Re: Hormone Replacement Study a Shock to the MedicalSystem

[Guest guest]

It also goes farther than that..the pharmaceutical companies are now

approaching the american pharmacists asking them not to prescribe generics

so that people's money is running out faster...i saw a blurb with peter

jennings about a woman coming out of the pharmacy and then finding out she

was not being given the generic cheaper equivalent

i guess if you recall at the time of your anthrax situation member the

company that was charging a fortune...then a generic came on and the

government would not allow it .....memory is not so good on the full

details..but why would they charge so much for the cipro when another

company could provide the same...at a cheaper price...

oh well ..sigh

sam

[ ] Hormone Replacement Study a Shock to the Medical

>> > System

>> >

>> > Hormone Replacement Study a Shock to the Medical System

>> > Wed Jul 10, 9:09 AM ET

>> >

>> > By GINA KOLATA with MELODY PETERSEN The New York Times

>> >

>> > The announcement yesterday that a hormone replacement regimen taken

>> > by six million American women did more harm than good was met with

>> > puzzlement and disbelief by women and their doctors across the

>> > country.

>> >

>> > A rigorous study found that the drugs, a combination of estrogen and

>> > progestin, caused small increases in breast cancer ( news web sites),

> heart

>> > attacks, strokes and blood clots. Those risks outweighed the drugs'

> benefits

>> > a small decrease in hip fractures and a decrease in colorectal cancer.

> Many

>> > of the 16,000 women in the study, supported by the National Institutes

of

>> > Health ( news - web

>> > sites), opened letters yesterday telling them to stop the drugs. In

light

> of

>> > the findings, the study had come to a halt.

>> >

>> > Hearing the news, some said the findings had persuaded them.

>> >

>> > " I may have taken my last pill this morning, " said Dr. Deborah Bublitz,

a

>> > pediatrician in Littleton, Colo.

>> >

>> > Others agonized over the consequences of suddenly stopping drugs that

help

>> > prevent bone loss and relieve menopause symptoms. Would they suffer

>> > torrential night sweats and embarrassing hot flashes? Or were the

> scientists

>> > simply exaggerating the risks, which were, after all, minuscule for an

>> > individual woman?

>> >

>> > Until recently, medical authorities were telling doctors to encourage

> almost

>> > every woman who had not had a hysterectomy to start taking the drugs

when

>> > she reached menopause and to take them for years, even for life. Now

the

>> > growing consensus seems to be that women should carefully consider

whether

>> > they want to start the drugs at all. Those who take them for more than

a

> few

>> > years should be aware of the risks, which, if slight, are real.

>> >

>> > The news of the study's findings came as such a surprise that doctors

were

>> > inundated yesterday with calls from patients. Some medical experts on

the

>> > hormone therapy said they had given up and taken their phones off the

> hook.

>> >

>> > " I'm just letting all my calls go onto the answering machine, " said Dr.

> Wulf

>> > Utian, executive director of the North American Menopause Society.

>> >

>> > But for Dr. Utian and others, this was a defining moment in medical

> history.

>> >

>> > This is the biggest bombshell that ever hit in my 30-something years in

> the

>> > menopause area, " Dr. Utian said.

>> >

>> > It was a powerful scientific counterattack to years of strong promotion

of

>> > hormone replacement. There were reams of scientific papers. Many fell

> short

>> > of absolute rigor, but in sum they pointed mostly in one direction,

that

> of

>> > benefit. There were compelling marketing campaigns by drug companies.

> There

>> > was also the eager adoption of the drug combination by doctors and

women

> who

>> > wanted to believe it worked.

>> >

>> > The new study was different from the rest because it involved

thousands

> of

>> > healthy women and had a

>> > control group, with half the women taking dummy pills. In addition,

it

>> > looked for evidence of disease

>> > like heart attacks and cancer rather than indirect indicators like

>> > cholesterol levels, which can be

>> > misleading.

>> >

>> > " This is definitive evidence, " said Dr. Deborah Grady, who directs

the

>> > Mount Zion Women's Health

>> > Clinical Research Center at the University of California in San

> Francisco.

>> >

>> > The tale of estrogen therapy began in 1966, when an enthusiastic

doctor,

>> > , wrote a

>> > best-selling book. He called it " Feminine Forever " and flew around

the

>> > country promoting it, telling

>> > women and doctors alike that estrogen, the feminine hormone, could

keep

>> > women young, healthy and

>> > attractive. It was just so natural women would be replacing a hormone

> they

>> > had lost at menopause just

>> > as diabetics ( news - web sites) replace the insulin their pancreas

> fails

>> > to make.

>> >

>> > " At age 50, there are no ova, no follicles, no theca, no estrogen

truly

> a

>> > galloping catastrophe, " Dr.

>> > wrote in 1972 in The Journal of the American Geriatric

Society,

>> > referring to the eggs and

>> > surrounding tissue. But, he continued, estrogen can save these women.

