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Re: Drug Company numbers

"If, as Pfizer wants, all those 50 million smokers were on Chantix, there would be 4,000 users who reported suicidal thoughts and more than 300 who killed themselves."

And how would they find out? The 2005 suicide rate in the US was 11 per 100,000. Therefore of 50 million smokers we would expect more or less 5,500 who killed themselves, whether they took Chantix or not.

Re: Re: Drug Company numbers

Well, if there were 5,300 suicides instead of the expected 5,000(6% increase), we might consider that we had cause for alarm.

However, WHO and health care people seem to believe that if there is any chance of harm(Precautionary Principle)things must be banned.

Some stuff anyway.
.......................
"Perhaps they already know that the drugs are not really having a widespread effect?"

Drugs and hospitals are having just the effect that these people want.

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.
Please note that there are three(3) times as many nursing homes as hospitals, then there are the mental facilities and prison facilities.

There are the people that get their medicines at a pharmacy and die without ever going into a hospital.

Nursing homes alone might add another 318,000 deaths and 6 million serious side effects!!!

Drug company drugs may be causing well over 424,000 deaths and well over 8 million cases of serious side effects each and every year.

http://www.ahrp.org/infomail/0702/23.php

July 23, 2002

Unhealthy Hospitals - 103,000 preventable deaths in 2000 - Chicago Tribune

"The number of people needlessly killed by hospital infections is unbelievable, but the public doesn't know anything about it. For years, we've just been quietly bundling the bodies of patients off to the morgue while infection rates get higher and higher." That's what Dr. Barry Farr, a leading infection-control expert told The Chicago Tribune.

The Chicago Tribune's investigative series, UNHEALTHY HOSPITALS, penetrates the healthcare industry's long hidden facts about the rising rate of infection-related, preventable hospital deaths. This comprehensive analysis of 5, 810 hospitals nationwide, examined the records of 75 federal and state agencies, plus internal hospital files, patient databases and court cases around the nation. The Tribune calculated 103,000 deaths in 2000 from hospital grown infections.

Hospitals and drug companies are doing all they can to slow population growth, at least in the USA.

Re: Re: Re: Drug Company numbers

Yes indeed,Hospitals and drug companies are doing all they can to slow population growth, at least in the USA.

Here is another view.

http://articles.mercola.com/sites/articles/archive/2004/07/07/healthcare-death-part-one.aspx

By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD

A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine frequently causes more harm than good.

The total number of iatrogenic [induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures] deaths shown in the following table is 783,936.

It is evident that the American medical system is the leading cause of death and injury in the United States. The 2001 heart disease annual death rate is 699,697; the annual cancer death rate, 553,251.

TABLES AND FIGURES (see Section on Statistical Tables and Figures, below, for exposition)

ANNUAL PHYSICAL AND ECONOMIC COST OF MEDICAL INTERVENTION

Condition...Deaths
Adverse Drug Reactions...106,000
Medical error....98,000
Bedsores......115,000
(Rotting to death-Gary K.)
Infection...88,000
Malnutrition......108,800
(Starving to death-Gary K.)
Outpatients....199,000
Unnecessary Procedures....37,136
Surgery-Related....32,000
(OOPS,left the forceps in the patient-Gary K.)
TOTAL
783,936

Then there is the ban on DDT and Malaria deaths.

Re: Drug Company numbers

Gary, it's unfortunately not possible to respond to everything in your poorly organised streams of consciousness and context-free quotes off the web.

Statins are a fairly unusual class of drug in that they are used exclusively prophylactically, ultimately they treat a biochemical endpoint which is known to affect risk of a real morbidity and mortality endpoint, and large trials are needed to demonstrate real-world efficacy in terms of the latter. The results of these, by the way, are (from a very brief perusal), impressive. It's worth noting - from your snippets - that it seems to be various government departments staffed by scientific illiterates, and the like promoting their more widespread use, rather than the manufacturers. Lipitor will be off-patent within 3 years and generics will be on the market within at worst 2 years of that, so you aren't going to see any more clinical development from Pfizer.

More generally, it's an inevitability of modern medicine that it effectively gives you a wider choice of things to die of, and the opportunity to spend longer dying of them. You can expect to see the authorities insisting more frequently on all-causes mortality being assessed as an endpoint in more such trials for diseases of later life. Drug-related deaths are always considered in any treatment decision and data on treatment-related deaths is collected in great detail in all clinical trials. One limitation of all clinical studies is that if you have a section of the population at elevated (relative to the general population) risk of death from cause X, you cannot usually determine in advance which members of that group will actually die of cause X and which will not. If treatment reduces deaths from cause X but treatment-induced deaths exceed the reduction in deaths from cause X, the drug does more harm than good and won't succeed. This is taken especially seriously because those who die of treatment might not have died of X anyway - you just can't tell. Several otherwise promising drugs have been scrapped for precisely this reason.

As I mentioned earlier, the next big challenge for medicine is to get better at predicting which patients will have a meaningful response to treatment. The current approach is generally post-hoc subgroup analyses in large-scale clinical trials, which rarely throw up anything of interest and the limitations of which are rather better appreciated in the drugs industry than the scare industry. How you can do this for a prophylactic treatment like statins where it is impossible to identify the individual responders (those who would have had a CVA without treatment) is for better brains than mine to determine. For the moment, life remains somewhat stochastic and as a consumer, you should pick your own poison and take your own chance, but I don't think desperately trying to find a conspiracy surrounding a product which the manufacturer no longer cares about is worth spending your remaining days on.

Re: Re: Drug Company numbers

"Lipitor will be off-patent within 3 years and generics will be on the market within at worst 2 years of that, so you aren't going to see any more clinical development from Pfizer."
----------------------

...producing $27.8 billion in sales in 2006. Half of that went to Pfizer (PFE) for its leading statin, Lipitor.(note: That's $13.9 billion)

Yes indeed, no company is going to try and protect that amount of income. PFE probably does not have a new,improved LIPITOR in the works,so as to make the generics outmoded and said product will not be promoted by hundreds of millions of dollars of advertising and the same results from clinical trials.
..................................

