(Including an analysis of the financial records of 12 major pharmaceutical companies from 2003-2015)
By David Belk MD & Paul Belk PhD
In previous sections of this website I’ve written about the bizarre, two-level pricing system for prescription medications. Most generic medications usually cost only pennies per dose. These include many of our most useful drugs. But brand-name medications, which are usually the newest drugs, can cost hundreds of times more than that—too expensive for some people even with insurance.
Of course two-level pricing systems aren’t unique to prescription drugs. We all know we can get the “supermarket brand” for less money than the name brand for most products. And in the over-the-counter aisle at a drug store, we know we pay several dollars more for Bayer aspirin than for exactly the same drug with a Walgreens label. But in these cases, the difference in prices are never hundreds of times more. Also, we’re far more aware of the exact prices of these products than we are of prescription drug prices.
So the question is, why?’ How did the system get to where many of our prescription drugs are cheaper than milk, but some are more expensive than luxury cars? And why did we let it happen?
Our “Bargain” with the Pharmaceutical Companies
Like everything in medicine there are complexities in the issue, but at the center it comes to something pretty simple: The pharmaceutical companies told us that we need to pay ultra-high prices for patented medications so they have the money to develop more wonder drugs. And we said something like, “OK, take what you need.”
So here I’d like to ask two questions: What are we getting in exchange for these extraordinary costs? And is it time to revisit the bargain?
First, let’s talk about how much we pay. Like almost everything in medicine, “we” in the U.S. pay much more for prescription drugs than almost anyone else in the world. Name-brands always cost more than generics, but the name-brand drugs cost far more in the U.S. than in the rest of the world.
The pharmaceutical companies wouldn’t argue with that. The graph below is taken from combining separate analyses done by AstraZeneca and GlaxoSmithKline that are included in their respective financial reports. It shows that 42% of all revenue to all of the pharmaceutical companies came from the U.S. between 2003-2013.
So here in the US, with 4-5% of the world’s population and 33% of the developed world’s population, we cover for 42% of all pharmaceutical revenue?
Let’s look at this another way. Consider the following table comparing the price pharmacies in the U.S. pay for some commonly prescribed medications to British Columbia’s national insurance coverage for the same medications.
|Medication and Dose||Price in the US||Price in Canada|
|Abilify 20 mg||$40.51 per pill||$4.33 per pill|
|Effient 10 mg||$12.59 per pill||$2.96 per pill|
|Humalog Insulin 100 units/ml||$12.47 per ml||$2.78 per ml|
|Pradaxa 150 mg||$5.64 per capsule||$1.78 per capsule|
|Spiriva 18 mcg||$10.98 per capsule||$2.34 per capsule|
|Xarelto 20 mg||$11.60 per pill||$3.06 per pill|
Table 1: Comparison of brand name drug prices in the US and Canada.
The difference is even bigger than it looks. First, because the prices shown for Canada are in Canadian dollars, and second because the prices shown for the U.S. are the prices the pharmacies pay in the U.S. for these drugs.
Why the difference? Because even though pharmacies in other Countries buy drugs from the same suppliers and pharmaceutical companies that our pharmacies use, they pay only at a fraction of the price our pharmacies pay.
Their Part of the Bargain
So, are we in the US just being chumps for paying many times the price for the same pill as a patient in Vancouver? Maybe, but before we get any further into that, we need to look at the other part of the bargain. The pharmaceutical companies tell us that they turn these high prices into research toward new cures for diseases. It’s true, we in the US seem to be picking up most of the research tab for the rest of the world, but if we’re curing diseases, maybe it’s worth it.
In other words, let’s see if the pharmaceutical companies are really delivering on their side of the bargain, and then we’ll go back and decide how much we should be paying them.
So next we’ll examine the research question: does pharmaceutical research really cost so much that, even with the prices they charge, they barely have any money left over at the end of each year? A good way to find out is to look at their annual financial statements. Each year every publicly traded company has to file an annual financial report with the SEC which lists annual revenues, itemizes costs, profits, etc…
I examined the annual financial reports of 12 major pharmaceutical companies over 13 years (2003-2015). These were among the world’s largest pharmaceutical companies and were responsible for a combined total of 42% of all of the world’s pharmaceutical sales from 2010-2013.
