Medical Whistleblower Advocacy Network

Our democracy is dependent on the ability of the will of the people to affect the actions of our elected 
officials. Only when we know to whom elected officials are beholden, can we hold our elected 
officials accountable. We have an obligation to ensure that our legislation, administrative policies and 
practices are consistent with protections for Constitutional Rights and also Human Rights under 
International Human Rights Treaties. Because of Supreme Court decisions like Citizens United, many 
political spenders, such as the pharmaceutical industry are effectively allowed to hide their true 
identities and to greatly influence legislation and administrative policies. When we as a nation do not 
have transparency or accountability regarding political lobbying efforts of huge corporate interests, we 
cannot draft legislation that protects the human rights of patients to safe and effective health care. We 
can also not protect vulnerable patients from being human subjects of research without their informed 
consent, as medicine is a profit driven business and patients are very vulnerable and trusting of their 
medical providers. 

Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for 
disabled persons and other individuals. MWAN provides information, referrals, and also direct human
rights defender advocacy services.  MWAN is a participating human rights advocate to the 2nd cycle of the 
United Nations UPR Process reviewing the record of the United States of America. 

Medical Whistleblower Advocacy Network is extremely concerned that the political power of the 
pharmaceutical industry has furthered a profit making agenda which has overshadowed the rights of 
patients and has led to the loss of human rights protections for vulnerable populations. The pursuit of 
the almighty dollar often overshadows corporate responsibility to the public. 

The Pharmaceutical Industry lobby has mounted a sophisticated grassroots campaign to provide 
political support for its position on key issues that affect its profit making enterprise – including 
expanded Medicare/Medicaid funding for off-label drugs. The industry has funded various groups to 
champion its positions, sponsored studies tilted to industry goals and hired public relations firms to 
spearhead campaigns to soften up public opinion and government policies. 

The Pharmaceutical Research and Manufacturers of America spent $12,650,000 on lobbying in 2014 
according to OpenSecrets.org. Pfizer Inc. spent $6,910,000, Amgen Inc. spent $6,590,00, Eli Lilly & 
Co. spent $5,776,000 and Novartis AG spent $5,435,000 and this is only what they actually disclosed, 
not what they funneled through other 501 C 4 non-profit organizations. No health professional activity 
is safe from the $200 billion pharmaceutical industry financial and political influence. The largest 
growing portion of that market is now psychiatric medications which are highly profitable products but 
of dubious benefit. Pharmaceutical companies spend a majority of their funds in marketing rather than 
research and development. Financial and political power allows the pharmaceutical industry to push 
their legislative agenda through Congress, influence regulatory actions of the FDA, and to control 
research at academic medical centers. Public research institutions funded by tax dollars are doing the 
basic research for the drugs, but the actual clinical trials are funded privately by the drug companies. 
Off-label drug use clinical data is used to expand FDA approval to additional diagnoses. In order to 
make patented drugs look better than they really are, clinical research trials are rigged. Government 
granted exclusive marketing rights are extended for years by protective and aggressive industry 
lawyers. The pharmaceutical industry has found that clinical safety trials are costly to perform. Instead 
they have sifted their emphasis to political pressure on targeted government officials to sway public 
policy decision making and thus be able to use federal tax dollars to pay for “off-label” use of welfare 
recipients as their human subjects. Controlling the decisions of the medical proxy decision makers is 
therefore their focus rather than making sure that medications are approved by the FDA as safe and 
effective. Annually, the pharmaceuticals industry spends nearly twice as much on marketing as it 
spends on research and development. According to the Center for Public Integrity the pharmaceutical 
and health products industry has spent more than $800 million in federal lobbying and campaign 
donations at both federal and state levels in the past seven years. (PublicIntegrity.org) The Supreme 
Court Decision, Citizens United v. Federal Election Commission has now even further extended the 
pharmaceutical companies influence over policy makers through unbridled secret contributions to 501 c 
4 organizations which then can lobby legislators on behalf of the pharmaceutical industry. Individual 
citizens of the U.S.A., especially persons with mental disabilities, cannot compete with equal lobbying 
actions to the pharmaceutical industry. Indeed, many with mental health diagnosis are actually stripped 
of their right to vote and even their right to petition their elected representatives for issues crucial to 
their human rights. Surrogate decision makers often controlled by the medical proxies make voting 
decisions for the wards and thus vote pro-pharmaceutical interventions. The human rights of wards of 
the court are lost in this political exercise of power. 

