drug safety

[Eos of the Eons]

Oh, come on now, the fatalities from properly prescribed drugs far outweighs any from herbs, supplements. and let's not make excuses as to why that is. The numbers are outrageous.

And how do you know that? Since supplements are unregulated, the information is lacking. We know plenty of people going to hospitals to be treated for adverse affects from CAM that are not regulated. Not to mention lives lost to unregulated CAM that would be saved by prescription medicine and other procedures denied them when using CAM.

The numbers are not outrageous. The numbers for those saved is an argument for prescription medicine - regulate, tested, and proven to work prescription medicine.

Some lovely effects of CAM:

MMWR for July 9 2004 [53(26);582-584] highlights lead poisoning cases from traditional indian medicine.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5326a3.htm

Ephedra. Nuff said.

Toxic Herbs: http://www.herbalwatch.com/Alerts/herbal_toxicherbs.html

Supplements Associated with Illnesses and Injuries:
http://vm.cfsan.fda.gov/~dms/fdsuppch.html

Hair Loss Supplement Poisons:
http://www.cbc.ca/story/science/national/2004/07/29/hair_loss040729.html

If you want to start slinging mud, then you can find it "on both sides". The only thing is, prescription meds are tested, and proven to work. Mistakes can be made in prescribing them, but at least the risks are known and accidents can then be prevented. With CAM it is an unknown, and accidents cannot be prevented.

There is far more risk to taking supplements and herbs, and far less benefits.

CAM supplements don't always have the active ingredient either, and hardly ever have the amount specified if it is present. There is no proof the active ingredient is safe or effective if it is present.

So it is buyer beware with CAM. Some tips for the consumers thinking of trying supplements:

http://www.agingeye.net/visionbasics/tips.php

Be aware, be alert, and be safe. Read the recommendations.

 

[merphie]

Oh, come on now, the fatalities from properly prescribed drugs far outweighs any from herbs, supplements. and let's not make excuses as to why that is. The numbers are outrageous.

Because other drugs are more widely used? Are you talking about legal drugs taken legally? Maybe it's because herbal medicine has very little active ingrediant?

Are you for herbal medicine?

 

[materia3]

There are a number of reasons why prescription medication related morbidity and mortality are better documented than
those which occur for so-called dietary supplements or herbal products masquarading as dietary supplements:

1. Such drugs are self-prescribed so are not part of the deceased patient's medical record, or rarely are. Users do not tell their doctors about their use of these products for a variety of reasons, most of them based on a paranoia that their doctors will tell them to stop.

2. Medical examiners searching for a drug related cause of death must know what they are looking for. They cannot and do not test for everything, and "everything" is what comprises the wide world of dietary supplements aka herbals. The real world doesn't consist of Quintsy, Jordan or CSI.

I have been on ME runs on DOAs.

In the decedent's home, the ME or police rarely scoop up non-prescription or OTC products and grab only prescription drug bottles. This is a big mistake but it is reality.

3. There is no formal, national reporting system (in the U.S.) for
deaths related to herbals; there is such a system for pescription drugs. In fact doctors are compelled by law to file such reports
on regulated drugs.

Therefore nobody knows how many deaths are directly related to unregulated self-prescribed herbal drugs. We got lucky with ephedra because its use was so pervasive and widespread. Everybody knew about it. MEs are also attuned to looking for illegal drugs such as cocaine, methamphetamines and opiates as causes of initially unexplained deaths so these drugs along with alcohol and marijuana is routinely tested.

We also got lucky about 10 years ago when a dozen young men in New York City died (7 deaths) or had survived cardiac arrests for no apparent reason until it was discovered they had ALL used a traaditional (chinese) digitalis-like drug being touted as an aphrodisiac. The FDA and the authorities moved swiftly to confiscate and ban this product; so fast in fact, the incident practically passed unnoticed except for an article in a major medical journal about the incident a year later.

 

[Dr. Imago]

We got lucky with ephedra because its use was so pervasive and widespread. Everybody knew about it.

