Our simple game plan is tailored for your success

• Limited number of students
  • Admissions are limited to thirty only, more personal attention is given to each student.
•  Study material
  • Each student is given around 25 books worth RS 6000 which cover both general studies and political science. These books covers the entire syllabus, students need not hunt for any extra material as this is more than adequate.
• Notes
  • Written notes provided for all the topics eases the exam preparation . Notes cover current affairs collated from leading competitive magazines and newspapers.
• Subjects experts
  • Every subject handled in the institute viz. (History, Economics, Biology etc) will be covered by Professional experts respectively.
• Work dairy
  • Every Student is provided with a work dairy, to keep the preparations more focused.  Every student should write  the number of hrs studied in each day so that it makes his study more regular and systematic.
• Tests
  •  There will be regular tests after the completion of every topic. These tests will help the students to improve on the preparations.
• U G C Exam
  • Coaching for UGC NET Exam will be provided for M A political Science students with a nominal fee. (Only for students who have the admission for  I A S 2010 batch )
• Free Coaching for K A S
  • Free coaching will be provided for   KAS prelims  (on further notification) for those students who have taken admission for IAS prelims 2010
• Question papers and solutions
  • Previous years Question papers along with solutions for general studies and political science will be provided to students .Study of atleast 10 yrs of previous Question papers will help the students for smart preparations
• References
  • Most of the students are confused as to how the questions are framed in UPSC  . Shrisai tutorials shall provide the source material for around 90  questions in General studies and 105 – 110 questions in political science of atleast 10 previous years papers. This helps the student to read only the relevant material.
• Counseling
  • There shall be free guidance and counseling given to students for other other government services like FDA,SDA,CDS,NDA etc

Political Science optional covers the below topics

•  
  •  Modern Indian History
  •  Political thinkers from plato to marx
  •  Political theory
  •  Governments of U K , USA, France, China, S A , Germany
  •  Indian political thinkers
  •  Indian Constitution

Total hrs of teaching – 250 hrs
General studies – 125 Hrs
Political science 125 Hrs

 More details at http://www.shrisaitutorialsforias.com

(NaturalNews) The FDA has issued a warning about the high overdose risk from the opiate painkillers Darvon and Darvocet, but has stopped short of banning the drugs as the United Kingdom has done.

Darvon and Darvocet contain a mix of an over-the-counter painkiller (either aspirin or acetaminophen) and the opiate propoxyphene, also known as dextropropoxyphene. The new FDA rules will require a tougher boxed warning on all products containing propoxyphene about the particular danger that the drugs pose when taken at higher-than-recommended doses.

“FDA is taking action to reduce the likelihood of such fatal overdoses in the United States while we investigate the safety of propoxyphene more fully,” the agency said. “In Europe, there is recent evidence that this medication may be more lethal in overdose than other pain medications.”

After the propoxyphene-acetominophen combination marketed in the United Kingdom as co-proxamol was withdrawn from the market in that country, the number of suicides and accidental overdoses from painkillers fell dramatically. Approximately 295 fewer people committed suicide with co-proxamol and 54 fewer people died from accidents involving the drug over a two-year period, with no corresponding increase in suicides or accidental poisonings using other painkillers.

“Major changes in prescribing after the announcement of the withdrawal of co-proxamol have had a marked beneficial effect on poisoning mortality involving this drug, with little evidence of substitution of suicide method related to increased prescribing of other analgesics,” Oxford University researchers concluded in a recent study.

The FDA’s ruling came in response to a petition by the consumer advocacy group Public Citizen, which had also requested that the drug be phased out of the U.S. market. Although an FDA advisory panel also voted 14-12 in favor of withdrawing the drug, the agency decided only to strengthen warnings on the drug and conduct further research at this time.

Sources for this story include: www.reuters.com.

There appears to be no end to this dichotomy of scaring our people to death with all this hype of how dangerous the H1N1 Flu is, while a great many of our intelligent, trained, credentialed medical people not only here, but around the world are saying just the opposite. What is one to believe?  I side with all those medically educated  individuals who know enough about this problem and the products and testing or lack thereof, to have arrived at choices which prevent them from any personal participation for themselves or their families.

Science is science.  Tests have results which lead to evidence.  I try to avoid “hype” – heaven knows we are given far too much of it!  Tho I have posted on this subject very much, it is in the interest of informing people in order to make more informed choices which “protect” their families.  This is after all, what we are all after.   Where does this confusion come from?     More importantly   – WHY?  Whose interests are driving this – dare I say   (?) – - coverup?  What is going on?

CDC: Data show that H1N1 vaccine is safe

By Mike Stobbe
ASSOCIATED PRESS

ATLANTA — There’s no evidence that the H1N1 vaccine is causing serious side effects, U.S. health officials said yesterday, in their first report on the safety of the new vaccine.
Since vaccinations began in early October, the government has been tracking the safety of the swine-flu vaccine. By mid-November, about 22 million Americans had gotten the vaccine, and there were about 3,200 reports of possible side effects, mostly for minor problems such as soreness or swelling from the shot.
Health officials didn’t expect to see serious problems: The H1N1 vaccine is basically the same as the regular winter-flu vaccine. And there were no signs of trouble in the tests conducted in the thousands to find the right dose.
Still, it is “very reassuring” to see that confirmed in the first report, said Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention. “The vaccine data so far really suggests this is a safe vaccine.”
The information comes from a voluntary reporting system that patients and doctors can use if they think something went wrong after a vaccination. Of the H1N1 reports, 177 were considered serious, including 11 deaths.
There’s no evidence that those deaths were because of the vaccine, and there was no common underlying medical condition seen in those fatalities, CDC officials said.
Since it was first identified in April, swine flu has sickened an estimated 22 million Americans, hospitalized about 98,000 and killed 4,000. It has proved to be similar to seasonal flu but a bigger threat to children and young adults.
Health officials are increasingly worried about severe cases of bacterial pneumonia seen in nonelderly adults this fall. H1N1 and bacteria can act as a dangerous one-two punch.

