after seeing the NBCC call to arms 4 Genentech--I decided2 post this negative

[Lani]

bit of news regarding Roche, who bought Genentech 3-4 years ago. Sure hope this doesn't hold up British government's approval of other Genentech drugs (TDM-1 , Perjeta, etc)


GALLERY: British medical journal slams Roche on Tamiflu

MARIA CHENG , The Associated Press
POSTED: Monday, November 12, 2012, 6:34 AM
LONDON - A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.

"I suggest we boycott Roche's products until they publish missing Tamiflu data," wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was "needlessly" spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of "essential medicines" by the World Health Organization, a list that often prompts governments or donor agencies to buy the drug.


Tamiflu is used to treat both seasonal flu and new flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the agency had enough proof to warrant its use for unusual influenza viruses, like bird flu.

"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.

In the U.S., the Centers for Disease Control and Prevention recommends Tamiflu as one of two medications for treating regular flu. The other is GlaxoSmithKline's Relenza. The CDC says such antivirals can shorten the duration of symptoms and reduce the risk of complications and hospitalization.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

"Despite a public promise to release (internal company reports) for each (Tamiflu) trial...Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

"Roche has made full clinical study data ... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.

Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

,,,,

Online:

www.bmj.com.tamiflu/

MARIA CHENG
The Associated Press

[Ellie F]

This has been simmering I believe. I also hope it doesn't delay drugs for bc. As you know we often have access to drugs later than the States as they require EU approval then are assessed by NICE!
Ellie

[phil]

whats nbcc's " call to arms " re Gen. ? Last i heard nbcc nat'l leadership was still brainwashed by This FDA against Gen., Big Pharma in general. We have abig issue w. This FDA , but its even more galling when non-scientist advocacy grps try to " play scientist " like nbcc, bc action on t dm-1, avastin.

[chrisy]

Phil,
The call to arms post was about NBCC wanting Roche/genentech to change the clinical trial design for adjuvant tdm1 studies to include a "non chemo" arm. This would be so that the question of can toxic chemo be avoided could be answered. Otherwise you just end up with tdm1 vs herceptin added to chemo. assuming he FDA approves of course.

[phil]

I would like to see nbcc's posting. i am suspiscious , they have shown NO support for quicker approval of t dm-1. i am no fan of nbcc's current leadership. since they personally went to fda hearing to support fda's revoking of avastin. they dont understand stage iv issues, and they are way too biased in favor of This FDA !

[Joan M]

Phil, here's the petition. One of our best chances at being breast cancer advocates comes from getting involved in clinical trial design. Also, saw your video on YouTube. Well done!! Joan

Petition to Genentech: Do What's Best for Women

October 22, 2012

To: Ian T. Clark, CEO, Sandra Horning, M.D., SVP Global Head, Clinical Research Hematology/Oncology

We urge Genentech to do what is in the best interest of women diagnosed with breast cancer. We are breast cancer patients and advocates who urge Genentech to fulfill the promise of targeted therapy and include a non-systemic treatment arm in the clinical trials to evaluate the adjuvant/neo-adjuvant use of T-DM1 for HER2+ early breast cancer. We also ask that you include non-anthracycline regimens for those arms which do include systemic chemotherapy. These trials represent an unprecedented opportunity for at least a subset of women to move their care toward less toxic treatment, without sacrificing treatment benefit.

These decisions must be considered in the context of the reality for women. We know that a significant number of women diagnosed with early breast cancer are overtreated. And we know that the number of these women is increasing, as the population is aging and more women are being diagnosed. We also know that there is no absolute cure for breast cancer and that our current treatments do not work for many women. It is critically important that while steps are being taken to improve the benefit from treatment, steps are also taken to reduce the harms from treatment. We do not want to see Genentech squander this opportunity to move patient care forward on both fronts.
The promise of targeted cancer treatment, and particularly with drug-antibody conjugates such as T-DM1 , is more effective treatment that is less toxic. The promise is to save lives with fewer long term health consequences. But this promise of targeted cancer treatment will never be realized without taking bold steps in clinical trial design now. We must move away from the systemic, toxic therapy and “add-on” model in breast cancer clinical trials and treatment.

