How the FDA, Big Pharma, and Doctors Cause Injury for Profit

In some ways the health care in America is the finest in the world. In other ways it is a severe risk to health, even deadly. The dark side of this issue involves medication profits at the expense of human health. This questionable health care approach costs at least 200 billion dollars a year and involves the costs of the drugs themselves, the injuries they cause, and the appropriate law suits that follow. The perpetrators of this fraud are the pharmaceutical companies acting in tandem with the FDA, doctors paid under the table by Big Pharma, and gullible doctors willing to write off-label prescriptions based on the hype they hear from doctors on the take and Big Pharma sales reps.

Creating a market demand for this fraud is a health care system that blindly pays for it. This issue is causing millions of injuries a year and tens of thousands of deaths. It makes the Ponzi scheme run by Bernie Madoff pale in comparison. It is ruining the legitimate health care needs of a nation. Any expansion of mandatory health care funding will only make it worse, since the current scheme is set to feed off patients who don’t pay full price (or often any price) for the medications they “need.”

The scandals involving inappropriate use of medications are so numerous they defy believability, with FDA management either tacitly allowing or actively helping the various drug companies. The FDA has a long history of pretense dating back to its inception over 100 years ago. It is part of the DNA of the FDA’s dysfunctional culture. FDA managers act in a revolving door capacity with the various industries they are supposed to be regulating. What FDA mangers actually do is more akin to the activities of a police-force bully. They seek to knock out competition for their friends in Big Pharma, Big Biotech, and Big Food, while acting as the gatekeepers of profits for the chosen few – often in disregard of the health consequences.

It was only a few years ago that the FDA didn’t even know what drugs it had approved to be on the market. Far worse, the FDA is quite lax on requiring the mandatory follow-up safety testing for the drugs that have been approved. On October 26, 2009 the Government Accountability Office¹ released a report blasting the FDA on this issue. The lack of FDA due diligence has resulted in a situation wherein doctors and patients do not have a clear picture of the actual risks of virtually any drug, including the blockbusters in common use (such as birth control pills). Big Pharma would rather not do these studies because when they do they often show the drug is far more dangerous than previously thought – which typically causes a drop in sales. Why would any drug company want to shoot itself in the foot?

The negative data submitted to the FDA during the drug approval process is seldom ever published in any meaningful way or context. Rather, Big Pharma ensures that mostly the positive studies submitted to the FDA find their way into the literature. Again, this skews the public understanding of the drug. FDA management has been known to coerce and threaten its scientists to suppress negative news about drugs, often over-ruling their scientists so that a dangerous drug can be put on the market. Such FDA management coercion of its own scientific staff came into full public view when it was discovered how Avandia, a diabetes drug, could get on the market without any warning that it causes heart failure

A classic example of Big Pharma intentionally suppressing the negative studies so as to paint a false rosy picture of a medication’s benefits are the anti-depressants. In fact, the entire theory of the use of antidepressants upon which FDA-approved drug dispensing is based has recently been called into question. Yet, these near-useless drugs are top sellers to our children. The FDA yawns when antidepressant use is strongly linked to heart disease.

The issue is complicated by the fact that the scientific literature was intended as a communication format between doctors, scientists, and other health professionals. It was never intended to have defense mechanisms against large financial interests trying to game the system for profit. The pharmaceutical industry ghostwrites many of the studies that promote the values of its drugs. Doctors and scientists put their names on the studies for a fee. Celebrity doctors are paid large amounts by Big Pharma to act as sales reps at “scientific” conferences. Universities and researchers who might publish negative data know they will be blacklisted from Big Pharma research spending in the future. Many doctors are on the Big Pharma payroll, taking what amounts to bribes, kickbacks, and other “gifts.” All doctors are subjected to intense Big Pharma propaganda as a major part of their training in medical school.

A drug company doesn’t even have to prove a drug fixes anything. Drugs simply have to prove they can move numbers on paper (surrogate endpoints). This lax standard of effectiveness causes individuals to go on drugs to change numbers, take more drugs due to the side effects of the ones they are taking, and before long they are on ten drugs that don’t fix anything – piling on cost to the health care system and taxpayers.

Once drugs are on the market, Big Pharma uses all manner of illegal marketing to create buzz and demand for their drugs in ways that have never been tested for safety (off-label use). Some regulatory action has been taken in recent months against these crimes, although the damage is already done and the false markets have been created as doctors seem to have little ethical concern writing prescriptions for uses that have never been demonstrated as safe or effective. And then the Big Pharma lobby goes to work trying to get laws passed to expand its market (even tagetting children).

Big Pharma builds the cost of the fines into the cost of the drugs, which are paid for in higher health care costs and taxes. It is how Big Pharma does business. The FDA is impotent in defending the public from harm. It has been proven that all the newer drugs of the past decade are twice as likely to injure. While the FDA manages to report on the problem, it fails to do anything effective about it (which is how they plea to get more funding from Congress to spend on their pet projects, not safety).

This shifts the burden of demonstrating proof of harm to lawyers representing individuals who have been harmed and independent, poorly funded researchers who must risk the wrath of their colleagues to shine a light lot on huge problems. Such researchers are often operating without the original data submitted to the FDA. It takes years to pin down a problem. By then, the drug in question has already made its money (and caused its harm) or its patent is about to expire (meaning it is no longer a top priority for the drug company). Even when researchers present their findings of rather alarming harm, the FDA management yawns, drags its feet several more years, and then waters down its findings on the obvious problems so as to limit legal liability for its friends.

