A FORUM on ONTARIO MEDICINE: business and professional
Information from various contributors edited by Dr.Alex Franklin MBBS(Lond.)Dip.Phys.Med(UK) DPH & DIH(Tor.)LMC(C)FLex(USA).Fellow Med.Soc.London, Liveryman of London Society of Apothecaries. Freeman of City of London. Member Toronto Faculty club & Toronto Medico-Legal society.
A Canadian court has granted a review of two researchers’ application
to quash the findings of a university investigation that found signs of
falsified data, according to the researchers’ lawyer.
Yesterday, the court ruled that the application by Sylvia Asa and her husband, Shereen Ezzat, to quash the University Health Network investigation’s findings be reviewed by a full panel of the divisional court.
That review should take place within the next few months, Brian Moher, the researchers’ attorney, told us. The pair are pleased with the outcome, Moher told Retraction Watch:
The applicants are grateful for the court order yesterday
directing that their application be heard by a full panel of the
divisional court.
As part of the “impartial” review, Moher said, the divisional court
will review materials that were part of the investigation by the
University Health Network, affiliated with the University of Toronto.
These include witness statements generated during the investigation,
findings from committees, and other relevant documents. They will not
conduct any additional interviews, he added.
After the investigation found signs of falsified data, Asa stepped down from her post as program medical director of Canada’s largest hospital diagnostic lab. The pair’s work has been subjected to three retractions, and one notice of concern. A number of their papers have been questioned on PubPeer.
We’ve reached out to Oncogene, Clinical Cancer Research and Cancer Research and
asked about papers authored by Asa and Ezzat that have been
discussed on PubPeer. We haven’t heard anything yet but we’ll update
with any reply.
This isn’t the first time researchers have taken to the courts over a
misconduct investigation — last month, a Massachusetts judge dismissed
a lawsuit by researchers who argued that an investigation by Harvard damaged their careers by costing them job offers. With reporting by Ross Keith
Parents should insist on CABLE TEMPLES for children's frames.(as is usual in Europe)..
Giving children library frames (which can be taken off easily) is absurd.. As well as falling off, the glasses often slip down the nose which means that the child is not looking through the optical centres of the lens..
Dr A Franklin MBBS (Lond.) etc :one of the last living patients of Sir Stewart Duke-Elder (1898-1978-emphysema) GCVO ,MD & DSc (St.Andrew's) PhD(Lond.)FRCS FRS..
Lenses are not always made exactly to prescription. especially the astigmatic correction. Occasionally lenses reversed with " neurological" symptoms.
Ask the tolerance accepted by the optical dispenser. Usually the more expensive the lenses, the more accurate the manufacture.
If the lenses are not accurate the optician can return the lenses for another set at no charge,
Opticians who are just Managers of large chains may be less`eager to return lenses. OWNER OPTICIANS
advised.
Dr Alex Franklin.
Toronto
Clinical case. Elderly lady with acute headache and blurring of vision. Referred to Toronto General Neurologist Prov.diag Trans. Ischaemic attack.. On further visit learned about new specs. According to Ophthalmologist round lenses were accidentally reversed by Optician. After adjusting lenses; cured. Spherical correction about same bilaterally. Astigmatic correction different. Patients often advised that a few weeks needed to get used to new prescription. So accepted new lenses from Optician.
Dr.Frances Oldham Kelsey,BA(McGill 34) MSc( McGill 35) PhD (Pharm.Chicago 38) MD (Chicago 50) F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, awarded Membership of Order of Canada at !01.
Photo
President John F. Kennedy
gave Dr. Frances Oldham Kelsey the nation’s highest federal civilian
service award in 1962, saying she had “prevented a major tragedy of
birth deformities.”Credit
The White House
The
sedative was Kevadon, and the application to market it in America
reached the new medical officer at the Food and Drug Administration in
September 1960. The drug had already been sold to pregnant women in
Europe for morning sickness, and the application seemed routine, ready
for the rubber stamp.
