Death By Supermarket (9 page)

Samuel Epstein, M.D., is a professor emeritus of environmental and occupational medicine at the University of Illinois Medical Center in Chicago, an internationally recognized authority on cancer causes and prevention, and the author of 260 peer-reviewed scientific articles and eleven books on this subject. Dr. Epstein told me, “I urged the FDA to encourage the use of aspirin, which is a Cox-2 inhibitor and is as effective as Celebrex and all the other Cox-2 inhibitor drugs, but without all the dangerous side effects.” But the FDA did not heed this warning.

Subsequent to the initial yanking of Cox-2 inhibitors from the shelves, we learned that FDA “drug advisors” were lobbying for some of these drugs to be returned to the market—despite their known problems. The press reported that ten of the 32 drug advisors to the FDA consulted in recent years for the drugs’ manufacturers. Nine of these ten had voted to
return the potential deadly Cox-2 inhibitors to the market. CBS reported, “If these ten ‘experts’ had not been drafted for the panel, neither Bextra nor Vioxx would have received enough votes to get the panel’s thumbs up.”
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The
New York Times
reported, “Researchers with ties to industry commonly serve on Food and Drug Administration advisory panels, but their presence has long been a contentious issue … Several of the panel members flagged with conflicts say most or all of the money from drug makers went not to themselves but to their universities or institutions.” (An indirect route to their salaries, bonuses, and perks.) The
Times
also mentioned that shares of Merck and Pfizer soared after the panel’s vote was announced.
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You have to wonder if the nine FDA drug advisors also held stocks in Merck and Pfizer?

How did these drug advisors ultimately arrive at their conclusions that unsafe drugs should be re-released onto the market? In 2000 Merck found itself in an untenable situation when they were faced with the death of a 73-year-old participant in a clinical trial who had likely died of a heart attack. The woman’s death, writes Merck’s top scientist Edward M. Scolnick, M.D., in an email, “put us in a terrible situation.” (As it turns out, in this twelve-week drug trial, called Advantage, eight out of 5,500 participants suffered a heart attack or sudden cardiac death.) The major issue appeared to be that Scolnick did not want the FDA to demand that Vioxx carry a warning for cardiac risks as it would then not sell as well as its competitor Celebrex, which did not warn of cardiac risk on its label. In fact, in other emails Scolnick “fiercely criticized the FDA and said he would personally pressure senior officials at the agency if it took action unfavorable to Vioxx.”
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And so Scolnick got his way and thousands of people were harmed.

In 2007, Merck reached a $4.85 billion settlement to resolve most of the roughly 50,000 lawsuits regarding Vioxx, apart from the $80 million deal the company cut with unions and insurers. By 2010, a shareholder lawsuit was still with the Supreme Court, and the company, in an attempt to appease shareholder derivative complaints against the company’s
officers, agreed to pay $12.5 million in legal fees and take steps to monitor the safety of its drugs.
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Perhaps the biggest head scratcher is Avandia, the blockbuster diabetes drug that hit the market in 1999 and became GlaxoSmithKline’s top cash cow. By 2006 its annual revenue was $3.2 billion. By 2009, sales had dropped to $1.2 billion following a damning study published in the
New England Journal of Medicine
in 2007 which linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods.
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Even though more than 83,000 users of Avandia experienced heart attacks due to side effects, instead of recalling the drug GSK developed another drug that could treat the condition caused by Avandia.
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In fact, before Avandia’s release, GSK had evidence that the drug causes the body to increase levels of a potentially deadly enzyme that the company’s researchers connected to heart disease in their own studies. But rather than disclosing the problems with Avandia, GSK instead patented a diagnostic test to detect the enzyme and then proceeded to pour millions of dollars into research to create the new blockbuster drug that would inhibit the enzyme that allegedly prevented Avandia-caused heart attacks.

