|One Nation Under Drugs: How Big Pharma Is Sabotaging Your Health and the Environment|
|Monday, 30 April 2012 00:00 | Written by Shane Ellison, M.S. | Commentary|
As a medicinal chemist, I tried to ignore my suspicion that an insidious and deliberate conspiracy to get each and every American hooked on drugs, while at the same time bankrupting them, existed between Big Pharma and the Food and Drug Administration (FDA).
I enjoyed my work. Drug design paid well and kept me comfortably isolated in a high-tech lab, fully equipped to help me bend and twist matter at will. The last thing I wanted to think of was a plot designed to sabotage health and wealth—while causing untold ecological damage—using my chemistry skills. But over time, experience confirmed my suspicion as fact and revealed something even scarier.
My doubts about modern medicine began while I was employed by Eli Lilly to design a new generation of Hormone Replacement Therapy (HRT) drugs, a class which includes tamoxifen and raloxifene. Initially, they were thought to block estrogen receptors and thereby halt breast cancer. As time progressed, it was learned that they were also capable of activating estrogen receptors and boosting cancer growth. The Journal of the American Medical Association recognized this trend and published, “Our data add to the growing body of evidence that recent long-term use of HRT is associated with an increased risk of breast cancer and that such use may be related particularly to lobular tumors.”
My task was made clear: Design HRT ‘knock-offs’ that are effective without causing cancer. My attempt to design safer alternatives began with small alterations to the two-dimensional structure of tamoxifen. It was unsuccessful. All chemical cousins acted as cancer fertilizer and after one year, the project was ended. Access to tamoxifen and other HRT meds, however, was not. Despite its ability to inflame cancer, tamoxifen continued to be used as the Gold-Standard in breast cancer treatment. As a young naïve chemist, I was determined to learn how such a dangerous drug could get through the prestigious FDA approval process.
Fueled by fear, women worldwide began pushing for more choices in cancer drugs, and in Big Pharma language, that means more drug approvals. Tamoxifen demand was successfully created and expanded every subsequent year thanks to ICI’s self-serving pink ribbon campaign. But, how did tamoxifen sail past the protective blood-brain barrier of the FDA? A quick lesson in statistical contortionism shows how.
Just like chemists manipulate the properties of matter, Big Pharma manipulates studies using “checkbook science.” This allows them to pay for both the design and the interpretation of clinical trials. Tamoxifen studies, for example, were conveniently stopped at just five years, the minimum amount of time required for cancer to develop. This successfully hid the drug's cancer causing problem. But just like their pink campaigns, there’s even more stink to be found.
In 1992, tamoxifen evangelist Dr. Bernard Fisher, working for the National Cancer Institute (NCI), received $68 million in federal money to assess whether the drug could prevent breast cancer. Fisher was accused of failing to report falsified data and enrollment fraud to the NCI in an effort to make tamoxifen appear safe and effective, thus casting further stench over the study and resulting in his termination as director. The smoke and mirrors showed that tamoxifen reduced breast cancer by 50%. In reality, it was an insignificant 1.3% absolute difference.
Checkbook science isn’t illegal by FDA standards. It’s been going on for more than 20 years. Known as the Bayh-Dole Act, US law was amended in 1980 to permit flagrant conflicts of interest, ones that allow the industry to design drug trials and hire experts to conjure up favorable results at will.
Once demand was created, and checkbook science in place, the FDA needed only one study to approve tamoxifen in record time–30 days. They did this by hiring advisors with Big Pharma financial ties to sit on its review committee. Failing to do their homework, only 10% of the case reports from women enrolled in the tamoxifen trials were reviewed by the committee. But, most alarming to me as a chemist, it was still given a green light as a preventive cancer treatment for healthy women!
Aiming for wealth, not health, Big Pharma hit the financial bull’s eye. As the most recommended drug treatment for women recovering from breast cancer, generic tamoxifen rakes in billions every year with few noticing its “little cancer problem,” as it became known in our lab.