"For the moment, life remains somewhat stochastic and as a consumer, you should pick your own poison and take your own chance."
--------------------------

Your words of wisdom are no doubt great solace to the 780,000+ families that had a loved one die an iatrogenic death.

If you die an iatrogenic death, I am sure your family will find great comfort and closure from said words of wisdom.

Re: Drug Company numbers

Pfizer _can't_ protect that income once their patent expires! Drug companies hire and fire in the tens of thousands at one go as drugs are launched or go off-patent, that's one of the quirks of the current system. No-one makes Coca Cola or Ferrari give up their intellecual property every 20 years, but if you're in the drugs business, that's standard practice. It has both advantages and drawbacks for the consumer.

Iatrogenic deaths are an inevitability of accepting medical treatment but it's usually more likely that death will result from refusing treatment. You take a treatment if rolling the dice is more likely to give you a positive result than a negative one, that's the entire purpose of the current clinical trials regime! It isn't actually in the interests of the drug companies to kill their customers.

Re: Re: Drug Company numbers

"Iatrogenic deaths are an inevitability of accepting medical treatment but it's usually more likely that death will result from refusing treatment."
-----------------------
Like blood transfusions?

http://www.theaustralian.news.com.au/story/0,20867,21912123-23289,00.html

Contrary to their benign image, blood transfusions are overused and often harm patients, experts say.

Lynnette Hoffman reports
| June 16, 2007

REFUSE at your own risk: for years that's the message doctors have relayed to Jehovah's Witnesses and others who've declined blood transfusions.

But transfusions are not the wonder procedure of popular, or even medical profession, imagination.

Mounting evidence shows they significantly increase the risk of post-operative complications - including infections, kidney failure, lung injury and death.
Yet instead of being saved as a last resort, they are still being performed when other safer options could be used instead.

In fact, more than 25 per cent of blood transfusions currently performed are unnecessary, according to a visiting US expert who spoke at the annual scientific meeting of the Australian and New Zealand College of Anaesthetists (ANZCA) two weeks ago.

Internationally renowned emergency medicine and anaesthiology professor Bruce Spiess told the conference that while blood transfusions have long been "believed to be helpful and a pillar of modern medicine'', there was now relatively little evidence to support such claims.

"Drug options are carefully tested and regulated through prospective, randomised double-blind testing, but blood transfusion stands apart,'' Spiess says. "It has never been safety or efficacy tested.''

It's a point that has been echoed by several Australian experts, including anaesthesists associate professor Larry McNicol and doctor Peter McCall at Austin Health in Melbourne.

"From the point of view of the risk of transmitting infections, blood transfusions are safer than they have ever been,'' McCall says.

"However, there is an ever-increasing body of research about adverse outcomes in association with them. Still there is a tendency to think that blood transfusions are mystical and lifesaving, and it is better to give them than to withhold them.''

The reasons not to make blood transfusion routine are becoming increasingly apparent: a person who has had a blood transfusion after surgery has up to four times the risk of wound infections. People who have blood transfusions during cancer surgery face up to twice the risk of the cancer recurring.

In his conference presentation, Spiess discussed Swedish research on cardiac patients that compared Jehovah's Witnesses who refused blood transfusions to patients with similar disease progression during open-heart surgery.

The research found those who refused transfusions had noticeably better survival rates.

Re: Re: Drug Company numbers

"It isn't actually in the interests of the drug companies to kill their customers."
------------------------------------
Drug companies' main interest is in their bottom line profits.

We all know that drug companies are pure,virginal, and squeaky clean.

Yet, an article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.

Please note that there are three(3) times as many nursing homes as hospitals, then there are the mental facilities and prison facilities.

There are the people that get their medicines at a pharmacy and die without ever going into a hospital.

Nursing homes alone might add another 318,000 deaths and 6 million serious side effects!!!

Drug company drugs that, by medical standards, are properly prescribed and properly administered, may be causing well over 424,000 deaths and well over 8 million cases of serious side effects each and every year.

How can this be?
What if the bottle your pills came in carried this statement: " Warning, ingredients in these pills made in China/India and may be contaminated. USE AT YOUR OWN RISK!"

You do not see this warning;but, quite possibly you should!!

http://www.abcnews.go.com/WN/story?id=4320554&page=1

How the FDA Checks Foreign-Made Drugs Sold in the U.S.
By LISA STARK and DANA WACHTER
Feb. 21, 2008

"Roughly 80 percent of active pharmaceutical ingredients are made outside our country," former FDA official Peter Barton Hutt said.

The nations that make the most drugs for the U.S. market are China, with 714 plants registered to make pharmaceuticals for the United States, and India, with 410. But the FDA says many of those facilities don't currently ship drugs to the U.S.

The agency is required to inspect U.S. plants every two years, but that isn't the case with foreign plants. Those facilities are put on priority lists based on the last time they have been inspected, or if they have new drugs being put on the market, versus drugs that are currently being manufactured.

There are two kinds of inspections - one is done when a plant first begins manufacturing a drug for the U.S. - the other are ongoing inspections. The FDA insists it certifies the good manufacturing process of all plants - foreign and domestic - when they begin manufacturing a drug. It was only because the agency confused the Chinese Heparin plant with another facility, that this was not done in this case, the FDA says.

It's also a staffing issue, the actual staff inspecting the plants overseas are mostly volunteers, and have certain schedules to follow when traveling and inspecting. It is estimated that the FDA inspects just 7 percent of foreign plants a year, and at that rate, it could take 13 years to check each plant.

Last year, for example, the FDA inspected only 14 plants in China, and 65 in India.

Another problem: The FDA doesn't even know exactly how many plants there are making drugs that wind up being prescribed for patients in the United States.

