Drug companies pay doctors big bucks for volunteers

Margaret Munro
CanWest News Service

Tuesday, February 24, 2004

Dr. Kam Shojania heads clinical trials at an arthritis research centre in Vancouver.
CREDIT: Vancouver Province, Canwest News Service
- - -

VANCOUVER - The research promoters come courting Dr. Kam Shojania every few weeks.
The busy rheumatologist was recently asked to enrol patients in a gene-therapy experiment sponsored by a U.S. biotech firm that involves injecting live, genetically engineered viruses in patients’ arthritic joints.

Other companies came looking for volunteers to test new drugs that promise to arrest the crippling effects of rheumatoid arthritis.

Money is not a problem. The companies will pay $3,000, $4,000, $5,000 for every patient Shojania enrols—sometimes much more. One current trial is paying $18,000 per patient.
“It’s very labour intensive,” says Shojania, who heads clinical trials at an arthritis research centre in Vancouver.

The young doctor says he turns down about half the studies he is offered. But the research promoters keep pitching more trials because Shojania has ready access to something they cannot buy: human volunteers.

Pharmaceutical companies are not allowed to pay patients with disease to test or try their experimental medicines. But the companies are permitted to pay doctors to test new drugs and treatments on patients as part of clinical trials, which are a sideline for a growing number of Canadian doctors.

Physicians say there are perks—a steady flow of research money, expense-paid trips to investigator meetings, being on the leading edge—but they insist they are not getting involved in clinical trials to get rich.

The money is compensation for work done and the patients benefit most by getting early access to new medicines, says Shojania.

But some people, privy to the deals doctors are signing with research companies, say the fees paid to doctors for enrolling patients in trials are often generous, and sometimes excessive.
“The max I’ve ever seen is $2,000 for a single visit,” says Dr. Muhammad Mamdani, who sits on an Toronto ethics board that reviews clinical trials and has seen a few eye-popping numbers cross his desk.

So has Dr. Douglas Kinsella, retired assistant dean of medical bioethics at the University of Calgary, who now works as a consultant in Kingston, Ont. He knows of one psychiatry trial that paid doctors close to $20,000 for every patient enrolled.

“The fee was excessive, as they often are,” says Kinsella, who is particularly concerned with the growing number of doctors in community clinics running drug trials “like a business.”

“The docs basically sign the forms and collect the cheques. The research nurses do most of the
work,” says Kinsella.

Dr. Paul Flynne, assistant registrar of the College of Physicians and Surgeons of Alberta, sees details of clinical trial contracts signed by community-based doctors in Alberta. “Money is an issue I can assure you,” he says.

Physicians cannot charge provincial health plans for work done for trials and are paid instead by the sponsoring companies. The fees, when broken down in the budgets Flynne sees, are often double the rate paid by provincial plans for the same procedures. A patient consultation and checkup that would earn a doctor about $150 from the provincial health plan typically pays closer to $300 when done as part of a trial, he says.

Simple trials, known as Phase 4s, involve new drugs approved by Health Canada and are widely seen as marketing tools. They usually entail the doctor giving a patient a new medication and asking him or her to fill out a questionnaire or two for the sponsoring company. Doctors are paid a fee for each patient they enrol -- $10 to $300 for what often takes no more than 15 minutes, says Mamdani. But fees can be even higher, he says, citing the $2,000 payment for a single visit which his ethics board ruled excessive and didn’t allow.

Phase 3 trials involve drugs not yet approved for use by Health Canada and typically involve several return visits to the doctor’s office. They pay $2,000 to $5,000 per patient. But the fee can climb to $10,000 or more per patient for more complex, time-consuming trials like the current arthritis project in Vancouver.

“It’s paying $18,000 per patient, but everything is spoken for in the budget,” says Shojania. The patients have to undergo a drug infusion every six months—a procedure that involves three nurses and a supervising doctor, he says. Then there are monthly checkups and tests over the course of the five-year study.

Shojania says the profit margin on trials is typically 10 to 20 per cent—money that he and his colleagues put towards other research projects at the arthritis centre.

Many observers say it is hard to know if the interests of the patients are paramount.

They say doctors and universities should be open and tell patients how much they are paid to enrol them in a study, be it $100 or $10,000. “I don’t see why it should be hidden,” says Flynne.
Ethicist Michael McDonald at the University of British Columbia is even more emphatic.

“Doctors should be absolutely clear how much they are being paid,” he says.

· Drug trials poorly run see page A2.

© Copyright 2004 Edmonton Journal

Why Soda Pop Drains You Dry

http://www.unhinderedliving.com/soda.html When I posted this, this site was down, hopefully it will alright by the you read this.

