(from Consumer Health Digest newsletter)
drugs
Drug company
fined $3 billion for marketing violations. (Consumer Health Digest #12-23 July 5, 2012)
GlaxoSmithKline LLC (GSK) has agreed to plead guilty and to pay
$3 billion to resolve liabilities arising from (a) the company's
unlawful promotion of certain prescription drugs for uses not
approved by the FDA, (b) its failure to report certain safety
data, and (c) its civil liability for alleged false price reporting
practices. [GlaxoSmithKline to plead guilty and pay $3 billion
to resolve fraud allegations and failure to report safety data.
US Department of Justice news release, July 2, 2012] http://www.justice.gov/opa/pr/2012/July/12-civ-842.html
The resolution is the largest health care fraud settlement in
U.S. history and the largest payment ever by a drug company. GSK
agreed to plead guilty to two counts of introducing misbranded
drugs (Paxil and Wellbutrin) into interstate commerce and one
count of failing to report safety data about the drug Avandia
to the FDA. Under the plea agreement, GSK will pay a criminal
fine of $956,814,400 and forfeiture of $43,185,600. The company
will also pay $2 billion to resolve its civil liabilities with
the federal government under the False Claims Act, as well as
the states. The civil settlement resolves claims relating to Paxil,
Wellbutrin, Avandia, and several other drugs, and also resolves
pricing fraud allegations and alleged kickbacks to physicians
who prescribed the drugs. The Associated Press has reported that
the improper marketing to doctors included expensive resort vacations,
European hunting trips, high-paid speaking tours, and even tickets
to a Madonna concert. [Holland J. GlaxoSmithKline to pay 3
billion for health fraud. Bloomberg/Business Week News, July 2,
2012] http://www.businessweek.com/ap/2012-07-02/glaxosmithkline-to-pay-3-billion-for-health-fraud.
JAMA debunks
common arguments against flu vaccine. (Consumer Health Digest #13-04, January
24, 2013)
A recent article in the Journal of the American Medical Association has
explained why five common arguments about influenza vaccine are
unfounded:
"The vaccine does not work."
"The vaccine causes the flu"
"I have an allergy to eggs."
"I cannot get the vaccine because I am pregnant or have an
underlying medical condition or because I live with an immunocompromised
person."
"I never get the flu/I am healthy."
The authors also advocate basic preventive measures such as hand
hygiene, cough control, and exposure reduction. The full article, Influenza
prevention update: Examining common arguments against influenza
vaccination, can be viewed online free of charge (link).
FDA ends
plan B emergency contraception restrictions. (Consumer Health Digest #13-31, August 22,
2013)
The FDA has approved Plan B One-Step emergency contraceptives
for use without a prescription for all women of child-bearing
potential. This action complies with the April 5, 2013 order of
the U.S. District Court in New York to make levonorgestrel-containing
emergency contraceptives available over-the-counter without age
or point-of-sale restrictions. Plan B One Step is a single-dose
pill that can decrease the chance of pregnancy by stopping ovulation.
It can be taken up to 120 hours after unprotected sex, but the
earlier it is used, the more effective it is. If taken within
12 hours, the pregnancy rate is 0.4%. If taken within 1 to 3 days,
the rate is 2.7%. The court case was spearheaded by the Center
for Reproductive Rights.
Australian
cigarette warnings appear to be effective (Consumer Health Digest #14-22 June 15,
2014)
Household consumption of tobacco products in Australia fell 4.9%
in the year that ended in March. [Innis
M.Australia's graphic cigarette pack warnings appear to work.
The New York Times, June 11, 2014]. The drop appears to be
due to rising prices and the packaging
regulations that took effect in December 2012. Australian
cigarette packages must now be plain except for large, graphic
warnings about heart disease, lung disease, and other serious
illnesses. The Supplier
Guide, which provides full details, can be viewed online.
ACP recommends
generics (Consumer
Health Digest #15-48 December 6, 2015)
The American College of Physicians has issued a position statement
calling for wider prescription of generic drugs. [Choudrey
NK and others. Improving
adherence to therapy and clinical outcomes while containing costs:
Opportunities from the greater use of generic medications: Best
practice advice from the Clinical Guidelines Committee of the
American College of Physicians. Annals of Internal Medicine.
Published online, Nov 24, 2015] The advice is based on a literature
review which concluded:
- Research shows that generic medicines are just as effective
as brand-name medicines.
- Many brand-name medicines are being used when equally effective
and less expensive generic options are available.
- By using more generic medicines, patients can save a lot of
money without having any impact on their health care or outcomes.
In addition, billions of dollars in health care spending could
be saved.
- Generic medicines decrease out-of-pocket costs for patients.
Some research shows that less expensive generic medicines could
help patients stay on their treatment plans. This is especially
helpful for patients with chronic conditions that require long-term
drug treatment.
- Some patients and physicians wrongly assume that lower costs
mean lower effectiveness, even when research shows the opposite.
- Clinicians should prescribe generic medicines, when possible,
in place of more expensive brand-name medicines.
