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Big
pharma is big business, says Greg Critser. The same marketers
who sell cornflakes and deodorants now persuade Americans that
they need drugs to solve problems from toenail fungus to shyness
to acidic stomachs.
Mr. Critser, the journalist who took an alarmed look at Americans' expanding waistlines in "Fat Land," contends in Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies that pill popping in the U.S. has reached an all-time high. That might not matter if there were no downside. But even as direct-to-consumer advertising has drummed up unprecedented demand for drugs, two defenders of America's health - physicians and the Food and Drug Administration (FDA) - have let down their guard. The result, he says, has been tragic. The real problem is the unknown long-term effects of indiscriminate drug taking. The real clinical trials of many FDA-approved drugs are taking place among the unsuspecting Americans who are routinely using them. He traces the roots of the high-profile drug industry scandals of recent years to decisions to deregulate the industry in the 1990s and make drugs just another consumer good to be aggressively marketed. Quotes, like this one from drug company executives counseling drug reps on how to push a product on doctors, catch drug marketers at their game: "That's where we need to be, holding the doctor's hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for everything ... I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 milligrams a day." Sobering statistics tell the story. A few examples: • More than 100,000 deaths per year come from drugs that are taken as directed by a physician (not through misuse or overdose). • Almost half of Americans take at least one prescription drug every day; 1 in 6 take three or more daily. • Drug companies pay for about 90 percent of the continuing-education classes physicians must take. • Washington has six times as many pharma-industry lobbyists as it does US senators. • Of the 1,035 new drugs approved by the FDA from 1989 to 2000, more than half offered no significant new benefits over older drugs. Today, prescription drugs "have become interwoven with the very notion of what constitutes health," Critser says. Pills are expected to prevent future diseases, wake people up, put them to sleep, improve all kinds of performance, and lengthen life. What can be done? Critser summarizes ideas also touted by other reformers: • Doctors should spurn all gifts from pharmaceutical companies - from free lunches to gift bags to phony "consulting fees." Says one doctor urging change, "Our system would never tolerate judges taking money from those that they judge, yet for some reason this doesn't apply in medicine." • The FDA should stop accepting "user fees" from drug companies and return to its role as a regulator. It should establish a drug safety unit, independent of its division that approves drugs for sale, and should insist on safety studies after drugs reach the market to reveal any ill effects missed during earlier testing. • The FDA should establish a comprehensive and compulsory registry for clinical trials - the tests that assess the efficacy and safety of drugs - so that companies can't hide unfavorable results. And it should require that new drugs show that they are superior to drugs already on the market. • Direct-to-consumer advertising should be banned for the first two years that a drug is on the market until its safety can be better ascertained. In the future, advances in genetics may be able to match patients and drugs much more accurately, better calibrating dosages and effects, and thereby reducing the chance of unintentional harm, Critser says. In the meantime, Americans should ask themselves if they really need to take so many drugs. The costs, he says, may be higher than they think.
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by Steve
Connor
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Published on
Monday, December 8, 2003 by the
Independent/UK
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Dr. Allen Roses, worldwide
Vice-President of genetics at GlaxoSmithKline (GSK), said fewer
than half of the patients prescribed some of the most expensive
drugs actually derived any benefit from them. It is an open
secret within the drug industry that most of its products are
ineffective in most patients, but this is the first time that
such a senior executive has gone public.
Dr. Roses, an academic
geneticist from Duke University in North Carolina, spoke at a
recent scientific meeting in London where he cited figures on
how well different classes of drugs work in real patients.
Drugs for Alzheimer's disease work in fewer than one in three
patients, whereas those for cancer are only effective in one in
four patients. Drugs for migraines, for osteoporosis, and
arthritis work in about half the patients, Dr. Roses said. "Most
drugs work in fewer than one in two patients mainly because the
recipients carry genes that interfere in some way with the
medicine," he said. "The vast majority of drugs - more than
90 percent - only work in 30 or
50 percent of the people," Dr Roses said. "Drugs out there on
the market work on some, but they don't work in everybody." Dr.
Roses deserves credit for being honest about a little-publicized
fact known to the drugs industry for many years.
"Roses is a smart guy and what
he is saying will surprise the public but not his colleagues,"
said one industry scientist. "He is a pioneer of a new culture
within the drugs business based on using genes to test for who
can benefit from a particular drug." Dr. Roses has a formidable
reputation in the field of "pharmacogenomics" - the application
of human genetics to drug development - and his comments can be
seen as an attempt to make the industry realize that its future
rests on being able to target drugs to a smaller number of
patients with specific genes. The idea is to identify
"responders" - people who benefit from the drug - with a simple
and cheap genetic test that can be used to eliminate those
non-responders who might benefit from another drug.
This goes against a marketing
culture within the industry that has relied on selling as many
drugs as possible to the widest number of patients - a culture
that has made GSK one of the most profitable pharmaceutical
companies, but which has also meant that most of its drugs are
at best useless, and even possibly dangerous, for many
patients. Dr. Roses said doctors treating patients routinely
applied the trial-and-error approach which says that if one drug
does not work there is always another one. "I think everybody
has it in their experience that multiple drugs have been used
for their headache or multiple drugs have been used for their
backache or whatever. It's in their experience, but they don't
quite understand why. The reason why is because they have
different susceptibilities to the effect of that drug and that's
genetic. Neither those who pay for medical care nor patients
want drugs to be prescribed that do not benefit the recipient.
