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December 27, 2018  

death by medicine part 2 

 

Something is wrong when regulatory agencies pretend that vitamins and nutritional supplements are dangerous. Many in the media, without scientific basis, denigrate the use of supplements, yet these “vitamin critics” ignore published statistics showing that the real hazard is government-sanctioned medicine.

 

In many respects, however, these regulatory agencies act as their own critics. The government is not blind to its own deficiencies in healthcare delivery. The Institute of Medicine (IOM), a part of the United States National Academy of Sciences, states:

 

“Healthcare in the United States is not as safe as it should be.... Among the problems that commonly occur during the course of providing healthcare are adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, suicides, restraint- related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities [all of which exact] their cost in human lives.”1

 

The IOM refers to “the nation’s epidemic of medical errors,” many of which involve adverse drug reactions (ADRs). The US Food and Drug Administration (FDA) says that “ADRs are one of the leading causes of morbidity and mortality in healthcare.”2

 

Archives of Internal Medicine published  “A Special Article” by Curt D. Furberg, MD, PhD, et al., entitled “The FDA and Drug Safety:  A Proposal for Sweeping Changes.” The section, “Problems with the Current System,” begins: “We see eight major problems with the current system of assessment and assurance of drug safety at the FDA.” The first problem states that the initial review for approval often fails to detect serious ADRs: “A study by the US General Accountability Office (GAO) concluded that 51% of all approved drugs had at least one serious ADR that was not recognized during the approval process.”3

 

The irony is that safer and less expensive preventive alternatives are often attacked or strategically ridiculed by regulatory powers, even—or perhaps especially—when proven effective. This condescending stance toward alternatives may be fueled by their relative lack of side effects in a competitive marketplace.

 

Until recently, health researchers could cite only isolated statistics to make their case about conventional medicine's dangers. No one had ever compiled and analyzed all of the published literature dealing with injuries and deaths caused by government-protected medicine.

 

One group of researchers meticulously reviewed the statistical evidence, and their findings, included in this book, are absolutely shocking. In Death by Medicine, we present compelling evidence that today’s healthcare system frequently causes more harm than good.

 

This fully referenced book reveals a number of startling facts:

The number of people having in-hospital, adverse reactions to prescribed drugs annually: approximately 5.9 million4 5

The number of annual adverse drug reactions taking place outside hospitals: 4.6 million6

The number of unnecessary and/or inappropriate antibiotics prescribed annually: approximately 46 million7

The number of unnecessary surgical procedures performed each year: 5.4 million8 9

The number of people unnecessarily hospitalized each year: 5.0 million10 11

 

The most stunning statistic, however, is that the total number of deaths caused by conventional medicine is over 900,000 per year. It is now evident that the American medical system is the leading cause of death and injury in the US. By contrast, the number of deaths attributable to heart disease in 2016, the most recent year for which final data is available, is 635,260. The number of deaths attributable to cancer is 598,038.12 The National Cancer Institute projects 609,640 people will die of the disease in 2018, an increase of 11,602 cancer deaths. 13

 

We originally decided to publish Death by Medicine to call attention to the failure of the American medical system. The almost complete lack of response from the medical industry was surprising, and we are updating the book to call attention to the fact that these problems have not been addressed in any meaningful way.  By exposing these gruesome statistics in painstaking detail, we provide a basis for competent and compassionate medical professionals, such as the courageous Dr. David Graham, to recognize the inadequacies of today’s system and at least attempt to institute meaningful reforms.

 

On November 18, 2004, David J. Graham, MD, MPH, Associate Director for Science and Medicine in the FDA’s Office of Drug Safety, testified before the US Senate. Dr. Graham graduated from the Johns Hopkins University School of Medicine, and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. Later he completed a three-year fellowship in pharmaco-epidemiology and a Masters degree in Public Health at Johns Hopkins, with a concentration in epidemiology and bio-statistics.14 His education and extensive experience qualify him to offer an expert opinion on pharmaceutical drugs.

 

Dr. Graham, who had spent twenty years working at the FDA, told the Senate:

 

"During my career, I believe I have made a real difference for the cause of patient safety. My research and efforts within FDA led to the withdrawal from the US market of Omniflox, an antibiotic that caused hemolytic anemia; Rezulin, a diabetes drug that caused acute liver failure; Fen-Phen and Redux, weight loss drugs that caused heart valve injury; and PPA (phenylpropanolamine), an  over-the-counter decongestant and weight loss product that caused hemorrhagic stroke in young women."

