FDA Whistleblower Resigns

Says Politics Trumping Medicine In Drug Approvals Probed by FDA For
Revealing Dangers Of Diabetes Drug Rezulin

Agency Has Probed Others Who Spoke Out

'PharmaGate' Taxis for Scandal Takeoff
http://cbsnews.cbs.com/now/story/0,1597,192528-412,00.shtml

      (CBS) FDA Medical Officer Robert Misbin, the scientist who blew the
whistle on the dangers of the diabetes drug Rezulin, resigned Monday,
complaining that politics and bureaucratic concerns are replacing sound
medical judgement in approving drugs, CBS News Correspondent Sharyl
Attkisson reports.
      Misbin had clashed with FDA management over the dangers of Rezulin,
and even wrote Congress saying it should be pulled from the market. It
finally was withdrawn last March, but only after dozens of liver-related
deaths linked to Rezulin.
      "The medical officer is ultimately responsible for drugs that are
approved... and I don't want to stay around for what's going to happen," he
says.
      The FDA began a internal investigation of Misbin after he wrote
Congress. Congress intervened, saying that amounted to retaliation against a
whistleblower.
      Misbin says he also recently got his first negative job performance
review. "The writing was on the wall," says Misbin.
      In his letter to Congressman Henry Waxman, D.-Calif., Misbin
complained, "I have been frustrated in my efforts to convince my superiors
that the time has come to remove Rezulin from the market."
      Misbin is not the first FDA scientist involved with Rezulin to face an
agency probe. In March, Internal Affairs interrogated Dr. Leo Lutwak, whom
they also accused of leaking data on Rezulin.
      Internal Affairs also investigated Dr. John Gueriguian, the original
scientist in charge of Rezulin trials, after he was the first to insist that
Rezulin was too dangerous to be sold.
      Doctors Gueriguian and Lutwak have since retired. Earlier this year,
Lutwak told CBS News he was furious about being questioned.
      "In my own agency I'm treated like...I'm treated worse than a
criminal! I'm accused, I'm threatened, I'm taken away from my work," said
Lutwak.
      Rezulin is used with other drugs to treat Type 2 diabetes, a
life-threatening disease that affects 18 million Americans and is a leading
cause of coronary heart disease, blindness, kidney failure, and limb
amputation.
      It was introduced in the United States in 1997. Shortly after that,
concerns emerged about some patients who developed liver problems after
taking the drug. To date, the FDA has linked 63 deaths to Rezulin.
      CBS News reported earlier this year that two researchers who conducted
clinical trials of the drug for manufacturer Warner-Lambert claim the
company told them to downplay problems with the drug.
      CBS News also reported that FDA documents showed tests of the drug
found liver enzyme levels six times the normal levels, even though
Warner-Lambert reported levels of "2 to 3 times...normal," a figure the
company later acknowledge to the FDA was "not correct."
      Warner Lambert asked the FDA for an objective review of Rezulin after
one CBS News report.
      In March, when alternative drugs for treating diabetes were approved,
the FDA asked manufacturer Warner Lambert to remove Rezulin from pharmacy
shelves.
      The drug maker complied.
      Warner-Lambert, however, maintained that Rezulin's benefits outweighed
its risks.
      In a statement explaining its decision to cooperate with the FDA the
company said, "repeated media reports sensationalizing the risks...have
created an environment in which patients and physicians are unable to make
well-informed decisions."


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* * *

For the Vaccine-Wary, a Lesson in History

      [By Jane E. Brody in the New York Times.]
http://www.nytimes.com/2000/10/03/science/03BROD.html


      Keep a Record
      A study conducted in the early 1990's by researchers at the University
of Chicago Children's Hospital revealed that parents could not be relied
upon to give health professionals an accurate history of their children's
immunizations.
      The main problem occurs because parents fail to keep a vaccination
card recording vaccines and the dates they are given, relying instead on
doctors to keep such a record. But when families move or switch doctors, the
records become incomplete or misplaced.
      At every well-child visit, the immunization card should be brought to
the doctor's office or clinic and the vaccines recorded. Likewise, this card
should be taken along if the child is brought to a hospital or emergency
room for any reason.

