COVID-19 shows we owe the pharmaceutical industry an apology
Here is where the pharmaceutical companies’ strength played a role, by taking up a challenge to which a weaker industry would not be equal.
By KFIR LUZZATOThe pharmaceutical industry must be allowed to continue developing and growing.(photo credit: PIXABAY)The pharmaceutical industry is something people love to hate. They have the drugs we need to stay healthy and won’t part with them except in exchange for hard cash; therefore, people conclude, they must be evil. And besides, the “free stuff for everybody” gang feels that pharmaceutical companies make too much money for their own good. The ideal some of these people fuzzily aim for is to have pharmaceutical companies dish out excellent cures for our illnesses and deliver them to us if not entirely for free, at some token price that won’t let them “enrich themselves at our expenses.”Unfortunately for them, it doesn’t work this way.If you can mention one drug discovered, developed, and brought to market by the government, please stand up. Anybody? I didn’t think so. Governments don’t discover or manufacture drugs; pharmaceutical companies do. But, here’s the catch: taking a new drug from discovery, through regulatory approval and finally onto the market costs money – a lot. We are talking typically about several hundred million dollars, and up to the billion-dollar bracket for a single drug. Who, in their right mind, would invest that kind of money without having a fair chance of making a profit? And the gain has to be commensurate with the investment; otherwise, that money would be invested elsewhere. It follows (which is not rocket science) that if we want a pharmaceutical company to invest hundreds of millions of dollars in developing a new drug that we need, we should pray that their return on investment will be hundreds of millions of dollars so that they will be around, capable and willing to develop the next drug.And that’s not all – what we, the consumers, know and see, is a costly drug making a fortune on the market. It pains us to think that the company that sells it is profiting from the misfortune of others. What we do not see, however, are the numerous drug candidates that failed before that drug hit the market, each of which cost a bundle. Drug discovery and development processes are long, expensive and often disappointing. A drug candidate may show promise in animal studies and human studies and fail just before the finish line after mind-boggling sums have been spent on it. A study carried out jointly by BIO, Biomedtracker and Amplion, covering the years 2006-2015, shows that the probability of a drug that passed Phase I to obtain regulatory approval is a mere 9.6%!Human studies are conducted in different stages, typically referred to as Phase I, Phase II and Phase III. In Phase I, healthy volunteers are given various dosages of the drug to assess its safety. Published data indicate that approximately 30% of the drug candidates fail in Phase I, which is merciful, because at that stage the massive investment had only begun.In Phase II, dosages found safe in Phase I are tested on a few hundred patients suffering from the disease that the drug seeks to address. That will determine its potential efficacy and, again, check for undesirable side effects. Here, too, about one-third of the drugs continue to the next stage.If the results of this phase show promise the drug goes into Phase III. There, thousands of patients are treated for as long as is needed to obtain statistically significant results, which would satisfy the onerous requirements of the regulatory authority, such as the US Food and Drug Administration. The FDA then studies these results and decides whether they can approve the drug for clinical use. Approximately 25% of the drugs that get into Phase III make it to approval.Some drug candidates drop out of the study when unexpected side effects are discovered, when the results point to disappointing effectiveness, or for other reasons that bar them from becoming commercial drugs. When this happens, the company that was developing the product is left with a gaping hole in its bank account and no way to recoup the investment.And then, when the company thinks that it has finally succeeded and is starting to make some money off the product in which it invested years of hard work and precious capital, here comes the regulatory authority and revokes the marketing approval. This may happen because of something that has been discovered after they originally approved it. Last October, for instance, the company AMAG Pharmaceuticals learned that a recommendation was made to the FDA to revoke the accelerated approval for its drug, Makena, due to a supposed lack of effectiveness.These facts are not evident to the general public. We only see how the pharmaceutical industry is vilified by people who think it is bon ton to attack it for being greedy and insensitive. I’m not saying that greedy companies don’t exist – some companies probably are, but not all pharmaceutical companies are created equal.The problem stems from our inability to state the simple truth: it is okay for an industrial company to make a profit and try to maximize it. Nobody will think of an ice cream company as “greedy and insensitive.” Nevertheless, most ice cream companies will do all they can to maximize their profit. The difference, they will tell you, is that you don’t have to have ice cream, while you must take a drug to stay well. That is true, but the other difference is that if the ice cream company goes bust, you can buy your ice cream elsewhere or give up ice cream altogether; however, you cannot afford to have the pharmaceutical company that makes the specific drug you need go bust, because if it stopped making the drug, or didn’t have the necessary funds to develop its next, improved version, you might not be able to get it elsewhere. The logical conclusion should be that we must support the pharmaceutical industry and hope it thrives and discovers and develops more drugs. Who knows, perhaps it may come up with the onedrug that can save our life in the future.And then along comes COVID-19COVID-19 unintentionally vindicates the pharmaceutical industry. For people familiar with the development of vaccines, the accomplishment of several pharmaceutical companies that developed a COVID-19 vaccine in a matter of a few months is simply amazing. Under ordinary circumstances, it takes years to reach a point where a vaccine can be approved.The COVID-19 vaccine given to medical staff at Ichilov Hospital on December 20. (Photo credit: Marc Israel Sellem)Here is where the pharmaceutical companies’ strength played a role, by taking up a challenge to which a weaker industry would not be equal. Making this happen is not just about intellect or even a mere matter of funds; it requires sophisticated equipment, outstanding scientists, and a research and development infrastructure that can only exist in a thriving industry.To maintain all those capabilities, the pharmaceutical industry must be allowed to continue developing and growing. Unfortunately for some who are displeased by their success, that cannot happen if we don’t allow them to make a profit. We don’t want to see investors and pharmaceutical companies take their money and invest it in real estate, electronic gadgets, or other lucrative markets from which our life does not depend; we want them to stay put and invest in the pharmaceutical industry to improve our and our children’s chances to fight insidious disease.So I would like to suggest to all those people who, to date, have failed to recognize the value of a healthy, prosperous pharmaceutical industry and, instead, have attacked it on every occasion, that this is a good time for you to say, “I’m sorry!”■The writer is a patent attorney and the president of The Luzzatto Group
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