Posts Tagged drugs

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The drugs don’t work: a modern medical scandal

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling.

Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits. Photograph: Photograph: Getty Images. Digital manipulation: Phil Partridge for GNL Imaging

 

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

Bad Pharma: How drug companies mislead doctors and harm patients
by Ben Goldacre

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

Read a lot more

Opinion:

These Big Pharma companies are running amok. They are out of control; concerned only with proftits and f**k the people!

They need to be brought to heel, and quickly.

Breaches of regulations or misleading doctors and patients by omitting facts should be fined, and fined heavily. I am not talking about a few paltry thousand out of petty cash, but fines that will really hurt their profits. I am talking about fines in their millions! Billions, if necessary.

Including the closure of the company for a third offence. Ban the company from doing any business in any field!

The only solution is to break the bastards!

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On the Brink of Sanity

Uruguay government aims to legalise marijuana

Uruguay’s illegal marijuana market is estimated to be about $75m (£48m) a year

Uruguay has unveiled a plan to allow state-controlled sales of marijuana to fight a rise in drug-related crime.

Under the bill, only the government would be allowed to sell marijuana to adults registered on a database.

Defence Minister Eleuterio Fernandez Huidobro said this was part of a plan to remove profits from drug dealers and divert users from harder drugs.

He said that the recent increase in murder rates was a clear symptom of a rise in drug trafficking crimes.

Ground-breaking bill

“We believe that the prohibition of certain drugs is creating more problems for society than the drugs themselves… with disastrous consequences,” Mr Fernandez Huidobro said, presenting the bill.

“Homicides related to settling scores have increased, and that’s a clear sign that certain phenomena are appearing in Uruguay that didn’t exist before,” he said.

The authorities blame the rise in crime in Uruguay on hard drugs, specifically crack cocaine.

The new bill envisages that some shops would be allowed to sell marijuana cigarettes at a price fixed by the authorities.

The government also wants to create a user database to supervise consumption.

BBC regional correspondent Vladimir Hernandez says the move is seen as groundbreaking in South America.

Several Central American leaders – including the presidents of Guatemala and Costa Rica – have spoken of the need to consider decriminalising some drugs in an attempt to undermine cartels.

In Uruguay alone, the illegal marijuana market is estimated to be worth about $75m (£48m) a year.

But the new bill has already proved controversial, and the debate in Congress could take several months, our correspondent says.

Source: BBC News

Opinion:

At least some countries are thinking along the right lines.

Americas war on drugs is futile, it can never be won. Why is America against drugs? Because they are bad… oh no, because they will interfere with the profits of the tobacco and alcohol industries. Once again, the politicians have been bought and paid for.

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War on Drugs a Failure

Summit of the Americas agree war on drugs a failure

This weekend’s Summit of the Americas did not produce a joint communiqué charting the future of the hemisphere, but the 31 leaders agreed on one thing: The U.S.-led war on drugs has been a dismal failure.

The summit pledged to create a panel of experts through the Organization of American States to consider drug policy reforms, and new approaches to stem the violence and power of the drug cartels.

Even Prime Minister Stephen Harper, who has created mandatory-minimum prison terms at home for minor drug offences, seems to have moved beyond the rhetoric of a Reagan-era counter-narcotics crusade: “Everyone believes… that the current approach [to the war on drugs] is not working, but it is not clear what we should do.”

The onus is on the hemisphere’s leaders, including Mr. Harper and U.S. President Barack Obama, to consider innovative, evidence-based policies. The decriminalization of marijuana – which comprises between 25 and 40 per cent of the drug cartels’ revenues – is one option. In the Netherlands, where licensed coffee shops can sell small amounts of marijuana, the rate of cannabis use is just 5 per cent, versus 14 per cent in the U.S. The policy of tolerance helps the government regulate cannabis sellers, and also distinguishes between soft drugs and cocaine and heroin.

In Portugal, where all drugs were decriminalized in 2001, there has been a decrease in serious drug use and drug-related deaths, and a savings to the criminal-justice system. “The aim shouldn’t be to totally decriminalize the whole enterprise, but to set some reasonable standards so that people don’t become criminals for minor drug use and clandestine organizations don’t make obscene amounts of money,” said Allert Brown-Gort, a Latin American expert at the University of Notre Dame in Indiana.

The problem with the current war-on-drugs policy is that it is unwinnable – and leads to weakened states, staggering levels of violence and continued drug consumption in Canada and the U.S. The U.S. spent $8-billion to help Colombia eradicate coca fields, only to have coca production shift to Peru and Ecuador and cartels set up new smuggling routes in weaker states. Guatemala and El Salvador now have the highest homicide rates in the world, while 50,000 people have been killed in Mexico since 2006.

In the words of Guatemalan President Otto Perez, a champion of drug liberalization, it is time to “stop being dumb witnesses to a global deceit” and consider treatment, harm reduction and decriminalization as viable alternatives.

Source: The Globe and Mail

Opinion:

Oh, they’ve just figured that out…

It has been evident for 20 years to everybody else!

As usual, the USA doesn’t agree, idiots!

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The Dope on Kiwis

Leader’s cannabis stance opens rift

ACT leader Don Brash has opened up a rift in his party over the decriminalisation of cannabis.

Epsom candidate John Banks – the party’s ticket into parliament – yesterday expressed surprise at Dr Brash’s call.

And the former police minister said he could not support a relaxation of marijuana laws. “I’ve always been opposed to drugs and I always will be opposed to drugs,” he said.

ACT’s president Chris Simmons said decriminalising the class C drug was “a step too far” and was not likely to become policy.

But Dr Brash received a surprise backer in former Federated Farmers boss Don Nicolson, the party’s agriculture spokesman.

“Don Brash … is saying that the cost is prohibitive and we are not winning the battle.

Source: Chch Press, Read more

Opinion:

For a moment there, I thought New Zealand was finally going to pull its head out of hthe sand.

Then I saw John Banks name, stupid bastard. His views are so prehistoric, that indicates he should have gone the way of the dinosaurs.

When is the world going to wake up like some (all too few) countries. The Holland, Belguim and Portugal experience shows that the fears of decriminalising drugs are not the ogre they think. How many times does this have to be demonstrated?

Just for the record, I don’t have a vested interest in this argument; while I have had the opportunity, I have never been tempted.

The decriminalising of drugs can only reduce the usage. Consider Prohibition in the USA; it showed that once alcohol was prohibited, usage rose only to be reduced with the end of Prohibition. The evidence of the countries that have decriminalised cannabis have supported that theory. The problems that have been encountered in these countries have been created by the influx of users from neighbouring countries whose laws don’t allow cannabis.

Possible Uses

The result of deciminalising frees up overworked police, reduces prison populations, creates employment, generates taxes and reduces a criminal activity (takes cannabis out of ‘mafia’ style hands). There are a host of products that cannabis can be used for.

It’s not just the drug.

New Zealand people need to have the debate, a referendum. Bugger the prehistoric politicians who, as usual, are laughably out of touch with reality.

New Zealand has a chance to lead the world. Don’t blow it Godzone… remember, he created the stuff.

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