An analysis of Canada’s pharmaceutical expenditures found that 80% of the increase in its drug budget is spent on new medicines that offer few new benefits. Major contributors included newer hypertension, gastrointestinal, and cholesterol drugs, including atorvastatin, the fifth statin on the Canadian market.
…………….We need to revive the Norwegian “medical need” clause that limited approval of new drugs to those that offered a therapeutic advantage over existing products.39 This approach led to Norway having seven non-steroidal anti-inflammatory drugs on the market compared with 22 in the Netherlands.40 Norway’s medical need clause was eliminated in 1996 when it harmonized its drug approval process with that in the EU. EU countries are paying billions more than necessary for drugs that provide little health gain because prices are not being set to reward new drugs in proportion to their added clinical value.
……………Data from companies, the United States National Science Foundation, and government reports indicate that companies have been spending only 1.3% of revenues on basic research to discover new molecules, net of taxpayer subsidies.23
…………….More than four fifths of all funds for basic research to discover new drugs and vaccines come from public sources.24 Moreover, despite the industry’s frequent claims that the cost of new drug discovery is now $1.3bn (£834m; €1bn),25 this figure, which comes from the industry supported Tufts Center,26 has been heavily criticised. Half that total comes from estimating how much profit would have been made if the money had been invested in an index fund of pharmaceutical companies that increased in value 11% a year, compounded over 15 years.26 While used by finance committees to estimate whether a new venture is worth investing in, these presumed profits (far greater than the rise in the value of pharmaceutical stocks) should not be counted as research and development costs on which profits are to be made. Half of the remaining $0.65bn is paid by taxpayers through company deductions and credits, bringing the estimate down to one quarter of $1.3bn or $0.33bn.27
Light DW. Basic research funds to discover important new drugs: who contributes how much. In: Burke MA, ed. Monitoring the financial flows for health research 2005: behind the global numbers. Global Forum for Health Research, 2006:27-43.
Pharmaceutical Research and Manufacturers of America. 2011 profile: pharmaceutical industry. PhRMA, 2011.
Light D, Lexchin J, Pharmaceutical research and development:what do we get for all that money? BMJ 2012;344:e4348 doi: 10.1136/bmj.e4348 (Published 7 August 2012), D W Light firstname.lastname@example.org
Prof John Sulston’s lecture on ‘What is science for’ at Oxford’s Sheldonian Theatre, and Prof John Harris made following remarks:
Who owns science? that is an important question, and an emotive one. Since 2000 there is a trend to increase investment from private sector and decrease public funding, but the consequence of driving science into profitable areas, sees all sort of dysfunctionality in West. There are unneeded drugs – you may criticize that, but I say that, and it is absolutely true – which is sold by aggressive and unethical marketing practices. With regard to human health there are consequences.
The trend to make science profitable has consequences – what should drive science is curiosity.
When Genetic Engineering Came Of Age
Today marks the 30th anniversary of an event that kicked off an important new era in drug therapies – the approval by the FDA of human insulin synthesized in genetically engineered bacteria. The saga is remarkable in several ways, not least of which is that although both the drugmakers and regulators were exploring unknown territory, the development of the drug and its regulatory review progressed smoothly and rapidly…………………………………………..Regrettably, the early salubrious regulatory climate has changed. Even with a toolbox of improved technologies and greater knowledge of pharmacogenetics, bringing a new drug to market on average now takes 10-15 years and costs over $1.4 billion. Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by political forces outside the FDA. Approval of a drug or other FDA-regulated product made with a brand new technology now would probably be further delayed by navel-gazing at a series of government-sponsored, “consensus-building” conferences.
The result is that fewer drugs enter the development pipeline and become available for patients who would benefit from them. Over the years government regulation hasn’t aged as gracefully as recombinant DNA technology itself.
Henry Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University‘s Hoover Institution. He was the founding director of the FDA’s Office of Biotechnology. His most recent book is “The Frankenfood Myth.”