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The North Suburban Chicago Freethinkers Meetup Group Message Board › The Cost of Pharmaceuticals: Part 1

The Cost of Pharmaceuticals: Part 1

Libertyville, IL
Post #: 1
At last night's meetup, we had some talk about pharmaceuticals - and I thought I'd share this from the Abbott Employee home page with the group.

Someone Asked Me About... The Cost of Pharmaceuticals - Part 1

We've all been there at one time or another - at a family gathering, or maybe a neighborhood party - and someone says "Hey, you work at a drug company, don't you? Why do medications cost so much?" Many people simply do not understand the process of how a drug comes into being, and the risk and complexity involved. Innovative drug development is an extremely risky business; a chemical has to make it through a truly daunting series of tests to be even considered a drug candidate. The reality of the situation is that the vast majority of ideas never even make it out of the laboratory, and most drugs end up failing at some point in the research and development process, sometimes after years - and hundreds of millions of dollars – have been invested in them. It's an expensive process that is only becoming costlier. The average cost to develop a new drug has almost doubled in the past 10 years. However, it is more than worth it when we end up with a medicine with the ability to change – and even save – people's lives.

So what's involved in creating a new drug? Why does it cost so much, and take so long? To help our colleagues across the company who don't live it day-to-day, Abbott Home is providing this brief article on the challenging, often frustrating, but ultimately rewarding process that leads to the launch of a new drug. (For the sake of clarity, we'll focus on the process used to create traditional, small-molecule drugs. Creating a biologic drug like HUMIRA requires similar steps but can be even more complicated and costly.)

Drug Discovery
The first step in making a new medicine is to identify an unmet need. We look for diseases or conditions that don't yet have effective treatments – like Alzheimer's disease - or that have treatments with unwanted side effects. Then we try to find a chemical or a protein – called a "target" - that plays an important role in the particular disease. Our scientists will then assemble a group of "lead compounds" – chemicals that may interact with that target. To do this, they can screen thousands of existing compounds to find suitable candidates. Or, as is often the case, they can study the structure of the target to develop a hypothesis about what a drug to interact with that target should look like, and then custom-build molecules that meet those criteria. The resulting group of molecules will have desirable features, but they most often have to be modified to increase their activity or to minimize side effects. This process, called "lead optimization," results in hundreds of potential drug candidates.

To choose which of these compounds will be tested further, researchers ask a series of questions. Will this particular compound be more effective than current medicines? Will it be possible to manufacture? How will the final product be formulated? With these answers in hand, we choose a handful of candidates to begin preclinical testing, that is, testing that takes place before the compound is tried in human subjects, in the clinic.

Preclinical Testing
At this point, we perform studies to evaluate the safety of each candidate, and to demonstrate that it has an impact on the disease target. We also perform tests to ensure that the medicine can reach its intended target and pass through the body properly. There are also early assessments at this stage to determine the compound's purity, stability and shelf life, as well as assessments designed to tell us whether or not the compound will be able to be made on a large scale. These studies can take as long as six years – and that's before the compound is ever tested in a single person.

Once preclinical testing is completed, the compound is ready to be tested in humans. But not before it's cleared by the appropriate regulatory agencies. In the United States, we file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). In Europe, a similar filing is known as Common Technical Document, or CTD. These applications communicate the results of our preclinical experiments, describe the chemical structure of the compound and how it is thought to work in the body, list any side effects found in animal studies and explain how the compound is made.

Clinical Trials
With the approval of the appropriate agency, we can finally begin clinical trials. You'll recall that we started with thousands of compounds. Maybe a few hundred of them survived the optimization process. Fewer still made it into preclinical testing. On average, five of those will make it this far. And at every stage of the process, the hurdles get higher, and more compounds will fail. But with every result, whether it's positive or negative, our scientists add to the pool of knowledge we need to eventually succeed. Over the years, this process has grown significantly more complex and costly.

There are three phases of clinical trials:

• Phase I
In this phase, the medicine is tested in a small group of healthy volunteers - usually between 20 and 100 people - to determine its safety profile; including the dose range, or the amount of medicine that can be safely administered to a patient. Pharmacokinetic, or PK, studies are performed at this time to examine how a drug moves through the body, including the length of time it's available to perform its intended function. Phase I studies can take from six months to two years to complete. (In some disease areas, such as cancer, Phase I studies are sometimes conducted with patients who have the disease.)

• Phase II
If the drug passes the tests of Phase I, it's time to see how it works in people who have the disease it's meant to treat. In this phase, anywhere from 100 to 500 volunteer patients are studied. Some of them are given the drug; others are given a placebo (an inactive compound designed to serve as an experimental control). The goal of this phase is to establish the "proof of concept" – to answer the important question of "Does this drug actually do what we designed it to do?" If the proof of concept is successful, our scientists also use Phase II studies to determine the proper dose of the drug – how much and how often it should be taken to achieve the optimal benefit. These studies are also used to further evaluate the drug's safety and to look for side effects. Phase II studies can run anywhere from six months to multiple years.

• Phase III
This is the critical "make it or break it" phase. The medicine is tested in large, randomized, placebo-controlled trials with much larger numbers - 1,000 to 5,000 patient volunteers in order to generate statistically significant data. Throughout the trials, patients are closely monitored to confirm that the drug is effective and to identify side effects that may not have been apparent when it was tested in the smaller group. Phase III studies can take as long as four years to complete, depending on the disease, the length of the studies, and the number of patients.

Vernon Hills, IL
Post #: 16
And dont forget, Big Pharma has to pay a lot of high priced lobbyists in Washington and also to mean contribute... to the politicians so they vote the way Big Pharma wants. And Big Pharma CEO`s have gigantic salaries. All this is reflected in the costs to the consumer.
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