September 19, 2016

Drug approval bureaucracy’s a killer

Drug approval bureaucracy’s a killer

The UK’s drug approval process is overly bureaucratic, stifles innovation and hinders patient access to life saving medicine. Reform is needed; Australia is leading the way. 

The announcement last month that we may have discovered the first effective Alzheimer’s treatment to act on the disease process itself, rather than just the symptoms, is hugely positive, but a burdensome and costly regulatory system is unnecessarily prolonging the fight against this devastating disease.

Pharmaceutical medicine has had a profound impact on our modern human history. More progress has been made in advancing our understanding of human medicine over the past century than all the previous centuries combined. Smallpox, polio and leprosy – once intractable human diseases, indiscriminate of wealth, race or social class, are now being consigned to the annals of history. The discovery of antibiotics has rendered many deadly bacterial infections virtually innocuous. The 1950s saw the introduction of Chlorpromazine – the world’s first antipsychotic medication – paving the way for the transformation and closure of the macabre Victorian asylums.

But as one war is won another begins. The startling rate of medical advancement has brought with it new challenges. As life expectancy increases, so too has the prevalence of other diseases such as cancer and neurodegenerative disorders, like dementia.

The explosion in new and effective treatments for once deadly diseases has been checked by a similar growth in red-tape and regulation, inhibiting patients’ access to lifesaving medication.

The onerous process costs time, money and lives. In the US – the world leader in the development of new pharmaceutical drugs – the cost of delivering a drug from ‘bench to bedside’ has increased exponentially since the 1970s. A US study by the Tufts Center for Drug Development found that in 1975 for a new drug to be approved the pharmaceutical industry spent on average the equivalent of £65 million in today’s prices for research and development costs. By 1987, that figure had tripled, to £195 million, and by 2005 costs had soared to £800 million. Cancer Research UK now estimates the figure to be approximately £1.1 billion.

The Tufts study also investigated the driving forces behind these soaring costs. Onerous requirements for supplemental testing, even when a drug has not been shown to pose any health risks, as well as costly delays triggered by unjustified demands for additional data were key factors. It found that from 1999 to 2005 the average length of a clinical trial increased by 70 percent; the average number of routine procedures per trial increased by 65 percent; and the average clinical trial staff work burden increased by 67 percent.

This symptom is not exclusive to America. In the UK, the European Medicines Agency (EMA) – a key arbiter in deciding whether new drugs enter the British market – is responsible for even more pronounced delays.

Even if a drug is approved in one jurisdiction, such as the US, it is often subject to supplementary testing requirements here in the UK & Europe, and vice-versa.

These soaring costs are stifling innovation and delaying the arrival of new life saving drugs. Analysis by the global consulting firm, Deloitte, suggests the result is that drug companies are becoming more cautious and less innovative in their approach. An increasing number of new drug submissions are for ‘me too’ drugs – drugs that are structurally very similar to already known drugs, with only minor differences. In the US, between 2006 and 2011, only ten truly innovative treatments were approved by the FDA out of a total of 35 submissions. The majority of new molecules launched between 2007 and 2011 already had established mechanisms of action.

The rising approval costs are also impacting on patients in other ways. In a bid to recoup the increasing costs incurred, pharmaceutical companies increase their prices, often at levels that preclude the ability for Government regulators, such as NICE – with their antiquated approval processes – to grant marketing licences to public health providers, including the NHS.

Despite international efforts to streamline approval processes, the systems remain cumbersome. In the UK, the Early Access to Medicines Scheme (EAMS) has been established allowing patients with life threatening illnesses to access unapproved medicines. Similar programmes have been established in other jurisdictions. But these are sticking plaster solutions that fail to adequately address the problem. More needs to be done.

It is vital the various jurisdictional regulators collaborate more closely to improve their approval procedures. In the UK, the main organisation tasked with reviewing drug safety, the Medicines & Healthcare products Regulatory Agency (MHRA), should be encouraged to work more closely with the US Food and Drug Administration (USFDA) and the EMA to streamline and standardise testing protocols. If successfully achieved, the economic and healthcare benefits would be immeasurable.

Last week, the Australian government announced the introduction of a novel solution to help facilitate new drug development and delivery. Under the new approval process, any drug that has been listed by a comparable overseas regulator, including the US Food and Drug Administration and the European Medicines Agency, can now be fast-tracked for approval and sale in Australia. This will remove superfluous regulation, lower drug company costs, encourage innovation and afford Australian patients quicker access to new medicines.

Opponents of simplifying existing drug approval processes are understandably haunted by the devastating impact of Thalidomide. Developed, approved and distributed to patients in West Germany during the 1950s at a time when effective drug trialling was in its infancy, the drug soon spread in popularity and was introduced to other jurisdictions (although notably in the US the FDA rejected the drug on the grounds of safety concerns).

Had drug trialling and distribution in 1950s been subject to the same standards as those present in the 1970s, the side effects of the drug would have been identified and authorisation for the treatment of morning sickness rejected.

Today, following further research, and with a fuller understanding of the drug’s side-effect profile, prescribed in the appropriate settings, Thalidomide is an important weapon in the battle against multiple myeloma.