Promo Magazine
The U.S. Food and Drug Administration is warning more than a dozen online cigarette sellers that they may be in violation of the new regulations against selling most types of flavored cigarettes to U.S. citizens and have 15 days to prove that they have stopped those sales or risk government action.

A ban on the U.S. sale of cigarettes flavored with anything other than menthol went into effect on Sept. 22 as part of the Family Smoking Prevention and Tobacco Control Act.

That law, enacted in June, gives the FDA power to regulate the content of tobacco products, along with the marketing and distribution of cigarettes and smokeless tobacco, and the impact of ads for those products on young people. The new law also lets the FDA limit the amount of nicotine in products and block labels such as “light” and “low tar” that appear to offer “healthier” cigarettes.

So some of us like BBT absolutely hate large scale cigarette smoke in places that clearly say don’t smoke, but we respect smokers’ freedom to light up.

When we began Carlson Laboratories in 1965, the Federal Food and Drug Administration (FDA) was attempting to classify nutritional supplements as Drugs so they could limit what was sold and limit RDA levels. Passed in 1974, The Proxmire Bill prevented the FDA from limiting availability or dosage. DSHEA, which passed in 1994, clarified the law further.

Now, a new Bill has been introduced into the US Senate by Senator Durbin of Illinois. Bill S-722, the so-called Dietary Supplement Safety Act, would greatly expand the Federal Food and Drug Administration’s (FDA) authority over dietary supplements and undermine the hard-fought victory the Nutritional Supplement Industry achieved with DSHEA, which sought to restrain the FDA’s historical abuse of discretionary authority over dietary supplements. And, despite its tit]e, this Bill will provide the consumer with no more protection than current law provides.

If passed into law, this bill will, however, subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is unwarranted, unnecessary and costly. By questioning the safety of any dietary supplement that receives even one complaint, hundreds of products that have been safely and beneficially used could be removed from the marketplace. This Bill threatens not only manufacturers, suppliers and health food stores, but consumers’ rights as well.

A unified industry effort is needed! We must inform the public of this Legislation and how it affects them and urge them to contact their state senators nationwide to oppose it. We need your help!

I am asking all readers to send a letter to their Senator to oppose S-722. Without your support, this bill stands a good chance of passing into law and affecting the health freedoms we take for granted now.

Susan Carlson, RPh

J.R. Carlson Laboratories, Inc.

15 College

Arlington Heights, Illinois 60004-1985

847-255-1600

Fax 847-255-1605

Date–

Dear Senator–:

I urge you to oppose any efforts by your fellow Senators to enact S-722, which has been erroneously named the Dietary Supplement “Safety” Act by its sponsor Senator Durbin.

This bill would allow the FDA to take away my dietary vitamin and mineral supplements.

Under existing law, the FDA has been given broad, legal authority to regulate all aspects of manufacturing, marketing and distributing dietary supplements. Rather than encouraging the FDA to start aggressively enforcing existing law, Senator Durbin’s bill would grant the FDA new enforcement powers without any corresponding increase in the protections accorded to consumers under the existing law. These new enforcement powers would include wide discretionary authority that would enable the FDA to remove from the market safe and healthful dietary supplements. This would completely undermine the primary goal of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”) to restrain the FDA’s historical abuse of discretionary authority over dietary supplements.

If adopted, this Bill would unjustifiably subject vitamins, minerals, herbal products and other supplements to an unwarranted level of government scrutiny. Beneficial products that have been used safely for hundreds–and in some cases, thousands–of years would be subjected to clinical evaluation using ambiguous standards. This would permit the FDA to fabricate safety concerns and remove safe, nutritious dietary supplements from the market.

Under the Durbin Bill, if a single report of an adverse experience occurring while taking a dietary supplement is received, even though it is not known to be causally related to the dietary supplement, the FDA can initiate procedures resulting in the termination of the marketing of the ingredient. All of these procedures are left entirely to the unbridled discretion and whim of the FDA.

Already, adverse experiences have been filed for: Vitamin C; Echinacea; Multivitamins; Glucosamine; Calcium and more.

I encourage you to oppose this extreme and unnecessary legislation and use your authority to encourage and support the FDA in fully exercising its already adequate enforcement powers.

Respectfully yours,–

Signature–

Name (print)–

Address/City/State/Zip–

FDA APPROVAL OF HIP RESURFACING SYSTEMS IN AMERICA

The first hip resurfacing system that was approved by the United States Food and Drug Administration (FDA) was the Birmingham Hip Resurfacing System (BHR) that is made by Smith & Nephew Inc. of Memphis, TN. The system was approved in May 2006.

A year later, in July 2007, FDA approved Corin Group’s Cormet hip resurfacing implant for sale in the United States.

In November 2009, Wright Medical Group Inc.’s Conserve Plus system for bone-saving hip-resurfacing surgery also received the approval of the Food and Drug Administration.

So today, there are 3 companies that have the FDA’s approval to sell hip resurfacing systems in the US.

The hip resurfacing system relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Those degenerative joint diseases include osteoarthritis and rheumatoid arthritis.

In the hip resurfacing system, the cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly polished metal.

The hip resurfacing system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

GET FREE QUOTE FOR HIP RESURFACING SURGERY
To request a FREE cost estimate for hip resurfacing surgery or any procedure please provide the following information in the comment box below and hit the “Submit” button:

• *Name
• *Email id
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• *Procedure desired
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Note: The fields marked with * above are mandatory.

FDA to Evaluate Safety and Legality of Alcoholic Beverages Containing Caffeine

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible.” — Dr. Joshua Sharfstein, Principal Deputy Commissioner of Food and Drugs, FD

What are caffeinated alcoholic beverages?

Caffeinated alcoholic beverages are alcoholic beverages to which the manufacturer has intentionally added caffeine and/or other stimulants that are metabolized as caffeine (e.g., guarana). An increasing number of companies are producing these beverages, with young people as the apparent marketing target. The reported prevalence of combined caffeine and alcohol use among U.S. college students is high as 28%.

What are the potential health concerns with caffeinated alcoholic beverages?

