>Trust Me – I am approved


> OK so you are NOT a Lab Rat, and you certainly did not sign on in any new Drug Trials taking place did you? but you are an unwitting player in Phase V Drug Trials.

What are they you ask:

In addition to post-marketing surveillance, further clinical studies take place after a new drug is in widespread clinical use. Such trials (some times referred to as Phase V studies) are designed to evaluate efficacy and safety relative to other marketed compounds, and to explore new indications for the drug. Reformulation to allow a more convenient dosing schedule may take place at this time.

Basically folks, when a new drug comes to market and is prescribed for your particular ailment, you are supposed to be watched very carefully by your Doctor, and any adverse effects should be reported ASAP to the relevant authority. Supposedly given enough adverse effects of a serious nature, the drug will be withdrawn.

Although much of what is written here says it applies to the United States of America, I can almost guarantee that it also applies to both Australia and the United Kingdom to some extent.

We all know that Heroin and Cocaine – and many other street drugs kill, and we also know that taking too much of many prescription drugs – as in an overdose, can also kill. Both those statements are no brainers right?

But did you know that prescription drugs, as provided by your doctor, can cause an untold number of hospitalisations and deaths worldwide?

Different reports give different numbers of deaths each year. Suffice to say that any death by prescription medication is ONE DEATH TOO MANY!

In the USA, the FDA is responsible for the approval of all drugs that are available on prescription (amongst other things). We are told there is a strict process which drug manufacturers must go through, before a new drug gains approval. Trails are run and the reports of good and bad effects must be reported to the FDA for evaluation.

A significant difference between Australia and many other countries is that participants are not allowed to receive payment for taking part in trials, under strict National Health and Medical Research Council (NHMRC) guidelines.

“They are not paid because we want patients to decide whether they want to participate based on access to treatment or medical benefit – not financial incentive,” says Dr Wegener. “If there are expenses, such as travel, they can claim that. Healthy volunteers can get paid for time they invest, but it’s not calculated on the basis of risk.”

But in many countries – including the US and UK – participants can earn money by taking part in trials. The men involved in the TGN1412 trial answered an advertisement offering about $4000 for participation in the trial.

The Orthomolecular Medicine News Service tells us:
If you have often suspected that drug studies are rigged by the pharmaceutical manufacturer, you are right.

“Drug studies skewed toward study sponsors,” reported The Washington Post.

“Industry-funded research often favors patent-holders, study finds.” Specifically, the American Journal of Psychiatry study authors said, “In 90% of the studies, the reported overall outcome was in favor of the sponsor’s drug. . . On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug.”

Marcia Angell, MD, former editor-in-chief of the New England Journal of Medicine, agrees.

“Is there some way (drug) companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways, and it happens all the time.” One “way to load the dice,” she writes, “is to enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people. Because young people generally experience fewer side effects, drugs will look safer.” Another of the “common ways to bias trials is to present only part of the data – the part that makes the product look good – and ignore the rest.” She adds, “The most dramatic form of bias is out-and-out suppression of negative results.

“You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: “Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties” in 17 years. “The patent was based on NIH-funded research.” That means you, the taxpayer, footed the bill. Harvard is in just as deep. In its own Faustian dealings with the drug companies, “a Harvard hospital has a deal that gives Novartis rights to discoveries that lead to new cancer drugs. . . Merck is building a twelve-story research facility next door to Harvard Medical School . . . In Harvard Medical School ‘s Dean’s Report for 2003-4, the list of benefactors included about a dozen of the largest drug companies.”

Clearly drug companies are more concerned with profits than with patients.

What a truly sad and ugly state of affairs is shown in the above article, but I suspect it is only the tip of the iceberg. It just would not pay the drug developers to advertise the negative effects experienced by those participating in the drug trials.

A growing number of trials sponsored by the drug industry are halted early on the grounds that apparent treatment benefits have emerged rapidly. The warning comes from Canadian researchers whose review of 143 randomised controlled trials has found a “frequent failure to report relevant information” and “implausibly large treatment effects” (JAMA 2005;294:2228-30).

