Archive for Drug

A new weight loss drug called HistaleanTM based on betahistine is believed to quell the cravings for fatty foods, and may have pronounced beneficial effects among women in particular.

The drug is developed by Dr. Nir Barak at the Tel Aviv University Sackler School of Medicine in conjunction with Obecure drug company. Betahistine is an approved drug for the treatment of vertigo and marketed worldwide for over thirty years.

Betahistine blocks the H1 and H3 receptors in the brain, receptors connected to the sense of fullness and craving for fatty products. This drug is safe and used for the treatment of over 100 million people who suffer from dizziness or vertigo.

A clinical trial conducted in the U.S. showed that women who took Histalean for three months managed to lose seven times the weight of women who were following a placebo treatment. What is more important is that none of the participants, males or females, did not complained of any serious side effects.

The results are based on a study that involved overweight people across the U.S. during a twelve week treatment period. The group of women who followed a treatment with high doses of Histalean lost almost three percent of their weight while women in the placebo group lost only 0,4 percent.

The new weight loss drug may be used with anti-psychotic drugs which lead to extreme weight gain for mental health patients. Always talk to a specialist before taking any weight loss pill.

(c) Project Weight Loss 2009. All rights reserved.

Project Weight Loss is a growing weight loss community featuring BMI calculator, calorie counter, carbs counter, diet planner, workout planner, and many other weight loss tools. Visit Project Weight Loss and start losing weight today!

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Dec
12

Phentermine Drug 101

Posted by: Pharma Tech | Comments (0)

For a faster and easier way to get medications, many consumers today prefer to utilize the service offered by the hundreds of pharmacies established on the Internet today. These websites truly benefit individuals who have a very busy lifestyle; too busy in fact that they can’t even make time to go to their local pharmacists to have their prescriptions refilled.

One of the most sought-after drugs at these service websites are the lifestyle medications. These drugs are prescribed by doctors to individuals who are diagnosed to have non life-threatening or minor health conditions such as impotence, baldness, wrinkles, or obesity. As treatment for obesity, among the most widely prescribed is the Phentermine drug.

Defining Phentermine drug

Phentermine is a lifestyle medication under the phenethylamine and amphetamine class. This drug is meant to suppress or decrease appetite, thus, helping one lose weight. The said drug is usually taken in combination with proper diet, behavioral modification, and regular exercise.

The United States’ Food and Drug Administration (FDA) approved Phentermine as a short term weight loss tool for obese individuals as their health is at risk due to excessive weight. The drug works by aiding the body in releasing certain brain chemicals that can control a person’s appetite.

Phentermine comes in a number of commercial brand names:

Anoxine-AM

Adipex P

Obephen

Obestin

Fastin

Phentrol

Obephen

Availability of Phentermine

Just like other prescription drugs, Phentermine is available in local drugstores as well as in the various pharmacy websites found on the Internet today. For those who are tight on budget and are always in a hurry, consumers can save money and time when they opt on buying cheap Phentermine at US-based pharmacies.

Phertermine intake administration

According to FDA officials, Phentermine should only be used on a short-term basis, usually a three months intake period. During the said duration, intake of this drug should be followed by a regular exercise regimen and a healthy daily diet.

Despite the claims of FDA that Phentermine should only be used on a short-term basis, clinical studies proved that the said drug is still showing its appetite-suppressing effects in a 36-week trial duration.

Moreover, doctors often recommend patients to take Phentermine before breakfast or an hour or two after breakfast. This is highly advised by physicians in order to avoid the risk of insomnia.

Side effects of Phentermine

The use of Phentermine may give a number of possible side effects. As the said drug works through the sympathomimetic pathways, it may increase heart rate and blood pressure. Below are the notable side effects of Phentermine:

Less common side effects

Blurred vision

Headache

Psychosis

Skin rash or itching

Vomiting or nausea

Stomach aches

More common side effects

Insomnia

Nervousness

Irritability

Increased blood pressure

As for overdose in the intake of Phentermine drugs, below are the symptoms consumers should watch out for:

Hallucinations

Confusion

Hostility

Fever

Seizures

Fainting

Mental depression

Restlessness

Tiredness

Once any of the enumerated overdose symptom is experienced, it is highly recommended for consumers to discontinue the intake of the said drug and consult their doctors.