[ASIDE]I may have mentioned before, but I'll say it again, that I'm applying for an anesthesiology residency here in the U.S. As part of my schooling, I've already done 8 weeks of electives in anesthesia.

What I find fascinating, and didn't realize until I started my rotations, is that ephedrine is routinely used as a "pressor" during anesthesia cases. It comes in a small vial of 50mg/mL, and it is diluted about 1:5 (sometimes 1:10) before injection. The indication for it's usage is when the patient's blood pressure starts to drop during the case, and when they typically do not have a compensatory increase in their heart rate.

I've seen this drug used a lot. Between 5-10 mg are given intravenously at a time, and it's amazing to see the patient's blood pressure and heart rate respond almost instantly.

I'm amazed, looking back, that this stuff used to be available over-the-counter in the U.S. as a supplement, often sold as Ma Huang or Ephedra where the exact amount of the active ingredient may not have been known. I feel fairly certain that the true number of serious adverse events were vastly under-reported during its availability.[/ASIDE]

-TT

 

[materia3]

Ephedrine has always been a prescription drug although it was widely distributed OTC for asthma but with no regard to its pressor side effect. Its even more amazing that digitalis is sold in over the counter herbal medications as well and still is; but whenever it is found, it is confiscated and banned. The initial spate of the total number of cases I mentioned above appeared in the CDC's MMWR which describes the first five cases, 4 of whom died from taking this herbal aphrodisiac:

Deaths associated with a purported aphrodisiac--New York City, February 1993-May 1995.

[No authors listed]

CDC- MMWR (not copyright; republication permitted/encouraged)

During February 1993-May 1995, the New York City Poison Control Center (NYCPCC) was informed about onset of illness in five previously healthy men after they ingested a substance marketed as a topical aphrodisiac; four of the men died. These cases were investigated by the New York City Department of Health, the New York City Department of Environmental Protection, and the Food and Drug Administration (FDA). Four cases were referred to the NYCPCC and one case to the New York City medical examiner's office. The decedents died from cardiac dysrhythmias, and all five patients had measurable levels of digoxin* detected in their serum. Digoxin had not been prescribed for therapeutic purposes for any of these patients, and none had medical conditions associated with endogenous digoxin-like immunoreactive substances. The purported aphrodisiac contains bufadienolides, naturally occurring cardioactive steroids that have digoxin-like effects. This report describes three of the five case reports, summarizes the investigations of the five cases, and underscores the health risks associated with inappropriate use of preparations containing digoxin-like substances.

The drug involved in the deaths cited above was not strictly a herbal but was classified as such by its makers in China. Known as Chan Su, it is a traditional Chinese medication; its aka Love Stone, which is used topically you can guess where. Both are derived from dried skin gland secretions of the toad Bufo bufo gargarizans and contain bufalin, cinobufotalin, cinobufagin, and other cardioactive steroids of the bufadienolide class.

And here is a more recent case in abstract of a lucky woman (who didn't die but could've) after taking a herbal cleanser whatever that is (but I can guess) which also contained digitalis.....

Ann Emerg Med. 2003 Mar;41(3):396-9.

Cardioactive steroid poisoning from an herbal cleansing preparation.

Barrueto F Jr, Jortani SA, Valdes R Jr, Hoffman RS, Nelson LS.

Department of Emergency Medicine, New York University School of Medicine and the New York City Poison Control Center, 455 First Avenue, Room 123, New York, NY 10016, USA. fbarrueto@hotmail.com

We describe a case of unintentional poisoning from a cardioactive steroid and the subsequent analytic investigation. A 36-year-old woman with no past medical history and taking no conventional medications ingested an herbal preparation marketed for "internal cleansing." Its ingredients were neither known to the patient nor listed on the accompanying literature. The next morning, nausea, vomiting, and weakness developed. In the emergency department, her blood pressure was 110/60 mm Hg, and her pulse rate was 30 beats/min. Her ECG revealed a junctional rhythm at a rate of 30 beats/min and a digitalis effect on the ST segments. After empiric therapy with 10 vials of digoxin-specific Fab (Digibind), her symptoms resolved, and she reverted to a sinus rhythm at a rate of 68 beats/min. (snipped)

So if anyone wants to find deaths associated with the taking of unregulated herbal medications, all one has to do is know what you are looking for and search them in MedLine, etc. They are out there but as a national statistic they do not exist.

