Let's say you have a wonderful
idea for a new drug, something that you have invented in your spare time
behind the prescription counter. Imagine this is a cream or an ointment that
you have been playing around with, adding a touch of this and a dash of that.
Maybe you've even tried it on yourself and know in your heart of hearts that
it is safe and effective. Maybe you have tried it on your spouse, your kids,
or even some friends. Everyone who has tried this stuff thinks it's the new
best thing since the introduction of sliced bread. You check around with your
friends in the pharmacy world and hear that it's going to cost thousands of
dollars to obtain a patent on this new drug and millions of dollars to go
through the FDA's new drug application approval process. This could take up to
a dozen or more years while the drug works its way through the stages of
clinical testing and safety and efficacy determinations. And you think that
whole process is an insurmountable barrier. Then you have the bright idea that
there must be some way to get around this gobbledygook. So you start looking
for loopholes. Before going any further down this slippery slope, consider the
facts and outcome of a recent case.1
Facts
In 1997 and 1998,
two entrepreneurs began talks with a physician who specialized in the
treatment of erectile dysfunction. These three individuals decided to use
telemarketing methods to make an anti-impotence drug product available to the
general public. The doctor proposed creating a gel containing the
prescription-only drugs prostaglandin, papaverine, and phentolamine. According
to the physician, urologists frequently combine these drugs into a
prescribable "tri-mix" that is injected directly into the erectile tissue of a
penis as an impotence treatment. The doctor believed a gel form of the tri-mix
applied through a urethral suppository would be "less aggressive" than an
injectable treatment. More specifically, he believed a gel would be easier for
users to apply and less likely to entail serious side effects. Without direct
injection into the penis, however, the doctor estimated that the tri-mix gel
would be unable to achieve the roughly 70% success rate of tri-mix injections.
In 1998, the two defendants
in this case formed US One Marketing Services Corporation (US One) as the
entity that would conduct the telemarketing for the new formulation. The
physician made arrangements to obtain the urethral suppository tri-mix from a
pharmacist in Connecticut who owned a prescription compounding pharmacy. The
product would be marketed as "Power Gel." Because the ingredients require a
prescription, the pharmacist insisted that the doctor provide prescriptions
naming an individual. The owners of US One and the doctor agreed that the
physician would write prescriptions in the names of his existing patients
without their knowledge. Under this scheme, the doctor would write the
prescriptions and fax them to the pharmacy. The pharmacist mixed up the
medicine and dispensed it with proper labeling as if these were real
prescriptions. The pharmacist shipped the drugs to the physician but billed US
One. In return, the owners of US One paid the pharmacist. The doctor then gave
the drugs to US One, where they were relabeled. Then US One would sell the
Power Gel to individuals (who were not patients of the physician) who ordered
it through telephone calls to the company. The defendants (two of the owners
of US One) admitted that they both knew that the doctor was writing
prescriptions in his patients' names, even though his patients were never
aware of this fact and never received either the prescriptions or the Power
Gel he prescribed.
The defendants purposefully
decided to promote Power Gel to a Spanish-speaking market. One of the men who
headed US One's sales efforts wrote scripts for radio advertisements and
infomercials in which both defendants appeared. In the advertisements, US One
represented that the Power Gel was 100% effective as a treatment for
impotence, and that it had zero contraindications or side effects. The
physician was also requested to "enhance" what he said in the advertisements
to increase sales and to declare that "nothing is better than Power Gel." US
One insisted that the doctor make no negative statements about Power Gel. The
advertisements emphasized that Power Gel required no prescription and could be
bought and used with complete discretion. The advertisements also claimed that
Power Gel was easy to apply, caused no pain, produced results in 10 minutes,
and caused a complete erection lasting from 30 minutes to an hour. Radio
advertisements, info mercials, and other promotional materials were written
in Spanish.
