Maker of Schizophrenia Medicine Clarifies Risks

[Rose Siding]

TRENTON, N.J., July 24 -- The maker of a popular medicine for schizophrenia has notified doctors that it had minimized potentially fatal safety risks and had made misleading claims about the drug in promotional materials.

snip>
The Miami Herald reported on Saturday that several boys in Florida developed lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was cited in a federal lawsuit filed earlier this month by a doctor who contends that children have been harmed and even killed by the misuse of drugs that he blames on the aggressive marketing by drug manufacturers.

"The FDA did not think we had provided enough information, so that is why further notification was done," Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of psychotic disorders, bringing Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago.


http://www.washingtonpost.com/wp-dyn/articles/A12138-2004Jul24.html

[Keirsey]

1. Johnson & Johnson Unit MINIMIZED Risks of Drug -Report

Johnson & Johnson Unit Minimized Risks of Drug -Report

NEW YORK (Reuters) - Janssen Pharmaceutical Products, a unit of Johnson & Johnson, notified doctors that it minimized the risks of a popular drug for schizophrenia in promotional materials, according to the Associated Press.
Janssen sent a two-page letter to health care workers this week to clarify the risks of the drug, the report said, citing Janssen spokeswoman Carol Goodrich.

Goodrich did not immediately return a phone message left by Reuters.

Last year the Food and Drug Administration told several makers of antipsychotic drugs to update their product labels.

The agency determined that Janssen's promotional material minimized the risk of strokes, diabetes, and other potentially fatal complications, according to the AP. The agency also said that Janssen had made misleading claims that the medication was safer than similar drugs.

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=5765328

So, will J&J be protected by the Bush administration's plan to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices?

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=102x706683

[KittyWampus]

2. The Treatment Of Schizophrenia Is Barbaric

My two brothers are diagnosed.

The treatment is almost ENTIRELY centered around heavy duty medication.

I mean HEAVY duty.

Next to nothing for behavioral modification... diet.

Western Medicine has a lot to answer for.

[WindRavenX]

4. It is quite inhumane

Western medicine is abused by the pharmaceutical companies that will sell out people's lives for a profit.

[Eurobabe]

6. exactly!! rather than find the 'cause' they treat

the symptoms. Kind of like our government.

[mom cat]

14. And Bush wants to let these monsters off the hook even if they

knowingly deceive the doctors, the FDA and the public about the side effects. The whole gang of them need to be in jail. I heard that there is room at Abu Ghraib. Shame on them!

[ze_dscherman]

5. Ever tried behavioral modification on a severe schizo?

Yes, it's bad that schizophrenia is mostly treated with heavy medication. However, medical treatment has changed a lot in the recent years. Also, I've never heard of behavioral modification working for "hardcore" schizos. No way. And please, show me a study that shows how diets can stop schizophrenia.

The sister of my GF is a diagnosed paranoid schizophrenic. It was horrific to see how bad she and those near to her (children)had to suffer, until she finally could be convinced that she needed medical treatment. Only medication has made her/their life bearable again. The only alternative to medication would have been a forced stay in a psychiatric ward. She was only steps away from that.

Just last week she did not take her meds for some days, and got a breakdown again. Hopefully, she's back to her meds and agrees she should not have stopped taking them.

Her treatment includes medication as a base - any treatment, intervention or even only dialogue is simply impossible without her meds. Only second comes therapy, which is mostly supportive and that helps her to cope with her illness.

[susu369]

8. Excellent post

Schizophrenia is a very complicated mental illness. Tests of those unfortunate to have the illness show abnormal brain shape and size - and, of course, the brain has metabolic misfunctions (chemical imbalances). A close member of my family is schizophrenic and it touches the lives of everyone involved - unless you have been there, please don't judge.

Yes, ze_dscherman, medical treatment has improved recently and keeps me hopeful.

[psychopomp]

19. From my clinical psychologist friend

the mere diagnosis of schizophrenia is often an admission of ignorance. What I mean by that is that the symptoms of schizophrenia are quite diverse and that often the diagnosis of schizophrenia is a default when the pattern of symptoms and behavior fall into a general area.

I hope that I got it right. Anyhow, AFAIK there is no clinical "cure" for schizophrenia and even RD Laing, with his very controversial attempts at therapy couldn't help people.

[Shiraz]

9. I too have a sister w/schizophrenia

also a brother and an autistic son who probably suffers some of the same symtoms as schizophrenia although we don't know for sure because he is non-verbal. I have watched my sister for years with and with-out meds. I agree she is way better with them. However , I think a lot more research could be done to understand exactly what could help medibolically. The side effects of the drugs can be debilitating. I think meds should be a last resort not the 1st line of treatment. I have recently been under pressure to put my son who just turned 14 on these drugs because he is "becoming hard to handle" I recently purchased a book called The Natural Medicine guide to schizophrenia by Stephanie Marohn and it states over and over that B vitamins can really help not to replace all meds but maybe reduce the dosages. There is a need for more research in this area.

