Fosamax

[Guest guest]

The problem is also these companies distort the research so that doctors don't

really know what is going on. Some of you may have seen the story about the

doctor from Sheffield in England who has been asking some questions of Procter

and Gamble about their rival to Fosamax. When a lot of money if there the

science is not top-notch.

Jan

 

See http://www.slate.com/id/2133061/

 

Rent-a-Researcher

Did a British university sell out to Procter & Gamble?

By Jennifer Washburn

Posted Thursday, Dec. 22, 2005, at 2:38 PM ET

 

Earlier this month, Sheffield University in Britain offered $252,000 to one of

its senior medical professors, Aubrey Blumsohn. According to a copy of a

proposed settlement released by Blumsohn, the university promised to pay him if

he would agree to leave his post and not make " any detrimental or derogatory

statements " about Sheffield or its employees. For several years, Blumsohn had

been complaining of scientific misconduct. His concerns primarily revolved

around a $250,000 research contract between Sheffield and the Ohio-based Procter

& Gamble Pharmaceuticals. Blumsohn claimed that the company had denied him

access to key data and then tried to ghostwrite his analysis of it. He further

alleged that P & G had engaged in such practices before.

Why did Sheffield, a top-flight research university, try to silence and get

rid of Blumsohn? The answer appears to lie in the complex and increasingly

compromised relationships that have grown up between some research universities

and the pharmaceutical industry. In 2001, the editors of nearly a dozen

prominent medical journals warned that growing industry interference with

academic research (from study design to data analysis and publication) was

threatening the objectivity and trustworthiness of medical research. The editors

issued new guidelines requiring all authors publishing in the journals to verify

that they " had full access to all of the data " related to their studies and that

they took " complete responsibility " for " the accuracy of the data analysis. "

But in the years since, universities with medical schools have become

dependent on drug companies for an ever-larger share of their research

budgets—roughly 80 percent of clinical research is now privately funded. And

drug companies, in turn, have pressed for greater control over the research

process, making it easier for them to obscure or delete negative results from

published academic papers. Earlier this month, the New England Journal of

Medicine accused Merck of failing to report three patient deaths in the trial

that led to FDA approval of the painkiller Vioxx, which was pulled from the

market last year because of its association with heart attacks and strokes. The

careful record Blumsohn kept of his dealings with Procter & Gamble and Sheffield

suggests that P & G didn't control academic research on its own. It needed

Sheffield University to permit incursions on scholarly independence.

placeAd(2,'slate.arts/slate')

 

In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism

specialist, and Dr. Richard Eastell, Sheffield's research dean, signed a

$250,000 research contract with Procter & Gamble. Blumsohn and Eastell were to

evaluate the effectiveness of P & G's osteoporosis drug, Actonel. The goal was not

to win FDA approval; Actonel was already being widely prescribed. Instead, the

Sheffield study would shed further light on how Actonel affects women's bones

and their susceptibility to fractures. According to Blumsohn, Eastell had

already reviewed blood and urine samples from two previous P & G clinical trials

of Actonel. Now Blumsohn was supposed to evaluate a third trial, with the aim of

providing a final analysis of all three.

But in the past, it seemed, P & G had not allowed Eastell to perform his own

data analysis. In an e-mail that Eastell wrote to P & G and copied Blumsohn on, he

confessed that while presenting a paper at the International Osteoporosis

Foundation, he had been unable to respond to questions about his own research

posed by a fellow academic. " I think that to avoid criticism in the future it

would be good if we could say that we had done the analyses independently, "

Eastell wrote in the e-mail. He suggested that Blumsohn be entrusted with the

independent analysis, so he could vouch for results that would be published

under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples from

women with osteoporosis. At this stage, they were " blinded " from knowing which

patients had taken Actonel and which had taken a placebo. This helped to ensure

objectivity. But when he finished examining the samples in December 2002,

Blumsohn says he asked P & G to release the codes for the raw data so he could

independently interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous e-mails

and other records document (here's one). P & G officials wrote back refusing to

permit independent access to the data. However, in a written statement, the

company denied that it withheld necessary data. " We have appropriately shared

our clinical data with both investigators and regulatory authorities, and have

conducted our business with the highest of standards. "

Meanwhile, Blumsohn says P & G began to analyze his Actonel data and write up

the final results for him to present at the American Society of Bone and Mineral

Research in Minneapolis in fall 2003. The previous April, P & G statistician Ian

Barton informed Blumsohn and Eastell by e-mail that Mary Royer, the company's

medical ghostwriter, would help write up the Actonel manuscripts for

publication. Blumsohn and Eastell would both be listed as authors. Barton

emphasized that the ghostwriter was " familiar with … our key messages. "

