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Generation Rx

"In this informed study of the U.S. pharmaceutical industry, journalist Critser sounds the impassioned alert that your medicine cabinet may be hazardous to your health." — Library Journal, starred review

"Critser lays out the cautionary facts in exquisite detail . . . solid, thorough and told with vigor." — Publishers Weekly

About the Book

Journalist Greg Critser scored exclusive interviews with the strategists, scientists, and current and former heads of GlaxoSmithKline, Eli Lilly, Merck, and Roche for his book Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies (Houghton Mifflin, October 2005).

Critser's no-holds-barred reporting in Generation Rx covers a lot of ground, from the effects the drug culture is having on our major organs to a first-ever inside look at the business and political story behind pharma's rise to power. Critser also looks at each "pharmaceutical tribe," from the skyrocketing use of psychiatric drugs for kids (beginning as early as 6 years of age), to the middle-agers using GERD (acid reflux) drugs daily that are permanently changing the acid balance of the stomach and are now known to be a risk for cancers, to polypharmacy among senior citizens — many taking 6, 8, or 10 different drugs each day, altering their neuro transmitters (brain function is impaired by pills, so more pills are prescribed, and the more brain function is affected-it's a vicious cycle).

About the Author

Greg Critser's articles and essays on the modern pharmaceutical industry and the politics of medicine have appeared in Harper's Magazine, USA Today, the Wall Street Journal, the New York Times, Forbes and the Los Angles Times. He is the author of Fat Land: How Americans Became the Fattest People in the World, which the American Diabetes Association called "the definitive journalistic account of the modern obesity epidemic."

"Wake Up and Smell the Cytochrome P450!"
How Prescription Drugs Alter Our Bodies: An Organ-by-Organ Account

Adapted from Generation Rx by Greg Critser

The Brain

Use of psychoactive medications — treating everything from attention deficit disorder (ADD) among the young to obsessive-compulsive disorder (OCD), depression, and even shyness among the middle-aged and elderly — is at an all-time high. Although these drugs offer fairly clear short-term benefits, researchers are increasingly concerned about the long-term implications.

• Brain scans show that antidepressants such as Paxil actually change the shape and structure of the brain stem and its surrounding areas.

• The frontal lobes of the brain, which manage feeling and thought, do not mature until age thirty. Will prescription drug use alter those key structures? As the UC San Francisco expert on child psychopharmacology, Dr. Glen Elliott, has noted: "The problem is that our usage has outstripped our knowledge base. Let's face it: we're experimenting on these kids without tracking the results."

• Among the elderly, who are filling prescriptions at record rates, drugs may be fundamentally altering the ability of the brain to process its own signals. According to one groundbreaking study, of the twenty-five medications most regularly prescribed to geriatric patients in the United States, thirteen have significant anticholinergic (neural transmitter) activity at the doses commonly prescribed.

The Stomach

The stomach is critical to maintaining health, mainly via its delicately balanced environment of acids and alkalis. But GERD (a.k.a. heartburn) drugs, such as Prilosec, Nexium, Tagamet, and Zantac, used on a scale never envisioned by their inventors, are increasingly disrupting that delicate balance and leading to a number of chronic conditions. Among them are:

• Malnutrition, including B12 deficiency, particularly among elderly patients, because the stomach needs acid to process nutrients properly.

• Susceptibility to pneumonia and other infections, because GERD drugs deplete the natural gastric barrier between the outside world of infections and bugs and the internal world of vulnerable organs.

The Liver

The liver processes all foreign substances into nontoxic waste. The liver's main cells, hepatocytes, take fat-soluble drugs and make them water-soluble and excretable. The fate of the hepatocytes is thus the fate of the body, at least concerning drug-induced problems. No wonder then, that drug-induced liver injury has become the leading cause for the removal of approved drugs from the market (some of which lead to jaundice, low blood sugar, liver scarring, internal bleeding, brain damage, eye damage, and even death).

This can happen to your liver even when drugs are taken properly:

• Painkillers can cause acute hepatitis. The analgesic Duract, which was tested in clinical trials for elevated liver enzymes in many patients, was linked, within a year of its release, to four deaths from liver failure and eight liver transplants.

• Blood pressure medications can block bile ducts.

• Antidepressants can cause hepatocyte damage. Serzone, from Bristol-Myers Squibb, was a potent liver enzyme inhibitor, preventing the liver from processing other drugs properly.

• COX-2 drugs can alter liver enzymes and cause liver damage.