Very scarey stuff. People who embrace these kinds of treatments should seriously reconsider their willingness to pop anything down their throats just because some bottle label, pamphlet, or self-professed or dubiously credentialed herbalist or website says its good to do so.

 

[Barbrae]

I just find it interesting (but sadly predictable) that Barb chose to slice off a short comparative comment relating to real medicine, and start a thread about testing and licensing systems, while totally ignoring the main thrust of the original post, which was the absolute lack of any testing or regulatory processes for homoeopathic remedies, and the complete lack of interest within the homoeopathic community regarding finding answers to the many points of disagreement regarding dose rates, expiry dates, interactions, storage requirements and so on.

Rolfe.

And I find it interesting that Rolfe can't GET OFF MY BACK. I have repeatedly answered questions you have posted, commented on your posts and put up with your constant insults and put-downs. Unless I am mistaken I have every right to discuss this topic (safety and efficacy of allopathic meds) with or without your approval.

What is your problem with taking a good look at the imperfections of allopathic medicine? Many here have commented "well, no one said modern medicine is perfect" - yes, that's true but God forbid someone try to discuss those imperfections and they are accused of tryign to avoid other issues or pointing fingers or whatever. So what you really mean is "allopathy isn't perfect but let's hide our heads in the sand so we don't ever have to look at those imperfections."

You knoe, you should be pleased that I started this thread as I actually learned something. I had always mistakenly thought that once a drug was approved for any use it could be prescribed for anythign - I was wrong about that and am very glad to have been set straight.

Regarding safety of herbal meds/homeopathy I think that safety studies should be done - I also think herbs should be regulated as far as active ingrediants and such.

None of that however lessens the fact that the numbers of adverse (seriously) advers effects of allopathic drugs are waaaay to high for my comfort level. None of it lessens the fact that drugs are ofetn pulled of the market because they proved to be unsafe - after your gold standard double blind placebo controlled studies said they were safe. Just yesterday the media reported the pulling of the 6month heartworm treatment fro dogs - after over 500 dogs died and thousands more had serious adverse effects - even though NO adverse effects were reported during the study (that was what was reported - and I don't believe everythign the media says but don't have the time to look at the studies myself - so).

Now, do you care to discuss this topic - or just cry that Barb is avoiding other issues again??? Just so ya know, I have answered and commented on waaay more of your quesitons or posts than you have done for me.

 

[Barbrae]

Very scarey stuff. People who embrace these kinds of treatments should seriously reconsider their willingness to pop anything down their throats just because some bottle label, pamphlet, or self-professed or dubiously credentialed herbalist or website says its good to do so.

I wholeheartedly agree. If someone chooses to take an unregulated substance then at the very least they need to reaseacrh different companies that sell said substance and also research the herb they are taking.

I also believe that anyone taking a prescription med needs to take charge of their own health and reseacrh that as well - probably more so.

 

[Barbrae]

Are you for herbal medicine?

absolutely

 

[Barbrae]

The short answer is yes, although the regulatory bodies for the USA (FDA) and UK/Europe (MHRA) have their own procedures. These procedures are pretty similar although what might get you a license in Europe will not auomatically get you one in the USA and vice versa.

Thanks for the info

 

[geni]

Just yesterday the media reported the pulling of the 6month heartworm treatment fro dogs - after over 500 dogs died and thousands more had serious adverse effects - even though NO adverse effects were reported during the study

Just for the record not all of those 500 deaths were due to the drug.

 

[merphie]

absolutely

My relatives sell that snake oil. So much for being skeptical.

 

[athon]

Ok Barbrae, you want an admission that the system is imperfect, then fine. It is, and I agree. Drugs that are seen to be safe have indeed later been found to be contraindicative, have been found to be incompatible in given instances, and have been found to be dangerous if used outside of the parameters it was tested in.

