Clinical Trials ( Human Experiments ) Results Concealed

February 22, 2014

To: President Obama, All U.S. Senators, Congressmen, Congresswoman and Director of National institute of Health Dr. Francis Collins

From: Lawrence J. Lightner, Long Valley NJ

Subject: Clinical Trials (Human Experiments) No Results Posted

Dear President Obama, Honorable Senators and Representatives and Dr. Francis Collins:

I recently downloaded 41,199 clinical trials being conducted for cancer from the NIH Clinical Trial’s website. Since I’m not fond of sugar coating terms used, I will refer to them as Human Experiments from here forward since that is in fact what they are. With a quick sort of the data, I’ve come to the horrifying realization that results, long after the experiments have been completed, are either not being released by the entities conducting the experiments or they are not being published by the NIH. According to the law, the responsible party has 1 year from completion of the experiment to submit results.

Both scenarios above seem to be in direct violation of Public Law 110-85 September 27, 2007, 110 Congress. I seriously doubt the NIH would be withholding the results of these experiments for any reason which leaves the only remaining possibility, the results are not being reported to the NIH as the law clearly requires. I’ll save you the time of looking it up, below is copied directly from the Clinical Trials Website and the law itself as passed.

"In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Responsible Party no later than 12 months after the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov)".

"FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds".

"See the statutory provisions amending Civil Money Penalties (PDF) and Clinical Trials Supported by Grants From Federal Agencies (PDF)".

The section it refers to is copied below:

"(2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as redesignated by section 226, is amended— (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (5), (6), and (7), respectively; (B) by inserting after paragraph (2) the following: (3)(A) Any person who violates section 301(jj) shall be subject to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding. ‘‘(B) If a violation of section 301(jj) is not corrected within the 30-day period following notification under section 402(j)(5)(C)(ii), the person shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected.

Now here is the most horrifying part of my research, Over 80% of the studies have NO RESULTS. In case you’re curious why I did the amount of research you’ll see below, my son Glenn died at the age of 14 on December 12, 2012. When his brain cancer came back a second time I asked an oncologist at New York University Hospital, "How do we make this stop," I received a one word answer, "Death". He then directed my wife and me to the Clinical Trials Website. As it turns out, it’s a great place to advertise hope, but in reality it’s a place to recruit humans to be experimented on and then conceal the results.

Under the search term of cancer there is a vast number of studies under different categories, for the purpose of this letter I was only interested in studies that introduced something into the human body. The most common are Toxic Chemotherapy Drugs followed by Radiation, biologics certain devices.

I eliminated Observational studies from my research since they are just that, observations, and don’t directly affect the human body. That accounted for 6,304 studies not in my percentages.

I eliminated 92 expanded access studies as they are ongoing and have no results.

I’m only interested in Interventional Studies which introduce Toxic Drugs, Radiation, etc. Into the human body. Much to my dismay, while reviewing the remaining 34,803 Interventional Studies, I came across many studies not categorized correctly. Sending a questionnaire to an Eskimo tribe in Alaska didn’t qualify as an Interventional study for my purposes. I had to manually remove an additional 1,577 like studies. That brings us down to the actual experiments being conducted on Humans and only experiments that pertain to cancer.

 Studies Completed 2007 = 1,155, No Results 1,095, 94.81% NO RESULTS to this day

 Studies Completed 2008 = 1,397, No Results 1,098, 78.60% NO RESULTS to this day

 Studies Completed 2009 = 1,751, No Results 1,361, 77.73% NO RESULTS to this day

 Studies Completed 2010 = 1,807, No Results 2,446, 80.02% NO RESULTS to this day

 Studies Completed 2011 = 2,042, No Results 1,643, 80.46% NO RESULTS to this day

 Studies Completed 2012 = 2,330, No Results 2,007, 86.14% NO RESULTS to this day

The average across 6 years is 82.96% of experiments conducted on humans have no results published. So my question is, "WHY NO RESULTS? And has anyone been PENALIZED?" Obviously the individuals and corporations responsible for reporting are ignoring the 156 page Federal Law and its penalties, a law that was passed by the Senate on September 19, 2007 and passed by Congress 24 hours later on September 20, 2007. You may also notice, the number of Human experiments has risen year over year as did the percentages of NO RESULTS from 2010 to 2012.

