2.
In The News: Flu Drug Maker Roche Rejects Calls to Allow Production Of Generics
Sabin Russell, Chronicle
Medical Writer Thursday, October 13, 2005
Tamiflu, a pricey antiviral pill invented
in a Bay Area lab and made in part from a spice used in Chinese cookery, has
emerged as the world's first line of defense against bird flu should the deadly
strain begin its feared spread among human beings.
As nations begin to stockpile the drug in
anticipation of a flu pandemic, calls are mounting for countries to sidestep
patents on the drug -- as
But Swiss pharmaceuticals giant Roche,
which acquired rights to the drug from Gilead Sciences Inc. of Foster City in
1996, said Wednesday it had no intention of letting others make it.
"Roche ... fully intends to remain
the sole manufacturer of Tamiflu,'' said company spokesman Terry Hurley.
The immediate problem is not the cost of
Tamiflu, which runs about $60 for a 10-pill course of treatment, but a
staggering gap between the sudden demand for it and the capacity of its sole
manufacturer to produce it.
Although Roche has increased production
of Tamiflu eightfold in the past two years, it will take $16 billion and 10
years to make enough of the drug for 20 percent of the world's population, said
Klaus Stohr, director of the World Health Organization's Global Influenza
Program, in comments to reporters in
"Something has to be done,'' said
Ira Longini, an Emory University professor whose computer model of a potential
avian flu pandemic shows that an outbreak could be snuffed out within a month
by rushing antiviral drugs to the place where it started. "When you think
of the potential damage a pandemic flu could do, and how little drug we have,
the situation is quite absurd.
[The SF Chronicle web posting of this
article stopped two paragraphs before the following which seems to be rather
important in accessing the populist notion that someone could simply make a
generic copy in a few months or a year or two. Even the World Health
Organization admits that it would take at least two years to put a plant in
action. It should be obvious that Roche, having years of research and know-how,
having the plants, the technical methods of production already in progress,
could expand their facilities and produce more Tamiflu far faster than any firm
starting from scratch. Why was this important assessment omitted by the SF
Chronicle from an otherwise excellent report from its web site posting, which
normally gives a more enlarged account than the printed page. Here is the
paragraph that was omitted:]
WHO flu chief [Klaus] Stohr is not
optimistic that generic produces would be able to make Tamiflu. He told
reporters in SF that the drug takes a full year to make and involves a
potentially explosive process that would drive out all but the most
sophisticate manufacturers. It would take a generic supplier at least “two
years” to put a plant into action.
James Love, director
of the Consumer Project on Technology in
"The WHO should buy stockpiles from
generic suppliers,'' he said. "If patents are in the way, the WHO should ask
the manufacturing country to issue the appropriate compulsory licenses. The
patent owner will receive royalties, but we will have the stockpiles."
U.N. Secretary-General Kofi Annan has
signaled a willingness to consider generic production of flu drugs and
vaccines. During remarks at the World Health Organization headquarters in
Roche will not release its Tamiflu
production figures, deeming it "commercially sensitive" information,
said Hurley, the company spokesman. However, he said the company produced
"many hundreds of millions" of the pills annually. In response to WHO
concerns about bird flu this summer, the company agreed to donate enough
Tamiflu to treat 3 million people.
Although public awareness of the pandemic
threat posed by the bird flu has blossomed in recent weeks, scientists have
been warning since 1997 that the rogue influenza strain known as H5N1 could be
the one that triggers a pandemic rivaling the devastating Spanish flu of 1918
-- which killed 50 million.
Tests on laboratory mice strongly suggest
that Tamiflu -- and a lesser-known inhaled antiviral, Relenza -- are the only
medications that can treat infection with the H5N1 strain.
Tamiflu has not been effective in the
treatment of the small number of people who've contracted the H5N1 virus in
"Late treatment is clearly
ineffective,'' said Dr. Frederick Hayden, a
Secretary of Health and Human Services
Michael Leavitt has said the
To read the entire report, please go to www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/10/13/MNG39F7MNG1.DTL&type=printable.
E-mail Sabin Russell at srussell@sfchronicle.com.
Vaccination Is The Medical Sacrament
Corresponding To Baptism
--Samuel Butler (1835-1902) English
author, Samuel Butler’s Notebooks (1951)
* * * * *
3.