The pharmaceutical industry gives millions to public advocacy non-profit organizations with a variety 
of missions, many of which then support the political agenda of the pharmaceutical firms. These non-
profit organizations are under no legal obligation to reveal their donors, and thus provide an avenue for 
support for positions favorable to the industry. Some of the groups that receive the industry funds are 
independent, but many are just a front for the pharmaceutical lobby such as The Institute for Policy 
Innovation (IPI). IPI does not disclose its funders, but according to the Foundation Center – Eli Lilly 
and Company Foundation is among the group's supporters. The Eli Lilly Foundation is funded by Eli 
Lilly and has the mission of providing financial support for non-profit organizations. With the support 
of Eli Lilly funding the IPI has published reports opposing drug re-importation and price controls and 
defending the industry's lavish spending on advertising, especially the direct-to-consumer advertising. 
Other known pharmaceutical industry grassroots political lobbying groups are Seniors Coalition and 
The United Seniors Association. The lobbying efforts by these so-called grassroots organizations can 
be very deceptive, such as the Consumer Alliance 2002 campaign against legislation that would have 
capped prices for prescription drugs. The Consumer Alliance faxed petitions to community leaders that 
warned the poor and disabled were in danger of losing access to affordable prescription drugs. It was 
revealed later by the Baltimore Sun, that Consumer Alliance was a front group used by Bonner and 
Associates on behalf of PhRMA. PhRMA spent more than $60 million on television and newspaper 
ads through a group called Citizens for Better Medicare. Citizens for Better Medicare claimed to be a 
grassroots organization consisting of numerous organizations and more than 300,000 individual 
members and had a mission to get passage of the Medicare prescription drug benefit in 2003. This 
legislation has dramatically increased the amount of federal funding through Medicare to pay for off-
label psychiatric prescription drugs. 

Off-label use is using a drug for a use that it has not been scientifically proven to be safe or effective – 
in other words the drug has not met the requirements to be approved by the federal regulatory agency 
the Food and Drug Administration. The pharmaceutical industry politically pushed for legislation 
which would permit them to sell their patented drugs off-label (drugs without Food and Drug 
Administration approval for that use). There is no need for the pharmaceutical industry to pay for 
costly pharmaceutical clinical research trials when they can sell the drug off-label and get the US tax 
payer to pay for it even if it is not even FDA proven to be safe or effective. The drug companies 
promote these patented off-label drugs by deceptive direct-to-consumer and direct-to-doctor marketing 
efforts. The practice of marketing drugs for purposes not backed by science is called “off-label 
promotion.” Off-label drug promotion undercuts expectations that drug safety and efficacy have been 
fully evaluated. The National Alliance for the Mentally Ill (NAMI) is a 501 C 3 which is funded by 
pharmaceutical companies such as Eli Lilly to provide educational materials to both doctors and 
patients touting the great benefits of the newly patented medications. Off-label promotion is illegal, 
but the pharmaceutical industry pays their attorneys well to fight the FDA in court and when they are 
finally criminally convicted the criminal penalties are not high enough to really prevent re-occurrence. 