According to two different research databases, there are two very different numbers for overseas plants. One lists about 3,000 plants that are recorded to be inspected, and the other indicates there are about 6,800. The FDA has concluded there are about 3,249, but it still isn't sure.


http://www.suburbanchicagonews.com/beaconnews/lifestyles/gott/977612,2_5_AU30_GOTT_S1.article
Are prescription drugs from abroad safe?
May 30, 2008
Q: Are generic prescription drugs from India safe to use?
A: Outsourcing is all too common today, whether we are talking about a pair of rubber boots or something as critical as cardiac medication. India has more facilities making drugs and drug ingredients for the American consumer than any other foreign nation today.

The Food and Drug Administration is responsible for ensuring the safety of all drugs made for American use regardless of where they were manufactured. However, during the past seven years, the FDA has conducted just 200 inspections at plants in both India and China, and many of those inspections were done with prior notice.

The FDA claims they are unaware of any health issues caused by drugs imported from India, but it also acknowledges that it would be impossible to determine whether contamination or poor quality causes some patients to get sicker or remain ill.

India is currently producing both finished drugs and drug ingredients for more than 350 types and strengths of heart medicines, antibiotics and antidepressants. Just 10 years ago, they were responsible for only eight.

This is largely because of cost. Americans want cheaper drugs, and these countries can make them for much less than U.S.-based companies. While most of these manufacturers provide high-quality products and ensure they meet FDA requirements, some companies are less than honest.

No matter where production occurs, counterfeit drugs are a problem. However, in India and China, this risk is increased simply because someone is out to make a quick buck.

--------------------------------

Dirty Drug Industry Secret: Their Pills are Made in China and India

Not long ago, the FDA warned Americans not to buy prescription drugs
from Canada because they might be "contaminated by terrorists." What
the FDA didn't bother to mention, however, is that most pharmaceutical drugs purchased in the United States are manufactured in places like China and India.

Foreign drugs were dangerous, the FDA warned, because they were not
subjected to rigorous quality control requirements -- the implication
being, of course, that brand-name pharmaceuticals sold in the United
States are not contaminated.

This has been proven to be yet another lie.

Heparin, a blood-thinning drug made by Baxter International, was
recently discovered by consumers to be manufactured in China, where
the quality controls were so low that this FDA approved, brand-name
drug was apparently deliberately contaminated with an adulterated
chemical.

It has now resulted in the death of dozens of consumers in the United
States.

The very scenario dreamed up by the FDA to warn consumers away from
pharmaceuticals purchased in Canada or Mexico turns out to be true --
for a brand-name drug sold at monopoly prices in the United States.

The FDA has not inspected 93 percent of the factories that
manufacture pharmaceuticals outside the United States, and many of
the pharmaceuticals manufactured for U.S. drug companies are
contaminated with metal parts from the gears of processing machines
or flecks of paint from factory walls.

Many brand-name drugs are NOT tested for contaminants before being
sold to consumers in the United States, Canada and other countries,
regardless of where they were manufactured.

Sources:
Organic Consumers Organization May 1, 2008

------------------------------------------------------

http://www.naturalnews.com/023149.html

Heparin Contamination Fiasco Reveals Dirty Secret of Drug Industry: Their Pills are Made in China!
by Mike Adams

Three astonishing facts about brand-name pharmaceuticals
So far, then, there are three astonishing facts that have come out of the recent news about Heparin:

Fact #1: Most U.S. prescription drugs aren't even made in the U.S.

Fact #2: Many U.S. prescription drugs are made in China, a country widely known to have the lowest quality control standards in the world.

Fact #3: U.S. drug companies don't even run quality control checks on the drugs they import from China!

That third fact should send a chill up your spine. What it means is that U.S. drug companies contract with cheap, low-end Chinese chemical factories to manufacture their drugs at something like two cents a pill (which they can mark up to $20 a pill or more...), and then they import these Chinese-made pills and don't even test them before selling them to U.S. consumers!

Big Pharma, it seems, just skips that step. Whatever the Chinese throw into their pill bottles, U.S. drug companies just buy it and pass it on to patients and consumers without bothering to test the pills before selling them. Wow. Talk about trading safety for profits...

So much for the "safety" of Big Pharma's drugs sold in the United States, huh? This isn't something you hear in Big Pharma's TV ads, is it? "Buy Vytorex. Made in China! Never tested for contaminants! Take at your own risk!"
------------------
WHERE DO YOUR PILLS COME FROM,DO YOU KNOW?We all know that drug companies are pure,virginal, and squeaky clean.

Yet, an article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.

Please note that there are three(3) times as many nursing homes as hospitals, then there are the mental facilities and prison facilities.

There are the people that get their medicines at a pharmacy and die without ever going into a hospital.

Nursing homes alone might add another 318,000 deaths and 6 million serious side effects!!!

Drug company drugs that, by medical standards, are properly prescribed and properly administered, may be causing well over 424,000 deaths and well over 8 million cases of serious side effects each and every year.

How can this be?
What if the bottle your pills came in carried this statement: " Warning, ingredients in these pills made in China/India and may be contaminated. USE AT YOUR OWN RISK!"

You do not see this warning;but, quite possibly you should!!

http://www.abcnews.go.com/WN/story?id=4320554&page=1

How the FDA Checks Foreign-Made Drugs Sold in the U.S.
By LISA STARK and DANA WACHTER
Feb. 21, 2008

"Roughly 80 percent of active pharmaceutical ingredients are made outside our country," former FDA official Peter Barton Hutt said.

The nations that make the most drugs for the U.S. market are China, with 714 plants registered to make pharmaceuticals for the United States, and India, with 410. But the FDA says many of those facilities don't currently ship drugs to the U.S.

The agency is required to inspect U.S. plants every two years, but that isn't the case with foreign plants. Those facilities are put on priority lists based on the last time they have been inspected, or if they have new drugs being put on the market, versus drugs that are currently being manufactured.

