Prescription for Disaster: The Dirty Dozen FDA-Approved Pharmaceutical Drugs

By Gary Null, PhD and Jeremy Stillman

The Food and Drug Administration is mandated with the responsibility to ensure that our foods and

medications are safe and effective. Hence, when a physician, primary health care provider or

pharmacist provides a consumer with these medications, there is a fundamental belief that these

work and will do minimal harm. Then we meet reality. The FDA has not only allowed

extraordinarily inefficient, extremely toxic drugs onto the market, but then has ran interference on

behalf of pharmaceutical companies and other special interests to protect their profits instead of

immediately withdrawing their drugs from the market.

The consequence of eating at a restaurant you don’t like is that you won’t go back again. The

consequence of taking a toxic drug is injury or death. The FDA has a long history of allowing

deadly drugs to be promoted and marketed. The FDA has not sought prosecution when prima facie

evidence proves that the manufacturers and their scientists, boards of directors and marketers knew

all along that these drugs did not work as claimed or had dangerous side effects that they withheld

from the FDA . These companies have engaged in overtly criminal activities and instead of ending

up in prison or bankrupt, no one is held accountable. Bonuses are given and the value of their

corporate holdings goes up- it’s all part of the cost of doing business today.

This article is to show you clear and exact examples of lethal and harmful drugs that should never

have been marketed – some of which are still available to consumers. They are drugs that an honest

and diligent FDA would never have allowed to be released on the market. Cumulatively, tens of

thousands of Americans have died and hundreds of thousands more have been injured. And the

standard penalty meted out for such criminality? Pay a fine. Smile. You got out of jail free.

Fen-Phen (fenfluramine/dexfenfluramine/phentermine)

The fen-phen diet drug cocktail was popularized in the mid 1990s as Americans rushed to take pills

that were heralded by Time Magazine as a “new miracle drug”.1 The new pill was known as Redux

and was a slightly modified version of Pondimim, a diet drug that had been on the market since

1974.2 Both Redux and Pondimim were to be used in combination with the phentermine, an

amphetamine-like stimulant. The drug was manufactured by American Home Products which

changed its name to Wyeth-Ayerst in 2002, and was later taken over by Pfizer in 2009. The active

ingredient in these diet pills were fenfluramine and dexfenfluramine - drugs that falls into the class

of selective serotonin re-uptake inhibitors (SSRI). 3 These drugs increase levels of serotonin

released in the body - a process that the drug’s maker claimed would induce feelings of satiety and

promote weight loss. In 1996 alone, over 18 million prescriptions for Redux were handed out by

physicians.4

In the summer of 1997, an article appeared in the New England Journal of Medicine by researchers

at the Mayo Clinic which linked fen-phen with primary pulmonary hypertension (PPH), a

debilitating and incurable heart valve condition that is often fatal. The report profiled a 29 year old

1Cohen, Kate. "The Fda - Fen Phen Nation | Dangerous Prescription | FRONTLINE | PBS." PBS: Public Broadcasting

Service. http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html (accessed October 21, 2011).2Ibid

3"Interviews - Leo Lutwak, M.d. | Dangerous Prescription | FRONTLINE | PBS." PBS: Public Broadcasting Service.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/lutwak.html (accessed October 21, 2011).4I Cohen, Kate. "The Fda - Fen Phen Nation | Dangerous Prescription | FRONTLINE | PBS." PBS: Public Broadcasting Service. http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html (accessed October 21, 2011).

woman who died from PPH just 23 days after taking fen-phen.5 In response to this paper and

dozens of reports to the FDA connecting fen-phen with serious cardiovascular problems, both

Redux and Pondimim were recalled on Setpember 15, 1997. American Home Products had profited

over $200 million dollars in the short time that Redux and Pondimum were on the market. 6

The dangerous side effects associated with taking this drug had been established before it was

approved in April 1996. Months before approving the drug, a letter to FDA officials from watchdog

group Public Citizen noted scientific studies linking dexfenfluramine with neurological damage and

a nine-fold increase in the risk of primary pulmonary hypertension. The Public Citizen letter also

cited clinical trials which concluded that the drug was largely ineffective in fighting obesity. 7

According to Debbie Danowski and Peter Lazaro ’s book Why Can’t I Stop Eating: Recognizing,

Undertstanding and Overcoming Food Addiction, medical studies have shown the risk of

developing PPH while taking fen/phen to be over 30 times greater. The book also points out that

the difficulty in diagnosing PPH in connection with these drugs- it could happen that a person’s

only symptoms will be shortness of breath and then death. 8

The gross negligence on the part of FDA in approving this drug was made clear during a PBS

interview with Dr. Stuart Rich, a consultant to FDA during the approval of Redux who now serves

as the president of the Pulmonary Vascular Research Institute . Rich expressed his disbelief over

5Brody, Jane E.. "Archive: Personal Health: Obesity drugs: Weighing the risks to health against the small victories.." The

New York Times . http://www.nytimes.com/specials/women/warchive/970903_1241.html (accessed October 21, 2011).6Cohen, Kate. "The Fda - Fen Phen Nation | Dangerous Prescription | FRONTLINE | PBS." PBS: Public Broadcasting

Service. http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html (accessed October 21, 2011).7Public Citizen. "Letter to FDA." Citizen.org. www.citizen.org/documents/1389.pdf (accessed October 17, 2011).

8Danowski, Debbie , and Pedro Lazaro, M.D.. Why Can't I Stop Eating?: Recognizing, Understanding, and Overcoming

Food Addiction. Center City: Hazelden, 2000. Print.

the FDA pushing fen-phen given the drug’s known serious effects on cardiovascular health and

marginal efficacy. Rich also explained that he was invited to testify with other experts before an

FDA drug approval committee on the safety and efficacy of Redux at a meeting that took place in

September 1995. During the meeting, the committee decided not to approve Redux on the grounds

that it was unsafe. However, before the final vote was cast, FDA division head James Bilstad

unexpectedly interrupted the proceedings and postponed the vote for another time. According to

Rich, none of the experts who previously testified were invited back to the next meeting which

ultimately resulted in the drug being approved in a 6-5 vote.9

After the approval of Redux, Dr. Rich appeared on the Today Show where he advised that the drug

be prescribed with utmost caution by physicians due to its potentially damaging side effects and

only in cases where obesity was a life-threatening problem. Rich explained to PBS that shortly after

his television appearance he received a phone call by an executive from drug maker American

Home Products. The doctor was told by the AHP representative in no uncertain terms that “bad

things would happen” if he continued to speak to the media about the weight loss medication.10

All told, American Home Products /Wyeth Ayerst has paid out over $14 billion to more than

200,000 fen-phen victims in legal settlements.11 An estimate on how many deaths can be attributed

to taking fen-phen is still the subject of debate but almost certainly numbers in the thousands.

