It is no consolation to the
roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still
buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed.A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joy ride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.
In Europe, governments are no longer willing to pay the high prices for drugs that they once did say
published reports
and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine!
Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators — yet “new” is conveyed as “better than any drug to date” in advertising. Some clinicians say Haldol, an inexpensive antipsychotic, and lithium, a similar affordable bipolar drug are
better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000 bubble.Before the
Vioxx scandal and major settlements over blockbuster drugs like
Zyprexa,
Bextra, Celebrex, Geodon and
Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).
But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported
ZS Associates. Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer)
announced it was eliminating 1,200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.
As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at
AstraZeneca,
Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.
Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals
accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010,
10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a
Union Carbide pesticide plant.
Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports
FiercePharma.
Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The
FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for
children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of
bone fractures by 30 percent.
In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that
Forbes
calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa)
asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”
Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “
The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a
Wall Street Journal
oped and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by
allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now?
Carl Zimmer writes about science regularly for the New York Times and magazines such as Discover, where he is a contributing editor and columnist.
He is the author of twelve books, the most recent of which is Science Ink: Tattoos of the Science Obsessed. His website is carlzimmer.com and his address is blog at carlzimmer dot com .
At back to back briefings on Capitol Hill late last week, the Center for Science in the Public Interest and the Center for a Livable Future presented a panel of experts to House and Senate staffers with a straightforward message on whether the overuse of antibiotics in animal agriculture is a human health issue: "the science is clear."
"The science is so clear that the political pressure on the FDA won't be able to keep us from moving forward," said founding director of the Center for a Livable Future, Robert Lawrence, a professor of environmental health at the Bloomberg School of Public Health and a professor of medicine at the Johns Hopkins School of Medicine. "The pharmaceutical and animal industries continue to deny the scientific evidence. We believe that the science is clear."
At the meetings, dozens of staffers were briefed on a new white paper put out by CSPI focused on these so-called superbugs and foodborne illness outbreaks. CSPI reported that in 2011, 167 illnesses, 47 hospitalizations and one death were linked to antibiotic-resistant foodborne pathogens.
Two of the outbreaks were connected to ground turkey -- one contaminated with Salmonella Hadar and one with Salmonella Heidelberg -- and one outbreak was connected to ground beef contaminated with Salmonella Typhimurium. "All of those bacteria were resistant to treatment from several antibiotics that are critically important to human medicine, including drugs in the penicillin, cephalosporin, and tetracycline families," CSPI reported.
The white paper also noted that since 2000, 38 outbreaks tied to resistant pathogens sickened 20,064, hospitalized 3,108 and killed 27 -- a count that includes an "enormous" 1985 outbreak of Salmonella Typhimurium caused by milk, which sickened 16,659, hospitalized 2,777, and killed 18.
"Antibiotics are the crown jewels of modern medicine, and they are critical to treating diseases in both humans and farm animals," said CSPI food safety director Caroline Smith DeWaal. "We must not continue to jeopardize the effectiveness of these drugs by using them recklessly for non-therapeutic uses on farms and in animal factories. Otherwise, consumers may face longer illnesses, more hospitalizations, and more fatalities when exposed to resistant strains of common foodborne pathogens."
CSPI quoted World Health Organization's position on the issue from last year: "WHO has long recognized that antibiotic use in food animals, which seems to outweigh antibiotic use for human therapy in many countries, contributes importantly to the public health problem of antibiotic resistance."
In the United States, around 80 percent of all antibiotics sold are given to food animals each year.
At the briefings, public health advocates called on Congress to pass legislation to limit antibiotic use in agriculture, by passing the Preservation of Antibiotics for Medical Treatment Act (PAMTA), and asked the U.S. Food and Drug Administration to take greater leadership on the issue.
"I would just love to see the United States taking a lead on this issue and show global leadership like we do on so many issues," said Lance Price, an associate professor at the Translational Genomics Research Institute in Arizona. "On this one, we are lagging far behind the rest of the world. All the warning signs are there...and the good science is there and we're doing nothing. It's a shameful thing. I hope that we can turn this and start taking the lead."
Biotecnika Info Labs Pvt Ltd, Bangalore is a Parent Company which runs India’s Largest Biosciences Career & education Portal. Biotecnika is where in technology meets life sciences.
