Phony drug data and buried bad clinical trial results

All my naivete about drug company research has been destroyed over the years I have spent as a medical writer.

I was also a volunteer participant of one of these clinical trials that was buried several years ago.

I volunteered for a phase 1 trial for an experimental gag DNA HIV vaccine trial, out of my commitment to the many patients I worked with during the HIV/AIDS epidemic here in NYC. After watching so many young people die, and knowing so many more around the world would also die from this scourge, I promised myself that I would do whatever I could to help stop it.

I searched for and found a phase one (safety) trial for an HIV vaccine that was recruiting 12 volunteers to take their new vaccine, offered by one of the world's largest pharmaceutical companies - one that would face tremendous world pressure to provide adequate vaccine to treat the epidemic, should they develop an effective product. They would have the means to manufacture and distribute it as well. The vaccine was the newest of it's type, and looked very promising in nonhuman trials.

They needed people who were at zero risk for contracting HIV, which I knew myself to be one, so I volunteered for the trial. They accepted me despite a long medical history of endometriosis, an immune system altering disease, and I was human # 12 to receive vaccination. After two injections of the DNA vaccine my long controlled endometriosis went completely out of control, causing serious kidney damage from rapid proliferation of endometriosis lesions that obstructed my ureters, my immune system crashed, and T cells dropped, permanently. I had to have an emergency hysterectomy and oophorectomy to try to stop the endometriosis from spreading even further.

At that point my emergency was reported to the clinical trial and documented as a serious adverse event likely related to the vaccine. I received a phone call from a study nurse saying my next follow up appointment had to be cancelled, and another one would be scheduled. Two months passed and there was no follow up call or appointment communication. I called the clinical trial and was told it was no longer being done at that location (a major NYC teaching hospital), and there was no follow up information available. I called the pharmaceutical giant and was completely stonewalled from any further information, even though as part of the agreement with them I had been promised safety checks and follow up as a study participant. When I was recovered enough from my major operation I physically visited the hospital, and found no evidence of the HIV vaccine trial, it had disappeared with no forwarding address.

I made a number of inquiries of staff at the department where the trial had been held, and no one would tell me anything. As I was leaving, an employee silently motioned with his head for me to come with him. He took me into a side hallway and just handed me a torn off slip of paper with a phone number on it, and left. It was the phone number to where the clinical trial had moved. They were not at all happy to hear from me.

I was able to find out that I had been given the vaccine, not placebo. There were no arrangements made for safety follow up. I was treated like an enemy. I contacted major media and no one would follow up on the story.

Four years later the pharmaceutical giant had given the vaccine to thousands more people, including those at risk for contracting HIV. It turned out that the vaccine not only did not protect people from HIV infection, it made them significantly MORE LIKELY to contract HIV by lowering their T cell counts, as it had done to me, making us more susceptible to a variety of infections and diseases, theoretically including cancer. 

The adverse trial data from my participation was buried.

They exposed countless people to the vaccine after someone like me, a "canary in the coal mine" with my pre-existing endometriosis, volunteered and gave them data that the vaccine could lower immunity, which they chose to ignore and bury.

I took the risk to join the phase 1 trial, and accept the adverse outcome for myself. I abhor that they ignored the data and put others at risk, along with millions of dollars that should have been spent pursuing a more promising, less dangerous vaccine or other treatment for HIV. I took the risk so others would not have to, but the drug company was too unethical to retain and use the data.

In this case the vaccine turned out to be much too dangerous to pass muster, but other cases of dangerous trial results being buried have allowed drugs to be approved for use by huge numbers of patients, such as antidepressants in children and teenagers that increase the likelihood of suicide, or Vioxx causing blood clots and strokes, and the list goes on.

Personally experiencing the unethical behavior of the pharmaceutical giants we all must trust to supply safe and effective medications and devices is a real learning experience, one I hope most people never have to undergo.

We must remain ever vigilant when such a huge industry retains such political power that they can defy regulation and scrutiny by any effective agency charged with public safety in the drug market, which our FDA should be. All our lives are at stake.