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Inadequate And Fraudulent Medication Testing Trials Threaten The Safety Of All Americans

  Is The Testing Of Prescribed Drugs Americans Take Done And Reported Honestly And Accurately?

Laurel Nokomis On Woman Health Issues

Laurel may be reached at FREELANCENEWSREPORT@juno.com

This is the first in a series on drug safety, testing and reporting.

After Merck was found to be holding contrary information to a drugs safety while in meetings with the FDA we Americans can readily see the passive attitude of the regulatory agency on the industry. Contrary test results are just one of the fraudulent considerations in drug safety.  Improperly administered studies and falsified documentation are the tip of the iceberg.

Currently we are in the heavily marketed cold and flu season. And one of the products being pushed is the flu shot.  For years, especially starting with swine flu, Americans have flocked to the magic shot that woulld keep them from the misery of the flu. On the horizon we see the looming spectre of the Chinese Avian flu and the potential crossover for human to human replication transmission with disasterous results.

In this interim, we American seek the magic shot that will save us from such fates.

The scientific process in testing such entities includes the solidity of the design of the study and the study conduct itself. Science is based on factors including documentation as well as replication and reproduceabililty of results. Additionally, testing on applicable patient/subjects falls under this methodology. A nicotine patch may be tested in non smokers to evaluate clearance of the drug via the liver and other bodily organs in both healthy and compromised individuals. Combating nicotine craving may be carried out simultaenously on smokers and non smokers as well as between smokers with use of the drug and with a placebo.  All testing approaches lend to the non influenced outcome of the data for the final decisions of efficacy and safety.

One problem right of the bat is the testing population of clinical trials. For a drug largely intended for North American diet and lifestyle populations we have people participating in studies that are from third world countries that normally have a diet entirely different from that given during the study.  An investigator from Chicago may not see anything wrong with using bratwurst in several meals during a study.  However, South American participants that have a diet of mostly vegetables and corn meal may have altered dietary patterns and therefore shifting clearance results to name one potental "confounding" effect.

Another factor in the testing of the drug is what is known as the wash out period. If a subject is in a study, usually they are not elegible to enter and dose in another study until a certain time period after their last clinical event from the prior study. Indigent populations are highly motivated for the cash received.  There are people that are professional study subjects. Third world visitors receive a kings ransom for the amount of time in the study, and if using a fake ID, a tax free ransom. Often subjects show up for study evaluation exams with little more to identify themselves than a passport. Recently some testing firms have required forms for submission to the Internal Revenue to verify that the social security card presented matches the name with the number on file. Often these cards are unsigned and hence technically not valid. Potential subjects have been observed reading the name off the card as they sign consent forms for study participation. A staffer in one study reported that a subject reported with a new name and a new social security number than previous studies claiming the United States government gave her a new card, name  and number once she got married.  Many staffers are there to collect a paycheck and often pay little attention to such discrepencies or even if the examining physician has the correct chart during examination. The staffers that are diligent often meet with attitude when trying to manage the situation on the up and up.

Currently in the cold and flu season, one flu vaccine that was tested at various facilities had at least one center that was not diligent in ensuring proper compliance to scientific standards. Outright fraud in the false production of study results was apparently swept under the table according to a confidential source. In particular the documentation of a testing center with a high hispanic staff and study population base was audited prior to submission to an FDA auditor.  Among such questionable findgs which were often met with comments from superiors of "I wish you hadn't shown me that" included multiple individual subject urinanalysis forms prepared on days when the subject had not appeared for appointments or the use of  outdated pregnancy test in the conduct of the study. While  clerical errors abound and can be explained away as such, repeated "flaws" in the clinical procedure lends doubt to the due diligence on the part of the investigator, staff and company. Such clerical flaws occuring even 10% of the time starts to raise doubts on the other 90% of the study data and product safety.

