Dr. Peter Breggin's
Center for the Study of Empathic
Therapy, Education and Living
Bring Out the Best In Yourself!
| Dr. Peter Breggin's Center for the Study of Empathic Therapy, Education & Living Newsletter |
||
| 12/10/2010 - Volume1, Issue 12 |
| In This Issue The US GAO Requests Info on Psychiatry and Children in Foster Care Sign Up Now for Dr. Breggin's Empathic Therapy, Education & Living Conference Guest Essay: Pharmaceuticals as a Market for “Lemons” Center for the Study of Empathic Therapy, Education & Living EmpathicTherapy.org 1-607-272-5328  Center for the Study of Empathic Therapy, Education & Living 101 East State St. #112 Ithaca, NY 14850 607-272-5328 Dr. Peter Breggin's Radio Hour! Listen Every Monday at 5pm New York Time. Go here to listen live or hear his archived shows. |
Dear [Contact.First Name], The U.S. Government Accounting Office is requesting information about psychiatric drugging of children in foster care. See our public service announcement below and if you are able to provide information, please do so. Our Empathic Therapy Conference is only three months away and we are just thrilled with the number of terrific folks who are already signed up to attend. Come join us for this singular event--It will be like no other! We have a guest essay this month from an author who examines how prescription drugs have become the biggest "lemons" in the market place. This essay will help us all to "buyer beware!" Very best, Ginger Breggin, Editor Government Accounting Office (GAO) Requesting Information on Psychiatric Drug Prescriptions for Children in Foster Care  At the request of Congress, GAO is seeking information regarding cases in which state foster children have been prescribed psychotropic medication outside of federal regulations or accepted medical standards of practice. These may include very young foster children prescribed certain kinds of psychotropic drugs, children prescribed psychotropic drugs in dosages that exceed accepted standards, children prescribed psychotropic drugs for purposes other than a medically accepted indication, or children taking numerous psychotropic drugs concurrently. If you have information about state foster children being prescribed psychotropic medication outside of regulatory and/or medical guidance and are willing to provide details, please e-mail GAO at FosterKids@gao.gov. Signed: Scott Clayton Analyst, Forensic Audits and Special Investigations U.S. Government Accountability Office (GAO) 1999 Bryan Street, Suite 2200 Dallas, TX 75201-6848 (214) 777-5721 Desk (214) 777-5758 Fax Time to Sign Up Now for Dr. Breggin’s Empathic Therapy, Education & Living Conference ~ April 2011 is 3 Months Away! Dr. Peter Breggin and I are thrilled by the early response to our upcoming Empathic Therapy Conference, April 8-10, 2011 in Syracuse, NY. We already have over 75 registered attendees including over 30 international registrants from the Far East, Australia, Africa, South America, and Europe. Attendees include psychiatrists, psychologists, counselors, social workers, RNs, Educators at all levels, Adovocates, family members and individuals who have personally experienced psychiatry’s abuse. We are proud to see this event evolving and growing into a singular and remarkable occasion to expand psychiatric reform and move beyond diagnoses, drugs, and electroshock for emotional overwhelm and crisis. The Empathic Therapy Conference is occurring at the Embassy Suites Syracuse, a comfortable and classy hotel in the heart of the beautiful Finger Lakes area of New York State. Be sure to reserve your lodging at the Embassy Suites now as the hotel books up in the spring! Don’t wait any longer—Sign up now for the conference and your lodging ~ Register for the Empathic Therapy Conference Reserve your room at the Embassy Suites Hotel Pharmaceuticals as a Market for “Lemons” Donald W. Light, Ph.D. talks about his book
The Risks of Prescription Drugs
My book is a short new book for general audiences. The Risks of Prescription Drugs assembles evidence that about 45 million Americans experience adverse reactions from prescription drugs. About 2.2 million of those become hospitalized, and about 110,000 die. This makes prescription drugs a leading cause of death, behind stroke. It also makes them a major source of added costs beyond their purchase price. A market for “lemons,” according to George Akerlof, who won the Nobel Prize in economics partly for his work on it, exists when the seller knows more about flaws or dangers in products than the buyer and can profit from not disclosing them. The stereotype for this kind of information asymmetry is the used car salesman who knows a car has a dodgy differential but puts a bright shine on the exterior and says, “Isn’t she a beauty? She runs like a dream.” This is not too different from how the painkiller, Vioxx, was sold for years after evidence of cardiac trauma and is estimated to have killed more people than any other drug in history. Drug companies know a great deal about the drugs they develop and test. Because they can price new drugs under patent at many times more than manufacturing costs in order to recover development costs, they have a strong interest in minimizing evidence of harm and maximizing evidence of benefits. The conflict of interest in having companies test their own drugs for public regulators, established to assure the safety and efficacy of new drugs, is obvious. The book summarizes ways in which companies can bias trials and still have them “random.” First, they can exclude people who are older, female, or sicker – often the people most likely to take the drug – so that evidence of adverse reactions is minimized. Then they can and