Vioxx (Rofecoxib)

9"Interviews - Stuart Rich, M.d. | Dangerous Prescription | FRONTLINE | PBS." PBS: Public Broadcasting Service.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/rich.html (accessed October 16, 2011).10Ibid11

"The Fen-Phen Follies." American Lawyer, March 1, 2005. http://www.law.com/jsp/tal/PubArticleTAL.jsp?id=900005424104&slreturn=1 (accessed October 19, 2011).

The recall of Merck’s Vioxx stands as one of the largest drug recalls in history. Despite internal

studies associating the drug with serious cardiovascular side effects before it came on the market,

the FDA approved Vioxx in 1999 to be used as a painkiller to treat conditions such as arthritis and

menstrual pain. Vioxx falls into the class of non-steroidal anti-inflammatory drugs (NSAID).

Over the next four and a half years, 100 million prescriptions for Vioxx were handed out as Merck

would rake in $2.5 billion a year in worldwide sales.12 All the while, thousands were dropping dead

from heart attacks induced by their drug.

One of the most outspoken critics of Vioxx has been Dr. David Graham, a physician who worked

for over 20 years with the FDA. He received degrees in from Johns Hopkins University Medical

School and trained at Yale and UPenn. In 2004, while holding the position of Associate Director

for Science and Medicine in the FDA’s Office of Drug Safety, he testified before Congress about

serious dangers associated with Vioxx that were ignored by FDA officials before it was approved

and expressed his conviction that harmful and dangerous drugs would continue to be released on the

market under the FDA’s dubious drug review process. 13 Graham also noted that studies carried out

by drug manufacturer Merck before Vioxx was approved indicated that taking Vioxx would

increase the risk of heart attack by five to seven times. 14

According to Shannon Brownlee’s book Overtreated: Why Too Much Medicine Is Making Us

Sicker and Poorer, a comprehensive study conducted by Merck that was released in 2000 confirmed

previous studies on Vioxx linking it with an increased risk of cardiac arrest and stroke. Brownlee

writes that instead of pulling the drug off the shelves, the FDA spent 18 months discussing with

12Nesi, Thomas J.. Poison pills: the untold story of the Vioxx drug scandal. New York: Thomas Dunne Books, 2008.

13"Testimony of David J. Graham, MD, MPH, November 18, 2004." finance.senate.gov.

finance.senate.gov/imo/media/doc/111804dgtest.pdf (accessed October 18, 2011).14Ibid

Merck how to word the warning that was to be placed on the label. By the time the warning did

appear on the label, it was so benign-sounding that it had very little effect on sales. 15

In a 3 year epidemiological study released in August 2004, Dr. Graham and his team uncovered that

taking a low-dose of Vioxx increased the risk of heart attack and sudden death nearly twofold while

a high-dose amount would increase that risk by 3.7.16 With such clear evidence of a heart attack

risk, Graham advised that Vioxx not be prescribed or taken by patients. On election day of that

same year, the FDA quietly posted to their website a report based on Graham’s study which

purported that Vioxx was responsible for an estimated 28,000 excess cases of heart attack or sudden

cardiac death. Graham contends that this is an underestimation and that it is more likely that the

sum lies between 88,000 to 139,000 and that 30%-40% of those individuals died while others

sustained life-altering damage to their health. 17

Graham intended on presenting his disturbing findings at the International Conference on

Pharmacoepidemiology in France. However, upon learning of his plans, directors within the FDA’s

Office of New Drugs and the Office of Drug Safety attempted to dissuade him sharing his

conclusions unless they were significantly altered. Graham was shocked at how unresponsive

management at the FDA was to these alarming revelations with one director going so far as to

suggest that Graham should change his conclusions because the FDA wasn’t “contemplating”

placing a warning on high-dose Vioxx. 18

15Brownlee, Shannon. Overtreated: why too much medicine is making us sicker and poorer. London: Bloomsbury, 2007.

16Testimony of David J. Graham, MD, MPH, November 18, 2004." finance.senate.gov.

finance.senate.gov/imo/media/doc/111804dgtest.pdf (accessed October 18, 2011).17Ibid18Ibid

Graham also spoke before Congress of the dangerous culture of non-disclosure and resistance that

exists within FDA offices, particularly the Office of Drug Safety and the Office of New Drugs,

where numerous cases of risky drugs were approved without taking into consideration serious

health concerns and other risky drugs were kept on the market despite indications they were

unsafe.19

It was only after numerous other studies had been published connecting Vioxx with heart attacks

and strokes that it was recalled 2004.20 Lawsuits stemming from the Vioxx scandal have obligated

Merck to pay out nearly $5 billion in compensation to victims in the United States.21

Rezulin (Troglitazone)

Warner-Lambert (which was later acquired by Pfizer in 2000) was the manufacturer of the diabetes

drug Rezulin. The drug was approved in January 1997 and within a matter of months, dozens of

hospitalizations due to liver toxicity in connection with Rezulin were being reported to the FDA.

Despite the dangers of the drug becoming manifest, agency officials remained supportive of the

drug . The agency was slow to take any action besides adding a warning on Rezulin’s label

explaining that patients taking the medication should have frequent tests evaluating their liver-

function.

The toxic effect of Rezulin on the liver had been proven in tests before the drug was given the green

light by the FDA. During the review process, concerns over the drug were raised by agency officer

19Ibid20

Brownlee, Shannon. Overtreated: why too much medicine is making us sicker and poorer. London: Bloomsbury, 2007.21

Goldstein, Jacob. "Merck Vioxx Litigation: Settlements and Pending Cases - Health Blog - WSJ." WSJ Blogs - WSJ. http://blogs.wsj.com/health/2010/02/10/vioxx-lawsuits-whats-been-settled-whats-still-going/ (accessed October 21, 2011).