A trial of T-DM1, a novel drug which includes a chemotherapy agent that is not dispersed systemically, provides the perfect opportunity to move away from a more toxic regimen. With T-DM1, women will still get chemotherapy. Using the old “add-on” approach will not deliver on the promise of real progress for patients. This is an opportunity to provide a model for research on future conjugates in breast cancer. We must act now and get it right.

And for those arms within the trial that will include systemic chemotherapy treatment, non- anthracycline based regimens are best for women. No prospective randomized clinical trial has shown anthracyclines to be more effective than other chemotherapies, while the toxicities are significant, including an increased risk of leukemia and harm to the heart. Considering non- anthracycline regimens seems particularly important now as we have evidence of a dramatic decline in their use in the community. The “standard of care” within the clinical trial design used to evaluate any new agent should reflect the actual care being given in the community in order to give relevant and meaningful results to patients.

We are hopeful that T-DM1 will provide meaningful benefit to those with early breast cancer, but we are also equally hopeful that Genentech will do what is best for women and will use this opportunity to decrease the harms women experience from treatment for early breast cancer.

Organizations Joining This Petition

National Breast Cancer Coalition Adelphi NY Statewide Breast Cancer Hotline & Support Program AdvancedBC.org Alamo Breast Cancer Foundation Ann’s Place Annie Appleseed Project Between Women, Inc. Breast Cancer Alliance of Greater Cincinnati Breast Cancer Care & Research Fund Breast Cancer Coalition of Nevada Breast Cancer Coalition of Rochester California Breast Cancer Organizations CARE Advocates Cedar Valley Cancer Committee's Beyond Pink TEAM Colorado Breast Cancer Coalition Delaware Breast Cancer Coalition Dr. Susan Love Research Foundation END Breast Cancer Illinois Georgia Breast Cancer Coalition Fund Inflammatory Breast Cancer Research Foundation Iowa Breast Cancer Edu-Action Linda Creed Breast Cancer Foundation Los Angeles Breast Cancer Alliance Louisiana Breast Cancer Task Force Maine Breast Cancer Coalition Metropolitan Washington, DC Chapter of NBCC Michigan Breast Cancer Coalition Minnesota Breast Cancer Coalition National Women’s Health Network New Hampshire Breast Cancer Coalition North Carolina Breast Cancer Advocacy Network Nueva Vida Oregon Breast Cancer Network Pennies in Action Rhode Island Breast Cancer Coalition Saul and Joyce Brandman Breast Center South Dakota Breast Cancer Advocacy St. Louis Breast Cancer Coalition Virginia Breast Cancer Foundation Viva Las Chicas Washington State Breast Cancer Deadline Action Network Wisconsin Breast Cancer Coalition Women of Color Breast Cancer Survivors’ Support Project You Can Thrive! Foundation Young Survival Coalition

[phil]

When original herc. was appr., was it given to all her2 + ? or just for Stage IV ? did they run trials for early stage ? and thus make those w/ strong over expr of Her2 wait yrs to get it ?
I think not, and, if not , then whats changed since 1996 ? Is the appr process now slower ?? Wheres the progress ? it seems insane to delay T DM-1 longer for early stage ? it has an effectiveness at late stages of 40-50 % , ( " the best survival stats ever seen so far " in her2 cancer , and that includes original herc ) and thus will have even greater results at early stage.
Again I say NBCC has been NO HELP w/ T DM-1, completely in This FDAs pocket.

[fullofbeans]

Tamiflu was a joke and action should be taken however this is where I have a big problem with the law those committing fraud in the company should be sued not just the company, I they do that they will take action only against Tamiflu pushers.

The billions spent on Tami could have gone to save lives, the tax payers should recall all profit (and bonuses) the company made on it.

As a matter of fact all data should be examinable.

This would restore faith through transparancies and allow faster approval of drugs such as TDM1.

If one part of the company is bad just cut that bit off.