In the 1990s, studies show that 180,000 medically-induced deaths occur each year in the USA.2 Most of these are prescription drug related. These astronomical figures are in spite of the fact that a large number of drug damages go unreported.

Since 1961, the total number of “safety-tested” medical preparations marketed worldwide has risen to over 205,000. Approximately 15,000 new preparations are marketed each year, while some 12,000 are withdrawn.3 The United States has the greatest annual sickness-care expenditure of any nation: $912 billion in 1993 alone.4 If money and medical treatment equals health then one would expect the United States to be the healthiest of nations. However, it only ranks 16th in the world in female life expectancy, 17th in the world in male life expectancy and only 21st in the world in infant mortality.5

Of course, a percentage of drug damages are due to the incorrect administration of drugs by physicians and patients. But how are harmful pharmaceutical drugs allowed onto the market in the first place, and why do we have so much faith in them? Pharmaceutical transnationals defy the intent of laws regulating safety of drugs by bribery, false advertising, unsafe manufacturing processes, smuggling and international law evasion strategies. But most of all they make dangerous drugs appear safe through the use of fraudulent and flexible ‘safety-tests’, the subject of this article…

Fraud in Clinical Tests

Drug companies can easily arrange appropriate clinical trials by paying for an application of the drug. The incentive for researchers to fabricate data is enormous. As much as $1000 per subject is paid by American companies which enables some researchers to earn up to $1 million a year from drug research.6 And they know all too well that if they don’t produce the desired data, the loss of future work is inevitable. Unfortunately, because of secrecy, most fraud in clinical trials is unlikely to be detected.

However, cases of data-fabrication in clinical trials have been uncovered where, for example, “patients who died while on the trial were not reported to the sponsor…. Dead people were listed as subjects of testing… People reported as subjects of testing were not in the hospital at the time of tests…” and where “Patient consent forms bore dates indicating they were signed by the subjects after the subjects had died.”7 Even if data from clinical trials is not falsified, it is often of little worth, because they are not performed appropriately. Trials involve relatively small numbers of people and the subjects taking part usually do not represent those who will use the drug after its approval; so many harmful effects of a new drug appear only when it has been marketed.

Fraud in Animal Tests – Vivisection

This problem of inappropriate and flexible testing of drugs and chemicals is even more pronounced with the use of so-called animal ‘models’; a practice termed vivisection. For instance, the fact that the animal is relatively healthy before the experiment means that disease and/or trauma has to be induced by violent and artificial means. This bears no relation whatsoever, to the spontaneous ways in which humans develop illness, often through a faulty lifestyle and diet.

For example, consider the case of osteoarthritis, a human degenerative disease resulting in grotesque and painful deformities of the joints. How do researchers attempt to mimic human lameness in dogs, cats, sheep and pigs? Joints are beaten with hammer blows, injected with irritating liquids, subjected to ionizing radiation and/or dislocated. It is obvious that the resulting fractures, hemorrhages, thromboses, contusions and inflammation bear no relation to human osteoarthritis, “which is a local manifestation of a generalized illness of the collagen.”8 Drugs tested on such artificially diseased non-human animals cannot possibly yield results relevant to a spontaneous, naturally occurring human disease.

Moreover, there is no true correlation between different species. For example, arsenic kills humans but is harmless to guinea-pigs, chickens and monkeys; Digitalis which is used to lower blood pressure in humans dangerously raises the blood pressure of dogs; Penicillin kills guinea-pigs; Chloramphenicol damages the blood-producing bone marrow in humans, but in no other animal. Many common laboratory animals such as dogs, cats, rats, hamsters and mice, do not require dietary intake of vitamin C. This is because their bodies produce it of their own accord. However, if you deprive humans, guinea-pigs and some primates of dietary vitamin C they will die of scurvy.

There are enough of these species differences to fill a book.9 In the words of former animal researcher Professor Piedro Croce, “No substance is toxic in itself, but only according to the species.”10

Not only are there differences between species, but even individuals of the same species react differently to a substance. For example, research carried out at the University of Bremen , published in a paper titled “Problems of activity threshold in pharmacology and toxicology” found that:

1. In ionizing radiation – young animals react differently from older ones.

2. In reactions to Tranquillizers – again, young and old animals react differently.

3. In the common method of testing pharmaceuticals and chemicals, the Lethal Dose 50% test, it was found that in the experiments carried out in the evening almost all the rats died: in those carried out in the morning all of them survived. In the tests carried out in winter, survival rates were doubled in contrast to those carried out in summer. In tests carried out on mice overcrowded together in cages, nearly all of them died, while those carried out on mice in normal conditions, all the mice survived.

The authors of this research, themselves vivisectors, concluded: “If such trifling environmental conditions bring about such widely differing and unforeseeable results, this means that animal experimentation cannot be relied upon in assessing a chemical substance and it is all the more absurd to extrapolate to problems of human health results which are intrinsically wrong.”11

Any true medical progress has in the past, as in present times, only been achieved through scientific study based upon the real world and natural disease, and not the artificial world of the experimental laboratory.

