Furious Seasons

January 24, 2008

FDA Now Requiring Suicide Assessments Of New Drugs

Pardon my really sarcastic attitude for a moment, but how the hell else does one properly reply to the inanity of federal regulatory agencies when it is pressed right in your face. Yet again.

OK. Strange as this might sound, the FDA is now officially entering the real world and is now requiring that detailed suicide and suicidality assessments be completed by companies and researchers trialing new drugs. Amazingly enough, the laziest (or the most hamstrung) agency in Washington, D.C. never required them before despite decades of evidence that some drugs caused these problems in both clinical trials and after approval. And it's not only some psych meds that have caused these reactions in people. Pfizer's stop smoking drug Chantix did, and so have cholesterol drugs and pain killers and so. Why the agency wasn't requiring a detailed assessment before is either the result of some truly amazing lobbying work by Big Pharma of of sheer stupidity on the FDA's part.

Here's the weird part though: the FDA didn't announce this new policy publicly because so much of what the FDA does is kept under wraps to protect industry instead of the public whom it's sworn to serve. Because why would regular old citizens give two hoots about what the taxpayer funded agency might or might not be doing to ensure the safety of the nation's food and drug supply? Anyway, the New York Times caught wind of this and has an interesting article on how this all came to pass.

Here's three more interesting bits: one, not all new drugs will be required to undergo the assessments; two, the FDA, if the article is to be believed (and I know the reporter involved, so I believe it), finally realized suicides and suicidality connected to drugs were a substantial issue in 2004, around the time of the hearings on suicide risks associated with anti-depressants; and, three, the suicide assessment instrument is remarkably basic, something clinicians and social workers have been using for decades, and researchers quoted in the article act as if it's the Rosetta Stone.

While I'm sure there will still be plenty of wiggle room for pharma companies to keep drugs from being assessed, this is better than nothing I suppose. But why the FDA didn't act as if this was a bigger issue in, say, 1993 is far beyond my small mind. There were five years of reports of suicidality attached to Prozac use at that point. Possibly, if the FDA had acted in the public interest then, me and people like me could've been saved some serious problems.

Anyhow, I want to offer sincere congratulations to David Healy and the many patients, and family members of anti-depressant-induced suicides for having forced the FDA to have those hearings in 2004--and for staying on the issue in the years since. Without their unselfish efforts, I doubt the FDA and the media would have ever paid much attention to the matter.

BTW, I am looking forward to the Drug Wonks post declaring that these new assessments are unnecessary, that they add too much cost to the research process and harm innocent pharma companies, and that they violate free market principles. I expect that post shortly.

Posted by Philip Dawdy at January 24, 2008 12:14 AM

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Comments

I can't believe Chantix is still on the market, much less being advertised.

Posted by: Puckett at January 24, 2008 02:21 AM

It's about fucking time. I nearly lost my life to psychiatric medications. Philip don't go giving David Healy a bunch of support. The guy is insane as all the others. When it comes to ECT he believes in unmodified and regressive shocks

Posted by: Jane at January 24, 2008 08:04 AM

The time the FDA should have acted was in 1991 when the first hearing on antidepressants (really just Prozac then) and suicidality took place. I've seen tapes and really it was exactly like the 2004 hearing only the victims were marginalized and treated in a patronizing and dismissive manner but, believe me, their stories were no less credible than anything presented in 2004. Can we even begin to imagine all the lives that might have been saved if they had been treated seriously from the get go? It's a disgrace and a crime against humanity.

Posted by: Sara at January 24, 2008 08:06 AM

Yes it would be nice if the FDA was a trusted watch dog for human beings, but it isn't and will never be. Honest to God, industry prevails over health each day, too bad people involved are not treated as if they committed a crime. As in prison. Lilly is just shutting people up with hush money.

Posted by: Stephany at January 24, 2008 09:40 AM

I agree with Sara that, if the FDA had acted promptly & ethically during the 1991 FDA Advisory Committee meeting on antidepressants [Prozac] and suicidality, there would have been many lives saved.

Also, if the Webecker trial in 1997 had not been settled secretly in the middle of the trial [even the judge suspected something and changed the verdict from "won" to "settled" after taking it to the KY Supreme Court], there would have been many additional lives saved.

If Pharma hadn't branded as Sceintologists all those who reported behaviors of suicidality on Prozac/SSRIs, then even more lives would not have been lost.

