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International Scam by Oxford Professors Kills 77


Two Oxford professors have evidently run an international scam in 30 countries to make a cheap, effective heart medicine look bad and promote the sales of expensive alternative medicines. Apparently, deliberate overdosing killed 77 patients. Drug companies gave the professors $9 million for their "study".

Isis-4 (Fourth International Study of Infarct Survival, directed from Oxford, England) compared the effectiveness of magnesium, Captopril, and nitroglycerine in preventing deaths after heart attacks. The American Heart Association summarized the Mg effects of ISIS-4 thus: Analysis of mortality data revealed 4 more deaths per 1000 patients treated with magnesium. (Journal of Myocardial Ischemia, Vol 6, No. 2, Feb. 1994) If 1/3 of the 58,050 patients received Mg, that would mean 77 deaths were caused by the administration of Mg in ISIS-4.

Dr. Richard Peto, the ISIS-4 coordinator crowed, "This was the biggest, and hence the most reliable, drug trial ever done, involving 58,000 acute heart attack patients in 1084 hospitals in 30 countries. ... These results will disappoint those who had trusted the positive claims from previous small trials of magnesium..." Press Release, Radcliffe Infirmary, Oxford, Nov. 7, 1993.

As a medical writer/editor, I couldn't believe it, so I dug deeper, and found that ISIS-4 was fatally flawed--apparently deliberately. Here are the facts:

1. ISIS-4 infused an excessive amount of Mg into the veins of these patients in a very short period of time, contrary to all previous experience of what worked best. I have been told by a prominent researcher that he and several other researchers had told the ISIS-4 coordinators that they were setting up the study wrong while they were still in the planning stage, but the coordinators wouldn't heed them.

2. Magnesium was only given for a day, while the expensive, competing drugs were administered for at least a month.

3. The ISIS-4 coordinators claimed all the drugs were administered within 24 hours after the heart attack, but other researchers have reportedly said that Mg was often not given until much later.

4. The $9 million cost of ISIS-4 was paid by the makers of the expensive heart-drugs Captopril (enzyme inhibitor made by Bristol-Myers Squibb) and Imdur (nitroglycerine made by Astra-Hassle).

5. In regard to the competing medication, Captopril, the coordinators stated, "Benefits might be even greater if treatment could be started as soon as possible after the attack." No such sentiments were expressed about Mg, but then Mg was not paying for the study.

6. I wrote the ISIS-4 coordinators about their timing of Mg administration compared to the successful use of Mg in Dr. Rasmussen's previous study. One ISIS-4 coordinator, Dr. Rory Collins, wrote me back that Dr. Rasmussen's study "probably did not enroll patients particularly early after onset."

7. However, Dr. Rasmussen's published work stated, "All patients were included in the study less than 3 hours after they had been admitted to hospital. (Rasmussen HS, et al. The Lancet, Feb 1, 1986, p 234-6). Dr. Rasmussen's study showed that Mg reduced mortality by 50% when given promptly.

8. Dr. Richard Peto, co-coordinator of ISIS-4, unsuccessfully asked the editor of the New England Journal of Medicine to dedicate an issue in honor of Dr. Bernard Fisher, after Fisher had falsified research evidence in another study. Dr. Peto wrote that the journal should also "explain why large-scale, randomized evidence is so important." Business Week, Aug. 22, 1994, p 71.

9. As a result of Dr. Fisher's falsified study, the U. S. Congress doubled the budget for auditing the truthfulness of such trials. Dr. Peto petulantly stated, "They're going to make all sorts of extra rules. It'll reduce the number of patients in random trials and the number of doctors who do them. Unless these people are stupid, they've got to realize this."

10. Professor James B. Pierce wrote a book that discussed Dr. Peto's previous ISIS-2 study: "Discrepancies need to be investigated, and this should be done by disinterested researchers whose work is not funded by the big drug companies. Heart Healthy Magnesium, 1994, p 98.

