04/29/15

Troubling Twin Studies

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©: lightwise | 123RF.com

In 2004, Paula Bernstein received a call from the agency where she had been adopted. The message was that she had a twin who was looking for her. Elyse Schein—Paula’s twin—had been trying to find out information from the adoption agency about her birth mother when she learned she had a twin sister. They met for the first time in a café in New York City. They talked through lunch and dinner about the 35 years they had been apart. Among the things they discussed was why they were separated at five months old. It seems they were part of a one-of-a-kind study on nature versus nurture of twins separated at birth.

All Things Considered” said the study was headed up by Peter Neubauer, a noted child psychiatrist and Viola Bernard, a child psychologist. The study ended in 1980, a year before the state of New York began requiring that agencies keep siblings together. Neubauer realized that public opinion would be against the study so he didn’t publish it. The data and results have been sealed until 2066 and placed in an archive at Yale University.

The sisters tried to reach Neubauer, but he initially refused to speak with them. Eventually he did agree to meet with them. Paula hoped he would apologize for separating them. Instead he showed no remorse and offered them no apology.

Of the 13 children involved in his study, three sets of twins and one set of triplets have discovered one another. The other four subjects of the study still do not know they have identical twins.

Since the 1920s, researchers in psychology and psychiatry have used twin research (but not the above method) to assess the potential for genetic factors to underlie psychological traits and psychiatric disorders. In the Introduction to his new book, The Trouble with Twin Studies, Jay Joseph noted how this research method is seen as a scientifically valid research method that provides an ideally suited “natural experiment” to assess the relative importance of heredity and environment. According to one estimate, about 800,000 twin pairs had been studied by 2009. “In almost all cases these studies are based on twin pairs reared together in the same family, while an extremely small yet influential handful of studies, twin pairs were said to have been reared apart in different families.”

MZ (monozygotic, identical) twins have 100% of the same genes, where DZ (dizygotic, fraternal) twins share around 50%. Twin researchers have argued that the greater similarity between MZ pairs for behavioral traits and disorders (physical and psychiatric) than same-sex DZ pairs is caused by the greater genetic resemblance of the MZ pairs. Therefore, twin researchers reason, “the trait or the disorder has an important genetic component.” Underlying this is the basic assumption of the twin method, that MZ and DZ twin pairs experience equal environments.

Yet, even twin researchers have concluded that MZ pairs experience more similar environments than DZ pairs. Jay Joseph quoted twin researchers as saying, “the evidence of greater environmental similarity for MZ than DZ twins is overwhelming.” Nevertheless, twin researchers have perpetuated the twin method by using circular reasoning, denying ignoring or downplaying the evidence that MZ and DZ environments are different or changing the definition of what constitutes an equal environment.

In an article that was also titled: “The Trouble with Twin Studies,” Joseph noted how the circular argument in effect says that identical pairs “create” more similar environments because they are more similar genetically. When defending the validity of the twin method, modern twin researchers “refer to the premise in support of the conclusion, and then refer back to the conclusion in support of the premise, in a continuously circular loop of faulty reasoning.”

Another tactic used to support the twin method is to first agree that identical twins grow up in more similar environments than fraternal twins. But then proponents say that it has to be demonstrated that identical and fraternal environments differ in ways that are relevant to the trait in question. If that cannot be done, then they argue the equal environment assumption is valid for that trait.

The bottom line is this: despite being cited in countless textbooks, scholarly journal publications, and popular books and articles, the little-disputed finding that identical pairs experience much more similar environments than fraternal pairs means that non-genetic factors plausibly explain twin method results. The fact that psychiatric twin studies continue to be cited in support of genetics, largely uncritically, speaks volumes about the scientific status of psychiatry in the 21rst century. Psychiatry’s acceptance of twin studies is even more remarkable in the context of the decades-long failure of molecular genetic research to uncover genes that investigators believe cause psychiatric disorders [see Joseph’s article, “Five Decades of Gene Finding Failures in Psychiatry”]—research that is based largely on genetic interpretations of the results of psychiatric twin studies.

There are a handful of studies whose twin pairs were supposedly reared apart from one another in different families. Advocates of twin studies assert that all behavioral similarities between reared-apart MZ twins (known as MZA pairs) must be the result of their 100% genetic similarity, since they have not had any environmental similarities.  Joseph said in “Studies of Reared-Apart (Separated) Twins: “Twin researchers and others view this occurrence as the ultimate test of the relative influences of nature (genes) and nurture (environment).”

Yet there were a variety of problems with these twins reared-apart (TRA) studies. Many twins experienced late separation and many twins were reared together in the same house for several years. Others had regular contact and/or a close emotional bond with each other. In one classic TRA study, twins separated as late as 9-years-old, or for only five years during childhood were counted as “separated twin pairs.” The same study counted a pair living next door to one another, brought up by different aunts, as a separated pair.

Far from being separated at birth and reared apart in randomly selected homes representing the full range of potential behavior-influencing environments, and meeting each other for the first time when studied, most MZA pairs were only partially reared apart, and grew up in similar cultural and socioeconomic environments at the same time.

In 1990, Peter Neubauer coauthored a book with his son, Alexander entitled: Nature’s Thumbprint. Within the Introduction was a tantalizing hint to what may have been information from Neubauer’s archived study. Father and son said that many years ago an opportunity arose to follow the development of identical twins from infancy. “With great curiosity a number of us decided to study the influence of the environment on the child.” No other identical twin study had explored twins reared apart as they matured and developed from birth on.

We could look at change as it happened. We would be there at birth and continue regular, intensive observations of separated twins and study their relationship with parents and siblings, collecting as much information as possible about behavior and growth. . . . In fact, it was our assumption that only by studying development as it happened could these disorders be accurately understood. Our study would therefore be useful to the investigation of both healthy and pathological growth, as well as to the ways the environment influences that growth.

Twin studies do not provide definitive evidence for the genetic basis of psychiatric conditions. The twin method is no more able to tease apart the potential roles of genetic and environmental influences for behavioral traits and “disorders” than family studies. As Jay Joseph noted, both research methods are confounded by environmental factors and should be evaluated in the same way: “neither provides scientifically acceptable evidence in support of genetic influences on psychiatric disorders and behavioral traits.”

04/27/15

Quantifying Impaired Drivers

19447830_sThe CDC statistics on alcohol-impaired driving are stunning. Every day almost 30 people die in the US in motor vehicle accidents. That’s about one person every 51 minutes. In 2012, 10,322 people died in alcohol-impaired accidents, 31% of all traffic-related deaths in the US. Looking at the most at risk drivers with BAC levels of 0.08 or higher involved in fatal crashes in 2012, 32% were between 21 and 24; 27% were between 25 and 34; 24% were between 35 and 44. Half of the children under the age of 14 killed in alcohol-impaired driving accidents were riding in the vehicle with the alcohol-impaired driver.

Two new studies on impaired driving were released by the National Highway Traffic Safety Administration (NHTSA). The Roadside Survey of Alcohol and Drug Use by Drivers (RSADU) found that since 2007, the last time the survey was done, the number of drivers with alcohol in their system declined by about 30 percent. Since the first survey in 1973, alcohol use among survey participants has decreased by almost 80 percent.  In 2014, about 8.3 percent had some measurable amount of alcohol in their system; 1.5 percent of weekend nighttime drivers were .08 or higher on breathalyzer tests. You can download copies of the two surveys and summaries of the results at the above link.

