How Reliable are the Testing Trials That Determine the Safety and Efficacy of New Drugs?
Eighty percent of new drug applications sent to the food and drug administration (FDA) consisted of trial data from studies done outside of the U.S. according to the inspector general’s report. There are 3,000 new drugs coming onto the market to treat 4,600 different conditions.
Only 271 trials were done in foreign countries for American use in 1990 and increased to 6,485 by 2008. Although many study trials occur in developed countries, thousands take place in areas where illiterate and impoverished people reside. One concern with this is whether regulations are being followed by these medical teams and to what extent. Litigation risks are minimal and the wealth they have may enable them too much protection.
During the nineties, manufacturers began contracting out all phases of development and testing to companies that recruit the patients and volunteers. They also draw up rules for the trials and conduct them, prepare reports, ghostwrite technical articles for journals and advertise for participants. Paid technicians implement the procedures, gather the subjects, administer the chemical formulations, collect urine and blood samples and sequester and feed the recruits.
Prescription Drug Injury
Americans are far more likely to be injured or die from prescription drugs, physicians and hospitals than by terrorists, bombs and planes. The pharmaceutical industry influences psychiatrists to prescribe psychoactive medications even for patients who the drugs haven’t been proven safe and effective for.
There has been an astonishing increase in the diagnosis and treatment of mental illness in children, some as young as two years old. The terrible-twos is a phase where healthy children are beginning to learn their boundaries and the importance of following instructions. To become fussy when hungry or tired is normal, as is also to not always be attentive while sitting in a classroom as well as is shyness. To be given mind-altering and likely addictive drugs during these critical stages of growth should be considered criminal at most and suspect at least.
Like A Horse and Carriage
The medical director of the American Psychiatric Association (APA) made a declaration in 1977 to strongly support a vigorous effort to remedicalize psychiatry. By having placed much emphasis on drug treatments, Psychiatry had become the darling of the pharmaceutical industry.
In a campaign to enhance their status they devised a deliberate plan to identify the organization as a scientific discipline along with the medical profession. They were also determined to advance their position over other mental healthcare providers. They fully embraced the biological model of mental illness and the use of psychoactive drugs to treat the various symptoms and newly developed diseases and diagnoses.
The APA set out to revise the Diagnostic and Statistical Manual of Disorders (DSM-III) reference book for its 3rd edition and strived to make it different. The 1st was published in 1952 and the 2nd in 1968 and reflected the Freudian views of mental health and illness. The DSM was mainly known only within the profession. The president stated in 1977 that it would clarify any doubts that they regard psychiatry as a specialty of medicine.
A professor of psychiatry at Harvard, Vaillant, stated in 1984 that the DSM-III represents a bold series of choices based on guess, taste, prejudice and hope and that the disadvantages within the contents outweigh its advantages.
It was reliable only in the form of consistency rather than in its validity, for example if most physicians agreed freckles were a sign of cancer, the diagnosis would be reliably consistent but not valid. The book simply reflects the unproven opinions of its authors. Citations of scientific studies supporting its conclusions are either non-existent or omitted. Statements of fact are to be supported by specific references of published scientific studies in all ‘medical’ publications.
The number of diagnostic categories have multiplied and the books became larger and more costly with each new edition. It has itself become one of the major sources of income for the APA having sold over a million copies.
Treatments for emotional distress, illness and depression should not be limited to psychoactive drugs as both psychotherapy and exercise have proven effective and longer lasting in comparison. More research is needed to study other methods of diagnosis and healing in the area of psychiatry.
book: The Epidemic of Mental Illness, Why?