Drug disasters

HLS proudly tell us of their links with some of the biggest biotech companies in the world. We have long argued that HLS’s defence of unscientific animal tests is linked to these companies releasing drugs which go on to kill people. Unfortunately for patients, there are many examples of HLS customers harming people in this way.

Over recent months, the disasters caused by HLS customers have continued.

Here are just a few examples of animal tested drugs disasters, how many of these were safety tested at HLS?:

It was reported in May 2008 that GlaxoSmithKlines (HLS customer) AIDS drug Abacavir was doubling the risk of heart attacks. [1]

In February 2006 a report into Adderall a drug made by HLS customer Shire Pharmaceuticals, linked 24 deaths to this drug for Attention Defecit Disorder, and experts urged monitoring of the effect of the drug on the heart.[2]

HLS customer GlaxoSmithkline were implicated with deaths among patients when their asthma treatment Advair was examined. The active ingredient, salmeterol, was linked to inducing asthma attacks, which were sometimes fatal. Forbes magazine claimed 4,000 people die each year as a result of taking Advair.

HLS customer Pfizer were linked to eleven deaths in a clinical trial for an Alzheimer’s treatment in March 2006.[4] Among patients taking a placebo, the death rate was zero. Pfizer were only marketing the drug: it was manufactured by Esai, another HLS customer.

Roche (now ex HLS customer) stopped recruiting for trials of cancer dug Avastin in 2005 after deaths rose in the study group but not in the control group. Some of the deaths were suspiciously sudden.[5]

HLS customer Bayers' antibiotic called 'Avelox' was released just weeks after Raxar was withdrawn from the market. Avelox also interfered with the heart and within a year it was cited in reports of 18 deaths.

HLS customer Pfizer's drug Bextra (a painkiller) narrowly escaped being withdrawn in America early in 2005, then later was withdrawn in April 2006 following more discoveries.[6] Patients were developing a rare but life threatening skin diseases.[7]

Carbenoxalone was used to prevent the formation of gastric ulcers but caused people to retain water to the point of heart failure. After researchers knew what it did to humans they tested it on rats, mice, monkeys, rabbits, but could not reproducing this effect.

HLS customer Pfizer's drug, Celebrex was linked to a more than doubled increase in heart attack risks.[8]

This antibiotic, causes a bowel condition called pseudomenbraneous colitis. Clindamycin was tested in rats and dogs every day for a year; moreover, they were able to tolerate doses ten times greater than humans are able to.

This antidiarrheal, passed tests in rats, cats, dogs and rabbits. But it had to be withdrawn all over the world in 1982 after it was found to cause blindness and paralysis in humans.

HLS customer Novartis's drug Clozapine has caused blood disorders.

HLS customer AstraZeneca manufacture Crestor. Reports in the summer of 2005 linked Crestor with double the rate of side effect rates of comparable drugs, and six times the rate of some similar treatments. Some patients died.[9]

Cylert (pemoline), a medication used to treat Attention Deficit Hyperactive Disorder, caused liver failure in 13 children. Out of these 11 either died or required a liver transplant.

Another suspicious clinical trial was reported in summer 2005 by a company long-suspected to be a HLS customer, Eli Lilly. A 19 year old drug trial participant was found hanging dead after taking an anti-depressant. Although these drugs have been linked by adverse drug reaction (ADR) reports and by expert analysis to suicide, Lilly denied the link in the case of Tracy Johnson.[10] Her death while testing Cymbalta, a similar drug to Prozac, caused concern as the drug is already on sale in Europe including the UK under the name Yentreve. The American drug regulators the FDA agreed that the drug was not linked to Tracy's death, although a spokesman for Tracy’s family said the FDA never spoke to them, and the drug was also linked to another 13 suicides and 41 deaths. It’s worth considering that stress urinary incontinence is hard to model in a beagle.

Manufactured by Janssen Pharmaceuticals this drug was designed as a treatment for nausea and vomiting, made but human hearts beat irregularly and had to be withdrawn. Scientists were unable to reproduce this in dogs even with 70 times the normal dose.