I uploaded each of the reports I examined here and listed the pages that contained all the information I used next to each link. I also prepared a four to eight page summary of what I thought were my most important findings about each company. I linked these summaries to the name of each pharmaceutical company on the webpage.
We’ll start by looking at one of these reports. A good example is the 2011 annual report for Pfizer. The report itself is 117 pages long but, not to worry, much of what we need to know can be found on page 17, which I show below. (PDF document page).
On page 17 you’ll find the above table which is an analysis of the consolidated statements of income for Pfizer. You can see from the first line that Pfizer reported just over $67 billion in revenue in 2011. A few lines down you can see that they spent just over $9 billion on research and development that same year. OK, $9 billion is a lot of money. It was nearly 14% of their total revenue.
But what’s really interesting is that you can see that Pfizer spent more than twice as much on Marketing (selling, informational and administrative expenses) as they spent on research; over $19 billion! And look at their profit for that year. They made just over $10 billion in net income (after taxes) which, by the way, is more than they spent on their research for that year.
So the cost of research wasn’t exactly eating all of Pfizer’s income pie in 2011. But that’s one pharmaceutical company’s financial statement for one year. How about the rest of them?
As I said before, I went over 13 years of financial reports for 12 major pharmaceutical companies and here is some of what I found:
-The combined total revenue for all 12 companies over 13 years was about $5.35 Trillion.
-The Combined total profits for these companies was about $1.05 Trillion.
-All 12 pharmaceutical companies spent a total of $887 Billion on research.
-The total amount they spent on marketing was nearly twice what they spent on research: $1.59 Trillion.
Here’s the same information in two graphs:
Figure 2: Total combined profits earned by all 12 major pharmaceutical companies from 2003-2015 compared to amount spent on marketing and research over the same time period. Proportion of total revenue allocated for each is below (figure 3).
As you can see, the pharmaceutical companies do spend a lot on research but their research budgets are dwarfed by their marketing budgets. They also made more in profits each year, on average, than they spent on research.
So let’s do some estimates. Just as an example, we’ll take that dose of Effient that we get for $12.60 and the Canadians for less than $3. The pill most likely costs just a few cents to manufacture (we know that from the cost of the generics), so the $12.60 is mostly profit. But they charge (us in the U.S.) $12.60, they say, to cover the cost of discovering it.
Yet from their own statements, only about $2.14 of the $8 (17%) goes into research. Another $2.50 is pure, after-tax profit, and a whopping 30%, or about $3.80 of that $12.60 pill goes, not to the scientists at the pharmaceutical companies, but toward buying all of those medication ads you love so much. So most of what we “buy,” when we pay the highest drug prices in the world, is high corporate profits and lots of television commercials of middle-aged men with very pretty wives.
What Does It Mean when They say “Research”?
But we can’t stop just yet. By their own reports, the pharmaceutical companies put about 17% of high drug costs back into research. Let’s see if that money is really going where we think it’s going. And while we’re looking, we’ll get some insight into another question about pharmaceutical research, which is: “Why do a lot of new drugs end up doing no better than the old ones, and why are so many recalled for safety problems?”
When we think of research, we might think of scientists in white coats skillfully synthesizing new compounds and conscientiously measuring their effects. This does happen in the design and testing of new drugs, and of course the money spent on that comes out of the research budget. But research money also goes to a lot of places you might not expect.
First, research buys drug studies. That’s what the pharmaceutical companies do when the drug’s already developed and they want to see if it really treats the disease it’s supposed to treat. There’s usually a pretty high standard for success in these studies and it’s pretty hard on a company when one fails.
So what happens if it looks like the drug almost works? First, it means the drug probably doesn’t add very much to medical therapy. But all too often a pharmaceutical company will just repeat a study. These repeat studies give blind chance another opportunity to make the drug look useful. So some of the “research” money is really used in making mediocre products appear better than they really are.
It also buys “in-process” research, which is what the company pays to take over another company, hoping that the new company might have some valuable drugs in its pipeline. In other words, this part of the research budget can be used essentially for corporate takeovers.
But here’s where the idea of pharmaceutical “research” really gets stood on its head: Pharmaceutical research is sometimes virtually indistinguishable from marketing.
