Licorice Prevents Sore Throats after Operations
http://www.naturalnews.com/z026492_licorice_sore_throats_anesthesia.html
 
Articles Related to This Article:
• Licorice Heals Ulcers, Inflammation, and Skin Conditions
http://www.naturalnews.com/024440_licorice_ulcers_inflammation.html

• Licorice Treats Peptic Ulcers and Helicobacter Pylori Infection
http://www.naturalnews.com/026711_ulcers_licorice_peptic_ulcers.html


 
 



NaturalNews Store Specials:
• Organic Palm Sugar at 40% off

• Maca, ancient superfood of the Inca at 50% off

• Himalayan Crystal Salt at 33% off

• Revolutionary new Hurom Slow Juicer at the lowest price on the 'net + FREE shipping!

See more at the NN store...
 

 
(NaturalNews) Imagine a tube is stuck down your throat and left there for up to a couple of hours. It would be no surprise that you'd end up with a raw feeling throat. That's just what happens to countless people who undergo surgery under general anesthesia. The endotracheal tube, also referred to as a breathing tube, that's used to keep airways open during an operation can result in an excruciatingly sore throat post-surgery -- a condition known as postoperative sore throat (POST).

When throat lozenges aren't enough to alleviate symptoms, some doctors prescribe heavy duty, side effect loaded pain relievers. Incredibly, one of the drugs sometimes used is ketamine, the same powerful, mind-altering medication known as the "date rape" drug. But a new study just published in Anesthesia and Analgesia, the official journal of the International Anesthesia Research Society (IARS), shows there's a safer, natural alternative -- gargling with a licorice solution.

The study, conducted by Dr. Anil Agarwal and colleagues at the Sanjay Gandhi Post Graduate Institute of Medical Sciences in Lucknow, India, included 40 patients who were undergoing spinal surgery. Five minutes before they were given general anesthesia with a breathing tube, the patients simply gargled with either a diluted licorice solution or plain water.

After their operations, the patients who received the licorice gargle had a lower rate of postoperative sore throat, including pain on swallowing. Two hours after surgery, 75 percent of the study participants who gargled with only water suffered from POST while only about a fourth of the research subjects who used the licorice gargle had a sore throat at all. The ones in the licorice group who did have sore throats had less severe symptoms than the patients who only gargled with water, too.

There was even more good news for those who used the licorice gargle: they were far less likely to develop a postoperative cough than the surgery patients who only gargled with water. This is important because coughing after surgery can lead to potentially serious complications.

In a statement to the media, the researchers noted the diluted licorice solution used in the study is easy to make and only costs a few pennies per patient. There were no side effects reported from the licorice gargle, either. Bottom line: for many patients undergoing surgery, licorice gargle appears to be a sweet, simple, inexpensive and effective way to prevent a common and uncomfortable medical problem.

"Licorice, derived from the root of Glycyrrhiza glabra, has been used for many millennia as an alternative medicine for treatment of inflammation, allergies, and gastric and duodenal ulcers," Dr. Agarwal and co-authors stated in their Anesthesia and Analgesia report.

In fact, according to the National Center for Complementary and Alternative Medicine (NCCAM), licorice root has anti-inflammatory effects and has been used to treat stomach ulcers, bronchitis, sore throats, and infections caused by viruses. The NCCAM web site points out that several clinical trials found that a component of licorice, glycyrrhizin, also might reduce complications from hepatitis C in some patients.

Naturally sweet, licorice is commonly used as a sugar substitute in foods and to make candy. It's also used as flavoring agent in some medicines. In the recent study, the licorice gargle's sweet taste made it quickly acceptable to patients.

For more information:
http://www.ncbi.nlm.nih.gov/pubmed/...
http://www.usdoj.gov/ndic/pubs4/476...
http://www.jci.org/articles/view/24...


Share  Buzz up!1 vote 0
diggs
digg



About the author
Sherry Baker is a widely published writer whose work has appeared in Newsweek, Health, the Atlanta Journal and Constitution, Yoga Journal, Optometry, Atlanta, Arthritis Today, Natural Healing Newsletter, OMNI, UCLA's "Healthy Years" newsletter, Mount Sinai School of Medicine's "Focus on Health Aging" newsletter, the Cleveland Clinic's "Men's Health Advisor" newsletter and many others.

