Select the Article of Interest below:
1. Congress
Recognizes Prescription Drug Problem
2. Generic
Drugs Just as Safe, Effective as Brand-Names
3. AMA
commends FDA dedication to generic drug program
4. Washington
AP Story: Bill H.R.4461.
5. Arthritis
Drug Vioxx Pulled Off Market WEBmd
6. Beware
of fake Viagra BBC News
Congress Recognizes Prescription Drug Problem
The disparity between drug prices in the United States and
those of other countries has now grown so large, that the
mainstream media has picked up the issue and it has become
one of the hottest political topics on Capital Hill.
In late 1999, a bill (HR 3240) was introduced into the House
of Representatives that would allow Americans to purchase
FDA-approved drugs from pharmacies anywhere in the world.
As a growing number of constituents have written their House
members urging them to support this bill, more Representatives
are joining as cosponsors.
The good news is that the Senate has introduced its own companion
bill that would enable Americans to purchase identical prescription
drugs from offshore pharmacies at a fraction of prices being
charged today. This bill (S 2520) is significant because it
is being backed by key Republicans, in addition to Democrats.
According to the Wall Street Journal (May 10, 2000), Republicans
in the past have protected the domestic pharmaceutical industry,
but "heavy pressure from constituents" is forcing
them to deal with the high cost of prescription drugs.
The Senate bill would allow American pharmacists, wholesalers
and individuals to purchase FDA-approved drugs, made at FDA-approved
manufacturing plants from anywhere in the world. The savings
to the consumer would be enormous, and for the first time,
drug companies would have to compete in a real free market
environment.
Not everyone agrees with us. While every politician acknowledges
there is a health care crisis fueled by inflated prescription
drug prices, there is a debate as to how to best remedy this
problem. Some politicians are proposing that Medicare pay
for prescription drugs, which amounts to nothing more than
a taxpayer subsidy to the pharmaceutical industry.
The problem with tax dollars being used to pay for prescription
drugs is the inevitable waste, mismanagement and fraud that
occurs when government bureaucracies try to regulate the marketplace.
Right now, the Federal government is litigating against some
large drug companies after finding that Medicare and Medicaid
sharply overpaid for dozens of drugs. Government officials
are seeking billions of dollars in restitution based on their
contention that these drug companies induced Medicare and
Medicaid to pay inflated prices for the drugs. Here is one
startling example of what happens when the government involves
itself with the free market:
The nutrient N-acetyl-cysteine (NAC) is sold as a prescription
drug to be delivered as an inhaler to treat certain pulmonary
problems. It is also approved as a drug to suppress the free
radical damage that occurs to the liver in the case of acetaminophen
(Tylenol ®) overdose. Here are the price differences between
the free market price and what Medicare has been reimbursing
for the NAC drug: 40¢ - Health food store retail price
for 1 gram of N-acetyl-cysteine
$5.05 - What Medicare pays for 1 gram of N-acetyl-cysteine
As you can see, in the free market environment, there would
be no health care crisis since the cost of prescription drugs
would amount to nothing more than pocket change, whereas the
proposal to let Medicare subsidize drug costs results in the
government overpaying for what the patient could purchase
on their own. One reason drugs are so overpriced is that the
FDA is blocking importations of the much lower priced identical
drugs from other countries. FDA over-regulation causes drugs
to cost so much, while at the same time hindering the development
of life saving therapies.
Educating U.S. consumers to their options and marketing these
offshore options aggressively will provide a benefit to all
Americans that depend on prescription drugs that they cannot
afford.
Generic Drugs Just as Safe, Effective as Brand-Names
By Steve
Mitchell
WebMD Medical News Archive
Aug. 28, 2001 (Washington) -- The recent availability of
a cheaper, generic version of the antidepressant Prozac has
once again raised the debate about whether generics are as
safe and effective as brand-name drugs.
Several drugs are scheduled to come off patent this year or
next and generic versions will inevitably become available
soon after their patents expire. This means a substantial
cost-savings for consumers as generics can be anywhere from
30% to 70% cheaper than their brand-name counterparts.
