Although the concept may seem simple, that of a psychiatrist prescribing medications that supposedly work, cause little or no harm, and are scientifically proven to meet at least these aforementioned three criteria, couldn't be further from simple. Many well-intentioned, very well-educated, highly experienced and dedicated psychiatrists face medication dilemmas in many ways and many times each day. Where is the properly researched, scientifically based drug information?
There are many elements that combine to make this search dauntingly difficult. Not necessarily in order or complete, the following are some:
1) Lack of reliable research. Reliable, high quality, properly done, easily accessible, double-blind placebo controlled research, should it exist (which it usually doesn't), is nearly impossible to find. Evidence-Based Medicine, perhaps the sine qua non of drug research information, is in its infancy and very hard to find.
2) Advertisements in medical journals are usually useless and often misleading. There are ugly and pretty pictures, the ugly to illustrate pre-drug nightmarish visage and the latter to illustrate beautiful butterflies, flowers and birds, ostensibly showing a drug's "success." These dueling pictures usually present only vapid information about the medications advertised.
In-article, relevant and reliable information as to how to find the research to support claims made in the advertisements are virtually always absent. For example, criteria for accepting advertisements by the New England Journal of Medicine (NEJM) -- one of, if not the most, prestigious medical journals in America -- can be read on it's website. Basically, the ads that are published are what drug makers want to sell. The rules of NEJM governing the publication of ads are virtually all designed to keep the NEJM from getting sued/held liable with very little if any attention paid to the need, quality, appropriateness, research support and safety of the drugs that are advertised. If you can't prove it, don't print it, would be a good start for medical journal advertising.
3) Separating properly done research from it's improperly done brethren, is nearly impossible. Journals do not publish but rarely the findings of failures. 'Researchers' seeking FDA approval of a drug usually follow the same pathway. Their bias is to find positives, not negatives. Car company ads will never point out their particular car's defects, but their wondrous features. If their car has 'real' wood ashtrays, we'll all know. Information on serious defects will be buried.
4) The FDA. A useful and reliable FDA would, of course, be very helpful. It should be a veritable Fountain of Eden of information about both new and past-approved drugs. It is neither. Previously FDA approved drugs form the vast amount of drugs that are frequently used. For every new drug approved, there are many that have long since been approved. Review of past FDA approved drugs is minimal or nonexistent.
The FDA has a set of steps that a new drug must pass to be approved. There were, until 1996, three steps to approval. Since 1996, the number has gone up to a whopping four. The FDA initiated Step 4 in its drug evaluating procedure in 1996, a required re-testing and reevaluation of new and recently approved drugs by the manufacturer, not the FDA. Presently, only 14 percent of drug companies follow this rule on at least one drug. There are no penalties for not following this procedure.
The parameters of this reevaluation are not clear, but are not followed anyway. Sixteen years since Step 4 and virtually no adherence. (Not to worry, the FDA is thinking of pulling from the market a drug whose Step 4 has been asked for by the FDA for 14 years without response. Haste must make waste.)
The FDA does no research of its own, but only receives information from the manufacturers of the drugs seeking approval. Obviously, that procedure is fraught with opportunities to manipulate test results. Clinical trials, Step 3, leading to FDA approval are usually woefully short, ordinarily lasting between 6-12 weeks. I sometimes think, cynically, that 6-12 weeks of 'trial,' usually compared against a placebo, is about enough time to see if someone drops dead or not. Nothing more.
For example, a newly FDA approved drug, "Intuniv" in an ad in September's "Clinical Psychiatry News," states, apparently proudly, that two clinical tests were run on this drug prior to FDA approval, one lasting six weeks, the other nine. Any information as to how these trials were done is absent. This drug is to be used by our children, diagnosed with ADHD/ADD. I think our children deserve a vastly more thorough evaluation by the FDA prior to approval of this or any drug. How one determines the actual usefulness and safety of a new drug in six to twelve weeks of clinical trials completely escapes me.
Marcia Angell, M.D. the first woman to serve as editor-in-chief of the New England Journal of Medicine and currently a Senior Lecturer in the Department of Social Medicine at Harvard University School of Medicine, has been a stern critic of U.S. health care in general and the pharmaceutical industry in particular. She is scathing on the topic of how clinical trials are conducted and advertised in America. She also comments on medical scientific papers.
5) Direct, personal, sales promotions to psychiatrists are usually professionally empty -- yet a social delight. Usually, psychiatrists are visited by pleasant, smart, attractive drug reps, extolling the virtues of their products. Their presentations usually include charts and graphs showing the superiority of their drugs over placebo. There is never a comparison of their Drug A and Drug B, which are similar drugs, but made by different drug companies. Pleasant visit, no useful information.
