Glaxo ‘Downplayed’ Warning on Heart-Attack Risk from Aids Drug
The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered heart attacks after using one of its drugs, abacavir. An anti-Aids medication, abacavir is taken by tens of thousands of people worldwide.
GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and abacavir are “unexpected” and “unconfirmed”. The company also said that it could find no association between abacavir use and heart attacks following a trawl through its internal data. However, it failed to mention that its own summary of product characteristics issued when the drug was launched in the late 1990s had described “mild myocardial degeneration” in mice and rats given the drug for two years.
Some scientists moni-toring the safety of Aids drugs are privately furious with GSK for downplaying the significance of one of the biggest safety trials of abacavir - one of several anti-virals taken by Aids patients in combined HIV therapy - when the findings were published last month.
“GSK was extraordinarily well prepared in terms of a statement that downplayed the significance of the findings,” said a scientist close to the safety study. “As a consequence, people are confused. They think there is something wrong with the study because GSK said it cannot find evidence to support findings of a link with myocardial infarction [heart attack].”
Alastair Benbow, European medical director for GSK, said the company takes information about drug safety seriously but did not want to highlight what may be “spurious observations” about abacavir.
The first public sign that abacavir may be linked with increased heart attack risk emerged this April when The Lancet published the worldwide “DAD” study into adverse reactions to anti-HIV drugs after clinical observations of 33,347 Aids patients across Europe, Australia and the US.
The study found that the risk of having a heart attack in patients taking abacavir was almost double that of HIV patients who did not take the drug.
Independent scientists who analysed the DAD findings said in The Lancet that the data was not strong enough to establish a causal connection because that would have required a different type of study; but they said the observed increase in the risk of heart attacks was “too strong to ignore”.
The same scientists also pointed out that the studies on which GSK relied for casting doubt on the DAD study were themselves not powerful enough to discount a link between the drug and heart attack risk.
To coincide with The Lancet publication, GSK issued a statement to its investors playing down the association between abacavir and heart attacks.
The statement did not say GSK had been made aware three years earlier of a report involving 34 cases of heart attacks in patients taking abacavir. The report or “signal” was sent to the company in May 2005 by the Uppsala Monitoring Centre in Uppsala, Sweden.
Didier Lapierre, GSK’s vice-president of clinical development, said to investors at the time of the April DAD study that the increased relative risk of heart attacks remained low in absolute terms and that patients should not discontinue treatment without medical advice.
“The DAD findings are unexpected, since we have not seen similar findings in our studies, and we are unaware of any potential biological mechanism that would explain them. In our own analysis of trials involving more than 9,600 patients, no increased risk of heart attack associated with abacavir was found,” Dr Lapierre said.
The US Federal Drug Administration and the European Medicines Agency have said that at present there is no reason to change the prescribing information for abacavir. But both are reviewing the safety data on the drug in relation to heart attacks.
©independent.co.uk
glaxosmthkline executives are not worried one bit….because they know they will NEVER go to prison…even if these findings are true. they will pay a a big settlement and pretend this never happened….SOP FOR DRUG COMPANIES
Smoke and Mirrors
When Mrs W.J.C. uses the word “OBLITERATE’ she is not joking . In his book “The Best Democracy Money Can Buy” Mr Greg Palast tells about how the president Mr W.J.C. sided with the big drug company (Glaxo) in denying the sale of cheap AIDS drugs ($2.00 per day per patient) by Argentina to Southern Africa where 2.5 million people were dying . Mr W.J.C. made the 2.5 million people wait until he was out of office when as a lobbyist he had them borrow one $ billion per year to buy the needed drugs at ($2.00 per day per patient) from the big drug companies . Today while Mrs W.J.C. campaigns promising good jobs with good pay Mr W.J.C. as a lobbyist is making deals to add an addendum to their NAFTA program by out sourcing more jobs to Columbia . That is CHUTZPA in capital letters .
It’s like a nursery rhyme that always leads to the same ending/conclusion. The drug companies boasted that the hormone replacement “therapy” drugs would do all these wonders for post-menopausal women until evidence began to suggest that these drugs CAUSED the problems they were purported to offset!
The same thing with diet drugs, or the latest fake sugar substitute. The companies rope in profit from those naive enough to turn their bodies into Guinea Pig experimental organisms, and once enough die or get sick, the drug is pulled but by then, big pharma has already been to the bank and seen NICE profits.
Since our legal structure demands a preponderance of evidence to prove that something in unsafe, new products do not have such a track record. Just as big tobacco hid the truth about the addictive quality of nicotine, these drug companies see a basis for profit and decide it’s cheaper to hide studies that draw due diligence knowing that by the time enough have suffered, they have already taken their profits and can plead “innocent.”
I related this point previously, and it is that there are now SO MANY dangerous chemicals in our food, air and water that it would be nearly impossible to isolate a single one and build a case around its dangers. The CLIMATE of predation is so vast that the guilty have built a web that grants protection to all offenders, except the MOST unlucky, or sometimes egregious. However, as this article suggests, this latest exposure is just ONE in a long line of many, and counting…
Hell, the NIH and entire pharma industry have played down the effects of AZT, that was withdrawn from distribution in 1965 because it is a known killer. Nevertheless, AIDS Inc resurrected this old drug in 1985 to keep the profits up, AND to ensure that people carrying the benign HIV will continue to die (not of HIV, but AZT poisoning).
Want to reduce death in Africa (and other hot spots)? Give them fresh water, decent sanitation, teach them about personal hygiene and safe sex. They do not need drugs.
Blimey, we in the west re-learned about this in the 19th century (the Greeks and Romans knew about it 1800 years earlier) and disease was almost eliminated. How many impoverished people must die before we eliminate Big Pharma profit greed and pass on this simple information?
I believe, overall, it’s well-established now that HIV-patients are FAR better-off with NONE of these anti-AIDS drugs (which test as CAUSAL for AIDS in patients with relatively-benign HIV-infections). [Other Causal-factors of AIDS-from-HIV include histories of protein-starvation, and related immuno-suppressant diseases — like TB/Malaria/etc…]
Maybe they are, some of them, effective after one actually has-AIDS?
Some studies have also shown that AIDS-mothers, who are untreated, are LESS likely to pass it along to infants…(one FL study, in-particular).
[OTOH…there is so much nonsense published re: AIDS that one doesn’t know ‘who’ to believe.]
Glaxo can test a drug on a few thousand people for a few months and declare it safe and lawmakers agree. Billions of people can smoke marijuana for ten thousand years with zero deaths and it is declared dangerous and illegal. Hmn.
@Maplefudge
Just read the latest White House Report screaming that MJ causes depression in teens:
http://www.cnn.com/2008/HEALTH/05/09/depression.marijuana/
The report seems unable to reason that the more depressed a teenager, the more likely they are to self-medicate. The report also repeats the long-held lie of conservatives that MJ is addictive, though there are zero studies to support this.