Does anyone remember DES? Another drug disaster for women?

[WillYourVoteBCounted]

Does anyone remember DES?

DES was supposed to save our Cervix? Prevent miscarriages, ease menopause?

Diethylstilbestrol DES

Diethylstilbestrol (DES) is a drug, an orally active synthetic nonsteroidal estrogen that was first synthesized in 1938. In 1971 it was found to be a teratogen when given to pregnant women.

From the 1940s until the late 1980s, DES was FDA-approved as estrogen-replacement therapy for estrogen deficiency states such as ovarian dysgenesis, premature ovarian failure, and post-oophorectomy.

It was first prescribed by physicians to prevent miscarriages (in women who had had previous miscarriages) in the 1940s as an off-label use.

On July 1, 1947, the FDA approved the first supplemental new drug application (by Squibb) adding prevention of miscarriage as an indication and approved 25 mg (and later 100 mg) tablets of DES for this indication, and approved applications of several other pharmaceutical.

Check with Wikipedia for individual citations

Grimes DA. Discovering the need for randomized controlled trials in obstetrics: a personal odyssey

A placebo-controlled randomized controlled trial published by Dieckmann and others (1953) failed to find any benefit. Despite the lack of solid evidence that DES prevented adverse outcomes, wide use continued. Decades later, a landmark case-control study highlighted the dangers of fetal exposure to DES, especially clear cell carcinoma of the vagina in the daughters of women who had received the drug during pregnancy (Herbst et al. 1971). Not until 1971 did the U.S. Food and Drug Administration first warn against use of DES in pregnancy. By the mid-1970’s, more than 200 cancers of the vagina, most associated with DES exposure, had been reported to a DES registry (Herbst et al. 1977). Because of the prominence of the Boston authorities, credible data were ignored because the problem was serious and DES “might work.”

[Warren Stupidity]

1. And in other news

Measles Returns


Published: August 24, 2008
There has been an upsurge of measles cases in the United States, mostly because of parents’ misguided fears of vaccinations. The number is still relatively small — but climbing. In the first seven months of this year, 131 cases were reported to the Centers for Disease Control and Prevention, more than during the same period in any year since 1996. No deaths were reported, but at least 15 patients were hospitalized.

http://www.nytimes.com/2008/08/24/opinion/24sun2.html

Keep up the good work.

[WillYourVoteBCounted]

7. when Big Pharma/FDA/GOP shills quit fracking up our medicines

people will re-learn trust that we could/should take, allow, or ingest meds.

People have good reason to be skeptical, but assholes will label these people
and insult them.

There's plenty of pro Pharma asshats to go around.

[Jim__]

10. Did you read the entire editorial?

From the last paragraph:

...Although vaccination rates remain high in this country, some experts fear that they may be starting to drop. Because it is so contagious, measles is one of the first diseases to reappear when immunization coverage declines. If confidence in all vaccines were to drop precipitously, many diseases would re-emerge and cause far more harm than could possibly result from vaccination.

Definitely undermines the quoted: mostly because of parents’ misguided fears of vaccinations.

[dropkickpa]

2. DES was not intended to "save our cervix"

Lies like this just highlight your inability to conduct a coherent discussion.

It was noted, in cases where women suffered miscarriage, estrogen levels dropped prior to the miscarriage. It was thought that THIS was the cause of the miscarriage. DES was intended to bring estrogen levels up in a effort to prevent miscarriage. There was NO requirement that studies be conducted with regard to safety and efficacy, which is a FAR cry from today.

Here's a little history lesson for ya!
http://www.fda.gov/opacom/backgrounders/miles.html

1962
Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. The new law also exempts from the Delaney proviso animal drugs and animal feed additives shown to induce cancer but which leave no detectable levels of residue in the human food supply.

1966
FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

1968
FDA forms the Drug Efficacy Study Implementation (DESI) to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.

1970
In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.

FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.

1973
THE U.S. Supreme Court upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation.

The FDA did not HAVE the power to enforce efficacy and saftey through studies until 1962, and it wasn't until 1973 that this power was confirmed by supreme court ruling.

[WillYourVoteBCounted]

3. the paternalistic approach remains in the 21st century

How about trying hard to say that we should let big pharma tell us what is best for women,
or paternalistic assholes tell us what is best for our daughters?

Some people work hard at the key board day in and day out to defend Big Pharma's
abuse of women.

Lies would be a nice word for what those busy typists do in that defense.

Parsing words is a skill for the typists.

[dropkickpa]

11. Blah blah blah

DES was not studied, it created and sold prior to regulations requiring safety studies. That is not the case with your most favoritist vaccine, gardasil. Gardasil went through rigorous safety and efficacy testing worldwide. The two also don't compare in that one was a synthetic hormone developed in the 1930's and the other is a vaccine, two very different things.

[WillYourVoteBCounted]

4. And another wonderful drug that harmed our cervix

but thats ok, it made someone rich, and that is what some here support.