Meetings, usually dinners, as of this year, have taken on a new and ominous quality. They used to be more fun. Psychiatrists can be suckers for meals, particularly dinners. Build a dinner at a nice restaurant and we will come. The format used to be that an expert, unfortunately paid by the drug company, would come and participate in the dinner, answering questions, offering information, etc. These meetings, depending on the speaker, were often very informative to the psychiatrists in attendance. The rules for these meetings have changed radically as of January 1 of this year. The speaker is only allowed to talk about the drug of the sponsoring drug company, unless, and only unless a question is brought up by attendees about other topics. The pall that envelops the audience with these restrictions and reluctance to ask 'other' questions, such as information abut other drug manufactures' similar drugs, is stultifying.
So, we have one more sales meeting and one less source of information and at least one less attendee -- myself.
Follow Ronald Ricker on Twitter: www.twitter.com/RonaldRickerMD
Leo Galland, M.D.: ADHD Is on the Rise: How to Use Nutrition to Treat Attention Deficit
Mark Hyman, MD: Science for Sale: Protect Yourself From Medical Research Deception
WebMD Drugs & Medications – Medical information on prescription ...
Transparency: The Most Prescribed Psychiatric Drugs - Health - GOOD
Oh, excuse me it isn't a bribe, it is a "speaking fee" and it isn't a paid for family vacation, it's a "business trip".
With that system, doesn't matter if you are insane, or have a paper cut, you won't be able to trust the person writing the scrips...
There is a remarkable opportunity at hand---an example of pretty much all that I have written in my exciting blog—about of all those pills. Aretha guides me---you know, “Dr. Feel Good”. You will see examples of problems that face regular people, Physicians (they’re usually regular people as well (no pun intended) unless ‘ka-boom”. These are your tasks. There will be a written exam. I can sell you some ‘written exam’ pills, although research has just started and a few have died, so I’m holding back, unless you want to go no label at all. (meet you on the corner, special today). You get to evaluate a new drug or mechanical device, depending on your point of view. Features you should look for should start with a careful search of the literature. The name of the company making this drug is Gelesis and it is called Attiva. Places to look (a hint) include Google, Huffington, and so forth. Items you should try to find include 1) mechanism of action; 2) side effects;) sponsor;) supporters, indivduals and institutions;( I’m giving no hints on individuals); current state of ‘research’; academic qualifications of supporters—this can be very important—good school equals good research. I went to Berkeley, Tufts Medical School, LA Children’s Hospital, was the National Institute of Mental Health, UCLA NPI, and the LA Psychoanalytic Institute. Hint, because of all that, you can believe anything I say). Now get to work. Exam in two hours.
http://www.youtube.com/watch?v=lXlIwnt0VgE
Not defending the Pharma Cos, but wanted to point out that Intuniv is NOT a "new" drug...it's the same thing as Tenex, which has been on the market for years, and has gone through rigorous FDA testing in order to be originally marketed. Tenex is used to treat hypertension and has been used as an off-label treatment for ADD/ADHD for several years. So Intuniv has gone through all of the original clinical trials, etc that any new Rx drug has...and clinical trial info is readily available on the web.
I do agree that the 2 short clinical trials in children is not much...especially if one doesn't know the sample size, etc for either of these trials.
http://www.drugs.com/pro/intuniv.html#splSection20
The way they market and sell these poisons on TV to the general public using Madison Ave-style subliminal techniques is criminal. They often invent diseases and scare people with TV ads into requesting these drugs from doctors.
Psychotropics should be used only in rare, extreme circumstances...today they are taken as casually as one drinks a cup of coffee in the morning and many doctors get paid commissions from pharma for prescribing them.. This is why in many doctors offices you see all kinds of ads for drugs - the coffee mugs, the wall clocks, the pens, the calendars - everything is full of ads bombarding patients with advertisements for drugs.
Psychiatrists have too much power in our society.They can take away your freedom by simply pronouncing you insane and a threat to yourself or others and , in many states, you can be locked up against your will till the psychiatrist decides to free you.
They will force feed you drugs in these institutions against your will. If you refuse, they will strap you down and inject you with psychotropic drugs. It's a form of pharmaceutical lobotomy. Doctors have that much power in this society.
A person close to me was recently prescribed a medication for depression and one other medication used to treat schizophrenia and depression. After about 3 months I have noticed a marked change in her - for the better - and I didn't expect it, but cannot deny that it happened. She's now a bit more social, laughs more, smiles more (not in a deluded way but in a genuinely happy way) and some of the self destructive behaviours she engaged in have stopped (smoking, for one).