Dr. John L. Gueriguian who showed that Rezulin was harmful to the the liver and heart and

accordingly should not be approved. Before the drug was approved, Warner-Lambert relieved

Gueriguian of his role reviewing the new medication and none of his work documenting the dangers

was submitted for the final review. 22 In his testimony before Congress, Dr. David Graham asserted

that when it came to Rezulin, the FDA’s Center for Drug Evaluation and Research “relied on risk

management strategies that were utterly ineffective and it persisted in relying on these strategies

long after the evidence was clear that they didn’t work”.23 Dr. Robert Misbin one of the FDA’s

medical reviewers, voiced his misgivings over the drug as the death toll rose by the hundreds before

the drug was recalled in 2000. Misbin was subject to intimidation and threats of being fired by FDA

superiors after he submitted internal e-mail correspondences to colleagues which detailed his

concerns over Rezulin to Congress. 2425

Even though official estimates place the number of deaths from Rezulin at fewer than 100, some

suspect that that figure could be 4 times higher.26 As of 2009, both state and federal courts have

required Pfizer to compensate most of the 35,000 personal injury claims have been filed by Rezulin

users. The pay outs have totaled around $750 million.27

Avandia (Rosiglitazone):22

Willman, David. "REZULIN: Fast-Track Approval and a Slow Withdrawal - latimes.com." Los Angeles Times - California, national and world news - latimes.com. http://www.latimes.com/news/nationworld/nation/la-122001rezulin,0,4831559.story (accessed October 21, 2011).23

"Testimony of David J. Graham, MD, MPH, November 18, 2004." finance.senate.gov. finance.senate.gov/imo/media/doc/111804dgtest.pdf (accessed October 18, 2011).24

Willman, David. "REZULIN: Fast-Track Approval and a Slow Withdrawal - latimes.com." Los Angeles Times - California, national and world news - latimes.com. http://www.latimes.com/news/nationworld/nation/la-122001rezulin,0,4831559.story (accessed October 21, 2011).25

 Willman, David. " The Pulitzer Prizes | Physician Who Opposes Rezulin Is Threatened by FDA With Dismissal ." The Pulitzer Prizes . http://www.pulitzer.org/archives/6484 (accessed October 21, 2011).26

"Drug Recalls - Rezulin Linked to Liver Failure & Heart Disease." Drug Recalls . http://www.drugrecalls.com/rezulin.html (accessed October 21, 2011).27

Feeley, Jef. "Pfizer Ends Rezulin Cases With $205 Million to Spare (Update1) - Bloomberg." Bloomberg . http://www.bloomberg.com/apps/news?pid=newsarchive&sid=act0akCefQwo (accessed October 21, 2011).

Originally marketed as a safer diabetes medication in the wake of the controversy over Rezulin, the

drug Avandia has generated one of the largest scandals in the history of pharmaceuticals. Before

and after the approval of the drug in 1999, numerous tests determined that Avandia was dangerous

to heart health. A study undertook by manufacturer SmithKline Beecham (which after merge in

2000, became GlaxoSmithKline) shortly before the drug was approved, concluded that patients

taking Avandia were at a significantly higher risk of experiencing heart problems compared to

individuals taking Actos, another competing drug.28 Not until 2010 were the results of this study

made public in an investigation by the New York Times.

A deposition reported on by the publication documented Avandia's deleterious effects on

cardiovascular health and provided a glimpse into the cozy relationship between the FDA and

leadership of GlaxoSmith Beecham. Unearthed in the deposition was an inter-office email message

in which a director at GlaxoSmith Beecham expresses his hopefulness that Dr. John Jenkins, the

head of the FDA's office of new drugs, would facilitate the drug's approval process despite its

dangers. The director wrote in his message that “it is clear the office of new drugs is trying to find

minimal language that will satisfy the office of drug safety”.29

The NYT also profiled a supervisor who was employed by the FDA's drug safety office, Dr.

Rosemary Johann-Liang. After recommending that Avandia's warning label be more strongly-

worded, Dr. Johann-Liang was admonished by agency officials and resigned from her position soon

28 Harris, Gardiner. "Diabetes Drug Maker Hid Test Data, Files Indicate - NYTimes.com." The New York Times . http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?adxnnl=1&ref=avandiadrug&adxnnlx=1319223846-h0flJ11Cg/QhDShZ5ZTTPg# (accessed October 21, 2011).29 Ibid

thereafter. Commenting on the apparent conflict of interest between Jenkins and the company she

stated that “this should not happen”.30

A Time Magazine investigation revealed that in 2007, GlaxoSmithKline representatives

successfully lobbied the FDA to keep Avandia (which had netted the company $3.2 billion the

previous year) on the market despite the company’s internal studies which demonstrated that the

drug increased the risk of heart attack by 46%. That same year, a study published in the New

England Journal of Medicine concluded that Avandia users were 43% more likely to have heart

attacks than the general population.31 This corroborated the findings of another independent study

linking the drug with myocardial ischemia in 2007 carried out by researchers at the Cleveland

Clinic.32

One study referenced in a New York Times article estimated that “from 1999-2009, more than

47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.” 33

After an investigation of Avandia, members of the Senate Finance Committee criticized the FDA

for failing to act as 83,000 reports of serious adverse events directly related to taking Avandia

flooded the agency’s offices from 1999-2007.34

30 Ibid31 Calabresi, Massimo. "Avandia Approval: FDA's Drug-Safety Protection in Doubt - TIME." TIME.com. http://www.time.com/time/magazine/article/0,9171,2010181-2,00.html (accessed October 21, 2011).32

Ibid33

Harris, Gardiner. "F.D.A. to Severely Restrict Diabetes Drug Avandia - NYTimes.com." The New York Times. http://www.nytimes.com/2010/09/24/health/policy/24avandia.html?pagewanted=all (accessed October 21, 2011).34

Emord, Jonathan. "Clear Case of Big Pharma’s Hold on FDA: Agency Ignored Dangers of Diabetes Drug Avandia | Health Freedom Alliance." Health Freedom Alliance. http://healthfreedoms.org/2011/01/12/clear-case-of-big-pharmas-hold-on-fda-agency-ignored-dangers-of-diabetes-drug-avandia/ (accessed October 21, 2011).