There are two kinds of inspections - one is done when a plant first begins manufacturing a drug for the U.S. - the other are ongoing inspections. The FDA insists it certifies the good manufacturing process of all plants - foreign and domestic - when they begin manufacturing a drug. It was only because the agency confused the Chinese Heparin plant with another facility, that this was not done in this case, the FDA says.

It's also a staffing issue, the actual staff inspecting the plants overseas are mostly volunteers, and have certain schedules to follow when traveling and inspecting. It is estimated that the FDA inspects just 7 percent of foreign plants a year, and at that rate, it could take 13 years to check each plant.

Last year, for example, the FDA inspected only 14 plants in China, and 65 in India.

Another problem: The FDA doesn't even know exactly how many plants there are making drugs that wind up being prescribed for patients in the United States.

According to two different research databases, there are two very different numbers for overseas plants. One lists about 3,000 plants that are recorded to be inspected, and the other indicates there are about 6,800. The FDA has concluded there are about 3,249, but it still isn't sure.


http://www.suburbanchicagonews.com/beaconnews/lifestyles/gott/977612,2_5_AU30_GOTT_S1.article
Are prescription drugs from abroad safe?
May 30, 2008
Q: Are generic prescription drugs from India safe to use?
A: Outsourcing is all too common today, whether we are talking about a pair of rubber boots or something as critical as cardiac medication. India has more facilities making drugs and drug ingredients for the American consumer than any other foreign nation today.

The Food and Drug Administration is responsible for ensuring the safety of all drugs made for American use regardless of where they were manufactured. However, during the past seven years, the FDA has conducted just 200 inspections at plants in both India and China, and many of those inspections were done with prior notice.

The FDA claims they are unaware of any health issues caused by drugs imported from India, but it also acknowledges that it would be impossible to determine whether contamination or poor quality causes some patients to get sicker or remain ill.

India is currently producing both finished drugs and drug ingredients for more than 350 types and strengths of heart medicines, antibiotics and antidepressants. Just 10 years ago, they were responsible for only eight.

This is largely because of cost. Americans want cheaper drugs, and these countries can make them for much less than U.S.-based companies. While most of these manufacturers provide high-quality products and ensure they meet FDA requirements, some companies are less than honest.

No matter where production occurs, counterfeit drugs are a problem. However, in India and China, this risk is increased simply because someone is out to make a quick buck.

--------------------------------

Dirty Drug Industry Secret: Their Pills are Made in China and India

Not long ago, the FDA warned Americans not to buy prescription drugs
from Canada because they might be "contaminated by terrorists." What
the FDA didn't bother to mention, however, is that most pharmaceutical drugs purchased in the United States are manufactured in places like China and India.

Foreign drugs were dangerous, the FDA warned, because they were not
subjected to rigorous quality control requirements -- the implication
being, of course, that brand-name pharmaceuticals sold in the United
States are not contaminated.

This has been proven to be yet another lie.

Heparin, a blood-thinning drug made by Baxter International, was
recently discovered by consumers to be manufactured in China, where
the quality controls were so low that this FDA approved, brand-name
drug was apparently deliberately contaminated with an adulterated
chemical.

It has now resulted in the death of dozens of consumers in the United
States.

The very scenario dreamed up by the FDA to warn consumers away from
pharmaceuticals purchased in Canada or Mexico turns out to be true --
for a brand-name drug sold at monopoly prices in the United States.

The FDA has not inspected 93 percent of the factories that
manufacture pharmaceuticals outside the United States, and many of
the pharmaceuticals manufactured for U.S. drug companies are
contaminated with metal parts from the gears of processing machines
or flecks of paint from factory walls.

Many brand-name drugs are NOT tested for contaminants before being
sold to consumers in the United States, Canada and other countries,
regardless of where they were manufactured.

Sources:
Organic Consumers Organization May 1, 2008

------------------------------------------------------

http://www.naturalnews.com/023149.html

Heparin Contamination Fiasco Reveals Dirty Secret of Drug Industry: Their Pills are Made in China!
by Mike Adams

Three astonishing facts about brand-name pharmaceuticals
So far, then, there are three astonishing facts that have come out of the recent news about Heparin:

Fact #1: Most U.S. prescription drugs aren't even made in the U.S.

Fact #2: Many U.S. prescription drugs are made in China, a country widely known to have the lowest quality control standards in the world.

Fact #3: U.S. drug companies don't even run quality control checks on the drugs they import from China!

That third fact should send a chill up your spine. What it means is that U.S. drug companies contract with cheap, low-end Chinese chemical factories to manufacture their drugs at something like two cents a pill (which they can mark up to $20 a pill or more...), and then they import these Chinese-made pills and don't even test them before selling them to U.S. consumers!

Big Pharma, it seems, just skips that step. Whatever the Chinese throw into their pill bottles, U.S. drug companies just buy it and pass it on to patients and consumers without bothering to test the pills before selling them. Wow. Talk about trading safety for profits...

So much for the "safety" of Big Pharma's drugs sold in the United States, huh? This isn't something you hear in Big Pharma's TV ads, is it? "Buy Vytorex. Made in China! Never tested for contaminants! Take at your own risk!"
--------------
DO YOU KNOW WHERE YOUR PILLS WERE MADE?

Re: Re: Drug Company numbers

"Iatrogenic deaths are an inevitability of accepting medical treatment"
-------------------------

Bedsores......115,000
(Rotting to death-Gary K.)
Malnutrition......108,800
(Starving to death-Gary K.)

The families of those 223,800 dead per year from rotting and starving might take issue with your inevitability theory.

Re: Drug Company numbers

Yeah, why stick to one point and deal with it succinctly in your own words to see if agreement can be reached, and then move on to something else, when you can copy reams of stuff off the web to overwhelm the reader with? Why not answer in your own words? It'd be much easier to take you seriously then.

Blood transfusion, like pretty much everything else pre-1970, has not undergone particularly rigorous safety and efficacy testing. The indications are so diverse it's difficult to know where to start. Certainly however, if you come into the ER with 2 litres of blood loss from a road accident, being a JW does not improve your odds of survival.

