Adverse Reactions : drug companies

This pill makes you rich

Bryan Hubbard — Fri, 12 Sep 2008 20:20:00 GMT

Let's get down to the real nitty-gritty of what medicine is all about - money. As stock watchers amongst you may know, Big Pharma is being marked down by City (and Wall Street) slickers, who are putting up 'Sell' notes wherever they are seeing a pharmaceutical company.

Why? Haven't drug companies found a cure for cancer yet? Or perhaps they're not getting the rapid recovery rate for their patients?

Not a bit of it. Had that been the criteria for drug companies' share price, they would have been in the bargain basement long since. No, the reason for the panic sell is simply that many drugs are now passing out of the protection of patent, and so can be copied - with very minor modifications - by all and sundry.

In the past few days, both AstraZeneca and GlaxoSmithKline (GSK) have been downgraded because several of their key profit-making drugs are soon to pass out of patent. GSK, in particular, faces a turbulent 2009 as some of its hot-shot drugs suddenly face stiff competition from the 'me-too' boys who will be swamping the market with very similar concoctions.

It's sad that medicine is so judged. As I've often observed, what purports to be a benefactor of mankind is, in fact, purely an instrument of gain for shareholders.

And the sooner everyone wakes up to that reality, the sooner we may finally see a medical model that first serves mankind and its suffering.

Pills and privilege

Bryan Hubbard — Mon, 18 Aug 2008 14:28:00 GMT

Drug companies enjoy a very privileged position among the industrial sectors. They are granted extraordinarily high levels of privacy and protection, non-drug competitors are not allowed to bring alternatives to market, especially in the area of cancer care, their relationship with doctors is protected by the Advertising Standards Authority and by the media, and their executives sit on many boards that control editorial output. If this were not enough, the pharmaceuticals also sponsor the largest network of lobby groups in the world that influence the thinking of governments everywhere.

Drug companies are not subject to the usual market forces, and can pretty much charge what they like for their drugs, especially if the drugs are new and still in patent. As the pay of their senior executives is shaped by the share price, and as the share price is, in part, determined by the profit line, it's not in anybody's interests to put a 'fair' price on a new drug.

As a result, cash-strapped health authorities such as the UK's National Health Service simply cannot afford the latest, innovative drugs. An organisation called NICE (National Institute for Clinical Excellence) has to make the tough decisions about what drugs to allow on the NHS, and what it has to leave off. It's a difficult place to be because it will inevitably make decisions that upset some group of patients, who may see some wonderful new compound as their only hope against an inexorable disease.

NICE's head, Sir Michael Rawlins, has been defending his position this week after calls that his organisation was barbaric for refusing a new kidney cancer drug onto the NHS list. He points out that the drugs could be sold for a tenth of their current price, and still leave a decent profit for the manufacturer.

Interviewed on BBC Radio 4's Today programme, Sir Michael was told by the interviewer that the drug industry is there to make a profit. This is, of course, its primary motive, as it is for any industrial combine, and its chief objective is to produce a good return for the shareholder.

Again, nothing unusual there.

That being the case, could someone explain why a for-profit group - that puts shareholders and profits before the well-being of the sick - is granted so many privileges and protections?

Now it's clear what the primary motivation is, it's time these safeguards were removed, and that the pharmaceutical industry were treated like any other.

Feather brained over avian flu

Bryan Hubbard — Wed, 22 Aug 2007 09:46:00 GMT

Governments are good at wasting our money. After all, that’s their job.

But the enormous amount of money that is being spent on avian flu vaccines for key public workers has to be up there as one of the most wasteful around.

The UK government last week committed a further £155m of public money on a new vaccine that doesn’t yet exist.

Absurd as that may sound, it is in fact a step in the right direction as nobody knows what the profile of the strain is until it begins to be transmitted between humans, if it ever happens at all.

So GlaxoSmithKline, the happy recipients of the government’s beneficence, will be preparing an appropriate vaccine the moment it knows what the human form of the avian ‘bird’ flu virus looks like.

Not that the UK government has been that smart, really. It has already wasted millions of pounds buying in 14.6 million doses of Tamiflu, which even the Centers for Disease Control and Prevention in the States has said is useless.

Although everyone agrees it is useless, the US government has spent $2 billion buying in 20 million doses of Tamiflu, followed by the Canadian government, whose own health spokesman reiterated the concerns about the vaccine.

All of this activity presupposes that the avian flu epidemic will actually happen. In 2005 we were warned that millions of us were about to die from ‘bird’ flu, more properly known as influenza A (H5N1) virus.

Since then, we have barely heard a dickey-bird (pun intended).

Should we execute our drug watchdogs?

