First and foremost, medications are expensive because of the FDA, the Food and Drug Administration.  It the Government’s arm that is SUPPOSED to regulate the safety of our food supply, and is SUPPOSED to make sure the drugs that come to market do what the manufacturers say they do, and the drugs are safe.

Unfortunately, like most other layers of government bureaucracy, it simply exists to feed itself, growing more and more ponderous, while at the same time making sure that it is tied so closely to the things it is supposed to regulate, that to do away with it would topple the industry it is supposed to regulate.

Big Pharma’s got a love-hate relationship with the FDA.  The tests the FDA requires for new drug approvals are so tortuous, and the hoops required between the tests, and the insistence on the exactly correct wording of, or modification to, the medication’s drug insert (the paper that lists the chemical structure, uses, adverse events, and side effects) make it horrendously expensive.  If you follow the bio stocks at all, you will know that there are several drugs that show a lot of promise, people buy the stock, and the FDA shuts the drug research, and usually the company down, for a very small percentage of patients that had problems with the drug.

On top of this, the studies they require really don’t tell you much outside of if the drug works better than placebo.(A sugar pill)  Essentially, the drug just has to show it’s better than nothing.  Anyone else think that’s just nuts? 

Additionally, when a drug is found to have some side effects or adverse event, the FDA overreacts and moves to protect its inherently bloated bureaucracy and either pulls the drug off the market, (Vioxx) or puts such ridiculously preposterous claims and restrictions on a product that really is useful that people suffer from not receiving it. (Antidepressants)  By engaging in this theatrical and melodramatic behavior, it makes the FDA look like it’s taking the concerns seriously, and that they are moving quickly to do something about it.  However, nothing really changes, and the people who rely on those medications continue to suffer.

The bottom line:  It costs, on average, $800,000,000 per drug to come to market.  And if the FDA pulls the plug on the medication, there is NO WAY to recoup the costs.  Trust me, you have to sell a lot of pills to break even, much less make a profit. 

My idea is to make Big Pharma do studies that compare the new medicine/equipment to existing medicine/equipment, and tell us why it's going to make patient care better.  Also, I advocate either scrapping the FDA and replacing it with something that isn't so closely ties to the industry, or giving it a different set of priorities.  I always think that less government is best government.

After Big Pharma gets the drug to market, you have to sell it.  And you either have to sell it to the doctor, or the patient.  How do you sell it to a doctor?  You take a person with a marketing degree, and no prior medical knowledge at all, and bomb the doctor’s lobby with about 50 drug reps a day, screaming (yes, screaming) about how their product is the best thing since sliced bread.  And then give the doctor samples so he can give them to his patients that may be on hard times, or can’t afford the medication, or even just to avoid having the patient spend money on a medication that may not work, or they may not react well with.  In June, 2003, I was working in a facility (Capstone), and I was curious what the monetary value was for the samples I was distributing.  I had my nurse keep track of all the samples I gave out for the month.  I worked three and a half days per week, for the month of June.  The grand total: $32,000.  For one doctor.  Part time.  In a small, rural, Midwestern town, in one month.  Gadzooks.

The other way Big Pharma sells its products is “direct to consumer advertising’.  Yes, the cute little commercials with butterflies and smiley faces and all that.  The idea is to have the patient come in and pressure the doctor to give them the medication.  So the doctor, if he’s a good one, will try to explain why or why not the medication is a good idea.  A recent example is Abilify.(BristolMyersSquibb)  Abilify has been advertised as an adjunctive therapy for depression.  It does work well for that.  But it’s not new news.  We have known for decades that adding a “mood stabilizer” to people who have not responded completely to antidepressants will help them.  But adding Abilify, even though it has proven to be better than nothing, is very expensive.

This brings me to my next point about the expense.  Americans want the latest, greatest, best, and expect it to be free or a couple of bucks.  It’s just not realistic.  So the doctor, even if he is a good doctor, will succumb to pressure like that, even though he knows better, and has a less expensive alternative, because he wants to make his patient happy and content.  Isn’t that why you go to the doctor?  Besides, he’s got another 50 people to see so he can make his quota under the managed care system he’s a slave in.

So let's get some legislation going that restricts direct to consumer advertising, limits drug rep influence, (the industry is already addressing this) and makes the information available to doctors and patients more useful.

The next point is probably the most important.  Other countries have a patent life on medications of 21 years.  That means the drug company has 21 years to pay off the research and marketing expenses, and to make a profit so they can do more research.  In the US, the government, in its pursuit of cheaper drugs, has made the patent life of a medication 7 years.  The idea was if a drug comes off patent, the generics will hit the market quicker and therefore make the medicine cheaper.  The problem is, the medication isn’t that much cheaper, and often is more expensive.  A good example is Prozac. (Fluoxetine)  We get requests from the pharmacies all the time for branded Prozac, because it is cheaper than the generics.  So drug companies need to recoup their research and marketing expenses in 7 years, and try to turn a profit at the same time, in one third of the time other countries give them.  That’s also why we don’t get any good medications from Europe.  It’s too expensive.

I advocate extending the patent life of medications to 21 years, allowing Big Pharma a chance to reasonably recoup the money they have spent.  This also allows them to be able to focus more on research and development, rather than advertising.  Remember, Big Pharma are the ones who have developed our new vaccines, antibiotics, and other modern miracles.  By extending the patent life of a medication to 21 years, you have reduced the cost of that medication by 2/3.

And lastly, the pharmacies themselves.  There are wildly fluctuating prices for medications, and depending on which pharmacy, you may or may not get a good price.  If you go to a place with higher prices, your insurance company will have to pay that higher price as well, even though your co-payment is the same at all pharmacies.  The latest example happened last week regarding a medication called Geodon.  I had two patients call me and tell me they paid over $700 (YIKES) for the script I had given them.  I told the drug rep about it, he called, and he got prices of around $500.  Then I had my nurse call.  One pharmacy was $400, another $450, another $689.  Gadzooks.  (Sometimes as a doc, you must use the expensive stuff for patient relief and safety.)  It happens with generics too.  Prozac can range from $4 to $128.  That’s in Des Moines and the surrounding suburbs. 

CVS/Caremark gave, GAVE mind you, their CEO a $300 million severance package about a year or so ago.  HOLY COW!  That's a lot of pills, my friends.  We need to address this preposterous machine, preferably by pressuring the pharmacies to set reasonable pricing standards, or through stringent legislation.  Big Pharma has done internal change, so I think the pharmacies can as well.  If not, legislation should be enacted.
And that, my friends, supporters, and fellow Americans, is why medications are so darn expensive.