[1]Dr. Eduardo Montaña, Pediatric Cardiologist at Children’s Cardiovascular Medicine in Georgia. Image Source [2].
by Brian Shilhavy
Editor, Health Impact News
A Pediatric Cardiologist from Georgia has pleaded guilty to illegally targeting teens for a cholesterol drug that was only approved by the FDA for a rare disorder.
According to court documents, Dr. Eduardo Montaña colluded with pharmaceutical company Aegerion to sell their drug Juxtapid to teenagers with heart problems, even though the drug was not approved for their conditions.
Dr. Montaña violated HIPAA laws of patient privacy by supplying the pharmaceutical company private medical records of 280 teenagers without patient knowledge or consent.
Drug company Aegerion was found guilty of criminal wrongdoing [3] in a Massachusetts court, and a sales representative of the company apparently knew that what they were doing was wrong, as the sales rep allegedly wrote in an email:
“By the way, I am sending this to you from my personal email because of the patient info :)” (Source [4].)
Juxtapid, which received FDA approval in 2012, is only suitable for use for patients with a rare lipid disorder: homozygous familial hypercholesterolemia, a genetic condition that obstructs the body’s ability to manage cholesterol.
It costs over $330,000 per patient per year [5], so the drug company had strong financial motives to expand its sales.
Dr. Montaña was a willing accomplice in their criminal activities, and reportedly hoped to get a kickback for himself. He requested a $236,000 grant from Aegerion, which the company allegedly declined. (Source [5].)
Dr. Montana’s bio [2] explains why he was an attractive doctor for Aegerion to approach to seek and expand their market for their cholesterol drug to children:
Dr. Eduardo Montaña is a Board Certified Preventive Pediatric Cardiologists and one of the few Pediatric Cardiologist nationally who is board eligible in Clinical Lipidology, the diagnosis, management and treatment of Pediatric Cholesterol disorders. (sic.)
The maximum penalty Dr. Montaña faces is one year in prison and a $50,000 fine. He has not been sentenced yet.
Pediatric Drugs and Cholesterol Drugs: The Wedding of Two Very Profitable Markets for Drug Makers
Cholesterol-lowering statin drugs are a $100 billion a year industry. Lipitor is by far the most profitable drug in the history of mankind among all pharmaceutical products, let alone being the most profitable cholesterol drug before its patent expired at the end of 2011. Sales to date from this one particular cholesterol-lowering statin drug have exceeded $140 billion.
Lipitor benefited from the change in marketing laws in 1997 that allowed pharmaceutical companies in the U.S. to advertise their products directly to consumers. Pfizer convinced an entire generation of Americans that they needed a pill to lower their cholesterol in order to prevent heart disease, in what will go down as one of the most brilliant and unethical marketing schemes of all time.
After Lipitor’s patent expired at the end of 2011, the FDA issued its first warnings against statin drugs [6], which has since been updated with more side effects and now includes: liver injury, memory loss and confusion, diabetes, muscle damage (professional athletes have been warned to not take statin drugs for years now), and increased hemoglobin A1c levels.
Soon after issuing these warnings, the lawsuits started trickling in.
Today, with more and more studies being published linking statin drug use to various side effects, those lawsuits have significantly increased, even though you are not likely to hear much about this in the mainstream media. One attorney predicted the lawsuits could reach 10,000 [7].
However, doctors continue to prescribe cholesterol lowering drugs, and drug companies continue trying to develop the next blockbuster cholesterol drug.
Since most people prescribed statin drugs are older people (one out of every four Americans over the age of 50 is currently taking cholesterol-lowering drugs), the next obvious target market is children.
Tapping in to the very large and very profitable pediatric drug market would open the door to increased sales for cholesterol drugs.
The fact that Aegerion is trying to cash in on the profitable cholesterol market by encouraging doctors to prescribe it “off-label” seems to be continuing, in spite of its criminal conviction, as is evidenced by the drug’s website [8], where they advertise the drug to “lower your bad (LDL) cholesterol numbers.”
Here at Health Impact News we have exposed the fraud over cholesterol drugs many times over the years. Cholesterol is an essential part of our bodies, and we would die without it.
The whole lipid theory of heart disease, which blames high cholesterol for heart disease, has been thoroughly proven wrong by the science. Honest cardiologists who understand the science and are not motivated by profit, have been sounding the alarm for many years, in spite of the corporate media’s censorship of this topic. See:
Cardiologist: Millions of People Taking Statin Drugs Will Continue to Have Far Greater Chance of Harm than Benefit [9]
Statin Scam: People with Higher Cholesterol Live Longer than People with Low Cholesterol [10]
Children Used in Drug Trials: Medical Kidnapping Expands Test Patients
Jewish twins kept alive to be used in Mengele’s medical experiments in Nazi Germany during WWII. These children were liberated from Auschwitz by the Red Army in January 1945. Image source [11].
As we have reported in the past, children all across America are targeted for drug trials to meet the demands of developing new pediatric drugs.
To enroll a child in a drug trial, typically parental approval is needed, and insurance companies will not typically cover the cost of care for drugs that are not yet approved by the FDA.
