Bringing drugs to marketplace no easy task

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Delta Waves conducts 30 different tests on patients to see which of the 80 different sleeping disorders they suffer from.

Every time a person pops a pill or takes a puff of an inhaler, he or she likely isn’t thinking about how many people and how much money went into researching that medicine.

There are five steps a drug must go through before it is available to the public. On average, it takes about eight-and-a-half years to study and test a new drug, according the Food and Drug Administration. It also costs drug companies millions of dollars.

For example, antibiotic development costs $400 million to $800 million, according to a study in the journal Clinical Infectious Diseases.

Pre-clinical research

Developing a drug is complicated, time-consuming and costly – and the end result is never guaranteed. Literally hundreds and sometimes thousands of chemical compounds must be made and tested to find one that can achieve a desirable result.

In a series of test tube experiments, called assays, compounds are added to enzymes, cell cultures or cellular substances grown in a laboratory. This process could require hundreds of tests – some of which might fail, but each test will indicate ways of changing the compound’s chemical structure to improve its performance.

Additionally, research is done on human genes and the immune system to learn more about diseases and how certain drugs might react.

Denver-based National Jewish Medical and Research Center performs basic and clinical research about patients with respiratory, immune and allergic disorders. It has gained national attention for its treatment of Andrew Speaker, an Atlanta man who recently became infected with an aggressive, drug-resistant strand of tuberculosis.

Testing

Once a drug compound is discovered, the FDA requires the developer to show that the drug is reasonably safe for use in initial, small-scale clinical studies. Unless there is information from previous clinical testing, a company must conduct pre-clinical studies to show the drug is safe for humans.

Pre-clinical drug development is done through laboratory animal testing, usually on at least two species.

There is laboratory at Colorado State University in Fort Collins that does research testing for anti-tuberculosis vaccines. Laboratory staff use mice and guinea pigs to test vaccines. The goal of the test is to find a cure for drug-resistant strands of tuberculosis, which resulted in the recent death of a 19-year-old woman in Colorado Springs.

Phase One

During Phase One the drug is introduced into humans. These studies are usually conducted in healthy volunteer subjects. Twenty-eight people are usually studied during Phase One.

Once the drug gets to human clinical trial phases, written disclosures become important because patients need to understand the potential risks associated with testing a drug. The FDA’s Center for Drug Evaluation and Research can stop a trial at any time if the drug company or research clinic does not fully disclose the risks or if the study becomes unsafe for participants.

Phase Two

During Phase Two, the drug is tested on patients with the particular disease to determine its effectiveness. This testing phase also helps determine short-term side effects. Usually several hundred people are needed to test the drug in Phase Two.

Clinical research facilities solicit patients through print and broadcast advertisements. They also receive referrals from doctors.

The clinics usually conduct interviews with prospective patients to determine if they meet the guidelines established by the drug companies.

Colorado Springs-Delta Waves is a research clinic which specializes in the treatment of people with sleeping disorders. In addition to interviews, the clinic studies people while they sleep.

There are 80 different sleeping disorders that can create health problems, including high blood pressure, heart stress and obesity, said co-owner Dale Moseley. Patients undergo more than 30 tests while they sleep. Staff members test everything from eye movement to breathing pattern to heart rate.

It is important for the type of sleeping disorder to be determined before medication is given because a misdiagnosis can be fatal. For example, if the source of a person’s insomnia is a blocked airway but he is given a sleep medication, the medication could prevent him from waking himself up, even if he is oxygen deprived.

Phase Three

Most of the research facilities in Colorado Springs test medication during Phase Three of the FDA’s drug approval process. Phase Three studies are intended to gather more information about effectiveness and safety of a drug to determine if the benefit-risk relationship is sound.

The William Storms Allergy Clinic provides diagnosis and treatment of nasal allergies, hay fever, asthma, chronic cough, bee allergies, food allergies and sinusitis.

During its studies, most of which are Phase Three, the clinic staff scratches a patient’s arm and places a liquid-antigen that has tree, grass or flower pollen or dander from various animals into the cuts.

The clinic, which conducts about five studies at any one time, has been part of the process that has made asthma medicines such as Advar, Flovent, Serevent and Pulmicort available. It also played a part in bringing Zertec, Allegra, Clariton and Singulair allergy medicines to the market.

Ongoing research

Once the medicine hits the shelves, research may continue.

Ongoing research helps the drug companies get more detailed information about how the medicine works with specific demographics or racial groups. Some animal testing continues after human tests begin to learn whether long-term use of a drug may cause cancer or birth defects.

Sometimes new drugs can become available to desperately ill patients before the drug has finished being tested. FDA will permit an investigational drug to be used if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population.

These patients, however, are not eligible to be included in the definitive clinical trials.

Sarah.Colwell@csbj.com