The FDA and drug companies: Must read

HAHAHAhahahaha, BlackCat!  Oreos and 20,000 gallons of milk!??  Say it ain't so!  

Black-cat -

Your posts are the best!

I love The Onion!!

WOW........Great news for all of us. Get out your grow lights and let the manufacturing begin.

No, this "news" isn't new.  We've even talked about it here on BCO multiple times.  

Again, if you read the information you'll see that the FDA is NOT trying to ban natural supplements. Again, even if you don't like or trust the FDA, you should read the information before running around like Chicken Little proclaiming things that just aren't true.  

Here's a link to a science-based article about this very issue, for those interested in facts over nonsense:

The Free Speech About Science Act (H.R. 1364), "health freedom," and misinformed consent 

I posted about Marcia Angell's book from around 2005...  but I don't entirely blame the FDA or Big Pharma.

This is also where consumers call the shots (no pun intended), both in terms of what they spend and what they spend it on, and in terms of just how willing they are to do the homework and the hard work of staying healthy.

A.A.

But how do you KNOW what's dangerous and what's not?? If the studies aren't being done, and no one wants to talk about safety because they'd rather make the $$, then you as the consumer are in the dark till a bad outcome happens, and then you're all pissed because there were no regulations! (you in general, not you personally, Kaara.)

And the average worker doesn't need protection, either, right? But thank god we have labor laws and worker safety standards.

Big Nutra is a HUGE business. They don't want to spend any $$ on research. It's a rare company that makes its product to "pharmaceutical grade"--which means they DO repsect the standard...

Self-governing????  So at the goodness of your heart, you really believe that all these big Nutra companies are just selling their products to help you feel good???

This is where I just don't get it. We all saw how self-governing worked with the mortgage industry, the investment banking industry, etc, etc, etc.  

Kaara, I hate to burst your bubble, but it's a just a bit naive to claim that the risk of dying or getting sick from a natural supplement is very low, so that makes taking anything okay.  

Yes, there is such a a thing as the Supplement Industrial Complex.  You think taking 68 supplements a day doesn't affect your body (and your purse, I might add) at all? 

The FDA is very far from perfect. No regulatory agency is. But it is not logical to argue from there that, therefore, what is NOT governed by the FDA must be desirable. Take fish oil if you believe in its merits; not because you have a problem with the pharma industry and government - that would not be a logical jump.

I'll add my article that I found here, so others will read The FDA Drug Co's and this article. I believe the FDA ....... (I won't repeat on here).

http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1

The U.S. Food and Drug Administration (FDA) secretly monitored the personal
e-mail of nine whistleblowers-its own scientists and doctors-over the course of
two years.

The monitored employees had warned Congress that the agency was approving
medical devices that posed unacceptable risks to patients.

Six of the monitored scientists and doctors recently filed a lawsuit against
the FDA, charging that the agency violated their constitutional rights to
privacy by monitoring lawful activity in personal email accounts, and using that
information to harass and ultimately relieve some of them of their positions.

According to the Washington Post¹:

"All had worked in an office responsible for reviewing devices for cancer
screening and other purposes.

Copies of the e-mails show that, starting in January 2009, the
FDA intercepted communications with congressional staffers and draft versions of
whistleblower complaints complete with editing notes in the margins.

The agency also took electronic snapshots of the computer desktops of the
FDA employees and reviewed documents they saved on the hard drives of their
government computers."

The FDA has declined to comment on the allegations, stating it does not
comment on cases involved with litigation.

However, according to internal FDA documents obtained by the plaintiffs under
the Freedom of Information Act, the agency had asked the Department of Health
and Human Services' (DHHS) inspector general to conduct an investigation back in
May 2010, stating suspicions that the plaintiffs had improperly disclosed
confidential business information about the devices.

The HHS inspector general's office found no evidence of criminal conduct,
stating the doctors and scientists had legal right to share their concerns with
Congress and journalists.

Hence no investigation was launched. But the FDA was not satisfied.

On June 28 that same year, Jeffrey Shuren, director of the FDA's Center for
Devices and Radiological Health wrote that, "We have obtained new
information confirming the existence of information disclosures that undermine
the integrity and mission of the FDA and, we believe, may be prohibited by
law," and again requested action be taken against the employees in
question. (Shuren is also the official who oversees mercury dental fillings,
which they have been fraudulently referring to as 'silver fillings'. Shuren had
promised to make an announcement about dental amalgam by the end of
2011. But with just six minutes left in the work year, at 4:54 pm on Friday,
December 30, the FDA conceded that no announcement was forthcoming - not in
2011, and maybe not at all.)

After consulting with general prosecutors, the inspector general declined the
second request for an investigation as well. Now the question is whether the
agency monitored their employees within legal limits, and whether the purpose of
the extensive monitoring was reasonable.