Let me give you another perspective on the kind of numbers represented in these experiments. The number of Humans experimented on during the same six year period is 1,797,089 and there is apparently no record of what happened to 1,433,320 humans after the experiment. That’s roughly the population of Delaware and Wyoming COMBINED that have no results posted.

According to information published by the National Institute of Health, 43% of all Human Experiments take place in the United States. Every other country on earth combined represents 51%. The remaining 6% are split between the U.S. and the rest of the Planet. That’s a pretty disproportionate share of experiments that U.S. Citizens are subject to in comparison to the rest of the world combined.

According to the American Cancer Society, "There will be an estimated 1,665,540 new cancer cases diagnosed and 585,720 cancer deaths in the US in 2014". That’s approximately the entire state of Vermont dying every year from cancer. I personally don’t agree with the death estimates, I think they are much higher. Consider someone undergoing chemotherapy, the toxicity of these drugs destroy the immune system. After treatment the body is devastated, susceptible to disease it would normally fight off. The individual contracts the flu and it kills them. Is that reported as a cancer death, NO.? Would that individual have died from the flu under normal circumstances, probably not? But what’s the Death Certificate going to show? That this individual died from flu complications, thus not being recorded as a cancer death notwithstanding the fact that the cancer treatment was the catalyst for the death. Originally my son’s death certificate was going to read Heart Failure due to Aspiration. My son didn’t decide to stop breathing on his own making his heart stop. The amount of cancer that exploded in his brain made him stop breathing. I made sure the death certificate indicated the actual cause. Cancer.

For families trying to save the life of a love one, the current denial of information makes it impossible to make an informed decision. Example, an oncologist is offering a trial (experiment) consisting of a combination of chemo drug "A" and chemo drug "B". In desperation, it sounds promising. What if drug "A" by itself showed absolutely no benefit in a previous experiment and drug "B" showed that everyone is was given to suffered from kidney damage? Are you likely to waste your time with that protocol consisting of both or would you look for something else. The answer is obvious. That’s why results are required, families need this information.

Someone suggest going directly to the sponsoring drug company’s website, surely they posted their results there. Unfortunately they don’t, the websites direct you back to the NIH website where we already know there is nothing, and some also suggest the IFPMA Clinical Trials Portal or National Center for Biotechnology Information. I sampled some of the No Result studies there and as expected nothing.

It’s clear that this country has an ever increasing cancer rate, its clear the "war on cancer" announced by President Nixon almost 50 years ago was nothing more than window dressing and that seems to be the status quo.

Unfortunately, it’s now abundantly clear that someone "J" walking across the street stands a better chance of getting vigorously prosecuted than multinational corporations that conduct human experiments in this country and conceal the results.

When our military fires a missile at a target they expect to hear one of three results. The missile hit its target-Good Result, the missile landed in the middle of nowhere-not a good result but not terrible, the missile landed on a school full of children-very bad result. All three are EQUALLY important results to the commander on the ground. We expect the same.

This needs to be fixed IMMEDIATELY, it’s already a law that Results Must Be Reported. There is no comprehensible reason American Citizens are to be denied information on human experiments conducted in this county. I would suggest any company that does not release their results by the end of April 2014 be retroactively fined from the day the results should have been tendered to present. Every entity that advertised an experiment on the NIH ClinicalTrials.gov website knew the rules when they posted the experiment. American Citizens want Transparency, Families dealing with cancer want results.

Respectfully, Lawrence J. Lightner, Long Valley, NJ.