At the best of times the line between “research” and “marketing” is pretty fuzzy. After all, what really is research and what exactly is marketing? The answers to these questions aren’t as obvious as you might think. Much of what defines research vs. marketing costs is a decision left to the pharmaceutical companies and they can be rather creative in how they assign these costs.
In their 2007 financial report, Roche reassigned nearly 800 million Swiss Franks from their marketing budget in the 2006 report to the research budget (PDF page 138). This shows how even the pharmaceutical companies have trouble making up their minds about the definition of “research”. Also, Bristol-Myers Squibb has separate listings for marketing and advertising. This means that, for some reason, Bristol-Myers Squibb doesn’t consider advertising to be a component of marketing.
Why such confusion? First, a lot of research has to happen outside the lab, and in medicine you obviously have to go to doctors and see how well the new drugs work on sick patients. But doctors are also your main customers—they’re the ones who decide whether to prescribe your drugs. And they’re your main advocates—they’re the ones people trust to say whether a drug is worth using.
So hiring practicing physicians to evaluate new drugs creates a potential conflict of interest for these doctors, blurring the research vs. marketing line further. Consider this: many of the very same doctors who will eventually prescribe these new drugs to their patients are first hired by the pharmaceutical companies to evaluate the drugs. And it is their evaluation which is presented to the FDA as part of the decision whether the drug is worth approving for patient use.
Is there a problem with that? Well, consider the following scenario:
Class sizes are far too large in a school district and, while the English teachers can prepare and deliver lessons, they can’t possibly have time to grade all the papers from their students quickly enough. The solution: hire outside graders to read, and grade, the papers. That’s not a problem—the town is full of English majors who are conscientious and more than qualified. The problem is that the school doesn’t have any money to pay the graders (there’s a reason class sizes got so big).
But still, it’s an affluent town and the Principal gets a very clever idea. Just let the students hire their own graders. Of course a grader has to have a degree in English and relevant experience, but otherwise the student can pick (and pay) whomever he wishes. And of course if he’s not satisfied with his first grader, he can hire a different grader for his next papers. Do you suppose a lot of really harsh graders will get hired, let alone rehired? Would you care to guess how many of those papers will get a grade of less than `A’?
Now these doctors aren’t paid specifically to ignore gaping flaws in a pharmaceutical funded study. But they are expected to use their judgment, and they’re generally paid pretty well (what company would risk underpaying the people who will determine whether their products get approved for market?). They also know that it’s solely the choice of the pharmaceutical company whether to ask them to evaluate future studies. And the money the company pays each of these doctors comes directly out of the research budget.
Another point about pharmaceutical research; the pharmaceutical industry paid the FDA about $712 million in 2013 for prescription drug user fees to “help” the FDA in the process of approving drugs for the sale and distribution in the US. That money paid to the FDA is also part of the research budget for the pharmaceutical companies.
Going Back to This “Bargain” We Made
Now that we’ve taken a closer look at how the money is spent after the pharmaceutical companies get it, let’s go back to the bargain—the one where we in the US agreed to pay far more for the same drugs than anyone else in the world—and ask “how did we end up making this bargain, anyway?”
In any market, an actual bargain can only occur when each party has the option to walk away. If you think the hamburger is too expensive in one store, you can shop in a different store. Or you decide to buy chicken instead. If the rancher can’t make money selling you beef, he’ll sell it to someone else. Or maybe he’ll decide to raise chickens. Somewhere in there, the two of you agree what the product is worth, and that’s what you pay.
But can you really “bargain” when buying prescription drugs? Think about it, when a doctor writes a prescription that’s the only drug you can legally buy. Your only other choice is to get no medication at all and remain sick. And, if the disease you have could kill you then the choice you have is literally “your money or your life”. Most people won’t choose to die in order to save money, even if it’s most of their money. So, since the patient really can’t just walk away she has no real ability to bargain at all.
But then why does the rest of the world pay so much less than we do? The answer is that, while individual patients have practically no bargaining power when buying prescription drugs that’s not at all true of governments. Virtually every other government in the world finds that pharmaceutical companies would rather lower prices significantly than simply not to sell in a particular country. So other governments bargain with the pharmaceutical companies on behalf of their citizens, and this type of bargaining significantly lowers the price of brand name medications in these countries.
