Psychology tells us that we essentially need three things to survive: food (including water), sleep, and a sexual outlet of some sort…drugs and alcohol are not needs! Lack of any one of these things means, in some cases, either death, or a disturbance in life until the need is in some way met! Rehab is an approach to recovering balance in the case of the abuse of drugs and alcohol. You cannot do anything exclusively without tiring of it, including drugs and alcohol! Rehab is about change, and nature and change are very much synonymous. You need time to work, time to eat, time to sleep, time to relax, time to be alone, time to dream, and to fantasize…in essence, life cannot be about any one thing to the point of detriment to other important areas of your life – including the use or abuse of drugs and alcohol. No one thing can be done exclusively without causing you pain (like from being too full from eating.) Rehab is applicable to recovering balance from drugs, alcohol, or any other behavior done to the exclusion of nearly all else.

People who abuse drugs and alcohol, and are in rehab, often suffer from an addictive personality. An addictive personality, or a “proneness to addictive behavior”, such as addiction to drugs and alcohol (or even rehab) often forms from an “unmet need” in life. Sometimes this unmet need is not even perceptible to the mind of the drug and alcohol afflicted (being as it is subconscious, occurring in early childhood perhaps, and beyond the reach of cognitive abilities, memory, or even traditional rehab. Hypnosis, or psychotherapy, is sometimes prescribed in addition to rehab from drugs and alcohol.) This “unmet need” tries to “meet” itself by means of the self bonding with an activity, like using drugs or alcohol…i.e., a drug or alcohol “fix”! In that the “unmet need” is trying to meet itself, and satisfy itself by artificial means, one becomes addicted to drugs or alcohol, or to a certain behavior or activity that brings physical gratification instead of emotional satisfaction; a sort of “pseudo replacement” for the real “unmet need”. Rehab from drug and alcohol abuse is both a spiritual and psychological process back to balance.

Drugs and alcohol’s relentless pursuit consumes the whole life, and never does truly fulfill (as rehab can.) It leads the addict along a trail of drug and alcohol ruins in terms of personal loss, psychological pain, incarceration, death, and hurt loved ones, who are all too often confused by the risky drug and alcohol behavior and madness! Only rehab can help to turn this around. It goes to show, like any good occult axiom, that “anything done to an extreme carries with it consequences to the other important areas of our life – parts of life that are important to us all, despite our view of their importance to us!” The damage caused by drugs and alcohol, and the damage in general caused by addiction, is tragic and sad, especially when it can be eradicated simply by means of abstinence, and rehab. Like the family would say, “If he has so many problems from using drugs and alcohol why does he continue to use drugs and alcohol?”

Also, with addiction, and even rehab from drugs and alcohol, the “self” is always essentially aware of its own predicament. The individual, unable to stay in rehab and truly save himself/herself from their own predicament with drugs and alcohol, the addict cannot stop using drugs and alcohol. Guilt, shameful feelings, and anger and irritation (even in rehab, where they must be dealt with), exist constantly! They are constantly in effect for the addict, even the addict in drug and alcohol rehab. The pain of drug and alcohol addiction spreads to those in close connection with the drug and alcohol addict, often affects physical health and dependability, and almost always runs a life into the ground in a myriad of ways! Until the addictive behavior is arrested by means of rehab, recovery from drugs and alcohol, or any form of addiction, cannot begin!

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Drugs and alcohol are widespread problems in the United States. In America, rehab and Twelve Step Programs are an integral part of treatment for drugs and alcohol. Often they go along with rehab for drugs and alcohol, which is in most cases short term. In rehab, you learn about the damage that drugs and alcohol WILL do to your life, and you are given an introduction to rehab and the Twelve Step Program. Unfortunately, rehab and the Twelve Step Programs are often described as having “revolving doors”. Drug and alcohol addicts attending rehab and Twelve Step Programs are often forced to attend, and though they may gain some insight into the nature of drugs and alcohol, rehab, and the Twelve Step Program’s method of recovery, pursuit of the program often proves FAR more difficult for those addicted to drugs and alcohol. The failure rate for rehab and drug and alcohol addicts involved in Twelve Step Programs has been as high as ninety-six percent! I do not know what the rehab failure rate is for drugs and alcohol today!

The Twelve Steps of Alcoholics Anonymous, written by “Bill and Dr. Bob” in the earlier part of this century, has since been adopted to fit drug and alcohol rehab and people with addictions of other sorts In rehab from drugs and alcohol, the essence of the Twelve Step Recovery Programs are the Twelve Steps themselves. Having been to rehab for drugs and alcohol myself, I am very familiar with each of the “Twelve Steps”, and what they mean, and what it is you are trying to achieve as you work each step.