Senator Charles Grassley doesn't seem to think so, stating that:

"The FDA has a huge responsibility to protect public health and safety.
It's hard to see how managers apparently thought it was a good use of time to
shadow agency scientists and monitor their e-mail accounts for legally protected
communications with Congress."

Systemic Corruption and Wrongdoing...

Although its roots go way further back, the current saga began in 2007, when
the plaintiffs, all of whom worked for the FDA's Office of Device Evaluation,
claim they began making internal complaints about a dozen radiological devices
about to be approved despite lack of proof of effectiveness. The doctors and
scientists were concerned that millions of patients would be put at risk.
According to the featured article:

• Three devices risked missing signs of breast cancer
  
• One device risked falsely diagnosing osteoporosis
  
• One ultrasound device could malfunction while monitoring pregnant women in
  labor
  
• Several colon cancer screening devices employed such heavy doses of
  radiation that they risked causing cancer in otherwise healthy people
  

They also recommended against approval of a computer-aided imaging device for
breast cancer screening a total of three times. But after the third rejection, a
senior manager, Donna-Bea Tillman, suddenly approved the device in 2008. This
and much more was detailed in a 2009 letter from an unknown number of FDA
employees to President Obama's transition team.^2,3 In that letter (in
which all the signatures were blacked out due to fear of retaliation from the
FDA), the authors clearly spell out the need for a complete overhaul of the
agency due to deep-rooted systemic corruption at the highest levels.

They write:

"On January 7, 2009, FDA physicians and scientists wrote to Mr. John
Podesta: Through this letter and your action, we hope that future FDA employees
will not experience the same frustration and anxiety that we have experienced
for more than a year at the hands of FDA managers because we are committed to
public integrity and were willing to speak out.

Currently there is an atmosphere at FDA in which the honest employee
fears the dishonest employee, and not the other way around. Disturbingly, the
atmosphere does not yet exist at FDA where honest employees committed to
integrity and the FDA mission can act without fear of reprisal. ... America
urgently needs change at FDA because FDA is fundamentally broken, failing to
fulfill its mission, and because re-establishing a proper and effectively
functioning FDA is vital to the physical and economic health of the
nation."

Remarkably, just two months later, Acting Commissioner Dr. Frank M. Torti and
FDA attorneys sent an email to all FDA employees stating they "must comply with
... obligations to keep certain information ... confidential ... [including] e-mail to
and from employees within FDA [that document the] deliberative process."
Furthermore, employees were told that "violation ... can result in disciplinary
sanctions and/or individual criminal liability."

A few days later, on March 24, 2009, Senator Grassley sent a letter to Dr.
Torti stating that:

"Your memorandum ... appears to run contrary to many statutes protecting
executive branch communications with members of Congress... I am concerned with
the timing of your memorandum, given some recent high profile matters concerning
your Agency and the release of information that has shown failures in FDA's
regulatory mission. [This] could be viewed ... as an effort to chill and/or
prevent FDA employees from exercising their rights under whistleblower
protection laws."

Congressional Hearing on Mammography Cover-Up is Overdue

Folks, this is a major story, and it's about to get much bigger... There's
loads of powerful and damning information out there that can, and will, be used
to call for a congressional hearing on the mammography cover-up. Decades ago, in
1974, the National Cancer Institute (NCI) was warned by professor Malcolm C.
Pike at the University of Southern California School of Medicine that a number
of specialists had concluded that "giving a women under age 50 a mammogram on a
routine basis is close to unethical."

And in the 1990's, Dr. Samuel Epstein started warning people about the
dangers of mammography, stating:

"The premenopausal breast is highly sensitive to radiation, each 1 rad
exposure increasing breast cancer risk by about 1 percent, with a cumulative 10
percent increased risk for each breast over a decade's screening... The high
sensitivity of the breast, especially in young women, to radiation-induced
cancer was known by 1970. Nevertheless, the establishment then screened some
300,000 women with X-ray dosages so high as to increase breast cancer risk by up
to 20 percent in women aged 40 to 50 who were mammogramed annually."

Since then, concerned FDA doctors and scientists have issued a number of
written warnings in the form of letters to various authorities, such as the
October 2008 letter to Representative Dingell, notifying him of corruption
within the FDA, which sparked a House Energy and Commerce Committee
investigation into Center for Devices and Radiological
Health (CDRH) activities. ⁴

A second letter, sent in January 2009 to HHS Secretary-Designate Tom Daschle,
Baltimore City Health Department Chief Joshua Sharfstein, and nine members of
Congress, delved into more detail. According to Medical Devices Today⁵:

"In the case of an April 2008 approval of a computer-aided detection
device for mammography, the scientists specifically charge (by title, but not by
name) ODE Director Donna-Bea Tillman "and her subordinates" with the "most
outrageous misconduct by ordering, coercing, and intimidating FDA physicians and
scientists to recommend approval, and then retaliating when the physicians and
scientists refused to go along."