>> > " Breasts and genital organs will

>> > not shrivel. Such women will be much more pleasant to live with and

will

>> > not become dull and

>> > unattractive. "

>> >

>> > Dr. died in 1981, but his son, , said yesterday

that

>> > Wyeth-Ayerst had paid all

>> > the expenses of writing " Feminine Forever " and financed his father's

>> > organization, the Research

>> > Foundation, which had offices on Park Avenue in Manhattan.

>> >

>> > Mr. , who lives in Cary, N.C., said the company had also paid

his

>> > parents to lecture to women's

>> > groups on the book. Wyeth said it could not confirm the account

because

> it

>> > was so long ago.

>> >

>> > By 1975, Wyeth's product, Premarin, had become the fifth leading

>> > prescription drug in the United

>> > States, said Nadine F. Marks, an associate professor at the

University

> of

>> > Wisconsin at Madison, who

>> > co-wrote a research paper on hormone therapy. " Even textbooks for

>> > gynecologists and obstetricians in

>> > the 1960's would explain how a woman's life could be destroyed if she

>> > didn't have estrogen in her

>> > body, " Dr. Marks said.

>> >

>> > During that time, however, two major studies published in 1975 in The

> New

>> > England Journal of

>> > Medicine ( news - web sites) indicated that estrogen substantially

>> > increased the risk of cancer of the

>> > lining of the uterus. Soon, doctors and drug companies found an

>> > alternative. They began giving

>> > estrogen with progestin, which counteracts the effects on the uterine

>> > lining, leading to monthly bleeding

>> > that resembles a menstrual period. Women who had had a hysterectomy

> could

>> > take estrogen alone.

>> > Women who had a uterus could take the hormone combination. The

problem

> was

>> > solved, or so most thought.

>> >

>> > Sales soared again in the 1980's, Dr. Marks said, after a major

>> > advertising initiative by the company,

>> > which promoted the hormones for the prevention of osteoporosis.

>> >

>> > There was no doubt that the drugs helped many women through a

difficult

>> > time when their sleep was

>> > disrupted by night sweats and their days by hot flashes.

>> >

>> > " There is nothing else out there that addresses the symptoms of

>> > menopause, " said Dr. Kusiak,

>> > vice president of global medical affairs at Wyeth.

>> >

>> > But scientists and doctors were saying something more that it could

be

>> > used for disease prevention.

>> >

>> > Many were impressed by evidence from dozens of observational studies

in

>> > which women who

>> > happened to take estrogen were compared to women who did not. The

> drawback

>> > to these studies,

>> > however, is that women who decide to take estrogen, studies have

shown,

>> > tend to be different from

>> > those who do not. They are healthier, leaner, less likely to smoke.

The

>> > question is, does estrogen make

>> > women healthy, or do healthy women take estrogen?

>> >

>> > Nevertheless, many of the studies indicated that those who took the

> drugs

>> > had fewer heart attacks and

>> > fewer strokes, that they had stronger bones and fewer fractures.

There

>> > were also laboratory studies

>> > demonstrating effects on animals and cells that seemed to support the

>> > observations.

>> >

>> > " There was all this mechanistic stuff, " Dr. Grady said. " I have six

> inches

>> > of papers suggesting that it

>> > improves coronary vasodilation, that it prevents atherosclerosis. " In

>> > fact, she said, the accumulating

>> > evidence for a heart disease benefit, although indirect, seemed

>> > overwhelming.

>> >

>> > Even a large study by the National Institutes of Health seemed to

> support

>> > the notion of benefit. It

>> > looked not at disease but at markers for disease, cholesterol levels

and

>> > bone density. Women who

>> > took hormones had better cholesterol levels and denser bones than

those

>> > taking a placebo.

>> >

>> > " If you look at this evidence and it's part of the mind-boggling

aspect

> of

>> > this whole story boy, the

>> > evidence for estrogen looked really strong, " Dr. Grady said. She and

> other

>> > experts were so persuaded

>> > that they wrote guidelines for the American College of Physicians

>> > recommending that women at high

>> > risk of heart disease take estrogen after menopause.

>> >

>> > Dr. Marcia Stefanick, the principal investigator of the new federal

> study,

>> > said that not long ago medical

>> > groups were recommending that as soon as a woman turned 50, she

should

>> > have a frank discussion

>> > with her doctor about hormone replacement therapy and that her doctor

>> > should encourage her to take

>> > the drugs.

>> >

>> > " This was what every 50-plus woman should do to prevent the disease

of

>> > aging, " Dr. Stefanick said.

>> > " They linked up a very beneficial product for treating menopausal

> symptoms

>> > to the answer for treating

>> > all of a woman's aging problems. "

>> >

>> > Even when some observational studies indicated that estrogen, and

more

> so

>> > the combination of

>> > estrogen and progestin, might increase the risk of breast cancer,

> doctors

>> > were not dissuaded.

>> >

>> > " A lot of people thought it was outrageous that women should worry

about

>> > breast cancer risk when the

>> > heart disease risk is so much higher, " Dr. Stefanick said.

>> >

>> > Even as some scientists and advocates for women began arguing that at

>> > least there should be a more

>> > vigorous test of the estrogen hypothesis, it retained its power.