In rehab from drugs and alcohol, the practice of the Twelve Steps is very similar both in nature and in approach of other well known religious practices and philosophies; teachings that teach one the values of living an honest and spiritual life. These older studies and practices teach self-discipline, healing, and other so-called “secrets”, and require their aspirants to achieve and maintain a “pure” life, and promise peace, enlightenment, and even unity with God to their’ followers.

READ ON…long before Twelve Steps of Alcoholics Anonymous, Healers, Mystics, Magicians, and Occultists also dared to tackle the problem of addiction to drugs and alcohol, or what they referred to as, “obsession”!

For more on this article plus other great “how to” articles, visit Rehab, drugs, and alcohol, or, Rehab, drugs, alcohol, and occult teachings.   Also download DVD Movies, Music Collections, Games, Books, Software, and Adult XXX Movies, Videos, and PC Games FREE.

The financial income of the people is greatly affected because of the financial crises. All the markets are sinking because they are suffering too much lose. But, humans can not live without the medications if they have the ill health. Thus, to all these men generic drugs could be a best option to save the money. Reasons for the cheap price of the generic drug are— the cost of production of generic drug is very less as compared with the original brand name companies, no investment is done for the research on generic drug as the research is already conducted by the brand name manufacturer, clinical trials are not conducted by the generic drug manufacturer because they are previously conducted by the brand name manufacturer, and no cost is involved in the advertising and marketing of the generic drug because they get the benefit of the advertising and marketing done by the original drug manufacturer. Thus, generic drug allows the manufacturer to earn lots of profits.

Generic drugs not only save the money of the customers but also save the investment of the government in the pharmaceutical sector. US govt. has saved about 1 Billion dollars because of the generic drugs in the year 2007-08. Insurers are also very beneficial due to the use of the generic drugs. Insurance companies are asking the doctors to follow the step therapy that means doctors should first prescribe the generic drugs and if these drugs fail to produce the required effect then they should prescribe the more expensive brand-name drugs. FDA is sending pamphlets to the big pharmacy chain in US to promote the generic drugs. FDA is even asking these pharmacies to promote the sale of generic drugs. FDA says that all drugs must work well and be safe. FDA makes sure that before approving that generic drugs are of high quality, strong, pure, and stable as their respective brand-name drugs.

Generic drugs are allowed to be sold in the market only after they satisfy the following criteria:

Generic drug should have the same ingredient as the original drug.

Generic drug must be identical or bioequivalent to the original drug.

The pharmacokinetic and pharmacodynamic properties of the generic drugs should be similar to the original drugs.

Generic drugs should be similar in strength in comparison with the original brand name drug.

The side-effects of the generic drug are less or more than the original brand name drug.

Generic drugs are manufactured in the world class units that are checked and then approved by the FDA. The safety of the generic drugs is not at all in doubt because no casualties till date are noted by the intake of the generic drugs. Thus even the pharmacy distributors believe in the generic drug manufacturer and thus the sale of generic drug increases. Customer is using generic drugs because of the cost benefits and he is enjoying the same effects that he used to get by the original branded drugs. Hence, we can conclude that generic drugs perfectly match the demand of time.

The financial income of the people is greatly affected because of the financial crises. All the markets are sinking because they are suffering too much lose. But, humans can not live without the medications if they have the ill health. Thus, to all these men generic drugs could be a best option to save the money. Reasons for the cheap price of the generic drug are— the cost of production of generic drug is very less as compared with the original brand name companies, no investment is done for the research on generic drug as the research is already conducted by the brand name manufacturer, clinical trials are not conducted by the generic drug manufacturer because they are previously conducted by the brand name manufacturer, and no cost is involved in the advertising and marketing of the generic drug because they get the benefit of the advertising and marketing done by the original drug manufacturer. Thus, generic drug allows the manufacturer to earn lots of profits.

Generic drugs not only save the money of the customers but also save the investment of the government in the pharmaceutical sector. US govt. has saved about 1 Billion dollars because of the generic drugs in the year 2007-08. Insurers are also very beneficial due to the use of the generic drugs. Insurance companies are asking the doctors to follow the step therapy that means doctors should first prescribe the generic drugs and if these drugs fail to produce the required effect then they should prescribe the more expensive brand-name drugs. FDA is sending pamphlets to the big pharmacy chain in US to promote the generic drugs. FDA is even asking these pharmacies to promote the sale of generic drugs. FDA says that all drugs must work well and be safe. FDA makes sure that before approving that generic drugs are of high quality, strong, pure, and stable as their respective brand-name drugs.