But
some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a
former family doctor and teacher in South Dakota who had just taken the
F.D.A. job in Washington, reviewing requests to license new drugs. She
asked the manufacturer, the William S. Merrell Company of Cincinnati,
for more information.
Thus
began a fateful test of wills. Merrell responded. Dr. Kelsey wanted
more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty
bureaucrat. She persisted. On it went. But by late 1961, the terrible
evidence was pouring in. The drug — better known by its generic name,
thalidomide — was causing thousands of babies in Europe, Britain, Canada
and the Middle East to be born with flipperlike arms and legs and other
defects.
Photo
Dr. Kelsey reshaped American drug safety rules.Credit
Associated Press
Dr.
Kelsey, who died on Friday at the age of 101, became a 20th-century
American heroine for her role in the thalidomide case, celebrated not
only for her vigilance, which spared the United States from widespread
birth deformities, but also for giving rise to modern laws regulating
pharmaceuticals.
She
was hailed by citizens’ groups and awarded honorary degrees. Congress
bestowed on her a medal for service to humanity and passed legislation
requiring drug makers to prove that new products were safe and effective
before marketing them. President John F. Kennedy signed the landmark
law that she had inspired, and presented her with the nation’s highest
federal civilian service award.
“Her
exceptional judgment in evaluating a new drug for safety for human use
has prevented a major tragedy of birth deformities in the United
States,” Kennedy said at a White House ceremony.
Dr. Kelsey was appointed to the Order of Canada
last month and presented with the honor in a private ceremony the day
before her death at her daughter Christine Kelsey’s home in London,
Ontario, where Dr. Kelsey had been living, according to John Swann, a
historian at the F.D.A. and a friend of hers.
In
1962, the F.D.A. set up a branch to test and regulate new drugs, and
Dr. Kelsey was put in charge of it. Later, she became director of the
agency’s Office of Scientific Investigations, and in a distinguished
45-year career with the F.D.A. helped rewrite the nation’s
medical-testing regulations, strengthening protections for people and
against medical conflicts of interest. The rules have been adopted
worldwide.
She
was born Frances Oldham in Cobble Hill, on Vancouver Island in British
Columbia, on July 24, 1914, one of three children of Frank and Katherine
Stuart Oldham. Frances attended schools in Victoria and McGill
University in Montreal, earning a bachelor’s degree in 1934 and a
master’s in science in 1935. In 1936, she enrolled at the University of
Chicago, where she earned a doctorate in pharmacology in 1938. She
joined the faculty that year and became an assistant professor of
pharmacology.
She
and Dr. Fremont Ellis Kelsey, a professor in the university’s
pharmacology department, married in 1943. He became a special assistant
to the surgeon general in 1962 and died in 1966. The couple had two
daughters.
Besides her daughter Christine, Dr. Kelsey is survived by another daughter Susan Duffield, two grandsons and a sister.
Dr.
Kelsey received her medical degree from the University of Chicago in
1950. She was an editorial associate for the American Medical
Association Journal in Chicago for two years before the Kelseys moved to
Vermillion, S.D. He became chairman of physiology and pharmacology at
the University of South Dakota medical school. From 1954 to 1957, she
taught pharmacology there, and for the next three years was in private
medical practice. She became a naturalized American in 1956.
Photo
Dr. Kelsey, in 2010, worked for the F.D.A. for 45 years.Credit
Brendan Smialowski for The New York Times
Her
husband’s appointment to a post at the National Institutes of Health
took the family to Washington in 1960. She accepted the F.D.A. job
evaluating applications for licenses to market new drugs. Merrell’s was
one of the first to cross her desk.
The
company made glowing claims for Kevadon’s safety and effectiveness. It
had been developed in West Germany, and since 1957 had been widely sold
in Europe and elsewhere as an excellent sedative, Merrell said, giving
prompt, deep, natural sleep without hangovers. Moreover, doctors had
recently been prescribing it to women to suppress nausea in pregnancy.