Rcon Franchesca V. Pascua is a web content writer and researcher who specializes in health and fitness topics. Want

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for what Baclofen is used

Oral: Therapy for trigeminal neuralgia (tic douloureux); tardive dyskinesia.

Intrathecal: Cerebral palsy spasticity in children.

How to Take Baclofen

Take Baclofen exactly as prescribed by health care provider. Baclofenis generally available in market in the form of Injection 3 mg/mL . Instruct patient before using Baclofen to take drug exactly as prescribed. If dose is missed it should be taken within 1 hr. Warn patient not to double up on doses. If there is not a substantive clinical response to increases in the daily dose, check for proper pump function and catheter patency. The daily maintenance of Baclofendose may be reduced 10% to 20% if patients experience side effects.

Dosage Instructions for BaclofenDrug

Oral: Treatment of reversible spasticity resulting from multiple sclerosis. May be of some value in patients with spinal cord injuries and other spinal cord diseases.

Intrathecal: Treatment of severe spasticity of spinal cord origin in patients who are unresponsive to or cannot tolerate oral baclofen therapy. Used intrathecally in single bolus test doses; chronic use requires implantable pump.

Contraindications for BaclofenDrug

Treatment of spasms from rheumatic disorders, stroke, cerebral palsy and Parkinson disease; use of intrathecal form via IV, IM, SC, or epidural routes.

Interactions of Baclofenw

ith other drugs

CNS depressants: May cause increased sedative effects.

Morphine (epidural): May cause hypotension and dyspnea.

What are the Side Effects of Baclofen -

Like other medicines, Baclofencan cause side effects. Some of the more common side effects of Baclofeninclude

* Hypotension; palpitations; chest pain.

* Drowsiness; weakness in lower extremities; dizziness;

* eizures; headache; numbness; euphoria; depression;

* onfusion; lethargy; insomnia; hallucinations; paresthesia;

* sthenia; anxiety; agitation.

* Pruritus; rash

* Tinnitus; blurred vision; taste disorder; nasal congestion.

* Nausea; vomiting; dry mouth; constipation; diarrhea; abdominal pain; anorexia

* Urinary frequency; enuresis; dysuria; impotence.

* Hypotonia; slurred speech; muscle pain; ankle edema; excessive perspiration; weight gain; back pain.

* Dyspnea; pneumonia; hypoventilation.

Warnings and precautions before taking Baclofen :

* Abrupt discontinuation has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that in rare cases advances to rhabdomyolysis, multiple organ system failure and death.

* The safety and efficay of Baclofen medicine have not been studied in children and adolescents.

* Give special attention to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen.

* Advise women before using Baclofen to inform health care provider if pregnant, planning to become pregnant, or breastfeeding while taking Baclofen. Insulin is recommended to maintain blood glucose levels during pregnancy. Prolonged severe neonatal hypoglycemia can occur if sulfonylureas are administered at time of delivery.

* Warn patient before using Baclofen not to discontinue medication abruptly. Explain that hallucinations or seizures may occur.

* Instruct patient before using Baclofen to report the following symptoms to health care provider: dizziness, nausea, hypotension, urinary frequency, retention, painful urination, headache, seizures, weakness.

What if Overdose of Baclofen ?

If you think you or anyone else taken overdose of Baclofen, immediately telephone your doctor or contact your local or regional Poisons Information Centre Seek medical attention immediately. You may need urgent medical attention. Vomiting, muscular hypotonia, muscle twitching, drowsiness, accommodation disorders, coma, respiratory depression, seizures (oral); drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures (intrathecal) are may be the overdose symptoms of Baclofen.

What if Missed Dose of Baclofen?

If you miss a dose of Baclofenmedicine and you remember within an hour or so, take the dose immediately. If you do not remember until later, skip the dose you missed and go back to your regular schedule. Do not double doses.

Storage Conditions for Baclofen:

Store at room temperature in tightly closed container. Have resuscitation equipment available during trial drug period if intrathecal administration is considered. Patient must have positive response to trial of intrathecal medication before use of implantable pump.