Generic drugs are allowed to be sold in the market only after they satisfy the following criteria:

•    Generic drug should have the same ingredient as the original drug.
•    Generic drug must be identical or bioequivalent to the original drug.
•    The pharmacokinetic and pharmacodynamic properties of the generic drugs should be similar to the original drugs.
•    Generic drugs should be similar in strength in comparison with the original brand name drug.
•    The side-effects of the generic drug are less or more than the original brand name drug.

Generic drugs are manufactured in the world class units that are checked and then approved by the FDA. The safety of the generic drugs is not at all in doubt because no casualties till date are noted by the intake of the generic drugs. Thus even the pharmacy distributors believe in the generic drug manufacturer and thus the sale of generic drug increases. Customer is using generic drugs because of the cost benefits and he is enjoying the same effects that he used to get by the original branded drugs. Hence, we can conclude that generic drugs perfectly match the demand of time.

Drug-drug interactions that affect the travel of drugs in the body can be further understood as those that affect absorption into the bloodstream, distribution within the body, breakdown into different products or removal from the body.

Absorption interactions can occur when one drug’s particles have a large enough surface area to cause another drug’s particles to stick to them, both drugs may also bind to each other, or one drug alters the acidity of the stomach contents or the rate at which the stomach moves it’s contents. These interactions can alter the ability of one or both drugs to get into the bloodstream. When a drug only reduces the rate of absorption of another, a patient on regular use of both drugs is usually unaffected. However, if one drug reduces the extent of absorption of the other, the patient can be exposed to lower levels of the second drug than required and the second drug may hence be ineffective in treatment.

Distribution interactions may occur when drugs reach the bloodstream and the tissues. Competition between two drugs can arise for binding to the same proteins in the blood or one drug may dislodge another from it’s connection with tissues. It is more common in the second instance when one drug displaces another from the tissues, to find that the displaced drug accumulates in the blood leading to a greater risk of an affected patient experiencing toxicity. An example is when the heart medications quinidine and Lanoxin® (digoxin) are taken concurrently, digoxin blood levels can rise and adversely affect the patient if not monitored appropriately.

While drugs can be broken down at many different sites in the body, the most common site is the liver. Here, a system of enzymes can be up-regulated or down-regulated by one drug to result in the quicker or slower breakdown of the other respectively. Examples of drugs that up-regulate specific enzymes in the liver, include the anti-epileptics Dilantin® (phenytoin) and Tegretol® (carbamazepine). The enzyme up-regulation effect usually takes place gradually with maximal effects observed in 7 to 10 days of starting the drug. It may also take an equal or longer time before normalcy is regained upon discontinuing the drug. Examples of drugs that down-regulate specific enzymes in the liver, include the antibiotics erythromycin and ciprofloxacin. The onset of enzyme down-regulation is usually faster than up-regulation.

The majority of broken down drug products as well as whole drugs are removed from the body through the passing of urine. When one drug affects the pH of the urine, this can affect another drug’s ability to get into the urine depending on how it’s form changes during the filtering process in the kidneys. Transporter molecules in the kidney that facilitate drug removal may also become more or less available to one drug as a result of the presence of another.

Drugs can also interact and exert a net effect by their direct actions on the body. Two drugs with similar effects when administered together can display synergism in action although acting at different sites or receptors in the body. An example is the drowsiness that can be experienced when a sedative like Valium® (diazepam) is taken concurrently with an antihistamine like Polaramine® (dexchlorpheniramine). Conversely when two drugs that have opposing effects are taken concurrently, the response to either or both can be reduced. An example is the opposing wakefulness and drowsiness that can result from consuming a caffeine-based anti-migraine preparation and a sedative.

Another set of action-related drug-drug interactions occurs when two drugs exert toxicity towards the same organ or tissue in the body. Concurrent administration of the two drugs can result in damage to the corresponding organ or tissue despite the individual dose of each drug alone not being enough to result in toxicity under normal circumstances. The common organs that are most often affected by such drug-drug toxicity interactions are the kidneys and the liver. Of note is also that one drug can increase the organ-toxic effect of another even though it does not exert any direct toxicity towards that organ by itself.