• Studies have shown that people who drink caffeinated alcoholic beverages drink larger quantities of alcohol.
• Caffeine can mask the negative effects of alcohol intoxication, increasing the chance that users will engage in potentially risky behaviors, such as drinking and driving, because they don’t feel that they are intoxicated.
• Users of caffeinated alcoholic beverages are also more likely to experience alcohol-related consequences, such as being taken advantage of or taking advantage of someone else sexually.
• Consuming these beverages may also be associated with adverse effects on heart rhythm, most likely in individuals with pre-existing cardiovascular conditions.

Is caffeine approved by the FDA for use in alcoholic beverages?

A food additive is presumed by the FDA to be unsafe unless its particular use has been approved by federal regulation or is Generally Recognized As Safe (GRAS) under the conditions of its intended use. The FDA has approved caffeine as GRAS for use only in non-alcoholic cola- type beverages at concentrations of no greater 0.02 percent. The FDA has not approved caffeine for use at any level in alcoholic beverages.

What is the FDA doing about this?

On November 13, 2009, the FDA issued a mandate to nearly 30 manufacturers* of caffeinated alcoholic beverages to produce within 30 days their rationale and supporting data concluding that their use of caffeine in an alcoholic beverage is either GRAS or prior sanctioned.** To be GRAS, the burden is on the manufacturers to show that 1) the use of caffeine is safe for use in alcoholic beverages based on publicly available scientific evidence and 2) there is a consensus among qualified experts regarding the safety of caffeine for this use. In their letter to manufacturers of caffeinated alcoholic beverages, the FDA states that, “If FDA determines that the use of caffeine in your alcoholic beverage is not GRAS or subject to a prior sanction, FDA will take appropriate action to ensure that this product is removed from the marketplace.”

*In the past year, Anheuser-Busch and Miller agreed to discontinue their caffeinated alcoholic beverages and agreed to not produce any caffeinated alcoholic beverages in the future.

**A substance is considered prior-sanctioned if its specific use in food was authorized by the FDA or the Department of Agriculture prior to September 6, 1958.

SOURCES: Adapted by CESAR from the following documents available on the FDA website at http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm: “FDA to Look Into Safety of Caffeinated Alcoholic Beverages; Agency Sends Letters to Nearly 30 Manufacturers,” FDA Press Release, 11/13/09; FDA, Questions & Answers on Caffeine in Alcoholic Beverages, 2009; CAB Letter to FDA from Attorneys General, 9/25/09; CAB Letter to FDA from Scientists, 9/21/09.

Perhaps the lowest of the “low-hanging fruit” in clinical trial document management efficiencies is in transitioning existing records management systems and signatures to an electronic platform. The FDA under part 11 of Title 21 of the Code of Federal Regulations describes guidelines in maintaining and submitting such electronic information to the FDA.

Under part 11, the FDA specifies that the following requirements will be enforced:

• Limiting system access to authorized individuals
• Use of operational system checks
• Use of authority checks
• Use of device checks
• Determination that persons who develop, maintain or use electronic systems have adequate training
• Establishment of policies that hold persons accountable for actions initiated under electronic signatures
• Controls for open systems
• Requirements related to electronic signatures

While this post is not meant to offer guidance on how to meet the above requirements (**disclaimer**), the following attributes that should be present to meet the above requirements are described here in summary as a reference, and should be thoroughly reviewed at the FDA website (here and here).

For electronic records:

• Portable electronic formats: Use an industry standard portable format that allows export and retrieval upon inspection.
• Retention: Archived records must be retrievable.
• Audit trails: Record operator actions in creating, editing, deleting records that affect GxP records.
• Security: Follow existing international security standards such as ISO/IEC.

For electronic signatures:

• System controls: Workflows, procedures, system design ensures verification.
• Signature controls: Use at least two identification controls (eg, username and password).
• Password controls: Rigorous rules, expiration and encryption.

A great reference: 21CFRPart11.com.

What are your experiences and challenges in meeting 21 CFR Part 11 guidelines?

Hi Kevin,

Could you please send me the links to the Liberation Wellness Hour Radio Show?

Have you noticed that the sale of your book online from amazon.com is increasing?  I have bought (or they have bought) 3 more copies for people who are all asking me about your diet plan.     People are starting to listen and spread the word.  My niece, who is morbidly obese and always has been, has lost 7 lbs already and her IBS is so much better in just one week! Her father (my brother) called me and thanked me for helping her find a diet she could get excited about.  He has been so worried about her, but anything he could say to her would sound like criticism, so he was very grateful that I gave her the information. She bought the book the next day.  Another niece, who weighs over 300 lbs, asked me to get your book for her.  I hope she can work the diet into her life, because her schedule is such that she eats on the run all the time.

Mike my husband has lost 12 lb already!

A friend at work has ordered your book and is all excited about it, and she has referred another co-worker, who is on a protein shake/nutrition bar diet (no real food) and working out 12 hours a week.  I showed her my copy of your book, and she said that it made a lot of sense, but I’m not sure she’s willing to go off her doctor-supervised diet of food that her father lost 50 lbs on in 3 months.

I have lost 10 lbs, which I really didn’t set out to do. My goal was to reduce my risk of cancer.   Lots of people are asking me about the diet, and one person said that my skin tone looked smoother and another said my hair looked shinier! Who knew?  I really have been spending a lot of my time at work talking about your ideas about food.  People are finally seeing the sense in it.

My aunt is harder to convince, but she just asked me to send her a copy of your book from amazon.com (she won’t use her credit card online).  She has a very skeptical side, and she also believes that most things in the government and media are manipulated, so I could see her making sense of the reason for real food being put down in favor of processed food, given the role of the FDA, the AHA, and the USDA.  She just might buy into it, as she is very self-disciplined about her diet, because she borders on diabetes.

My parents have stopped using Smart Balance in favor of butter now, as a result of my pleading and showing them that butter was really the better alternative.  I hope to get my mom off soy milk and my dad off white bread.  My dad has incredible carb craving cycles, and he is a borderline diabetic.  He’s going to be a hard sell, since he loves his desserts and candy.

Anyway, I wanted to thank you for writing the book.  It has helped so many people already and I wouldn’t be surprised if it became a best-seller.  I’m certainly doing my part to spread the word.  Thanks for telling the truth!

