“No one should approach the temple of science with the soul of a money changer.”

Thomas Browne

Opposition from Big Pharma

Obviously, this is about money.  Meds prescribed for depression, bipolar, PTSD, anxiety, etc., generate tens of billions in revenue per year.  For decades these drugs have provided some of the largest income streams for the pharmaceutical industry.  Consider the business model of these drugs to understand why ketamine is a threat to them:

  • A pharma company spends huge sums to develop a new psychotropic drug and get FDA approval, up to $5B. Often, the drug is only a tiny bit different from the others in its class.  But that small difference is enough to secure a patent.
  • The patent means no one can manufacture the drug except the company that developed it. They are free to charge whatever they want, because there’s no competition.  The company sets a price that will recover the cost of development and also provide a profit.  Even after accounting for the fact that the company spent a lot before it sold a single dose, the profit margin on a new, patent-protected drug is often colossal.  These drugs provide shareholders with returns many, many times the original investment.
  • The company identifies doctors and hospitals that can influence other medical professionals, and it pays them to prescribe the drug, which makes other doctors feel confident about prescribing it themselves. (Elsewhere this would be prosecuted as bribery, but it’s completely legal in the US.)  The drug is marketed aggressively to consumers, often with ads that say “Ask your doctor if X is right for you.”  If the marketing and payoffs succeed, potentially millions of patients could be prescribed the drug.  Psychotropics are often very hard to quit, so millions of patients could be locked in as long-term revenue sources.
  • When the patent expires, anyone is permitted to manufacture generic versions of the drug, and the company’s monopoly disappears. Prices will fall dramatically, up to 95%.  More companies will get in on the game.  They can earn money selling a generic version, but competition will keep their profit margins modest.

Ketamine is an old, generic drug whose patent expired long ago.  It’s one of the most widely used drugs in the world, and dirt cheap.  Even if ketamine therapy becomes universal and ketamine production soars, it will never produce blockbuster profits, because competition will keep prices low.

Obviously, there’s vastly more money to be made with a patented drug.  Drug development is conducted by commercial enterprises whose goal is profit, not altruism.  Like any business, they will do what is in their financial best interest.  So the drugs that will be brought to market are those that are the most profitable, and not necessarily the most effective.

Follow the Money
Prescribing psychotropic meds used to be something only done sparingly, and only by psychiatrists, who presumably had specialized training and knowledge of how these drugs affected the brain. But thanks to relentless and effective marketing by pharmaceutical companies, today 80% of psychotropics are prescribed by non-psychiatrists, usually family doctors. This has created a colossal new market for psychotropic drugs, which have racked up trillions in global revenue over the past 25 years. Here’s an interesting look at how antidepressants have been marketed through the years.
Big pharma has a lot to lose if a more effective, cheap, fast-acting, generic treatment were made available to patients who today spend predictable billions on Zoloft™, Cymbalta™, Paxil™, Prozac™, Celexa™, Luvox™, Depakote™, Lamictal™, Effexor™, Lexapro™, Seroquel™, Remeron™, Wellbutrin™, Abilify™, Neurontin™, Topamax™, Parnate™, Nardil™, Marplan™, Norpramin™, Anafanil™, Pamelor™, Sinequan™, Surmontil™, Risperdal™, Zyprexa™, Desyrel™, Pristiq™, Fetzima™, Latuda™, Brintellix™, Edronax™, Vivalan™, Geodon™, Deanxit™, Symbyax™ . . . . . . . you get the idea.

So what happens when a new use is found for an old, generic drug like ketamine?  Since it’s already FDA approved for other uses, doctors are free to use it off-label on depression.  But without FDA approval for this new use, insurance won’t cover it.  To get FDA approval, someone must invest billions to conduct FDA trials.  Which pharmaceutical company will make that investment when ketamine can never produce enough profit to recover the cost?  Answer:  none of them.

Each time a new patient has successful ketamine therapy, it costs big pharma.  Each time a new doctor starts offering ketamine therapy, it costs big pharma.  Those are lost opportunities to sell patented, high-margin drugs to the same patient year after year.  It not only threatens the revenue stream of existing drugs, but also those in the R&D pipeline.

Of all the forces opposing ketamine therapy, this one is the hardest to mitigate.

Misleading Consumers
Patients who are prescribed SSRIs are often not fully informed of what they may face when they try to discontinue the med. Withdrawal syndromes for these drugs can involve extreme physical and emotional symptoms, even suicidality. Once a patient gets on an SSRI, they may find it impossible to get off later. Even if the drug doesn’t help their condition or the side-effects are unbearable, the withdrawal syndrome can be even worse. Patients often try to quit these drugs repeatedly over several years without success. “Hooked” patients like these will produce reliable revenue for years. For example, in this document by the FDA and posted on its website, the agency details how one SSRI manufacturer allegedly misled consumers and failed to acknowledge an extremely severe discontinuation syndrome.
Big pharma operates within a larger system that also includes the government (FDA), academia, doctors, hospitals, and capital markets.  This system has no safeguards to ensure that drug development provides maximum benefit to society, or maximum relief to patients.  Pharma is free to pursue profit to the exclusion of all other factors.

It’s understandable why pharma opposes ketamine therapy as a threat to shareholder value.  Is it reasonable to expect a for-profit company, in a capitalist economy, to act against its own financial interests?  That question would be easy if we were talking about an industry that deals in non-essential products like toys or handbags – the answer would be no.  But in reality we’re talking about human suffering:  one million suicides per year, years of lost productivity, and hundreds of millions living lives of abject misery.

Big pharma is just the largest moving part in a badly broken system.  This system allows profit to trump patient wellbeing by making FDA approval impossible in spite of overwhelming scientific evidence that ketamine therapy works.  It rewards companies that pursue the most profitable drugs instead of the most effective ones.  It nurtures conflicts of interests by allowing researchers to be on big pharma payrolls at the same time they perform research in the public interest with taxpayer funds.  The list goes on and on.

We don’t know how to fix this system.  The issue is much too large for us, and it’s charged with politics, ideology, money, and power.  There are other organizations that work on this issue.  Seek them out if you’re interested.  Here, we simply want to explain this immensely powerful force opposing ketamine therapy.

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