The defendants also wrote a
pamphlet that US One distributed with each Power Gel shipment. The pamphlet
discussed the physical causes of erectile dysfunction, then described the use
of Power Gel and how to apply it. In a section entitled, "Subsequent Effects,"
the pamphlet mentioned the possibility that an erection might last "a little
while" after sexual relations, in which case the pamphlet instructed to "use
some ice [on the penis] for a period of time no longer than 10 minutes." The
pamphlet also mentioned: "You may feel some pain in the penis, testicles, and
in the area between the penis and the rectum." The "Subsequent Effects"
section concluded: "In general, these effects are most often experienced with
the first several uses and disappear completely in the following application."
The pamphlet later asserts that "30% of those who used this product did not
respond to the treatment, 10% complained of discomfort, and there has been no
indication of priapism or prolonged and painful erection."
Customers who contacted US
One interested in Power Gel talked to US One's telephone sales people who had
instuctions to say that there were no contraindications or side effects to
Power Gel, that it would not cause burning or discomfort, and that it could be
used by men with high blood pressure, with diabetes, or who had undergone
heart or pros tate surgery.
Despite these
representations in US One's marketing and materials, the physician had
previously told the defendants that Power Gel would only help 30% to 40% of
users. The doctor also knew and claimed that he informed the defendants that
the placebo effect for impotence treatments of all kinds is roughly 30% to
40%.
In the court's opinion,
these representations by the doctor communicated to the defendants that:
Power Gel would be
no better than a placebo at treating impotence. None of US One's marketing
mentioned that prostaglandin, an ingredient of Power Gel, may cause harmful
uterine contractions and that Power Gel users should therefore wear a condom.
None of US One's materials discussed in any detail the potential side effect
of priapism, a dangerous and painful persistent erection that can require
medical treatment to prevent permanent damage to the penis. None of the
marketing stated that either Power Gel or its ingredients were prescription
drugs. The advertisements and pamphlet also failed to discuss in any detail a
range of other known side effects of Power Gel's ingredients.
In reviewing the side
effects of similar drugs, the court noted:
Power Gel shares
some similarities with MUSE, a prescription prostaglandin administered by
intraurethal suppository. MUSE has a far higher concentration of prostaglandin
than does Power Gel. Even so, MUSE is effective in less than 40% of users
because the prostaglandin is not injected directly into the penis, as in the
more effective tri-mix treatment. Known side effects of MUSE include a drop in
blood pressure, fainting and loss of consciousness, and burning and pain in
the penis. These side effects are serious enough that the first dose of MUSE
is always administered in the doctor's office.
Shortly after US One began
selling Power Gel, the defendants expressed to the doctor an interest in an
oral alternative to Power Gel. The doctor proposed vasomax, an orally
administered phentolamine, and sent the defendants literature about the
product. The defendants decided to sell their own oral phentolamine under the
name "Vigor," and they established the same arrangement with the Connecticut
pharmacist to obtain the drug. The doctor continued to write fraudulent
prescriptions ostensibly for his patients and to fax these prescriptions to
the pharmacist. After receiving the prescriptions, the pharmacist would ship
the Vigor to the doctor. In turn, the physician would hand the Vigor over to
the defendants at US One, and US One would pay the pharmacist.
The physician made it clear
to the defendants that Vigor was not an improvement over Power Gel, and that
it could likewise be expected to show only a 30% to 40% success rate, i.e.,
about the same as a placebo. Moreover, both the doctor and pharmacist
explained to the defendants that Vigor was another prescription drug with side
effects and contraindications, posing special dangers for users with high
blood pressure. Despite having been informed of the low effectiveness of Vigor
and the risks involved in using it, the defendants marketed Vigor to the
Spanish-speaking community in much the same manner as they were marketing
Power Gel. The advertisements for Vigor stated that it required no
prescription and had no contraindications or side effects. Both defendants
told US One's salesmen to tell potential customers that Vigor could be used by
anyone, including sick people or people with heart conditions.
Investigation
Sometime during
the summer of 1998, a pharmacist working for the Florida Department of Health
heard some of the ads for Power Gel. The pharmacist made contact with an
investigator for the FDA in Florida. These two individuals contacted the Miami
Police Department to voice their concerns about the legality of Power Gel.