 

" My research also led to the withdrawal from outpatient use of Trovan, an antibiotic that caused acute liver failure and death. I also contributed to the team effort that led to the withdrawal of Lotronex, a drug for irritable bowel syndrome that causes ischemic colitis; Baycol, a cholesterol-lowering drug that caused severe muscle injury, kidney failure and death; Seldane, an antihistamine that caused heart arrhythmias and death; and Propulsid, a drug for night-time heartburn that caused heart arrhythmias and death. . . ."

 

"I have done extensive work concerning the issue of pregnancy exposure to Accutane, a drug that is used to treat acne but can cause birth defects in some children who are exposed in utero if their mothers take the drug during the first trimester. During my career, I have recommended the market withdrawal of twelve drugs. Only two of these remain on the market today—Accutane and Arava, a drug for the treatment of rheumatoid arthritis that I and a co-worker believe causes an unacceptably high risk of acute liver failure and death."15

 

The Los Angeles Times reported that witnesses told the Senate panel that "Merck & Co. and the Food and Drug Administration knew before the agency approved the company’s Vioxx® painkiller in 1999 that the drug could have serious adverse effects on the heart. . . . But the FDA gave its approval without resolving the concerns, and Vioxx® was aggressively marketed to point up its pain relief qualities, not its risks. "16

 

Testifying about Merck’s Vioxx®, Dr. Graham states:

 

"Today . . . you, we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could have, should have, been largely or completely avoided.  But it wasn’t, and over 100,000 Americans have paid dearly for this failure. In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust."17

 

In the same way the FDA attempts to quash vitamins, they allegedly attempted to suppress scientific research, presumably to keep Vioxx® and other drugs afloat, according to Dr. Graham. “Not only did the FDA ignore known risks from Vioxx® and related drugs but . . . it tried to prevent Graham and others from publicizing their own research that proved the extent of these risks.”18

 

When it comes to new medications, Attorney Blake Bailey observes:

 

"The FDA . . . uses the studies of the companies who stand to gain billions of dollars and are under intense pressure to beat a competing company to make it to the market with a similar product. Many of the scientists and medical doctors go to work for these companies after a tenure with FDA."19

 

Dr. Graham made it clear in his testimony that, throughout his career, he had only worked for the FDA, not for any companies.

 

Committee Chairman Charles E. Grassley (R–Iowa) said he was concerned that the FDA “has a relationship with drug companies that is too cozy.”20

 

Sen. Jeff Bingaman (D–New Mexico) said the problem was within the FDA’s own culture: “The culture within the FDA, being one where the pharmaceutical industry, which the FDA is supposed to regulate, is seen by the FDA as its client instead.”21

 

In Graham’s view, the drug safety problems began in 1992 with the passage of a law aimed at getting lifesaving drugs onto the market faster. To speed up approvals, the law forced pharmaceutical companies to foot most of the bill for the review process. That left the FDA “captured by industry,” says Graham. “He who pays the piper calls the tune.”22

 

Edward J. Markey (D–Massachusetts) noted that a 2006 survey conducted by the Union of Concerned Scientists reported that 18.4% of FDA scientists surveyed reported that they had been asked to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document.23

 

The American Society of Health-System Pharmacists reports that Graham testified “in February [2007] that, had it not been for the protection of Sen. Charles Grassley (R–Iowa), FDA would have fired him for publicly speaking out about his concerns about Vioxx® and other drugs.”24

 

Dr. Graham says, “You need to weed the garden patch of drugs that aren’t doing what they’re supposed to do. The FDA has not been very good about that; it likes to cultivate all these weeds.”25 Dr. Graham “named five other drugs whose safety is suspect, and noted that the FDA as currently configured is incapable of protecting America against another Vioxx®.’”26 Many media sources present at the hearing, such as the Los Angeles Times and Medscape Medical News,27 report that Graham then added, “We are virtually defenseless,”28 but this sentence does not appear in the final transcript and may have been stricken from the record. One report begins, “The American public is ‘virtually defenseless’ if another medication such as Vioxx® proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee.”29