[LeftishBrit]

8. It wasn't intended to 'save' our cervix

The purpose was to correct hormonal causes of pregnancy loss (in fact, these turned out really to be hormonal effects); and was NOTHING to do with treating cervical weaknesses that can cause late miscarriage. And certainly nothing to do with cervical cancer.


'but thats ok, it made someone rich, and that is what some here support.'

NONSENSE! That is NOT what anyone here supports - we almost all support universal single payer health care, and are not great lovers of the 'profit motive' in health. We support the vaccine, or at least its universal availability, because we honestly think that the benefits outweigh the hypothesized risks.

And if you don't like - as you obviously don't - to have your motives questioned and to be accused of prudishness or anti-science bias, then you should similarly not impugn OTHER people's motives and imply that we support the vaccine because it 'makes people rich'! That is NOT the reason!!!!!!

[dropkickpa]

13. As an addendum

DES was not a "make one company rich" substance, as gardasil is alleged to be, it was a widely available synthetic, here's just some of the most commonly used names and spellings for DES and similar drugs (with extra citation flavor)

http://www.cdc.gov/DES/consumers/about/history.html

Nonsteroidal Estrogens:

Benzestrol

Chlorotrianisene

Comestrol

Cyren A

Cyren B

Delvinal

DES

DesPlex

Dibestil

Diestryl

Dienestrol

Dienoestrol

Diethylsteilbestrol dipalmitate

Diethylstilbestrol diphosphate

Diethylstilbestrol dipropionate

Diethylstilbenediol

Digestil

Domestrol

Estilben

Estrobene

Estrobene DP

Estrosyn
Fonatol

Gynben

Gyneben

Hexestrol

Hexoestrol

Hi-Bestrol

Menocrin

Meprane

Mestilbol

Microest

Methallenestrol

Mikarol

Mikarol forti

Milestrol

Monomestrol

Neo-Oestranol I

Neo-Oestranol II

Nulabort

Oestrogenine

Oestromenin

Oestromon

Orestol

Pabestrol D
Palestrol

Restrol

Stil-Rol

Stilbal

Stilbestrol

Stilbestronate

Stilbetin

Stilbinol

Stilboestroform

Silboestrol

Stilboestrol DP

Stilestrate

Stilpalmitate

Stilphostrol

Stilronate

Stilrone

Stils

Synestrin

Synestrol

Synthosestrin

Tace

Vallestril

Willestrol


Nonsteroidal Estrogen-Androgren Combination:

Amperone

Di-Erone

Estan

Metystil

Teserene

Tylandril

Tylostereone

Nonesteroidal Estrogen-Progesterone Combination:

Progravidium

Vaginal Cream Suppositories with Nonsterioidal Estrogens:

AVC Cream w/ Dienestrol

Dienestrol Cream

[valerief]

17. DES mutilated a lot of cervixes (put hoods on them) and kept cervical

cells from maturing properly. That increased cervical cancer risk.

Glad they caught mine in time.

[dropkickpa]

18. I am well aware of that

But it was NEVER marketed as having anything to do with the cervix as the OP claims.

[valerief]

21. I am well aware of that. It didn't prevent miscarriages either. nt

[dropkickpa]

22. And it was prescribed for this in the 1940's

When there were no controls in place requiring safety or efficacy studies of drugs, and women's healthcare was, frankly, still pretty much in the dark ages. That is not the case now. The two don't compare, no matter how much people want them to.

Completely different situations, different substances, different mode of action, different inteded purpose, one had no testing (no requirements) and one had extensive testing (per requirements), one is a drug one a vaccine, one was for pregnancy retention one to prevent infection with a virus, one is patented (gardasil) one was NEVER patented (DES in all it's myriad forms and permutations), the list goes on and on.

I haven't heard any of the objector yet claim that gardasil gives cervical cancer, though surely that is next. That would be the only place in which the two would compare, IF it were to happen and actually be PROVEN to happen (not just random google-fu hearsay, actual medical proof).

[valerief]

23. and the fifties. I know. nt

[beam me up scottie]

26. Actually, WYVBC did suggest that Gardasil causes cancer :

WillYourVoteBCounted (1000+ posts) Mon Aug-04-08 11:57 AM
Response to Reply #24

38. You should start your own thread extolling the virtues of Gardasil and Merck
no one here wants more women to get cervical cancer, but it is possible Gardasil
CAUSES cancer.

Merck didn't test it to see if it doesnt, and some girls have developed warts after
getting the vaccine.

[dropkickpa]

29. Holy carp

Yer right!!!:daily:

[newfie11]

5. I have over the years seen several daughters who's mom used DES

Everyone of them had problems due to DES in uterio. "First Do No Harm" doesn't seem to apply to big pharma.

[LeftishBrit]

12. Look - there have been medical mistakes and wrong and dangerous theories through the ages

Long before Big Pharma, doctors were bleeding patients as a main method of cure; giving emetics and laxatives for all ailments; prescribing poisons such as arsenic and yes, the dreaded mercury! It wasn;t usually that they wanted to harm people; they were doing what they could with the knowledge they had, often in a situation where patients were likely to die if untreated. They were certainly sometimes dangerously arrogant and rigid about continuing with the practices they'd always known. The most harm they caused was from something they *didn't* do - wash their hands - which had to do with ignorance, not any profit motive.