Agents began an investigation that included making several undercover
purchases of Power Gel. An analysis of the purchased products confirmed that
they contained prescription-only drugs. The Florida pharmacist also called US
One to purchase Vigor. A salesperson told him that Vigor is a naturally
occurring product that has no side effects and was safe to take regardless of
the purchaser's age or medical conditions, including high blood pressure.
Vigor was also tested and determined to contain a prescription-only drug.
The defendants were
arrested, and the promotional material was recovered. In addition, two
complaint letters from customers were found that indicated that (1) Power Gel
does not work, and (2) application of Power Gel had injured the customer's
penis and had been very painful. The government also contacted other customers
of US One, 10 of whom eventually testified at the defendants' trial. These
witnesses testified that they had purchased either Power Gel or Vigor as a
result of advertisements stating that the products were safe for everyone,
that they had no side effects, and that no prescription was required. During
their phone calls with US One, none of these 10 customers was asked about his
medical history, and some were told that the products were safe even after
informing the US One salesperson that they had high blood pressure or
diabetes. Several former customers reported serious side effects upon using
the products, including irritation in the penis that lasted two days after
using Power Gel, burning upon urination, bleeding from the penis, anxiety, and
shortness of breath.
Trial Court
On November 13,
2001, a federal grand jury approved a 26-count indictment against the two
owners of US One, the physician, and the pharmacist and his pharmacy, charging
them with conspiracy, mail fraud, wire fraud, and crimes related to the
misbranding of prescription drugs.
On September 18, 2002, the
pharmacist pleaded guilty to one count of dispensing drugs without a
prescription. He was sentenced to 10 months imprisonment and was ordered to
pay a $10,000 fine. On November 15, 2002, the physician pleaded guilty and was
sentenced to 24 months of imprisonment and was ordered to pay $29,523.34 in
restitution. Both the pharmacist and the physician testified at the trial of
the remaining defendants.
After a three-and-a-half
week trial, a jury returned guilty verdicts against the defendants on felony
charges. Following federal sentencing guidelines, the judge sentenced both
defendants to between 51 and 63 months (4.25 to 5.25 years) of imprisonment,
three years of supervised release, and $29,523.34 in restitution. The
defendants appealed both convictions and their sentencing orders.
Appeal
In an
extraordinarily long and detailed opinion, the appeals court affirmed the
trial court determinations completely. The judges observed that the defendants
devised a scheme to sell treatments for erectile dysfunction, which were sold
without a prescription written to the end user. The court held that the
evidence was sufficient to convict the defendants for the conspiracy. Evidence
showed that the treatments were prescription drugs and that the defendants
were selling them without obtaining prescriptions. According to these judges,
the defendants' intent to defraud or mislead was established, because the
defendants knew that a doctor involved in the scheme was obtaining the drugs
by writing fraudulent prescriptions. Evidence was also found sufficient to
convict the defendants of mail fraud. The court found that defendants were not
entitled to resentencing, as there was no proof that the outcome would have
been different under an advisory Guidelines scheme.
Analysis
If you have not
been convinced that a "get rich quick" scheme about marketing drugs without
going through the basic formalities is a bad idea, think again. Go find the
entire opinion,1 and read it in full. No pharmacist should ever
accept a pitch that is too good to be real. It's an old cliché: If it's too
good to be true, it isn't true. Walk away from these kinds of golden
opportunities. Sitting in jail, having to pay enormous fines, and losing your
license to practice pharmacy are factors you should consider before
agreeing to engage in an enterprise that smells funny. These days of Internet
technologies that help people avoid legal niceties, like having a prescription
for a prescription-only drug, are temporary. You will get caught eventually.
Try to remember your ethics instruction. As pharmacists, we are expected to
live up to some very high standards.
REFERENCE
1. US v. Munoz
and Llona, Slip Op No 03-16216 (November 23, 2005), 11th Cir, 2005 U.S.
App. Lexis 25250 on appeal from the United States District Court for the
Southern District of Florida DC Docket No 01-01029-CR-AJ.
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