By: ashu

For More Article Of This Author Visit :: http://www.thearticleinsiders.com/

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Dec
09

Is Lipitor A Dangerous Drug?

Posted by: Pharma Tech | Comments (0)

Atorvastatin, marketed under the trade name Lipitor, is used for lowering cholesterol. Atorvastatin inhibits the enzyme located in hepatic tissue that produces mevalonate, a small molecule used in the synthesis of cholesterol. This lowers the amount of cholesterol produced which in turn lowers the total amount of LDL (low density) cholesterol. In 2005, Lipitor sales totaled $12.2 billion, making it the largest selling drug in the world at the time.


Atorvastatin is indicated as an adjunct to diet for the treatment of hypercholesterolaemia. In a clinical trial, after 2 years, a relative risk reduction of 16% in the primary end point rate (death, heart attack, unstable angina, coronary revascularization, or stroke) was seen in patients receiving intensive treatment with the drug. The benefit of intensive treatment was apparent, in some instances, within 30 days.


If you have high cholesterol, chances are your physician has already talked to you about Lipitor. Doctors like to prescribe it because it works quickly and easily. However, you need to understand the risk consequences associated with taking these sorts of drugs, because there is a potential for dangerous and sometimes permanent side effects. Some patients have suffered severe health consequences and were not adequately forewarned by their doctors.


Some of the more well known side effects associated with drugs known as statins (statins is the scientific classification for drugs such as Lipitor) include liver damage, sexual dysfunction, and peripheral neuropathy. But there have been other studies that have revealed other subtle problems that develop within the patient, which can have huge ramifications for the health of that patient later in life.


In a study performed by Finnish doctors, doctors assessed the effects of the statin drug Zocor on 120 men ages 35 to 64. All of the men had high cholesterol levels, ranging from 232 to 309. One group of men was told to maintain their current diet, while the other group was required to reduce their daily intake of saturated fat to less than 10 percent of total daily calories, and to keep their daily cholesterol consumption below 250 mg.


Then, each of the 2 groups was divided into 2 subgroups. One subgroup would take 20 mg of Zocor per day, while the other group received a placebo. This was continued for 12 weeks, at which point each subgroup switched so that the subgroup that had been receiving the placebo would receive the Zocor for the next 12 weeks, and vice versa. At the beginning of the clinical trial, and after the first 12 weeks, as well as at the end of the second 12 weeks, the cholesterol, blood pressure, insulin, and weight of each patient were measured.


The Zocor clearly worked, because it decreased cholesterol levels by 20.8 percent, while diet alone only decreased cholesterol by 7.6 percent. However, there was an astonishing finding. It was discovered that the drug increased fasting serum insulin levels by 13 percent, and decreased serum concentrations of important antioxidant vitamins by as much as 22 percent. This was a huge revelation.


Decreased insulin sensitivity can lead to a whole host of problems down the road, such as blindness, diabetes, and kidney disease. And antioxidants protect us from a whole host of problems, such as organic brain disease, cancer, and atherosclerosis. So, even though these cholesterol drugs perform a valuable function (lowering cholesterol), they can cause a whole range of other problems and diseases that can make a patient severely ill later in life.


So, you should think long and hard before using cholesterol-lowering drugs. The aforementioned side effects may not be equally severe in all people who take the medication. However, you might be better off working closely with your doctor to develop a program of diet and exercise before using drugs like Zocor or Lipitor to lower your cholesterol.

Jim Pretin is the owner of http://www.forms4free.com, a service that helps programmers make an HTML form

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What is Regulatory Affairs???? :-

Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.

They have a major contribution in company’s success both Commercially and Scientifically.

Careers in Regulatory Affairs:-

Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.

Selling drugs is not like selling anything else, when we sell drugs we need to be confident that

They do what they claim to do They have been through a tough testing process to get from the lab to the market The side effects are well documented

 

This is where regulatory affairs come in.

“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”

The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.

With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.

There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone.  On an average there has been over 30% rises in salaries in Pharmaceutical Sector.

Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.

What you will need to become a RA professional :-

A good background knowledge of the pharmaceuticals and medical environment A meticulous approach to work Attention to detail. Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure.

Global Institute of Regulatory Affairs (GIRA)

GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.

