Risks?To Using Live Viruses/ Animal/Insect / Cells

 

 

 

 

Associated Press | December 2, 2005
By ANDREW BRIDGES

 

 

 

By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.

 

 

The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from long-standing open records and meetings laws that apply to most government departments, according to legislation approved Oct. 18 by the Senate health committee.

 

 

Those exemptions would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill. The legislation also proposes giving manufacturers immunity from liability in exchange for their participation in the public-private effort.

 

 

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Sen. Richard Burr, R-N.C., said when the Committee on Health, Education, Labor and Pensions approved the bill.

 

 

The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics as well as chemical, biological and radiological agents.

 

 

But it is the secrecy and immunity provisions of the legislation that have alarmed patient rights and open government advocates. The agency would be exempt from the Freedom of Information and Federal Advisory Committee acts, both considered crucial for monitoring government accountability.

 

 

"There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. "That is a cause for major concern and should raise major policy concerns," Weitzel said.

 

 

Burr spokesman Doug Heye said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential business information already is exempt from FOIA.

 

 

"There's no secrecy involved in BARDA," Heye said. "That is absolutely false. This is an agency that will be putting out information daily."

 

 

Some Democrats question whether the public would accept drugs or vaccines developed in conjunction with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line health care workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about the vaccine's safety, which health authorities initially downplayed.

 

 

"Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement. "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."

 

 

The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless "willful misconduct" can be shown.

The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill.

 

 

Another industry group, the Biotechnology Industry Organization, declined comment.

The National Vaccine Information Center, an advocacy group, called the legislation "a drug company stockholder's dream and a consumer's worst nightmare."

 

 

The proposed law comes amid growing concern about pandemics and the government's ability to meet such threats. For instance, the United State needs another three to five years to develop the manufacturing capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday on NBC's "Meet the Press."

The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.

 

 

"While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said. "One of the reasons is (they) don't want to put their very existence on the line."

 

 

 

"These provisions are extremely dangerous," Wolfe said. "The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics, is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act to increase public scrutiny and increase the correctness of decisions that are made."

Republican and Democratic lawmakers alike agree the drug industry needs some protections to encourage it to produce emergency stocks of vaccines and drugs, but Democrats have balked at providing blanket immunity without first establishing a compensation fund for patients.

Republicans are pushing for liability protections for vaccine manufacturers on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking to add such protections to a defense appropriations bill.

Frist spokeswoman Amy Call said drug company concerns about liability are real.

"There's really no financial incentive for them to get into the market, sell to the government at a reduced rate and then open themselves up to losses that could potentially bankrupt them," Call said.

 

 

The push for liability exemptions may force the Burr bill to the sidelines until the next session of Congress, Republican and Democratic aides said. But Call said Frist intends to pursue the legislation.

 

 

 

..............................................

 

 

 

 

Another excellent post.

 

This is my opinion based on  the facts you present. There should be no logical reason to not allow the Freedom to obtain information on what is used in a vaccine unless it is something that is dangerous to begin with.  In which case it should not be used.

 

In the event that a vaccine is produced that would have the potential in some individuals to cause harm, then the maker and the government need to present the public with the facts. If then the public chooses to take the risk it is a informed consent.  That could happen. If a killer virus like Avain were to be easily spread and a fast vaccine produced, a computer can figure out the odds of how many people may be adversely effected by it, and from what. That information should be shared.

 

My son with lupus absolutely can not use a live virus. Therefore the choice is easy, but he has the right to make that choice. To think of him putting his arm out in trust to only be vaccinated with something that could cause his death would be cruel and unusual treatment and torture.

 

If people are dying left and right and a vaccine has a 70% chance of not causing side effects but a 30% chance of causing a bad side effect, it is up to each individual to make their own educated choice.

 

There could be many circumstances where we may need that vaccine, and the makers would have to be relieved of responsibility, we will have to trust that they are in the business to save people and not kill them. We will have to believe that they have our greater interests in mind. One way would be to vaccinate their families with a random innoculation chosen by a citizen. That would sure be a test wouldnt it??

 

In deadly situations we have to throw the rules out the window. There is never a situation where lying to the public should be a option.

 

With Avain at a eighty percent death rate, or higher in a pandemic, it has that right now and that is when the patient has the ability to be put on a vent and has all kinds of highley skilled people caring for them, in a pandemic the average person would have no vent and no medical care, so if a vaccine came out that would be 100% effective in stopping it, but as many as 30% of the people may die or suffer a side effect I would go with the vaccine myself, the math is with me as far as odds go.