The pharmaceutical industry's political agenda is profit making – not provision of affordable, safe, 
health care for all. When the government becomes a third party payer for off-label drug use and the 
Medicare/Medicaid legislation mandates payment of any cost of psychiatric drugs then administrators 
cannot place reasonable cost-saving measures in place. When newer, more expensive drugs are used 
off-label, it increases health care costs. The pharmaceutical industry has effectively turned welfare 
recipients into human subjects for the testing of their patented drugs off-label and lobbied for the 
federal government Medicare program to pay for this off-label use. Deceptive marketing through 
contract with prescribing doctors and other medical professionals has expanded the off-label drug use 
in this country and has increased health care costs. Highly profitable and expensive patented 
medications are over-used and our population is over-medicated. Off-label drugs such as gabapentin 
for chronic pain and olanzapine (Zyprexa) for dementia have shown that off-label use has potentially 
very negative consequences. The highest rates of off-label use were for anticonvulsants (74%), 
antipsychotics (60%), and antibiotics (41%). In an examination of off-label prescribing of 160 
common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label 
drug uses (73%) were shown to have little or no scientific support. Atypical antipsychotics and 
antidepressants were particularly likely to be used off-label without strong evidence. ( Radley DC, 
Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 
2006;166: 1021-6.) 

Getting informed consent from a patient is a process, not just a formality, and engaging in that process 
is of the essence of good medical care. But informed consent cannot happen when research data is 
suppressed and safety information is withheld from prescribing doctors and patients. Informed consent 
to use a medication is consent obtained freely, without threats or improper inducements, and after 
appropriate disclosure to the patient of adequate and understandable information in a form and 
language understood by the patient. Engaging in an informed-consent process between a clinical 
doctor and a patient is an essential part of the standard of care in medicine. The involvement of human 
beings in such research is prohibited unless the subject or the subject’s legally authorized representative 
has provided prior informed consent, with only very limited exceptions. A waiver of informed consent 
by the Institutional Review Board is supposed to be granted only in circumstances where the research 
presents no more than minimal risk to subjects, and the waiver will not adversely affect subjects’ rights 
and welfare. Wards of the court have surrogate decision makers for both legal and medical decisions, 
thus wards are prevented even from effective appeal to the Judge or even to their US 
Congressmen/Congresswomen. Thus the pharmaceutical industry's influence on surrogate decision 
makers such as doctors can effectively control what medical care is given. In the U.S.A. the 
guardianship system offers few procedural protections, and has spawned a profit-driven professional 
guardianship industry that often enriches itself at the expense of society’s most vulnerable members—
the mentally ill. 

We must support the right of federal regulatory agencies to do their job in researching what is safe and 
what is not. The Food and Drug Administration's restrictions on off-label promotion serve two 
substantial interests: ensuring that both doctors and consumers receive accurate, scientifically based 
information, and assuring that drugs have been proven safe and effective. Right now Jazz 
Pharmaceuticals is off-label marketing Xyrem which is the sodium salt of GHB – a well-known date 
rape drug. Xyrem is a Schedule III drug, but when diverted to illegal use it is a Schedule I DEA 
Controlled Substance. In the December 2012 case US v Caronia, the company appealed its conviction 
for off-label promotion claiming constitutional free speech. The ruling US v Caronia removes the 
liability for drug sales representatives which are left unsupervised 99 % of the time, yet control much 
of the industry's communication with physicians. 

We need to hold elected officials accountable for the public health and safety and therefore we need to 
know who is giving them campaign contributions in order to influence their decisions. The 
pharmaceutical industry is currently influencing our elected officials so effectively that we are actually 
force drugging wards of the court with off-label psychiatric drugs that have no proven efficacy or 
safety. Pharmaceutical lobbying is hidden within so many countless NGO's that we have no idea which 
elected official is being influenced. This money from secret sources has led to wide spread corruption 
within the health care industry and has undermined the protections for human subjects, patients and has 
forced the US taxpayer to pay for expensive off-label drugs which are not only ineffective but in many 
cases dangerous. 

Today the pharmaceutical industry has unprecedented ability to spread money to influence thinking, 
mental health practice, and policy making. We need to impose reasonable restrictions on those who 
can exercise such immense financial and political power. 

For additional information please see my written statement for the record, The State of Civil and 
Human Rights in the United States, Senate Judiciary Subcommittee on the Constitution, Civil Rights 
and Human Rights, December 9, 2014 or visit my website: 
http://MedicalWhistleblowerNetwork.Jigsy.com