Incredibly, Avandia has still not been fully recalled. In the fall of 2010, FDA officials placed heavy

restrictions on the drug – only if patients can prove they have tried every other anti-diabetes drug

and are aware of the risks involved can they be prescribed the medication. 35

In a mega-settlement involving over 10,000 victims seeking compensation from GlaxoSmithKline

for Avandia-related injury in 2010, the company agreed to pay $460 million. This comes on the

heels of the first round of Avandia lawsuits which obligated GlaxoSmithKline to pay around $60

million. About 3,000 additional cases are still waiting to be decided on.

Celebrex (celecoxib)

Originally manufactured by Pharmacia (which was taken over by Pfizer in 2002) Celebrex was

approved in late 1998 by the FDA and like Vioxx and Bextra, is a special type of non-steroidal anti-

inflammatory drug (NSAID) known as a COX-2 inhibitor. Touted as a new wonder drug to help

patients suffering from rheumatoid arthritis and osteoarthritis more effectively and with fewer side

effects than other medications, Celebrex was soon shown to have serious effects on cardiovascular

health. Just 3 months after Celebrex was being prescribed, the Wall Street Journal reported on 10

deaths related to the drug.36

Celebrex was marketed as an alternative to traditional NSAIDs such as ibuprofen that had been

known to cause gastrointestinal side effects. This claim was later found to be untrue when a Health

Canada study in 2002 showed that, in fact, Celebrex was not less damaging to the stomach than

35"Avandia (Drug) - Health - The New York Times." Times Topics - The New York Times.

http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/avandiadrug/index.html?scp=1&sq=rezulin&st=cse (accessed October 21, 2011).36 " Searle Responds to Journal Report On Celebrex Side Effects." P\S\L Group. http://www.pslgroup.com/dg/f8f2e.htm (accessed October 14, 2011).

either ibuprofen or another NSAID, Voltaren. In less than two years on the market in Canada,

health authorities had already received 70 reports of gastrointestinal bleeding related to the

medication.37

In 2005, Pfizer admitted that an internal study from 1999 on the elderly showed that Celebrex posed

a serious risk to heart health. The results of this study which were disclosed to the FDA in 2001

revealed that, compared to the placebo group, individuals taking Celebrex were nearly 4 times as

likely to experience a heart attack. 38 An additional study appearing in the New England Journal of

Medicine documented that taking the prescribed 400mg dose of celecoxib resulted in a 3.4 fold

increase in cardiovascular-related death, myocardial infarctions or stroke. Among those taking the

200mg dose, the risk was 2.5 times greater. 39 In light of these findings, Pfizer agreed to withdraw

public advertisements for Celebrex in 2004- still, the pharmaceutical giant continues to manufacture

the pills and enjoys the full approval of the FDA.40

Bextra (valdecoxib) 

Bextra was approved by the FDA in 2001 to treat arthritis; at the time of approval the agency turned

down a bid from the drug’s maker, Pharmacia ( later taken over by Pfizer in 2002), to approve

Bextra for patients dealing with acute pain after surgery. According to Melody Petersen’s book

Our Daily Meds, the FDA did not disclose to the public that they did not approve the drug for post-

37 "Vioxx, Celebrex: Concerns over popular arthritis drugs." CBC. http://www.cbc.ca/news/background/drugs/cox-2.html (accessed October 19, 2011).38 Berenson, Alex, and Gardiner Harris. " Pfizer Says 1999 Trials Revealed Risks With Celebrex." The New York Times . http://www.nytimes.com/2005/02/01/business/01drug.html?adxnnl=1&adxnnlx=1319464929-du17+q0mWBTaw02euxZRqA (accessed October 18, 2011).39 Solomon, Scott D et al "Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention." New England Journal of Medicine 325: 1071-1080 (2005). http://www.nejm.org/doi/full/10.1056/NEJMoa050405#t=abstract (accessed October 18, 2011)40 Berenson, Alex. "Pfizer to Halt Its Advertising of Celebrex to Consumers." The New York Times . http://www.nytimes.com/2004/12/19/business/19cnd-cele.html (accessed October 24, 2011).

surgical pain. The reason for this was concealed in secret agency documents which discussed a

clinical trial of Bextra being used on patients undergoing heart bypass surgery. In the trial, patients

were shown to have “an excess of serious adverse events, including death.” These confidential

documents also established that Bextra, despite claims by the manufacturer, was shown to be no

more effective at alleviating pain than lower-priced painkillers such as naproxen and ibuprofen. 41

In an interview with the New York Times in 2004, Dr. Garret FitzGerald, a cardiologist and

pharmacologist at UPenn and a leading expert in COX-2 drugs, expressed his concerns over the

dangers of Bextra saying the drug was “a time bomb waiting to go off” that appeared even more

deadly than Vioxx. 42 He drew his assertions in part on a study of 12 clinical trials whose results

were presented at a meeting of the American Heart Association; the study concluded that patients

taking Bextra were more than twice as likely to suffer heart attacks and strokes. One of the study’s

authors interviewed by the newspaper was Dr. Curt Furberg of Wake Forest University’s School of

Medicine. Furberg stated that “we showed that Bextra is no different than Vioxx, and Pfizer is

trying to suppress that information”. 43

Further, Bextra was never shown to decrease cases of adverse events related to gastrointestinal

health.44 Bextra was finally removed from the market in 2005 when the FDA asked Pfizer to carry

out a voluntary withdrawal of the drug as evidence piled up linking Bextra with heart attack, stroke

as well as acute skin conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

41 Petersen, Melody. Our daily meds: how the pharmaceutical companies transformed themselves into slick marketing machines and hooked the nation on prescription drugs. New York: Farrar, Straus and Giroux, 2008.42 Harris, Gardiner. "New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks." The New York Times. http://www.nytimes.com/2004/11/10/business/10drug.html (accessed October 13, 2011).43 Ibid44 Ibid

45 This request for voluntary withdrawal came less than 2 months after the FDA Panel Advisory

Panel recommended the drug remain available to consumers. 46

In February 2005, Senate Finance Committee Chairman Charles Grassley blasted FDA authorities

over the apparent conflict of interest between Big-Pharma and members of the regulatory panels

that voted in favor of keeping both Bextra and Vioxx on the market. Grassley pointed out that 10

members sitting on the 32-person advisory board had worked as consultants or had otherwise been

employed by Pfizer.47 In the cases of Bextra and Vioxx, these 10 people voted in favor of the drugs

remaining available to consumers. The Center for Science in the Public Interest noted that nearly

all of the panel members charged with making these life-altering decisions had ties to other

pharmaceutical corporations.48

In a 2008 settlement, Pfizer agreed to settle nearly all the injury cases related to Celebrex and