The FDA has come under fire from both the industry and the US government over the last 6 months because its inspections of manufacturing facilities outside the US are hopelessly inadequate. Notwithstanding that, Baxter need to take responsibility for the product they ship, but intentional contamination (as is now suspected with their affected batches of heparin) could happen anywhere you have someone sufficiently psychopathic (as can all manner of other unsalubrious activities), so unless you think it's something *****s and darkies are particularly prone to doing just for a laugh, one incident is not grounds for a general broadside against the entire industry.

I don't think anyone has claimed the drugs industry is squeaky clean, it's a business like any other. It also has to follow vastly more rules than any other, meaining negligent rule breaches are going to be more common than elsewhere, and intentional rule breaches that get detected will have greater consequences and greater publicity. I can point to several recent instances of investigators going to prison for inventing data (usually for personal financial reasons since it's pretty hard to systematically bias a double-blind trial), and purely financial crimes within the drugs industry are routinely punished with jail terms. Let's compare this to certain British arms manufacturers who openly operate multi billion dollar slush funds. Oh, but that's in the national interest, isn't it {rolls eyes}?

I am not interested in the raw number of patients who die of adverse events due to properly prescribed and administered medications because this needs to be compared to the number who would die if no medications were administered - which is the only way to ensure you suffer no side effects of medication. Even the most innocuous drug can kill someone with the first dose, the question is "is the drug more likely to do harm or good?", not "will this drug kill no-one". Even administering a homeopathic pill carries the risk of choking to death on it. The biggest scandal here is the OTC medications which are considered safe for the public - paracetamol being a case in point. It's ineffective and dangerous but you can get that, but not codeine (which is highly effective and extremey safe) largely because of America's war on some drugs.

I'm not sure how you pin bedsores and malnutrition on the drugs companies. Some of that will be down to hospital failures, but you can give every patient 2 nurses and 3 roast dinners a day and you will still find someone too sick to be moved and too sick to eat.

Re: Re: Drug Company numbers

"I am not interested in the raw number of patients who die of adverse events due to properly prescribed and administered medications because this needs to be compared to the number who would die if no medications were administered - which is the only way to ensure you suffer no side effects of medication. Even the most innocuous drug can kill someone with the first dose, the question is "is the drug more likely to do harm or good?", not "will this drug kill no-one".
---------------------------------------

This brings us back to the 'Number Needed to Treat"(NNT).

If the NNT is 100 or more,as is common, and the number of adverse side-effects is 10% to 15% or more,as is common; then, to prevent 1 death, you may cause 10-15 deaths or more.

You may consider this a reasonable trade-off; but, I do not.
.................

"one incident is not grounds for a general broadside against the entire industry."
--------------

I eagerly await your proof that there has been only this one incident.
......................


"I'm not sure how you pin bedsores and malnutrition on the drugs companies. Some of that will be down to hospital failures, but you can give every patient 2 nurses and 3 roast dinners a day and you will still find someone too sick to be moved and too sick to eat."
------------------------------

True,of course, the drug companies do not prescribe or administer drugs, this is done by the Health Care community. The same people that are responsible for the deaths from rotting and starvation.

There are tho, rather close ties between drug companies and Health Care people.

223,800 deaths is not a small number, I eagerly await your number of deaths among patients that have 2 nurses and 3 roast beef dinners a day.

I trust these patients are quite common in the NHS?

Re: Drug Company numbers

Now you're confusing adverse events with deaths! It's quite true that for every patient you save, 10 or 15 might get diarrhoea or a headache, but if 10 or 15 died for every one that was saved this would be apparent from the trials and the drug would never make it to market. It's up to the individual if they value the benefit more than the side effects. Some people might be happy to put up with diarrhoea for a reduced risk of heart attack, others not. If you don't like the side effects, you can always stop taking the drug - it's that simple!

As I said earlier, several drugs have gone this way (they end up doing more harm than good in a clinical trial large enough to detect the difference). Probably only 1 in 50 products that enters clinical development ever gets marketed.

Re: Re: Drug Company numbers

"10 or 15 might get diarrhoea or a headache...the drug would never make it to market...It's up to the individual if they value the benefit more than the side effects. Some people might be happy to put up with diarrhoea for a reduced risk of heart attack, others not.

-------------------
I understand that you are probably the smartest person on the planet amd your OPINION should be enough for me;however, it would be ever so nice if you would provide FACTUAL DATA and SOURCES to substantiate your OPINIONS.

We are not talking about diarrhea or a headache,I am talking about deaths and serious side effects including liver damage, muscle pain, cognitive impairments, and sexual dysfunction.

Nor am I talking about clinical trials, I am talking about drugs that are marketed, prescribed, and highly advertised and have been for many years.

Statins,for instance,MIGHT prevent 52,000 heart attacks,none for women,number of deaths NOT known; but,520,000 to 780,000 people,women included, may suffer serious side effects including liver damage, muscle pain, cognitive impairments, and sexual dysfunction,the number of deaths from these side effects has not been stated.

http://articles.mercola.com/sites/articles/archive/2004/07/07/healthcare-death-part-one.aspx

By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD

A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine(and drug companies-Gary K.) frequently cause more harm than good.

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer SERIOUS SIDE EFFECTS.
(Note: including an estimated 10% to 15% of statin users that suffer side effects, including liver damage, muscle pain, cognitive impairments, and sexual dysfunction.)

Please note that there are three(3) times as many nursing homes as hospitals, then there are the mental facilities and prison facilities.

There are the people that get their medicines at a pharmacy and die without ever going into a hospital.

Nursing homes alone might add another 318,000 deaths and 6 million serious side effects!!!

Drug company drugs may be causing well over 424,000 deaths and well over 8 million cases of serious side effects each and every year.(including liver damage, muscle pain, cognitive impairments, and sexual dysfunction-Gary K.)