In January 2006 HLS customer Novartis were linked to a typical ADR scenario – treating a relatively minor condition and risking a life threatening one. Warnings were added to eczema cream Elidel after it was linked to cancer.[11]

Eraldin was supposed to treat heart disease, but it caused deaths and blindness in humans despite the fact that no untoward effects could be shown in animals. When introduced, scientists said it noted for the thoroughness of the toxicity studies on animals. Afterwards, scientists were unable to reproduce these results in animals.

In February 2006 HLS customer Astra Zeneca’s blood thinner Exanta was found to cause liver damage and they were forced to withdraw it.[12] It was unclear whether the ‘rapid onset’ of liver disease was linked to deaths in clinical trials.

An antiviral medication Fialuridine brought out by HLS customer, Eli Lilly caused liver damage in seven out of 15 people. Five of these eventually died and two more needed liver transplants.

This HLS customer has released Imigraine, Zyban, Seroxat, Relenza, Septrin, Phenylpropanolamine (PPA), Sumatripan, Flovent, Selacryn, Wellbutrin, and Ridaura, which have all caused illness, injury or death.

The dose of asthma treatment 'Isoproterenol' was calculated in animals. Unfortunately, it was much too toxic for humans. 3500 asthmatics died in Great Britain alone due to overdose. It is still difficult to reproduce these results in animals. HLS customer Abbott Labs manufactured Isoproterenol.

Sanofi, another HLS customer, produced Ketek, an antibiotic. It has been linked with liver damage in patients and effects have included death and transplant. It was also linked to drug-induced hepatitis.[13]

The pharmaceutical companies Pharmacia and Upjohn discontinued clinical tests of its Linomide (roquinimex) tablets for the treatment of multiple sclerosis after several patients suffered heart attacks.

GlaxoSmithKline are a notorious customer of Huntingdon Life Sciences. Their drug Lotronex was withdrawn from the market in February 2000 after it casued five deaths in the USA. A further 93 patients had to have surgery due to the effects of Lotronex, including removal of the colon. In clinical trials 27% of Lotronex patients suffered severe constipation, compared to just 5% in a group taking no active treatment. Lotronex was a treatment for irritable bowel syndrome, a condition which causes discomfort but is not serious - unlike Lotronex which not only worsened the condition but lead to death.

In 1993, Boots' heart drug Manoplax was withdrawn less than a year after its launch following large scale human trials which suggested a link to increased rates of death and hospital admissions in patients. Manoplax had been extensively animal tested in studies using dogs, cats and other animals. Despite this however, it was only following clinical trials with human patients that the dangers of this drug became apparent.

Novartis's (HLS customer) Methysergide caused scarring of the heart, kidneys and blood vessels.

Danco Laboratories have had a boxed warning (the strongest possible) after its abortion pill Mifeprex (mifepristone) was linked with four cases of sceptic death. The bacteria has been identified, but too late for the four women who died and the others who may have been infected.[14]

There remains no animal model is Parkinson’s Disease. Even if there was, the ADR caused by Mirapex would have been impossible to detect. The drug, manufactured by HLS customer Boehringer-Ingelheim Pharmaceuticals Inc. was found to cause a desperate urge to take part in gambling. A retired government intelligence worker told how he lost thousands before finding other patients had similar experiences on an internet site. A lawyer representing patients said he had spoken to 200 Mirapex patients who had developed compulsive addictions including gambling, shopping and sex.[15]

Johnson & Johnson (now ex HLS customer) have also been implicated in their own right. An analysis of the data available on their heart failure drug Natrecor (nesiritide) showed the likelihood that it caused a higher risk of death or renal damage.[16] A whistleblower from the FDA, David Graham, stated that this drug could possibly be as dangerous as Vioxx.[17]

An antidepressant linked to kidney and liver failure, anemia, and death in humans. Animal testing had indicated that it could be used without side-effects occurring.

