Wednesday, December 06, 2006

Unethical research on pregnant women with herpes

PUBLIC CITIZEN PRESS RELEASE


Drug-Company Sponsored Research Trial Needlessly Put Indigent Pregnant
Women and Their Infants at Risk

Placebos Administered to Pregnant Women With Genital Herpes Simplex
Virus Resulted in Unnecessary Cesarean Deliveries

WASHINGTON, D.C. – Dozens of primarily indigent pregnant women
enrolled in a drug-company sponsored research trial were needlessly
put at risk by being treated with a placebo rather than a generic drug
proven to help them, according to a letter authored by Public Citizen
and two medical school professors and obstetricians published in the
December edition of the journal Obstetrics & Gynecology.

The trial, funded by Glaxo-Wellcome (now GlaxoSmithKline), measured
the efficacy of valacyclovir administered to pregnant women with a
history of genital herpes simplex virus (HSV) in reducing outbreaks of
genital HSV lesions at the time of labor. Women with HSV outbreaks
during pregnancy, especially those who experience a first episode, are
more likely to have another outbreak while in labor. When this occurs,
a Cesarean delivery is routinely performed to prevent HSV transmission
to the baby, which can result in sometimes-fatal neonatal HSV
infection.

The clinical trial ran from April 1998 to November 2004 at Parkland
Hospital in Dallas, which serves a predominantly low-income
population. The results were published in the July 2006 edition of
Obstetrics & Gynecology, the official journal of the American College
of Obstetricians and Gynecologists (ACOG).

Valacyclovir is a drug that is converted in the body into acyclovir.
Since 1999, acyclovir has been recommended by ACOG to be considered at
36 weeks of gestation for pregnant women with their first episode of
HSV during that pregnancy to prevent another outbreak at the time of
labor and the need for a Cesarean delivery. The authors of the study
ignored this guideline by including in the trial 62 women who had a
first episode of genital HSV during the pregnancy, most presumably
recruited after the ACOG guidelines were published.

In addition, four of the researchers who wrote the 2006 article
published a review article in 2003 that concluded that acyclovir
significantly reduced Cesarean rates for women with both first and
recurrent episodes of HSV compared to a placebo. Nonetheless, for more
than a year after submitting their findings, the researchers continued
to enroll women with both first and recurrent episodes, half of whom
received placebos.

"At the very same time these researchers were publishing their
conclusion that acyclovir could reduce Cesareans, they weren't
offering this drug to these indigent patients," said Dr. Adam Urato,
an obstetrician at the University of South Florida and one of the
letter's authors. "They were knowingly placing their patients at
higher risk. Did the patients understand that the researchers
themselves had concluded that acyclovir reduced the risk of Cesarean?"

As a result of this conduct by both the drug company and the
researchers, a significant number of the women assigned to receive the
placebo had an HSV outbreak that led to a Cesarean section – an
outbreak that likely could have been prevented if they had been
appropriately treated with acyclovir. The Declaration of Helsinki,
developed by the World Medical Association as a statement of ethical
principles in medical research involving human subjects, states that
any "new method should be tested against those of the best current
prophylactic, diagnostic, and therapeutic methods."

The authors of the letter called upon the University of Texas
Southwestern Medical Center at Dallas, which authorized the study, to
issue a formal apology to the pregnant women enrolled and to perform a
full investigation as to what went wrong to allow such a trial to take
place. They also called for compensation for the women involved in the
trial who were not properly treated and underwent Cesarean sections.

In addition, they urged ACOG and the editors at Obstetrics &
Gynecology to initiate an inquiry as to how this study was handled by
the journal. The Declaration of Helsinki also implores journals that
"reports of experimentation not in accordance with the principles laid
down in this Declaration should not be accepted for publication."

"Indigent pregnant women represent a particularly vulnerable
population," said Dr. Aaron Caughey, an obstetrician at the University
of California, San Francisco, and the lead author of the letter. "That
a research trial could be performed that put pregnant women at risk
when an effective medication was available flies in the face of
responsible medical research."

Public Citizen has a long history of involvement in the debate over
the appropriate use of placebos in clinical trials, particularly in
developing countries. "We have long contended that if researchers and
drug companies could get away with administering placebos under
questionable conditions in developing countries, they would do the
same to poor people in the United States," said Dr. Peter Lurie,
deputy director of Public Citizen's Health Research Group. "Now they
have."

