Why The Prices Of Drugs Are So High?

Some medications are fairly affordable and others have astronomical prices. For example, take two drugs that treat prostate cancer. One is $600 and the other is worth a brand-new BMW 3X. Aside from the backroom deals and corporate corruption, there are legitimate reasons as to why some pharmaceutical drugs are insanely expensive. It's usually an issue with the science behind making the drug.

All new drugs have to be approved by the FDA and must go through a rigorous set of clinical trials to meet feasibility safety and effectiveness standards before being sold. This involves a total of five phases: a preclinical phase and other 4 phases. Will be going through each of these phases to see the whole process.

Preclinical phase

The first is the preclinical phase. Once a specific market has been determined by your marketing team, say cancer patients, the next step is discovering a drug to treat the disease. The drug discovery begins by conducting research on different candidate medications and then testing them to see which works best

After months and months of experiments, scientists have finally found a drug with promising results. But this is a new drug that's never been used before. Sure, it seems to work fine on a cell culture in a petri dish, but how does it work in an entire human body? What are the side effects? How much is toxic and what is an effective dose? This means researchers will have to run multiple tests on the drugs in a body, how it interacts with major, organs how its metabolized and what exactly is a safe dose. Most of this is determined using animal models such as rabbits, pigs or monkeys.

So, the drug is determined to be safe and now it's time to start testing on human subjects. Nope! The drug has only been tested on a small scale for the most part in milligram quantities. Now it has to be scaled up to be produced in kilogram quantities to administer it to thousands of patients in for clinical phases. This means running tests on stability, performance, packaging and adjustments to manufacturing processes.

All right, now you finally have a safe drug in large supply with a workable dosage onto the first phase.

Phase One

In the first clinical phase, the drug is given to 50 to 100 healthy patients in predetermined doses known as the first human dose. This testing includes giving patients a single dose or multiple doses at higher concentrations, the effects of the drug when taken with food and the effect of the drug when taken with other drugs. Basically, phase one just makes sure that the drug is safe at different doses and in every condition possible. Phase one clinical trials take from six months to a year to complete with 70% of drugs getting approval. Once the drug dose has been approved to be safe with healthy patients, the FDA moves on to phase two.

Phase Two

This phase involves testing the drug on a small sample group of about 300 patients that had the disease. This phase is very crucial. Sure, the drug was proven to be safe in the first phase and to verify the dose. But the second phase actually tests to see if it works. It's totally possible for a drug to be safe passing phase one and then found not to work in phase two.

If this does happen then it's back to the drawing board in the preclinical phase. And not surprisingly this does happen quite often with drug companies as only 33% of drugs move on to phase 3. Additionally, phase two takes about two years to complete.

Phase Three

The FDA approves that the drug appears to work, but only on a small group of sick individuals. Now the drug is tested on more sick patients, this time between 300 and 3,000. This requires that testing is done on multiple sites and in multiple countries. Additionally, phase 3 compares the drug to the gold standard of a treatment that is currently being used to treat the disease.

With all these conditions in place, it takes between 1 and 4 years to finish phase 3 with only 25% of drugs getting an approval.

Phase Four

This phase is pretty short and sweet as the drug is approved to be sold, but still, undergo surveillance from the FDA to evaluate long-term effects on patients. On average, it takes about 10 years to develop a drug from the preclinical phase to getting it approved in phase four. With a long timeline like that, the one thing you should take away from this article is that drug development is very expensive resulting in 1.8 billion dollars for the average drug to be developed.

During that 10 years, the company has to pay employees, equipment, materials, FDA application fees and restarting projects multiple times. In addition to the costs of developing a drug, high prices are often made to account for the major loss of profits in multiple drugs that never get FDA approval. With only 1 in 4 drugs getting past phase three trials that send 75% of companies back to the drawing board.

Between 2006 and 2015 the average rate of success for a drug to be approved was just 9.6%. Of course, it wouldn't be right if I didn't mention it, but the drug companies often keep their developmental cost confidential from the public leading some people to believe that the costs are inflated and not entirely true.