There is no doubt that the Internet helped speed up the process of the FDA finally looking into suicidality and psychiatric problems on all drugs.
When a person goes to a search engine and types in "Prozac +Violence" and the page reads: "1 - 10 of 795,000, then that person knows something is terribly wrong.

The FDA probably knows that the Internet is watching them. Makes me so glad.

Posted by: Rosie at January 24, 2008 02:38 PM

Dear Sirs,

Ulf Jonasson, Doctor of Public Health, on YouTube:

Darvon, Darvocet, Co-Proxamol – the worst drugs ever.

http://www.youtube.com/results?search_query=jonasson+darvon&search=Search

Friends,

I would like to tell you a story, a very sad story about a painkiller that has been around in the Amer-ican society since 1957 – that is exactly 50 years. The name of the drug is DARVON or DARVON-N or DARVOCET. It is basically the same drug. In Europe the drug is called DISTALGESIC or CO-PROXAMOL. The working substance in the drug is PROPOXYPHENE or DEXTROPROPOXYPHENE as we call it in Europe.

We think drugs - containing PROPOXYPHENE - are the worst drugs ever, among prescribed drugs. No single drug in the history has caused so many fatal deaths as these drugs have done during the last 50 years.

How come I can sit here and say that? Are you supposed to believe me?

We – my wife Birgitta and myself - Ulf Jonasson, we are both doctors, PhD:s – have studied the dan-gers with PROPOXYPHENE since 1993, that is 13-14 years.

We have written and published eight scientific articles about PROPOXYPHENE. We have also written and defended two doctorial dissertations about the drug and its fatal consequences. And to get our alar-ming data outside the academic world, we also wrote a popular science version of our research that was published both in Swedish and English. The English name of the book is “Fatalities due to use or misuse of painkillers “

We think we have studied the consequences of using PROPOXYPHENE in a quite proper way, and therefore we will tell this sad story about a drug that probably have killed more people than any drug in the history.

One of the “Big Pharmas” in US, Eli Lilly “invented” PROPOXYPHENE in 1953 and it took some years before it came out on the market. There was a need for a painkiller - without side effects in the early 50s – and Lilly found PROPOXYPHENE. Have you heard this story before - a drug without side effects???

The drug was called DARVON – I am sure you have heard about it - and it became immediately very popular. It was not for the pain killing effects the drug became a financial success. Later on, studies showed that the pain killing effect was not better than aspirin or acetaminophen – like Tylenol. The users felt good, because DARVON is an opiate – close to methadone, morphine and heroin – and it influence your brain, you feel good. The drug influences your Central Nervous System.

As I told you before, we have studied PROPOXYPHENE since 1993. Our main result was that during the investigated years 1992 – 1999 - eight years - 200 persons in Sweden, were poisoned to death every year due to PROPOXYPHENE – poisoning. 200 persons died every year because they used a very popular painkiller and we thing this was very alarming. Sweden is a quite small country we have just about nine million inhabitants. In United States there are soon 300 million inhabitants and we knew, thanks to international statistics, that the American people used even more PROPOXYPHENE that the Swedish people did. Is it therefore possible for us to assume that there is more that 30 times as many fatal deaths in United States as in Sweden. Yes, we think so.

If we look at the consumption of PROPOXYPHENE in United States compared to Sweden, we find some very interesting figures. The average consumption of PROPOXYPHENE in Sweden - during the investigated years 1992-1999 - was 2 400 kg/year. In United States you consumed an average of 99 400 kg/year. It is more than 41 times as much in US than in Sweden. Is it possible that the numbers of fatal deaths in US are about 40 times more??? What do you think?

Here are some more figures. We know that consuming 2 400 kg/year in Sweden, caused 200 fatal death every year. You can say that it became one fatal death for consuming every 12 kilograms in Sweden. I think you understand and accept the metaphor. How many fatal death could that be if you consumed 99 400 kilogram a year in US??

The numbers are so high, you will not even think about them. And it gets even worse if you think back 50 years, consuming 80 – 90 - 100 000 kilograms a year in 50 years!!! In 2005 the consumption was 110 040 kg.