International
Medicine: What's so Bad about Assembly
Line Healthcare? By Jon Miller
The
October 8, 2005 news article from Singapore titled Thinking Out-of-the-Box
Helps Alexandra Hospital Reduce Patient Waiting Time starts out "It worked
for Toyota cars, so why not for patients at hospitals?" Why not indeed?
According
to the article the impact of Lean healthcare on patient flow included
productivity improvement by 400% (from 22 to 70 patients seen per hour by a
staff of 12) and wait times cut in half. This helped bring the cost of the
health screening to $10 per patient (the article does not say what the original
cost was). These are typical Lean implementation results.
The
article mentions a million dollars of grant money in the Quality Improvement
Fund through the Ministry of Health. It's on the table for any of you Lean
healthcare consultants out there with time on your hands and an interest in
helping out hospitals in
What
struck me about this article was the seeming ease with which this hospital
adopted the "assembly line" concept. I have to confess having much
less success at persuading hospitals in the
Let's
be patient-centered for just a moment and imagine that healthcare doesn't
revolve at all around MDs or their preconceptions of what a healthcare delivery
process should be. A supreme example from
In
American English the colloquialism "production line" or
"assembly line" is a negative term generally used by artists,
craftsmen, designers or knowledge workers to mean work that is impersonal,
mechanical or uncreative. To people who think what they do is different each
time and impossible to standardize or streamline, or that they need a lot of
"mental set up" or thinking time between transactions having their
work measured and paced by a production line does not seem like a good idea.
This is certainly one way of looking at the world.
When I hear the words "assembly line" I get a
warm feeling. Really, I do. This, I am fairly certain, puts me in the minority.
Of course I think of the
To read the entire
report, please to go www.gembapantarei.com/archives/000243.html.
* * * * *
4.
Medicare: Governor Vilsack Brings Lean Government to
In a
TPM (Total Productive Maintenance) Cafe blog entry titled Making Government
Work, Governor Tom Vilsack of
Just a sample on this Lean government blog entry: "We combined four departments of government into one administrative agency, which improved service within state government and saved money at the same time."
There's
more good information at the governor's Results Iowa website, including some
good improvement metrics called the Operational Scan as well as their
Enterprise Strategic Plan that is reminiscent of top level Hoshin Kanri (www.mcts.com/Hoshin-Kanri.htm) objectives
(which they appear to have cascaded down to at least the departmental level).
It's
great to see a governor who is using Lean to cut costs when revenues fall so
the state can maintain services for citizens. Write to your senator, governor
or congressman and ask them to do kaizen at your local government! It's our
duty as citizens (customers of the government) to ask, it's their duty as
public servants to make wise use of our resources.
To read the
entire report, please go to www.gembapantarei.com/archives/000239.html.
* * * * *
5. Medical Gluttony: Does My Father Really Have Pneumonia
Every Month Requiring Hospitalization?
Medical excesses do not always reside with
the patient. Frequently they are system induced. When the system is run by a
large variety of physicians and nurses, complicated by government mandates and
intrusions, the health safety factor which was the reason for the initial
mandate, has a life and excess of it’s own.
A Puerto Rican man, age 92, is brought in
by his daughter after she insists on a pulmonary consultation because her
father is transported to the hospital at least once a month. He stays several
days, and is sent back to the facility on antibiotics. Each time, she is told
he has pneumonia or congestive heart failure. She sees no change in his
condition before he goes or after he comes back. She feels this is very
disruptive to her father’s final years on earth. He was a truck driver for most
of his life. The daughter does not know what exposures he may have had during
the course of this employment. The patient is rather senile and doesn’t speak
English.
The patient is seen with his chest x-ray,
which is very abnormal with plaques, fibrosis, and consolidations. There were
also several hospital notes from two hospitals where he was hospitalized. These
list pneumonia and heart failure along with hypertension and
hypercholesterolemia as his diagnosis. The University note also lists the
previous chest x-rays, which have shown plaques, fibrosis, and consolidations
consistent with asbestosis.
