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Nationwide Shortage of Tamiflu – and Other Good News
In March 2000, doctors in most of Israel went on strike. Deaths dropped by 20% – except in the areas where physician contracts stopped them from striking. Sometimes less is more, at least in the short term.
With this background, consider oseltamivir, brought to market by Roche more than 20 years ago, branded as Tamiflu and prescribed for adults and children with influenza A. It has been wildly successful, and even after prices dropped when the drug went generic, its world-wide market exceeds one billion dollars. Suppose oseltamivir became unavailable during a bad flu season. Would that cause a health catastrophe – or would it look more like an Israeli doctors’ strike?
Don’t just stand there – do something.
My healthy ten-year old grandson recently saw his pediatrician after 4 days of fever, aching, and cough. The doctor ran a test to confirm Influenza A, and prescribed 5 days of Tamiflu. Of course he did. Doctors find it very difficult to simply reassure patients about self-limited illnesses; a prescription drug conveys the doctor’s concern and authority. After the first dose made the patient nauseated, my daughter sought my opinion. I advised that the benefits of the drug are greatest when started promptly, and the FDA approval specifies a 48-hour cutoff. My grandson’s symptoms had already bee been present for twice that long. Starting the drug late carries all the harms and little of the benefit. The script was ‘off-label,’ i.e., perfectly legal to prescribe, but outside of FDA guidance.
My daughter put the drug up on the shelf. The next day she developed all the same symptoms that her son had had initially – almost certainly Influenza A. This was the ideal situation for Tamiflu to work its wonders. Should she take it? This called for a quick look at the evidence.
The dubious provenance of a “World Health Organization Essential Medicine”
US and European regulatory agencies approved the drug in 1999 for prevention and treatment of Influenza A. It was wildly successful. The W.H.O added it to their Model List of Essential Medicines, and governments stockpiled billions of dollars of it in anticipation of future pandemics.
Tamiflu had been approved based on ten studies, only two of which were published, and all of which were conducted or heavily influenced by the manufacturer. The British Medical Journal had to conduct a multi-year legal campaign to get a look at all those unpublished studies.
Many years ago, a Scottish physician named Archie Cochrane advanced the idea that medical treatments should be adopted only when careful studies showed them to do more good than harm. The Cochrane Collaborative carries on his philosophy today. In 2014 a team of Cochrane researchers led by Dr. Tom Jefferson reviewed all that was then known about oseltamivir. They concluded that the drug shortens symptoms in adults by about 17 hours. It does not save lives or even keep patients out of the hospital. It might prevent pneumonia in one patient in a hundred. It causes vomiting and headache. When used as prevention, it reduces symptoms but does not reduce spread.
Governments’ fiduciary duty to protect the profits of Big Pharma
Spending billions to stockpile a drug that does not reduce the spread of a disease? Again, Dr. Jefferson to the rescue. In early 2020 he brought a whistleblower suit in U.S. Federal Court, accusing Roche of making false claims and demanding $1.5 billion, the amount that US public health authorities had spent to stockpile the drug. Our government’s response? In November 2022, the US Department of Justice asked the judge to throw out the case.
In the era of COVID, most western governments have been eager to recommend, and purchase, enormous quantities of drugs and vaccines, approving a hybrid COVID vaccine after it boosted antibody levels in 8 mice, and promoting vaccines and Paxlovid for groups never shown to benefit from them (and least likely to). As I write this, the federal government is responding to the Tamiflu shortage “crisis” by releasing supplies from its stockpile, in the absence of evidence that it will slow disease spread or save lives.
It is nothing new for Big Pharma to outsource its marketing department, and not just to public health authorities. We have seen it for years in industry-sponsored Continuing Medical Education, and in the recruitment of ‘thought leaders,’ influential doctors who travel the country shilling product in return for cash and perks. But until last year I had not noticed health insurers joining the game.
The Parable of the Wise and Foolish Patients
In The Gospel According to St. Matthew, chapter 25, Jesus tells a parable of the 10 wise and the 10 foolish virgins. The wise ones prepared for a long night vigil by bringing extra oil for their lamps; the foolish ones did not, and missed the wedding party. A parable is a simple story that draws an important lesson from a minor everyday event. The genre lends itself well to moral teaching, but does not transfer well to complex decisions about medical treatment.
In the fall of 2021 I got a letter from the Chief Medical Officer of my insurance company, UnitedHealthcare, offering me their WellAtHome kit. To help me through the anticipated flu season, United would send me a thermometer, a home COVID test, a 5 day supply of Tamiflu, and a number to call for a telemedicine visit. The theory was that if I felt sick and had a fever, I would take the COVID test, then consult the Tel-E-Doc. If the test was negative, I would start Tamiflu at once for presumed influenza.
To motivate me, United showed me two brief clinical vignettes. The first video showed a member who took his temperature, had a negative COVID test, called the service, and took the Tamiflu. That patient recovered quickly and did not need any further medical care. The other member did not have the kit, waited 3 days to call his doctor, missed the opportunity to benefit from Tamiflu, and needed a long and debilitating hospital stay.
This simplistic narrative grossly misrepresents the data, and I wanted to correct it. Unfortunately, United’s C.M.O. didn’t leave me his cell phone number. I called Member Services, explained that the entire premise of their campaign was faulty, and tried to talk my way up to the medical department. I got only a promise that somebody from that department would contact me about my concern.
Back to that Tamiflu script
Both patients recovered without anti-viral therapy. Had either of them completed a course of the drug, a True Believer patient, or doctor, would have interpreted their recovery as showing a benefit from the drug.
We were cautioned about this kind of thinking 150 years ago when Oliver Wendell Holmes, Sr, physician, poet and essayist, said “I have learned at least three principles … not to take authority when I can have facts, not to guess when I can know, not to think a man must take physic because he is sick.”
Roche would not have hired Dr. Holmes as a thought leader.
Mark Buchanan, MD is an internal medicine physician. Now retired from clinical care, he teaches ethics at the University of Connecticut School of Medicine.
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