DES - and thalidomide - were disastrous and tragic errors, and by the standards of modern medical testing, gross negligence; but they were not some sort of deliberate evil conspiracy.

[newfie11]

15. Where millions of dollars are concerned I wouldn't be so sure

a test here or there was overlooked. I have 40 years in the medical field and I don't trust big pharma. Back when doctors were bleeding pts, etc they were not making millions or even the equivalent of it. It is not the doctors I am talking about today. There was no big pharma then. I am not condemning everyone. Human nature being what it is I would not bet the farm there have not been shenanigans with drugs. Companies have spent tons of money just to get to the FDA stage. I don't know how it is in the UK. Here in the states things maybe different.

[Fire_Medic_Dave]

16. So how much money did Merck make on Vioxx after they settled the claims?

I'm guessing that Merck sincerely regrets the way they handled Vioxx. If they had handled it differently it would probably still be on the market providing relief for a lot of people on whom it worked well without side effects.

David

[newfie11]

19. I know 3 women that needed blood transfusions and one almost died from the effects of Vioxx.

All three had to have emergency surgery. All are ranch women with limited insurance/ very high deductibles and could least afford the medical bills.
These are women I saw for other reasons and they just happened to mention what happened. Don't get me wrong,I do believe in drugs but I think to many are coming out without enough testing.

When you consider how much merck makes off all the drugs and the fact it does have some liability insurance I think they are not hurting from Vioxx.

See below.

http://prawfsblawg.blogs.com/prawfsblawg/2005/08/merck_juries_an.html

Merck won't likely be paying for the entire verdict out of its own pocket. Layers and layers of insurance cover these sorts of cases: Merck undoubtedly has insurance, and the insurance company probably has reinsurance. To be sure, premiums may rise for the industry (though don't forget that the insurance industry is itself a competitive marketplace) and litigation will ensue between Merck and its insurer and reinsurers. But let's not overstate the case against the astronomical award: it isn't going to put Merck out of business.


It apparently didn't hurt their share price either.

http://blogs.wsj.com/health/2007/11/09/merck-shares-rise-on-vioxx-legal-relief/

[Fire_Medic_Dave]

20. I agree it isn't going to put them out of business.

Nor should it. Hopefully they will learn from their mistakes and be more open with the public about possible side effects.

David

[LeftishBrit]

6. I am very aware of that.

However, it does not discredit *all* medications and vaccines. Moreover, a vaccine is not a drug. A vaccine could be dangerous in the short term - and occasionally some have proved to be; e.g. swine flu. However, vaccines do not remain in people long enough to cause an unexpected health risk in 20 or 20 years time (whereas some drugs could).

Look: I have myself observed government deception about a health risk. Not a drug, but a food. The British government in the early 90s refused as long as it could to acknowledge that BSE (mad cow disease) was a potential risk to humans, due to the possible negative impact on British agriculture. Eventually they had to acknowledge it, and no doubt a number of people did as a result of the deception die from 'new variant CJD' (though many people had already cut out beef).

Does that make me more sceptical of what governments say? - certainly. However, I am not going to assume that ALL foods that the government say are OK are dangerous, any more than that they are all safe!

[On the Road]

9. My Ex Had Congenital Damage from DES

It was not as publicized as thalidomide but it affected a lot of women in the 50s.

[Inkyfuzzbottom]

14. So far so good for me...

My mother was pumped full of it while pregnant with me. Hopefully I'm not living on borrowed time.

[Caution]

24. Anyone remember The Pill?

That was used in the late 20th Century and the early 21st Century until the right-wing political movement in the United States was joined by the HPV "hoax" crowd, HIV denialists and "autism is caused by vaccines" crowds who eventually undermined the scientific method used successfully for nearly 100 years to create miracle cures for billions of people. The Pill was eventually banned because it caused "abortions" thus "killing babies." Successive generations of women were thus turned into breeding slaves for the rabid right-wing religious fanaticism. Tens of thousands died of cervical cancer, millions of AIDS and finally the plague that nearly wiped out mankind when smallpox was re-introduced. Vaccination would have saved these people.

Now in the year 2147, what remains of humanity are attempting to recreate the scientific knowledge that was nearly wiped out by an ignorant few.

[beam me up scottie]

25. The denialists and the religiously insane won't be happy until they bring back the Dark Ages.

I'm glad that Carl Sagan isn't alive to see this.

[cosmik debris]

27. I knew it was all about sex when the OP posted a cartoon

showing soldiers with fixed bayonets escorting girls into a whore house to get their sex vaccine.

It is all about their fixation on little girls private parts.

That used to be called perversion. Now it seems to be an admirable trait. Go figure?

[beam me up scottie]

28. And don't forget the suggestion that "innoculation(sic) leads to riskier sexual behavior"

Classic misogyny.