 

Lest we believe the tragedy of Vioxx sparked a tightening of regulations and much-needed soul-searching on the part of the FDA, it is instructive to examine one of the most alarming new public health crises of our time, the opioid epidemic. Since we first published Death By Medicine, drug overdose has grown to eclipse all other causes of accidental deaths, including automobile accidents and firearms. In 2017, 70,237 Americans died of drug overdoses, setting a new record over the previous year,30 when the age-adjusted rate of drug overdose deaths was more than three times what it was in 1999.31

 

While opioid painkillers have legitimate therapeutic uses, they are known to carry a high risk of addiction and for this reason were seldom prescribed to non-terminal patients until the mid-1990s. In 1996, when Purdue Pharma unleashed OxyContin, its extended-release formulation of the opioid painkiller oxycodone, doctors had just been told that pain was the “fifth vital sign.” Along with blood pressure, pulse, temperature, and respiratory rate, pain would be assessed with the “same zeal” at every doctor’s visit, according to the American Pain Society. In conjunction with the American Academy of Pain Medicine, the group issued a statement endorsing the use of opioids for treatment of non-cancer chronic pain in 1995, part of a nationwide “Pain is the Fifth Vital Sign” campaign that had soon penetrated to the depths of the medical establishment, from the Veterans Affairs system to the Joint Commission.32

 

Everything about treating pain was suddenly up in the air; doctors were hit with a marketing blitz warning of this hidden epidemic. Here was a major problem that no one had given much thought to, and here was a pill advertised as a non-addictive, one-stop solution.33 But as journalist Chris McGreal documents in his book American Overdose, and unbeknownst to many of the doctors undergoing this pharmaceutical re-education, Purdue Pharma was working behind the scenes from the beginning of the Fifth Vital Sign campaign, “essentially writing the policy that promotes the prescribing of its own drugs,” shaping the new medical orthodoxy to cut themselves in for a bigger share of the profits.34

 

OxyContin sales rocketed from $48 million in 1996 to $3 billion in 2010. A victim of its own popularity, the drug had by 2004 become both the most popular opioid painkiller and the market and one of the most abused drugs in the US. Even then, it had its doubters: the Medical Letter on Drugs and Therapeutics found as early as 2001 that OxyContin was no better than other opioids, including morphine and instant-release oxycodone, in relieving chronic back pain and cancer pain when given at 12-hour intervals. That was the same year Purdue Pharma spent a then-unheard-of $200 million to market and promote a single drug.

 

During the first five years OxyContin was on the market, over 5,000 doctors, nurses, and pharmacists attended over 40 national pain-management and all-expenses-paid speaker-training seminars sponsored by Purdue, as estimated by the General Accounting Office, which undertook a comprehensive study in 2003 to assess the problem of prescription opioid diversion. That study also found that the distribution of branded material such as hats, plush toys, and even CDs was “unprecedented for a schedule II opioid.”35 While many physicians think themselves above being influenced by corporate such gifts, a 2017 study found a marked change in prescribing habits in medical centers that banned or limited pharmaceutical gift-giving (a practice euphemistically called “detailing”). In some cases, prescribing of drugs that were heavily detailed declined by 8.7 percent. Changes were even more profound in centers that not only prohibited detailing but punished violators.36

But Purdue’s marketing genius extended beyond showering doctors with gifts. Using “prescriber profiles” documenting the prescribing patterns of medical professionals, they were able to single out doctors in a given area with the highest rate of opioid prescriptions and focus on targeted marketing to those doctors. Dr. Art Van Zee, writing in the American Journal of Public Health, refers to a “lucrative bonus system” that in many cases eclipsed representatives’ entire salary, leading Purdue to pay $40 million in sales incentive bonuses in 2001 alone.37

 

