HIDDEN CLINICAL TRIALS (ISSUE 106)

By Diane Gold

Hidden clinical trials is a real phenomenon. And, I use the word “hidden” because its opposite is “visible,” “disclosed,” “public.” With all the government regulation in the United States, the European Union and other areas; we would think that the regulations would arrange to remove drug trial misconduct.

We are sophisticated, ethical, socially minded, philosophical healers of our brothers and sisters. Right?

Not so right.

Here are 9 edicts that would insure the ethical handling of clinical trials. They would make it unnecessary and highly unlikely for any personal decisions to be made that would favor a sponsor, government, outside loyalty or trial recipient in any way so that empirically true results would prevail. It would also almost guarantee publication so that trial recipients who may have chosen to do the trial because of the added benefit of helping others, actually get to help others. And doctors who read the literature about certain drugs almost would be guaranteed that the literature they are viewing is complete literature on a particular drug.

PROPOSED EDICTS

1)  Sponsors shall not have access to trial progress or results.
2)  Every person who signs up for a trial shall be told the truth up front.
3)  Every person who signs up for a clinical trial shall receive a government stamped copy of the final trial, or of the results as far as the trial goes.
4)  All trial results, whether the trial goes to term or not, shall be published.

5)  There shall be a monitoring body for all pharmaceutical trials, government or private.
6)  The monitoring body of all clinical trials shall not be nor shall ever have been connected to the sponsor.
7)  The employees of the monitoring body shall be paid an extensive salary.
8)  Government trials shall be monitored by the monitoring body.
9)  The monitoring body shall not know the name of the sponsor, including government trials.

THE REALITY

Unfortunately the edicts above are not clinical trial reality. Although pharmaceutical drug trial regulations are many, they are not carried out or the monitoring of their execution does not exist, strangely enough.

To date, according to Ben Goldacre in his book Bad Pharma, drug companies are the ones who pay for the trials. Here’s a quote from the book, also used in an article by Forbes,

“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analyzed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments.”

Most of Bad Pharma talks about the fact, though, that trials are not published all the time and put patients at risk by non-publications. He was inspired to write the book in the first place when, after reading all the published research on an approved drug, his prescribing it to his patient based on the facts that were public, led to patient complications that could have been avoided if all negative results had been published.

OUR RIGHT TO INFORMATION

What Henry I. Miller says in his Forbes article, taken from his experience as an FDA  medical officer, is that many drug studies that are not published are not negative but inconclusive. What I say is there should be some sort of very accessible bank to everyone, patients, friends of patients and medical personnel, alike, with all study results, so that those who are evaluating a drug, whether taking it or prescribing it, can make the most informed decision based upon all previous experience that anyone has had with it, regardless of why its results may not have been published.

Plus, having a transparent archive would insure that drug companies, politicians (who support drug companies for political contributions) and editors of medical journals would not be in control of what becomes available information. Unfortunately, more medical and lay people hear about medical journal reviews; but, doctors who are prescribing and patients who diligently do research on behalf of themselves would have a complete overview from which to make as informed decision as possible about any drug or treatment with the transparency factor in place.

It’s pretty complicated as to whether a trial is negative or whether a trial is inconclusive. But all work should be available, in fairness to the patients who give their bodies for the trials.

ISN’T IT OUR RIGHT TO KNOW?

This reminds me of the waiver to a clinical trial I considered. One of the questions they asked is,

“Do you want to give your permission for us to use your DNA in future studies?”

I asked about whether I would have access to track where it went and the outcome it achieved. Of course, the researcher said they could not include that caveat. Based on not knowing the ethics of the users of my DNA and the fact that there might not be transparent results of its use, I declined, although I considered the opportunity to contribute to humanity an honor and my decision to say no weighed heavily on my heart.

I believe it is our right to know.

BIAS

Getting back to parameters for fair drug protocols, here’s a question.

“Do we have the exact same interpretation about an altercation at school that involves our child as the same situation when our child is not involved?”

Of course, the answer is a big, whopping,

“No,”

Even when we are trained specifically for this situation, it is nearly impossible to keep our emotions out of it.

This comparison is similar to a drug company and its bias toward the drug trial it sponsors, akin to its offspring or child. We are human, and, therefore, have biases toward our own.

CONCLUSION

What can we do about hidden clinical drug trials?

We can be aware that all information may or may not be reported to anyone outside the sponsoring drug company. We can express our concern to our friends, our doctors and to drug companies.

We put up with common ways of corporations because we want their services. If we are more demanding of what we deserve and demand an end to hidden drug trials, the breakthroughs in pharmaceuticals will be more meaningful, more honest and more healthful.

ACTION STEPS

Here are several action steps for the concerned human, which I know we all are:

1)   Ask to see the literature on any drug that you are considering. This means the actual data on the drug, rather than a consumer brochure.

2)   Don’t be intimidated by any medical professional who tells you s/he wants to start you immediately on some drug – unless your life is immediately at risk – to the point where you agree to a drug without knowing its information.

