Thursday, March 5, 2009

Pharmaceutical Plagarism

The Fallacies Associated With ‘Me-Too’ Pharmaceuticals

“But corruption is neither need based nor greed based. It’s simply opportunity based.” -----Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.

It has been said by others that the pharmaceutical industry should not have government regulation or interference from anyone interfering with their autonomy- because that would drastically limit if not eliminate their progressive innovation regarding the restoration of the health of others with their drugs.

Also what has been stated by this industry that their internal controls prevent wrongdoing, so there is no need o be under surveillance. So, according to some, the public’s health would be potentially unfulfilled and possibly harmed without the copious innovative products of this industry.

As with other issues we face as citizens, this is another attempt by an industry that is constantly attempting to integrate fabricated fear in our minds- void of any proof or reason, and this is a fallacy.

As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall, those innovators and lifesavers of the past.

Over the last several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement. Of all drugs approved by the FDA, few offer any clear clinical advantages over other drugs for certain patients.

The approved drugs, called new chemical entities, that have been FDA approved lately which were developed by drug companies, possess microscopic therapeutic advantages over existing drugs that are presently prescribed for particular patients.

This inefficient drug development process by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased, ‘me too’ drugs.

These drugs essentially are small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project. That’s why you have a half a dozen statins or ARBs available to you. The are all equivalent, biochemically.

This ‘me too’ objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a pending drug awaiting approval to only be slightly superior to a placebo, the copies of drugs that already exist are approved by the FDA.

While unnecessary, these me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market or disease state, which means the drug company who develops a me too drug hopes to eventually make over 1 billion dollars a year on such a drug, at least.

For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. While unnecessary for the health of others, this is where the research dollars are going with those in the pharmaceutical company.

As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected. They create clinical trials to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class both during and after the creation of these me too drugs. Yet again, if they are in the same therapeutic class, they are all essentially the same regarding efficacy and safety.

Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.

Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, some me too drugs occasionally are beneficial for patients for some reason or another, but should absolutely not be a primary objective of the drug companies to create them as often as they do.

Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry presently. It appears that, thanks to the Bayh-Dole Act of 1980 in the United States, the pharmaceutical industry is allowed to license newly created synthetic small molecules from those in the academic world, and then proceed with development of another’s creation that the pharmaceutical company will claim as their innovation to the public.

Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is greatly demonstrated with other industries and is the apex of business operations in the United States.

This pharmaceutical industry model is an exception to typical business operations, and the reason for this remains an unknown, as far as the etiology of those who take their drugs being deprived of expected cost reduction in this costly environment of drug spending. So a drug company comes out with a me too drug, and claims it is unique rather deceptively, so there is no cost advantage for the consumer.

This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely created for their own profit, clearly illustrates their focus on their avoidance of true research and discovery for the sake of their own profit viewed by them as of being of greater importance.

Innovation, along with ethics, use to define this pharmaceutical industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods for the public health. Perhaps more cures and more therapeutic options would be available if the objectives of the pharmaceutical industry were for the benefit of the health of others.

Hopefully, such historical qualities of drug companies will return some time, in time.

“Most people are other people. Their thoughts are someone else’s opinions, their lives a mimicry, their passions a quotation.” --- Oscar Wilde

Dan Abshear
Author’s note: What has been written was based on information and belief.

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