[KittyWampus]

10. Did I Even BEGIN To Imply Medication Isn't Warranted Or Necessary?

Re-read my post.

[ze_dscherman]

15. You called it barbaric

so your post sounded to me as if you'd think that behavioural changes and diet were superior to medication, and I don't agree on that.

The treatment of "madness" has a long history of "barbarism". It's been a long way from the "lunatic asylum" where "madmen" were just locked up to straightjackets, thorazine and haldol, to the newer medications, as applied to my GF's sister.

In her case, to see her suffer from severe paranoia, and to see what that caused - loss of job, two children taken away, unwanted pregnancy, loss of money and friends, severe stress also for close relatives - now that was barbaric. Unfortunately, doctors were part of her paranoia system, so it took a lot of patience and some trickery to finally make her see one and take medication ("They are only after my money and want to poison me").

Her overall condition has much improved with the regular medication, together with therapeutic work, a legal guardian/social worker and much support from relatives. Only when her condition worsens and paranoia overwhelms her, she drops medication.

So, what's barbaric about modern medicine in this case?

[LibLabUK]

7. Western Medicine has a lot to answer for.

Right it has a lot to answer for:

The global eradication of smallpox.

The almost total eradication of polio, diphtheria, cholera, measles, pertussis, and rubella in Europe and the US.

Extending the lifespan of people in Europe and the US to far beyond what it was only 100 years ago.

Lowering the infant mortality rate by an order of magnitude in Europe and the US in the space of two or three generations.

And that's only the tip of the iceberg.

What's the track record of alternative medicine?

[KittyWampus]

11. Taking Medication AS PRESCRIBED Is A Leading Cause of DEATH

and that doesn't even count people who suffer permanent negative effects from medications taken properly.

And before you trash alternative medicine (which I didn't even REFERENCE in my post) why don't you come up with a coherent point?

Western Medicine now relies almost ENTIRELY on medicating Mental Illness.

All that is seen is the chemical imbalance. All that is considered for treatment is chemical intervention.

It is an unbalanced and unhealthy view of Humanity and Life.

[LibLabUK]

13. Hmm

""Taking Medication AS PRESCRIBED Is A Leading Cause of DEATH""

tu quoque

Nice.. but ofcourse that's an often repeated fallacy.

"And before you trash alternative medicine (which I didn't even REFERENCE in my post) why don't you come up with a coherent point?"

My post addressed your outrageous claims about "western medicine" having a lot to answer for. I agreed that it did, and I listed the ways in which "western medicine" had contributed to all our benefit, facts often overlooked by people who say things like you had just done.

"All that is considered for treatment is chemical intervention."

I'm not a psichiatrist, but is it possible that this is the only treatment that has been shown to be effective? Evidence-based medicine and all being the order of the day.

I'm not prepared to do a medline search right now, because I'm at work, but may be you know, have their been peer-reviewed studies on alternative treatments for schizophrenia published? What were the results?

[KittyWampus]

18. It's FACT-Not Fallacy. Prescription Drugs Taken AS PRESCRIBED 4th Leading

cause of death. We are being LIED to by the Science/Pharmacological Industrial Complex. The FACT that Prescription Drugs taken PROPERLY as a leading cause of DEATH appeared in the Journal OF American Medical Association.

And about going beyond just using medication for schizophrenia... yes, I have seen papers reviewed in mainstreamn press about using behavior modification and diet. It'd take a good bit of searching to try and track it down. Will look tonight! :)

Here's info about Prescribed Drugs as leading cause of death.
....................................................................................................................................................................
JAMA - The Journal of the American Medical Association Adverse Drug Reactions May Cause Over 100,000 Deaths Among Hospitalized Patients Each Year .
http://www.ama-assn.org/sci-pubs/sci-news/1997/pres_rel.htm#jma71005
............................................................................................................................................................................
From CNN Website which obfuscates that its the FOURTH leading cause. Of COURSE they take the LOW estimate:
Study:

Drug reactions kill an estimated 100,000 a year-

Adverse reactions to prescription and over-the-counter medicines kill more than 100,000 Americans and seriously injure an additional 2.1 million each year, researchers say.

Such reactions -- which do not include prescribing errors or drug abuse -- rank at least sixth among causes of death in the United
States, behind heart disease, cancer, lung disease, strokes and accidents, according to a report published in this week's Journal of
the American Medical Association. The report was based on an analysis of existing studies.

"Serious adverse drug reactions are frequent ... more so than generally recognized," the researchers said.

The researchers analyzed studies of hospital patients conducted during a 30-year period, from 1966 to 1996. They found serious
drug reactions affected 6.7 percent of patients overall and fatal drug reactions 0.32 percent.

In the study, serious injury was defined as being hospitalized, having to extend a hospital stay or suffering permanent disability.

The authors said the most surprising result was the large number of deaths. They found adverse drug reactions ranked between fourth and sixth among leading causes of death -- depending on whether they used their most conservative or most liberal estimates.