Statins
http://www.businessweek.com/print/magazine/content/08_04/b4068052092994.htm

James M. Wright, is no ordinary family physician. A professor at the University of British Columbia, he is also director of the government-funded Therapeutics Initiative, whose purpose is to pore over the data on particular drugs and figure out how well they work. Wright's team was analyzing evidence from years of trials with statins and not liking what it found.

Yes, Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death.

But Wright had a surprise when he looked at the data for the MAJORITY of patients, who don't have heart disease. He found no benefit in people over the age of 65, AND NO BENEFIT IN WOMEN OF ANY AGE.(My highlighting-Gary K.)

(Note: Drug companies spend about twice as much on advertising as on research-Gary K.)

Pharmaceutical companies spend more on marketing than research

http://noedb.org/library/features/25-shocking-facts-about-the-pharmaceutical-industry

(No where in that advertising for statins do they state that for people over 65 suffering from Alzheimer's Disease the statins may increase their rate of loss of mental function for no benefit.-Gary K.)

He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials.

But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization.

"Most people are taking something with no chance of benefit and a risk of harm," says Wright.

Such drugs are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006.

Several recent scientific papers peg the NNT for statins at 250 and up for lower-risk patients, even if they take it for five years or more.

What's more, statins have been in use now for 20 years, and there's little evidence yet that the NNT decreases the longer people take the drug.

Most important, the statin trials of people without existing heart disease showed no reduction in deaths or serious health events, despite the small drop in heart attacks.

"We should tell patients that the reduced cardiovascular risk will be replaced by other serious illnesses," says Dr. John Abramson, clinical instructor at Harvard Medical School and author of 'Overdosed America'.

An estimated 10% to 15% of statin users suffer side effects, including liver damage, muscle pain, cognitive impairments, and sexual dysfunction.

Re: Drug Company numbers

I understand that you are probably the smartest person on the planet amd your OPINION should be enough for me;however, it would be ever so nice if you would provide FACTUAL DATA and SOURCES to substantiate your OPINIONS.

===

You mean the way you uncritically copy and paste the same stuff over and over again? The way you multiply up hypothetical deaths in a manner which our bending author has repeatedly criticised (starting with a figure for all AEs rather than deaths, multiplying by a theoretical number of facilities, to supposedly demonstrate that lipitor causes a holocaust and draw the preposterous conclusion that it might maybe could be responsible for about one fourth of all deaths in the US every year?)

Why don't you refer to, for example, the SmPC for lipitor - here: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=1424

Section 4.8 has the most pertinent information on adverse events, but you should also refer to section 4.4. This document will be based on all completed clinical trials and post-marketing reports of adverse events. Where is the liver damage, cognitive impairment and sexual dysfunction? There are clear indications that liver function should be monitored for, but no liver problem, cognitive or sexual problem even qualifies for the very rare (<0.01%) category of AEs. Doubtless these AEs have been reported in a small number of cases, they may even be attributable to the drug - as indeed some deaths will have been, but it's crude diversion to say "x% of people get serious side effects like liver damage (meaning what, precisely?), cognitive impairment ... when the n% figure actually covers all adverse events from the trivial right up to and including death.

If this drug actually killed more people than it saved, that would be obvious from the clinical trials and it would never have been marketed.

Here's a better example for you to chew on:

The contraceptive pill saves no lives at all, but it kills hundreds of women a year worldwide. Why isn't the contraceptive pill banned? Under your criteria (I infer you accept no medication-related deaths at all) it definitely would be. It isn't because millions of women are prepared to accept a very small risk of death from contraceptive-induced DVT in return for the unprecedented sexual freedom the pill offers them.

Re: Drug Company numbers

Erratum: impotence is reported as an uncommon (<1% and >0.1%) side effect of lipitor.

Funnily enough, even as a young, healthy, relatively fit and full-blooded male, I can report that over my lifetime to date, and considering all the occasions on which erectile function has been called for, impotence has been an uncommon (<1% and >0.1%) occurrence (and towards the lower end I might add) without the intervention of any prescription medication whatsoever. It's occurrence in a mere <1% of old, fat, diabetic people with heart disease and/or other chronic illnesses on metabolism-changing drugs is hardly cause for concern.

Re: Re: Drug Company numbers

James,

Out of interest on the basis that you would be much better qualified and better experienced than I to interpret the results of medical trials I would assume that the 'official' figure for sexual disfunction would be based on a total loss of function for a percentage of those taking the treatment rather than an occasional loss of function across all patients studied.

Is that in fact how such things are measured or might results sometimes be published that conflate the two, very different, assessments?

I would imagine that any measurement of other possible serious side effects - liver damage for example - would be on the 'permanent' rather than 'occasional' basis though digestive tract problems could well be 'occasional' rather than permanent for the most part I suppose.

Presumably one could convert the small percentages for the adverse effects reported into NNT figures, or vice versa, to obtain a clearer comparison of the pros and cons. (Though I doubt very much such a comparison would be crystal clear.)


Grant

Re: Drug Company numbers

Hello Grant, and thanks for a considered reply free of red mist.

The reported frequency of loss of sexual function (let's drop the euphemism and say impotence) is just that - a reported frequency. This means patient in clinical trial (or on marketed product) goes to doctor, and says he can't get it up. On a clinical trial, with impotence being a known side effect, it's quite possible the attending physician directly asks the patient if he's been unable to perform when required to do so. If the patient answers in the affirmative, that's recorded. Then the clinician has to make a judgment about whether or not the AE was likely to be related to the drug. This is of course somewhat subjective, and will be coloured about what the known side effects are (e.g. the clinician knows lipitor can cause impotence thus is likely to attribute impotence in a subject on lipitor to lipitor, even if he was just too tired to be bothered). Given the nature of this particular complaint, it is probably under-reported, but systematically so, thus relative frequencies are still of use when comparing between groups of patients in the same trial, for example.