Why Vivisect? How Many Drugs Do We Need?

Why do drug companies rely on such unreliable and dubious methods for testing drugs? The answer is simple. If drugs were tested properly using true scientific methods, such as in vitro cultures of human cells and properly carried out human clinical trials, the vast majority of them would not be approved for marketing because their harmfulness and ineffectiveness would be all too apparent.

For instance, in 1981 the United Nations Industrial Development Organization (UNIDO) in collaboration with the World Health Organization (WHO), published a list of a mere 26 drugs, from the 205,000 marketed drugs, that were considered “indispensable”, with 9 being more indispensable than the others.12 Other medical commissions in Chile 1972, and Sri Lanka 1978, came to similar findings, that there are not more than a few dozen drugs worth keeping. However, both existing governments were ousted shortly thereafter by U.S. backed forces. They were replaced with administrations open to American trade and the products of the chemical-pharmaceutical industry.13 This should cause anyone who thinks that we need more drugs to reconsider their opinion. It is plain to see that inconsequential and ambiguous methods of drug-testing are essential to protect the astronomical profits of the pharmaceutical industry.

Drug Companies Make These Admissions!

If you have difficulty accepting this explanation then consider the following statement from Eli Lilly’s August 1993 Prozac 20 Consumer Product Information pamphlet:

“There can be no such thing as absolute safety with prescription medicines. Individual patients sometimes react differently to the same dose of the same medicine and it is possible that some unwanted side effects will not be known until a medicine has been widely prescribed for a number of years.”

If they admit that even individuals of the same species react differently to an identical product, then why test on other species? Dr Herbert Gundersheimer, one of many doctors against vivisection, explains:

“Results from animal tests are not transferable between species and therefore cannot guarantee product safety for humans… In reality these tests do not provide protection for consumers from unsafe products, but rather are used to protect corporations from legal liability.”14 When people are damaged by unsafe products (such as pharmaceutical drugs, industrial and household chemicals, cosmetics…etc.) and attempt to take legal action, manufacturers can claim to have adhered to “safety” tests and are thus absolved of having consciously marketed a harmful product.

Thalidomide: A Case Example

This is what happened in the case of Thalidomide, a drug which after years of extensive animal tests was marketed as a perfectly safe tranquillizer for pregnant mothers. The end result: more than 10,000 grossly deformed new born babies. During the lengthy trial of the manufacturers in 1970, numerous court witnesses, all animal experimenters, stated under oath that the results of animal experiments are never valid for human beings.15

One of these experts was the Nobel Prize winner Ernst Boris Chain who co-discovered the anti-bacterial effects of penicillin. According to the court records on 2 February 1970 he stated: “No animal experiment with a medicament, even if it is tested on several animal species, including primates, under all conceivable conditions, can give any guarantee that the medicament tested in this way will behave the same in humans: because in many respects the human is not the same as the animal.”16 Because they had performed the required animal safety-tests, and because these did not show evidence of any danger, the manufacturers of Thalidomide were found not guilty by the court of consciously marketing a harmful drug.

This is the real value of animal experiments. Firstly, they can be manipulated, whether consciously or unconsciously, to produce results favourable to a financial backer. Secondly, they serve as a legal alibi for corporations when their products kill and injure people. It is worthy of note that Professor S.T. Aygun, a virologist at the University of Ankara, who uses only the so-called ‘alternative’ methods, discovered the danger of Thalidomide to humans and Turkey was spared the tragedy.17

Birth Defects Skyrocket

The incredible reaction to the Thalidomide tragedy by the pharmaceutical lobby was that it was a ‘rare exception’ and that it ‘emphasizes a need for more rigorous animal testing, not less.’ This explanation was accepted by most people. So animal testing increased, along with the output of ‘safety-tested’ drugs. The consequences of this? In the 1950s in the Federal Republic of Germany, 3 out of every 100,000 babies were born malformed. By the 1980s, 500 out of every 100,000 were born malformed.18 This is more than a 100-fold increase.

In the United States birth defects have increased more than 350% in the last 25 years. In the late 1950s, 70,000 American babies were born with birth defects every year. In the 1980s this toll reached 250,000 a year.19

The reason for this increase in human birth defects is known. A survey by doctors in West Germany revealed that 61% of malformations in new-born children and 85% of all stillbirths are attributable to the damage caused by drugs taken by the mother during pregnancy.20 Remember, all these drugs were found to be “safe” through extensive animal testing!

Why do people believe so firmly in vivisection? The answer to this lies in their education.

The Drug Story

With most of the world’s major drug companies under its control, the Rockefeller organization has, since the early part of this century, been the largest single private source of funding for medical science and education in the United States and Britain . The aim of this lavish funding for our education is to produce a curriculum designed to indoctrinate students with beliefs favorable to the profits of the pharmaceutical-chemical industry. Only colleges and medical facilities that predicate the massive consumption of chemical drugs, “safety-tested” on animals, as the secret to health, are recipients of drug company largesse.