Figure 1 of the report showed a decline in each of three breath alcohol concentration (BrAC) categories since 1973. Individuals who tested at .08 and above, the legal limit in all states, dropped from 7.5 percent in 1973 to 1.5 percent in 2013-2014. This was an 80 percent drop in the percentage of alcohol-impaired drivers on the road on weekend nights. Results, which are no surprise, show that more people are driving with alcohol in their system on weekend nights (Friday and Saturday) than during the daylight on Fridays. “During weekday daytime hours (Friday), only 1.1 percent of drivers were alcohol positive, while at weekend nighttime hours (Friday and Saturday), 8.3 percent of drivers were alcohol positive.” Weekday drivers above the .08 BrAC level were quite low, at .04 percent. See the chart below taken from the NHTSA report.

BrAC chartNHSTA administrator Mark Rosekind said that the survey results showed how “a focused effort and cooperation among the federal government, states and communities, law enforcement, safety advocates and industry can make an enormous difference.” Nevertheless, there is no victory as long as one person dies in an alcohol-related crash.  He then said that the survey raised questions about drug use and highway safety.

The RSADU survey found that 22.5 percent of weekend nighttime drivers tested positive for some drug in oral fluid and/or blood test. This was almost identical to the Friday daytime rate (22.4 percent). When illegal drugs versus legal medication were distinguished, there was a clear difference. More individuals tested positive for illegal drugs on weekend nighttime than Friday daytime (15.2% versus 12.1%, respectively). There was actually a decrease with legal medications from 10.3% during daylight, to 7.3% on weekend nighttime.

The drug with the largest increase in weekend nighttime use was THC. In 2007, 8.6 percent of weekend nighttime drivers tested positive for THC. In 2013-2014, 12.6 percent of weekend nighttime drivers tested positive for THC; a 48 percent increase. The report noted how changes in state policy on marijuana use, now legal in many states for medical use and a growing number of states for recreational use, may have contributed to the increase in marijuana use by drivers.

Further caution interpreting the survey results is needed because drug presence does not necessarily imply driving impairment. “For many drug substances, drug presence can be detected after impairment that might affect driving has passed.” One example is with marijuana. THC can be detected in blood and urine samples several weeks after heavy users have last used marijuana. So there is some indication that reported percentages of impaired drivers from marijuana were high.

Although the attempt to survey impaired drivers is noble and needed, I’m not sure I am all that encouraged by the reported drop in the percentages of alcohol-impaired drivers. Neither am I alarmed at the reported increase with THC positive drivers. And here’s why—I believe all the results are under reporting the true percentages. This is simple common sense. The survey was COMPLETELY VOLUNTARY. You cannot assume that individuals who stopped for the survey were a representative sample of all the impaired drivers on the road at that time! Here is a summary of the methodology given within the executive summary of the National Roadside Survey:

The National Roadside Survey collected information from volunteer drivers at 300 research checkpoints across the Nation. The survey methods were reviewed and approved by an Institutional Review Board and all data was completely anonymous. Drivers were free to pass by the research site or pull in to find out details of the survey. A small fee (up to $60) was offered to compensate drivers for their time. About 85 percent of drivers who pulled into the research site chose to provide breath samples, more than 70 percent provided oral fluid, and over 40 percent chose to provide blood samples.

Although 85.2 percent of the eligible drivers who entered the data collection site to get information on the survey participated, how many just passed by? Additionally, only 42.2 percent provided blood samples.

The second survey, the “Drug and Alcohol Crash Risk” study, assessed whether crash-involved drivers in Virginia Beach over a 20-month time period had drugs in their system at the time of the crash. THC was the most frequently used drug, by 7.6 percent of the crash-involved drivers. However, 6.1 percent of the control group drivers also tested positive for THC. Overall, 16 percent of the crash-involved drivers and 14.4 percent of the control drivers tested positive for drugs. When the data looked at illegal versus legal drugs, 10.4 percent of the crash-involved drivers used an illegal drug, while 8.8 percent of the control group used an illegal drug. See the table below taken from the “Drug and Alcohol Crash Risk” study.

illegal legal drugsAgain, should be used when interpreting the results of the survey as indicating impairment. In some cases, “drug presence can be detected for a period of days or weeks after ingestion.”  The discussion indicated its results were consistent with previous research, including the NHTSA’s 2007 Roadside Survey (RSADU). Driver impairment from both alcohol and other drugs is a serious safety concern. However, drugs other than alcohol have a less-certain impact on driving impairment. This is primarily due to the lack of reliable research into quantifying the driving impairment of substances other than alcohol.

Understanding the effects of other drugs on driving is considerably more complicated than is the case for alcohol impairment. This stems from the fact that there are many potentially impairing drugs and the relationship between dosage levels and driving impairment is complex and uncertain in many cases.

Particularly with the recent legalization of marijuana in several states and the growing acceptance of medical marijuana, more studies into the driving impairment from marijuana need to be done.

04/24/15

Effective Biblical Headship

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© designpics | 123RF.com

The twentieth century has seen a revolution in the relation of women and men. Women have been ‘liberated’ from the status of ‘second-class’ citizens. Not since a first-century rabbi named Jesus taught women about the Jewish faith has so dramatic a change in roles been introduced.  (James Hurley, Man and Woman in Biblical Perspective)

There is a section from Hurley’s book, “What does ‘headship’ entail?” that I regularly use and discuss with individuals when I do marital counseling. Although I do see couples with other problems, the majority of couples have conflict that grows out of a failure of husbands to exercise the biblical headship Hurley summarizes here.

I’ve known of husbands who tracked their wives’ menstrual cycles and said that their arguments as a couple were directly correlated to their wives’ periods. Others have tried to argue that this and other concerns were indications of there being “something wrong” with their wives. I’ve known husbands who failed to give their wives access to their online banking and checking accounts; even access to the computer itself. Others, when angry at their wives, have given them “the silent treatment.” One such individual didn’t talk to his wife for about six months. Other husbands, when they didn’t get the response they wanted from their wife, would call family and friends to tell them about the issue and try to get them to convince their wives.

All of these behaviors occurred within self-described Christian marriages. And in one way or another they were failures of the husband to exercise proper biblical headship, as Hurley described it. He began this section on headship by saying that it would be a major mistake to narrowly conceive headship as just ‘the right to command,’ wrongly applying the biblical passages saying that a wife should submit to her husband. If kept to this narrow understanding, headship quickly becomes dehumanizing and unworkable.

Authority to lead must include the necessity to delegate authority. If the person in charge of any situation believes that all authority must reside with him alone, then he must make all the decisions and take all the actions. Not only is such micromanagement impractical, it rapidly becomes absurd. Some men feel their authority or headship is threatened if they are not consulted on decisions as small as what meals should be served. Their wish to hold all the reins regularly frustrates family members. “Any initiative on the part of others threatens their relatively fragile sense of control. Such headship is crippling to a family and to a marriage relation.”

The husband cannot hope to exercise his ‘command’ in every area and soon finds himself occupied at every turn with the defence of his status [or headship]. The more thorough he is in his ‘control’ the more exhausted he will be from trying to be an expert everywhere and the more his family will feel alienated from him.

