Aspirin is a synthetic compound that was made from salicylic acid which in turn was extracted from willow. Willow has been used for milleniums but was restricted by its irritant properties giving side effect. Eventually salicylic acid was found to be the active compound. The addition of acetyl group to salicylic acid occurred just before the 1900’s forming acetyl salicylic acid and was patented by the drug company Bayer under the name of Aspirin. This patent lasts 20 years and then anyone is legally free to copy to produce the exact replica of the medicine. It is currently sold at less than a pound (Sterling Currency) for a months supply of treatment i.e. it is extremely cheap medicine.
Some of the critics of modern medicine continue to claim that medical research is controlled and monopolised by the drug industry and therefore are able to manipulate the prescribing habits of doctors in general. That drug research is restricted to that which can be patented as that is where the financial gain is. Using the example of aspirin we will dispell these false claims.
Drug Industry & Patents
Patent is like a ‘copy-right’ that the person or company who discovers a new medicine have exclusive rights to manufacturer and sell that treatment for a period of 20 years before others can legally copy the exact same medicine. Many potential drugs are unable to get a license to be used upon the general public by way of prescription. To achieve this much needs to be done to prove safety and to prove effectiveness and with this comes a large associated financial cost and thus the patent is the means to compensate for those losses and to allow room for profit. Normally from the discovery of a new drug to it receiving a license to be used as a medicine takes about 8-12 years on average due to all the number of safety studies and requirements needed. Many discovered potential drugs will not receive a license as with later studies some safety issues are discovered with it and with it is a financial loss to those that were researching it. Those that do achieve a license will have about 8-12 years of the patent left to recuperate losses and then make some profit. Pharmaceutical companies are not charities they are business entities with shareholders and they are competing with several other pharmaceutical companies and against several research universities to try to bring the next break through in treatment and in the process advancing medicine but for it to continue there needs to be a means to make a profit for the drug. Otherwise research in to new and existing medicines would cease.
The drug industry being allowed to make profit is no different to many other industries. Just like we see authors writing best sellers. In years gone by, we have witnessed one or two companies blatantly failing to disclose research data and they have been exposed for this. Likewise they have tried to look at effectiveness of soft endpoints and have been forced by the medical establishment to look for hard endpoints (see later). They have statistically manipulated data yet they have been exposed and continue to be scrutinised as a result. They may at times bring out similar products to old and this is all known (usually as an isomer). However along with this we still are getting new treatments, for example in diabetes alone over the past 7 years or so there have been four classes of new treatments.
We should have more concern for over the counter medicines which do not need licences to the same extent of prescription medicines and make outrageous unsupported claims and mega billions particularly in the supplement industry. In fact it is the very quacks and others that reason with questionable proof that launch accusations against the drug industry yet make billions through the supplement industry. They antics remind of the English phrase;
“the pot calling the kettle black”
where each accuses the other yet both have major deficiencies.
Clinical trial funding
The majority of published trials are community funded and not by the pharmaceutical industry and this will be demonstrated by the example of Aspirin later. The pharmaceutical industry does not always play fair as discussed above and thus when community funded trials are inconsistent in their findings to that of the former it raises eyebrows and questions from the medical experts. In particular it is well known that side effects are less reported in a few industry funded trials. They achieve this during the run-in period prior to the trial starting and partcipants are still being recruited. They expose some study participants to the drug prior to the trial starting and excluding them from the trial if they develop side effects. Here the community funded trials are particularly useful in assessing the rate of side effects. There are several other bad practices but the main point is that the medical experts are aware of such attempted trickery and how to identify and account for it. The benefit of allowing industry funded trials is that much larger studies can be done which can pick up rare effects that may only occur in specific types of people or illnesses. Like wise larger studies help to better determine the hard endpoint benefits and prove they did not occur just by chance.
Soft & Hard Endpoints
It is important to stress that just because a medicine (or a food substance) possesses a certain property does not necessitate that it will give overall benefit. To clarify, a medication may reduce inflammation by 90% which can be measured (these are called “soft endpoints”) but what we really want to know is that illness (such as heart attacks) being reduced and more importantly death that results from illness (we call these “hard endpoints”). This distinction is important because a chemical may have a property that reduces one factor for heart attacks but it may have another property which worsens a different risk factor such as making the blood more stickier and likely to clot leading to an overall increase in heart attacks (which was seen with a drug called Vioxx, Rofecoxib – and so lost its license – this was a case where data was deliberately omitted by the people within the pharmaceutical company).
This hard endpoint criteria is now the gold standard for medical trials however the population of a study needs to be extremely high usually close to 50k plus people to help to demonstrate such a benefit above placebo. No other health disciplines (e.g homeopathy, naturopathy, etc) are able to demonstrate such observed effects on hard endpoints. It is the medical profession that has pushed the drug industry into adopting hard endpoints in their clinical trials otherwise those trials are not considered as sufficient medical standard if soft endpoints are brought in the presence of existing hard endpoints. The use of soft endpoints has been restricted to preliminary trials due to its recognised problems however it is still a common practice among dubious and flimsy based treatments that are often advocated by ‘quacks’; those who pretend to have expertise.
Simple or complex medicines
Another point that some of the critics who claim to lean toward natural remedies claim is that modern medicines are complex and not simple. This is complete opposite to the reality when you find some thing in the wilderness such as a plant or herb then it is made up of many substances modern medicine attempts to isolate the active ingredients from that naturally occurring substance just like salicylic acid was isolated from willow. The majority of modern medicines are a single active ingredient with the other ingredients being present in small amounts to allow that active ingredient to maintain a long self life, give a pleasant taste, or change the form to solution or tablet, etc.
Often those that lean towards so-called natural remedies feel that the synthetic nature opposes the natural disposition of man. A response to this is “when is a thing no long natural?” it could be argued when food is cooked it is no longer natural as several chemical process are undertaken in the original substance and the chemicals now changes form. The metal ‘iron’ many would regard as naturally occurring but it is not rather ‘iron-ore’ is naturally occurring and there is a chemical process to extract iron from iron-ore. Likewise fertilisation of plants occurs by bees and other insects while in they search for nectar. Manual cross fertilisation of plants by man can be classed as now no longer natural. Yet it was something that the Prophet (sallahu alayhi wasalim) thought that it may be better to avoid but it turned out that the harvest the following year was less as a result to which he responded that the worldly affairs are known better by the people. Therefore it is not the so-called ‘natural’ nature that is looked at rather one looks toward the desired result whether its safety and its effectiveness can be proved through observation or experiance in achieving the desired goal. In our discussion of willow and aspirin then aspirin has been able to achieve less side effects. Even those that practice herbalism will often try to make a particular herbal medicine more tolerable or reduce a side effect by adding a second herb. This is no different to adding an acetyl group to salicylic acid.
Aspirin – most investigated modern medicine
Getting back to aspirin, despite its age of over a century it remains the most researched drug with an estimated 700 to 1000 trial every year and at least a dozen large-scale trials undertaken since its patent expired which demonstrates the plain error of the critics and quacks that claim old treatments are not investigated as they are not profitable. Pubmed database alone returns 57,520 citations for aspirin and there are other databases of medical research. The point is that these have been done after the patent has expired and more indications for its usage is being discovered time and time again.
Presented below is very interesting read on the history of Aspirin on a timeline with a list of many trials after patent being expired. We are continuing to find new benefits in aspirin and the most recent being its protection in colon cancer.