Ahava cannot get treatment now. Because of the medicine she took before. And because of their obstinance in breaking their contract with their patient.
In the words of Joshua Strahl, who put it so well:
Dear Tesaro Pharmaceuticals, you are in business to find ways to save lives.That's noble.And you are conducting a blind test (drug vs. placebo) to show your drug's efficacy. That's scientific methodology.Part of your contract with the patient undergoing the clinical trial is that if it becomes medically necessary you will reveal to the doctors if the patient was receiving your drug or a placebo.That's human.But, here my friend and neighbor Ahava Emunah Lange is Patient 1, and the drug that she is taking in your trial is not working. Her Ovarian Cancer has returned.Now, if she was on your real drug then her oncologists would know that that chemical is not working for her and they would switch her to a different drug. BUT, if she was on the placebo, then her oncologists would try the chemical that she was supposedly taking during the trial. Releasing this information to her doctors does not invalidate the trials results - we know that she did not react to whatever she was taking. Either the chemical didn't work or the placebo didn't work for her. If her doctors are not informed they cannot move ahead with her treatment, and my friend will die.So, your scientific methodology has been preserved.The question remains: are you in the business of saving lives?Will you honor your commitments to a human?Will you do the noble thing here?We hope that you will, because we are passionate about saving our friend Ahava.There is a petition to sign to try to pressure Tesaro Pharmaceuticals to release the information to Ahava's doctors, as they are contractually obligated to. If the doctors do not get this information, Ahava will not be able to receive any treatment and will die.
Please sign and share the petition
Ahava wrote a bit about it herself, including showing the clause in the contract in which they commit to giving the information should it be medically necessary...
If you are in a position to help somehow, please do. If not, please share. Maybe someone who reads it from my share or your share or by someone who shared it after seeing it from you, will be the person who can have some influence on the matter. Maybe a massive amount of public posts about this will shame them into releasing the information they contractually agreed to release!
This is a matter of life or death.
Ahava Emuna bat Chava Ehta
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Refuah Shleima to Ahava. Please put out her full name bat ..... so people can pray for her. May H' send miracles for all those who need it.
ReplyDeleteAhava Emuna bat Chava Ehta
DeleteI'll add it to the post
done. is there anywhere to contribute $ to her cause? also, i emailed the company directly -- they can be emailed at: contact@tesarobio.com.
ReplyDeleteI urge everyone to sign petition and also blitz their inbox with emails requesting they act immediately.
great idea. yasher koach.
DeleteAlso, the study number for the Tesaro Niraparib clinical trial with the FDA is NCT01847274. That can be referenced and the FDA can be emailed as well.
an email i sent to the Massachusetts AG's office. Feel free to copy, sign with your own info, and email them:
DeleteTO: ago@state.ma.us
CC: contact@tesarobio.com
RE: Tesaro Niraparib clinical trial - study number NCT01847274
Dear Sir or Madam,
Tesaro is a Waltham, MA based biopharmaceutical company which is conducting a study on a new drug for ovarian cancer.
Ahava Emunah Lange, an Israel based, young mother of five is a participant in the study.
Her ovarian cancer has returned and her life is threatened. According to the contract she signed with Tesaro, they must divulge whether she is getting a placebo or the test drug if her doctors deem it medically necessary.
She is trying to get Tesaro to release the information on what she is taking as a participant in the study.
Inexplicably, and tragically (and perhaps criminally, and civilly) Tesaro is NOT releasing this information to her Israeli based doctors.
This is not only unacceptable, but against the terms of her agreement with Tesaro.
I urge you to conduct a thorough investigation into this matter. I believe Avaha Lange is a US citizen and deserves a speedy release of the information her doctors seek, per the terms of her agreement with Tesaro.
Time is of the essence. Please let me know you are going to respond to this urgent and life threatening situation.
Sincerely,
[fill this out, include your full name, phone number and email]
The company is located in Waltham, MA, USA. I suggest a complaint to the state Attorney General's office, with a copy to Tesaro. The AG consumer protection division might not touch it, but it is worth putting Tesaro on notice that real steps are being attempted. A contact to a Boston area Jewish newspaper would be good, too. Once the story becomes local news in Tesaro's backyard, their self-interest and fear of bad PR may work, where their interest in healing seems lacking.
ReplyDeleteCopy your emails to the following: FDA Drug Approval Process: Sandy Walsh, 301-796-4669
ReplyDeletesandy.walsh@fda.hhs.gov
They have released the information. Social media pressure can work wonders.
ReplyDelete