Primarily, though, Purdue Pharma cashed in on OxyContin by breaking out of the cancer pain market – the traditional domain of opioid painkillers – into chronic non-cancer pain, which represented 86 percent of the total painkiller market in 1999.  The move was facilitated through more than 20,000 educational programs on pain-related topics, which the company either sponsored directly or supplied with financial grants, and through financial contributions to influential bodies like the Federation of State Medical Boards, the Joint Commission, the American Pain Society, the American Academy of Pain Medicine, and the American Geriatrics Society, which changed its prescribing guidelines in 2009 to recommend opioids for “all patients with moderate to severe pain” where previously it had touted over-the-counter pain relievers.38 Their “educational programs” glossed over the lack of studies demonstrating OxyContin was effective in treating chronic pain. A 2010 study by insurer Accident Fund Holdings found that when medical care and disability payments were taken into account, the cost of a workplace injury was nine times higher when an opioid pain reliever was prescribed – to say nothing of the very serious risk of developing a physical dependency on the drug. If anyone asked, however, Purdue Pharma merely claimed the addiction risk was minimal – “less than one percent,” according to its marketing materials. This was a key factor to consider when prescribing opioids for non-terminal patients. Purdue’s cherry-picked data ignored existing studies showing that chronic pain patients taking opioids developed addiction at rates up to 50 percent.39

Purdue Pharma wasn’t stupid. A Justice Department investigation found the company knew its pills were being diverted, abused, stolen, and over-prescribed even during those early years, but continued to market OxyContin as non-addictive. Internal company emails suggest the company was already aware of the drug’s illicit popularity by 1997, with reports of doctors stopping prescribing it altogether because of the amount of drug-seekers entering their clinics, doctors getting arrested for writing excessive prescriptions, and patients caught “doctor shopping” – cadging scripts from multiple physicians for the same complaint. Indeed, Purdue’s predicament in 1999 is best summed up by one of its own sales representatives, who wrote in an email, “I feel like we have a credibility problem with our product.”40 From 1997 to 1999 alone, sales representatives’ communications contained over 100 instances of the words “crush,” “snort,” and “street value,” while the Sackler family that owns Purdue Pharma received multiple reports about abuse of OxyContin and an earlier drug the company had produced, MS Contin. A Los Angeles Times investigation found that despite the marketing materials describing OxyContin as providing 12-hour pain relief, the company knew it lasted eight hours at most. This left the patient craving more and setting the stage for addiction. However, Purdue Pharma executives testified the company was unaware of the abuse potential of its blockbuster drug until 2000, when the Maine State Attorney General issued the first statewide warning.

 

After the four-year investigation, federal prosecutors wanted to indict the top three Purdue Pharma executives on felony charges for misrepresenting OxyContin’s addictiveness and effectiveness, but George W. Bush’s Justice Department declined to aggressively pursue the case. Instead the court chose to settle with the company for $634.5 million in 2007. Purdue Pharma’s defense team included former New York City mayor Rudy Giuliani.41

 

The settlement was supposed to send a message, according to prosecutor Randy Ramseyer, that drug companies were going to be held “to a higher standard.” Instead, it was business as usual, and Purdue Pharma was far from the only company making money in the opioid gold mines. From 2007 to 2012, drug distributors flooded West Virginia with 780 million opioid pills; that is equivalent to 433 pills for every man, woman and child in the state. Over those five years, the rate of overdose deaths from oxycodone and hydrocodone (marketed under brand names including Vicodin and Lortab) skyrocketed 67 percent. Three drug distributors - McKesson, Cardinal Health, and AmerisourceBergen – made $17 billion shipping pills to West Virginia.42 Even after State Attorney General Darrell McGraw filed a lawsuit against twelve of the pill wholesalers alleging they’d shipped an excessive quantity of opioids to West Virginia – millions of pills to pharmacies in towns that in some cases had residents numbering in the thousands – it took years for the gravy train to stop running as distributors began tentatively cranking out reports of suspicious pharmacy orders only to have the state pharmacy board do nothing.43

The government’s mistake was expecting a $634 million slap on the wrist to deter a company that was raking in billions of dollars a year from the sale of these drugs – OxyContin had netted over $31 billion for Purdue Pharma by 2016 – or to deter copycats who knew a tasty market when they saw one. Hook a non-terminal chronic pain patient and you have a customer for life. Doctors went along with the program because the appearance of propriety was scrupulously maintained. When the protocol wasn’t followed, as with the doctors who quit prescribing the drugs because their waiting rooms were flooded by addicts, their decision to abandon chronic pain patients had less to do with concern for popular welfare than concern for their own reputations. No prescriber wants to be tagged as a “pill mill.”

