It was quite a year for organic chemistry, 1898, as the acetylation of salicylic acid and morphine produced the respective drugs, aspirin and heroin. These went on to have a huge impact on the next hundred years, with aspirin becoming the most popular legal drug in history, and heroin the most popular illegal drug in history.

In 1897, the Bayer chemist Felix Hoffman discovered the aforementioned process for modifying salicylic acid, but his product, aspirin, was initially ignored, and actually considered to be toxic to the heart. However, the powerful men at Bayer had another drug in mind as the future blockbuster, Heroin. Test subjects at the Bayer company loved Heroin, and it actually derived its name from the description given it by those individuals, as it made them feel "heroic;" likewise, the scientists considered it "heroic" because it was four times stronger than morphine, and without the addictive potential, they added.

It was presented in 1898 to a group of German physicians as a drug ten times more effective as a cough medicine compared to codeine, but with only a fraction of its toxic effects. Interestingly, at that time in the late 19th century, there was a desperate need for cough suppressants, in light of the rampant tuberculosis and pneumonia at the time. Heroin, with its respiratory-depressant and sedating effects, gave a restorative night's sleep to those with coughs due to tuberculosis--or the common cold.

By 1899, the Bayer corporation was producing approximately one ton of heroin annually, and exporting it to 23 countries. But the United States market was particularly enthusiastic, as there were already a significant number of morphine addicts in residence, living at a time when the regulatory environment was fairly laissez-faire. One could purchase heroin lozenges, tablets, and elixirs.

However, by 1902 researchers in the United States and Europe were reporting cases of addiction ("heroinism"). By 1913, Bayer stopped making heroin. At that time, many East Coast cities were homes to an increasing population of recreational heroin users. In 1914, one had to have a prescription to obtain heroin. And in 1924 the United States banned the manufacture and use of heroin.

Unfortunately, little progress in pharmacologic pain relief has occurred since 1898, when pain relief in the form of the anti-inflammatory aspirin and the opiate heroin was introduced to the public. The world still finds aspirin a helpful pain reliever; but it is more popular now as being beneficial to the heart. Heroin also has moved on. In the early 1900s, the average heroin addict was a middle class woman in her forties; today, the average heroin addict is a male in his late teens. Mother's little helper went hip. But that does not help those with chronic pain.

There have been very few novel therapies approved by the United States Food and Drug Administration since 2005, and thus the FDA is funding research to determine the best way to increase the delivery of new therapies to the nearly 80 million Americans with acute and chronic pain. Of course, all of this must be approached in the context of an epidemic of prescription pain killer abuse. It is so important that research answer the questions that need answering in an efficient and confounder-free manner.

But this is easier said then done, as pain clinical trials are often unsuccessful.

It has been noted that patients in the placebo group of such studies often have marked and unexpected improvements. Researchers are left with study results that show little meaningful differences between the pain-relieving effects of the study drug and the placebo, despite the fact that initial pilot studies often show great effect. One reason for such a finding could be that the patient appreciates the "support" shown him for simply showing up for scheduled research appointments with a kindly research nurse. Research has indeed shown that in clinical trials involving psychiatric therapies, the greater the number of visits, the greater the improvement in the well-being of the placebo group.

We humans like having attention paid to us.

So, the FDA is seeking ways to improve clinical trials of pain relieving drugs by considering, for example, reducing the number of follow-up visits during the study. In the meantime, a dedicated team will be carefully perusing FDA data bases from hundreds of pain clinical trials, in addition to studies already published, in the hope that they can develop standards that pain researchers can follow to maximize their abilities to accurately answer the hypotheses they propose.

This FDA initiative is aptly named ACTION (Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks).

Those with chronic pain hope this ACTION leads to more activity in the pharmaceutical world; because we need another 1898, without the heroics.

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