This item is a powerful and timely reminder regarding the profound
extent to which a private interest is prepared to betray the common
interest even in medicine.
At present the commons is locked in battle with Big Pharma, Big Banks
and Big Agriculture who are all patently pressing wrong headed but
lucrative agendas. What is worse by far is that it has become
possible for the whole political establishment to be outright bought
in order to shill these private interests.
Let us also not forget big insurance and its ugly stepdaughter
healthcare.
In all cases, big has become an outright disaster and demanding
action which continues to be bought of.
These corporations have long learned their lessons and make sure that
everybody in a position to cause trouble is somehow bought of.
Today, Frances Kelsey would never have been allowed to have that
position. Remember that revolving door!
If Frances Kelsey
Could Protect America from the Pharmaceutical Industry in 1962,
Congress Can Today
Wednesday, 15 May 2013
In recent weeks,
Congress has been looking into last year's outbreak of meningitis,
which killed 53 people and injured more than 700 Americans in 20
states. The cause was a tainted steroid distributed by the New
England Compounding Center(NECC), which is part of an obscure $2
billion-a-year niche of the pharmaceutical industry called
"compounding pharmacies. Recent reports document that this rogue
industry is out of control, operating dangerously in the shadows and
putting the lives of millions of Americans at risk. Democrats have
been trying to give the Food and Drug Administration (FDA) the
authority to regulate this shadowy niche of the drug industry, but
the companies and their Republican allies have pushed back, arguing
that states can do a better job and that stronger federal regulations
aren't needed. Sometimes it takes a scandal to get the public's
attention, but it also helps to have a courageous figure who takes on
big business to protect public health and safety. This David vs.
Goliath conflict not only makes good drama. It can also make good
public policy. And that's exactly what happened a half century ago
when Frances Kelsey almost singlehandedly took on the pharmaceutical
industry.
Frances who?
You've probably never
of her, but she may have saved your life. In the early 1960s, Kelsey
- a doctor and research scientist with the FDA - saved thousands of
babies from severe birth defects by stopping a big pharmaceutical
company from marketing the drug thalidomide. Equally important,
Kelsey's courageous stance inspired Congress to revise the rules for
approving new drugs protecting tens of millions of Americans, then
and now, from unsafe medicines.
Kelsey's battle with
the makers of thalidomide is not only an inspiring tale of how one
individual's expertise and courage protected the public interest
against the corporate push for profits, but also a warning to drug
companies and their lobby groups fighting new drug safety rules that
would put public health and safety over drug company profits.
After World War II,
many Americans and Europeans got hooked on sleeping pills and
tranquilizers. One out of seven Americans took them regularly.
Thalidomide was first introduced in Germany in 1957 by Chemie
Grunenthal, a drug company. It was considered safe enough to be
sold as a sleeping pill without a prescription. Then doctors began
giving it to their pregnant patients suffering from morning sickness.
By 1960, the company was marketing thalidomide in 46 countries, but
not the United States. Its sales were almost on a par with aspirin.
In 1960,
Richardson-Merrell Pharmaceuticals applied for FDA approval to market
thalidomide in the United States under the brand name Kevadon. At the
time, pharmaceutical companies were required to show their drugs were
safe, but could sell drugs 60 days after they submitted requests to
the FDA, so long as the agency didn't object, which it rarely did,
because it mostly relied on the manufacturers for information. At the
time, the FDA did not require scientific clinical trials. Drug laws
back then allowed companies to send new drugs to doctors for
"research purposes," so Richardson-Merrell distributed
thalidomide tablets to more than a thousand doctors who gave them to
about 20,000 patients. Approximately 3760 of them were women of
childbearing age, including at least 207 who were pregnant. The
doctors were not required to track their patients to find out if the
drug was working or having any harmful side effects.
Assuming that the
Kevadon application was a slam-dunk, the FDA assigned it to Kelsey,
who had just arrived at the agency a month earlier. Born on Vancouver
Island, British Columbia in 1914, she had earned both her bachelor
and master of science degrees in pharmacology from McGill University,
and her Ph.D. in pharmacology as well as a medical degree from the
University of Chicago. She taught pharmacology at the University of
Chicago and the University of South Dakota and worked as a general
practitioner from 1957 to 1960, when she moved to Washington to work
for the Federal Drug Administration (FDA). She was one of only seven
full-time physicians reviewing drug applications.
Kelsey's power to
approve - or deny - the company's application was the result of the
1938 Food, Drug and Cosmetic Act that - for the first time - required
pharmaceutical companies to prove that their products are safe before
they can be sold. The pharmaceutical industry vigorously opposed the
1938 law, claiming it would be economic disaster for the drugmakers
and pharmacies.
Despite powerful
opposition, the law passed after a scandal that outraged the public.
In late 1937, hundreds of children were poisoned and died after being
given the antibiotic, Sulfanilamide, which was dissolved in a toxic
solvent to make it easier for children to take.