 

OxyContin itself fell off in popularity after 2010, when Purdue Pharma reformulated the drug to make it impossible to crush, snort, or inject. By then, other opioids had stepped in to fill the void: Vicodin, Roxicodone, Lortab, Opana. But more popular than these was heroin. Economists William Evans and Ethan Lieber have suggested that OxyContin’s reformulation actually kicked the heroin epidemic into high gear, as addicts, desperate for the high they could no longer get by crushing and snorting or injecting the pills, were driven to the streets in search of stronger and cheaper highs. In a paper published in the National Bureau of Economic Research in April 2018, Evans and Lieber found that oxycodone deaths dropped off after August 2010, just as heroin deaths began climbing.44 Certainly the heroin epidemic that currently has America by the throat grew out of the prescription opioid problem: according to a 2014 JAMA Psychiatry study, a full 75 percent of heroin users began their addictions with prescription pain pills.45 Other studies have placed the number as high as 86 percent for young users,46 and the number of heroin users under 25 doubled during the last decade as the prescription opioid wave began to recede. Heroin users are at higher risk than prescription pill addicts even though the drugs are chemically almost identical. Not only do they face varying potency, especially with street supplies frequently laced with the ultra-potent synthetic opioid fentanyl, but because their drug of choice is illegal, they are treated as criminals if they do turn up in a hospital. Heroin-related overdose deaths increased threefold from 2010 to 2014, and a 2017 RAND Corporation study blames the reformulation of OxyContin for up to 80 percent of those deaths.47

 

By 2016, another prescription drug had eclipsed heroin in overdose deaths. Fentanyl, a synthetic opioid up to 100 times stronger than morphine, was once prescribed only to the most hopeless cases – cancer patients in hospice care, at death’s door, with nothing modern medicine could do for them any longer except alleviate their suffering a little. The fentanyl that has permeated the illegal drug market, however, is different from pharmaceutical fentanyl, according to law enforcement. Manufactured in Chinese labs and smuggled into the US through methods as pedestrian as mail-order, it is used to cut street drugs, giving heroin an added punch that’s often tragically unexpected. Actor Philip Seymour Hoffman is believed to have died from injecting fentanyl-laced heroin after a long struggle with addiction. Non-methadone synthetic opioids – a category that includes fentanyl and its analogs – killed over 19,000 people in 2016, almost twice as many as the previous year and more than heroin or pills.48

 

Instead of dealing with or even trying to understand the causes of addiction, the CDC has emphasized the need to expand access to naloxone, an opioid antagonist that can reverse overdose if given within a certain time window. While the patent on naloxone expired long ago, drug companies have been experimenting with novel formulations of the drug, combining it with other drugs (Suboxone), creating extended-release versions (Vivitrol), and patenting innovative delivery systems to keep profits high (Evzio). The cost of a two-dose package of naloxone auto-injectors spiked from $690 in 2014 to $4,500 in 2016 as US states began to adopt laws meant to expand access to naloxone, allowing third-party prescribing and standing-order (no prescription needed) access.49 As the price goes up, it’s worth noting that fentanyl overdoses frequently require more than one dose of the life-saving drug, meaning even more money doled out by governments with the best intentions of fighting the opioid epidemic ends up in the pockets of the drug companies fueling it. Meanwhile, pictograms alerting passersby to the presence of a naloxone kit behind the counter now appear in the windows of businesses in many large US cities.

 

In September 2018, Richard Sackler, a member of the wealthy family that owns Purdue Pharma, acquired a patent for a rapid-dissolving wafer of buprenorphine, a drug used to treat opioid dependence. The drug is not new, but the delivery system is. As of late 2018, Purdue Pharma faced over 1,000 lawsuits (with plaintiffs including 30 US states) for essentially creating and fueling the opioid epidemic. Now the company is poised to cash in on one of its most lucrative “cures.”50 While it is beyond the scope of this book to speculate as to why, with 5 percent of the world’s population, the US consumes 80 percent of its opioid supply, it is depressingly predictable that the medical industry also avoids such speculation, instead preferring to develop new drugs to treat dependency on the old. This is not surprising, given that pharmaceutical companies are major donors to groups like the American Society of Addiction Medicine ($100,000 from Reckitt-Benckiser, makers of Suboxone, which combines buprenorphine with a naloxone “booby trap” so it cannot be crushed and injected) and the American Academy of Addiction Psychiatry (whose board includes three directors who serve on pharmaceutical companies’ speaker boards).51