Biblical headship and authority are then for the sake of encouraging and building others up. Christ repeatedly said that those who would be leaders of his followers must be servants of all (Matthew 9:35). Biblical leadership or headship involves the responsibility of taking action for the sake of others, rather than the right to command them.

It may be a husband’s responsibility in a biblical marriage to take the initiative, but not to do it all. Any attempt to make all the decisions undercuts real headship and leadership. He needs to seek the counsel of his wife and family and to often defer to their expertise. This is not an abdication of his responsibilities, but an effective fulfillment of them. “Christ does not guide his church without paying the closest attention to the needs, desires and abilities of his people. . . . The husband’s relation to his family should reflect a similar involvement.” So headship modeled after Christ should take into account the needs and abilities of the family members for whom the decisions are made. 

The husband and father who understands his role as merely to provide money and give orders fails to truly be the ‘head’ of his family. “If he is to know their growing abilities and changing interests,” he needs to be involved in their lives. He needs to be to his family as Christ is to the church (Ephesians 4:14-16). Jointly with his wife, he should help to prepare their children to be godly adults. He must also know her if he is to love her as Christ loved the church (Ephesians 5:25-30). “Headship demands involvement. Involvement demands time.” So within his relationship to other family members, the husband and father is to be an example to them. 

A few pages after this section, Hurley discussed “the exercise of authority.” He commented that modern Christians tend to understand authority in the manner of the Gentile kings against whom Jesus warned (Matthew 20:25-26). In our culture, we are often concerned with such matters. “The model of Christ and the church, however, has more to offer than bald ‘right to command.’” Turning to Christ’s leadership as a model, we see that “He does not crush us or impose his will in a way which denies our humanity or initiative.” Applying what he said previously about husbands and wives, Hurley said:

The exercise of authority and leadership in any organization will be most effective if it is done in such a way that the abilities of those under authority are developed to their fullest rather then suppressed. This demands that the leader be aware of the thoughts and abilities of those under him. They in turn must be satisfied that their input is heard and respected. Authority must be delegated and initiative must be given to subordinates. If they can never act without first checking out their actions, progress will quickly be stifled. Resentment and suspicion will take its place. Christians must consider carefully how to administer and how to respond to authority in their home and in their church life. Failure to do so will inevitably produce destructive results.

James Hurley wrote Man and Woman in Biblical Perspective in 1981, during his time as an Associate Professor at Westminster Theological Seminary in Philadelphia—my alma mater. He left the seminary to complete a Ph.D. at Florida State University in 1985 and has been the Professor of Marriage and Family Therapy and Counseling at Reformed Theological Seminary since June of 1985.

04/22/15

A Drug in Search of a Disorder

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© Sergey Nivens | 123RF.com

When the DSM-5 was published in May of 2013, binge eating came out of the closet of Appendix B, the section for potential “disorders” needing further study. “Binge Eating Disorder” became a psychiatric diagnosis (Code: 307.51) in its own right. Before that time, binge eating had received a backhanded diagnosis under the rubric of “eating disorder not otherwise specified.”  Without official standing as a coded eating disorder, binge eating suffered from diagnostic insecurity and poor self-esteem. It didn’t have an official diagnostic category like anorexia and bulimia or an FDA-approved medication to treat it. But now, less than two years since it became an official psychiatric disorder, that is no longer the case.

The American Psychiatric Association (APA) defined binge eating disorder as: “recurring episodes of eating significantly more food in a short period of time than most people would eat under similar circumstances.” Some episodes would include marked feelings of a loss of control. A binge eater might eat too quickly, even when not hungry. They may feel guilty, embarrassed or disgusted. They may binge eat alone to hide the behavior. “This behavior is associated with marked distress and occurs, on average, at least once per week over three months.” There is a more complete description of the diagnostic symptoms here in “Promoting Amphetamines for Over-Eating.”

On January 30, 2015, the FDA announced that the ADHD drug Vyvanse (lisdexamfetamine dimesylate) was approved to treat binge-eating disorder in adults. It is the first such drug approved to treat this condition. “Vyvanse was reviewed under the FDA’s priority review program.” Expedited reviews can be done to treat a serious condition, especially if it’s seen to provide “a significant improvement” over available therapies. But, “Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied.”

Common side effects from Vyvanse include: dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety. More serious, but less common side effects include: “psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults.”  Vyvanse might also cause “psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.” Oh, and it’s a Schedule II controlled substance with a high potential for abuse. In fact, OxyContin, fentanyl and cocaine are also Schedule II controlled substances. The DEA said these drugs are considered dangerous, “with use potentially leading to severe psychological and physical dependence.”

The FDA Adverse Events Summary for Vyvanse reported the following adverse events out of 14,311 consumers to its FDA Medwatch reports between 2004 and 2012: off-label use; insomnia; DECREASED APPETITE; aggression; headache; anxiety; nausea; DECREASED WEIGHT; irritability; fatigue; SUICIDAL  IDEATION; depression; agitation; overdose; feeling abnormal; abnormal behavior.

The New York Times reported that the marketing strategy for Vyanse sheds light on how pharmaceutical companies seek to “influence the treatment and diagnosis of a medical condition” in order to make billions of dollars in sales. Shire, the pharmaceutical company dispensing Vyvanse, seems to have followed a familiar drug industry method of promoting awareness of a disorder before more directly marketing its treatment.

Soon after Shire won FDA approval of its drug to treat Binge Eating Disorder, Monica Seles began to make the rounds of television talk shows such as “Good Morning America” and “The Dr. Oz Show” to relate her personal struggle with binge eating. She was also interviewed by People Magazine. Seles said that one of the reasons she decided to do this campaign was “to raise awareness that binge eating is a real medical condition.” Seles is a paid spokesperson for Shire. She declined to say what she’s getting paid by Shire.

Shire CEO Flemming Ornskov said that about five years ago researchers noticed the similarities between ADHD and binge eating, so they decided to study Vyvanse for the condition. As early as 2011, Shire’s CEO said that the company hoped to generate “multiple billions of dollars” from expanding Vyvnase use into new areas of illness, like schizophrenia, depression and binge-eating. International Business Times reported that in 2014 Vyvanse made $1.5 billion for Shire in sales for 2014. The company hoped to grow its revenue from the $4.91 billion it made in 2013 to $10 billion by 2020 And Vyvanse is a significant part of that projection. Shire’s current patents for Vyvanse don’t expire until 2023. The approval of Vyvanase for BED means that Shire will gain an additional three years of exclusivity with the drug.

In her article for The New York Times, Katie Thomas quoted Dr. Timothy Walsh of Columbia University, as saying: “Once a pharmaceutical company gets permission to advertise for it, it can often become quite widely prescribed, and even tend to be overprescribed, and that’s a worry.”

There were 3 clinical trails in process for additional potential drug treatments for BED:  Cymbalta (Eli Lily), Lamictal (GlaxoSmithKline), and Nuvigil. Cosgrove et al. reported that the DSM-5 work group that approved binge eating as a diagnosis included three individuals with financial ties to Eli Lily, three people with relationships to GlaxoSmithKline and one person with a relationship to Shire.