The letter also includes a bullet-pointed list of nine "examples of
wrongdoing" by the ODE Director, including ordering physicians and scientists to
ignore FDA guidance documents and allowing manufacturers to market unapproved
devices."

In October that same year (2009), the US Preventative Task Force revised its
recommendations on mammograms,⁶ stating
that women in their 40's should no longer get routine mammograms for early
detection of breast cancer. Instead, the panel recommended waiting until the age
of 50, and only doing one mammogram every other year, instead of yearly. They
also suggested women between 40 to 49 should talk to their doctor about the
risks and benefits of the test, and then decide if they want to be screened. The
Canadian task force followed suit in November last year.⁷

Many cancer organizations were outraged and have shunned the task forces' new
directive; completely ignoring the data supporting their decision... The main
reason behind the changed guidelines? The inherent dangers and short-comings of
mammographic screening...

Could More Women Be Harmed than Helped with Mammography?

While roughly 15 percent of women in their 40's detect breast cancer through
mammography, many other women experience false positives, anxiety, and
unnecessary biopsies as a result of the test, according to the data. In fact, a
full decade ago, a Danish study published in The Lancet concluded that
previous research showing a benefit of mammograms was flawed and that
widespread mammogram screening is unjustified.

That mammograms are still recommended at all speaks volumes about
the state of modern medicine...

Mammograms expose your body to radiation that can be 1,000 times greater than
that from a chest x-ray, which poses risks of cancer. Mammography also
compresses your breasts tightly (and often painfully), which could lead to a
lethal spread of cancerous cells, should they exist.

In April 2011, the prestigious Cochrane Collaboration chimed in, saying
mammography screening may cause more harm than good⁸. For their informative
leaflet, please see the following link. Even more provocative is
the new book, Mammography Screening: Truth, Lies and Controversy by
Peter C. Gøtzsche, Professor of Clinical Research Design and Analysis
Director at The Nordic Cochrane Centre, and Chief Physician. The very first
paragraph of the book's ad reads⁹:

"The most effective way to decrease women's risk of becoming a breast
cancer patient is to avoid attending screening."

Now, that's a bold statement! And it's backed up by facts. According to the
Cochrane Collaboration, for every 2,000 women invited for screening over the
course of 10 years, just ONE woman will have her life prolonged. Meanwhile, 10
healthy women, who would not have been diagnosed with cancer had it not been for
the mammography screening, will be misdiagnosed as having breast cancer, and
will be treated unnecessarily. Additionally, more than 200 women will experience
significant psychological distress for many months due to false positives.

Did You Know? There are No Guidelines for Lumpectomies...

These sad and shocking statistics are worsened further by reports such as
this one, published in the New York Times on January 31,¹⁰ revealing that
oncologists (cancer surgeons) perform lumpectomies without any guidelines
whatsoever, despite the fact that it's the most commonly performed breast cancer
surgery there is. According to the cited study, about half of all women
undergoing a second lumpectomy may not have needed it. On the other hand, some
who did not get repeat surgery may have benefited from it.

According to The New York Times:

"Rates of repeat surgery can vary widely by doctor, from zero percent to
70 percent, according to the study. The additional operations are done when
pathology reports on tumor specimens suggest that the first operation may have
left behind some cancer cells. But surgeons differ when it comes to
interpreting those reports.

... Such uncertainty about a cancer operation that has been in use for 30
years is "a shame," said Dr. Laurence E. McCahill, the first author of the study
and a surgeon and assistant director of the Lacks Cancer Center in Grand
Rapids, Mich.

... [Another] major reason for the variation in repeat operations after
lumpectomy is that there is no consensus among surgeons about how big a rim or
"margin" of healthy tissue should be taken out when a cancer is removed.
Surgeons try to cut cleanly around a tumor and remove enough of a margin to
ensure that they excised all the cancer."

Indeed, you'd think they'd have it nailed down a bit better by now, but it
just goes to show that a lot of what the general public assumes is science-based
medicine is anything but. Interestingly, a study by the Norwegian Institute of
Public Health indicates that spontaneous remission of breast cancer is not quite
as miraculous as we might think. In fact, it's actually quite common. According
to their findings, more than one in five invasive cancers detected in the study
by mammography vanished without ever being treated!^{11, 12}

All in all, there's convincing evidence that mammography is not all it's
cracked up to be, and the FDA is not doing it's stated job to protect your
health. Instead, they're busy catering to industry and skirting the boundaries
of the law to protect their own and their client's behinds; their client, of
course, being the drug- or medical company-the ones they're supposed to be
regulating and keeping honest...

It's going to take a lot to change the course of this agency at this point,
but indeed it must be done. Or the entire notion of a safety- and efficacy
standard for drugs and medical devices of all kinds will be moot.