The Law Most Likely to Kill You
by Mary Ruwart
many as 1 out of 3 people who have died from disease in the last
40 years did so needlessly because of a single law passed by Congress
in 1962! Here’s my "insider" story.
19 years, I was a research scientist with the Upjohn Company, a
mid-sized pharmaceutical company. I once joked that we were so busy
complying with superfluous regulations, we had little time to discover
new drugs. Unfortunately, it’s no laughing matter.
2003, enough studies had been published on the 1962 Kefauver-Harris
Amendments to estimate the true cost of these FDA regulations. Researchers
had long suspected that they had thwarted innovation, driven up
drug prices, and delayed the introduction of life-saving pharmaceuticals.
to the passage of these Amendments, the FDA primarily regulated
only drug safety. The Amendments gave the FDA authority over drug
manufacturing, advertising, animal studies, and the design of clinical
result was predictable: the time it took to take a drug from the
laboratory to the market went from 4½ years to 14½ years. Because
patent life was 19 years or less, manufacturers had insufficient
time to recover their costs before a drug went generic.
1984, Congress passed the Waxman-Hatch Act, which partially restored
the patent years destroyed by regulation. The act estimated that
regulations were responsible for a whopping 84% of the 14½-year
development time. Prior to 1962, about 15% of the development time
was consumed by regulatory requirements.
the AIDS epidemic arose, pharmaceutical companies began to develop
treatments. However, most AIDS patients couldn’t wait the 14½ years
that it then took to get through the regulatory red tape. A small
group of concerned activists hired underground chemists to make
the very drugs that we were working on.
the time the FDA gave us permission to test our new drugs in people,
virtually the entire AIDS community had already received them. Since
the regulatory testing had to be done in people who hadn’t yet received
the drug, we had to wait for new cases to be diagnosed.
the actions of the AIDS activists were illegal, neither the FDA
nor the pharmaceutical companies chose to prosecute. Indeed, the
AIDS community demonstrated that lay individuals, working with concerned
medical professionals, could manufacture, distribute, and test new
therapies with a minimum of side effects!
amendments might have saved, at best, 7,000 lives. In contrast,
many more died waiting the extra 10 years for life-saving drugs.
According to my calculations, about 4.7 million people died over
the last 40 years while the life-saving drug they needed was tied
up in regulatory red tape!
that's just the beginning. The amendments have destroyed at least
half of the industry's innovative capacity, preventing some life-saving
drugs from ever reaching the market.
example, when I filed a patent for the treatment of fibrotic liver
disease with prostaglandins, an FDA examiner called me personally.
"You must encourage your company to develop this product," he insisted.
"We lose 100,000 people each year to fibrotic liver disease, and
we have absolutely nothing to offer."
studies required by the Amendments, however, were especially long,
difficult, and expensive. Studies with new, breakthrough drugs often
are. If we guessed wrong the first time and had to repeat years
and years of studies, our patent would run out and we’d never recoup
our investment. In spite of the FDA’s support, we had to abandon
this potentially life-saving drug.
death toll from losing half of our innovations from 1962 to 2003
is somewhere between 4 and 16 million people depending upon the
assumptions used. Adding the 4.7 million deaths due to an extra
10 years of development time suggests that as many as one out of
three people who died of disease since 1962 may have done so needlessly.
1962 Kefauver-Harris Amendments may very well be the deadliest law
that Congress ever passed.
J. Ruwart, Ph.D., [send
her mail] is the author of Healing
Our World in an Age of Aggression and Deadly Secrets
Behind Soaring Pharmaceutical Prices, which details her cost/benefit
assessment of the Kefauver-Harris amendments. You can get a FREE
copy of Deadly Secrets during her one-day
special promotion on October 12.
© 2005 LewRockwell.com