The Deception Of Pharmaceutical Innovation

Many of us are under the perception that the pharmaceutical industry is an industry of innovation to improve and restore the health of others. Not necessarily. It has been said by others that the pharmaceutical industry should not have government regulation or any interference from our government because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others. The inference is that the public’s health would be limited and possibly harmed from such mandated control regarding this health care issue. As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason, quite possibly. As it has turned out, the pharmaceutical industry has appeared to have created what was claimed to be undesirable results on their own, overall. Innovation by the pharmaceutical industry appears limited. Managed care, another for profit organization, limits our health care choices and options, in one way or another. And unfortunately, harm has been caused by this industry to others. Seems the government was not needed for these conclusions by such corporations to thrive regardless. Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by research and discovery with government involvement in possibly over half of these meds with clear clinical and novel advantages for certain patients, it is believed. Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief, and these meds have become known as me too drugs. This inefficient or lack of drug research by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is the development of certain medications that would allow a me too drug to be profitable, so it seems. With these me too medications, drug companies essentially make small molecular variations of an original molecule in a particular class of medications to begin development of their cloned drug. In other words, they tweak the original molecular design in a new member of a particular class of medications, with the hope of profit, yet absent of true innovation. 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 potential med to be superior to a placebo in at least two mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others regarding their treatment regimens, and

because of this, drugs in a class become plentiful and numerous, as usually these drugs are members of a very lucrative class of medications. So it seems that the me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means the drug company intends on making over 1 billion dollars a year on such a drug, at least, which happens at times with me too drugs due to the size of a particular market. For example, statin drugs, for high cholesterol patients, is a 20 billion dollar market, it is believed. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to that is so often saturated with me too meds, with few exceptions. The differences overall are minor once again with most me too drugs, and competition certainly exists between them. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning at times to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class through statistical gymnastics, perhaps. In addition to statin drugs, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension, such as a class called ARBs. There may be a dozen drugs in a particular class that are all essentially the same in regards to their treatment abilities for patients with such disease states, as well as their mechanisms of action. On rare occasion, a me too drug might actually superior, such as Lipitor. Then again, a me too potentially could be more toxic as well. Also, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, the me too drugs occasionally are beneficial for patients, but should absolutely not be a primary objective of the drug companies to create them as often as they do, one could posit. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and this seems to be absent and void of existence today compared with their objectives they had in the past. 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, as price differences in certain classes of medications are minimal at best. This fact of price reduction is normally demonstrated with other industries and is the apex of business operations. With the pharmaceutical company, one could conclude that its industry is one of collusion with its colleagues than actual competition that benefits the patients. This pharmaceutical industry

model is an exception to what is a typical result that happens in other industries, and the reason for this remains an unknown, as far as the etiology of patients being deprived of this costly disadvantage. The etiology maybe can be explained by one who is an expert in economics, yet my opinion is that of a layperson regarding this issue. This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their apparent focus on these issues over true research and science. 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 and products for the public health. Yet hopefully, such historical qualities of drug companies will return some time, which would require a paradigm shift that does not appear to be happening presently. "Tell a lie loud enough and long enough and people will believe it" --- Adolph Hitler Dan Abshear