Likewise, drug companies through ownership and advertising revenue exercise a dictatorial influence over the mass-media as they do also upon party politicians through ‘donations’. Meanwhile, doctors who heal by inexpensive natural means, thereby threatening pharmaceutical profits, are decried as quacks, driven out of the country or into jail.21

Perhaps the most revealing point, however, is that the founder of the Rockefeller dynasty, John D. Rockefeller, lived in excellent health to the age of 95 as did his son John D. Jr., who died aged 86. What was their secret to a long healthy life? Both attributed this to a frugal diet of natural food, the advice of a homeopathic doctor only, and the complete avoidance of synthetic drugs!22

In summary, the most powerful corporations in the world do not want us to know the truth about pharmaceutical drugs and drug-testing even if our lives depend on it. And of course, they do. As the drug companies acknowledge, it means that every time we take a drug or are exposed to chemicals in our food and environment, we are the real guinea pigs.

NOTES:

1. Hans Ruesch, Naked Empress – the Great Medical Fraud, CIVIS, Massagno/Lugano, Switzerland , 1992, p.12.

2. Lucian Leape, “Error in Medicine”, Journal of the American Medical Association (JAMA), 1994, vol.

272, no. 23, p.1851.

3. Hans Ruesch, Naked Empress, op. cit., 1992, p.12.

4. Arthur Baker, Awakening Our Self-Healing Body – A Solution to the Health Care Crisis, Self Health Care Systems, LA, California, 1994, p.5.

5. ibid., p.9.

6. John Braithwaite, Corporate Crime in the Pharmaceutical Industry, Routledge & Kegan Paul, London, 1984, p.105.

7. ibid., pp.51-52.

8. Piedro Croce, Vivisection or Science – A Choice to Make, CIVIS, Switzerland , 1991a, p.37.

9. ibid, p.22-23.

10. Piedro Croce, “That’s Why I am Against Vivisection”, CIVIS Foundation Report, Massagno/Lugano, Switzerland , 1991b, no. 7, p.1.

11. Croce, op. cit., 1991a, p.19.

12. Hans Ruesch, Naked Empress, op. cit., 1992, p.191. 13. ibid., p.92-96,191.

14. Herbert Gundersheimer, 1988, in 1000 Docton Against Vivisection (and Many More), Hans Ruesch (Ed.), CIVIS, Switzerland , 1989, p.29.

15. Hans Ruesch, Slaughter of the Innocent, CIVITAS Publications, Hartsdale NY , 1991, pp.359-367.

16. Werner Hartinger in CIVIS International Foundation Report, Hans Ruesch (Ed.), CIVIS Massagno, Switzerland, 1991, no. 11, p.3.

17. Ruesch, Siaughter of the Innocent, op. cit., 1991, p.367.

18. ibid., pp.365-366.

19. Javier Burgos, Hidden Crimes (Film), SUPRESS, Pasadena , California , 1986.

20. Croce, op. cit., 1991a, p.52.

21. Ruesch, Naked Empress, op. cit., 1992, p.97-119.

22. ibid., p.115-116.

The above article appeared in New Dawn No. 34 (January-February 1996)

The post Why Do Pharmaceutical Drugs Injure and Kill? appeared first on Alternative Complementary Medicine.

Originally, ghostwriting was confined to medical journal supplements sponsored by the industry, but it can now be found in all the major journals in relevant fields. In some cases, it is alleged, the scientists named as authors will not have seen the raw data they are writing about – just tables compiled by company employees.

The doctors, who may also give a talk based on the paper to an audience of other doctors at a drug company-sponsored symposium, receive substantial sums of money. Fuller Torrey, executive director of the Stanley Foundation Research Programmes in Bethesda, Maryland, found in a survey that British psychiatrists were being paid around $2,000 (£1,400) a time for symposium talks, plus airfares and hotel accommodation, while Americans got about $3,000. Some payments ran as high as $5,000 or $10,000.

“Some of us believe that the present system is approaching a high-class form of professional prostitution,” he said.

Robin Murray, head of the division of psychological medicine at the Institute of Psychiatry in London, is one of those who has become increasingly concerned. “It is clear that we have a situation where, when an audience is listening to a well-known British psychiatrist, you recognise the stage where the audience is uncertain as to whether the psychiatrist really believes this or is saying it because they them selves or their department is getting some financial reward,” he said.

“I can think of a well-known British psychiatrist I met and I said, ´How are you?´ He said, ´What day is it? I´m just working out what drug I´m supporting today.´”

Marcia Angell, former editor of the New England Journal of Medicine, wrote a year ago that when she ran a paper on antidepressant drug treatment, the authors´ financial ties to the manufacturers – which the journal requires all contributors to declare – were so extensive that she had to run them on the website. She decided to commission an editorial about it and spoke to research psychiatrists, but “we found very few who did not have financial ties to drug companies that make antidepressants.”

She wrote: “Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers´ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.”

In September her journal joined the Lancet and 11 others in denouncing the drug companies for imposing restrictions on the data to which scientists are given access in the clinical trials they fund. Some of the journals propose to demand a signed declaration that the papers scientists submit are their own.