 

I think that most of the people benefited from the Polio vaccine. I know my father considered Jonas Saulk  one of the biggest heroes of his time. My dad was crippled due to a accident, he knew what it was like to go through life crippled and he felt that a disease that made people crippled was a horrible thing. I hear much more about the devastation of Polio then I do the 1918 flu from my folks and my grandparents.

 

I know that the contaminated polio vaccine was used, if this was a deliberate choice of a manufacturer, they should be sued out of escistance.

 

 

 

My dad was a construction worker. He put in asbestos in the sixties when it was considered a miracle insulater not only did it insulate but it was also fire retardent.

 

We all know that later asbestos was not so good and removed due to the cancer and lung disease causing side effects.

 

One of the companies that is huge, I am not going to name it for fear of trouble. Think of the number three and a ltter of the alphabet.  This company produced respirators (masks for over the nose and mouth) to construction workers to protect them when they went back in and removed this stuff.

 

It was rumored that the masks used did not in fact filter out the smaller pieces of asbetos. Therefore the workers went in thinking they were protected and were not.

 

My  father died of asbestosis. Before his death, in a testimony for  a class action suit against number three alphabet letter, he was asked all kinds of personal questions involving his first marriage which was sixty years prior to the time he was being questioned. The point of this was to discredit his testimony, so this mega company, considered one of the foremost manufactuers of all things scientific and inovative, tried their hardest to make him look old, senile. 

 

My father responded that he prefered to not talk about his first marriage. My sister and brother in law who were present at the testimony were disgusted at the lengths this company would go to, to avoid having to pay for what they knew was their mistake. You see all the masks or respirators in question were no longer available to be tested to see if they in fact were defective.

 

My brother in law remembered that my dad, had a case of them left over in his garage. He informed the attorneys and the suit was settled out of court. This company by the way, one of the leading manufactuers of the N-95 masks we are all buying for bf and other virus.

 

And we all herd in to these eateries...no wonder there are so many stomach aches etc.

 

If we invited a few hundred people through our kitchens, every day, how well would we be.

 

I may curtail eating out.

 

 

(thanks for sharing about your fam.)

NEW HAVEN - Protein Sciences Corp., the Meriden company that said last week that it might gear up to make tens of thousands of doses of swine flu vaccine, has struck a deal with authorities in Mexico to operate a vaccine manufacturing facility there.

Company chief executive Dan Adams said Protein Sciences has not committed to manufacturing a swine flu vaccine yet — in Meriden, Mexico or anywhere else — and the Mexican factory might or might not make swine flu vaccines.

Adams said Protein Sciences officers had been in Mexico in recent days and that Mexican officials were in Connecticut on Monday.

"We have a deal with the Mexicans," he told a room of about a dozen people attending the 16th Annual Crossroads Venture Fair at New Haven's Omni Hotel.

Adams declined to disclose any of the Mexico deal's terms, including where the factory is and which Mexican authorities the company has been dealing with, saying only that some of the country's most senior political figures were involved.

The company is awaiting approval of its own vaccine for seasonal flu, made from cell cultures rather than eggs, as is typical for flu vaccines today. Protein Sciences, with $8 million in 2008 sales, provides related services to pharmaceutical companies.

The company has been struggling to close a $150 million deal with the U.S. federal government to produce vaccines for pandemic viruses, and Adams has expressed frustration with the progress, alleging that lobbying by unnamed bigger competitors had caused the delay.

"They've been jerking us around for about 15 months," he said of U.S. authorities.

Although much of the scare from last week has subsided, the outbreak of swine flu has drawn attention to Protein Sciences outside North America as well as in Mexico and the United States. The company is also in "very serious discussions" with health officials in Australia, Adams said.

The company, which says it has all the information it needs to produce a swine flu vaccine, is still trying to assess demand for it, according to Adams. He said the company does not think the disease poses "a serious threat." The factory in Mexico could also be used for making the seasonal flu vaccine Protein Sciences hopes to introduce later this year.

There is currently no vaccine for swine flu, also called H1N1, which has killed two people in the U.S. and nearly 30 in Mexico since it emerged in late April. Nearly 2,000 people have been infected worldwide, according to the World Health Organization.

The company is trying to raise $18 million to $20 million by June 1, much of it for repaying a loan related to a failed merger.

Protein Sciences plans to decide by about May 22 whether to proceed with a swine flu vaccine, Adams said. The vaccine wouldn't necessarily prevent people from catching the disease but would make it less harmful, he said.

...............................................................

 

 

 

 

...................................................................................................................................

 

 

 

 

.......................