We could add another couple of levels of testing on, for the drugs to be compared and tested in relation with a larger range of other chemicals, on a more varied population...which would increase costs even more than a rich person could afford, and mean that a drug designed today would not be available for close to twenty years.

The system does have holes. It's the same argument that anti-immunisationists have, though; people do suffer from modern medicine. But two things have to be considered--

1) How many benefit in contrast with those affected?
2) Because we can ask questions, the system is able to be ammended and drugs can be removed if found to be either dangerous or ineffective.

This system falls down completely if drugs can be prescribed outside of it. Unlike drugs that have been questioned, homeopathy is allowed to still be prescribed. Unlike drugs that are argued to be ineffective, it is still used as a medicine. If homeopathy was given a chemical name, it would have fallen by the wayside long ago.

So there you have it. Medicine throughout time has unfortunately had its problems. It is an evolution, and one that is perfecting itself as time goes on. We are allowed to argue that some things aren't as good as we once thought. The one trait that best arms a scientist, afterall, is humility.

Athon

 

[Asolepius]

Oh, come on now, the fatalities from properly prescribed drugs far outweighs any from herbs, supplements. and let's not make excuses as to why that is. The numbers are outrageous.

Please note that this site is all about evidence. You will need to tell us what these outrageous numbers are. Also note that drugs are regulated and thus we have the numbers, herbs are not so we don't have the numbers. We are all happy to cross swords with truly objective debaters, but not with people who rely on unfounded emotive claims.

 

[Asolepius]

I wholeheartedly agree. If someone chooses to take an unregulated substance then at the very least they need to reaseacrh different companies that sell said substance and also research the herb they are taking.

Well this is going to be difficult. Last week I went into a Chinese medicine shop. The proprietor could not tell me what any of his products contained. He showed me a bottle labelled 'psoriasis tablets'. There was nothing else on the bottle. It might have contained something to which I was fatally allergic, but he was totally unconcerned. Barbrae, I think that posters to this thread have given you a wealth of answers to your questions. The difference between them and you is that they are objective and know what evidence is. Did you read my post about drug development? Do you understand that, whatever the medicine, you are unlikely to detect uncommon adverse events in pre-marketing clinical trials? Herbal medicines (a) do not have a clean safety record, and (b) are perceived by many as innocuous because so little data are collected about them. Let's have a level playing field.

 

[Anders W. Bonde]

Barbrae,

Please answer the following questions in your own words, your own opinion is what I'm curious about:

Why is it that there is an absolute lack of any testing or regulatory processes for homoeopathic remedies?

Why is complete lack of interest within the homoeopathic community regarding finding answers to the many points of disagreement regarding dose rates, expiry dates, interactions, storage requirements and so on?

[questions courtesey Rolfe]

Barbrae,

This is a debating forum. When people ask questions, you answer to the best of your abilities - that's the netiquette. Having questions repeated because you do not answer them or because you divert and obfuscate is not "getting on your back", it is simply repeating the questions because you may have overlooked them. Ignoring questions will give the other posters the impression that you are unable to answer the questions or simply uncomfortable with them. No need to found such speculation, is there? - Just answer the questions!

Thank you.

 

[Eos of the Eons]

Herbal Remedy Deadly

http://www.washingtonpost.com/wp-dyn/articles/A62671-2004Sep4.html?referrer=emailarticle

When a medical checkup indicated trouble with his prostate gland, John Meyer decided to try a natural remedy. Ignoring his wife's skepticism, the southern Arizona man went out and bought an herbal supplement promoting "prostate health."
... an artificial estrogen considered so dangerous it was pulled from the market years ago, and a blood thinner that in high doses is used as rat poison...The company pleaded no contest to a felony charge

...Polls show most Americans think the products are safe and assume the government is testing them

...Many of the most exaggerated health claims about PC-SPES were made not on the bottle's label, where they would be subject to federal regulations

...funding also came from a prostate-cancer foundation created by Michael Milken, the convicted junk-bond financier

...Thirty-five people or their estates have come forward to claim harm, including men whose breasts grew so large they had to have them surgically removed, and others who inexplicably bled to death.