12 comments:

  1. Got Herpes? Do not despair. You are not alone. 1 in 5 men and 1 in 4 women are living with herpes. Don't Let Genital Herpes Run or Ruin Your Life. Dating and relationship help for people with genital herpes now http://www.STDromance.com

    ReplyDelete
    Replies
    1. I want to thank Dr Azuka for the Herbal HIV medicine he gave to me and my daughter, i was suffering from HIV when i gave birth to my daughter and that was how my daughter got the sickness indirect from me, but to God be the glory that i am heal with the herbal medicine that Dr Azuka gave to me when i emailed him. i want to use this medium to tell everyone that the solution to our sickness has come,so i will like you to contact this great healer on his email address, dr.azukasolutionhome@gmail.com with him all your pains will be gone,i am really happy today that i and my daughter are cured of HIV, we are now Negative after the use of his Herb medicine, my specialist doctor confirm it. once more i say a big thank to you Dr Azuka for healing hands upon my life and my daughter, i say may God continue to bless you abundantly and give you more power to keep helping those that needs your help. email him now he is waiting to receive you. {dr.azukasolutionhome@gmail.com} or What's App +2348132777335

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      Delete
  2. It is absurd to think it is necessary to experiment on children and anyone who does not have the capacity to make an eduated decesions. In addition, it is unethical to even pose this experiment as an option. This goes right back to the syphills experiemnts that were preformed onafrican American males in the 60's and 70's. NO ONE has a right to put others at risk.

    ReplyDelete
  3. Am jonas kita Dr ASAKASUKU cure me of HSV-2 after i have lost my son. i was
    diagnosed with the herpes type 2 after doing colposcopy. It was extremely
    painful I got them around the inner part of my bum. i visited different
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    ReplyDelete
  4. I want to give a testimony on how I got cured from Herpes Virus, I'm Ellen Peters. Few months back I was having some symptoms . I went to see a doctor and many blood tests was done on me, later on I was told I had Herpes. My doctor told me that there's no cure for Herpes I felt bad, I went online searching for a possible cure for Herpes Virus, I saw a post of Dr. Oba a herbal doctor that's helping people get cured from HIV, HEPATITIS B, CANCER e.t.c. I contacted him and told him how I'm feeling he said his herbal medicine can cure me. He sent me the medicine via Courier Service and I received the medicine some days after he sent it, i took the medicine as prescribed by him. Before the completion of the medication the symptoms stopped. I went to the doctor and carried out another blood test, surprisingly I was Negative. I haven't had any symptoms anymore. Dr. Oba is great, and his herbal medicine has no side effects. You can reach him on dr.obaherbalhome@hotmail.com , dr.obaherbalhome1@gmail.com, website (drobaherbs.webs.com) call/whatsapp +2348151943640

    ReplyDelete
  5. I am from New York. I was in trouble when doctor told me that I have been diagnosed with Genital Herpes… I though about my Family, I know my Family will face a serious problem when I’m gone, I lost hope and I wept all day, but one day I was surfing the internet I found Dr. Atiti contact number. I called him and he guided me. I asked him for solutions and he started the remedies for my health. Thank God, now everything is fine, I’m cured by Dr. Atiti herbal medicine, I’m very thankful to Dr. Atiti and very happy with my hubby and family. email him on atitilovespell@gmail.com OR contact his number:+2349051208634

    DOCTOR Atiti CAN AS WELL CURE THE FOLLOWING DISEASE:-

    1. HIV/AIDS
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    if you have this disease listed above DR Atiti is the right herbal doctor that can cure you.email him now and also share the same testimony after you are cure his email is atitilovespell@gmail.com

    ReplyDelete
  6. I am from New York. I was in trouble when doctor told me that I have been diagnosed with Genital Herpes… I though about my Family, I know my Family will face a serious problem when I’m gone, I lost hope and I wept all day, but one day I was surfing the internet I found Dr. Atiti contact number. I called him and he guided me. I asked him for solutions and he started the remedies for my health. Thank God, now everything is fine, I’m cured by Dr. Atiti herbal medicine, I’m very thankful to Dr. Atiti and very happy with my hubby and family. email him on atitilovespell@gmail.com OR contact his number:+2349051208634

    DOCTOR Atiti CAN AS WELL CURE THE FOLLOWING DISEASE:-

    1. HIV/AIDS
    2. HERPES
    3. CANCER
    4. ALS
    5. Hepatitis
    if you have this disease listed above DR Atiti is the right herbal doctor that can cure you.email him now and also share the same testimony after you are cure his email is atitilovespell@gmail.com

    ReplyDelete
  7. Have been suffering from (HERPES SIMPLEX VIRUS) disease for the past four years and had constant pain, especially in my knees. During the first year,I had faith in God that i would be healed someday.This disease started circulating all over my body and i have been taking treatment from my doctor, few weeks ago i came on search on the internet if i could get any information concerning the prevention of this disease, on my search i saw a testimony of someone who has been healed from (Hepatitis B and Cancer) by this Man Dr Eromosele and she also gave the email address of this man and advise we should contact him for any sickness that he would be of help, so i wrote to Dr.Eromosele telling him about my (HERPES Virus) he told me not to worry that i was going to be cured!! hmm i never believed it,well after all the procedures and remedy given to me by this man few weeks later i started experiencing changes all over me as the Dr assured me that i have cured,after some time i went to my doctor to confirmed if i have be finally healed behold it was TRUE, So friends my advise is if you have such sickness or any other at all you can email: dreromoselespellhome@gmail.com or call +2347038110398. He told me that he also help people to cure HIV VIRUS and also help people to bring their ex lover back. contact dr Eromosele if you have any problem. email: dreromoselespellhome@gmail.com