       Most parents now raising questions about the safety and wisdom of
childhood immunizations have never seen a case of whooping cough, polio,
measles or mumps. Parents now in their 20's and 30's grew up in an era when
they and all their schoolmates were protected against such serious
infections by a series of vaccinations administered early in life.
      Few such parents realize that small children can die or become
brain-damaged from a measles infection. They do not remember when children
were forbidden to swim in public pools all summer so they would not contract
polio. Nor have they seen children placed in iron lungs because polio had
crippled their respiratory muscles.
      As a 59-year-old, I have a clear recollection of these unfortunate
events. I also clearly recall my own experience with horrific cases of
chickenpox (scarred for more than a decade), measles and mumps on both sides
of my face simultaneously. And I can still hear the whooping coughs of a
childhood friend who developed pertussis and had to be hospitalized in
isolation.
      Ill-informed hysteria about the safety of current vaccines could once
more bring these awful childhood diseases to the fore. To be sure, most
parents who now resist childhood immunizations are well intentioned. They
are only trying to protect their children from purported serious side
effects that have been bandied about in print, on the air, on the floor of
Congress and now on the Internet. The Internet also offers guidance on how
parents can skirt the immunization requirements for entering school.
      How accurate are the accusations against vaccines, and what price
might we pay for heeding them at the expense of the immunizations now
universally recommended by pediatric and public health officials?
      A pro-vaccine Web site, www.Pkids.org, offers some cautionary
statistics regarding failure to immunize.

      Before Vaccines
      When I was a child, 13,000 to 20,000 cases of paralytic polio were
reported in this country every year. Now there are none. Before children
were routinely immunized against measles, nearly every American child got
it - three million to four million cases, resulting in some cases of measles
encephalitis and an average of 450 deaths a year.
      The vaccine reduced measles cases by more than 95 percent. But as has
been made clear from outbreaks of measles that have occurred where rates of
childhood immunization were low, the scourge of measles can return quickly
and easily.
      Whooping cough (pertussis), too, was nearly a universal occurrence of
childhood that killed 5 of every 1,000 children born in this country before
pertussis immunizations. From 150,000 to 260,000 cases were reported each
year, with up to 9,000 pertussis-related deaths. In the 1970's, the British
showed what could happen when pertussis vaccination rates dropped. After
questions were raised about the safety of the vaccine then in use,
immunization rates dropped to 60 percent in Britain and in the next few
years, a series of pertussis epidemics occurred, including one resulting in
more than 100,000 cases and 36 deaths. And in Japan, by 1979 pertussis
vaccination coverage dropped to 20 percent from 80 percent, leading to more
than 13,000 cases and 41 deaths.
      Before we had a vaccine for Haemophilis influenza type b (Hib), 20,000
infants and children each year developed invasive Hib infections, two-thirds
of which resulted in meningitis, a disease that killed 600 children each
year and left many others with seizures, complete hearing loss or mental
retardation. The vaccine, introduced in 1987, has resulted in a decline in
Hib of more than 97 percent, to only 33 cases last year.
      Parents who refuse to have their children vaccinated are basically
counting on the fact that most children are immunized, conferring a kind of
herd immunity. But as a serious outbreak of measles in Alaska shows, all it
takes is one child with an active infection to cause widespread problems
among those not properly immunized.
      Last spring, in a Washington Post editorial, Dr. Julian Orenstein, a
fellow of the American Academy of Pediatrics who practices emergency
medicine in Fairfax, Va., warned colleagues to "bone up" about infectious
diseases that they thought had disappeared: measles, mumps, whooping cough.
"They may return," he said, because "some parents have stopped trusting the
vaccinations that kept those illnesses at bay."

      Safety Concerns Answered
      The concerns of parents, and some medical professionals, have not gone
unheeded. Although follow-up studies did not support British fears that
brain damage or sudden infant death could occur in rare cases after
pertussis inoculations, a new vaccine was developed that lacked the
potential for such an effect. While the old vaccine was based on whole
cells, the new one is acellular, made from only part of the infectious
organism. The new vaccine is associated with fewer minor side effects, yet
it appears to be as effective as the whole-cell vaccine in preventing
whooping cough.
      The switch from the original injected Salk polio vaccine to the oral
Sabin vaccine resulted in rare but serious cases of vaccine- related
paralytic polio. From 1980 to 1994, 124 American cases of vaccine-associated
paralytic polio were reported. The Salk vaccine was made from inactivated
viruses that could not cause disease. The Sabin vaccine, though easier to
use and highly effective, was made from live attenuated viruses, some of
which apparently retained their infectious potential. The current
recommendation for healthy children is administration of four doses of the
inactivated Salk vaccine - at 2 months, 4 months, 6 to 18 months and 4 to 6
years. The resulting immunity is as good as with the Sabin vaccine, but the
risk of vaccine-induced polio is nonexistent.
      With regard to measles vaccine, which is given along with vaccines for
mumps and rubella, no change has been made in either the vaccine itself or
its recommended administration schedule. Yet some parents suspect that the
vaccine or the combination of the three vaccines (M.M.R.), or some other
vaccine combination, is responsible for a rise in autism cases among infants
and toddlers.
      Studies have found no causal connection between the vaccines and
autism. Rather, the autism cases seem to be coincidental with immunizations
and their rise could simply be a result of better recognition and diagnosis.
Also, though perhaps not noticed by parents or their pediatricians, symptoms
of autism are usually present at birth whereas the three-part M.M.R. vaccine
is administered at 12 to 15 months of age.
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