This information should have stopped the
notion that the patient was having something new and acute such as heart
failure or pneumonia. However, with the fragmentation of medical care brought
on by mandates and the hassles of being a personal physician in this age of
government micromanaging every aspect of health care, the physician that covers
the facility receives the x-ray report, probably on a phone call from a nursing
attendant, and becomes frightened with all the bureaucratic intrusions and
possible malpractice suit for not saving a patient’s life, (most likely doesn’t
even know the patient or his age) or worse yet, a Medicare Audit for
inappropriate care, and just tells the facility attendant “Send him to the
hospital emergency room for an evaluation.” The physicians in the hospital
emergency room, who may not have previously seen this patient, have no prior
records, will practice defensive medicine, admit him and probably repeat the
studies done elsewhere to which they do not have access. After a few days, the
hospitalist, rather than the personal physician, feels comfortable that the
x-ray represents chronic changes from a lifetime of exposures, and is
irrelevant to his current condition. The patient then is discharged back to the
facility.
But no one evaluates the cost in the
overview of health care. There is no hospitalization, no matter how brief, that
will cost less than several thousand dollars. If the personal physician, who
had seen the patient previous to his move to a facility, had been allowed to
continue to cover his patient, he would have prevented the massive health care
costs over a number of months. But with all the Medicare and bureaucratic
intrusions, very few physicians will take it upon themselves to follow even
their long time patients in multiple facilities that they choose. And the
facilities prefer to have their own doctor manage hundreds of patients even
though the doctor may not know any of them. The available information is
gleaned by an attendant, who may not have had any major medical assistant
training, and the level of care plummets and the cost of care rises
astronomically.
The approach by medical bureaucrats would
be to increase the extent and complicity of the algorithms of all possible
human responses in a highly variable, unpredictable medical situation which
would only further complicate health care delivery, further lower the level of
care and continue the upwards spiral in health care costs.
The only answer is to free the personal
physician from all bureaucratic, government, insurance carrier and HMO
intrusions and allow him to use his superior judgment in health care. Many
specialists feel the personal physician does not order enough tests. But isn’t
excessive unnecessary testing a major problem in runaway health care costs?
Isn’t it better to have a personal family doctor or internist or pediatrician
who knows the patient well in charge of keeping costs in line without hurting
the patient, rather than Medicare, HMO or insurance administrators policing the
system from afar, not knowing the unique needs of the patient and having no
idea of what damage they are doing to this patient by withholding treatment?
Having the personal physician in charge will normally improve the quality of
care and reduce health care costs to the lowest possible level. And that’s not
counting the elimination of the probable hundred billion dollar bureaucracy
micromanaging health care.
We have to ask ourselves
whether medicine is to remain a humanitarian and respected profession or a new
but depersonalized science in the service of prolonging life rather than
diminishing human suffering.
Elizabeth Kübler-Ross
(Swiss-born US Psychiatrist, on Death and Dying Ch 2, 1969)
The
Complicated Medicare Rules & Regulations
Will Soon
Prevent More Americans From Receiving Health Care
Than Poverty
or Lack of Health Insurance
* * * * *
6.
Medical Myths: Universal Coverage Means Access to Health Care
Many Americans, patients,
politicians and even Medical Societies argue that Americans should be covered
with a universal health plan, such as
Dr. Jacques
Chaoulli challenged restrictions in
Medical Fact:
Universal coverage only means that you have access to a waiting list. You may
never get Health Care. You may also die waiting.
* * * * *
Dr Edwards: Mrs Ruth, an 85-year-old lady with severe
heart disease, managed to survive an episode of congestive heart failure.
During a follow up evaluation she told me, “I think I’m falling in love with
you.” How, she could be my grandmother. I’ve been trying to redirect her
emotions for months, but it doesn’t seem to work. I’ve alerted my staff that
the exam door must always remain open when she’s here and I want them inside
the examining room if the door is closed.
Dr Rosen: Yes, I remember during psychiatry in medical
school, the professor said many patients would fall in love with you. It was
important to recognize this as a clumsy way for a patient to express
appreciation or say thank you. But it does seem difficult to inform the patient
that they are trying to say thank you for what they feel were services of
tremendous help to them. After all, almost all of what we do in life is of a
very personal nature – something that someone outside of medicine has
difficulty in comprehending.