It took 1,354 cardiac-associated deaths from Avandia in 2009 for the FDA to intervene in late 2010 with regulatory action. Even then the FDA didn’t remove Avandia from the market (although European regulators did). Instead the FDA imposed restrictions. Avandia couldn’t be administered without the doctor first trying other less risky treatments. When proceeding with Avandia, the doctor is required to meet with the patient to discuss the risks, and the patient has to agree in writing to accept the risks.
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Meanwhile GSK continued to spin the risk benefit of Avandia, downplaying the risks even as they paid out $60 million to settle seven hundred lawsuits and thousands more lawsuits flooded in.
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David Graham, M.D., M.P.H., who has been with the FDA for twenty-six years, is currently the associate director for science and medicine in the
Office of Drug Safety. In November 2004, Dr. Graham appeared before the Senate Finance Committee and subsequently appeared on the
PBS Online News Hour
program to tell the country that the FDA was “incapable of protecting America from another Vioxx. Simply put, FDA and the Center for Drug Evaluation and Research (CDER) are broken.”
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(The CDER, a branch of the FDA, responds to written inquires regarding prescription and over-the-counter drugs.)

Another drug that is astonishingly not ringing any alarm bells is acetaminophen (the active ingredient in Tylenol). Because OTCs are FDA approved, most people blithely self-prescribe without pondering the prospect of acute liver failure. Partly as a result of the Cox-2 inhibitor debacle, Americans have been lulled into a false sense of security over the use of a acetaminophen. A study in the December 2005 issue of
Hepatology
reveals that, because the FDA has not educated Americans about acetaminophen poisoning, most have no clue how easy it is to overdose on it. People with cluster symptoms can end up taking a variety of OTCs, all containing acetaminophen, without realizing they’ve reached or exceeded the maximum adult daily dose of 4,000 milligrams. Tim Davern, M.D., who is a gastroenterologist with the liver transplant program of the University of California at San Francisco and a coauthor of the above-mentioned study, commented on this scenario: “It’s extremely frustrating to see people come into the hospital who felt fine several days ago, but now need a new liver.”
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Autism spectrum disorder (ASD) is a disorder of mental introversion, aloneness, inability to relate, repetitive play, and rage reactions. In
Rolling Stone
, attorney and environmentalist Robert F. Kennedy writes, “Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the [mercury-based] preservative [thimerosal] be given to extremely young infants—in one case, within hours of birth—the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.” (The most recent data from the CDC puts autism at an average of one in 110 children, or 1 percent of children.)
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Dr. Boyd Haley, an authority on mercury toxicity, was quoted
in Kennedy’s article, “You couldn’t even construct a study that shows thimerosal is safe. It’s just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage.” Rep. Dan Burton, a Republican from Indiana, who oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism, stated in his House Government Reform Committee final report, “This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin.”
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Although the FDA is now “working with drug companies” to reduce the amount of thirmerosol in vaccines, it has not stopped them from using it.
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In addition to Cox-2 inhibitors, acetaminophen, and thimerosal, the FDA failed to protect Americans from the serious risk of heart valve damage from the weight-loss miracle-in-a bottle Fenfluramine and Phentermine (Fen-Phen). The FDA failed to restrict the acne drug Accutane, even though it was known to cause Thalidomide-like birth defects when taken by pregnant women and is now known to cause liver damage, irreparable GI problems, and depression. The FDA allowed the sale of the cholesterol-lowering medication Crestor, even though it can lead to kidney failure.

