Lobbying
Lobbying (also Lobby) is the intention of influencing decisions made by legislators and officials
in the government by individuals, other legislators, constituents, or advocacy groups. A lobbyist
is a person who tries to influence legislation on behalf of a special interest or a member of a
lobby. Governments often define and regulate organized group lobbying that has become
influential.
In United States, the pharmaceutical lobby — also known as the drug lobby or Big
Pharmaceutical — refers to the paid representatives of large pharmaceutical
and biomedicine companies in the United States who seek to influence federal government
policy.
Controversies
Prescription Drug Costs
Critics of the Pharmaceutical lobby argue that the drug industry's influence allows it to promote
legislation friendly to drug manufacturers at the expense of patients. The lobby's influence in
securing the passage of the Medicare Prescription Drug Improvement and Modernization Act of
2003 was considered a major and controversial victory for the industry, as it prevents the
government from negotiating prices with drug companies who provide those prescription drugs
covered by Medicare. As a result, 61 percent of Medicare spending on prescription drugs is
direct profit for pharmaceutical companies.
The high price of U.S. prescription drugs has been a source of ongoing controversy.
Corporations claim the high costs are the result of pricey research and development programs,
while critics point out, in addition to the industry's profits, the high proportion of pharmaceutical
budgets devoted to marketing and lobbying.
Influence over Doctors
The pharmaceutical industry's sponsorship of clinical research has come under increased scrutiny
in recent years, as authors of publications favorable to the industry often receive compensation
from major drug companies, thereby raising doubts about their research's objectivity.
Additionally, advocacy groups within and beyond the medical profession have asserted that
direct advertising to physicians, free samples, and research stipends encourage doctors to
overprescribe medications. Doctors who were financially tied to drug companies were also
instrumental in devising treatment guidelines that recommended medications manufactured by
those same firms.
Cases
Premarin: Low-Profit Treatment for Menopause, or an Anti-Aging Miracle?
The drug Premarin was first approved by the FDA in 1942 for treating the symptoms of
menopause. Since only a minority of women have menopausal symptoms that are severe enough
to require medical therapy, projected sales of the medication were not particularly impressive.
When gynecologist Robert Wilson published several hyperbolic journal articles and his best-
selling book, Feminine Forever, Premarin’s place as an anti-aging agent for women was secured.
Dr. Wilson’s foundation received a total of $1.3 million from various drug companies, including
Wyeth, the maker of Premarin.
The Marketing of Statins for Cholesterol
With the nation’s collective attention focused on lowering LDL cholesterol levels to prevent
cardiovascular disease, statin drugs have been pushed to the fore as the holy grail of laundered
lipid panels. In truth, regular physical activity is far more effective at reducing mortality from
heart attacks and strokes than is a lower LDL cholesterol level—but lifestyle changes cannot be
marketed for profit. Five of the 14 experts who formulated cholesterol guidelines in 2001
disclosed financial ties to companies that manufacture statins, and four of the five (including the
panel’s chair) had relationships with all three makers of the best-selling drugs. The panel’s
recommendations—which included the widespread use of statins—were published in the May
16, 2001, issue of JAMA and quickly became protocol for virtually all physicians who treat
patients majorly children.
COX-2's for Arthritis: A Case of Misrepresentation
At the end of 2001, 57% of all money spent on arthritis drugs in the US was being spent on
Celebrex and Vioxx, both of which were among the top 10 selling drugs. Earlier that same year,
Pharmacia Corporation was required to notify physicians that the company’s marketing of
Celebrex had been “false or misleading and therefore in violation of the Federal Food, Drug, and
Cosmetic Act.” Unfortunately, the effectiveness and safety of both medications had already been
extolled in highly-esteemed medical journals read by all physicians. Evidence uncovered in the
interim suggests that both Vioxx and Celebrex were marketed as safer alternatives to older anti-
inflammatory drugs when manufacturers were aware that they actually weren’t—and possibly
manipulated data to protect the medications’ status in the marketplace.
Multiple other instances of “Big Pharmaceutical’s” misbehavior have been brought to light.
Now, with direct-to-consumer advertising, drug companies exhort patients to demand the newest
medications hitting the market. So even if physicians can partially loosen the grasp of the
pharmceutical industry, they’ll still have to contend with misinformed patients.