Better regulation does work. In 1987, in the midst of the HIV/AIDS pandemic – and motivated by onerous approval requirements for promising investigational drugs – AIDS Coalition to Unleash Power (ACT UP) was formed. Through a combination of civil disobedience, effective lobbying and peaceful protest, the group successfully saw Congress approve the accelerated approval pathway for HIV medication. The result was the faster introduction of effective anti-retroviral therapies. Today, HIV has been transformed from what was once a death sentence into a chronic condition.

Effective drug trialling is a vital component to ensuring public health, while ensuring public confidence in pharmaceuticals. But too much regulation, although harder to see, can be far more deadly and detrimental to patient lives.

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  • Nockian

    No article ? Maybe it’s spread to comment central ?

    Central banks don’t work any better than any other kind of soviet style producer. They produce too many tractors when we need more ploughs. This is because banking isn’t independent, it isn’t laissez faire capitalism that is being practised, but the soviet style economics of central planning. It is not, per se, the fault of the central banks, anymore than it was the fault of the Russian tractor factories for under/ over producing as a result of state diktat. Unfortunately we have a mixed economy, which is 50% socialistic and has been expanding for several decades-most of us now give over 60% of our earnings to government directly (it’s probably a bit more depending on inflation and inflexible tax bands).

    The answer is to get the state out of commerce, then the central banks will either survive or collapse within a laissez faire banking system, but first we must begin to accept the truth, that we cannot continue to sustain such a gargantuan welfare system and its associated government. If we want to produce more, we need to be taxed less, we must save not spend.

  • ratcatcher11

    If everyone saved and did not spend there would be a massive worldwide slump, so it is obvious there has to be spending. Making things for sale is thus important, services alone cannot sustain an economy. One of the biggest problems is Keynsian economics that are basically tax, print and spend socialist policies. We do not need the government to build a railway we need a private company to build the railway which will compete with air travel fairly, not by taxing air travel to make it it less profitable. Thus the governments air taxes should be scrapped and private companies encouraged to re open rail lines closed by Beeching. This is the development we need not government spending 90 billion of money on an HS2 line built from somewhere to nowhere and never stops to pick up passengers.

  • Debs

    Expansion of economies cannot go on forever no matter what so called monetary policy is. You dont need to be an economics expert to realise it.

    All I know is governments and banks seem to be constantly coming up with schemes to leave we the lowly tax payer with less of our money.Forget about the trumpeted tax cuts ,everything else is going up accordingly except real wages of course. Dont even mention the Green scam or the cheap labour scam.

    Bail ins and cashless society are two more scams I have seen trailed in various media outlets over the past few years. Gradually our hard earned money is being prised away from us to fritter away on who knows what.

    They wonder why Trump got elected.

  • Nockian

    The market will raise rates eventually, regardless of wether the central bank wishes it or not. The problem is that we have all become mesmerised at central bank control, when, in reality, at this stage they have little at all. They cannot raise rates to normal, because, firstly, we don’t know what normal looks like (it could already be normal) and secondly any increases will create an avalanche effect-let’s face it, no one but the wealthiest wants to bring down countries governments through a collapse in public spending leading to actual anarchy on our streets.

    The bogey man of fractional reserve is a myth that has permeated libertarian consciousness, in a free market banks would have to take risk or they would, by any definition, not be free market. Banks are not currently lending to private individuals because capital requirements are already so high-they have become zombified businesses that look like they function, but are like the shops we set up as kids with funny money and plastic fruit. The market is broken as far as banks are concerned, they are no longer part of it.

    Fixing the problem cannot begin by looking at the central bank, nor the main banks. It’s far too late to consider than anything can be done at this stage, we are so far beyond normal that we aren’t looking at a functioning banking system at all. It would be like bleeding the radiators to solve a broken boiler.

    The problem we have is at its heart a simple one. It’s the problem that labour refused to accept when the banks blew up. We have an unsustainable welfare system and an over sized government. We have to tackle our public spending first of all and I see little sign that any current, nor perspective government is prepared to give the public the awful news about the reality.

    Even the great Tory saviours have flunked out of the monetary boiler rooms. The situation is dire, there is no fuel left, we have been ripping up the ships timbers to maintain the illusion of tranquil sailing progress, but eventually the ship will sink for lack of substance. There is no monetary policy that can save us, all we are going to get is an ever growing war on cash, savers and anyone who tries to make a profit. We are going to end up in the late stages of a soviet style melt down whilst spinning mirrors to pretend it isn’t happening.

    We all know what’s going on, we can offer solutions, make sympathetic noises and talk up any temporary progress, but the reality of the situation is now apparent. We have to do what every debtor must eventually conclude; that our spending has unfortunaly exceeded our earning capacity and all those red letters mean some drastic rethinking is required. We are going to reach the end of the road, not by a sudden explosion, but the drift into monetary authoritarianism which will result in ever greater protectionism and falling living standards. We are in great danger of losing the West to the East and ending up as country cousins of a world of declining freedoms and the rise mysticism.

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