The FDA didn’t warn doctors and parents about the risk of suicide among children taking antidepressants. The use of antidepressants has tripled in the last ten years, and spending has increased by 130 percent. Antidepressants have obscenely high profit margins, as much as 569,958 percent in the case of Xanax.
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Drug companies make so much money that they can handle the occasional lawsuit, even one as large as the Vioxx debacle, and still show a profit. SSRIs have not been pulled by the FDA even though they increase the incidence of suicidality.
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Almost all of the homicidal and suicidal “school shooters” (the ones whose medical files haven’t been sealed) had been taking psychiatric drugs, either SSRIs such
as Prozac or psychostimulants such as Ritalin.
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Studies have shown that 4 to 8 percent of people under the age of eighteen will become psychotic, suicidal, or homicidal from SSRIs.
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These drugs continue to be prescribed and FDA approved, even though a review of twenty years of studies in the
Journal of the American Medical Association
in early 2010 concluded that antidepressants are no more helpful than placebos.
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The FDA’s failings are not exclusive to the pharmaceutical industry, said Dr. Epstein, “Whether you want to look at it from the standpoint of indifference, conspiracy, or conflict of interest, the FDA poses a great danger to consumers. What’s happening now with these drugs is symptomatic of the FDA.”
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While the recent drug scandals may make it appear as if the FDA has all of a sudden sunk to an all-time low, it appears that this government agency has had problems for a very long time. Herbert L. Ley. M.D., FDA commissioner from 1968 to 1969, said, “The thing that bugs me is that the people think that the FDA is protecting them—it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.”
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Richard Crout, former director of the FDA’s Bureau of Drugs, testified way back in 1976 that the FDA was in serious shape. “I want to describe the agency as I saw it. No one knew where anything was … There was absenteeism; there was open drunkenness by several employees … there was intimidation internally … People—I’m talking about division directors and their staffs—would engage in a kind of behavior that invited insubordination; people tittered in the corners, throwing spitballs—now I’m describing physicians; people would slouch down in their chairs and not respond to questions; and moan-and-groan, [making] sleeping gestures. This was a kind of behavior I have not seen in any other institution from a grown man … FDA has a long-term problem with the recruitment of personnel, good, scientific personnel.”
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In June 2006, after reviewing the results of a fifteen-month inquiry he had initiated, Representative Henry A. Waxman (D-CA) said, “Americans
have relied on FDA to ensure the safety of their food and drugs for 100 years. But under the Bush administration, enforcement efforts have plummeted and serious violations are ignored.” Waxman was referring to a 54 percent drop in warning letters to drug companies and medical device manufacturers from 2000 to 2005. In addition, there was a 44 percent decline in seizure of dangerous products and a 65 percent decline in enforcement actions concerning devices such as implantable defibrillators and pacemakers.
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When it comes to our food supply, the FDA is greatly responsible for our evolution from a real, living food diet to a supermarket factory-food diet, but not solely responsible. Food additives would not be getting FDA approval in the first place if companies weren’t applying for approval. It’s widely known that Washington players hop from government positions to law firms to corporate positions to elected office and back again. Career advancement in Washington and the biotech industry (an industry with far-reaching implications in food production) is predicated on favors and back scratching. In researching this book, I found dozens of references to people who went from White House careers to positions at Monsanto, from Congress to Monsanto, from federal agencies to Monsanto and the biotech industry, and from Monsanto and the biotech industry to government employment. When decisions are made about public health and safety, career and financial interests often influence these decision makers.

The sad state of affairs concerning our food supply has been developing since the late 1800s as the food, diet, and pharmaceutical industries systematically cultivated a complex and inextricable web of relationships with (some, not all) FDA scientists and other researchers, administrators and attorneys, biotech attorneys, elected officials, government agencies, lobbyists, medical associations, medical and scientific journals, and doctors. This tangled, powerful network of relationships has influenced what you have been putting in your mouth and what you will put in your mouth in the future. The billions of dollars in profits racked up by these industries through the sales and consumption of their products wouldn’t be possible
if it weren’t for tickets and invitations to sports events, operas, symphonies, theater performances, and invitations to prestigious movie premiers, lunches, dinner parties, birthday parties, weddings, golf games, and exotic vacations, as well as the honorariums, grants, donations, kickbacks, payoffs, and miscellaneous and sundry “favors” accepted by the support players listed above.
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