(Aust Prescr 2003;26:51-2)
The Editorial Executive Committee welcomes letters, which should be less than 250 words. Before a decision to publish is made, letters which refer to a published article may be sent to the author for a response. Any letter may be sent to an expert for comment. Letters are usually published together with their responses or comments in the same issue. The Editorial Executive Committee screens out discourteous, inaccurate or libellous statements and sub-edits letters before publication. The Committee's decision on publication is final.
Editor, – According to Professor Ron Penny, there is an unbelievablearray of effective medicines that have reduced the number of HIV/AIDS relateddeaths in Australia from 2790 in 1992 to 97 in 2001.
The World Health Organization (WHO) has categorically stated that access toinnovative medicines and vaccines has been substantially the most importantfactor in achieving the dramatic decline in mortality rates throughout thetwentieth century.1
These statements contrast starkly with the opinion of Dr Moran who hypothesisedin her recent editorial ('Whyare global drug prices so high... and other questions' Aust Prescr 2003;26:26-7)that the interests of the prescription medicines industry lie in 'maximisingprofits and growth, not in identifying and filling health needs'.
There are many industry driven programs that treat disease and alleviate sufferingin resource poor countries. One of the most successful partnerships is theAccelerating Access Initiative program that includes UNAIDS (Joint United NationsProgramme on HIV/AIDS), WHO, the World Bank and pharmaceutical companies. Thiscurrently has 27 000 people on antiretroviral therapy throughout the world.2
Dr Moran suggested that the medicines industry targets 'money-spinner drugsand diseases'. This ignores the critical fact that in Australia these diseasesare precisely the diseases that are the focus of the seven National HealthPriorities (asthma, cancer, cardiovascularhealth, diabetes, injuryprevention, mentalhealth and arthritis)established not by the medicines industry but by Australian Health Ministers.
Innovative cures to treat disease only come from the research-based medicinesindustry because governments and even venture capitalists are not preparedto invest in such a high-risk venture. Latest research estimates that it costsabout $1.1 billion3 tobring a new medicine from discovery to patient - along a 12-15 yearjourney.
This vitally important commitment of the medicines industry is ignored byDr Moran.
Kieran Schneemann
Chief Executive
Medicines Australia
Canberra
References
1. The World Health Report 1999. Geneva: WorldHealth Organization; 1999. p. xxi.
2. Accelerating Access Initiative Progress Report June2002. Geneva: World Health Organization; 2002.
3. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation:new estimates of drug development costs. J Health Econ 2003;22:151-85.
Dr M. Moran, author of the article, comments:
I absolutely agree that the pharmaceutical industry develops useful, new drugs.My point is that they only do so when these new drugs are also likely to deliversubstantial profits, thereby effectively restricting new drug development tocommon diseases of Western consumers.
I am not criticising industry for seeking profitable research investmentsnor suggesting that they stop doing so - this is unrealistic. What I amsaying is that profit-seeking firms should not be in charge of setting globaldrug research agendas, since the vast bulk of the world lies outside theirsphere of economic interest. An alternative model is needed: for instance,an international research and development convention to define research needsand establish mechanisms to fund these.
I disagree that 'innovative cures only come from the research-based medicinesindustry because governments are not prepared to invest in such a high riskventure'. This is not true. Half of the US$70 billion invested in drug researcheach year comes from the public sector, chiefly as funding for basic research,which is the highest risk part of the drugdevelopment pipeline.1 TenAIDS drugs were fully developed or supported by publicly funded research2,and the US Government supported the clinical research for 34 of the 37 newcancer drugs marketed in the USA since 1955.3
The time for pointing the finger or seeking public relations wins is over.We must accept that our current system is not delivering the drugs the worldneeds and start working together to solve this problem.
References
1. The 10/90 Report on Health Research 2001-2002. GlobalForum for Health Research; Chap. 6, p.107.
http://www.globalforumhealth.org (goto Publications)
2. Consumer Project on Technology. Additional notes ongovernment role in the development of HIV/AIDS drugs. February 23, 2000.
http://www.cptech.org/ip/health/aids/gov-role.html
3. Nader R, Love J. Federally funded pharmaceutical inventions.Testimony before the Special Committee on the Aging, of the United States Senate.February 24, 1993.
http://www.cptech.org/pharm/pryor.html
Editor, – Your fascinating article outlines the decision by one pharmaceuticalcompany to employ unethical strategies to promote off-label uses for gabapentin(Aust Prescr2003;26:18-9), adecision which could be described as corporate risk. However, the prescriberand the patient also share the risks associated with off-label prescribing.While the final paragraph highlights an 'imperative to carefully weigh thepotential benefits and harms' of off-label prescribing, I believe the articlestopped prematurely in developing this notion of who bears the risks.
Off-label prescribing includes using the drug for an unapproved indication,or at an unapproved dose or by an unapproved route, or disregarding the contraindicationsor precautions of the product information. In the gabapentin example, a beliefby prescribers that off-label use was supported by clinical evidence was probablyunfounded. The decision as to whether this use was appropriate will come downto standards of reasonable care. The pharmaceutical company will consider thatits drug has been used in an unauthorised manner and so cannot officially sanctionsuch prescribing.
It has been noted that 'prescribing outside the licence [approved productinformation] alters, and probably increases, the doctor's professional responsibility'.1 Whenconsidering prescribing a drug, it is important to be aware of what is on thelabel to minimise the chances of being left 'hung out to dry'.
Craig Patterson
Pharmacist
National Prescribing Service
Sydney
Reference
1. Prescribing unlicensed drugs or using drugsfor unlicensed indications. Drug Ther Bull 1992;30:97-9.
Editor, – Further to the articles in Australian Prescriber on prescribingof gabapentin (Aust Prescr 2003;26:18-9),in addition to the issues discussed, there are legal issues for the prescriberand the manufacturer/sponsor of the product to consider.
My first observation is that prescribers who use gabapentin for a conditionwhich is outside the marketing approval in Australia could be subjected toa compensation claim should a patient suffer a serious adverse event due tothe drug. If such an event occurred it could also involve the promoter of thedrug if off-label promotion was involved.
The second observation concerns prescribing gabapentin as a pharmaceuticalbenefit. The National Health Act provides penalties for prescribing 'restricted'and 'authority required' drugs for other than the allowable conditions determinedfor that drug. In instances of off-label prescribing, the prescriber has breachedthe legislation. The articles allude to off-label promotion of gabapentin overseas.If this occurred in Australia it follows that the manufacturer promoting thedrug for an off-label condition may also be party to an offence under the NationalHealth Act.
Brian Foster
Pharmacist
Melbourne
(Until 1996 I was Manager of the Pharmaceutical Benefits Branch of the HealthInsurance Commission in Victoria. I joined the Pharmaceutical Branch of theCommonwealth Department of Health in 1969 and retired from the Health InsuranceCommission in 1996.)
Editor, – In the article 'Treatmentof ocular toxoplasmosis' (Aust Prescr 2002;25:88-90) sulfadiazineis described as a sulfur analogue. Itis, however, a sulfa analogue as sulfuris the element and sulfa, or sulfonamide, is the class of antimicrobial havingthe chemical group -SO2NHR in its structure.
Lisa Blair
Pharmacist
Cairns
