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[joseph1951]

Gli antidepressivi della classe SSRI non funzionano.
Hanno un effetto quasi identico al placebo.


Oggi sono stati pubblicati i risultati dello studio poliennale sul monitoraggio dell’efficacia degli antidepresivi della classe SSRI ,condotto sia in Inghilterra che negli Statti Uniti sotto l’egida del Professor Irving Kirsch dell’University Of Hull e pubblicati online (su internet) sul Public Library of Science. L’effetto degli SSRI (Prozac, Venlafaxine Seroxat e Effexor, ecc.) ha dimostrato che questi composti sono leggermente superiori al placebo nell’allievare la depressione e che Gli efffetti collaterali gravi di tali trattamenti , protratti per lunghi periodi di tempo sono molto seri, (su 1/3 dei pazienti trattati).

Si presume che la minoranza dei pazienti che ha tratto beneficio da tali composti abbia geni che neutralizzano gli effetti nocivi di questa classe di composti.. E’ stata altresi’ confermata la tesi di aumento dei suicidi e di ideazioni suicidarie causata da questi composti.. Viene messo altresi' in dubbio il prescrivere questi farmaci per attacchi di panico.

Da dieci anni predico che gli SSRI non funzionano nella maggior parte dei pazienti e che sono dotati di un meccanismo di azione troppo alieno alla biochimica umana (inibitori del reuptake della serotonina , inibitori della ricaptazione della serotonina).

L’inibizione della ricaptazione della serotonina impedisce alla cellule cerebrali di riassorbire la serotonina che hanno eliminato

Le cellule nervosa fanno entrare la serOtonina nelle cellule cerebrali, quando ne hanno bisogno e poi la fanno uscire , la “sputano fuori dalla cellula”, quando essa non serve piu’, e poi la riportano all’interno della cellula quando ne hanno di nuovo bisogno. La ricatturano al bisogno.

L’inbizione della ricaptazione degli SSRI impedisce alla cellua nervosa di ricatturare la seronina e riportarla all’interno della cellula,. In un primo tempo ,le cellule reagiscono aumentando il numero dei recettori serotoninergici presenti sulla parete cellulare, ma, poiche’ il meccanismo degli SSRIS e la loro farmacodinamica sono diversi da quelli fisiologici, la ricapatazione della serotonina da parte delle cellule nervose, non avviene in maniera soddisfacente, quindi le cellulle nervose continuano a produrre sempre piu’ freneticamente, ulteriori recettori di superfice della serotonina , finche’, alla fine, collassano, mentre la sertonina si accumula nel cervello all’esterno delle cellule nervose,

Inzia cosi’ il processo iperosidativo del cervello, causato dagli SSRI.

Gli SSRI hanno effetti anticolinergigi di grado variabile.

Alcuni, quail il Prozac facilitano il rilascio dell’Ossido Nitroso (Ciclo NO/ONOO) mentre altri , qualI la Velafaxine, L’effexor, ecc inibiscono il rilascio dell’ossido nitroso.


1
Uno squilibrio del ciclo NO/ONOO provoca tacicardia parossisitica, sbilancio della pressione, problemi ortostatici, capogiri,, vertigini, sudorazione profusa, iperventilazione, vasodilatazione, ecc.

Sono tutti sintomi che depongno per una sregolazione del ciclo NO/ONOO e che si possono produrre anche sperimentalmente, in soggetti sani, con nitroderivati, usando composti quali la nitroglicerina, il cardio-max, il sildenafil, ed infine per avere un’effetto violento con i “popper” (nitrito di amile , nitrito di butile, ecc).

Gli psichiatri classificano questi sintomi “come attacchi di panico” mentre da anni io sostegno che potrebbero benissimo essere (almeno in certi casi) rilasci improvvisi e massicci di ossido nitroso dovuti a disregolazione del ciclo NO/ONOO, secondaria a disfunzioni metaboliche mitocondriali, oppre disregoazione causata da agenti tossici.

Detto per inciso anche l’asunzione di dosi massiccie di un amminoacido essenziale quale la l-arginina, puo’ provocare tale rilascio di ossido nitroso, tramite il rilascio repentino di ossido nitoroso, e causando tutti i sintomi descritti sopra, che gli psichiatri chiamano “attacchi di panico”. La venalfaxina e l’effexor riducono gli “attacchi di panico psicosomatici", inibendo il rilascio dell’ossido nitroso, ma al costo di gravi effeti collaterali.

