The FDA approved AZT in a record 20 months, a move that remains controversial today.
O HIV it was first reported in 1981, but it was until six years later - in March 1987 - that a drug to fight the virus was approved by the Food and Drug Administration (FDA). On the 30th anniversary of this milestone, Time magazine takes a look at the story behind the controversial azidothymidine medication, commonly known as AZT.
Also known as Retrovir or zidovudine, the AZT compound was not originally raised with HIV in mind but was developed in the 1960 decade to fight cancer. Decades later, scientists at pharmaceutical giant Burroughs Wellcome made a version of AZT to fight HIV.
To speed up drug approval, the drugmaker conducted a study of 300 people who had AIDS. After 16 weeks, the test was discontinued because those taking AZT were much better than those not taking. The results were considered a breakthrough, and the FDA approved the drug on March 19, 1987, in a record 20 months, according to Time.
Approval was granted despite many questions remaining unanswered - by For example, how long would the benefits last? - and despite other issues involving the trial itself. In fact, Time notes, the trail remains controversial today.
Then came a greater controversy: the price. At about $ 8.000 per year ($ 17.000 in today's dollars), AZT was unattainable to many.
Today, we have more than 41 drugs to treat HIV, many in combination and with far fewer side effects.
I, Claudio Souza, remember this “little medicine” well…
They were 6 tablets every four hours.
The first dose I took and although my stomach gave me a kick I held.
Then four hours later I took 10 and minutes later I threw up.
The third one I took, patted my stomach and came back, the nurse in the support house came to give me, I didn't want to take… She checked, she checked and I checked… I took and vomited instantly! I told her not to bring that back to me; and she came I did not take. Pow! There were six pills every 4 hours!
The next day I went back to the doctor who gave me the medication and put it on the table and said to him:
“Look… If I'm supposed to die in six months, as I was told, I better live without vomiting.
I got up, he called me and I did not even look back, I disappeared and almost two and a half years later, well beyond the six months that I was praised, the cocktail came, which was not like AZT. But I took a combination that used DDI, one that was larger than a fruit-salt tablet, and in the package I swore to myself I never read a package insert again, on the list of adverse reactions to the uninspiring expression :
- Fulminant pancreatitis
And I took it, with the c… in hand, for six months, in a routine that required fasting before one hour and after another hour, because, for the sake of “bioavailability,” they had to were received in an environment of “gastric hyperacidity” that generated an ulcer and determined the change.
And last Sunday one person, contravening all the precepts of education, took my number where I make WHATSAPP available and called me.
"Desperate", he had known he had the virus for two years, but he did not take the medication because, according to him, the doctor said the medication was "very strong". And that there would be no gain, considering the fact that he has a count of CD4 high and a viral load who remained stable at a “safe limit” and now he had to take the medication (three in one) and was desperate about it. He was fully aware of his clinical situation! Desperation I see in the people who arrive here awakened with a reagent result in hand, received in a laboratory where everything, including the colors of the walls are pasteurized and all the attendants have nails well done (I have the impression that this is, to get the vacancy , a condition Sine Qua Non (…) Where only charitable humanity lacks a psychologist and on duty to help absorb the first impact!
God knows how I stayed and how many things I thought on that sad day
Sad thing is to love well who does not know how to forgive I got to sing
Today I give thanks to God, because I saw in what you became! Get it!
“A lot of tuning… the violet you stole for me is the only one that blooms”… I think, in fact, this was the only thing blooming near you
Think of him living what I and hundreds of thousands lived 20 years ago…
Moral of the story:
Sunday… Mobile off
A little more about AZT by Wikipedia
Zidovudine was the first drug approved for the treatment of HIV infection /AIDS. Jerome Horwitz The Barbara Ann Karmanos Cancer Institute and Wayne State University of Medicine Synthesized AZT in 1964, Using a Federal US National Institutes of Health (NIH). AZT was originally thought to be an anticancer drug, but was archived when it was concluded that it was not sufficiently effective against tumors in rats.
Em 1974 W. Ostertag Max Planck Institute na Germany Obtained evidence that AZT was active in a culture of retrovirus Of mice . At 1984, shortly after confirmation that HIV was the cause of AIDS, scientists at Burroughs Wellcome Co. (BW) began researching new compounds to treat the disease. Burroughs Wellcome already had experience in viral diseases, led by scientists including Gertrude Elion, David Barry, Phil Furman, Marty St. Clair, Janet Rideout, Sandi Lehman among others. His research effort focused on the viral enzyme Reverse transcriptase. Reverse Transcriptase is an enzyme that retroviruses, including HIV, use to replicate. Scientists at BW began by identifying and synthesizing compounds and developing a screening test for retrovirus activity in mice. A compound code BW A509U has been tested and demonstrated potent activity against the viruses of these rodents.
At the same time, Samuel Broder, Hiroaki Mitsuya, is Robert Yarchoan do National Cancer Institute (NCI) of two USA they had also started their own independent program to develop AIDS therapy. Scientists at BW were not working directly on HIV, so the two groups decided work together. In February 1985, NCI scientists demonstrated that the BW A509U had a potent anti-HIV activity in the test tube, and a few months later, they started the initial phase 1 of Clinical trials Of AZT at NCI in collaboration with scientists at Burroughs Wellcome and Duke University . This trial demonstrated that the drug could be administered safely to HIV patients and CD4 in HIV patients including those with AIDS… Continuar lendo in Wiktionary, the free dictionary.