol does, but boy…6 pills a day. Makes me feel like a real pill pusher!

    • Miz — wow, I had no idea that welchol was 6x a day. Yowzer. The thing about statins side effects are that they’re relatively easy to pick out and that stopping isn’t usually a big deal.

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