By now, Blumsohn thought he knew what those " key messages " were. In 2004,

P & G's main rival, Merck, was due to publish a head-to-head study comparing its

osteoporosis drug, Fosamax, with Actonel. Many doctors considered Fosamax more

effective at increasing bone density and decreasing the rate at which bones

degenerate—and thus probably also more effective in preventing fractures, the

biggest concern for women with osteoporosis. Fosamax's global sales were $3

billion a year, compared to about $1 billion for Actonel. In the summer of 2003,

Blumsohn received a copy of P & G's proposed " statistical plan " for analyzing his

data. It stated that the purpose of his research was to bring about an

" Osteoporosis Paradigm Shift. "

Eastell's earlier research asserting P & G's claims about the effectiveness of

Actonel appeared in June in the prestigious Journal of Bone and Mineral

Research. Eastell and his co-investigators stated that " all authors had full

access to the data and analyses. " Based on Eastell's earlier e-mail, Blumsohn

knew that wasn't true and that Eastell had most likely violated the new

safeguards that medical journal editors had put in place in 2001. Blumsohn says

he warned Eastell they could both be accused of scientific fraud if they kept

authoring papers without seeing the underlying data. A few days later, P & G's

Barton sent an e-mail reiterating that Blumsohn could not perform his own

independent analysis of his data but could come to P & G's offices to look at it.

When Blumsohn sat down with Barton at the company's Surrey headquarters in

late July, he says he spotted something peculiar. In one critical graph showing

how Actonel affects fracture rates, Blumsohn noticed that 40 percent of the

patient data was missing. Inclusion of the data, he thought, would have

disproved P & G's " key message " about Actonel's effectiveness in reducing bone

fractures. Several months later, Blumsohn recorded a meeting in which Barton

expressed concern that if P & G included the missing 40 percent of the data, Merck

would exploit the results. " Because that is contradicting our original

manuscript, " he said. " I just know what Merck are like. I think they are going

to use it. "

P & G denies that it skewed data to achieve desired results, saying that

Blumsohn " was given access to all of the data related to his research. " But the

company's previous written statements seem to contradict this assertion. When

Blumsohn's lawyer filed a formal data request on his behalf, P & G responded: " It

is not the standard practice of P & G to allow unlimited access to raw data from

clinical trials to individual investigators, as these data are proprietary. "

In November, Blumsohn won a few concessions. He says P & G agreed to remove the

graph he'd objected to from an oral presentation and to delete some text from a

paper appearing in his name. But P & G's educational materials and other writings

continued to make assertions about Actonel's effectiveness, which Blumsohn

believed the data he'd seen did not support.

Increasingly, Blumsohn felt he was doing battle not only with P & G but with his

university. Shortly after Blumsohn complained about the apparent manipulation of

his Actonel data, he recorded a conversation in which Eastell warned, " The only

thing we have to watch all the time is our relationship with P & G. " The P & G money

" is a good source of income, we have got to really watch it. "

Over the next 22 months, Blumsohn wrote formal complaint letters to various

Sheffield officials. The university didn't investigate his claims, according to

an article in the British Times Higher Education Supplement. In July, Blumsohn

announced that he would go public with his concerns. Sheffield suspended him in

September, citing, among other things, his " refusal to comply with a reasonable

management instruction by briefing journalists. " Sheffield then offered him the

$300,000. Sheffield states that it repeatedly asked Blumsohn to provide evidence

supporting his allegations and urged him to bring that evidence " through the

proper channels. " The university says legal negotiations were initiated " at

Blumsohn's request " and " undertaken in good faith by the University. "

Universities have long accepted funding from pharmaceutical companies to

conduct clinical drug trials. But in the past, their professors insisted on

running those trials independently of the sponsor. As the Blumsohn case makes

clear, this arm's-length relationship appears to be breaking down. Earlier this

month, the Wall Street Journal reported on the growing willingness of some

academics to sign their names—and lend their prestige—to articles and editorials

penned by drug-company ghostwriters. In addition to the Vioxx episode, recent

reports indicate that published academic studies related to the drugs Celebrex,

Paxil, and Zoloft appear to have been skewed when their authors permitted the

suppression of negative results.

The British Parliament has promised to investigate Blumsohn's allegations. And

in January, medical journal editors will be gathering once again to discuss what

can be done to restore the integrity of the research they publish. One idea

that's been floated in the United States is a new arm of the National Institutes

of Health that could serve as a repository for complete clinical trial data

while also monitoring trials and verifying the accuracy of published results.