3)   Take excellent control of your own health care. After all, if you won’t, who will? This means review the literature on any prevention, disease or drug that may be part of your life.

4)   Make your own informed decision on whether or not you CHOOSE to accept a recommended drug, drug trial or therapy of any kind.

5)   Lastly, survey the drug manufacturers who are involved in any drug you may be considering taking. If a drug has already been approved, ask whether you can see the data of trials that has not been published. If there is a clinical trial, ask the following:
a)   Do you register this drug trial through a government agency, and which one?
b)   Is there a document I can have that mentions this registration?
c)   Do you post the results of this drug trial, and where?
d)   Is there a document you can give me that mentions this posting?
e)   If this trial does not go to completion, will the information at the time it ends be posted?
f)   Do you have ongoing access to the testing results during the trial?
g)   Do you have the right to make modifications during the trial?
h)   If I participate in the trial, may I personally receive results of the trial I am entering through my referring medical professional?

FINAL NOTE
In 2007, the FDA Amendment Act required all trials of any drug or device must be registered. Also, for a drug to be approved, its results must be posted to clinicaltrials.gov within a year of the end of the trial.
According to a paper by A.P.Prayle et al, BMJ 2012;344:d7373, that looked at compliance:

The paper included a partial sampling of trials. Of those trials required to be posted; only 1 in 5 trials had been reported;  next, the daily fine for non-compliance of reporting is not high enough to be meaningful to a drug company that makes $4 billion a year per drug (the fine is $10,000 per day/$3.65 million yearly); and very surprisingly, no fine has yet been assessed to any drug company for not posting their results.

One last bit of info that makes the pharmaceutical system shockingly cloaked is this. According to rules that are different in every country, referenced in Bad Pharma; drug companies apply for authorization to use a drug for a specific purpose with a specific market, such as using a drug for adults with depression. The clinical trial data for adults, for an example market, with depression, for an example disease, must be furnished to get approval. If clinical trials are performed on children, a different example market, for the same or different disease, and the company does not apply for authorization to use the drug on children with that disease, the drug companies are not required to report data or side effects. Also, they’re not required to report results if their trial is done out of country.

Doctors often prescribe “off label,” which means using a drug originally approved for one market or disease, but now being used for another. In one such case, one of the major 10 drug companies did not report that suicide was a suicide effects in children for 10 years. Why? It wasn’t a requirement, and revealing this would have cut their sales volume. They knew about the side effects through hidden clinical trials that could have warned doctors not to prescribe the drug to children.

Don’t we all have the right to know?

FEEDBACK

Please leave  a comment and LIKE us.

DIANE GOLD, AUTHOR

Diane Gold, Founder of Warriors of Weight, Turning Habits Into Health, is a mentor in tai chi, kung fu and meditation, a music, fitness and stress expert, dedicated mom, studying plant-based nutrition and habit change.

The topic of clinical trials being hidden is rather controversial. She says,

“It’s a matter of pride, not money. It’s more advantageous to announce the results of every clinical trial. It is certainly the only ethical thing to do, even though it may not positively affect the bottom line of the drug company, immediately.

“What a great PR opportunity, though. Any of the major pharmaceutical houses first to comply could take the huge opportunity directly in front of them to gain brand dominance. By being the first company to regularly register and report drug trial outcomes, they would be trusted and save money because this would be free advertising.

“If we remind the drug companies that they would gain huge loyalty and trust by making their clinical trials transparent, they might be interested.”

EXTRA ACTION STEP

“Give a drug company’s marketing department a call this week with the reminder. They just might be interested in listening to all of us.”

CHANGING FOOD HABITS: ARE YOU EATING GMOs, ORGANIC FOODS OR … (ISSUE 79)

By Diane Gold

For years, we have been ingesting food that has been modified to yield bigger crop, faster growth, more eye-appealing shape, resist or repel certain insect infestation and more.

We have been polluting our air through crop dusting modification, exposing ourselves to the sickness from toxin exposure, used to bio-technically modify seed and now, are faced with super insects made strong through genetically modified chemical resistance and the sicknesses that come from these super bugs. There is talk that humans should not be eating toxins. Not a new revelation.

Biotech companies want to make money. Great. They should have the right. However, the regulations put forth for these companies should not be removed disguised as developing technologies that will feed the world – IF the health risks have not been examined.

Governments are the regulators. Governments are we, the people. Regulating food is an issue that needs an amendment, as I see it. As part of the wonderful Open Government Act that is fabulous in words, I’d like to see transparency in food labeling. Why would a government as large and powerful as the United States not require transparency from which we could all benefit? And the answer is _________.

Of course, governments are corporations. They deal with other corporations. When one corporation does a business deal with another, a purchase or transaction is made.

Sometimes money is not exchanged, but favors, instead. When a corporation subsidizes government programs, the government may offer lenient regulations, in gratitude. This is where governing gets tricky.
How does a government accept help from big business, (which it needs to subsidize breakfast for children, senior flu shots, food for animals and environmental programs) and still stay neutral? Not easily.