And this gem from Justin Smith

A few days ago, a study was published in the Journal of the American Medical Association (JAMA), that looked at the effects of stopping trials early. This study found that trials stopped early almost always show much better results for the drug being tested than if the trial was allowed to run its full duration.

In fact, the JAMA study showed that any drug benefits may be doubled by stopping the trial early. This means that the 0.55 percent reduction in deaths found in the JUPITER trial would have almost completely disappeared if the trial was allowed to run its full course.

Did you know ‘they’ openly tell us There is no such thing as a totally safe drug, and the approval process must recognise the risk/benefit ratio of any particular drug.

I can actually remember a Cardiologist telling me if I did not take a particular drug I would die….. I was not offered a suitable alternative and no discussion was entered into. The suitable alternative did not contain ingredients which caused me deep bodily distress. Eventually I got my GP to prescribe the alternative for me.

I cannot ever remember being told that a prescription medication, being given to me for a particular ailment had side effects which could be lethal! or that YOU and I are effectively guinea pigs, still being used to test the drug even after it is released on Prescription.

Postmarketing:

After a new drug is approved, the manufacturer must monitor the use of the drug and promptly report any additional, previously undetected side effects to the FDA. Doctors and pharmacists are encouraged to participate in the ongoing monitoring of the drug. Such monitoring is important because before the drug is marketed, even comprehensive studies can detect only relatively common side effects (that occur about once in every 1,000 doses). Important side effects that occur once in every 10,000 (or more) doses can be detected only when a large number of people use the drug, that is, after it is on the market. The FDA may withdraw approval if new evidence indicates that a drug may cause severe side effects. For example, the diet aid fenfluramine was withdrawn from the market because some people who took it developed serious heart disorders.

I don’t know about you, but learning that as little as 5,000 patient volunteer’s may be the only ones who have taken part in a drugs trial – before it is approved for wider consumption is quite frightening! Not an aweful lot of subjects is it especially when you consider that quite often it is younger, healthier volunteer’s who have been used in the testing process.

Another thing I have as yet, to come across is an indication that during drug trials, testing is done to ensure there is no cross interaction with other medications. When one is on multiple medications, surely one must be concerned about possible adverse reactions caused by the cocktail of drugs you are consuming.

“Trust me – I have been approved by whomever”, suddenly does not sound so reassuring now does it? And when it all boils down to the nitty gritty – if something does go wrong, what comeback do you have?

Swine flu manufacturers have now been granted legal immunity in case something goes wrong that causes side effects associated with the vaccine. Kathleen Sebelius, Secretary of Health and Human Services signed a document making federal officials and vaccine makers immune from lawsuits related to any ill effects from the swine flu vaccine.

At the start of this blog I said it was NOT ONLY the USA I was writing about. Things discussed here have happened elsewhere on our planet. For instance:

Think the swine flu vaccine was carefully tested before being injected into Canadian children, pregnant women, and the general population? Think again. It was a rush job.

REFERENCES USED:

Phase V Drug Trials

US Food and Drug Administration

Australian Drug Regulatory System

UK’s Drug Regulatory System

Orthomolecular Medicine News Service

BMJ – more drug trials end early

Justin Smith: Ever wondered why Statin Drug Trial stopped early?

Postmarketing of drugs

The Truth about Drug Trials

No such thing as a 100% safe drug

The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

Lily Australia – Drug Development Process

What went wrong with Vioxx?

Swine Flu Manufacturers – granted immunity

Think Swine Flu Vaccine was carefully tested?

SEE ALSO: Newswise March 30, 2010

HealthGrades Patient Safety in American Hospitals Study March 2010

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About JustMEinT Musings

I like writing, reading and expressing my opinions. I prefer natural health and healing to pharmaceutical drugs. Jesus Christ is my Lord and Saviour.
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