White blood cells are the main cells that "execute" the immune functions for the body. There are various types of white blood cells taking part in different parts of the immune system. They include the acquired immune system, which can form antibodies and activated lymphocytes that attack and destroy specific foreign organisms or toxins.

Cells involved in the acquired immune system include cytotoxic T cells, helper T cells and suppressor T cells.

The T lymphocyte system can kill foreign bodies directly once induced by the antigens of foreign bodies and/ or by the subsequent activation of plasma and "memory" cells of the B lymphocyte system, which produce antibodies upon antigen stimulation and activation.

There is another innate immune system that does not need antigen stimulation and activation. Cells involved in this non-specific immunity include natural killer cells, macrophages, and neutrophils. These cells act as the body's first line of defense and can kill the foreign bodies before the activation of the T and B lymphocytes. In addition to immune cells, some small molecular proteins also take part in the immune system and help regulate and mediate the activities of the immune cells. These proteins are called cytokines. Interleukins (IL), interferon (IF), tumour necrosis factor (TNF) are examples of cytokines.

Astragalus (Astragalus membranaceous)

Astragalus, is an important Chinese herb. It is also known in its other names such as: huang chi, and huang qi. Root of the herb is used medicinally.

According to TCM, astragalus enhances immunity by protecting the body from invasion by the Six Evils of aberrant or extreme environmental energies, such as wind and cold, and by increasing circulation of wei-chee (protective energy) around the surface of the body. It also stimulates production and circulation of immunological factors in the blood. (1)

Modern research validates the traditional immunotonic claims for astragalus. A fluid extract of astragalus restored normal immune response in 90% of cancer patients studied. (1) Astragalus increases the production and activity of white blood cells specifically involved in fighting disease. Astragalus does not attack cancer cells directly. It, however, strengthens the body's own immune defenses against the development of cancer.

One of the problems of chemotherapy and radiotherapy in cancer patients is a pronounced lowering of the body's already low immune response ability. Research strongly indicates a positive role of astragalus administration in these patients. It enhances natural defense function by stimulating the responsiveness of T cells. Studies at the University of Texas at Houston showed that T cells of cancer patients with feeble T cell activity became more aggressive when incubated with astragalus compared to healthy controls.(2)

Astragalus extracts are being used in China to fight several kinds of cancer. The herb has been shown to potentiate killer cell effectiveness in some experiments. In one model, a lymphokine was used to generate lymphokine-activated killer cells. The problem is that this process is normally associated with excessive toxicity. When researchers added astragalus to the lymphokine, it significantly reduced the amount of lymphokine needed to activate the killer cells, thus reducing the toxic side effects to a minimum. Astragalus was also found to significantly boost the production of macrophages.

Astragalus helps the body resist virus infections, particularly in the lungs, by increasing production of interferon, an immune factor that inhibits viral growth.

One study demonstrated that chronic bronchitis patients experience significant reduction in symptoms when using astragalus. A combined astragalus- interferon treatment was found to be significantly more effective in preventing the common cold than interferon alone. (3)

Astragalus is currently under study as a treatment for AIDS due to its powerful enhancement of immune response. Astragalus has been shown to significantly reduce the number of T-suppressor cells in cases of human immune deficiency.

Astragalus' immunotropic properties are enhanced when it is combined with ginseng, Codonopsis, schisandra, angelica, and/or licorice. It can also be blended with echinacea. Chinese medicine always use herbs in combination. Astragalus is a component of several well known Chinese medicinal formulae.

Safety

Astragalus is safe. No toxicity has been observed in animal and human studies.

Recommended Dosage

Decoction: 8-12 grams, in two doses, on an empty stomach.

Astragalus Liquor: steep 80-100 grams of the sliced root in 1 liter of spirits for 2-3 months; take 1 ounce, twice daily, on an empty stomach, straight or diluted with 1-2 ounces pure water.

Use with 40-50 grams ginseng for better results.