I'm certain she is not representative of every single psychiatric patient, however your claims of horror simply do not apply to her, and, I suspect, to many people who have received a genuine benefit from psychotropics.
Say what you like about the evils of "big pharma", but my friend is improving her life, and I, for one, am grateful.
The drugs aren't perfect. They don't make your life perfect. They just make it so that you can function.
Drugs are often used to mold healthy people into conventional, well-adapted, consumer units who produce and help perpetuate a sick society. Society needs people who 1) work in order to be able to consume the garbage corporations sell and keep the economy "growing", 2) are obedient and respect the capricious laws imposed on them and don't challenge govt authority, 3) adhere to the specific moral standards of the whole, and 4) function according to consensus reality - which is why entheogenic plants like Peyote and Ayahuasca are illegal even for spiritual ritualistic use. Hallucinogenics enable people to step out of the mental construct they've been hypnotized and conditioned to accept as the only valid reality.
Society invests years or schooling ( from pre kindergarten to post graduate ) and media to condition people a certain way and those trippy plants can undo all that work very quickly.
People who don't fall into those neat categories are diagnosed as bipolar, ADHD, manic depressive, psychotic, etc. and then they are pharmaceutically lobotimized.
I'm so grateful that we have drugs that can help allievate human suffering. Do I think big pharma goes too far? You bet. Dry mouth, restless legs, etc. are conditions that DON'T need medicine per se.
But don't go throwing out the baby with the bathwater.
Now we are in a similar situation to that of the late 19th century again.
Give the patients 'medicine' (drugs) to 'correct their chemical imbalance' which we know too little about - but what and who is going to work with them on their life issues?
Drugs can't work on your life issues and they can't resolve them.
I am appalled at the common idea that any feeling of unhappiness is a mental illness, any deviation from an imagined norm of how we should feel (where is the research on that norm?) can only be 'treated' by drugs that often lead to life long dependency.
why is nobody talking with the patient?
why are patients encouraged to think of themselves as malfunctioning machines who depend on the expensive input of chemicals rather than as people who work through life issues?
I don't take medication so that I can 'be happy' all of the time. I take medication so that I don't feel 24/7 anxiety, have panic attacks without warning, can leave my house without crying in fear, and get out of bed in the morning, to name a few reasons. I have suffered since I was a child. I exercise, take supplements, don't eat processed food, etc.
If you had ever dealt with such issues, you would understand. It's easy for someone who doesn't need the drugs to vilify those who make the drugs and those who do need them.
http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/
As a technologist and lawyer, I have the following suggestions:
1. Criminalize acts by researchers (including government employees) for ghostwriting research papers, falsifying data, and withholding of conflicts and negative research results. If such acts result in pharmaceuticals causing illness/death, homicide charges could result.
2 Criminalize acts by BigPharma management/employees which fund/promote any of the activities listed in 1 above, including falsifying/withholding data provided to the FDA for drug approvals.
3. Establish an anti-revolving-door policy for FDA employees to avoid being compromised by other institutions, as follows: anyone who has worked at the FDA would not be able to work for any company in the medical industrial complex for at least a year after quitting their post. The reverse would also be true.
4. All of the research conducted at universities receiving any federal funding would be posted free, and there would be open dialog with consumers via the web.
Roy Mankovitz, Director
http://www.MontecitoWellness.com
A research organization
Anti-revolving door policies are nice until you are looking for a job. You assume that someone who has left the Pharma industry is morraly corrupt and incapable of doing a proper job. It is just as likely that someone who has left a Pharma company is upset (how many layoffs have there been lately?) and will have a grudge against the industry but I guess that is OK. If someone is biased improperly, they should be fired but until you come up with a diagnostic test for such bias these policies are morally wrong based upon the presumption of guilt.
Your number 4 sounds like a good idea but do you really expect that someone who is spending 50% of their time writing grant proposals in order to put food on the table will spend any amount of time in "open dialog with consumers via the web"? Not realistic.
http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201010290807dowjonesdjonline000408%20&title=merck-books-950-million-reserve-to-settle-us-vioxx-probe
Nobody goes to jail, and FDA employees are, for the most part, shielded from criminal suit.
Your comments to my points 3 and 4 appear to be excuses for continuing the current dysfunctional system, rather than proposals for change.
Considering that the medical community is at least the third leading cause of death in the U.S., it would seem that radical changes are needed. See:
http://www.jhsph.edu/bin/s/k/2000_JAMA_Starfield.pdf
Got any positive suggestions? You can find more of mine in “The Wellness Project.”