Several articles have noted a variety of concerns with the FDA approval of Vyanse to “treat” Binge Eating Disorder. International Business Times quoted Sandy Walsh of the FDA office of media affairs as saying they had no direct evidence of how Vyvanse worked in BED: “The exact mechanism of action of the drug in reducing the symptoms of BED is … unknown.”  Melissa Gerson, the clinical director of an outpatient treatment center specializing in eating disorders, said she would not recommend a drug alone to treat BED. “I can’t imagine how you would see any long-term improvements in the symptoms.”

A Shire website, BingeEatingDisorder.com noted how someone could talk to their doctor about BED. They provided a Doctor Discussion Guide, saying on its link, “Not sure how to start the conversation with your health care provider?” A tip at the bottom of the homepage suggested that the individual could “Print, e-mail, or take a screen shot of this page, and bring it to discuss with your health care provider.”  The New York Times reported that some experts were concerned that the content appeared to coach patients on how receive a diagnosis or shop for a new doctor if they weren’t successful.

Some drug safety experts questioned why the FDA fast tracked approval of Vyanase—even foregoing a review by an advisory committee. For decades, amphetamines like Vyanase, have been known to be a widely abused class of drugs when prescribed for obesity. The marketing end run done by Shire to avoid this pitfall was to promote Vyanase for binge eating and acknowledge that about 80% of the people with BED are overweight or obese WHILE COMPLETELY IGNORING the history of amphetamine abuse with weight loss. Don’t forget that weight loss and appetite suppression are already known to be common side effects when taking Vyanase and other amphetamines. And the FDA didn’t see this move or call them on it?

A spokesperson for the FDA said that Vyanase was granted priority approval because there was no other drug treatment available for BED. “And it did not ask an advisory committee to review the issue because Vyanase is already sold as an ADHD drug and its safety profile is well known.” REALLY?  Dr. Daniel Carlatt said:

I’m concerned that the FDA’s approval of Vyvanse for binge eating disorder is going to worsen our problems with stimulant abuse. . . . Vyvanse is a derivative of Dexedrine. We’ve seen epidemics of Dexedrine abuse in the past when it was used to help people diet. I predict that the FDA has just opened the gates to another similar epidemic – after all, binge eating disorder is a subjective diagnosis that could be potentially expanded to cover many millions of people.

04/20/15

Medical Reform or Medicinal Con?

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© lightwise | 123RF.com

In my home state of Pennsylvania, the legislature is considering the legalization of medical marijuana. At least one activist believes it will happen in 2015: “We have the votes for it. It’s going to happen this term.” Jon Delano of KDKA cited Jay Costa, the Democratic Senate leader, as saying the medical marijuana bill is likely to be approved this spring. Legislation has been introduced in the Senate and gone to committee. “And it is very likely over the course of the next couple of months it will pass through the Senate and make its way over to the House.”

The new governor, Tom Wolfe, has publically said he would support medical marijuana in PA: “I believe that doctors who can now prescribe some of the most potent drugs in the world should be able to prescribe medical marijuana.” The problem seems to be in the State House, which is currently holding hearings on its own legislation. Tony Romeo with CBS Philly reported that law enforcement stressed the need for strict regulatory control if medical marijuana was legalized. Republican Matt Baker, chair of the House Health Committee said:

I am very cynical and skeptical about moving forward with this. And I think there are a lot of unresolved issues, and when you talk with the medical groups and the scientific community, they’re very, very concerned about us putting on white coats and trying to play doctor here.

Polls indicate that most Americans support the legalization of medical marijuana. More than half of the US population now lives in a state where marijuana in some form (medical or recreational) is legal. But take some time to really review this compilation of surveys on marijuana legalization on PollingReport.com. Several polls by organizations like the Pew Research Center, Gallup, and CBS News show a changing trend of Americans over time to agreeing that marijuana should be legalized, when the question is put as: “Do you think the use of marijuana should be made legal, or not?” All three organizations reported results that were essentially the same as the October 2014 Gallup poll—51% said yes to legalization; 47% said no to legalization.

But now look further down at a nationwide poll by the Pew Research Center taken in February of 2014, when the question answers had more options. There the question was: “Which comes closer to your view about the use of marijuana by adults? It should be legal for personal use. It should be legal only for medicinal use. OR, It should not be legal.” The results were: 39% said marijuana should be legal for personal use; 44% said it should be legal for medicinal use; 16% said it should not be legal; 2% were unsure or refused to answer.

Then the Pew Research Center published their newest poll on legalizing marijuana on April 14, 2015. This survey reported that 53% of Americans favored legalization, while 44% opposed legalization. Millennials (18-34) had the strongest support for legalization, with 68% in favor and 29% opposed. Among those who said marijuana should be legal, 78% did not think the federal government should enforce federal laws in states that allow its use. Conversely, among those who think marijuana should be illegal, 59% said there should be federal enforcement.

The most frequently cited reasons for supporting legalization are its medicinal benefits (41%), the belief that it is no worse than other drugs (36%) and its potential for tax revenue (27%). The most frequently mentioned reasons why people oppose legalization were that it hurts society and is bad for individuals (43%), and it is a dangerous, addictive drug (30%). So it seems that the Pew Research polls suggest there is more support for the use of medicinal marijuana than recreational marijuana.

Returning now to the compilation of results on Pollingreport.com there are some further interesting results in two other polls. In a CNN/ORC Poll done in January of 2014 the legal, not legal dichotomy gets most Americans saying marijuana should be legalized. And there is support for decriminalization measures as well. However, there are two other interesting results. 88% percent of the people polled think that marijuana should be able to be legally prescribed for medical purposes by their doctor. When asked if Colorado’s legalization of recreational marijuana was a good idea, a bad idea, or if you want to wait and see what happens before deciding, 33% thought legalization was a good idea; 29% thought is was a bad idea; and 37% wanted to wait and see what happens before they decide!

A Fox News Poll taken in February of 2013 asked if you thought that most people who smoke medical marijuana truly need it for medical purposes or just want to smoke marijuana; 30% said they truly needed it; 47% thought they just wanted to smoke it; 12% said it depended upon the person; 11% were unsure. Although there aren’t many well-accepted medical uses for marijuana as this point in time, there are some.

A 2007 study in the journal Neurology showed that marijuana is effective in reducing neuropathic pain in HIV patients. Live Science also reported marijuana, when combined with opiates, led to dramatic levels of pain relief. It has been helpful in reducing stiffness and muscle spasms in MS (Multiple sclerosis). It appears useful for reducing nausea induced by chemotherapy. Medical marijuana has been touted as a treatment for glaucoma, but other drugs are more effective.

Legalizing medical marijuana now will not just legitimize its medicinal use for these generally accepted conditions, it would permit the medicinal use of marijuana whenever the individual has been given a prescription for it by a doctor. Without reliable, scientifically replicated studies of the claims for medical marijuana efficacy, we would be returning to the times of patent medicine, where medical marijuana is claimed to treat almost anything and everything. The CNN polled opinion that medical marijuana users didn’t really need it, but just wanted to smoke it would then come true.

Sensible use of medical marijuana should follow the established procedures for all medicinal substances—approval by the FDA. As the medical usefulness of marijuana for a condition is demonstrated through this process, it would then become a FDA approved medicine.  I realize that once marijuana reaches this bar of approval, it would then be available for off label use for other medical conditions. But it would also then be REGULATED like all other medical treatments. The current process of state-by-state legislative approval of marijuana for medical purposes circumvents this regulative process. It was established to protect American citizens from the fiascos of past medical treatments that turned out to be ineffective at best and harmful at worst.