Obscene amounts of drug profits were going to the pharmaceutical titans, their shareholders—and even to the FDA. That’s right, rather than being funded solely by taxpayers, our drug administration is being paid by the very industry it’s supposed to regulate. This is legal—courtesy of the Prescription Drug User Fee Act. Today, the Center for Drug Evaluation and Research at the FDA is dependent on drug companies for nearly half of its funding.
Drug lobbying is another slimy practice that greases the “FDA-Big Pharma revolving door,” and blurs the line between the drug industry and the US government. According to a report by the Center for Public Integrity, Congressmen are outnumbered two to one by lobbyists for the pharmaceutical industry. And many are later put onto the government payroll and vice versa. Total pharmaceutical lobbying in 2009 came to a whopping $267,893,947, enough to feed 502 million starving African children. Instead, it pays to grease the drug approval pipeline via 450 lobbying organizations, 1,743 lobbyists, and 1,113 revolvers (congress and senior congressional staffers who revolve in and out of the private and public sectors).
Once completed, drug companies recruit doctors to put their names on the reports as authors. These reports are then published in respected medical journals. The dangling carrots for this deceitful practice are money and prestige. Ghostwriters earn up to $20,000 per report and doctors receive the acclaim of being published. Ultimately, patients get bad drugs disguised as good medicine resulting in carnage like the Vioxx™ body count–88,000 people died from taking “the safest pain killer,” as it was lauded in ghost written articles.
As deplorable as medical ghost authoring sounds, it’s more common than you might think. It is estimated that nearly half of all published journal articles are written by ghostwriters and many of the rest may not be entirely untainted. British Journal of Medicine editor, Dr. Richard Smith, admitted that, “We are being hoodwinked by the drug companies. The articles come in with doctors’ names on them and we often find some of them have little or no idea about what they have written.” And Dr. Jeffrey Drazen, editor for the New England Journal of Medicine, insists he can’t find drug review authors who don’t have financial ties to drug companies.
If John Galt—the noble, fictional scientist in Ayn Rand's novel, Atlas Shrugged—symbolizes the power and glory of the human mind, FDA approval is his biggest threat. Sloppy FDA standards have created a corporate drug leviathan that is robbing every man, woman and child in its path of life, liberty and the pursuit of happiness. This profit-pulling monster has no checks or balances, which makes it almost impossible to fight and scary as hell to witness through the eyes of a chemist.
Toxic drugs are being consumed daily, as if they were vitamins. Women, adorned in pink ribbons, are asking for tamoxifen by name thanks to cancer “awareness campaigns” founded by the drug’s maker. Men are being herded into taking cholesterol lowering drugs. Children are being labeled with psychiatric disorders at breakneck speeds so our tax dollars can get them hooked on drugs even faster. Athletes are being poisoned with drugs disguised as artificial sweeteners like aspartame and sucralose courtesy of energy drinks and sport bars. And soccer moms are unknowingly compromising the health of their families by buying synthetic drugs disguised as multivitamins. And all of this is occurring under the “watchful” eye of the FDA.
A 2008 Associated Press investigation discovered that the drinking water supplies of at least 41 million Americans are laced with prescription drugs. The report revealed these shocking facts:
The Bottom Line
Every year, prescription drugs kill an estimated 106,000 Americans—more people than the Vietnam, Afghanistan and Iraq wars combined and three times the number killed by automobiles. This makes prescription drugs the fourth leading cause of death in the US after heart disease, cancer and stroke. And the trend of increasing prescription drug deaths has been going on for about 35 years according to researchers writing in The Journal of the American Medical Association. Those who profit from prescription drugs should hold some sort of record for having the most reckless disregard for human life.
The tally of those injured and sickened by pharmaceuticals is even higher. And now, thanks to the explosion of prescription drug use, even those of us careful not to purposefully put prescription drugs into our bodies are being dosed against our will each time we drink water from a poisoned aquifer.
It’s time we shield the FDA from Big Pharma’s influence, giving our government regulators the independence they need to make impartial decisions in the public interest.
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