Bextra in an $894 million settlement with about 7,000 parties.49 In addition to personal damages, in

2009, Pfizer was mandated by the Justice Department to pay $2.3 billion for an off-label, illegal

campaign that advertised Bextra and several other drugs. Pfizer was charged with making claims

that the medication could be used as a substitute for drugs like morphine for patients dealing with

pain after surgery. 50 One Pfizer executive, Mary Holloway, who helped spearhead the illegal

45 Fields, Theodore et al "Bextra® Withdrawal from the Market - HSS Physicians Reflect on Options for Patients in Pain - HSS.edu - HSS." Hospital for Special Surgery. http://www.hss.edu/conditions_bextra-withdrawal-hss-physicians-reflect-options.asp (accessed October 24, 2011).46 Ibid47 Alonso-Zaldivar, Ricardo. "Senator Questions FDA Panelists' Ties to Industry - latimes.com." Los Angeles Times . http://www.latimes.com/news/nationworld/washingtondc/la-na-fda26feb26,0,7305839.story (accessed October 24, 2011).48 Ibid49

Johnson, Linda A.. "Pfizer Reaches Massive Settlement In Celebrex, Bextra Lawsuits." The Huffington Post. http://www.huffingtonpost.com/2008/10/17/pfizer-reaches-massive-se_n_135518.html (accessed October 21, 2011).50

Edwards, Jim. "Pfizer Exec: Company Approved of Off-Label Bextra Promotion | BNET ." BNET - The CBS Interactive Business Network. http://www.bnet.com/blog/drug-business/pfizer-exec-company-approved-of-off-label-bextra-promotion/1934 (accessed October 21, 2011).

campaign, was fined $75,000 and given two years probation. Another sales manager at the

company involved in the scandal was Thomas Farina who was ordered to serve a 6 month sentence

of home confinement.51

Baycol (Cerivastatin)

Baycol was approved by the FDA in 1997 as a cholesterol-lowering statin drug. The drug was

manufactured by German company Bayer which teamed up with SmithKline Beecham (later

became GlaxoSmithKline) to market the drug. Baycol quickly drew criticism for its potentially

fatal side effects including rhabdomyolysis, a rare condition characterized by the disintegration of

muscle tissue and subsequent release of myoglobin into the bloodstream. 52 Myoglobin has been

shown to damage kidney tissue and in some cases, lead to acute kidney failure.53

A 2003 German study concluded that individuals taking Baycol were 16-80 times as likely to

develop Rhabdomyolysis compared to people taking other statins.54 In October 1999, the FDA

openly recognized the dangers associated with the Baycol in a letter to the drug’s maker which

specifically stated that the medication’s package insert was minimized the risk of rhabdomyolysis.55

51Ibid52 "Documents suggest Bayer knew Baycol problems - Page 2 - CNN." CNN.com. http://articles.cnn.com/2003-02-23/justice/bayer.documents_1_baycol-bayer-philip-beck/2?_s=PM:LAW (accessed October 21, 2011)53 "Rhabdomyolysis - PubMed Health." National Center for Biotechnology Information. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001505/ (accessed October 24, 2011).54 M, Zeitlinger . "Clinico-pharmacologic explanation models of cerivastatin associated rhabdomyolysis." Wien Med Wochenschr. 153(11-12):250-4. (2003). http://www.ncbi.nlm.nih.gov/pubmed/12879633 (accessed October 18, 2011).55 "Baycol (cerivastatin sodium tablets)." U S Food and Drug Administration Home Page. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172265.htm (accessed October 12, 2011).

Even still, the FDA approved 0.8 mg dose of the drug in 2000 – doubling the previously allowable

amount. 56

The drug was recalled in August 2001 after it was linked to 53 deaths worldwide. More recently.

researchers have discovered that the number of deaths attributable to Baycol exceeds 100. 57 There

have been roughly 8000 personal injury lawsuits related to the drug which have obligated Bayer to

pay victims more than $1.1 billion.58 Over 1000 more lawsuits are still pending.59

In 2004, officials with the Journal of the American Medical Association issued a public statement

stating that the FDA is incapable of policing itself in matters of drug safety. The editors referenced

Baycol in particular as a clear example of the agency’s unresponsiveness and slowness in pulling

dangerous drugs off the market. The JAMA authors also recommended that an independent

oversight committee be commissioned to review the safety of approved pharmaceuticals. 60

Accutane (isotretinoin):

Manufactured by the the Swiss pharmaceutical company Hoffman-LaRoche , Accutane was

approved by the FDA in 1982 as a treatment for severe cystic acne. Included in the long list of side

effects that have been associated with Accutane are depression, psychosis, suicidal behavior,

56 "Baycol Timeline -- Key Events in the History of the Recalled Cholesterol Drug Baycol | Market Wire | Find Articles." Business Library. http://findarticles.com/p/articles/mi_pwwi/is_20050229/ai_mark02051931/?tag=content;col1 (accessed October 18, 2011).57 Homola, Victor . " BAYER SAYS IT FACES 400 MORE BAYCOL LAWSUITS - New York Times." The New York Times . http://www.nytimes.com/2003/02/06/business/company-news-bayer-says-it-faces-400-more-baycol-lawsuits.html?src=pm (accessed October 5, 2011).58 "Baycol Lawsuits." Lawyers.com. http://toxic-torts.lawyers.com/Toxic-Torts/Baycol-Lawsuits.html (accessed October 4, 2011).59 Ibid60 Russel, Sabin. "FDA lax in drug safety, journal warns / Independent agency is sought to prevent conflicts of interest." SFGate. http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/11/23/MNGSPA04NI1.DTL (accessed October 24, 2011).

hepatitis, birth defects, acute pancreatitis, night blindness and inflammatory bowel disease.61 The

FDA also advised users that it “may stop long bone growth in teenagers who are still growing”. 62

In a testimony before congress, Dr. Janet Woodcock, the director of the FDA’s Center for Drug