Reform must start at the federal level. Given that marijuana has been a Schedule I controlled substance, its availability for the kind of medical research needed to gain FDA approval has to be increased. So a first step would be changing its status from a Schedule I controlled substance to that of Schedule II. The reclassification would make it easier to do the needed research on its legitimate medical uses. I’d suggest delaying the approval of medical marijuana in Pennsylvania and the other states where it is not yet legal until research demonstrating its medical usefulness has gone through the FDA clinical trial process. This would delay the approval of medical marijuana, but it would establish a more stable path forward for the legitimate medical use of marijuana. Debates for the off label medical use could occur alongside those now going on for other classes of FDA approved drugs such as antipsychotics and antidepressants.

Incidentally, there was a bill introduced in the U.S. Senate to reclassify marijuana from Schedule I to Schedule II, the Compassionate Access, Research Expansion and Respect States (CARERS) Act. While it is gaining support, key leaders in both parties have reservations. As the Motley Fool pointed out, the proposed loosening of federal restraints comes just as a new study of the effects of heavy marijuana use on long-term memory in adolescents was published. I hope that if ongoing research demonstrates the need for further restrictions on the medicinal use of marijuana, there would be public and legislative support for that as well.

I suspect this suggestion would not be acceptable for many medical marijuana activists because their final goal is not just the medicinal legitimization of marijuana. Acceptance of medical marijuana may be the first steppingstone towards the legalization of recreational marijuana. As the polls show, there seems to be wider support for the medical use of marijuana than for the recreational use of marijuana. So press for the medical use of marijuana now, and then recreational approval at a future date.

04/17/15

The Blessing of Persecution

© Kiya | 123RF.com

© Kiya | 123RF.com

It seems Jesus thought what he said in the eighth beatitude, namely that his disciples will be persecuted, needed to be driven home and required some unpacking.  Leon Morris noted where Matthew used the verb “persecute” in three consecutive verses (5:10-12), underlining the importance of the concept. In Matthew 5:11 and 12, Jesus then switched from the third person to the second person, now speaking directly to his audience. You are blessed when others revile (mock) you and persecute you (harass you for what you believe) falsely on his account. You are to rejoice and be glad if it happens, because you must be doing something right.

What they are doing right is living out the righteousness he just described in verses 5:3 through 5:10. There is also a warning in what Jesus said. If you attempt to live righteously in this world for me (on my account), then you will be persecuted. When we try to live as Jesus would live, we should expect the same persecution he received. As he said elsewhere, “If the world hates you, know that it hated me before it hated you” (John 15:18).

The hatred, persecution or abuse can be both verbal (mocking, demeaning, reviling) and physical. Pointing to the persecution of the prophets, then telling his disciples to rejoice when they are persecuted as the prophets were persecuted, clearly indicates this. Jeremiah’s life and ministry is a good example. He was mocked for his prophetic declaration of God’s judgment against Judah (Jer. 18:18). The religious leaders and false prophets also tried to have him executed for treason when he was imprisoned in a cistern (Jer. 38:1-6).

When I look at the character traits listed in the beatitudes, there doesn’t seem to be anything that should target the disciples of Jesus for persecution. Striving to be poor in spirit, meek, merciful, pure in heart or a peacemaker seem to be good things. Individuals who grieve or mourn their own sinful actions aren’t readily seen as people who need or should be mocked and reviled. In a similar way, I don’t get the mocking and ridicule I’ve seen heaped upon Alcoholics Anonymous and Twelve Step recovery. Here are a couple of examples.

The first is the “Cougarblogger.” Here is a sampling of some of her articles: “12 Things the Cult of Religion of the 12 Steps Does NOT Want You to Know;” “Rules for Sex Offenders—Attendance in 12 Step Cult Meetings;” “Dangerous Criminal in You Alcoholics Anonymous Meeting;” Fake ASAM ‘Doctors’ Push AA Cult for Profit;”  “Never Call Yourself an “Alcoholic” or “Addict.” Here is a quote from the last listed article:

“Why do you hate 12 step programs so much?”  When I get asked this question, in my head I think, “Why don’t you?!?!”  Then I realize they are either ignorant, have a relative/friend in the cult, (who gives all credit for their very lives to the cult), or are a stepper (or ex-stepper), themselves.  What is most astounding is when ex-steppers defend the cult, but then I quickly realize the power of the brainwashing.  Even those who have left (gotten free really), feel the need to defend the cult.

There is no way to have a conversation with someone like that. Her mind is made up. To use a 12 Step recovery saying, it’s either her way or the highway.

The charge of A.A. being a religious cult has been around for awhile. I think the classic argument for this position is Alcoholics Anonymous: Cult or Cure? by Charles Bufe. Even Bufe, who assessed A.A. according to a description of what a cult was that he himself developed, acknowledged that it is difficult to answer if A.A. is a cult. Unequivocally, he thought A.A. was religious (the first of his 23 criteria). He distinguished between institutional and communal A.A and thought that institutionally, A.A. was a cult; but communally, it wasn’t, “though it comes close, and does have many dangerous, cult-like tendencies.”

Another blogger, julietroxspin, is a self-described activist for secular treatment options for alcohol and drug abuse treatment. She also blogs on The Fix (as Juliet Abram). A sampling of her articles on A.A.R.M.E.D. with Facts, are: “There are No Rules Only Suggestions;” “I’m Deathly Allergic to AA;” “AA Needs to Give a Damn About It’s Bad Reputation.” A sampling of her articles for The Fix are: “Normies React to the 12 Steps;” “Can an AA Critic and a 12-Step Advocate Get Along?;” “Recovery Bullies.” In “I’m Deathly Allergic to AA,” Juliet stated:

I can say I worked the steps, I felt the mental shift inside changing my interpretation of the past. Guilt. Blame. Darkness. The steps were harming me, not because I “quit before the miracle happened,” but because I “kept coming back.” Because I’ve been abused, I can get addicted to abuse. It’s real simple, and real deadly.

While Juliet is clearly anti-A.A., I think she is trying to be more objective than “Cougarblogger.” I suspect that both of them would see my reflections on how the Sermon on the Mount applies to A.A. and recovery as evidence of how A.A. is religious. But to do so you have to assume an understanding of “religion” that different than that of A.A. and William James in The Varieties of Religious Experience from which they self consciously drew their distinction between “spiritual” and “religious.”

Evangelical Christians have also been critical of A.A. and what they saw as integrating psychology with Christian doctrine. Gary and Carol Almy said that: “The 12-step groups follow the doctrine of the psychology gospel and are determined to grab the benefits of what Paul called ‘the new life in Christ’ without the crucifixion of the old.” Martin and Deidre Bobgan see A.A. as Christless religion, offering a counterfeit salvation: “Because of the many versions of God represented in AA, professing Christians are uniting themselves with a spiritual harlot when they join A.A.”