Laws
governing new drugs had been on the books for decades but were not
always rigorously enforced, and F.D.A. approval was often routine. But
Dr. Kelsey, working with a chemist and a pharmacologist, found the
evidence for Merrell’s claims about Kevadon to be insufficient. She
withheld approval and asked Merrell for more data on toxicity, strength
and purity.
Merrell
stood to make millions and was anxious to get moving. It had tons of
Kevadon in warehouses, ready for marketing, and 1,000 American doctors
had already been given samples for “investigational” research. The
company supplied more data, but also mounted a campaign to pressure Dr.
Kelsey. Letters, calls and visits from Merrell executives ensued. She
was called a fussy, stubborn, unreasonable bureaucrat.
But
she refused to be hurried, insisting that there was insufficient proof.
In February 1961, she read a letter in The British Medical Journal from
a doctor who suggested that thalidomide might be causing a numbing
condition in arms and legs. She notified Merrell, and the company began
its own inquiry. In May, she told Merrell that the drug might affect the
limbs of fetuses. The company called the evidence inconclusive.
“I
had the feeling,” she wrote after a meeting with company executives,
“that they were at no time being wholly frank with me, and that this
attitude has obtained in all our conferences, etc., regarding this
drug.”
Six
months later, European reports indicated that the drug was linked to an
epidemic of phocomelia, a rare but monstrous malformation of limbs in
newborns. Merrell withdrew its application as reports of the births of
“thalidomide babies” came in from many countries. Kevadon samples given
to American doctors were traced, but not all were retrieved. Seventeen
births of babies with deformities were reported in the United States,
according to the F.D.A.
Eventually
researchers learned that thalidomide crossed the placental barrier and
retarded development of the fetus, whose drug-metabolizing enzymes are
undeveloped. No one knows how many babies were affected by thalidomide,
but estimates range into the tens of thousands in Europe alone. Many
were born without arms or legs, some with no limbs or with withered
appendages protruding directly from the trunk. Some had no external ears
or deformities of the eyes, the esophagus or intestinal tracts.
After
an article in The Washington Post led to global coverage, Dr. Kelsey
was hailed as a hero. She insisted that her pharmacologist, Oyam Jiro,
and chemist, Lee Geismar, as well as her superiors share the credit. But
attention focused on her partly because the Kennedy administration and
its allies in Congress wanted to use the case to pass stronger drug
regulations. The 1962 law required tighter proof of the safety and
effectiveness of new drugs, full disclosure of side effects and generic
names, and swift removal of unsafe drugs from the market.
When
she became widely known, Dr. Kelsey, a tall, graying woman who spoke
softly and never wore cosmetics, seemed modest to the point of shyness.
But she testified in Congress, spoke to women’s groups and at college
forums and gradually became accustomed to the spotlight.
In
2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame,
joining the ranks of Helen Keller, Eleanor Roosevelt, Margaret Mead and
other luminaries. She retired in 2005, and in 2010 was honored by Dr.
Margaret Hamburg, then the F.D.A. administrator, as the first recipient
of an award that continues to be given annually in her name.
Ontario NPs have the right to refer patients. OHIP is slow to pay Specialists.
Surprisingly U.Toronto Teaching Hospital Mt Sinai does not have Staff Dermatologists. Nurse practitioners refer patients to Dermatologists.in private practice.
OHIP admits payment is slow due to computer having to be programmed.
OHIP requires a referral note for a patient to see a Specialist; for OHIP to pay the fee. Private patients who claim to be outside Ontario do not need a referral note.
Chris DOUCETTE (T.Sun)
Robinson arrested...and charged with two counts of fraud under $5,000 and assault.
Charged people for blood tests. Used one needle into skin. Another syrnge with coloured fluid. Also
charged people for Xrays. No xray machine. Used downloaded Internet xrays.
(COMMENT:Ontario College of Physicians and Surgeons caused Robinson to close a previous office at 2828 Danforth in 2011. CPSO Registrar Dr. R.Gerace failed to follow-up with an inspection of the new office. Should Liberal Party Minister of Health Dr Eric Hoskins OC MSC MD FRCPC take over responsibility of protecting the public? Obviously the CPSO is unable to do the job.)