But there is a loophole: seize custody of the child by removing them from their families and putting them into state custody, with a foster parent. Once a child is the ward of the state, drug trials can occur without parental approval, and all of the child’s medical needs can be billed to Medicaid.
There have been Congressional hearings on this practice, and bills have been proposed to stop drug experimentation on children put into foster care, but it still remains a legal practice today. See:
Medical Kidnapping in the U.S. – Kidnapping Children for Drug Trials [12]
We are not currently aware of any families who have lost their children due to this illegal activity by pharmaceutical company Aegerion or Dr. Eduardo Montaña, but if you have a child diagnosed with homozygous familial hypercholesterolemia, and you lost custody of your child by an agency like Child Protection Services (CPS) in your state, please contact us at MedicalKidnap.com [13]. We would be interested in publishing your story and exposing this very evil practice.
Pharmaceutical Companies: Largest Criminal Organization in the World
It has been well documented that pharmaceutical companies comprise the largest group of illegal criminal activities of any other group in the world.
Richard Smith, editor of the British Medical Journal until 2004, wrote an opinion piece in 2013 about a book published by Peter Gøtzsche, the head of the Nordic Cochrane Centre, entitled “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare.”
The characteristics of organised crime, racketeering, is defined in US law as the act of engaging repeatedly in certain types of offence, including extortion, fraud, federal drug offences, bribery, embezzlement, obstruction of justice, obstruction of law enforcement, tampering with witnesses, and political corruption. Peter produces evidence, most of it detailed, to support his case that pharmaceutical companies are guilty of most of these offences. (Source [14].)
The “largest fraud settlement in U.S. history” was against a pharmaceutical company:
On July 2, 2012 the British drug maker GlaxoSmithKline plead guilty to three counts of criminal misdemeanor and other civil liabilities relating to the prescription drugs Paxil, Wellbutrin and Avandia, and agreed to pay a total of $3 billion in fines–$1 billion to settle criminal charges, and $2 billion to cover civil liabilities.
The payment is the largest fraud settlement in U.S. history, and the largest fine ever paid by a drug company. (Source [15].)
The Department of Justice lists the largest FALSE CLAIMS ACT SETTLEMENTS & JUDGMENTS on their website [16] between 2009 and 2016, and “Health Care Fraud” tops the list with 19.3 BILLION. Coming in a distant second is Housing & Financial Fraud at 7 BILLION. (Source [16].)
In 2010 a panel of doctors with the Public Citizen’s Health Research Group produced a study [17] showing that while the defense industry used to be the biggest defrauder of the federal government under the False Claims Act, the pharmaceutical industry has now overtaken them. The study found that:
U.S. spending on prescription drugs has increased from $40 billion in 1990 to $234 billion in 2008. In this era of rapidly rising drug costs, the illegal pharmaceutical company activities that have contributed to such inflated spending have garnered a significant amount of media attention.
Recent billion dollar settlements with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, provide evidence of the enormous scale of this wrongdoing.
In the conviction against Aegerion in this case with Dr. Eduardo Montaña, District Judge William G. Young lamented how the U.S. Government allows criminal pharmaceutical companies to get off so easily, and continue doing business.
Existing laws that protect pharmaceutical companies apparently prevented Judge Young from automatically issuing the harshest penalty, as the federal government generally strikes a plea bargain with the pharmaceutical company to keep them in business.
What is left unexplained is why the government does not simply let Aegerion collapse in disgrace. Surely Aegerion is not too big to fail.
The point is, I do not know and the proffered “C” plea does not begin to explain the financial picture in detail. Apparently the parties think their representations suffice.
They do not. I have a job to do – an independent judicial responsibility I may not delegate to others.
Most problematic, this “C” plea provides not one cent of restitution to the actual victims. This result is justified say the parties by the multi – million dollar proposed settlement between Aegerion and the third-party payors, federal and state, who were fleeced into paying for misbranded drugs.
Thus, governmental actors (who inferentially provided most of the purloined funds) get partial repayment but the actual victims, many of whom suffered medical complications and physical and emotional harm, get nothing.
How can I possibly justify such a result?
Judge Young goes on to explain [18] that there now exists “A Two-Tier Criminal Justice System.” One for non-business criminals, and one for large businesses like pharmaceutical companies that never go to trial, but settle their cases through plea deals.
District judges throughout the United States play two vital roles in our constitutional polity. They try cases and sentence offenders.
These two functions lie at the very heart and core of the judicial function. Upon their proper and dispassionate discharge rests much of the moral authority of the third branch of our government.
The “C” plea displaces the common law adversarial proceeding and thus directly affects the judicial role.
Somehow, we seem to be forgetting that the very reason for our judicial existence is to afford jury trials to our people pursuant to the United States Constitution.
[Plea deals] undermine the rule of law by facilitating a shadow system of adjudications away from any oversight. . . . [Plea deals] also undermine the legitimacy of the criminal justice system in a second way–by creating the perception that certain business organizations are ‘Too Big to Jail.’
Read Judge Young’s entire opinion here [18].