The one exception is the US government. As the single largest market for medications in the developed world, you can imagine our government is in the best possible position to bargain on our behalf. And, even though this strategy works for all the other governments, our government won’t do it. US law prohibits our government from taking any active role in negotiating the prices charged by pharmaceutical companies. And for practical purposes, that fact is the reason that we pay more (much more) than anyone else in the world for drugs. That is the “bargain” we (or really our Congress) made.
This has led to a rather unusual business for pharmacies in other Countries like Canada: they’re able to sell prescription medications here in the US for far less than the price US pharmacies pay for these medications. In other words, pharmacies in other Countries buy drugs from the same suppliers and pharmaceutical companies that our pharmacies use, only at a fraction of the price our pharmacies pay. These international pharmacies can then sell them back to us online for a fraction of the price we would be charged here in the US for these same drugs.
Now, this practice is technically illegal in the US and the FDA warns us that a lot of counterfeit and unsafe drugs are sold on the internet this way. That’s actually true for anything you buy online (don’t give your bank account number to a Nigerian prince either). But the fact is, there are legitimate online pharmacies that are able to sell brand name prescription medications here in the US for a fraction of the price our pharmacies pay for these medications. And this is only possible because ours is the only government in the world that chooses not to protect us from being gouged by the pharmaceutical companies.
Why does our government opt out on this task? There are two reasons often given. First, there’s the argument that the government shouldn’t interfere because we have a “free market” for drugs. Americans have a great deal of faith in our market system, but in this case, our “free market” offers absolutely no freedom when purchasing prescription medications. As we discussed, you don’t choose which medications you’re prescribed; and people don’t (often can’t) shop around and compare the prices of brand name medications. In other words, it’s a free market minus any evidence of freedom.
What are we Really Getting in Return?
But our discussion here largely concerns the second justification often given for giving up all control over drug prices. We’re told that the high prices Americans pay for drugs are needed to generate the money needed to cure diseases. We’ve taken a long look at where the money goes.
Briefly, lots of marketing, lots of profits, and “research” that’s a combination of some new drug development, repeated attempts to get old drugs approved, more marketing and corporate takeovers. But even if most of the money we pay goes to marketing and profits, it’s still reasonable to ask whether the pharmaceutical companies are delivering results. In other words, are they developing new drugs to cure diseases? That’s where we’ll go now.
The Golden Age of the Pharmaceutical Industry
Not too long ago many of the new pharmaceutical products were having a revolutionary impact on health care. Between 1970 and the mid 1990’s dozens of new medications changed the way we doctors practiced medicine. Peptic ulcer disease, a chronic painful stomach condition often requiring surgery and lengthy hospitalization, could suddenly be managed with no hospitalization using new classes of antacids, and then cured with a new course of oral antibiotics.
New drugs treated malignant high blood pressure before it led to strokes, heart failure and kidney damage. Medications for heart disease and diabetes prolonged the lives of patients by years or even decades. New classes of oral antibiotics were more effective than the drugs that previously could only be administered in the hospital, and so patients with severe infections (pneumonia, diverticulitis, severe cellulitis) could now be sent home with pills.
In 1993 Barbara Bradfield became the first woman ever to be cured of metastatic breast cancer. The treatment was Herceptin™, the first of another new class of medications called monoclonal antibodies. Soon, several other monoclonal antibodies were developed as targeted treatments for other types of cancer and severe rheumatological diseases.
When the first of the protease inhibitors was introduced in 1995 it proved to be the key to arresting the AIDS epidemic that had been accelerating for more than a decade. AIDS, a plague that was unheard of prior to 1982, and an almost guaranteed death sentence, was killing tens of thousands of people each year in the US in 1995. These deaths were all but ended by the pharmaceutical companies by 1999.
This was an era in which medical miracles were so common that doctors started taking them for granted. Because of what the pharmaceutical industry produced, many diseases that required lengthy hospitalization and/or major surgeries in the past can now be treated at home with a few pills. The golden age of the pharmaceutical industry lasted about two decades and produced many new medications that cured the previously incurable and treated the previously untreatable.
Financial Risk and the End of an Era
Almost two decades have passed since then. The protease inhibitors were among the last of the truly revolutionary classes of medications to come from the pharmaceutical industry. Since then, almost all new medications have been variations of old medications with a slight improvement (if even that) or a new indication. Few new classes of medications, almost no medical miracles, nothing that has significantly changed the way we practice medicine has come from the pharmaceutical industry since the late nineties.