D’altro canto, vi e’ da rilevare che molti “attacchi di panico” rispondono bene alle terapie che agiscono migliorando il funzionamento mitocondriale e che, al contempo, riducono i fenomeni iperossidativi.

L’arginina, esercita un’effetto opposto a quello della lisina. La l-arginina serve a produrre l’ossido nitroso, migliora il numero degli speramatozooi, ecc.

Se sommiinstrata in dosi masiccie, l’arginina puo’ ache attivare il virus dll’Herpes, mentre la lisina lo disattiva.
In certi casi, in certe persone, un disfunzionamrnto del ciclo NO/ONOO potrebbe essere causto da un rapporto anomalo di arginina/lisina.
L'arginina viene usata anche in dosi alte ed assieme a vitame per ottenere un effetto viagra naturale, aumnento delle erezioni e della loor durata.

Cmq dosi elvate di arginina andrebbero assunte solo su consiglio di medico- o su consiglio di un esperto nutrizionle.
Infatti, l'assunzione di dosi masiccie di arginina puo' causare episodi catatonici e/o schizofrenici, in soggetti predisposti.

Ritornando agli SSRI


La notizia sull’inutilita’ terapeutica degli SSRI e’ stata riportata dai maggiori quotidiani inglesi , quali il “The Independent”, “The Guardian” e il “The Times”.

Il nafazodone non e’ stato preso in considerazione in quanto gia’ ritirato dalla casa farmaceutica che lo produce, per via dei gravi effetti collaterali riscontrati durante l’uso clinico.

Per altri SSRI, le case farmaceutiche che li producono non hanno inviato le documentazioni contentti i dati rilevanti al Professor Kirsch. Chissa' perche.


Nel frattempo, l’industria famaceutica non se ne e’ stata con le mani in mano: ha cambiato i foglietti illustrativi dei farmaci sotto accusa, suggerendono di usarli nelle “sindromi da tensione premestruale" (sic!)

Nel Regno Unito si prescrivono 31 milioni di ricette di antidepressivi all’anno, per un costo complessivo di 390 milioni di Lire sterline, di cui 120 milioni per i soli SSRI.
------------------------------------------------------------------------------------------------

Anti-depressants 'over prescribed'
26 February 2008

Research indicating that new-generation anti-depressants work no better than dummy pills was seized upon as evidence that doctors are over-prescribing.

Mental health campaigners said millions of people with depression were not getting sufficient access to talking therapies due to GPs being over reliant on prescribing drugs such as Prozac.

It follow a review of clinical trials that found that such drugs had no more effect than a placebo for mildly depressed patients and for most people suffering severe depression.

The study showed that even trials suggesting benefit for severely depressed people did not provide evidence of clear clinical benefit, researchers said.

Dr Tim Kendall, deputy director of the Royal College of Psychiatrists Research Unit, said the findings were "fantastically important".

A group of experts, led by Professor Irving Kirsch, from the Department of Psychology at the University of Hull, analysed 47 clinical trials using data released under Freedom of Information rules by the US Food and Drug Administration (FDA).

The researchers looked at four commonly-used anti-depressants and the clinical trials submitted to gain licensing approval.

They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).

They found little evidence of benefit when analysing both unpublished and published data from the drug companies.

Furthermore, the seemingly good results for very severely depressed patients came from the fact a patient's response to the dummy pill decreased rather than any notable increase in their response to antidepressants.

************************

For Further Information:

The Independent - The vested interests that conspire to bury bad news
The Times - Depression drugs don’t work, finds data review
BBC NEWS - Anti-depressants 'of little use'