Soda pop is not good for you. Of course, you have probably
suspected this, but perhaps you don't know the extent to which
drinking carbonated, caffeinated, sugared, or artificially sweetened
beverages destroys your body.

If you look at the list of ingredients in most soda pops, you will
likely see most or all of these listed:

caffeine
carbonated water
phosphoric acid
sugar
aspartame
acesulfame-k
sucralose

Let's start with carbonated water. As you know, our bodies require oxygen to remain healthy. For every can of carbonated soda ingested, the amount of oxygen in the blood is decreased by 25% for up to three hours. If you are drinking several sodas per day, you are depriving yourself for a significant amount of oxygen.

Calcium, magnesium, and phosphorus must be maintained in the proper balance for bone health.

When too much phosphorus is in the blood, calcium is leached from the bones, causing osteoporosis.

Even in citrus sodas which contain citric acid instead of phosphoric acid, calcium is needed to normalize blood pH.

It has been said that the fastest growing group of people with osteoporosis in this country is teenagers....because of the huge number of sodas they consume.

As far as caffeine and sugar are concerned, they both cause dehydration, and the massive depletion of minerals.

A study was done in which two groups of children aged 13-18 years of age were given one of two drinks, a caffeinated sugar-free drink, or a drink containing both caffeine and sugar.

When caffeine was added, calcium excretion in the urine increased by 25%.

When sugar was added, urinary calcium loss almost doubled (1). Both caffeine and sugar also cause dehydration.

Sugar in particular is destructive because its ingestion lowers immune function by reducing the ability of white blood cells to ingest and destroy bacteria.

This lowered immune function can last for five hours or more after the ingestions of sugar (2).

Sucralose, also marketed as Splenda, breaks down into small amounts of 1,6 -dichlorofructose, a chemical similar to chlorinated pesticides.

There has not been adequate testing of this product before it was released for fidyl public use, and many of the post-approval studies are alarming. To ready about it, go to Sucralose Toxicity Information Center .

Aspartame, or Nutra Sweet, has an alarming health record. Read my article about Aspartame. Even though this article is about how aspartame poisons the pregnant woman and her unborn child, you can see how it would do similar things in the bodies of others. Also, see the Aspartame (Nutra Sweet) Toxicity Info Center .

Acesulfame-k is a dangerous chemical. Read Sample Quotes from Cancer Experts' Letters on Acesulfame Testing .

I hope you will consider giving up the drinking of soda pop. It would contribute significantly to your level of wellness, and probably help reverse many existing health problems.

Everyone knows the week after Halloween is hell week at school right? From what? Sugar! So why have sugar in the hallways?

-transcription of presentation by Ken Anderson

LOSING YOUR FEAR OF FAT

Marcia Smith ND, PhD
There is much controversy about dietary fat - what’s good, what’s bad, how much?

Over the past 20 years Americans have become frightened of fat. Every time they enter a market and see the prevalence of low-fat and fat-free foods they are, in a sense, being programmed to believe that fat is bad. This is an unfortunate situation since consumption of sufficient fat is necessary for the proper construction of cell membranes and hormones. Because of all the adverse publicity and advertising, many people acquire a fear of fat. Common sense is the key to breaking the fear.

Historical Perspective on the Consumption of Fats and Oils

If you look at cultures around the world prior to the 20th century, you will find that their fat consumption came from eating whole, unprocessed foods - lean meats, fish, eggs, milk , nuts, seeds, and low-glycemic grains. They braised, broiled, boiled, or steamed food that couldn’t be eaten raw. They did not “deep fry.” The processes of chemical extraction and hydrogenation of oils are a 20th century phenomena. Prior to the 20th century, oils were pressed from various nuts and seeds. They were sold fresh, and had a short shelf-life. There was an “oil man”– similar to a “milk man.” There is currently controversy surrounding the consumption of the saturated fats from animal protein sources.

Many societies, especially those farther away from the equator, have depended on animal protein and fat as a mainstay of their diet for thousands of years. There has been an acceleration in many health conditions in the 20th century, yet the consumption of saturated animal fat has not accelerated. Therefore, no correlation can be drawn between saturated animal fat alone as a primary health risk Research indicates that perhaps the quality of the saturated fat and not the saturated fat itself is the key.

The composition of the fat in animals that graze on the open range is different from that of animals raised in feed lots. There is also evidence that the fat in eggs has a very different composition when the chickens consume organic feed. Health enthusiasts shop for range-fed beef as well as wild game such as buffalo, elk, deer, etc. They also find that lean cuts of lamb are another good choice since lambs are not feed-lot raised.