I will also mention some figures about the PROPOXYPHENE-situation in United Kingdom. They have also had huge problems with fatal poisonings due to PROPOXYPHENE. In the year 2004, some 1,5 million persons got 7,5 million prescriptions on their version of PROPOXYPHENE, namely CO-PROXA-MOL. These 7,5 million prescriptions became more than 900 000 000 CO-PROXAMOL pills. In the same year there were around 24 million prescriptions in United States, these 24 million prescriptions became almost 3 billion pills containing PROPOXYPHENE. This is 3 followed by nine zeros…

The medical product authorities in UK; the MHRA, decided January the 31st, 2005 that PROPOXY-PHENE – products would be phased out in the country till the end of the year. They did not succeed doing that. Why, there were so many problems to stop using the drug for the users, so many side effects, so much suffering to get rid of the drug.

MHRA then decided the drug to be out of the market in the end of the year 2006, but they did not succeed this time either. Today - the MHRA are saying that the drug definitive will be out of the market last December this year. Will they do that??? I do hope so.

Why do not the US authorities inform the American society about these harming drugs? We can put the answer in just two worlds, THE LAW. We have different laws in Sweden and in US. In Sweden we have one federal law for all four branches of the forensic medicine, which are medicine, chemistry, psychiatric and genetics.

In United States you have different laws in different states. In some states you have the old English system of CORONERS – and they are more investigators than medical doctors, you also have the MEDICAL EXAMINER SYSTEM, and they are medical doctors, but usually not specialists in forensic medicine.

And most important of all, in Sweden, the medical doctors take a blood test of all dead persons that come to the forensic medicine station. And these blood tests are all screened for every legal drug there is in Sweden, and that includes PROPOXYPHENE. Thanks to that routine we find our PROPOXYPHENE-cases, and unfortunately you do not find so many PROPOXYPHENE cases.

In Unites States, the decision to take a blood test is on the level of every one of the 3 200 counties in the country. And by many reasons the needed blood tests are mostly not taken. I think this is a big problem for your country, you loose lots of important information in many areas of medicine, missing the prevalence of PROPOXYPHE is just one.

I would like say a few more worlds about who are responsible for these tragedies, the many fatalities due to poisoning from PROPOXYPHENE. The manufacturers are - as I said earlier - ELI LILLY. The have earned billions of dollar during the last 47 or 48 years. Why do I not say the last 50 years?

The reason I say 47 or 48 years is that ELI LILLY sold the rights to their brands DARVON and the others - to some less known US pharmaceutical companies. And these companies were apparently not aware of our research. If they have known about this research, they would have been stupid to get into this crazy business of a drug that kills. LILLY has known about research since 1999 – at least in Sweden. We have printed proof for that.

LILLY is afraid of the consequences when the drug will be banned. They are afraid of how many people that will sue them because they have lost some dear ones, a father, a mother, a brother, a sister, a cousin, an aunt, an uncle or just a very close friend – that have died after that they have used a painkiller, fore example DARVON, DARVON-N or DARVOCET.

Do you remember VIOXX?? This drug was withdrawn from the market in 2004. The manufacturer, MERCK & Co, said that there was in increasing risk to get heart problem when using VIOXX. They talked about increasing risk,we talk about fatal deaths, thousands of fatal deaths – just in United States. Now MERCK & CO has to pay billions of dollars in damages.

You can say, that ELI LILLY, almost to the last minute - earned millions of dollars every year on their PROPOXYPHENE- drugs. Both in Sweden and in UK they did the same thing. They sold DISTALGESIC to another company in Sweden and UK. Kind of a surprise for this company – they bought a drug that was banned just after a short time.

Money are apparently more important than human lives for ELI LILLY, It is a simple as that.

I would like to finish this message by telling you how things could develop. After restrictions were implemented twice in Sweden, 2001 and 2005, thanks to our research - we now can say that 500 – 600 lives have been saved, just in Sweden. During 1992-99 some 200 persons were poisoned to death every year. The Medical Product Agency in Sweden recently informed that during the year 2005, 56 persons were poisoned to death. And we feel proud of what we have done.

We now feel a moral obligation to inform about the dangers with PROPOXYPHENE all over the world. And we know that, when the FDA will ban DARVON and the OTHER PROPOXYPHENE-brands, lots of lives- thousands and thousands - will be saved in Unites States. If the FDA doesn´t do that, the sad story continues.

We thank you for watching this video.

Good bye

Ulf Jonasson
Doctor of Public Health (DrPh), Journalist
Lövdalsvägen 5, SE-640 20 Björkvik, Sweden
Phone: +46(0)155-714 55
Cellphone: +46(0) 730 23 26 00
http://www.folkpartiet.se/ulfjonasson

Posted by: The Doc at January 28, 2008 12:52 PM