Another transparent “solution,” rehab clinics are a wellspring of unlimited profits. Largely unregulated, depending on the state in which they are located, most provide some version of what passes for the “gold standard” of addiction treatment: 12-step therapy, which costs nothing and has a relapse rate of over 90 percent. Anything beyond that is up to the facility, and some charge as much as $60,000 for a 28-day stay, competing for wealthy patients with the promise of “equine therapy” and other spa-like amenities. Insurance often does not cover these stays. From 1997 to 2011, there was a 900 percent increase in patients seeking treatment for addiction to opioids.52 The number is almost certainly higher today. With an estimated 2.1 million Americans addicted to prescription opioids as of 2015, plus another 500,000 addicted to heroin and as many as a quarter of the 92 million adults who were prescribed opioids in 2015 hooked on their meds, business is booming.53 54 The legal trend favoring treatment over incarceration is promising and should be applauded, but the flaws in the current rehab model are so numerous it would take another book to list them all.

 

Viewing the opioid epidemic as a mass iatrogenic plague is not as simple as the example of Vioxx, because the drugs themselves have therapeutic potential and many take them with no ill effects. But over-prescription, greed, and pharmaceutical mission creep turned tens if not hundreds of thousands of patients into addicts, reduced to scoring their pills (or heroin) on the street when the legal route became too expensive or troublesome, and pills diverted from legitimate channels started a generation of heroin users on the road to perdition. With upwards of 70,000 Americans dying of drug overdoses annually, this epidemic can be laid at the feet of the medical profession, and everyone in the chain of care must share the responsibility. In 2010 alone, 254 million prescriptions for opioids were filled in the US, enough to medicate every adult for a month.55

 

While prescription guidelines have changed - the CDC no longer recommends opioids for most chronic pain conditions, and the American Medical Association dropped pain as a “vital sign” in June 2016 – the damage is done.56 Those 70,000 overdoses actually brought down the American life expectancy in 2017.

 

The expedited rollout of Dsuvia (sufentanil), an opioid 10 times stronger than fentanyl, was announced in October 2018. Dr. Raeford Brown, chairman of the FDA’s Anesthetic and Analgesic Advisory Committee, stridently opposed the drug’s approval, warning the agency, “I predict that we will encounter diversion, abuse and death within the early months of its availability on the market.” The medical industry would be wise, Brown wrote, to learn from the past: “Once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market.”57

 

Yet the FDA crusades to prevent us from taking dandelion root.

 

Natural medicine is under siege, as pharmaceutical company lobbyists urge lawmakers to deprive Americans of the benefits of dietary supplements and bioidentical hormones.  Drug company front groups have launched slanderous media campaigns to discredit the value of healthy lifestyles. The FDA continues to interfere with those who offer natural products that compete with prescription drugs.

 

These attacks against natural medicine obscure a lethal problem that until now was buried in thousands of pages of scientific text. In response to these baseless challenges to natural medicine, here is an independent review of the quality of “government-approved” medicine. To support the bold claim that conventional medicine is America’s number one killer, every count in this indictment of US medicine is validated by published, peer-reviewed scientific studies. The startling findings from this meticulous study indicate that conventional medicine is the leading cause of death in the United States.

 

What you are about to read is a stunning compilation of facts that documents that those who seek to abolish consumer access to natural therapies are misleading the public. Over 900,000 Americans die each year at the hands of government-sanctioned medicine, while the FDA and other government agencies pretend to protect the public by harassing those who offer safe alternatives. A definitive review of medical peer-reviewed journals and government health statistics shows that American medicine frequently causes more harm than good.