But are consumers risking safety or a decrease in effectiveness
by switching to a generic? Not according to the FDA.
A generic drug must contain the exact same active ingredient
as the brand-name, and the FDA also requires the generic manufacturer
to conduct laboratory tests and studies in humans to prove
that its drug has the same effectiveness and same side effects
as the branded drug.
Some groups have made claims that generics may not be as safe
or as effective as branded drugs. But in a study conducted
a few years ago the FDA randomly sampled generic and brand-name
drugs and found no difference between the two types of drugs.
The agency also issued a letter to doctors and other healthcare
workers in 1998 in which it reiterated its position that generics
are equivalent to brand-names and that there are no concerns
about safety or effectiveness when switching from one to the
other. That is still the FDA's current position, spokesman
Jason Brodsky tells WebMD.
"You cannot put a generic drug on the market without
proving to FDA that it is absolutely equivalent," says
Clay O'Dell of the Generic Pharmaceutical Association, a trade
group that represents generic drug manufacturers.
Health insurance companies agree with this, and generally
try to encourage their beneficiaries to opt for the generic
by requiring a lesser co-pay for generics because "you
can save money and get the same effect," Joe Luchok of
the Health Insurance Association of America, a trade group
that represents health insurance companies, tells WebMD.
"It's not a case of trying to save money at the expense
of quality," Luchok says.
However, there has been considerable concern raised about
the interchangeability of generic and brand-name drugs that
fall into a class known as narrow therapeutic index or NTI.
These drugs, which make up less than 5% of all prescription
drugs, work in a narrowly defined level in the body and there
is little wiggle room for higher or lower amounts.
The FDA specifically stated in its 1998 letter that generic
NTI's are equivalent to brand-name NTI's, and there are no
safety or effectiveness concerns about switching from one
to the other. Despite this, many doctors still do not like
to switch patients from a brand-name to a generic NTI or vice
versa for fear that slight manufacturing differences could
alter the levels of the drug in the body.
A recent study in the journal Neurology found that participants
taking a generic version of an NTI antiepileptic drug called
phenytoin had lower levels of the drug in their bloodstream
than those taking the brand-name, Dilantin.
Although there were no "serious adverse events"
among the study participants, the findings raise concerns
that the generic may not control epileptic seizures as effectively
as the brand-name, the study authors said, adding that generic
epilepsy drugs should not be switched for brand-name drugs,
at least not without informing the patient and doctor.
In its 1990 guidelines on generic substitution for antiepileptic
medication, the American Academy of Neurology echoed those
concerns, saying pharmacists should be required to inform
patients and doctors when switching generic for brand-name
antiepileptics.
The Academy also writes that specific information on the generic
drug should be made available to doctors before the switch,
and doctors "should avoid switching between formulations
of antiepileptic medications except when medically necessary."
Finally, the group urges further research "where fluctuating
drug levels can produce disastrous results."
In an editorial accompanying the study in Neurology, neurologist
Ronald Lesser, MD, of Johns Hopkins University School of Medicine
in Baltimore, Md., says the findings point to flaws in the
FDA's policies on generic drugs.
Lesser writes, for instance, the variability of the generic
formulation of the drug should be the same as the variability
of the original formulation. He also points out that the economic
benefit of switching may be swallowed up by the extra monitoring
that is needed to maintain the level of the drug in the patient.
Pfizer, the manufacturer of the brand-name drug, participated
in the study. The company submitted the results of the study
to the FDA, but it does not give the agency any reason to
be concerned about patients switching to the generic phenytoin,
the agency's Dale Conner, PharmD, tells WebMD.© 2001
WebMD Corporation. All rights reserved.
AMA commends FDA dedication to generic drug program
June 13, 2003
The AMA yesterday commended the Food and Drug Administration
(FDA) for its commitment to providing America's patients with
access to safe and effective generic drugs. Calling the FDA's
efforts a "great leap forward," AMA President Yank
D. Coble Jr., MD, praised the administration for "revising
its regulations and review procedures while also increasing
its financial commitment to its generic drug program."