Gratefully,

Sharon Miles, Centreville. MD



What nature set out to do, the pharma companies took upon themselves to upgrade. And understandably so – it must be hard to run a business on just the finite supply of official diseases nature has to offer. Medicines to cure diseases are so ho-hum, as are vitamins to prevent them. The leaves drug companies to do only one thing – invent diseases! Come on now, don’t even question its ethics,. Advertising has always invented the need for commodities one could completely do without. Just extend that idea to creating diseases. Say, for instance, Apulchritis – the condition of not being stunning, drop-dead gorgeous.

I must confess, upon being told of the existence of cosmetic drugs, my ever fainéant mind was quite thankful thinking of the twenty potentially saved minutes. Imagine, you swallow a tiny pill, and the blush, lip color, mascara etc. magically appear on your face.  Of course, all in a perfect blend so it looks like you never quite wore it to begin with. It’s another story that this isn’t exactly what cosmetic drugs mean. In fact, they promise something even bigger. C’mon, mascara is obviously for losers – so what if one can make it appear magically on one’s lashes? The real deal lies in enhancing them [sic] lashes themselves. And while we’re at it, let us tighten up that skin as well. Because if you’re too smart to subscribe to what we (want you to) think, the least we could do is make you feel miserable for having “inadequate” lashes, or a non-20-year-old skin when you are 67.

What do you mean how authentic, of course, it’s all tested and proven! Well, uh, kind of – did you not look at the before/after pictures that has transformed so many <del>suckers</del> clients? I’ve always wondered if these before/after pictures actually allude to before/after GIMP. But that’s for me to wonder and them to no – for them to deny, that is.

You do see why pharmas are the world’s next superheroes, don’t you? They don’t let tinpot agencies like the FDA get in the way of their creativity. Don’t get me wrong, it’s not like the FDA is ethical uptight about such innovations. But understandably, their approval is required, and they are answerable to authorities themselves. So instead of bothering the poor agency with incessant appeals for drug-approval, why not invent a way to get around them? Please welcome Neutraceuticals – you know, that “stuff”, which isn’t quite a medicine (since medicines need FDA approval), but it’s a very “necessary” dietary supplement to prevent any “disease” the drug might have cured? Yes, any disease. Even slight weight gain.

I have always appreciated genuine creativity. I have nothing against the genius of these inventors, nor will I stand in the way of fools suckers their clientele.  But dear pharmas, while you are at it, would you humor the woes of a small blogger and come up with a solution for small things that annoy much? Here’s her wishlist:

Aspirit: Asprin’s little cousin; completely eliminates hangovers.

Pedolacrytinnitol: Shuts off the adult tympanum to the shrill whine of a child once the frequency reaches that of F#.

Macromemory Plus: Enables one to still remember the big things after making sure the tiny details are taken care of. This is for those out there who remember to pack the phone charger and camera batteries, but leave the phone/camera behind. You know who you are.

Micromemory Minus: Selectively erases any painful memories – or for that matter happy memories that might make the present painful. Yes, they did make a movie to this effect. But the good news is, the pill won’t have Jim Carrey.

Flavorridex: There are some foods that otherwise taste phenomenal, but for the presence of one atrocious dominating flavor. To me, these are cinnamon or cardamom in dessert. Take this pill to savor the delicacy with the unflavor.

Irony Plus: Helps reduce or eradicate sarchasm. Especially when it’s you the sarcasm is directed at.

There, that’s a start. I refer you to the imaginative readers for more gems.

“The thing that bugs me is that the people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks they are doing are as different as night and day.”

- Herbert Lay, M.D., Former FDA Commissioner

According to its mission statement, “the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

From its inception in 1906 as the Bureau of Chemistry, the FDA has been mired in an incestuous conflict-of-interest culture.

Virtually every pharmaceutical company is publicly traded company whose officers and directors have a legal responsibility to increase shareholders value and profits. Who owns stock in these drug companies? Many of those in Congress, individuals who work for the FDA and the FTC. In fact they often know in advance of a product approval and can purchase stock prior to public announcement at which point the company’s stock skyrockets. That which is insider trading from Martha Stewart is perfectly legal for those who work in government.

European countries require proof of safety, in the U.S you have to prove it isn’t safe. By the time its withdrawn from the market the company has earned millions.

That having been said, here’s an interview with investigative reporter Sharyl Attkisson on the Swine Flu…and hang on for Part 2.

John English

Last week I had the opportunity to participate in the NOV Program meeting for the Delaware Valley ISPE. The presentation for the evening was by Anita Michael, a member of the FDA Philadelphia Office; the topic was “FDA Failure Investigations and Quality Systems.” There were quite a few questions asked after the talk. The first was – “Why wasn’t there more focus on risk management?” I would like to share a few observations on the presentation with you.

The presenter was a field level Investigator, not a policy person. The talk focused on how the field staff is using the Quality System as the key way of opening up deficiencies within a site. Her advice was very basic – and effective, that the complaint files and the failure investigations are two different sources of information that can show failure to follow through in specific instances. Questions can be raised about the failure, the recall (or not), were related products/ components/ processes reviewed, and if it was ‘operator error,’ where are the training records. Another was that the annual reporting can show process modifications that warranted filings but instead were treated as simple changes. The mantra is – “If one system fails, they all fail.” Their approach to the quality system can very easily lead into all of the other systems.

My suggestion is that this was a pragmatic statement that the ‘risk-based’ decision is to use the quality system as the best way for the inspection team to generate observations that can be turned in 483’s. The second best area she suggested for citations was Production Equipment and the presentation covered both of these items, as well as numerous others, in the 47 slides. Perhaps you will find it useful, if only as a review.

If you would like to receive a copy of the slides, please drop a note to info@pharmalogika.com.

——
John English is a consultant to the life sciences industry.