The success of Prozac, the antidepressant which became a cult “happy” drug in the 1990s, substantially raised the stakes in psychiatry. Its promotion coincided with the decline of state funding for research, leaving scientists in all areas of medicine dependent on pharmaceutical companies to fund or commission their work. That in turn gave the industry unprecedented control over data and ended with research papers increasingly being drafted by company employees or commercial agencies.

The responsibility of scientists for the content of their papers takes on serious significance in the context of court cases in the US, where relatives of people who killed themselves and murdered others while on SSRIs (selective serotonin reuptake inhibitors) – the class of drug to which Prozac belongs – claimed the drugs were responsible. According to David Healy, a north Wales-based psychopharmacologist who has given evidence for the families, the companies have relied on articles apparently authored by scientists who may in fact have not seen the raw data.

Dr Healy, who had unprecedented access to the data that the companies keep in their archives, said: “It may well be that 50% of the articles on drugs in the major journals across all areas of medicine are not written in a way that the average person in the street expects them to be authored.”

He cites the case brought last year against the former SmithKline Beecham (now GlaxoSmithKline) by relatives of Donald Schell. The court found that the company´s best-selling antidepressant, an SSRI called Seroxat, had caused Schell to murder his wife, daughter and granddaughter and commit suicide.

The company´s defence was based on scientific papers which analysed the results of trials comparing Seroxat with a placebo and found there was no increased risk of suicide for depressed people on Seroxat. But the raw data probably does not support that, argues Dr Healy. Some of the placebo suicides took place while patients were withdrawing from an older drug. When the figures are readjusted without these, he says, they show there is substantially increased risk of suicide on Seroxat.

This raises the question of whether the eminent scientists whose names were on the papers ever saw the raw data from the trials – or saw only tables compiled by company employees, he says. David Dunner, a professor at the University of Washington, who co-authored one of the papers in 1995, admits he did not see the raw data. “I don´t know who saw it. I did not,” he said. “My role in the paper was that the data were presented to us and we analysed it and wrote it up and wrote references.”

His co-author Stuart Montgomery, then of St Mary´s hospital medical school in London, declined to answer calls and emails from the Guardian. The third name on the paper is that of Geoff Dunbar, a company employee.

The World Health Organisation has expressed concern about the ties between industry and researchers. Jonathan Quick, director of essential drugs and medicines policy, wrote in the latest WHO Bulletin: “If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.”

EducationGuardian.co.uk © Guardian Newspapers Limited 2002

By Sarah Boseley, The Guardian
Thursday February 7, 2002

Reprinted from:
EducationGuardian.co.uk

The post Guardian – Scientists Are Accepting Large Sums of Money appeared first on Alternative Complementary Medicine.

AstraZenca spokeswoman Kellie Caldwell said the group was “alarming patients” and was “basing its allegations on unscientific information and what we believe is an incomplete analysis of the data.”

Reports of muscle damage
The group said it had reviewed reports of cases of rhabdomyolysis, a life-threatening muscle breakdown, and compared them with the number of prescriptions filled for each drug. The reports were submitted to the FDA between Oct. 1, 2003, and Sept. 30, 2004.

For Crestor, there were about 13 reports of rhabdomyolysis for every million prescriptions filled, Public Citizen estimated. That rate was 6.2 times higher than the rates for all other statins combined.

The lowest rate among other statins was 0.6 reports per million prescriptions of Bristol-Myers Squibb’s Pravachol.

“These data affirm the pre-approval findings from clinical trials of increased muscle damage/rhabdomyolysis for Crestor compared with other statins and refute the FDA statement that the rates are ‘similar,'” Public Citizen said in a letter to acting FDA Commissioner Lester Crawford.

Last week, the FDA said it had completed a review of Crestor’s safety and concluded risks of muscle injury were similar to those of other statins. To reduce the risk, doctors were advised to consider the lowest possible dose for certain patients.

“We stand behind these statements. Nothing has changed,” FDA spokeswoman Laura Alvey said Thursday.

In December, the FDA warned the company over misleading newspaper advertisements suggesting the agency did not have any safety concerns about the drug.

AstraZeneca has repeatedly defended Crestor as safe and effective when used according to directions. “This is nothing new,” Caldwell said.

Public Citizen first petitioned the FDA to ban Crestor in March 2004.

Millions of people around the world take statins, including Pfizer Inc’s popular Lipitor — the world’s best-selling drug.

Bayer AG’s statin Baycol was pulled from the market in 2001 after it was linked to more than 100 deaths, many from the same muscle-damaging condition.

Source: www.msnbc.com

The post Crestor Risks Higher than Other Statins appeared first on Alternative Complementary Medicine.

That hearing was held to explore the FDA’s record on warning people about drug risks. During his testimony, David J. Graham, associate director of the FDA’s office of drug safety, said underpublicized safety risks of five drugs — weight loss medication Meridia; acne drug Accutane; asthma medication Serevent; cholesterol drug Crestor; and painkiller Bextra — could lead to restrictions or withdrawal of the drugs from the market.