The “persecution” of A.A. and 12 Step recovery has been mocking and demeaning at times—curiously—from both religious and nonreligious sources. But remember what Jesus says here in the Sermon on the Mount: “rejoice and be glad” when you are persecuted. Nonreligious members of A.A. won’t like or agree with the promised reward in a heaven they don’t believe in. But they could see an “eschatological” ending of their own by working the Steps—continuing in abstinence until they die.

One last comment related to the “prophets” mentioned by Jesus in the Sermon on the Mount. Stanton Peele, another A.A. critic, approvingly mentioned Charles Bufe’s prediction of the end of “A.A.’s reign of terror over” American alcoholism treatment. Bufe, writing in 1998, suggested that several factors would “virtually ensure that AA will begin to shrink significantly” within five to ten years. “They make it entirely possible that AA will cease to exist as a significant social movement by the second quarter of the 21st century.”

In 2014, Alcoholics Anonymous estimated its total groups at 115,300, with more than 2 million members in over 170 different countries. Data on A.A. members and groups I received in 2007 indicated there were an estimated 2,044,855 members and 113,168 groups worldwide. (See my free ebook, The Age of Miracles is Still with Us). So far, it doesn’t seem that A.A. is “shrinking significantly.” And it doesn’t seem likely that it will “cease to exist as a significant social movement” by the beginning of the second quarter of the 21st century. Will it still be around by 2050? Let’s wait and see. I think the words that Sam Shoemaker, an Episcopal minister, spoke in 1955 are relevant: “I believe that A.A. will go on serving men and women as long as it may be needed, if it keeps open to God for inspiration, open to one another for fellowship, and open to people outside for service.”

This is part of a series of reflections dedicated to the memory of Audrey Conn, whose questions reminded me of my intention to look at the various ways the Sermon on the Mount applies to Alcoholics Anonymous and recovery. If you’re interested in more, look under the category link “Sermon on the Mount.”

04/15/15

(Not) Lost in the Mall

© Petro Feketa |123RF.com

© Petro Feketa |123RF.com

Elizabeth Loftus became a pariah to the repressed memory movement in 1990s when she published her seminal study, “The Formation of False Memories,” famously known as the “Lost in the Mall” study. Simply put, Loftus and her graduate student were able to successfully plant a pseudo-memory in 6 of the 24 individuals in the study that they were lost in a mall at the age of five. Loftus said that if there were three words to describe memory, she would say it is suggestive, subjective, and malleable. Here is a brief YouTube video describing the experiment. Here is one that includes an interview with one of the study’s participants.

She concluded her study saying that people can be led to remember entire events that never happened; events that were “biologically or geographically impossible.” Without independent corroboration, Loftus said, we cannot reliably distinguish between real and false memories. The study has become well known enough, that the technique of memory implantation is referred to as the “lost in the mall” technique.

It led to ethics complaints filed against Loftus with the American Psychological Association (APA) by two individuals who had successfully won lawsuits against family members who sexually abused them. Loftus resigned from the APA before being informed of the ethics complaints, and no charges were brought against her. These two individuals published articles in the journal Ethics & Behavior, claiming that what Loftus had done in her study was a breach of ethics.

Loftus responded in the same volume of Ethics & Behavior, “Lost-in-the-Mall: Misrepresentations and misunderstandings.” The link is to her abstract. If you google the title, you will see a researchgate.net link to a pdf of her original response. Loftus systematically and methodically addressed a variety of their accusations, noting where they had misrepresented or misunderstood her research and claims. Some of the issues she addressed included: how she developed the idea of being “lost in a mall” for the experiment; how there were several other similar studies at the time investigating “the malleability of memory;” and showing where the two individuals charging her with a breach of ethics had falsely accused Loftus of misrepresenting the study’s results under oath.

There was even a response from Psychology Today that discussed the charges of misrepresentation against Loftus and her resignation from the APA. Jill Neimark commented on how Loftus has been violently hated by some women and psychotherapists (repressed memory specialists?), who seemed to be trying to destroy her reputation. Neimark noted how Loftus’ resignation from the APA was in response to a report she had been asked to complete for a special task force on recovered memory. “Its six psychologists had become so polarized–along exactly the same fault lines as the culture at large–that they produced two separate reports.”

The complaints [linked above], when studied, are baseless. Nobody would resign over them. What they seem to poignantly reveal is the sound and fury of women so enmeshed in pain and anger that, though both claim to have wonderful lives, they cannot turn swords into plowshares and walk away from a battle that gave their lives tremendous, if tormented, meaning.

Why take the time to rehash this? Because I want to introduce you to a TED talk by Elizabeth Loftus, who has continued to research and study false memories. In her talk she shared some compelling stories and statistics that raise important ethical questions on memory. She began with a story of a man who was wrongly identified as a rapist and convicted of the crime. The key evidence in his conviction was that he was identified, wrongly as it turned out, by the victim. Loftus noted a project with information on 300 individuals who were falsely convicted and imprisoned up to thirty years for crimes they didn’t commit. DNA testing proved they were actually innocent.  When these cases were analyzed for how they were wrongly convicted in the first place, it was discovered that 75% of them were due to faulty eyewitness memory.

“Many people believe that memory works like a recording device. . . . But decades of work in psychology has shown that this just isn’t true.” Memory is constructive and reconstructive. It’s a bit like a wikipedia page, said Loftus. You can go in there and change it, but so can other people. Loftus was recently part of a study with military personnel who were undergoing training to be prepared for what could happen if they were ever captured as prisoners of war.  “In some conditions more than half of the subjects exposed to a misleading photograph falsely identified a different individual as their interrogator after the interrogation was over.” When you feed someone suggestive (mis)information, you can distort, contaminate or change their memory.

She described how the 1990s raised the specter of repressed memories, sometimes, of horrific acts of ritualized sexual abuse. When she began to look at these “bizarre, unlikely” claims, Loftus noticed that many of them involved experiences with psychotherapy using techniques of imagination, dream interpretation, and hypnosis; sometimes exposure to false information. Her “Lost in the Mall” study came out of that context.

There have been other studies done that successfully implanted false memories besides those done by Loftus. A study in Tennessee planted a false memory of narrowly escaping from drowning as a child. A Canadian study successfully implanted a false childhood memory of a vicious attack by an animal—50% of the time. In Italy, they were able to successfully implant a false memory of witnessing demonic possession as a child.

Loftus then described newer studies she’s done that have shown where false memories can influence later behavior. False memories of sickness with certain foods resulted in less consumption of that food at a picnic; planting a “warm fuzzy” memory of a healthy food like asparagus, could motivate people to eat more asparagus. These studies have shown how false memories can effect later behavior long after the memories take told. So now there are new ethical questions being raised. When should we use this technique? Should we ban its use? She suggested that parents could use this technique to get their children to eat healthier foods; or to eat less. And again, Loftus was vilified.

If I’ve learned anything from these decades of working on these problems, it’s this. Just because somebody tells you something and they say it with confidence, just because they say it with lots of detail, just because they express emotion when they say it, it doesn’t mean that it really happened. We can’t reliably distinguish true memories from false memories. We need independent corroboration. . . . Memory like liberty, is a fragile thing.