Because of the numerous drugs available and the many more that are constantly arriving, drug-drug interactions can be quite common. However, the adverse effects can be minimized through consultation with an experienced medication expert. When such interactions are anticipated early, the most appropriate countermeasures can be readied to maintain well being.

Features of urine and saliva drug testing
Both the urine drug testing and the saliva drug testing have their own advantages as well as some disadvantages.

Collection of specimen:
The major advantage of saliva drug testing over urine drug testing is its least invasiveness of privacy while collecting specimen. This has been a controversy since a long time in all the places of drug testing. The process of collecting saliva for a drug test is obviously less invasive compared to the case of urine drug test.

Chances of adulteration:
The chances of adulteration in saliva drug test are very less, compared to urine drug test. In case of saliva drug test, it is feasible to collect the specimen under legible supervision. Thus, minimizing the chances of tampering the specimen. This is not possible in case of urine drug testing. However, saliva drug test is not completely free from adulteration.

Detection period of drug abuse:
The detection period of drug abuse through saliva drug test is shorter, compared to urine drug test. The detection period in case of saliva drug test is around 20 hours to 1 day approximately, whereas it is around 3 days in case of urine drug test.

Accuracy of results:
The accuracy rate of both, urine and saliva drug tests are deemed by the United States court system. However, the accuracy rate of urine drug test results is much higher than that of saliva drug test results, the risk of false negatives is high in both the drug tests.

Cost of drug test
Cost-effectiveness is the major advantage of urine drug tests compared to any type of drug tests. The cost of saliva drug test is a little higher, compared to urine drug test. However, the cost of saliva drug testing complies with the quality of the drug test.

As both saliva drug test and urine drug test, have their own advantages and disadvantages it is not feasible to use any one of them in all the situations. Based on the comparison of features mentioned above, it will be easier to analyze and choose a drug test according to the situation.

A drug that is structurally very similar to already known drugs, with only minor differences. The term “me-too” carries a negative connotation. However, me-too products may create competition and drive prices down1.

The majority of the new products the industry puts out, are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo, they can get the regulatory green light2.

This isn’t surprising at all, as someone who works in the field, but these so-called “me-too” drugs, which are reportedly better than their forebears, is driving costs. A “me-too” drug is a drug that has its origins in another drug. Probably the most famous example of this is Prilosec (“The Purple Pill”) and Nexium (“Today’s Purple Pill”). Prilosec’s active ingredient is omeprazole. Nexium’s active ingredient is called esomeprazole. The difference is that Nexium is the left-handed version of omeprazole. In chemistry, S stands for sinister, which means the molecular conformation has a left-handed orientation. (D would be right handed.) So this S-omeprazole is one half of the mixture that comprises its predecessor. By specifically picking only the S conformation, the drug is made more potent. This sounds great, but its efficacy is only marginally better than Prilosec-, which has a generic version, and costs about a third less than Nexium. Some other “me-too” drugs are: Claritin (loratidine) and Clarinex (desloratidine), Celexa (citalopram) and Lexapro (escitalopram)3.

What are “Me-Too” drugs?

Ever since the advent of modern chemotherapy, when drugs were discovered and developed through the process of screening thousands of molecules for a variety of disease conditions, using animal models, there has been a growing criticism that too many molecules were developed with similar chemical structure and the same pharmacological profile, with very little to distinguish them from each other in terms of their therapeutic utility. In other words, once the first breakthrough discovery is made of a new pharmacological activity for a new molecule, subsequent years saw the emergence of a host of new molecules or “me-too” drugs from the same chemical class and possessing the same pharmacological profile.

Such follow-up drugs have been termed molecular modifications, molecular roulettes or copycats, the development of which are alleged to be motivated by purely commercial considerations. They are also deemed to involve lower levels of innovation, compared to the original molecule. It is important to analyze in a historical perspective the end results of such efforts in different therapeutic areas of developing new molecular entities, as later generation products, after an initial breakthrough discovery has been made and the technical, medical and commercial merits of developing such drugs.

Development of “Me-Too” drugs

The success rate in the discovery of new chemical entities with fundamentally new chemical and biological profiles of activity are very low. In fact, even chemical entities within the same structural class of an approved drug are becoming rare now, compared to the period of sixties to eighties. In 2001, $ 26 billion was spent on developing new drugs and the U.S. FDA approved only 9 new chemical entities. At the same time, two thirds of the drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those, in newer forms and formulations4.