>> >

>> > Dr. Stefanick said that when the new study was being planned, doctors

> and

>> > researchers said it was

>> > unethical because in the most rigorous studies, a group of women

would

> be

>> > taking placebos. They

>> > would be denied the benefits of the hormones, these critics said.

>> >

>> > All along, as hormone therapy grew in popularity, some refused to be

>> > convinced. One group, the

>> > National Women's Health Network, said it was offended by the message

and

>> > questioned the data.

>> >

>> > The message, said Pearson, executive director of the network,

> " was

>> > sexist and ageist. " It had a

>> > constant refrain, she added. " Stay young. Stay healthy. Stay sexually

>> > vital. Be less of a pain to your

>> > husband. "

>> >

>> > " The claims were too good to be true, " Ms. Pearson said. " Each time

> there

>> > was anything negative

>> > about the drug, a new claim arose to keep it alive. "

>> >

>> > " The science was accurate but it was extrapolated beyond

imagination, "

> Ms.

>> > Pearson said. " We started

>> > saying: Not proven, not proven, not proven. "

>> >

>> > In 1990, when Wyeth, the leading maker of estrogen, went before the

Food

>> > and Drug Administration (

>> > news - web sites) with a request to label the drug as protective

against

>> > heart disease, Ms. Pearson was

>> > there.

>> >

>> > " We stood there and said, Hello? You couldn't approve a drug for

healthy

>> > men without a randomized

>> > clinical trial. Even aspirin had to have a randomized controlled

trial

>> > with healthy men, " she said, alluding

>> > to the data that persuaded the F.D.A. to allow aspirin makers to

market

>> > their product as protective

>> > against heart attacks. In a randomized controlled trial, patients are

>> > divided at random into groups, with

>> > each group taking a different treatment or placebo. They are

considered

>> > the gold standard of scientific

>> > evidence.

>> >

>> > The agency's advisory committee recommended that the company be able

to

>> > market estrogen as

>> > protective against heart disease, but the panel was overruled by the

>> > agency, which said better data

>> > were needed.

>> >

>> > In the end, Wyeth began a randomized controlled study that most

doctors

>> > and researchers assumed

>> > would prove estrogen's beneficial effects on the heart. The study,

known

>> > as HERS, involved women

>> > who had already had heart disease, a group in whom effects should be

>> > easiest to find.

>> >

>> > At the same time, amid lobbying by women's groups and criticism by

>> > congresswomen about the lack of

>> > attention paid to women's health, Congress appropriated money for a

new

>> > research initiative at the

>> > National Institutes of Health. That led to the latest huge and

expensive

>> > study of hormone replacement

>> > therapy.

>> >

>> > The emerging data from both that study, the Women's Health Initiative

> and

>> > HERS are sobering. HERS

>> > found that far from protecting women against heart attacks, the

>> > combination therapy actually increased

>> > their risk in the first few years of taking the drugs.

>> >

>> > The Women's Health Initiative includes a group of women who have had

>> > hysterectomies and who are

>> > taking estrogen alone. That part of the study is continuing because

the

>> > data have not shown significant

>> > risk or significant benefit from the hormone.

>> >

>> > The other part of the study, of women taking the hormone combination,

> was

>> > the part that was halted. It

>> > found that if 10,000 women take the hormones for one year, eight more

> will

>> > develop invasive breast

>> > cancer than a similar group not taking the hormones, seven more will

> have

>> > heart attacks, eight more will

>> > have strokes and eight more will have blood clots in their lungs. The

>> > benefits are six fewer instances of

>> > colorectal cancers and five fewer hip fractures.

>> >

>> > There is no one overwhelming danger, said Dr. Claude Lenfant,

director

> of

>> > the National Heart, Lung

>> > and Blood Institute. " It is a global risk. "

>> >

>> > Dr. Grady says she is absolutely convinced by the new evidence. " This

is

>> > such compelling evidence that

>> > women and their physicians ought to be finding a way to get off

> estrogen, "

>> > she said. But, she added,

>> > she is not sure that is what will happen.

>> >

>> > Many questions remain and it is possible that future studies will

find

>> > that benefits outweigh risks,

>> > perhaps with different combinations or formulations of hormones. The

> study

>> > did not look at estrogen

>> > patches, which deliver just estrogen, through the skin. There are

also

>> > different formulations of

>> > progestin.

>> >

>> > Dr. Utian of the Menopause Society said he was not surprised that an

>> > active debate seemed to be

>> > emerging.

>> >

>> > " There are an awful lot of interests at stake here beyond women's

> health, "

>> > he said. " There are

>> > investigators with research grants, N.I.H. grants and grants from the

>> > pharmaceutical industry. There are

>> > academics with careers to build. " Added to that, he said, are medical

>> > specialists gynecologists are

>> > comfortable with hormones, internists with statins to lower

cholesterol

>> > and protect against heart

>> > disease, bone experts with drugs like bisphosphonates to protect

against

>> > osteoporosis.

>> >

>> > " It's not just a matter of what the data says, " Dr. Utian added.

" Truth

> is

>> > opinion. "

>> >

>> >

>> >

>> >

>> > _________________________________________________________________

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>> >

>> >