NOTES

  1. Institute of Medicine, US National Academy of Sciences. November 1999. To Err Is Human: Building a Safer Health System. http://www.iom. edu/Object.File/Master/4/117/ToErr-8pager. pdf (accessed January 25, 2009).
  2. Center for Drug Evaluation and Research. U.S. Food and Drug Administration. Preventable Adverse Drug Reactions: A Focus on Drug Inter- actions. Last updated July 31, 2002. http:// www.fda.gov/cder/drug/drugReactions/default. htm#ADRs:%20Prevalence%20and%20Inci- dence (accessed January 25, 2009).
  3. Furberg, C. D., A. A. Levin, P. A. Gross, R. S. Shapiro, and B. L. Strom. 2006. The FDA and drug safety: a proposal for sweeping changes. Arch Intern Med 166 (18):1938–42.
  4. Miguel, A. et.al. Frequency of adverse drug reactions in hospitalized patients: a systematic review and meta-analysis. Pharmacoepidemiology and Drug Safety: Nov 2012; 21(11):1139-54. https://www.ncbi.nlm.nih.gov/pubmed/22761169/
  5. American Hospital Association (AHA). Fast Facts on U.S. Hospitals, 2018. AHA. https://www.aha.org/statistics/fast-facts-us-hospitals (accessed 21 Dec 2018)
  6. Office of Disease Prevention and Health Promotion. Prevent Adverse Drug Events. Health.gov. https://health.gov/hcq/ade.asp (accessed 21 Dec 2018)
  7. Centers for Disease Control and Prevention (CDC). CDC: 1 in 3 antibiotic prescriptions unnecessary. CDC, May 3, 2016. https://www.cdc.gov/media/releases/2016/p0503-unnecessary-prescriptions.html
  8. Lyu, H. et.al. Overtreatment in the United States. PLoS One. 6 Sep 2017. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181970
  9. Hall, M.J. et.al. Ambulatory Surgery Data from Hospitals and Ambulatory Surgery Centers: United States, 2010. National Health Statistics Reports. 28 Feb 2017; 102(1). https://www.cdc.gov/nchs/data/nhsr/nhsr102.pdf
  10. Fingar, K.R. et.al. Trends in Potentially Preventable Inpatient Hospital Admissions and Emergency Department Visits. Healthcare Cost and Utilization Project (HCUP) Statistical Brief #195. November 2015. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb195-Potentially-Preventable-Hospitalizations.pdf
  11. Schlesinger, Robert. https://www.usnews.com/opinion/blogs/robert-schlesinger/2011/12/30/us-population-2012-nearly-313-million-people
  12. Heron, Melonie. “Deaths: Leading Causes for 2016.” National Vital Statistics Reports. 26 Jul 2018; 67(6). https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_06.pdf
  13. National Cancer Institute. Cancer Statistics. National Institutes of Health. https://www.cancer.gov/about-cancer/understanding/statistics (accessed 21 Dec 2018)
  14. US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
  15. Ibid.
  16. Alonso-Zaldivar, R., FDA Called ‘Defenseless’ Against Unsafe Drugs, Los Angeles Times, November 18, 2004. http://www.mcall.com/topic/ la-111804vioxx_lat,0,7473253.story (accessed January 31, 2009).
  17. US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
  18. National Coalition Against Censorship. FDA Sup- pressed Vioxx Studies Despite Evidence of Serious Health Risks, November 25, 2004. http:// www.ncac.org/FDA_Suppressed_Vioxx_Studies (accessed January 30, 2009).
  19. Bailey Esq, B., Bad medicine, Texas Injury Law, July 27, 2008. http://www.txinjurylawblog.com/ tags/drugs-accolate-accutane-arava-1/ (accessed January 30, 2009).
  20. Alonso-Zaldivar, R., “FDA Called ‘Defense- less’ Against Unsafe Drugs,” Los Angeles Times, November 18, 2004. http://www.mcall.com/topic/la-111804vioxx_lat,0,7473253.story (accessed January 31, 2009).
  21. Associated Press. F.D.A. Called ‘Defenseless’ Against Unsafe Drugs, New York Times, 18 November 2004. http://biopsychiatry.com/bigpharma/fda.html (accessed January 31, 2009).
  22. Yale Medicine. FDA’s top safety critic keeps a watchful eye on the public good, Summer 2005. http://yalemedicine.yale.edu/ym_su05/faces. html (accessed January 31, 2009).
  23. Young, D., Safety Experts Call for Accountability from FDA, Drug Firms. American Society of Health-System Pharmacists, March 23, 2007. http://www.ashp.org/import/News/HealthSystemPharmacyNews/newsarticle.aspx?id=2503 (accessed January 31, 2009).