    ReplyDelete

  8. ZIKA DISEASE

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    3. CANCER
    4. ALS
    5. AMOEBIC MENINGOENCEPHALITIS
    6. ANTHRAX
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    9. BRING OF EX LOVER BACK TO LOVE YOU AGAIN

    ukospelltemple@yahoo.com / Website: ukospelltemple.wixsite.com/mysite

    ReplyDelete
  9. Thank you Dr. Okuns herbal your medicine is a good remedy for herpes cure, and Removing Warts you can contact him via E-mail: herbal.home247@yahoo.com for any types of diseases solutions or WhatsApp him on: +2348078467513

    My name is Mary Hanson, am from United State. I want the general public
    to know how this great man called Dr. Okuns cure me and my sister from GENITAL HERPES with the herbal medicine gotten from Dr. Okuns, he cures other diseases too like STD, SYPHILIS, My own was worst I have suffered for Human papilloma virus HPV) for 2years he cure me too, herbal is a great medication. he have a medicine that is 100% percent assured to cure any type of disease and you don't need to spend so much money anymore . I want you to contact Dr. Okuns on: herbal.home247@yahoo.com My family is now a brand new one, so stop your worries and go get your herbal medicine now to get your family free from deadly disease. Once again thanks to Dr. Okuns you can contact him now via phone number: +2348078467513 or email him on: herbal.home247@yahoo.com

    ReplyDelete
  10. I am Mary Wilson From USA
    It is no longer news that the Acquired immune deficiency syndrome Herpes Virus is increasing by the day. The fear is that many people living with the sickness are scared of saying it because of the stigma that comes along with it.I am bold enough among many others to state that there is now a potent cure to this sickness but many are unaware of it. I discovered that I was infected with the virus 3 months ago, after a medical check-up. My doctor told me and I was shocked, confused and felt like my world has crumbled. I was dying slowly due to the announcement of my medical practitioner but he assured me that I could leave a normal life if I took my medications (as there was no medically known cure to Herpes). I went from churches to churches but soon found that my case needed urgent attention as I was growing lean due to fear of dying anytime soon. In a bid to look for a lasting solution to my predicament, I sought for solutions from the voodoo world. I went online and searched for every powerful trado-medical practitioner that I could severe, cos I heard that the African Voodoo Priests had a cure to the Herpes syndrome. It was after a little time searching the web that I came across one Dr uwa(A powerful African Voodoo Priest), who offered to help me at a monetary fee. I had to comply as this was my final bus-stop to receiving a perfect healing. My last resolve was to take my life by myself, should this plan fail. At last it worked out well. He gave me some steps to follow and I meticulously carried out all his instructions.
    Last month, to be precise, I went back to the hospital to conduct another test and to my amazement, the results showed that " I am NEGATIVE".
    You can free yourself of this Herpes virus by consulting this great African Voodoo Priest via this e-mail: druwaherbalcenter@gmail.com or call and whatsapp him on +2348063930531 He will help you and his herb medication is sure.
    he has the cure on all this disease as he told me and it listed.
    GENITAL WARTS/
    PREGNANCY.
    EPILEPSY.
    GENPILENCIN.
    HIV AIDS.
    PREGNANCY
    DIABETICS
    STROKE.
    EXPANDS OF PENIS BREAST
    H.P.V TYPE 1 TYPE 2 TYPE 3 AND TYPE 4. TYPE 5.
    HUMAN PAPAILOMA VIRUS.
    HERPES.
    SYPHILIS.
    CANCER.
    HEPATITIS A B and C.
    HIRE BLOOD PRESSURES.
    AND BODY BOILS.
    AND BODY DISEASES .
    THANK TO YOU ALL FOR YOUR TIME OF READING MY TESTIMONY AND MOST ESPECIALLY YOU
    Dr Uwa I PRAY TO GOD TO NEVER LET ME AND MY FAMILY FORGET YOU IN OUR LIFE.

    ReplyDelete
  11. MUST READ: HOW I GOT CURED FROM ALS DISEASE) I am from U.S.A and my name is Clara Wilson. I was diagnosed of ALS disease (Lou Gehrig’s disease) in 2013 and I have tried all I can to get cured but all to no avail, my life was gradually coming to an end, until i saw a post in a health forum about a herbal doctor from Africa who prepares herbal cure to cure HIV/AIDS and all kind of diseases including ALS, MND, Epilepsy, Leukemia, Asthma, Cancer, Gonorrhea etc, at first i doubted if it was real but decided to give it a try, when i contact this herbal doctor via his email,(dr.ezomorootandherbals@gmail.com), he prepared an ALS herbal portion and sent it to me via courier service, when i received this herbal portion, he gave me step by step instructions on how to apply it, when i applied it as instructed, i was cured of this deadly disease within 7 days, I could not walk or talk understandably before but after i took the herbal cure as he instructed i regained strength in my bones and i could talk properly unlike before, I am now free from the deadly disease, all thanks to Dr.ezomo Contact this great herbal doctor via his email dr.ezomorootandherbals@gmail.com

    ReplyDelete