Whatever the solution, something needs to be done soon. Scholarly independence

has already taken too many hits.

 

Jennifer Washburn is a fellow at the New America Foundation and author of

University, Inc.: The Corporate Corruption of Higher Education.

 

 

 

Jay Jones <herblsens wrote:

Fosamax

by Marcelle Pick, OB/GYN NP

[Guest guest]

My dear auntie was put on Fosamax and began having severe back pains

and numbness. She followed my advice and ditched the Fosamax and

switched to herbal products, thankfully in time. She is doing fine now.

 

Fosamax will likely end up being the next Vioxx - but not until the

FDA covers for it long enough for Merck to rake in billions of dollars

in profits. Just my humble opinion, of course.

 

FYI - this aunt is the wife of my 85 year old uncle whom mainstream

medicine failed to help and who then used oleander to get rid of his

lung cancer that was metatisizing to other parts of the body.

 

He is now cancer free and quite the active fellow.

 

 

oleander soup , robert-blau wrote:

>

> Ah, the wonders of pharmaceuticals . . .

>

> [hsibaltimore.com]

>

> Dear Reader,

>

> If you were thinking about purchasing an 882-foot ocean liner, you would

> probably want one that wouldn't sink if it hit an iceberg. So if an

> ocean liner salesman told you he had just the thing – guaranteed

> unsinkable – except for one small caveat that it might sink if it hits

> an iceberg, you would probably tell him, " I'll get back to you later. "

> Later – as in " never. "

>

> A patient who's considering the use of Fosamax (the medication that

> prevents bone loss) might get the same sort of " get back to you later "

> feeling if she happens to come across a recent study in the New England

> Journal of Medicine that offers yet another reason to avoid this

> medication like a leaky ocean liner.

> -----------

> Giving bones a break

> -----------

> The Fosamax web site advises patients who use this drug to stay fully

> upright for at least 30 minutes after swallowing a dose. This is

> necessary to help the pill reach the stomach quickly, otherwise the dose

> may irritate or even ulcerate the esophagus, prompting heartburn and

> possible chest pain.

>

> But once Fosamax gets to the stomach and enters the blood stream, some

> users may wish they'd never swallowed it at all.

> This past January, the FDA sent an alert to physicians stating that

> biophosphonates like Fosamax may cause severe bone pain. But the Fosamax

> web site takes that warning even further, telling patients who use the

> drug to contact their doctor in the event of " severe bone, joint, and/or

> muscle pain. "

>

> Biophosphonates increase bone density by tinkering with a remarkable

> process that keeps bones strong and healthy. We tend to think of bones

> as static structures, hard as rock, but in fact our bones are alive with

> a constant turnover of osteoblast cells (which increase bone density)

> and osteoclast cells (which remove bone). When biophosphonates intrude

> on this process – boosting osteoblasts by removing osteoclasts – the

> complex natural balance is put at risk.

> How much risk? According to Dr. Joseph Lane of Cornell Medical College,

> this drug that's supposed to protect bones may actually increase

> fracture risk.

> -----------

> Time for a holiday

> -----------

> Based on previous research that shows a potential link between prolonged

> biophosphonate use and increased risk of thighbone fracture, the Cornell

> team examined a group of fifteen women who had used Fosamax for an

> average of about five years. Each of the subjects had also experienced a

> thighbone fracture. Dr. Lane's analysis showed that ten subjects had a

> similar, very specific type of fracture. Among these ten, Fosamax had

> been used for an average of more than seven years.

>

> Dr. Lane explains to HealthDay News that slower bone turnover caused by

> biophosphonate use may prompt a gradual microdamage in the thighbone.

> Over time this damage slowly takes its toll, making some patients

> susceptible to fracture when they experience a fall – even a very

> light fall from a standing position.

>

> And then Dr. Lane tells HealthDay exactly what we've come to expect in

> studies that put a popular medication in a very poor light: Patients who

> take Fosamax should keep taking it. And he adds: " This is a great drug

> that does wonderful things. "

> Right. Please ignore the heartburn, bone pain, and broken legs. (The

> HealthDay article also notes that Fosamax was recently linked to

> increased risk of irregular heartbeat.)

>

> But after Dr. Lane completes his genuflection to this wonderful drug, he

> makes a suggestion that reveals something closer to reality: He tells

> HealthDay that women who use Fosamax for a long period and have low bone

> turnover might want to talk to their doctor about taking a " bone

> holiday, " and discontinue use for a year.

