When clinical trials go bad...Dr Jay S Cohen.

[Guest guest]

New-Drug Roulette

Courtesy: Daily Health News.[Now that the Times of India has carried a detailed article on the dangers of clinical trials in India, it is imperative that all Indians be educated about the pros and cons... - Jagannath]I often hear commercials on the radio soliciting participants for

clinical trials of one drug or another. On occasion the trial is for a

fatal condition -- more often it is for a condition that is relatively

well controlled with current methodologies. While I can understand

taking a chance when you're out of choices, the risk of taking

treatments and/or drugs that have not been tested against large groups

of people for more common problems makes it somewhat of a game of

Russian roulette.

To learn more about the ins and outs of clinical trials, I spoke with Jay S. Cohen, MD, author of What You Must Know About Statin Drugs and Their Natural Alternatives (Square One) and

Over Dose: The Case Against the Drug Companies

(Tarcher/Penguin). He told me that there are more than a few horror

stories about clinical trials gone bad, which is not surprising given

headlines in recent years with dangers of drugs that have been approved. Given the risk involved,

it is vital that you carefully compare the pros and cons before

considering being a participant.

THE POSSIBLE BENEFITS

Clinical trials come with both special opportunities and special

risks. On the one hand, you must consider the degree to which your

illness is causing you pain and reducing your ability to function,

observes Dr. Cohen. If your prognosis is poor and you cannot get help

otherwise, you might think about a clinical trial. He adds that

clinical trials are not for life-threatening diseases alone, but might

also be appropriate for less serious conditions that nevertheless have

a major impact on your quality of life -- for example, irritable bowel

syndrome (IBS) or migraines or chronic insomnia.

The National Institutes of Health (NIH) defines the benefits of participating in a clinical trial as...

Gaining access to new treatments before they are available to the public. Obtaining expert medical care at a leading medical facility. Playing an active role in your own health care. Helping others by contributing to medical research.

In addition, participants are often lured to participate by the

promise of medical supervision. In a world where approximately 16% of

the population is without health insurance, the promise of medical

oversight throughout the trial can be a major benefit to some.

THE POSSIBLE RISKS

On the other hand, Dr. Cohen points out that there are potentially

serious risks with clinical trials. He notes that the US Food and Drug

Administration (FDA) advises exercising caution with new drugs, because

it is not yet known what all their possible side effects are and

research is still ongoing. When you are talking about clinical trials,

you are talking about experimental drugs or treatments that have not

been tested on large groups of people and indeed may end up failing in

its larger test... or in a long-term study. There is no way to know.

This essentially makes you a guinea pig of the drug companies, warns

Dr. Cohen. He adds that Big Pharma has a vested interest in getting new

drugs and treatments approved, so you cannot always rely on the total

objectivity of the study personnel, especially if the study is funded

by a drug company.

According to the NIH, the risks involved in clinical trials include...

Potential for unpleasant, serious and even life-threatening side effects to experimental treatment. Treatment is not always effective. A clinical trial may require more of your time and attention

than regular treatment, such as trips to the study site, multiple

treatments, hospital stays or complicated dosage requirements.

DO YOUR HOMEWORK

Before joining a clinical trial, Dr. Cohen highly recommends that

you do your homework. Don't simply accept at face value the advice of

those with economic interests in getting new drugs or treatments

approved. Be sure to get a second opinion from an impartial, unbiased

health-care professional. Additionally, go on-line at sites such as

MedlinePlus (www.medlineplus.gov) and PubMed (

www.pubmed.gov)

to learn all you can about the treatment, and "google" the name of the

drug. There you might turn up accounts of personal experiences, the

good, the bad and the ugly. The official US government site for

clinical trials is www.clinicaltrials.gov.

Before deciding to participate in a clinical trial, Dr. Cohen

advises that you ask about the specific risks of the drug being tested,

and how it compares with the benefits and risks of current medications.

The NIH additionally recommends that you should ask...

What is the purpose of the study? Who is going to be in the study? Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before? What kinds of tests and experimental treatments are involved? How do the possible risks, side effects and benefits in the study compare with my current treatment? How might this trial affect my daily life? How long will the trial last? Will hospitalization be required? Who will pay for the experimental treatment? Will I be reimbursed for other expenses? What type of long-term follow-up care is part of this study? How will I know that the experimental treatment is working? Will results of the trial be provided to me? Who will be in charge of my care?

NEWER IS NOT NECESSARILY BETTER

As experience has proven again and again in recent years, new drugs

(including newly approved drugs) are more likely to have as yet

unidentified risks, cautions Dr. Cohen. As examples, he cites the

anti-inflammatory painkillers Vioxx and Bextra, best-sellers at first

that were suddenly yanked from the market when serious,

life-threatening risks proved to outweigh benefits. In clinical trials,

you are taking on even more risk. Perhaps it's worth it, perhaps it's

not. Only you can make this decision, after careful consultation with

experts and loved ones... and after carefully weighing all the risks

and benefits. Population reduction, a globalist goal, allows monopoly ownership of the earth’s resources – less population means more for them! War, famine, suppressed cures for catastrophic diseases, abortion acceptance, and health-destroying, cancer-producing Monsanto monopolized genetically modified foods all reduce world population and produce big profits. - Deanna Spingola, Political Researcher.

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