Since the time of Hippocrates, willow bark extract was known to diminish pain and inflammation. Lewis and Clark drank willow bark tea, not knowing the chemistry behind the effects. By the mid 1800s, however, industrial chemistry was off and running, and the active ingredient, salicylate, was discovered. In 1897, a scientist at the German firm Bayer wanted to help his father’s arthritis and set about creating a compound of salicylate that was less irritating to the stomach lining. He developed modern “aspirin,” or acetyl-salicylic acid, and within two years the drug was selling around the world. It not only changed the lives of arthritis victims, but it inspired chemical companies to search for other new medicines thereby launching the pharmaceutical industry.
Everyone has heard the quip that if aspirin were invented today it would never make it through the U.S. Food and Drug Administration, or FDA. And that may well be true. Aspirin has caused numerous deaths over the years – mostly from gastric bleeding, but some from overdose and allergy. In the flu pandemic of 1918, some of the deaths are postulated to have resulted from aspirin overdose, not the viral disease, per se. And although it is probably the cheapest anti-inflammatory out there, it cannot be said to be unique. Since 1957, the FDA rules not only on safety, but on efficacy and now on redundancy. In other words, if you produce a drug that offers no improvement over current drugs – even though safe and efficacious – you are likely to be prohibited from marketing it.
Notice it took less than two years to get aspirin from bench studies to worldwide distribution. Today, on average it takes 15 years of a drug company’s time and research and development resources to pass through the sphincter of the FDA. What is the result of this long, drawn-out process? Are we – as they claim – safer? I think just the opposite.
In medicine, we speak of errors of “commission” – problems from administering a treatment, and errors of “omission” – errors that arise from failing to give treatment. The FDA supposedly prevents harmful drugs from getting to market (an error of commission) and points to its withholding approval for thalidomide – a mutagenic drug approved with damaging effect in Europe – as its model for safety.
But in truth, the dangers of thalidomide were determined by doctors in the field, not government office workers, and the FDA stalled for reasons totally unrelated to the eventual findings. They took credit – rather like taking the score when a pool ball unexpectedly falls into the correct pocket. Never look surprised. Look like you meant it.
But the FDA makes us all – in the words of Sam Kazman of the Competitive Enterprise Institute – “silent victims” due to “errors of omission.” We are being deprived of life-saving drugs because it is intrinsic to the FDA to stall approval.
Some of the wasted approval time is just more government bureaucratic nonsense.
Even the current FDA Commissioner Margaret Hamburg conceded before Congress, “The FDA is relying on 20th century regulatory science to evaluate 21st century medical products.”
But the real truth is more one of human nature. As Mr. Kazman points out, the most devastating problem to an FDA regulator is not some silent death in Kansas due to lack of a new cardiac drug, but rather injured patients lined up before a congressional committee testifying about a drug that was passed.
As a variant on the principle that if you do nothing you can never be wrong, FDA regulators’ self-interest is best served by passing the fewest drugs possible. During one 10-year period, not one new cardiac drug was approved – and this from the world’s leading pharmaceutical industries.
So, the next time you hear an FDA honcho at a press conference bragging how they will be saving 35,000 lives each year with the new cardiac drug they just passed, remember the 35,000 people who died each year waiting 15 years for that FDA approval.
And it is important to realize that the FDA is not a team of crack researchers – although it does incestuously employ former drug company people – nor is it a group of actively practicing physicians. They are paper pushers.
When the anti-inflammatory drug Vioxx came out, as an orthopaedic surgeon seeing a high volume of patients, I tried using it. It had undergone “extensive testing” and “FDA approval.” Within three weeks, I advised my patients to get off the drug, told my office manager not to refill any prescriptions, and had her call all of our patients we gave the drug to and suggest they switch to another brand. Within three weeks of observing patients, I had seen too many side effects, the same side effects that caused the FDA to withdraw the drug from market three years later.
Now I am not the brightest bulb in the box, but when it comes to evaluating treatments, I will stack the cumulative experience, clinical skills and knowledge of a nation of physicians over a few government wonks any day.
And then there is cost. It has been estimated that 25 percent of the cost of any drug is due to the FDA. I suspect it is higher. If aspirin is any indication, what the FDA drags out into 15 years could be done in two or three.
Between 1994 and 2004, according to a study from the FDA itself, the utilization of NMEs – new molecular entities (i.e. new drugs) – went down by nearly half while the cost of research nearly doubled. And this in an age of computerization, sequencing of the human genome and efficient chemical engineering. The lost opportunity and costs are staggering.
There is another result of the long FDA approval: dishonesty. Again, consider human nature. When raising children to be honest, does it help to punish them severely for being honest about mistakes? Or does it cause them to hide their mistakes? When the cost of honesty is too high, there is a tendency to dishonesty.
In a free market, such as the environment for the creation of aspirin, when a line of research proves unsafe, it is easy to drop it and move on – because the research and development costs are relatively low company expenditures. But when the major company budget is sunk into a product now 13 or 14 years into the FDA approval pipeline, what will the company do if problems are noticed?
Obviously if serious life-threatening issues arise, they cannot avoid withdrawing the drug. But how about lesser problems that may be “under the radar”? It would only be natural for companies heavily invested in a drug to minimize problems toward the end of development so as not to lose their considerable investment.
So what is the answer? Remember when the Good Housekeeping Seal of Approval meant something? Or name brands? Manufacturers were free to produce products, and you as the consumer were free to choose name brands you trust over white labels, Seal of Approval items over those not-so-blessed.
If we can’t disband the FDA – which would be my first choice to save untold taxpayer dollars – let’s at least make it an advisory board. You can choose to take unapproved (and thus cheaper) drugs, or you can pay more for the FDA-approved variety.
Keep in mind, in our litigious environment it is certainly not in the best interest of any drug company to produce a bad drug.
And in my hypothetical system, cancer victims are free to seek “unapproved” treatments, not having the luxury to await 30-year clinical trials. Drug prices would come down, not only for the big companies, but because now little companies could compete, and competition always reduces price. Most importantly, the marvels of today’s science, instead of being throttled by overregulation, will be unleashed to create a marvelous new world of medicine.