Evaluation and Research, spoke about the serious dangers posed by Accutane to its users noting that

over a 20 year period, government authorities have received over 23,000 reports of adverse events

in connection with the drug. Among the top five most commonly reported adverse events were

“induced abortion” as well as “suicidal ideation”. 63 Woodcock's testimony before lawmakers came

in 2002- about 7 years before the drug would finally be pulled from the shelves in June 2009. The

drug's withdrawal was prompted not by the FDA, but Roche, which made the decision while facing

a growing number of Accutane-related lawsuits. The drug is still being marketed by other firms

internationally under different names.64

One prominent figure who opposed the drug was US Congressman Bart Stupak. Stupak’s 17 year

old son committed suicide with a firearm after taking the drug. Upon reviewing internal FDA

documents, Stupak surmised that the FDA’s estimate that 167 suicides had been caused by

Accutane was inaccurate and that the number could be as high as 20,000. 65

61 Edwards, Jim. "Acne Drug Accutane’s Side Effect Is Death. So Why Is It Still on the Market? | BNET ." BNET - The CBS Interactive Business Network. http://www.bnet.com/blog/drug-business/acne-drug-accutanes-side-effect-is-death-so-why-is-it-still-on-the-market/4240 (accessed October 10, 2011).62 "Medication Guide- Accutane." FDA.gov. www.fda.gov/downloads/drugs/drugsafety/ucm085812.pdf (accessed October 12, 2011).63 "Concerns Regarding Accutane (isotretinoin)." FDA.gov. http://www.fda.gov/newsevents/testimony/ucm115126.htm (accessed October 18, 2011).64 Edwards, Jim. "Acne Drug Accutane’s Side Effect Is Death. So Why Is It Still on the Market? | BNET ." BNET - The CBS Interactive Business Network. http://www.bnet.com/blog/drug-business/acne-drug-accutanes-side-effect-is-death-so-why-is-it-still-on-the-market/4240 (accessed October 10, 2011).65 Mitchell, Steve. "Hill committee: Accutane causes suicide - UPI.com." UPI.com. http://www.upi.com/Science_News/2002/12/11/Hill-committee-Accutane-causes-suicide/UPI-56881039653795/ (accessed October 2, 2011).

James T. O’ Donnell’s book Drug Injury: Liability, Analysis and Prevention highlighted the debate

over Accutane within the offices of the FDA. In 1990, the FDA's Dr. David Graham noted in one

correspondence with his peers that “the magnitude of injury and death has been great and

permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related

birth defects. There is no alternative to immediate withdrawal”. 66

O’Donnell also writes that 90% of the women who had been treated with the drug from 1982-1987

did not have severe cystic acne.67

So far, more than 5,000 personal injury lawsuits have been brought against Roche, the majority of

which are still pending. 68 One case that has been settled involved New Jersey resident Andrew

McCarrell, who developed inflammatory bowel disorder and had to have his colon removed after

taking the medication. In 2010, he won a $25 million lawsuit against Roche. He won on the

grounds that the labeling of Accutane did not adequately represent the risks involved. 69

Cylert (pemoline):

In 2005, Abbot Laboratories discontinued its production of Cylert; a drug used to treat attention

deficit hyperactivity disorder. After 30 years on the market, Cylert was removed by the FDA after

66 Donnell, James T.. Drug injury: liability, analysis and prevention. 2. ed. Tucson: Lawyers & Judges Publishing Company, 2005.67 Ibid68 Edwards, Jim. "Bad Data: How Quants Convinced Roche to Compromise Patient Safety | BNET ." BNET . http://www.bnet.com/blog/drug-business/bad-data-how-quants-convinced-roche-to-compromise-patient-safety/5354?tag=mantle_skin;content (accessed October 17, 2011).69 "Accutane Lawsuit: Andrew McCarrell Wins $25 Million After Having Colon Removed." The Huffington Post. www.huffingtonpost.com/2010/02/17/accutane-lawsuit-andrew-m_n_465598.html (accessed October 13, 2011).

public outcry over the medication's effects on liver health. During its time on the market, several

studies concluded that the users of Cylert were much more likely to experience acute liver failure

than the general population.

Cylert was responsible for at least 13 deaths and hundreds of serious adverse reactions.70 Cylert is a

perfect example of how a harmful drug can remain in good standing with the FDA for many years

even when it is known to be deadly and there are safer alternatives. After a 1995 study concluded

that individuals taking Cylert were 45 times more likely to suffer liver failure, health authorities in

the UK acted swiftly to pull the drug off the market. It would be another 10 years before the FDA

agreed to do the same. 71

Even though the FDA required stronger warning labels that advised physicians to test the health of

the liver of patients taking Cylert, agency documents reveal that these warnings went unheeded.72

This is a frightening notion considering that the agency wrote in one alert to health care

professionals that “the reporting rate for liver failure with pemoline is 10 to 25 times greater than

the background rate of liver failure in the general population.” 73

In an open letter to the FDA's Acting Commissioner, Lester Crawford, the advocacy group Public

Citizen raised concern over the use of pemoline and pointed out the critical fact that only about 10%

of all adverse events are reported to FDA officials. Using the agency's own data on acute liver

70 "Public Citizen Letter to FDA." citizen.org. www.citizen.org/documents/1389.pdf (accessed October 11, 2011).71 DuBois, Shelley. "Why the EU banned Avandia but the FDA didn't - Sep. 24, 2010." CNNMoney . http://money.cnn.com/2010/09/24/news/companies/FDA_Avandia_GSK_ban.fortune/index.htm (accessed October 12, 2011).72 Harris, Gardiner. "Citizens' Group Wants Hyperactivity Drug Taken Off the Market." The New York Times . http://www.nytimes.com/2005/03/25/business/25warning.html?pagewanted=print&position= (accessed October 24, 2011).73 Moore, Elaine A.. The amphetamine debate: the use of Adderall, Ritalin, and related drugs for behavior modification, neuroenhancement, and anti-aging purposes. Jefferson: McFarland & Co., 2011.

failure caused by pemoline, Public Citizen extrapolated that the actual incidence of liver failure

among users of pemoline could be 168 times greater than in the general population. Further, the

watchdog group claimed that the 13 deaths officially linked to Cylert is a deceptive underestimate

of the actual figure.74

DES (Diethylstilbestrol)