More than 15 million prescriptions were filled for the five drugs during the first nine months of this year, according to IMS Health, a pharmaceutical information and health care consulting company. While the makers rigorously defend the drugs’ safety when taken as directed, some people who take them are scared.

Michael Miller, director of the Center for Preventive Cardiology at the University of Maryland Medical Center in Baltimore , said at least 10 patients have called asking what to do. While some research suggests that Crestor carries greater risk of serious side effects than other statins, Miller said current knowledge does not warrant taking most patients off the drug. He will continue to monitor patients carefully and won’t prescribe Crestor to those at high risk for the most serious side effects.

If you are taking one of these drugs and want to consider another treatment, experts recommend consulting with your doctor before stopping or changing any regimen. Some drugs interact with others, so you should tell your doctor about any drugs — prescription or over-the-counter — you’re taking on a regular basis.

For those taking any of the five drugs, risks and options are discussed below.

• Meridia Used for weight loss, works by “acting on the appetite control centers in the brain,” according to its maker, Abbott Laboratories. The drug works best when combined with a low-calorie diet, the company says.

Risks Elevated risk of cardiovascular side effects, including heart attack and stroke.

Drugmaker Response Illinois-based Abbott says it stands behind the safety of the drug.

Alternatives The best way to drop pounds: Eat less, move more, doctors said. “I very much believe in behavior modification and lifestyle changes,” said Tania Heller, medical director of Suburban Hospital ‘s Center for Eating Disorders and Adolescent Obesity. For patients at high risk for complications of obesity — such as those with type 2 diabetes — drugs may help speed weight loss, Heller said. “But the key point to get across is not to rely only on medication” to lose weight, she said.

• Accutane A synthetic form of Vitamin A, used to treat severe acne.

Risks Can cause severe birth defects when taken by pregnant women.

Drugmaker Response The risk for birth defects when the drug is taken by pregnant women has been known since its 1982 approval, said Carolyn Glynn, spokeswoman for Roche Pharmaceuticals. Roche and the companies that distribute the three generic forms of Accutane require doctors to test women for pregnancy before prescribing the drug, and to sign forms stating they’ve educated patients about known risks.

• Serevent A long-acting inhaled bronchodilator (a drug that widens the airways in the lungs) used for long-term management of asthma and chronic obstructive pulmonary disease.

Risks “Rare but serious asthma episodes and asthma-related fatalities occurred in a study with Serevent,” GlaxoSmithKline reports on its Web site. “These risks may be greater in African Americans.” Researchers think risks are higher for people with certain types of beta receptors (which exist on cells that line the surface of organs, including the lungs); this type of receptor seems more common in black patients. Some people of other races may have this type of beta receptor, too, doctors said.

Drugmaker Response GlaxoSmithKline says it addressed this concern by adding a “black box” to Serevent’s label in August 2003, warning patients and doctors of this risk, according to a written statement the company issued on the day of Graham’s testimony. Patients should not stop taking Serevent without their doctor’s approval, the statement says.

• Bextra A COX-2 painkiller often used to treat osteoarthritis.

Risks Bextra may have the same cardiovascular risks as those that caused Merck & Co. to pull Vioxx from the market in September. Some experts say that COX-2 drugs in general may be unsafe for long-term use. Existing research both confirms and refutes this risk, so more studies are needed.

Drugmaker Response Pfizer considers the drug to be “safe and effective,” said spokeswoman Mariann Caprino. The drug company looks forward to the FDA’s February 2005 meeting on the safety of Bextra and Celebrex, the only other COX-2 drug left on the market, Caprino said.

• Crestor A statin drug used to treat high cholesterol.

Risks Kidney failure and rhabdomyolysis, a rare but potentially fatal muscle disease. Complications are more likely at higher doses (the highest approved dose in the United States is 20 milligrams; highest dosages elsewhere extend to 40 milligrams).

Drugmaker Response In a written statement issued Nov. 19, AstraZeneca said senior FDA officials reassured the firm that “there is no concern in relation to Crestor’s safety and that they [the FDA] have issued a statement explaining that Dr. Graham’s testimony does not reflect the views of the agency.” The company has also run newspaper advertisements to reassure patients taking Crestor of the drug’s safety.

Diet and exercise are also powerful tools to help keep cholesterol and blood pressure in check, though doctors caution patients not to forego medication for levels deemed dangerously high by their doctors.

But don’t stop taking your medication even if your cholesterol levels dip into safer territory. Former president Bill Clinton, who underwent emergency heart bypass surgery in September, had stopped taking his statin medication after losing weight and becoming more fit. His LDL — or “bad” cholesterol — level had decreased since his last presidential physical, from 177 to 114 when measured the week before his heart surgery. The recommended LDL level is less than 70.

By January W. Payne

Washington Post Staff Writer
Tuesday, December 7, 2004; Page HE01

The post Five Brands of Risk appeared first on Alternative Complementary Medicine.

Dr. Cohen: Dr. Graveline, you have written some strong opinions about the cholesterol lowering-drug Lipitor, the most prescribed drug in America. Why?