Eating fish, especially deep sea fish from cold waters, is a source of healthy fat (essential omega-3 fatty acids). The fish with the highest levels of these healthy oils are anchovy, sardines, salmon (Chinook), herring, mackerel, and tuna.

Understanding the criteria for assessing a good oil

A saturated fat is chemically stable, solid at room temperature, and unlikely to oxidize. (The consumption of oxidized fat can create damage in the body.) As you move to fewer saturated chemical bonds the fat becomes liquid and is called an oil instead of a fat. When it has quite a few unsaturated bonds it is referred to as polyunsaturated. As you move away from the saturated state, you increase the risk of oxidation - especially if the oil is heated. Monounsaturated is structurally closer to a saturated fat and is, therefore, more stable than polyunsaturated oil.

The large scale development of the polyunsaturated oils (most commercial cooking oil) is a 20th century phenomenon. Many of these commercial oils are produced with high heat and chemical solvents. These processes can strip away the natural antioxidants contained within the unprocessed oil, and consumption of this type of commercial oil, especially when heated, can contribute to oxidative, free radical damage at the cellular level. High-quality, cold-pressed or expeller-pressed polyunsaturated oils (such as safflower, sunflower, and walnut) may be somewhat better than the less-expensive, widely available commercial oils because they usually have been exposed to lower levels of heat during processing. They are best used for salad dressing rather than for cooking.

Why is heat a problem for oil?

The human body was designed to recognize and utilize oils that are in a specific shape – the cis-form. When the polyunsaturated oils are heated, they can change into the transform – a shape which the body doesn’t recognize. It is like trying to fit a round peg into a square hole.

When this trans form is incorporated into cells, it can wreak havoc in cell metabolism. Polyunsaturated oils are often hydrogenated or partially hydrogenated. A hydrogen molecule is added to make the oil more solid – artificially creating a “saturated” or “partially saturated” vegetable fat. These oils are frequently found in many processed and packaged foods.

Hydrogenated vegetable oil has the consistency of butter and, therefore, in used in margarine. Partially hydrogenated oils are included in processed foods to extend the shelf life of the products. These hydrogenated and partially hydrogenated oils are a source of the undesirable trans-fats. As margarine is a processed food, most margarine and butter substitutes are a source of trans -fats.

As mentioned above, monounsaturated oils (such as olive, peanut and avocado) are relatively stable, even when heated. And therefore are considered acceptable for sauteing. They are also fine for salad dressing, especially “extra virgin” olive oil. Flaxseed oil is an excellent source of healthy, essential, omega-3 fatty acids. It is a polyunsaturated oil that is carefully prepared at a low temperature. It is generally stored in dark, opaque, bottles and sold in the refrigeration case. It is considered a perishable food. It should not be used for cooking, but can be used in salads and to dress vegetables that are already cooked. Flaxseeds are beneficial for their fiber as well as their oil. They need to be ground fresh (in a coffee grinder) in order to make their oil available.

Fresh, ground flaxseeds taste great sprinkled on vegetables or in salads. They can also be added to “smoothies.”

The Mannatech Dietary Needs Assessment recommends that all five body types add at least two tablespoons of essential fatty acids to their diet on a daily basis. Some good choices would be high quality safflower, walnut, or flaxseed oil.

Butter has been churned for centuries, making it an oil that has withstood the test of time. It can be used in moderation on vegetables and in sauces.

Nourishing Traditions by Sally Fallon, Pat Connolly and Mary Enig Ph.D describes many of the health benefits associated with butter.

Think before you eat – use common sense.

In conclusion, I urge you to think before you eat. When thinking of eating or drinking a food that contains a fat or oil, ask yourself if the fat or oil is as close as possible to its natural state and if it is in a form that has withstood the test of time. If the answer to these questions is “yes,” then enjoy! Fat is
essential and it adds taste to your foods. In moderation it is definitely part of a healthy diet.

REFERENCE BOOKS

These easy-to-read books are filled with the scientific references to back up the opinions of the authors.

Erasmus, Udo, Fats that Heal, Fats that Kill, Alive Books, 1994.
Fallon, Sally M.A, Connolly, Pat & Enig, Mary (PhD), Nourishing Traditions,

New Trends Publishing, Inc., Oct, 1999.
Gittleman, Ann Louise, Beyond Pritikin, Bantam, December 1995.

Schwarzbein, Diana ( MD), The Schwarzbein Principle Health Communications, Inc., 1999