More contamination troubles for Genzyme. Unsanitary homosexuals contaminate equipment.
Done Being Politically Correct
ination_troubles_for_genzyme/
Genzyme Corp., the Cambridge biotechnology giant that has spent five
months scrambling to regain its footing after detecting a virus at its
Allston plant, is facing a new contamination problem: bits of steel,
rubber, and fiber found in drugs made by the company and shipped from
the same site.
Federal regulators yesterday warned doctors to look for foreign
particles in five Genzyme drugs used to treat rare genetic disorders,
including two - Cerezyme and Fabrazyme - that have been rationed because
of the viral contamination detected in the Allston Landing plant last
summer. The five drugs represent roughly half of Genzyme�s $4.6 billion
in annual sales.
The diseases treated by these enzyme replacement drugs are rare. About
5,500 people worldwide, for example, depend on Ce rezyme, the
best-selling Genzyme drug, while about 2,500 use Fabrazyme. Cerezyme
treats Gaucher disease, which causes fatty substances to accumulate in
the liver, spleen, and other organs. Fabrazyme treats Fabry disease,
which prevents the body from breaking down oils and fats that build up
in the eyes and kidneys.
Particles are believed to have been found in less than 1 percent of the
Genzyme drugs based on product lots examined, according to a statement
from the Food and Drug Administration. The FDA warned physicians,
however, to carefully examine vials of the products and filter them
before they are given to patients - steps that are considered standard
procedure within the industry. If they find particles, the FDA asked for
the vials to be returned to the manufacturer. The agency warned that
ingesting the particles could have effects that include allergic
reactions and blood clotting.
FDA inspectors arrived at the Allston plant last month to begin an
investigation into Genzyme�s production operations.
�Based on information the agency has from Genzyme, we don�t believe this
is a wide-scale problem,�� said Dr. Jason Woo, associate director of
medical affairs in the compliance office at the FDA�s research center in
Silver Spring, Md. �But we do not have information that fully defines
the scope of the problem.��
In other circumstances, the FDA might have required Genzyme to recall
drugs contaminated with particles, Woo said. But because the Cambridge
company is the sole supplier of many of its products, the agency agreed
the �orphan�� drugs should be kept on the market with intensified
production scrutiny, he said.
Patients who use Genzyme�s drugs have been carefully following its
efforts to rebuild inventories after last summer�s highly publicized
plant shutdown and the viral decontamination that followed, but some
were caught by surprise by yesterday�s development. Linda Rubenstein, a
Gaucher disease patient in Carlisle, said she hadn�t heard about the new
contamination. Rubenstein hasn�t received a Cerezyme injection since
July because of rationing and doesn�t expect to get one for several
months. She has not experienced a return of symptoms.
�It�s frustrating having to wait and not get the Cerezyme,�� she said,
�but I think Genzyme has done a good job about keeping us informed.��
Rubenstein said she would withhold her opinion about the new setback
until she could learn more about it.
The information that sparked the FDA�s warning to doctors was based on
reports filed by Genzyme. The company sent a letter to health care
practitioners Wednesday, recommending precautions similar to those
outlined by the FDA. The letter, posted on the company�s website
yesterday, noted that the problem was unrelated to this summer�s viral
decontamination in Allston.
In the letter, Genzyme said it has reviewed a database of problems with
its products in recent years. �This review has not identified any safety
concerns to suggest that patients treated with Genzyme products have
been exposed to foreign particles,�� the letter said.
Geoff McDonough, senior vice president and general manager for genetic
diseases at Genzyme, said particles are an issue for all biotechnology
manufacturers.
There are moving parts in the company�s production machinery, and
workers wear sterile gowns in the �finishing�� labs where Genzyme
workers fill vials for shipment to health care providers, McDonough
said. �Those moving parts and sterile gowns can shed microscopic fibers
or pieces of stainless steel that get into the vials,�� he said. �We
look at every vial as part of our finishing process. We remove the vials
that have particles found in them, and we throw them out.��
For the past three weeks, the FDA has been conducting an investigation
at Genzyme�s Allston Landing plant on the Charles River. Agency
officials wouldn�t comment on that inquiry, and didn�t say why they
chose yesterday to issue the advisory on the particle contamination.
The FDA has monitored efforts to combat such contamination at Genzyme
and other companies for years, but has become more sensitive to the
issue recently, as biotech companies have tried to agree on standards
for particle inspections. Earlier this week, under FDA scrutiny, drug
maker Hospira Inc. of Lake Forest, Ill., recalled dietary supplement and
anesthesia products because of contamination.
The level of contamination cited in yesterday�s FDA warning is not
unusual, McDonough said. Particles are generally found in about 1 in 100
vials, or 1 percent of the product before it leaves the plant, he said.
McDonough said a smaller fraction of vials with particle contamination,
about 0.02 percent, are discovered by health care practitioners and
returned to Genzyme. �Based on the information publicly available, we
think our rates are within the industry experience,�� McDonough said.
�But the FDA has clearly asked us to focus on doing things better, and
we�re focused on that.��
Shares of Genzyme yesterday plunged 7.3 percent, a loss of $3.89, to
$49.28 on the Nasdaq stock exchange, their biggest drop since February,
as investors absorbed the news of the latest setback.
Industry analysts said Genzyme has been working hard to restore its
credibility at a time when regulators have allowed a pair of
competitors, Irish drug maker Shire PLC and Israeli start-up Protalix
Biotherapeutics, to expand use of rival treatments to Cerezyme in the
clinical trials necessary before those drugs are approved for commercial
use.
�This is a new contamination issue that Genzyme has to deal with,�� said
John L. Sullivan, research director for Leerink Swann, a Boston
investment bank specializing in health care and life sciences. �They
should still be able to resolve this and put the issue behind them.��
In addition to Cerezyme and Fabrazyme, the drugs covered in the FDA�s
warning are Myozyme, which treats Pompe disease, a muscular disorder;
Aldurazyme, which treats mucopolysaccharidosis, a metabolic disorder;
and Thyrogen, which treats thyroid cancer. Cerezyme and Fabrazyme are
manufactured in Allston, while Myozyme and Thyrogen are produced in
Framingham and sent to Allston for finishing. Production of Aldurazyme,
which formerly was made in Allston, was shifted to a Genzyme partner in
California about 18 months ago. It was covered in the FDA advisory
because vials filled in Allston remain in the inventories of health care
providers.
juanjo
homophobic coward, wrote:
> http://www.boston.com/business/healthcare/articles/2009/11/14/more_co...
> ination_troubles_for_genzyme/
>
> Genzyme Corp., the Cambridge biotechnology giant that has spent five
> months scrambling to regain its footing after detecting a virus at its
> Allston plant, is facing a new contamination problem: bits of steel,
> rubber, and fiber found in drugs made by the company and shipped from
> the same site.
>
The reality is this lying puke is posting random news articles blaming
democrats and homosexuals for the actions of people who are not
identified as either.
Jeff Strickland
"juanjo" <jonp...@mindspring.com> wrote in message
news:8fa9ffed-62e9-49ab...@d9g2000prh.googlegroups.com...
<JS>
I read the story and could not figure out how the OP drew the conclusion in
the Subject Line. Then I got it, the company is in MA., and everybody that
lives there must be gay. (This is not a position I believe or promote, it's
the conclusion I have to draw about the OP's conclusion expressed in the
Subject Line.)
If MA allows gay marriage, and the company is in MA, then the people that
work at the company must be gay, therefore gays caused the problem because
everybody at the company is gay because gays live in MA.
Wow.
</JS>