This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.

The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.

Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years

Please contact GIRA for  “FREE Counseling & Course Prospectus”

To know more on RA and its Career visit White Paper section on

Global Institute of Regulatory Affairs

www.regulatoryinstitute.com

 

 

Sumit Gupta

Global Institute of Regulatory Affairs – www.regulatoryinstitute.com

Email ? info@regulatoryinstitute.com / girapune@gmail.com

Categories : Trials
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Drug trial data -

Recently a clinical drug trial was carried out on a new anti-HIV treatment which increases the rate of healing of ’seeping wounds’ of AIDS sufferers. The medical biologists carrying out the trial implemented a ‘double-blind’ test. A total of 400 people were subjected to the trial, with two groups of equal-size for each medicine. 200 of group A were given the new drug, X, while 200 of group B were given an existing drug, Y.
At the end of 7 days everyone was assessed.
It was found that 24 of those in group A had their wounds healed.
It was found that 14 of those in group B had their wounds healed.

My calculated chi-squared value was 2.34 and my null hypothesis was rejected at p0.05 and p0.01.

Evaluate the use of chi-squared test in the drug trial data analysis above. Is it an appropriate statistical analysis of data in making probability judgements on future use of such drugs and why?

Categories : Trials
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Null hypothesis – The number of people in Group A with healed wounds is equivalent to the number of people in Group B with healed wounds.

Drug trial data -

Recently a clinical drug trial was carried out on a new anti-HIV treatment which increases the rate of healing of ’seeping wounds’ of AIDS sufferers. The medical biologists carrying out the trial implemented a ‘double-blind’ test. A total of 400 people were subjected to the trial, with two groups of equal-size for each medicine. 200 of group A were given the new drug, X, while 200 of group B were given an existing drug, Y.
At the end of 7 days everyone was assessed.
It was found that 24 of those in group A had their wounds healed.
It was found that 14 of those in group B had their wounds healed.

Can anyone based on my null hypothesis do the chi-squared analysis for the drug trial data above?

Categories : Trials
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SUWON, SOUTH KOREA–(Marketwire – November 23, 2009) – AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.

Under the agreement terms, Hengdian Group will pay RMB 5 million Yuan as a research fund for the study of acute myocardial infarction (AMI) and burns immediately after signing and additional RMB 5 million Yuan as an upfront after completion of the phase II clinical trial for stroke, AMI or burns in China. Hengdian Group will provide 12 percent of the net sales as royalty to AmKor upon the commercial sale of the Neu2000 product in China. Moreover, Hengdian Group, as a pharmaceutical company specialized in active pharmaceutical ingredient (API) production for global clinical trials, is responsible for producing API and drug products of Neu2000 for multinational clinical trials through AmKor and Neurotech.

Neu2000 is a moderate, NR2B-selective N-methyl-d-aspartate (NMDA) receptor antagonist and potent antioxidant, which is developed as a dual cytoprotective drug for stroke, spinal cord injury (SCI), AMI and burns by Neurotech Pharmaceuticals Co., Ltd. (Neurotech) in South Korea. These therapeutic mechanisms have been among the most sought after activities in the pharmaceutical development of neuroprotectant and evaluated its efficacy over the past few decades through numerous studies of animal model such as ischemic stroke and SCI.

Neu2000 is an investigational stroke treatment with proven human safety through phase I clinical trial in Quintiles US. In the double-blinded, phase I clinical trial, Neu2000 showed excellent safety profiles up to 6 g per healthy young humans (80 subjects) and up to 4 g per normal elderly humans (15 subjects) without serious adverse events. Neu2000 did not show any Central Nervous System toxicities compared with other NMDA antagonists which have failed due to clinical toxicities. As dosing of only 125 to 1500 mg of Neu2000 per human was enough to exceed the therapeutic plasma concentrations showing maximal efficacy in animal models of stroke, SCI, and AMI, AmKor made a decision to move toward clinical proof-of-concept trial of Neu2000 for the target diseases.

Dr. BJ Gwag, President and CEO of AmKor and Neurotech, said, “We are pleased to establish a partnership with Hengdian Group with sincere trust and belief in the relationship and are going to plan phase II clinical trials of Neu2000 first in South Korea and China.”