11. Dr. Alan Gaby, Medical Editor of the Townsend Letter For Doctors, (May, 1996) expressed the following thoughts (Paragraphs 11,12,13). "Magnesium infusions were given for only 24 hours in ISIS-4, compared to 48 hours or more in the other studies. Since prevention of life-threatening arrhythmias is one of the effects of magnesium and, since some of these arrhythmias occur after the first 24 hours, the shorter duration of treatment may have reduced the effectiveness of magnesium.

12. Many of the patients in ISIS-4 did not receive magnesium until after they had been given fibrinolytic drugs. It is well known that when blood flow is rapidly restored to the heart by these drugs, a situation known as "reperfusion injury" can occur. The rapid restoration of blood flow causes the release of so many free radicals that the heart can be damaged. One of the possible benefits of magnesium is that it may prevent reperfusion injury. However, for that benefit to be realized, magnesium has to be given before or during fibrinolytic therapy, not later on as in ISIS-4.

13. Perhaps the most important difference between ISIS-4 and the "positive" studies was in the dosage of magnesium used. In the studies in which magnesium was most effective, the dose during the first 24 hours was 50-65 mmol. The most effective dose appeared to be 55 mmol. It is well known that an overdose of intravenous magnesium can cause hypotension and bradyarrhythmia; potentially serious side effects for a patient with compromised cardiac function. Results of a previous study had suggested that 75 mmol/day of magnesium is the threshold for toxicity. However, patients in ISIS-4 received 80 mmol of magnesium during the first 24 hours. It should therefore not be surprising that magnesium-treated patients in ISIS-4 had an increased incidence of second- or third-degree heart block and significant increases in heart failure and deaths due to cardiogenic shock. Those adverse effects are exactly what might be expected from an overdose of magnesium. Even the LIMIT-2 study, in which magnesium reduced mortality, may have pushed the limits of safety by administering 73 mmol of magnesium in 24 hours. That could explain why there was only a 24% reduction in mortality in LIMIT-2, compared with reductions of 70% or more in trials that used 50-65 nmol of magnesium. Apparently, the benefits of magnesium diminish as the optimal dose is exceeded and, past a certain point, the treatment becomes harmful.

14. The ISIS-4 coordinator stated misleadingly, "The IV magnesium infusion used in ISIS-4 was similar to that used in the Second Leicester Intravenous Magnesium Intervention Trial (Limit-2) namely, an 8-mmol bolus given over approximately 15 minutes, followed by 72 mmol infused over 24 hours." The truth is that Limit-2 gave 73 mmo1 over 24 hours, while ISIS-4 gave 80 mmol over 24 hours. The most effective dose appears to be 55 mmol. Why did ISIS-4 overdose contrary to known "good practices"? Why did the coordinator conceal the overdose under the rubric of "similar"?

It is unfortunate that so many millions of dollars were spent on a study that failed to replicate the protocols used in earlier work. Misfortune notwithstanding, ISIS-4 does not negate the results of the other studies. When used properly, magnesium still appears to be a safe, effective, and inexpensive treatment for AMI, wrote Dr. Gaby.

It appears that 77 lives were deliberately sacrificed to enlarge drug company profits and make cheap magnesium look bad. Several thousand more Mg test-subjects may have died because Mg was not used to best effect.

This apparent mass-murder may never be investigated or brought to trial, since it involves 58,050 patients in 1084 hospitals in 30 countries. Who would have jurisdiction? Scotland Yard? Interpol? The cost of such a trial, involving thousands of witnesses in 30 countries would probably be more than the $9 million that ISIS-4 cost, and I don't believe any jurisdiction is willing to spend that kind of money. The drug companies have deeper pockets than do the prosecutors.

Deliberately biased research is worse than no research. Instead of saving lives, it costs lives.

Additional background material can be found at:



American Heart Journal, Aug 1966, Vol 132, No. 2, Part 2 (Am Heart J gives 6 articles reviewing ISIS-4)

This page was first uploaded to The Magnesium Web Site on April 9, 2000