The examples of the drugs involved in this fraudulent charade are numerous, and especially involve drugs known as blockbusters (the big sellers). One of the most egregious examples is the atypical anti-psychotic medications – poisoning our children and elderly with unthinkable off-label use that is incredibly damaging to health. The atypical anti-psychotics include Zyprexa (Eli Lilly), Seroquel (AstraZeneca), Risperdal (Johnson & Johnson), Geodon (Pfizer), and a handful of others.

Since Eli Lilly knew that Zyprexa caused diabetes and didn’t let patients know this, they have already settled numerous “failure to warn” lawsuits totaling 1.2 billion dollars. This year they agreed to another 1.42 billion, $615 million to settle the Justice Department’s criminal investigation and approximately $800 million to settle the civil investigations brought by the states for Medicaid fraud. “Specifically, the plea states that Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia, although Zyprexa is not approved for such uses,” the company said in a statement. Eli Lilly agreed to a misdemeanor charge, which is apparently the new standard for what a drug company gets when it kills elderly Americans (previously it was nothing). A May 2009 study published in the Archives of Internal Medicine shows that even a single dose of anti-psychotic medication to an elderly patient doubles the risk of a serious adverse event leading to hospitalization and/or death.

Anti-psychotics have become popular for their off-label use as the “drug of obedience.” If you want a zombie, give the person an atypical anti-psychotic. They became incredibly popular in nursing homes, especially if a senior citizen arrived upset at the idea of being put in a nursing home. Or to keep patients with dementia from stirring up trouble. Likewise, children in orphanages are another popular target. These are extremely expensive drugs paid for by Medicare and Medicaid (taxpayers).

On October 29, 2009 AstraZeneca reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits regarding Seroquel. One of the investigations was over improper activity of physicians involved in Seroquel clinical trials, apparently hiding the results of a negative drug trial prior to FDA approval and the other was over off-label use resulting in many children and elderly taking Seroquel.

Pfizer has agreed to pay $2.3 billion to settle criminal and civil liability due to its illegal off-label promotion of Bextra (a painkiller already pulled from the market), Geodon (like Zyprexa, an atypical anti-psychotic that injures children), Zyvox (an antibiotic), and Lyrica (an epilepsy drug). Pfizer will plead guilty to one felony count violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud. Geodon has a smaller percentage of the 12-billion-dollar-a-year poisoning campaign of our children and elderly, pulling in around $750 million. It was widely promoted in an off-label manner for ADHD and behavioral issues facing children - a market that has been fraudulently created and continues to rack up sales.

And this past week Risperdol went on trial for its off-label uses. The opening day of testimony saw one of its salesman admit he promoted the drug for off-label uses and did so knowing what he was doing was illegal – expect another large settlement.

While these settlements seem large they are costs that are passed on to the health care system as part of the price of the drug. Off-label financial penalties are nothing more than a marketing cost. And once the market is created doctors keep prescribing the medications for off-label use, thereby sustaining sales far in excess of any penalty.

None of these financial penalties is as the result of FDA actions. To the contrary, in the midst of major controversy the FDA was found encouraging the use of these drugs on children! It is the lawsuits that are defending public safety because the FDA does not do its job.

And then there are the independent studies that finally prove what the FDA likely knew over a decade ago. This past week a study in the Journal of the American Medical Association² showed that children taking atypical anti-psychotic medication gained on average 18 pounds in 12 weeks. The shocking part of the study was not the massive weight gain – it was that it took over a decade for independent researchers to prove what the FDA and Big Pharma already knew. Needless to say, these children are on a fast track to heart disease, as changes in their LDL cholesterol and triglycerides clearly indicated.

The anti-psychotic medications serve as an example of the disregard for human health on the part of Big Pharma, the FDA, doctors and psychiatrists on the take, and those standing ready with their off-label Rx pads. Tens of billions in fraudulent profit has been made and continues to pile up. There are numerous other blockbuster drugs with similar sordid tales. This is how business is done. It is fraud. The FDA drags its feet and will continue to drag its feet, regardless of what studies are published. The FDA management is part of the fraud.

In the short term the only way to stop this fraud is to prevent federal programs (Medicare and Medicaid) and insurance companies from paying for any off-label medication use. Also in the near term, off-label prescribing laws need to be drastically changed to protect the public. The use of all types of psychotropic medications on children needs to be drastically curtailed or outright banned. Over the next five to ten years medications already on the market need to prove their safety and actually prove they fix something in a definable period of time. If all a drug can do is change numbers it is, once again, nothing that taxpayers and insurance companies should have to pay for.

If people want to use drugs to change numbers, suppress symptoms, and conduct an experiment on themselves – fine – let them do so at their own expense. The problem with health care reform is that President Obama is in a big hurry to pass legislation with this system of fraud built in. In fact, the entire system is positioned to benefit thanks to the financial support Big Pharma is lending the administration, as the administration tries to make insurance companies out to be the villain. Unless fraud is tackled head on, including the White House truly cleaning up its own FDA, there is no chance for containing health care costs in the current system or in anything currently proposed by the House or Senate.