The Cost of Medical Research; It’s Not What You Think

health care spending

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The drug companies use the cost of drug development as a rationale for charging massive amounts for new drugs when they get brought to market under a patent.

The reality is that many of these drugs are priced far above what it cost to bring it to market and definitely beyond what it costs to produce.  In other words, it has nothing to do with what the drug company’s costs were or are; it instead has to do with how much the market will bear the costs.  This leads to massive profits.

But this is NOT were the true cost of these drugs lie for society.

The true cost lies with the fact that many of these drugs are a complete waste of money.  (This of course does not begin to account for the damage done from drugs that are later taken off the market or given black box warnings for safety reasons discovered after the drug was launched)

Sound a little extremist?

Before you judge me, you need to understand the concept of SURROGATE END MARKERS, which I have discussed many times before.  A surrogate end marker is used in drug research studies to basically save money and time.

The ultimate classic example is cholesterol lowering drugs.  Lipotor was initially approved and based on its ability to lower cholesterol levels.  What I usually point out is that no one really gives a hoot about his or her cholesterol levels, it’s just that no one wants to have a heart attack or stroke.  Using cholesterol as the surrogate end marker for heart attacks, the Pfizer did not need to run years-longer, more expensive studies to see if Lipitor actually lowered rates of heart attacks.

And that’s what happened.  It took YEARS before the studies on statins were done and published to see if cholesterol lowering drugs actually lowered rates of heart attacks.  When the dust finally settled on the topic, the results were less-than-stunning.  About a 1% absolute reduction in the rates of heart attacks.

The amount of money wasted (and continuing to be wasted) on this class of drugs is beyond most of our comprehension.

If this was an isolated example everything would be maybe OK, but it’s not.

Blood pressure medications for stage 1 hypertension (systolic <160 or diastolic <100) do not lower the risk of heart attack, stroke or death.  What the heck are we wasted BILLIONS of dollars on them then???  (I’d love an answer, but I fear the question is largely rhetorical)

Fancy new cancer drugs that improve “disease free survival” do not actually help cancer patients live longer but cost tens of thousands of dollars more per patient.

But we can’t leave diabetes medications out of the mix.  About a decade ago, there began a massive shift in research dollars towards a gut hormone called GLP-1 that happened after researchers found that a compound in Gila monster spit could act the same in our bodies.

Since that time, published research on this hormone and the class of drugs that could slow down our body’s own breakdown of GLP-1 (normally only last about 1-2 minutes in our own body) has dominated the diabetes medical journal landscape.  These two types of drugs (GLP-1 like drugs and drugs that slow down our body’s breakdown of this same hormone) hit the diabetes drug market at a full-on sprint with names like Byetta, Vicotoza, Januvia and Onglyza.

And they weren’t cheap (lots of variables, but on average $300+ / month)

But no one could argue that they did a better job of control blood sugar (if you can ignore those pesky side effects like acute pancreatitis and pancreatic cancer).  But one COULD argue that the lesson from the past about using surrogate end markers almost always ends up to be a bad plan.

You see, most diabetics die of heart-related complications.  This means that any drug used to treat diabetes really has to have an impact on heart disease if it’s going to be worth squat.

I’m betting you can see where I’m going with this….

In this particular study, researchers evaluated any published studies done on the benefit of DPP-4 inhibitors (the drugs that block the enzyme that breaks down GLP-2 so quickly) and major adverse cardiovascular events (MACE).  Here’s what they found when they looked over 69 different trials with almost 68,000 patients:

  • Luckily, when compared to another class of diabetes drugs called sulfonylureas, DPP-4 inhibitors were associated with a 42% lower risk of MACE.
  • But when the DPP-4 inhibitors were compared to the newest class of drug for diabetes (SGLT2 inhibitors, which allow sugar to be lost through the kidneys) they were linked to a 89% higher risk of MACE.
  • When compared to placebo the expensive, heavily used, new class of drugs that mess with the GLP-1 pathway, there was no benefit on major cardiovascular events.

To sum this up, an entire new class of drugs designed to help diabetics manage blood sugar are pretty much worthless at preventing the major complication in diabetics.

With this in mind, it doesn’t matter squat what it cost to develop or what it costs to manufacture because the drug doesn’t really help diabetics in the long run.  This means that cost to society is equal to pretty much every dime spent by the healthcare system on this class of drugs PLUS the medical costs associated with the sometimes dangerous and fatal side effects from the drugs.

Good thing more people have access to drugs through the Affordable Care Act.

James Bogash

For more than a decade, Dr. Bogash has stayed current with the medical literature as it relates to physiology, disease prevention and disease management. He uses his knowledge to educate patients, the community and cyberspace on the best way to avoid and / or manage chronic diseases using lifestyle and targeted supplementation.