So, what can we do to help?

ACTION STEPS

1) We can become educated about food and genetic modification and change our habit of thinking that food is pure, and we can change our buying habits.

Here are three important points:

a) ingredient labels on packaged food show the major percentage of food substance. Trace ingredients under a certain percentage are not required to be included. That means, if animal bone substance is used to bleach sugar (not common in the US any more), and there is no animal substance detectable in the finished product, it does not go on the label. Our habit of believing in these labels needs to change. It should be noted that packaged goods that have 70% organic substances in them are able to use the word “organic.”

b) there is no ingredient label on produce. Our habit of believing that all produce is the same needs to be looked at. Organic food is not genetically modified. Organic food is produced without using most conventional pesticides; fertilizers made with synthetic ingredients or sewage sludge; bioengineering; or ionizing radiation.That means mineral oil (fossil oil), lipids, proteins, waxes and alkaloids can be used on organics. animals can be used. Yuck. That means oil can be organic since it’s not synthetic.

There are three organic categories:

1. 100% organics, made with 100% organic ingredients.

2. organic, which means made with 95% organic ingredients.

The USDA Organic seal is used with the first two categories only, 100% organic and 95% organic. There is no apparent differentiation between the two categories unless the manufacturer decided to list 100% organic. Most 95% organic producers would take advantage of the public’s ignorance in thinking a product with this label is 100% organic, rather than listing it as 95% organic.

3. made with organics, made with 70% organic ingredients and no GMOs.

Did you know these distinctions?

On both organic and non-organic produce, there are coatings (wax): organics with wax from bees, wood rosin and carnauba and non-organic from petroleum.

c) bananas, both organic and non-organic, are ripened by spraying ethylene on them. This is one synthetic chemical that is allowed because it acts identical to the chemical that naturally off-gasses in bananas that ripen naturally and are not picked early for shipping. Ethylene “gassing” is used on citrus that may look green, organic and non-. This process is not on any label. Why?

2) We can express to our government reps that we want the FDA label what is and what is not a GMO (a genetically modified organism). Since we are striving for a transparent way of living, we, as consumers, deserve to know what is in a bunch of produce or a package of food or prepared food that is ready to eat.

We don’t have this now. Isn’t this our right?

3)  Join a group that knows more about this topic so that you can become more educated and take some of the action steps these groups have set up.

nongmoproject.org/learn-more is a good place to start. There’s also a march on March 25, 2013, targeting the largest supplier of modified seed (around 90%). It is not the only one, but it’s the big one: organicconsumers.org/monsanto

CONCLUSION

The risks of modifying seeds are known to exist. More research is needed to create data on all the side effects, but it is certain that there are correlations between certain sicknesses and genetically modified seeds.

In the same way we have executive, judicial and legislative branches of government, we need some system of checks and balances when it comes to the food industries ability to donate to or benefit the government and the government’s ability to reciprocate by regulating in favor of the industry.

We read headlines all the time that talk about “the government’s” doing this. Aren’t our representatives in government there to listen to what we have to say?

The time is now to be educated and active about the food we eat and the government’s ability to regulate on behalf of the health of its citizens with no eye on how this regulation will affect corporate donation to programs.

Old habits die hard. Now that our eyes are opening, and many of us are aware of the uncertainties of consuming GMOs, let’s work on changing our habit of consuming without asking. Let’s be diligent so that we can create healthier habits to pass on to our children and to theirs. The more of us who require non-GMO food, the less expensive it will be to certify it as “non-GMO” by label on a package or bushel of produce.

In November, 2013, the citizens of Washington State will vote on a mandatory labeling bill. Approximately, 37 states are working on bills. Some call their bills, “Right To Know.”

We’re all in this together. Let’s take action now.

FEEDBACK

Please leave  a comment and LIKE.

DIANE GOLD, AUTHOR

Diane Gold, Founder of Warriors of Weight, Turning Habits Into Health, is a mentor in tai chi, kung fu and meditation, a music, fitness and stress expert, dedicated mom, studying plant-based nutrition.

She has been studying labeling for four several decades . She says,

“The fact that the labeling system has not been modernized at the same rate as our discoveries in human nutrition reflects an imbalanced assessment on the government’s part regarding our internal health. This can also be seen by how slowly integrative medicine is appearing, which includes nutrition, fitness, mind body programs. And these, as of this writing, are only insurance reimbursable if an MD, no other kind of doctor, oversees the program.

“Be tenacious with nutrition. Spread the word about the benefits of organic food, non-GMO food, plant based food, unprocessed food. Take a step to change food habits one step at a time.

“SPECIAL ACTION STEP

“If you want to go for it, make a special commitment that for one meal on the day of your choice, you will refrain from any GMO foods. Do it for 3 weeks in a row, and see how much easier the third time is than the first. Then, if you’ve accomplished three weeks worth, continue the process, whatever that is for you. Your old ways that didn’t include this will be changed. And you will be healthier.”