The fact that impotence is reported in itself says nothing about the frequency or severity of impotence. Every individual event that actually gets reported - from "it took me a bit longer than usual to get it up" to "I was unable to have sex for a month" is recorded as an individual event - naturally severity, duration, etc are also recorded, but this level of detail is not present in the easily accessible public documentation.

Again, where an adverse event has a permanent outcome ("I can't get it up at all now"), this is also explicitly recorded. Such cases are usually rare and need a great deal of individual follow-up to establish whether or not there is any causal relationship with the drug.

"Liver damage" is pretty vague, and unlikely to be permanent. The Lipitor instructions suggest monitoring of liver enzymes (ALT and AST which are very specific markers of general liver injury), and caution in anyone with >3x the upper limit of normal of those enzymes. Well, you can give yourself 3x ULN of both from one heavy drinking session. Somewhere between 2-5% of the population is walking around with effectively permanently elevated AST and/or ALT due to obesity, alcohol use etc. About 20% of the US population has "liver damage" (fatty infiltration, most likely due to diet) which can theoretically become permanent, but fortunately in the majority of cases does not. Remove the insult and the liver recovers. Even the most intractable alcoholics with completely rotted livers can vastly improve their liver function by simply removing the cause of the damage - and most people really do have to drink hard over many many years to do any permanent damage. One would imagine something similar with most drugs (other than those like paracetamol which can produce fulminant hepatitis with a single overdose), and with the usual caveat that there are always exceptions. Just like the occasional social drinker who dies of liver failure at 40 after 20 years at 2 pints a week, someone somewhere will almost certainly be done in by liver failure induced by {product name omitted for obvious reasons}. Unfortunately we are in no better a position to identify that individual in advance than the drinker is to determine that he has a congenitally weak liver that reacts particularly badly to alcohol.

I don't think you can turn AE data into NNT. NNT is not really a useful guide for the individual facing a treatment decision (interestingly prophylactics are arguably an exception - but unlike statins most drugs are administered to treat present disease, not potential future disease, so in most cases you as the patient tend to care not, quantitatively, how effective the treatment is, merely that it is qualitatively more effective than not treating) - it is more useful for assessing the cost-effectiveness of treatments over a population.

Re: Re: Drug Company numbers

James.

Thanks for that. Very interesting.

I think when people are dealing with trying to understand medical (and other) reports based on a potentially large number of variables and absent consistent reliable inputs (e.g. self reporting is very unlikely to be reliable or consistent even at the individual level) there is a greater potential for confusion than understanding. Who this helps and who it hinders is a matter for speculation.

I few years ago I spent some time trying to analyse Road Traffic Accident data. About 4 million records so a large sample. Not statistical analysis - I don't have the skill. Just an attempt to find areas that might stand out as problems and be suggested for specific attention.

Few appeared of any consequence and those that did were likely to be coding artefacts. On the other hand some of the 'obvious' road safety assumptions seemed less obvious in the light of the results but, given variability of reporting and interpretation and, indeed, question marks about accuracy, nothing really jumped out and demanded further attention.

Had I been paid to do it I would no doubt have found something to 'report'. But as it was all done in my time with no commercial objective I was able to put it away and accept that chaotic systems and events - traffic, the weather, Premium Bond winnings and so on are probably not understandable in terms of definitively managing change - although people often suggest they can exert control over Premium Bond returns!

Most medical reports seem to be dealing with similar numbers for an 'effect' to the ones I found in the RTA data files.

I take your observation about NNT but in terms of some of the inferences Gary's points address I can't see why the pro's and cons cannot be made clearer.

So for example;

If using the blunderbuss approach and providing drugs to all we might see a result along the lines of

250 people on medication = 1 useful intervention.

at 1% total risk of adverse reaction 2.5 people of the 250 would possibly experience attributable sexual problems (or whatever the suggested number might be for a given negative response.)

Of course if one of those affected was also the one for whom the intervention was useful he might find it acceptable and the 'risk' for the other would drop dramatically in percentage terms but little in real terms.

Given the target age group for the treatment the issue of sexual function may not be so important - if the statins don't make you less active sexually then something else will - age, opportunity or a prostate problem typically. It may be no big deal for the affected few on that basis.

However regular digestive tract problems or liver related events, which may go under reported just as readily as sexual dysfunction in a male population, are more directly inconvenient. If one was at high risk of heart related illness then such inconvenience may be acceptable, though if it was perpetual and persistent one might change one's mind. But if is a side effect mainly where the affected people were not clear risk candidates for the target disease nor did it act as a warning or treatment for other possible diseases then those affected would have no benefits at all AND some de-benefits which would likely have some costs associated with them - perhaps more than the savings benefits for the 'at risk' patients.

Of course if smart marketing could persuade people that a 10% chance of adverse response was acceptable for the potential benefits AND the supplier concerned had suitable treatments for the malfunction the potential for secondary sales could be significant ...

I hope I am being overly cynical when suggesting that.

I'm not sure about the efficacy of assessing cost effectiveness over a population. I can see its desirability for planning but in my commercial experiences in service industries the results rarely go to plan and quite often are completely fudged if one is able to look a little way beneath the surface. Furthermore the benefits are projected over several years during which period so many things change, usually, that the comparison becomes pointless.

I don't think there is a way around that and we have to live with it BUT at least we should publically recognise the limitations and potential consequences.

How one does that successfully in the emotive arena of Health I have no idea. I suspect it would be impossible.


Grant

Re: Re: Re: Drug Company numbers

Drugs that treat a disease are indeed different from drugs prescribed to prevent a problem.

That said, statins(notably Lipitor) are by far,the most frequently prescribed drugs in the USA and make a great deal of money for the health care establishment.

These statins are also heavily advertised and promoted, drug companies spend about $57.5 billion per year on advertising and promotion. This is about twice as much as they spend on R&D.
http://www.sciencedaily.com/releases/2008/01/080105140107.htm

Statins are prescribed for a great number(millions) of people for whom there is NO benefit.