In clinical trials test drugs are adminstered on a random basis with the true nature of the drug being known to those not involved in the day to day conduct of the study. This helps to make sure that staffers and subjects aren't influenced in there perception of what was given and hence what results are expected. In the course of studies, subjects have symptoms. Any symptom, regardless of severity is documented as to type, severity and duration. Ever look at an ad for a drug in a magazine and the full page of tiny print on the following page that includes a heading "ADVERSE REACTIONS"? An Adverse Reaction Event is aymptom noted. The job of statiticians is to slush numbers and wash out those findings that are not statistically significant or "not determined mathematically to be a random and unrelated episode." There is one problem in this clinical scenario, it is subjective. By subjective I mean that study participants must report it or staffers must be astute enough to discern it is occuring.  One source mentioned that an unlicensed nurse from South America was staffing a study that had her spouse as a subject. The spouse subject had passed out in his seat which can be common in this setting and is known as a vaso-vagal episode. When someone mentioned her spouses fainting, this nurse dismissed it as him taking a nap and returned to chatting with her female coworkers. Quality of education and training will be addressed in another installment. But, adverse events are the core findings desired in clinical trials. Without their being reported, we have no foundation for the safety of drugs. This can be compounded by secrecy. Secrecy due to a subject being currently enrolled in another study as can be the case with out patient trials or the refusal of the subject to report symptoms for fear of being dropped from the study and hence losing income. Another source told me that one such situation included a female subject with an apparently severe headache and exhibiting behavior of such by grimacing, keeping her eyes closed, taking ice from drinks to apply to her head and that the severity of her situation was largely ignored by staff from the prior shift. Upon approaching the subject to generate some documentation and suggesting that if symptoms were too severe she could stop participation she responded with "you tell us to tell you when we have pain but when we do you send us home and we lose money." These adverse reaction events are documented and are not "closed out" until symptoms cease.  One subject with an ongoing reaction from one study was caught trying to qualify for another study.  Recurrent study participants openly note on their qualifying paperwork that they had not been in a clinical study for a year when in fact they had just gone off study at the same facility a week earlier. The paperwork I am told is volumous and unless management and staff is on the lookout for such fraud it is seldom caught, but it is evident that it is largely ignored or even encouraged lest a test be short of it's study subject quota.

If Chinese products don't kill us first, our ongoing greed no doubt will.

To Be Continued...

The Choice Of Sarah Palin Proved To Be An Insult To Intelligent Women

Or "I have the question here in my cue cards that I want to lie about."

by Laurel Nokomis freelancenewsreport@juno.com

Ok, so here I am darling, a die hard Republican. And  "Oh Boy, a woman on the ticket!" That was as far as it got. If John McCain would have tapped Beth Dole, it may have been another story. Sacrifice the seat in North Carolina, what a great choice she would have been. And, yes, a better choice than John McCain. I pulled for Romney.

Romney and Dole would have been the ticket of my choice, not yet another embarrassing bimbo insulting my gender. Katie Couric, you were just too soft on her. Thanks for being nice, but... not one Supreme Court decision came to mind? Even if she could not recall the name of Lilly Ledbetter, perhaps she would have recalled the news about the hearing had she not been glued to Richard Roberts or CBN. 

The last thing we need running this country is another dumb baby making overworked housewife pregnant and barefoot in the kitchen while her husband is off snowmobiling.  Didn't anyone question the plane floating in the lake in front of her lakefront home?   Oh she managed that by being frugal with the household budget.  And after eight years of deception in the White House do we want a govenor that openly conducts gubernatorial business on private emails to thwart the legal process. I won't ask if she's stupid, I will merely say it. She is stupid. And, she is an insult to every hardworking American woman that struggles everyday to make ends meet and gain respect in a still predominately man's world. And, unfortunately there are still alot of impressionable stupid women out there considering how they went online to shop for her glasses, shoes and even got their hair dyed brown. Hey, all you girls out there, stop thiking with your uterus.