AmKor, a Neurotech’s subsidiary, is a clinical-stage company focused on the development of drugs to treat the body’s response to injury. Its principle efforts are currently directed at advancing Neu2000 through phase II clinical trials in stroke, SCI, AMI and burns.

Neurotech is a biopharmaceutical venture company which discovers and develops new drugs for the treatment of neurological and inflammatory diseases.

The R&D of Neu2000 was supported partly by “National Research Laboratory grant,” “G7 grant” and “Functional Proteomics Project of the 21st Century Frontier Research Program” from the Ministry of Science and Technology in Korea. It was also supported by grants from “Brain Research Center” in Ajou University School of Medicine and from “Driving Force Project for the Next Generation” by Gyeonggi Provincial Government in Korea.

Hengdian Group is at the present one of the largest Chinese conglomerates, ranked 3rd in the “Top 10 National Private Enterprises,” with a total yearly turnover exceeding 16.7 billion RMB (over 2 billion USD). The headquarters is based in Hengdian, Zhejiang Province and the group has 3 public companies — electronics, pharmaceutical and chemical industry, film and entertainment — more than 60 sub-companies and about 200 manufacturing factories with over 40,000 employees.

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SUWON, SOUTH KOREA–(Marketwire – November 23, 2009) – AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.

Under the agreement terms, Hengdian Group will pay RMB 5 million Yuan as a research fund for the study of acute myocardial infarction (AMI) and burns immediately after signing and additional RMB 5 million Yuan as an upfront after completion of the phase II clinical trial for stroke, AMI or burns in China. Hengdian Group will provide 12 percent of the net sales as royalty to AmKor upon the commercial sale of the Neu2000 product in China. Moreover, Hengdian Group, as a pharmaceutical company specialized in active pharmaceutical ingredient (API) production for global clinical trials, is responsible for producing API and drug products of Neu2000 for multinational clinical trials through AmKor and Neurotech.

Neu2000 is a moderate, NR2B-selective N-methyl-d-aspartate (NMDA) receptor antagonist and potent antioxidant, which is developed as a dual cytoprotective drug for stroke, spinal cord injury (SCI), AMI and burns by Neurotech Pharmaceuticals Co., Ltd. (Neurotech) in South Korea. These therapeutic mechanisms have been among the most sought after activities in the pharmaceutical development of neuroprotectant and evaluated its efficacy over the past few decades through numerous studies of animal model such as ischemic stroke and SCI.

Neu2000 is an investigational stroke treatment with proven human safety through phase I clinical trial in Quintiles US. In the double-blinded, phase I clinical trial, Neu2000 showed excellent safety profiles up to 6 g per healthy young humans (80 subjects) and up to 4 g per normal elderly humans (15 subjects) without serious adverse events. Neu2000 did not show any Central Nervous System toxicities compared with other NMDA antagonists which have failed due to clinical toxicities. As dosing of only 125 to 1500 mg of Neu2000 per human was enough to exceed the therapeutic plasma concentrations showing maximal efficacy in animal models of stroke, SCI, and AMI, AmKor made a decision to move toward clinical proof-of-concept trial of Neu2000 for the target diseases.

Dr. BJ Gwag, President and CEO of AmKor and Neurotech, said, “We are pleased to establish a partnership with Hengdian Group with sincere trust and belief in the relationship and are going to plan phase II clinical trials of Neu2000 first in South Korea and China.”

AmKor, a Neurotech’s subsidiary, is a clinical-stage company focused on the development of drugs to treat the body’s response to injury. Its principle efforts are currently directed at advancing Neu2000 through phase II clinical trials in stroke, SCI, AMI and burns.

Neurotech is a biopharmaceutical venture company which discovers and develops new drugs for the treatment of neurological and inflammatory diseases.

The R&D of Neu2000 was supported partly by “National Research Laboratory grant,” “G7 grant” and “Functional Proteomics Project of the 21st Century Frontier Research Program” from the Ministry of Science and Technology in Korea. It was also supported by grants from “Brain Research Center” in Ajou University School of Medicine and from “Driving Force Project for the Next Generation” by Gyeonggi Provincial Government in Korea.