Dr. Graveline: I have discovered that the stronger statin drugs such as Lipitor can be associated with profound cognitive disturbances in some patients. There are now thousands of patient case reports of amnesia, forgetfulness, confusion and disorientation, at times severe and incapacitating. With some cases lasting months and years, another very important point is that cognitive side effects can appear after months and years of seemingly trouble-free use.

Dr. Cohen: Can you give some examples?

Dr. Graveline: A 70 year old lady who lives alone and chops her own wood feared she had intruders when she found wood for her buck stove all split and scattered about and discovered a plate of partially eaten food in her kitchen. She searched the house from top to bottom and was about to call the police when she noted that the tracks in the new snow outside her porch near the woodpile were hers. She was the unknown intruder. This unnerved her, but after she discontinued her statin drug, she reverted to her usual alert, independent self.
A U.S. Air Force loadmaster wanted to know how long his Lipitor associated memory lapses might last. He stopped the drug on his own but knew his job was in jeopardy if he reported this event to his flight surgeon.
A woman hiker “woke up” lost in the woods.
A businessman awoke in his car miles away from anything familiar to him, and a passing highway patrol officer was convinced that his disorientation must be due to drinking or drugs. In a manner of speaking he may have been right, for this man was on Lipitor and since that episode has become an anti-statin activist.
A CEO of a large company remains unable to formulate new memory and is no longer employable, an apparent victim of permanent memory impairment following amnesia episodes associated with Lipitor.
The list goes on and on.

Dr. Cohen: You yourself developed amnesia after taking Lipitor. What happened?

Dr. Graveline: The first episode happened after I had been prescribed Lipitor for my modestly elevated cholesterol. I had returned from my usual morning walk in the woods when my wife noticed me walking aimlessly in our driveway as if I were lost. I did not recognize her and refused to enter our home. I reluctantly accepted cookies and milk and somehow she got me into the car to see my family doctor and neurologist. One year later, I was urged to resume taking Lipitor by my doctor, who refused to believe that a statin had caused the first amnesia episode. Hours after taking the first dose, my wife found me in the greenhouse with that “gone” look in my eyes again. This time, during the 12 hour episode, I regressed all the way back to my teen years with precise recall for all my high school friends and events. Gone were all memories of my college years, medical school, my marriage and four children. And my exciting 10 years in the USAF as flight surgeon and research scientist. I had no recall of being a family doctor for 23 years, a NASA astronaut, or the author of nine books. All of these memories were completely lost from my mind, just as if they never happened.

Dr. Cohen: The image we see of amnesia in the movies is humorous, not serious or dangerous. What is the reality?

Dr. Graveline: Experiencing total global amnesia is nothing like you see it presented in the movies. Imagine yourself with an abrupt and complete loss of ability to formulate new memory — a conversation with a loved one, a beautiful scene, a major event in your life, all gone like a whisp of smoke. And in the retrograde form, add the loss of major memories of the life lived — marriages, deaths, children, careers.

Dr. Cohen: You practiced medicine, right? Didn’t you prescribe statin drugs like Lipitor and Zocor?

Dr. Graveline: I practiced medicine as a solo family doctor for 23 years until 1993. Since I am board certified in preventive medicine as well as family practice, I applied preventive medicine concepts liberally in my practice and, yes, these concepts included cholesterol control through the use of medicines. The statin drugs available during the last decade of my practice were not today’s more powerful top-seller statins like Lipitor and Zocor. I used these earlier drugs liberally and encountered no major problems. However, cognitive and other statin side effects seem to come with today’s more powerful drugs, and doctors and patients must be made aware of the negative aspects of their aggressive use.

Dr. Cohen: But just because a person gets a symptom while taking a medication, that doesn’t mean the drug is the cause. What’s the evidence on statins and cognitive problems?

Dr. Graveline: Initially, when I seemed to be the only case, my evidence was purely intuitive. Lipitor was the only medication I was taking when, six weeks later, I had my first attack of amnesia. A year later, at the time of my next astronaut physical, I was rechallenged with Lipitor and after six weeks an even worse bout involving both anterograde and retrograde amnesia occurred. Even though I was now convinced that both of my experiences stemmed from the Lipitor, no one else was. Only when I discovered the statin study at the University of California, San Diego, did the truth finally begin to emerge. I learned that there were several other cases just like mine. A few months later, when the People’s Pharmacy column published my case report, a flood of cognitive case reports from patients all over the country on statins poured in. Until that time, these patients had assumed their lapses, forgetfulness, confusion and disorientation were from old age, senility or early Alzheimer’s. We now have thousands of case reports including many who are rechallenge cases like mine. And just recently, the journal Pharmacotherapy published a review article of 60 patients having statin-associated memory problems (Wagstaff, LR, et al., July 2003). In my judgment, the evidence for statins causal role is overwhelming.

Dr. Cohen: And that’s why you are now publishing “Lipitor, Thief of memory”?