>

> A bone holiday! Sounds nice. And while your bones are enjoying the

> relief of a drug-free holiday, that might be a perfect time for a

> nutrition makeover. In the e-Alert " Rags to Riches " (1/25/07), you'll

> find several suggestions from Jonathan V. Wright, M.D., and HSI Panelist

> Allan Spreen, M.D., about the key nutrients necessary for optimal bone

> health, at this link:

> http://www.hsibaltimore.com/ealerts/ea200701/ea20070125a.html

>

> Sources:

> " Atypical Fractures of the Femoral Diaphysis in Postmenopausal Women

> Taking Alendronate " The New England Journal of Medicine, Vol. 358, No.

> 12, 3/20/08

> " Fosamax Linked to Unusual Femur Fractures " HealthDay News, 3/19/08,

> nlm.nih.gov

>

[Guest guest]

Hi. I'm new here and have not had a chance to read all the files and past posts yet, but I do have a question about oleander and leukemia. I read in the Natural News interview that oleander had been active against leukemia, but then it never mentioned this again--addressing more "regular" type cancers. Many herbalists and nutritionists are at a loss as far as leukemia is concerned. They don't really see it as regular cancer I guess.

 

Does anyone know anything about oleander and leukemia, or have had any experience with this?

 

Thanks

Renee

 

----

 

FYI - this aunt is the wife of my 85 year old uncle whom mainstream

medicine failed to help and who then used oleander to get rid of his

lung cancer that was metatisizing to other parts of the body.

 

He is now cancer free and quite the active fellow.

 

[Guest guest]

Oleander has had some very good success against leukemia. When Dr.

Ozel first made his oleander extract that later became the patented

medicine Anvirzel, some of his earliest uses and successes were

against leukemia.

 

 

oleander soup , " Gaiacita " <gaiacita wrote:

>

> Hi. I'm new here and have not had a chance to read all the files

and past

> posts yet, but I do have a question about oleander and leukemia. I

read in

> the Natural News interview that oleander had been active against

leukemia,

> but then it never mentioned this again--addressing more " regular " type

> cancers. Many herbalists and nutritionists are at a loss as far as

leukemia

> is concerned. They don't really see it as regular cancer I guess.

>

> Does anyone know anything about oleander and leukemia, or have had any

> experience with this?

>

> Thanks

> Renee

>

> ----

>

> FYI - this aunt is the wife of my 85 year old uncle whom mainstream

> medicine failed to help and who then used oleander to get rid of his

> lung cancer that was metatisizing to other parts of the body.

>

> He is now cancer free and quite the active fellow.

>

[Guest guest]

Thanks Tony. Is the recommended dosage the same for leukemia as for any other cancer? The daily amount taken I mean?

 

Samala,

Renee

 

----

 

Oleander has had some very good success against leukemia. When Dr.

Ozel first made his oleander extract that later became the patented

medicine Anvirzel, some of his earliest uses and successes were

against leukemia.

 

[Guest guest]

Yes, it would be the same and the recommended maximum amount (5 ml 3

times daily for the OPC supplement and 1 tablespoon 3 x daily for the

home remedy) should never be exceeded. It is my firm belief that any

form of oleander should begin with smaller doses and then work up to

the max dose as the body becomes accustomed.

 

 

oleander soup , " Gaiacita " <gaiacita wrote:

>

> Thanks Tony. Is the recommended dosage the same for leukemia as for any

> other cancer? The daily amount taken I mean?

>

> Samala,

> Renee

>

> ----

>

> Oleander has had some very good success against leukemia. When Dr.

> Ozel first made his oleander extract that later became the patented

> medicine Anvirzel, some of his earliest uses and successes were

> against leukemia.

>

[Guest guest]

[From NorthStar Nutritionals]

 

Sticks and stones may break your bones…

 

But Fosamax is not the answer.

 

According to Merck, their drug Fosamax (which is in a class of drugs

called bisphosphonates) is designed to change the way the body breaks

down and builds up bone in an effort to help curtail the bone loss

associated with osteoporosis.

 

But recent reports are showing that it does way more than that.

 

Forms of the drug are taken either once a day, first thing in the

morning, or once a week, also first thing in the morning. According to

the Fosamax website, it reduces the activity of cells that cause bone

loss, decreases the rate of bone loss and increases the amount of bone

in most patients.

 

Something else you might notice on the Fosamax website is that the

benefits of the drug take up about a third of the page while the

side-effects and precautions take up the balance.

 

Aside from the fact that you can't eat or drink anything for 30 minutes

after taking it, you can't lie down for 30 minutes either because it can

cause severe damage to the esophagus and stomach.