John English

The updated IOM chapter (Updated 07 MAY 2009) is something I happened on while doing a search. This is the entire IOM section Chapter 5 Establishment Inspection, not just my favorite section on “Subchapter 5.3 – Evidence Development.” The major updates in the document include adding the term “regulatory notes,” significant attention to Personal Safety Plans [inspections may be getting harder on the inspectors] and attention to updating databases [perhaps a consequence of plant mis-identification in the heparin crisis last year]. That said, the document is a very comprehensive read, useful as an introduction to the practical end of our field or a refresher. You will even find a fully filled out 482 (Notice to Inspect) and things like notes on how to add pictures to a Turbo-483.

http://www.fda.gov/ora/inspect_ref/iom/pdf/chapter5.pdf

 ——
John English is a consultant to the life sciences industry.

Timco Worldwide Inc. issuance of a voluntary recall of Large Seedless Watermelons because of possible health risk

 Davis, CA – November 22, 2009 – Timco Worldwide Inc. is recalling a limited number of its Large Seedless Watermelons because they have the potential to be contaminated with Salmonella. No illnesses have been reported to date in connection with this occurrence. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. The Large Seedless Watermelons included in this voluntary recall were distributed to select grocers, wholesalers and processors in California and Texas. The Large Seedless Watermelons are stickered with the “MelonUp!” label with the PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6. The potential for contamination was noted after routine testing, by a distribution company, which revealed the presence of Salmonella on the outside rind of a melon randomly selected for testing. Timco Worldwide Inc. elected to exercise an abundance of caution and initiate the recall in the interest of public health. No illnesses have been reported to date in connection with this occurrence. Consumers who have purchased Large Seedless Watermelons in the markets noted above (with the MelonUp! label) are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-530-757-1000 press “4” for Food Safety. (Hours of business: Monday through Friday 8AM to 5PM PST). As with all fresh fruits and vegetables, Timco Worldwide Inc recommends that fresh melons are washed before cutting and/or consuming them.

Hello everyone!  We’re still monitoring the H1N1 situation in the European Command area of responsibility.  Vaccinations have begun for our military members and we’re doing our best to get the vaccination to everyone. 

There are still lots of questions out there and I want to answer some of those in this blog.  I will continue to keep you posted on the latest information.  In the meantime, if you have questions you want answered, feel free to comment on my blog and let me know what’s on your mind.

Since vaccinations have started for military members, everyone wants to know when the vaccinations will become available for beneficiaries? 

The H1N1 vaccine for Europe is coming from two sources. The first was purchased by DoD under contract from Novartis. The second was purchased by Health and Human Services from Sanofi to cover all of the U.S. population. This obviously a huge order and production continues.

The DoD shipment arrived first and has been used to cover our active duty folks. Since we had some additional supply of this vaccine, we used the excess to treat our family members who are at highest risk (such as those who are pregnant or with chronic conditions such as cancer, diabetes, and other chronic disease conditions).

The shipment of the HHS vaccine will come in at small amounts at time. Sufficient amounts have been ordered and should be available for all who want it. However, for those unwilling to wait, TriCare has allowed for family members to obtain the vaccination from their local host nation providers without prior approval and then obtain reimbursement for this. While not FDA approved, the European Union has their own equivalent safety and approval process. The current vaccines that are approved by the European Union are produced by known international manufacturers who provide vaccines worldwide for not only Europe but the U.S. and others.

Another question weighing on the minds of many is why young children and young adults experience the heaviest burden from H1N1?

First, children are congregated in schools, daycare centers, playgrounds and other areas where they are in close contact with each other. Children also tend to be less disciplined with hand-washing, cough control and other preventive measures. Children can spread virus for many days without showing symptoms of flu.

Regarding adults, many older adults have been exposed to similar flu viruses during their lifetime and as such may have some level of partial immunity that prevents them getting the disease or they may get a milder form of it. Our younger adults do not have this protection, thus we recommend the vaccination.

Folks are wondering if hand sanitizer is better than the good old washing your hands with soap and water?

Good ol’ soap and water works, as long as you use the soap and you allow sufficient contact time for it to work. Ideally you should lather up and rub for about 30 seconds (about the length of time it takes to sing Happy Birthday to yourself). Hand sanitizer is a good alternative when traveling or during the day when actual use of soap and water is not available. This helps reduce the germ burden on your hands and limit the spread of disease.

And of course, people want to know if the H1N1 vaccination really works?

The H1N1 vaccine was designed to specifically target this unique pandemic virus. This virus is taking over the usual flu viruses we see seasonally. The vaccine helps us generate protective antibodies against this pandemic strain. While the majority of us do develop protective antibodies, a small number of folks don’t which could lead to a flu episode despite having received a shot. Additionally, the virus may mutate which can also cause a decrease in effectiveness. So far we have not seen this occur. I still strongly recommend you get vaccinated.

Lastly, people are concerned about proper vaccination of their children and are confused about how many doses of vaccine are required for children under 10 years old?

Some kids require twoshots and others only require one. Let me explain.  After doing studies on how effective a single vaccination performed in children, the FDA found that children under 10 did not develop a high enough antibody response to provide adequate protection. The CDC currently recommends that children six months to nine years old, who are receiving the influenza vaccine for the first time, receive two doses, separated by four weeks.

Keep your questions coming!  That’s what I’m here for!

(Col Dave Schall is the European Command Surgeon. He has served in this capacity for over three years. He is a graduate of the University of Missouri Kansas City School of Medicine. He has a Masters in Public Health from the Johns Hopkins University. He is board certified in Aerospace/Preventive Medicine as well as Otolaryngology Head & Neck Surgery. He completed a Fellowship in Otology/Neurotology Skull base surgery.)

Howard S. Katz writes:

One of the pivotal events in the destruction of America is the case of Harry Hoxsey. Hoxsey’s great grandfather had been a veterinarian (in the early 19th century). His favorite horse developed cancer on its forelimb, and Dr. Hoxsey put the horse on a distant pasture so that he would not have to see it die. He came out a few weeks later to collect the corpse but found the horse in full health prancing around with great energy and no sign of cancer. Dr. Hoxsey went over that field with a fine tooth comb and found 4 herbs which, when combined, cured cancer. However, he was afraid of persecution by the cancer establishment of his day and never went public with the cure, instead keeping it as a family secret. This lasted until the early 20th century when his great grandson, Harry Hoxsey, went public with it. The herbs were: red clover, Oregon grape root, poke root, sarsaparilla, stillingia, buckthorn, burdock, cascara sagrada, prickly ash berry, licorice and Irish moss.