"The FDA's expanded educational programs and scientific
studies on bio-equivalence - the degree to which the generic
behaves like the brand drug after administration - will help
increase physician and patient confidence that generic drugs
are a safe and effective alternative," said Dr. Coble.
"This commitment to education and safety in the FDA generic
drug program is just as important as the time and money saved
in getting generic drugs to consumers."
Recognizing the benefits of strong leadership, the AMA applauded
the U.S. Department of Health and Human Services Secretary
Tommy Thompson and FDA Commissioner Mark McClellan for their
"work to provide all Americans with safe, effective and
affordable drugs in a timely fashion," said Dr. Coble.
Content provided by: AMA Member
Communications
Washington AP Story: Bill HR 4461
By Philip Brasher
The Associated Press
WASHINGTON (AP) - Amid growing public resentment of high
prescription drug prices, the House voted overwhelmingly Monday
to prevent the government from discouraging the purchase of
drugs in Canada or other countries.
An increasing number of Americans have been going to Canada,
Mexico and other countries to purchase prescription drugs
cheaper than what they cost in the United States.
Technically, it's illegal to import prescription drugs that
were originally made in the United States, and the Food and
Drug Administration sometimes sends warning letters to people
caught doing it. The agency gives its employees discretion
to permit imports of drugs that violate its restrictions so
long as they are intended for personal use.
The House approved, 363-12, an amendment to an FDA appropriations
bill that would prevent the agency from enforcing the importation
ban, so long as the drugs are for personal use. A second amendment,
approved 370-12, would bar the agency from sending the warning
letters. "People's lives are being shortened today because
of the abnormally high and ridiculously increased price of
prescriptions,'' said Rep. Tom Coburn, R-Okla.
Because of cost controls, drugs can cost several times less
in Canada, Mexico and Europe than in the United States, leading
some Americans to buy their pharmaceuticals by mail order
or else join bus trips across the border to fill their prescriptions.
For example, Prilosec, a popular ulcer medication, costs
$400 for 100 capsules in New York but $184 in Canada and $107
in Mexico, said Rep. Joseph Crowley, D-N.Y.
"Prescription drugs and medicines are not a luxury,
they are a necessity,'' added Crowley.
High drug prices have emerged as a significant issue in this
year's political campaigns. Polling indicates the issue of
prescription drugs is a priority for Americans 65 and older,
a group that accounted for more than one-quarter of voters
in the 1998 elections and is regarded as a key swing group
in the fall campaign.
Republicans pushed a bill through the House last month that
would use private insurance and federal subsidies to cover
some of the cost of prescription drugs for senior citizens.
FDA spokesman Lawrence Bachorik said the agency is concerned
that the House legislation could undermine its "ability
to protect consumers and patients from substandard, poorly
manufactured or otherwise risky drugs.''
"The FDA stands ready to work with Congress on these
issues,'' he added.
The bill is H.R.4461.
Arthritis Drug Vioxx Pulled Off Market
Long-Term Vioxx Use Raises Heart Attack, Stroke Risks
Sept. 30, 2004 -- Long-term use of the painkiller Vioxx doubles
a person's risk of heart attack and stroke, a huge clinical
trial shows.
Responding quickly, Vioxx maker Merck & Co. already has
pulled the popular drug off the market. It's one of the most
widely used drugs ever to be yanked from pharmacy shelves.
Worldwide, 2 million people are taking Vioxx. Last year, Merck
racked up $2.5 billion in Vioxx sales. After the announcement,
Merck's stock dropped by more than 25% in heavy trading.
Merck and the FDA held separate news conferences to discuss
the Vioxx withdrawal.
"We believe this voluntary withdrawal is in the best
interests of patients," Merck CEO Raymond V. Gilmartin
said at the Merck news conference.
"We think Merck is doing the right thing. Although the
risk that an individual patient will have a heart attack or
stroke is small, this risk did double [for long-term Vioxx
users]," Steven Galson, MD, acting director of the FDA
Center for Drug Evaluation and Research, said at the FDA news
conference.
Small Risk Not Worth Taking
Merck's action is the direct result of a huge clinical trial
comparing Vioxx to sugar pills. The trial's main goal was
to see whether Vioxx could prevent recurrent colon polyps.