===============================================
Stati Uniti


February 26, 2008
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Today's Top Stories:
1. Study: Antidepressants useless for most
2. Pfizer yanks Lipitor ads starring Jarvik
3. Supremes leaning toward pre-emption?
4. Mylan steps into pain-patch void
5. FDA issues more alerts--or does it?
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What’s New
1. Study: Antidepressants useless for most
Comment | Forward to a friend
Here's a study guaranteed to put almost every drugmaker on the defensive. Researchers analyzed every antidepressant study they could get their hands on--including a bunch of unpublished data obtained via the U.S. Freedom of Information Act--and concluded that, for most patients, SSRI antidepressants are no better than sugar pills. Only the most severely depressed get much real benefit from the drugs, the study found.
That's quite a conclusion, considering that antidepressants are among the world's top-selling meds, accounting for billions in revenues every year. Manufacturers rushed to defend their products, saying that regulators in many countries had reviewed the data and concluded the drugs were effective. GlaxoSmithKline, for instance, said that this new study only looked at "a small subset of the total data available."
But the study didn't come as a surprise to some, including one U.K. expert who's published research showing that drug companies only tend to publish data that shows their products in good light. The new paper, published today in the journal PLoS Medicine, breaks new ground, according to The Guardian, because the researchers got access for the first time to an apparently full set of trial data for four antidepressants: Prozac (fluoxetine), Paxil (paroxetine), Effexor (venlafaxine), and Serzone (nefazodone). And the data said..."the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance." Ouch.
The study could have a ripple effect, affecting prescribing guidelines and even prompting questions about how drugs are approved. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported," one of the researchers said. In other words, all trial data needs to be made public.
- read the coverage from the BBC
- see this article and column in The Guardian
- see this Q&A about the study in The Telegraph
Related Articles:
Antidepressants--Top 10 Warnings and Recalls of 2007. Report
Positive data more likely to find its way to public. Report
U.K. ratchets up antidepressant warnings. Report
Suicide stats fuel debate over SSRI drugs. Report



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2. Pfizer yanks Lipitor ads starring Jarvik
Comment | Forward to a friend
All right, already, Pfizer says. The drugmaker is pulling its Lipitor ads that feature artificial heart inventor Robert Jarvik. That's after a flurry of media coverage--in which Jarvik was shown to lack a license to practice medicine and, horror of horrors, to lack rowing ability. The latter deficiency was relevant, of course, because one ad showed Jarvik sculling across a lake, only it wasn't the doctor but a body double.
"The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions from our primary goal," a Pfizer statement said. "Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople."
Pulling the ads probably has a bit to do with a Congressional investigation as well. You'll recall that the House Committee on Energy and Commerce had been looking into the ads, questioning whether Jarvik was qualified to recommend the cholesterol med. Now, the committee's lead investigators are chuffed. "I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Jarvik," said Rep. Bart Stupak, who chairs the subcommittee on oversight.
However, the committee doesn't appear to be satisfied. Stupak told the New York Times that the group intends to continue investigating. Including taking a meeting with Jarvik himself.
- read Pfizer's release
- see the article from the New York Times
- check out the item and one ad video at Pharmalot
- see the commentary at DrugWonks
- read the item at the Wall Street Journal Health Blog
Related Articles:
Congress wants more on Jarvik. Report
Lipitor doc doesn't practice rowing, either. Report
House objects to Pfizer's Lipitor pitchman. Report
Drug ads challenge reputation of inventor. Report
3. Supremes leaning toward pre-emption?
Comment | Forward to a friend
Yesterday court-watchers got another sneak peek at which way the Supreme Court might lean when they hear the big drug liability case next term. In hearing arguments over Michigan's law that shields pharma from liability suits unless they commit fraud to get their drug approved, Justices Stephen Breyer and Anthony Kennedy "expressed broad skepticism" about liability suits against drug makers, Forbes reports. Breyer said--and this is key--that the suits second-guess the FDA's decision to approve the drug. An expert agency is better qualified to make decisions about a drug's safety than is a jury of 12 randomly selected citizens, Breyer said.
Of course, that sentiment is just what drugmakers would like to see borne out when the Court takes on the case of Wyeth v. Levine in October. In that case, the court is being asked to determine whether FDA approval pre-empts personal injury lawsuits. Last week, the Supremes decided that for medical devices, a specific type of rigorous FDA approval does shield manufacturers from liability suits.
If the wind were ever blowing in drugmakers' favor on this issue, it's now. Before the Bush administration, the FDA argued that lawsuits gave patients additional protection, the New York Times notes. Now, the administration says lawsuits conflict with the agency's ability to do its job. So, apparently, believes Justice Samuel Alito, who asked yesterday whether a state lawsuit should be allowed to proceed even though it might "very seriously interfere with what the FDA is doing."
Ironically, part of the government's argument in this case is that the FDA competently oversees the drug and device markets. An assessment that, after recent expert critique and importation snafus, is certainly open to question.
- read the Forbes article
- check out the NYT article
Related Articles:
Supreme Court shields device makers. Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report
4. Mylan steps into pain-patch void
Comment | Forward to a friend
Color Mylan vindicated. When Johnson & Johnson recalled one of its popular Duragesic painkiller patches two weeks ago, the FDA called on the generics maker to help fulfill demand. Of course Mylan agreed--and in doing so has been touting its patch technology.
You see, the J&J patches were recalled because of potential problems with their drug reservoirs. This type of delivery system is sometimes referred to as a "ravioli" patch because the active gel is stored in the middle of the adhesive. In some of the recalled patches, the reservoirs were leaking, raising the risk of overdose.
Mylan's patch, however, uses a "matrix" design that embeds the active ingredient within the adhesive, so leakage isn't an issue. The company has been pointing out the risks of reservoir patches for years, a spokeswoman told the Wall Street Journal Health Blog. Now, as the blog notes, Mylan gets to say it told you so.
- see the item for more
Related Articles:
Millions of fentanyl patches recalled. Report
Another company recalls fentaynl patch. Report
Mylan CEO intent on new global biz. Report
5. FDA issues more alerts--or does it?
Comment | Forward to a friend
Another week, another safety alert from the FDA. According to the Washington Post, the agency has issued 14 advisories since early November, leading one Wall Street analyst to suggest a color-coding system a la the Department of Homeland Security--so that we can all know instantly just how serious the risk might be.
The agency confirms that the seeming uptick in alerts isn't our imagination. It's communicating concerns to the public more quickly these days; one official said the regular early warnings are fulfilling a promise from HHS Secretary Mike Leavitt to tell the public sooner about adverse drug reactions. And perpetual FDA critics such as Rep. John Dingell call the increase in activity "a quantum improvement."
The Post goes on to detail the different sorts of warnings and give examples of each. But in picking up the story, the Eye on FDA blog did a little due diligence and found a different angle. FDA MedWatch Alerts did increase--from 2003 to 2005. In 2003, there were 108; in 2005, 300. But in 2006 the number dropped to 120, and in 2007 barely grew, to 157. So far in 2008, the FDA has issued only 19 MedWatch alerts. That is indeed more than one a week. But at the going rate, we'll end the year at only around 145.
- see the report from the Washington Post
- read the follow-up at Eye on FDA
ALSO: RPM Report is predicting--or perhaps just speculating--that the FDA is gearing up for a significant crackdown on drug investigators. Report
Related Articles:
Top 10 Drug Warnings and Recalls of 2007. Report
FDA badly needs more money, staff. Report
FDA can't guarantee drug safety. Report

