Posts Tagged ‘FDA’

Suggestible You 11

March 27, 2017

“Suggestible You” is the title of a book by Erik Vance.  The subtitle is “The Curious Science of Your Brain’s Ability to Deceive, Transform and Heal.  This is the eleventh post on this book. This post deals with depression.

Vance describes depression as like being chemically sedated into someone you don’t recognize.  He writes that given the choice, he might prefer excruciating chronic pain to depression, then goes on to note many people suffer from both.  He notes that about 7%  of Americans will experience clinical depression this year, losing the United States more than $200 billion.

It is clear that placebos are effective against depression.  Remember that to be declared effective the drug is compared against a placebo.  But when antidepressant drug tests are examined about 75% to 80% of their efficacy can be attributed to placebo effects.  Moreover, there was no real difference between high and low doses, which is odd.  Differences are expected with truly effective drugs.

Moreover, over the past few decals, scientists have noticed a distinct uptick in the power of the placebo effect on pain and depression trials.  Some experts even say that if Prozac had to compete against the placebo effect today, it would not have been cleared by the FDA.  Once a drug clears the Phase III, placebo-controlled trial, it is certified regardless of how it performs in later experiments.

For drug manufacturers trying to get new drugs approved, this is a problem.  But it should not be a problem for depression sufferers.  Remember the reason of including placebos in these tests is that placebo effects are real.  Placebos are much less expensive than the drugs, and carry no side effects.  HM wonders, as long as they are 75% to 80% effective, why take the drug.  Physicians should also be asking the same question.  Now it is clear why drug companies continue to try to develop new anti-depressants.  But after some many decades of research, with all the antidepressants already approved, and with placebos being largely effective without any adverse effect why bother.? At some point the difficulty in exceeding the effect of the placebo might prove so expensive that drug companies might abandon the effort.

© Douglas Griffith and healthymemory.wordpress.com, 2017. Unauthorized use and/or duplication of this material without express and written permission from this blog’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Douglas Griffith and healthymemory.wordpress.com with appropriate and specific direction to the original content.

The Exploitation of Patients with Alzheimer’s Disease

June 17, 2012

The Outrage of the Month published in the Public Citizen Health Letter1 begins “For the second time in less than two years, the Food and Drug Administration (FDA) at the behest of companies seeking to exploit the large market for Alzheimer’s Disease has approved a product with little proven benefit and documented risks.” According to the article, the earlier of these unwarranted FDA approvals occurred in July 2010 when the FDA approved a new high-dose version of the top selling Alzheimer’s drug Aricept 23. The article states that the agency approved the drug over the objections of most of its own scientists who argued that the drug did not improve overall functioning, but caused considerably more side effects than the older, lower does version of the drug.

According to the article, the most current example is the dye Amyvid that is injected into patients with possible Alzheimer’s disease and on the basis of a brain scan is used to detect amyloid plaque in the brains of such patients. Although amyloid plaque is found in the autopsies of those who have died from Alzheimer’s disease, it can also be found in individuals who never evidenced any symptoms of the disease. This test is inaccurate. It has been found to detect plaque in some patients who do not have Alzheimer’s disease and failed to detect the plaque in some patients who have the disease. Nevertheless, the dye is a financial boon for the drug manufacturer as was Aricept 23.

It is important to realize that there is no drug that cures Alzheimer’s disease. Some drugs have been shown to slow the progression of the disease. A friend of mine has a father-in-law who is suffering from Alzheimer’s and is undergoing expensive drug treatments. His father-in-law has no idea who is son-in-law is or even who himself is. This raises an interesting question. Are these drug treatments enhancing life or delaying the release from suffering that death provides? I stress that this is a question for each individual to decide.

See the Healthymemory Blog post “The Myth of Alzheimer’s” that reviews the book written by Peter J. Whitehous, M.D. Ph.D. Whitehouse is a renowned researcher into drugs for the treatment of Alzheimer’s. He has given up on there being a drug to cure the disease and is researching other methods for coping with dementia. He does not believe that Alzheimer’s is a distinct disease, but is rather a manifestation of dementia. It is interesting to note that the founder of Alzheimer’s disease, Alois Alzheimer, never was convinced that it was a distinct disease.

It should be realized that this is just another instance of the problem with medical care in the United States. Hardly anyone in the United States receives the best medical treatment. The plight of the uninsured is well known, but few realize that those at the other end of the treatment spectrum, those who receive treatment in the most expensive health care system in the world, are also ill-served. People at this end are grossly overmedicated and undergo unneccesary costly operations. See the book, Worried Sick: A Prescription for Health in an Overtreated America,” by Nortin M. Hadler, M.D.

1May 2012, 28, 5. Sidney M. Wolfe, M.D. (ed).

© Douglas Griffith and healthymemory.wordpress.com, 2012. Unauthorized use and/or duplication of this material without express and written permission from this blog’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Douglas Griffith and healthymemory.wordpress.com with appropriate and specific direction to the original content.