Statin advertising never mentions that for the majority of people there is no benefit in taking them.

http://www.businessweek.com/print/magazine/content/08_04/b4068052092994.htm

James M. Wright, is no ordinary family physician. A professor at the University of British Columbia, he is also director of the government-funded Therapeutics Initiative, whose purpose is to pore over the data on particular drugs and figure out how well they work. Wright's team was analyzing evidence from years of trials with statins and not liking what it found.
Yes, Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death.

But Wright had a surprise when he looked at the data for the MAJORITY of patients, who don't have heart disease. He found no benefit in people over the age of 65, AND NO BENEFIT IN WOMEN OF ANY AGE.

He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials. But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization.

"Most people are taking something with no chance of benefit and a risk of harm," says Wright.

If women(they do not worry about 'getting it up' and men over 65( many,due to old age and etcetera,can not 'get it up'-for some reason many of their wives seem relieved)who take statins were removed from the numbers, the percentages for for 'not getting it up' might be very different.

13,000,000 Americans are on statins, since women are 51% of the population, we might presume(I can find no numbers)that over 6,500,000 women are on statins with no benefits. If 15% of them suffer serious side effects,such as liver damage, muscle pain, and loss of cognitive reasoning, that is 975,000 women suffering serious side effects for no possible good reason(except that it makes a huge amount of money for the drug company/health care establishment).

I have no idea how many men over the age of 65 have not had a heart attack and thus would receive no benefit from taking statins;but, it is probably more than just a couple.

Re: Re: Re: Re: Drug Company numbers

www.whp-apsf.ca/pdf/statinsEvidenceCaution.pdf

Evidence for Caution: Women and statin use

It has been estimated that 3 million Canadians take a statin drug every day.

About half of those prescriptions were for women ranging in age from 15 to over 75 years old.
(USA women are probably the same,thus the 6.5 million women mentioned previously,is about right)

An Austrian study (also prospective), which compared cholesterol levels and health outcomes for over 80,000 women and 67,000 men over a 15-year period, found that high cholesterol in women over the age of 50 was not a predictor of cardiovascular problems
or stroke.

Their research confirmed five previous studies (including the Framingham study), which found that high cholesterol was not a strong predictor of cardiovascular problems in older women (and men.)

Low cholesterol at over age 50 was associated with higher death rates from cancer, liver disease and
mental illness.
................
Statins lower cholesterol and serious side effects include liver damage and loss of cognitive functions.

The prescribing of statins to women of any age and men over the age of 50 is immoral, unethical, and disgusting, tho it does provide huge profits for the health care/drug company folks!!

Re: Drug Company numbers

Gary, that's the fourth time you've posted the same cut'n'paste job. Do you think we can't read or something?

I don't know where you are, presumably in the USA since you talk about advertising so much - but in civilised countries direct-to-patient advertising of most prescription medicines is banned, and quite rightly.

Most patients who take statins will not benefit from them since most people will go through life without experiencing a relevant cardiovascular event. That is quite clear. Most people will also go through life without experiencing a road accident resulting in injury, but that is likewise not an argument against taking measures to reduce your risk of such an accident.

Re: Re: Drug Company numbers

"Most people will also go through life without experiencing a road accident resulting in injury, but that is likewise not an argument against taking measures to reduce your risk of such an accident."
....................

If the measures taken did not reduce your risk of such an accident and did cause you to suffer serious health problems,if not die,I would indeed argue against such measures and find fault with those that caused the use of them for financial gain.

Most patients who take statins will not benefit from them because there are no benefits for them to have,only the chance of serious side effects.

As for the multiple posting of studies and data, I consider such to be more useful to the readers of this forum than unsubstantiated opinions.

That is,of course, just my opinion.

Re: Drug Company numbers

Grant, self-reporting of adverse events indeed results in inconsistencies, the method is not perfect but we don't have anything better yet. The whole point of conducting adequately large trials over several centres or indeed countries, and where feasible double-blinding trials with more than one treatment arm (and stratifying randomisation so you don't end up with all the incompetent but highly strung doctors with placebo patients and the competent but laid-back doctors with patients on active product etc etc) is to attempt to even out the random element in such inconsistencies.

The problem with risk is that people don't understand it. Hell, most doctors and scientists don't understand it either. And as illustrated by OBA there are several different ways of reporting a change in risk, and you can pick one which either overstates or understates the case, depending on the spin you want to use. Do drug companies like to put a positive spin on their products? Is the pope still Catholic? Is there widespread dishonesty and fraud within the industry? In my opinion, no. The simple fact is that the drugs industry is the most tightly regulated industry in the world. You cannot legally make a claim about a medicinal product without having the data to back it up. If the same standards were applied to the green industry, it would be very much smaller.

Re: Re: Drug Company numbers

James,

Yep, this is never going to be an easy analysis or message to advise the masses.

Drug trials do indeed have controls that the simpler collection examples I played with almost totally lack, though the results are pretty similar in terms of very small percentage occurrences for any single factor in nearly all cases.

I can't blame the drugs companies - their risks are large both in development investment and subsequent usage litigation when it occurs. In the US, in particular, this seems a bit like a vicious spiral.

I can also understand why the developers seek to extend patents based on manufacturing methods or just about anything they can.

But I'm not sure how well the concept of huge numbers of people taking concoctions that are of no use to them fits with either fiscal or moral responsibility. And there certainly seems to be some evidence that the rationale for 'health' advice could be misleading people with the potential that they would miss other signs of problems or potentially assume that they were doing all they needed to in order to protect their lives and, by inference, the wealth and health of their families, businesses and so on.

Likewise 'the authorities' may believe their investment in health is all it should be when in fact it is not. But then there would be nothing very new about 'the authorities' getting something wrong or backing the wrong horse. It's more a question of the size of the bet.

Of course for the cost of the relatively expensive placebo a number of more critical and directly and evidently beneficial cases may be disallowed the treatment they need, at least in the NHS system that could be the case. Whether that means that overall it is still a good outcome for the country is another matter.

I doubt there is a single clear answer.


Grant