References

1. Daniel Reed, "A Handbook of Chinese Healing Herbs," Shambhala, Boston, MA

2. Wang,D.C. "Influence of astragalus membranaceous (AM) polysaccharide FB on immunologic function of human periphery blood lymphocyte." Chung Hua Chung Liu Tsa Chih, 11(3), 180-183, 1989.

3. Hou, Y ., et al. "Effect of radix astragali seu hedysari on the interferon system." Chin. Med. J., 94(1), 35-40, 1981.

Titre du document / Document title
Risk factors for infection after spinal surgery http://cat.inist.fr/?aModele=afficheN&cpsidt=16904298
Auteur(s) / Author(s)
FANG Andrew (1) ; HU Serena S. (1) ; ENDRES Nathan (1) ; BRADFORD David S. (1) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) Department of Orthopaedic Surgery, University of California, San Francisco, CA, ETATS-UNIS

Résumé / Abstract
Study Design. A retrospective case control analysis of 48 cases of postoperative infection following spinal procedures. Objectives. Spinal procedures that became infected after surgery were analyzed to identify the significance of preoperative and intraoperative risk factors. Characterization of the nature and timing of the infections was also performed. of Background Data. The rate of postoperative infection following spinal surgery varies widely depending on the nature of the procedure and the patient's diagnosis. Preoperative comorbidities and risk factors also influence the likelihood of infection. Methods. A review of 1629 procedures performed on 1095 patients revealed that a postoperative infection developed in 48 patients (4.4%). Data regarding preoperative and intraoperative risk factors were gathered from patient charts for these and a randomly selected control group of 95 uninfected patients. For analysis, these patient groups were further divided into adult and pediatric subgroups, with an age cutoff of 18 years. Preoperative risk factors reviewed included smoking, diabetes, previous surgery, previous infection, steroid use, body mass index, and alcohol abuse. Intraoperative factors reviewed included staging of procedures, estimated blood loss, operating time, and use of allograft or instrumentation. Results. The majority of infections occurred during the early postoperative period (less than 3 months). Age >60 years, smoking, diabetes, previous surgical infection, increased body mass index, and alcohol abuse were statistically significant preoperative risk factors. The most likely procedure to be complicated by an infection was a combined anterior/posterior spinal fusion performed in a staged manner under separate anesthesia. Infections were primarily monomicrobial, although 5 patients had more than 4 organisms identified. The most common organism cultured from the wounds was Staphylococcus aureus. All patients were treated with surgical irrigation and débridement, and appropriate antibiotics to treat the cultured organism. Conclusions. Aggressive treatment of patients undergoing complex or prolonged spinal procedures is essential to prevent and treat infections. Understanding a patient's preoperative risk factors may help the physician to optimize a patient's preoperative condition. Additionally, awareness of critical intraoperative parameters will help to optimize surgical treatment. It may be appropriate to increase the duration of prophylactic antibiotics or implement other measures to decrease the incidence of infection for high risk patients.
____________
b) Infections
There is no specific data on the occurrence of infection of artificial discs, but early and mid-term infections may occur as likely as in anterior fusion with 0 and 12% in lumbar instrumented fusion [20]. Nevertheless due to the prevalence of motion and a neo-joint formation, late haematogenic spread infection as known from hip and knee arthoplasty is possible in the immunocompromised TDR patient, with detrimental effects on the patient's health and function.

Postoperative infections of the spine can optimally be visualised by MR with contrast. A sensitivity and specificity of 93% and 97% makes the MRI superior to all other radiological imaging modalities [21]. If MRI-scans are not available or stainless steel implants were used radionuclide imaging should be used to reveal focal increased uptake. If available PET-CT scans should be considered to diagnose a suspicious postoperative spinal infection, since PET has a higher specificity than radionuclide scintigraphy.
http://www.pssjournal.com/content/3/1/15

How to Treat a Weak Immune System With Aromatherapy
by Kathi Keville

Browse the article How to Treat a Weak Immune System With Aromatherapy
How to Treat a Weak Immune System With Aromatherapy

Many essential oils have a remarkable ability to both support the immune system and increase one’s rate of healing. Some of these same essential oils are also powerful antiseptics. One way these oils fight infection is to stimulate the production of white corpuscles, which are part of the body’s immune defense. Still other essential oils encourage new cell growth to promote faster healing. As an extra bonus, the regenerative properties of these essential oils improve the condition and tone of the skin. All can be used in conjunction with herbal remedies designed to improve immunity. Relaxation achieved through a massage or bath lowers stress, improves sleep, and thus stimulates the immune system. (For more information, see the article on Aromatherapy Stress Relief for additional treatments that can be part of your immune therapy.)