Julia Shaw and Stephen Porter recently published a false memory study where they successfully planted a memory of committing a crime in the minds of 21 of 30 (70%) undergraduates. None of the participants had a criminal history. Within another group of 30 undergraduates in the same study, 23 of 30 (76%) believed they had experienced a traumatic event as a teenager.  “And they were able to do it within only three hours.”  In an article about this research, Susan Perry noted that neuroimaging studies have shown “that true and false memories trigger the same kind of brain activity patterns.” Again the researchers stressed the importance of independent corroboration to reliably tell the difference between true and false memories.

04/13/15

The Economics of Heroin

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© Berna Namoglu | 123RF.com

I live in the suburbs of Pittsburgh. At least nine times each week I drive past a retail store where someone I know once told me they shot up heroin in the store’s parking lot. The store sits on a busy street. This incident was a few years ago, but I’m pretty sure that wasn’t the only time someone used heroin in my neighborhood, because it’s happening all around me.

A teacher from the Montour School District was recently charged with two counts of possession with intent to deliver. Police said he was selling heroin out of his home. The school district suspended him immediately. The school district’s solicitor said there was no evidence that the man possessed or sold drugs on school property. The accused has been a math teacher for at least a decade. The ironic twist is that he rented his home from the Robinson Township police chief, who said he’s never had any problems with the accused … until now.

The Pittsburgh Post-Gazette reported at the end of February 2015 that three people from Armstrong County were charged in connection with an overdose death linked to fentanyl-laced heroin known as “theraflu.” I work part time at an outpatient treatment center in Pittsburgh and remember when the theraflu scare was going on in January last year. Seventeen people from around Pittsburgh died of overdoses in a week. A local medical examiner at the time said it was  “major public health crisis.”

An ongoing investigation of drug trafficking in Homewood and other communities in the Pittsburgh metro area recently added 14 new defendants to the 40 who were originally indicted in October of 2014. US Attorney David Hickton said they were “important cogs” in a multi-state drug distribution ring. “They would be the Pittsburgh connection to this organization that has reach far beyond out state.” The trafficking involved heroin, cocaine and crack cocaine coming from Los Angles to Homewood via Cleveland. Harold Hayes of KDKA said: “The FBI says the long-term investigation has led to the indictment of more than 100 people and the seizure of more than $1 million.”

The 2014 National Drug Threat Assessment Summary (NDTS) published by the DEA stated that the threat posed by heroin in the US has been increasing across the country, particularly in the Northeast and North Central regions. The two major geographic areas for heroin supply in the US are Mexico and South America. Together they account for 96% of the heroin analyzed by the DEA in 2012. The NDTS reported that heroin seizures increased 87 percent in five years, from 2009 to 2013.

The observed increase in demand for and abuse of heroin is said to be the result of individuals who used to abuse prescription opioids switching to heroin. Reasons given for the switch include: the relatively lower cost of heroin than prescription opioids; the decreasing availability of prescription opioids versus the increasing availability of heroin; the reformulation of OxyContin, making it more difficult to abuse. My own experience with people abusing heroin is that the switch is mostly market driven, by the cost differential and the availability of heroin.

In 2013 and 2014, the Northeast and Midwest reported a spike in overdose deaths from fentanyl being sold as heroin. Fentanyl is 30 to 50 times stronger than heroin. The overdoses include both new and experienced users. Thinking they are buying heroin, the users typically don’t realize they are buying fentanyl or a fentanyl-heroin mixture. Between 2005 and 2007 over 1,000 overdose deaths were traced back to a single laboratory in Mexico. The lab was seized and destroyed. The recent outbreak, noted above, covered a wider geographic area than in 2005-2007 and involved both fentanyl and fentanyl analogs.

In Mexican states like Sinaloa and Guerrero, poor farmers living in wood-plank, tin-roofed shacks with no indoor plumbing are growing the poppies that eventually become the heroin sold in American cities like Pittsburgh. Jake Bergman, reporting for the PBS show Frontline, noted how Sinaloa has been the breadbasket for Mexico for decades. Now it a drug-rich area, “the cradle of the biggest traffickers Mexico has ever known.” They even have their own “patron saint”—Jesus Malverde. Malverde’s legend says he robbed from the rich and gave to the poor. Nevertheless, he was hung by the governor of Sinaloa in 1909. His “sainthood” is not recognized by the Roman Catholic church. Father Antonio Ramirez said: “Nobody has become a saint robbing and killing, he was a bandito.”

Nick Miroff reported last year for the Washington Post that the drug trade in Sinaloa has been going through a transition lately. Farmers who used to grow cannabis are now planting opium poppies. Rodrigo Silla, a lifelong cannabis farmer, said it’s not worth it anymore. The wholesale price for a kilogram of cannabis dropped from $100 to less than $25. “I wish the Americans would stop with this legalization. . . . There’s no other way to make a living here.” The Silla family consists of three generations of drug farmers.

A kilo of the raw, sticky opium sap that is used to make heroin sells wholesale for $1,500 in the northern Sierra Madre, nearly double its 2012 price, according to growers. With fertilizer and favorable weather, a well-tended poppy field can yield eight kilos of sap per acre, nearly enough to make a kilo of raw heroin.

David Shirk, a researcher at the University of California at San Diego said that the farmers are simply diversifying because they have a product losing its value. “The wave of opium poppies we’re seeing is at least partly driven by changes we’re making in marijuana drug policy.”

Sinaloa has grown opium poppies since the time of the arrival of Chinese settlers in the last half of the 19th century. But large-scale production did not begin until World War II. Japan controlled the Asian opium market and the US military needed morphine for its soldiers. During this time, many Sinaloans made a fortune. Everyone was growing it. Even some government officials got into the opium export trade. After Japan was defeated, the US no longer wanted the inferior Sinaloan opium. “But many farmers continued to produce opium and heroin; operations became more clandestine, and a smuggling network was set up.”

Writing for the Associated Press, Mark Stevenson reported that farmers in Guerrero don’t like growing opium poppies, but it’s the only thing that will guarantee them a cash income. Humberto Nava Reyna, the head of a group promoting development projects in the region said: “They can’t stop planting poppies as long as there is demand, and the government doesn’t provide any help.” Residents say there are no local users. “It all goes for export, a lucrative business mostly run by the Sinaloa Cartel.”

So it’s sounding like the war on drugs needs to begin changing tactics. Instead of spending so much time and energy on chocking off the supply routes, there should spend more time and energy on drug treatment and prevention to dry up the demand. And there should be some funds given to Humberto Reyna and others like him to help the multi generational drug farmers transition to non-drug crops. And I think I’ll start praying for the Silla family and other drug farmers when I pass by that retail store in my neighborhood.

04/10/15

The Discipline of Relationship

© : Rafal Olkis 123RF.com

© : Rafal Olkis 123RF.com

Oswald Chambers spent a good bit of his time in My Utmost for His Highest teaching and reflecting on the believer’s relationship with God. He said a personal relationship with Christ, not public usefulness, was the central element of concern in his teaching. The “whole strength” of his Bible Training College was that “here you are put into soak before God” (October 19th). So I’d like to look at some of the advice he had for maintaining and developing our relationship with God.

The first thing to recognize is how sin itself is a fundamental relationship. The Christian religion, Chambers said, bases everything on understanding sin as wrong being, not wrong doing. It is “deliberate and emphatic independence of God.” Other religions deal with sins; the Bible alone deals with sin. He noted that the first thing Christ faced in the individual was the heredity of sin. “And it is because we have ignored this in our presentation of the Gospel that the message of the gospel has lost its sting and its blasting power” (October 7th).