HLS customer Serono, were implicated when they admitted that Multiple Sclerosis drug Novantrone was dangerous.[18] “Diminished cardiac function may occur early on in the treatment with Novantrone”, they admitted it, although only relabelled the drug and continued to sell it. Experts spotted the problem – animal testing, and concluded. 'Experimental allergic encephalomyelitis is not a suitable animal model for testing treatments for multiple sclerosis and it is time to explore alternative experimental and therapeutic approaches.'[19]. An analyst said “The drug is burdensome already because it has a large side effect catalog"[20] The drug was licenced from Amgen, who are also a HLS customer.[21]

Opren was promoted, by HLS customer Eli Lilly, as a new wonder drug with a unique potential to treat arthritis and prevent the condition deteriorating. Indeed it did, but only in laboratory rats. In 1982 Opren was withdrawn from sale in Britain after 3,500 reports of side effects, including 61 deaths. Long-term studies with rhesus monkeys had failed to provide any evidence that the drug might cause liver damage, the main cause of death in human patients. Other animal studies commissioned by the manufacturers had also failed to suggest that Opren might cause the photosensitive skin reactions suffered by many of the human victims of this drug.

Pacific Pharmaceuticals:
"Premature baby drug doubles risk” called the Daily Telegraph in January 2006, and again attention was turned to a HLS customer. Pacific Pharmaceuticals had released an antibiotic aiming to prevent premature birth. A study by experts and supported by baby health charity Tommy’s found it doubled the chance of a premature birth, causing an estimated 20 premature births every week.[22]

This heart medication, was withdrawn from the market when it produced liver failure which had not been predicted by animal testing. Even once the particular type of liver failure was known, it still could not be induced in animals.

In 2008 it was reported that at least 12 babies had died during GlaxoSmithKlines (HLS customer) vaccine trials. GSK uses children from poor families, who are "pressured and forced into signing consent forms," the Argentine Federation of Health Professionals, or Fesprosa, said. [23]

In the summer of 1997 Roche releaed a high blood pressure treatment, 'Posicor'. By the following June there had been 100 reported deaths. Roche themselves admitted that Posicor patients had a death rate 10% higher that those on similar treatments. Posicor offered nothing that existing safer drugs couldn't offer. An official from the American Food and Drug Administration (FDA), who oversee drug approval said of Posicor "there are a lot of other effective therapies out there, why not be safe with the public?". If they had been, those 100 people would probably be alive today.

HLS customer Astella Pharma's eczema cream protopic has been linked to cancer.

GSK also manufactured an antibiotic, 'Raxar' which was withdrawn in Decemeber 1999 after thirteen people died taking it. Raxar gave patients an irregular heartbeat, interfering with the QT interval. There were already plenty of other antibiotics on the market.

American Home Products diet pill 'Redux' was withdrawn from the market after 17 months when the pill was linked to 123 deaths by the FDA. The pill caused heart valve damage and respiratory problems.

The diabetes medication troglitazone, better known as Rezulin, was tested on animals without significant problems, but caused liver damage in humans. Its' manufacturer Parke-Davis/Warner-Lambert admitted that at least one patient had died and another had to undergo a liver transplant as a result.

ADHD drug, Ritalin was referred to in a report by the US regulators early in 2006 which said there were concerns over the heart risks of the drug.[24] Manufacturer Ciba-Geigy Corporation is a division of Novartis, a long-term, high profile HLS customer.

This diuretic, was thoroughly tested on animals, but it was withdrawn in 1979 after 24 people died from drug induced liver failure. This drug was made by Glaxo and Eli Lily, both HLS customers.

Arthritis drug 'Suprofen' was withdrawn from the market when patients suffered kidney toxicity. Prior to its release researchers had this to say about the animal tests: '...excellent safety profile. No...cardiac, renal, or CNS [central nervous system] effects in any species'.

Bristol Myers-Squibb (HLS customer) drug Sorivudine, a treatment for Shingles, caused 14 deaths.

