Giving birth to one medicine for millions of lives

People may not realize this, but each medicine – whether it is in tablet, capsule, gel, or syrup form – that goes inside the body came from a molecule that is one in seven million. In fact, it was born out of several millions of compounds that have gone through at least a decade of labor from different parts of the globe. Millions of lives around the world are depending on that one medicine.

Tremendous research and development (R&D) procedures see to it that each type of medicine that comes out in the market and into the hands of the user is safe, efficient, and of high quality. To do this, scientists and medical experts go through 10 to 15 years of clinical trials and laboratory tests before one substance can be declared and approved as medicine. Thousands of people from various parts of the globe are involved in ensuring the success of these trials.

The production of one medicine that is fit for market distribution begins with the discovery of millions of compounds. Out of these millions, thousands will fail strict standards of efficacy, quality, and safety. Thousands more will fail in ensuing years.

In Pfizer’s case, about 12 candidate medicines are left for further tests. The entire process may even be stopped if even one out of the three standards is not met. Billions of dollars spent on these series and years of tests go down the drain.

On its own, Pfizer Global Research and Development (PGRD) spent $7.4 billion on privately funded biomedical research in 2005. That’s $20 million a day, making it the world’s biggest R&D allotment in the pharmaceutical industry today.

"Pharmaceutical companies cannot afford to cut R&D expenses. Lives are at stake in the development of healthcare products so cost should be the least concern. The entire process of developing safe, efficacious, and quality medicines demands thorough and long-term study and this requires considerable resources," says Dr. Angelo Arreza, a pulmonologist and Pfizer’s cluster physician for anti-infectives.

The main reason why R&D takes years to complete is the paramount consideration for safety. This includes the safety of research participants, as well as the culture, laws, and regulations of the countries where each study is conducted.

According to Dr. James Wee, an internal medicine specialist and Pfizer’s cluster physician for metabolism and urology, safety is prioritized over efficacy in the R&D process. In clinical trials, for example, healthy individuals are tested with candidate medicines, after which they are tested for adverse reactions to the medicine. This process can take several years.

"There is no shortcut for conducting safe R&D processes to come up with quality medicines. That’s how pharmaceutical companies come up with reasonable assessment of a medicine’s safety and efficacy. Since regulatory authorities require a battery of tests, the public is ensured that any product that reaches the market is not only efficacious but will likewise not cause the patient additional harm," Wee explains.

Any product that has gone through extensive and intensive study has the advantage of credibility. In the case of well-researched medicines, this assures patients that the medicine they take is the exact same medical composition used in the successful trials. They can have the peace of mind knowing that the medicine they are taking has proven its therapeutic benefits involving real patients in real settings, with its efficacy being published and confirmed by the medical community over the years.

Herein lies the big difference between innovative medicines and their generic forms. The generics depend highly on the patented drug’s heavy R&D, thus not going through the same laborious process and not having to spend huge amounts of time and money. Once the patent of such an innovator product elapses, all that the generic form has to do is copy the composition of the well-researched medicines.

Studies do not stop once the medicines have reached the consumer level. Pfizer, in particular, invests in several post-marketing studies conducted by independent members of the scientific community to check on the products’ performance.

The costs involved in facilitating R&D continue to rise as environments continue to change through the years. Tools and procedures become more sophisticated. However, it doesn’t change the fact that pharmaceutical companies will continue to use R&D as its core operation in coming up with new and better medicines for the future.

At present, Pfizer has around 200 products in the pipeline and three million more potential medical compounds. About a decade or so from now, these compounds may or may not find their way into the market as potent medicines. But the public can be assured that whatever comes out of the pipeline has been meticulously researched for many, many years.

"The industry has to keep looking for new ways to develop new medicines that will address unmet medical needs and save lives," Wee says.