The lure of independence from God is as old as the Garden of Eden. Then it was desire to be “like God” in knowing good and evil. It was the gleam of this “fruit” from the tree in the midst of the garden that caught their eye and led Adam and Eve to disobey God. They saw and coveted the potential to be independent judges of the world around them. So they took and ate. The first thing they “knew” was that they were naked and afraid.

This knowledge, not their physical nakedness, was the reason for their fear. Before eating the fruit, they were “both naked and not ashamed” (Genesis 2:25). They realized that eating of the fruit independent of the command of God had altered both their very being and their relationship with God. Independence from God meant the loss of relationship with God. Created in the image of God, Adam and Eve could not but feel that kinship in the presence of God. But their rebellion changed them and altered their ability to experience that kinship. So now in the presence of God they were ashamed because they knew they were different and the former relationship with Him was gone.

The lost relationship was the reason God sent his Son. The death and resurrection of Christ “tore the veil” of separation with God. Chambers commented that the cross of Christ was a “superb triumph,” shaking the very foundations of hell. “There is nothing more certain in Time or Eternity than what Jesus Christ did on the Cross: He switched the whole of the human race back into a right relationship with God” (April 6th). The cross is the gateway into His life. “His Resurrection means that He has power now to convey His life to me. When I am born again from above, I receive from the risen Lord His very life.”

Oswald Chambers

Oswald Chambers

When Our Lord rose from the dead, He rose to an absolutely new life, to a life He did not live before He was incarnate. He rose to a life that had never been before; and His resurrection means for us that we are raised to His risen life, not to our old life. One day we shall have a body like unto His glorious body, but we can know now the efficacy of His resurrection and walk in newness of life. “I would know Him in the power of His resurrection.” (April 8th)

In Christ, relationship is restored. Intimacy with God is again possible. The imagery in Psalm 131:2 uses a mother and child to describe this closeness: “I have calmed and quieted my soul, like a weaned child with its mother; like a weaned child is my soul within me.” Chambers said that a child’s consciousness is so “mother-haunted,” that even though the child is not thinking about its mother, when a calamity arises, the relationship it wants is with its mother. “So we are to live and move and have our being in God, to look at everything in relation to God, because the abiding consciousness of God pushes itself to the front all the time” (June 2nd).

So we must guard against allowing anything to injure our restored relationship with God. And if something does injure it, we have to take the time to make it right. “The main thing about Christianity is not the work we do, but the relationship we maintain.” This is all that God asks us to look after (August 4th). Because of what Christ did on the cross, “Nothing is easier than getting into a right relationship with God except when it is not God Whom you want but only what He gives” (April 27th).

The golden rule for our lives is to keep it open towards God. “The rush of other things always tends to obscure this concentration on God.” The outstanding characteristic of our life as a Christian should be an unveiled frankness before God, so that our life becomes a mirror for the life of others. Chambers cautioned to be aware of anything that could befoul that mirror. He said it would almost always be a good thing that wasn’t the best. We should never be hurried out of the relationship of abiding in Him. “The severest discipline of a Christian’s life is to learn how to keep ‘beholding as in a glass the glory of the Lord’” (January 23rd).

04/8/15

Sola Fide with Drugs

© Awakenedeye | Dreamstime.com

© Awakenedeye | Dreamstime.com

Between May of 1999 and July of 2002, a researcher employed at the Stratton Veterans Affairs Medical Center in Albany New York falsified documents in a clinical trial drug study that contributed to the death of a subject. The researcher “knowingly and willfully” misrepresented the results of a blood chemistry analysis to qualify an individual with impaired kidney and liver function for the study. As Charles Seife reported, the study subject died as a direct consequence of the first dose of the treatment. “The researcher pleaded guilty to fraud and criminally negligent homicide and was sentenced to 71 months in prison.”

Although this episode is described in detail in FDA documents as well as court documents,none of the publications in the peer-reviewed literature associated with the chemotherapy study in which the patient died have any mention of the falsification, fraud, or homicide. The publications associated with 2 of the 3 other studies for which the researcher falsified documents also do not report on the violations.

This was just one of the four case examples described by Seife in his JAMA Internal Medicine article, “Research Misconduct Identified by the US Federal Drug Administration.” His study sought to identify publications describing clinical trials to which the FDA had given its severest warning (an OAI—official action indicated—warning) after doing routine inspections. Once the published articles were identified, Seife tried to determine if there was any subsequent acknowledgement of the violation.

From the documents he and his students gathered together, they found approximately 600 clinical trials mentioned as potentially having OAI violations. They then submitted requests for the FDA OAI notifications through the Freedom of Information Act. Because of extensive redactions (censoring for legal or security purposes), most of the trials in the documents could not be identified. When key information was available, they were able to identify 101 trials with one or more OAI grades. From these, they were able to glean 57 trials with 1 or more FDA inspections of a trial site with evidence of “significant departure from good clinical practice.” These violations included actions such as: underreporting adverse events, violations of protocol, violations of recruitment guidelines, and various forms of scientific misconduct.

In 22 of these trials (39%), the FDA cited researchers for falsification or submission of false information; in 14 (25%), for problems with adverse events reporting; in 42 (74%), for failure to follow the investigational plan or other violations of protocol; in 35 (61%), for inadequate or inaccurate recordkeeping; in 30 (53%), for failure to protect the safety, rights, and welfare of patients or issues with informed consent or institutional review board oversight; and in 20 (35%), for violations not otherwise categorized. Examples of uncategorized violations include cases in which the investigators used experimental compounds in patients not enrolled in trials, delegated tasks to unauthorized personnel, or otherwise failed to supervise clinical investigations properly.

The 57 clinical trials in their study had resulted in 78 articles published in peer-reviewed journals. “Of these 78 articles, only 3 publications (4%) included any mention of the FDA inspection violations despite the fact that for 59 of those 78 articles (76%), the inspection was completed at least 6 months before the article was published.”

This led Seife to conclude in: “Are Your Medications Safe?” that for more than a decade, the FDA has shown a pattern of burying the details of scientific fraud and misconduct. “The agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted.” So no one finds out which data is bogus; “which drugs might be on the market under false pretences.” The FDA has repeatedly hidden evidence of scientific fraud from the public, from its trusted scientific advisors—even as they were attempting to decide whether or not a new drug should be allowed on the market. They even stonewalled a congressional panel investigating a case of fraud regarding a dangerous drug.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate.

Seife’s research and conclusions are disturbing on so many levels. The FDA knows about dozens of scientific papers whose data are questionable, but the agency had said and done NOTHING. Even when itself is “shocked at the degree of fraud and misconduct in a clinical trial.” Seife said the most common excuse given by the FDA is that revealing which drugs’ approval relied upon tainted data, would compromise “confidential commercial information” that could hurt the drug companies if it was revealed. Another excuse is that the FDA doesn’t want to confuse the public by revealing misconduct that in the FDA’s judgment, doesn’t “pose an immediate risk to public health.”

The FDA wants you to take it on faith that its officials have the public’s best interest at heart. Justification through faith alone [sola fide] might be just fine as a religious doctrine, but it’s not a good foundation for ensuring the safety and effectiveness of our drugs.