One important way to assist your immune system is a lymphatic massage that uses essential oils. Lymph nodes are located around the body, particularly in the throat, groin, breasts, and under the arms. They are like filtering centers for cleansing the blood. The lymphatic system moves cellular fluid through the system, cleansing the body of waste produced by the body’s metabolic functions. Lemon, rosemary, and grapefruit are especially good at stimulating movement and supporting the cleansing action. A lymphatic massage involves deep strokes that work from the extremities toward the heart. You can even do this on yourself. Rub the oil up your arms to the lymph nodes in your armpits. From the center of your chest, rub again toward the armpit, and then down your neck. Massage your legs from your feet up to the groin.

Essential oils for the immune system: bergamot, grapefruit, lavender, lemon, myrrh, rosemary, tea tree, thyme



Aromatherapy Immune System Boost

This invigorating massage oil will keep your immune system in prime working condition.


Immune Tonic Blend


6 drops lavender oil
6 drops bergamot oil
3 drops lemon oil
3 drops tea tree oil
2 drops myrrh oil (expensive, so optional)
2 ounces vegetable oil
Combine ingredients. Use as a general massage oil or over specific areas of the body that tend to develop physical problems. For example, if you come down with a lot of chest colds and flus, rub this blend over your chest. Use 1 to 2 teaspoons in a bath or 1 teaspoon in a foot bath. Without the vegetable oil, this recipe is suitable for use in an aromatherapy diffuser, simmering pan of water, or potpourri cooker. Use in some form several times a day when trying to build up your own natural immunity.
 


To learn more about Aromatherapy and other alternative medicines, see:


Aromatherapy: Here you will learn about aromatherapy, how it works, what part essential oils play, and how to use aromatherapy.

Essential Oils Profiles: We have collected profiles of dozens of plants that are used to produce essential oils. On these pages, you will learn the properties and preparations for the most popular essential oils.

How to Treat Common Conditions With Aromatherapy: Aromatherapy can be used to treat a number of conditions, from asthma to depression to skin problems. Here you will learn how to treat some common medical problems with aromatherapy.

Home Remedies: We have gathered over a hundred safe, time-tested home remedies for treating a wide variety of medical complaints yourself.

Herbal Remedies: Herbal remedies and aromatherapy can be very similar, and they stem from similar historic roots. On this page, you will find all of our herb profiles and instructions for treating medical problems with herbal remedies.

http://health.howstuffworks.com/wellness/natural-medicine/aromatherapy/how-to-treat-a-weak-immune-system-with-aromatherapy.htm/printable

http://www.spine-dr.com/site/surgery/surgery_complications.html

Strategies for revision

When faced with a failure of the implants, timing is of paramount importance in terms of the relationship to the date of the initial surgery. If it is within two to three weeks, the approach is relatively easy, as the early wound healing frequently does not prohibit going in through the same plane. From three weeks to six months is most difficult, as the tissue is friable and can be densely adherent at the same time. Retroperitoneal fibrosis around the great vessels and ureters represents a formidable technical challenge. Beyond six months it is still difficult, but not as treacherous as the intermediate period.

If there is no neural entrapment and no vascular impingement, posterior fusion in situ is a reasonable safe option, and if the timing is early, revision of the device can also be considered.

When there is neural entrapment, if this can be correctible posteriorly, this is preferable for safety reasons. Depending on the timing of the problem's occurrence, anterior revision is another option, if postoperatively early enough, and depends on the source of the neural compression.

With vascular impingement revision or removal of the implant must always be considered. If there is coronal malalignment, I personally prefer posterior reduction and subsequent anterior removal and fusion. With coronal malposition, the segment may have lost its intrinsic stability, and is therefore too unstable to revise. If there is only sagittal malalignment, then revision or fusion anteriorly done with anterior plate can be considered, or subsequent posterior pedicle fixation if a fusion is desired. Posterior fusion with subsequent anterior fusion is also a viable option.