“We are a fast growing Bio-techno-media company with extremely talented and fun Loving people you would love to work with. Biotecnika is run by a group of Doctorate & post Doctorates of lifesciences & together we help in the upliftment of postgraduates from any lifesciences background. If you do not like processes, hate pyramid type organizations; love creativity, innovation and fun at work; you will love it here. You will find a very flexible work environment, which treats people like human beings”
- Post: Business Development Executive
- Company Name: Biotecnika Info Labs Pvt Ltd
- Location: in Bengaluru/Bangalore
- Experience: 0 to 3 yrs
- Salary: INR 1,75,000 - 2,50,000 P.A
- Opening(s): 5
Qualification & Duties
- Must be a MSc graduate in Bioscience
- 0 - 3 years Sales experience.
- MBA preferred
- Good written and oral communication
- Client follow ups
- Candidate should be willing to sell services and product.
- Candidates have to generate leads, qualify the leads on the sales strategies, identify the potential client, client interaction and maintain client relationship.
- Understanding the requirement of client and offering them with the appropriate services and product.
- Follow up with clients.
- Ability to meet multiple objectives within an organization.
- Work on Online marketing, Social Media Marketing, Email marketing, Tele Marketing as well as Field marketing
- Selling should be your signature statement.
- Maintaining relationship with clients and providing business leads, client interaction, team building, follow up with clients.
- Identify potential clients; manage existing account/customer relationships.
- Understanding the requirements of the clients & positioning an appropriate Solution
- Should be able to travel on demand as per the Company Policy.
- Liaisoning with Colleges / institutes for upliftment of biosciences
Desired Candidate Profile
Education:(UG - Any Graduate - Any Specialization, B.Com, B.B.A, B.Pharma, B.Sc,
B.Tech
/B.E.) AND (PG - MBA/PGDM - Advertising/Mass Communication, International Business, Marketing, Other Management,
M.Tech
- Bio-Chemistry/Bio-Technology, Biomedical,
M.Sc
- Bio-Chemistry)
- A minimum of 0 - 3 years of marketing experience
- Good organizational skills and the ability to understand detailed information.
- Basic IT and numeric skills.
- Good interpersonal skills to form effective working relationships with people at all levels.
- A proven track record of 'making a difference'.
- Creative, resourceful, detail-oriented, highly organized.
- Excellent verbal and written communication skills.
- Good Presentation skills.
- Time Management Skills.
- The potential to handle a leadership role.
- Candidate should have pleasing personality with excellent communication skills (Verbal & Written).
- Only candidates who can relocate to bangalore may apply
Executive Name:Sylvia Fernandes
Contact Company: Biotecnika
Address: #2628, 4th Floor 27th Main, Sector 1 HSR Layout, Landmark - CPWD Quarters BANGALORE,Karnataka,India 560102
Apply to Email Address :
jobs@biotecnika.org
Telephone: 80-91-65705331
Reference Id: MAR-10-BDE
Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.
“It’s a total outrage,” said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. “These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug.”
The institute offers an MSc in '
Bioinformatics
and
Biotechnology
'. The course will provide competence in both
Biotechnology
and computational biology/
Bioinformatics
by providing training in the areas of cell and
molecular biology
, computer science, statistics,
Bioinformatics
and so on (syllabus available below).
IBAB has been running a Postgraduate Diploma in
Bioinformatics
since 2002, and the 11th batch is currently doing its coursework. It has also been running a Postgraduate Diploma in Laboratory Biotechniques since 2004, and the 8th batch has completed its coursework. The two popular programmes are now being discontinued to enable the faculty to focus on the MSc programme.
Every student is provided
- Access to a fully loaded high-end PC and extensive access to the internet for the entire duration of 2 years.
- Lectures are delivered by in-house faculty, distinguished academics and industry scientists from leading institutions/companies within the country or from abroad.
- A significant amount of time is devoted to learning through material available on-line, journals, seminars, tutorials, group discussions etc.
- Thus the extensive lecture/tutorial program is supplemented by an enabling environment and associated self-learning through assignments and project work.
The 2 year MSc course is structured into 4 semesters, as below.
1.) ADMISSION PROCEDURE
- Application processing fees (non-refundable)
- Rs. 500/- for students from India and non-industrialized countries
- Rs. 1000/- for NRI/Foreign students from industrialized countries
- Rs. 500/- for students from India and non-industrialized countries
A Demand Draft for the above mentioned amount in favour of 'Institute of
Bioinformatics
and Applied
Biotechnology
' payable at Bengaluru needs to be sent to the institute (please see next section for other documents that also have to be submitted).