Of the 1,035 drugs approved by FDA during 1989 to 2000, only 361 or 35% contained new active ingredients. Of these, only fewer than half were granted priority review status by the FDA. One impression is that these drugs are slightly altered versions of existing drugs, with little to offer in terms of better activity or tolerance, let alone new pharmacological profiles. The implication is that such drugs are developed, as patents on top-selling original drugs run out and not many truly new medicines are discovered. The indication that many of these drugs do not offer any major advantages over existing drugs is given by FDA’s unwillingness to grant priority review for most of them.

On the other hand, conventionally, the Regulatory Agencies, including the FDA, are not obliged to consider better efficacy over existing drugs as a criterion for approval; rather, they require only the establishment of efficacy and safety of the new drug over a placebo.

How good are they?

Notwithstanding such perceptions, historically, many “me-too” drugs have proved to be considerably better than their original counterparts. Examples are a series of generations of beta-blockers, which came up after the original drug Propanalol was discovered by ICI, with most of them having merits in terms of better efficacy, cardio-selectivity and safety. Ranitidine, the first follow-up drug after the introduction of the first H-2 receptor antagonist, Cimetidine, was followed by Famotidine and in each case these “me-too” drugs had notable merits over the original drug.

Apart from the major breakthrough in the development of orally active beta lactam antibiotics of the Penicillin and Cephalosporin class, within the same oral derivatives, there have been considerable improvements brought about by change in the side chains incorporated by condensation of specific agents with 6-APA, 7-ADCA and 7-ACA. A whole new range of broad-spectrum antibiotics of these structural classes could thus be developed. In each of the major classes of antibiotics, classified according to the mechanisms of their action, namely inhibition of cell wall synthesis (Beta Lactams, Vancomycin), inhibition of bacterial protein synthesis (Erythromycin, Tetracycline, Streptomycin), inhibitors of DNA or RNA replication (Quinolones, Rifamycins), inhibition of Folate Coenzyme biosynthesis (Sulfa drugs, Trimethoprim), there have been several “me-too” drugs marketed.

An important recent example to show that ‘me-too” drugs need to be developed is the case of the oral hypoglycemic drug Troglitazone, approved as an anti-diabetic drug in 1997. The drug was withdrawn from the market following reports of unacceptable hepato-toxicity. The follow-up “me-too” drugs, Rosiglitazone and Pioglitazone are much less toxic and are today widely used. If these drugs were not developed, the withdrawal of Troglitazone would have left a major therapeutic gap in anti-diabetic therapy.

“Me-Too” drugs: Strategies for New Drug Research for Indian Companies

Breakthrough innovations in pharmaceutical industry, of new drugs, such as the first beta blocker, the first NSAID, the first of each class of Antibiotics, Calcium Channel blockers, ACE inhibitors, Sulfonyl Ureas, Biguanides, Insulin, Glitazones, Glinides, Tricyclic Anti Depressants,major and minor Traquillisers, Selective Serotonin Receptor inhibitors, H-1 and H-2 Receptor antagonists, Proton Pump inhibitors etc are relatively rare and even though a few of the original drugs under these classes are still very much in use, they have been superceded in most cases, by later generation products, many of them “me-too”. The newer drugs are discovered both through incremental innovations on the original drugs as well as through new research.

Generally the original discovery leads to feverish activity both within the innovator company as well as in Competitors’ laboratories, to develop better products in the same therapeutic category. The essential caveat for commercial success, however, is that the newly discovered molecules should meet the minimum standards of patentability. For example within three years of the discovery of the highly successful Sildinafil Citrate (Viagra), three more new versions for the same indications have been patented and developed5.

Me-too drugs also provide therapeutic advantage6. For the practicing physicians, there’s the benefit of established drug MoA with a “me-too” medication, coupled with clinical studies that – hopefully – show patient-centered benefits such as better adverse events profiles, less frequent dosing, less bothersome potential for drug/drug interactions, and so forth. A “me-too” drug is a helluva lot easier to incorporate in practice than a totally novel medication7.

“Me-Too” drugs: The hidden dynamics

The most common criticism of drug development centers on the so-called “me-too” drugs that employ the same biological mechanism as pioneer brands. This involves a lot more than such high-profile targets as the anti-ulcer drug Nexium. We should be thinking about antidepressants, cholesterol-reducing drugs, diabetes treatments, anti-psychotics, and other therapeutic categories that have seen both blockbuster sales and rapid innovation. There is quite a bit of evidence that follow-on drugs do a lot of patients a lot of good. The newer statins, for example, often out-perform the older ones in clinical trials where the endpoints are the number of heart attacks and deaths prevented.