So how is it that an industry that gave us so many revolutionary, life saving wonder drugs in decades past is now reduced to peddling gimmicks and repeatedly recycling old ideas?
The “golden age of the pharmaceutical industry” was drawing to a close as early as 1990 when the pharmaceutical companies began to tire of new ideas. New ideas are always expensive and risky. Even the most brilliant sounding ideas often go nowhere when tested clinically.
This innovation fatigue had become so serious by the early 1990’s that Herceptin, the monoclonal antibody that first cured metastatic breast cancer, almost didn’t even get tested. In his book “The Emperor of All Maladies,” Siddhartha Mukherjee describes the difficulty Genentech scientists had convincing their executives to fund the testing of Herceptin after it had already been developed in 1990:
“… but Genentech was worried that pouring money into the development of another drug that failed would cripple the company’s finances. Chastened by the experience of others–”allergic to cancer” as one Genentech researcher described it– Genentech pulled funding away from most of its cancer projects.” (Page 418)
Herceptin had already been developed, but Genentech executives didn’t care. Testing to see if it worked risked wasting money and these executives were becoming very risk averse. Genentech executives weren’t alone in their risk aversion either. From 1995-1997 Novartis executives tried equally hard to kill Gleevec– another miracle drug that suppresses a deadly form of leukemia indefinitely–because they feared that the trials needed to clear Gleevec would cost too much (Page 436).
Fortunately, both Gleevec and Herceptin got the funding they needed and are now providing billions of dollars in revenue to the pharmaceutical companies that tried to kill them. They were among the last new ideas to get funding from the drug companies though. By the time Gleevec came on the market in 2000 the door had mostly shut on novel pharmaceutical research.
By 1990 the pharmaceutical industry knew they already had a lot of very effective products that were making them lots of money each year. They had patents that were generating billions of dollars a year and would continue to do so for many years to come. They also knew they could probably find a number of new uses for the classes of medications they already had. The most profitable course they saw at that point was to just coast; put no more funding into new foundational research and just keep pushing what was already working for them. That’s exactly what they did, and it worked!
The profits made by the pharmaceutical companies exploded over the last decade without them putting out any new products that were even remotely innovative. But that strategy can only work for a little while. Two decades after they shut the door on actual innovation the revenue from the old ideas is starting to run dry.
So, we in the US continue to overpay for brand name prescription medications, but the pharmaceutical industry has given us almost no new important therapies in more than 15 years. A somewhat unexpected result of this is that, total pharmaceutical revenue has been nearly flat since 2010.
You can see from the above graph that the total revenue from the twelve largest pharmaceutical companies has barely increased at all since 2010. It has actually dropped slightly since 2011 despite a more than 50% increase in the cost of brand name prescription drugs in the US since 2012.
What changed? A flood of Generic drugs came on the market.
Because there really is a market for generic drugs, we don’t pay any more for most generics than people in other countries. In 2003, most of the medications prescribed were still under patent. Today, the opposite is true. The effect is easy to see in the following graph, which shows the dramatic loss of revenue when the patent Bristol-Myers Squibb owned on Plavix expired.
Figure 6: Bristol-Myers Squibb lost their patent for Plavix in 2011 and, as you can see, that cost them over $6 billion a year in lost revenue from just the US.
Profit Without Innovation
The pharmaceutical companies haven’t been taking all of these patent losses lying down. They’ve instituted a number of measures to help offset the amount they’ve been losing to lost patent protection:
1) They’ve fought very hard, and in every way they can, to delay the expiration of drug exclusivity whenever possible. This process is called “evergreening” a patent. For example, they can apply for a new indication for an old drug just prior to it’s patent expiration. They can change the delivery system for, say, an inhaler. They can alter the recommended doses of a drug by a small amount– they have a lot of tricks for maintaining exclusivity and these tricks can often delay generic competition for several years.
2) In 2013 the pharmaceutical companies got the US Supreme Court to allow them to pay generic drug makers to delay the release of generic equivalents of medications for a time after the patent for a medication expires.