Also Noted
TODAY'S SPOTLIGHT... Vasella defends dual role at Novartis
Novartis Chairman and CEO Daniel Vasella (photo) got a bit defensive at his company's annual meeting yesterday. Questioned about his pulling double duty as chairman and CEO, Vasella countered that firms with one person in each slot spend too much time and money settling conflicts between the two. Report
> Lawmakers investigating Genentech's pricing of macular degeneration drug Lucentis have backed off of holding hearings on the issue. Report
> A new study suggests that antibiotics are overused in people dying of dementia and should be reconsidered because of the growing problem of resistant superbugs. Report
> Sanofi Pasteur is sending 6 million doses of yellow fever vaccine to help quell an epidemic of the disease in Latin America. Release
> Pfizer has cut its workforce at a plant in Groton, CT, to a small shutdown crew; at its height locally, Pfizer employed thousands of people, and most recently had about 500 workers. Report
> Bayer has proposed a 2007 dividend of €1.35 per share, up from €1 per share a year ago. Report
> In a study that may change the way that cancer drugs are developed and prescribed, scientists have determined that genetic mutations are different in every cancer patient, suggesting that drugs will need to be "tailored" for small groups. Report
> Patients most likely to benefit from genetic testing are either avoiding it altogether or paying for it themselves to keep hereditary disease out of their health records--and most importantly, off the books of their insurers. Report
> The International Stem Cell Forum is meeting in San Francisco, bringing together 21 stem cell research institutes and representatives from 19 countries to review such issues as the moral and ethical guidelines needed for research and the registry of ESCs lines. Report
> High rainfall, biodiversity and rapidly growing populations are considered breeding grounds for new outbreaks of diseases like SARS and Ebola. Report
> Clarus Ventures has raised $660 million for its second life sciences fund. Report
And Finally... You know it's trendy to bash DTC ads when Saturday Night Live gets in on the act. Report

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