Me-too drugs are also a powerful tool for cutting health care costs. We should be glad that our research industry does not target only brand new biological mechanisms. That would be a very expensive business model indeed. Fortunately, the industry also works on marginal improvements, exploiting opportunities to make drug therapy better and sometimes opening the door to really radical improvements that happen to lie more or less next-door, scientifically speaking. In the meantime, we get price competition as a by-product. Me-too’s almost always undercut the prices of the pioneer drugs.

Another part of the me-too story gets almost completely ignored even though it is extraordinary important. For me-too manufacturers, advancing the science is a way to gain a competitive advantage. The classic example is the statin class of cholesterol drugs. Research on one of the follow-on drugs (Pravachol) demonstrated for the first time that using a statin to reduce cholesterol would actually prevent deaths from heart attacks, something that had previously been assumed without proof. Additional trials for several statins, including Lipitor, the formidable challenger to Zocor and Pravachol, have demonstrated that serum cholesterol is far more important than almost anyone thought (for preventing strokes, for example).

There are lots of other stories about the benefits of new research from me-too drugs, but they are part of a larger story: new uses for old drugs. The data showing a slowdown in new drug approvals exclude essential information: discoveries of new uses for old drugs. This kind of discovery has become so common that it amounts to a “new-use” revolution. One of the scientific ironies of the new era of pharmaceutical research is that as drugs become more tightly targeted on biological mechanisms, their uses actually become more diverse. This is because the body typically uses specific mechanisms over and over again, sometimes in what appear to be completely unrelated ways.

Consider the SSRI antidepressants. A recent Science article on the diverse and unexpected applications of drugs that fiddle with serotonin reuptake which is what the SSRIs do concluded that the very term “antidepressant” is misleading because there is no scientific reason to think of this drug as being just for depression. Fighting depression just happened to be the first really useful condition that was explored for this very interesting class of drugs.

Another example is the Cox-2 inhibitors like Celebrex (and Vioxx, which is important in this story and may return to the market partly for this reason). These were invented to relieve arthritis pain. But the Cox-2 enzyme turns out to be important for lots of things including cancer and Alzheimer’s. Clinical trials to exploit these leads have been underway for years. Celebrex has already been approved for reducing the risk of colorectal cancer, and Vioxx has also achieved promising results. Of course, the big news recently has been that these drugs may cause heart attacks. But even here, me-too economics is of surpassing importance. The traditional NSAIDS (non-steroidal anti-inflammatory drugs) like Alleve and Advil may have the same heart attack risks. The potential risk has been there for decades, but only the new drugs-the Cox-2s-have been put through large-scale long-term clinical trials because those are the only ones still under patent. This is an example of how me-too drug development adds importantly to the research base. Thanks to the me-too’s, we are learning about NSAIDs, heart attacks, cancer and probably much more.

Also dominated by new uses are the new-targeted cancer drugs, which attack such specific biological mechanisms that they avoid killing every fast-growing cell in sight (as traditional chemotherapy tends to do).

The implications are clear. The annual count of new drug approvals will only show a tick when a new cancer drug or a new statin gets its very first approval. But a new use for an old drug can be as valuable as an entirely new drug, or even more valuable when you consider that we know more about the safety profile of old drugs and one drug will sometimes do the work of two (preventing both heart attacks and strokes, for example)8.

Me-too products can sometimes have important advantages on tolerability or dosing. It could help create more competition and lower the price. If you have five me-toos, possibly the sixth is something that is a little better. That is for the plans to decide on behalf of their patients. And even if it has the same mechanism of action, more competition could help drive down the price of the entire class. That’s an important influence, with potentially an improvement in health from greater access.

How bad are they?

Even though the major problem of antibiotic therapy, namely drug resistance cannot be addressed by the development of “me-too” drugs, due to the propensity of the same class to develop cross resistance; in most cases, the new semi-synthetic derivatives had distinct advantages over the earlier ones. Thus, for example, the first generation Cephalosporins are useful for gram-positive infections, while the second-generation drugs cover a broader spectrum including gram-negative organisms. The third generation drugs provide resistance against the beta lactamase enzyme, as well as acting against some of the most intractable infections, such as those caused by Pseudomonas and Klebsiella strains.

Even while the pharmaceutical industry turns out families of me-too drugs for relatively mild conditions in affluent people, it pays almost no attention to serious diseases, such as malaria, affecting impoverished people. It also gives short shrift to less profitable drugs, so there now are shortages of some vaccines and life-saving drugs9.

