Developing Effective and Safe Drugs for People with Diabetes
It is a long and difficult road.
When you hear about a new medication approved by the FDA (Food and Drug Administration) for people with diabetes, and available at your local pharmacy, that medication has been 15 to 20 years in the making with an average cost of 1.5 billion dollars. This long and arduous road is commonly referred to as R & D or research and development. Developing drugs is sort of like the restaurant business; for every 10 new attempts, only 1 is successful. Getting a drug past the FDA these days is very difficult generally, and even more so in today’s current climate of extreme cautiousness because of concerns for public safety.
The first thing that needs to happen is that a new diabetes medication must be discovered or invented in a laboratory. Then it is studied in laboratory animals. If this stage is completed without any negative safety signals, the new drug is studied in individuals without diabetes— again looking closely for safety issues. After this step, the drug is studied in large numbers of people with diabetes to find the most efficacious dose and, once again, examined to make sure it is safe. These multicenter studies often include several national and international research institutions collecting data for analysis.
Once all the studies have been completed and data analyzed, the application is submitted to the FDA. If you think doing your taxes is a pain, you would not believe the paperwork involved in a new drug application (NDA). For example, when Amylin Pharmaceuticals applied to the FDA for approval of Symlin, they delivered the paperwork in a large delivery truck. The FDA normally has 6 months to one year to review and reply with an answer. There may be a special hearing open to the public to discuss the application with proponents and critics. It is also not uncommon to get an outright rejection or an "approvable" letter, which then requires more studies to satisfy efficacy or safety concerns.
The work is not over once the FDA officially approves the drug. The company with the drug must now market the medication to the prescribing care givers, which involves sponsoring conferences, medical meetings, local lecture series, as well as advertising and publishing data in medical journals. Direct to consumer announcements and advertisements also take place to let patients know about the new medication. Don't forget that the drug manufacturer must have a plant that has received the FDA stamp of approval and has the capability to make enough medication to keep up with the projected demand. Many of these activities listed above have to be started well ahead of the FDA meeting where the approval or rejection is made. Millions and millions of dollars are spent on drugs that in the end do not make it to market. The money spent on these failed medications is all part of R&D, all part of the cost of developing those few medications that ARE successful, approved by the FDA, and land in the pharmacy. So, a lot of money is needed to find one safe, effective drug. This is the main reason why drug and device companies must make a profit on their successes--to put money in the bank for newer innovations. If every drug quickly went generic, then there would not be any new advances!
The last important issue is about the risk versus benefit ratio. There is no drug that is totally free of side effects and diabetes is a pretty serious condition. The risk to benefit ratio should be tolerated at a higher level than with a condition that is only a cosmetic problem. Diabetes and the complications of diabetes represent a complex group of medical conditions that will require many innovative therapies to prevent and aggressively treat these health problems. It is important to understand the complexities of drug development and to have an appreciation of what it takes for a pharmaceutical company to bring an advance to the pharmacy shelves. Taking Control of Your Diabetes acknowledges the companies that are working so hard to bring these advances to all of us living with diabetes.
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