Hengdian Group is at the present one of the largest Chinese conglomerates, ranked 3rd in the “Top 10 National Private Enterprises,” with a total yearly turnover exceeding 16.7 billion RMB (over 2 billion USD). The headquarters is based in Hengdian, Zhejiang Province and the group has 3 public companies — electronics, pharmaceutical and chemical industry, film and entertainment — more than 60 sub-companies and about 200 manufacturing factories with over 40,000 employees.

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PILLS, PILLS and MORE PILLS

We are fortunate to live in a time having medications that alleviate uncomfortable, even life threatening symptoms of physical and mental dis-ease. Yet, traditional medicine in the developed countries continue to use only two primary methods to treat patients complaints; medication, generally in the form of pills, and surgery.

When you visit your doctor and have a symptom, you get a pill, a second symptom, another pill, a third symptom still another pill with little regard for the drug interactions, neutralization of the efficacy or increased effects that one drug may have on another.

Take a woman in her sixties who has high blood pressure, headaches, and fatigue and is overweight. She will be given a pill to lower her blood pressure, another to regulate her cholesterol, another to increase her energy and yet another for her headaches, possibly another to regulate her weight. Five medications. She may get short-term relief but faces potential long-term ramifications, including possible life threatening side effects and complications.

Where and how do doctors decide what drugs to prescribe? From drug company representatives of course. They haunt offices of physicians offering bribes in the form of candy for the office staff for “just a minute to talk to the doctor,” to free samples, inscribed pens, to lavish gifts including cherished tickets to college and professional sports games, trips and dinners in fancy restaurants. In fact a whopping 30 % of the marketing budgets of pharmaceutical companies is used to “educate “ physicians and lure them into writing prescriptions for their latest banner drug. Other obvious methods of drug use seduction are television and print media ads to encourage people to request a specific medication from their doctors.

This is blatant conflict of interest.

I have personally been prescribed Vioxx, Permex, Advandia and female hormones when generic and /or cheaper alternatives were/are available. I am 74 years old and I have Type 11 diabetes with a family history of heart disease, yet the Federal Drug Administration (FDA) either warned or removed all of these drugs from the market due to the danger of causing heart attacks and strokes. What was my doctor thinking of when he put me on these drugs? Or was his decision motivated by propaganda by some drug salesman?

These designer, non-generic drugs are very expensive for both the Medicare Advantage program (ultimately the tax-payer), my insurance company, and for me with an expensive co-pay, when they paid at all. I live on a fixed income and paying of expensive drugs creates a financial hardship for me. Additionally they put me in life threatening danger of an early death.

The FDA as the alleged watchdog on drug safety is not doing its job. They are just another front for unscrupulous drug companies who value profit more than developing drugs that can save lives. They claim to be understaffed.

Take Advandia for example, it is prescribed to over 1 million Americans for treatment of Type 11 Diabetes. In an analysis by Steven Nisson, M.D. of the Cleveland Clinic and former president of the American College of Cardiology reported in the New England Journal of Medicine on May 21, 2007 that his analysis of 42 clinical trials suggest that the drug could cause a 43% increase in heart attack risk. Yet doctors continue to prescribe it for their patients.

Drugs are often tested by pharmaceutical companies on 25-year-old medical students who are paid to be guinea pigs, and then after approved by the FDA prescribed for 65-year-old woman or seventy five year old man who have different body weights, blood pressures, and other medical problems.

The drug testers have a lot to lose by reporting any side effects, namely that they may be excluded from the current test or future tests and thus lose the money they are paid. So even when they experience side effects they don’t report them. Even so–called double blind studies have problems in credibility for the reasons outlined above.

Congress must be more pro-active in:

1. Overseeing the role of the FDA,

2. Regulating the conflict of interest between drug companies and physicians,

3. Price controls.

This is a serious issue for America and must be addressed immediately.

Nancy O?Connor, Ph.D. is a retired Psychologist and nurse. She is the author of Letting Go With Love: The Grieving Process, How To Grow Up When You?re Grown Up. How To Talk To Your Doctor. She lives in Tucson Arizona and is writing a book on the life of her Great grandmother and the six daughters and one son she raised. You can order her book or reach her at http:www.lamripospress.com

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