Harry Hoxsey opened clinics around the country. The district attorney in Dallas, TX sided with the establishment and tried to shut Hoxsey down. Then the DA’s brother got cancer; he went to Hoxsey, and Hoxsey cured him. The DA (to his credit) did a 180º about face and became a big Hoxsey supporter and later Hoxsey’s attorney. Then the Journal of the AMA called Hoxsey a quack. Hoxsey sued for libel, brought in his cured patients and proved to a jury (“12 good men and true”) that he indeed could cure cancer. In 1960, the FDA banned the Hoxsey treatment. His nurse moved to Tijuana, Mexico and set up a Hoxsey clinic which still operates today.

The medical-industrial complex would be out billions. The FDA protects corporations, not you.

If the smell of beets makes you gag but you simply can’t get enough sour crème and chive potato chips, your Mom may be to blame — and not because of what she fed you growing up. Several studies show that food preferences may be set even before you’re born, as early as 13 weeks after gestation. And those preferences derive from what your Mom ate while you were in the womb. 

Read more at Jon Barron’s Natural Health Blog

Reflecting back on the H1N1 outbreak during the Michigan 2009 “MacRib Test”:

http://www.publicbroadcasting.net/michigan/news.newsmain/article/1/0/1568739/Michigan.News/114.Michigan.Schools.Closed.by.%27Swine.Flu%27

114 Michigan schools have closed so far this school year [within less than a week], amid concerns that Swine Flu is spreading.

School officials across the state are seeing rising student absentee rates.

Martin Ackley is the spokesman for the State Department of Education. He says schools are reacting quickly to reports of H1N1.

Southwest Michigan by itself had more than half of all schools closed nationwide that week due to H1N1 aka swine flu. Despite that, there was barely a mention of Michigan being the “epicenter” (the word used by the CDC in local coverage) in the mainstream media. However, while Michigan schools were closed down and restaurants went empty that week, the MSM only reported school closings in distant countries like Iraq. But, let’s look back a week before the outbreak happened:

http://www.wwmt.com/articles/kalamazoo-1368197-margin-0in.html

The number of flu-like cases in a nine county region of southwest Michigan is nearly double what it was the year before. Experts say the high number of cases is due to H1N1. There have been 1,100 cases since the beginning of 2009.
 
Now, the first H1N1 vaccination clinic is operating in Kalamazoo.
 
The clinic is by invitation only, and first up was health care workers from around Kalamazoo County.

….

Most of those at the clinic Thursday [10-15-09] were given the flu mist, the shots are being saved for those who can’t get the mist because of other health concerns.
 
Among those at the clinic on Thursday were paramedics and public safety officers who are also first responders.

A few days later that area of Michigan became the CDC’s “epicenter” during the week of 10-19-09. Let’s move over to Detroit on the southeastern side of Michigan:

http://www.freep.com/article/20091016/FEATURES08/91016048/1319/Swine-flu-vaccine-arrives–fire-fighters-roll-up-sleeves

Firefighters and other emergency personnel today rolled up their sleeves and submitted their upper arms for the injectable vaccine at the Wayne County Department of Public Health’s administration building in Wayne, as officials repeatedly urged the public to get inoculated.

….

Authorities said they’ve received both injectable vaccine and nasal mist. The mist is now set aside for emergency preparedness and health professionals; the vaccine is being distributed — at least in the district covered by the Wayne County Department of Public Health — to targeted populations.

….

The Wayne County Health Department has made free shots available at the following locations…

Detroit is a major population center and has easy highway access (via interstate 94) to Kalamazoo, but Detroit schools stayed open. BTW, why would a major outbreak happen in a little rural area instead of one of the major population (incubation) centers nearby like Detroit, Chicago, or Indianapolis? Why did the outbreak never cross the state line south of Kalamazoo and enter rural northern Indiana?

In any case the article itself is a bit confusing: the first responders were getting shots, but later it said they’re supposed to get the mist. I guess it’s just a coincidence that the kids of Detroit where their first responders got shots didn’t get sick while the kids around Kalamazoo where their first responders got mist did get sick a week later.

Let’s move over to some other articles that got my attention on vaccines, resistance, and immunity:

http://www.healthzone.ca/health/newsfeatures/article/700026

Unpublished Canadian data are raising concerns about whether it’s a good idea to get a seasonal flu shot this season.

Drawn from a series of studies from British Columbia, Quebec and Ontario, the data appear to suggest that people who got a seasonal flu shot last year are about twice as likely to catch swine flu as people who didn’t.

A scientific paper has been submitted to a journal and the lead authors – Dr. Danuta Skowronski of the British Columbia Centre for Disease Control and Dr. Gaston De Serres of Laval University – won’t speak to the media. Journals bar would-be authors from discussing their results publicly before they go through peer review.

That got my attention like a 2×4 to the face considering I received my first seasonal flu shot in 3 years in Fall 2008 and became sick with a very high fever for the first time in at least 5 years in June 2009. I would later find out this fever was during a time our state health officials stated that the only active virus roaming the region was H1N1. I guess it’s just another coincidence…

A number of influenza and infectious diseases experts know of but are unwilling to speak publicly about the paper. But several were quick to note that British and Australian researchers haven’t seen the phenomenon either. The lack of corroboration in other jurisdictions is “a red flag,” said one expert, who does not believe the findings are true.

Another flu expert who was willing to speak on the record said they do not make sense to him either.

“I cannot think of a good reason why this is biologically likely, especially since we have sufficient evidence now that … there is priming in the population by the way the vaccine is working,” said Dr. Arnold Monto, of the University of Michigan.

He was referring to the fact that studies of swine flu vaccine show a single dose induces a strong and likely protective response in teens and adults. That suggests humankind’s long exposure to seasonal H1N1 viruses has “primed” or awakened our immune systems to recognize the new virus and fight it off.