As discussed by Dr. Bailey, if there is expulsion anteriorward, it is helpful to know as best as possible where the vein is and whether the vein is compressed. Venogram and ultrasound can be helpful in this regard.

Since we do not have good data on long-term follow-up on these cases and know some instances of expulsion and failure occur, a prophylactic approach would make sense. We use a tight-weave vascular tubular graft or a large enough piece to be folded over so that there are two layers of graft, one opposite the great vessels, one opposite the disc operative site, extending at least halfway up the vertebral bodies, cephalad and caudad. These are anchored into position to the prevertebral fascia. If revision has to occur in the future, dissection can safely be done between the layers of graft material, and the posterior layer can easily and safely be cut to expose the interspace, while the anterior vascular graft layer can be used to shield the vessels and facilitate retraction.

Susan Bailey MD Vascular Surgeon
James Zucherman Orthopedic Spine Surgeon

Here is a link to a review of that study

http://www.spine-health.com/blog/surgery/lumbar-herniated-disc-surgery-better

A very large study, the Spine Patient Outcomes Research Trial (SPORT) has recently concluded and found that both surgical and non-surgical treatments tend to help patients with pain from a lumbar herniated disc. Due to problems with the study design, however, it is difficult to say much more than that. Unfortunately, because the trial did not demonstrate that surgery is superior to non-surgical treatments for a lumbar herniated disc, there is new concern among spine physicians that insurance companies may now cite this study as "evidence" that surgery is not necessary.


Note, the above link come from a site dominated by spine surgeons ... if you know what I mean.  Yeah, I'll bet they are concerned!  If they are so concerned, why dont they pool some of their sacred investments and fund an independent study?  They certainly do seem to have plenty of time to work for the device makers, and naturally invest in the devices they are testing ...


The link to the actual report is broke, so here's what I found
http://www.dhmc.org/spine/Research/Spine_Patient_Outcomes_Research_Trial_%28SPORT%29/index.html

 
CDRH seeks input on preliminary 510(k) program and utilization of science reports 
To address concerns about the FDA’s 510(k) reform process, the Center for Devices and Radiological Health (CDRH) held a 2-hour Webinar on August 31, allowing FDA officials to answer questions that medical device companies and others have about the Center’s preliminary assessments of the FDA’s 510(k) program and how science should be used in the decision-making to clear medical devices.

The Webinar took place nearly a month after the August 4 release of the FDA’s two documents, which provided comprehensive evaluations of the 510(k) program for clearing medical devices, entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations.”

The reports were compiled by two internal committees formed in Fall 2009, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.

Improvement needed
During the 510(k) revamping process, the CDRH conducted “significant outreach” via town meetings and public dockets to obtain needed input on the documents from stakeholders, Jeffrey Shuren, MD, director of the CDRH, said. The Webinar provided another forum to address questions raised during the 60-day review period for the documents, which ends October 4.

“There’s widespread recognition that there’s significant room for improvement in the way we operate,” Shuren said during the Webinar.

“These reports represent a blueprint for smarter medical device oversight with the tools CDRH needs to drive innovation and help bring the best technologies to patients while continuing to ensure the safety and effectiveness of medical devices,” he said.

In addition to Shuren, those fielding questions from the virtual audience were Alberto Gutierrez, MD, Office of InVitro Diagnostics CDRH; Christy Foreman, Office of Device Evaluation CDRH; and Dr. Jonathan Sackner-Bernstein, Associate Center Director, Post Market Operations, CDRH. The event’s format involved online participants anonymously e-mailing questions about the Draft 510(k) and Use of Science in Regulatory Decision Making reports to the CDRH officials, who answered them aloud.

Both reports are available at the FDA’s website.

New device classes
Some of the questions centered on concern over whether the review of current or soon-to-be submitted 510(k) applications would be impacted during the 510(k) revamping process. Shuren said that the Center’s work to finalize the two reports, which are expected to be complete later this year, with some recommendations possibly being phased in, would not affect the timeline for review of 510(k) submissions in process. He also noted the existence of these preliminary reports should not keep companies from submitting their new products for 510(k) clearance.

