In September, Merck & Co, one of the world’s largest drug makers withdrew its painkiller Vioxx from the market based on evidence that it heightened the risk of heart failure among patients. Some have argued that this episode highlights some deep- rooted flaws in the pharmaceutical industry and have called for even more rigid government controls over medicines. They are wrong; the discovery of the side- effects and voluntary withdrawal of Vioxx demonstrate the strength of the private, competitive drugs industry. More regulation is the last thing patients need.
Before Merck withdrew Vioxx, it had sold over 90 million prescriptions of the drug worldwide. Vioxx is one of a class of drugs known as Cox II inhibitors that block pathways that cause pain, but do not block those that produce the chemicals that protect the stomach’s lining. Unlike other painkillers, Cox II inhibitors don’t cause painful stomach ulcers and are therefore popular.
Of course Vioxx was not the only Cox II inhibitor, there are others in this class, such as Pfizer’s drug Celebrex. Industry critics have long campaigned against numerous drugs in the same class, so-called ‘me too’ drugs, because they don’t add anything new. However ‘me too’ drugs do create a more competitive environment and give greater choice to prescribing doctors. Thank goodness there are alternative Cox II inhibitors. If Vioxx were the only one, many patients would now be compelled to use older painkillers that have more side-effects.
However, the process by which Merck discovered the heart problem side-effects of Vioxx also highlights the benefits of competition in the drugs industry. Cox II inhibitors are known to prevent certain cancers, particularly colon cancer. Merck was attempting to discover if Vioxx could be used as a more general anti-cancer drug when it found the heightened risk of heart failure. The fact that Merck operates in a competitive environment forced it to continuously try to improve its drugs and find new uses for them. This time it didn’t work out for Merck, but the ongoing and dynamic process of scientific discovery, driven by competition, is what produces new drugs and ultimately improves the lives of patients.
Many drugs do not reveal all their medical applications and benefits immediately. For example, new uses for aspirin are continuously being found. The first anti-retroviral drugs for AIDS patients came out of anti-cancer drugs. As long as companies are engaged in the process of trying to boost their profits, they will constantly try to find new uses for their drugs. Far from being a problem, ‘me too’ drugs are of benefit to patients and can advance medical science.
In the wake of Vioxx, US drug regulator, the Food and Drug Administration has been investigated by Congress. Of course no one seems to consider that the FDA should bear some financial liability for approving Vioxx. The answer according to some, including Senator Edward Kennedy is to add yet another layer of bureaucracy to drug approval. Yet this assumes that a risk-free world is possible and that the lengthy and enormously expensive process to which new drugs have to be subjected comes at no cost to patients.
Drug regulators the world over want to ensure that medicines do what they are supposed to do and do not expose patients to undue harm. That sounds like a good idea and should give some confidence to consumers. Yet these regulations are not free. It can take years and up to US$800million to develop a new drug from the initial discovery of a promising molecule. Much of the time and expense is incurred because of the onerous regulations that delay the launch of a new product. Every day that a drug spends on the desk of an FDA investigator is a day of lost revenue and lost profit. This means that drug companies have less money to utilise in discovering new medicines or improving their existing ones.
Aside from the purely financial cost of regulations, there is a colossal human cost. While any given drug struggles through the bureaucratic tangle that is the FDA (or its equivalent in South Africa, the Medicines Control Council) patients that could benefit from that drug go without, and sometimes die. The bureaucrats that are supposed to be protecting us may also be harming us by not allowing us to make informed decisions, with our doctors, about what drug to use according to our own individual risk profiles.
The voluntary withdrawal of Vioxx may have been a financial and public relations nightmare for Merck, but it demonstrates the strength of the whole industry. The fact that Merck, and other private companies, have reputations to defend and long term shareholder interests to think of forces them to act responsibly. The medicine regulators on the other hand are not answerable to these constituencies. On the contrary, the thousands of patients that could benefit from drugs that are awaiting approval have no idea why they are denied medicines and choices or who is holding up their medicine. A better model may be to privatise drug testing and encourage competition between different certification agencies that have both their long term reputations and shareholders to think of. This could only be an improvement on the intransigent and unaccountable state regulators.
Vioxx shows us how valuable the competitive drugs industry really is and should demonstrate to government the need to encourage ever more competition, discovery and dynamism in the sector. Unfortunately the South African government sees the pharmaceutical industry as the enemy of patients rather than the solution to healthcare problems and passes ever more restrictive and onerous laws. Patients the world over would benefit from a good dose of competition and deregulation among drug producers and regulators. Detractors may point out that that would just boost drug company profits. They may be right, but it could also draw more competitors into the production of pharmaceuticals, make companies more innovative, allow them to respond more rapidly to the needs of patients, and reduce prices to consumers.
Author: Richard Tren is a director of the South Africa based health advocacy group, Africa Fighting Malaria. This article may be republished without prior consent but with acknowledgement to the author. The views expressed in the article are the author’s and are not necessarily shared by the members of the Free Market Foundation.
FMF Feature Article\14 December 2004