Large Prescription Drug Companies Lack Innovation In New Drug Development,Wall Street Journal Letter States
Main Category: Pharma Industry / Biotech IndustryArticle Date: 08 Jul 2008 - 9:00 PDT
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Large drug companies that "license or otherwise acquire discoveries from universities or small biotech companies, then develop them for commercial production and sponsor the clinical research necessary for FDA," are "hardly creative in the scientific sense," Marcia Angell of Harvard Medical School writes in a Wall Street Journal letter to the editor in response to an opinion piece published on June 28 (Angell, Wall Street Journal, 7/7).
Benjamin Zycher, a senior fellow at the Manhattan Institute, in the opinion piece wrote that it is "current mythology" that "most drug innovation comes from publicly funded research." He wrote, "All or almost all of the drugs and drug classes would not have been developed -- or their development would have been delayed significantly -- in the absence of the scientific or technical contributions of pharmaceutical firms" (Kaiser Daily Health Policy Report, 6/30).
According to Angell, "[T]he examples of innovation (Zycher) cites date back to the 1980s or earlier," adding, "Nearly every top-selling drug today has progenitors dating back many years, often based on NIH-funded research in universities." She continues, "The problem with this sequence -- publicly funded innovation handed off to the drug companies -- is that the industry expects to be rewarded as though it were the source of innovation, pricing drugs as high as the traffic will bear and doing everything possible to extend its exclusive marketing rights." Angell concludes, "The only really innovative thing about" the pharmaceutical industry today "is the claims of its apologists" (Wall Street Journal, 7/7).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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Development Without The Research
posted by Dan on 8 Jul 2008 at 3:34 pmThe Potential Fallacies Associated With Me-Too Medications
“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 our government at all 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. Also what has been stated by this industry that their internal controls prevent wrongdoing? So, according to some, the public’s health would be limited and possibly harmed without the copious innovation of this industry. 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, and 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.
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients. 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. This inefficient drug development 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. 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 their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.
And 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 making 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. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions. The differences overall are minor once again with most me too drugs, overall. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, 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 meds. 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, they license molecules from those in the academic world, and then proceed with development of another’s creation they claim as their own.
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. This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending, yet it can be speculated that the me too drug makers claim uniqueness of their me too drug, which is rather deceptive.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems. 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 potentially for the public health if the objectives were focused on their true purpose. Yet 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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