The big problem with me-too drugs is that they are chemically very similar to other drugs already available, yet they are marketed as if they were important new breakthroughs, with very high prices. Many new, expensive me-too drugs are not necessarily better than older and less expensive drugs. Most of the time they are compared with placebos and not older drug comparisons.

“Me-too” drugs are responsible for 80% of increased spending in recent years, and on average they are four times more expensive than the comparable, older alternatives10. By Patented Medicines Pricing Review Board’s (PMPRB) definitions, at the time of their introduction “me-too” drugs were judged to provide moderate, little or no improvement – in terms of effectiveness and safety – compared to older alternatives. However, on average, “me-too” drugs cost about 2.5 times as much per prescription as comparable older drugs. The question is whether the perceived or real differences justify the increased costs. New drugs do have a role in some situations and for some patients. However, it makes sense to use the older equally effective drugs whenever possible11.

Changing FDA rules to discourage me-too drug approvals would make R&D far more expensive, would discourage competition and therefore raise healthcare costs, and would forestall the wave of new research that has revolutionized our scientific understanding of the therapeutic categories where competition has been most intense.

Conclusion

New drugs are not required to improve on old ones, and there’s usually no way to know whether they do. Although the FDA must test drugs before they are marketed, they don’t need to be compared with similar drugs already on the market. The FDA only requires they be reasonably safe and better than nothing-a low standard indeed. This loophole in FDA regulations opens the door for an unlimited number of me-too drugs, which are easier to develop than innovative drugs.

Given everything, it should come as no surprise that these more expensive “me-too” drugs cost the medical industry money. The prevalence of the me-too’s really says an awful lot about the lack of innovation within the pharmaceutical industry. If you look at the new drugs marketed over the last six years, 78 percent weren’t even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the F.D.A. as unlikely to be improvements over drugs already on pharmacy shelves.

At the same time, there are shortages of some important drugs that the pharmaceutical companies aren’t much interested in making because they are not as profitable as the me-too’s. But the companies don’t have to turn out needed drugs, if they are not lucrative. And they don’t.

References

1. http://www.medterms.com/script/main/art.asp?articlekey=33748

2. http://www.motherjones.com/news/qa/2004/09/09_401.html

3. http://polyscience.org/2005/09/me-too-drugs

4. http://www.shvoong.com/books/465475-me-too-drugs

5. http://www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=14604&sectionid=46

6. http://direct.bl.uk/bld/PlaceOrder.do?UIN=162532605&ETOC=RN&from=searchengine

7. http://www.archivum.info/sci.med/2005-09/msg00257.html

8. http://www.aei.org/publications/filter.all,pubID.27443/pub_detail.asp

9. http://blogs.wsj.com/health/2007/05/17/in-praise-of-me-too-drugs

10. http://www.chepa.org/KnowledgeExchange/LabelleLectureship/tabid/84/Default.aspx

11. http://www.ti.ubc.ca/pages/letter59.html

Patients on a placebo improved about 75 percent as much as those on drugs. Yoga, relaxation imaging, meditation, Cognitive Behavioral Therapy and other forms of therapy can help combat this debilitating illness.

Most common side effects of antidepressant therapy include sexual problems, drowsiness, sleep difficulties, anxiety, nervousness and nausea. While some side effects may go away after the first few weeks of drug treatment, others can persist and progressively get worse.

In adults over the age of 65, selective serotonin reuptake inhibitors pose an additional concern. Studies show that SSRI medications may increase the risk for falls, fractures, and bone loss in older adults. The SSRIs can also cause serious withdrawal symptoms if you stop taking them abruptly. Once you’ve started taking antidepressants, stopping can be difficult; many people have withdrawal symptoms that make it difficult to get off of the medication and may require opiate detox.

If you decide to stop taking antidepressants, it’s essential to taper off slowly. If you stop abruptly, you may experience a number of unpleasant withdrawal symptoms such as crying spells, extreme restlessness, depression, anxiety, dizziness, fatigue, and aches and pains. These withdrawal symptoms are known as antidepressant discontinuation syndrome. Antidepressant discontinuation syndrome is especially common with Paxil or Zoloft. However, all medications for depression can cause withdrawal symptoms.