Between 76,000 and 137,000 U.S. hospital patients died from adverse reactions in 1994, and the "ballpark estimate" is 106,000,
Pomeranz said. The low estimate, 76,000 deaths, would put drug reactions sixth. The ballpark estimate would put them fourth, he
said.

The study found an additional 1.6 million to 2.6 million people were seriously injured. The ballpark estimate was 2.1 million.

snip
Dr. Sidney M. Wolfe, director of the consumer advocacy Public Citizen Health Research Group, said he believes the numbers are on target.

"I've read most of these studies, and they represent large hospitals, small hospitals ... a heterogeneous sample of the kinds of hospitals in this country, and include a whole range," Wolfe said.
........................................................................................................................................................................................
Book on Amazon:

Death By Prescription : The Shocking Truth Behind an Overmedicated Nation by Ray D. Strand, Donna K. Wallace

Here's Editors Review-

*The leading drug problem in the U.S. today is not the use of illegal drugs—it is the use of legal drugs.
*The fourth leading cause of death in the U.S. is properly prescribed and administered medication. By adding improperly prescribed medication to that equation, it becomes the third leading cause of death.
*There are over 2 million hospital admissions and 180,000 deaths each and every year in the U.S. due solely to adverse drug reactions
*When the FDA approves a medication for use by the general public, less than half of the serious drug reactions are known. You—the patient—become the final clinical trial.

[RobinA]

21. So...

Does your "research" indicate how many people's lives are made BETTER by prescription drugs? How many have been saved by prescription antibiotics alone?

[ze_dscherman]

17. If I didn't take my "western" med's I would die a miserable death

How many people would have died without these "killer medicines"?

I'm a diabetic, and of course my medicine could easily kill me. Just a bit too much of insuline ... But without my injections I pretty well know what would happen to me.

Other cases in my family where "western medicine" helped? My mother survived colon/uterine cancer. She had suffer a lot from both sickness and the treatment, but she's gratefull she survived her ordeals. 20 years of life is a lot. My father got several emergency bypasses some 10 years ago, and now enjoys pretty good health.

My parents also had the luck of good accompanying "alternative" treatments - from acupuncture to ayurveda, and changed their lifestyles and diets - but they would sure be dead without "western" medicine.

I advise to stay out of extremes. Sure, western medicine has its flaws, but so has alternative medicine. I personally know of a case where a highly praised homepathic doctor almost killed a child by insisting to not treat its severe diarrhea with conventional methods. Luckily, the child's mother began thinking independently again and the child was treated in hospital. Oh, and some days ago there was a trial in our region where parents acutally let a small child die of malnutrition/sickness because they insisted to treat it only homepathically and gave it only a vegan diet. The mother was a trained nurse ...

Nevertheless, I'm pretty much convinced that a wholesome approach to health is far superior than just the treatment of symptoms with chemistry. At least, that's the way I live!

[Zidane]

16. As someone who was put on it for a month

for depression (by an incompotent doc) I can attest the meds ARE heavy duty.

It put me in some kind of "near sleep" state in which I wanted to sleep immensely, but was unable to do so no matter how hard I tried. It also impaired me to an extent where it was difficult to walk.

I took 2 pills before I quit - 1 to those the effects, and once more to make sure it wasn't a fluke.

Depression meds are sugar pills in comparison.

[AngryAmish]

22. Schizophrenia stopped Freud cold

Why? The disease is due to poor brain chemistry, not bad thoughts about one's mother. (I know that this is a poor representation of Freud's theories. However, there is no discernible difference b/w religion and Freudianism. Neither are disprovable.)

The medical treatment of schizophrenia have helped many people live normal, non-institutionalized lives. There are heavy side-effects, but the alternative is much worse by and large.

Why do Americans live so long despite eating crappy food, smoking to beat the band and boozing like no tomorrow? Wait for it...Science based, double-blind tested, non-superstitious western medicine.

[TeqBert]

3. Bush Blocks People's Access to Courts

President Bush is changing the rules that govern people's access to the court system. Pres. Bush is making the FDA the floor and ceiling concerning court cases involving pharmarcy and medical equiptment companies.

[newyawker99]

20. Hi TeqBert!!

Welcome to DU!! :toast:

[noonwitch]

12. Risperdol appeared to have less side effects than previous meds

I don't know much about this recent study, but it is one of the newer meds used for schizophrenia and other conditions. The old ones, like Thorazine, Stelazine, etc., left the patients so drugged up that they couldn't differentiate between their symptoms and reality. Risperdol doesn't cause the same level of confusion and the patients were considered better off.

It is a newer drug, so perhaps the FDA didn't study long-term effects as it should have, or it is a drug that shouldn't be prescribed to certain age groups. But the goal of using a drug like Risperdol to treat schizophrenia was a positive one-to have less negative side effects than previous medications.

Perhaps some schizophrenics can learn to function without meds, particularly if they have people to manage their money, clean their house and make sure their physical needs are taken care of. But most need to be independent and to function in society. And violent schizophrenics need to be medicated, because it beats incarcerating and jailing them to protect society and themselves.