| p>It isn't just animal testing that allows a new | | | | Even a history of allergy, drugs of abuse or strong |
| medicine to be sold or prescribed to the public. Many | | | | medication can end the recruitment abruptly. The GP |
| medicines (drugs), never even get through the | | | | doctor is paid to reveal all previous and present |
| system owing to the strict laws surrounding the | | | | medical information since birth. He or she can advise |
| second phase of research, namely, testing in healthy | | | | against the volunteer's participation without giving any |
| HUMAN volunteers. Pharmaceutical companies invest | | | | justification. |
| on average £500 million on every new drug | | | | When the volunteer wishes to join a particular study, |
| developed from conception to getting the 'piggy to | | | | more exclusion criteria sift out the few from the |
| market'. Whilst the public may have been aware of | | | | hundreds on the database. Eligible volunteers are |
| animal and patient trials (studies), few people were | | | | mailed giving out study details without mentioning |
| aware of the Healthy Human Volunteer Studies. That | | | | their remuneration. They must then attend a full |
| is - until one went wrong several years ago. | | | | medical and pass all of the tests. This includes, BMI, |
| The five stages of recruitment for these healthy | | | | BP, urinalysis, blood tests, and ECG and a full physical |
| volunteers are extremely tedious. They are done | | | | examination by a doctor. Any slight deviation from |
| mostly for the safety of each volunteer and to | | | | the study criteria will deselect the volunteer. A small |
| satisfy the MHRA regulations. Volunteers who | | | | percentage payment will be made for their |
| complete a study can receive hundreds or even | | | | participation. After a week, the volunteers come |
| thousands of pounds in remuneration. This fact can | | | | back for a consent visit where they are told all the |
| sometimes entice people to withhold information and | | | | negative reports from the animal testing phase along |
| put their health at risk. The Drug Company is | | | | with any anticipated side effects from the new |
| responsible for making it as safe as possible for | | | | study drug. They sign a consent form declaring they |
| every volunteer who tests a new medicine. | | | | understand the risks but can withdraw at any time. |
| Strict advertising laws prevent the public from being | | | | Some studies last three months. |
| coerced into volunteering. Initial advertising is done to | | | | Finally, before the study begins, a restriction period |
| attract people as 'volunteers' and the subject of | | | | takes place for scientific reasons. This may include: |
| money is prohibited. Once a candidate volunteer | | | | not eating various foods, caffeine, and alcohol or do |
| shows any interest, an array of exclusion criteria | | | | extra exercise for days or weeks. The day before, |
| prevent even the most likely person from getting | | | | they undergo another full medical and are required to |
| through the first visit. A personal meeting is arranged | | | | pass all the tests once again. So in all, the recruitment |
| and initial height, weight and BP checks are | | | | process means that an awful lot of 'piggies stay at |
| performed. As much information is given as possible. | | | | home' and never get anywhere near the market. |
| A full medical history is taken from the volunteer. | | | | |