Dr. Graveline: Yes. Generally speaking I have not been excessively critical of statins, and I repeatedly cite their value for high-risk patients for our options are few at this time. My only concern is with the lack of awareness of both patient and prescribing doctor of the potential of the statin class of drugs to seriously interfere with the memory process. Rare, yes, but with so many millions now on these drugs, we are talking about tens of thousands of people in whom memory impairment of varying degrees can be expected.

Dr. Cohen: How has the medical establishment dealt with all of this?

Dr. Graveline: Doctors, like their patients, have been completely uninformed about the cognitive side effect issue with statin drugs. Time and again they assure and reassure their distraught patients that their memory lapses are “to be expected at their age”, or are possibly a “touch of senility” or perhaps even “early Alzheimer’s”. So complete has been the ‘brainwashing” of doctors by pharmaceutical reps and statin drug literature that a possible side effect to the statin drug is the last thing most of them consider. Now, after more than ten years of prescribing statins and reassuring patients of their safety, the last thing a doctor wants to hear is that he has been wrong all this time.

Dr. Cohen: What about the FDA?

Dr. Graveline: I am awaiting our watchdog FDA’s explanation of the report in Pharmacotherapy involving 60 memory cases gleaned from the FDA’s own Medwatch reports over the past four years. Unfortunately, during this time, the FDA has not seen fit to issue a special warning to physicians. Is that not the FDA’s role?

Dr. Cohen: You’ve established a website. What’s been the response?

Dr. Graveline: Over the past year my website has received just under 50,000 hits from patients all over the world interested in the side effects of statin drugs, especially the cognitive side effects of forgetfulness, confusion, disorientation, or amnesia. Currently between 100 and 200 hits daily are being received as a result of three articles I’ve posted: “Lipitor, Thief of Memory;” “Statins and the Flyer;” “Cholesterol, Friend or Foe?”

Dr. Cohen: You’ve warned that Lipitor and other statins may create a serious hazard in pilots taking these drugs. Why?

Dr. Graveline: As a former USAF and Army flight surgeon, one of the first thoughts that entered my mind after my experience with Lipitor was what might happen if my amnesia occurred while I was piloting my ultra-light aircraft? So you can imagine my concern when I learned that these drugs are commonly used not only by military pilots, but also are allowed by the FAA for flight crew members operating today’s jumbo jets and other commercial aircraft. The e-mails I have received from flight crewmembers telling of their “memory lapses” or of an “inability to multitask” will make you shudder.

Dr. Cohen: You are familiar with my research and book Over Dose showing that patients are often prescribed excessive doses of Lipitor, Zocor, and other statins. What is your perspective on this?

Dr. Graveline: I believe that excessively high starting doses — which incidentally are the initial doses recommended by the drug companies in package inserts and the Physicians’ Desk Reference (PDR) — are a huge problem with many medications, but it is especially true with statins. Another clear indication of this is that many cognitive side effects occur when statin doses are increased. I firmly believe a doctor prescribing drugs should follow your mandate to “start low and go slow.” This simple rule, if followed, would greatly diminish our side effect problems. Another important factor is our growing awareness that cholesterol and LDL levels may not be reliable indicators of statin drug effectiveness. Statins appear to work by suppression of the inflammatory process underlying arteriosclerosis and its offspring atherosclerosis. A growing body of research data does now tell us that statins appear to have a direct effect on inflammation within artery walls and on platelet inhibition. Cholesterol reduction seems to be largely irrelevant to this process and to the resulting improvement in CV risk. There is reason to believe that the dosage of statins required for this anti-inflammatory action may be much less than presently prescribed starting doses with very favorable impact on the side effect profile. Much additional research is necessary to define the specific mechanisms involved.

Dr. Cohen’s comments:
Adding scientific weight to Dr. Graveline’s concerns is the article in the July 2003 issue of Pharmacotherapy: “Statin-associated memory loss: analysis of 60 case reports and review of the literature.” This article examines 60 cases of statin-associated cognitive impairments from the FDA’s Medwatch system. 36 cases occurred with Zocor, 23 with Lipitor — the most powerful statins — and 1 case with Pravachol, with is also being prescribed at stronger initial doses today. Most interesting are the 4 rechallenge cases: people who again developed cognitive problems with a second course of statins, just as Dr. Graveline did. According to accepted guidelines for assessing adverse drug reactions (Naranjo et al., 1981), the development of symptoms on rechallenge is considered definite evidence of an adverse drug effect. Cognitive impairments, like most statin side effects, are believed to be dose-related: the stronger the drug and dose, the greater the risk. Some people do need strong doses of statins, but throwing millions on stronger doses than they need or tolerate is not the answer. More on this in my upcoming book that will be published this summer on statin drugs and natural alternatives for lowering levels of cholesterol, C-reactive protein, and other cardiac risk factors safely.

Copyright 2004, Jay S. Cohen, M.D. All rights reserved. Readers have permission to copy and disseminate all or part of these articles if it is clearly identified as the work of: Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com. You may not use this work for commercial purposes.