Aren't "all natural" supplements fun!! It's like a surprise bag at your birthday party...too bad the contents can kill or disfigure you.

the products could be put on the market relatively quickly. The herbal supplements did not have to undergo tests in humans because the company was not promoting them on the label as treatments for specific diseases.

Instead, the labels on various remedies touted support for "healthy joints" or offered "immune system enhancing properties." The Chens hit upon their biggest success with a supplement they called PC-SPES, labeled for "healthy prostate function."

The maker is a chemist from Taiwan, wanting to "marry chinese herbs and western medicine. Also...

Her scientific collaborator was Xuhui "Allan" Wang, an herbalist who liked to tell people he was a descendant of the doctor who served the last emperor of China.

It's a five page article, and fascinating.

 

[Sarah-I]

Anders,

I think this was one of the answers that you were looking for.

Barb. Regarding safety of herbal meds/homeopathy I think that safety studies should be done - I also think herbs should be regulated as far as active ingrediants and such.

 

[Anders W. Bonde]

Sarah-I,

Thanks for your help. However, Barbarae's reply in no way explains why testing for safety and efficacy is not already being done to homeopathic remedies by the homeopathic community and society at large. Why is there no quality control on homeopathic remedies today? The stuff has been purveyed for 200 years? What are homeopaths waiting for? It is not just a sfety issue - it is equally much an improvement of efficacy issue.

What I want to know is why the homeopaths do not actively work for the establishment of a level playing field - common regulation for all medication.

I also want to know why the real medicine industry has not long since embraced homeopathy, as they would ceratinly be able to afford the clearance procedures - even though I am sure the OTC and other producers of magic water/sugar pills could afford it, too.

 

[Prester John]

The numbers of deaths caused by medicine do seem to be rather high, however you really need to understand how death certificates work to understand the actual figures. Death certficates have a cause of death on them. This cause of death is never "old age".

Suppose you go into hospital for a heart operation, you are going to die without the operation, but you have the operation, its a success, but you get infected in the hospital, MRSA septicaemia, maybe you die, in which case your one of the MRSA numbers that makes the news, maybe not, you are given Vancomycin, its working, but being old your Kidneys pack up and you die, then you'll get Kidney failure caused by Vancomycin (fatal drug reaction). The patient would have died without the interventions and made it to the Cardiac arrest list.

To point at the numbers and go shock horror is disingeneous, misleading and dishonest. There may well be issues worthy of debate, but first an actual understanding of the figures is neccessary.

There are undoubtably mistakes made, errors of judgement, unexpected reactions,but then, hospitals are dangerous places, lots of people die there, you wouldn't catch me in one

 

[Anders W. Bonde]

Barbrae,

If someone chooses to take an unregulated substance then at the very least they need to reaseacrh different companies that sell said substance and also research the herb they are taking.

Yes - but as these companies are unregulated, how can they trust what the caompanies say? You can't! Even you use the word 'unregulated' about them. That's the whole point: researching claims of unregulated companies is an exercise in futility - at best you can google a company to see if they have been in the (bad) news, like for instance the way it went with Pan Pharmaceuticals. Is that a fair way to treat consumers?

I also believe that anyone taking a prescription med needs to take charge of their own health and reseacrh that as well - probably more so.

The need should be less, due to the regulation and research that is actually carried out for reasons of public safety.

Would you kindly care to elaborate on why you think that anyone taking precription medication should research their own health more than those taking the unregulated stuff? Are you trying to argue that more regulation results in less safety and vise versa?

BTW:

Originally posted by Barbrae:
Oh, come on now, the fatalities from properly prescribed drugs far outweighs any from herbs, supplements. and let's not make excuses as to why that is. The numbers are outrageous.

That's also scaremongering, Barbarae. Show us the numbers and avoid apples-to-oranges comparisons.