Dr. Donald Low, chief microbiologist at Toronto’s Mount Sinai Hospital, was reserving judgment on the findings. But he said this kind of effect of previous exposure raising the risk of future illness is seen in some diseases, like dengue fever.

“We don’t see that in flu,” Monto countered.

Unless there is a different sort of “priming” taking place. Or a mismatch. This next article is very important when considering vaccines and the concept of “cellular immunity”:

http://www.google.com/hostednews/canadianpress/article/ALeqM5gJLYIRDvHWdvSLZTUQ_yymuF5rBg

Just when you thought the issue of seasonal and pandemic flu shots couldn’t get any more confusing, European researchers are questioning whether it makes sense to vaccinate little kids against seasonal flu.

The scientists, from the Erasmus Medical Center in Rotterdam, the Netherlands, argue preventing small children from being infected by – and developing immune responses to – seasonal flu viruses might make them more vulnerable when a flu pandemic rolls around.

Note: this is a different set of researchers than the previous article.

But the Dutch scientists, who don’t refer to the Canadian research in their article, say giving kids aged six months to 59 months flu vaccine prevents them from acquiring a broad immune response to flu viruses that can only be induced by infection.

Vaccines trigger development of antibodies to the proteins on the surface of flu viruses, proteins that change often to evade the immune system. But when you catch the flu, something called cellular immunity also kicks in. It teaches the body to recognize other parts of a flu virus; those parts don’t change as much from one virus subtype to another.

The next few paragraphs are extremely important. Read closely:

Without that cellular immunity, the Dutch researchers say, children who experience a pandemic could have more difficulty fighting off the new flu strain. They suggest this may explain why the majority of fatal cases of H5N1 avian influenza have occurred in children and young adults.

They also report that they tested the theory in mice, some of which were vaccinated against the H3N2 strain of flu and others of which were experimentally infected with the same virus.

The mice were then exposed to the highly lethal H5N1 virus. The vaccinated mice died but the mice that had been previously infected with H3N2 suffered milder disease.

….

The Dutch researchers, led by Dr. Guus Rimmelzwaan, say more research is needed to see if their theory is true.

But they also suggest young children who live in areas where H5N1 viruses are endemic in poultry should not be vaccinated against seasonal flu, because blocking the development of cross-protective immune responses in these kids could raise the risk they face if they become infected with H5N1.

I know we started off discussing H1N1 and ended up with H5N1, but this doesn’t change the concept of cellular immunity. This next article explores how parents are approaching the concept of building natural immunity instead of using vaccines:

http://www.thrivinghealthywomen.com/info/infoprint.asp?documentid=397

And although many pediatricians are readying stern lectures in support of vaccinating children, several in Southern California contacted by The Times acknowledged they have doubts about recommending a vaccine that is still in testing for all of their young patients.

“A significant proportion of our population don’t want to get it,” says Sherman Oaks pediatrician Mikayel Abramyan. “I don’t even know whether I will advocate for it right now.”

To date, notes Abramyan, who saw a fair amount of novel H1N1 over the summer, the illness has been mild, and many parents of the children he cares for “want them to get their immunity that way instead of a flu shot,” he says. While Abramyan says he rarely lets such preferences go unchallenged, “it’s a reasonable position, and I understand it on an individual level. . . . I understand where they’re coming from.”

….

“I haven’t seen enough evidence to show that swine flu is as deadly and as scary as it’s made out to be,” says Stuart-Nystrom, who last week was fighting a respiratory infection. Stuart-Nystrom thinks that media outlets have whipped up the threat in a bid to gain viewers. And “anything brought out by big business, by corporations, that makes me wary for sure. . . . I’m not sure they have our interests in mind.”

Nor is the Venice mother confident that the Food and Drug Administration can reliably assure the overall safety of the vaccine. Pointing to a recent spate of contaminated-food recalls, she said that the FDA’s relationship with the industries it regulates may be too close for the agency to operate effectively as an honest broker.

She also voiced the widely held belief that immunity acquired the natural way — through a child’s having caught an illness — is stronger and longer-lasting than that acquired by vaccination. That claim is much debated among physicians and infectious-disease specialists, with evidence falling on both sides of the debate.

….

“There’s so much information out there,” Stuart-Nystrom says. “The scary thing is, you don’t know what’s right and what’s wrong.”

Since one paragraph in the above article mentioned a “debate” over the long-lasting effects of vaccination, I’d like to jump to another virus, the vaccines promoted, and their not-so-lasting protection. Here’s one link straight from the FDA:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm

The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

Genital HPV infections are the most common sexually-transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide.

….

The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

….

Studies also were performed to measure the immune response to Cervarix in girls ages 10 years through 14 years. Their immune response was similar to that of women ages 15 years through 25 years, indicating that the vaccine should have similar effectiveness in the 10 through 14 year age group.

The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.

No vaccine is 100 percent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine.

Provides protection for 6.4 years against a virus which I’ve heard other people state that most healthy females will overcome on their own. But wait, what else is in this vaccine:

Cervarix contains the adjuvant ASO4. ASO4 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL) and is the first vaccine licensed by the FDA that includes MPL as an adjuvant. An adjuvant is a substance incorporated into a vaccine that enhances or directs the immune response of the vaccinated individual.

Little is known about how adjuvants really work and there is a lot of debate in the scientific community. However, every time I hear about a new adjuvant being injected into someone I can’t help but think this is just a modern version of snake oil. Let’s switch to a different HPV vaccine and some recent revelations from one of its former researchers:

http://www.cbsnews.com/stories/2009/08/19/cbsnews_investigates/main5253431.shtml

Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.

Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.

Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

I’m going wrap up this blog post and let you contemplate the “risk-versus-benefit” comment from Dr. Harper. It will be helpful for deeper thinking by putting that comment into context with the earlier articles on cellular immunity, the unintended consequences of vaccinating for weaker (or the wrong) viruses and how this will play into long term health. I will do some more posts on health care in the future. Thanks for reading today.

Defining a “MacRib Test” as used earlier in this post.