DES was a synthesized form of estrogen widely used in the USA from 1940-1971 to prevent

miscarriages and premature labor. A 1953 study carried out by the University of Chicago revealed

that the drug was no more effective at preventing miscarriages than the placebo.75 Between 5 to 10

million women were prescribed DES by their physicians - even after its ineffectiveness had been

established.76 In 1971, a study connected DES with an uncommon vaginal cancer known as clear

cell adenocarcinoma in the daughters of women who had been given DES. In 1971, the FDA

rescinded its approval of the drug to be used on pregnant women.77

The numerous health hazards linked to DES have become evident over the years. Research has

shown that DES daughters are 30% more likely to develop breast cancer than the general

population.78 In addition, research has shown that DES daughters have higher rates of infertility and

they are more likely to develop abnormal precancerous cells in the cervix.79

74 Public Citizen Letter to FDA." citizen.org. www.citizen.org/documents/1389.pdf (accessed October 11, 2011).75 "DES timeline ." Boston.com. http://articles.boston.com/2011-04-18/lifestyle/29444354_1_des-education-des-exposure-des-lawsuits (accessed October 24, 2011).76 "Ibid77 Ibid78 Rothke, Joy. "Health Library Articles." HealthDay. http://consumer.healthday.com/encyclopedia/article.asp?AID=647261 (accessed October 12, 2011).79 Diethylstilbestrol (DES) and Cancer - National Cancer Institute." National Cancer Institute. http://www.cancer.gov/cancertopics/factsheet/Risk/DES (accessed October 2, 2011).

Among DES sons, the health risks posed by the drug are also significant. DES has been linked to

non-cancerous epididymal cysts, genital abnormalities and infertility in DES sons. 80 These health

complications have been found to extend to the grandchildren of DES users.81

On behalf of their constituents who were affected by the DES scandal, Massachusetts senators John

Kerry and Scott Brown wrote a letter to FDA commissioner Margaret Hamburg in the winter of

2010 requesting that the agency issue an apology. In February 2011, the FDA responded in writing,

calling the fallout from the misuse of DES “a tragedy” but did not apologize for their lack of

oversight on this multi-generational health disaster.82

Determining how much money was paid out to victims of DES in court by the drug’s various

manufactures is a difficult task. Around 200 companies manufactured the drug. Many of the

lawsuits brought against the manufacturers occurred decades after the damage had been done and

most plaintiffs did not recall the company who produced the pills that they or their mothers had

taken.83 Accordingly, in all cases settled after 1980, companies were required to compensate

victims according to the percentage of the market share they held while the drug was being

prescribed. A 1983 issue of Mother Jones reported that the Indianapolis-based pharmaceutical firm

Eli Lilly was involved in DES-related claims that exceeded $3 billion in the 1970s. 84

Yaz (Drospirenone)

80 Ibid81 "Ibid82 "John Kerry - United States Senator for Massachusetts: Press Room." kerry.senate.gov. http://kerry.senate.gov/press/release/?id=fd5e856f-6e84-4332-b434-3f17549071b5 (accessed October 7, 2011).83 Wehmhoefer, Richard A.. Statistics in litigation: practical applications for lawyers. Dubuque, Iowa: Shepard's/Mcgraw-Hill, 1985.84 Johnson, JT, and Mark Dowie. "DES Revenge." Mother Jones, Feb. - Mar. 1983.

Bayer’s biggest moneymaking drug, Yaz is an oral contraceptive that was approved by the FDA in

2006. It is also used to treat premenstrual dysphoric disorder and moderate cases of acne. Known

side effects of Yaz include blood clots, stroke and heart attack. While the drug has yet to be taken

off the market, recent months have witnessed growing public concern over the safety of the popular

medication.

Two 2011 studies on drospirenone determined that women taking the drug have a 2 to 3 times

higher risk of deep vein thrombosis than women taking another contraceptive containing the

synthetic hormone levonorgestrel.85 These findings were consistent with an FDA-run study that

showed a 50% increase in the incidence of venous thromboembolism among women taking

drospirenone.86 FDA authorities issued a statement in September 2011 saying that the agency “has

not yet reached a conclusion, but remains concerned, about the potential increased risk of blood

clots with the use of drospirenone-containing birth pills.”87

The FDA, in fact, quietly went about recalling several batches of Yaz in 2009 after Bayer failed to

manufacture over 32,000 boxes of the product “within specification”.88 Jim Edwards of the bNet

news network reported in 2010 that the recall went largely unnoticed because the agency chose to

place the recall information in the small print of an “Enforcement Report” from November 25,

2009, on their website; not bothering to add it to the section titled “Recalls, Market Withdrawals &

85 Gardner, Amanda. "FDA turns to advisory panel for Yaz safety analysis - USATODAY.com." USATODAY.com. http://yourlife.usatoday.com/health/medical/breastcancer/story/2011-09-27/FDA-turns-to-advisory-panel-for-Yaz-safety-analysis/50568528/1 (accessed October 3, 2011).86 Ibid87 "FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone." FDA.gov. http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm (accessed October 25, 2011).88 Edwards, Jim. "Did You Know the FDA Recalled Bayer’s Yaz Contraceptive? Neither Did Anyone Else | BNET ." BNET. http://www.bnet.com/blog/drug-business/did-you-know-the-fda-recalled-bayers-yaz-contraceptive-neither-did-anyone-else/4754 (accessed October 2, 2011).

Safety Alerts”.89 Edwards also wonders how many women were exposed to tainted pills

unnecessarily due to slow action by the FDA; he notes that the recall occurred over 6 months after

the FDA inspected Bayer’s contraceptive drug.90

Overall, 285 cases of death has been reported to the FDA in connection to Yaz and over 3,000

cases of pulmonary embolism and 2,000 incidents of deep vein thrombosis – both of which are

potentially life-threatening.91 In the US and Canada, approximately 5,000 women have filed

lawsuits against Bayer seeking compensation for injuries related to taking Yaz.92

Premarin

This estrogen-based hormone replacement therapy is sold by Wyeth Pharmaceuticals (part of Pfizer

since 2009) to alleviate the symptoms of menopause in women. First approved by the FDA in 1942,

the drug is created from pregnant mares' urine – hence its name.