Dr Edwards: This
85-year-old patient came in today with a new gray and blue plastic splint on
her fractured right ankle. But the unusual part was that for age 85, she was
well made up, had on a new complementary (to the color of her boot) suit and
blouse, heels and hose on her left foot, and tried to give me a squeeze. I had
trouble disengaging as I helped her up on the exam table.
Dr Rosen: I
remember the previous State Medical Board had cops who would investigate such
occurrences when someone who didn’t understand patient care, or may have even
been a member of the physician’s staff, observed such advances, and would
report it anonymously to the State Medical Board. The Board would just assume
this was non-professional conduct or sexual indiscretion with a patient that
must have been instigated by the physician and would arrest them. This
intrusion into medical practice will eventually drive physicians out of
medicine and patients will be totally at the mercy of, and subjected to,
non-medically trained medical bureaucrats.
8.
Voices of
Medicine: From the Various Local and Regional Medical Journals and the Press.
Doctor Interview: Patients
Also Need to Communicate by Vicki Rackner, M.D., President, Medical Bridges, Seattle,WSJ,
October 7, 2005; Page A17
I
appreciate Laura Landro's excellent "Informed Patient" column "Teaching
Doctors How to Interview1" (Personal Journal, Sept. 21).
Let's be honest. When it comes to communication, doctors fall into one of two
categories: those who get it and those who don't. Those who get it are more
likely to take advantage of a program that enhances their patient interview
skills.
As
both a doctor and a patient, I think of the medical interview as a dialogue.
While I applaud those physicians who invest in communicating more effectively,
patients can make a similar commitment. Patients can be coached to prepare for
their doctor appointments. They can be clear about their observations, fears,
concerns and expectations. They can be encouraged to ask for an understandable
statement of the medical problem and treatment options.
The reality is that patients have more skin in
this game than doctors; patients have a strong incentive to communicate
clearly. In fact, the patient is the great untapped resource that offers
solutions to our current health-care conundrum.
URL for this article
(subscription required): http://online.wsj.com/article/SB112863888548962167.html
______________________________________________
Medical
Records: How Long to Keep Them by Sondra
K Jacoby, Executive Director of the Santa Barbara County Medical Society, as
excerpted from CMA On-Call.
Sondra Jacoby discusses some
of the factors to consider before you pitch the old patient records.
Medi-Cal records must be
retained for three years after the date of last service. Every physician who
prescribes, dispenses or administers a controlled substance classified as
Schedule II or III must make and keep a record of that transaction for at least
three years. Workers' Compensation examiners must retain all medical-legal
reports for five years from the date of the employee's evaluation.
HIPAA does not create new
rules for retention of medical records, but does create rules for physicians to
maintain all of the following in written or electronic form for at least six
years from the date of creation: a) HIPAA Privacy Rule required policies &
Procedures, b) all HIPAA Privacy Rule related communications required to be in
writing, and c) all HIPAA Privacy Rule related actions or designations required
to be documented.
The statute of limitations in
Jacoby suggests that despite
statutory requirements, all Medical records be retained indefinitely, or 25
years since the date last seen or 10 years after a minor reaches age 18. Since
99 percent of claims against hospitals are filed within 20 yeas of the
incident, she suggests a minimum of ten years as a reasonable alternative.
URL: www.sbmed.org/webpages/publications.asp
- mmn
______________________________________________
Author
D Silk, MD, the editor of the Bulletin
of the Orange County Medical Society, suggests that we should stop
crowing about the evolution of medicine from a cottage industry to big
business as if that transition means progress. He says it doesn't. "Like
your grandmother's pies and hand-tailored suits, some services are better done
by individuals working in their own microenvironments than in corporate
beehives. Turning out sick patients on a production line . . . is a sociologic
experiment that [is] unfortunate for our patients and ourselves . . . despite
widespread dissatisfaction . . . Even a flawed system may last for two or three
decades before its weaknesses become so prominent that it disintegrates. It
took Russian Communism 70 years to fall of its own weight. . . Doctors were not
perfect before corporate medicine besmirched the horizon. But when medicine was
a cottage industry, a single error in technique or judgment resulting in a
malpractice suit . . . became a local headline. Now billion dollar frauds by
corporate medicine are almost daily headlines. When the service must be
personal and individual, private schools, portrait painting, playwriting,
tailor-made suits, home cooking, dressmakers, nurses, and doctors are all examples
of the superiority of what some may derisively call a cottage industry."