2.) Application form
Fill up all details on-line and seprately send DD, 2 passport size photos and photocopies of marksheets to IBAB by post/courier. THIS IS THE ONLY OPTION FOR APPLYING. There is no hardcopy form available by downloading or by requesting a copy.
The online form will be processed only on receipt of the DD.
3.) List of necessary documents
- Regular candidates:
- Photocopies of all certificates/marksheets
- NRI/Foreign candidates:
- Photocopies of all certificates/marksheets
- Proof of NRI/Foreign status (stamped page from passport)
DO NOT send any original certificates/marksheets.
4. Important information:
a. Date of online test: To be announced later.
b. Date of Interview: You will be given a date between 16-19 July 2012. In case you have a problem with your allotted date, write to
msc2012@ibab.ac.in or call 080-285 289 00 or 01, 9611 872 946, 900 829 6547 between Monday and Friday from 10:00am to 5:30pm.
c. If a seat is offered, the last date for accepting it is 5 days after being intimated. At this time a token sum of Rs. 20,000/- (adjustable against the fees due at the time of joining) has to be paid to the institute.
d. Course commences: 18 August 2012.
5. Eligibility for the course
a. A recognised BSc degree in any branch of science or technology, viz. life sciences (
Agriculture
,
Biotechnology
etc.), physics, chemistry, mathematics, statistics, engineering, pharma, veterinary or medicine with minimum of 55% marks. Thus, the following degree holders may apply: BSc, BTech, BE, MBBS, BDS, etc. Please contact IBAB in case you have a doubt about whether you are eligible.
b. Students awaiting their results can also apply, provided their average percentage of previous semesters/years is at least 55%.
c. There is no age limit.
Fees
Application processing fees (non-refundable):
1. Application processing fees (non-refundable):
Rs. 500/- for students from India or non-industrialized countries
Rs. 1000/- for NRI/Foreign students from industrialized countries
A DD for the above mentioned amount in favour of “Institute of
Bioinformatics
and Applied
Biotechnology
” payable at Bengaluru, should be sent to IBAB by post/courier or submitted in person after filling up the form online. Please note the other documents that also have to be submitted (2 passport photos and photocopies of marksheets) .
2. Course fees per semester:
- For Indian students and students from non-industrialized countries.
- Academic fees: Rs. 50,000/- per semester. This includes tuition fees, laboratory fees, software fees and library fees. This has to be paid within a week of the joining date for each semester. In addition, there is a security deposit of Rs. 20,000/- (refundable only on completion of the course) to be paid upon joining.
Please download the details and schedule of payment of course fees and hostel fees.
Partial waiver of fees through scholarships in case of a few deserving students may be feasible.
For NRI/Foreign students from industrialized countries
- Academic fees: Rs. 75,000/- per semester. This includes tuition fees, laboratory fees, software fees and library fees. This has to be paid within a week of the joining date for each semester. In addition, there is a security deposit of Rs. 30,000/- (refundable only on completion of the course) to be paid upon joining.
Please download the details and schedule of payment of course fees and hostel fees.
Contact for further queries (between 10:00am and 5:30 pm, Mon-Fri): 080 - 285 289 00/01/02.
Mobile: 9611 872 946 / 900 829 6547
You can also send an email to
msc2012@ibab.ac.in
Syllabus
- The syllabus is liable to change over time. Please download the current syllabus from here.
Cactus Communications is a pioneering language services company serving more than 25,000 clients across 73 countries. In line with its mission—growth through effective communication, Cactus offers specialist academic editing, medical communications, publication support, transcription, and training services to individuals and corporations across sectors such as academia, publishing, and pharmaceuticals.