Bryan Hubbard — Thu, 31 May 2007 11:46:00 GMT

The Chinese have given us many things over the years. There's wall building, the recipe for chop suey, and those neat jackets without collars. Now they're teaching us how to treat our drug regulators . The Chinese authorities have decided to execute...(read more)

How doctors choose the 'right' drug for you

Bryan Hubbard — Fri, 18 May 2007 12:00:00 GMT

It would be nice to think that he balances and deliberates before making his choice - but there are more dubious pressures at play. All has been revealed by a drug company salesman who has just retired, and perhaps has a pang of conscience. He writes:...(read more)

A missed opportunity

Bryan Hubbard — Fri, 11 May 2007 11:30:00 GMT

America's senators have missed an enormous opportunity to give their citizens genuine protection against a pharmaceutical industry that is all too rarely brought to account. Instead they voted overwhelmingly in favour of moves that draw the industry and the drug regulator, the Food and Drug Administration, even closer together.

The Senate has voted 93 to 1 in favour of a 'drug safety' measure - S.1082 - which deepens the financial ties between the industry and the FDA. Drug companies will be doubling the amount of money they pay to the regulator, thus giving strength to the notion that the drug industry is becoming increasingly self-regulating in the USA.

The new measure fails to exclude foods and nutritional supplements, and so the protection enjoyed by these harmless substances that was enshrined by the DSHEA law has all but been overturned.

Worse, a novel and radical move - known as the Grassley amendment - was defeated by a single vote. This amendment, classified as S.1039, attempted to bring in genuine drug safety protection for consumers.

As it is, an industry that kills 100,000 Americans every year - and that's according to the most conservative figures available - will continue to generate enormous profits with impunity.

It gets nasty for Nice

Bryan Hubbard — Fri, 17 Nov 2006 14:50:00 GMT

For such a haven of faceless bureaucrats, NICE has suddenly become the hate figure of the UK. NICE - or the National Institute for Health and Clinical Excellence - is the gatekeeper of the National Health Service, and it is the ultimate arbiter of the drugs that are prescribed by doctors.

Sometimes drugs are turned down on grounds of cost, sometimes because they just don't work. For the drug company, a rejection is nothing less than a commercial disaster, especially if the drug concerned is a pioneering one that would have cost at least £150m to get approved.

The patient, too, may see the drug as the great hope. It happened with the *** cancer drug Herceptin, and it's happening again with the Alzheimer's drug Aricept. If the drug is the 'answer', then NICE's rejection is nothing less than a callous disregard of human life.

Alzheimer's sufferers and their carers are planning a major protest against NICE's decision with nationwide marches and demonstrations. The same thing happened with Herceptin, and the government finally wilted to public demand.

In the case of Aricept, the protestors are being joined by the manufacturer, Pfizer, which is calling for a judicial review of NICE's rejection. If it goes ahead, it will be the first time that NICE has been challenged in court, and itvmay well not be the last.

But how does the patient know that the drug is the solution to his or her ills? In the case of Aricept, there are a few anecdotal reports that the drug has helped, but a major review that was published in 2004 concluded that it wasn't providing any benefits, even to the early-stage patient.

A similar story can be told about Herceptin. Many of the protests were encouraged by the drug manufacturer which eventually got its way.

Will the same happen with Aricept? You betcha it will.

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Mr Bush's poodle

Bryan Hubbard — Thu, 16 Nov 2006 17:22:00 GMT

Most agree that the American health model is in meltdown. Driven by insurance money, surgeons perform too many unnecessary operations while doctors dispense too many unnecessary drugs. Not only does this aggressively interventionist approach keep medical costs high, it also means others wait longer to get on the medical merry-go-round.

Not content that the model is plain wrong, health officals in the USA want to export something similar to the UK. The US's deputy health secretary Alex Azar is lobbying the UK government to allow America's drug companies unlimited access to the National Health Service (which, in case I'm accused of bias, also doesn't work well).

Azar wants a free for all, where every drug that's been approved is made available on the NHS as part of a free market culture. And to add meaning to this market, drug companies would also be permitted to advertise directly to the patient, just as they are in the US right now.

There's a very special reason for Azar's remonstrations, and it's all to do with an organisation called NICE (National Institute for Clinical Excellence). NICE's principal function is to act as gatekeeper to the NHS to ensure that its budgets are not overstretched by drugs that are either ineffective or just too expensive.

NICE has been seen as the bad guy over a range of drugs that patients believe might be their saviour. If by chance they are, it would be a world first in medicine. Follow the threads and you discover that many patients have been 'encouraged' to demand a drug be made available either directly or indirectly by the manufacturer itself.

Poor old NICE is seen as the party pooper. And several recent heated meetings between UK government officials and drug company representatives bear out this image. The drug companies made it clear they were prepared to withdraw their substantial investment in the UK unless a 'better environment' for novel and innovative drugs was established.

So what will Mr Blair do in the months left to him as Prime Minister? Will he continue to be the Bush poodle that we all know him to be, or could it be that the recent mid-terms in the USA have shifted the power balance between the two war mongers?

For once, Mr Blair won't cave in. The NHS is too much of a sacred cow to meddle with, and the American drug companies will be seen to be hollow blusterers.