*
* * * *
9.
Book Review: 
HEALTHY COMPETITION - What’s Holding Back Health Care and How to Free
it by Michael F Cannon & Michael D
Tanner, Cato Institute Washington, DC © 2005, ISBN 1-930865-81-3, 173 pp,
$10. Introduction: What Can
Competition Do for Patients?
In
the introduction, the authors give us their views on the current health care
situation in the
The
burden of paying for health care is only part of the problem.
Furthermore,
patients seem to be losing control over their health care decisions. Many
patients would value being able to make their own health care decisions, with
the advice of their doctors, more than they value being able to choose their
own cars, car insurance, or computers. Yet Americans have fewer choices when it
comes to health insurance than they do with car insurance.
Employers
have been making decisions about Americans’ health insurance for as long as
anyone can remember. Government also makes many health insurance decisions for
consumers, particularly senior citizens. In recent years, employers and
insurance companies have begun making what amounts to treatment decisions as
well. Although managed care probably does eliminate some unnecessary costs,
patients resent the lack of choice this entails, and doctors resent the
intrusion on their professional judgment.
Quality,
affordability, and choice seem to present tradeoffs: getting more of one seems
to involve getting less of the others. On the one hand, employers, insurance
companies, and government can set limits on what treatments they will cover.
This may eliminate low-quality care. But it also reduces patient choice and
would sometimes block access to necessary care. On the other hand, if patients
are given free rein, what’s to prevent them from overutilizing the health care
system or choosing low-quality care and imposing costs on everyone else?
How can high-quality health care be made affordable,
without sacrificing patient choice? That is a question asked over and over
again in health policy circles. It underlies debates over health insurance,
prescription drugs, primary and preventive care, hospital care, and aid to the
poor. And it has stumped policymakers in
Why Competition? Competition is a tool for
finding answers we don’t have.
To read the rest of the
introduction and why competition gives us the health care answers, please go to
the Cato Bookstore: www.catostore.org/index.asp?fa=ProductDetails&method=cats&scid=33&pid=1441272.
To read some of the other book reviews that are
available, please go to www.delmeyer.net/PhysicianPatientBookshelf.htm.
This
will never be a civilized country until we expend more money for books than for
chewing gum. –Elbert Hubbard
* * * * *
10. Hippocrates & His Kin:
Impotence Pills May Cause You To See In Blue
Federal health officials are examining
rare reports of eye damage among some men using impotence drugs. The drugs also
may have other rare side effects on vision. Warning labels for Viagra, Cialis
and Levitra list such potential side effects, according to the drugs’ Web
sites. Example:
Viagra
“Less common side effects that may occur are temporary changes in color vision
(such as trouble telling the difference between blue and green objects or
having a blue color tinge to them), eyes being more sensitive to light or
blurred vision.”
I
explained the side effects of the pill to a patient, including headache,
indigestion and a temporary blue tinge in one's vision, to which he replied,
"Well, I'd rather have a red velvet tinge to my vision during these times,
but blue will do."
______________________________________________
An attorney at a medical
conference was describing a pain doctor with the expert medical witness lying
under oath. The judge refused to rule against the perjury testimony. The
attorney told the doctors that if this case would be mentioned to entering law
students, he estimated that 90 percent of the class would immediately leave and
find another career or profession.
Can’t we enroll a “stoolie” in
each
______________________________________________
Last
year the Internal Revenue code achieved a new Olympic record for complexity,
with nine million words -- 12 times the length of the King James Bible. High
tax rates and mindless tax complexity are an economic ball and chain. We hope
President Bush's tax reform commission will cut through the class-warfare
blather later this month and endorse a simple, broad-based, single-rate tax
system.
http://online.wsj.com/article/SB112864535887162338.html?mod=todays_us_opinion
______________________________________________
John Grisham, a
lawyer turned novelist with a genre of legal thrillers, mentioned that a
half-billionaire attorney was complaining that he could be a billionaire by now
if he didn’t have to share half of his winnings with patients. Well, it looks
like the Visa class action suit has become nirvana. I received an extensive
packet of documents to complete and forward to the claims administrator in
To read more Hippocrates
columns, please go to www.delmeyer.net/hmc2003.htm.
* * * * *