There has been a flurry of discussion around social media and its implication in the last few  months , So I thought it would be good to have some of these arguments laid out in one single post. Social Media has entered every business and industry even, inside the US Intelligence Community, who sorted out their knowledge-sharing problem and a problem with locating expertise—throughout the  bureaucracy of 16 federal agencies—using  simple tools like an intelligence community–wide Wiki and blogging environments among other things

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Social Media and Sales

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: that usual rhetoric many sales managers would say now a days.   Does Social Networking help sales people sell I liked that statement especially since it came from Microsoft executive.  As I have also faced the ire of top management for using social media in my career, . So this report is an eye opener for opponents of social media for sales. Read the Full Article.

LinkedIn insiders know that you can use the site’s information for more than job, sales, and partnering leads – you can find out what others are up to as well. There are downside to using Linkedin last fall an Apple employee revealed that he was managing a team developing a new chip for the iPhone while the information was still secret. . So be careful LinkedIn or any other social tools can bite you back if not used properly.

I would partly agree to the argument that social media and internet created a lot of distractions, but I dont think this is something new, we had distractions in our daily life and in office environments even before theadvent of internet. the only difference now it is easier not to do your job and indulge in something else while you are supposed to be at work when in office.

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Social Media and Influence on Decision Making

Second on my reading list was the study conducted by Don Bulmer (Vice President Global Communications- SAP ) with Society for New Communications Research. Take a look at this in his blogpost  at Social Media’s Impact on Business and Decision Making Everyday Influence blog .  Result of the study concludes that Top execs  are influenced by social networks . The copy of the report is on SNRC website

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Social Media Investments

Third on the reading list was a New Study from Deloitte, Beeline Labs and the Society for New Communications Research Indicates Despite the Recession, 94 Percent of Enterprises Continue to Invest in Online Communities & Social Media  Full Article

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Then there was  presentation by Steven Tylock, on Social networking meets sales , the presentation is on  Microsoft website

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Compliance and Social Media

The Society of Corporate Compliance and Ethics and the Health Care Compliance Association conducted a survey among compliance and ethics professionals in late August 2009 to see what employers are doing about the use of these sites by their employees.

They got back almost 800 responses from their members using an online survey tool.

• 50% of respondents reported that their company does not have a policy for employee online activity outside of the workplace
• Of those companies that do have a policy, 34% include it in a general policy on online usage
• Of those companies that do have a policy, just 10% specifically address the use of social network sites

It would be interesting to see How companies are going to include a clause on their information protection and compliance rules to define what information an employee can add to his linkedin profile during or after his tenure with the organization, especially information related to projects.

For example When an IA rep uses Twitter to send a link to an article from an online magazine, newspaper, or other site to clients and prospects “following” him, that communication is subject to SEC advertising rules. However, Bernstein says that merely sending a link is not advertising—as long as you don’t give your opinion.

A “recommendation” on your Linkedin profile by a client does indeed constitute a testimonial and, thus, violates SEC rules prohibiting RIAs from using client testimonials in advertising.

The SEC will be busy in coming months addressing the many issues posed by advisor use of social media. FDA has already release its framework on use of social media in Drug Marketing.

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Drugs, Heallthcare, FDA and Social Media

The FDA is currently considering how to handle social media, such as SideWiki, Facebook, etc. Companies such as Google, Sermo, and Twitter are playing an increasing role in marketing products to consumers and healthcare professionals, whether our customers like it or not. Technology and Life Sciences companies are pushing the FDA to come up with standards and templates. The following article has some great links to presentations from PhRMA, Google, and even from Pfizer’s Chief Medical Officer.  

Read about Googles pitch to FDA for online Drug Advertisements from the wall street journal

An archived webcast and other details of the FDA  Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools is available at the FDA website

Here what emerged from this hearing

FDA explained in the Federal Register notice that “entities should review any Internet sites sponsored by them for Drug Adverse Event Information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an Adverse Drug Event on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.”

Numerous speakers stated that drug manufacturers are hesitant to fully engage in online social media specifically because they want to avoid learning about potential AEs and the resulting reporting obligations, particularly because the guidance in this area is unclear

Pending further guidance, companies should prepare for further FDA scrutiny of this area by developing compliance
policies to address the challenges of involvement in Internet and social media tools, including but not limited to:
„„policies relating to employee involvement in social media, and in particular statements regarding company products;

„„company involvement in physician and patient-focused social media, including both company-sponsored sites and third-party sites run by third-party organizations (and particularly those receiving manufacturer support through grants or other funding);

„„addressing the challenge of Sidewiki and similar functions that make third-party generated information directly available in conjunction with company websites;

„„updating promotional review policies to ensure consistency with developing FDA approaches to risk communication on the Internet, including sponsored links;

„„policies regarding statements that company-affiliated parties (e.g., investigators, patients) may make on the Internet, which may constitute endorsements or testimonials requiring both review and specific disclosures; and

„„ensuring a consistent and compliant approach to pharmacovigilance with respect to Internet-reported adverse events of Drugs.

I know one company that provides  Content Monitoring, Control & Recording across Web 2.0; User Behavior Reporting over Multiple Modalities, Regulatory Compliance for management and security of Web 2.0 applications such as social networking, blogs, wikis, webmail and social networking sites such as Twitter, Facebook and YouTube instant messaging, and Unified Communications. But at a cost of $9,200, it would be out of reach for individual and SMEs.  Still have a look at the recent press release by factime on its FaceTime’s Unified Security Gateway

What is the FDA’s position on the promotion of FDA-regulated products on social media? The Food and Drug Administration Center for Drug Evaluation and Research is announcing a public hearing to discuss issues related to the promotion of FDA-regulated medical products including prescription drugs for humans and animals, prescription biologics, and medical devices using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties including but not limited to consumer patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. The public hearing will be held on November 12 and 13, 2009 from 8am to 5pm each day. Look for more updates on this blog.

Aspirin kills 400% more people than H1N1 swine flu

Natural News
November 20, 2009

Did you catch that? The 16,500 figure for deaths each year doesn’t even include over-the-counter painkiller drugs! If you add in those numbers, you’re probably looking at something closer to 40,000 Americans kills each year by these drugs. And that makes these drugs 1000% more deadly than swine flu (because 40,000 is ten times greater than 4,000).