Since the 510(k) Working Group has proposed changes to the premarket notification program that include introducing subsets of class II devices of class IIa and class IIb, this spawned questions about the type and level of evidence needed for them. For new class IIb devices, clinical or manufacturing information or potentially additional evaluation in the post-market setting may be required to support substantial equivalence claims, according to the 510(k) Working Group report executive summary.

When asked whether stakeholders may provide input to the Center on the criteria for devices that are appropriate for class IIa vs. IIb, Shuren said, “The public will have input. What we plan to do is issue draft guidance and get public comment on that before we would go out with final criteria.”

New de novo approach
CDRH’s Foreman discussed the level of clinical data for 510(k)s compared to premarket approvals. “Part of what we would like to achieve with this report and clarity applied to the regulatory process is identifying up front which devices we think would need clinical data, but by saying a 510(k) needs clinical data, that doesn’t necessarily mean that it needs a double-blind, randomized control study of 1,000 patients. We just need some level of clinical evidence to establish the equivalence of that device,” she said.

Among the many other questions were inquiries about the proposed recommendations related to rescinding a 510(k) clearance and off-label use considerations.

Shuren said the Center’s assessment requests expediting the handling of de novo devices. Currently they require a non-substantially equivalent determination via the 510(k) process before being considered for clearance through the de novo pathway. “The Center is recommending that we take steps to streamline this process so it truly is a viable path forward for lower risk novel devices,” he said.

The science report included plans to enlist the help of more outside experts as resources in the device evaluation process, among other recommendations.

Reference:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm
 

Stryker Settles OP-1 Allegations in Massachusetts

BY LAUREN UZDIENSKI, AUGUST 26, 2010
The Massachusetts Attorney General's office announced today that Stryker has settled a number of allegations over off-label marketing for OP-1 for $1.35 million. The state alleged that Stryker promoted OP-1 for indications outside its HDE as well as withheld information about these restrictions from physicians.

The company will pay $325,000 in civil penalties, $875,000 to "fund efforts to combat unlawful marketing and other programs to benefit health care consumers" and $150,000 to cover attorneys’ fees and investigative costs.

The state's complaint was filed yesterday.

Stryker is still facing a federal inquiry into their OP-1 marketing practices. Last October, the company and several executives received a federal indictment associated with off-label marketing of OP-1, with charges including alleged wire fraud, conspiracy, misbranding and making false statements to the FDA.

See all posts on Biologics | Stryker
ShareThishttp://www.healthpointcapital.com/research/2010/08/26/stryker_settles_op1_allegations_in_massachusetts/?utm_source=email&utm_medium=htmlemail2&utm_campaign=weekly

Hi Iron Eddie,

Although the insurance companies are not surgeons, they do base their rules on exhaustive studies.  Of course, they will err on the side of caution (less payouts) ... but we have to understand that doctors nowadays tend to err on the side of overtreating - out of a sense of defensive medicine.  Also, the medical practices, hit with massive insurance, tend to hyper-inflate their expenses - as we have seen in recent news.  So the insurance companies retaliate with ridiculousness rules.

I'll try to find the study, a collection of thousands of conservative care vs. surgery, which basically says the long term results were not much different.  That is, they found that surgery more often than not worked, but so did conservative therapy.  The question to me was: for those who had surgery, how many of them ended up severely worse? For those who had conservative therapy, did the PT provide a long-term change which prevented recurring injury.  ( This is conjecture until I find the article )

Did you doc say you have degenerative disease?  (It makes a HUGE difference)

I Like your 'handle'!

Hello Fellow Spine bloggers: Regardless of our personal opinion of the FDA, we need to lobby congress to increase the FDAs budget to insure that in depth investigations into clinical trials and defective spine products (among many other implant devices) are given the competent review necessary to protect the consumer.

In an article titled: New F.D.A. Chief Says She’ll Toughen Enforcement Efforts http://www.nytimes.com/2009/06/17/us/17fda.html?_r=2&scp=5&sq=FDA%20Commissioner&st=cse

Dr. Hamburg spells out the reasons why these device manufacturing companies are getting away with biomedical malfeasance. This is due in part to the lack of funding from congress that this agency direly needs to enforce the laws and regulations in place to protect the consumer from biomedical malpractice.