Similar hormonal drugs marketed by Pfizer are Prempro and Premphase. The family of drugs has

been linked to increased risk of cancers and promoting the onset of dementia in elderly women.93

89 "Enforcement Report for November 25, 2009." FDA/gov. http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm192035.htm (accessed October 24, 2011).90 Edwards, Jim. "Did You Know the FDA Recalled Bayer’s Yaz Contraceptive? Neither Did Anyone Else | BNET ." BNET. http://www.bnet.com/blog/drug-business/did-you-know-the-fda-recalled-bayers-yaz-contraceptive-neither-did-anyone-else/4754 (accessed October 2, 2011).91 "Drug Report: Yasmin." Adverse Events. www.adverseevents.com/drugdetail.php?AEDrugID=2381&BrandName=YASMIN (accessed October 11, 2011).92 "VIDEO: Marketplace looks into alleged Yasmin risks - Health - CBC News." CBC.ca . http://www.cbc.ca/news/health/story/2011/01/20/yasmin-marketplace.html (accessed October 24, 2011).93 Singer, Natasha, and Duff Wilson. "Menopause, as Brought to You by the Drug Companies." The New York Times . http://www.nytimes.com/2009/12/13/business/13drug.html?pagewanted=all (accessed October 24, 2011).

Research carried out in the 1970s that appeared in the New England Journal of Medicine showed

that Premarin increased the risk of developing endometrial cancer fivefold.94 A study undertaken in

1980 Boston university Medical Center concluded that roughly 15,000 cases of endometrial cancer

could be attributed to the drug between 1971-1975 alone.95

Tens of thousands of cases of breast cancer and more than 1500 reports of death have been reported

to authorities in connection with Premarin and its variations.96 Along with the litany of dangerous

side effects attributed to the drug, many animal rights activists have raised objections over the

production of Premarin which subjects mares to uncomfortable living conditions throughout their

lives and results in the premature slaughter of horses.97 Despite all this, Premarin, Premphase and

Prempro remain on the market.

Wyeth has successfully won most of the lawsuits brought against it connected with to damage from

Premarin. Still, the company has paid hundreds of millions of dollars worth of compensation to

victims and upwards of 10,000 cases are still pending.98 In a landmark case from 2008, Wyeth was

ordered by a Nevada court to pay a combined $134 million to three women who developed breast

cancer after taking Premarin.99 In 2009, a Philadelphia state court ruled in favor of two women in a

lawsuit seeking compensation from Pfizer for damages related to the company’s hormonal drugs.

94 Ziel, Harry K., and William Finkle. "Increased Risk of Endometrial Carcinoma among Users of Conjugated Estrogens." New England Journal of Medicine 293:1167-117 (1975). http://www.nejm.org/doi/full/10.1056/NEJM197512042932303 (accessed October 12, 2011).95 Singer, Natasha, and Duff Wilson. "Menopause, as Brought to You by the Drug Companies." The New York Times . http://www.nytimes.com/2009/12/13/business/13drug.html?pagewanted=all (accessed October 24, 2011).96 "Search Results: Premarin." Adverse Events. http://www.adverseevents.com/searchresults.php?keywords=premarin (accessed October 9, 2011).97 "PMU Industry." Equine Advocates. http://www.equineadvocates.org/issueDetail.php?recordID=5 (accessed October 6, 2011).98 "Potential Premarin Recall Lawsuit for its Side Effects." rotlaw.com. http://www.rotlaw.com/premarin/ (accessed October 5, 2011).99  . "Verdicts & Settlements January 14, 2008: Nevada woman wins $47.6M in hormone therapy case | Lawyers USA | Professional Journal archives from AllBusiness.com." AllBusiness.com. http://www.allbusiness.com/legal/torts-damages/8890217-1.html (accessed October 9, 2011).

In total, the women were given a payout of $103 million.100 Bloomberg News reported in June 2011

that Pfizer agreed on a settlement of $330 million settling 2,200 separate claims from individuals

seeking compensation for developing breast cancer related to the use of Prempro.101

100 Wilson, Duff. "Another Loss for Pfizer in Hormone Drug Suits." The New York Times. http://www.nytimes.com/2009/11/24/business/24wyeth.html (accessed October 24, 2011).101 Feeley, Jef. "Pfizer Said to Pay $330 Million to Settle Prempro Lawsuits Claiming Cancer - Bloomberg." Bloomberg . http://www.bloomberg.com/news/2010-08-27/pfizer-settles-arkansas-prempro-case-before-retrial-over-punitive-damages.html (accessed October 2, 2011).

Looking Ahead at the FDA and Pharmaceutical Drugs

An impartial investigation of the FDA’s record on prescription drugs reveals a sordid history

defined by rampant negligence and depraved subservience to special interests. By allowing these

drugs to be released and remain available to consumers despite ample evidence of their toxicity, the

FDA has failed to protect the health and safety of Americans. The decisions of this group are

directly responsible for the death of tens of thousands of people and the injury of hundreds of

thousands more.

We are currently in the midst of a national health crisis marked by soaring rates of obesity, diabetes

and cancer. As the health of Americans declines, more and more people are turning to a dizzying

array of prescription medication for help. A 2010 report from the CDC showed that spending on

prescription drugs in 2008 topped $234.1 billion – more than double what Americans were paying

in 1999.102 If the standards drug safety enforced by the FDA continued to be left unchecked, we can

expect to see unprecedented death and injury from taking pharmaceuticals in the coming years. It is

therefore more important than ever that we hold the FDA accountable for approving harmful drugs

and failing to remove them once are on the market. We must demand that measures be

implemented that ensure comprehensive oversight and transparency in the FDA’s drug review

process. Anything less than a complete overhaul of the current system will undoubtedly send us on

a dangerous path of medical tyranny that we can’t afford to tread.

102" Data Briefs - Number 42  - September 2010." Centers for Disease Control and Prevention.

http://www.cdc.gov/nchs/data/databriefs/db42.htm (accessed October 19, 2011).

Dr. Gary Null is the host of the nation’s longest running public radio program on nutrition and alternative medicine, and a multi-award-winning director of progressive documentary films, including Vaccine Nation (2008) and Autism: Made in the USA (2009) 

Jeremy Stillman is a Research Associate with the Progressive Radio Network.

Endnotes