Post : Data QC Specialist
No of Opening : One
Experience : 1 to 5 yrs
Job Desciption : As part of his/her key responsibilities, the Data QC specialist at Cactus will
1.Review regulatory documents (e.g., protocols, amendments, IBs, CSRs, eCTD, summary documents, appendices, and clinical trial disclosures) for data accuracy against source data and consistency between the document text and the in-text tables
2.Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements
3.Check documents generated by writers for data errors by checking annotated references
4.Check documents generated by writers for fact errors (discrepancy between source data and document, discrepancy within text, discrepancy between figures/tables and text)
5.Be responsible for the accuracy of data (numerical and otherwise) in the documents/projects assigned
6.Ensure timely delivery of documents
Education : M.Pharma,
M.Sc
-
Agriculture
, Anthropology, Bio-Chemistry, Biology,
Botany
, Dairy Technology, Environmental science, Food Technology,
Microbiology
,
Zoology
Location : Mumbai
Contact Details :
Executive Name : Neha Khan
Contact Company:Cactus Communications
Address : Off Link Road Andheri (West)
Mumbai,Maharashtra,India 400001
If you think you meet all these requirements and have the potential to be a part of this dynamic and quality-focused team, please mail in your resume to editor@cactusglobal.com
Deadline : 09.04.12
Melatonin in autism spectrum disorders: a systematic review and meta-analysis
Developmental Medicine & Child Neurology Volume 53, Issue 9, pages 783–792, September 2011
DANIEL A ROSSIGNOL1, RICHARD E FRYE2 1International Child Development Resource Center, Melbourne, FL, USA 2Division of Child and Adolescent Neurology and Children’s Learning Institute, Department of Pediatrics, University of Texas Health Science Center at Houston, Houston, TX, USA.
This systematic review and meta-analysis is a good summary of existing knowledge about the role of abnormalities of melatonin secretion in children with autism, the possible genetic mechanisms underlying this, and the benefits of treatment with melatonin on sleep behavior and possibly some daytime autistic behaviours (including improvements in behavioural rigidity, ease of management for parents and teachers, social interaction, temper tantrums, irritability, playfulness, academic performance and alertness).
The article is available at:
http://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2011.03980.x/full
A reminder that our list of Victorian sources of Melatonin from compounding pharmacies is available at
http://www.wch.org.au/genmed/clinical.cfm?tab=m&type=title&doc_id=2399
under “melatonin”.
MIKE
Aim The aim of this study was to investigate melatonin-related findings in autism spectrum disorders (ASD), including autistic disorder, Asperger syndrome, Rett syndrome, and pervasive developmental disorders, not otherwise specified.
Method Comprehensive searches were conducted in the PubMed, Google Scholar, CINAHL, EMBASE, Scopus, and ERIC databases from their inception to October 2010. Two reviewers independently assessed 35 studies that met the inclusion criteria. Of these, meta-analysis was performed on five randomized double-blind, placebo-controlled studies, and the quality of these trials was assessed using the Downs and Black checklist.
Results Nine studies measured melatonin or melatonin metabolites in ASD and all reported at least one abnormality, including an abnormal melatonin circadian rhythm in four studies, below average physiological levels of melatonin and/or melatonin derivates in seven studies, and a positive correlation between these levels and autistic behaviors in four studies. Five studies reported gene abnormalities that could contribute to decreased melatonin production or adversely affect melatonin receptor function in a small percentage of children with ASD. Six studies reported improved daytime behavior with melatonin use. Eighteen studies on melatonin treatment in ASD were identified; these studies reported improvements in sleep duration, sleep onset latency, and night-time awakenings. Five of these studies were randomized double-blind, placebo-controlled crossover studies; two of the studies contained blended samples of children with ASD and other developmental disorders, but only data for children with ASD were used in the meta-analysis. The meta-analysis found significant improvements with large effect sizes in sleep duration (73min compared with baseline, Hedge’s g 1.97 [95% confidence interval {CI} CI 1.10–2.84], Glass’s ? 1.54 [95% CI 0.64–2.44]; 44min compared with placebo, Hedge’s g 1.07 [95% CI 0.49–1.65], Glass’s ? 0.93 [95% CI 0.33–1.53]) and sleep onset latency (66min compared with baseline, Hedge’s g?2.42 [95% CI ?1.67 to ?3.17], Glass’s ??2.18 [95% CI ?1.58 to ?2.76]; 39min compared with placebo, Hedge’s g?2.46 [95% CI ?1.96 to ?2.98], Glass’s ??1.28 [95% CI ?0.67 to ?1.89]) but not in night-time awakenings. The effect size varied significantly across studies but funnel plots did not indicate publication bias. The reported side effects of melatonin were minimal to none. Some studies were affected by limitations, including small sample sizes and variability in the protocols that measured changes in sleep parameters.
Interpretation Melatonin administration in ASD is associated with improved sleep parameters, better daytime behavior, and minimal side effects. Additional studies of melatonin would be helpful to confirm and expand on these findings.
Mike
Prof Mike South,
Royal Children's Hospital, Parkville, Victoria 3052, Australia
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