Psychiatrists often do not offer patients non-drug treatments, nor do they conduct thorough medical examinations to ensure that a person’s problem does not stem from an untreated medical condition. At times, they might fail to inform patients of the nature of the diagnoses, which would require informing the patient that psychiatric diagnoses based on behaviors with little scientific or medical validity (no X-rays, brain scans, chemical imbalance tests to prove anyone has a mental disorder).

All patients should have what is called a “differential diagnosis.” The doctor obtains a thorough history and conducts a complete physical exam, rules out all possible problems that might cause a set of symptoms, and explains any possible side effects of the recommended treatments.

There are numerous alternatives to psychiatric diagnoses and treatment, including standard medical care that does not require a psychiatric label or drug. Governments should endorse and fund non-drug treatments as alternatives to potentially ineffective and dangerous drugs. Limiting drug treatment can lead to the reduction of drug addiction.

The resources below may be helpful for individuals looking for more information on the following topics:

Information about Non-Drug Approaches to Mental Health and/or Safely Getting Off Psychiatric Drugs

Safe Harbor includes links to find medical doctors (by zip code) who can assist with helping people safely get off of psychiatric drugs and medical personnel who will treat people without the use of psychiatric drugs.
http://www.alternativementalhealth.com

The Road Back — How To Get Off Psychiatric Drugs Safely
http://www.theroadback.org

Opiates is one of the five metabolite groups called SAMHSA-5 that can be tested for workplace drug testing under SAMHSA guidelines. The opiate drug tests detect the presence of codeine, morphine, and 6-acetyl-morphine. The presence of 6-acetyl-morphine shows recent heroin abuse.

Urine drug testing:
Urine test is a common method of detecting opiate and its metabolites in urine specimen. Morphine can be detected in urine for 2 days, codaine for 2 to 3 days and heroin for 3 to 4 days. The cutoff concentration for initial test of opiate metabolites is 2000ng/mL. The confirmatory cut off level for morphine and codeine are 2000ng/mL and 10ng/mL for 6-acetylmorphine.

Hair drug testing:
Many opiates can be detected using hair tests. Hair tests require a sample of hair about 90 to 120 strands. The standard hair screen uses the most recent 1.5 inches of growth for testing. Hair tests detect substance abuse over a long period. Morphine, codeine and heroin can be detected for up to 90 days using hair tests. The initial cutoff level for opiate metabolites is 200 pg/mg and confirmatory cutoff value is also 200 pg/mg.

Saliva drug testing:
Saliva tests are easy to administer and adulteration of the specimen can be avoided. Morphine and heroin can be detected in saliva for 1 to 2 days and codeine for 2 to 3 days. The initial cutoff concentration level for opiate metabolites is 40ng/mL. The confirmatory test cutoff level for Morphine and codeine are 40ng/mL each and 4 ng/mL for 6-acetylmorphine.

Opiate abuse continues be a serious threat to public health. The above information will surely help you to understand different methods of opiate drug testing and choose the better one to detect this harmful drug without much hassle.

The commonest drug tests are hair, saliva and blood drug examinations. In the case of hair drug tests keratin is made use of to check the drug. Keratin are dead cells paid off of protein.  Hair samples can be collected from anywhere in the body. To pass hair drug test, Detox products like shampoo are accessible which places sealer around the cuticle scales which no solvent can dissolve. These shampoos are commercialized in various names like ultrakleen shampoo, test pass deluxe shampoo etc.

If you swallow detoxifying capsules you will clear the drug test for urine. These do the work of a flushing chemical that eliminates metabolites from the body. This product speeds urinary process temporarily, letting the body to break down the metabolites. Capsules are effective from 1 hour after ingestion to about 5 hours.

Do you know that a drug test is coming up soon? In this case, do not eat marijuana anymore. If your abstinence period is long you will pass the drug examination. The main psychoactive substance in marijuana is known as THC. For random test, THC urine test is opted. The period of time for which THC stays in the system differs from person to person. One way to pass a drug test is to cleanse your system in natural way. Drink lot of of liquid and do physical exercise. For those of you who want to know how to pass a drug test at a short notice then keep in mind that consuming some aspirin a few hours ahead of the test may help to pass a drug test, else detoxin kits are commercially obtainable to clean THC from the system.

A clear urine sample looks shady. The laboratory might nullify it. Consume vitamin B to come out of this situation. You can obtain Vitamin B in detox drinks or tablets. This is one point that you require to remember if you wish to know how to pass a drug test. If you have enough time ahead of the test, you may go for detox seven days cleansing programme or 10 days Hair-Urine-Blood cleansing program. For particulars on how to pass a drug test, log on to passthedrugtest.com.