But the trial was also designed to look at the drug's long-term
safety.
For the first 18 months of the trial, patients taking Vioxx
every day had no more heart attacks or strokes than those
taking placebo pills. But after 18 months on Vioxx, patients'
heart attack and stroke risks doubled, Peter S. Kim, PhD,
president of Merck Research laboratories, announced at the
Merck news conference.
"If you ask after three years of treatment how many
patients would have had a [heart attack or stroke], it would
be 7.5 out of 1,000 patients on placebo, and 15 out of 1,000
patients on Vioxx," Kim said. "The difference becomes
discernable after 18 months and then continues."
If Vioxx were the only drug available for patients experiencing
arthritis pain, that risk might be worth taking. But there
are plenty of other alternatives. Vioxx belongs to a small
class of drugs called Cox-2 inhibitors. One alternative is
to switch patients to one of the two other drugs in this class
-- Celebrex and Bextra. Another alternative is to switch to
one of the drugs in the large group called nonsteroidal anti-inflammatory
drugs (NSAIDs), such as naproxen or ibuprofen.
It's not yet clear whether Celebrex and Bextra have the same
heart effects as Vioxx. There's some evidence that Celebrex
is more heart friendly than Vioxx, but this is far from proven,
says Carl Lavie, MD, medical co-director of cardiac rehabilitation
and preventive cardiology at the Ochsner Clinic Foundation
in New Orleans.
"Celebrex doesn't raise blood pressure at high doses
-- certainly not at the doses we use -- and there seems to
be no increase in heart disease events," Lavie tells
WebMD. "I would feel very comfortable, if a patient needs
a Cox-2 inhibitor, to use Celebrex. This might be the case
with Bextra, too, but I am not aware of the same kind of positive
findings."
BBC News: Viagra bought online 'often fake'
As many as 50% sold could be fake!
Half of men buying the impotence
drug Viagra online are getting counterfeit tablets, study
findings suggest.
Dr Nic Wilson from the University of London tested Internet-sold
samples using a new technique that accurately spots the ingredients
of tablets.
She told the British Pharmaceutical Conference in Manchester
how many authentic-looking tablets were fakes.
Drug giant Pfizer, which manufactures Viagra, is conducting
its own investigations into the fake copies.
Counterfeits
Dr Wilson used a technique called near infrared (NIR) microscopy
which provided a detailed picture of what was in each tablet.
This technology is similar to the older method called NIR
spectroscopy but gives much more information.
There is a high probability that the tablets have no clinical
effect
Researcher Dr Nic Wilson
Dr Wilson explained: "A counterfeit tablet may contain
lactose as an ingredient in the bulk tablet, whereas the authentic
tablet does not.
"NIR spectroscopy could only show that the tablet is
different, while NIR microscopy could actually identify the
likely presence of lactose."
Many of the samples tested contained less of the active ingredient
sildenafil than authentic Viagra.
They also contained different components from the bona fide
Viagra.
Dr Wilson said: "We don't know that 'wrong' components
will be harmful, but the user runs the risk of poor quality
and possible toxicity, not to mention the fact that there
is a high probability that the tablets have no clinical effect."
She said NIR microscopy should help regulatory authorities
monitor the movement of counterfeit tablets.
Crackdown
It is the job of the Medicines Healthcare products Regulatory
Authority to investigate any reports it receives of websites
under its jurisdiction which appear to be in breach of regulations
regarding advertising, or sale and supply of medicines.
In 2003, counterfeit Viagra with an estimated value in excess
of £2.35m was seized.
Pfizer said it welcomed the research and was also analyzing
the samples.
A spokesman said: "We do not recommend that anyone obtains
any prescription-only medicine online without seeing a doctor.
"Without knowing what ingredient is in a counterfeit
medicine a patient could be putting their health at risk.
"It is important for men to see their doctor if they
have erectile dysfunction as it may be an indicator of a more
serious condition.
"Viagra may not be suitable for all men and there are
also some men for whom sexual activity is not considered safe
or for whom an oral treatment may not be appropriate."
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