Lobbying for Retail Pharmacy Profits
Profits on generic drugs now subsidize the branded pharmaceutical supply chain for wholesalers
and retail pharmacies. Generic margins are under pressure, most immediately under the proposed
AMP rules for Medicaid. The retail pharmacy industry now realizes that the reimbursement
debate will not be fought solely on the basis of economics.
Community Pharmacists Launch Grassroots Lobbying Campaign
A grassroots lobbying effort launched earlier this month by the National Community Pharmacists
Association is on track to establish a 100,000-member patient coalition by the end of the year. So
far, more than 1,000 community pharmacists and 5,000 customers across the U.S. are
participating in the Fight4Rx campaign. The $250,000 campaign will work to prevent cuts in
pharmacy reimbursements from Medicare and Medicaid; allow small pharmacies to unite and
negotiate drug prices directly with the federal government; and prevent mandates that would
require people enrolled in government-sponsored health coverage programs to use mail-order
pharmacies.
Drug-Free Workplace Policy - Drug / Alcohol Testing
It is the purpose of the companies to help provide a safe and drug-free work environment for our
clients and our employees. With this goal in mind and because of the serious drug abuse problem
in today's workplace, the company explicitly prohibits:
1. The use, possession, solicitation for, or sale of narcotics or other illegal drugs, alcohol, or
prescription medication without a prescription.
2. Possession, use, solicitation for, or sale of legal or illegal drugs or alcohol away from the
Company or customer premises, if such activity or involvement adversely affects the
employee's work performance, the safety of the employee or of others, or puts at risk the
Company's reputation.
3. The presence of any detectable amount of prohibited substances in the employee's system
while at work, while on the premises of the company or its customers, or while on company
pharmaceutical companies. "Prohibited substances" include illegal drugs, alcohol, or
prescription drugs not taken in accordance with a prescription given to the employee.
The Company will conduct drug testing under one or another of the following circumstances:
Random Testing: Employees may be selected at random for drug testing at any interval
determined by the Company.
For Cause Testing: The Company may ask an employee to submit to a drug test at any time it
feels that the employee may be under the influence of drugs or alcohol, including, but not limited
to, the following circumstances: evidence of drugs or alcohol on or about the employee's person
or in the employee's vicinity, unusual conduct on the employee's part that suggests impairment or
influence of drugs or alcohol, negative performance patterns, or excessive and unexplained
absenteeism or tardiness.
Post-Accident Testing: Any employee involved in an on-the-job accident or injury under
circumstances that suggest possible use or influence of drugs or alcohol in the accident or injury
event may be asked to submit to a drug and/or alcohol test.
Relationship between Government and Pharmaceutical Companies
The relationship between government and pharmaceutical-companies is complex, with both
positive and negative aspects in terms of what can be called the "public good." Thus an accurate
and complete understanding of this relationship necessitates an examination of the three main
theories of political economy.
The Free Market- Growing out of the theories of Adam Smith, the essentially free-market
approach argues that the public good can be seen as synonymous with economic efficiency and
gains in the standard of living for individuals. According to Smith, the "invisible hand" (the
aggregate of undisturbed decisions by buyers and sellers in the open market) tends to produce
better goods, at cheaper prices, for more people.
Socialism- According to socialism, the public good is seen in terms of economic equality and of
checking the exploitative power of pharmaceutical companies. Therefore, the only remedy would
be for the government, on behalf of the people, to take control of pharmaceutical companies and
direct what goods would be produced at what prices.
The Third Approach- A third option in terms of political economy was proposed by the
economist John Maynard Keynes. It was his contention that pharmaceutical companies fully
controlled by government would inherently lead to inefficiency and a lowering of the standard of
living. On the other hand, he also argued that a purely free market system would tend to
undermine itself in the long run, and lead to an unstable social situation due to inequalities and
contradictions. Currently, most developed countries use a variation of Keynes's policies,
allowing a large degree of private pharmaceutical companies while maintaining strict regulation
of certain aspects of the economy through the government. Today's relationship between
government and pharmaceutical companies is thus neither lassez faire nor socialist, but rather a
combination of both, essentially what is called a "mixed economy."