  24. Ibid.
  25. Loudon, Manette, interviewer. The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower, parts of this interview appear in Gary Null’s documentary film, Prescription for Disaster, Garynull.com, August 30, 2005, reprinted by Natural News. http://www.naturalnews.com/011401.html (accessed January 31, 2009).
  26. US Senate Finance Committee. Testimony of David J. Graham, MD, MPH, November 18, 2004. http://finance.senate.gov/hearings/ testimony/2004test/111804dgtest.pdf (accessed January 30, 2009).
  27. Yale Medicine. FDA’s top safety critic keeps a watchful eye on the public good, Summer 2005. http://yalemedicine.yale.edu/ym_su05/faces.html (accessed January 31, 2009).
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  34. Big Pharma’s Opioid Tragedy Now Plaguing America. The Gary Null Show. 21 Dec 2018 http://prn.fm/gary-null-show-12-21-18/
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  40. Meier, Barry. Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused. New York Times. 29 May 2018. https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html
  41. ibid.
  42. Eyre, Eric. Drug firms poured 780m painkillers into WV amid rise of overdoses. Charleston Gazette-Mail. 17 Dec 2016. https://www.wvgazettemail.com/news/cops_and_courts/drug-firms-poured-m-painkillers-into-wv-amid-rise-of/article_99026dad-8ed5-5075-90fa-adb906a36214.html
  43. Eyre, Eric. ‘Suspicious’ drug order rules never enforced by state. Charleston Gazette-Mail. 18 Dec 2016. https://www.wvgazettemail.com/news/health/suspicious-drug-order-rules-never-enforced-by-state/article_3c9f1983-9044-5e97-87ff-df5ed5e55418.html
  44. Evans, W.N. et.al. How the Reformulation of OxyContin Ignited the Heroin Epidemic. National Bureau of Economic Research. April 2018. https://www.nber.org/papers/w24475
  45. Cicero, T.J. et.al. The Changing Face of Heroin Use in the United States. JAMA Psychiatry. 2014;71(7):821-826. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/1874575
  46. Compton, W.M. et.al. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. New England Journal of Medicine. 14 Jan 2016; 374:154-163. https://www.nejm.org/doi/full/10.1056/NEJMra1508490
  47. Alpert, Abby et.al. Supply-side drug policy in the presence of substitutes: Evidence from the introduction of abuse-deterrent opioids. National Bureau of Economic Research. January 2017. https://www.nber.org/papers/w23031.pdf
  48. National Institute on Drug Abuse. Fentanyl and Other Synthetic Opioids Drug Overdose Deaths. National Institutes of Health. May 2018. https://www.drugabuse.gov/related-topics/trends-statistics/infographics/fentanyl-other-synthetic-opioids-drug-overdose-deaths
  49. Denvir, Daniel. These Pharmaceutical Companies Are Making a Killing Off the Opioid Crisis. The Nation. 15 Dec 2017.  https://www.thenation.com/article/these-pharmaceutical-companies-are-making-a-killing-off-the-opioid-crisis/
  50. Schott, Paul. Sackler family member faces scrutiny for opioid-treatment patent. Stamford Advocate. 7 Sep 2018.  https://www.stamfordadvocate.com/business/article/Sackler-family-member-faces-scrutiny-for-13212975.php
  51. Sontag, Deborah. Addiction Treatment with a Dark Side. New York Times. 16 Nov 2013. https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html
  52. Kolodny, op.cit.
  53. Thompson, Dennis. More than 1 in 3 Americans prescribed opioids in 2015. CBS News. 1 Aug 2017. https://www.cbsnews.com/news/more-than-one-third-americans-prescribed-opioids-in-2015/
  54. Eban, Katherin. OxyContin: Purdue Pharma’s painful medicine. Fortune. 9 Nov 2011. http://fortune.com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/
  55. ibid.
  56. Garrett, Linda. Pain Management in the Era of Opioid Addiction. California Hospital Association. https://www.calhospital.org/sites/main/files/file-attachments/garrett-3_up-painmanagementslides.pdf
  57. Goodnough, Abby. FDA Approves Powerful New Opioid Despite Warnings of Likely Abuse. New York Times. 2 Nov 2018. https://www.nytimes.com/2018/11/02/health/dsuvia-fda-opoid.html
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