Kelsey, who as a
graduate student had helped with the Sulfanilamide investigation,
quickly figured out that there was something fishy about
Richardson-Merrell's Kevadon application. She had seen a British
study that linked thalidomide to significant neurological side
effects. She discovered that many of the company's claims that the
drug was safe were not backed up with evidence. She asked the company
for additional information. She demanded that Richardson-Merrell
contact the physicians who were given Kevadon samples, but the
company didn't comply. She then asked the company for the names of
patients who had been given the samples, but the drug company didn't
provide the list. Instead, Richardson-Merrell harassed Kelsey with
constant phone calls, went behind her back to talk with her superior
and threatened to file a lawsuit.
Kelsey refused to back
down. She conducted further research and discovered that some of the
documents used to "prove" thalidomide's safety were
falsified. She discovered that some European doctors reported that a
growing number of children were being born without limbs or with
flipper-like arms and legs, but Chemie Grunenthal denied that there
was any connection between these deformities and the drug.
Assuming that the FDA
would rubber-stamp its application, Richardson-Merrell had already
created a marketing brochure for its salespeople claiming that it had
". . . firmly established the safety, dosage and usefulness of
Kevadon by both foreign and US laboratory and clinical studies."
But thanks to Kelsey, the company never got to use those brochures.
She recommended that the FDA deny the company's application.
Her concerns were
vindicated when it came to light that at least 10,000 children in
Europe were damaged by thalidomide. Thanks to Kelsey, the United
States was spared this tragedy, with fewer than 50 cases of
thalidomide-related birth defects, due to the samples the company
provided doctors, who then gave the drug to their patients.
But Kelsey did more
than stop one drug company from marketing a dangerous drug to the
public. She was also the catalyst for a major change in federal drug
safety laws.
Senator Estes Kefauver
(D-Tenn.) had been trying for years to pass legislation to strengthen
federal regulation of drug approvals, but industry lobbying had
thwarted any progress. Then, on July 15, 1962, the Washington
Post published a front-page article by reporter Morton Mintz,
"Heroine of FDA Keeps Bad Drug Off Market," exposing
Kelsey's role in preventing a thalidomide epidemic. The publicity
strengthened Kefauver's hand. The drug companies opposed Kefauver's
efforts to strengthen government rules and FDA authority. They
claimed that new pretesting requirements would harm patients by
keeping drugs off the market; that publicizing the side effects of
drugs was unnecessary because it was really the physicians'
responsibility to warn their patients; and that increased regulation
of drugs would give government control over our lives.
But as the horrible
effects of thalidomide on newborns became public, the industry
opposition was overwhelmed by public demands for more government
regulation and safer drugs.
Congress soon enacted
the Kefauver-Harris Drug Amendments Act in 1962 - giving the FDA more
authority to demand that drugmakers prove their products were not
only safe, but also effective before receiving approval to market
them in the United States. The law mandated that drug manufacturers
maintain records of adverse events linked to drugs and promptly
report these to the FDA. It required that advertisements of
medications include information about their side effects.
Kelsey's unrelenting
demands to use her legal authority despite intense pressure from
powerful industry leaders made her a heroine and restored the
public's faith in government to protect people from reckless and
greedy corporations who would knowingly put dangerous products on the
market. In fact, Kelsey's determination made her one of the 10
"most admired women in the world," according to a Gallup
national survey.
Kelsey, the patron
saint of drug safety, was a government bureaucrat, working in
anonymity until her name surfaced because of a sympathetic newspaper
reporter. For her courage, she was publicly honored. In 1961,
President John F. Kennedy presented Kelsey with the Distinguished
Civilian Service Medal. In 2010, the FDA initiated the Dr. Frances
O. Kelsey Award for Excellence and Courage in Protecting Public
Health. Fittingly, it selected Kelsey - then 96 years old - as the
first recipient.
If you are in your 40s
or 50s, thank God that Frances Kelsey was there, working quietly in
her FDA office, making sure that your doctor didn't prescribe
thalidomide to your mother.
Today's corporate
lobbyists - like Richardson-Merrell Pharmaceuticals 50 years ago -
never claim that they want to weaken government to increase profits
for shareholders. They argue, instead, that government standards are
a "burden," that they are "arbitrary," that they
snag companies in "bureaucratic red tape," that they deny
consumers "choice" in the marketplace and that they "kill
jobs." These words are consistently echoed by the Chamber of
Commerce, industry lobbyists, right-wing think tank propagandists,
and their allies in Congress, especially (but not only) Republicans
who do the bidding for drug and food companies, the mining and oil
industries and other business interests.
When you hear words
like that coming from the mouths of corporate executives and their
lobbyists, think about the thousands of people like Dr. Kelsey
working today in government offices and labs around the country,
quietly protecting Americans from products that could kill or injure
them if their manufacturers were allowed to make and market them.
They work as researchers and inspectors for the FDA, the Occupational
Safety and Health Administration, the Federal Aeronautics
Administration, the Environmental Protection Agency, the National
Transportation Safety Administration, the Centers for Disease
Control, the Consumer Product Safety Commission and other federal
agencies. Every day, they save lives.
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