NOTE TO READERS: The purpose of this Letter is solely informational and educational. The information herein should not be considered to be a substitute for the direct medical advice of your doctor, nor is it meant to encourage the diagnosis or treatment of any illness, disease, or other medical problem by laypersons. If you are under a physician’s care for any condition, he or she can advise you whether the information in this E-Letter is suitable for you. Readers should not make any changes in drugs, doses, or any other aspects of their medical treatment unless specifically directed to do so by their own doctors.

Source: www.MedicationSense.com

The post Interview: Duane Graveline – Medical Doctor, Astronaut, and Critic of Lipitor and Other Cholesterol-Lowering Statin Drugs appeared first on Alternative Complementary Medicine.

Amid the pile of internal reviews and memos, according to the journal, is a document dated November 1988 that reports Prozac (fluoxetine) had caused behavioral problems, including agitation and serious panic attacks, in clinical trials.

The issue of disclosure is a loaded one. The FDA announced in October that antidepressants such as Prozac would now have to carry a “black box” warning that health-care providers should be on the lookout for, among other things, increased agitation, panic attacks, and aggression among users of the drugs.

This latest report also fuels the ongoing debate over which clinical studies should come to the attention of federal regulators and which should never the see the light of day.

“The discovery of research, reportedly ‘missing’ for the past 10 years, that connects Prozac to increased suicidal tendencies and violence is one more tragic example of a greater problem: Unless we mandate that all research be disclosed to the FDA during the drug approval process, regulators have no choice but to make their decisions based on the best-case scenarios that drug companies report to them,” U.S. Rep. Maurice Hinchey (D-N.Y.), whose office is reviewing the documents, said in a statement. “These decisions affect the health and lives of millions of Americans. If Eli Lilly’s research indicated dangerous side effects of their product and they withheld that information, they knowingly jeopardized the public’s health. Their failure to disclose what they knew may have cost lives.”

Morry Smulevitz, manager of global product communications at Eli Lilly, said he couldn’t comment on the documents because he hasn’t seen them at all.

“Certainly Lilly is obliged to public disclosure of all clinical trial data so health-care providers and patients can make informed treatment decisions,” he said. “Prozac has been prescribed for over 50 million people all over the world. It is one of the most studied drugs in the history of medicine, and its safety and efficacy is well-studied and well-documented and well-established. Beyond that, unfortunately, it’s really difficult without having the ability to review the supposed missing documents that we’re not aware of to know what we’re trying to make comments upon.”

Smulevitz said he had requested the documents from Jeanne Lenzer, a New York-based medical investigative journalist who received them and then sent them on to the BMJ and the FDA. But, he said, the request was not met.

Dr. Richard Kapit, the FDA reviewer who originally approved fluoxetine in 1987, told the BMJ that he had never been given the Lilly data.

“If we have good evidence that we were misled and that data was withheld, then I would change my mind [about the safety of fluoxetine],” he said in a statement. “I do agree now that these stimulatory side effects, especially in regard to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug.”

The documents in question reportedly disappeared during a product liability suit brought in 1994 by families of the victims of Joseph Wesbecker, who, in 1989, killed eight people and wounded another 12 with an AK-47 before turning the gun on himself at his workplace in Louisville, Ky. Wesbecker, who had suffered a long history of depression, had started using fluoxetine just one month before the shootings.

The relatives’ civil suit alleged that the company had known about possible side effects of the drugs, including a tendency towards violence.

The jury ruled 9- 3 in favor of Lilly, but, in a shocking turnaround, the company later admitted it had made a secret deal with the plaintiffs. In 1997, the judge on the case, John Potter, amended the verdict to “dismissed as settled with prejudice,” meaning it could be reopened. Potter was presiding over another case Thursday, and could not be reached for comment on the latest developments.

“It’s been a big puzzle for many years,” Lenzer said. “The documents went missing during a critical period in the [wrongful death] trial.” Lenzer would not reveal who had sent her the documents.

The internal company document that stood out to Lenzer, she said, was one that discussed the finding that 38 percent of people have a stimulation effect, such as panic attacks and agitation, and that 19 percent of those could be attributed to the drug.

According to Lenzer, the document stated “one in five [patients] could be expected to experience this activation. And, later in the document, they talk about how to do damage control, how to get the doctors not to worry about this. Maybe the information actually got out and got buried. It’s like a little flicker of a flame. Obviously they didn’t get this out to a wide circulation. They didn’t get it out to the people who needed to know. They didn’t get it to the FDA safety officer who reviewed it.”

Dr. Peter Breggin, the medical expert in the Wesbecker case, has said the activation effects could be higher than 38 percent.

Lenzer, however, said she is concerned that what she called a pattern of secrecy among drug companies continues.

She referred to the Treatment for Adolescents with Depression Study (TADS), the results of which appeared in the Aug. 18 issue of the Journal of the American Medical Association . Although the findings were hailed as a victory for antidepressants, Lenzer stated in a September letter to the BMJ that the research had a flawed methodology and failed to report certain negative results.

“This is still going on. It’s not just 16 years ago. It’s going on today, right now,” she said.

An FDA spokeswoman said the agency had no comment at this point.

By Amanda Gardner
HealthDay Reporter

More information

The U.S. Food and Drug Administration has more on antidepressant use in children.

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