Eli Lilly (HLS customer) drug, Strattera, was criticised by regulators after being linked to suicidal thoughts and other behavioural problems in teenagers.[25] Eli Lilly also make Prozac, which was revealed in later 2005 to be the cause of a greater risk of birth defects for mothers taking it.

Roche's (now ex HLS customer) flu drug Tamiflu was linked to abnormal behaviour, hallucinations, and reports of two suicides – all among children. The European regulator requested a report on all psychiatric effects.[26] Although many of the events were in Japan, the American regulators also said they would “examine reports of up to 12 deaths and 75 cases of children who suffered health problems after using Tamiflu”.[27]

In June 1992, Teflox was withdrawn from sale in the UK after it had been given to 20,000 patients in only 8 months. The manufacturer Abbott Laboratories, (a HLS customer) withdrew the antibiotic after tests showed it could cause liver and kidney problems, and a life-threatening shock reaction.

Produced by HLS customer Astra, Zimeldine was withdrawn worldwide in 1983, just one year after its launch. In the UK there were over 300 reports of side effects, many of them serious, and seven deaths. This drug was tested on rats, mice and dogs - none of the tests predicted such serious side effects.

HLS customer, Bristol Myers-Squibb caused facial swelling with their drug Vanlev.

HLS customer Pfeizer's Viagra hit the news, this time linked to blindness. Reports of temporary and permanent blindness have been filed by patients who took the drug, which alters blood supply to the retina.

Merck generated much of its income from Vioxx (painkiller) before it was found to be linked to an increased heart attack risk, and summer 2005 saw the first court trials find against the drug company. The first trial awarded a widow $253 million, and left others wondering whether it was tested at HLS animals by another of HLS’s customers.

Around the same time it emerged that animal data had indicated Vioxx protected the heart, and indicated it could be an effective heart drug, while human data suggested it was a heart risk. [28]] Incredibly it seems the animal studies were given more credence than the clinical reports. As the trials progressed, an expert testified that a single dose could cause a potentially lethal heart attack.

Merck's arthritis drug Zomax killed people.

[1] Independent. May 2008.
[2] Reuters. 6 February 2006.
[3] CNN. 17 March 2006.
[4] LA Daily News. 14 February 2006.
[5] Friday 27 January 2006 Pharma's year of trouble and strife from Nature Reviews Drug Discovery
[6] Oklahoma News Channel 8, 16 November 02
[7] Painkiller 'may double risk of heart attacks' Daily Telegraph (London 01/03/2006)
[8] Reuters. 24 May 2005.
[9] The Independent on Sunday. 19 June 2005.
[10] Daily Record. 20 January 2006. Novartis drug gets 'black box' warning
[11] Philadelphia Inquirer. 15 February 2006.
[12] DowJones. 20 January 2006. FDA Issues Alert On Sanofi Antibiotic Ketek.
[13] FDA Medwatch. 19 July 2005.
[14] Popular Parkinson's drug linked to gambling. July 11, 2005
[15] Sackner–Bernstein, J. et al. JAMA 293, 1900–1905; 2005
[16] Friday 27 January 2006 Pharma's year of trouble and strife from Nature Reviews Drug Discovery
[17] Reuters. 25 May 2005.
[18] Chaudhuri A, Behan PO. Treatment of multiple sclerosis beyond the NICE guideline. QJM 2005;98: 373-8. Chaudhuri A, Behan PO. Multiple sclerosis: looking beyond autoimmunity. J R Soc Med 2005; 98: 303-6.
[19] Reuters. 25 May 2005.
[20] Reuters. 25 May 2005.
[21] Daily Telegraph. 13 January 2006.
[22] Trading Markets.
[23] News Medical Net. 12 February 2006.
[24] Strattera
[25] Marketwatch. 18 November 2005.
[26] MSNBC. 18 November 2005.
[27] The Times. 28 May 2005.
[28] The Times (London). 28 August 2005. Comment: Vioxx lessons.

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