some have run trials long enough to pick up the main, beneficial effects but not long enough to detect adverse reactions which often occur later. Companies often test against indirect measures of clinical benefit, known as surrogate end points, and this has led them to develop entire new risks or disease models, such as the serotonin model of depression that led to SSRI drugs being sold in the billions without clear evidence that they reduced depression itself. Another surrogate disease model discussed in the book is taking statins to reduce cholesterol on the assumption that it will reduce heart disease. The Risks of Prescription Drugs also summarizes other techniques that bias trial results, such as manipulating dosages, sample size, the placebo effect, and which adverse effects are not recorded or reported. No one should be surprised: if we ask companies that stand to make huge gross profits to test their own products for public safety, we should expect them rationally to do all they can to get their most promising drug-candidates approved. Regulators like the FDA have a hard time sifting through the cartons-full of data and rely on the companies to report the results more than most people realize. Moreover, they are largely or wholly funded by the companies they regulate. They insist this does not affect their ability to make objective reviews in the interest of public safety. The book describes the ways in which companies keep negative results from being published and orchestrate (the term is “ghost manage”) which results will go to which scientific journals so that the published literature available to doctors understates the risks of harms even more. This double understatement of harms in the scientific literature then becomes the basis for sales reps trained in the arts of friendly persuasion to tell doctors, in private face-to-face conversations, how they can help their patients by prescribing these new drugs. The goal of sales reps is to get doctors, as the experts that patients trust, to write more prescriptions for their products. Doctors insist they are too smart to have their independent clinical judgment compromised by inducements, friendship, rewards for listening to presentations, or free samples of the most expensive new drugs in a therapeutic class. Yet studies show that company techniques result in doctors subsequently prescribing more of the products being promoted. In other words, companies know what they are doing, and doctors insisting they are not being taken in provides the perfect cover. Evidence also indicates that when patients report adverse side effects, their doctors are likely not to attribute it to the drug they prescribed, even when they are known side effects of the drug. The book describes the Risk Proliferation Syndrome, a set of institutional practices that maximizes the number of people exposed to the risks of prescription drugs. Reinforcing the ways in which companies test their own drugs and then are allowed to maximize their influence on doctors is approving drugs that are little better than existing ones. Independent review teams conclude that about 85 percent of new drugs are little better; so that most of the time, there is little advantage to offset the risk of harms. Companies have developed an elaborate system for promoting new drugs for unapproved uses, where evidence of benefit is even thinner or non-existent. Usually, doctors do not tell patients the drug when they prescribe a drug for an unapproved use, a clear violation of informed consent it seems to me. The manipulation of asymmetrical information in markets for lemons can be addressed. Trust can be restored, and the epidemic in adverse drug reactions stopped. Recommendations made in the book’s last chapter include approving drugs that are more beneficial than existing drugs against real clinical outcomes and paying no more for drugs that are no better. These changes would reward companies to develop clinically superior drugs, rather than flooding the market with scores of marginally innovative drugs so the marketing departments can set about persuading doctors to prescribe them. Another is to have clinical trials publicly funded and run to meet established standards for verifiable, objective measures of safety and efficacy. This would also reduce the large, risky investments that companies have to make and enable prices to be lower. Systems for patients reporting adverse effects directly to an independent safety institute already exist and wait to be implemented. Used cars are no longer a “market for lemons.” Buyers are given a full report of a detailed inspection and repairs made. Further, they’re given a 90-day warranty in case something was missed. As far as I can tell, pharmaceuticals are now the largest market for “lemons” in the world, but they need not be. WARNING -- Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems. In short, it is not only dangerous to start taking psychiatric drugs, it can also be dangerous to stop them. Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision. Methods for safely withdrawing from psychiatric drugs are discussed in Dr. Breggin's books, Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock and the Psychopharmaceutical Complex (New York: Springer Publishing Company, 2008) and Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (New York: St. Martin's Press, 2008).
Peter R. Breggin, MD is no longer affiliated with the Center for the Study of Psychiatry, informally known as International Center for the Study of Psychiatry and Psychology, which he founded and led from 1972-2002, and Dr. Breggin is no longer involved in its conferences. Copyright 2010 Peter R. Breggin, MD |
||||