3) They’ve raised the prices of the few patented medications left in the US substantially in the last few years. The following table clearly shows this pattern:
|Medication and Dose||Indication||October 2012 Price||June 2016 Price||Price Increase|
|Abilify 20 mg||Depression||$26.35 per pill||$40.51 per pill||54%|
|Advair 250/50||Asthma||$3.97 per inhalation||$5.48 per inhalation||38%|
|Benicar 40 mg||Blood Pressure||$4.26 per pill||$7.10 per pill||67%|
|Byetta 10 mcg||Diabetes||$128.58 per dose pen||$232.59 per dose pen||81%|
|Cialis 20 mg|| Antique
|$23.64 per pill||$49.79 per pill||111%|
|Crestor 20 mg||Cholesterol||$4.99 per pill||$8.09 per pill||62%|
|Diovan 160 mg||Blood Pressure||$3.43 per pill||$5.89 per pill||72%|
|Effient 10 mg||Heart Disease||$6.80 per pill||$12.59 per pill||85%|
|Geodon 40 mg||Psychosis||$8.16 per capsule||$14.13 per capsule||73%|
|Gleevec 400 mg||Leukemia||$189.91 per pill||$324.46 per pill||71%|
|Januvia 50 mg||Diabetes||$7.30 per pill||$11.75 per pill||61%|
|Lyrica 50 mg||Pain||$3.00 per capsule||$5.57 per capsule||86%|
|Pristiq ER 50 mg||Depression||$4.84 per pill||$9.42 per pill||95%|
|Vytorin 10/40||Cholesterol||$4.70 per pill||$8.24 per pill||75%|
|Xarelto 20 mg||Atrial Fibrillation||$7.59 per pill||$11.60 per pill||53%|
Table 3 shows the average (NADAC) price pharmacies paid for 15 medications. It shows the average cost for these medications in October 2012 compared to the average cost for the same medications in June 2016. In just 3 1/2 years most of the listed medications rose at least 60-90% in price.
This rapid escalation in medication prices has managed to offset some of the losses to the pharmaceutical companies but it hasn’t significantly increased the total amount we in the US have paid for our drugs. That’s an important point: The overall cost of pharmaceuticals in the US hasn’t been going up and, in fact, outside of a few select medications, most drugs are now a lot cheaper.
These techniques the pharmaceutical companies are using to cut their losses generally provide no new therapeutic benefit—they just renew their ability to demand very high prices (at least in the US).
Conclusion: A Broken Promise from an Industry in Decline
Starting in the 1970’s the pharmaceutical industry churned out incredible treatments for diseases so rapidly that they seemed to have a factory for miracles. Many horrible diseases went from long-term suffering in the hospital to rapid cures at home. Prices were lower then, the economy was growing rapidly and few would argue against continuing to feed this golden goose. By allowing pharmaceutical companies to charge as much as they wanted for their medications, they would have the tools and the incentive to continue to create new and better medications.
We’ve kept our part of that bargain for a long time without asking very many questions. But now we see that the miracle factories seem to have been boarded up for many many years—the industry executives seem to have decided they were just too risky to keep open when they already had so much money coming in. And now it’s been a long time since we’ve seen much in the way of new therapies. We’ve kept sending the money, but what we’ve gotten back is mostly television commercials, paid physician promoters, and pretty young pharmaceutical representatives who take your doctor’s time to try to convince him to prescribe expensive patented drugs instead of generics that work just as well. In short, we’ve bought marketing. And corporate profits that are still among the highest of any industry.
The “research” we’ve purchased has often gone not into finding better drugs, but into finding how to make the drugs look better. Or into extending their patent protection for reasons that don’t make them better. Some legitimate research still occurs, to be certain, but it has much less impact in an industry that became risk-averse decades ago.
And strangely enough, in failing to uphold their part of the bargain to provide new and innovative therapies, the pharmaceutical companies have themselves started to suffer. Nine of the twelve companies whose financial records I examined have had flat or declining revenue for the last several years. That trend is likely to continue, and even get worse, in an industry that continues to live in the past.
And what of the rest of us? We’ve blindly pumped trillions of dollars into an industry with an assumption that they’d continue to turn that money into medical miracles. It’s plainly obvious that industry decided nearly two decades ago they’d rather keep most of that money than continue to revolutionize health care. Since the pharmaceutical companies haven’t done much to keep their end of this bargain, isn’t it time we stopped giving into their demands? Every other Country in the World figured them out years ago. When will we be ready to open our eyes and start doing the same?