In my last post I outlined the clinical tests that led to the approval of AZT/Zidovudine as the first anti-HIV drug.

What I want to do now is look at some of the non-clinical issues that surrounded the approval and use of the drug. I’m sure this list is far from exhaustive so I’m more than happy to hear about other issues.

1) An Expensive Distraction

Not everyone believed that HIV was the cause of AIDS (see, for example, here). So, for them, any pursuit of anti-HIV treatments simply distracted attention – and, more importantly, funding – from research into the real cause(s) of AIDS.

2) Approval Process

AZT was approved for use on people with AIDS in a remarkably short time frame. In the late 1980s, the US drug approval process normally took around 8 years. AZT was approved in 20 months.

Central to this approval was a 1986 trial of the drug on 282 people with AIDS. Half were randomly allocated AZT, the other half were given a placebo. Neither the participants nor the researchers knew who was allocated what.

The researchers concluded the trial prematurely on the grounds that early data had demonstrated conclusively that the drug worked. All of the participants were then put on AZT. Shortly afterwards, on March 20th 1987, the US Food and Drug Administration approved the drug for use on people with AIDS. We began using it in Australia shortly thereafter.

Understandably, after nearly six years of fear and hopelessness, the arrival of AZT was welcomed with some optimism. Even if it did come with one or two problems.

The first was the requirement that it be taken every four hours, day and night. Consequently it was impossible to get more than four hours unbroken sleep. And the second issue was its toxicity, which often caused problems such as anaemia.  We saw a lot of this in Sydney, and ended up bringing most of our guys in for regular blood transfusions.

But then, in June 1987, journalist John Lauritsen wrote a long and highly critical article about AZT in the New York Native. Lauritsen had obtained documents relating to the 1986 drug trial under the Freedom of Information Act and he claimed that these demonstrated serious irregularities with the trial.

For example, he claimed that the toxicity of AZT had been understated in order to get FDA approval. Almost half of the people receiving AZT had required numerous blood transfusions because their bone marrow and immune systems were being damaged. A few had been taken off the drug altogether because they couldn’t tolerate its side effects.

He went on to make a number of other claims about irregularities in the trial. These included:

* Some patients increased their chances of getting AZT by pooling their medications with others on the trial

* The trail had been ‘unblinded’ prematurely so researchers knew who was getting AZT

* There had been a sudden increase in deaths after the trial was ended after 16 weeks

Unsurprisingly then, he questioned whether the trial really had proven the benefits of AZT. He argued that the drug did more harm than good and declared:

“Recovery from AIDS will come from strengthening the body, not poisoning it. Do not take, prescribe or recommend AZT.”

In April 1989, Sunday Times reporter Brian Deer also undertook a lengthy investigation of AZT, including the 1986 drug trial. His findings pretty much echoed Lauritsen’s.

He claimed that the trial had ended just as the side effects of the drug were beginning to kick in and that few patients were able to take the drug long-term. He also claimed that both doctors and patients knew what they were taking and their treatments had been adjusted accordingly.

But despite Lauritsen’s article – three months after AZT became available – many people with AIDS chose to take the drug. It wasn’t as if they had a great deal of choice. Facing a possible death sentence – and an unpleasant one at that – it’s not easy to accept the idea that the one glimmer of hope might be bad for you.

Even if you could acknowledge its toxicity, the risk was worth taking if it extended your life, hopefully until a better drug came along. After all, there was already talk of new drugs on the horizon. And even if the drug turned out to be snake oil, it was still something after a wait of nearly six years.

And so some people chose to take AZT whilst others didn’t. I even knew a man in Sydney who actively urged others not to take it – while continuing to take the drug himself!

3) Access

So taking or not taking it was not simply a black or white matter. Ultimately, there was a general consensus that everyone had the right to take it if they so chose. Certainly that was the view of AIDS activist group ACT UP, who decided to step in when Burroughs Welcome priced AZT beyond the reach of many people with AIDS in the US.

From March 1987, AZT was the only anti-HIV drug available to people living with AIDS around the globe. That, in itself, gave the company a huge market. Consequently, the company’s share price rose dramatically from the moment the drug when on the market, rising 40% in just over two years.

And yet, in their rush to optimise their profits, they priced AZT at $10,000 a year. They reluctantly agreed to drop the price to $8,000 when threatened with a  congressional enquiry. But it was still one of the most expensive drugs available.

The cost was beyond the reach of many people living with AIDS. Even for those with health insurance, it quickly exceeded the limits that health insurance providers would pay. And, of course, for those without health insurance, it made access to the drug almost impossible.

ACT UP tried a range of strategies to have the price lowered. In the first instance they met with the company – but without success. Then they invaded, then barricaded themselves into, Burroughs Wellcome’s North Carolina offices Still no change.

Then they met with the company again – this time with 15 other AIDS organisations. When this failed to bring about any change, they called for a boycott of Burroughs Wellcome products. The company still refused to change its position.

So, on September 14th, 1989, some of ACT UP’s members infiltrated the New York Stock Exchange on Wall Street just before opening time. After chaining themselves to the VIP balcony they threw fake hundred dollar bills onto the trading floor. Then they unfurled a banner that read SELL WELLCOME.

Their final act was to set off foghorns, drowning out the ringing of the opening bell, and disrupting a decades only tradition.

Four days later, Burroughs Welcome dropped the price of AZT to $6,400 a year.

Meanwhile, on 9th October 1987, under a banner reading “Give people the choice”, London’s Capital Gay newspaper reported, , “Hundreds are still denied AZT”.

The reason, as Dr Charles Farthing from St. Stephen’s Hospital explained, was that the government wasn’t giving the National Health Service enough money to buy enough of the drug. The money was only about one quarter of what was needed.

I was living in Australia at that time so don’t know any more details about this. It certainly doesn’t surprise me, given the moral as well as the fiscal climate of Margaret Thatcher’s government. Thatcher herself was a major obstacle in the UK’s response to the AIDS crisis.

If anyone can tell me what happened with this I’d be very grateful.