Pharmacogenetics has the promise of removing much of the
uncertainty."
Response rates of
pharmaceutical drugs - drug efficacy rate in percent:
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American Ginseng Reduces Blood Sugar: Implications For DiabetesScience Daily
Natural Researchers at St. Michael's Hospital and the University of Toronto have found
that taking American ginseng
before a meal reduces blood sugar in people both with and without diabetes.
Dr. Vladimir Vuksan, lead investigator for the study,
says that these findings may have important implications for the treatment and
prevention of diabetes, a disease affecting approximately eight per cent of North
American adults and continually rising. The study appears in the April 9 issue of
the Archives of Internal Medicine, a publication of the Journal of the American
Medical Association (JAMA).
"Although preliminary, these findings are encouraging and indicate that
American ginseng's potential role in diabetes should be taken seriously and investigated further.
Controlling after-meal blood sugar levels is recognized as a very important strategy in
managing diabetes. It may also be important in the prevention of diabetes in those
who have not yet developed the disease." Cholesterol Drugs - Pharmaceutical Fantasy Steven Milloy - Fox News
Pfizer's Lipitor edged out Bristol-Myers Squibb's
Pravachol in a head-to-head competition
between the two cholesterol-lowering drugs, a new study reported last week. It appeared
to be a disappointing result for study-funder Bristol-Myers. Not to worry, though. There
seems to be a move afoot to make sure there are plenty of profits for all.
The study compared the health outcomes among heart-attack patients treated with either Lipitor
or Pravachol, members of a class of drugs called statins.
Twenty-two percent of Lipitor
patients died or experienced further adverse coronary events during the clinical trial
compared to 26 percent of Pravachol patients. Although I'm not sure that such a small
difference in a single clinical trial really proves that Lipitor is a better treatment than Pravachol,
what struck me is how the study was being used as a platform for the unnecessary pushing of
expensive drugs on the general public. . . . .
In the WOSCOP clinical trial where healthy people with high cholesterol were treated
with statins, the five year death rate
for treated subjects was reduced by a mere 0.6%, according
to Dr. Ravnskov. To achieve that slight reduction, about 165 healthy people had to be treated
for five years to extend one life by five years. As statin treatment is expensive--as much as
$1,400 per year--that efficacy amounts to a drug cost of nearly $1.2 million to extend one
life by five years. It certainly would be nice if we could afford to spend so much money treating
so many healthy people for such a slight result, but it's not clear that we can. While Dr. Topol
did note in his editorial the high costs of universal statin therapy, he apparently never even
considered that some sort of cost-benefit analysis might be in order.
Another notable aspect of Dr. Topol's widely reported recommendation that the statin-taking
population should be tripled is that the
New England Journal of Medicine opted not to disclose
that Dr. Topol's employer, the Cleveland Clinic, receives financial support from both Pfizer and
Bristol-Myers. Dr. Topol's expertise
and reputation, combined with the fact that Pfizer's and
Bristol-Myers' support for the Cleveland Clinic doesn't involve statins, was the rationale for not
disclosing the potential conflict of interest, a Journal spokesman told me. Regardless of whether
the Cleveland Clinic is funded by Pfizer and Bristol-Myers on statin research, they still are
supported financially by those companies and a prominent Cleveland Clinic employee
recommended that Americans triple their use of Pfizer's and Bristol-Myers' products. If that
doesn't at least appear to be a conflict, I'm not sure what is.
Statins do produce some benefits in some situations. But until we know better what those benefits
and situations are, it is irresponsible to recommend a mass prescription for the public.
America-on-statins may be the pharmaceutical industry's fantasy, but we simply can't afford it. By Maggie Fox,
Health and Science Correspondent Thu Jul 27, 2:34 PM ET WASHINGTON
(Reuters) - People who ate a low-fat vegan diet, cutting out all meat and dairy,
lowered their blood sugar more and lost more weight than people on a
standard American Diabetes Association diet, researchers said on Thursday. They lowered their
cholesterol more and ended up with better kidney function, according
to the report published in Diabetes Care, a journal published by the
American Diabetes Association. Participants said the vegan diet was
easier to follow than most because they did not measure portions or count
calories. Only three of the vegan dieters dropped out of the study, compared
to eight on the standard diet. "I hope this
study will rekindle interest in using diet changes first, rather than
prescription drugs," Dr. Neal Barnard, president of the Physician's
Committee for Responsible Medicine, which helped conduct the study, told a news
conference. An estimated 18
million Americans have type-2 diabetes, which results from a combination of
genetics and poor eating and exercise habits. They run a high risk of heart
disease, stroke, kidney failure, blindness and limb loss. Barnard's team and
colleagues at George Washington University, the University of
Toronto and the University of North Carolina tested 99 people with type-2
diabetes, assigning them randomly to either a low-fat, low-sugar vegan
diet or the standard American Diabetes Association diet. After 22 weeks on the
diet, 43 percent of those on the vegan diet and 26 percent of those on
the standard diet were either able to stop taking some of their drugs such
as insulin or glucose-control medications, or lowered the doses. The vegan dieters
lost 14 pounds (6.5 kg) on average while the diabetes association dieters
lost 6.8 pounds (3.1 kg). An important level
of glucose control called a1c fell by 1.23 points in the vegan group and
by 0.38 in the group on the standard diet. [Home]
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