I have been prescribed a combination of two very expensive anti-cancer drugs, Mekinist and Tafinlar. The manufacturer, Novartis, has instructed me to keep the small pink Mekinist pills refrigerated in their original plastic vial and take one each morning on an empty stomach. I am told to take two unrefrigerated Tafinlar capsules, twice a day — also on an empty stomach. The Novartis literature doesn’t say why I must keep and take the medication in this pattern, and my oncologist can’t explain it, either.
That said, early indications are that the two medicines are slowing the progress of my inoperable bone cancer. That’s good. The first time I paid for a month’s worth of the medicine the bill was $2,600. Six months later, the cost had jumped to $3,006 — an increase about double the rate of inflation. No one has offered an explanation for that, either.
While the pharmaceutical industry and its army of supportive medical professionals hold that I should shut up and just be grateful that these drugs are, apparently, extending my life for a few months, I don’t see it that way.Â
On the contrary, I feel uncomfortable accepting the imperialistic ways the American medical industry dispenses both its wisdom and its products to consumers.
I am frustrated that the public — or the myriad agencies that represent us in the medical arena — don’t demand that drugs be more patient-friendly and transparent. Why, for example, does Mekinist need to be refrigerated, but not Tafinlar? Why do I take one pill of one medicine, but two of the other? Why do I take one once a day, and the other twice a day? Couldn’t the two medicines or the doses be combined?Â
The FDA doesn’t require answers to these questions. All it wants to know is whether a new drug, medical device or surgical procedure can be shown to be both safe and effective. No one is looking to “improve” the product, only to develop sufficient data to get it on sale.Â
The last thing Big Pharma cares about, seemingly, is whether the new drug can be made easier to consume or less costly to its prospective users. But drug companies might get interested in those two issues if competition were introduced into the prescription drug arena.Â
But Big Pharma, of course, is not interested in competing for earnings. The drug companies are perfectly happy with the stunning profits they can generate with their patent-protected monopolies. Yet all of us know how competition can bring improvements that benefit consumers.Â
In fact, competition happens in nearly every corner of the American economy except those regulated by the federal government. So, the question is whether competition can be introduced in the government-controlled prescription drug space to encourage medicines to work better (and perhaps cheaper) for consumers.Â
Drugs like Mekinist and Tafinlar are protected by patents, which give the inventor exclusive rights to the methodology in exchange for disclosing its details.Â
But consider this: What if another company were to see a way to improve a patented, lucrative proprietary drug — and could demonstrate that the improvements would significantly benefit consumers in terms of convenience, price or efficacy? Why shouldn’t that company be granted a second patent for its innovations and become a competitive seller of the same drug? Wouldn’t the public be better served by such a change? (We know all about the cost of bringing proprietary drugs to market, but shouldn’t that fall on deaf ears when so much of drug development these days involves huge chunks of public money for their development?)Â
More interestingly, it might be easier politically to improve patent law than change drug regulations. For one thing, Big Pharma does not own the legislators or bureaucrats in the Congress and executive branch that control patent policy in the same way they own these groups in the medical field through the jobs, campaign contributions, travel opportunities, speech honoraria, research grants and the like they offer to elected and appointed career public servants.Â
But hear the consternation from Big Pharma at this suggestion: A threat to the Golden Goose of endless profits must be squashed now. But why shouldn’t we disrupt the proprietary drug industry in a way akin to how Amazon changed the bookselling business? And why shouldn’t the intellectual property lawyers be at the forefront of the revolution, given all the new business they might generate?
Over the years, the drug industry has corrupted the way our government is supposed to work. We must end it. And only we can. Urge your doctors and elected representatives to consider changing the patent rules governing medical inventions to benefit consumers as well as our health.
Godfrey Harris is a public policy consultant based in Los Angeles.