Additional side effects can include severe bone, joint or muscle pain.

As well as something called osteonecrosis of the jaw…also known as

bone death.

 

Just to make sure we're on the same page here…a drug designed to

prevent and reverse bone loss, can actually cause bone death. But I'm

still not done…

 

According to a recent study conducted by researchers at the University

of Washington, women using Fosamax are nearly twice as likely to develop

an irregular heartbeat (atrial fibrillation): a condition that can cause

palpitations, fainting, fatigue, or congestive heart failure.

 

It might also interest you to know that osteoporosis diagnoses shot from

roughly half a million to about 3.6 million once the class of drugs was

introduced in the mid 1990s. It was around that time that Merck also

started selling bone density testing equipment…

 

…hardly a coincidence I'm sure.

 

So, do the risks outweigh the benefits? Well that depends on who you

ask.

Study leader, Dr. Susan Heckbert, thinks that, although careful judgment

is required, the benefits do justify the risks for women at high risk

for fractures.

But according to a report written by Dr. Susan M. Ott in the Annals of

Internal Medicine, while much of the Fosamax advertising would lead you

to believe it's a bone-builder, the evidence shows it is actually a bone

hardener…and that bones could actually become more brittle with

long-term use.

 

Another study, published in the Journal of Clinical Endocrinology and

Metabolism, further supports this. It notes that six patients using this

class of drug had spontaneous fractures that took anywhere from three

months to two years to heal during therapy with the drug.

Conversely, in an I-wish-it-was-funnier-than-it-is study, funded and

published by Merck, they found that women using the drug for five years

or more could expect its effects to last indefinitely. It's hard to say

if that's a good thing or a bad thing.

 

In the mean time, a new " medical food " recently hit the market called

Fosteum. It's essentially a soy derivative with zinc and vitamin D and

it's meant to be taken along with a calcium supplement.

" Medical foods " is new category that allows drug companies to make the

claims that supplements can't—while still requiring a prescription.

 

Just how effective is it? Well, there's not a ton of information

available just yet, but in clinical studies, 85 percent of patients saw

increases in bone density (compared to those taking vitamin D and

calcium only).

And since all of the ingredients are considered GRAS (generally

recognized as safe), at least you don't have to worry about your jaw

rotting away if you take it.

I'll be sure to keep you posted as more information becomes available.

 

Until next time,

Allan Spreen, M.D.

NorthStar Nutritionals

[Guest guest]

I really wish someone would say whether oleander is changing their health picture or not, and how long they've been taking it. I have cancer, and taking it for that. I'd like some info on how long for results. I did order OPC, but will start to make some ... I appreciate the feedback on making it. Kinda scary.

I want to order Tony Isaacs book online, not in print form. Unfortunately, from the Sutherlandia site, you are required to start a PayPal credit card, not just use my own card. I refuse! Is there any other way to order it online?

Fosamax. It is extremely harmful, creates brittle bones. Loretta Lanphier has a site, Oasis of .... (Google her name), with loads of wonderful alternative info. In it she suggests calcium orotate, magnesium orotate, strontium, and other minerals. The nagging ache in my back ended when I used it, and returned when I ran out. However, I've since read that osteoporosis is a disease of too much dairy in any form. Unknown where infants breastfeed and dairy is not used by adults.Rhoda

[Guest guest]

I had an elevated PSA 3 years ago. This is a marker for prostate cancer. The higher the PSA the more likely PC. Within 3 months of taking OS and beta-sitosterol, my PSA was back in the normal range.Tony and will not be back for several days. They can give you more info.Dr. Michael L GoebelRhoda Mead <firefly541 wrote: I really wish someone would say whether oleander is changing their health picture or not, and how long they've been taking it. I have cancer, and taking it for that. I'd like some

info on how long for results. I did order OPC, but will start to make some ... I appreciate the feedback on making it. Kinda scary. I want to order Tony Isaacs book online, not in print form. Unfortunately, from the Sutherlandia site, you are required to start a PayPal credit card, not just use my own card. I refuse! Is there any other way to order it online? Fosamax. It is extremely harmful, creates brittle bones. Loretta Lanphier has a site, Oasis of .... (Google her name), with loads of wonderful alternative info. In it she suggests calcium orotate, magnesium orotate, strontium, and other minerals. The nagging ache in my back ended when I used it, and returned when I ran out. However, I've since read that osteoporosis is a disease of too much dairy in any form. Unknown where infants breastfeed and dairy is not used by adults.Rhoda

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