• Diabetes medications can inflame the liver so badly that patients die, as was the case with Parke-Davis's Rezulin.

• Arava, used for rheumatoid arthritis, has generated a substantial number of liver injuries.

The Heart

The heart, comprised of muscle tissue, arteries, and highly specialized cells that keep it firing properly, is at the center of our circulatory system. Yet more and more prescription drugs for chronic diseases alter parts of the heart. Grim textbook examples include:

• Pain killers such as Celebrex (and recently withdrawn Bextra and Vioxx) alter the delicate environment of artery walls, making them less able to contain the "bursting" of plaque and small bumps, leading to blockage and heart attacks. Vioxx alone is thought to have caused more than 100,000 heart attacks before being pulled from the market.

• The diet drug Redux worked by stimulating the release of the neurotransmitter serotonin, leading to appetite suppression. But too much serotonin in the heart and lungs led to the thickening of heart valve tissue and the blood vessels that run through the lungs and into the heart. This caused a form of high blood pressure known as primary pulmonary hypertension, causing the heart pump to strain and break down: 45,000 patients on Redux reported heart valve damage or primary pulmonary hypertension.

• SSRIs: The increased serotonin generated by many of today's most popular antidepressants is metabolized identically to Redux. Already Effexor has been the subject of concern over similar cardiopulmonary problems.

The Lungs

We process many of today's most advanced pharmaceuticals through the lung's blood vessels. And the number of drugs with the potential to cause pulmonary disease has risen from 19 in 1972 to 150 in 2002. Many are predictably toxic, such as cancer-treating drugs and those for other acute conditions. But many are for chronic conditions, from heart drugs to drugs for pain.

Here are some of the complications that drugs can cause in the lungs:

• Between 3 percent and 20 percent of all patients taking ACE inhibitors develop a hard, dry cough. The reason: the same enzymes that the drugs inhibit to decrease blood pressure are needed to suppress bronchospasms.

• Methotrexate, a common drug for rheumatoid arthritis, can weaken the lungs' natural protective pathways and allow for opportunistic infections.

• Nasal sprays known as alpha-adrenergics can cause obliteration of pulmonary vessels.

• Relenza, the antiflu treatment promoted by Glaxo, is now known for causing dangerous bronchospasms.

• Amiodarone, a drug used for heart arrhythmia, has been shown to cause severe lung diseases.

Shocking Pharma Facts

Adapted from Generation Rx by Greg Critser

1. Over the past decade, the use of prescription drugs, almost all for chronic diseases, has soared. The average number of prescriptions per person, annually, in 1993 was seven, and in 2004 it was twelve.

2. The amount spent to advertise prescription drugs directly to consumers in 1980 was $2 million. In 2004 it was $4.45 billion.

3. The number of Americans who annually request and receive a prescription for a specific drug after seeing a commercial is 8.5 million.

4. The FDA, the AMA, and every leading medical institution in the country and abroad have noted that liver damage, once rare, is now the leading reason for withdrawing a drug, usually a new drug, from the market.

5. There are more than 106,000 deaths a year from serious adverse reactions to drugs that have been properly prescribed.

6. In 2000 the American Society of Clinical Pharmacologists pegged the percentage of elderly patients receiving nine or more medications at 27 percent, compared to 17 percent in 1997.

7. The Journal of the American Medical Association showed that 5 percent of all hospital admissions for the elderly were due to drugs "known to cause drug-drug interactions." Physicians had either ignoraned these risks or chose to disregard them. The cost: approximately $16,000 per hospitalization.

8. National spending on prescription drugs, mainly via the Medicare bill, will cost us more than one trillion dollars over the next decade.

9. Between 1996 and 2002, the industry spent half a billion dollars to employ 600 full-time lobbyists, among them 24 former members of Congress.

10. Pharma's new political clout enabled it to push through a Medicare prescription drug act that forbade the federal government from negotiating for lower drug prices — something citizens of every other industrialized democracy (and many underdeveloped) take for granted. The congressman who shepherded the bill is now the $2-million-a-year president of PhRMA, the industry's main lobbying group.

11. The FDA is too weak to stand up to this political machine. The drug giant GlaxoSmithKline was cited by the FDA for deceptive and misleading advertising fourteen times between 1997 and 2001 but was never fined.

12. The FDA issued eighty-eight notices of violation between 1997 and 2001 for misleading print and TV ads but could not levy a single fine.

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