John Oliver
lampoons drug company marketing (Consumer
Health Digest #16-12 - April 3, 2016)
Comedian John Oliver has examined how drug companies spend billions
of dollars to influence doctors to prescribe their products. The
extent to which the marketing strategies work is difficult to
measure, but the companies themselves believe that they are effective.
Oliver's 17-minute
video has had more than 6 million views since it was posted
on YouTube two months ago.
AMA expresses
concern about the use of "smart drugs" (Consumer Health Digest
#16-27 - July 17, 2016)
The American Medical Association House of Delegates has voted
to discourage the prescribing and use of prescription drugs for
cognitive enhancement in healthy individuals. These products,
referred to as nootropics or "smart drugs," include
prescription drugs, dietary supplements, or other substances that
are claimed to improve brain functions such as executive function,
memory, learning, and/or intelligence. [AMA
confronts the rise of nootropics. AMA news release, June 14,
2016] The new policy statement noted:
- Prescription drugs that are FDA-approved to treat attention-deficit
hyperactivity disorder or narcolepsy are commonly used by students
and others seeking to boost memory, learning or other aspects
of cognition.
- While prescription stimulants carry real risks, they do not
make people smarter. The available evidence suggests the cognitive
effects of prescription stimulants appear to be highly variable
among individuals, are dose-dependent, and limited or modest at
best in healthy individuals.
- More than 100 substances from amino acids to botanical preparations
are claimed on Web sites to improve cognitive performance, but
their safety and efficacy have not been systematically examined.
The AMA will urge the FTC to examine advertisements for these
products to ensure that they are not misleading.
FDA attacks
sale of marijuana derivative as cancer cures (Consumer Health Digest#17-41 - November
5, 2017)
The FDA has ordered four companies - Greenroads
Health, Natural
Alchemist, That's
Natural! Marketing and Consulting, and Stanley
Brothers Social Enterprises LLC -to stop selling cannabidiol
(CBD) products with unproven claims that they are effective against
cancer. The products include oil drops, capsules, syrups, teas,
and topical lotions and creams. Some were also marketed as an
alternative or additional treatment for Alzheimer's and other
serious diseases. CBD is a component of the marijuana plant that
is not FDA approved in any drug product for any indication. [FDA
warns companies marketing unproven products, derived from marijuana,
that claim to treat or cure cancer. FDA news release, Nov 1, 2017].
Cannabidiol
promoters warned (Consumer
Health Digest#19-14 April 8, 2019)
The Federal Trade Commission (FTC) and the U.S. Food and Drug
Administration (FDA) have jointly sent warning letters to Nutra
Pure LLC, PotNetwork
Holdings, Inc., and Advanced
Spine and Pain, LLC (d/b/a Relievus) because they believe
the companies are illegally marketing products containing cannabidiol
(CBD) to treat a variety of serious diseases and conditions. [FTC
joins FDA in sending warning letters to companies advertising
and selling products containing cannabidiol (CBD) claiming to
treat Alzheimer's, cancer, and other diseases. FTC Press Release.
April 2, 2019] CBD is a chemical compound found in marijuana
and hemp that does not produce a high. In 2018, the FDA
approved a cannabidiol preparation (brand name Epidiolex) to treat
two rare, severe forms of epilepsy. But since 2015, the FDA
has ordered
many companies to stop making unapproved claims. The market
for unapproved CBD products is nevertheless burgeoning, as consumer
protection is lacking. The FDA and others
have found that some CBD products have not contained dosages claimed
by marketers. Dangerous chemicals have
been found in popular CBD vaping liquids. Although there is
great interest in potential medical uses for CBD, the
evidence for its safety and effectiveness falls far short of the
marketing hype for available products.
Cardiologist
blasts cholesterol denialism (Consumer
Health Digest #24-22 - June 2, 2024)
Christopher Labos, M.D., C.M., M.Sc., has briefly reviewed the
history of debate about the safety and effectiveness of lowering low-density
lipoprotein cholesterol (LDL-C) to
prevent coronary heart disease mortality. He argues that the arrival
of statin drugs should have settled the matter and the drugs work
by lowering cholesterol. He notes:
• The Scandinavian
Simvastatin Study (4S) showed lowering cholesterol not
only prevented heart attacks but also reduced cardiovascular and
all-cause mortality. Twenty-six
randomized studies later, it’s hard to come up with a
credible reason for why you think cholesterol has nothing to do
with heart disease.
• The new cholesterol medications such as PCSK9 inhibitors
have also proven another point. We can lower cholesterol to unheard-of
depths with no safety risk.
• Don’t like statins? Many myalgia symptoms with statins
might be due to the nocebo
response. But even if you have side effects, just try something
else. There was a time when you could have doubts about the role
of cholesterol in heart disease. But you should have changed your
mind by now. I have. Denying the lipid hypothesis is no longer
valid scientific skepticism; it’s pseudoscience.
[Labos C. Cholesterol
denialism is pseudoscience. Medscape, May 2, 2024]
page
created: July
15th, 2012 and last updated:
June
7th, 2024