The giant orthopedic device manufacturing corporations, i.e. Stryker, Zimmer et al are spewing out implant medical devices as recklessly as the octomom gave birth to eight babies because her fertility doctor saw an opportunity to make a name for himself in the field of fertility medicine. I am making this comparison more as analogy to the criminal reckless disregard that the physician and the manufacturing company behind the fertility drug given to octomom had for the public consumer than as a case in point about spinal implants. The problem is that these giant manufacturing companies have one directive in mind for cluttering the market place with competing and some harmful or defective devices. The bottom line and profits for the stockholders are what drive this industry. They rely on the chaos theory and the fact that the FDA is underfunded and cannot catch every rouge surgeon in the act of falsifying data or having a huge conflict of interest which puts the subject or patient at risk in the name of obscene profits. 

"The F.D.A. is badly in need of money and vigorous leadership. Congress in recent months has increased the agency’s budget, and the Obama administration has asked for still greater financing. The hope is that Dr. Hamburg can use the money and her own talents to revive the agency, much as she did the New York City Department of Health in the 1990s. "
....June 17, 2009
New F.D.A. Chief Says She’ll Toughen Enforcement Efforts
By GARDINER HARRIS
WASHINGTON — Dr. Margaret A. Hamburg, the new commissioner of the Food and Drug Administration, promised Tuesday to toughen enforcement and hire new leaders for the agency.

In her first round of interviews with reporters since becoming commissioner last month, Dr. Hamburg also said the agency’s staff was eager to begin regulating the tobacco industry once President Obama signs legislation, as he has said he will, giving the F.D.A. power to oversee tobacco companies’ marketing efforts and products.

“We now have an opportunity to really make a difference with what is probably the No. 1 public health concern in the nation and the world,” she said.

The F.D.A. is badly in need of money and vigorous leadership. Congress in recent months has increased the agency’s budget, and the Obama administration has asked for still greater financing. The hope is that Dr. Hamburg can use the money and her own talents to revive the agency, much as she did the New York City Department of Health in the 1990s.

To discuss the issues confronting her in her new post, Dr. Hamburg sat down for interviews in the agency’s small suite of downtown offices next to the headquarters of the Department of Health and Human Services. She has promised to make the agency more transparent, but with so little time on the job, she did not have much to be transparent about, and she spoke generally in broad terms.

She did say, however, that she would hire new leaders and improve the agency’s standing within the scientific community, in part by encouraging greater study of its responsibilities.

“Regulatory science has never been developed as a legitimate and important and really interesting branch of science,” she said.

She also said that to oversee the increasing flood of imported foods, medical devices and drugs, the F.D.A. would have to create far more partnerships with foreign regulators.

And while she said she would collaborate with industry, she promised to be a tougher cop. “Under my leadership, we’ll see a somewhat more aggressive posture with respect to enforcement,” she said.

Unanimously confirmed by the Senate in May, praised by conservative Republicans and liberal Democrats alike, Dr. Hamburg maintains wide support among a diverse and often fractious set of industry, consumer and patient advocacy groups.

But that wide support is bound to fracture as she makes clear whether she will favor speedy reviews of new drugs and devices, or greater assurances of their safety; quick and broad recalls of foods that may be contaminated, or slower and more narrow pullbacks of only those products that have proved to be unsafe.

Dr. Hamburg complimented the F.D.A.’s work force and marveled at its broad responsibilities, a nod to the delicate task of turning around an agency filled with proud veterans.

That agency has been riven in recent years by internal disagreements that have spilled not only into advisory meetings but also into Congressional hearings and news accounts, some of which have suggested that decisions have been overly influenced by lawmakers or complaints from industry.

A top priority, Dr. Hamburg said, is improving the agency’s science base and “really assuring that all voices are heard in terms of evaluating the science, and that decisions are made based on available data and evidence without undue or inappropriate interference from other sources.”



Home
World U.S. N.Y. / Region Business Technology Science Health Sports Opinion Arts Style Travel Jobs Real Estate Automobi