Ever wonder how paracetamol ended up on the shelves of every chemist, super market or off license. It’s so readily available and in abundance no one would think it cost years of research and investment to have it flood the market today.
The reality is it takes a minimum of 10 years from identifying a new chemical entity that could have a therapeutic potential to developing it into a licensed marketable drug. It is no surprise then that this process can cost millions of pounds/ dollars. Admittedly in the 1960’s it probably took under 5 years to reach this same end goal. But with several incidences of flaws in the safety and efficacy of drugs it was only right that more stringent laws and regulations be put in place for the protection of mankind. After all, no one wants to see a repeat of the thalidomide disaster. (Read about the thalidomide disaster here: http://www.thalidomideuk.com/smithellsnewman.htm).
The downfall of this however is the increasing cost and lengthy time invested in getting a drug onto the market. As such the drug development process has now become more of an economic concern as supposed to medicinal satisfaction. Many small start-ups and medium sized companies have been put out of business as they cannot afford the resources to compete with the bigger pharmas. Others have had to merge to increase capital and decrease cost of operation. But why should an industry which focuses on health care be turned into a competitive market place?
Securing a patent has become the life blood of any pharmaceutical company. The company income and job security is guaranteed for about 20 years by which time they are sure to have made a return on investment and exclusivity can be lost. Don’t be surprised then by the very hush hush nature of many researchers. Usually once a lead compound is identified the patent is filed even before work on formulations begins. Out of every 10,000 compounds identified only 1 makes it to the market place. You simply have to get in first before someone else does or you lose years of investment.
It is for this reason that the initial cost of new drugs on the market is almost absurd. How else would you play it if you run a pharmaceutical company focussed on developing new drugs? It’s a business and not a charity. Yes there are patients who could benefit from affordable drugs and it is for their sake that these products are made in the first place but the cost of medicines is an issue for government not industry and it needs to be addressed.
Cancer patients have to fight for the right to be prescribed what seems to be overly priced medication and HIV sufferers are dying of AIDS due to unaffordability of anti-viral medication. The national institute for health and clinical excellence (NICE) ruled that the cancer drug Avastin used so effectively in other developed countries for the treatment of bowel cancer be banned simply because of high cost. Ok so Avastin costs £20,800 for a ten-month course and is taken intravenously but surely this cannot be right because people’s lives are at stake. However, if the pharmaceutical industry started putting emotions into pricing, they will be out of business before the close of day.
Truth is with changing times comes new ailments of concern and the need for new drugs will forever be in demand. These past few years have seen incidences of the SARS virus outbreak in Asia and swine flu in the west. Malaria continues to be a problem due to mutations as is the hospital infection MRSA and clostridium difficile bug. Drug development has to continue however long it takes from the bench to the shelf. On the contrary however a recent report by Deloitte raised concerns over the 25% increase in cost of developing a new drug and the drop in the number of drugs at the last developmental stages from 23 to 18. http://www.guardian.co.uk/business/2011/nov/21/pharmaceuticals-drug-research-costs-rise?CMP=twt_fd
Drug development should be a matter of international concern and governments have to come together to address the challenges facing the pharmaceutical industry before the world is wiped clean by a deadly pandemic with no cure.